WOMEN HEALTH CONTRACEPTIONS
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- WOMEN HEALTH CONTRACEPTIONS
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RF_WH_3_PART_2_SUDHA
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focus on contraceptive research
UNFPA
PATH
Volume 4, Number 1/January 1991
Sterilization
Akhter, H.H. et al. The need for prophylactic antibiotics after female sterilization: tetracycline in
Bangladesh. Contraception, Vol. 42, No. 3, September 1990, pp. 297-308.
A study of 1,350 women from rural and urban Bangladesh who were treated with one of two anti
biotics or placebo following minilaparotomy sterilization found that infection rates seven days after
surgery were significantly lower with tetracycline (6%) than with placebo (10%). Infection rates did
not differ significantly between the ampicillin and placebo groups or between the tetracycline and
ampicillin groups. Treatment was for five days, four times each day, with 250 mg tetracycline (453
women), 250 mg ampicillin (449 women), or placebo (448 women): treatment type was unknown to
patients and providers. The authors concluded that although their findings could be used to justify
the current practice in Bangladesh of providing all female sterilization patients with a 5-day course
of tetracycline, a cost analysis of this practice was needed. They recommended that programs focus
on identifying causes of infection and reducing infection rates without the use of antibiotics.
MacLennon, A.H. et al. Post-operative discomfort after ring or clip tubal ligation — is there any
difference and do indomethacin suppositories help? Contraception, Vol. 42, No. 3, September
1990, pp. 309-313.
This randomized study of 95 Australian women whose laparoscopic tubal sterilization involved
either a Falope ring (42 women) or clip (53 women) found no difference between occlusion devices
in immediate postoperative discomfort. Furthermore, there was no difference in postoperative side
effects or analgesic requirement between women who, one hour prior to surgery, were given either
a rectal suppository containing 100 mg of the anti-prostaglandin indomethacin (47 women) or
placebo (48 women). The type of suppository administered was unknown to patients and
practitioners. There was no statistically significant difference between the device groups in analgesic
requirements, side effects, or need for overnight hospital stays. Although a narcotic analgesic was
required by more women who were pretreated with placebo than with indomethacin, there was no
statistically significant difference between treatment groups in overall analgesic requirements. The
authors concluded that (1) immediate postoperative discomfort rates are the same for the two
devices and (2) their results do not substantiate those of a small, case-control study that showed
preoperative use of indomethacin rectal suppositories reduced postoperative pain in Falope ring
sterilization patients.
Yan, J.S. et al. Comparative study of Filshie clip and Pomeroy method for postpartum
sterilization. International Journal of Gynecology and Obstetrics, Vol. 33, No. 3, November 1990,
pp. 263-267.
This prospective comparison of the Filshie clip and the Pomeroy method of sterilization among 200
postpartum women in Taiwan found no difference between groups in perioperative complications
or long-term sequelae up to two years after surgery. Women were randomly assigned to receive
tubal occlusion by Filshie clip (100 women) or the Pomeroy method (100 women). All procedures
were performed by the same physician:The women were evaluated in the postoperative period by a
second physician who did not know which method had been used. One-month follow-up data were
obtained for 85% of women in the Filshie clip group and 86% of women in the Pomeroy method
group. There was no-difference between groups in postoperative pain or complications, which were
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mild and infrequent. Some 96% of women in the Filshie clip group and 97% of women in the
Pomeroy method group completed at least one follow-up visit 6-24 months after surgery. There was
no statistically significant difference between the groups for any of three possible long-term side
effects, including duration of menstrual flow, amount of menstrual flow, or dysmenorrhea. No
complications or complaints related to the procedure were reported by members of either group at
long-term follow-up. The authors concluded that both methods are effective among postpartum
women and have a similar, low complication rate.
Intrauterine Devices
Sivin, I. et al. A randomized trial of the Gyne T380 and Gyne T380 Slimline intrauterine devices.
Contraception, Vol. 42, No. 4, October 1990, pp. 379-389.
This one-year prospective study of 966 women from 5 international centers found no statistically
significant difference in the performance of the Copper T 380A and the Copper T 380A Slimline, a
modified version of the Copper T 380A designed to make loading the device into the inserter tube
easier and to facilitate insertion. Women were randomly assigned to use the Slimline (698 women)
or the standard model (298 women) but were not told which device they had received. At one year,
pregnancy rates were extremely low for both devices: 0.3% for the Slimline and 0.4% for the
standard model. One-year continuation rates also were very similar: 79% for the Slimline and 80%
for the standard model. The difference in termination rates for bleeding and/or pain was not
statistically significant: 7.2% for the Slimline and 9.5% for the standard model. The rate of expulsion
was higher in the Slimline group (5.6%) than in the standard model group (2.6%), but the difference
was not statistically significant. Reports of pain at insertion were the same: approximately 37% of
women from each group reported pain with insertion. There was no statistically significant differ
ence between devices as reported by providers in ease of loading the device into the inserter tube.
Male Hormonal Methods
World Health Organization Task Force on Methods for tire Regulation of Male Fertility. The
Lancet, Vol. 336, No. 8721, October 20,1990, pp. 955-959.
A World Health Organization study of 271 healthy men from 10 centers in 7 countries found that in
a majority of men, weekly injections of 200 mg testosterone enanthate caused azoospermia (absence
of sperm in semen) within 6 months. Among men who achieved azoospermia, weekly injections for
up to 12 months provided safe, effective, and reversible contraception. The study included men age
21-45 with normal sperm analysis and no history of infertility and whose stable partner had no
history of infertility. At six months, the cumulative lifetable rate of azoospermia was 65%. The mean
time to attain azoospermia was 120 days. After achieving azoospermia, some 157 men entered a 12month efficacy phase, during which weekly injections were the only contraceptive used. Only one
pregnancy occurred during the efficacy phase (0.8 pregnancies per 100 person-years). Cumulative
annual discontinuation rates were highest for unachieved azoospermia within 6 months (23%);
personal reasons (13%); medical reasons (12%), primarily acne; and difficulties with the injections
(8%), such as objection to their frequency. Once injections ceased, the mean time to recovery (sperm
concentration of at least 20 million/ml) was 3.7 months. The authors noted that the major
limitations of the regimen were the frequency of injections and inability of the treatment to
uniformly produce azoospermia. A second stage of the study will assess whether treatment with
testosterone enanthate that significantly reduces sperm but does not cause azoospermia can
effectively prevent pregnancy.
r* urrent
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General
Eslami, S.S. et al. The reliability of menses to indicate the return of ovulation in breastfeeding
women in Manila, The Philippines. Studies in Family Planning. Vol. 21, No. 5, September/
October 1990, pp. 243-250.
This prospective study of 40 breastfeeding women in the Philippines showed that for women who
menstruate during the first six months postpartum, first menses was not a good indicator of
resumed ovulation. For these women, about two-thirds (67%) of the menses were anovular and the
mean time from first menses to ovulation was almost 16 weeks. Six months after delivery, however,
less than one-fourth (22%) of the first menses were anovular and the mean time from anovular first
menses to ovulation was a little more than 7 weeks. Menstrual status was determined by weekly
interview and ovulation was detected by hormone assays of daily urine samples. The authors
concluded that in breastfeeding women, the resumption of menses is an inaccurate marker for
returned fertility during the first six months postpartum but is a reliable indicator after six months.
Franks, A.L. et al. Contraception and ectopic pregnancy risk. American Journal of Obstetrics and
Gynecology, Vol. 163, No. 4, Part I, October 1990, pp. 1120-1123.
In this article, investigators calculated incidence rates for ectopic pregnancy associated with various
methods and concluded that incidence rates may be a more accurate reflection of actual risk than
relative risk estimates. Typically, method-related ectopic pregnancy risks are expressed as relative
risk estimates and often are conflicting, due to control group selection bias common to case-control
studies. To calculate incidence rates the authors multiplied the pregnancy rate with each method
(based on perfect use by 1,000 women in the first year of use) by the proportion of ectopic
pregnancies observed with that method in the United States. For the tubal sterilization calculation,
the proportion of pregnancies that are ectopic was derived from literature reviews; for the IUD
calculation, this proportion was derived from two large IUD cohort studies. For combined oral
contraceptives (OCs), barrier methods, and vasectomy it was assumed that the method did not
affect the site of implantation and that ectopic implantation was the same as the overall proportion
among reported pregnancies in the United States. The resulting estimated ectopic pregnancy
incidence rates per 1,000 woman-years varied more than 500-fold: OCs, 0.005; vasectomy, 0.005;
condoms, 0.100; diaphragm, 0.150; tubal sterilization, 0.318; IUD, 1.020; no method, 2.600. The
authors noted that because most of the IUD cohort data pertained to the use of non-medicated IUDs
(which are less effective than currently widely-used copper IUDs), the incidence rate for IUD users
may be overestimated. The authors also estimated incidence rates with typical use: vasectomy,
0.0075; OCs, 0.15; condoms, 0.60; tubal sterilization, 0.64; diaphragm, 0.90; no method, 2.60; IUD,
3.06. Again it should be noted that the IUD pregnancy rate used for this calculation is higher than
the rate associated with copper IUDs in wide use today: actual ectopic incidence rates associated
with no method and with IUD use are believed to be very similar.
Gajanayake, I. and J. Caldwell. Fertility and its control: the puzzle of Sri Lanka. International
Family Planning Perspectives, Vol. 16, No. 3, September 1990, pp. 97-102.
The authors of this article argue that contraceptive prevalence survey data from Sri Lanka support
the theory that discrepancies between fertility and contraceptive use seen in some countries are due
to substantial underreporting of the use of traditional methods, such as rhythm, withdrawal, and
abstinence. Three surveys (1975,1982, and 1987) showed increasing contraceptive prevalence but
little change in fertility. In all three surveys, fertility levels predicted on the basis of reported
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contraceptive use were higher than actual rates. The authors concluded from vital registration,
census, and survey data that former unreported users of traditional methods who later accepted and
reported using sterilization accounted for much of the increase in prevalence between surveys. The
authors note that their findings should remind researchers of the need to carefully tailor survey
instruments to local conditions. The findings also underscore the need to consider that traditional
method use may be underreported in contraceptive prevalence data.
Mosher, W. Contraceptive practice in the United States. Family Planning Perspectives, Vol. 22,
No. 5, September/October 1990, pp. 198-205.
This article describes trends in contraceptive use between 1982 and 1988 among U.S. women overall
and by age, race, ethnic origin, marital status, education, income, and fertility intention. Data were
drawn from the last three cycles of the National Survey of Family Growth (1973,1982, and 1988) and
focused on 1988 data. For each cycle, data were gathered using personal interviews with a
representative sample of about 8,000 women age 15-44. Overall, in 1988 approximately 60% of 57.9
million reproductive-age women were currently practicing contraception. Of the 40% not using
contraceptives, some 7% were at risk of pregnancy but not trying to become pregnant. Between 1982
and 1988 the distribution of contraceptive users changed in several statistically significant ways:
IUD use fell from 7% in 1982 to 2% in 1988; use of female sterilization rose from 23% in 1982 to 28%
in 1988; diaphragm use dropped from 8% in 1982 to 6% in 1988; and condom use rose from 12% in
1982 to nearly 15% in 1988. In 1988, female sterilization was the most prevalent method among evermarried women. Increases in the use of female sterilization were greatest among the formerly
married, the less educated, those with lower incomes, Hispanic, and black women. Overall,
diaphragm use declined and condom use increased most among younger women, never-married
women, and those who intended to have more children. Several possible explanations for the trends
were proposed, including the withdrawal of all but one IUD from the U.S. market in the mid-1980s
and a rising concern about sexually transmitted diseases, including AIDS.
^Abstracts
ISSN: 1012-2680
Current Abstracts is published quarterly. It features abstracts of recent articles on contraceptive methods and products
selected from a large number of publications. Its objective is to keep United Nations Population Fund (UNFPA) Country
Directors and family planning decision makers'up-to-date on current contraceptive research findings and reports. The
abstracts reflect the content of the selected articles and do nbt constitute endorsement by PATH of the conclusions or
methodology. Current Abstracts is funded by,UNFPA.
Program for Appropriate Technology in Health (PATH) and Program for the Introduction and Adaptation of
Contraceptive Technology (PIACT) are nonprofit, international organizations dedicated to improving health, especially
the health of women and children in developing countries. PATH will provide a full copy of any article abstracted in
Current Abstracts to readers on request. Send requests to Current Abstracts, PATH, 4 Nickerson Street, Seattle, Washington
98109-1699, US.A.
© Program for Appropriate Technology in Health (PATH) and Program for the Introduction and Adaptation of
Contraceptive Technology (PIACT) 1991. All rights reserved.
injectables :
immaculate
contraception ?
COUNTER FACT NO. 3
A CED HEALTH CELL FEATURE
"Look after the people and the population
will take care of itself" was the slogan
adopted at the Bucharest conference in
1974, the World Population Year—a slogan
which tacitly admitted that the "population
explosion" was not the cause of poverty
but a symptom of it. Without a back-up
system of improved socio-economic conditions,
it was recognised that the mere availability
of contraceptive facilities could make a
small family possible but not necessarily
MARCH 1983
In the Industrialised World
THE CONSUMPTION EXPLOSION
third world has :■ world's people - 70%
desirable.
Seminars
and slogans
notwithstandings,
well-entrenched
myths
still
flourish and
influence national and international attitudes,
policies and measures adopted to tackle
the population problem. In recent years,
however, the subject of population control
and the use and abuse of contraceptives
has generated increasing popular attention
and controversy, raising a host of relevant
questions and focussing on a number of
vital inter-related issues.
These
include
the
intrinsically unequal
First World — Third World dynamic, the
enormous amounts of aid funnelled from
developed countries to developing countries
through international
agencies,
and the
Western attitude towards what is considered
a "Third World problem" rather than a
consequence of the international economic
order. Also, attention . has been focussed
on the dumping of unsafe contraceptives
by the West on the Third World, and the
use of Third World women as guinea pigs
to test new and untried contraceptives.
Finally, with rapid technological advances,
the contraceptives coming into vogue today
reveal the growing lack of control women,
the world over, possess over their bodies.
Each child born in industrialised world consumes
20 to 40 times as much as child born in developing
world. So small population increase in rich world
puts 8 times as much pressure on world resources
as large population increase in poor world.
...and
IN THE GLOBAL VILLAGE
2000AD
It the world In the year 2000 Is Imagined as a
global village of 100 people, then 68 of these
people will be Aslan,13 will be African, 10 Latin
American, 9 European, 5 North American and
6 Russian.
- 2 -
In this context it is important to differentiate between birth control and
population control. The former is "about people deciding to exercise control
over their own fertility. Population control means that fertility is controlled
by the decisions of outsiders, national govts, religious bodies, international
agencies and, on a limited scale, doctors and social workers..." (1)
The latest "miracle contraceptives" being touted as the best are the injectable
contraceptives (ICs) better known by their brand names Depo Provera and
Norigest. Like all miracles these too need to be examined more carefully.
In January of this year, Dr. Badri Nath Saxena, deputy director general of
the Indian Council for Medical Research (ICMR) announced in press releases
in several national dailies, that a new IC had been successfully tested on
2,600 women in 14 centres around the country. (2) The IC tested was nore
thisterone enanthate or NET-EN which is marketed mainly by the German
multinational Schering and costs between Rs. 27 and Rs. 45 per injection
(according to a report in the Feb. 15 issue of India Today, the ICMR has
been told by the government "that prices can be reduced substantially once
the drug is mass-marketed"). The Institute for Research in Reproduction
(IRR) in Bombay, affiliated to the ICMR, is also conducting further trials
of NET-EN. Unfortunately, even preliminary results are not available to
the public. (3)
In the absence of sufficient information on NET-EN and its research in India,
this issue will discuss ICs in general. It will focus primarily on DP, as this
is the most well-documented IC today. DP has not been officially sanctioned
by the Indian government, but has been used sporadically by private family
planning workers in various parts of the country. The example of DP, as
we shall see later, does raise questions about the use of ICs in general and
will be particularly relevant, once ICs receive the green signal from the
Indian government.
What Are Injectable Contraceptives?
Injectable contraceptives are progestogens — synthetic compounds with the
effects of the natural female hormone progesterone (it prepares the uterus
for the fertilised ovum and maintains pregnancy). Developed in the early
'50s, the first progestogens metabolised quickly, and were effective only
when given in small, frequent doses. Thus in the early '50s when Dr. George
Pincus, an American scientist, and his colleagues experimented with using
these progestogens. for fertility control, they concentrated on developing
oral contraceptives.
In 1953, Dr. Karl Junkman discovered that certain progestogens have longlasting effects when injected. His research group synthesized norethisterone
enanthate (NET-EN), which is produced by Schering AG a West German phar
maceutical company. It is marketed under the brand name Norigest and will
be available for family planning agencies under the brand name Noristerat.
- 3 -
Schering AG began testing Norigest in 1957. Major field trials were conducted
in Peru, but other studies were conducted in Egypt, Europe and elsewhere.
Norigest was first marketed in Peru in 1967 but was withdrawn four years
later because of toxicologic findings in rats. (Since then some researchers
have maintained that the results of trials on rats were not necessarily applic
able to humans). W
At the same time as Schering was experimenting with Norigest, the Upjohn
company in the USA developed Depo Medroxyprogesterone Acetate (DMPA),
which is marketed under the brand name Depo Provera (DP). Upjohn began
clinical trials of DP in 1963 and by the late sixties had begun marketing
it in several countries.
How Do They Work?
Injectable progestogens like Depo Provera and
in four ways :
Norigest prevent pregnancy
a)
by inhibiting ovulation;
b)
by changing the texture of the cervical mucus and making it thicker/'
thus forming a barrier to sperm;
c)
by making the lining of the uterus (endometrium) less suitable for
the implantatjon of fertilized ovum (because the natural hormonal
balance is .altered); and
d)
by decreasing the rate of transport of the ovum through the fallopian
tubes to the uterus.
Depo Provera depends largely on its ability to prevent ovulation; while Norigest
works by thickening cervial mucus, not necessarily by preventing ovulation.
This is probably because the two injectables are derived from different sources:
Depo Provera is derived from a compound structurally similar to progesterone
while Norigest is structurally similar to testosterone (a hormone secreted
by the testes.)
THE CASE OF DEPO PROVERA
Depo Provera is the more widely used of the two injectable contraceptives
(ICs) currently available. A report in the World Health Organization's (WHO).
World Health estimates that it accounts for about 98% of the ICs used in
the world. (5) DP is used in more than 80 countries including France, Sweden,
West Germany and Norway, some of which are countries usually credited
with being particularly vigilant about the safety of drugs. Within the Third
World, DP has been used extensively in Asia, especially in Thailand and Bangla
desh. It has also been an essential component of family planning programmes
in Africa and Latin America.
- 4 In recent years, the use of DP has become highly controversial and campaigns
to restrict and even ban it have sprung up in several countries. The central
issue at stake is the balance between the safety of DP and its benefits.
The Benefits
For a start, injectable contraceptives like DP are highly effective. In Population Reports, a bulletin of the George Washington University Medical Centre,
the authors of "Injectable and Implants" claim that IC's are as effective
in preventing pregnancy as the Pill, and slightly more effective than progestogen-only
"mini pills" and markedly more effective than
Intra-Uterine
Devices (IUDs). When pregnancies do occur, they do so shortly after the
first injection, when the ICs have not yet taken full effect or- just before
the end of the effective period of 3 months. (6)
DP is also easy and quick to administer. All it takes is an injection every
3 months. Besides, in most of the Third World, including India, injections
are considered the best form of medicine. Thus women are by no means
averse to the idea of an I.C. In fact, they even welcome it. Population control
agencies have heavily endorsed the use of DP and other ICs. The International
Planned Parenthood Federation (1PPF) describe ICs as the "most dependable
and useful method of family planning". (7) But what are the medical side
effects?
Side-Effects
The whole issue of DP's side-effects continues to be hotly debated. Two
distinct "camps" have developed. One for and the other against. Those in
favour of DP comprise the drug corporations like Upjohn, population control
agencies like the IPPF, the medical advisory panel of the U.S. Agency for
International Development (USAID), the WHO, the American College of
Obstetrics and Gynaecology and doctors who for years have been using DP
in their family planning programmes. Those against DP include the Washington
based Health Research Group (affiliated to Ralph Nader), the National Women's
Health Network and other health activists and feminist groups.
The main problem, as far as the debate is concerned, is that there have
been very few studies on the long-term effects of DP. In the words of Robert
N. Hoover, Deputy Chief, environmental epidemiology, American National
Cancer Research Institute, "There is essentially no good epidemiological
study of Depo Provera to date".(8) Most of the limited research on DP has
been conducted by the "camp" for DP, and its opponents claim that as a
result, the studies have been biased in favour of the drug. (9) Furthermore,
DP's opponents allege that access to research reports on DP and its side
effects is controlled by DP supporters. (10) This only makes any assessment
of DP's side-effects more difficult.
The
following are some of the side-effects, unearthed by various studies.
1.
MENSTRUAL CHAOS : DP disrupts menstrual patterns of most users.
-5Bleeding problems of varying degrees, from light spotting to heavy bleeding
and even complete absence of bleeding, (amenorrhoea), have been reported.
Nash has reported that "as many as 11 to 30 days with bleeding are seen
in a month in 10 to 35 percent of patients in the first months of use."(11)
Apart from the
inconvenience, increased bleeding can result in or even
exacerbate anaemia in women. (This would be particularly dangerous for
Indian women as most of them are anaemic.) Also, in many countries where
menstruation is considered unclean, there are all kinds of taboos and practices
that separate women from the family during their periods. Thus constant
bleeding becomes a tricky socio-cultural problem.
After about a year of using DP, amenorrhoea becomes a problem. According
to one estimate, amenorrhoea appears in upto 60% of users.'(l,2)Family planning
workers explain that amenorrhoea is not a harmful side-effect :
"We explain that these side-effects are not harmful. Sometimes they
believe us and sometimes they do not listen. The women are always
worried about amenorrhoea and menstrual disorders. They say that
they really have a problem to go on with their activities." (13)
While amenorrhoea is not considered harmful, there is very little in the
medical literature regarding the effects of long-term DP-induced amenorrhoea.
As Toppozada points out :
"Very little is known about the possible risks induced by cycle altera
tions caused by DP...The impact of prolonged amenorrhoea upon the
health of users is poorly understood. What would the cycle alterations
impose upon the state of health among women with endemic diseases
or with metabolic disorders is another unresolved question.... There
is a paucity of information regarding any metabolic disturbances or
hormonal changes related to prolonged amenorrhoea". (14)
Disruption in the menstrual cycle often necessitates the administration of
additional drugs to combat side-effects. Frequently, estrogen is given to
women in order to control the bleeding. Some doctors even use it routinely
with every shot of DP. In her article "Depo-Provera : the extent of the
problems", Jill Rakusen has noted that "whatever the regimes given the use
of DP becomes increasingly questionable when another potent drug with
its own potential side-effects is used to combat those of the first drug,
particularly when : (a) the women concerned had no need of drug treatment
in the first place; and (b) the promoters of the first drug - DP - argue that
it is valuable precisely because it is not considered to be implicated with
the same risks as oral contraceptives containing oestrogen". (15)
2,
INFERTILITY : While the long term effects of DP on fertility have
not been adequately researched, several health workers and researchers
have reported a delayed return to fertility through use of DP. A study quoted
in Population Reports of 144 women who discontinued DP in order to get
pregnant, revealed that the "median time to conception was 13 months from
the assumed end of contraceptive
protection". By comparison, the median
time of conception after discontinuing the use of the IUD or diaphragm is
2 months. (16)
Fertility studies from Chieng Mai, Thailand, the centre of one of the biggest
- 6 DP projects, have shown that "while there is a delay in the return of fertility
among women discontinuing Depo use compared to IUD users, by 24 months
after discontinuation there is no significant difference between the two
groups in the proportion of women who have become pregnant. Unpublished
data from the study suggest that the same is true when Depo users are com
pared to pill users". (17)
As there is not enough research and documentation on the effects of DP
on fertility, several countries and organisations that have endorsed DP have
placed restrictions on its use. For example, the WHO and the IPPF have
advised that women who have not yet completed their families should not
be given DP. (18)
3.
CANCER :
a)
Breast Cancer : A seven year beagle study sponsored by the Upjohn company
itself first raised alarms about potential breast cancer risk. It was found
that beagles given a high dose of DP developed breast tumours. Subsequently
these results were dismissed by DP's promoters who argued that (1) The
beagle studies were of no relevance to humans because the dogs were given
high doses of DP not comparable to those given to women and (2) beagles
are an inappropriate species for comparison with humans, because they are
known to be susceptible to certain progestogens and to mammary tumours.
It is true that beagles are especially susceptible to mammary tumours.(19)
But, as the Health Research Group has pointed out, "if no problems were
shown up in these beagle studies, few would be arguing that the animals
used were inappropriate".(20)Based on the beagle studies, the American Federal
Drug Administration (FDA) withdrew its approval in 1970 of "Provest", a
contraceptive pill marketed by Upjohn containing the same hormone, DMPA,
as DP. Yet curiously the drug in its injectable form was not banned in the
U.S. till 1978.(21)
Much of the research on breast cancer and DP is not freely available. How
ever, even Upjohn concluded in 1973 that more research was necessary before
ruling out the risk of breast cancer. (22) The beagle study has been repeated
by Upjohn and its results have probably been released to the FDA, which
is currently reviewing its ban on DP in the U.S. (23)
b)
Cervical cancer : There is some evidence that DP users face a higher
risk of cervical cancer than non-users.
Upjohn conducted'
a study on the incidence of cervical cancer among DPusers. When this was compared to the findings of the American Third National
Cancer Survey, it was found that the cervical cancer rate among DP-users
was three to nine times higher than that of the general population recorded
in the National Cancer Survey. DP supporters criticized the above finding,
arguing that the incidence of cervical cancer in the general population is
often under-reported, because unlike DP-users, they do not undergo regular
cervical smear tests to check for cancer (DP-users are generally advised
to check regularly for cervical cancer by taking smear tests).
- 7 -
However, Anita Johnson of the Health Research Group claims that Powell,
a scientist who conducted the original Upjohn studies on cervical cancer,
compared the incidence of cervical cancer in DP-users and the "general
population" in his hospital and although he had screened the letter for cancer,
he still found a higher incidence among DP-users. (24)
c)
Endometrial Cancer (cancer of the lining of the uterus) : In 1978, Upjohn
released a 10-year study on 52 rhesus monkeys that had been divided into
four treatment groups :
i)
16 monkeys given DP doses 50 times the amount given to humans
ii)
16 monkeys given DP doses 10 times that given to humans
iii)
4 monkeys given the same doses as that given to humans
iv)
16 monkeys given no DP at all - the control group.
After 10 years, 2 of the monkeys in group (i) had endometrical cancer. How
ever the authors of a booklet that campaigns for a ban on DP have written:
"A less widely circulated critique of the monkey studies has revealed
that two years after the project began, the animals in the group recei
ving mid and high doses of the drug had abnormally protruding clito
rises. Three out of the sixteen monkeys in the high dose group were
dead (N.B. not from cancer), compared to one which died in the control
group. These 3 monkeys in the high dose group were replaced with
fresh monkeys more than a year and a half after the start of the
experiment". (25)
As in the case of the beagle studies, there has been much dispute on the
question of using monkeys to assess cancer risk in humans. Upjohn (as also
the WHO) has criticized its own monkey studies asserting that monkeys'
reaction to progestogens differs from women's reactions.
4.
FOETAL ABNORMALITY : Certain progestogens when given in large
doses causes masculinisation of external genetalia of female foetuses. No
such effect has been reported in humans with doses of DP as high as 400
mg or with Norigest, although large doses of DP has caused masculinsation
in rat and rabbit foetuses.(26)
In their article in the May 1982 issue of WHO's magazine World Health,
Hall and Hoick have written that "it appears that physical growth and develop
ment (of children of DP-users) proceed normally at least upto 13 years of
age". They have also noted that "a limited amount of information suggests
that there is nd increase in the incidence of congenital abnormalities among
children exposed in utero to contraceptive doses of Depo or NET-EN".(27)
At the same time, Hall and Hoick have stressed the need for more long
term research.
5.
EFFECT ON LACTATION : There is apparently no effect on children
exposed to DP or NET-EN via breast milk, although the drugs and their
bi-products can be found in breast milk. (28)
6.
OTHER SIDE EFFECTS : These include
headache, backache, abdominal
- 8 -
discomfort, nervousness, dizziness,
gain, nausea, fatigue and diarrhoea.
depression,
decreased
libido,
weight
What emerges from this brief discussion of DP's side-effects is that there
is considerable uncertainty and dispute about the safety of the drug. In the
cases of cancer and infertility, in particular, no definitive
claims can be
made either for or against DP. Perhaps the current information regarding
the safety of DP is best summed up in the WHO's report on the drug:
"...Studies thus far have not shown any serious short or long-term effects
of DMPA or NET-EN. However, both DMPA and NET-EN have been used
for a relatively short period of time, and the potential long-term effects
(more than 15 years) are not known. With regard to metabolic effects the
areas in which research should continue are on the effects and physiological
consequences of long-term use of DMPA and NET-EN on carbohydrate and
lipid metabolism. In addition further research is needed regarding the risk
of neoplasia among women using DMPA or NET-EN. Finally, the effects
on the later development of infants who are exposed to DMPA or NETEN in utero or through breast milk are not known. Research should continue
in these areas..."(29) (N.B : lipids are fats and fat-like substances in the
body; neoplasia are any tumours).
However, the same report concludes that DMPA or NET-EN "appear to
be acceptable methods of fertility regulation. Clinical evidence from more
than 15 years of use as contraceptive agents shows no additional and possible
fewer adverse effects than those found with other hormonal methods of
contraception..." (30) It also adds that the high effectivity and the reversi
bility of the two injectables makes them particularly advantageous for
fertility regulation.
This view is held by countless others also who argue that virtually all contra
ceptives have side-effects and that ICs are "the best of the bad lot". Many
also assert that in nations where thousands of women die every year at
childbirth or because of unwanted pregnancies, it is absurd to condemn
ICs like DP on the grounds of an unproven cancer risk that at most will
affect a handful of women.
These and other arguments advanced for the use of ICs will be discussed
in the final section of this issue. But first, let us take a look at what is
perhaps the most dangerous "side-effect" of ICs like DP - their misuse,
by those who are in a hurry to achieve their population control "targets".
Injectable Contraceptives & Social Control.
The problems connected with ICs go far deeper than an awareness of their
medical side-effects. As we shall see in this section, the potential for abuse
of ICs is a particularly nasty "side-effect" and one that has already surfaced
in countries where DP has been used.
In her article in Women, Health and Reproduction, Helen Roberts has noted
- 9 -
that there are several interest groups in the birth control empire, the least
powerful of which are the women using contraceptives.(31)A major disadvantage
of ICs is that they take fertility control out of women's hands and into the
hands of the medical profession, social workers and population control agencies.
The participation of women in regulating their own fertility is limited to
being passive recipients of an injection.
This is particularly dangerous, because in most of the Third World, including
India, injections are considered to be the best form of medicine. Injections
are increasingly seen as the panacea for all ills. Thus there will be little
difficulty in promoting the belief that because contraceptives like DP and
Norigest are injectable, they must be good.
Considering these facts, it is not surprising that population control proponents
have been most enthusiastic about ICs. The IPPF, a major distributor of
DP, has been one of the most vocal promoters of the drug.(32)
Besides, injectables are good business. According to market analyst Arnold
Snider of Kidder Peabody and Co. in New York, the value of DP sales has
already reached about $25 million. He has said that "oral and injectable
methods have an incredible profit margin" and that they are "among the
most profitable of all pharmaceuticals". (33) Without question, the biggest
market potential for contraceptives is in the Third World. There is already
evidence that drug corporations like Upjohn have been aggressively marketing
ICs abroad. Rakusen writes :
"In a deposition unearthed by Minken (1979), the manufacturers of
DP admitted paying $ 2,710,000 in bribes to employees of foreign
governments and to their intermediaries for the purpose of obtaining
sales to government agencies. Bribes to hospital employees raised
this total to $ 4,098,000, and further $ 147,579 was paid out 'in connec
tion with foreign governmental actions related to the company's busi
ness'. Upjohn's deposition specifically notes that the above figures
exclude 'small amounts which were paid to minor government employees
to expedite governmental services'. (34)
Supporters of DP often claim that it is very easily accepted by women who
want contraception. They argue that women eagerly choose DP. But as we
have seen above, there are several powerful interests actively and aggressively
promoting DP and this must be remembered when discussing "free choice"
and DP's high acceptability. Moveover, various studies have shown that women's
"choice" of contraceptives is largely determined by those responsible for
giving out contraception. In Studies in Family Planning the results of WHOsponsored research on women's choice of contraceptive methods revealed
that "in India and Korea, 68% of women choosing Depo-Provera said that
the individual providing the balanced presentation was the most important
person influencing their choice."(35)
On the question of choice and informed consent, already several abuses have
been reported in countries where DP has been used. Bonnie Mass cites the
- 10 case of a Black woman in the U.S. who was threatened with the loss of her
social security money if she did not accept the drug. Further, a young girl
from Scotland was given DP under the guise of a glucose injection and finally
there is the case reported by the campaign against DP of, a young Black
girl in London who was given an injection of DP without her knowledge,
while she was under a general anaesthetic having an abortion. (36)
Of the women whose consent is obtained, it is doubtful whether they are
given the full details of possible side-effects. Again in Britain, there have
been several cases of Asian women who were not told about side-effects
such as bleeding.
It is certainly not fanciful to suggest that such abuses of ICs might well
occur in India. Already there have been instances of abuse of other contra
ceptives. In a recent conference on sexism in the Indian health care system,
several delegates reported that IUDs have been inserted without the co'nsent
of women who were undergoing abortions. Then why single out ICs for attack?
Obviously the misuse of any method of contraception, and denying women
the right to free choice, is totally unacceptable. We should certainly press
for a close monitoring of all birth control methods currently in use. But
a particularly disconcerting feature of the injectable method is the ease
and speed with which it can be administered (this is often cited as a benefit
of DP), and thus misused by population control agencies and the state, even
if this endangers women's health. All of this indicates that while ICs seem
to be the "best of the bad lot" compared to other contraceptives, the potential
for misuse is also the greatest.
It may also be true that our maternal mortality rate, outweighs the possible
cancer risk due to the use of ICs. But, surely we should be pressing for im
provements in our health care system, instead of introducing a drug about
which several questions remain.
Another strong case for injectables is that put forth by Dr. Hari John, a
well-known figure in the community health field in India :
"DP is the most popular choice that women in South India make. Women
in South India choose DP because they are totally deprived, and have
no say in any aspect of their lives ... if they want contraception their
husband accuses them of wanting extra-marital sex. Most forms of
contraception are very difficult to hide, and DP is the only one their
husbands won't know about. Using DP is the only way these women
can have control over any aspect of their lives." (37)
Dr. John has pointed out a very real problem faced by millions of Indian
women today. No doubt at first glance injectables seem to be the perfect
answer — at least in the short-term. But in the long-term, this solution does
nothing to question the real problem underlying the attitudes she discusses :
the unequal relationships between women and men in our country. And in
fact by failing to challenge these relationships, ICs used under the conditions
she describes might even buttress the sexist status quo.
- 11 From this discussion, it is clear that ICs are not the "miracle contraceptives"
somfe people would have us believe. And focussing on the medical side-effects,
as yet shrouded in controversy, can distract our attention from some important
questions that remain unanswered. Should we be developing methods that
are easier, faster and more convenient for those whose main interest is to
control the swelling numbers of the Third World? Or should we be developing
new techniques that are safe and involve women in controlling their own
fertility? Why is there so little research on the safer barrier methods of
contraception, such as the diaphragm and the cervical cap? And why is all
contraceptive research directed at women, though it is men who are more
sexually dominant? Are women alone condemned to accepting full respon
sibility for contraception?
Instead of blithely accepting any new contraceptive method developed in
the West, it is time population control proponents stopped to confront some
of these issues.
-12-
NORIGEST AND DEPO PROVERA
Norigest
Depo Provera
1.
Derived from compound structu
rally similar
to testosterone
1.
Derived from compound similar
to progesterone.
2.
200 mg given at 84-day
vals.
inter
2.
150 mg given at 90-day
vals.
3.
Works
largely
by altering
nature of cervical mucus
3.
Works
largely
ovulation.
4.
Pregnancy
rate higher
than DP *
4.
5.
Some evidence that it disturbs
menstrual patterns less than DP. *
5.
6.
After
discontinuation,
return
to fertility quicker (3-6 months
after
discontinuation)
than
in DP's case. *
6.
Lower
pregnancy rate than
Norigest. * ‘
Causes considerable disruption
of menstrual patterns - more
than Norigest. *
After
discontinuation,
return
to fertility slow (13 months
after
discontinuation)
than
in Norigest's case. *
From Population Reports, Series K, Number 1, March 1975.
by
inter
inhibiting
- 13 -
References
(01)
Campaign Against Depo-Provera, "Depo Provera", p. .39.
(02)
India Today, Feb. 15 issue, p. 79-81.
(03)
When we visited the IRR, we were told that no information on NETEN could be released.
(04)
"Injectables and Implants",
March 1975, K-2.
(05)
Hall, Peter E. and Hoick, Susan E., "Injectable Contraception" in World
Health, May 1982, p. 2.
(06)
Population Reports, Op. cit., K-3-K-4.
(07)
"Factsheets" on Depo Provera, International Planned Parenthood Federa
tion (1978), as quoted by Jill Rakusen, "Depo-Provera : the extent
of the problem", in Women's Health & Reproduction (ed) Helen Roberts,
Routledge <5c Kegan Paul, London, 1981.
(08)
Sun, Marjorie, "Depo-Provera" Debate Revs Up at FDA" in Science,
Vol. 217, 30 July 1982, p. 426.
(09)
Rakusen, Jill, "Depo-Provera : the extent of the problem” in Women,
Health & Reproduction, (ed) Helen Roberts, Routledge & Kegan Paul,
London, 1981, p. 83.
(10)
Ibid., p. 94.
(11)
Nash, H.A., "Depo-Provera No. 4, p. 377-93.
(12)
Benson Gold, Rachel and Willson, Peter D., "Depo-Provera : New Devel
opments in a Decade
Old Controversy" in International Family Planning
Perspectives, Vo. 6, No. 4, Dec. 1980, p. 158.
(13)
Ali, Azam, Hussain, Zahid and Cohen, Nicholas "Results following
the uses of Depo-Provera injection in the River Project", Save the
Children Fund (UK) in Bangladesh, p. 4.
(14)
Toppozada, M, evidence to U.S. Select Committee on population House
of Representatives, as quoted in Rakusen, Op. cit., p. 88.
(15)
Rakusen, Op. cit. p. 88.
(16)
Population Reports, Op. cit., K-8.
(17)
Benson Gold, Rachel and Willson, Peters D., Op. cit., p. 157.
Population Reports, Series K,
'—————
a
Review" in
Number
Contraception,
Vol.
1,
12,
- 14 -
(18)
Population Reports, Op. cit., K-12 ;
Hadley, Janet, "The contraceptive injection some things you should
know about it", leaflet issued by the Campaign Against Depo-Provera,
p. 8.
(19)
Rakusen, Op. cit., p. 93.
(20)
Ibid.
(21)
Campaign against Depo-Provera, Op. cit., p. 8.
(22)
Rakusen, Op. cit., p. 94.
(23)
Newsweek, January, 24th 1983, p. 44.
(24)
Campaign Against Depo-Provera, Op. cit., p. 9.
(25)
Campaign Against Depo-Provera, Op. cit., p. 10.
(26)
Population Reports, Op. cit., p. K-9.
(27)
Hall and Hoick, Op. cit., p. 3-4; My brackets.
(28)
Ibid; Population Reports, Op. cit., p. K-12.
(29)
Hall and Hoick, Op. cit., p. 4.
(30)
Ibid., p. 4.
(31)
Roberts, Helen, "Male hegemony in family planning" in Women, Health &
Reproduction, (ed) Helen Roberts, Routledge & Kegan Paul, London, 1981.
(32)
See note (7)
(33)
Sun, Op. cit., p. 428.
(34)
Rakusen, Op. cit., p. 78.
(35)
"User
Preferences for Contraceptive Methods in India, Korea, the
Philippines, and Turkey" in Studies in Family Planning, Vol. 11., No. 9/10,
September/October 1980, p. 271.
(36)
Rakusen, Op. cit., p. 80-84.
(37)
Smith, Carol, "Depo-Provera, control of fertility - two feminist views."
in Spare Rib, No. 116, March 1982, p. 51.
- 15 -
ABOUT CED
The Centre for Education & Documentation (CED) is an independant non
profit organisation involved in research-cum-action oriented programmes,
catering to the need of scholars, professionals, students, development workers
and other concerned individuals.
Established in 1978, and registered under the Societies and Public Trusts
Acts, the CED collects, collates researches and disseminates information
on a wide range of subjects of social importance.
Besides conducting and initiating independent studies, the CED organises
seminars and workshops on related topics and houses a library of books and
a collection of clippings from a wide spectrum of newspapers, magazines,
journals, both from India and abroad.
Above all, the CED provides a focal point for like-minded individuals and
groups to interact with one another in order to relate theory to experience
and action, in their respective areas of involvement.
THE CED HEALTH CELL specialises in documentation and dissemination
of information concerned with health issues. It is in touch with other similar
groups in various parts of the country.
Our address
:
Centre for Education & Documentation,
3, Suleman Chambers,
4 Battery Street,
Behind Regal Cinema,
Tel : 220019
Bombay 400 039.
(Open 11.00 a.m. to 7.00 p.m. on weekdays. Fridays 11.00 a.m. to 2.00 p.m.)
WH -3-48
BAN INJECTABLE CONTRACEPTIVES ~
INDIAN WOMEN DESERVE A BETTER DEAL
A campaign group has been formed in Bombay to, protest
against the Drug-controller of India approving NET-EN as a
contraceptive. Tiro companies - UNICHEM and GERMAN
REMEDIES - have been given licences to manufacture this
drug.
Today's protest demonstration in front of Oberoi Towers,
where tho Family Planning Association is holding a closed
door conference of 'experts' on NET-EN. Ue plan to continue
with the campaign and expand it to include all longacting contraceptives.
What are Injectable Contraceptives? Injectable Contracept-.
ives ( I c) prevent pregnancy more or less in the same way
as oral contraceptives. But they are adminis t er ed by
in j oct ion and are
*
citing
The beat-known ones are
Depo-provera and NET-EN
Depo needs only one injection
every 3 months and nET-EN. cno every 2 months.
population control enthusiasts consider injeatables
tho ideal form of contraception for woaen in the thirdworld because of the ease with which tliex can be administered.
on a mass -scale and the low failure rate. To those who
Look at women in the third world as nothing but faceloss
factors to be considered in any strategx of population
control thox cook up, the benefits seem overwhelming and
the 'r.-.sks' in terms of women's health negligible. There
has been a concerted campaign lately to 'sell' the idea
of I C's through tho media and elsewhere. The conference
organised by the Family Planning Association on 28th and 29th
December 1984 at Oboroi, is part of this 'marketing
strategy’.
Depo-provera and NET-EN -the controversial contraceptives. ..
Depo-provera has been thp centre of a fight- between
Health groups and women's groups on the one side and
Pharmaceutical companies on the other since the sixties,
when tho Upjohn Co. of USA sought approval for it in the
sixties,' Upjohn has fought a hard and long battle in the
U S unsnodessfully« They desperately wanted approval
before their exclusive rights on the drug expired. The
campaign in tho U S and elsewhere brought Depo-provera a
'bad name'. Approval for its manufacture has not been given
by the Drug-controller of India. But neither has any
explanation been iven to the public or to interested
groups^ about why it has not been approved.
Meanwhile,
■NET-EN another I C about which not much is known has been
approved in India and licence to manufacture it has been
granted to two companies - Unichon and Gorban Remedies.
Both Depo-provera and NET-EN have been used in India
for several years now for research purposes. This research
has been carried out maily on poor women by voluntary
agencies who conduct community health programmes, under tho
supervision of the Indian Council of Medical Research. The
reports of the studies have not been published till today
2
and ICKR has refused to make it available to anyone. All
interested parties arc supposed to take their word for it
that while Depo is not so good, NET-EN is just fine. Past
experience with contraceptives and other drugs does not
inspire in us any such trust or'confidence, We believe
that we have a right to know the details of the research
studies, to make our own investigations and to come to our
own conclusions. We do not consider the masses of women
mere pawns in population control strategics to whom cont
raceptives are 'sold' on the basis of incentives- without
prior information.
What we do know about ICs is quite disturbing. Upjohn
Co., conducted two animal safety studies in the sixties a seven year one on. beagle dogs and a ton year one on
monkeys. Within three and a half years of the dog study,
all dogs on high doses and half on low doses were dead due
to inflamation of uterine lining.
(The two on low doses
who survived had their uteruses removed.) All control
dogs end survived except ono which died of bite wounds
and four which were sacrificed by the researchers. The
dogs also developed cancer of the breasts, drug-induced
diabetes and various other problems. At this point, Upjohn
declared that beagle dogs were not the ideal animals to
judge risks to hinan females. Later even the monkey
studies in which cancer of tie uterus occured were said to
be 'irrelevant to human experience1. Ths history of this
controversy has been marked with disinformation and a
desparate desire on the part of the company to maximise
profits without making sure first that the drug is safe.
Breast cancer, two types of uterine cancer, serious
menstrual disturbances^ and masculinisation of female foetuses
are some of the serious effects of Depo—provera, Others are
depression, decreased libido, nausea, dissiness,(weight
gain without any increase in nutrition)etc.
The W H 0 report on I Cs (1982) says that, the
majority of women on I Cs have their menstrual cycle dis
rupted, The extent of disruption is stunning.
"loss than
one third of women on Depo report having any normal
menstrual cycle during the first year of usage1 and
'approximately half the users ( of NET-EN) reported at:
least one normal menstrual cycle during the first year'.
Both the above quotes from the W H 0 report are examples of
the concerted attempt to underplay the dangers of I Cs, In
fact, a significant number of women stop having their
periods only to have severe bleeding aftei' injections are
withdrawn while others bleed every day of the month while
on the drug. But everyone concerned seems to feel that:
it is a minor side-effect. For Indian women who hold the
world record for anemia, it is a very very significant
side effect.
There is far less information available about NBT-EN
on human metabolism, on infants exposed to them through
breast-milk or about their carcinogenic properties. No
one seems to know why the majority of women on these
drugs suffer from menstrual chaos. No do they know why
these women put on weight without more nutrition or why
they are depressed.
3
Yet the advocates of I Cs, including the W H 0, consider
them an ideal form of contraception. Their favourite
phrase is risk-benefit ratio. According to them if the
benefit outweighs risk, the drug should be used.
Biit the risks are taken only by women. The benefits are
mair.tyh f or the pharmaceutical companies, the population
control experts and the Governments of third world countries.
There is a lot that is wrong, with cur family planning
p-aiici.es. Its always our families and their plans. A
beginning must be made somewhere to correct therji. Lets
start with the newest strategy which, is about to be imposed..
on the masses of Indian women. Lets struggle against the
inundation of this country with ICS.
OUS; DEMANDS:
;) Ban all long-acting contraceptives and
withdraw approval for NET-EN.
2)
Make public all studies in India an Depo and NET-3N.
immediately.
3)
Stop experimenting on third world women with hazardous
drugs and contraceptives.
i)
Institute a public enquiry on the controversial
■Injectable and implanted contraceptives.
UO-'T US IN OUR STRUGGLE FOR A BETTER DEAL FOR OUR WOMEN.
Campaign group against long-acting contrqctp'tXyes ♦
1,
Forum Against Oppression Of Women.
2)
Women’s Centre, Bombay.
3)
Medico-friends' Circle.
4-)
Stree Mukti Sanghatna
5)
Sangharsh Vahini.
COMMUNITY
(Turrent
y\bstracts
focus on contraceptive research
CEU
47/1,(FJrstFloor)St. Marks Boa
*
8ANGAL0BE - 560 001
UNFPA
PATH
Volume 3, Number 2/April 1990
Oral Contraceptives
Vessey, MT. et al. Mortality among oral contraceptive users: 20 year follow-up of women in a
cohort study. British Medical Journal, Vol. 299, No. 6714, December 16,1989, pp. 1487-1491.
This British cohort study involving 17,032 women who were followed up annually for an average of
almost 16 years found no overall effect of oral contraceptive (OC) use on mortality. Women entered
the study from 1968-1974 when they were age 25-39 and using either OCs, a diaphragm, or an IUD.
The overall relative risk of death among OC users compared with diaphragm/IUD users was 0.9.
Although the number of deaths in specific disease categories was small, trends were generally consis
tent with other reports, with relative risks for OC users compared with diaphragm/IUD users as
follows: cervical cancer, 4.9; ischemic heart disease, 3.3; ovarian cancer, 0.4; breast cancer, 0.9. The
value for breast cancer may have been affected by the fact that few women in this study began using
OCs before age 20. The relative risk of circulatory disease among OC users was 1.5, while the
corresponding relative risk from a large 1981 British cohort study of long-term OC use was 4.2. While
these results support the view that the risk reported in 1981 may have been overestimated, women in
this study showed a low overall mortality and thus may not represent the general population.
Wolner-Hanssen, P. et al. Decreased risk of symptomatic chlamydial pelvic inflammatory disease
associated with oral contraceptive use. Journal of the American Medical Association, Vol. 263,
No. 1, January 5,1990, pp. 54-59.
This U.S. case-control study investigated the relationship between OC use and pelvic inflammatory
disease (PID) and found that, among women already infected with C. trachomatis, OC users were at
decreased risk of symptomatic PID compared with non-users. Study cases were 141 women with
verified PID and controls were 739 randomly selected, sexually active women with no clinical
evidence of PID. Overall, cases were significantly less likely to have used OCs than controls (odds
ratio, 0.50). The negative association between OC use and PID was stronger when women infected
with only C. trachomatis were considered separately. Among these women, the odds ratio between
OC use and PID when compared with non-use of OCs was 0.22 and when compared with use of no
contraceptive method was 0.17. In general, these associations remained the same when analyses were
adjusted for potentially confounding variables including age, race, etc. In contrast to two earlier
studies, no association was found between use of OCs and PID among women infected with only
N. gonorrhoeas.
Sterilization
Koetsawang, S. et al. Long-term follow-up of laparoscopic sterilizations by electrocoagulation, the
Hulka clip, and the tubal ring. Contraception. Vol. 41, No. 1, January 1990, pp. 9-18.
This study examining the long-term effects of female voluntary surgical contraception (VSC) found a
cumulative eight-year pregnancy rate of 1.5%, with pregnancies occurring as late as seven years after
the procedure; 75% of the pregnancies were ectopic. The study also found that the need for
hysterectomy among VSC acceptors was unrelated to VSC or to tubal occlusion technique. Some 70%
of women who had VSC at least 42 days after delivery at a Bangkok hospital from 1973-1976 returned
for follow-up 4-12 years after the procedure. Of these 499 women, 42% had had electrocoagulation,
(Current
Zxbstracts
APrU i»o
•
37% had used a Hulka clip, and 21% had used a tubal ring. Four pregnancies were confirmed, all
occurring between two and seven years following VSC: three ectopic pregnancies in the
electrocoagulation group and one uterine pregnancy in the Hulka clip group (no pregnancies
occurred in the tubal ring group). Because pregnancies occurred as late as seven years following
VSC, the authors concluded that short-term failure rates for female VSC probably do not represent
actual failure rates. Other conditions often thought to be sequelae of VSC, including adnexal
masses, pelvic infection, and various conditions requiring hysterectomy, could not be linked to VSC
or to the use of a specific occlusion technique.
Long-acting Progestins
Klavon, S.L. and G.S. Grubb. Insertion site complications during the first year of NORPLANT®
use. Contraception, Vol. 41, No. 1, January 1990, pp. 27-37.
First-year clinical trial data on insertion site complications among 2,674 NORPLANT® acceptors in
seven countries showed that infection and expulsion rates were low, but that a substantial
proportion of insertion-related complications occurred after the first two months of use.
Complication rates varied widely among countries and between clinics within a country. At one
year, complication rates were: insertion site infection, 0.8%; expulsion, 0.4%; local reaction, 4.7%.
While most complications occurred within 60 days of insertion, some 35% of insertion site infections
and 64% of expulsions occurred after 60 days; about two-thirds of these infections and expulsions
were among women without insertion site complications during the first 60 days. Possible causes of
later infection were (1) trauma to the insertion site causing it to open or (2) change in the
immunologic environment of the implants. The authors recommended that implants be removed
when infection occurs: of 16 women with infections who did not have the implants removed
immediately, half eventually had them removed.
A
Paul, C. et al. Depot medroxyprogesterone (Depo-Provera) and risk of breast cancer. British
Medical Journal, Vol. 299, September 23,1989, pp. 759-762.
This New Zealand population-based case-control study found no overall increase in risk of breast
cancer with use of the three-month injectable contraceptive Depo-Provera (DMPA), but found
increased risks in users who: (1) were diagnosed with breast cancer before age 35, (2) had used
DMPA for at least two years before age 25, and (3) had used it recently. Cases consisted of 891
women age 25-54 with recently diagnosed breast cancer selected from the National Cancer Registry;
controls consisted of 1,864 women randomly selected from electoral rolls and matched to cases by
age. DMPA had been used by 12.3% of cases and 13.5% of controls. The relative risk of breast
cancer (adjusted for confounding variables) with any duration of use was 1.0. In women age 25-34,
the relative risk was 2.0. For women who first used DMPA before age 25, the relative risk was 1.5.
In both groups, risk was higher in those who used DMPA for six years or longer. The relative risk
for women who last used DMPA within five years was 1.6; the highest relative risk in these women
was associated with the shortest duration of use. For all categories of duration of use, risk declined
with increasing time since last use. The authors determined that a possible explanation for this
finding is that DMPA increases the risk of breast cancer only during the first few years after
exposure, suggesting that it may act as a promoter during late stages of carcinogenesis. The authors
commented that these results could be interpreted to mean that DMPA has an initial harmful effect, followed by a protective effect, and noted the need for additional research to clarify the findings.
f)
A
fTurrent
ZTbstracts
April 1990
World Health Organization (WHO) Task Force on Long-Acting Systemic Agents for Fertility
Regulation. Microdose intravaginal levonorgestrel contraception: a multicentre clinical trial:
I. Contraceptive efficacy and side effects; II. Expulsions and removals; III. The relationship
between pregnancy rate and body weight; IV. Bleeding patterns. Contraception, Vol. 41, No. 2,
February 1990, pp. 105-167.
The results of a large WHO multicenter clinical trial of the levonorgestrel-releasing vaginal ring
showed that: (1) the ring, which releases 20 mcg levonorgestrel per day and is used for 90 days, was
an effective and safe contraceptive for at least one year; (2) expulsions occurred frequently but did
not necessarily lead to discontinuation; (3) pregnancy rates increased with increasing body weight;
and (4) ring use disrupted menstrual bleeding patterns in about half of all users. The study,
conducted from 1980-1986, involved 1,005 women at 19 centers in 13 countries, including 9
developing countries. The one-year life-table pregnancy rate with the ring in place was 3.7%. The
12-month discontinuation rate for all reasons was 50%; principal reasons for discontinuation were
bleeding disturbances (17%), expulsions (7%), and vaginal symptoms (6%) (including discharge,
irritation, or infection). The 12-month first expulsion rate was 29%; some 57% of first expulsions
occurred with defecation. Weight was positively correlated with risk of pregnancy, with pregnancy
rates ranging from 1.7% for 40 kg women to 9.8% for 80 kg women. Daily menstrual diaries kept by
70% of the women showed that approximately half experienced bleeding irregularities; of these,
25% experienced irregular bleeding, 10% had prolonged cycles, 10% had shortened cycles, and only
a few experienced amenorrhea or continuous prolonged bleeding.
Intrauterine Devices
Sivin, I. IUDs are contraceptives, not abortifacients: a comment on research and belief. Studies
in Family Planning, Vol. 20, No. 6, November/December 1989, pp. 355-359.
The author argues that studies on the mechanisms by which IUDs prevent pregnancy clearly
demonstrate that IUDs are contraceptives and not abortifacients: IUDs appear to act primarily by
interfering with fertilization. Sensitive assays to detect human chorionic gonadotropin, an early
indicator of pregnancy, have been used to look for signs of early abortion among IUD users and
have shown that IUD users experience the same or lower rates of embryonic loss as noncontraceptors. Microscopic searches for eggs in the Fallopian tubes and uteri of IUD users have
shown that fertilization is rare with IUD use. In one case-control study, uterine searches found
fertilized eggs in only 1.5% of attempts in IUD users, compared with 22% of attempts in non-users.
Several studies have shown that IUD use reduces both the number of sperm that reach the oviduct
and their fertilization capacity. Two large studies found a significantly lower incidence of ectopic
pregnancy among IUD users than among non-contraceptors—further evidence that IUDs exert a
contraceptive effect outside the uterus.
Pregnancy Termination
Harris, B.M.L. et al. Risk of cancer of the breast after legal abortion during first trimester: a
Swedish register study. British Medical Journal, Vol. 299, No. 3, December 1989, pp. 1430-1432.
In contrast to most previous reports, this prospective Swedish study found no overall increase in
risk of breast cancer in young women after a first trimester induced abortion. The study cohort
’urrent
Lbstracts
April 1990
consisted of 49,000 Swedish women who underwent legal first trimester abortion before age 30 from
1966-1974. The women were followed using the Swedish cancer register to identify cases of breast
cancer diagnosed more than five years after abortion. A comparison of observed cases of breast
cancer (65) with expected cases of breast cancer (84.5) yielded a relative risk of 0.77. Women who
were parous at the time of abortion had a significantly lower relative risk (0.58) than women who
were nulliparous at the time of abortion (1.09). Whether this difference was due to the post
ponement of a first birth among the nulliparous women or to a differing effect of early pregnancy
termination could not be determined from the data. The authors noted that confounding factors
such as smoking and family history of cancer were not considered in this or previously reported
studies.
Silvestre, L. et al. Voluntary interruption of pregnancy with mifepristone (RU 486) and a
prostaglandin analogue: a large-scale French experience. The New England Journal of Medicine,
Vol. 322, No. 10, March 8,1990, pp. 645-648.
This study of 2,115 French women who terminated pregnancies using mifepristone (RU 486) plus a
prostaglandin analogue found that the drug combination, as administered in France, is safe and
effective for terminating early pregnancy. Only pregnancies of 49 days amenorrhea or less were
included in the analysis. The drug regimen involved administration of a 600 mg oral dose of
mifepristone followed 36-48 hours later by vaginal or intramuscular administration of a
prostaglandin analogue. The overall effectiveness rate was 96%; pregnancies continued in 1.0% of
the women and incomplete abortions occurred in 2.1%. In the remaining 0.9% of treatment failures,
a vacuum aspiration or dilation and curettage procedure was used to complete pregnancy
termination because of excessive uterine bleeding: one of these women required a blood
transfusion. A vacuum aspiration or dilation and curettage procedure also was used to complete
pregnancy termination in the other cases of treatment failure. Side effects, primarily abdominal
pain and gastrointestinal complaints, were generally mild and concentrated in the 24-hour period
following prostaglandin administration (when fetal expulsion was most likely to occur). The
effectiveness rate was slightly higher (98.7%) and the time to fetal expulsion shorter among women
given the highest recommended dose of prostaglandin (0.5 mg sulprostone). Higher prostaglandin
doses were associated with more pain and longer duration of bleeding, however. The authors
concluded that more research is required to optimize the prostaglandin dose and to establish criteria
for selecting between pharmaceutical and surgical abortion methods.
fTurrent
Abstracts
ISSN: 1012-2680
Current Abstracts is published quarterly. It features abstracts of recent articles on contraceptive methods and products
selected from a large number of publications. Its objective is to keep United Nations Population Fund (UNFPA)
Country Directors and family planning decision makers up-to-date on current contraceptive research findings and
reports. The abstracts reflect the content of the selected articles and do not constitute endorsement by PATH of the
conclusions or methodology. Current Abstracts is funded by UNFPA.
Program for Appropriate Technology in Health (PATH) and Program for the Introduction and Adaptation of
Contraceptive Technology (PIACT) are nonprofit, international organizations dedicated to improving the availability,
acceptance, safety, and continued use of health and contraceptive products in developing countries. PATH will provide
a full copy of any article abstracted in Current Abstracts to readers on request. Send requests to Current Abstracts, PATH,
4 Nickerson Street, Seattle, Washington 98109-1699, U.S.A.
© Program for Appropriate Technology in Health (PATH) and Program for the Introduction and Adaptation of
Contraceptive Technology (PIACT) 1990. All rights reserved.
(Turrent
Abstracts
focus on contraceptive research
UNFPA
PATH
Volume 3Z Number^/October 1989
Oral Contraceptives
Schlesselman, J.J. Cancer of the breast and reproductive tract in relation to use of oral
contraceptives. Contraception. Vol. 40, No. 1, July 1989, pp. 1-38.
The author reviewed the results of studies published since 1980 investigating possible associations
between use of oral contraceptives (OCs) and cancers of the breast and reproductive tract. He
concluded that the data suggest no relationship between OC use and risk of breast cancer through
age 59. For women under age 45, however, data from several studies raise questions about a
possible increased risk linked to OC use before a first full-term pregnancy. OC use is associated
with a duration-related protective effect against endometrial cancer: the risk is reduced by about
60% with four years or more of use. OC use also is associated with a duration-related protective
effect against ovarian cancer: the risk is reduced by about 50% with four years of use and by
60%-80% with seven years or more of use. Evidence suggests that OC use is linked to a slightly
increased risk of cervical dysplasia, carcinoma in situ, and invasive cancer. Studies of cervical cancer
are difficult to interpret, however, due to their failure to control for factors that could distort
findings, such as number of sexual partners.
World Health Organization Task Force on Oral Contraceptives. The WHO multicentre trial of
the vasopressor effects of combined oral contraceptives: 2. Lack of effect of estrogen.
Contraception, Vol. 40, No. 2, August 1989, pp. 147-156.
This double-blind study of 680 women age 18-34 in six countries (developed and developing) found
no significant difference in the effect on blood pressure after one year of use of combined OC
formulations containing either 50 mcg or 30 mcg estrogen. Results were the same for standard
statistical analysis and life-table analysis. The investigators argued that their findings provided
some evidence against the hypothesis that it is either the estrogen alone or the estrogen-to-progestin
ratio in combined OCs that produces hypertension in some OC users. They noted that the results
should be interpreted cautiously due to the relatively small sample size of the study, however. They
advocated additional, larger studies to rule out minimal effects of estrogen and to investigate the
relative effects of various progestins.
| Of special interest | A recently distributed issue of Population Reports (Series A, Number 7)
provides a comprehensive report on lower-dose OCs (defined as those containing less than
50 mcg estrogen), including their effectiveness, use, benefits, and risks. A copy of the report can be
obtained by contacting the Population Information Program, The Johns Hopkins University,
527 St. Paul Place, Baltimore, MD 21202, U.S.A. Single copies are provided free of charge.
Sterilization
Hapugalle, D. et al. Sterilization regret in Sri Lanka: a retrospective study. International Family
Planning Perspectives, Vol. 15, No. 1, March 1989, pp. 22-28.
This study of 817 women from urban and rural areas in Sri Lanka who accepted sterilization
between 1980 and 1983 and who received payment for undergoing the procedure found that 14%
(7'urrent
z\bs tracts
October 1989
subsequently regretted undergoing the procedure. No association was found between regret and
the amount of payment received for accepting sterilization. Regret was defined as wanting to have
another child or wishing sterilization had occurred later or not at all. The most important factors
associated with regret were: not having one child of each sex, being under age 25, being married
fewer than five years, having two children or fewer, having a husband who opposed sterilization or
with whom it was not discussed, not having control over the sterilization decision, and having a
child die subsequent to the procedure. The authors noted that counseling, especially for individuals
with risk factors for regret, is a cost-effective means of reducing regret.
Rivera, R. et al. Menstrual patterns and progesterone circulating levels following different
procedures of tubal occlusion. Contraception, Vol. 40, No. 2, August 1989, pp. 157-169.
This prospective study of 65 Mexican women whose surgical sterilization involved one of three
tubal occlusion techniques found statistically significant differences in menstrual bleeding patterns
associated with minilaparotomy/Yoon ring placement compared to other techniques and no
sterilization. The investigators considered the differences medically and clinically unimportant,
however. One year after the procedure, women whose sterilization involved minilaparotomy and
Yoon ring placement (19 women) tended to have menstrual cycles lasting about 2 days longer and
bleeding-free intervals lasting about 10 days longer than women sterilized by laparoscopy and Yoon
ring placement (24 women), women sterilized by minilaparotomy and the Pomeroy technique (22
women), and nonsterilized women (26 women). No differences were observed between any of the
groups for other bleeding characteristics, such as total days of bleeding, or for frequency of
ovulation.
Rulin, M.C. et at Changes in menstrual symptoms among sterilized and comparison women: a
prospective study. Obstetrics & Gynecology. Vol. 74, No. 2, August 1989, pp. 149-154.
This U.S.-based prospective study found that tubal sterilization did not change the frequency or
duration of menstrual cycles or the occurrence of between-cycle bleeding but increased the
frequency with which dysmenorrhea (cramping with menses) was reported by sterilization
acceptors. Perceptions of menstrual parameters were assessed before sterilization and about 10
months later for a cohort of 657 women. Perceptions of the same menstrual characteristics also were
obtained twice for 956 nonsterilized women of similar age and parity. The only significant
difference between the groups related to dysmenorrhea: during the second interview the
sterilization group reported a net increase of almost 11%, compared to a net increase of 2% reported
by the nonsterilized group. When the analysis controlled for contraceptive use that could affect
bleeding events (such as IUD or OC use), differences were more pronounced. Sterilization
techniques included the Pomeroy technique (used postpartum), the Falope ring, and bipolar
electrocautery.
Long-acting Progestins
Thomas, D.B. et al. Monthly injectable steroid contraceptives and cervical carcinoma. American
Journal of Epidemiology, Vol. 130, No. 2, August 1989, pp. 237-247.
A recent analysis of hospital-based case-control data from Chile and Mexico found little or no
elevation in risk of cervical cancer among ever-users of certain monthly injectables marketed in the
(Turrent
Abstracts
October 1989
two countries. The analysis was part of the World Health Organization Collaborative Study of
Neoplasia and Steroid Contraceptives and was prompted by an earlier analysis of Chilean data in
which a strong association (ninefold increase in relative risk) between use of these monthly
injectables and cervical cancer risk was observed. The monthly injectables contained the long-acting
progestin dihydroxyprogesterone acetofenide plus a shorter-acting estrogen (usually estradiol
enanthate). The adjusted relative risks among women who had ever used the monthly injectables
were as follows: for invasive cervical cancer, 1.31 (data from Chile) and 0.65 (data from Mexico);
and for carcinoma in situ, 0.81 (data from Chile). The analysis included a total of 342 cases and 1,672
controls. The investigators concluded that the earlier finding likely was due to chance but that a
causal relationship could not be ruled out. They recommended that monthly injectables continue to
be monitored for their possible carcinogenic effects.
Fertility Awareness
Sheon, A.R. and C. Stanton. Use of periodic abstinence and knowledge of the fertile period in 12
developing countries. International Family Planning Perspectives, Vol. 15, No. 1, March 1989,
pp. 29-34.
An analysis of data from the Demographic and Health Surveys carried out between 1986 and 1987
in 12 African, Asian, and Latin American countries found that in 10 countries fewer than 22% of
women had ever practiced periodic abstinence and fewer than 7% currently practice the method.
Current use was highest in Peru (18%) and Sri Lanka (15%). At least half of all current users in 7 of
11 countries (Brazil, Colombia, Ecuador, Morocco, Peru, Sri Lanka, and Trinidad/Tobago) were able
to correctly identify the fertile period. The vast majority of users relied on the calendar rhythm
method. Between one-fourth and slightly more than one-half of current users in seven countries
used an additional method (usually condom or withdrawal) sometime during the month. The
authors noted that if use of periodic abstinence is to increase, programs promoting the method must
help women, especially less-educated women, learn to identify the fertile period correctly.
General
Alauddin, M. and M. VanLandingham. Young, low-parity women: critical target group for
family planning in Bangladesh. Asia-Pacific Population Journal, Vol. 4, No. 1, March 1989,
pp. 49-58.
Based on a review of Bangladesh contraceptive prevalence surveys from 1979 to 1985, the authors
advocated targeting young, low-parity couples for family planning services in Bangladesh.
Prevalence data showed that the increase in contraceptive use observed since 1979 was primarily
among older couples with three or more children, while use among low-parity women age 15-24
remained quite low. The authors argued that young, low-parity women should be targeted because:
1) they make up an increasingly high proportion (44% in 1987) of all women of reproductive age,
2) early adoption of contraception for child-spacing may result in continued child-spacing
throughout a woman's reproductive life, 3) there is evidence of high demand for contraceptives
among women age 15-24, and 4) this age group has the highest fertility rate. The authors
recommended several field-level interventions (including training fieldworkers to effectively reach
young couples) and national-level interventions (such as emphasizing temporary child-spacing
methods and directing some messages to community and religious leaders and men in general).
'urrent
Lbstracts
October 1989
Coeytaux, F. et al. An evaluation of the cost-effectiveness of mobile family planning services in
Tunisia. Studies in Family Planning. Vol. 20, No. 3, May/June 1989, pp. 158-169.
This report on the cost-effectiveness of 63 mobile family planning service delivery units serving 868
rural sites in Tunisia concluded that use of mobile units was appropriate for extending services to
remote rural areas. The study estimated that for mobile unit services provided in 1985, the median
cost per visit was US$4.93 and the median cost per couple-year of contraceptive protection
(including tubal ligation) was US$18.66. Average costs per visit varied among mobile units, ranging
from less than US$1.00 to greater than US$27.00. The investigators estimated that mobile units
provided one-third of all national program services while accounting for one-fourth of national
program costs. To increase mobile unit cost-effectiveness, the investigators recommended
improving vehicle reliability, giving more attention to OC promotion, and reducing constraints to
IUD provision.
Fakeye, O. and O. Babaniyi. Reasons for non-use of family planning methods at Ilorin, Nigeria:
male opposition and fear of methods. Tropical Doctor. Vol. 19, No. 3, July 1989, pp. 114-117.
A 1986 survey in Ilorin, Nigeria, of 646 sexually active women who were not using contraceptives
revealed that almost one third (31.4%) did not use contraceptives because their husbands objected to
family planning. Other frequently cited reasons for non-use included not wanting to use
contraception until the desired number of children were born (13.6%), fear of contraceptives (13.3%),
and previous negative experience using a method (11.3%). The survey also revealed that fewer than
half (45.7%) of the women could accurately identify the nearest source of contraceptives and only
37% said they knew how to use a contraceptive method. The researchers recommended short- and
long-term information, education, and communication strategies to increase contraceptive use:
short-term strategies to teach women about family planning, overcome fears, and dispel negative
rumors about various methods and long-term strategies to change men's perceptions of family
planning. The researchers also recommended ways to improve access to contraceptive supplies.
(Turrent
YXbstracts
ISSN: 1012-2680
Current Abstracts is published quarterly. It features abstracts of recent articles on contraceptive methods and products
selected from a large number of publications. Its objective is to keep United Nations Population Fund (UNFPA)
Country Directors and family planning decision makers up-to-date on current contraceptive research findings and
reports. The abstracts reflect the content of the selected articles and do not constitute endorsement by PATH of the
conclusions or methodology. Current Abstracts is funded by UNFPA.
Program for Appropriate Technology in Health (PATH) and Program for the Introduction and Adaptation of
Contraceptive Technology (PIACT) are nonprofit, international organizations dedicated to improving the availablity,
acceptance, safety, and continued use of health and contraceptive products in developing countries. PATH will provide
a full copy of any article abstracted in Current Abstracts to readers on request. Send requests to Current Abstracts, PATH,
4 Nickerson Street, Seattle, Washington 98109-1699, U.S.A.
© Program for Appropriate Technology in Health (PATH) and Program for the Introduction and Adaptation of
Contraceptive Technology (PIACT) 1989. All rights reserved.
"Injectible Contraceptives - a Threat
to Women's Health"
This was the subject of a well-attended meeting organised
by the Joint Women’s Programme.
(
Dr Marie Mascprenhps, Director CREST
*
outlined.the dangers
of a long-acti'ng contraceptive's injected into women.
Depo-Provera and NET-EN were potent and powerful forms
of hormones given by injection for birth control protection
upto 3 months. These drugs are banned in USA because, of the
harmful effects with fatal results when researched upon.
The research on Depo-Provera. ^showed that within 3 yvears on
all the dogs oh high dosage were dead and half of those/low
dosage. Breast cancer, uterine cancer, serious menstrual
disturbances, masculinisation of female, foetus and other
side effects like depression etc, were found. The WHO
report on these drugs showed,that the majority of women
suffered from severe menstrual disturbances.
In India some research has been done by the ,-ICMR. The
reports of these studies have not been published till
today. Meanwhile the Family Planning Association of India
is planning to use them on.a mass' scale. Hormonal implants
lasting for 5 years are also sought to be introduced.
Women's organisations in Bombay have already voiced their
protest against the introduction of injectible contraceptives
The Joint Women's Programme sees this as a matter of human
concern and; requests all health bodies, women's organisations
and the Indian Medical Association to join in making the
following demands.
1.
Ban all long-acting contraceptives, in particular. NET-EN
2.
Withdraw manufacturing licences to German Remedies and
■Hnichem and any other companies, for long-acting
contraceptives.
3.
Make public immediately all studies on NET-EN and
DEPO-PROVERA.
This experimental immunocontraception approaches are directed
at inactivation of either one or more hormones, gamettf£ or early
embryo antigens.
The reproductive system is exquisitely sensitive
to hormones and several ere involved in a chain like manner in
the process of gametogenesis^ in accessory reproductive organ
function in preparation of the reproductive tract for implantation
and in sustenance of pregnancy.
The gonadotropin releasing hormone
f
(GnRH) a decapetide synthesized ano secreted by the hypothalmus
stimulates the secretion of £®ilicular s ti mi la ti ng hormone (FSH)
and Luteinizing hormone (LH) .
GnRH, FSH and LH are made by
both male anf demale and inactivation of the bioactivity can
influence male as well as female fertility.
The gonadotropins
act on the male gonads to generate sperms and testosterone in
the female gonadotropins are involved in follicular development
ovulation and production of female sex hormones, estradiol (E^)
and progesterone (P) .
In the first half of the cycle S2 dominates.
The cervical nucus during this phase and in particular around the
day of ovulation is permissive of the ready passages of sperms.
In the post ovulation^^s^ydominated by P the cervical mucosal
glycoproteins have a-tfeend confirmation, hindering the passage of
sperms,
progesterone is important for uterine receptivity,
for
implantation of the embryos and for tne continuity of pregnancy.
Compounds or antibodies interfering in the production or action
of this hormone during early pregnancy causes abortion.
GnRH
-
As far as immunological approaches against GnRH are concerned
bioeffective immune responses could be elicited in monkeys and
baboons employing GnRH linked to TT administered with .a Ithpc or
other permissible adjuvants.
High antibody titers were induced
2
in these primates by booster injection after 4 to 5 months of
primary immunization and the antibody response was of Long
duration.
But this approach may not be readily acceptable for
contraception as coincident with the blockage of fertility in
the reduction of sex steroids.
But immunisation against GnRH
may be useful for control of precocious
as well as
in patients of sex hormone dependent cancers such as carcinorrLa
of the prostate and breast cancer.
On the FSH Vaccine & LHRH - (A contraceptive vaccine for use by
the Human Male) Results of a feasibility study carried out in
Adult Male Bonnet Monkeys -NR Moudgal, G S Murthy, N Ravindranath,
A J Rao, M R N Prasad.
Among the various methods being evaluated for contraceptive use
in the human males - the development of an effective contraceptive
vaccine appears attractive & currently Lhfespossible immunogens
are considered - Two are pl4ypeptide hormones (Luteidjaing hormone releasing hormone (LHRH) and follicle - stimulating Hormone
(FSH) and third is a sperm specific protein (Lactic dehydrogenese
X (LDH-X).
LHRH - The Luteinzing hormone releasing hormone (LHRH) analogues
in combination wi^h andogen substitution are either more active
than the native decapep'tide and are known as agonists or they block
the function of LHRH and thereby act as antagonists. But the
ultimate effects of both analogues are identical i.e. suppression
of pituitary gonadotropin section. During the last ten years a
number of LHRH agonists becante available for clinical use in
the treatment of prostatic carfwd£ia/? Some of these agonists
have been used in clinical trials for male fertility regulation.
Similarly studies are being carried out determine the contraceptive
e^fgriency of these antagonists.
.
I
•f^-l
I
J
Another approach to anti-LHRH is immunisation against LHRH. According
to the Annual Report of National institute of Immunology LHRH
vaccine in male rats demonstrated production of consistently high
antibody titre accompanied by a destine in testosterone levels.
The vaccine was found to be safe by to&Bocological studies in
monkeys and there was no
abnormalities in rats.
The only difficulty with this method is that since blockade of
LH section
to cessation of testosterone production and
consequently loss of libi'qo
immunisation with LHRH would
require continuous testosterone supplementation with exogenous
testosterone. The long term effects of continuous testosterone
supplementation remains to be investigated.
FSH Vaccine
- A male contraception vaccine might soon be
developed if the findings of recent research on rata and monkeys
on the regulatory role of one of the two hormones secreted by the
pitutory gland. Follicle stirnulatig|(^S Hormone (FSH^olds true.
According to Professor Moudgal of the Department of Reproductive
Biology at the Indian Institute of Sciences, Bangalore, neutralisation
of FSH which is required for initiating sperm production - can be
brought about by introducing an FSH antigen which produces an
antibody that blocks the action of FSH leading to a drop in sperm
count besides reduction in the mortality of sperms to the
fallopian tube (where fertilisation takes place) thereby resulting
in impotency.
V
2
|
The hqtmone DFSH isolated in the laboratory from frozen sheep
pitutories
has been used as the immunogen. Its
efficacy has been tested thus f<jr in more than 30 monkeys. In
addition to our own tests, the efficacy of the vaccine was tested
in two collaborating laboratories, one situated in New Orleans
and the other in New Delhi. All these laboratories used the
same protocol and adjui&int
The protocol itself
consisted of th4f^fe. to four primary immunisations given ten days
apart and boosters given at intervals of 100 days. All the
immunized monkeys responded positively by producing high
antibodies capable of neutralizing hFSH
Sperm counts in ejaculater obtained periodically by electroejaculator start showing a sharp reduction by 150 days of
immunization. This reduction ranges between acutSoligosperrst^S—
to azoosperrWfe.. ..
During this entire period -ofc immunization
which has thus for covered 380 to 550 days no significant change
in serum testosterone has been observed. This is particularly
advantageous as no testosterone supplementation was required to
maintain
/ j
Ten of the immunized monkeys have been woted
with a
total of 50 proven fertile females
None of the male were
able to impregnate the females thereby demonstrating that FSH
immunization had rendered them infertile. What is of interest
is that infertility could be achieved without compromising
or resorting to testosterone supplementation.
But one of the major consideration in the development of FSH
vaccine is the long term effect active immunization may have on
a) sperm production, particularly with respect to the quality
and number of sperms produced ^recovery of testicular function
following cessation of immunization and c) clinical well being
which includes absence of diseases due to immune complexes.
|
.
A
But according to the scientists (mentioned above) the immunization
has not resulted in deleterious effection the health status of
the monkeys (For more than nine years Tn bonnet monkeys or for
.oA
years in Rhesus monkeys) immune complexes were not detected
i ^"circulation nor were precipitated immune complexes found in
any of the organs/tissues.
No doubt such immunological approach is fraught with risks. No
one really knows the long term impact of playing with the body's
natural defence system and the health hazard it poses.
2
1)
Cycloprovera, a combination of 2, Mg DM:M and 5 Mg
Oestradiol Cypionate ^nd (ii) HRP 102, a combination of
50 Mkg NoAhindrone enanthate (NET-MN) and 5 Mg Oestradiol
Valerate.
Preliminary results in a study of 2,4-00 women in three countries
■ showed both formulations are highly effective, both preparation
induced bleeding patterns like the normal menstrual/cycles and
'i side effects have been minor.
,
Noreth^ndrnna containing Nuerosphoreo tested in about 200
women with different formulations of 3 month infections have
irevented -regnancy and caused very few side effects other than
menstrual irregularities,. The 3 month injections containing
75 Mg of norethAndrone release on an average O.48 mg noreth&tidrone
per day as compared to 0.5 to 1 mg in combined oral contracep
tives/ -Irregular menstrual bleeding is the only common side
effect and only a'few complained of mild headaches or nausea.
Mo changes have been observed in blood pressure, heamoglobin,
serum lipoproteips, etc. The reversibility is rapid.
one month injection with 15 or 30 mg NET has been tested
in 30 women in Mexico. The implant favoured by the Population
Council named Norplant contains leVonorgestrel and proved to
be highly effective, safe and lixed by its users.
3iode gradable Implants
The problem associated with the removed of Norplant implants
led to the development of biodegradable implants.
Those undergoing clinical trial at present include capronor
and Norethftndrone Pellets. Capronor contains progestin
Levonorgestrel. NorethinArone pellets are made of 15 % nure
cholesterol and 85 % Norethindrone (NET). Current trial
Involve implant that are Less than 0.2.';. cm in diameter and
either 2.5 cm (16 mg) and 4 cm long (26 mg.levonorgestrel).
The polymer carrier remains largely intact’o^efe^ 18 to 2.1+ months.
The phase II clinical trials comparing the 2.5 and 4 cm capsules
began in early 1987 and are being conducted by the US National
Institute of Child Health and Human Development (NICHHD) the
"r.H.O. and the Indian Council of Medical Research (ICMR).
Norethindrone_E.el2ets. Each of these Pellets contain 35 mg
NET which is released as the pellets gradually biodegrade.
Preliminary trials have been conducted with two, three and four
pellets in over 100 women in four countries. Both according
to a Characteristic and status of Biodegradable Implant1 as of
March 1987 was estimated to be available by Mid 1990's.
\
Given all the imported contraceptives and rese rch underway in
Indian laboratories - to provide a wider range of birth control
methods - ’will India soon experience a "second birth control
revolution".
this interna tiona 1 data on Norplant raises many issues:
The ethics of "pre-introductory studies done in developing
countries designed to give physicians experience with the system
to approval".
On this plea 14', 000 women from developing
countries were subjected to the trial.
On the basis of the data procured from the developing countries
it was recommended by a panel member of the FDA Committee/USA
r
(iaul Manganiello, KO OaS tmouth b’niversi ty Medical School) that
"• e feel that its is a safe and effective means of contraception
from the information derived from the Third World countries
safe and effective means
it would also be
and hence
of contraception in the United States".
population council you must note has data from studies on
55,UOJ women in 44 countries including about 10,000 from
China,
approximately i,000 women from India, 1,000 from Egypt and 800
from Sri Lanka.
Trials of Norplant capsules or Norplant - 2 rods
Conntry
Bangladesh '
Brazil
jo. of women
600
3600
Chile
900
Egypt
2 600
Haiti
India
3500
Jama ica
Kenya
200
Korea
200
300
100
Mexico
300
Nepa 1
500
300
2
Country
Ho. of Women
Phillipines
300
Senega 1
Singapore
100
300
Taiwan
100
united States
1100
Zambia
200
Total
15^00
out of 55,000
£s tima ted No • of dorplant ix Uorplant-2 acceptors by country
as of September: 1387.
-gentry
ot Acceptors
porplant Capsules approved for
General use.
CKina
--------------------------------- ?------ - ---- -y- 12, 0 0 0
Colombia
2, 000
jominican ucpul>lic
2,000
Ecuador
2, 000
Pin la nd
10,000
Indones ia
i?eru
Sri Lanka
1,50, 000
1,000
800
Sweden
10,000
Thai la nd
20, 000
venezula
1,000
On its Efficacj ’ x-aul Bardin (nc>rplant Expert) admitted that a further clinical
trial is being conducted on 6,000 women "and they will oe followed
tor over five years whether they continue or not " to ascertain and
“look tor adverse events (rates) that we were not able co detect
in Phase-Ill clinical trials".
This indicates that its Safety
is still an unresolved issue.
Some of the issues raised by the
Committee members were (a)
Whether the capsules would migrate over time?
(b)
If irregular deeding could mark underlying endometrial cance
(e)
If the female children would experience nv=sculinisation
function?
4
abnormalities o? the implant remains in the mother during
pre gna ncy?
r
Apart from these doubts the fda reviewed Ridgely Bennett noted
several disadvantages of these products
1)
Meed to insert and remove by a health professional
2)
implants may be vis^t/sj.e.
3)
Approxima tely 25% of the women who discontinued use of the
implant over five years did so because of disturbances in bleeding
pa tterns .
4)
pain and unnecessary surgery may result from enlarged ovarian
follicles among others.
Beside these issues- The clinical trial on the developed arid
developing countries
(which is attached ) reveals the presence of
many serious medical problems like Hypertension, ovarian cyst,
corvical cancer, gall bladder problems, aneamiat^ectopic pregnancy.
In one instance a birth defect was also reported.
Out of 101
accidental pregnancies - 27 with unknown outcome.
In ^gnina
cardiovascular and circulatory problem played a major role for
Norplants termination.
Hypertension
- heart rate problems and
few cases of myocarditis manifested itself.
Again although
Hematologic (blood related) events were uncommon yet the few cases
that occurred were so dramatic that in the case of Californian
"Oman due. to severe anemia (due to excessive bleeding) she had
to not only discontinue Norplant but also take recourse to blood
trans fus ion.
As fer as the problem of ovarian exists associated with implant
use is concerned it may pose a serious problems (a) It may grow to 5-7 cm.
(b)
May persist for a number of weeks.
(c;
Will regress on its own.
(d)
No intervention is recommended.
White all this is happening-growth and regression of the cyst -
the woman is bound to experience terrible pain and discomfort.
Again ectopic prognancies rate is not insignificant.
pregnancy rate was 0.16 per 1,000 woman years.
The ectopic
Given this
possibility of ectopic pregnancy it was stressed that "survellance
should provide reasonably precise information with respect to
short and middle term health effects particularly rates of ectopic
pregnancy" .
But even this kind of surveillance cannot address very
long term questions such as the relative risks of gynecological
cancers or "atherogenic" cumulative circulatory and cardiovascular
diseases .
ICMR Task Force on Hormonal Contraception:Comparative Evaluation of contraceptive efficacy of norethisterone
Denanthate (200 mg) injectable contraception given every two or
three months.
National Programme of Research in Human Reproduction
Division of Reproductive Biology & Fertility Control. ICMR -
Ansari Nagar New Delhi, India.
Institutions that participated:- R G Kar Medical College, Calcutta;
MLN Medical College, Allahabad; Baroda Medical'College, Baroda;
Institute for Research in Reproduction, Bombay; K E M Hospital
Pune; K G Medical College, Lucknow1; Medical College, Gauha'ti;
All M S, New Delhi; Medical College, Jammu; Kasturba Hospital,
Delhi, K E R hospital, Bomoay; 8 p Medical College, Bikaner;
Institute of obstetrics
Gynaecology, Madras; Medical College,
Allepey; R M S P Hospital, Calcutta; J J Hospital, Bombay; I C M R
New Delhi.
The National Family Welfare programme of India is oeing supported
and strengthened through research and development in contraceptive
technology by the Indian Council of Medical Research (ICMR) "Newer
and better methods of fertility control are being evaluated by
ICMR through its network of Human Reproduction Research centres
located in different parts or the country, prior to their inclusion
in the National Family Welfare programme.
The ICmR through its network of HRRC's initiated a randomized
Phase-11 clinical trial, in March 1981 to evaluate the contraceptive
efficacy, and safety of injectable Net OEN (200 mg) given in two
different treatment schedules of 60 + 5 days and 90+5 days.
After exclusions - 2388 subjects, 1181 for 60 + 5 day schedule
and 1207 for 90+5 day schedule were considered for analysis
2
constituting 28, 513 woman months of use.
A total of 41 involuntary pregnancies were reported out of which
21 pregnancies occurred within the first six months when all the
subjects received injectable NET OEN (200 mg) at an interval of
60+5 days.
The method failure rate at six months was 1.2 per
100 users for the 60+5 day schedule and 0.7 per 100 users for
the 90+5 day schedule.
The remaining 20 method failures occurred
after 6 months of treatment.
Of these only one was reported in
the 60+5 day schedule whereas alarmingly high method failures
were seen with the
90+5 day treatment schedule.
in the case of the 19 failures occurred in the 90+5 day schedule
it was observed that the majority of these (13) had occurred during
the 3rd month following the injection.
These observations clearly
indicate that 90+5 day treatment has lower efficacy Decause the
contraceptive effect of the drug does not last beyond 65 days.
Moreover keeping in view the fact that the average body weight of
Indian woman is lower than their counterparts in Western countrie^
it is likely that the body weight may be an important
ea-tirge-
factor responsible for higher method failures and more failures
were reported amongst women with a
body weight of 40 kg and below.
The effect of the body weight on the hormone metabolism is
incompletely understood.
However in a small study no effect of
the body weight was seen in Thai women either on the metabolism
of NET OEN or the return of ovulation.
The available evidence in
the literature also suggests that women in different population
groups may metabolize the injectable progestational steroids at
different rates.
Whereas the Indian women ovulated within 10
weeks after an injection of 150 mg DMPA, the Swedish women did
3
not ovulate for at Least 20 weeks.
in contrast after an injection
of 200 mg NET OEN Indian and Thai women took twice as long as
Brazilian women to resume ovulation.
Surprisingly the method failures within the first six months
where all the study subjects received 200 mg NET OEN at 60 + 5 day
intervals were higher in the present trial as compared to the WHO
study certain difficulties in administering the drug such as the
Leakage of NET OEN soLution from the syringes was reported in
generai and specificaLly from the centres where maximum pregnancies
were reported.
It was suggested that to prevent it would be useful
to pre-pack the drug in sterilized disposable syringes.
Discontinuation rates per 100 women by Reasons for Discontinuation:
Reasons
Treatment
Schedule 6 months
Rates + SE
12 months
13 months
1.4+0.4
pregnancy 60+5
I
1.2+0.3
1.2+0.3
90+5
24 months
1.4+0.4
II
0.7+0.3
1.8+0.4
2.3+0.6
Mens trual
I
3.5+0.6
7.5+0.9
11.1+1.1
15.6+1.5
dis turb&nces
II
8.8+0.9
19.5+1.3
31.2+1.6
42.2+1.9
Heavy & prolo
I
3.5+0.6
7.5+0.9
11.1+1 .1
nged bleeding
II
3.2+0.5
6.5 + 0•3
10.6+1.1
15.6+1.5
13.5+1.3
Irregular
I
10.6+1.1
11.8+1.2
12.1+1.2
II
2.5+0.5
4.0+0.6
7.8+0.9
bleeding
Amenorrhoea
I
II
1.6+0.4
1.8+0.4
7.6+0.9
23.8+1.9
20.1+1.7
Other medical
0.9+0.3
2.7+0.6
3.2+0.7
reas ons
I
II
6.9+0.8
1.5+0.4
13.2+1.3
12.7+1.2
1.2+0.3
2.3+0.5
3.7+0.7
4.4+0.3
Persona L
I
11.6+1.1
22.0+1.5
29.7+1.9
La te for
followup
Los s to
followup
II
I
II
I
II
5.1 + 0.7
3,54-0.6
1.7+0.4
2.3+0.5
7.6+0.9
7.3+0.8
I
Total discontinuation ratell
21.8+1.2
22.0+1.2
9.2+0.9
3.3+0.6
4.7+0.7
10.3+0.9
10.0+0.9
41.5+1.4
40.2+1.4
lo.9+l.4
4.9+0.8
5.9+0.8
11.2+1.0
11.0+0.9
56.9+1.5
55.5+1.5
23.1+1.7
4.9+0.8
5.9+0.8
11.7+1.0
11.9+1.0
68.6+1.5
67.4+1.5
I
Continuation
II
rate
No of Acceptorse I
St frWe§inning II
78.2
78.0
58.5
59.8
43.1
44.9
31.4
32.6
1181
1207
921
939
644
678
281
296
7.5+0.9
6.6+1 .2
46.4+1.5
4
It is clear that discontinuations due to menstrual disturbances
which was 7.4 per 100 users tor 60+5 day schedule and 8.8 per 100
users for the 30+5 day schedule at 6 months of contraceptive
treatment rose in geometrical progression and reached a 43.5 per 100
users and 42.2 per 100 users at the 24 month of NET OEN use.
Discontinuation due to other medical reasons which amounted to
3.2 and 4.4 per 100 users tor 60 + 5 days and 90+5 days treatment
schedule were not only considered to be small in proportion but
also unrelated with the use of the drug.
They ranged from
deseases like ^faundice/infective hapatitjs which occurred in
10 cases to a host of other ailments like hypertension (1)
palpitation (3) pain in chest (3) allergy (4) T B (2) fever (3)
psychiatric problem (2) ■. eight gain (3) prolapse uterus (1)
ovariar^cyst (1) breast tenderness (1) weakness/ headache (10).
What is important to note is that the continuation rates were
marginally lower than those observed under similar conditions for
intrauter//-£■- devices in our country.
Moreover the continuation
rate drastically declined during the second year due to personal
reasons and amenorrhoea.
In fact the project itself stipulated
discontinuation of women having amenorrhoea of more than . •
one year.
1OH 3
7•
Comparative Risks and Costs of Male and Female Sterilization
Gregory L. Smith, MD, MPH, George P. Taylor, MD, MPH, and Kevin F. Smith, MD
Abstract: Couples who are considering elective sterilization
should compare the risks and costs of male and female sterilization
procedures as part of the decision process. Morbidity, mortality,
failure rates, and short-term costs associated with male and female
sterilization procedures were estimated from data available in
previous case series. Male sterilization procedures were found to
have zero attributable deaths and significantly less major complica-
tions when compared to female sterilization procedures. N<j
than 14 deaths a year can be attributed to female stenlt,
procedures in the US. Male and female sterilization pr
efficacy rates that are not significantly different from eaclrin
The short-term costs of female sterilization are 3.0 to 4.1: riS
of vasectomy. (Am J Public Health 1985; 75:370-374;)^
Introduction
cent2 and is dependent on the type of sterilization fini
and the skill of the surgeon. The re-anastomosis in the
would be associated with significantly less costs and risk
complications than the comparable female procedure^
There are over 15 million surgically sterilized adults in
the United States, 19 per cent of US couples with a wife 1544 years of age.1-2 Each year close to one million surgical
sterilizations are performed, the number of vasectomies
being almost equal to the more popular tubal ligation.1’2
Sterilization is now the most common method of fertility
control among married couples over age 30? When socio
economic, family, and marital factors are looked at, those
couples whose wives are undergoing tubal ligation are not
significantly different from those couples whose husbands
are undergoing vasectomy?
The goal of this analysis is to estimate comparable
efficacy, complication, and mortality rates and short-term
costs associated with male and female sterilization proce
dures.
Previous publications2-5-11 have shown that sterilization
is safer than using temporary contraception or no contracep
tion.
Generally, sterilization is requested after procreation
for the sexual couple or single person is deemed to be
complete,2 J “-’ a very different situation than that of couples
or single persons choosing temporary contraception. The
costs, efficacy, and risks associated with temporary versus
permanent sterilization are used for a different set of deci
sions by different groups of individuals. The person who
elects to be sterilized expects that for a given level of
efficacy and cost that he or she will have the lowest rate of
complications and mortality possible.
The psychological and social aspects of choosing male
versus female sterilization by members of a sexual couple
are not discussed in this analysis. However, we recognize
that the risks, efficacy, and costs associated with the differ
ent sterilization procedures are only part of the information
necessary for informed decision making by the consumer
and the health care provider.
While the reversibility of the sterilization procedure is
not a conceptual issue, it may be an empirical issue in the
decision process. Clinical success of both male and female
sterilization reversal is reported to range from 10-50 per
Address reprint requests to Gregory L. Smith, MD. MPH. Captain, US
Army Medical Corps. Division of Preventive Medicine, Walter Reed Army
Institute of Research. Washington. DC 20307-5100. Dr. Taylor is with the
General Program. Harvard School of Public Health; Dr. Smith is with the
Department of Pediatrics, Lincoln Medical Center, New York City. This
paper, submitted to the Journal July 16, 1984, was revised and accepted for
publication October 5. 1984.
O 1985 American Journal of Public Health 0090-0036/85S1.50
370
Methods
A literature search was done to capture all case sefe
publications presenting data on deaths, complications,“igf
failures of tubal ligation and vasectomy procedures;ip tfe
US. Because of the changing nature of sterilization, inclijj.
ing a multiplicity of techniques the increasing skill ofi!<
surgeons, and an increasing awareness of the associahj.
risks, only case series published after 1970 were review#;.
Each case series was reviewed for consistency of thedufa,
tion of attributable mortality,, morbidity failure, andatnsi
mum follow-up interval of three years. Over 50 case,serifs'
were reviewed, including a variety of retrospective ia!'
prospective study designs. The numerator and denomir.®
data from the case series were combined and averaged
produce estimates for the morbidity, failure, and mortality.
rates for tubal ligation and vasectomy. A Poisson distrite".
tion was assumed in calculating the 95 per cent confident?
intervals of each estimated rate.
Because the case series varied in informational detail,^
was not possible to calculate the rates by age, race, ix? ■
socioeconomic status. Thus the estimates are for all
males and females undergoing’sterilization. There is eyr 1
dence in studies from lesser developed countries to suggest
that for any age, race, or socioeconomic status the riskratie
among the various sterilization methods will be relatively
constant even though the absolute rates will differ.10
Forty-eight per cent of tubal ligations are done wife
one month of an abortion or parturition, but this does 0$
affect complication rates.’ Only complications and fatalife
directly attributed by each author to the tubal ligafe
procedure are included in the risk estimates.
Procedure Costs
The procedure costs estimates are intended only W
reflect the short-term costs. Costs associated with failure^
complications, recuperation time, or death are not include!"
Because cost information was complete and easily avail
able for Boston and Dallas, these data were used to estinuB
procedure costs. It is recognized that these estimates tW
not be appropriate for less urbanized areas, or statistic
*.;
metropolitan areas with a lower cost-of-living index.
The procedure costs include the surgeon’s fee, anes ■
sia fee, and the facility costs for the operation and
operative care. The maximum allowable insurance.p
*
-
AJPH April 1985, Vol.
RISKS OF MALE AND FEMALE STERILIZATION
■
to the surgeon and anesthesiologist for tubal ligation
B ?Sasectomy were used to reflect the physician costs. The
B a nl regional diagnosis-related group (DRG) payments for
E implicated laparoscopy and laparotomy tubal ligation
E ^vasectomy, for Dallas and Boston, were used to reflect
k n npatient costs, excluding physician fees. An average
|
rnatient post-operative facility fee for Dallas and Boston
**
I farS’OO is used in the cost estimates for that proportion of
■ (ut»l
*li?
ations and vasectomies done as outpatient proce-
K ^"^Only very rarely is a vasectomy done as an inpatient
E nroccdure. It may be included occasionally as an inpatient
I nroccdure when the patient was hospitalized for another
■ indication. or when the patient is at high risk for complica-
I '^Data are not available on the number of person admitted
I to the hospital for the purpose of undergoing vasectomy.
***
I However' s0 as not t0 underestimate the costs associated
| »i(h.these inpatient procedures, 5 per cent of vasectomies
t uil^ikncluded as inpatient procedures in this cost estimaj tun”
Data are not available on the proportion of vasectomy
| patients who stay in outpatient post-operative facilities.
***
I However, a random telephone survey of Dallas and Boston
| primary care physicians who regularly perform vasectomy
■ showed outpatient post-operative facilities to be used in
’ most instances. In order not to underestimate the costs of
I vasectomy, all outpatient vasectomies will be included as
using post-operative facilities.
'
Nationally, about 25 per cent of laparoscopy tubal
ligations and 2.5 per cent of laparotomy tubal ligations are
E done .is outpatient procedures." Those procedures done as
| outpatient procedures will be included as using post-operaJ live facilities.
fable 1 shows the estimated procedure costs for inpaf ncnl and outpatient vasectomy, laparoscopy, and laparotoL my tubal ligation.
Mortality Kate
No deaths were reported in any of the case series, and a
review found no reported deaths in the US attributvasectomy.>-2 Potts, rt al,10 in reviewing relative
nsks ol sterilization in lesser developed countries quote a
’I'crxmal Communication, representative from Health insurance Insli<>l America.
..Phiine survey of area hospitals, outpatient facilities, and physicians.
"’Personal communication. Dr. William Pratt. National Survey of
>■"1111 Growth. National Center for Health Statistics.
rate of 0.1/100,000 procedures in India, with most of the
deaths attributable to tetnus or sepsis. This is the only value
that exceeds zero in the available literature. A theoretical
argument for a dose-related risk of death from anaphylaxis to
the 3-5cc subcutaneous injection of anaesthetic has been
made12 but no estimate is available.
A mortality rate of zero will be used for later calcula
tions.
Cumulative Failure Rate
In the case series, failure was defined as continued
presence of motile sperm in the semen three months after the
procedure. Close comparison with tubal sterilization failure,
the occurrence of pregnancy in a previously sterilized wom
en is not possible.’ In this analysis, the cumulative failure
rate for vasectomy will be compared with that for tubal
ligation, with the understanding that the vasectomy failure
rate may be an overestimate of the actual number of failed
vasectomies that result in pregnancy of the spouse.
Eight US studies from 1971-74 from a review by Hatch
er,2 where the current standard procedure was performed,
found nine failures in 5,638 vasectomies. This gives a rate of
0.16/100 procedures (95 per cent confidence limits 0.070.28).
Long-Term Mortality Rate
The long-term mortality rate is related to sterilization
failure which leads to pregnancy and its associated maternal
mortality risks. The number of pregnancies which are as
sumed to occur from each failure is multiplied by the
maternal mortality rate for US women 15-44 years of age
(9.2/100,000 pregnancies). On the one hand, this overesti
mates mortality because not all failed vasectomies would
lead to pregnancy; on the other hand, it underestimates the
true mortality because the average age of wives of vasectomized men is older than that of all US pregnant women.’
In calculating estimates for male and female steriliza
tion, the assumption is made that there are no elective
abortions.
Complication Rate
Major complications are those associated with signifi
cant morbidity and/or large additional costs: all complica
tions requiring intravenous antibiotics, hemorrhage requir
ing transfusion, operative complications or trauma requiring
further repair or extended hospitalization.
Minor complications include fever or localized infection
treated with oral antibiotics not requiring hospitalization.
superficial hematoma, localized pain or complaints not re
quiring hospitalization or surgical repair.
Only those case series reporting complications that can
be categorized into minor or major were used for the
parameter estimation.
TABLE 1—Estimated Short-term Sterilization Procedure Costs
Procedure Type
Anesthesia &
Physician Fee
Outpatient
Facility
Inpatient
(DRG rate)
Total
Outpatient Vasectomy
Inpatient Vasectomy
Outpatient Laparoscopy
Inpatient Laparoscopy
Outpatient Laparotomy
Inpatient Laparotomy
$251
$251
$673
$673
$710
$710
$200
$ o
$200
$ 0
$200
$ 0
$ 0
$ 900
$ 0
$ 952
$ 0
$1303
$2013
SOURCE: Health Insurance Institute of America, Blue Shield Health Insurance, Federal Register DRG payment schedtile for Dallas
and Boston, 1983-1984.
April 1985, Vol. 75, No. 4
SMITH, ET AL.
Fifteen studies in a review by Hatcher2 found seven
major complications out of 16,319 vasectomies, 0.43/1,000
procedures (95% confidence limits 0.17-0.81).
We have not used the minor complication rate, howev
er, because of the considerable underreporting particularly
in the case of tubal ligation, which would be expected to
have a minor complication rate approaching 100 per cent if
the definition were applied literally.
Sexual Dysfunction—Ho significant difference has been
found in the rate of sexual dysfunction between couples with
male and female sterilization.3
Alder, et al,l} prospectively studied 90 matched couples
undergoing surgical sterilization. He found that in the cou
ples where the husband had undergone vasectomy there was
a higher frequency of intercourse, fewer sexual problems,
and more satisfactory marriage than couples where the wife
had undergone tubal ligation.13 These differences were not
felt to be secondary to the procedure but related to underly
ing differences in the couples.
Arteriosclerotic Cardiovascular Disease and Vasecto
my—On the basis of animal studies, it has been postulated
that damage to the arterial walls by deposits of circulating
immune complexes may have followed vasectomy.3-14-13-16
Two recent reviews1417 of 13 large US epidemiologic studies
to evaluate this hypothesis found no increase in ASCVD in
vasectomized men.
Sperm Antibodies—Thirty to 50 per cent of men who
have undergone vasectomy develop antibodies to
sperm.3-1417 This has raised concern about the development
of immunological disease in vasectomized men. Two recent
reviews of a number of large US epidemiologic studies on
the subject1417 found that sperm antibodies had a negative
effect on fertility in males who had undergone vas re
anastomosis procedures. No other immunological health
effects were identified.
In summary, the available evidence does not support
sexual dysfunction, arteriosclerotic cardiovascular disease,
or immunological disease as complications of vasectomy.
Therefore, they will not be included in the major complica
tion category of this analysis.
Tubal Ligation Risks
Mortality Rate
Several reviews of tubal ligation or complications of
tubal ligation present mortality rates from 2.5lO.O/IOO.OOO.’-111"-24 The most common causes of death were
complications of general anaesthesia (38.0 per cent), opera
tive trauma (27.5 per cent), sepsis (24.0 per cent), and
myocardial infarction (10.3 per cent).’ No deaths have been
reported due to complications of local anaesthesia with tubal
ligation procedures in the US,’ but tubal ligation performed
under local anaesthesia would still retain the mortality risk
from operative trauma, sepsis, and myocardial infarction.
Mortality rates are calculated for laparoscopy and lapa
rotomy tubal ligation procedures, using two large US case
series.’-31 For laparoscopy tubal ligation, there were 21
deaths attributable to 444,565 procedures, a rate of
4.72/100.000 (95 per cent confidence limits 2.70-6.74). For
laparotomy, there were 13 deaths attributable to 567,000
procedures, a rate of 2.29/100.000 (95 per cent confidence
limits 1.22-3.71).
Cumulative Failure Rate
The cumulative failure rate for laparoscopy tubal liga
tion was calculated from 21 case series, most of which were
372
reviewed in a paper by McCausland.25 There v/crt-<7
failures among 55,877 sterilized women;-®Hg
of 0.28/100 (95 per cent confidence limits 0.23-0.32)
case series were used to estimate the failure rate.forfeqg
omy tubal ligation.22-23-27 There were 17 failures.
5,213 sterilized women, a rate of 0.33/100 (95 p-j.?/
confidence limits 0.18-0.48).
Long-Term Mortality Rate
Unlike vasectomy, there is an increased rath (if eca
*,
gestation with an associated increased maternal mot®
among women with failed tubal ligation.28-31 The proptS
of such women with tubal gestation ranges from 16-5(f3
cent, depending on the type of procedure.28-30 The
series by McCausland23 is the only study with deife
information of ectopic pregnancy rates by type of procafe.
McCausland found 49 ectopic pregnancies out of 160fef-i
laparoscopy tubal ligations, an ectopic pregnancy rat? cfi-.
per cent. He also reported 13 ectopic pregnancies putptjjj'
failed non-laparoscopy tubal ligations, ectopic preg8|BK|
rate of 12.3 per cent.
Rubin, et al,M estimated, for all women in‘the^uwf
1978, 37 deaths attributable to 42,400 ectopic pregnSSH
an estimated ectopic pregnancy mortality rate of 87/10(1$) <
ectopic pregnancies.
To estimate the long-term mortality rate, the expecuj .
number of ectopic pregnancies is multiplied by the ectofr. j
pregnancy mortality rate. The estimated number of bos..
ectopic gestations is multiplied by the non-ectopic matchsii
mortality rate for the US.7
Complication Rate
■■ -/S--.
For laparoscopy tubal ligation, four case series
®
*
used.13-21-26-27 There were 214 major complications atnw.f
10,179 women undergoing sterilization, a rate of 2.1/10005.;
per cent confidence.limits 1.8-2.4). For laparotomy !®
ligation, three case series were used.13-24-27 There werejS
major complications among 1,651 undergoing sterilizatfeiv
rate of 6.2/100 (95 per cent confidence limits 5.0-7.3j?SBB
Post-tubal Syndrome—The question whether tubal Jip-'
tion predisposes women to menstrual disturbances has fe ;
explored in several studies.13-24-27 It has been concluded fet;the observed differences in menstrual function after total.
ligation may be attributed to. the older average age, and’S
previous pelvic disease and birth control methods. Therefore
menstrual disturbance is not considered a complication rf
tubal ligation.
Results
Table 2 shows the costs, mortality, complication, a®-'
failure rates for 100,000 sexual couples or single person
*;;
undergoing sterilization. Within the confines of the variaife
of the available case series and the assumptions discussed
*
the Methods section, these data are comparable.
.->;<■
Table 3 shows the risk ratios (RR) for tubal ligatioc
compared to the reference vasectomy. The attributed;
mortality RR and the major complication RR for tubiligation procedures are each approximately two orders
magnitude greater than vasectomy. The short-term costs.«<.
tubal ligation are 3.0 to 4.1 times greater than vasectoffl^B
In Figure 1, the first section shows the estimated ra'c>
from Table 2 applied to the actual numbers of sterilization .
in 1981—i.e., 400,000 vasectomies, 140,500 laparoscope
and 299,500 laparotomy tubal ligations.
In the second section of Figure 1, the same ratesjgH
numbers of procedures are applied in a hypothetical SfflS
AJPH April 1985, Vol. 75, j
RISKS OF MALE AND FEMALE STERILIZATION
TABLE 2—Estimated Death,, Complication!, Failures and Costa for Tubal Ligation and Vasectomy (per
100,000 procedures)
Sterilization Procedure
Laparoscopy
Tubal Ugatlon
Laparotomy
Tubal Ligation
Vasectomy
4.72
0.09
4.81
2100
276
2.29
0.06
2.35
6170
326
0
0.02
0.02
43
160
143.6
198.5
48.6
Procedure Mortality
Long-term Mortality
Attributable Mortality'
Major Complications
Sterilization Failures
Short-term Costs
(Millions $)
•Attributable = Procedure Mortality plus Long-Term Mortality
TABLE 3—Risk Ratios for Mortality, Complications, Failures and Costs for Tubal Ligation and Vasectomy
(Vasectomy Is reference RR = 1.0)
Sterilization
Procedure
Laparoscopy
Tubal Ligation
Laparotomy
Tubal Ugation
Long-term Mortality
5.7
•(1.1-18.1)
241
(146.9-393.8)
49.0
(32.0-75.1)
3.9
(0.7-13.8)
117.5
(63.4-217.8)
143.0
(104.6-198.2)
2.0
(0.9-4.5)
4.1
Attributable Mortality
Major Complications
Sterilization Failures
(0.9-3.4)
3.0
Short-term Costs
Vasectomy
1.0
1.0
1.0
1.0
1.0
*95 per cent confidence limits
lam tn which all of the tubal ligations are done as outpatient
procedures, using only local anaesthesia. This is the "best
rutr" situation for tubal ligation.
In the third section of Figure I, the same rates and
numbers of procedures are applied in a hypothetical situa
tion in which all of the sterilization procedures are done as
mectomy. This is the “best case" situation for vasectomy.
This would lead to an estimated 100 per cent reduction in
mortality, 85 per cent reduction in major complications, and
62 per cent decrease in costs with the same efficacy rate as
the other alternatives.
Discussion
This method of analysis and rate estimation is flawed by
the variability of the case series used including differences in
study population, physician experience, and technique.
However, by using the raw data from a large number of case
series reflecting such a large variety of experience, the
estimated rates may be close to the real-life situation. The
actual differences among the sterilization procedures will not
be adequately known until a large, well-designed prospective
study is conducted among sexual couples requesting elective
sterilization.
With this limitation in mind, we believe that our data
suggest that vasectomy is safer and considerably less expen
sive than tubal ligation, with efficacy rates not significantly
different from tubal ligation.
REFERENCES
Reproductive Impairment among Married Couples: United States, 1982.
Data from National Survey of Family Growth Data, Series 23, No. 11.
National Center for Health Statistics. Washington, DC: Govt Printing
Office.
2.
Hatcher RA, Guest F, Stewart F, et al (eds): Contraceptive Technology
1984-1985. New York: Irvington Publishers. 1984.
3.
Vasectomy—safe and simple. Popul Rep 1983; 11:63-94.
4.
Markman LM, Frankel HA: The choice of sterilization procedure .among
married couples. J Fam Pract 1982; 14:27-30.
5.
Sachs BP, Layde PM, Rubin GL, et al: Reproductive mortality in the
United States. JAMA 1982; 247:2789-2792.
6.
Keeping JD, Chang A, Morrison J: Sterilization: a comparative review.
Aust NZ J Obstet Gynaecol 1979; 19:193-202.
1.
M.Jor
Complication,
(x WOO)
Sterilization
Failure,
(x WOO)
Short-twm
Coat,
(xSlOO million)
Estimated Rate,
IRE I—Actual and Hypothetical Risks and Costs of Sterilization Proce1 <1981 data.
April 1985, Vol. 75, No. 4
373
SMITH, ET AL
Ory HW: Mortality associated with fertility and fertility control: 1983.
Fam Plann Perspect 1983; 15:57-63.
Rubin GL, Ory HW, Layde PM: The mortality risk of voluntary surgical
contraception. Biomed Bull 1982; 3:1-5.
9.
Peterson HB, DeStefano F, Rubin GL, et al: Deaths attributable to tubal
sterilization in the United States, 1977 to 1981. Am J Obstet Gynecol
1983; 143:131-136.
10.
Potts M^ Spcidel JJ, Kessel E: Relative risks of various means of fertility
control when used in lesser developed countries. In: Sciarra JJ, Zatuchni
GI, Speidel JJ (eds): Risks, Benefits, and Controversies in Fertility
Control. Hagerstown, MD: Harper And Row, 1977.
11.
Peterson HB, Greenspan JR, DeStefano F, et al: The impact of laparos
copy on tubal sterilization in United States hospitals, 1970 to 1978; Am J
Obstet Gynecol 1981; 140:811-814.
12.
Ackman CFD, Maclsaac SG, Schual R: Vasectomy: benefits and risks.
Int J Gynaecol Obstet 1979; 16:493-496.
13.
Alder E, Cook A, Gray J, et al: The effects of sterilization: a comparison
of sterilized women with the wives of vasectomized men. Contraception
1^80; 23:45-53.
14.
Massey FJ, Bernstein GS, O’Fallon WM, et al: Vasectomy and health:
results from a large cohort study. JAMA 1984; 252:1023-1029.
15.
Lipshultz LI, Benson GS: Vasectomy—1980. Urol Clin North Am 1980;
7:89-105.
16.
Advance Report on Final Mortality Statistics, 1980. Monthly Vital
Statistics Report 1983; 32:1-40.
17.
Perrin EB, Woods JS, Namekata T, et al: Long-term effect of vasectomy
on coronary heart disease. Am J Public Health 1984; 74:128-132.
18.
Peterson HB, Lubell IL (eds): Sterilization: A Worldwide Epidemiologic
View, Chicago: Year Book Medical Publishers, 1983.
19.
Peterson HB, Greenspan JR, Ory HW, et al: Tubal sterilization mortality
7.
8.
surveillance, United States, 197^-1979. Adv Planned
Aubert JM, Lubell I, Schima M: Mortality risk associated
sterilization. Int J Gynaecol Obstet 1980; 18:406.
' 'VJSSh
Phillips JM. Hulka J, Hulka B, et al: American Association
ic Laparoscopists, 1976 membership survey. J Reprod MedjSJSS
22.
Peterson HB. DeStefano F. Greenspan JR, et al: Mortality
cd with tubal sterilization in United States hospitals. An
Gynecol 1982; 143:125-129.
23.
Phillips J. Hulka JH, Keith D, et al: Laparoscopic *proccdurer La..
survey for 1975. J Reprod Med 1977; 18:219-225.
24.
Newton JR, Gillman S: A retrospective survey of female steni^;. ;
the years 1968 to 1973, analysis of morbidity and
complications for 5 years. Contraception 1980; 22:295-311^^^8
25.
McCausland A; High rate of ectopic pregnancy: incidence ard gjL.
Am J Obstet Gynecol 1980; 136:97-101.
;
26.
Cunanan RG. Courcy NG, Lippes J: Complications of laparoscopy
sterilization. Obstet Gynecol 1980; 55:501-506.
27.
Brenner WE: Evaluation of contemporary female sterilizatinnt^K
Reprod Med 1981;26:439-453.
!
28.
Peterson HB, Lubell I, DeStefano F, et al: The safety
tubal sterilization: an international overview. Int J Gynaecol Obstofi?
21:139-144.
?
29.
Rubin GL. Peterson HB. Dorfman SF, et al: Ectopic pregn^VL'
United States: 1970 through 1978. JAMA 1983; 249:1725-17088
30.
Barnes AB, Wcnnbcrg CN, Barnes BA: Ectopic pregnancy:
and review of determinant factors. Obstet Gynecol Surv 193L^S
356.
31.
Qvigstad E, Jerve F: Ectopic pregnancy following tubal sterilfofa/L;
Gynaecol Obstet 1982; 20:279-281.
20.
21.
1985 International Study Tour to Japan:
A Focus on Health and Aging
An international study tour to Japan and Hong Kong will be conducted July 20-August 4, 1985. A
comprehensive view of the health care system with an emphasis on services for the older adult in Japan
will include visits to the Metropolitan Tokyo Research Institute for the Aged. National Institute of
Public Health. Ministry of Health. Life Planning Center, universities, hospitals, public health
departments and long term care facilities. The study tour will be co-directed by Drs. Geri Marr
Burdman. Margaret F. Dosch. and Kiyoka Koizumi. Continuing education credit available for health
and social service professionals. For further information, contact:
\
Dr. Margaret F. Dosch
Department of Health Education
University of Wisconsin-La Crosse
La Crosse. WI 54601
Tel: (608) 785-8I62
Dr. Geri Marr Burdman
P.O. Box 357
Mercer Island. WA 98040
Tel: (206) 232-7029
374
,'L;
B
.
jab
121
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OCTOBER 1986
A Feminist Understanding of Contraception
(Manisha Guptc)
Few topics related to the women’s health movement
are as controversial as is contraception. Liberating
heterosexual women at one end by giving them the
choice to control their own reproduction, it snatches
away the same control when contraceptives, many of
them invasive and harmful, come as a packaee deal
with population control programmes that select,
motivate and whenever necessary coerce helpless
targets. Male hegemony exists in medicine, in policy
and decision making and in research. Do women end
up having lesser choice and lesser control over their
bodies through the usage of existing contraceptives?
what designs operate to keep control of women’s
bodies out of the latter’s hands? And is there a solu
tion?
g&o understand the above, it becomes necessary to
cliffy our own position regarding contraception.
It is particularly important to do so when we are faced
with the possibility that injectable contraceptives may
be officially introduced into the Indian government’s
family planning programme. Whereas our fight
should be directed against all contraceptives that are
invasive, harmful and which have systemic effects,
at this moment it is necessary to concentrate our
efforts to examine injectable contraceptives vis a vis
the personal choice of a woman regarding contracep
tion.
The present paper, based largely on existing in
formation, attempts to bring forward some views re
garding contraception, the choice that women are
able or unable to exercise when confronted with unsafe
contraceptives within a target oriented, coercive popu
lation control programme.
Feminism and
Contraception :
As regards contraception, one argument put
forward is that while it does help a woman to avoid
conception the availability of contraceptives has made
women ‘sexually available’ for men. The argument
has been especially true in the context of our Western
sisters and the recent works of Germaine Greer and
Betty Friedan bear testimony to the fact that the sexual
revolution of the West, did infact oppress women
themselves. The same argument is put forward in
India by well meaning persons about the abortion
issue. What they want to stress upon and to warn is
that once contraceptives are available, men become
more irresponsible in their sexual relation with wo
men, since then a woman’s sexual availability can be
separated from unwanted conception and the accompa
nying guilt and responsibilities. In the event that con
ceptions do occur, the woman then is made to go
through repeated abortions, much against her will
and her physical well being. The position of these
protagonists is in principle quite different from that
of the moralists who see sexuality without conception
as evil, especially if it occurs outside marriage, and who
consider accidental pregnancy ensuing out of such a
relation as a well deserved punishment.
Let us examine this position and its consequences.
In fact, one might raise a counter question in argument.
Are we trying to say that if contraceptives were not
made available, women too would no longer be
‘available’ for sexual purposes? In such a situation,
what would be our analysis ? The fact is that partri
archy is powerful and all pervading. It adapts itself
to almost every situation with incredible ease. Infact
it has the power to mould situations, even progressive
and radical, for newer forms of oppression. It existed
in feudal society, it functions hand in hand with
capitalism; what is even more depressing is that it
has also not been driven out of post revolutionary
societies, nor from left movements. It should not
surprise anybody therefore if it exploited the sexual
revolution of the West or the availability of contracep
tives in general.
Our fight therefore has to be directed against the
real enemy. Patriarchy that oppresses us, degrades
us to being sexual objects, that refuses to accept
responsibility of conception and child rearing and
which overtakes any move by us to gain control of our
own bodies. Withdrawal of legalised abortion or of
contraception would in result be no different from what
rightist moralists would desire in complacent glee: a
further punishment for women. If we accept the fact
that a woman is not free sexually, then to take away
her defence mechanisms would amount to victim
blaming.
Within marriage, the ‘availability’ of the wife for
sexual gratification in relation to the contraception
issue raises delicate questions. Similar to the argu
ment raised earlier, does a wife become a sexual slave
only when the couple practices contraception? The
reality of the sexual rights of a husband is more deep
than is contraception. Restitution of conjugal rights
is one such issue that encroaches on to the human
rights of the wife. In the Hindu family, the wife
cannot raise the issue of rape within marriage, because
according to the law she has given her consent once
and for all during the marriage ceremony, itself.
Legal cases have been filed by husbands when the wife
has refused to bear children. Where does contracep
tion figure in these cases?
have the freedom to control their own reproduction,
within or without marriage.
From this point, emerges another hotly debated
issue: is contraception solely the responsibility of the
woman? It is clearly not so, and we have to constant
ly question as to why there is more research into
contraceptives for women as compared to those for
men, why women are the more favoured target group
in population control programmes and why unsafe
and invasive contraceptives are being dumped onto
women. Ideally, contraception should be shared
equally by the couple and significantly, the natural
family planning method which is the safest method of
contraception demands such mutual cooperation and
understanding. The man respects the women’s de
mand against conception and actively cooperates.
Here, however, we are referring to the man who hand
les an intimate relationship with some amount of
responsibility. He may well be exception to the rule.
In Bombay city alone the officially registered MTPs
in a single year were around 50,000 besides many
more that go unregistered, (Karkal, 1985) proving
that there were atleast so many unwanted pregnancies
in one city in one year.
The point one is trying to make is that while we
are aware that contraception is shared responsibility,
in the absence of a pro-women milieu, avoiding un7
wanted conceptions through contraception becomes
the woman’s last line of defence.
Is
there
a
choice?
If contraception is liberating because it allows a
woman to control her own fertility, existing contracep
tives tell a sad tale. Contraceptive choice today is
not determined so much by the woman in question,
but by designs that are beyond her control. These
designs work at national and international levels,
namely the government’s policy regarding population
control and the interests of multinational companies.
The interests of the latter become clear when one
realises the tremendous potential market that they have
in healthy women all over the world. Three to five
million women in seventy countries were on depo
provera alone, in 1978 (Corfman, 1978). According
to the 1981 Census of India, 43.4% of all women are
in the reproductive age group and of these 80.48%
are married. That makes for 11.6 crores of married
women in the reproductive age group only on the
Indian subcontinent. Since injectables are to be
used as a spacing method, all of these women become
potential targets at least once in their lifetimes.
The woman’s choice and control over her own
sexuality would more often be much reduced within
marriage. Each time she goes through an unwanted
sexual experience, she may not be actually ‘raped’,
often, the consequences of not sleeping with her hus
band may far outweigh the consequences of having
slept with him. She may be threatened with insecu
rity, with the accusation of not fulfilling her conjugal
duties, of frigidity and in dire circumstances with
desertion. In such a situation, infact contraception
comes to the rescue of a woman: she can at least hold
on to one end of the rope, however feebly.
One is definitely not making a case that wives and
women in general are sexless and that everytime they
undergo a heterosexual experience, they are doing
it against their own will, only to gratify the man.
Of course not. Women can and should express their
sexuality in their own right. And yet, they should
It is therefore easy to understand the direct and
indirect involvement of drug manufacturers in research
2
a shot of DP without her knowledge when she was
under general anaesthesia for abortion (Rakasen,
1981). Social workers from Scotland report that a
young girl was given a shot of DP, disguised as a
glucose injection. In Britain, Asian women in their
post partum period are routinely given a DP shot along
with the rubella vaccine, without any consideration
for the child that would absorb the hormonal drug
whilst breastfeeding.
related to long acting contraceptives and the implicit
bias underlying all these research studies. Even
‘prestigious’ international bodies such as the Inter
national Planned Parenthood Federation (IPPF)
describes all injectable contraceptives as a ‘most
dependable and useful method of family planning
(IPPF, 1978). Contraceptive technology is more
under the control of multinationals than it is with
women. Delivery of contraceptives may lie with
women, as it does in Britain or in India; but this in
itself does not mean that decision making or the power
to decide on a particular contraceptive on a macro
level lies with women. Male hegemony exists and
contraception therefore remains an area where all
heterosexual women are disadvantaged by a limited
choice. (Roberts, 1981). Moreover, the medical
establishment is male dominated and much worse,
women are made to fit into male defined categories.
It is with this preconceived bias that the medical esta
blishment sees our menstrual problems. Since our
gynaecological disorders are termed as ‘psychosoma
tic’ there is little understanding for menstrual chaos,
pain or other psychological disorders that invasive
contraceptives induce inside our bodies.
The above examples are only the tip of the iceberg.
They are vivid because one can clearly see how choice
is snatched from us, throughabuse of the injectable,
but the general picture would be more subtle. Th
roughout the world, especially in the developing
countries, injectables would be pushed for the ‘sake of
convenience’. The question is: whose convenience?
When the woman in question cannot decide which
contraceptive she must use, ‘informed consent’ is
actually telling half-truths and when she cannot cont
rol the long term sequelae of the systemic and hormo
nal effects on her body, it is inhuman to speak of
‘convenience’. Infact, it is the convenience of the
drug companies and the dons of population control
that is being considered, so that this dangerous hormo
nal preparation can be administered to ‘ignorant and
irresponsible’ women.
The findings of many of the reasearch studies are
questionable. In field trial studies, the necessary
physical examination is not always performed on
women because it would discourage a woman to
continue to participate in the study and would
give FP a bad name at the village level (Balasubrahmanyan, 1981). No long term follow up is also
conducted. On what basis then are claims of safety
made? Hormones can cause long term havoc, there
fore women taking hormonal contraceptives have to
be monitored for years. Not only they but in the
event that they used these drugs in the post partum
period, their children too have to be watched
until the latter reach puberty. In this context, our
fight has also to be directed against the Pill and all
contraceptive preparations that cause hormonal and
systemic effects. Our concentrated effort against the
introduction of injectables, however is more because
least control over our own bodies is possible with
long acting contraceptives, the dangerous effects of
which we cannot remedy by immediate withdrawal and
the higher potential of abuse that is related with
injectables.
References:
Long acting contraceptives, especially injectables
are very important where the question of choice is
concerned. The ‘value’ of injectables, as the pro
ponents of PC see, lies exactly in the fact that it steals
choice from women into the hands of male hegemony.
A fourteen year old black girl from London was given
3
1.
Balasubrahmanyan, Vimal, ‘After the Pill’
Maintream, Vol. XX No. 13, Nov. 1981
2.
Corfman, P.A., Evidence to US Select Com
mittee Hearings on Population, US. House of
Representative, 1978 (quoted by Jill Rakusen,
1981)
3.
International Planned Parenthood Federation
‘Factsheets’ on Depo-provera.
4.
Karkal Malini, Science Age, 1985 (Informa
tion Collected through personal communica
tion).
5.
Rakusen, Jill, Depo-provera: thee xtent of the
problem. A case study in the politics of birth
control (in) Women, Health and Reproduction
Ed. Helen Roberts, Routledge and Kegan
Paul, 1981.
6.
Roberts, Helen, Male hegemony in family plan
ning (in above book)
Sexist and Racist Implications of New Reproductive Technologies
(Excerpts from a paper presented at the XI World
Congress of Sociology, N. Delhi, August 1986.)
After atomic technology has come under heavy
attack, bio-technology, mainly genetic engineering
and reproductive technology, are propagated, to
gether with computer technology, as the great hope
in the so-called third technological revolution of ‘high
tech'. In this paper I shall concentrate on the impli
cations of the development of new reproductive
technologies. But it should be borne in mind that in
practice these technologies do not exist simply side
by side but are combined in a number of ways. This
is particularly true of the combination of genetic
engineering and reproductive technology. It is pre
cisely this possibility of their combination which
brings to light their destructive potentialities. The
discourse of these technologies is usually following
the principle of divide and rule: fundamental research
is divided from the application of the research results,
genetic engineering is divided from reproductive
technology, the application of reproductive techno
logy in industrialized societies is divided from that in
the under developed societies. This separation of
spheres and contexts which de facto are linked makes
a critical assessment of this technological develop
ment very difficult if not impossible.
3.
These technologies are legitimized by those who
want to sell them by humanitarian arguments: to help
infertile couples to have a baby out of their own flesh
and blood, to help women to avoid handicapped
children, to diminish the hazards of pregnancy and
child bearing etc. The methodological principle is
to high light the plight and unhappiness of a single
individual and to appeal to the solidarity of all to help
that individual. In this they use all kinds of psycho
logical blackmail. But the individual cases are used
to introduce these technologies and to create the
necessary acceptance among all women. The aim is—
total control of women's reproductive capacity. In
this woman as a person with human dignity is disre
garded.
4.
It is often argued that these technologies as
such are not good or bad, and that in a better society
these technologies could be of great use to mankind.
This argument is based on the widespread belief that
science and technology are neutral and separated
from social relations. A closer analysis carried out by
feminists in recent years has however revealed that the
dominant social relations are also part and parcel of
technology itself. This means, we can no longer say
that reproductive technology or genetic technology
as such are good, only their application is bad. The
very methods and basic principles of this technology
have to be criticized (1).
They are based on ex
I shall start with a few basic theses:
ploitation and subordination of nature, on exploita
1.
These technologies have not been developed tion and subordination of women, on exploitation
and are not produced on a mass scale to promote and subordination of other peoples, i.e. colonies. It
human happiness but to overcome the difficulties of is in this context that one can speak of an inherent
the present world system to continue its model of sexist, racist and ulimately fascist bias of the new re
permanent growth of commodities and accumulation. productive technologies.
As markets for durable consumer goods are no longer
expanding new needs have to be created for the new
Gena Corea in her book ‘The Mother Machine’
commodities developed by the scientists and the gives ample evidence of the ideological continuity
Industry. The female body with its generative capa between the eugenics movement and today’s genetic
cities has now been discovered as a new area of “in engineering and reproduction technology. She quotes
vestment” and profit making, for scientists, medical the marxist geneticist Muller, who won a Nobel
engineers and entrepreneurs, in a situation where Prize for his work on the effect of nuclear radiation
other areas of investment are no longer very promis on genes as having said, that infertility, which seemed
ing- (I).
to be on the increase, provided an excellent opportu
nity, for the entering wedge of positive selection,
2.
These technologies are introduced in a situation since the couples concerned are nearly always, under
of social relations between men and women, which such circumstances, open to the suggestion that they
are world wide based on exploitation and subordina turn their exigency to their credit by having as
tion. It is a historical fact that technological innova well-endowed children as possible (2).
tions within exploitative and unequal relationships
But what constituted the difference between Muller,
lead to an intensification of the inequality and ex
ploitation of the groups concerned and not to their who dreamt of breeding more men like Lenin, Newton,
Leonardo, Pastetl", Beethoven, Omar Khayyam,
reduction.
Pushkin, Sun Yet-Sen, Marx (2) was that in the
meantime it was no longer necessary to have complete
men women and make them copulate or prevent this
in order to achieve those superior beings. Genetic
research had meanwhile advanced and it was possible
to use donor sperm of geniuses to fertilize women
with. Of course the women should also possess
‘superior’ quality eggs. A further step in the perfec
tion of the technological means for the application
of the principle of selection and elimination are the
various methods of quality control and above all invitro fertilization (IVF). It is possible today not
only to isolate and select ova and sperm but also to
isolate genes, to cut up the DNA to examine which of
the chromosomes are defective, to recombine and
manipulate pieces of the DNA and thus directly in
fluence the genetic substance. Geneticists are busy
everywhere now to map the genetic pool of humans, to
discover ever more “genetic defects”: I would not be
surprised if in the near future we would see a whole
range of diseases being declared as genetically caused.
The ideology of socio-biology and of eugenics will
provide the criteria for what is to be understood as
‘valuable" and what as ‘defective’. These new “heredi
tary diseases” will provide an ample market for the
application of “gene-therapy”, and pre-natal diagno
sis, and neo-eugenics. The aim of this whole move
ment is to adapt the human being to the destructions of
the environment which technological process and the
growth model have caused.
Sexist biases permeate the new reproductive techno
logies as well as genetic engineering at all levels. In
general they imply that motherhood, the capacity to
bring forth children, is changed from natural process,
in which woman cooperated with her body as a
conscious human being, to an industrial production
process, in which the woman’s body is made totally
transparent, the processes of childbearing totally
rationalized, planned and controlled by the medical
experts, the product, the child, monitored at all stages
of its production, the woman herself being more than
ever objectified. In patriarchy she has long been an
object for male subjects. But what is new with the
new reproductive technologies is that she is no longer
one whole object, which has to be put under male
control, but she can be divided up in a whole series of
objects, which can be isolated, examined, re-combined,
sold, hired, or simply thrown away, like ova which
are not used for experimentation. This means in the
last analysis that the integrity of the woman as a human
person, an individual, i.e. a person who cannot
be divided up is destroyed by these technologies. It
is the old ideology of dominance of man over nature,
the ideology of scientific rationalism which has led to
this stage of destruction of the woman as a human
person, and her division into an arsenal of reproduc
tive matter. This rationalization process goes hand
in hand with an extension of poverty relations into the
female body. Women, who have been fighting for
reproductive ‘rights’ in recent years, have coined
the slogan: My belly belongs to me or, I am the
master of my belly 1 Such slogans convey the same
logic of private property. With the new reproductive
technologies this logic reveals its final destructiveness.
A woman who considers her womb, her ova, her
embryos, her ‘property’ can sell them or can buy
those of other women. On a more specific level, this
sexism manifests itself in various ways: For women
these new developments mean above all, that their
reproductive capacity will be put under rigid quality
control. One of the scientists working in this field
said that in future no woman would have the right to
burden society with a disabled child. The social
pressure on pregnant women to bring forth perfect
children is already enormous today and will grow
further. In the industrialised societies women are
already now subjected to a whole series of pregnancy
tests. If she is more than thirty, she is counted among
the ‘risk-pregnancies’. She is more or less put under
heavy pressure by her doctor to undergo an amnio
centesis. Yet, the risk of hurting the foetus is almost
as big as that of having a child with Down-Syndrome.
In the western industrial societies amniocentesis is
used to detect diseases of the foetus like the Down
syndrome. In countries like India and China the fe
male sex of the foetus is already considered the ‘defect’,
and leads to large scale abortion of female foetuses.
Vimal Balasubramanyam has rightly observed, that
this genocidal tendency, made possible by modern
reproductive technology, was advocated by some of the
western propagators as a more effective measure of
population control. ‘Breeding male’ was seen as
the remedy against the ‘population explosion’. Here
we see the close interconnection of racism and sexism
(3).
Apart from the total quality control which women
will have to undergo, the new reproductive technolo
gies provide the technical tool to rob women of their
autonomous reproductive competence and to put it
into the hands of medical experts. Following the
above mentioned general scientific methodology,
women are divided into their relevant reproductive
part, as ovas, uteri, and embryos. The female body
is treated as an arsenal of reproductive raw material
out of which the medical engineer selects those parts
which he needs for the industrial production of child
ren. Gena Corea writes that the girls who are born
today most probably feel, when they grow up, that
(MFC News contd. from p. 8)
giving birth to a child is a highly complicated affair,
for which only the medical experts have the necessary
competence. The producer of children will then be
those medical experts, not the women (2). This
loss of the competence of childbirth can already be
observed with many women today.
ORGANIZATIONAL MATTERS:
1. There was some misunderstanding regarding
the members of the cells formed at Patiala (see MFC
Newsletter Feb 1986). The reformulated cells are:
Cell 1. Critical analysis of Government Health
Policies and Programmes (Ravi Duggal,
Padma Prakash, Abhay Bang)
It seems that the technocrats now want to
get control over the life-giving processes after they
have been the masters of death so far. All their power
was hitherto based on the ultimate power of destruc
tion, whereas they had to depend on women to create
life. The new reproductive technologies are an attack
on this bastion. We can observe a rapid develop
ment of IVF clinics in many countries and research in
this field is advancing by leaps and bounds. More
and more the ‘natural’ processes of giving birth is
also manipulated.
Cell 2. Alternative strategies in Health Care (Abhay
Bang, Narendra Gupta, Ashok Bhargava).
Cell 3. Investigative field research to support health
action (Padma Prakash, Sathyamala, Kamala
Jayarao. Anil Patel).
Cell 4. Communications/lobbying on specific health
issues for policy changes (Marie D'Souza,
Ulhas Jajoo, Mira Shiva, Dhruv Mankad,
Anil Patel)
If we ask how medical experts got.such sweeping
control over women’s reproductive capacities, we have
to remember the whole contraceptive movement in the
last decades. Before sterility was defined as a disease
by the WHO, ‘fertility’ had been treated as a disease
for many years. Not only pharmaceutical firms who
wanted to sell their contraceptives, not only the medi
cal establishment had an interest in calling women’s
fertility a disease, but the women themselves became
“sick of their fertility” as one woman from Canada
put it at the Emergency Conference on Reproductive
Technology in Sweden in 1985. By looking at ferti
lity as a purely biological affair, by treating it as a
disease, women handed over the responsibility for
their generative powers to medical experts and to
scientists. Instead of changing the sexual relations of
men and women, women’s emancipation was expected
as a result of technological innovation and medical
treatment. And in fact, in the course of time many
women became de facto sick, not by their fertility as
such, but by treating it with contraceptives of various
sorts.
2.
Convenor’s Experience: Dhruv Mankad sharing
his experience during the past six moths as Convenor,
felt that over the years the physical volume of mfc’s
day to day work has increased. Since the convenor
like other members of mfc, is also involved in local
work, increasing preoccupation with mfc work en
croaches upon the local work, sometimes to such
an extent as to eclipse it. This would at some time
necessitate either a full time convenor for mfc or at
least a much quicker turnover of convenors.
Other administrative matters such as the member
ship position, finances, publication and distribution
of the anthologies etc. were also discussed.
— Dhruv Mankad, Convenor MFC
References:
By treating fertility and sterility as diseases, the
possibility of looking at them as socially and
historically influenced is barred. They are defined
as purely biological categories and hence fall into the
responsibility of medical experts. Any movement
against the sexism inherent in the new reproductive
technologies has to fight against the biological deter
minism implied in the definition of sterility and ferti
lity as diseases. It is this definition, backed by the
WHO, which puts women worldwide at the disposal
of powerful interests, mostly in the hands of men.
1. Maria Mies: Why do we need all this?—A
call against genetic engineering and reproduc
tive technology: Women’s studies International
Forum, Vol 8 No. 6, 1985.
2. Gena Corea : The Mother Machine: Repro
ductive Technologies, From Artificial Insemina
tion to Artificial Wombs, Harper and Row
Publishers, New York, 1985.
3.
—Maria Mies
6
Vimal Balasubramanyam: Medicine and the
Male Utopia, EPW, 23 October, 1982.
PH 3
n the era of Deregulation, Free Trade
I
and Foreign Investment, Indian Gov
ernment is allowing the entry of many
products which are hazardous to both
people and environment and are banned in
many countries. In fact, India is fast be
coming a dumping ground for banned prod
ucts and wastes. The list includes banned
pesticide, Monocrotophos, by Ciba Geigy,
Plastic Scrap from Pepsi, Cowdung from
Holland and lead wastes from the UK and
Germany. The latest entry in these prod
ucts is a hazardous contraceptive injection,
Depo Provera. The Indian Government
through the Drugs Controller ofIndia gave
permission to manufacture and-market
this contraceptive in India. This drug will
be manufactured by Max Pharma, India,
in foreign collaboration with Upjohn Co, a
Issued in Public
US drug Multinational Corporation. In
Interest by
April 1994, Max Pharma launched this
Public Interest
drug with much fanfare in India amidst
Research Group
protests by women's groups. Upjohn Co,
142, Maitri
with a $4 billion turnover, is the 16th
Apartments, Plot
largest health care corporation in the world.
No. 28,1.P. Extn.
Started in 1988, Max India is involved in
Delhi-110092
pharmaceutical, electronics, and packag
Phone-cum-Fax—
ing business, collaborating with many
91-11-2224233
Price : One Rupee
Multinational Corporations. The Family
Planning Association of India (FPAI), an
NGO, is to launch Depo through its wide-
network, another step in the State washing its hands off its
istory of Depo Provera
responsibilities. This hazardous injectable contraceptive which
has been the centre of a great deal of controversy, could get
approved by the US Food and Drug Administration (FDA) only as
1960 : Depo Provera (DMPA) approved by the US Food and
Drug Administration (FDA) for treatment ofmiscarriage
late as 1992. However, even before FDA approved its use as a
contraceptive in the US, it was already in use in 90 countries
(mostly Third world), on millions of women, which, given its
dubious safety record, amounts to a massive experiment on
women. Depo Provera has an annual sales of Rs 300 crorq|
(US$ 100 million), and is channelised mostly through the USAID.
How does Depo Provera work
and endometriosis.
1963 : Studies begin of Depo Provera as a 'birth-control shot'.
1967 : Upjohn Co. first applies for permission to market the
h
nodule formation in rats.
1972 : US FDA approves the drug for use in treatment of
Depo Provera is a progestogen, an artificial form of progesterone,
the hormone produced during the second half of the menstrual
advanced endometrial and renal cancer.
1974 : US FDA withdraws its approval of 1960 for DMPA,
cycle. Synthetichormones act by imitating the function ofnaturally
occuring hormones. But by being artificially introduced at wrong
drug as a contraceptive. Approval denied.
W971 : Depo Provera banned in Peru because of observation of
because of possibility of birth defects.
1976
: DMPA introduced in Indonesia.
times,.they disrupt the delicate natural hormone balance.
1977
: DMPA introduced in Sri Lanka.
DMPA acts on the hypothalamus-pituitary axis in the brain by
1978
introducing progesterone into the blood stream at times when its
addition to inhibiting ovulation, also thickens cervical nucus, and
makes the uterus a hostile environment for fertilisation in case
ovulation does occur.
countries lifted.
1983 : US FDA, yet again, rejects Upjohn application for
approval.
1985 : Dept, of Health, UK approves Depo Provera for
Depo Provera in India
Manufacturer
: US FDA, once again, denies approval of DMPA as a
contraceptive. But, all restrictions on sales to third world
level is supposed to be low i.e. soon after menstruation. DMPA, in
: Max Pharma, India
| ^>ng term use, but not "first-choice" contraceptive.
1986 : Womens' and Health Groups in India file a case in the
Supreme Court asking for a ban on Net-en and other
Foreign Collaborator: Upjohn Co, USA
hazardous contraceptives like Depo Provera.
Compound
: Medroxyprogesterone Acetate
1992
: FDA approves DMPA for contraceptive use in the US.
Dosage
: 150 mg. every 3 months
1993
: Indian government gives approval to Depo Provera.
Proposed Cost
: Rs 150 per injection.
1994
: Depo Provera launched in India.
Status
: No mandatory clinical trials
[DMPA]
fetuses, osteoporosis, or the mechanism that causes breast cancer.
Hazards of DMPA Use
The most common adverse effects are—menstrual cycle
irregularities (varying from frequent bleeding to complete ab
In fact, whatever little data exist, point to the extremely unsafe
and dubious nature of the drug.
sence of menstruation), extreme weight gain or loss, headache,
[ Barking up the Wrong Tree: Beagle Dogs and Biased Researcl
nervousness, mood changes, dizziness, fatigue, blood pressure
The Depo Provera case amply demonstrates biased research
changes, fluid retention, abdominal pain. It is unsuitable as a
setting out to prove whatever is convenient. For years, positive
spacing method (between one child and the next) because return
results of drug trials on animals like monkeys and beagles were
of fertility is not assured. The other adverse effects are—
.the green signal to go ahead with human trials. In recent trials on
H
DMPA is associated with a decrease in bone density, sinceW
'beagle dogs, tumour formation was noted after introduction of
inhibits estrogen production. Long term use may contribute to
progestogens (Depo). Suddenly, beagle dogs were found, even by
the development of osteoporosis (brittleness and thinning of
the WHO, to be "inappropriate to investigate the effects of
bones, leading to repeated fractures pain and disintegrating
progestogens in humans". Beagle dogs were now found to be so
vertebrae.
different from humans that negative results would not necessarily
E Data show a link between low birth-weight babies and neo
■
■
be seen in women—for once women undergoing clinical trials were
natal mortality and (accidental) use of Depo Provera during
elevated to the status of human beings! To consider the subject
pregnancy, masculinization on female fetuses, feminisation of
rather than the drug unsuitable is highly questionable.
male fetuses, congenital abormalities.
The other fraud is that of statistics. Incidence of endometrial
The link between breast cancer and DMPA has not been ruled
carcinoma in monkeys is dismissed as "insignificant". Signifi
out. Some data indicate doubling of the risk of breast cancer
cance obviously has more to do with political motives than with
for younger women, with use of DMPA for over two years.
statistical inferences.
There is increased incidence of cervical cancer in women using
Upjohn also turned a blind eye to the fact that in the seven year
DMPA for more than five years.
beagle studies, 18 of20 dogs receiving Depo, died, by claiming that
^jeagle dogs are especially prone to breast tumours.
e
■
DMPA causes changes in lipid metabolism, a risk factor
B
Effects on breast-feeding infants is unknown. Since DMPA
developing atherosclerosis and cardio-vascular disease.
passes into breast milk, giving DMPA to mothers of nursing
babies violates the restrictions on use of children in medical
experiments, evolved after the Nuremburg trials.
Upjohn has had twenty years to compile data but has failed to do
so. There is little or no data about effect of DMPA on developing
El
Ethical Questions_______________
Injectable contraceptives, especially DMPA, have a notorious
track record as regards ethics. Long before it was approved for
contraceptive use, physicians in the US were prescribing DMPA
to "promiscuous" teenagers and psychiatric patients deemed
incapable of managing their own contraception. It was also used
on immigrant women, with whom communication is 'difficult'.
In countries of the North, the use of DMPA on minorities smacks
of a racist and capitalist bias. It has been used on Black and
Chicano women in the US; Maori, Black and working class women
in New Zealand; and West Indian and Asian women in Britain.
stances, rather than othermore immediate side-effects. Moreover,
the hostility of the population control establishment to critics
concerned about cancer may prevent abnormal conditions from
being looked into. Thus, how much "objectivity" can be attrib
Quite often, these women have been administered Depo without
uted to data related to a drug generated by the very interests
their knowledge and consent.
that stand to profit from its extensive use?
The highest use ofDMPA in countries reporting a high 'acceptabil
The constant pursuit of approval for Depo in US and Canada, is
ity, (like Jamaica, Indonesia, Tonga, Thailand), is amongthe least
well-selected, least well-informed and least well-monitored pop^
not for the small US or Canadian market. Upjohn intends to
^apitalise on the high international reputation and influence a
lation. This despite the fact that its long-term safety record is
US-Canadian license would holdfor other countries where Upjohn
unestablished.
hopes to license Depo. This also has to be seen in the context ofthe
I Contraceptive Research: The onslaught ofPopulation Control)
increasing caution of governments in the Third World about
In 1984, both UK and the US received recommendations from
panels of experts convened to consider the merits of DMPA as a
long term contraceptive. Despite access to the same data, the UK
panel recommended marketing approval, but the US Public Board
of Inquiry did not. Differing national policies helped shape the
interpretation of data, and thus the divergent outcomes.
Contraceptive research policy in the US during the last 30 years
is changing with the liberalising inroads made by the Clinton
administration. For example, the reversal of the "Mexico City
Policy" which forbade financial support—domestic or overseas—
to institutions that may provide abortions.
A
licensing a drug unregistered in the country of origin.
A drug for long-term use as a contraceptive should never be used
in a country like India where specific studies on the tolerance of
the drug, its side effects and potential dangers have not been
carried out in the target population. The desperate hurry to
introduce Depo is because an injectable contraceptive is "ideal" in
the eyes of the population control lobby, since it is completely out
of a woman's control and can be given even without her knowledge.
The assurances of Upjohn regarding conducting post-marketing
surveillance (PMS) are touching, but lacking any sincerity or basis
I
Quotable Quotes
Upjohn Co. USA, has worked vigorously to get approval for Depo
"... population explosions, unless stopped would lead to
Provera. Not only does Upjohn manufacture Depo, it also controls
revolutions: population control is required to maintain the
most of the information about it. It spends millions of dollars a
normal operation ofUS commercial interests around the world".
year on research, ($6 million on one study in New Zealand alone—
Dr. Ravenholt former Head of the USAID
an amount equivalent to the entire annual budget of the Medical
Research Council of New Zealand), and investigates mainly
"Allowing Depo Provera into India is part and parcel of
liberalisation ofthe economy," Dr. P.Dasgupta, Drugs Controller
cancers, whose causes are difficult to prove under any circum-
of India. _________________________________________________
■3
n
in reality. In a country like India, a prescription for the most
potent drug can be had for a song, and infrastructure for carrying
out PMS simply does not exist. Collection and use of reports of
adverse reactions which even in rich Northern countries tend to
produce fragmentary and often unreliable results are completely
impracticable in developing countries. Informed consent is again,
a far cry, where women's "choice" of contraceptives is shaped by
marketing techniques of MNC-backed drug companies, and the
nexus between doctors and pharmaceutical companies preclu^:
any "independent" decision making by women. Noresterat (Net
en) another injectable contraceptive, manufactured by Schering
A.G., Germany will soon be on the market, another move violative
of all ethics, in keeping with 'liberalisation'.
An individualistic perspective of "leave-it-to-the-individual" robs
the discussion of the drugs impact on the group as well as socio
political realities. The only hope, when the state is abdicating its
responsibilities, is for the Indian people to reject Depo Provera and
similar tools of control.
What You Can Do
■ Write letters of protest asking for ban of Depo Provera in India to
Drugs Controller of India, Ministry of Health & Family Welfare,
Nirman Bhavan, New Delhi -110 001
H Organise meetings of youth, women, NGOs, student groups
various levels to discuss the implications of Depo Provera.
■ Write letters to Max Pharma India to withdraw from this project.
Address: 12th floor, Devika Tower, 6, Nehru Place, New Delhi
■ Write letters in newspapers, magazines and journals expressing
your view's on this controversy.
■ Contact the following groups working on this issue :
Saheli, Under Defence Colony Flyover, New Delhi - 110024
Jagori, C-54, South Extension II, New Delhi -110 049
Forum for Women's Health : 2, Vishwadeep, 95, Bhau Daji Rd,
Matunga, Bombay, 400 019.________________
KI
PJH 3>
TeZ. Coz.6q0j
r'^nnooi.
Co-LGSJ z^Zli^G UcCg-o^.
ARCH
■
fflResu conrvnunitq health & development
Po. Mangrol
Via. Rajpipla-393 150
Dist. Bharuch (Gujarat) India
November 28, 1994
Enclosed with this letter is a copy of the paper on our experience and
efforts to introduce Copper-T as a spacing method. The paper discusses
the problem posed by the community women to accept Copper-T and
subsequently their readiness to accept it after health education.
We think ii would be useful to share our experience with you and get
your critical comments and feedback.
With thanks.
Your'ssfe^
Daxa Patel. ——------
IUD Acceptance - Hurdles and Possible Solutions
Introduction:
India is one of the first third world countries that adopted population control as a national goal
more than four decades ago. Initially the policy was focused on child spacing as well as
permanent sterilization, but gradually the focus shifted to sterilization almost to the exclusion
of spacing methods. One could see some efforts to popularize intra-uterine devices (IUDs),
condoms, etc., in the early phase, but these unsteady beginnings were very soon abandoned.
The health authorities took non acceptance of IUDs and condoms for granted and assumed
that women will not accept IUDs. This almost sole reliance on permanent sterilization has got
population control program stuck in the rut. The strategy has failed to make required dent in
the demographic profile of the country. Excesses during emergency of 1975-77 made
sterilization program extremely unpopular amongst Muslims, Tribals and even Harijans.
Meanwhile other third world countries like Bangladesh and Indonesia, that were way behind
India as far as fertility statistics were concerned, have made rapid progress in this regard by
adapting predominantly child spacing programs.
ARCH (Action Research in Community Health & Development) has been working for last
fourteen years in a predominantly tribal area of eastern part of Bharuch District in Gujarat to
develop appropriate primary health care programs. For the first 10 years of our work in this
area we thought it wise not even to mention birth-control. This would antagonize the rural
population. Then women first made their needs known to us through increasing demand for
induced abortions. It was soon clear that women, while reluctant to accept permanent
sterilization soon after the birth of second or third child, were yearning to get respite from
rapid succession of pregnancies and also unwanted pregnancies. They desired small families
through spacing, but not sterilization soon after completing the desired family size. Condoms
are still not popular, nor are the oral contraceptive pills. But nothing definitive about them
should be said, looking at our experience with IUDs.
Apart from the permanent sterilization, IUD is one spacing method known to a large number
of women of all classes. Yet, despite their desire for spacing, most of the women are very
reluctant to accept it. As is to be expected, they have many misconceptions about where IUD
is placed in the body, what it does and how it works. Many women have revealed to us that
they believe that it would go up in the chest or would be lost in the abdomen, it is hot and
causes loss of weight and energy. Also both men and women strongly fear that with IUD in
place they will both get stuck during sexual intercourse and separation will be impossible
unless doctor intervenes. These perceived fears and apprehensions have to be systematically
dealt with through sensitive health education program. In this paper we present our experience
in this regard.
Method and Material:
Between January 1987 and December 1990, 56 women (Group A) of all castes and economic
categories came to Mangrol Dispensary for IUD insertion. During this period we were just
beginning to learn about the fears and misconceptions of women regarding IUDs and had not
yet developed a need specific health education program to dispel them.
By 1991 our understanding of the reasons behind women’s misconceptions and fears had
improved and from January 1991 we initiated a process of free and friendly exchange of
information to bridge the gap of radically different views of women about anatomy leading to
various types of differing perceptions. For the first time they saw through the slides tl at
uterus, vagina, fallopian tubes, etc., are completely separate from the gastrointestinal tract in
2
the abdominal cavity. We also developed a simple low cost model of thermocol showing
uterus, cervix, vagina and fallopian tubes for demonstration. All women who came for IUD
insertion were first shown this model and the whole process of IUD insertion was shown to
them by actually inserting IUD in the model through cervix into the uterus and left in uterum
with small thread freely hanging in vagina. They could see that uterus is a separate organ
closed from above and the IUD cannot go up in the chest the fear of getting stuck by IUD was
also not real. It was also easier for them to see that with the help of thread hanging freely in
the vagina, the IUD can be easily removed any time they wanted. All possible problems of
leucorrhoea, bleeding and pain were explained at the time of insertion and the women were
asked to visit the dispensary if such problems occurred so that appropriate treatment could be
given. 80 women (Group B) accepted IUDs during this period of three years from January 91
to December 93.
There was no change of techniques, IUDs, instruments or sterilization method between the
two periods. For each woman a separately autoclaved set of instruments, towels etc., was
used. The same doctor introduced IUDs during both periods. IUDs were supplied in standard
sterilized packs from the nearby government Primary health center in Lachharas. Detailed
records were kept of all subsequent visits and reasons for IUD removal were recorded in all
cases. Follow up contacts were made in cases where women did not visit the dispensary on
their own.
For the purpose of statistical analysis of difference in the rates of IUD removal / retention we
have followed life-table technique (‘Statistical Methods in Epidemiology’ by Harold Kahn and
Christopher Sempos, Oxford University Press, 1989. PP. 168-180). Rates of IUD removals in
each 2 month time interval after the date of insertion upto 2 years were worked out for both
groups. Those cases where no follow up contacts could be made (2 in Period A and 1 in
3
Period B) have been considered as withdrawn in the very first time interval. Those cases in
group B (period 1991-93) where the women were still continuing with the IUDs on November
1,
1994 (date of analysis) and had not yet completed 2 years since insertion were considered
withdrawn in appropriate time interval by taking into account the time they had already
retained the IUDs. There were no such cases in group A (period 1987-90) as all women who
got IUDs inserted in this period had completed more than 2 years on November 1, 1994.
Results:
Tables 1 shows education of women in groups A and B. As is seen the two groups are not
significantly different from each other in this regard (P = 0.60).
Table 1. Education of Women in two Groups:
Education
Category
Illiterate (0)
Group >4
(1987-90)
12
21%
Group B
(1991-93)
20
25%
Primary (1 to 4)
9
16%
9
11%
Secondary (5 to 7)
15
27%
17
21%
Secondary (8 to 10)
14
25%
26
33%
Higher Secondary (10+)
6
11%
8
10%
Total.
56
100%
80
100%
Table 2 shows mean age of women with standard deviation in two groups. They are also not
significantly different from each other (P> 0.60).
Table 2. Mean Age of Women in two Groups:
Group B
(1991-93)
Group A
(1987-90)
No. of Women
Mean age in years
Standard deviation
56
23.9
5.6
4
80
23.4
4.5
Tabic 3 shows caste breakdown of the women in two groups. As can be seen proportion of
tribals had increased sharply in group B.
Table 3. Caste groupings in two Groups:
Castegroup
Upper castes
OBCs
Scheduled castes
Scheduled tribes
Muslims
Total
Group A
(1987-90)
34
61%
6
11%
4%
2
13%
7
13%
___ 7
56
Group B
(1991-93)
31
39%
10
13%
1
1%
33
41%
5
6%
80
Table 4 shows the number of women who complained of leucorrhoca, excessive menstruation
or pain during first six months since IUD insertion in both groups and also the number of
women who got their IUDs removed because of them. The proportion of women who
complained of these problems is not significantly different in the two groups (P = 0.39 ). But
significantly higher number of women in group A also got their IUDs removed because of
these problems in group A (80 % of those who complained against 20% in group B.
P = 0.0002).
Table 4. Complaints of Leucorrhoea, Bleeding or Pain in
two Groups:
Group B
(1991-93)
Group A
(1987-90)
No. of Women who accepted IUDs
Those who complained of
Leucorrhoea, bleeding or Pain within
six months of IUD insertion
Those who also got their IUDs
removed because of these problems.
80
56
20
36%
23
29%
16
80%
5
22%
Tables 5 presents life-table analysis for women in groups A and B respectively. As is seen, at
the end of six months from insertion 66 % and 89% women had retained IUDs in groups A
and B respectively while corresponding figures at the end of one year are 48% and 77%
respectively. This differences is highly significant (P = 0.002). The rate of IUD retention for all
intervals is also significantly higher in group B (P = 0.025).
Table 5: Life-table analysis for Removal / Retention of IUDs
Time at
beginning
of interval
(months)
No. at
beginning
of interval
IUDs
removed
in the
interval
x to x+2
Cases
withdrawn
in the
interval
x to x+2
X
Ox
2dx
2wx
0
2
4
6
8
10
12
14
16
18
20
22
24
56
52
44
36
32
28
26
26
24
23
23
20
15
2
0
2
4
6
8
10
12
14
16
18
20
22
24
80
74
72
70
66
61
55
53
47
40
27
19
14
Ox
adjusted
for with
drawals.
Ox - 2wx/2
O'x
8
8
4
4
2
0
2
1
0
3
5
2
0
0
0
0
0
0
0
0
0
0
0
55
52
44
36
32
28
26
26
24
23
23
20
5
2
2
4
5
1
1
3
5
6
1
2
1
0
0
0
0
5
1
3
2
7
7
3
80
74
72
70
66
59
55
52
46
37
24
18
6
Probability of
IUD
IUD
IUD
retention
retention
removal
from time
during
during
of insertion
interval
interval
upto x+2
(1-P1)
(2dx/O'x)
(x+2)P0
2px
2qx
Group A (Period 1987 - 1990}
96%
96%
4%
81%
84%
16%
66%
81%
19%
59%
88%
12%
52%
87%
13%
48%
92%
8%
48%
100%
0%
45%
92%
8%
43%
95%
5%
43%
100%
0%
37%
86%
14%
28%
75%
25%
___
Group B (Period 1991-1993)___________
93%
93%
7%
91%
97%
3%
89%
97%
3%
84%
94%
6%
78%
8%
92%
98%
77%
2%
76%
98%
2%
72%
94%
6%
65%
89%
11%
54%
83%
17%
95%
52%
5%
88%
46%
12%
Table 6 shows reasons for IUD removals in two groups. It is seen that removals due to
leucorrhoea, bleeding, pain, etc., have fallen sharply in group B.
Table 6. Reasons for IUD Removals in two Groups
Reasons for IUD Removal
Leucorrhoea & Pain
Excessive Menstruation
Desires Child
Desires Permanent Sterilization
Spontaneous Expulsion
Other
Total
Group A
(1987-90)
18
46%
11
28%
6
15%
3
8%
0
0%
1
3%
100%
39
Group 8
(1991-93)
27%
10
19%
7
30%
11
8%
3
16%
6
0%
0
700%
37
Discussion:
This study could have missed out other influential variables in the two periods, but we do not
believe that any positive time trend affecting the outcome is operating in this locality and
community to affect the difference in rates of IUD removals. The living conditions and the
civic amenities available to these communities remain essentially unchanged. The difference in
the rates of IUD retention in two groups could possibly be related to the fact that significantly
higher number of tribal women are included in group B who may may have greater capacity to
bear with body pain and discomfort. A closer look at the data, however, shows that the drop
in rate of IUD removal is steep and across all the caste groups. The tribal women’s possible
greater pain bearing capacity is not an explanation. Moreover if the higher thresold of physical
discomfort in tribals was indeed an explanation, one would have expected much higher
proportion of tribal women opting for IUD insertion in group A. In fact our understanding is
that the level of apprehension amongst tribals is very high.
The proportion of women who reported leucorrhoea, bleeding or pain in first six months after
IUD insertion is essentially same in two groups. But rate of IUD removal due to these
7
problems is significantly higher in group A, which strongly supports our contention that
intensive and specific health information related to woman’s reproductive system about which
there are widespread misconceptions and apprehensions, has had positive effect on acceptance
and continuation of IUDs. The findings are strongly suggestive and need to be followed up in
a community setting. We have not been able to do proper bacteriological tests on women who
came with specific complaints, but on clinical examination there was no evidence of infection
except for one woman in group B in whose case IUD was promptly removed. It should be
noted that despite complaints a large majority of women who had been given appropriate
health education were reassured and could continue to retain IUDs and on followup showed
no adverse effects. This is an important finding at a time when IUD has been discarded by all
concerned, including health activists. Given all the limitations of this study it can be said
cautiously that IUDs can be a decent choice to women who in large numbers are demanding
child spacing in subdued voice rather than permanent sterilization. There is reason to believe
that similarly other groups of eligible couples are waiting to be offered condoms and oral
contraceptives.
Dr. Daxa Patel & Ambrish Mehta
ARCH, Mangrol
21 November, 1994.
L)H 3-
Family
Planning
Methods
Questions and Answers
FAMBLY PLANNING METHODS
Questions and Answers
|t is now generally understood that family planning
means having children by choice and it is possible not to
have children when the parents do not want them. Thus,
if the couples desire, they can prevent conception by
using any family planning-methods that might be liked
and selected by them.
There are several methods of contraception or preventing
pregnancy i. e. natural methods, non-terminal artificial
methods and terminal methods.Some are to be used by
men and some by women. The couples have to select the
methods of their choice and liking and use them as and
when they want. Non-terminal methods are suitable for
spacing the birth of children, but can also be used for
limitation. The terminal methods are accepted only when
couples decide not to have any more children.
Efforts have been made here to provide information in
the form of questions and answers about these methods
and also to remove certain common doubts and fears
about certain methods.
NATURAL METHODS
|
(a) COITUS INTERRUPTUS |
Q What is Coitus Interruptus ?
A Coitus Interruptus means withdrawal of the penis
before ejaculation. This is also known as
"Withdrawal' method. This is perhaps the oldest
contraceptive procedure known to man.
Q How does Coitus Interruptus avoid conception ?
A Coitus Interruptus avoids the flow of semen into the
female genital tract.
Q What are the advantages of Coitus Interruptus ?
A This method requires no supplies and no particular
preparations. It costs nothing.
Q What are the disadvantages of Coitus Interruptus ?
A In order to practise it successfully, it is necessary
that the man must have sufficient self-control. Some
men are physically or emotionally unable to use this
method. Unless the woman reaches orgasm prior to
the withdrawal, additional manual stimulation may
be necessary for sexual satisfaction.
Q Is there any possibility of failure of this method, and
if so, how ?
A This method may fail due to escape of semen before
ejaculation or delayed withdrawal or deposit of
semen in the women's external sexual organs which
may result in pregnancy,
Q What are the side-effects of Coitus Interruptus ?
A Although a vide variety of gynaecological, urological.
neurological and psychiatric ills have been attributed
to this practice, the cause-and-effect relationship
has never been established. Many couples continue
to use the method for years without apparent illeffects and with adequate sexual satisfaction for
both partners.
|
(b) RHYTHM METHOD |
Q what is Rhythm Method ?
A The Rhythm Method is based on the avoidance of
coitus during unsafe period i.e. the days when it
could result in the simultaneous presence of
fertilizable ovum and mobile spermatozoa.
Q What is considered safe period and unsafe period
according to the Rhythm Method ?
A In every month there is a certain period when
intercourse does not lead to pregnancy. This period
is called the safe period. This is calculated on the
basis of the menstrual cycle of a woman.
In order to find out the exact days of safe period
and unsafe period one should count eleven days
backward from the expected date of commencement
of menstruation. For example, if menses are
expected to commence on the 28th of a month, the
date backward by eleven days will be the 17th. Now
go back by 5 days more and note down the dates.
They will be 16th, 15th, 14th, 13th, and 12th.
Ovulation from the ovaries of the woman can occur
on any of these 5 days. To this we should add
2 days more for the life of the sperm and one day
for the life of the ovum. Thus, this middle period of
eight days i. e. 16th, 15th, 14th, 13th, 12th, 11th,
10th, and 9th of the month will be full of possibility
of pregnancy. This is known as unsafe period. The
8 preceding days, and the following 11 days are
regarded as safe period. There will be no ovum to
meet the sperm during these days and a coital act
performed during this period will not result in
pregnancy.
Q What are the disadvantages of Rhythm Method ?
0„„i* r.
A This method greatly reduces
the opportunity for
intercourse. However,
coital act can be
performed during unsafe
periods only by using
some suitable methods
of contraception.
Besides it is unsuitable
for a women with
grossly irregular
menstrual cycle.
Successful practice of
Rhythm Method also
requires considerable
self-control and an equally strong desire
to control fertility. This method also requires correct
calculations and proper understanding.
Q Are there any chances of failure of the Rhythm
Method ?
A Apart from taking a chance on the days known as
unsafe, the main reasons for the failure of Rhythm
Method are errors in recording the menstrual history,
errors of calculation, the inherent variability of the
menstrual pattern and exceptionally long survival of
sperms in the female genital tract.
Q Are there any side-effects of the Rhythm Method ?
A No, there are no side-effects of the Rhythm method,
|
(c)
abstinence]
Q What is abstinence ?
A Abstinence means non-indulgence in sexual
intercourse when children are not required,
Q How for is the abstinence practicable ?
A Abstinence requires a high degree of self-control on
the part of the men and women. This may not be
possible in many cases.
NON-TERMINAL
METHODS
|
(a) NIRODH |
Q What is 'Nirodh' or condom ?
A 'Nirodh' or condom is a contraceptive r_jber sheath
which covers the penis during intercourse and
prevents the flow of semen into the vagina. 'Nirodh'
is the Indian name of condom.
Q What are the advantages of the use of 'Nirodh' ?
A The 'Nirodh' offers relaible protection not only
against pregnancy but also against venereal
infections. If can be used in almost any situation
where intercourse is possible.
Q What are the disadvantages of 'Nirodh' ?
A There are no perceptible disadvantages of the use of
'Nirodh'. However, some men and women consider
the rubber membranes an obstacle to sexual
sensation.
Q Is there any possibility of the failure of 'Nirodh'?
A Pregnancy may result from a break or tear of the
rubber sheath or from the escape of semen at the
open end of the 'Nirodh', if withdrawal is delayed.
Q What are the side-effects of the use of 'Nirodh' ?
A There are no side-effects of its use. However, an
occasional individual may be sensitive to rubber.
Q How popular is the use of 'Nirodh' in India ?
A 'Nirodh' is one of the most popular conventional
contraceptive devices used in india-it is freely
available from the Family Welfare/Planning Centres,
Public Health Centres and Sub-Centers and is
widely sold at the rate of 25 paise for three pieces.
|
(b) diaphragm]
Q What is a Diaphragm ?
A
Diaphragm, also known as pessary, is made of soft
rubber and has a flexible metal spring around its
circumference. It is used by women. It lies diagonally
across the vaginal canal. The Diaphragm covers
cervix, the upper Part of vaginal opening into the
uterus. Diaphragm is always prescribed by doctors
and should be used in combination with a vaginal
Jelly or cream which acts as a spermicide as well as
a lubricant for inserting the Diaphragm.
Q What are the difficulties in the use of Diaphragm ?
A The Diaphragm are of different sizes (i. e. from
50mm to 105 mm). It requires a pelvic examination
by a physician or a trained health worker to select
the Diaphragm of a correct size. In order to be
effective it must be fitted properly. The women
must also know as to how to insert the Diaphragm
and how to remove it.
Q How effective is the use of Diaphragm ?
A If used properly the Diaphragm offers a high level
of protection against unwanted pregnancy.
Q In what conditions the use of Diaphragm proves a
failure ?
A Even a well-fitted Diaphragm may be incorrectly
inserted, so that, it fails to cover cervix, or it may
be displaced during the orgastic expansion of the
inner two-thirds of the vaginal barrel.
Q Are there any side-effects ?
A Normally there are no side-effects of the use of
Diaphragm. However, reactions to rubber or to one
of the components of jelly or cream may be reported
in rare cases.
(c) spermicides"
Q What is a spermicide <
A Jellies, creams,
I
foam tablets, etc.,
|
contain chemicals
which kill the sperms.
These spermicides are
intended to be used
without a diaphragm.
Q How are spermicides used?
A Creams and jellies are applied in the vagina with the
help of applicator and foam tablets are inserted with
the help of fingers. Foam tablets dissolve in vagina
on contact with moisture to release carbon dioxide,
producing dense foam.
Q What is the mode of action of spermicides ?
A These materials immobilize sperm on contact with
the ejaculate. They destroy the sperms in the
[
semenal fluid in the vagina and so the woman cannot
conceive.
Q What are the advantages of spermicides ?
A They are relatively simple to use and do not require
pelvic examination. The foam tablets are inexpensive.
Q What are the disadvantages of the use of
spermicides ?
A Many users complain of vaginal leakage (messiness)
and excessive lubrication. Foam tablets also require
a waiting period of several minutes to allow for
melting or disintegration.
Q What is the effectiveness of spermicides?
A Spermicides used alone appear to be less effective
than spermicides used in combination with the
Diaphragm. However, foam tablets appear to be
more effective than other types of spermicides.
Q In what circumstances the spermicides do not prove
effective?
A An inadequate quantity or quality of spermicidal
material is the most obvious reason for the failure.
Some spermicides dissolve or disintegrate slowly and
are inadequately distributed throughout the vagina.
Some couples fail to observe the waiting period.
Q What are the side-effects of spermicides?
A In some cases they cause irritation and/or
inflamatory changes of the mucous membrane.
(d) INTRAUTERINE DEVICE?"]
Q What is an Intrauterine Device
(I.U.D) ?
A An Intrauterine Device,
/| fll h
commonly known as loop/
I ]T I
copper T, is placed by the
xI II 1
doctor inside the uterus.
Its presence there prevents pregnancy.
Q Does loop interfere with the normal sex life of a
woman?
A No, it does not interfere with the normal sex life of
a woman.
Q Are there any complications after loop insertions?
A In certain cases excessive bleeding and back-ache is
reported after loop insertions. It may continue for
|
Q
A
Q
A
Q
A
|
Q
A
Q
A
Q
A
Q
A
a few days. The first few menstrual period
might also be comparatively heavy and may continue
for a longer duration. But they become normal
within a few months. However, doctor should be
consulted for unusual bleeding and pain. The doctor
removes the loop if he/she finds that it does not
suit a particular woman.
Can every woman use loop?
Experience shows that loop does suit about 25% of
women. However, the doctor alone can say after
thorough medical examination whether the loop
should be inserted or not.
Is there any truth in the rumour that loop causes
cancer?
The loop does not cause cancer or any other disease.
This has been proved by scientific studies.
Does the loop cause sterility ?
No, actually the best point in favour of the loop is
that it is a reversible method. When the woman
wants a child, she can get the loop removed.
(e) PILL]
What is the pill?
The pill is a contraceptive to be taken by mouth.
Starting from the 5th day after menstrual flow
begins a woman has to take one pill a day for 21
consecutive days. She can wait for 7 days and start
taking the pill all over again. The pill should not be
missed even for a day because its stoppage increases
chances of pregnancy.
Can all women take the piH?
The pill should be taken only when prescribed by
doctor after thorough medical examination.
Are there any side-effects of the pill?
In certain cases tiredness or dizziness, weight gain,
nausea, stoppage of the menstrual periods,
vomitting, feeling of sickness, tenderness of the
breasts, in between period bleeding are reported.
Generally they disappear after regular use for three
to four months.
Should the pill be continued during in-between
period bleeding?
The regularity of taking the pill should be
maintained Irrespective of any in-between period
bleeding and full course of the pill should invariably
be taken.
TERMINAL METHODS
Sterilisation
|
Q
A
Q
A
Q
A
Q
A
VASECTOMY |
What should a couple do when they do not want
any more children?
There are terminal methods both for men and
women, Male operation is called vasectomy and the
female operation tubectomy, it is not necessary
for both husband and wife to undergo these
operations. Only one of them may decide to go in
for the sterilisation operation and that would
provide them a permanent relief from future
pregnancy.
What is vasectomy ?
The male sterilisation operation is called vasectomy.
This operation is performed practically without any
trouble. The male vas is cut and then both the ends
are tied. The Incision is done at both sides of the
scrotum. The whole procedure takes 16 to 20
minutes.
How long should a man abstain from coitus after
vasectomy?
Abstinence or use of 'Nirodh' by the male after the
vasectomy operation Is essential for a period of six
to eight weeks. This Is because some residual sperms
may still be present In the semen after the operation.
After the proscribed period the male should get his
semen tested. Ho can stop using contraceptives after
the doctor has declared the absence of sperms In his
semen.
(I)
Does vaseotomy lead to Impotency?
No, this la a baseless fear. As no sexual glands are
removed. In this operation, the question of
Impotenoy does not arise. However, wherever such
complaints are reported, they aro generally due to
psyeholoolgal reasons.
Q Are there any side-effects or complications after
vasectomy operation?
A There are no side-effects or complications after
the operation provided it has been performed by
a competent surgeon after full asceptic precaution,
|
(ii) TUBECTOMY |
Q What is tubectomy operation?
A Tubectomy operation is performed on women,
This is somewhat different from vasectomy
operation and also not as simple as vasectomy, This
can be performed at any time but preferably three
or four days after delivery, The fallopian tubes^of
both the sides are cut and tied. After the operation
the woman has to lie in bed for about a week,
Q Are there any side-effects of tubectomy operation?
A No, there are no side-effects of tubectomy operation
and the woman continues to feel normal,
Q Is it possible to have children after undergoing
sterilisation?
A Both male and female sterilisation operations are
permanent terminal methods, They are accepted only
after it is decided not to have any more children,
However, in exceptional cases where the couple
might like to have more children later on, the
vasectomy or tubectomy operations can be reversed
by a competent doctor, but it is a complicated
surgery
— —H
Designed & produced by the Directorate of Advertising & Visual
Publicity, Ministry of I. & B., for the Ministry of Health and Family
Welfare and printed at Glasgow Printing Co. Private Ltd. Howrah.
September 1978
2/8/78-PPVI
English—80,000
Birth control vaccine our idea
1
li^e^ osays award winner
a vaccine can be used to control method is also said to be safe and screening. These have been
By TABISH KHAIR
without any deletrious side-effect licensed to Indian companies. Two
The Times of India News Service birth, without effecting other body
An added benefit is that the of them are already in the market.”
functions, is a new one?'
Dr Talwar also lists the Nil
NEW DELHI, July 23.
Not only is the idea a new one, vaccine will afford protection from
R G.P. Talwar, the latest re it is brilliant in its theoretical some other diseases by way of the among his achievements. He says,
carrier molecule used. ...
In effect, ..
if “I created this from scratch in
cipient of the prestigious simplicity. As is well known, the uuiici
Order Of The Legion of Honour, average vaccine is used to help the the diphtheria toxoid is the carrier 1983. Over the years it has
France’s highest civilian award, organism generate anti-bodies molecule attached to HCG, the achieved international eminance.”
docs not conform to the awry- against foreign elements that may body will also be vaccinated 'The Nil leads research in some
fields
of immnnnlnov
immunology and is one of
M< nf
haired, absent-minded image of the enter it. Dr Taiwar’s idea was to againsst an attack of diphtheria. fi'
the premier institutes of im
quintessential scientist. He is develop a vaccine which can gener- And so on.
What are some of his other munology in the world.
smartly dressed and extremely
Dr Talwar was also the head of
contributions? Replies Dr Talwar,
alert.
“Another vaccine is an anti-leprosy the department of biochemistry at
The immaculate buildings and
one. It is currently on trial in two the All India Institute of Medical
grounds of the National Institute of
major hospitals of Delhi as well as Sciences (AIIMS) for 18 years. He
Immunology, which he established
in Kanpur Dehat, which has a did his master’s degree from Pun
almost single-handedly, attest to
community of 3,62,000 people. jab University and his doctorate
his organisational capacities. Yet,
This vaccine can upgrade im from the prestigious Pasteur In
Dr Talwar is very much a scientist
in Paris. “So, now you know
munological responses of the pa- stitute tn
— his heart lies in his laboratory.
dent and accelerate recovery from my French connection," he quips.
That is where he rushed the mo
the disease.”
Awards are nothing new for Dr
ment he finishes giving an inter
Talwar. He has received a number
view to The Times of India.
A special feature of this vaccine of prestigious awards and lecNot only is Dr Talwar the found
is that it can be used to cure tureships, including the Basanti
ing director of Nil, he can also be
patients who are resistant to drugs. Devi Amir Chand senior prize of
credited with laying a strong foun
The success rate is said to be much Indian Council of Medical Redation for immunology in India.
higher than that of traditional ther- search, the national award in bioThe French honour, awarded to an
apy.
medicine, the Alexander Von
Indian scientist for the first time, is
Dr Talwar adds, “One of the Humbolt Foundation medal and
in recognition of his various con
injectibles developed by me has the sir JC Bose award.
tributions to this growing and ex
already completed the stage of
He has published over 200 origDr G.P. Talwar
citing field.
lesting. It has been cleared by the ;nai papers and is the author/editor
Explains Dr Talwar, “The ate anti-bodies against Human drug controller and has been of 13 books. One of the hybrid cell
French award is not for any one Chorionic Gonadotropin (HCG), licensed to a private sector under c]Ones developed by him, was the
contribution. It is for the general the pregnancy hormone.
the trade name of Talsur. The tai is first Indian bio-technology product
body of my works.” He goes on to
This was tougher than it sounds, from my name and the sur is from t0 be acquired by a leading U.S.
bestow part of the credit on his co because the human organism gen- the
of the worker who tested company.
--- name
workers, whom he describes as crates anti-bodies only against it-"
So much about the scientist.
“committed scientists of a high foreign molecules and not against
Essentially, this injectible can be what about the man? “Well, I am.
calbirc.” “I am happy to have "native” ones. The way out was to used to sterilize male animals basically a refitgee from Punjba.
created this institute for us to work conjugate the beta sub-unit of HCG without affecting their virility. This we came over during the partition.
together,” he adds.
with (foreign) carrier molecules vaccine can arrest the proliferation Now, for all practical purposes, I
However, the field which is like tetanus toxoid or diphtheria of scrub animals and is crucial to belong to Delhi. I have three chilalmost entirely Dr Taiwar’s crea toxoid. This ensured that anti the success of artificial insemina- dren — two daughters and a son.
tion, is the idea of a birth control bodies were created to attack the tion.
My son is an architect He is
vaccine, now in the second stage of HCG and render it “infertile.”
That is not al^ Dr Talwar and his studying at MIT (the U.S.). My
trial. Says the professor, “The idea
This birth control vaccine has team of brilliant scientists are also wife used to be a teacher.”
of ? birth control vaccine is ours. the advantage of being reversible. working in many other “departAre any of his children into
This was an entirely now concept. Il’s effect will last for approximate ments” of immunology. He says, scientific research? “I hope my
Nowdt is a reality.
ly a year (though the exact time “Along with my colleagues, I have grandson will be a scientist,” re“Normally, vaccines have been span is still to be determined) and also developed diagnostic kits for plies Dr Talwar, with a twinkle in
used to protect the body and com can be indefinitely prolonged by the detection of pregnancy, ty- his eyes. Interview over, he disapbat some diseases. But the idea that taking booster injections. The phoid, amoebiasis and blood group pears into the laboratory.
D
Table 1 ■ Priorities for Biotechnology In India
Priorities
Health
Energy
Prophylactic
Therapeutic
Diagnostic
Hygiene
Population Control
Biomass
Energy Plantation
Biofuels and Bioreactors
Industry
Conservation of Forests and
Afforestation
Pollution Recycling
Waste Recycling
Fermentation (Antibiotics,
Organic Acids)
Biofuels
Food and Feed
Metallurgy and Mining
Oil Recovery
Environment
Communication, Informatics
Computer Based Information
Collection and Dissemination
Agriculture
Education and Training
Soil Feniility
Bio-Fertilizers
New Varieties
Nitrogen Fixation
Quick Propogation through
Tissue Culture
Improvements to Animal
Health and Productivity
University Level Education
Specialized Training Program
Source.’ Government of India, Department of Science and Techno
logy, National Biotechnology Board, Long Term Plan for Biotechno
logy in India. New Delhi: The Department, April 1983, p. 14.
Table 2 - Biotechnology Actiritfea with Time Horizon In Different Sector In India
l)H 3
-UP-JRT OF THE PUBLIC BOARD OF INQUIRY ON DEPO-PROVERA
17 OCTOBER, 1984
^\?.i.nss. GF EACT
'
DATA AVAILABLE ON THE LONG-TERM RISKS OF DMPA
ARE INSUFFICIENT AND INADEQUATE TO PROVIDE A
-- -- -——--- BASrS FOR A DECISION WHETHER THE BENEFITS OF
THE DRUG AS A CONTRACEPTIVE OUTWEIGH ITS DIS
ADVANTAGES UNDER CONDITIONS CF GENERAL MARKET
ING IN THE USA
I.
■ -
i
There are adequate data to assess the efficacy and
benefits of DMPA as a contraceptive.
There is also
sufficient information on its short tern side effects and
risks, The drug is clearly a highly effective contraceptive
. with certain specific advantages, and it doos not appear to
pose'any immediate irreversible serious side effects.
' Ho-, over, the facts relating to the long tern consequences of
the use cf the drug are inadequate and insufficient to
provide a basis for risk assessment. This is a serious
deficionoy in light of the specific questions that have been
raised that the drug may have major adverse effects following
its Long term use or that may become evident only after a
latent period. Most important among these has been the
concern over the drug's carcinogenic potential.
The long term consequences of he use of DMPA on
neoplasias, in particular of the breast and uterus, as well
osteoporosis and atherosclerosis are of particular rele
vance for any risk/benefit assessment of the drug's use in
■ko United States because of the susceptibility of tlie
population in this country to these diseases.
In the absence of adequate data on the long term
consequences of the drug it is not possible to arrive at any
scientifically defensible conclusion whether or not the
"benefits of the drug, when used as a contraceptive, outweigh
its risks for the average healthy individual in the United
States. xt also makes it impossible to compare the risk/
benefit ratio . of DMPA with that of other drugs available
for contraception.
Tic
DATA FROM THE STUDIES CF RHESUS MONKEYS HID BEAGLE
DOGS CAN NOT BE DISMISSED AS IRRELEVANT TO THE HUMAN
WITHOUT CCITCLUSIVE EVIDENCE TO THE CONTRARY. SUCH
EVIDENCE IS NOT AVAILABLE AT THIS TIME. THEREFORE, THE
FACT THAT MALIGNANT NEOPLASIAS DEVELOPED IN TWO
SPECIES IN TARGET ORGANS CF SEX STEROIDS MUST BE
CONSIDERED AS AN INDICATION OF A POTENTIAL OF
P.ROGESTOGENS, INCLUDING DMPA, TC PROMOTE THE DEVELOP
MENT CF MALIGNANCIES IN TARGET ORGANS
The findings from animal tests implicate DMPA as a
potential promoter of neoplasias because;
-- ---.1) . Chronic administration of DMPA. wajS ' associated with the
development of malignant neoplasias in two mammalian species.
Data are also inadequate to establish effect of MPA. on
bone and on the profile of plasma lipoproteins, inform
ation needed to evaluate whether the long term use of
the drug will or will not predispose the individual to,
osteoporosis or to atherosclerosis. Our conclusions of
Law do not rely on this finding.
- 2 2)
The neoplasias developed in target organs of sex
*
steroids
3)
There is good evidence to support the conclusion that
in both species the malignancies were drug related.
4)
There is no evidence to support the conclusion that
the effect of the drug is to be attributed only to the
administration of excessively high doses and that the effect
of lower doses would differ qualitatively from those of
higher doses
*
Therefore, DMPA in these experiments exhibited the
characteristics of a potential carcinogen according to
generally accepted criteria. Under the circumstances, to
dismiss the findings as irrelevant to the human would require
conclusive experimental evidence of fundamental differences
among the species in the basic mechanisms of action of the
hormone or in the responses of target cells. There is as
yet. no such evidence at hand. Specifically, there are no
data on the histogenesis of the neoplasias nor on the
meehanism of action of progestogens on the presumed cells of
origin of the neoplasias in the teat animals. Therefore,
there is no evidence to support the claim that the
malignancies developed either in c ell types unique to the
species or as a result of a species specific response of
target cells to progestogens. Conversely, data on women who
have been exposed for prolonged periods to the relatively
unopposed action of progestogens are inadequate to warrant
the conclusion that their response to this hormonal state in
terms of neoplasias would differ in some fundamental way
from the two species of test animals.
III.
THE DATA ON THE HUMAN ARE INSUFFICIENT Al® INADEQUATE
TO EITHER CONFIRM OR REFUTE THE IMPLICATION OF THE
/-NIMZ® DATA THAT DM?A MAE INCREASE THE RISK OF CANCER
IN UOMEN USING DMPA AS A CONTRACEPTIVE.
The available data on the human can not provide a basis
for conclusing whether DMPA, used as a contraceptive, does
or does not influence the incidence of carcinomas in general
or of the accessory organs of reproduction in particular,
because;
3) They fail to provide information on an adequate number
of long term users of DMPA, or on ex-users who have been
followed for a long enough period of time. There are only
minimal data on subjects that have
used DMPA for 5
years or longer wjth most of the data reported having been
obtained from women who have used the drug for 2 years or less.
2)
In the majority .of the studies there were no controls
followed in parallel with those using DMPA. In many
studios from developing countries there is not even informat
ion on the background incidence of the diseases being
studied in DMRA users that could serve as a basis for
comparison.
3)
In a number of the retrospective studies there is
reason to question the adequacy of the record keeping on
subjects receiving DMPA and, therefore, of the possibility
- 3 -
of retrieving tho data subsequently for any valid analysis.
To obtain th.© direct evidence needed to resolve the
issue would have required purposeful, systematic collection
and recording of data on users of DMPA and appropriate
controls with consideration of the natural history of the
diseases being monitored. Not until recently have subh.
studies been initiated. Until they are completed and full
reports of them available their value as evidence is limited.
IV,
IN CASE OF CONTRACEPTIVE FAILURE WITH DMPA, THE RISK
CF A MOTHER GIVING BIRTH TO A MALFORMED CHILD IS
UNLIKELY TO EE MEASURABLY GREATER THAN THAT POSED BY
THE ORAL CONTRACEPTIVESJ Th© chaHCE IN EACH CASE CAN
BE ESTIMATED TC BE SMALL ENOUGH NOT TC POSE AN OBSTACLE
TO THE USE CF THE DRUG AS A CONTRACEPTIVE WHEN OTHERWISE
INDICATED.
Data have not bsen systematically collected on offspring
that have been inadvertently exposed to DMPA in *
utero
Conclusions, therefore, can only be based on the body of
epidemiological data obtained on the effects of a variety of
sox steroids, including progostogons, on tho developing human
fetus.. In those cases, the drugs had been administered for a
variety of indications and at various times during pregnancy.
This is clearly a less than ideal data base. Nonetheless it
can provide some genoral estimate of the magnitude of the risk
According to these data the risk of various malformat
ions attributable to protestogens for the various malformat
ions implicated is low. The rate of contraceptive failure
with DMPA when used appropriately is also low. Consequently,
the chance of a mother bearing a malformed child following
contraceptive failure can be estimated to be small. However,
because DMPA is a long acting depot preparation, tho
exposure of any susceptible fetus to tho drug is likely to
bo more prolonged than with oral contraceptives.
Consequent
ly, th© range of critical and vulnerable events that may come
under the drug's influence may also be expected to be greater
than with oral contraceptives,
. t should bp possible to
counter balance this disadvantagS of DMPA by ensuring that
contraceptive failure is kept at a minimum and taking the
necessary steps to avoid inuecting women already pregnant.
As with oral contraceptives this risk should not, in itself,
constitute a reasonffor not using the drug if otherwise
indicated,
There have been no direct determinations of the concent
rations of.MPA in tho blood of breast fed infants of
mothers receiving DMPA as a contraceptive nor if the amount
of the drug transferred passed onto tho infant is sufficient
to have a biological effect. This information is needed
before advocating tho use of DMPA as a contraceptive to
lactating mothers in the postnatal period and before it is
possible to conclude that the drug does not pose any risk
of functional teratogenicity.
The Effects of Quality of Services upon IUD Continuation
Among Women in Rural Gujarat
Daxa Patel
*
Anil Patel
*
Ambrish Mehta
*
* Action Research in Community Health (ARCH)
Mangrol, Rajpipla
Introduction
India is one of the first developing countries that adopted the reduction in population growth as a
national goal moie than four decades ago, in the 1950s. Although initially the policy focused on child
spacing methods (oral contraceptives, condoms, IUDs) as well as limiting methods (sterilization), the
focus gradually shifted over entirely to sterilization. The 1992-93 National Family Health Survey1
reports that contraception prevalence rate in India was 41 per cent. Of these the vast majority (75 per
cent) were covered by sterilization. 5 per cent were covered by IUD, and about 9 per cent were covered
by condoms and oral contraceptive pills. Acceptance of IUDs in urban areas was reported to be three
times more than in rural areas.
Program managers have tended to take the non-acceptance of IUDs, and other spacing methods
like condoms and pills, for granted and have assumed that women would not accept IUDs or other
spacing methods. Relatively few efforts have been devoted to understanding reasons behind low
acceptance of non-permancnt methods such as IUDs, oral contraceptives and condoms, and there have
been very few efforts to devise intervention approaches to improve IUD acceptance and continuation.
This paper presents data concerning an intervention programme in which the response to the IUD was
quite positive among the target population of rural women.
Background of ARCH
Action Research in Community Health (ARCH) has been working in the eastern part of rural
Gujarat since 1980 to develop appropriate primary health care programs. Ten villages with a population
of about 8000 are intensively covered by the program. This is a predominantly tribal area where 70 per
cent are tribals and 30 per cent others including Harijans (out-castes), upper castes, other backward
castes and Muslims. The economy is dominated by dry land agriculture, although there has been an
expansion of irrigation facilities in recent years. The literacy rate is expectedly very low. About one-third
of the women in 1995 were illiterate and another 15 per cent completed their primary education without
significant numerical or reading ability.
Modern health services are virtually non-existent; there is a heavy reliance on traditional healers
and other unqualified local practitioners. Our field data from 1996 indicate that ninety percent of
deliveries are home deliveries conducted by traditional.birth attendants. There is a government primary
health centre about 8 kilometers away, but its focus is upon female sterilization. People recognize that
health workers from the health centre visit their hbuses'niainly to encourage sterilization, so they do not
rely on these workers for regular health services. For the first decade of our work in this area (1980-
1990) ARCH intentionally chose to avoid advocating contraceptive services in the project area, since
doing so would antagonize the rural population. As women began to trust us, they became more willing
to discuss their needs during pregnancy; this included seeking information for ending unwanted
pregnancies, preventing future pregnancies and asking about routine care during pregnancy. Nearly 30
per cent of the pregnant women who came for antenatal care in 1994 said that they did not want the
pregnancy. It was clear to us that women, while reluctant to accept permanent sterilization soon after the
birth of a second or third child, wanted some means of spacing their pregnancies. People in this area are
not aware about, and do not use condoms or oral contraceptive pills to prevent pregnancy. The IUD is the
sole spacing method known to a relatively large number of women of all socio-economic classes. Despite
their desire for spacing, most of the women are very reluctant to accept IUDs and most of those who
accept it retain this method for only a limited time. This reluctance of women in rural India to accept and
continue using IUDs and other spacing methods is generally well-known. However, the reasons for this
reluctance are still not adequately understood.
In a major review of the research studies on family planning dropouts, Kreager (1992) observed
that the varieties of determinants usually studied are a basic set devised for medical purposes but
undeveloped with reference to social, cultural and psychological factors.2 He further observed that the
interrelations of medical, cultural, social and psychological factors in early discontinuation of oral
contraceptives and IUDs are not clear. Studies reviewed by him do not generally attempt to identify the
reasons for discontinuation in terms of these factors. The review article, which encompassed 20 studies
on IUDs across the world, repeatedly stressed the importance of socio-cultural factors and one of its
important conclusions is "the extent of personal, cultural, social and psychological factors in this pattern
of initial difficulty (in acceptance of IUD) and the extent to which they can be manipulated to improve
the continuation is unknown".
On the other hand Huezo. et al.( 199_) in a multi-centre study involving six countries on
acceptability and discontinuation of contraceptive methods, reported a paradoxical and unexpected
finding that high levels of counseling tend to be associated with higher risk of discontinuation.3 The
authors call this finding counterintuitive and have tried to explain it. However, when the content of the
counseling is examined, it is clear that it does not relate to relevant socio-cultural factors which shape
women's expectations and apprehensions. Counseling devoid of such socio-cultural sensitivity may only
accentuate women's fears and apprehensions about the side effects they are informed about.
g
Our intimate and long interaction with all segments of this rural population has shown that
women did not know where the IUD is inserted in the body, what it does, nor how it works. The majority
of women have revealed to us that they believe that it would ascend up into their chests or could be lost
in the abdomen, that it causes 'heat', or that it could cause a loss of weight and energy. A strong fear
exists that with an IUD in place, the partner would get stuck during sexual intercourse and that separation
would be impossible without a doctor's intervention. Some women even fear that IUD insertion could
result in death. We have also come to know that similar apprehensions and misconceptions are not
limited to the ARCH project area, but are also prevalent' in other parts of rural Gujarat as well. These
perceived fears and apprehensions, rooted as they are in false conceptions of their bodies, must be
addressed systematically by means of a sensitive and specific health education program. This paper
describes the experience in developing such a program, and explores the impact of this program upon
levels of contraceptive continuation.
Methods and Materials
At the very outset, we should state that ARCH had not initially planned a study of IUD acceptance and
continuation in the population. This study evolved in response to an emerging need in the community. As
in ARCH's other health programs—including antenatal and postnatal care, iron-folic distribution for
pregnant women, immunization, child weaning practices—ARCH maintained proper records, followed
standard medical procedures and undertook proper follow-up care. The findings present our experiences
in eliciting information concerning women’s perceptions and needs related to family planning.
Intervention Strategy
Phase I
During the initial phase of the ARCH project (1980-86) the focus was on curative services and children's
health. While women's reproductive health problems were becoming increasingly apparent, we were still
extremely reluctant to undertake an initiative with regard to family planning because of the strong
negative reaction against the family planning program run by the Government.
We began, however, to perceive a need for fertility control among community women we
interacted with. As a result, from the beginning of 1987 onwards, we took the initiative to offer spacing
methods to those who came to the dispensary seeking these services. Through the end of 1990, a total of
56 women of various castes and economic categories came forward for IUD insertion. The IUD was
inserted by an experienced senior doctor (one of the authors). We followed the usual textbook
4
Our intimate and long interaction with all segments of this rural population has shown that
women did not know where the IUD is inserted in the body, what it does, nor how it works. The majority
of women have revealed to us that they believe that it would ascend up into their chests or could be lost
in the abdomen, that it causes 'heat', or that it could cause a loss of weight and energy. A strong fear
exists that with an IUD in place, the partner would get stuck during sexual intercourse and that separation
would be impossible without a doctor's intervention. Some women even fear that IUD insertion could
result in death. We have also come to know that similar apprehensions and misconceptions are not
limited to the ARCH project area, but are also prevalent' in other parts of rural Gujarat as well. These
perceived fears and apprehensions, rooted as they are in false conceptions of their bodies, must be
addressed systematically by means of a sensitive and specific health education program. This paper
describes the experience in developing such a program, and explores the impact of this program upon
levels of contraceptive continuation.
Methods and Materials
At the very outset, we should state that ARCH had not initially planned a study of IUD acceptance and
continuation in the population. This study evolved in response to an emerging need in the community. As
in ARCH's other health programs—including antenatal and postnatal care, iron-folic distribution for
pregnant women, immunization, child weaning practices—ARCH maintained proper records, followed
standard medical procedures and undertook proper follow-up care. The findings present our experiences
in eliciting information concerning women’s perceptions and needs related to family planning.
Intervention Strategy
Phase I
During the initial phase of the ARCH project (1980-86) the focus was on curative services and children's
health. While women's reproductive health problems were becoming increasingly apparent, we were still
extremely reluctant to undertake an initiative with regard to family planning because of the strong
negative reaction against the family planning program run by the Government.
We began, however, to perceive a need for fertility control among community women we
interacted with. As a result, from the beginning of 1987 onwards, we took the initiative to offer spacing
methods to those who came to the dispensary seeking these services. Through the end of 1990, a total of
56 women of various castes and economic categories came forward for IUD insertion. The IUD was
inserted by an experienced senior doctor (one of the authors). We followed the usual textbook
4
precautions of clinically screening women with obvious gynecological infections, using sterilized
instruments and followed an aseptic technique of insertion. Routine advice were also given to clients
about the need for reporting in case of excessive bleeding or pain and to have the IUD removed in three
years time. More women from higher castes accepted IUDs, most likely because they had heard more
about this method. Our understanding of women's fears and misconceptions regarding IUDs was poor.
Women, hesitant and non vocal as always, rarely revealed to us their deep fears and apprehensions. In
this context, there was little education and counseling being provided which would accurately respond to
their deeply-rooted and legitimate apprehensions.
In 1989. ARCH conducted a small study to assess family planning needs and the use of different
contraception methods. In six project villages, 492 eligible couples were registered, out of which 282 (57
per cent) had already undergone sterilization. From the remaining 210 (43 per cent), 44 women were
randomly selected from different caste groups for open ended, in-depth interviews. 88 per cent of these
women expressed a desire for spacing between births. Only 20 per cent were familiar with oral pills,
about 40 per cent knew about condoms, and 70 per cent knew about IUDs. However a large majority of
these women had deep fears about IUDs. Actual acceptance levels of any of the spacing methods was ■
extremely low.
During the early years when women came for IUD removal, any physical problems which they
had were attributed to the IUD. For example, one woman had a sore throat and thought this was due to
the IUD which had come up to her throat. She was understandably desperate for its removal. Another
woman was very apprehensive and could not sleep for two nights because a neighbor told her that she
had pain in her abdomen because of the IUD and that it might have entered her liver. During the internal
examination when we told her that her IUD was still inside the womb and the thread in the vagina was
visible, the relief on her face was palpable. She still insisted, however, upon its removal. In numerous
cases no amount of reassurance worked and we found it necessary to remove the IUD.
Phase II
By 1990. intensive informal interaction had begun with our female health workers belonging to the same
community and sharing the same fears and beliefs before they joined ARCH. By that time, our
relationships with the village women had also improved. Intimate and informal discussions with these
women revealed their understanding about the female anatomy -especially the relationship between the
reproductive and the gastro-intestinal systems. They had no knowledge that the reproductive system is
comprised of the vagina, cervix, uterus, etc., and that it is a separate and completely independent system
5
from the gastro-intestinal system. They did not know that the stomach'and the uterus are two different
organs and that the uterus, where the IUD is placed through the vagina, is closed from above. We
realized that merely screening for infections and using aseptic techniques for insertion, though essential,
were by themselves insufficient to ensure acceptance. A specific health education program about
women's bodies had to be introduced.
From January of 1991 onwards, we initiated a process of free and friendly exchange of
information in the community group meetings, and also in our clinic when women came for an antenatal
check up, in an effort to bridge the gap between the different conceptions of the woman's body. For the
first time, women were presented, through slides, models, posters and pictures, that the reproductive
organs were completely separate from the gastro-intestinal tract in the abdominal cavity. We also
developed a simple low-cost thermocol model (a light weight polymer plastic material used in
packaging) of the uterus, cervix, vagina and fallopian tubes for the purpose of demonstration. All women
who came for an IUD insertion were first shown the entire process of IUD insertion on this model. Even
women who came in the clinic for different reasons were encouraged by the female health workers to see
forthemselves the models and pictures. This demonstration included actual insertion of IUD in the
model through the cervix, into the uterus and leaving it in the uterus with a small thread freely hanging in
vagina. This demonstration, which only took a few minutes, was helpful because women could see that
the uterus is a separate organ which is closed from above. Thus, they could see that the IUD cannot go up
into the chest and similarly the fear of partner getting stuck during intercourse because of the IUD was
also not real. It also became apparent to them that, with the help of the thread hanging freely in the
vagina, the IUD could easily be removed at any time by the doctor or the female health worker in the
clinic. All the possible problems of initial discharge, bleeding and pain were explained at the time of
insertion, and women were asked to visit the dispensary if any such problems occurred so that
appropriate measures could be taken.
During the second three-year phase (1991-93), 80 women accepted IUDs. In this phase, medical
screening of women’s reproductive tract infections (RTIs), and the aseptic technique of insertion and
instrument sterilization were performed largely unchanged from the first phase. For each woman, a
separately sterilized set of instruments, towels etc., was used. A senior woman health worker was also
trained to insert the IUDs, while in Phase 1 only a doctor inserted the IUDs. In both phases, the same
brand of IUDs were supplied in standard sterilized packs from the nearby government health centre.
Records were kept of all complaints, clinical findings and treatment given in all subsequent visits, and
the reasons for IUD removal were also recorded. Follow up contacts were made in cases where women
6
did not visit the dispensary on their own to learn whether the IUD was still in place or had been removed,
as well as the reason for removal.
For purposes of statistical analyses of the differences in the rates of IUD removal / continuation,
we have followed the life-table technique described by Kahn and Sempos (1989). Rates of IUD
removals in each 2-month time interval after the date of insertion up to 24 months were calculated for
both groups. Those cases where no follow up contacts could be made (two cases in Phase 1 and one case
in Phase II) have been considered as withdrawn in the very first time interval. Those cases in Phase II
(1991-93) where the women were still continuing with the IUDs on April I, 1995 and had not yet
completed two years since insertion, were considered as withdrawn at appropriate time interval by taking
into account the time they had already retained the IUDs. There were no such cases in Phase I (1987-90)
as all women who got IUDs inserted in this initial period could be followed for at least two years on
April 1, 1995.
Results
Table 1 shows that IUD acceptors in both phases are essentially similar with regard to age, education and
desire for spacing. Their composition differs decisively, however, with regard to caste. Whereas upper
caste women predominate in Phase I, tribal women predominate in Phase II, indicative of greater
acceptance among tribals.
Table 2 shows the number of women who complained of discharge, excessive menstruation or
pain during the first six months after IUD insertion in both phases and also the percentage of women who
had their IUDs removed within six months due to these problems. The proportion of women who
complained of these problems is slightly higher among the first group of acceptors, although not
statistically significant. However, among women who complained of complications, the number of
women who subsequently had their IUDs removed due to these problems is significantly higher in Phase
1 (80 per cent) than in Phase II (22 per cent). The possible reason is that during Phase I, in the absence of
specific and relevant counseling about woman’s body, even normal or usual difficulties of initial period
were magnified by women. In addition, these women were continually advised by other women that the
IUD is very problematic.
Table 3 shows the number of women who complained of excessive menstruation, pain in the
lower abdomen and other complaints, which were clinically investigated, within two years after IUD
insertion. This information was based on follow-up visits in the clinic. It shows that the proportion of
women who complained of these problems was high in both groups, but the number of problems appears
7
less in the Phase 11 group. The number of women who retained the lUDJn Phase II was significantly
higher, however.
Table 4 shows that six women (16 per cent) in Phase II reported spontaneous expulsion. This is
probably related to the fact that 4 out of 6 such IUDs were inserted by a senior female health worker who
was under training. More women complained of leucorrhoea, pain and excessive menstruation and had
the IUD removed in Phase I than in Phase II. This likely reflects changes in perceptions due to
appropriate health education.
Figure I shows curves of IUD continuation rates in the two phases, based on life-table analysis
shown in Appendix I. At the end of six months after insertion, 89 per cent in Phase II versus 66 per cent
of the women in Phase I continued to have IUDs in place. The corresponding figures at the end of one
year were 77 per cent versus 48 per cent, respectively, and at two years, 52 per cent versus 28 per cent,
respectively. These differences are highly significant (P = 0.001). The rate of IUD continuation for all
intervals was also significantly higher in Phase 11 (p<.01). The above difference is obtained when
removals of IUDs for all reasons are considered as drop-outs. The difference increases further when only
the removals due to IUD related problems like leucorrhoea, pain, excessive bleeding are considered.
Removals due to desire for child or permanent sterilization, etc., are not considered as drop-outs.
Figure 2 shows curves of IUD continuation rates in two phases considering removals due to IUD
related problems only (Appendix 2). Here also as in Figure I, the differences in continuing rates at all
intervals are highly significant (P = 0.0002 ).
Discussion
This study does not argue that the IUD is either the best spacing method available for rural women or the
most preferred method. What can be demonstrated, however, is that given the voluntary choice of
methods made by women, IUD’s continuation rates can be improved markedly by providing specific
health education which effectively addresses women's perceived fears and apprehensions.
Although it is possible that this study may have overlooked other influential differences between
the two intervention phases, we do not believe that differences in the rates of IUD removals are the result
of any other positive time trend operating in the project communities under study. The living conditions
and amenities available to these communities remained essentially unchanged over the two study phases.
The difference in the rates of IUD retention between the two groups could possibly be related to the fact
that Phase II includes a significantly higher number of tribal women, who may have greater capacity to
bear with body pain and discomfort. This may be true but the point to be made is, it is the anxiety and
8
apprehensions about the IUD that prevent poor women from accepting the method in the first place.
Once these fears are allayed, women are most probably ready to tolerate the discomforts rather than risk
another unwanted pregnancy.
The proportion of women who reported leucorrhoea, bleeding, or pain in first six months or even
later on after IUD insertion is essentially the same in both groups; however, the rate of IUD removal due
to these problems is significantly higher in Phase I (Table 2). This finding strongly supports our
contention that dissemination of specific, easily understandable information, dealing directly with
peoples’ deeply held fears and beliefs related to woman’s reproductive system, has had a positive effect
on the continuation of IUDs.
Discussions with our female health workers revealed how the information network within the
community was gradually established. They said that in Phase I, their own understanding about the IUD
was much less than in Phase II. In Phase II they worked in the clinic as well as in the community and
undertook other activities related to women's health in the community including antenatal and postnatal
care and health education. They were thus able to win the trust of the community much more in Phase II
than in Phase I. In Phase I, if women had any problem after IUD insertion, they would only attribute this
to the IUD. However during Phase II, they regularly discussed their problems with the female health
workers and were usually reassured. The fieldworkers explained that the reproductive system was like a
box closed from above, which most women found very reassuring. During Phase 1, family members and
neighbors often made women more apprehensive and scared, and advised them to remove the IUD if
there were even any trivial problem. Later because of wider health education, the understanding of the
community as a whole increased.
The data obtained in this clinical setting while limited in number, are interesting and need to be
followed up in a community setting. During both phases of this study, we have not been able to carry out
bacteriological tests on women with specific complaints. There was no evidence of infection upon pre
insertion clinical examination, with the exception of one woman in Phase II whose IUD was promptly
removed. It should be noted that despite complaints, a large majority of women who had been given
appropriate health education could be reassured and willing to continue with the IUD. On follow-up,
these women were usually found to have no adverse effects. This is an important finding at a time when
the IUD has been abandoned by many programmes concerned with family planning. With respect to the
replicability of our intervention strategy, we would like to point out that although a good relationship
with the community was necessary to learn about deeply rooted conceptions of women's bodies and
functions and associated fears, it should be clear that the counseling of women does not require intimate
interactions and an exceptionally high order of dedication of the health staff, for the fears are understood.
9
The important point is that any pre-insertion counseling must incorporate quite specific information
about the female anatomy, using easily available visual materials. Intimate and prolonged interaction is
not necessary' to successfully do this. The method itself and the models used were extremely simple and
cheap, and easily reproducible. Typical government clinic and staff could easily use these methods and
contents of counseling and health education to replicate these results. It can be cautiously concluded that
the IUD can be one of the choices to women, who in large numbers but subdued voices, are demanding
child spacing rather than unwanted pregnancies or permanent sterilization.
10
The important point is that any pre-insertion counseling must incorporate quite specific information
about the female anatomy, using easily available visual materials. Intimate and prolonged interaction is
not necessary to successfully do this. The method itself and the models used were extremely simple and
cheap, and easily reproducible. Typical government clinic and staff could easily use these methods and
contents of counseling and health education to replicate these results. It can be cautiously concluded that
the IUD can be one of the choices to women, who in large numbers but subdued voices, are demanding
child spacing rather than unwanted pregnancies or permanent sterilization.
10
Life table analysis of IUD continuation rates in two phases:
Time at
beginning
of interval
(Months)
IUDs
removed in
the interval
x to x+2
Appendix 1.
Ox adjusted
for with-lUD
drawals
Ox-2wx/2
Number at
beginning
of interval
Cases with
drawn in
the interval
x to x+2
Ox
2wx
2dx
O'x
Probability of
IUD
Removal
during
interval
(2dx/O'x)
2qx
%
IUD
Continuation Contmuatioi
from time
during
interval
interval
up to x+2
(1-P1)
(x+2)PO
2px
%
%
Phase I (1987-1990)
0
2
4
6
8
10
12
14
16
18
20
22
24
56
52
44
36
32
28
26
26
24
23
23
20
15
2
0
0
0
0
0
0
0
0
0
0
0
2
8
8
4
4
2
0
2
1
0
3
5
55
52
44
36’
32
28
26
26
24
23
23
20
4
16
19
12
13
■ 8
0
8
5
0
14
25
96
84
81
88
87
92
100
92
95
100
86
75
0
2
4
6
8
10
12
14
16
18
20
22
24
80
74
72
70
66
61
60
59
56
44
38
33
29
1
0
0
0
0
0
0
0
6
0
4
2
5
2
2
4
5
1
1
3
6
6
1
2
80
74
72
70
66
61
60
59
53
44
36
32
7
3
3
6
8
2
2
6
12
14
3
7
93
97
97
94
92
98
98
94
88
86
97
93
96
81
66
59
52
48
48
45
43
43
37
28
Phase II (1991-1993)_
93
91
89
84
78
77
76
72
64
56
55
52
__________
Appendix 2.
Life Table Analysis of IUD Continuation Rates in two Phases:
(Removals due to Problems like Leucorrhoea, Bleeding, or Pain Considered Drop-outs.)
Time at
start
of
interval
in
months.
No. at
begi
nning
of
interval
X
Ox
with
drawn
in the
interval
xto
x+2
52
44
36
32
28
26
26
24
23
23
0
2
4
6
8
10
12
14
16
18
20
22
24
80
74
72
70
66
61
60
59
55
44
38
33
29
2
0
0
0
0
0
0
0
0
0
0
0
0
2
1
0
2
0
0
1
1
0
0
2
1
0
0
0
0
0
0
0
6
0
4
2
1
0
0
1
0
0
0
1
5
4
1
2
3
0
1
0
2
0
0
0
0
0
0
0
Sponta
neous
Expul
sion or
other
reason
2dx2
Desire
of child
or want
sterilizahon
Leucorhoea.
heavy
bleeding or
Pain
2dx
2wx
0
2
4
6
8
10
12
14
15
18
20
22
Probability of
IUD
IUD
IUD
Adjusted
Removal Continuation Continuation
Ox for
from time
withdr
ue to Leu., during
of insertion
interval
Bleed, etc.
awals.
upto x+2
during
(1-P1)
Ox-2wx/22dx1/2interval
2dx/O'x
2dx2J2
(x+2)P0
2px
2qx
O'x
Phase 1 (1987 ■ 1990)____________________
96%
96%
4%
55
0
85%
88%
12%
51
0
72%
84%
16%
44
0
66%
91%
9%
36
1
62%
93%
7%
31
0
58%
92%
8%
28
0
58%
100%
0%
26
0
56%
96%
4%
26
0
56%
100%
24
0%
0
56%
100%
23
0%
0
49%
14%
86%
23
0
42%
84%
19
16%
0
IUDs Removed due to
Cases
2dx1
2
6
7
3
2
2
0
1
0
0
3
3
1
2
3
3
1
1
2
1
2
0
0
78
74
72
70
65
61
60
59
51
42
36
31
■
2%
3%
2%
5%
5%
2%
2%
4%
2%
5%
0%
0%
Phase II (1991-1993)____________________
98%
98%
96%
97%
95%
98%
91%
95%
87%
95%
86%
98%
85%
98%
82%
96%
81%
98%
77%
95%
77%
100%
77%
100%
Table 1. Selected characteristics of women accepting IUDs during 1987-90 and 1991-93
Characteristic
Education
Phase I
(1987-90)
Phase II
(1991-93)
Mean Age (years)
23.9
____________ 23.4
25%
None
21%
Primary (1 to 4)
16%
11%
Primary (5 to 7)
27%
21%
Secondary (8)
34%
48%
Upper castes
61%
39%
Scheduled tribes
13%
41%
Social
Groups
Scheduled and other
backward castes
15%
14%
Muslims
13%
6%
Desire of
spacing
through
use of IUD
Spacing before first child
4%
0%
Spacing between children
58%
58%
Spacing before permanent
sterilization
38%
42%
Total (N)
100%
100%
.
Table 2. Complaint of discharge, bleeding or pain: Phase I and II IUD acceptors
Percentage of women who complained
of leucorrhoea, bleeding or pain within
six months of IUD insertion
Of those who complained, percentage
who:
had their IUD removed
retained IUD
' Total number of women who accepted IUD: 56
2
Total number of women who accepted IUD: 80
Phase I1
(1987-90)
Phase II2
(1991-93)
36%
29%
80%
22%
20%
78%
Table 3. Problems anytime after IUD insertion
Information available
Phase 1
Phase II
80%
87.5%
No problems
29%
40%
Excessive menstruation
22%
14%
Vaginitis .
13%
13%
Cervicitis
7%
10%
P1D
22%
20%
Pain in abdomen
7%
3%
No information
20%
12.5%
Total (N)
100%
100%
■
Table 4. Reasons for IUD removal in 2 phases
Reasons for IUD removal
HhaseI
(1987-90)
Pnase II
(1991-93)
27%
Leucorrhoea and pain
46%
Excessive menstruation
28%
19%
Desire child
15%
30%
8%
Desire permanent sterilization
8%
Spontaneous expulsion
0%
16%
Other
3%
0%
Total
100%
100%
Percentage Continuing IU
Figure 1. Life after IUD Continuation Rates: 1989-90 and 1991-93
Figure 2. Curves of IUD Continuation Rates in two Phases:
{When only Removals due to IUD related Problems are Considered Drop-outs.)
References
'
National Family Health Survey, India: 1992-93
2
Kreager Philip: 'Family Planning Drop-outs Reconsidered - A Critical Review of Research and
Research Findings', International Planned Parenthood Federation, London, November 1977.
3
Huezo C. M., Malhotra U., Sloggett A. and Cleland J: 'Acceptability and continuation of use of /full
reference contraceptive methods’, A multi-centre study.
4
Kahn Harold, Sempos Christopher: 'Statistical Methods in Epidemiology' Oxford University Press,
1989. pp. 168-180.
Mythic Origins of Menstrual Taboo in Rig Veda
■
-
■ :
•
"
■ <•
..
-ncil I
... ■ l.wlw
Janet Chawla
4...
..
Jh
;
°
p-„ . ,
,■ iz. .1
,. !( ■ ...; ! - l ,i.
■ :: i- ■: 1|.:
, . A..crucial subtext can be read infeii tinist agitations, against,the jnjec,table <:o\ly.,-..:ep,tiye.Depo;,f
’roy
.
iaibody is, not do -be-problematised as tlu■ site- of pathology, and- victimised, for it:
I,potential ferliliiv., Menstrual ion-is,q
' normal, -natural female physiological.function, in this context it is appropritn
'e to reflect‘Upon traditional nmlniriil
constructions of the fethale body and I)ie meanings of menstruation within Indicm symbolic systems - meanings which'
■L
Jadidn worn en's '{and men's), experiences^,of female,
.:?ld,-n;,mniwihl -I
.[MENSTRUATION isthenjqnthlyhieeding >’..-■.H
0itfiais
i.parts..p/,
rls^a-'(,ti\c;.
’^qf/,'tile '
, the cycles and processes of nature (seasons, ;;1n.*
bpfmon-pregnant women of, childbearing ,.the .atmosphere, .river, waters, the,earth) , .mcnstru ulion.ofj the. goddess lire cvlebfated .
-, age.; This, article, explores , aspects ,of mustbe respected arid sensitively handled. i,,during the,monsoon season. Boththe fertile
uniquely Indian cultural' meanings of (, lronically.itseemsas.though this,sepsitiyity i. earth npd woman pius.t rejij^be^.cneraled and
..menstruation and constructions of woman’s > ...does not extend to the natural physiological’ ^celebrated..?.; j/;,
-nj'
bqdy. 1, will.Jirst.contextualise these ; cyclicity,of wpmeh’.s bodies; menstruation.
- Bhaltacliaryyy notes thi)||l|ie.;iu^pici<|psJ .meanings and, constructions in relation to . ( One group, of jyppjcn'.s health, activists J iiesf.o.f^iens.truatioii, representing potential
i.Jhe contemporary discussion of and feminist •; fhave.acciiratcly described the,situatipp.,"ln j.fertility;isjiymlioiisedby,blqixlyr,ijiccolour .
n.agitation against the injectalrie,hormonal ,.. tlie, case,:'6f, .hormones i used . for ,or,al, , ,of blood and is'regarded,aj sadretj. SiiKlur ■
contraceptive Depo-Proveraj . . ,
..injectable and implantable contraception, [' applied ih.the part|Of lhe.inariieo Roman’s .
, .Feminist groups' have been, agitating j , never, before Jiave, so. many women .been . hair symbolises the saciediiess of her fertile
/against the Drug Controller, of India’s , , given ; potent medicine continuously to |,potential.(whin exercised jvitliintheconriijes
attempts to allow the introduction of Depo- . ..suppress a,condition (fertility.j.that.is^not ,.of patriarchal.marriage I) Deities and sacred ■.
...Proyera in the, Indign marketplace. . a disease|2). .
!. objects,arc daubed with red colouring as a,
. .Opposition to pepo (and other hormonal j,-, I would suggest that a crucial subtext can -part of ritual, worship. Within Indian,cujt.ure.
contraceptives. Net-en and Norplant).has ... .be read in feminist agitations against Depo- i.jred. signifies auspiciousness,(and potential
ft been, articulated by critics utilising various ,. Proven):,.the. female body is .not,.to ,be .. growth -r these ancient,religious ideas.and
■p discourses. Women’s groups have used the . problematised as the site of pathology, and [ Symbols are definitely .lipked.lo tlie blppd
.. medical research and language to expose the ■ , victimisedllfor. its, potential fertility. :l|of menstruation |
, many negative side-effects of injectable and Menstruation is a normal, natural female < pi. .Understanding these nuancesoljlndia's
. implantable contraceptive technology .and ...physiological .function. |
cultural history it is not surprising (p.find
., emphasised tire dangers of its use with poor ■
Within this context it.is appropriate to [ that some studios have shown that Indian
( and rural women where health is already , refleciupontraditibhalculturalconstruct- women experience menstrual.irregularity.
'compromised. Human rights and feminist ., ions qf the female body and the,meanings ,,spotting, or .luck,‘of, menstruation, as
E Organisations as ,Well.,as,:the,,socially . of menstruation within Indian symbolic ,,tsignificunlprol;lehispl|.Sbciolqgin(.Veenii
• concerned medical community have used .... systems ,-r meanings..which undoubtedly •| Dus explains-, tj,c,, qultural ...assumptions
I, the issue of resource distribution to question , have shaped.lndian women's (and m.enjs) ,,,}vhich. un<l[:rj(ie.|this .expcrieii.c.i;;,;”,’:’,,the
. those 'developmentwallahsi and .bilateral ..experiences of female Iwdily processes. [Jjem if.e,', b>Q|<^.y’|'?m»iku^;|,li»tj,:?.h$ijli(i^n?./>f
funding agencies, who advocate a ‘quick
.Obviously, traditiqnal ]ndiah.|cul{uritl y.regularity of, ryituie available ipmupkind..'
.technological ,fix’.„apprqach to family ...constructions of,..menstruation ..differ, H.For.theHindus. i^is.the regular jiyriqdicity
, planning and population control. Critics of , .considerably from the,bio-medical model.; (, pf menstruation that js th.e guuruple.c.of.liie
the New Economic Policy point out that.in , In many parts of south India a girl s,first. .. regularity of na|urc. Thus, the.y'or.d. r.tu'■■ the name of liberalisation, free trade, and .menstruation wasunfilrecently celebrated .[Stands for bothjica^ons and the incnstifial
I ,’development’foreign multinationals and H publicly;.,after emerging from seclusion ,.cycle. Similarly, the word for tljewomilh’s
,. their Indian collaborators (such as U pjohn ■■ the young woman was bathed, dressed in ...menstrual cycle.and the.moon's cyclciis
, and Max Pharma- -. the purveyors of Depo) . bridal finery, and gat landed with fldwers. ./lie same, showing,thal.tiiei;hythn^s of the
I, will have,laissez-faire access to the Indian ..Aesthetic renderings of a young woman I body(and the rhythms,oljth^ cl|^mos..are
..consumer without the..monitoring and ..kicking an Ashoka.trec imply that,it is her I in harrnony-',(5].t Hjiwe,ver./,,the ..Hindu
.^protection of a coherent .national drug i Shakti .which causes the tree to bloom, .In ..traditions ..themselves are ,alslj' deeply
.. tantric rituals, which probably have their .ambivalent, .iiv.their, con jitructions,,.Of
'^n’olicy.
,-. This is. of course, ,a gross oyersimpli- origins in tribal and folk cultures, menstrual .menstruation as tliyfollbwinj: inye^tigalipn
ficationqfacomplexdebate.Neycrthcless, .. blood,ryas one of the offerings made tojjie zof.thc menstrual taboo reyeajsj,
Ciy.ll.' - '-.hjiow.
■ ., i,
- . .•>;. / :» .I!-, /-•ji.lv-o - riiib
there is a significant.omission from this . goddess;
. According tobistorian N N Bhattacharyyu, sju.o-. •,|-..y. w.•iqdhui.iTi.il.iil) Inivfli.ti^p.v.'l,' discussion. The most frequently encount
ered consequence of Depo-Prpvera (or its different areas of India have had notions of ;i,c
..Jii ioi
' .. active ingredient DMPA.-y a synthetic form , the menstruating goddess. In Punjab it was .,,...Cpminentary„.qn, thy, Rig jJ^cdi^ has
believed that Mother .Earth (’Dharti Ma’) ..occupied human,.minds foc|tJitera.lly
.. of. the female hormone,progesterone) is
— alteration in the, menstrual, cycle. “Some ... ’slept’ for a week each month. In some parts millennia. .Very . lew.,of Jhosi; minds
happened to:bc worn,en’s.' I begayiny. study
women will experience unpredictable or ,j of the Deccan after the ’navaratra’ goddess
• , prolonged bleeding prspqtling... most users .. temples,were closed from the tenth IbThe , of the.Rig Vedic tex tin oydci; to understand
develop amenorrhea, (suppression of full moon day while she rests and refreshes .,the.mythic origins,pl’-,the ritual, taboos
I
herself.
In
the
Malabar
region.
Mother
Earth
1,
associated witli menstruation. Ip this article
menstruation) ajter several months- of
, .was believed to rest during th6 hbt weather i 1 will present the womiin-ccbtrcd,concerns
. i«e ’ [lj (emphasis mine).
•
In this currentugeof ecological awareness, . until she got the first shower of rain|3J. Still .which 1 bring to the,Rig Veda, a feminist
. many peopleare beginning loiecognlse that today indie Kamakhya temple pt'Assam, and ..jinlerprelation of (he textual material, and
I Economic and Political Weekly
October 22. 1994-
<•2817
speculations about the historical meaning
of the mythic and symbolic elements of the
narrative.
Having worked as a childbirth educator
and advocate of ’natural childbirth’ among
voluntary organisations I became increas
ingly frustrated with the medical model of
pregnancy and birth. Surely. 1 reasoned.
there must be traditional, indigenous and
empowering knowledge about women's
bodies. I decided to document traditional
Indian childbirth practices which seemed to
me to be more congruent with my natural
childbirth orientation. I worked with the
Ankur-Action India women s health group
in Delhi to collect stories of women from
all classes and religious backgrounds about
their experiences with menstruation.
pregnancy, birth and mothering.
From these interviews emerged two
conceptual areas which appeared signi ficant.
One was ritual pollution. Almost every
womanspokcofher body ns being considered
unclean or impure during the lime of
menstruation and post-partum. Women told
of being prohibited from going to the Mandir.
Masjid or Gurdwara performing or
participating in Pujas. not reading holy books
as well as the importance of bathing rituals
after menstruation. One basti woman
described the blood of childbirth as 'rook
hua’ (stagnant) and the placenta as nau
inahena ka narak kund’ (nine months' hell
Second was the well worship rilual(5].
Many of the ’basti’ women mentioned a
ritual worship of the well (or in the
resettlement colonics the ’nal’.orwatertap)
on chalti’ after childbirth. As they described
the ritual it was actually worshipping the
watersource ratherthan a purification ritual.
Thus I encountered two seemingly
contradictory ritual and belief systems. In
brahmanical Hinduism woman’s body and
procreative capacity is defined as a source
of ritual impurity. Water or bathing is
understood to be purifying: washing away
bodily pollution. On the other hand the
worship of the water source, a womancentred ritual involving singing and
celebration, constructs both the well and
water as sacred. Symbolically the well is
analogous to the yoni. Wells in many parts
of India are constructed in a yonic shape.
Just as the baby emerges from the watery
womb - the source of life - so the well, in
lite traditional Indian setting, was the source
of water, necessary for the continuing life
of people, plants, animals. Interestingly
someslum women in resettlementcolonies
□round Delhi reported tile community water
tap (in the absence of the village well) as
the focus ofritual celebration post-partum.
1 asked myself rather simple questions:
why are menstruation and the blood of
childbirth considered ritually polluting?
What are the origins of a belief which so
categorises women’s body and the
2818
miraculous biological processes which bring
Aryan indigenous peoples; simultaneous]
new human life into the world? (I should
seizing and exploiting natural resource
and appropriating pre-existing cultuj
acknowledge thatdefining women’s bodily
forms. Howdid thcdcification oflndraan.
processes as polluting and antithetical to
the demonisation of Vritra construct j
religious practice is not unique to Hinduism.
Itisalsoapartofthejudeo-Chrislian-Islamic ideology which legitimised the Inch,
tradition.) I gotmy first inkling of an answer European domination over the nativ..
when I discovered the myth ol Indra slaying peoples? What can be inferred from th,
narrative and symbolic content of the tex
Vritra.
Myths arc traditional stories which serve about Iho social organisation, values
to unfold part of the world-view of a people cultural forms of the original inhabitant
of the subcontinent? Second, I will use a
and or explain a practice, belief or natural
a working hypothesis the idea that ths
phenomena. Myth serves various functions
figure of Vritra is inextricably linked witf
tn any given society. First, a metaphysical
a pre-existing matrislic social system atnl
function: myth orients a person vh’-«-vi.rthe
a world-view which valued the sacred (o
world, the cosmos, and society and imbues
experience with meaning, often understood powerful) feminine.
Existing critical literature recognises lh«
as rel igious or spiritual. Second, myth serves
marginality of women in the Rig Veda
a social function of providing role models.
J Gonda acknowledges that “Women ar
prescribed or tabooed actions and
dramatically revealing consequences of a rare subject; they are mainly mentioned
in metaphors and. as a collectivum. it
behaviour. Third, myth provides a
pedagogical tool: as the young hear the similes”|8]. Wendy Donigcr O'Flaheru
stories of their elders, they learn about categorically states “The Rig Veda is >
book by men about male concerns in >
themselves and (he world and begin to
world dominated by men: one
these
understand their environment and the
behaviour expected from them in ways concerns is women, who appear throughou
the hymns as objects, though seldom as
acceptable to their family and group [6].
In the Rig Veda Indra’s slaying of Vritra subjects”[9|.
(or the Vritras) is referred toover 100 times.
The text, however, speaks for itselfon tin
Most Vedic scholars agree that this killing
general category of women: “Indra himself
is the central dramatic event in India's oldest hath said, the mind of woman brooks no
discipline. Her intellect hath little weichf
existing text.
In the Rig Veda. Vritra is depicted as the (RV VIII 33.17). (Ironically this aphorism
withholder of the waters, the demon of is put in the mouth of a heroic warrior knowr
forneitherhis intellect nor hisself-discipline.;
droughts, a snake or dragonlike figure who
dwells in the rivers or celestial waters, or “With women there can be no lasting
in a cavern in the earth. He lives in the caves friendship: hearts of hyenas are the hearts
with the cows. Indra kills Vritra with his of women ” (RV X 95.15).
thunderbolt, thus releasing the waters, the
Indologists have interpreted natural
cows, and wealth, prosperity, and progeny. symbolism in the Rig Veda within various
Keith notes that Vritra is the primary conceptual frameworks. However the task
enemy of the Vedic gods: "He is a serpent of decoding what Gonda refers to as ‘similes
with power over the lightning, mist, hail and and metaphors' as real human persons, not
thunder, when he wars wi th Indra; his mother just part of the natural flora and fauna, has
is Danu. apparently the stream or the waters not. to my knowledge, been attempted.
of heaven, but he bears that name himself Androcentric scholarship, both Indian and
as well a Danava. offspring of Danu.” western, has been quite happy^Vleave
According to Keith. Vritra paradoxically unchallenged categories of ’man- culture
resides within the waters, but also on lofty whereas woman = nature’ (and primal
heights which suggests the waters of the air. peoples = nature whereas dominant
His name denotes ”... the encompasser of peoples = constructed culture). I suggest that
the walers, rather than the holder back by the cows, rivers, and caves can be read as
congealing them: the cloud mountain is referents to both the mythic feminine and
therefore said to be in his belly”. Indra, the to real historical women and groups of
Vritra slayer, is also tire breaker of forts.
women. (More precisely, ’proto-historical
Keith notes that Vritra “has 99 forts which because there is considerable evidence that
Indra shatters as he slays him”|71. It is this our hypothesised matrislic society was, in
frequently used epithet of Indra as ’fort fact, the pre-Vedic, Harappan civilisation.
breaker' which has led some scholars to The Harappans had a form of writing which
speculate that the aboriginal peoples (the has not yet been deciphered, and is thus
Vritras, Asuras, Dasas or demons of the Rig
technically ’proto-historical'.)
Vedic text) were the occupants of the
Interestingly Vritra, in factall thedemons
Harrapan cities such as Mohenjodaro.
of the Rig Veda, are known by matronymics
1 will attempt to understand the figure of rather than patronymics. Vritra is a Danava,
Vritra in two ways. First, by reading the text son of Danu. In one passage, describing his
as an historical documentreflecting the Ary an death, the Rig Veda links the two in imagery
encounter with, and subordination of pre ofcowand calf: "The vital energy of Vritra s
0”^)
Economic and Political Weekly
October 22, 1994
“Vritra was the absolute master — in the same
must not be accepted from her; for that is
modierebbed away, for Indra had hurled his
the food of women. Therefore they feel a manner as Tiamat or any serpent divinity deadly weapon at her. Above was the mother.
of all chaos before the Creation; or that the
loathing for her while she is in that condition
below was the son: Danu lay down like a
saying “she shall not approach”.
great serpent, keeping the waters for himself
cow with her calf" (RV 1.32.9. translation
(9)
“Those *brahmana in whose houses alone, had left the whole world ravaged by
O’Flaherty).
menstruating women sit, those who keep no drought."
My hypothesis is that Vrilra is mythically
sacred fire, and those in whose family there
Bui Sjoo and Mor interpret the pervasive
and symbolically linked to pre-patriarchal.
isnoSrutiya - all these are equal Io shudras.”
Indo-European serpentand dragon metaphor
pre-Vedic social formations. By re
In this text we find practices relating to in a radically different fashion. They state
interpreting the slaying of the 'son of the
mother', we discover- the mythic origin of theseclusion and restrictions of menstruating unequivocally that “the serpent of chaos is
women explicitly linked to die mythiedrama originally and always a woman’s body. As
the laterbrahmanic pollution ideology which
the Great Mother of Chaos. of mailer still
devalues and de-sacralises the female bodily of Indra’s slaying of Vrilra. This myth is
processes of menstruation and childbirth found first in the Rig Veda and subsequently unformed and undifferentiated, she holds
while simultaneously glorifying the woven through various texts - in this paper the earth like an egg in the pure energy of
patriarchally constructed instituion of we shall only considerthe Rig Veda, but the her coils." Sjoo and Mor understand the
Satapatha Brahmana and the Taitlireya “Great Mother of Chaos" to represent the
‘motherhood’.
Samhiia of the Black Yajur Veda also are
Tlie Dhannashaslras, the lawgivers’
'time before the gods’, which preceded the
treatises on how to live a proper life, contain germane to an understanding of how female establishment of patriarchal hierarchies and
various proscriptions on what a mens physiology is constructed, symbolically and distinctions. Within this woman-centred
narratively
linked
to
the
mythic
slaying
of
truating woman should and should not do.
interpretation, “the dragon of matter, the
In this text. Chapter 5 of the Vasishtha Vritra. and incorporated into Vedicsacriltcial Undivided One older than the individuation
liturgy and ritual.
Dharmashasira. menstrual taboos and
of forms", also signified the flesh and blood
Mircea
Eliade.
writing
of
the
Vrilra
myth.
woman’s subordinate social position are
bonds which unified the people. These
notes the Indian practice of astrologically authors link the snake/dragon with "the
related to the myth of Indra s Vritraslaying.
(1)
A woman is not independent, the males determining the placement of a peg into the indigenous 'masters of the ground’ - the
earth
before
building
a
structure.
The
peg
malrifocal
peasantry - who are invaded.
itre her masters. It has been declared tn the
Veda. "A female who neither goes naked is to secure the head of the snake (thought conquered, plundered, co-opted by the
to reside in the earth) and prevent it from
nor is temporarily unclean is paradise".
'dragon-slayers’ of patriarchal history..."In
(2)
"Their fathers protect them in childhood, shaking and destroying the building. “But Sjoo and Mor's analysis Indra's murder of
die act of foundation at the same tune repeals
their husbands protect them in youth, and
Vritra initiates the creation, notof thecosmos,
their sons protect them in age; a woman is
tire cosmogonicactforto “secure" thesnake’s
but of patriarchy. "...In the Indo-European
never fit for independence. "
head, lo drive the peg into it is to imitate view the dark, serpentine Danu and Vrilra
(3)
The penance to be performed by a wife the primordial gesture of Soma (R V 2.12.1) had withheld the walers in the mountain
for being unfaithful to her husband has been orof Indra when die latter "smote the Serpent hollows’ and so hindered the world from
declared in the section of secret penances. in his lair” (6.17.9) when his thunderbolt coming into being. The Indo-European
(4)
For month by month the menstrual “cutoff its head" (1.52.10).“ According to patriarchal world, that is"fll].
excretion takes away her sins.
Eliade’s interpretation the serpent Vritra
The violence of the Vritra murder is
(5)
A woman in her courses is impure during symbolises chaos, the formless and non
recapitulated in the ritual metaphor of the
three days and nights.
manifested. He supports this understanding serpentneeding to be pegged for masculine
(6)
During her period she shall not apply
by textual references to Vritra as “undivided
construction' to take place. (That this
collyrium to her eyes, nor anoint her body,
(aparvan), unawakened (abudhyam), metaphor is still operative in the folk mind
nor bathe in waler; she shall sleep on the
ground; she shall not sleep in the day-time, sleeping (abudhyamanam), outstretched is obvious from the worship of the Nag
(asayanam)."
Eliade
proceeds
to
state
that
which took place in many Garhwali villages
nor touch the fire, nor make a rope, nor clean
her teeth, nor eat meat, nor look at the Indra’s “hurling of the lightning and the after the Uttarkashi earthquake.) We are
planets, nor drink out of a large vessel, or decapitation are equivalent to the act of claiming that another paradigm of order.
Creation,
with
passage
from
the
non
not
primal chaos, can be discerned in the
out ofjoined hands, or out of acopper vessel.
(7)
For. it has’been declared in the Veda. manifested to the manifested, from the text; one that is congruent with women’s
procreative capacity, menstrual and lunar
“When Indra had slain Vritra.'the three formless lo the formed [10J.
Eliade’s notionofprimalchaos isoutdaled cycles and the hypothesised malrifocal
headed son of Tvashtri, he was seized by
and androcentric. The new physics is social order. I am suggesting that what
sin, and he considered himself to be tainted
withexceedingly great guilt. All beings cried radically changing scientists’ conceptions preceded Vedic ideology on the sub
out against him saying to him “O thou slayer of order and chaos. Phenomena previously continent was not the primal chaos of
of alearned Brahmana!” He ran to the women
understood as chaotic now seem to display chythonic peoples, but a previously
for protection and said to them, “Take upon
an underlying senseof order. It is masculine unrecognised, humanly constructed, social
yourself l he third pan of this my guilt caused
'creation' which involves hurling of lightning order. The death and dismemberment of
by the murder of a learned B rahmana." They (read sperm) and decapitation is a rather Vritra can be viewed as a metaphor for the
said. "Let us obtain offspring if our husbands anomalous symbol for creativity. What has
Indo-European exerciseof power, symbolic
approach us during the proper season, at
previously been understood as 'primal chaos’
and martial, over the pre-existing peoples
pleasure let us dwell with our husbands until might now reveal itself as a matristic social
and their culture.
our children are bom.” He answered. “So
and symbolic order. The creative order of
The mythic Indra was, after all. a warrior
be it”. Then they took upon themselves the
the menstrual cycle and the rhythms of labour par excellence; the Rig Veda is a martial
third part of his guilt. That guilt ofbrahmanamurder appears every mont h as I he menst rual may involve stress and pain - but not the document. Scholars have debated whether
violence
to
the
'other'
depicted
in
the
Indrathe warfare was literal, ritual, symbolic How. Therefore let him not eat the food of
a woman in her courses; for such a one has VritrasIaying.Theessenlialquestion remains between groups of men. men and demons.
gods and demons, etc. But Vedic study, both
put on the shape of the guilt of brahmana- “what/whom is really being killed?"
Eliade
reasons
that
because
Vritra
had
Indian and foreign, has neglected a crucial
murderer.
(8)
Those who recite the Veda proclaim the confiscated the waters and was keeping them question which Uma Chakravarty poses:
in the hollows of the mountains that either "Whatever Happened to the Vedic Dasi?"
following rule: “Collyrium and ointment
Economic and Political Weekly
October 22, 1994
2819
I
I
i
Chakravarty. in her deconstruction of “the "The only possible explanation lies in a constructed as being heroic, dharmic and
myth of the golden ageof Indian womanhood
clash of cults, tli at of the old mother-goddess sacred, as exemplified in Krishna’s advice
as located in the Vedic period", emphasises being crushed on the river Beas by the new to Arjuna in the Bhagavad Gita.
the historiographic foregrounding of “the war-god of the patriarchal invaders, Indra."
We have foregrounded the symbolic
Aryan woman (the progenilorof the upperKosambi explains the survival of the connection between the idea of rta or cosmic
caslc woman) as the only object of historical
independentfeminincreprcsented by Ushas order and menstrual rhythms. Other.scholars.
concern". Chakravarty notes “It is no wonder in terms of her redefinition; she assumes, Bhattacharya more recently, and the older
then thatthe Vedic dasi (womah in servitude), within an androcentric pantheon, the more Vedic Sanskritists. Pischerand Geldner. have
captured and subjugated, and enslaved by familiarpatrilineal roles of women - mothe •. also noted this sym bolicconnection. Further
the conquering Aryans,- but who also wife and daughter. “That she survives after validating this line of understanding rta is
the scientifically documented phenomenon"
being ’killed'can only indicate progressive.
represents one aspectof Indian womanhood,
disappeared without leaving any trace of comparatively peaceful, assimilation of her of menstrual synchrony.
In 1971 the American researcher. Martha
surviving pre-Aryan worshippers who still
herself in 19th century history"! 121.
The Indo-Europeans infiltrated the sub regarded her as mother of the sun. wife of McClintock documented the phenomena of
continent in differentwaves,! 1500-1200 BC.
the sun. daughter of heaven”! 16], That the human intra-group menstrual synchrony! 18],
The Aryan hymn singers of the Rig Veda metaphor of rape is used, within the text. She observed that the menstrual cycles of
lionised the exploits of Indra - hisswigging to assert the domination of god over goddess frequently interacting women tend to become
of Soma. his.rape of Ushas. his plundering implies that the practice of actual rape was synchronised over time, and that this
of booty forhis followers and also his killing utilised as a method of pacification of human synchronisation is related to the extent and
ol'Vrilra. Sukumari Bhaltacharji calls Indra women as well. Bloodshed, rape and plunder frequency of contacts between individual
a culture hero [13].
are all masked in the Rig Veda as the heroism
women. Anthropological work on the Yurok
Indians of northern California'and aboriginal
As Chakravarly's historiographic essay of the solar god. pushing back the frontiers
Australians point towards the 'precontact'
implies, a focus on the dasi arid the figure of darkness and primal, chaotic disorder.
of Vrilra implicitly questions the legitimacy
Evidence of a Rig Vedic overlay on a pre existence of menstrual sy nchrony among the
and sanctity of this heroic paradigm. W arfare existing meaning system is provided by women of these groups, as well as describing
has always been a different experience for Dipak Bhattacharya in his chapter on the ritual forms celebrating menstruation and
men and for women.
birth of Agni. Ina section interestingly titled female bonds. The work of McClintock and
Gerda Lemer describes the historical
“The flow of rta from the obscured mothers these anthropologists has tremendous
process of die enslavement of women in of Agni". Bhattacharya grapples with the relevance to woman-centred attempts to
west Asia and a similar situation probably imagery of rta’ (cosmic order) and 'rajas’
understand early human culture.
existed in ancient India as well. “Biological
(menstruation). Agni is said to be born 'in
Returning to the mythic Vrilra-slaying
and culural factors predisposed men to the depth of the great’ and 'in the yoni of two questions remain in this interpretation.
enslave women before they had learned how this rajas' and is referred to as 'the embryo One. why in the Rig Veda is Vritra grouped
loenslavcmen". Ixrner suggests that physical of the walers’. The aqueous origin of Agni widt thedasas. and in the laterlexts. including
terror and coercion, which were an essential
in the atmospheric region is a well recognised the Dharmashastrasquoted above, his slaying
ingredient in (he process of turning free vedic idea. Bhattacharya writes of the is referred to as a hrahminicide. which would
persons into slaves, took, for women, the symbolic meaning of 'the waters'. “It has lead us to see him as a brahmin? Second.
form of rape. “Women were subdued to be noted that in a different context Pischel why is Vritra usually rendered in the neuter.
physically by rape: once impregnated, they and Geldner recognise that the waters are .. rather than masculine, gender? It seems to
might become psychologically attached to imagined as females with their regular me that although the Rig Veda is the earlier
their masters...Free sexual access to slaves peculiarities, mainly periods.Thchighwalers document actually the later texts containmarks them off from all other persons as of the rains are regarded as catamenia more information about the aboriginal
much as their juridical classification as (menstruation) and their drying up as peoples. In the later Vedas, puranas and
properly..." Lerner concludes that there
menopause. In the context of the birth of epics. Vritra is further personified, fleshed
exists "overwhelming historical evidence
out. and conceptualised. The process of
Agni the rains may symbolisenotcatamenia.
for the preponderance of the practice of but locial (childbirth) discharge"! 17J.
assimilation and absorption of pre-lndo
killing or mutilating male prisoners and for
This symbolic nexus of the waters, rajas European material allowed for what wemight
the large-scale enslavement and rape of the (also meaning atmospheric vapour) and rta call ’prakritisation ’. i e. the transformation
female prisoners"! 14],
or cosmic order indicate an original mythic of the Aryan world-view, which we find
Lerner's view is entirely congruent with structure which sacralises menstrual and lunar more starkly presented in the Rig Veda.
historians’ views of Rig Vedic times. R S rhythms and recognises these rhythms. Brahmins, as a priestly caste, did not yet
Sharma describes Vedic life. "Spoils of war embodied by women, as principles ofclarity exist in Rig Vedic limes. The notion of
and cattle formed die main forms of property.
hrahminicide describing Indra’s slaying of
and order, as well as the source of life.
Cattle, horses, and women slaves were
Perhaps to the indigenous peoples. Vrilra is thus an anachronism. Perhaps the
generally given as gifts"! 15], I am suggesting
woman’s blood was awesome and numinous.
brahmins, while formulating these later texts
dial the Rig Veda, however, tentative an Women bled monthly, in cyclical harmony were appropriating some of the power and
historical source, can he read as a mythic with the moon, and yet did not die - rather legitimacy of Vrilra (or proto-brahminic
version of a lived past. Indra’s slaying of miraculously produced new life. The blood forms) to themselves. This is a reasonable
Vritra, like his'rape of Ushas, cun be shed by them, during menstruation and assumption because Vritra is textually
understood, not just as a phantasmagorical childbirth may have been considered sacred identified as having special powers and may
metaphor, but as the mythic rendering of real
emblems of cosmic order. Indra’s slaying of have functioned among the autochthonous
human experience; of the encounter between
Vrilra ended that symbolic connection. As peoples as a shaman. Nevertheless thedevice
the Indo-European patriarchal infiltrators
the Dharma shastras elucidate, menstrual of the ’hrahminicide' shows that the later
and the extant social formation.
blood comes to be considered loathsome - brahmin priests in some way identified
D D Kosambi interprets Indra’s rape of powerful, dangerous and threatening. Indra themselves with the Vritra figure.
Ushas. the goddess of dawn and renewal. expropriates women’s function of bloodlet
The Rig Vedic Vritra is both a demon.
"an otherwise inexplicable event" in terms ting. The warrior is socially sanctioned to dasa, and magician or priest. He exercises
the power of ’maya’ or illusion. The use
of a conflict of belief and ritual systems. shed his enemy's blood - that act is
I 2820
Economic and Political Weekly
October 22. 1994
of the neuter gender in referring to Vritra
and the Vritras ean be related to the literal
meaning of ‘vritra’ which is concealingcovering-hiding and defending-resistingprotecling. (The root vr conveys the idea
of aiding or succouring, in a positive sense.
sheltering [1K|. Most interpreters have
favoured a natural phenomenal under
standing as mentioned above. This level of
meaning is certainly present but not
exclusive of a socio-symbolic as well
biological-symbolic (women’s biology)
jeading. The neuter guilder may have been
used because the reference is finally to (he
indigenous people's system, a social and
Symbolic formation. Within the Vedic text
this system is represented in the form of
protective resistance and concealment masking the beliefs and practices, ruses
and manoeuvres, of a defensive aboriginal
population.
> ‘
II
lir'/ljs section I will present other textual
eviuv.ke which supports this woman-centred
reading of the Rig Veda. Hirst 1 will further
substantiate the argument that the similes
and metaphors of cows, walers, maids.
mothers in fact arc signi tiers for the
generative capacity of women and that this
imagery can bcread historically as referring
to the Aryan assimilation of women from
a pre-existing matrifocal social order. Then
1 will consider two different, but not
mutually exclusive, meanings of rta: Ria
as the cosmicorderof menstrual and lunar
rhythms, and a Marxist understanding of
rta as denoting a pre-vedic. egalitarian food
distribution mechanism. I shall then present
grammatical and symbolic material relating
to the notion of ’mothers-in-common'
which further documents the existence of
a matrilocal familial pattern. Within this
context I will examine the symbolic
significance of the few references to blood
in llr^ig Veda.
Cows-Water-Women-Mothers
CLUSTER OF MEANING
In RV 6.47.2-4 the 'sweet juice’ of Soma
“boldencd Indra when he slaughtered Vritra...
He who hath created lhe breadth of earth,
lhe lohy heights of heaven. He formed the
nectar in the three headlong rivers." This
cosmogonic act of Indra/Soma involves the
s aying of Vritra and depositing the nectar
(read sperm) into the headlong rivers (read
genealogies ot women). Wilson comments
Titus Soma has deposited the ambrosia in
'Ll three principal receptacles". This mythic
death and creation, of course, operate on
many levels. Traditional scholarship has
.emphasised the cosmological symbolic
( ndra as solar god); the world of nature
Undra as vegetation god); and the ritual
context of the Vedic sacrifice (hymns with
tlurgical function). But social and biological
’’ rala o| meaning also are evident.
Gnomic and Political Weekly
rhythms, woman’s physiology may haveIn RV 3.61.3-5 the "Bull, who wears all
functioned as a prc-patriarchal gynocentric
shapes" is the male inseminalor. the
ordering principle which was both symbolic
“Everlasting Ones’ impregner".
“The Goddesses, the Walers, stayed to and matrilocal. This involves recognising
both the processes of menstruation (asa sign
meet him; they who were wandering separate
enclosed him. Streams! die wise Gods have of the independent, cosmically syncronised
rta) and the biological primacy of the mother
thrice three habitations."
(human beings are not a sexually dimorphic
“Child of three mothers, he is the lord in
synods."
species - lhecentral humandramaofcrealing
“Three are the holy Ladies of the Walers.
new human life happens in the female body
thrice here from heaven supreme in our not in the male body).
assembly.”
The Rig Vedic hymns reified the female
Tile child of the three mothers’ is Agni.
body and provided the symbolic structure
We have already pul forward Dipak which sacralised patriarchal. Aryan
Bhaltachaiya's lhesisof rta and the obscured
motherhood (Adiii) while demonising the
mothers of Agni. Griffith supposes “the
independent female energy Cditi'. ‘danu’.
Ladies of the Walers" to be the Ila. Sarasvati
the demon ol’defloralion. ‘drub’) and beg ins
and Bharati(20j. In a socio-physiological
the process, developed in later texts, of
interpretation the ‘cows’ (which are assigning a negative valence to menstrual ion
inseminated by the bull) - ‘holy Ladies of as death fluid.
the Waters' (women) - 'Mothers’ cluster
RV 3.60.16-17 reads;
’signifies in both social and symbolic realms.
Let the milch-kinc (read women) that have
no calves stream downward, yielding- rich
Clans or genealogies of women which were
nectar, streaming, unexhausted. These who
‘wandering separate’ that is not attached to
are ever new and fresh and youthful...
any male, or malrilineally constituted.
What
lime lhe Bull bellows in other regions.
become assimilated into the Indo-European
another herd receives lhe genial moisture;
palriarchy[211. They are thus honoured as
For he is Bhaga. King, the earth’s protector...
‘supreme in our assembly' as Aryan
In RV 3.33.6-10 the walers-women are
progenitrices. And thcsalutation ‘Streams!’
(indeed the omnipresentmetaphorof women encouraged to co-operate and be easily
as water) is thus honouring the facts of female traversed after the demon is slain.
Indra who wields lhe thunder dug our
physiology - bodily fluids which indicate
channels: he smote down Vritra. him who
generative capacity as producers of progeny:
stayed our currents...
menstrual, vaginal and amniotic fluids.
That hero deed of Indra must be lauded
Part of the interpretive problem is that
forever that he rent Ahi in pieces. He. smote
not only were previous commentators
away lhe obstructors with his thunder and
androcentric, they also shared the patriarchy’s
eager for their course, flowed the waters.
discomfort with Irankdiscussionof women’s
List quickly sisters, to lhe hard who comelh
bodies and sexuality. The facts of female
to you from far away with car and wagon.
biology stream out of the text. From the
Bow lowly down: be easy to be traversed;
pundit Sayana to tlie Victorian Indologists.
stay Rivers, with your Hoods below with our
commentators were more comfortable with
axles.
Yea. we will listen to thy words. () singer.
interpretations involving heavenly bodies
With wain and cur from far away thou contest.
(han female ones. It has taken the Freudians
Low, like a nursing mother, will I bend me
to legitimise a discussion of sexuality, but
and yield me as a maiden to a lover.
this discussion is still phallocentric and
The hymn encourages thesisters to listen
individualistic (not exploring the textual
evidence foran alternative social formation). or accommodate lhe bard; receiving the word
The present interpretation foregrounds of lhe singer is analogous to receiving lhe
women as persons capable of full participa seed of Indra (‘bow lowly down’, ‘be easily
traversed’). The extension of the imagery to
tion in the formulation of societal and
’like a nursing mother" and ’amaiden loiter
symbolic systems and female physiology as
a locus of power. (When we speak of female lovcr’ further validates this reading and
physiology we do so in a gynocentric sense reminds us of Lerner’s suggestion that the
of the total range of female bodily process; motivation for women to submit to slavery
menstruation, female capacity for sexual was lhe experience of being.impregnated.
giving birth, and forming attachments within
pleasure, as well as potential for pregnancy.
the patrilineal family.
childbirth and lactation.) Such a holistic.
womancentrcd - and biologically accurate Cosmic Ria and Young Maids
definition of female physiology implicitly
questions the patriarchal assumption of
In lhe text we find ample evidence to
woman’s value as ’the mother of sons'.
support I) ipak B hattachary a's interpretation
We are positing that female physiology of "the flow of Ria from the obscured
(inclusive of the later desacraliscd aspect of mothers" as a veiled reference to
menstruation) may have been a powerful
menstruation. RV 4.19.2-7 reads;
and positivesymbolic referent in themeaning
Thou slowest Ahi who besieged the walers,
syslemsof indigenous peoples. Emblematic
antlduggesl out their all-supporting channels.
of the generative natural world and cosmic
The insatiate one. extended, hard to waken;
October 22. 1994
2821
who slumbered in perpetual sleep, O Indra,
Bhattacharyya proceeds to argue that “the
that strengthens’ may connote female fluid
The Dragon, stretched against the seven
Vedic rta must have originally been what
(in later texts female ‘seed’). During
prone rivers, where nojoint was. thou rentest
pregnancy, when menstruation ceases, that Engels called ‘ the simple moral grandeur of
with thy thunder...
female blood is often understood to grow ancient gentile society’, and this explains
They ran to thee (Indra) as mothers to their or ‘strengthen’ the foetus. In the Rig Vedic why the Vedic poets felt the loss of rta for
offspring: the clouds, like chariots, hastened
which the breakdown of ancient collective
hymn singers preoccupation wi th offspring,
forth together. Thou didst refresh the streams
this ‘food’ is also seen to strengthen the life was responsible". He also notes the
and force the billows...
Aryan patriline. Within the context of the moral and ethical qualities originally
He (Indra) let the young Maids skilled in
Law, unwedded, like fountains, bubbling. Vedic sacrifice that ‘food’ becomes Soma. attributed to the character of Varuna, friend
Perhaps within the previous ritual system of to all and the guardian of rta. (These moral
flow forth streaming onward.
the indigenous ‘demon-priests’. like Vritra, and ethical qualities of Varuna stand in
Indra slays the Ahi/Vrilra/Dragon figure
who is “stretched out against the seven prone female bodily fluids were considered the complete opposition to the amorality of
Indra.) Although Bhattacharyya’s Marxist
rivers”. The rivers-women then run to Indra symbolic ‘food’.
Finally we must ask about the significance methodology may seem obtrusive today, his
subdued, in achildlike fashion. He ‘refreshes
of thefemale demon in this passage. I would scholarship stands. “Rigvedic passages
the streams’ in imagery which almost sounds
like contributing genetic material to a gene argue that the Aryan appropriation of a pre relating to the ria convincingly prove that
pool. But most interesting is the fact that existing social and symbolic form is a violent the said concept had direct or indirect bearing
these maids are ‘skilled in Law’.orrta.This act; the indigenous reaction, and the on the process .of obtaining means of
description reinforces the association of rta continuation of non-Aryan ritual and social subsistence”.
N N Bhattacharyya thus provides a
with menstrual rhythms. These young women process is constructed in the Vedic text as
are ‘unwedded’.or not within a system of an anathema, demonic. As we shall see with plausible explanation of themechanism, the
the demon of defloration in Suryaa’s Bridal dice game, by which a pre-Vedic egalitarian
patriarchalmarriage. Once impregnated they
and the demon-priest Vritra himself, it is society may have implemented distribution
'flow forth' with much sought after Aryan
entirely plausible to read the demonic as of resources. (Thematically the motif of the
offspring.
In RV 4.23.7-10 Indra turns his hand signifier for what is being excluded or dice game is often linked with women in
Hindu mythology. In the Uma-Maheshwar
against an independent female spirit and the forcefully appropriated by the emerging
iconography Uma is depicted as winning a
next three stanzas elaborate on rta. The Aryan world-view.
Thus ambiguous meanings exist not just game of dice, beating an emaciated Shiva.
commentators are creative in their
because of the multi-levelled planes of real ity
In the famous dice game sequence of the
explanations of what rta symbolises in this
operating within the text, but also because Mahabharata. Draupadi is gambled away by
context.
(7)
About to slay the Indra-less destructive the VedicpoeLs areswitching hack and forth her husband.)
Veena Das. in writing of Draupadi. has
spirit he sharpens his keen arms to strike her attempting to reconcile conflicting symbolic
and social systems of the pre-Vedic cosmic indicated that the motif of pollution is
[according to Griffith.druh-lhe mischievous
female spirit who does not acknowledge rta and the ‘new world order’ of Aryan dominant in the rendering of her character.
Indra]...
hegemony.
This pollution motif allows her to “reveal
(8)
Eternal Law hath varied food that
Within a Marxist interpretive framework. the dark side of the male codes of heroism
strengthens; thought of eternal law removes N N Bhattacharyya suggests an alternative.
and chivalry"[24]. According Io Das the
transgressions. The praise hymn of eternal
but not mutually exclusive, meaning for die symbols of menstrual pollution were used
• law. arousing, glowing, hath opened the deaf Vedic rta. He identifies gambling and dice.
by Draupadi to interrogate the male-ccntied
ears of the living.
always heartily condemned in the canonical events in the Mahabharata discourse. This
Firm seated arc eternal Jaw’s foundations;
(9)
texts, with an ancient tribal redistribution irony would be even more pronounced if.
in ns fair fonn are many splendid beauties.
By holy law long lasting food they bring us; system which was egalitarian, not in fact, the motif of the dice game hearkens
hierarchical. His understanding provides back to a pre-existing moral order of rta in
by holy law cows come to our worship.
(10)
Fixing eternal Law he. loo, upholds it: anotherdimension to the phrase ‘food which which women were not rendered as property
and menstruation was not depicted as
swift moves the might of Law and wins the strengthens’ mentioned above.
Bhattacharyya writes that “Evidently dice polluting.
booty. To Law belongs the vast deep Earth
and Heaven: milch-kine supreme, to Law were thesymbol of ancient social justice and
It is relevant that al Mohenjodaro and
their milk they render.
casting the lot was a means of equal
otherHarappan sites (which, as previously
Commenting on stanza 8 Sayana writes distribution of wealth inearly Vedic times...” noted, some Indologists suggest may have
"the word rta means Aditya, or Indra or I understand Bhattacharya to bedescribing been inhabited by the Dasas or demons of
sacrifice". Griffith claims “its meaning varies
something like an ancient ‘kitty party’ where
the Rig Veda) many small, cubed artifacts
slightly in this and the two following stanzas,
the harvest or available resources were have been unearthed which archaeologists
but the original idea of regularity. conformity allocated via a game of chance. All would have called ‘dice’. In addition no system
to or establishment by eternal order or law sooner or later receive their share, but the of coinage (for a city of 60.000 inhabitants)
is found throughout". About Rk 10 Griffith timing would depend on the throw of the dice. has been found that is pre-Buddhist.
claims the establishes of the law is also its
As Bhattacharyya points out, rta cannot
upholder. Wilson translates “the worshipper possibly only denote cosmological or natural
Collective Mothers
subjecting rta tojiis will verily enjoys rta". laws because these laws would not have
Rk 8 relates rta with ‘food that streng been subject to change. “There is no doubt
Thecows-waters-rivers-mothersclusicrof
thens ’. O’ Flaherty mentions that “the Vedic
*
thatrta stood forapeculiarcomplexof moral
imagery leads toa consideration of the group
materials abound in texts in which semen and physical laws, but this is not all. Rta also orcollective mothers concept. D D Kosambi
is regarded as a form of food. Butter and stood foroUier principles... One point which has written “There is, moreover, an ancient
honey, frequent metaphors for Soma come should be stressed is that the Vedic poets tradition of mothers-in-common thatcannot
to be compared with semen"[22].Butin the eventually felt the loss of rta and strongly be reconciled with . Vedic father-right. Il
context of this hymn, and following the urged for its revival. If it were exclusively would be difficult Io explain Panini 4.1.115
interpretation thatthemenstrualrhythms are
the physical and cosmic laws, there was no unless mothers-in-common were taken for
emblematic of cosmic rhythms, the ‘food need of such lamenting..."[23].
granted by the mastergrammarian." Kosambi
Economic and Political Weekly
October 22. 1994
Tryambaka- Which was later
acknowledging the power and generativity
explained away as meaning ‘with three eyes'
of the female body. ‘The Chieftain of the
originally meant 'with three mothers'. He
Mighty Stride’ is Visnu as the sun. His
suggests that this notion, which seems fantasy
mothers (plural), the many young Dames
,t’,hcPatnlineal mind, appears in “the legends
(plural), arc, according toSayana“the regions
oI Jarasamdha bom of two. and Jantu."born
of space which generate all beings". Here
of a hundred molhers-in-common show”.
we encounter the Vedic (and probably pre
According to Kosambi this demonstrates
Vedic) notion of the generative power of air
that there was an undeniable tradition of orspace which is. within lhetextcontinually
many mothers with equal status, even for a subordinated or appropriated by the power
single child".
of Indra (lightning, seed, semenic rain) to
Kosambi appropriately identifies this create life.
mythology’ as the historical patriarchal
Keith writes of the opposition of the gods
[^ork‘nS an original matrifocal culture.
to the demons or dasas. "That in many cases
Tjiese legends were meant to explain the historic men may be meant when Dasas are
record away when society had changed to overthrown is true; but gods of the defeated
the extent that the original concept seemed
aborigines may also be denoted, and more
fantastic...However, seen mothers who generally powers of the air. opposed to the
equally bear a child-in-common (without gods". Keith explains that the Dasyus seek
any particular father) is a primitive concept
to scale heaven, but Indra vanquishes them
in some kinds of pre-patriarchal society, and
from birth. Indra wins the sun and the waters
the inexplicable notion is present even in the after defeating them. Keith also mentions
Rig Veda'[16).
that “a Dasa is husband of the waters...”[25]
Kost ip>i, although he gives noreference, further corroborating our socio-symbolic
may have been referring to RV 3.55:
interpretation.
(3)
My wishes fly abroad to many places: Inonecontext(RV8.66.5)Vritra is referred
1 glance back Io the ancient sacrifices. Lei
to as a Gandharva. or celestial (air) being.
us declare the truth when fire is kindled.
"Indra in groundless realmsofspace pierced
(4)
King (Agni) Universal, born io sundry the Gandharva through, that he might make
quarters, extended through the wood he lies brahmans' strength increase". This notion
on couches. One mother rests, another feeds of generativity and sexuality (not involving
L . the infant...
patriarchal marriage or procreative intent)
(5)
Now lying far away, child of the two continues in the male-air-Gandharva. fernaleMothers, he wanders unrestrained.the single
waler-Apsara personification of sexual
youngling. These are the. laws of Varuna
elements.In the Arthashastra and Manusmri ti
and Mitra...
Interpretations of the two mothers have the term 'Gandharva marriage' refers to a
love marriage, by mutual consent, which is
included 'heaven and earth , and "the lower
and upper branches of the wood for the not considered in the ideal or dharmic
category. Manu commented that “it has
sacred fire’. But the reference to ancient
sexual intercourse for it’s purpose”[26].
sacrifices (which probably means ancient
The acquiescence of the ‘cows-walersrituals) combined with the realistic
women-mothers’ to thedesigns of progenydomesticity of “one mother rests, another
obsessed Aryans involved leaving behind
feeds the infant" combine to suggest
her 'airy fairy’ consort (now symbolically
previous matrifocal familial and ritual
killed by Indra) and accepting anothermodel
patterns.^
of generativity which located power
In Rl W54.14-1S. a hymn to Visvadevas.
source-seed in the male god, in this case
themes of groupmothers. the Vritra-slaying.
Agni. (RV 3.57.3) “Fain to lend vigour to
rta. and fear of childlessness appear.
the Bull, the sisters with reverence recognise
(14) To Visnu rich in marvels, songs and
praises shall go as singers on the road of the germ within him". Within the dominant
Bhaga. the Chieftain of the Mighty Stride patriarchal Aryan symbolic formulation.
. » whose Mothers, (he many young Dames. ideological justification for assimilation of
the much needed indigenous womeni never disregard him.
(15) Indra, who rules through all his powers mothers, it is the seed-germ which becomes
sacralised and deposited in the stream
* * heroic, hath with his majesty filled earth and
heaven. I .ord of brave hosts. Fort crusher. mothers: the blood of women, and blood
generally, is excluded or demonised.
Vritra-slayer. gather thou up and bring us
1 store of cattle.
Blood in Rig Veda
(IX) Aryamun. Adili deserve our worship;
the laws of Varuna remain unbroken. The
O' Flaherty in her analysis of "the origins
lol of childlessness remove yc from us. and
I let our course be rich in kine and offspring. of the sexual fluid hydraulic systems of
The road of Bhaga’ is noted by Griffith Hindu texts" writes that blood is seldom
as meaning “on the path ol good fortune or mentioned in the Rig Veda - surprising for
felicity". Actually one of the meanings of such an earthy and martial document. She
'bhaga’ is vagina or yoni. The ancient mentions that “one late and notoriously
problematic hymn asks, ‘Where is die earth’s
conception seems to have been one of yoni
as metaphoric source of all things. breath, and blood and soul’ ? (RV 1:164:6)”.
Economic and Political Weekly
October 22. 1994
O’Flaherty points out the commentator
Sayana’s anachronistic understanding of
this passage. Sayana “interprets this as a
reference to the gross body (of earth and
blood) and the subtle body (of breath and
soul)...despite the probable anachronism of
this interpretation, the Vedic text itself is
certainly a clear reference to blood as the
essence of the earthly body"[22|.
This nostalgic paen to the "breath and
blood and soul” of the earth, located in
a hymn to Visvadevas, displays the
Vedic poets' longing for the lost rta. as
N N Bhatlacharyya has noted. The text
assigns equal value to the elements of earth.
blood and soul which differs from the later
Vedic hierarchical distinction of subtle body/
gross body understood by Sayana.
Relevant portions of the hymn as translated
by Griffith read:
(4) Who has beheld him as he sprang to
being, seen how the boneless One supports
the bony? Where is the blood of earth, the
life, the spirit? Who may approach the man
who knows, to ask it?
Griffith and other commentators relate the
boneless one to the unsubstantial. Prakrti or
Nature and the source of the substantial.
material world. Still common as a traditional
image is thebelief that the mother contributes
the fleshy, unsubstantial material for the
foetus, and the father contributes the hones.
Patrilineal and patrilocal familial structure
may be projected onto the body of tile foetus
in this Vedic notion of embryology.
(8) The mother gave the Sire has share of
Order; with thought, at first, she wedded him
in spirit. She. the coy Dame was filled with
dm’ prolific; with adoration men approached
to praise her.
'
The mother is identified as source, gifting
the sire with his procreative function, share
of order, rta, congruent with Dipak
Bhattacharyya’s notion of the ‘obscured
mothers of Agni". The initial wedding exists
in the realm of mind and spirit. She is
subsequently impregnated by the dewprolific
or semenic rains. This shift marks the
transition from the matrifocal to the
patriarchally constructed mother.
(15)
Of the co-bom they call the seventh
single-bom; the six twin pairs are called
Rsis. children of Gods. Their good gifts
sought of men are ranged in order due. and
various in their form move for the Lord who
guides.
(16)
They told me these were males, though
truly females: he who hath eyes see this, the
blind discern not. The son who is a sage hath
comprehended: who knows this rightly is his
father's father.
Griffith cites Wilson’s observation that
the males/females reference is 'a piece of
grammatical mysticiam' - but there is
nothing mystical about the formal
transfiguration of seven ‘rivers’ or
genealogies of women into seven families
of rishis. Griffith himself demures ‘the
meaning is obscure’. This rk may be an
2X23
(35) Cutting, carving, and chopping into
work of "droil de seigneur” literally the
acknowledgement of the appropriation of
pieces - see the colours of Surya which the rightto ’deflower' the virgin' bride.(I use
metaphors of fertility and the substitution
priest alone purifies (RV 10.85.27-30. 34of the palriline for the matriline. The
the word ’virgin' here in the patriarchal
35
trans
O'Flaherty).
knowledge of the sage of being his father's
sense of unpenetrated, inexperienced
fatlK. operateson two levels: the pre-existing
O’Flaherty comments that verses 28-30 sexually: not in it's original sense of not
esoteric knowledge of all human life of and 34-35 concern the defloration of the belonging to any man - free, unexploited
divine origin - the lack of human paternity bride and the staining of the bridal gown yet fecund as in contemporary usage, 'a
virgin forest’.)
within a matristic system being attributed with her blood. She explains that “this blood
to a divine father: and the hrahmanic con becomes a magicspirit, potent and dangerous
I would argue that the defloration sequence
struct of the pitrs or male ancestors who are though not necessarily evil: the defloration
located in Suryaa's bridal involves a
continually reborn within the same pa triline. is an auspicious event but too powerful to misreading or distortion of pre-existing
(17)
Beneath the upper realm, above this allow its emblem to remain present esoteric knowledge[28]. This misreading
lower, hearing her calf al fool, the Cow hath afterwards". According to O'Flaherty the subordinates otherconceptionsof the.sacred
risen. Witherward. to what place hath she
masculine (linked with mountains, clherial
magical power of the bkxid ol defloration
departed? Where calves she? Not amid this
is transferred to the bride’s family and to space, withholding of the walers, the
herd of cattle.
Gandharva. the shamanic Vritra). The
[This rk echoes in structure and lone rk 4. the husband, but it becomes evil if allowed
marriage-defloration
passage in the tenth
The sentiment expressed is a questioning to pollute the husband. Thus Soma performs
mandala is a late addition to the Rig Veda.
lament - something has been lost and that a mediating function "by exercising his droit
All
the
citations
regarding
rta and the
de
seigneur.
Soma
takes
upon
himself
the
something relates to the blood and breath
maidens, the collective mothers, andcowsand soul of the earth and to the Cow giving first and most powerful stigma of the blood
watcr-women-mothers imagery are in the
birth. The independent feminine truly'calves of defloration".
O’Flaherty emphasises the multiple earlier family books. It may be that the
not’ within the Aryan herd of catlie.]
Although this hymn has been interpreted meanings of stanza 33-35. Literally, of earlier esoteric notions of the mystical
cosmologically. inrclation to months, years, course, this verse describes the cutting up generative power of woman’s body,
admittedly already defined in the mistime
the sun, lightning, fire, dawn, etc. it is per of the blotxl-stained robe: "but the words
voice and rendered poeticallJPand
fectly congruent with a socio-physiological usually refer to the cutting upof the sacrificial
reading.
animal, and there is a furthcrovertoneof the symbolically, in the tenth mandala become
Another mention of blood (RV I :87:16) physical injury of the defloration itself, the institutionally harnessed in tbeconstniction
refers to demons who are smeared with sacrifice of the maidenhead on the altar of of the patriarchal marriage ritual.
Suryaa. cosmically nominated asdaughter
blood of men. horses and cattle and who mairiage"[27|. The hypothesis of a pre
steal away the milk of cows. This reference existent matrifocal social order presupposes of the Sun. is wed to Soma who. asO'Flaherty
seems to reflect a practice of applying blood expression of female sexuality, unfettered noted, is here linked with the moon for the
to the body. Wecan understand this literally by patriarchal marriage and not identified only time in the Rig Veda. Suryaa. adorned
as camouflage for cattle raiders or with the production of progeny for the with red flowers symbolic of menstruation,
is encouraged to enter the world ofpatriarchal
sym bolically, as aritual practice using blood
pa triline. The demon ofdefloration then can
immortality (as the mother of sons), at lire
or both. In any case the reference clearly be read as asignifierforthe violation of the
associates (he demons with application of independcnland powerful feminineon manv same time anothermale figure (Visvavasu.
levels:
blood to the body.
a Gandharva) is banished and her cosmic
According toO’Flaherty "There is in the - The political because the institution of connection with Varuna (guardian or rta is
Rig Veda one veiled but highly charged patriarchal marriage renders woman as an severed (RV 10.85.21 -25 trans O' Flaherty).
reference to female sexual blood - not object of exchange.
Mount the world of immorality, 0 Suryaa.
menstrual blood, but the blood of - The personal violence involved in the
that is adorned with red flowers... Prepare
an exquisite wedding voyage for your
defloration”(19|. The divine prototype for forcible breaking ofthe hymen of the newlyhusband.
patriarchal marriages is found in a passage married girl.
’Go away from here! For this woman has
referred to as 'Suryaas Bridal’. Her Suryaa -The sexual as androcentric preoccupation
a husband’. Thus I implore Visvavasu with
(the daughter of Surya, the sun) is wed to with penetration., for example Urvashi’s
words of praise as 1 how to him. 'Look for
Soma - according to O’Flaherty the only reprimand of Puruvas’ aggressive sexuality
another
girl who is ripe and still^Qs in
lime ip the Rig Veda when Soma is regarded (RV 10.95.5 trans O’Flaherty “Indeed you
her father's house. That is your bfifllhght
as the moon. Relevant portions of the hymn pierced me with your rod three times a day
find it.
(RV 10:85) read:
and filled me even when I had no desire.
‘Go away from here, Visvavasu, we implore
(27)
May happiness be fated for you here 1 followed your will. Puruvas...").
you as we bow. Look foranothergirl. willing
through yourprogeny. Watch overthis house - The religio-symbolic in which the
and ready. Leave the wife to unite with her
as mistress. Mingle your body with that of woman’s experience is excluded from
husband'.
your husband...
determination of collective meaning, and
May the roads be straight and thornless on
(28)
The purple and red appears, a magic she instead is rendered a cipher in an
which our friends go courting. May Aryaman
spirit; [Griffith translates ’fiend'| the stain androcentric symbolic system. In this case,
and
Bhaga united lead us together. 0 Gods,
is imprinted...
may the united household be easy to manage.
(29) Throw away the gown, and distribute the textual analogy between the girl’s
bloody garment’s and thesacrificial animal.
I free you from Varuna’s snare, with which
wealth to the priests. It becomes a magic
the gende Savitr bound you. In the seat of
spirit walking on feet, and like the wife it (Th is demonof de floration bears astri king
the Law, in the world of good action, I place
resemblance to the traditional popular
draws near the husband.
you unharmed with your husband.
(30) The body becomes ugly and sinisterly notion of the churel - the demonic spirit
I free her from here, but not from there. I
pale, if the husband with evil desire covers of the woman who dies in childbirth.)
have bound her firmly (here, so that through
The demonisation of the blood of
his sexual limb with his wife’s robe...
the
grace of Indra she will have fine sons
(34) It bums, it bites, and it has claws as defloration demands the construction of a
and be fortunate in her husband's love.
dangerous a poison is to eat. Only the priest heroicmasculine figure inorder to. borrowing
The banishment of the Gandharva is
who knows the Surya hymn is able to receive UmaChakravarty’s phrase, “manage female
another version of theslayingofVritra.Thc
sexuality". Hence the priest does Soma’s
the bridal gown.
woman's role is now that of faithful wife
■ 2824
Economic and Political Weekly
October 22. 1994
a problem to Indra, the guilt of the slaughter
of Vritra. alluded to in verse 7." If we lake
the slaying of Vritra as the symbolic
equivalenlof the decline of malrifocal social
groupings and the desacralisation ot the
independentcosmic feminine then the holistic
meaning of this hymn is clear. Indra's flaw
(which his own mother recognised as a threat
to her life) is his independence of a malrifocal
moral order, his strength and tendency
towards violence: his violent birth, his violent
dismemberment of Vritra. his slaying of his
own father - indeed his rupture of a pre
existing, peaceable, malristic social and
symbolic order.
The issue within this violence then
becomes protection. Indra s mother, within
the context of (he Vedic hymn, first func
tions to protect Indra (both from his father
and from his own violent character) and
then abandons him to the protection of the
waters.
In stanza 6 Indra’s mother speaks of the
waters who are now flowing happily and
onomolopoetically. Through Indra's
mother’s words the waters are rendered in
the male voice, symbolically constructed as
free and happy. But previously they were
"screaming together like righteous women”.
O’Flaherty succumbs to androcentric
perspective and reads this as referring to
screaming for help when Vritra assaults
them. But nowhere in any version oflhe Rig
Veda have I read of imagery which speaks
of'Vritra's ‘assault’ on the walers/women.
Vritra encloses, contains and lies with the
walers, but does not assault them. 1 read
screaming together like righteous women’
as theprolestol the violated fetninine/feinales
which is silenced (by the poets) and then
becomes poetically and aesthetically
rendered. The text itself acknowledges the
problem of interpreting the message ol the
waters. “Ask them what they are saying..."
In stanza 7 Indra’s mother continues in
a tentative and questioning voice betraying
the ambivalence of the shifting positions of
the waters from righteous protest to gur
gling poesy, to praise and invitation, to
willingness to take on Indra’s guilt. And
again the Vritra slaying is mentioned as
releasing the waters.
Inslanzas Hand? Indra’s molherrepealedly
uses the phrases ’not for my sake’ and for
my sake’ indicating that she may be faulted
for the motivation of her actions. First she
claims that her rejection of Indra as a child,
and h: < subs eq uenl s wa I lowing by the demonchildl arth was 'not forhersake'. (According
toSaj ana, ’demon-childbirth’ was Kusava,
a rakshasi who swallowed Indra at his birth,
and Roth states this reference is the name
ofariver - again the river-womcn-molhers,
in this case demonic, imagery.) But Indra's
mother will lake credit for the waters
nurturing the child and his own
independence. The question of acting in
/
I
2826
aboriginal peoples) or raped. Ushas
one's own self-interest is operative here.
(independent cosmological feminine).The
Indra triggers (he entire drama by rejecting
earlier elemental imagery of cows-watersbirth through the vagina and endangering
maids-mothers is replaced by (he patriarchal
his mother. She reacts ambivalently, by
institution of marriage in Suryaa's bridal
rejecting him - but "not for her own sake ’.
hymn from Bcxrk Ten. Rta. cosmic order.
Shedistanccs herself from the swallowing
is subordinated to dharma, right action, as
evil-childbirth (obviously symbolic oflhe
rejected powerof the (’yoni) and in the next defined and elucidated by die emerging
stanza proceeds to distance herself from the priestly caste.
Tire patriarchal synthesis effected by the
shoulderless one( Vritra) who is said tohave
Vedic poets involved the construction of a
not acted for her sake. Why the need for this
symbolic structure which glorified women
disavowal ol’ both demon-childbirth and
in their role of mothers and simultaneously
Vritra unless both are linked to her rage at
her son’s heroic strength which threatens excluded or mystified and demonised the,
female biological fluid of blood. Imageryof
and marginalises her? But she also allies
cows-walers-women-mothers facilitated
herselfwith the nurturing walersand Indra’s
art iculationsof feminine generativity which-*
independence because these tire congruent
were developed into mechanisms of social
with the construction oflhe heroic masculine
and symbolic control of female sexuality.
and malerna 1 fem inine. ultimately espoused
by the Vedic poets. The contradictory nature
Both the religious ritual of the sacrifice and
the social grouping of the patrilineal family
oflhe maternal waters is a continuing theme
structurally reflect a focus on the masculine
throughout later texts and mythology.
figures of Indra and Agni as (he source of
As O’ Flaherty notes "none of the principals
in the drama is named except Indra; later sacred authority, object of ritual practice,
commentary identifies the mother with Aditi
and dominant biological metaphor.
Tire mythic slaying of Vritra. son" the
and the father with Tvastr". “I would argue
dial Indra's molherhas no name here because
mother, symbolises this paradigmatic shift
she is still generic for Mother - or more
from the female body to the male body as
appropriately within the early Vedic period - principle social and symbolic metaphor. The
Kosambi’s ‘mothers-in-common”’. She is
generative female power of childbirth is
singular only because she is the mother of eclipsed by the sacrificial dismemberment
Indra and thus patriarchally constructed. But
of the cosmic male: it is out of Purusha's
the hymn is permeated by her deep
body which the world is created - tire Vedic.
ambivalence towards her hero-son.
androcentric world, that is.
Finally Indra’s violation oflhe integrity
My initial investigation was prompted by
oflhe female body, within the pre-existing the seeming ly con trad ictory attitudes towards
symbolic system emblematic ofcosmic and
the female body displayed by die basti
natural order, and rupture ot malristic
women’s rituals of well worship after
indigenous social groupings is his moral childbirth and observations of menstrual
flaw and crime. The Vedic poets silence the taboos. The Dharmashastra outline of
protests of the righteous women/waters and
menstrual prohibitions and beliefs linked
the discourse excludes the female voice.
this practice to the Vedic myth of Indra
Women as persons are subordinated to slaying Vritra. I was not familiar with any
gendered symbols within the emerging
textual or historical sources which would
brahmanic context.
give information about the well worship
Women taking on the sin of Indra, in the
ritual .so my efforts have been to detect an
form of their menstrual blood, elaborated on alternative positive valence to water as Mfxl
in the later texts, is only hinted at in the Rig source rather than merely ritual purifiSon
Veda. But Indra’s avoidance of his mother’s or washing away sins within the context of
yoni, and the silencing or symbolic the Rig Veda.
construction of the waters/women are
My working hypothesis of pre-existing
narrative elements which precede the meaning systems and matristic indigenous
suggestion that they will absorb his kinship groupings evolved into a
culpability.
methodology of a socio-physiological ■»
reading of the text. A foregrounding of Vritra
in
reveals his. and all demons, matrilineal origins, linkage to the transformative
Thus within the Rig Veda the elemental elements of air. water, and earth (as opposed
and numinous powerof the feminine/female to the Indra- Agni element of fire), and ritual
is nominated, symbolised, appropriated - function as demon-priest. The symbolic
managed and controlled. Vedic gender nexus of cows-waters-women-mothers.
categories of primal female power are read within the historical context of I
constructed. Those able to be controlled are Aryan assimilation of indigenous women.
designated as sacred - Vac (the word), and and concern with progeny, validates this
Aditi’ (patriarchal motherhood).Those more socio-physiological interpretation. Dipak
difficult to manage are demonised - Nritti Bhattachary a’s analysis of “the flow of Rta
(death), Danu and Dili (mothers of tire from the obscured mothers of Agni” and
Economic and Political Weekly
October 22. 1W
ni-u 3.
• UNFB4
United Nations
Population Fund
DEPO/Injectable study proposal/
January 22, 2002
Dear Dr. Narayan,
As you are aware, injectable contraceptives approved by Government of India, are being
offered to women in India through private clinics/social marketing outlets. However,
concerns have been expressed by different sections of civil society about the conditions,
especially at the service delivery level at which injectable contraceptives are likely to be
made available to women. As women have a felt-need for effective contraceptives, it has
been stated that providers may highlight or women may choose injectable contraceptives
due to the convenience of injection, and during counseling health risks and side effects
may be down played by the provider or ignored by the women resulting in abuse of
women's right to information. On the other hand, excluding or limiting availability of the
Injectable contraceptive has been viewed as undue restriction on women’s choice in India
since women in India and many other countries have free access to injectable
contraceptives.
Studies have been sponsored by private agencies/pharmaceutical companies to address
some of these issues but a few questions still remain. Therefore, UNFPA in collaboration
with Government of India proposes to support a people-centered research that would
offer insights about clients and providers’ perspectives on injectable contraceptives. This
research will be done in a transparent manner.
The broad terms of reference of the proposed study are:
To identify client perspectives vis-a-vis injectable contraceptives with a special focus
on women’s perceptions. These would include attitudes/attributes on side-effects,
availability, efficacy, accessibility, confidentiality, return of fertility after
discontinuation, choices offered and attitudes of service providers, quality and
adequacy of counseling, product image, affordability, etc.
2. To ascertain and analyze providers’ views on client barriers/ inhibitions, quality of
counseling, technical expertise, choice of provider, follow up mechanisms, client
satisfaction with injectable contraception service delivery.
3.
To identify any individual, social, gender and cultural issues related to decision
making for injectable contraceptive use and its continuation in different regions and
groups in the country.
4. Identify programmatic implications emerging from the research findings.
1.
Dr. (Ms) Thelma Narayan
Community Health Cell,
367, 1st Main, 1st Block, Koramangala,
Bangalore
Karnataka
(J
b
. J o'7
I L
,
55, Lodi Estate, New Delhi-110003-India
Phone : 4628877 Fax : 4628078,4627612 Email :india@unfpa.org
Website: www.unfpa.org.in
• UNFR4
United Nations
Population Fund
The study will be multi centric so as to capture regional diversities, if any, with respect to
clients/providers perspectives. Accordingly it has been agreed to conduct the study in
four regions of the country i.e. North, West, East and South.
A Technical Advisory Group having representation from experts, academic institutions,
non-governmental agencies and Government has been constituted to advise UNFPA
throughout the process of designing and monitoring this multi-centric study. Similarly a
larger Reference Group has been constituted consisting of stakeholders with diverse
points of view.
Considering your long experience in conducting research on such issues, we look forward
to receiving a proposal from your organisation on the following format.
1.
2.
3.
4.
5.
6.
7.
Details of study design
Tools for data collection
Proposed time frame
Analysis plan both for an initial short term phase (3 months) and long term phase
Budget(including justification)
CV of Principle Investigator/s
Citations from published work of Principle Investigators/organisation
We are also enclosing terms of reference for the proposed study. We will very much
appreciate receiving a line in confirmation by email dinesh.agarwal@unfpa.org.in, in
case your organisation is interested in participating in this multi-centric study. If we do
not receive any response from you by 4 February 2002, we will presume that your
organisation is not interested to be a partner for this study. A detailed proposal should be
send to us by 25 February 2002.
With best regards,
Francois.M.Farah
UNFPA Representative
Encl: Terms of Reference
EkojSJj t o
Terms of Reference
A Multi-centric Study on User and Provider
Perspectives on Injectable Contraceptives in India
I.
Background
Following Drug Controller of India approval, the injectable contraceptive, DMPA, was
approved by Government of India in for use in private sector and social marketing. The
other injectable contraceptive, Net-En, though registered, inJndia-in-lS8.6 was also only
marketed for use in 1994 along with DMPA. Depot-medroxyprogesterone acetate
(DMPA), an injectable contraceptive approved by Government of India, is being offered
to women in India through private clinics/social marketing outlets. However, concerns
have been expressed by different sections of civil society about the conditions, especially
at the service delivery level at which injectable contraceptives are likely to be made
available to women. These include non-availability of facilities for counseling, clinical
examination and_fpllow up, lack of proper information-sharing with clients and providers
particularly about the health-risks and side effects of injectable contraceptives. As women
have a felt-need for effective contraceptives, it has been stated that providers may
highlight or women may choose injectable contraceptives due to the convenience of
injection, and during counseling health risks and side effects may be down played by the
provider or ignored by the women resulting in abuse of injectables. On the other hand,
excluding or limiting availability of the Injectable contraceptive has been viewed as
undue restriction on women’s choice in India since women in "many other countries have
free access to injectable contraceptives.
A review of literature on experiences with injectables in India articulated a need for
research in the Indian context related to users and provider perspectives. Taking into
cognizance, GOTsJnterest in expanding method choicejin NPP-2000,?UNFPA proposes
to support research that would offer insights and analysis in this area and contribute
towards development of client-centred and gender-sensitive contraceptive delivery
programmes.
This brief note spells out the terms of reference for a multi-centric collaborative research
study to identify client and provider views and concerns on injectables in India (primarily
DMPA). The terms of reference are to be used for inviting detailed proposals from
interested research institutions/ organisations from different parts of the country.
IL
Objectives
1. To identify users' perspectives vis-a-vis injectable contraceptives. This will also
mean understanding the evolving perspective of clients at different times.
To analyze providers' views on service provision with reference to injectable
contraceptives.
3.
To identify Individual, social, gender and cultural issues related to decision making
for injectable uses and its continuation.
4.
To identify policy and service provision implications that may emerge from research
findings.
2.
III.
Research Design
1. Suggested categories of respondents: The longitudinal study design is proposed to
incorporate perspectives of different groups and from diverse settings. This is
suggested to include settings such as socio-economic, rural vs urban, users and
service providers from private clinics, government hospitals, NGO FP clinics.
Categories of different service providers such as doctors, nursing personnel, health
workers serving (prescribing as well as not prescribing),and users (continues users ,
discontinuing users, non-users) in different age groups (women in reproductive age
group, youth/college students). Other respondent categories suggested are spouses of
acceptors and non-acceptors. Besides types of concerns of users, responses regarding
who should provide injectables and willingness to pay, ability to pay would also be
included.
2.
Time frame-. It is suggested that this study is conducted in two phases. First phase for
three months duration will provide information on a cross section of multiple cohorts
ie those started using injectable contraceptive recently, those using for 9-12 months
and also those using for a much longer duration. All clients accepting injectable
contraceptive from identified private clinic or social marketing organisation, during
the first three month period will be included in the study and data gathered will be
processed as per analysis plan. Second phase will last for 24-30 months so as to
provide comprehensive information on reasons for discontinuation as ascertained
during follow up visits and also on return of fertility. Individual organisations would
submit the time frame and plan of activities in the detailed proposal.
3.
Methodology. The studies would be conducted by using qualitative methodologies.
The study will have following two dimensions:
□ First, an overview paper compiling issues in India. The objective of this paper would
be to review existing studies on the subject in India and establishing further research
needs. This will help to pull together the contentious issues needed to be looked at in
the client/provider perspective research. This would build a common understanding
among the agencies as well as facilitate development of comprehensive research
tools/questionnaires. This paper would be done either by one of the participating
2
organisations or some independent researcher. In case your organisation is interested
in developing this overview paper, a separate proposal may be submitted,
independent of larger research proposal.
□ Second, qualitative study employing focus group discussions, loosely structures
open-ended questions, in-depth probing of key informants etc. will be considered
for collection of data.
4.
Research tools'. A set of research instruments would be prepared by the research
teams in a methodology workshop jointly at a workshop where methodological issues
would be discussed and common research tools finalised. The tools would include
both open and closed-ended questions and carry clear instructions for investigators.
The tools would need to be translated into regional languages as necessary.
5.
Training: Special attention will need to be given to train staff about the concept and
objectives of the research as well as on gender dimensions. The study staff will be
made aware about injectables, contraceptive dosage types, effects on women’s health.
A meeting of research teams to orient all members on approach and methodology is
important since injectables is a sensitive and new area.
6. Involving different partners: A technical advisory committee to the research teams
comprising of policy makers, women’s health advocates, health care providers/users
is proposed and would assist in planning and support to the multi-centric research
project.
IV.
Data collection and analysis
The proposal submitted would include a plan for data collection and analysis for both
phases. A common data analysis plan will be finalised during the methodology workshop.
The plan for data collection would include information on field work and planning tasks
such as pre-testing designing of formats, questionnaires, deciding on number of
interviewers/facilitators, writing job descriptions, training of interviewers, materials and
administrative arrangements.
The document would describe in details the plan of analysis, each of the analytical
techniques to be used indicating how these would meet the study objectives. Information
on what software will be needed and how data entry will
be accomplished, whether transcription of tape recordings will be necessary is also
suggested to be included as feasible.
Analysis is suggested to be carried out separately for each respondent groups. In addition
to quantitative analysis, qualitative data would be analyzed to make observations
regarding both commonalities and contrasts in information, attitudes and practices in
respondent groups. The analysis is proposed to would include discussion on the
biomedical and gender dimensions to the research findings, as appropriate and feasible. A
3
secondary data analysis of existing studies has been suggested to provide the context and
emerging issues.
V.
Limitations and anticipated constraints
The proposal should include discussion on limitations of the study and the possible
situational factors that might influence the research. Explanation of the limitations and
assumptions of the study and also how to overcome the constraints are suggested to be
discussed in the document.
VI.
Utilization of results and dissemination plan
The study proposal should include a section on the utilisation of the study’s findings.
This section should:
□ identify organisations who be most interested in the study
□ Discuss how you will involve these organisations in planning, implementation
analysis and dissemination stages of the study
□ Indicate what you believe will be the most likely policy or programme implications to
arise from the study
The research proposal should include a section that describes the plan for dissemination.
The plan should specify:
□ who are the potential users of the findings
□ which particular finding will be of most interest to each user group
□ what channels would be used to reach each group.
VII.
Budget, phasing and time frame
A line item budget and detailed work plan needs to be included with the proposal.
Justifications for all aspects of the budget should be included in the proposal as well as
the suggested sample size and sampling design.
VIIL
Ethical considerations
Last but not the least, a plan is needed for the protection of human subjects. The plan
should be in accordance with international human rights documents and the laws of the
country. Three basic ethical principles guide research involving human subjects: respect
for persons, beneficence, and justice. These three principles, in turn, are applied in
research involving human subjects through the procedures of informed consent, risk
benefit assessment and the selection of subjects for research (8).
IX.
Annexure
An annexure including the following is also suggested to be submitted with the proposal:
brief bio-data of the principle investigator, list of related research studies conducted,
resources and facilities already available, availability of trained interviewers etc.
4
X.
References
1. Contraceptive Efficacy, side effects and acceptability of Norethisterone enanthate:
Indian experiences. ICMR. New Delhi. 1981-1983.
2.
Analysis of price change on the perceptions and use of DMPA among users using RH
services in Uttar Pradesh. Population Council and PSS. March 1998.
3.
Post Marketing Surveillance study on Injection Depo-Provera. Final Report. October
1999. Pharmacia and Upjohn
4.
Introducing DMPA Injectable Contraceptive to Private Medical Practitioners in urban
Gujarat. Population Council. DKT, AVSC, (ongoing study)
5.
Miles MB, Huberman AM. Qualitative data analysis: an expanded source book 2nd
edition. Thousand Oaks: Sage 1995.
6.
Varkevisser CM, et al. Designing and conducting health systems research projects.
Vol 2 Part 2. HSR Training Series. WHO Geneva 1991.
7.
Qualitative research in Women’s Health. Guideline for Critical Appraisal of
proposals. UNICEF.
8.
Stephenson P. The protection of human subjects in biomedical and behaviour
research: principles and applications. A discussion paper. Bucharest R0:UNICEF
1991
5
Page 1 of 2
hrictm iueniiiy
rrom:
jooi L. Jacooson <Ci-iAi'iGt(g/genderheairh.org >
To:
"Thelma" <sochara@vsnl.com>
-Sen
*
*.
vuwjCC
Thtjrsifev, Julv 31 9003 19 44 AM
NwW Article. Beyond the Magic Bullet - Emergency Contraception in India
Dear Thelma.
I am writing io send von a new article on Emergency Contraception (EC) in India written by
P.upsa Mallik, Program Director for South Asia al (he Center for Health and Gender Equity
(CHANGE). The article can be accessed from our homepage at www. genderheal th. ora or directly
through this link http://www.gcndcrhca1th.org/pubs/MallikECPillsIndiaJu12003.pdf This article one in a series examining government and donor policy shaping reproductive and sexual health
and rights in South Asia - is based on extensive research on contraceptive choice conducted by
Throughout India, marriage and child bearing patterns are changing, and a rising number of
Hlallied WOiliCii idvC iiiv i'ioks vl
* uiliuivildCu piCgHaHCy ibf
a lOugCi’ pOiliOll of
* tlicir 11VCS. UliillCu
need for modem methods of contraception to space or limit births is increasing apace. Today.
modem spacing methods, such as birth control pills and intrauterine devices accounts for only 7
percent of the current 48 percent of contraceptive use. A much iaraer share some 34 percentds
t-’C'.’OUnled for bv female s!erih'-z>»!i>vn High rates of female sterilization in India reflect a historical
emphasis by ilic goveritmeiii on effm is to limit population growth rates at the expense pf
individual choice While in theory government policy has changed, injtracticc access to modem
methods of Cvixtx'accpiioix I'cnianis oCvex'Cxy xiimtOw. xdoreover, xittxC xias been Gone to address tae
social and cultural constraintsveguerras' tow levels of female empowerment and high rates of
in marriage - that limit women’s ability to exercise control over when and whom they many and
when thev bear children.
As a result, hieh rates of unintended presnanev and complications ot unsafe abortion pose a
major public health problem throughout India; While abortion is technically legal, real access to
early, safe aoonion services is highly uneven in much of the country. Half of an estimated 6.7
million abortions (hat take place in India each year have been deemed to be unsafe, and
complications of unsafe abortion account for a large shar e of maternal illness and death. By
increasing access to EC. the Government of India and major international donor agencies can
substantially reduce the number of unintended pregnancies and unsafe abortions throughout India.
Yet while EC is officially sanctioned tor use in India, access to this method also remains highly
limited. In her article, Mallik examines these factors including both the constraints to and
potential for expanding access io EC throughout the country. Her analysis is based on field trips,
extensive interviews with key actors ’
and literature review. Wc hope you find it helpful.
wishes
LmIi* t
*9?r
I?ir?c
Center Tur Health arid Gcirdci Equity (CHANGE)
6930 Carroll Avenue. Suite 910
ihe Center Ibr Health and Gender Equity is a U.S.-based international reproductive health and
XVp nnndiirt research, policy analysis,
eV^dence~baSed 5»rtvo£3£v in 0111
rights nr 0310i?<
*fion
enoris io make pumic iieaiih dim ninnan iignis principles niiegrai io U.S. niieniaiionai popuiaiion
and health policies and programs. For more information or to be added to our database, please e-
8/o/u3
Beyond the Magic Bullet: Introduction of
Emergency Contraceptive Pills in India
July 2003
CENTER
HEAL TH
-
/W N
' V <',
"
by Rupsa Mallik
Introduction
Recently, emergency contraceptive pills1 have
been introduced as part of the national
Reproductive and Child Health (RCH) program
in India (Ministry of Health and Family Welfare
2002). Emergency contraception (EC) can play a
unique role in providing women in India with a
second chance to prevent an unintended
pregnancy . In turn, EC can also be part of an
effective strategy to reduce persistently high
rates of death and illness from complications of
pregnancy and childbirth in India. Finally, EC
can also help reduce heavy reliance on unsafe
abortion, complications of which alone account
for 13 percent of all maternal deaths nationwide
(Ganatra and Johnston 2002,159).
As part of a broader spectrum of choices in
reproductive technologies, EC can dramatically
increase women's agency and ability to make
informed choices regarding pregnancy and
reproduction. As with other methods, real access
to EC will be determined only in part by the
efforts of the government and donor agencies to
increase supplies and services.
Deeply
embedded gender disparities persist across
regions, classes anil castes in India, limiting
women's autonomy in marriage, sex, and
reproduction, and, particularly in areas where
son preference remains strong, also severely
restricting women's access to and use of
contraception and safe abortion. The failure to
address these and other constraints facing
women will undermine efforts to increase use of
EC and other contraceptive methods. This
article assesses the potential role of EC to
increase women's reproductive choices and
preven I unwanted pregnancies and unsafe
abortion in India, and examines the steps
required to increase access to EC to women
throughout the country.
The Role of EC in Reducing Unwanted
Pregnancies and Unsafe Abortions
O\ er the past decade, desired family size in
India has fallen, but the rate of contraceptive use
has remained low, particularly for spacing
methods. An estimated 55 percent of all currentJyj
married women have ever used conlracepli'
high share of whom have completed their families
and been sterilized. Only 6 to 8 percent of marrii d
women use spacing methods, a very iow
proportion given that a large share ol currentlymarried women are voting and have vet io
complete their desired family size (Ill’S and ORC
Macro 2000, 129).
Low rates of contraceptive use have contributed io
a high rate of unintended pregnancy in India,
which in turn has contributed to heavy reliance on
induced abortion. According to one study, there
are an estimated 6.7 million abortions annually in
India (Chhabra and Nona 1994). Abortion is legal
but safe procedures remain relatively inaccessible)
Some studies suggest that at least half ol all
abortions conducted in India are unsafe as a result
of crude abortions and lack of post-abortion care
(Coyaji 2000).
A recent study conducted in
Madhya Pradesh, one of the largest slates in India.
indicates that 23 percent or close to one-fourth of
all women decide to undergo an abortion .if least
once by the time they reach their late thirties
(Malhotra el al. 2003, 17).
High rates of unintended pregnancy and unsafe
abortion in India are the result of a range of
factors. One is the persistently high level of unmet
need for birth spacing methods among married
women of reproductive age. Despite a long
history of support for family planning, al least 25
percent of all married women below age 20 still
lack access to birth spacing methods, according to
NFHS-1I.2 Tliis high level of unmet need among
those most al risk of unintended pregnancy is a
product of both the government's population
policy, with its historical and continuing emphasis
on female sterilization as the primary means ,>t
birth control, and of the broader failure of die
health system to meet women's needs.
Lack of access to modern methods ol contraception
is comnoundcd bv social and cultural . onslrami.
6930 Carroll Avenue, Suite 910, Takoma Park, Maryland, USA
www.genderhealth.org
Introduction of Emergency Contraceptive Pills in India: Beyond the Magic Bullet
Rupsa Mallik, July 2003
Introduction of Emergency Contraceptive Pills in India: Beyond the Magic Bullet
Rupsa Mallik. July 2003
X number of actors are working to improve this
situation, The recent introduction by the Government
ot India of EC into the RCl I program was the result of
concerted efforts of a number of national and
international organizations that have helped build
consensu1' on the safety and efficacy of EC as postcoital contraception, as well as on the urgent need to
introduce dedicated EC products as part of the RCH
program (ICMR 1997; Nayyar 2000; AllMS and WHO
20011. A number of private manufacturers have been
simultaneously granted approval for marketing
dedicated EC products bv the Central Drug Standard
Control Organization (2002)'.
has entered into a joint venture with a company in
India, Contech Devices Private Limited to market its
product. Norlevo. German Remedies and its Indian
subsidiary Cadila Healthcare have approval from the
Central Drug Standard Control Organization io market
an EC product under the brand name Ecee-2. Mort
recently other companies too have received approval le
market their products, increasing the potential numbei
of dedicated EC brands to between four and seven.
a result of the increased competition for market share
the price of one dose of the levonorgestrel regimen has
declined from Rupees 120 (approx S3) to Rupees '■(;
(approx SI) during the past y ear.
Currently, EC pills are being made available through
medical officers at the district and sub-district level and
guidelines have been published by the Ministry of
Health and Family Welfare (MOHFW) providing
comprehensive information on counseling, eligibility
MBteria for EC. and client assessment, side effects, and
procedures for initiating regular use of contraception
(MOI II W 2002).
Ihe Government of India has
completed procurement of EC pills from private
manufacturers and distributed supplies to local and
district hospitals. The Government of India has also
proposed a monitoring system at the national level that
will examine the profile of users to accurately gauge
the real benefits of the provision of EC pills as part of
the RCH package.
The role of international organizations has been critical
in promoting EC globally as well as in India Ihe
formation of the International Consortium of
Emergency Contraception in the mid-nineties helped
catalyze efforts to promote EC in developing countries
Some of the original Consortium members —such as tin
Population Council and Wl lO-played a kev role in
promoting EC in India, ihe Federation of Obstetrics
and Gynecological Societies of India (FOGS1), thi
Indian Council of Medical Research and the National
Institute for Research in Reproductive I lealth have also
played a key role in advocating for EC introduction as
part of the RCH program and remain actin
individually in addition to their participation in
existing networks on EC.
Plans are in place to increase awareness of EC pills
ths • ..b. Ihe National Strategy foi 'A x ial Marketing (200'1). A
mimee: oi social marketing organizations have already
taken the lead in promoting EC pills as part of their
program. Parivar Seva Sanstha (PSS) has developed its
on n brand of EC pills and intends launching the
>ducl as part of its social marketing initiative in
jasthan. PSS has been actively collaborating with the
MOI IFW to conduct action -csearch on awareness and
u-r . : l' r- method Ihe I .rml\ Planning Xssociation
. . • mtro. nice.: ' 1 pills on a pilot basis as
part <»f its basket of choices in select districts of Madhya
Some women's groups too continue to provide inputs
to expand the Goyirnmeiat of '-id:
efforts
have pointed out the nvi d to cie.a an nl• rr..v. ■
package to help women develop a better
understanding of their own bodies and reproductivi
processes, which in turn increases understanding of thi
difference between long,-term contraceptive methocis.
EC, and induced abortion. I hese and other efforts to
expand access to ba-i, r, pi-, del'.. h. all! 'n!
have become even m r. .rili.a : ■ n
become available. Io- ex.rnpli Kt -A-,.
,
abortions has recently- been approved lor marketing in
India and is likely to become part of the method mix in
the RCH program.
•
Ihe private sector is a key player in making EC pills
available. Currently a number of companies have the
license to manufacture EC pills in India,
Levonorgestrel, the raw material for EC pills, is not
available in India and needs to be imported. Some of
the companies that are currently marketing dedicated
products include CIPL.A under the brand name Pill 72,
and 11R \ Pharma Laboratoire, a French Company, that
Ihe valuable role that II can play in preventinj
unwanted pregnancies anil reducing the risks from
unsafe abortions and complications of unintended
pregnancy are clear. Randomized controlled trials
place the efficacy rale of Ihe levonorgestrel regimen a1
83.9 percent (Ho and Kwan 1993; WHO |9'->8) w-ith
limited side effect. However, repeated use ot EC pills
Center for Health & Gender Equity 301-270-1182 fax 301-270-2052
6930 Carroll Avenue, Suite 910, Takoma Park, Maryland, USA
www.genderhealth.org
Introduction of Emergency Contraceptive Pills in India: Beyond the Magic Bullet
Rupsa Mallik, July 2003
raise the risk of hormonal imbalances, disrupted
menstrual cycles, and increased risks of complications
m pregnancy. In other words the benefits of EC rest as
much on its limited use as it does on the efficacy of the
actual product as post-coital contraception. Moreover,
while EC can help prevent an unintended pregnancy it
does nothing to protect women against SIDs and
HIX AIDS.
For ail these reasons the role of EC as a back-up and. a
bridge to sustained use of spacing methods needs to be
a important component of all efforts to increase access
to EC.
Beyond the Magic Bullet
(liven these realities, it is critical that, in making EC as
part of the RCH program, the Government of India and
major international donor agencies simultaneously
guarantee access to EC along with other methods of
. -.-lion. in particular spacing methods.
In
meorv, a number of spacing methods are available in
the family planning program in India. In practice,
millions of women remain without access to such
methods. The decision of the MOHFVV to include
ECs as part of the RCH program is an important first
step towards ensuring informed choice and quality of
care in family planning services for vyomen.
Any effective strategy to reduce unintended
pregnancies and unsafe abortion in India has to involu
access to both information on and supplies of a widi
range of contraceptive options, including but not
limited to EC. Today, however, several obstacle-remain, including the hick of financial and technical
resources, lack of skilled providers, and pool
infrastructure, among challenge'- within (lie healtl
sector. In addition, neither the government nor major
international donors have done nearly enough t<
address the deep-rooted constraints on women s ability
to make sexual and reproductive health decision 01
even to gain access to health services.
Bringing about significant improvement in the sexua
and reproductive health of women is a formidable task.
It can only be attained as a result of a better
understanding of the complex interrelationship
between society, people, services and technology (Yilei
2001). In that context while the specific benefits of a
method, in this instance EG, can and should bt
highlighted, this method also needs to be integrated
within a broader more holistic framework to promote
reproductive health and rights. I he following
recommendations include both immediate steps that
need to be undertaken to improve access to IX in India
as well as long-term strategies that need to >v
simultaneously pursued to guarantee at a minimum
expanded access and informed choice with regard
contraception use for women in India.
a positive role by working through their distribution
networks to create enh,w.’-'d iv.w pcs'-.
q-.-. ■
use their long-Mandin . .-- id-. . ’.I •. e- i.
w 01 k ng with < hemi-ts ,
pl uni,
sector to help design
information packages.
suitable
-r
and
accessibk
Developing training modules and undertaking training
of providers in the public and private sector
There is a need to develop training module'- that can
used to raise knowledge about and in turn increase
prescription of EC pills. Systematic training oi
providers needs to be undertaken at all levels of sera i, delivery. This component is critical as it proa ides tin.
window' of opportunity to also counsel women any
Center for Health & Gender Equity 301-270-1182 fax 301-270-2052
6930 Carroll Avenue, Suite 910, Takoma Park, Maryland, USA
www.genderhealth.org
Introduction of Emergency Contraceptive Pills in India: Beyond the Magic Bullet
Rupsa Mallik. July 2003
couples on the use of a regular spacing method. The
various medical associations through their national and
state-level chapters can play a proactive role by hosting
meetings for private medical doctors who easily
number in the thousands. Similarly, the MOHFW and
international donor institutions can work with training
institutes to include training modules as part of its on
going RCH training programs.
Undertaking campaigns that can help raise public
awareness about EC
Il is evident from various studies that current
know ledge about EC's is extremely low particularly
among contraceptive users in both rural and urban
settings. Raising awareness in both these groups needs
to be jumpstarted. This is critical, as the market has
already been flooded with various dedicated EC
products. However, efforts to speedily deliver
product-related information should in no way
mpromise the quality of information that is given to
xnni. One stakeholder that I met in India put it aptly
when she said 1EC material needs to be able to
communicate the ideology behind the product as much
as product related information.'
•
Incorporating
WHO
contraceptive
guidelines for policy and service
method-mix
It is now a commonly acknowledged fact that a
contraceptive method mix approach at the level of
servae delivery is the minimum basis for assuring
5
informed choice and guarantee of quality in fannh
planning services for women (Baveja ei al. 2000; VVI It '
1994). This framework provides the basis for designing
information and knowledge based tools for beili
providers and users and needs to be incorporated
while implementing the above recommendations.
first step to further a comprehensive approach could be
taken by the various stakeholders who are promoting
new technologies.
Renegotiating population policies
It is also evident that past policies designed to catalyze
India's demographic and fertility transition did not
take into account gender-based norms and inequities
and in some instances even served to exacerbate them.
The most glaring evidence of this is the emergence of
severe sex ratio disparities in the 0-7 age group as a
result of sex selection.-' Another piece of evidence is the
fact that of the current 48 percent contraceptive use,
female sterilization accounts for 34 percent of that use
(UPS and ORC Macro 2000). This is irrefutable evidence
that gender-based inequities result not only in limiting
the choice and timing of contraceptive use but also
place a disproportionate burden on women. These need
to be addressed at all levels, but in particular at the
level of government and donor policies and programs
Unless they are addressed the introduction of a new
method, however beneficial, is unlikely to result in
meaningful choices for women.
Mallik is Program I >i rector -South Asia at the Center for I leal th and Gender l-quit v
11 WGI ( orrespon teiu ■
the paper should t’e directed to Rupsa Mallik at i‘mallik&igenderhealth.ore, For additional . opie-, ..nd .m email i.>
Ltendi-i health .oi l’.
'.!' ■ i Jits reserved bv the i. enter for Health and Gender Equilv. \o part of this document ni.n be > epi odui ed. liisseinniaiedj
published, oi transferred, except with prior permission and appropriate acknowledgmen' ol the Center lor I ie.illh and
r.ier l-emlv. Suggested ■ ilation: Mallik, Rupsa. Introduction of Emergency Contraceptive I 'ill-, in India llinend lhe '.Ijr,
(lakonia Park, Mil- Center for I lea I th and Gender Equity, July 2003).
Center for Health & Gender Equity 301-270-1182 fax 301-270-2052
6930 Carroll Avenue, Suite 910, Takoma Park, Maryland, USA
www.genderhealth.org
Introduction of Emergency Contraceptive Pills in India: Beyond the Magic Bullet
Rupsa Mallik. July 2003
6
References
XII India Institute of Medical Sciences (AllMS) and World Health Organization (WHO). 2001. < oiwlmm <m National Cotv+ivm-S
I'meig fj{ i (■, •>7/.--.?;
■ Report mid Recommendations. New Delhi: AllMS and WHO. January.
Baxeia. R K. Buckshce; K. Das, cl al. 2000. ‘Evaluating Contraceptive Choice Through the Mclhod-X1i\ Xpprocuh ' i<•-«■/ .a. •
I‘hex icr Science. bl: L13-119.
I.
Bhatt RA 1996. ‘Role of Familx Planners and Service Providers in Emergency Contraception' in (eds) C.P. Pun and P i X X an • <• -I
/-(f ,j( Kb, Federation of Obstetrics and Gynecological Societies ol India pp 1-24.
< liir .br j. lx and S.C . Nona. 1094. Abortion in India- An Overview. Delhi: Ford Foundation.
Coxaji. K. 2000. Earlv .Medical Abortion in India: Three Studies and Their Implications for Abortion Services.' loivnal ej Aim
AL-.;. .» l\<>u/en's Association (JAMWA). Volume 55:191-94.
Llh rlson < . Webb A., Blanchard K., Bigrigg A., Haskell S., Shochel T., and J. Trussell. Modifying the Yuzpe regimen of emergen
*
\
..ontj .h option: A multicenter randomized controlled trial Obstetrics and Gynecology 2003; 101(6); 1160-1167.
Ganaba, B and I l.B. Johnston. 2002. ‘Reducing Abortion-Related Mortality in South Asia: A Review ol (Xmslraints and a Road Xlap ioi
Government ol Andhra Pradesh (GOAP). 1997. Andhra Pradesh Population Policy.
Go\ c rnment of Uttar Pradesh (GOUP). 2000. Uttar Pradesh Population Policy.
•
Pi’. and M.S.W. Kwan. 1995 X Prospective Randomized Comparison of Levonorgestrel with the Yuzpe Regimen in Post-Coital
ntmception. Human Reproduction. <8: 389-92.
*
Indi
n Council of Medical Reseaii h. 1997. Emergency Contraception. ICMR Bulletin. March. X-'olume 27(3).
International Institute for Population Studies (Ill’S) and ORC Macro. 2000. National Family Health >urvey iNHlS-2). /99S-99- '-/DMumbai: 1PPS.
lohnstun, I l.B. 2002. Abortion Prat tic e in India: A Review of Literature. Mumbai: CEHAT and 1 lealthwalch I rust.
Malhotra. A; iNyblade, L; Parasuraman, el al. 2003. Realizing Reproductive Choice and Rights: Abortion and < \mtrmcp!itm in India.
IX ishington DC : International Center for research on Women (ICRW).
Xlitt .1 S 2001. Profile and Perceptions of Emergency Contraception Usersand Providers: AllMS Experience.' Presented at the Meeting
of the (. oiibortium on National Consensus on Emergency Contraception. New Delhi. January.
Xlncbirx of Health and Family Welfare (MOI IFW). 2002. Chddelines for Administration of emergency Contraceptive Pii!< by Medbal Uffict •
New Delhi: Gox eminent of India
— 2<W. National Population Policy, 2000. New Delhi: Government of Jndia.
Narav.ma, G. 199b. Family violence, sex and reproductive health behavior among men in Uttar Pradesh, India (I ^published p. i- ■’
Naw ar, X. 2000 Increasing Access to Emergency Contraception in India.' Health and Population
^^nonal Institute ot Health and family Welfare. 23(3): 107-114
Pcispcclivt - mid K.-cc- New Delhi
^ti i i i P and 1. sarvardekar. 2001. (. onstrainls in Introduction of Emergency Contraception in the National F.irniiv Welfare Ph- *un.i
!’re<inied at tin Xleeting of the Consortium on National Consensus on Emergency Contraception. New I )elhi. lanuai x
Sumi.ir.ix alii, .A 200'1. ‘Should Emergency Contraception be Widely Publicized?' Presented al the Xleeting ot the x’onxoriium < i
National Consensus on Emergency Contraception. New Delhi. January.
Von Hcrt/en, II. et al. 2002. ‘low does mifepristone and two regimens of levonorgestrel for Emergent \ contraception. a WHO
multi. enter randomized trial/ I.mice!. 360:1803-10.
World Health Organization (WHO). 1998. 'Randomized Controlled Trial of Levonorgestrel Versus the Yuzpe Regimen ol Combined
Or< I * ontraceptivevS for Emergency ( ontraception.' Lancet. 352: 428-33.
... |
A lethod-Mi \ Guidelines for Policy and Service Deliivry. Geneva: WH().
Yitei. ‘A 2901 Report and Recommendations - Consortium on National Consensus for Emergency Coulr/hephon.' New Delhi: AIIXH. lanuai
Center for Health & Gender Equity 301-270-1182 fax 301-270-2052
6930 Carroll Avenue, Suite 910, Takoma Park, Maryland, USA
vAvw.gcncierhealth.org
ICMR - Task Force on I U D.
Randomized Clinical Trial with IUD (Levonorgestral Intreetonona
Device (LNG) CUT 380 AG, CUT 220C and CUT 200b.
A 36 month study.
National programme of Research in Human Reproduction.
Division of Human Resource Development Research.
Institutions which participated -MLN Medical College, Allahabad
Medical college, Aurangabad K £ M Hospital, Pune, Queen Mary's
Hospital, Lucknow, Gauhati Medical College, Gauhati, Kehical
college, Baroda, Kasturba Hospital, Delhi, Medical College &
£den Hospital, Madurai, Medical College, Madurai, SCB Medical
College, Cuttack, Safdarjung Hospital, New Delhi, G S V M Medical
college, Kanpur, R M S P Hospital Calcutta, J J Hospital Bombay.
Division of HRDC, ICMR, New Delhi.
A total of 1905 subjects were randomly allocated to four types
of IUDs and were observed for 45,683 women months of use.
While no method failure was observed with levonofgestr/l (LNG)
IUD, 11 women became pregnant with other .devices.
4 with Coppeer T
1 with Copper T 220 C and 6 with using Copper T 200b,
380 AG.
indicating method failure rates of 1.0, 0.3 & 1.6 respectively at
36 months of use.
ICMR initiated a multicentre comparative randomized clinical
trial in August 1983 at its HRDC located in different parts of the
country.
IUDs.
The main objective of this study wasto compare the newer
Levonorgestral (LNG) CuT 380 AG and CuT 220if with CuT 200b
which is currently in the National Family Welfare Programme.
2
The enrolment of the study started in August 1983, a total of
1964 subjects were enrolled at 14 centres upto February 1986 after
which enrolment was stopped. Of the 1964 data on 59 subjects
(15 subjects with LNG, 10 witty Cut 380AG, 14 with CuT 22u|? and
20 with CuT 200b were detectsd from analysis due to non adherence
to the criteria for subject selection.
Results - This report included results of 1905 subjects of these
475 subjects were allocated to LNG IUD, 434 to CuT 380AG, 496 to
CuT 220c and 500 to CuT 200b.
The women were observed for 10589,
10869, 12076 and 12149 women months of use, respectively.
Continuation rates at 12, 24 & 36 months were significantly lower
with LNG IUDs as compared to copper devices.
Discontinuation due to partial or complete expulsion of device
ranged from 10.6 in the case of LNG (IUD) to 8.3 (Copper-T 220C)
to 8.5 (Copper-T 200b)
to 7.6 (Copper-T).
pelvic Infection/Vaginal Infection;-
A total of 30 subjects were discontinued due to vaginal & Pelvic
infection.
Out of these, 14 cases were for vaginal infection and
16 cases were pelvic infection.
The pelvic infection for 36
months ranged from 1.8 (LN3 IUD) to 1.2 (CuT 380AG), 1.7 CuT 220c)
to 1.2 (Cut 200B).
Menstrual Abnormalities :Major reason for removal of IUDs was altered menstrual pattern.
Discontinuation due to this reason was highest in subjects using
the (LNG IUD) (13.8, 21.9, & 27.9 at 1 year, 2 years & 3 years
respectively).
Compared to Copper IUD users - what is interesting
3
that while the rates due to prolonged bleeding were comparable
for all the devices the ENG, IUD had significantly higher
discontinuation rates due to amenorrhoea and irregular bleeding
cumulative net discontinuation rates per 100 users due to
different types of Menstrual Abnormalities.
Reasons for
discontinuetron
Months
_______
Prolonged
bleeding
Irregular
bleeding
Arnenorrhoea
LNG
Kate+SE
Copper T
380 AG
Rate + SE
Copper T
220 C
Rate + SE
Copper T
200 B
Rate + SE
12
6.2+1.2
5.4+1 .1
5.4+1.1
24
7.7+1.3
8.3+1.4
36
8.8+1.4
10.5+1.7
8.5+1.3
13.8+1.8
12
2.7+0.8
1.1+0.5
0.7+0.4
0.9+0.5
24
5.6+1.2
2.0+0.7
1.2+0.5
1 .5+0.6
36
7.9+1.5
2.4+0.9
1.6+ 0.6
3.2+1.0
12
5.4+1.2
0.8t0.4
0.7+0.4
24
10.3+1.6
0.8+0.4
0.0+0.0
0.3+0.2
0.7+0.4
36 14.1+2.0
0.3+0.4
0.3+0.3
0.7+0.4
Other Medical Reasons \
A total of 51 subjects discontinued due to other medical reasons
such as abdominal pain, urinary infection, allergy, weight changes,
chest pain, jaundice, weakness/headaches etc.
Another interesting feature while a previous study carried out
by the ICMR with CuT 200 it was observed that the continuation
rates with CuT 200 were 69.9 & 52.6 per 100 users at the end of
12 & 24 months. But in the present study the continuation rates
(Lu 1 te c
with this device were higher (82.4, 68.8 & 45.4 per 100 users at
A-
the end of 12, 24 & 36.
Therefore the difference between the
continuation rates observed in these studies could be due to
changes in attitudes and perceptions of provided as well as
acceptors towards this method of fertility control
Telegraph; News ; Indians rest ancient herb recipe as a contraceptive
Search For i
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irruSeptemner2003
'Jtelegraph.co.uk
□NgWgJlome___
Indians test ancient herb recipe as a contraceptive HExtemal links
} -J_____________ ! By David Orr, in Delhi
: JCity news
(Filed: 28/09/2003)
! Practicalr-Crossword
a yiiryeda, net
^Society
Indian scientists are developing the first herbal
jFactfiie index
contraceptive pill, using a recipe rediscovered in a
' 'Feedback
2,500-year-old medical text.
i_Law reports
Mart cartoon
The drugs origins lie in India's ancient system of
■Obituaries
medicine known as ayurveda. meaning "science of
’ Opinion
life” in Sanskrit. The main ingredients of the herbal
^Weather
contraceptive, pippaiyadi yoga, are two shrubs that
; Week at a glance grow in the Himalayan foothills: false pepper
(embelia ribes) and long pepper (piper longum).
jAbotn us
These are mixed with borax, a naturally occurring
mineral.
□Contact us
The drug is about to undergo clinical trials on
humans, and scientists hope that it could be on the
market within two to three years, offering a
relatively cheap, non-toxic contraceptive.
'The indications are very promising,' said Prof Roy
Chaudhury, the president of Delhi Medical Council
and head of India’s herbal contraceptive
development task force. "This would be a great gift
from India to the world."
Tn the ancient world. Europeans are also believed to
have used herbal contraceptives. One, a resinous
plant called silphiura, was highly valued by the
Romans; in fact it was over-harvested and became
extinct.
More recently, Europeans seeking inner well-being
have embraced ayurvedic medicine. Scientists too
are starting io recognise its merits: trials on a herbal
diabetes treatment used by Indian forest dwellers
have been completed and the product is due on the
market soon.
Traditionally, pippaiyadi yoga is taken as a powder
file:'CfWINDO...'Telegraph News Indians test ancient herb recipe as acontraceptive.ht
9/30/03
telegraph; News ; Indians test ancient herb recipe as a contraceptive
Page 2 of 3
contraceptive would be taken as a daily pill for
three weeks each month. It is believed to inhibit a
woman’s ovulation.
In all, dozens of plants are mentioned in India's
ancient medical texts as being effective in
preventing pregnancy, but whether they contributed
to the carefree coupling of the Kama Sutra is
unknown. When trials resume in coming months,
scientists will also test Chinese hibiscus (hibiscus
rosa sinensis), a small tree native to southern India,
for its contraceptive properties.
Developing an effective and safe herbal female
contraceptive would be a coup for India, With a
population in excess of one billion, it has the
world's lowest consumption of the modern
contraceptive pill, with two per cent of females
using it.
While hundreds of claims for natural binh control
products have been made around the world, none
has yet met the standards demanded in clinical drug
trials. Herbal products that are effective can also
have harmful or unpleasant side-effects. "When
Chinese scientists developed a male contraceptive
pill based on the seed of the cotton plant, largescale trials showed that it lowered men's sperm
counts but also diminished libido.
"It's too early to say if we're looking at a big
breakthrough with the herbal contraceptive," said
Dr Gerard Bodeker, a senior clinical lecturer in
public health at the University of Oxford Medical
School. "But the work being done in India is very
important and it merits close attention," he added.
Prof Chaudhury said: "Ayurvedic practitioners say
there’s no need to test the herbal contraceptive
because they know it works.
"But it's got to be subjected to modem, clinical
trials,The way it’s used by tribal people, it might be
only 60 to 70 per cent effective. That sort of
percentage might be all right with another drug, but
with a contraceptive, I wouldn't be satisfied unless
we could guarantee 98 per cent effectiveness."
^23 September 2003: Britons lead the way for
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9/30/03
Strengthening Decentralisation
Key Issues for Action
Presentation for the Gender and
Decentralisation Forum
Bhubaneswar, 30 October 2000
Purpose
• Assess constraints and potentials of
decentralised governance in India
• Address concerns of inclusiveness,
accountability and efficacy of local
governance institutions
• Identify priority areas for strengthening
decentralisation initiatives
Decentralisation and the Indian Context
• Economic Reforms in the 1990s
- Structural Adjustment and impact on public
expenditure, especially at the state level
• 73rd and 74th Constitutional amendments
and follow up (1996 Act)
- panchayats to prepare plans for economic
development and social justice
• Differential Progress in states
Panchayati Raj and Livelihood Security
• Skepticism about Panchayati Raj
- Reincarnation of existing bureaucracy
- Concerns regarding inclusiveness, accountability and
effectiveness of PRIs
• Livelihood security for the poor is a key to their
effective participation
- better wages, decent work and rights over common
property resources
• Need for a supportive macroeconomic policy
framework
Theme Areas
• Legal and administrative anomalies
• Panchayat finance and budgets
• Urban context
• Gender Issues
• Current Imperatives and strategies for the
future
Legal and administrative anomalies
Status of the Gram Sabha
- Extension of Panchayati Raj to Scheduled Areas Act,
1996
Inter-tier relationships
Issue of rotation
Administrative and procedural anomalies
- Relationship with treasury, line departments and
agencies
- Relationship with existing people’s institutions (both
customary and informal bodies)
Panchayat finance and budgets
Funds
- Untied funds
- Revenue raising powers
- Rationalization of Centre- State fiscal transfers
Innovative approaches
- Kerala People’s Plan
- District Budgets in Madhya Pradesh
Eleventh Finance Commission Recommendations
Urban context
74th Amendment gives constitutional mandate to
Urban Local Bodies (ULBs)
- Role of elected bodies and representatives (ward
councillors, mayors)
- Metropolitan and District Planning Committees
Parastatal Bodies
Municipal Reform:
- Focus on urban poverty
- Productive neighborhoods and slum networks
Gender Issues
Women’s role as leaders
- Constitutional provision for reservation
- Field reality: surrogate representation, marginalisation,
victimization for speaking out
- Linkage with participation in user groups and village
committees
Lessons from two rounds of panchayat elections
- Empowerment through participation
- Improvement in literacy levels
Training issues
Two-pronged Strategy
Decentralisation from above
- transfer of “funds, functions and functionaries”
Decentralisation from below
- role of informal groupings and campaigns
- social mobilization
- audit and accountability initiatives
Both should mesh together, not oppose
Issues for International Partners
National priorities
- Ninth Plan focus on “cooperative federalism”
- Eleventh Finance Commission
Dialogue with state governments
Grassroots decentralisation as the response to
globalization: ensuring community driven
management:
- Linkage between user groups and Panchayati Raj
Institutions (PRls)/ Urban Local bodies (ULBs)
Moving from advocacy to action
Saheti
..—^uinrnpti'c Resource Centre
ABOVE SHOP NOS. 105-108, DEFENCE COLONY FLYOVER MARKET (SOUTH SIDE), NEW DELHI 110 024. TEL: 4616485
Campaign Against Anti-Fertility Vaccines
25.11.98
Dear friends,
This is brief report of the campaign events around the International Immunology
Congresses. Our interventions were very effective, and we really made our presence felt. Some
of us attended the Congress on Reproductive Immunology (27-30th October) and made
interventions at the end of relevant sessions. In the inaugural session on 27th October, GP
Talwar blatantly stated the 'population control agenda' of AFV research and publicly admitted
that his earlier line of research on the anti-hCG vaccine had reached a dead-end.Instead, he
said, he was shifting focus to ’active immunisation' for 'emergency' contraception - which has
many associated problems, which we will critique in detail in the near future
Saheli, the Forum for Women’s Health, Mumbai (FFWH) and the Women's Global
Network for Reproductive Rights jointly drafted a Statement on behalf of the International
Campaign which outlined our concerns regarding the hazards of the vaccines and potential for
abuse. The next day, on the 30th, after the session on immuno-contraception, we read out the
statement, which was met with a lot of hostility from scientists, who felt-it was not the ‘right forum'
to raise such questions. We then distributed the Statement, and discussed issues of ethics and
social context of medical research with the scientists present. '
On the afternoon of the 30th, we held a Press Conference jointly organised by Saheli
and FFWH. Members of the International Campaign also addressed the journalists. Although
AFVs and contraceptive research are not a "burning issue” in the Indian context, over the years.
our work has managed to generate considerable interest in the issue. This groundwork helped us
mobilise a wide cross section of the press, so it was a very well attended Press Conference.
Saheli released the report, "Target Practice Anti-FertilityVaccine Research & Women's Health".
On the 31st, we had a campaign meeting, co-organised by Saheli and FFWH. First, we
had a session by Imrana Qadeer (Prof, at JNU University), giving an overview of health policy in
India, and the shifts in the Reproductive Health Policy. The other session was on the direction,
and politics of Contraceptive Research and the challenges ahead of the women's movement
presented by Saheli. The afternoon session was on the International Campaign, by Judith
Richter, followed by a session on social responsibility of scientists by Shree Mulay. Finally, we
had a strategy planning session. Although we d'd not reach any 'conclusions', there was a good
discussion, especially about co-option of the agenda of the women's movement by the
population control establishment, and the role of advocacy groups in this context. About 35
A women attended this meeting - a few groups from outside Delhi, and the majority were local
groups.
On the 1st of November, we held a protest demonstration at the inaugural ceremony of
the International Immunology Congress. In this protest we were joined by women's groups like
Sabla Sangh, students groups like Democratic Student's Union, and democraticygrotljJshike
•
Peoples' Union for Democratic rights. In all, the protestors (men and women) totalled about 60.
Since the President of India was inaugurating the Congress there was a lot of security and police
presence. Yet, we managed to sneak right up to the hall, and hand out leaflets to hundreds of
scientists who were attending the event. We shouted slogans, sang songs and displayed
placards for about an hour (quite an achievement considering the heavy security and threats to
arrest us, and strong-arm tactics by the lone police-woman present I). According to journalists
who were inside the inauguration, our presence was very noticeable, and everyone was
discussing us and our pamphlets. We also got quite a bit of press coverage the next day.
Please let us know if you would like a copy of our report (Suggested contribution Rs 25,
+ Rs10 mailing cost), or any campaign material - pamphlets etc.
In solidarity,
•
(For the Saheli Collective)
105-108 $
<JTTefl4l TStsfkT
fafcr”!).
M
- 110 024. qf
'
—WOMIH'J RESOURCE CENTRE
ABOVE SHOP NOS. 105-108. DEFENCE COLONY FLYOVER MARKET. NEW DELHI - 110024. TELEPHONE: 4616485.
TARGET PRACTICE:
ANTI-FERTILITY VACCINE RESEARCH & WOMEN'S HEALTH
- Synopsis of a Saheli Report. Released 30.10.98.
The world-wide obsession with 'over population’, propagated by the population control
establishment has resulted in making women the target of coercive policies, and subjected them
to the trials and use of many invasive contraceptives. In the name of 'increasing women’s choices',
long-acting, hazardous contraceptives are dumped on women. Implants and injectables such
as Norplant, Net-En and Depo Provera have been tested and used on countless women,
especially in the Third World.
w
All over the world, a relentless search continues for ‘appropriate sites’ within a
woman’s (or a man’s) body that can be targeted by Anti-Fertility Vaccines for contraceptive
effect. In India, as in several other countries, countless animal and human trials have resulted in
a method that is scientifically unsound and inherently unsafe.
In medical terms, the potential risks that all subjects of human trials have been exposed
to range from allergies and hypersensitivities to auto-immune diseases and permanent infertility.
Almost three decades after the research on Anti-Fertility Vaccines began, the method still has
an efficacy rate that at best is an unacceptable 80%, its safety is not yet conclusively established;
long term toxicity and teratological effects not ruled out and the effect on pregnant women or
children bom during or after the trial not conclusive. While scientists and institutions engaged in
the pursuit of Anti-Fertility Vaccines cite lack of data as the very reason for continuing this line of
research, women and health groups have consistently contested this argument on several
grounds.
Opposition has been raised against the very principle of ‘treating pregnancy as a
disease’ and causing an immune response against it. Other characteristics of Anti-Fertility
lycines like the long duration of effect, and the fact that they can distributed on a mass scale,
and administered to people without their knowledge, open up another critical area of concern :
their inherent potential for abuse. Experiences of women all over the world have highlighted the
numerous situations in which such long-acting, invasive and provider-controlled methods of
contraception are abused. This is of particular significance in a country like India where the
population control' agenda of the state, has already cost countless women their health and
well-being.
The unethical research so far carried out has further substantiated these apprehensions.
Human trials have been initiated without adequate or conclusive animal studies, internationally
accepted requirements for ‘informed consent’ have been flouted and long term follow-up remains.
till date, completely unsatisfactory. Contrary to all ethical norms of'scientific practice’, the interests
of science and society have taken precedence overtne inreresis or well-being of trial subjects.
While the development of Anti-Fertility Vaccines has broadly followed the pattern of
other invasive, provider-controlled contraceptives, certain new elements have characterised
it. The media has been consistently used to garner support against mounting protests from
the womens health movement. Many of the cnticisms of the women's movement about longacting, provider controlled contraceptives are also sought to be turned on their heads.
Researchers claim that Anti-Fertility Vaccines do not cause hormonal disturbances and
disruption of the menstrual cycle like other long-acting hormonal methods. Such a claim masks
the fact that these vaccines do interfere with the hormonal balance, and in addition have
serious potential heath risks. Researchers claim that they are in agreement that long-acting
duration are not in women's interests, and that these vaccines are not 'provider controlled’
because a woman can ’choose’ whether or not to get a booster shot and continue with the
vaccine. And so. while these hazardous Anti-Fertility Vaccines work to control women's fertility
by any means, we are told that women’s choices are being widened by the development of
these vaccines.
National and international action by women’s groups and health activists has
opposed the development of the ‘vaccine-approach’ for the last five years now. It has highlighted
the unethical and unsound scientific basis of this research, the health hazards it poses forwomen
and the social implications of its use.
On one hand, this debate has forced the scientific establishment to become more
accountable to health activists. But on the other hand, concerted attempts have been made to
obscure the issues at hand. Changes in the nomenclature of Anti-Fertility Vaccines, from Birth
Control Vaccines to Fertility Regulatory Vaccines and now. to Immunological Contraceptives
reflect- no real shift in the perspective of the developers of such a technology: The co-option by
the population control establishment of the language and concerns of the women’s movement
masks the extreme dichotomy between the needs of women and the priorities of providers.
Research and funding institutions claiming to be pro-women repeatedly reassure women's groups
that the development of Anti-Fertility Vaccines for men is also underway. Yet, serious concerns
about the health risks of these vaccines on men persist. Moreover, the fact is that most of the
vaccines being developed are designed to be used on women.
We need to question why there is a need for a population policy at all. and change
the terms of the debate. Land reforms, provision of basic needs, ensuring equitable access to
food, housing, health, education and other necessities will contribute to moving towards a more
humane society. Top-down, resource-intensive research and planning can only serve the interests
of the dominant in any society. A radical reorientation of contraceptive research must necessarily
encompass women's need for safe and effective barrier methods which are within the control of
women. Scientific research must take into account the real needs of people, and patriarchal and
class biases have to be challenged. Only tackling the real inequalities between men and women
and addressing women’s needs, would contribute to overall change. The scientific community
must take social responsibility and consider the full consequences of their research. They must take
up the challenge and have the courage the immediately stop such research!!
WE CALL FOR A HALT TO THE DEVELOPMENT
OF ANTI-FERTILITY VACCINES !
/eA' ^42.^30
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Copies Available From Saheli Women's Resource Centre
VII International Congress of Reproductive immunology
l ime to Stop Research on Anti-fertility ‘Vaccines’
Over the past week, around 200 scientists and clinicians met at the National Institute of Immunology,
New Delhi with the aim to 'discuss the latest advances in basic and applied reproductive immunology’.
We, members of the International Campaign Against Population Control and Abusiye,
Hazardous Contraceptives attended this conference to learn about recent 'developments’ in immunocontraception and share our concerns. We also hoped to stimulate a debate within the scientific
community about the feasibility and desirability of the direction of this research.
The World Medical Association’s Helsinki Declaration on ethics in clinical trials states that
"the purpose of medical research involving human beings must be to improve diagnostic, therapeutic
and prophylactic procedures” (our emphasis).
Having heard the scientific communications over three days, we fail to be convinced of the
advantages of immunological methods of fertility control over currently existing contraceptives in
terms of efficacy, reliability, safety for users and their potential children, or for the expansion of
people’s reproductive choices. Three decades after the commencement of this research significant
drawbacks persist, namely:
♦ an unacceptably low efficacy rate (<80%)
• unreliability due to unpredictable variations in immune responses
♦ an initial lag phase before the method is effective as a contraceptive
♦ inability to ‘switch ofT immune response if a person changes their mind or experiences adverse
reactions.
We believe that such an efficacy profile cannot justify exposing women to potential adverse
effects such as the possibility of auto-immune diseases, immune-complex diseases, allergies (including
potentially fatal anaphylactic shock), permanent infertility and interference or exacerbation of existing
diseases or immune-disturbances.
We are also very concerned about the potential for abuse that is inherent in anti-fertility
“vaccines”. Such a method can be easily administered on a mass scale with or without a person’s
knowledge or consent. The stated aim of the research community has been to develop a method which
acts for at least 1 -2 years after a single administration. The impossibility discontinuing the action of
the method on demand will put them beyond any means of preventing or containing such abuse.
In fact, it is disturbing that none of the discussions at the congress considered the social and
ethical implications of the anti-fertility ‘vaccine’ research. It has been the historical experience of
women that they are targeted for eugenic and popu letion control purposes with long-acting and hazardous
.contraceptive methods. Therefore, we-would have, liked to sec some evidence that the scientists,were
cognizant of the social context of the ultimate application of the technologies they are developing.
We have expressed out concern that research criteria used are not centered around people’s
health, wellbeing and reproductive self-determination. As could be seen from the opening session to
• .the conference, the primcaim.was - and still is-the developmentof mass-fertility control methods for.
;>'P<?pulation.controk .We.ur.gescientists-invo!ved in’basis:eKdapplied'research to take social-responsibility?,
and consider the full consequences of their research. We hope that they will take up the challenge and
have the courage the stop this research! I
Forfurther information, contact:
. 31 October, I998-
Women’s Global Network For Reproductive Rights, NZ Voorburgwal 32, 1012 RZ, Amsterdam, The Netherlands.
Forum For Women's Health, 5 Bhavana Apartments, Opp. Golden Tobacco. Santa Cruz (West), Mumbai -400 056.
Saheli Women's Resource Centre, Unit Above Shop Nos. 105-108, Defence Colony Flyover Market, New Delhi 110 024
A CALL TO ALL SCIENTISTS
AT THE INTERNATIONAL CONGRESSES OF IMMUNOLOGY
NEW DELHI, 27 OCTOBER- 6 NOVEMBER, 1998
We demand an immediate halt
to the unethical research and development of Anti-Fertility Vaccines
because of high health hazards and the potential for abuse.
The anti-people, particularly anti-women,
policies of population control and drive for profiteering cannot determine
the direction of contraceptive research.
Scientific goals cannot be pursued at the cost of
the health and well-being of women and men.
3
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Formore information contact:
Forum For Women's Health
5 Bhavana Apartments, Opp. Golden Tobacco
Santa Cruz (West), Mumbai -400 056
Saheli Women’s Resource Centre
Unit Above Shop Nos. 105-108
Defence Colony Flyover Market, New Delhi 110 024
RESEARCH ON
ANTi-FERTILITY
VACCINES/
, I HEALTH ISSUES
Caution on two contraceptives
Women's groups and activists warn that two injectable contraceptives that will possibly be included in
the national family planning programme may not be completely safe.
T.K. RAJALAKSHMI
way into the Indian market in 1994 with-
ears about the
injectable contraceptive- in u.e
national family pl...’::?- <■
have been raised v.
di . '
Supreme Court's ' '.2 on .\tijfj-’ -.
a case filed by Strce Shakti S r. Ji.
Saheli and others in 1986 p!c.’4i:’<: >.■; a
stay on the Phase IV clinical tri. is
en (Norethisterone Enanrhanate,' ri.-.l
entry into the programme. Without
making a direct reference to a case filed
in 1993 against hazardous drugs by the
Drug Action Forum, the court assured
women’s organisations and health
activists that neither Net-en nor DepoProvera (Depo Medroxy Progesterone
Acetate), another contraceptive against
which a case is pending in court, be per
mitted for mass use for now. During hear
ings, the court had asked the Drug
Technical Advisory Board (DTAB) to
examine its sub-committee’s August
1995 recommendations that “the use of
Depo-Provera should be restricted to
women who would be aware of all the
implications of its use”.
While the report pertaining to DepoProvera was reproduced in die affidavit
filed by the government this year, the
Union Ministry of Health and Family
Welfare proposed to include Net-en in
the family planning programme even in
places where facilities for follow-up and
counselling were not available. Women’s
and health groups fear that both the
injectables would come to be used even
in places where the infrastructure does
nor exist.
Depo-Provera and Net-en, both syn
thetic derivatives of progesterone, sup
press ovulation, make cervical mucous
inhospitable to sperm and make the lin
ing of the uterus unsuitable for implan
tation. Depo-Provera is a three-monthly
injectable developed by Upjohn of the
United States, while Net-En is a product
of Schering AG of Germany.
What has raised the hackles of
women’s groups and health activists is the
manner in which Depo-Provera found its
F
82
which is about confirmatory trials, states:
“The purpose of these trials is to obtain
sufficient evidence about the efficacy and
safety of the drug in a larger number of
patients generally in comparison with a
standard drug or a placebo. These trials
may be carried out by clinicians in the
therapeutic areas concerned, having facil
ities appropriate to the protocol. If the
drug is already approved/marketed in
other countries, Phase III data should
generally be obtained on at least 100
patients distributed over three or four
centres primarily to confirm the efficacy
and safety of the drug in Indian patients
when used as recommended in the prod
uct monograph for the claims made.”
Dr. C. Sathyamala, an epi- _
demiologist trained at theo
London School of Hygiene and 5
Tropical Medicine, says the5
Drugs Controller ofIndia made”
post-marketing
surveillance
(PMS) conditional for the sale
of Depo-Provera, thereby sub
stituting Phase III trials. In her
bookAw EpidemiologicalReview
of the Injectable Contraceptive
Depo-Provera, published by
Medico Friends Circle and
Forum For Women’s Health,
she points out that Upjohn used
Chiang Mai, a remote rural area
in Thailand, as its “testing
ground” for Depo-Provera.
Sathyamala feels that the unlet
tered women of Chiang Mai
were perhaps not informed diat
they were taking part in clinical
trials and that no protection,
legal or otherwise, would have
been given to them. It is felt that similar
tactics may have been deployed in the PMS
conducted between June 1994 and
December 1997 among Indian women by
' lessor Rustom P. Soonawala, obstetrician and gynaecologist and Consultant.
The PMS study covering 1,079 women
was conducted at 10 centres to observe the
side-effects and acceptability of DepoProvera 150 mg. A report submitted in
1999 concluded that no failure of contraception was reported during the survey
and no drug-related adversity was found.
It said that, “neither pregnancies nor
deaths were reported during the study”
and that “the results indicate that DepoProvera 150 mg is a safe and effective con
traceptive,
and
that
sufficient
pre-treatment counselling on the expect
ed hormonal effects would greatly increase
the acceptability of this method of con
traception.” Interestingly, two of the three
authors of the report are from Pharmacia
and Upjohn.
During the course of die study, some
women were reported to have discontin
ued the contraceptive. The reasons attrib
uted for this were “non-serious medical
Baldfaced, boldfaced
or barefaced lies?
meant “confident”, a sense that soon
turned into “impudent”, as confidence so
often does. Not until 1884 did the Italian
printer Giambattista Bodoni use boldface
to describe a darkly thick, or bold, type
face, which looks like this and is easily
distinguished from lightface type.
From bare and bold to bald-.Thc ety
mology of baldfaced should interest angry
animal rights advocates. All the early uses
referred to animals: in 1648, “a bawldfacd\\ei$det"-, in 1677, “a sorrel Mare...
bald-faced'-, and in 1861, “our bald-faced
hornet.” And of course, the symbol of
America was “the bald eagle.”
In its original sense, bald did not
mean “hairless, shiny-pated, cueball-like,
suedeheaded.” It meant “white”. The top
of our symbolic eagle’s head is not feath
erless; the last time I patted one, its head
and neck were covered with smooth white
feathers.
In the 13th century, the balled coot
was a water bird with a white mark on its
forehead, lingering in the lingo today in
thesimile baldasacoot. Baldfaced whiskey
was a 19th-century Americanism for pale,
raw liquor, and a boiled, biled or baldfaced shirt was a cowboy’s go-to-meetin’
white shirt. The Celtic Wmeant “a white
mark", and the Sanskrit bhala, “fore
head", from the Indo-European bhel,
“white, shining.” Had enough? At bot
tom, it’s white. That’s why horses with
white markings on their noses are often
called Old Baldy, same as the snow-cov
ered mountain.
In current use, then, baldfaced lie is
the most popular because it sounds most
resounding; barefaced lie continues to run
strong with no connotation of any pur
suit of the hirsute; and boldfaced lie
sounds like a printer’s error. In every case,
kill the hyphen.
Jane Kennedy of The San Francisco
Examiner called it “telling lies”. In The
Atlanta Journal and Constitution, Betty
Parham and Gertie Ferris wrote in 1992,
“Although its origin is uncertain, 'woof
ticket' is a somewhat dated phrase that
refers to an outrageous or exaggerated
boast meant to intimidate or impress the
listener.”
Woof is a Black English pronuncia
tion of “wolf”. According to Geneva
Smitherman’s 1994 Black Talk, a woof
ticket is “a verbal threat, which one sells
to somebody; may or may not be real.
Often used as a strategy to make another
person back down and surrender to what
that person perceives as a superior
power.”
Tom McIntyre, Professor of Special
Education at Hunter College in New
York, noted nearly a decade ago:
"Woofing is especially effective against
chose who are unfamiliar with it and don’t
realise that it is most often ‘all show and
no go.’... The menacing behaviour can
usually be defused and eliminated by
informed, tactful action." He advised
teachers to “look secure and self-assured
while you withdraw.” In the context of
the basketball star Howard’s remarks,
wooftickets are not to be bought; on the
contrary, he uses the phrase to show that
performance, and not intimidating atti
tude, is needed to “get it together.”
HERE’S a word that pops up every
four or eight years: interregnum.
TThe
Latin means “between reigns."
The interregnum, or interregencie, origi
nally meant the interval that a throne or
position of leadership was vacant, as
between the death or removal of one sov
ereign and the accession of the next. This
invited trouble, as in the Cromwell era.
William Blackstone, in his 1765
“ W/E can sell all die wooftickets we Commentaries, held that in England “the
W want,” the Washington king is made a corporation to prevent in
Wizards’ basketball forward, Juwan general the possibility of an interregnum
Howard, said, but “it’s about perfor or vacancy ofthe throne." The word now
mance out there... We’ve got to get it means “an intermission in the order of
together." A reader asks: “Any idea what succession” and, more generally, “a
Juwan Howard is talking about?”
breach of continuity.” Specifically, in the
As early as 1985, Clarence Page of United States, it means “the period
The Chicago Tribune defined selling woof between the election of a new President
tickets as “an invitation to fight". In 1996, and his inauguration.”
FRONTLINE. DECEMBER 3, ’000
But it is not limited to political
power: The breakfast-table autocrat
Oliver Wendell Holmes wrote, “Between
the last dandelion and violet... and rhe
first spring blossom... there is a frozen
interregnum in the vegetable world."
The word, lest we forget, is spelled
with two r’s. It received a special play dur
ing the transition from Jimmy Carter to
Ronald Reagan, which wags called the
interreaganum.
HE book-publishing industry has its
own new term for a variation of a
T
release date: laydown. “This review copy
is being sent to you,” Knopf Publicity
notifies me, “with the understanding that
you will not run your review before
Tuesday, July 18 —which is the National
Laydown Date for bookstores all across
the country. (Official Publication Date is
July 25.)”
A laydown date is the day that a book
officially goes on sale. It is used especial
ly when the publisherwants to restrict any
sale or revelation of the news in a book
before it leaks. The publication date is a
week or month after that, giving review
ers time to noodle the book around and
buyers the feeling that they are getting the
jump on their neighbours.
Laydown without the date means
“distribution '-.Publishers Weekly (where’s
the apostrophe?) wrote recently about a
Beades book that “hits the stores with a
worldwide laydown of 1.5 million
copies.” The noun has a sinister use
among arms merchants (an obliterating
strike is a nuclear laydown) and can also
be found in the lexicon of graphic artists,
construction workers and railroaders. But
its most prevalent use is in gambling, as
the adjective in a laydown hand.
In poker, it’s the “showdown”, when
all hands are laid open for all players to
determine the winner. In bridge, a laydown hand is a wanning hand placed face
up on the table all at once, rather than
being played out. This bridge meaning
has been extended to a general “sure
thing.” A Boston economist told The
New York Times. “The Fed has more rea
son to tighten than not - but it’s not a
laydown."
Some of us who respect reasonable
embargoes resist marketing manipula
tion. ! it’s say I go ro a bookstore, the
bookseller sells me a book and I spot a
news store in it. Would I feel free to use
it in a column no matter what its laydown
or ; till:,.:tion dare? You her I would;
that’s.-.laydown.
*
events”, which, interestingly, included
irregular bleeding, in some cases heavy,
amenorrhea (absence of menstruation),
urinary tract infection, abdominal pain,
bloating abdomen, post-coital bleeding,
weight gain, abdominal cramps and even
viral hepatitis. Women’s and health
groups were disturbed by the conclusion
that was reached that the symptoms were
non-serious.
In fact, at a workshop convened by
rhe Institute
for
Research
in
Reproduction in Mumbai in December
1998 to review the status of the available
injectable contraceptives in the Asian
region vis-a-vis India and to discuss the
inclusion or otherwise of such contra
ceptives in the national family planning
programme, the consensus was that the
injectables had side-effects.
Women’s and health groups cau
tioned the government against their
inclusion in any form in the family plan
ning programme. Concerned about the
“deliberate misrepresentation of infor
mation”, they urged the government to
disallow the use of such hazardous drugs
as the existing health infrastructure was
not capable of providing the necessary
follow-up for such long-acting contra
ceptives. Further, the non-accountability
of pharmaceutical companies, coupled
with evidence to the contrary about their
efficacy, they said, provided the grounds
for a ban on all injectables.
Interestingly, Depo-Provera is more
commonly used in developing countries.
In developed countries it is not an item
of "popular choice”.
RIGINALLY introduced in 1967,
Women’s groups, such as the AU
Depo-Provera was publicised in India Democratic Women’s Association,
India in 1994 by a leading advertising Sama and Jagori, and health forums such
group, which proclaimed it to be the as die Medico Friends Circle and the
world’s most widely used and widely avail Forum for Women’s Health, maintain
able and largest used preparation of its that Depo-Provera has been indicted for
kind, and that it had been successfully causing a climacteric-like syndrome (pre
used by over 30 million women in 90-odd mature menopause), irreversible atrophy
countries. Sathyamala says that, even if of the ovaries and endometrium (inner
one concedes that Depo-Provera is the lining of the uterus) leading to sterility,
“largest used” preparation, its overall use deaths due to spontaneous formation of
is low and that except in South Africa it clots inside blood vessels (thrombo
does not appear to be an important con embolism), a 10-fold increase in the birth
traceptive ofchoice even in countries with of Down’s Syndrome babies and
no restriction on its use. There is a stark increased infant deaths. There are height
difference in the share of injectables used ened chances of breast and cervical can
among the black and white populations cer as well. Activists of rhe organisation
of South Africa. Some 41 per cent of the have accused Upjohn of suppressing
contraceptive users preferred injectables. and/or underplaying the life-threatening
A break-up ofthis figure revealed that per implications of the injectables and in the
sons using injectables constituted only 3 process misleading the medical commu
per cent of the 79 per cent of white nity as well as the Drugs ControUer of
women, who used modern methods, India. Studies on Depo-Provera have
while users of injectables formed 27 per been funded by Upjohn or direcdy car
cent ofthe 49 per cent ofthe black women ried out by its bio-statistical division. The
who used modern methods. Quoting var dissenting groups feel that given the large
ious studies and papers, Sathyamala writes body of scientific information on the
that in developed countries, where Depo- injectable, the conduct of another study
Provera is registered as a drug, it is pre that was part of a PMS was nothing but
scribed primarily to mentally challenged an attempt to mislead and misinform the
women, women with a problem of drug authorities.
addiction, indigenous populations such as
The introduction of the injectables
native Americans in the U.S. and Maoris cannot be seen in isolation of the gov
in New Zealand, sexually active adoles ernment’s population policy. The
cents, coloured women and women from activists argue that while the National
low-income groups.
Democratic
AUiance
government
According to Sathyamala, Depo- appears to have given up coercive meth
Provera is a long-term, systemic, invasive ods of population control, Stare govern
contraceptive, which acts at multiple lev ments were doing exacdy the opposite.
els. Its potency and the ease While a Bill to debar people with more
with which it can be used have than two children from contesting elec
been cited as reasons for its pro tions was still on the national agenda,
motion in sections with high Haryana and Delhi have passed a legisla
birth rates and low “motiva tion debarring persons with more than
tion” levels. By not taking the two children from contesting the local
women’s experience seriously, body elections. In Maharashtra, the third
it is more than likely that child is excluded from rhe benefit of the
important morbidities are Public Distribution System. In Uttar
being left out, she argues. Pradesh, Rajasthan and Madhya Pradesh,
When a woman reports a the disincentives include the denial of
symptom while being on access to government schemes.
Depo-Provera, the general ten
Evidently, these disincentives could
dency seems to be to “reassure ’ push women and their families into
her that the reported symptom accepting what they perceive as safe and
is not associated with the use of long-acting contraceptive methods.
the contraceptive.
Women'', ar,nips are not against family
planning and contraception, but they
O
At a health camp for women.
Women's groups oppose
providing easy access to
injectable-type
contraceptives in the
name of choice.
contraceptives in the name of choitv.
while rhe truth is that for rhe majority of
I POLICY ISSUES
Thrust on
biotechnology
Tamil Nadu unveils a comprehensive biotechnology policy in order
to take advantage of the emerging industrial activity in this sector.
ASHA KRISHNAKUMAR
ITH 5,000 species of flowering
plants, 22,500 sq km of forest
W
cover and a coastline of 1,000 km, Tamil
commercialise products and patents;
* the establishment of a medicinal plants
park near Madurai to focus on sourcing
raw materials in a sustainable manner and
offer value addition to scientifically test
ed herbal and traditional medicines;
* continuing government’s support to
the women’s biotechnology park at
Kelambakkam, near Chennai, which
would concentrate on microenterprise
and traditional biotechnology products;
★ the starting of a marine park at
Mandapam in Ramanathapuram district
to devise ecologically sustainable methods
to conserve sea weeds and plankton; and
* the opening of a Bioinformarics and
Genomics Centre at the Tidel Park in
Chennai in order to exploit the
germplasm base and the vast pool of tal
ented bioinformatics scientists and lowcost software skills in the State.
Tamil Nadu is committed to encour
aging biotechnology entities, consisting
of research organisations, service
providers, knowledge workers and com
panies, which will commercialise the new
products and processes, and to creating a
network to facilitate the transfer of infor
mation and knowledge among the vari
ous entities.
According to the policy document,
schemes are being worked out to protect
and develop various biosphere reserves,
such as the Gulf of Mannar off
Rameswaram, the Pichavaram man
groves in Nagapattinam district and
Muthupettai in Tiruvarur district. The
Global Environment Facility has
announced an assistance of $7.85 million
to protect the Gulf of Mannar.
Industrial activity has so far been con
fined largely to first generation biotech
nology enterprises such as fermentation
of antibiotics. To broaden the industrial
base, a large number of plant tissue cul
ture units are being set up, besides pro
moting the production of food and
industrial enzymes, classical fermenta
tion products (antibiotics and immuno
modulators), bioenergy and bio
polymers, and other such activities.
According to the policy document, all
efforts are directed towards the creation
of a critical mass of industrial activity in
biotechnology. A two-pronged strategy
Nadu is exceptionally rich in biodiversi
ty. This kind of wealth, rarely occurring
in a State, needs to be put to sustainable
use, especially since the market for
biotechnology products in the country is
expected to double to Rs. 15,000 crores
in the next five years. By putting in place
an exhaustive biotechnology policy,
Tamil Nadu has become one of the first
States to take advantage of this antici
pated growth. The landmark policy,
which provides a comprehensive scien
tific plan to put to use the State’s natur
al
resources
to
promote
the
biotechnology industry, was unveiled by
Chief Minister M. Karunanidhi on
September 12.
The policy comes with a firm commitment by the State government on f
financial and procedural matters in order "
to enable its speedy implementation.
Karunanidhi said: “The idea is to provide
a policy framework as well as suitable
implementation structures to convert the
bioresources of the State into economic
wealth in ecologically and socially sus
tainable manner.” He said that the grow
ing demand for biotechnology products
and the State’s potential to tap the mar
ket for them had encouraged the govern
ment to announce the policy'. The policy,
based on the recommendations ofa com
mittee appointed by the government
under the chairmanship of the agricul
tural scientist Dr. M.S. Swaminarhan,
focusses on product development in the
four segments of technology — medicine,
agriculture, environment and industry.
The State’s biotechnology enterprise
would involve
* the setting up of a biotechnology incu At a facility involved In the process of developing transgenic plants, at the
bator park near Chennai to develop and M.S. Swaminathan Research Foundation. Chennai.
VO VA - 3>-
Clinical use of Depo-Provera
for contraception
Andrew M Kaunitz, MD FACOG
Associate Professor, Department of Obstetrics and Gynecology
University of Florida Health Science Center, Jacksonville, Florida, USA
Since it was first developed for contraceptive use in the early 1960s by The
Upjohn Company', Depo-Provera has been the subject of intensive study and
review by academic medical investigators, government authorities, international
health organizations including the World Health Organization (WHO), and The
Upjohn Company itself. Clinical experience with Depo-Provera, which has
accumulated over several decades, has exceeded 3 million women-months2, and
over 1000 scientific papers have been published2.
Initiation of contraception with Depo-Provera
Timing of the first injection. The ideal time to initiate contraception is within
5 days of the beginning of menses. This ensures that the woman is not already
pregnant, and prevents ovulation during the first month of use’.
Dose and injection site. Depo-Provera is supplied as an aqueous suspension of
microcrystals, which should be administered by deep intramuscular injection
into the gluteal or deltoid muscle, using a 21-23 gauge needle. The vial should
be shaken vigorously just prior to use, to ensure that a uniform suspension is
administered. After injection, there is an initial peak in the blood concentration
of the drug5, but the low solubility of the microcrystals at the injection site
results in prolonged circulating levels of the active progestagen:
pharmacologically active levels persist for 3-4 months after injection. Doses of
Depo-Provera ranging from 50 to 400 mg/ml are marketed in the USA and
elsewhere. Pharmacokinetic comparison suggests that the higher dose
preparations are associated with reduced drug bioavailability4; therefore,
150 mg/ml should be used for contraceptive purposes.
Clinical trials with Depo-Provera
Depo-Provera, 150 mg every 3 months, has been demonstrated to be an
extremely effective contraceptive. Taking the mean of all available studies, the
'typical' failure rate is 0.3%’. The shortest reported period before return to
fertility, whether measured by time to conception, time to ovulation, or serum
levels of the drug, appears to be 4 months after the last injection. The
recommended dosing frequency for Depo-Provera is every 3 months. Thus, a
conservative estimate of the 'grace period' for women seeking continued
contraceptive effectiveness suggests that pregnancy should be excluded before
reinjecting women who are more than 2 weeks late for their Depo-Provera
injection.
Depo-Provera,
150 mg every
3 months by deep
muscular
injection, is
an extremely
effective
contraceptive
39
Kaunitz
The contraceptive efficacy of Depo-Provera has been evaluated in five large,
controlled, multicenter studies conducted from the mid-1960s to the late 1980s
Two of these studies were sponsored by The Upjohn Company and three were
conducted by the WHO. The major demographic features of these studies are
highlighted in Table 1. All studies were open, because blinding and the use of
Table 1
Demographic features of
.the multicenter studies of
Depo-Provera
Study design
Drug and dose
18
Multicenter, open study in
healthy women of
demonstrated fertility
Depo-Provera,
150 mg in 3 ml
Unpublished
Multicenter, open study in
healthy women of
demonstrated fertility,
with history of reasonably
regular menstrual cycles
Depo-Provera,
50 mg in 3 ml
Multicenter, randomized, open,
concurrent-control study in
healthy women
Depo-Provera,
150 mg in 1 ml
Reference
8
Depo-Provera,
150 mg in 1 ml
Depo-Provera,
100 mg in 1 ml
40
10
Multicenter, randomized, open,
parallel-group, active-controlled,
study in healthy, non-breast
feeding women
Depo-Provera,
150 mg in 1 ml
9
Multicenter, randomized, open,
parallel-group, active-controlled,
study in healthy, non-breast
feeding women of demonstrated
fertility
Depo-Provera,
150 mg in 1 ml
• Pearl Index.
••Life table method.
f W.HC? lUt nors ^‘?lat,ed th,e P^gnancy rate by life table analysis, but they refer to
units of the Pearl Index (per 100 woman-years).
Clinical use for contraception
concurrent control treatments was considered neither practical nor ethical.
Demographics and baseline characteristics. The contraceptive effectiveness
of Depo-Provera, 150 mg every 3 months, was assessed in 7240 women: 4200
women in the Upjohn-sponsored studies and 3040 women in the WHO-
Dose
regimen
Number of
subjects
Patient-months
experience
Study duration
Pregnancy rate
First injection
between 3rd and 7th day
of the menstrual cycle in non^ostpartum patients, and at
ist 4 weeks after delivery in
postpartum patients,
following injections every
3 months
3905
82,384
Median:
13 months
15 (0.22/100
woman-years)
*
Every 3 months
155
2003
Median:
13 months
0 (0.0)
140
1841
0 (0.0)
First injection within first
5 days of menstrual cycle;
following injections every
3 months (± 7 days)
607
5429
609
5507
Every 3 months
1587
20,550
NA
3(0.1/100
women after
12 months)”
Every 84 days (±5 days)
846
4782
NA
4 (0.7/100
woman-years)'
59% patients
completed
1 year (both
groups)
0 (0.0)
2 (0.44/100
*
woman-years)
All drugs were administered in aqueous solution by intramuscular injection.
NA = not available
41
Kaunitz
sponsored studies. In addition, 609 women were treated with Depo-Provera,
100 mg every 3 months. Thus, the contraceptive efficacy of Depo-Provera was
assessed in a total of 7849 women, representing 122,496 patient-months
of experience,
The racial distribution, between non-white and white women, was
approximately equal in the Upjohn-sponsored studies, but racial distributions
for the WHO-sponsored studies are unavailable. The methods used to report
age statistics varied in different studies, but the mean or median subject age
appears to have ranged from 23 years to 28 years. Similarly, statistics on parity
were also reported differently, but the mean or median parity appears to have
ranged from 2 to 4.
Pregnancy rates
All studies reported the 'use effectiveness' of Depo-Provera, which takes into
account all pregnancies that occur while a woman is still using the method7.
Failure rates were based on the number of pregnancies that occurred in women
who were receiving Depo-Provera. Both 'method failures' (pregnancies
occurring while the woman was using the method correctly) and 'patient
failures' (pregnancies occurring while the woman was using the method
incorrectly) were included in the calculations, but women who were pregnant
on admission to the study were not included.
There is a wide
body of scientific
evidence
demonstrating
he contraceptive
efficacy of
Depo-Provera
Table 2 summarizes the failure rates in each of the five studies. Failure rates for
Depo-Provera, 150 mg every 3 months, ranged from 0 (no pregnancies reported)
to 0.22 pregnancies/100 woman-years, calculated by the Pearl Index, and from
0 to 0.7 pregnancies/100 women/year, calculated by life table analysis (though
the WHO authors expressed the rate per 100 woman-years). In 86,228 patientmonths of experience with Depo-Provera in the Upjohn-sponsored studies, 15
pregnancies were reported, representing a failure rate of 0.2/100 woman-years
of use. In 36,268 patient-months of experience with Depo-Provera in the WHOsponsored studies, 9 pregnancies were reported, 2 of which were in women
receiving Depo-Provera, 100 mg every 3 months. Thus, in the Upjohn and WHO
studies combined, there were only 24 pregnancies among 7849 women using
Depo-Provera for 122,496 patient-months.
The first WHO study compared Depo-Provera at doses of 150 mg and 100 mg,
each given once every 3 months8. Results suggested that the lower dose was less
effective than the higher dose. Trials using Depo-Provera at doses of 250-500mg,
administered once every 6 months, produced unacceptably high rates of
pregnancy and therefore excluded the use of these higher dose, less frequently
administered regimens.
In the second WHO study, Depo-Provera was compared with another injectable
contraceptive, norethisterone enanthate (NET-EN)’. The failure rates for DepoProvera, 150 mg every 3 months, were lower than for NET-EN 200 mg
administered either every 60 days or every 60 days for the first 6 months and
every 84 days thereafter.
The third WHO study was scheduled ' run for 2 years, but was terminated
after 1 year because the failure rate foi 4ET-EN, 200 mg every 84 days, exceeded
the maximum allowable rate of 2%'°. 1 e 12-month gross pregnancy rate for
Clinical use for contraception
Reference
Dose
regimen
Failure rate
Number of Number of 1 Life table Pearl
| subjects 1 pregnancies [ analysis
*
"
*
Index
Upjohn-sponsored studies
18
150 mg in 3 ml
every 3 monfhs
3905
15
0.32
0.22
Unpublished
150 mg (50 mg in
3 ml) every 3
months
155
0
0.0
0.0
150 mg in 1 ml
every 3 months
140
0
0.0
0.0
WHO-sponsored studies
150 mg in 1 ml
every 3 months
607
0
0.0
0.0
100 mg in 1 ml
every 3 months
609
2
0.4
0.44
10
150 mg in 1 ml
every 3 months
1587
3
0.1
Not done
9
150 mg in 1 ml
every 84 days
846
4
0.7+
Not done
8
* Pregnancies/100 women after 12 months.
" Pregnancies/100 woman-years.
t Calculated bv life-table analysis; however, the WHO authors expressed the rate in units of
'woman-years'.
Depo-Provera, 150 mg every 84 days, was estimated to be 0.7 ± 0.4/100
woman-years. The rates were calculated by life table analysis, but were
expressed in units of 'woman-years'. Although this rate was higher than those
reported in other trials of Depo-Provera at the same dose, it was significantly
lower than the rate for NET-EN (3.6 ± 0.7/100 woman-years).
When the results of these five studies are compared with historic control data, it
is clear that Depo-Provera, 150 mg every 3 months, provides users with highly
effective contraception. Its use effectiveness is higher than that of oral
contraceptives (OC), and comparable to that of implants2-’ and surgical
sterilization' (Figure 1).
Other studies of Depo-Provera's contraceptive efficacy. Another Upjohnsponsored study examined the contraceptive efficacy of Depo-Provera, 150 mg
once every 3 months". This study comprised 100 healthy, postpartum women
some of whom used Depo-Provera for up to 3 years. During the course of this
study, no pregnancies were reported. Three other studies of Depo-Provera,
150 mg every 84 or 90 days, also reported results that were in close agreement
with the results of the Upjohn-sponsored studies'2-".
Table 2
Failure rates in the
multicenter studies of
Depo-Provera
Kaunitz
Figure 1
Contraceptive failure
rates: percentage of
women experiencing an
accidental pregnancy in
the first year of use (after
Trussell and Kost')
Patient acceptance and continuation rates
Continuation rates reflect patient acceptance of this approach to contraception.
Tweive-month continuation rates were determined by subtracting the
discontinuation rate for all reasons (except protocol completion) from 100% and
in the Upjohn and WHO multicenter trials, rates for Depo-Provera ranged from
49% to 71%. The rates reported for Depo-Provera were similar to those reported
for NET-EN and indicate that, among women enrolled in a clinical trial, over
half would continue using Depo-Provera after 12 months. Those who
discontinued use did so in order to conceive, for medical or personal reasons, or
because of contraceptive failure or side-effects.
Comparison with historic data on continuation rates for other reversible
contraceptive methods suggest that Depo-Provera is well accepted in a variety
of patient populations. Studies in Nigeria15 and Thailand15 reported 12-month
continuation rates of 46.7% and 59.1%, respectively. The Thailand study also
found a strong correlation between the desire not to have any more children and
higher continuation rates: rates for those who did not desire any more children
were about 50% higher than for those who did.
Return to fertility
Injectable contraceptives have not permanently affected fertility in the
populations studied17; pharmacokinetic studies have correlated the return of
ovulatory cycles with the decrease in serum levels of Depo-Provera. However,
because return to fertility is commonly delayed beyond the end of the last 3month injection period, some have thought that Depo-Provera causes
irreversible suppression of ovulation. Unfortunately, these concerns have led
some clinicians and family planning programs to prohibit the use of DepoProvera in adolescent and nulliparous women.
Return to fertility following Depo-Provera use has been assessed in a number
of ways. Several investigators have followed patients who discontinued
Depo-Provera in order to conceive, and measured the time from the last
Clinical use for contraception
injection to conception. Other investigators have measured the time from last
injection to first ovulation, using physiologic markers of ovulation.
Time from last injection to conception. In the first Upjohn-sponsored study
(reference 18, Table 1), 193 (5%) of the 3905 women discontinued the study in an
attempt to conceive. Out of 188 of these women, 114 (60.6%) became pregnant
(based on chance, 89% would have been expected to conceive7) and 74 (39.4%)
were either lost to follow-up or decided not to become pregnant”. Of the 114
who became pregnant and for whom data were available, 78 (68.4%) conceived
within 12 months, and 95 (83.3%) within 15 months of their last injection: the
median time from last injection to conception was 10 months, with a range of
4-31 months (Figure 2)“. When these findings were adjusted to reflect the 3month period in which the drug was still active, the expected 12-month
conception rate after discontinuing Depo-Provera was 82.8%, which was similar
to that reported for OCs (87.0%) and intrauterine devices (IUD; 86.8%)“.
Pardthaisong21-22 compared the rates of return to fertility in a group of 796 Thai
women using Depo-Provera, 150 mg every 3 months, with the rates for 437 OC
users and 125 IUD users, all of whom discontinued their contraceptive method
to become pregnant. The women were followed for up to 4 years after they
discontinued use. Former Depo-Provera users had a longer median time to
conception (10 months from the date of the last injection) than either former OC
users (3 months) or IUD users (4.5 months). However, almost 70% of former
Depo-Provera users had conceived within the first 12 months of discontinuation
and over 90% had conceived within 24 months. Within 3 years of discontinuing
contraception, fertility rates were similar in all groups.
These observations have important implications regarding patient counselling
before Depo-Provera is initiated, because candidates need to be alerted to the
possibility of a prolonged duration of contraception. Nevertheless, as
Figure 2
Fertility as determined by
the pregnancy rate after
discontinuation
of Depo-Provera
(after Schwalhe and
Mohberg”)
Kaunitz
Depo-Provera does not have any permanent impact on fertility, it is an
appropriate choice for appropriately evaluated and counselled adolescent and
nulliparous women interested in long-term contraception.
Duration of use. Neither age nor duration of Depo-Provera use appears to affect
significantly the time to return of fertility”-21. In the Schwallie and Mohberg
study (1974)”, the average duration of infertility following the last injection was
independent of patients' age or duration of Depo-Provera therapy. Comparable results
regarding duration of Depo-Provera use were reported by Pardthaisong (1984)21. In that
study, age also did not appear to affect the return of fertility until 5 months after
Depo-Provera discontinuation; thereafter, fertility returned sooner in women
under 25 years of age than in those aged 30-40 years21. This result is not
unexpected, as fecundity declines with age - the proportion of women aged
15-24 years with impaired fecundity has been reported to be 4.8%, compared
with 12.1% among women aged 35-44 years23.
Data from Schwallie and Mohberg indicate that women with lower final body
weights conceived sooner that those with higher body weights.
Benefits of Depo-Provera
The benefits of
Depo-Provera
include
convenience,
privacy and a
reduction in
menstrual blood
flow
Contraceptive benefits. Depo-Provera is an appropriate contraceptive choice
for many women and is particularly appealing to those who prefer the
convenience of an injection once every 3 months to taking tablets daily or the
use of barrier methods. Unlike non-degradable implants, such as Norplant,
which must be surgically removed by a trained healthcare worker, DepoProvera contraception can be discontinued by the woman herself; all that is
required is a decision not to return for the next injection. If privacy is important,
Depo-Provera offers several advantages, as no storing of contraceptive supplies
is needed and no one other than the healthcare providers has any means of
determining that injectable contraception is being used.
Depo-Provera can be used immediately postpartum"2* and has not been
associated with problems of infant nutrition or development when used by
lactating women2526. Clinicians and patients should, however, be aware of the
fact that women receiving Depo-Provera immediately postpartum are initially
more likely to report frequent episodes of bleeding or spotting than other
women using Depo-Provera. Nursing mothers should wait until the sixth
postpartum week before receiving their first Depo-Provera injection. In our
clinic (Jacksonville, Florida, USA), most women who use Depo-Provera begin
using this method postpartum and receive their first injection before they are
discharged from hospital.
Non-contraceptive benefits. Long-term use of Depo-Provera reduces menstrual
blood loss and therefore often results in an increase in hemoglobin levels. A well
controlled trial found that hemoglobin levels and erythrocyte survival increased,
and the incidence of painful menses decreased, in women using Depo-Provera22.
Injectable contraception may, therefore, be particularly suitable for women who
are prone to anemia or who suffer from hemoglobinopathy.
46
Clinical use for contraception
Side-effects of Depo-Provera
Menstrual changes. The most commonly reported side-effect is a change in the
menstrual bleeding pattern, which occurs in almost all women using DepoProvera. Episodes of unpredictable, irregular bleeding and spotting, lasting
7 days or more, are common during the first few months of use. With increasing
duration of use, the frequency and length of episodes of bleeding and spotting
decrease, and amenorrhea becomes more common. Approximately 50% of
women using Depo-Provera for 1 year report amenorrhea.
Menstrual changes are the most common cause of dissatisfaction with and
discontinuation of Depo-Provera. This can, however, be markedly reduced by
appropriate selection and education of users, as well as by supportive follow-up
measures. Women who are uncomfortable, for whatever reason, with the
menstrual changes that inevitably accompany the use of injectable contraception,
should be counselled to choose alternative methods. In many cases, however,
concerns about menstrual changes result from anxiety about pregnancy or
gynecologic disease. Thus, well informed and supportive healthcare providers,
who give easy access to follow-up counselling and evaluation, can do much to
promote women's satisfaction and contraceptive continuation. In the author's
experience, many women using Depo-Provera view amenorrhea as one of the
favorable aspects of their contraceptive choice.
Medical intervention for irregular bleeding is seldom necessary for women using
Depo-Provera. In cases of reported heavy or persistent abnormal bleeding,
gynecologic evaluation to exclude unrelated conditions, such as vaginitis,
cervicitis or cervical lesions, is appropriate. Treatment with oral estrogen (e.g.
conjugated estrogen, 1.25-2.5 mg/day for 10-21 days) will minimize or eliminate
the bleeding11 but it often recurs after discontinuing estrogen. However, even in
women reporting continuous, heavy, vaginal bleeding, anemia is uncommon
and, if not present, counselling and reassurance of the woman is more appro
priate than estrogen therapy. An alternative type of contraception, rather than
m,edical or surgical intervention is the solution for women who are persistently
dissatisfied with the menstrual changes. Dilatation and curettage has little role in
the management of menstrual changes in women using Depo Provera.
Other side-effects. Although a variety of minor and reversible side-effects may
occur in women using Depo-Provera, major problems are rare. Headache,
dizziness, bloating of the abdomen or breasts, depression, loss of libido, and
alopecia are occasionally reported. Weight gain is commonly reported and in
study populations, an average gain of 5.4 pounds after 1 year of use was
reported. Further weight gains with continued use may occur
.
*
As in women using OCs, laboratory evidence of impaired glucose tolerance is
sometimes seen in Depo-Provera users, but overt glucose intolerance seldom
occurs. Women with a history of diabetes should, however, be monitored for
signs of the disease. Changes in hepatic transaminase levels have not been
reported in women using Depo-Provera2*, including those with a history of viral
hepatitis10. Very high doses of Depo-Provera may induce Cushingoid facies, but
Contraceptive doses do not produce clinical evidence of glucocorticoid excess or
adrenal suppression.
* Please refer to package insert for further information.
Patient
education and
support do much
to promote
acceptance of
the menstrual
changes that
accompany
injectable
contraception
Kaunitz
Patient selection
The contraceptive efficacy of Depo-Provera has not been found to be affected by
the patient's weight or the use of concurrent medications. Women who are
taking antibiotics or anticonvulsant medications, however, require careful
observation.
Appropriate candidatesfor Depo-Provera. Depo-Provera may be an ideal
contraceptive for women seeking a highly effective method of birth control but
who have experienced problems with other reversible methods. This includes
women who have difficulty in remembering to take pills, who prefer the
convenience of injections, or who experience side-effects, such as nausea, when
using OCs. Others may select Depo-Provera because medical factors preclude
the use of oral or intrauterine contraception, or because Depo-Provera offers
Table 3
Medical conditions and
special situations in
women that make the use
of Depo-Provera
contraception
appropriate
• Postpartum
• Conditions in which the use of estrogen-containing contraceptives may be
inadvisable:
- migraine headaches
- hypertension
- systemic lupus erythematosus
- valvular heart disease
- age greater than 35 years, combined with smoking
• Conditions in which Depo-Provera may offer additional non-contraceptive
benefits:
- menorrhagia/leiomyomata uteri
- endometriosis/dysmenorrhea
- hemoglobinopathy
• Concomitant use of anticonvulsants or antibiotics that may reduce oral or
implantable contraceptive efficacy:
- phenytoin
- phenobarbital
- carbamazepine
- primidone
- rifampin
• Conditions in which poor compliance with other contraceptive methods
may occur:
- psychosis
- mental retardation
- intravenous drug abuse
- adolescence
• Conditions in which pregnancy poses specific fetal risks:
- use of teratogenic medications such as isotretinoin, oral anticoagulants
and valproic acid
- human immunodeficiency virus infection/AIDS
Clinical use for contraception
non-contraceptive benefits to their condition. In some women, use of concomitant
medications may reduce the efficacy of oral or implantable contraception and
others are at risk of non-compliance when using oral or barrier contraception.
Finally, pregnancy poses specific fetal risks in some women. Examples of
conditions and situations that place women in these groups are listed in Table 3.
Inappropriate candidates for Depo-Provera. Depo-Provera is not suitable for
women who may want to become pregnant in the next 1-2 years, who are not
prepared to accept menstrual changes or amenorrhea, or who are unwilling or
unable to receive injections every 3 months. Contraindications also include
undiagnosed vaginal bleeding, urinary tract bleeding, breast pathology and
pregnancy.
References
1.
Richard BW, Lasagna L. Drug regulation in the USA and the UK: the Depo-Provera story. Ann
Intern Med 1987; 106:886-91.
2.
Liskin L, Blackbum R, Ghani R. Hormonal contraception: new long-acting methods. Popul Rep
1987; 15:58-87.
3.
Mishell DR. Long-acting contraceptive steroids, postcoital contraceptives and antiprogestins. In:
Infertility, Contraception, and Reproductive Endocrinology. (Mishell DR Jr, Davajan V, Lobo RA,
eds). Boston: Blackwell Scientific Publications, 1991; 872-94.
4.
Siriwongse T, Snidvongs W, Tantayapom P, Leepipatpaiboon S. Effect of depomedroxyprogesterone acetate on serum progesterone levels when administered on various cycle
days. Contraception 1982; 26:487.
5.
Ortiz A, Hiroi M, Stanczyk FZ, Goebelsmann U, Mishell DR Jr. Serum medroxyprogesterone
acetate (MPA) concentrations and ovarian function following intramuscular injection of DepoMPA. / Clin Endocrinol Metab 1977; 44:34-8.
6.
Wright CE, Antal EJ, Gillespie WR, Albert KS. Effect of injection volume on the bio-availability of
sterile medroxyprogesterone acetate suspension. Clin Pharmacol 1983; 2:435-8.
7
Trussell J, Kost K. Contraceptive failure in the USA: a critical review of the literature.
Stud Fam Plan 1987; 18:237-83.
8.
WHO Task Force on Long-Acting Systemic Agents for Fertility Regulation, Special Programme
of Research, Development, and Research Training in Human Reproduction. A multicentered
phase ID comparative clinical trial of depot-medroxyprogesterone acetate given in three-monthly
doses of 100 mg or 150 mg: 1. Contraceptive efficacy and side effects. Contraception 1986; 34:22-35.
9.
WHO Expanded Programme of Research, Development, and Research Training in Human
Reproduction, Task Force on Long-Acting Systemic Agents for the Regulation of Fertility.
Multinational comparative clinical evaluation of two long-acting injectable contraceptive
steroids: norethisterone enanthate and medroxyprogesterone acetate. 1. Use-effectiveness.
Contraception 1977; 15:513-33.
10.
WHO Task Force on Long-Acting Systemic Agents for Fertility Regulation, Special Programme
of Research, Development, and Research Training in Human Reproduction. Multinational
comparative clinical trial of long-acting injectable contraceptives: norethisterone enanthate given
in two dosage regimens and depot-medroxyprogesterone acetate. A final report. Contraception
1983;28:1-20.
11.
Mishell DR, El-Habashy MA, Good RG, Moyer DL. Contraception with an injectable progestin: a
study of its use in postpartum Women. Am J Obstet Gynecol 1968; 101:1046-53.
12.
Salem HT, Salah M, Aly MY, Thabet Al, Shaaban MN, Fathalla MF. Acceptability of injectable
contraceptives in Assiut, Egypt. Contraception 1988; 38:697-710.
13.
Castle WM, Sapire KE, Howard KA, Efficacy and acceptability of injectable
medroxyprogesterone. A comparison of 3-monthly and 6-monthly regimens. S Afr Med J1978;
53:843-5.
Chinvanthananond P, Samransamruajkit S. New regimen of injectable contraceptives. / Med
Assoc Thai 1987; 70: 198-203.
14.
49
Kaunitz
15.
Fakeye O. Contraception with subdermal levonorgestrel implants as an alternative to surgical
contraception in Borin, Nigeria. Int ] Gynecol Obstet 1991; 35:331-6.
16.
Narkavonnakit T, Bennett T, Balakrishan TR Continuation of injectable contraceptives in
Thailand. Stud Fam Plan 1982; 13:99-105.
17.
Fotherby K, Howard G. Return of fertility in women discontinuing injectable contraceptives.
J Obstet Gynecol 1986; 6(suppl 2): S110-S115.
18.
Schwallie PC, Assenzo JR. Contraceptive use-efficacy study utilizing medroxyprogesterone
acetate as an intramuscular injection once every 90 days. Fertil Steril 1973; 24:331-9.
19.
Schwallie PC, Mohberg NR. Medroxyprogesterone acetate: an injectable contraceptive. Adv
Planned Parenthood 1974; 12:36-44.
20.
Schwallie PC, Assenzo JR. The effect of dep-' medroxyprogesterone acetate on pituitary and
ovarian function, and the return of fertility following its discontinuation: a review. Contraception
1977; 10:181-202.
21.
Pardthaisong T. Return of fertility after use of the injectable contraceptive Depo-Provera:
up-dated data analysis. J Biosoc Sci 1984; 16:23-34.
22.
Pardthaisong T, Gray RH, McDaniel EB. Return of fertility after discontinuation of depot
medroxyprogesterone acetate and intrauterine devices in Northern Thailand. Lancet 1980;
i: 509-12.
23.
Mosher WD, Pratt WF. Fecundity and infertility in the USA, 1965-88. Adv Data 1990;
192:1-12.
24.
Jones JR, Lonky S. Use of injectable contraceptive immediately post partum. NY State J Med 1971;
71:2279-82.
25.
Karim M, Ammar R, Mahgoub SE, Ganzhoury BE, Fikri F, Abdou I. Injected progestogen and
lactation. Br Med J1971; 1:200-3.
26.
Jimenez J, Ochoa M, Soler MP, Portales P. Long-term follow-up of children breast-fed by mothers
receiving depot-medroxyprogesterone acetate. Contraception 1984; 30:523-33.
27.
De Ceulaer K, Gruber LA, Hayes R, Sargent GT. Medroxyprogesterone acetate and homozygote
sickle-cell disease. Lancet 1982; ii: 229-31.
28.
Speroff L, Glass RH, Kase NG. Dysfunctional uterine bleeding. In: Clinical gynecologic
endocrinology and infertility. 4th ed. Baltimore: Williams & Wilkins, 1989:265-82.
29.
Tankeyoon M, Dusitsin N, Poshyachinda V, Larsson-Cohn U. A study of glucose tolerance,
serum transaminase and lipids in women using depot-medroxyprogesterone acetate and a
combination-type oral contraceptive. Contraception 1976; 14:199-214.
30.
Mark I. Medroxyprogesterone acetate as a contraceptive for female drug addicts. Scand / Soc
Med 1983; 11:75-80.
31.
Emans SJ, Grace E, Woods ER et al. Adolescents' compliance with oral contraceptives. JAMA
1987; 257:3377.
FIVE INTRAUTERINE DEVICES
FOR PUBLIC PROGRAMS
THT? POPULATION COU^C L
I HE POPULATION COUNCIL has played a major
role in developing and evaluating intrauterine devices
(IUDs). As a result of the Council's work, five IUDs are
now available to governments and nonprofit agencies
in developing countries at prices well below those
quoted commercially. The five IUDs are:
the Copper T 380
the Copper T 220
the Nova T
the Copper T 200
the Lippes Loop
Three versions of the Copper T—the 380 (Model
TCu 380A), the 220, and the Nova T—appear to be
among the world’s most effective IUDs, having annual
pregnancy rates near 1 per 100 users. Under condi
tions that prevail in many developing countries, the
use-effectiveness offered by these new IUDs is ex
pected to be equal or superior to that provided by oral
contraceptives. Based on current evidence, these
three IUDs can be used by women without needing to
be replaced for at least 15 years.
These devices are now being made available to
public sector programs at low cost in both bulk
packaged and individually packaged forms. This
booklet provides information about them and where
and how they can be obtained.
The Population Council’s long involvement in IUD
development has helped to make available other IUDs
as well at low cost to public sector programs. Two of
these IUDs—the Copper T 200 and the Lippes
Loop—are also described in this booklet for programs
that may wish to use them.
Copper-bearing IUDs have gained widespread
use since their development in the early 1970s. Vari
ous types of copper-bearing IUDs have been ap
proved by regulatory agencies in both developed and
developing countries. Based on clinical studies, field
experience, and on the results of toxicological and
teratological investigations, Copper T IUDs appear as
safe as nonmedicated IUDs.
Details of the investigations carried out by the
Population Council, as well as manufacturing and
packaging procedures and specifications, are avail
able to public agencies from the Population Council
upon request.
IUDS AVAILABLE AT LOW COST TO THE PUBLIC SECTOR
The Copper T 380 consists of a plastic T with copper
collars on its horizontal arms and tightly wound copper
wire on the vertical stem. Total surface area of the
copper is 380 sq. mm. The Copper T 380 is the most
effective IUD ever developed by the Population Coun
cil, with an annual pregnancy rate below 1 per 100
users per year. In Population Council studies, this de-
Two-Year Comparison of the Copper T 380 and
Copper T 200 among Parous Women
Copper T 380
Copper T 200
Statistically
significant
difference
0.8
9.2
5.4
6.9
Yes
No
22.8
20.1
No
4.7
50.5
4.0
49.9
No
No
Device
Pregnancy
Expulsion
Removals for bleeding
& pain
Removals for other
medical reasons
Continuation of use
~
U
vice exhibited a cumulative pregnancy rate of only 1.9
per 100 users at the end of four years of use.
In its other performance characteristics, the Cop
per T 380 is very similar to the Copper T 200.
Because Copper T devices are smaller than most
nonmedicated devices such as the Lippes Loops C
and D, they are somewhat easier to insert and are
better tolerated by women who have never borne a
child. Among such women, rates of removal for bleed
ing and pain have been higher for the Copper T 380
than those observed for the Copper T 200.
There are no important differences between the
Copper T 380 and either the Copper T 200 or the
Lippes Loop regarding rates of uterine perforation, ec
topic pregnancy, or pelvic inflammatory disease.
Part of the contraceptive effectiveness of all cop
per IUDs comes from the minute quantities of copper
that slowly dissolve in the uterine environment. Since
this causes the copper wire to become depleted, the
Copper T 380 should be replaced with a new device
after six years. The Copper T 380 is also made with a
copper wire containing a core of silver (Model TCu
380Ag). Because the silver core prevents the wire
from developing breaks as the copper dissolves,
theoretically the effective lifetime of this device is ex
tended by at least 10 years for a total of at least 16
years of effective use. Programs wishing to select the
silver-core copper wire should specify this preference
when purchasing the device.
The Copper T 380 is manufactured with a plastic
ball at the bottom of the vertical stem; the ball is in
tended to guard against cervical penetrations.
The Population Council is preparing a formal re
quest to the US Food and Drug Administration for ap
proval of the Copper T 380 with silver-core wire (Model
TCu 380Ag).
_
Conner T 220
II
I II:
II
II
Model TCu 220C
This Copper T device consists of a plastic T sur
rounded by seven solid copper collars: two on the
horizontal arms and five on the vertical stem. The
Copper T 220 is much more effective than either the
Copper T 200 or Lippes Loop D, and it is nearly as
effective as the Copper T 380.
In addition to being more effective, the Copper T
220 is expelled less frequently and has had lower
removal rates for bleeding and pain than the Loop D.
i
Two-Year Comparison of the Copper T 220 and Lippes
Loop D among Parous Women
Two-year rates
per 100 women
Pregnancy
Expulsion
Removals for bleeding
& pain
Continuation of use
Copper T 220
Device
---------- ------------------Lippes Loop D
1.2
6.6
3.3
10.0
8.8
70.2
12.9
66.6
Statistically
signinuctHL
difference
Yes
Yes
No
Source: Siwii v
qj
There are no major differences in the rates of uterine
perforation or pelvic inflammatory disease between
the Copper T 220 and either the Lippes Loop D or
Copper T 200. In the United States, the ectopic preg
nancy rate observed with a Copper T 220 has been
marginally higher than that of other copper IUDs or
nonmedicated devices. In European studies of the
Copper T 220, the rate has been similar to that re
ported for nonmedicated devices.
Based on the rate of copper loss, the Copper T
220 is expected to remain fully effective for the repro
ductive life of the user. At present, clinical studies to
determine the effective lifetime of this device extend to
six years.
The Population Council is not seeking US Food
and Drug Administration approval for the Copper T
220 device in view of the greater effectiveness of the
Copper T 380 device. However, because of the posi
tive results obtained with the Copper T 220 in clinical
trials conducted by both the World Health Organiza
tion and the Population Council, it is available to public
programs that desire to use it.
Two-Year Comparison of the Copper T 220 and
Copper T 200 among Parous Women
Copper T 220
Copper T 200
Statistically
significant
difference
2.2
6.0
6.0
7.1
Yes
No
15.9
15.2
No
6.8
58.5
5.4
54.6
No
No
Device
Two-year rates
per 100 women
Pregnancy
Expulsion
Removals for bleeding
& pain
Removals for other
medical reasons
Continuation of use
Source: World Health Organization, 1979
Developed and tested in Scandinavia, this device
utilizes a modified plastic T with silver-core copper
wire on the vertical stem; total copper surface area is
200 sq. mm. Plastic knobs on the ends of the horizon
tal arms and a small loop on the vertical stem are
designed to minimize uterine penetrations.
The Nova T appears to offer higher effectiveness
than the Copper T 200.
The Nova T and the Copper T 200 exhibit similar
clinical performance with respect to expulsion rates
and removals for medical reasons.
Two-Year Comparison of the Nova T and Copper T 200
among Parous and Nulliparous Women
Nova T
Copper T 200
Statistically
significant
difference
1.4
6.9
3.6
5.4
Yes
No
17.4
15.5
No
6.0
60.2
5.8
63.6
Device
Two-year rates
per 100 women
Pregnancy
Expulsion
Removals for bleeding
& pain
Removals for other
medical reasons
Continuation of use
No
No
Source: Allonen et al.. in preparation.
The Nova T is made with silver-core copper wire,
Approval of the Nova T by the US Food and Drug
which prevents the copper from fragmenting as it dis
solves. Theoretically, the effective lifetime of this Nova
T device should be about 15 years.
Administration has not been requested. The device is
available in most Scandinavian countries, and is ap
proved by their regulatory agencies.
INSERTION OF COPPER T IUDS FOLLOWING CHILDBIRTH OR ABORTION
Most IUD insertions are performed several months after
delivery or termination of pregnancy. IUDs also can be in
serted immediately following childbirth, but they exhibit much
higher expulsion rates under such conditions.
IUDs can be inserted immediately after a therapeutic
abortion. Copper T devices appearto be superior to the Lippes
Loop under such circumstances:
Two-Year Comparison of the Copper T 220 and Lippes Loop D
Inserted Immediately Following Therapeutic Abortion
Device
Two-year rates
per 100 women
Pregnancy
Expulsion
Removals for bleeding
& pain
Continuation of use
CopperT220
Lippes Loop D
Statistically
significant
difference
2.0
3.9
4.7
9.3
Yes
Yes
11.2
, ,71.6
14.8
63.4
No
Yes
Source: World Health Organization. 1979.
Copper T 200
I.
Model TCu 200
Model TCu 200B
Also available with
silver-core copper
wire: Model TCu
200B-Ag
|f
si
?
Also available with
silver-core copper
wire: Model TCu
200Ag
The Copper T 200, the earliest Copper T, consists of a
plastic T with a coil of copper wire 200 sq. mm. in
surface area wrapped around its vertical stem.
Like other Copper Ts, the device is easy to insert
in women who have never borne a child, and is better
tolerated by such women than the larger nonmedi
cated plastic devices. Comparative studies of the
Copper T 200 and Lippes Loop D show little difference
in effectiveness between the two devices. But
menstrual blood loss is significantly less with the Cop
per T 200.
There are no important differences between the
Copper T 200 and Lippes Loop regarding rates for
uterine perforations, ectopic pregnancies, or pelvic in
flammatory disease.
The Copper T 200 made with copper wire should
be replaced with a new device every three to four
years. The Copper T 200 is now available with copper
wire containing a core of silver, which prevents the
wire from fragmenting as the copper dissolves.
Theoretically, the silver-core wire should add at least
10 years of effectiveness to the device. Programs
wishing to select the silver-core copper wire should
specify this preference when purchasing the device.
The Copper T 200, Model TCu 200B, has been
approved by the US Food and Drug Administration.
This device is manufactured with a plastic ball at the
bottom of the vertical stem. The ball does not signifi
cantly influence performance of the device, but may
offer protection against possible cervical penetrations.
The Copper T 200 is also available without the ball
(Model TCu 200). Both models also can be obtained
with silver-core copper wire (Models TCu 200B-Ag
and TCu 200Ag, respectively).
IUD SHELF LIFE
Unless directly exposed to light, freezing temperatures, or
extremely high temperatures, Lippes Loops and Copper T
IUDs can be stored without deterioration for many years, since
the plastic and copper are very stable
In an accelerated stability study. Copper T 200 devices
were rigorously analyzed and tested after being stored in the
dark at 50°C and low humidity for 36 months. No important
physical changes in the devices were detected.
Nor does prolonged storage appear to affect the sterility
of individually packaged devices. Full sterility was retained
after three years of storage at 37CC and 80% relative humidity
or 50°C and variable humidity. Based on this research, indi
vidually packaged, presterilized Copper Ts should remain
sterile for many years of storage as long as the plastic pouch
remains sealed and no moisture enters the pouch. The
cardboard shipping boxes are not waterproof, however, and
should be stored in dry places away from any direct contact
with water.
This nonmedicated plastic device is used throughout
the world. Four models—A, B, C, and D—are avail
able. Loop D is considered the standard against which
the performance of other devices is measured. Loop C
is the same size but more flexible, and is recommend
ed for insertion in women who have had the Loop D
removed because of excessive bleeding or pain. Loop
B is smaller in size, and is recommended for women
with small uteri who have.had a previous pregnancy or
for women who have had a miscarriage. Loop A is the
smallest size, and is recommended for women who
have never had children.
Although some newer intrauterine devices have
proved to be more effective, Lippes Loop models C
and D provide excellent protection and exhibit high
continuation rates among women age 35 and over.
The effective lifetime of Lippes Loop devices is proba
bly in excess of 15 years. Because it is made of non
medicated plastic, the device has not required US
Food and Drug Administration approval.
HOW PUBLIC PROGRAMS CAN OBTAIN THESE IUDS
The Population Council does not sell or supply the
IUDs described in this announcement, but it has en
sured that supply channels are available. Public health
and family planning programs in developing countries
can obtain these IUDs in two ways: through commod
ity grants from international assistance organizations
or by direct purchase from manufacturers.
Family Planning International Assistance (FPIA)
COMMODITY GRANTS
supplies IUDs to some family planning programs.
Contact the regional directors of FPIA in Nairobi,
Manila, Dacca, or Bogota or write to:
Chief Operating Officer
Family Planning International Assistance
810 Seventh Avenue
New York, New York 10019
USA
Some international assistance organizations provide
contraceptive commodities to public programs upon
request. Programs should direct inquiries to such
The International Planned Parenthood Federation
(IPPF) is able to supply IUDs to some family plan
agencies:
The Agency for International Development
(USAID) supplies Lippes Loops and USFDAapproved copper IUDs. Inquiries should be made
to the AID mission representative attached to the
local US embassy.
ning programs. Write to:
Dr. Carl Wahren, Secretary-General
International Planned Parenthood Federation
18-20 Lower Regent Street
London SW1Y4PW
The Pathfinder Fund supplies IUDs to some family
PURCHASE FROM MANUFACTURERS
planning programs. Contact the regional repre
sentatives of the Pathfinder Fund in Jakarta,
Dacca, Bogota, Santiago de Chile, Salvador
(Brazil), Cairo, or Nairobi or write to:
Mr. Howard Gray, Executive Director
The Pathfinder Fund
1330 Boylston Street
Chestnut Hill, Boston, Massachusetts 02167
USA
As a result of agreements with the Population Council,
The United Nations Fund for Population Activities
(UNFPA) considers requests for IUDs from gov
ernments or other agencies having local govern
ment approval. Write to:
Mr. Dennis Badham
United Nations Fund for Population Activities
485 Lexington Avenue
New York, New York 10017
USA
the manufacturers listed below will sell the intrauterine
devices described in this announcement at reduced
cost to public governmental programs and nonprofit
institutions that supply devices free of charge or at
nominal cost to women in developing countries.
(Profit-making organizations do not qualify for pur
chase at these reduced prices.)
Supplier
A
<0
IUDs Oltered_________
Type of IUD
Model Number
Copper T 220
TCu 220C
Lippes Loop
Finishing Enterprises, Inc.
(Formerly Hallmark Plastics. Inc.)
copper T 200
908 Niagara Falls Boulevard
North Tonawanda, New York 14120
Att: Mr. Paul Bronnenkant
A, B, C, D
TCu 200B
Niagara Hallmark Devices
4536 Portage Road
Niagara Falls, Ontario, Canada
Att: Mr. Paul Bronnenkant
Copper T 380
TCu 380A
TCu 380Ag
Copper T 220
Copper T 200
TCu 220C
TCu 200
TCu 200Ag
TCu 200B
TCu 200B-Ag
Ortho Pharmaceutical Corporation
Route 202
Raritan, New Jersey 08869
Att: Mr. D. K. Wemtinger
Lippes Loop
A, B, C, D
Biotec Laboratories
Prolongacion Sanctorum 5
Naucalpan, Edo, de Mexico
Att Lie. Benigno Estrado
IUDs Offered_________
Model Number
Supplier
Type of IUD
Ortho Pharmaceutical (Canada) Ltd.
19 Green Belt Drive
Don Mills
Ontario M3C 1L9. Canada
Att: Mr. Eric Milledge
Lippes Loop
Copper T 200
A, B, C, D
TCu 200
Outokumpu Oy
Box 60
SF-28201 Pori 10
Finland
Copper T 380
Nova T
Copper T 200
TCu 380Ag
NovaT
TCu 200
TCu 200Ag
TCu 200B
TCu 200B-Ag
Pharmaceutical Plant Leiras
P.O. Box 415
SF 20101
Turku, Finland
Att- Mrs Soili Jarvela
Copper T 380
Nova T
Copper T 200
TCu 380Ag
NovaT
TCu 200
TCu 200Ag
TCu 200B
TCu 200B-Ag
Schering AG
P.O. Box 650311
D-1 Berlin 65
West Germany
Att: Mr. Degen
Copper T 200
TCu 200
USE OF BULK-PACKAGED IUDS
IUDs may be packaged in two ways: either in bulk as nonsterile
lots, or individually, as complete, presterilized units, with
Inserters, Bulk packaging is cheaper, and bulk-packaged IUDs
can be transported and stored more readily. IUDs packaged as
complete, presterilized units are more convenient for im
mediate use. however, since they eliminate the need for sterili
zation procedures prior to insertion. In comparative field
trials, no significant difference in rate of removal of devices
because of pelvic infection was detected between bulk-
One-Year Termination Rates for Pelvic Infection,
Copper T 200 and Lippes Loop D among Parous Women
Country
Individually packaged.
presterilized
Copper T 200
Colombia
0.5
Iran
1.7
Korea
0.8
Philippines 1.5
Thailand
0.3
Bulk-packaged
Lippes Loop D
0.5
0.8
1.2
0.5
0.7
packaged units (Lippes Loop) or individually packaged, pre
sterilized units (TCu 200).
Clinic personnel using bulk-packaged IUDs should be
trained in appropriate sterilization procedures and the proper
technique for loading and assembling of the sterilized compo
nents prior to insertion. Before insertion, all components—
IUD, inserter tube, movable flange, and plunger—should be
submerged completely in an antimicrobial solution (such as one
part of benzalkonium chloride, Zephiran ®, in 750 parts water)
for at least 30 minutes. Prolonged submersion of copper IUDs
will result in some discoloration of the copper but this will not
affect the performance of the IUD. Solutions containing iodine
are not recommended for sterilization of copper IUDs because
of their oxidizing properties. Iodine solutions may be used for
sterilizing Lippes Loops, however.
if inserters are to be reused, they should be thoroughly
cleansed in water immediately after the insertion procedure
and then replaced in the antimicrobial solution. Because the
shape of the insertion tube may become distorted after re
peated use, no more than five insertions are recommended for
each tube. The plungers and n
- : --ay be reused
many times without distortion.
Lippes Loops and Copper T devices are available
in unsterilized bulk lots or as individual, presterilized
Approximate Prices in US Dollars
for Single IUD (August, 1979)
units. The individually packaged IUDs come with an
inserter in each package, along with instructions and
information on use of the IUD. The instructions are
usually printed in English, but some suppliers can pro
vide printing in different languages, usually at added
cost. Bulk-packaged unsterilized inserters are avail
able for use with bulk-packaged IUDs.
Prices vary somewhat from manufacturer to man
ufacturer. Also, they depend on the size of the order
and the type of packaging, labeling, and shipment
required. Not all manufacturers offer all IUDs. Fur
thermore, delivery, packaging, labeling, and other
supply matters vary from manufacturer to manufac
turer.
The approximate price of inserters suitable for the
various IUDs is US$0.10 each.
Programs interested in purchasing IUDs are ad
vised to request information about availability, cost,
terms, storage instructions, and other aspects of sup
ply directly from the manufacturers listed above and to
select the supplier that best meets their needs.
Device
Individually
prepackaged
sterile units
with inserter
Bulk-packaged
(without inserter,
unsterilized)
Copper T 380
Copper T 220
Nova T
Copper T 200
Lippes Loop
$0.80-1.20
$0.85-1.20
$1.20
$0.65-1.20
$5.00
$0.35
$0.50
not yet determined
$0.20
$0.08-0.16
SOURCES
Allonen, H„ Luukkainen, T„ Nielsen, N.C., Nygren, K.-G.and
T. Pyorala. “Two year rates for Nova T," paper in prepara
tion.
Jain, A.K “Safety and effectiveness of intrauterine devices,"
Contraception. 11, no. 3, 1975.
Jam, A.K. and I. Sivin. “Lifetable analysis of IUDs: Problems
and recommendations," Studies in Family Planning, 8, no.
2, 1977.
Luukkainen, T., Nielsen, N.C., Nygren, K.-G., Pyorala, T. and
A. Kosonen. "Randomized comparison of clinical perfor
mance of two copper releasing IUDs. Nova T and Copper
T 200 in Denmark, Finland and Sweden." Contraception,
19, no. 1. 1979.
Roy. S.. Casagrande, J., Cooper, D.L. and D R. Mishell, Jr.
“Comparison of three different models of the Copper T in
trauterine device," American Journal of Obstetrics and
Gynecology, 134, no. 5, P. 568-574, 1979.
Sivin, I. "A comparison of the Copper T 200 and the Lippes
Loop in four countries," Studies in Family Planning, 7, no.
4, 1976
Sivin, I. Interoffice memorandum, 23 May 1975.
Sivin, I. and J. Stern. "Long acting more effective copper
T IUDs." Studies in Family Planning, 10, no. 10, 1979.
Tatum, H J. “Comparative experience with newer models of
the Copper T in the U.S.,’' Analysis of Intrauterine Con
traception, Segal, S.J. and F. Hefnawi, eds. North
Holland/American Elsevier, 1975.
Tatum, H.J. "Intrauterine contraception," American Journal
of Obstetrics and Gynecology. 112, P. 1000-1023, 1972.
Thiery, M., Van der Pas. H.. Van Kets, H., Boogers, W., Haspels, A. and J.J. Amy. "Four years' experience with the
TCu 220C, a long-acting multisleeved copper intrauterine
device," Advances in Planned Parenthood, XIV. no. 1.
1979.
Tietze, C. and S. Lewit. “Comparison of the Copper T and
Loop D: A research report." Studies in Family Planning. 3,
no. 11,1972.
Tietze, C. and S. Lewit. "Evaluation of intrauterine devices:
Ninth progress report of the Cooperative Statistical Pro
gram," Studies in Family Planning, 1, no. 55, 1970.
World Health Organization HRP/79.1 Rev. 1, 1979.
Zipper, J., Medel, M„ Goldsmith, A. and D.C. Edelman. “Six
year continuation rates for Cu T 200 users," Journal of
Reproductive Medicine, 18, no. 2, 1977.
THE POPULATION COUNCIL
John D. Rockefeller 3rd. Founder
Chairman of the Board of Trustees 1952-77
Board of Trustees
Robert H Ebert. Chairperson
President. Milbank Memorial Fund
New York. New York
Mary I. Bunting. Vice Chairperson
President Emerita. Radcliffe College
New Boston. New Hampshire
George Zeidenslein. President
Robert Cassen
Fellow
Institute of Development Studies
University of Sussex
Brighton. England
Abda Rockefeller Dayton
Contraceptive and Pregnancy Counselor
and Board Member
Planned Parenthood of Minnesota
Minneapolis. Minnesota
Margaret Dulany
Associate in Education
Harvard Graduate School of Education
Cambridge. Massachusetts
William T Golden
Treasurer and Director
American Association
for the Advancement of Science
Washington. DC.
W. David Hopper
Vice President. South Asia
International Bank for Reconstruction
and Development
Washington. DC.
Akin L. Mabogunje
Professor of Geography
University of Ibadan
Ibadan. Nigeria
Yoshinori Maeda
Honorary President
Asian Broadcasting Union
Tokyo. Japan
Vina Mazumdar
Chief Editor and Director. Women's Studies
Indian Council of Social Science Research
New Delhi. India
Carmen A. Miro
Chairman. International Review Group
of Social Science
Research on Population and Development
Mexico City. Mexico
Jose A. Pinotti
Director, Faculty of Medical Sciences
University of Campinas
Campinas. Sao Paulo. Brazil
Helen M. Ranney
Professor of Medicine and Chairperson
Department of Medicine. University of California
San Diego. California
Masri Singarimbun
Director, Population Institute
Gadjah Mada University
Yogyakarta, Indonesia
Sarah R. Weddington
Assistant to the President. The White House
Washington. D.C.
James D. Wolfensohn
General Partner and Member
of the Executive Committee
Salomon Brothers
New York. New York
Officers
Chairperson of the Board
Robert H. Ebert
President
George Zeidenstein
Vice Presidents
C. Wayne Bardin
James J. Bausch
George F. Brown
Paul Demeny
Secretary
Hugo Hoogenboom
Treasurer
James J. Bausch
Assistant Treasurer
George A Babb
November 1979
This booklet is intended as a brief overview of currently
available data and is not intended to serve as a full
presentation of all the safety, efficacy, and other data
concerning these IUDs. More detailed technical infor
mation is available and may be specifically requested
from:
The Population Council
Center for Biomedical Research
The Rockefeller University
1188 York Avenue
New York, New York 10021
THE POPULATION COUNCIL
One Dag Hammarskjold Plaza
New York, New York 10017
Printed in the U S A
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