HEPATITIS B VACCINATION MISLEADING POLICY & PROMOTION.pdf

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extracted text: Hepatitis B Vaccination
Misleading
Policy & Promotion

Drug Action Forum - Karnataka
Dharwad
&

TEST Foundation
Chennai

HEPATITIS B VACCINATION - MISLEADING POLICY AND
PROMOTION IN INDIA. By Dr Gopal Dabade of Drug Action Forum
- Karnataka. A critical appraisal of the policy of the Government of
India on hepatitis B vaccination.

Published by:

Drug Action Forum - Karnataka**
57, Tejaswinagar,
Dharwad 580 002
Karnataka, INDIA
Tel +91 (0)836-2461554
drdabade@sancharnet.in
Printed in collaboration with :

TEST Foundation,
4, Sathalvar Street,
Mogappair west,
Chennai 600 058,
Tamil Nadu, INDIA
Tel +91 (0)44-26244211
testfoundation@rediffmail.com

Copyright © 2004 by Drug Action Forum - Karnataka,

First edition March 2004
Contribution towards the book Rupees 10/r

~

— ■■■■

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*Drug Action Forum - Karnataka is part of Jana Swasthya Abhiyan (People’s Health
Movement - India www.phmovement.org). Also a member of AIDAN (All India
Drug Action Network) and HA1-AP (Health Action Forum - Asia Pacific
www.haiap.org).

Drug Action Forum - Karnataka campaigns for the rights of the people for Rational
Drug Therapy & Policy.

Hepatitis B vaccination
Misleading policy
and
promotion

Drug Action Forum - Karnataka & TEST Foundation
57, Tejaswinagar,
Dharwad 580002,
Karnataka INDIA
Tel +91 (0)836 2461554
drdabade@sancharnet.in

CONTENTS
1.
2.
3.

4.
5.
6.
7.

8.
9.

Preface
Forward
Hepatitis B vaccine in India
- a controversy

iii
V

>

Introduction

>

Lack of resources

1
2

>

Absence of epidemiological basis

6

>

Alternatives

8

> Summary and conclusion
To whom is the vaccine
hepatitis B indicated
Vaccination Policy and
the Public-Private
Unsafe Injection & Hepatitis B
Misleading promotion
Letter from Healthskeptism
Letter to Union Minister for Health
& Family Welfare

11

12
12
15
16
17
18

10. Correspondence with drug companies
and Drug Regulating authorities :

*
*

Letters to SKBP
Letter from state Drug Controller, Bangalore

20
22

*

First letter from GSK

23

*

Reply to GSK from DAF-K

24

*

Reply from GSK

25
26
27
29
31

* Reply to GSK
* Letter to Wockhardt Ltd
11. Letter from British Medical Journal
12. Tear page addressed to health minister
ii

PREFACE
Last week in my sleepy home town there was a news
item about a quack who was going around and pressurizing
public to get vaccinated for hepatitis B vaccine, which in reality
was not even a vaccine. The local bodies including the doctors’
association caught him and handed him to police for further
probing and action. That was indeed a good job by the local
vigilant community and the doctors.
But what happens when the policies of the government
are formulated by ‘quacks’ or by policy makers who hijack the
issues in favour of the business world and are NOT in favour
of people’s health. Health policies of any country effect each
and every individual. Little do we realise that people in far off
rich and big cities plan if a child in a remote village should get
a particular vaccine or not. If the policies are pro people it
definitely helps people if not they can be catastrophic. Often the
common man is at a loss to understand the policies. Drug
Action Forum - Karnataka has taken up this particular issue on
hepatitis B vaccination policy so as to make it available to
common man the policies of the Government of India in a
simple presentation. It is one such effort of DAF-K to demystify
medicine for common man.
We also want to reach the policy makers and groups that
would be interested in such issues. Please help us in reaching
them. So we look forward for your involvement and sugges
tions on this.
In this booklet we also present our correspondence with
the Karnataka State Drug Controller, Bangalore and the drug
companies. DAF-K had taken note of a misleading advertise
ment by a leading drug company.
Let it NOT be presumed that DAF-K is against vaccines.
Far from it. We need vaccines and vaccine policies that help in
iii

preventing diseases with keeping people as priority. In fact we
need much more than vaccines and Drug action Forum Karnataka believes that:1. Health is not only a right but also everyone’s responsibility.
This is more true in a situation where we live in a world
where medical information is NOT demystified.
2. Knowing about the drugs and vaccine that the person is
using is one’s right.
3. A well informed non medical person is in a much better
situation to prevent and treat common health problems.
4. Medical information needs to be demystified so that non
medical persons are in charge of their health problems.
“Health for All, now” can only be achieved when people
have access to information. And this is one such attempt by
Drug Action Forum - Karnataka.
The last page in this booklet is a tear page. Kindly send
the letter to the Health Minister and mark us a copy of the
same.
Dr Gopal Dabade
Drug Action Forum - Karnataka

iv

People’s Health Movement
Global Secretariat : CHC, # 367, Jakkasandra 1st Main,
1st Block, Koramangala, Bangalore - 560 034 India.
Tel.: 91-80-5128 0009 / Telefax: 91-80-552 53 72
E-mail: secretariat@phmovement.org
Website: http://www.phmovement.org

Networks
• Asian Community Health
Action Network (ACHAN)
• Consumers InternationalRegional Office for Asia
and the Pacific (CIROAP)
• Dag Hammarskjold
Foundation (DHF)
• Gonoshasthaya Kendra,
(GK)
• Health Action
International (HAI) - Asia
- Pacific - HAIAP
• International People’s
Health Council (IPHC)
• Third World Network
(TWN)
• Women’s Global Network
for Reproductive Rights
(WGNRR)
Past Coordinator
Qasem Chowdhury,
GK, Savar, Bangladesh

Present Coordinator
Ravi Narayan,
CHC, Bangalore, India

FOREWORD
The ‘Health For All’ challenges in
countries like India need responses
that are relevant to the ‘socio economic-cultural - political context.
These responses cannot be just
passive transfers of global guidelines
or recommendations often derived
from practitioners of Public Health in
very different types of health care
systems and social realities.
Technology transfers in response
to public health challenges also need
to be subservient to people’s needs
and national capacities and not only
determined by ‘pulls’ and ‘pressures’
from the promoters of the technology.
Public and professional debate and
dialogue, based on technical and
social evidence, is therefore, crucial
in this search for relevance and
context.

Immunisations have been a
significant part of the public health
armamentarium, especially for
improving child health. However, the

PHM Resource Centre: Gonoshasthaya Kendra, Nayarhat, Dhaka -1344, Bangladesh
Tel: 880-2-770 83 16,770 83 35-6; Fax: 880-2-770 83 17;
e-mail: gksavar@citechco. net

v

non-government organisation,3 in India, CEHAT (Centre for
Enquiry into Health and Allied Themes) (http://www.cehat.org/),
which is a active critic, in the field of public health. The major
concerns of it has been on the issue of lack of resources for
introducing the vaccine and the absence of epidemiological
basis of hepatitis-B and also in addition has come out with
better alternatives for the same.
Today vaccination policies seem to have shifted towards
Public-Private Initiatives (PPIs) and away from equity. The
Director General of the WHO has come out strongly in favour
of such Public-Private Initiatives (such as GAVI) to treat infec
tious diseases. Health has become an economic asset and is no
longer primarily seen as a basic human right. In vaccination
programmes the focus now appears to be creating markets for
new vaccines. Achieving equity in access to a limited number
of essential vaccines, the objective of the EPl does not seem to
be the primary objective any more. The notion of market failure
and the lack of new vaccines are attractive ideas for the
pharmaceutical industry as it can play a leading role in ‘sup
porting’ the development of new vaccines.4
It is interesting to note that the first disbursement by GAVI
made for the year 2000/2001, totalled US dollar 150 million
from the initial commitments totalling US dollar 1.03 billion. Of
this initial disbursement 90% was allotted for the introduction
of new vaccines and single use injection materials, while only
10% went to strengthen immunisation services. Anita Hardon
commented: “The emphasis on the introduction of new and
under-used vaccines in GAVI reflects a more general shift away
equity towards technological innovation and disease eradication
in global health programmes. This appears to indicate funda
mental move in vaccine policy from, the values of the Post-Alma
Ata (PHC) era” For more details look under “Vaccination
Policy and the Public Private Mix”, page number 13.
Lack of resources

The Indian Academy of Paediatrics (IAP), an organisation
2

representing the paediatricians of the country has recommended
that all the new born infants should be vaccinated with hepatitis
B vaccine and to implement which would cost Rupees 1250
million (around 26 million US$) annually for the hepatitis-B
vaccine alone, at the rate of Rupees 50 (around 1.04 US$) per
new born for the 25 million annual births in India. Compare
this with the budget in the year 2000-2001 of Rupees 1250
million (around 26 million US$) allotted by the Government of
India for its National Tuberculosis Programme. And Rupees
1050 million (around 22 million US$) for Malaria control.
Tuberculosis & Malaria obviously being major killers in India.
According to World Health Organization (WHO); “India
has more TB cases than any other country in the world. Every
year, 2 million people in India develop TB and nearly 500,000
die from it - more than 1,000 every day. The disease has
become a major barrier to social and economic development.
More than 300,000 children are forced to leave school each
year because of their parents’ tuberculosis, and more than
100,000 women with tuberculosis are rejected by their families
due to social stigma.”5
It is necessary to address these questions in a
developing country like India, where financial resources
is always a constraint. Secondly, in any case, modern health

•2.

care management should consider cost efficacy and effective
ness of any healthcare intervention that is paid through public
money.
Also given the fact that for the maximum efficacy of
hepatitis-B vaccine, to prevent the ‘mother to child’ (which is
the most dangerous mode of transmission in India), this vaccine
would have to be given during the first twelve to twenty-four
hours of birth as per the recommendation of WHO, the
American Academy of Paediatrics and other major agencies.
This would be impossible, because 77% of deliveries, in India
take place at home.
3

Absence of epidemiological basis

Recommendations by WHO are that, Universal and Se
lective Vaccination for countries with a carrier rate of and below
2%, respectively, should be carried out. In India, there has been
controversy over the prevalence of the disease. The quoted
study, by medical bodies has been that of S.PThyagarajan et.
al., which puts the carrier state in India at 4.7%. This is not
acceptable, as it suffers from three errors as per Phadke Anant
& Kale Ashok;
1. HBsAg (hepatitis-B surface antigen) positive rate has been
confused with carrier rate- the studies used are all one time,
cross-sectional studies of prevalence of HBsAg positive in
mostly blood donors. This positive rate is quite different
indicator than the carrier rate. Carrier stage in hepatitis-B
virus infection is persistence of infection for six months or
more.
2. Thyagarajan^et al have included three studies on profes
sional blood donors and one from the dental personnel.
The basic limitation of blood bank data is that, some of the
blood donors are professional blood donors (blood dona
tion is often income generation, for the donor), all though
they are recorded as voluntary blood donors. The preva
lence of hepatitis-B is quite high in professional blood
donors. Also many of the blood donors do so repeatedly.
So it is wrong to include such high-risk groups in estimating
prevalence in general population.
3. An elementary error had been committed in calculating the
average from various studies. The average of 4.7% has
been calculated by simple taking average of the averages of
individual studies, irrespective of number of the cases in the
studies.
Phadke Anant & Kale Ashok have used the same data
used by Thyagarajan et al, and have rightly excluded the
studies on professional blood donors and dental personnel, and
4

calculated the average of the HBsAg positive rate in different
centres. In this process, excluded studies, which did not men
tion the number of persons tested. The average of the positive
rate in the remaining studies was found to be 2.64%, which
broadly agrees with the data available from other studies. For
example, in the same book in which Thyagarajan et al’s paper
has been published, a study of HBsAg positive rate in pregnant
women coming to the antenatal clinics was found to be 2.8%.
Phadke Anant & Kale Ashok further clarify that the rate
of 2.64% based on the data used by Thyagarajan et al is not
the point-prevalence. To find out the proportion of the HBsAg
positive, being actually infected with the hepatitis-B virus, apply
the corrective factor of Positive Predictive Value (PPV). Assum
ing the sensitivity and specificity of the HBsAg test to be 100
and 99 percent respectively, the PPV of this screening test is
67.1% at the prevalence rate of 2%, as mentioned in the chart
given next page. Assuming for a moment that the prevalence of
HBsAg positive in India is around 2% then the true, prevalence
of HBsAg positive would thus be :
(HBsAg positive rate) (Positive Predictive value)
100

2.64x67.1 _ 1
100
’
I

•
°’

Which comes to 17.7 million in a population of 1000 million.
Studies, which have followed up initial HBsAg positive
patients for six months, have found that about 75 to 80% of
these continue to be positive and hence are carriers. Extrapo
lating from these findings to the above estimation of HBsAg
point-prevalence of 1.47% in India, HBsAg carrier rate works
out to be : .
1.77% x 0.80 f= 1.42%.6
Based on low carrier -rate alone, it is clear that the
Universal Strategy is invalid in India.

5

Chart A

Positive Predictive Values (PPV) of a screening test with
a sensitivity of 100% & specificity of 99% with a varying degree
of prevalence subsets of population of 10.000 each.
Preva
lence

Infected
Persons

(a)

(b)

(c)

(d)

(e)

(f)

(g)

(h)

1%

100

100

0

9900

9801

99

50%

2%

200

200

0

9800

9702

98

67.1%

3%

300

300

0

9700

9603

97

75%

4%

400

400

0

9600

9504

96

80%

5%

500

500

0

9500

9405

95

84%

6%

600

600

0

9400

9306

94

86.5%

7%

700

700

0

9300

9207

93

88.2%

8%

800

800

0

9200

9108

92

89.7%

9%

900

900

0

9100

9009

91

91%

10%

1000

1000

0

9000

8910

90

91.7%

2500

2500

0

7500

7425

75

97%

25%

Sensitivity
100%
True False
(+)
(-)
-fives -fives

Non
infected
persons

Specificity
PPV
99%
(c/c+g)
True False xlOO
(+)
(-)
-fives -tives

Alternatives

The critics are of the opinion that Selective Vaccination
Strategy is an alternative, where in screening of all pregnant
women for HBsAg and then give the first dose of the vaccine
within 24 hours of birth, to the newborns of only hepatitis-B
positive mothers. This strategy can be further be made Highly
Selective Vaccination (HSV) strategy which would involve the
followingr1. In first year, screening all pregnant women for HBsAg
positive and then from second year onwards, to conduct
6

this screening every year for the primigravida only.
2. Administer the first dose of vaccine immediately after birth,
to all the new'born of the HBsAg positive mothers in the
first year and also to subsequent newborns of these HBsAg
positive mothers.
3. From second year onwards vaccinate also the newborn of
every additional group of HBsAg positive primiparous
women.
It has been observed that the cost efficacy of this Selec
tive Vaccination Strategy, (around Rupees 5227, which is
around 109 US$), is much greater, than Universal Vaccination
Strategy, (around Rupees 9260, which is around 193 US$) per
infant protected from HBeAg (hepatitis B e antigen). Secondly,
to cover all the pregnant women and their newborn in a year,
the total annual cost of the programme for Universal and
Selective vaccination for a cohort of 10,000 would be Rupees
5,00,000 (around 10425 US$) and Rupees 1,15,000 (around
2398 US$) respectively.
This cost can be further reduced considerably, if we
screen only the primagravida pregnant women from the second
year onwards, and continue to vaccinate infants subsequently
borne to the cohort of the HBsAg positive mothers detected
earlier.
Apart from the cost-efficacy advantage described of this
Highly Selective Vaccination Strategy, it would automatically
provide data for monitoring the prevalence of HBsAg positive
rate amongst childbearing women. Secondly this strategy is
logistically much more practical than the Universal Vaccination
Strategy, as it gives 6-7 months to screen the pregnant women
for HBsAg during antenatal check-ups. Secondly only about 3%
of the newborns will have to be vaccinated within 24 hours of
birth. The mothers of these babies would have been detected
well in advance and it would be much easier to track down and
vaccinate within twenty-five hours, five (around 3%) of the 150
births that would occur in one year in a 5000 population. 7
7

Comparative Cost Efficacy of Universal and Selective
Hepatitis-B Vaccination in a Cohort of 10,000 Pregnant
Women and Their Newborns
Z

1 ■■

Selective
Strategy

Universal
strategy

1 Cost of HBsAg screening for 10,000 Rs.
antenatal cases (at Rs. 10) (A)
1,00,000
2 HBsAg Positivity Rate
3% (B)
3 Number of HBsAg Positive moth 300
ers

4 Vaccine cost of the vaccination of
the newborns of positive mothers
at 50 per child for 3 doses(C)
5 Cost of screening and vaccination
(row 1 + row 4)
6 Number of HBeAg carrier children
prevented (D)
7 Cost of preventing one HBeAg car
rier (row 5 /row 6)
8 No. of primi gravida to be screened
from year II onwards, annually (E)

Rs.
15,000

Rs.5,00,000

115,000

5,00,000

22

54

Rs. 5227

Rs. 9260

3000

9 Annual cost of screening additional Rs.
batch of primigravida and vaccinat 34,500
ing babies of HBsAg positive primiparous women (30% for row 5)

10 Cost of vaccinating 600 babies that Rs.
would be borne to the cohort of 300 30,000
HBsAg positive mothers in say next
5 years
11 Annual cost of this vaccination i Rs. 6,000
spread over 5 years
8

Contd....

12 Total annual cost of the programme
(row 9 + row 11)
13 Total annual cost of this programme
if all the 25 million pregnant women
in India are to be included in this
programme (40,500 x 25 millions/
10,000)
14 Total cost of this programme in year
I, if all the 25 million pregnant
women in India are to be included
in this programme (115,000 x 25
millions/10,000)

Rs.
40,500
Rs.101
million

Rs.287.5
million

Rs. 1250
million
(25
million x
Rs 50)
Rs. 1250
million(25
million x
Rs 50)

NOTES -

A) The kit cost per test during September 2001 was around
Rs.20 per test, (with some price variation with different
manufacturers). We assume that in the mass screening, this
cost would come down to Rs. 10/- per test,
B) Kant Lalit, Arora Narendra; Transmission of Hepatitis B
Virus in Children : Indian Scenario; in Hepatitis-B in India.
Sarin S.K., Singal A.K., (editors) CBS Publishers and
Distributors, 1996, Table-2. (We have rounded off this
figure in table II)
C) The cost of the vaccine during September 2001 was
Rs. 100/- per child for 3 doses. We have assumed that this
would come down to Rs.50/- per child in a mass-vaccina
tion programme.
D) Row 6 from table II
E) With around a 3-child norm in India, we assume that 30%
of all the pregnant women would be primigravida.
F) Assuming the 3 child-norm, each of these 300 HBsAg
positive mothers would on an average, give birth to two
more children in the subsequent, say five years.
9

The other additional alternative is Intradermal Vaccina
tion of hepatitis-B, as this would reduce the vaccine cost to onefifth, since the dose of vaccine in intradermal route is one fifth,
that of intramuscularly route. Though there are no studies that
have followed up the vaccine for 3 to 5 years, but there is
evidence that this could give adequate protection, though
further studies are required to confirm these results. Majority of
the published studies show that intradermal route, when given
in adequate dose, is as effective as intramuscularly route and
that acceptability is not a problem, if it is much cheaper then
it is more likely to be widely used. 8
Summary and conclusion

Of the adults who are infected with the virus, almost 95%
will recover most with no symptoms at all and all with life long
immunity to the virus. Fewer than 5% will live essentially
“symptom - free”, with declining but continues infectiousness.
About one fourth of this 5% will face life threatening liver
complications decades later.9
So it may b? concluded that hepatitis-B virus infection is
not a priority issue in India, as Indians have a lifetime risk of
less than 0.1% of dying due to consequences of hepatitis-B
infection. Today in the Indian situation there is no need to
eradicate hepatitis-B infection, but rather should aim at reduc
ing HBeAg pool. This is because the HBeAg positive, persons
are the ones which have much higher risk of developing serious
liver disease and are the most infectious to others. Persistent
presence of HBeAg in the hepatitis-B virus carrier is often
associated with Chronic Active Hepatitis.5
Even if the Universal Vaccination of infants is done it will
not eradicate the hepatitis-B virus infection in the near future,
because it will take forty years to stop the vertical transmission.
So after forty years of Universal Immunisation all the ‘below
forty’ (i.e. childbearing population) would have been protected
and hence vertical and also horizontal transmission would be
10

stopped, in this age group. To stop the horizontal transmission
amongst the above forty year-age group, it would take another
twenty-five years of Universal Immunisation (as life expectancy
in India is at present sixty-five years, though this figure is likely
to increase, with further increase in the demand of the vaccine.)
As mentioned earlier vaccine cost for Universal Vaccina
tion of only the newborn would be Rupees 1250 million
(around 26 million US$), at Rupees 50 (around 1.04 US$) per
child, for three doses. If all the children up to the age of two
years (as covered by under EPI), the vaccine cost would be
Rupees 3750 million (around 78 million US$) in the first year
of the programme. Compare this with the cost involved in
Highly Selective Vaccination, which would be around Rupees
287.5 million (around 6 million US$) in the first year and
Rupees 101 million (around 2 million US$) per year there
after.6
Though 152 countries have already introduced the hepatitis-B vaccine and 39 more countries will introduce it, the work
of Phadke & Kale indicates that there is a need to have critical
fresh look at this programme.
References

Noronha Fredrick, Vajpayee to launch hepatitis B immuni
sation programme. Indo-Asian News Service. Health india. 8 June 2002. Available from URL http://
www.symonds.net/pipermail/health-india/20Q2-June/
000028.html as on date 3/1/2003.
2) Indian Academy of Pediatrics. IAP Immunization Time
Table. Available from URL http://www.iapindia.org/
timetable.cfm as on date 3/1/2003.
3) EHM News Bureau -Mumbai, Cehat Urges Centre to
abandon Hep-B universal immunisation. Available from
URL http://www.expresshealthcaremgmt.com/20021Q31/
hospi3.shtml as on date 14/1/2003.
4) Hardon Anita, Vaccination Policy and the public/private

1)

3

11

5)

6)

7)

8)

9)

mix. Health Action International, Public-Private Partnership
Addressing Public Health Needs or Corporate agendas?
Report on the HAI Europe/BUKO Pharma-Kampagne Semi
nar. 3rd November 2000. http://haiweb.org/campaign/PPI/
seminar200011 .html#item5 as on date 14/1/2003.
World Health Organisation. President Clinton Helps TB
patients. Action brings attention to India; Success in Treaty
TB, World TB Day, Press Release WHO/20. 24,h March
2000. Available from URL http://www.who.int/inf-pr-2000/
en/pr2000-20.html as on date 3/1/2003.
Phadke Ananth & Kale Ashok, Some Critical Issues In The
Epidemiology Of hepatitis-B In India. Indian Journal Of
Gastroenterology, 2000, Volume 19, Supplementary 3,
December, C76-CT1.
Phadke Ananth & Kale Ashok, Selective versus Universal
hepatitis-B vaccination in India, Paediatrics Today, Volume
41, July 2002, pages 199-207.
Phadke Ananth & Kale Ashok, The case for Intradermal
Route Hepatitis-B vaccination. Available from URL http://
www.cehat.org/publications/pa31a74.html as on date 3/1/
2003.
Dunbar Bonnie, Hepatitis B vaccine. Available from URL
http://www.ias.org.nz/ as on date 14/1/2003.

TO WHOM IS THE VACCINE HEAPTITIS B INDICATED

1. To newborn if mother is hepatitis B positive.
2. To individuals who come in contact with blood and
blood products like:> Pathologists and hematologists,
> Surgeons and dentists,
> Persons working in blood bank,
> Individuals needing repeated blood transfusions,
> Medical students,
> Others with such similar exposure to blood.
12

VACCINATION POLICY AND THE PUBLIC-PRIVATE MIX

Public-Private 'Partnerships’

Addressing Public Health Needs or Corporate Agendas?
Report on the HAI Europe/BUKO Pharma Kampagne Seminar 3 November 2000
HAI Europe (http://haiweb.org/campaign/PPI/seminar200011.doc)
by Anita Harden, Medical Anthropology Unit,
University of Amsterdam
Global vaccine efforts led by UN agencies have slowly
given way to more donor-appealing initiatives led by private
foundations. This shift in public health policy is already affect
ing how money is being spent on vaccines. Greater involve
ment by the research-based industry and private charities has
promoted new, more hi-tech medicines against more diseases.
At the same time, up to 25% of children in many developing
countries still receive no vaccinations. In her presentation,
Anita Harden, traces how donor-driven projects have started
to weaken the role played by long-standing public bodies,
national governments and local industry. She also raises
concerns about how today's vaccine campaigns leave little
room for voices from the South and consumers.__________
Vaccination programmes are critically important for public
health. They are also extremely appealing to donors. When one
considers the reason why, the various aspects of vaccines make
the answer clear: By supporting such initiatives one can change
the world, eradicate a disease, make war against viruses and
sign your name on the cure.
In the past, donors supported vaccine programmes for a
number of reasons, including:
• prevention is better than cure
• vaccines are a cost-effective intervention
• contributing to the eradication of disease
• delivering a "magic bullet" cure
13

• the ease of delivery, and
• no compliance problems.
Progress on immunisation over time :

In 1974, WHO expanded its public health programme
called the Expanded Immunization Program (EPI). In 1978 the
importance of vaccines was included in the declaration released
on the Alma Ata Conference. A few years later, in 1984, the
Child Survived Taskforce was created, this was an early public
private partnership. The taskforce made an effort to increase
vaccinations through the Universal Coverage of Immunization
(UCI) campaign. UNICEF declared the reaching of UCI, i.e.
80% coverage of the world's children, in 1990. Following this
achievement, the 1990's ushered in an era of donor fatigue and
decreasing vaccination coverage rates in many developing
countries.
In the 1990's, three new vaccine campaigns were intro
duced. Firstly, there was a move to eradicate polio backed by
huge private funding (US$400 million was donated). This
private money skewed regular public services as EPI's regularly
scheduled national immunisation days were interrupted by new
polio vaccine drives. The second campaign involved the intro
duction of user fees in the Vaccine Independent Initiative
sponsored by UNICEF. With this change in policy, UNICEF
announced its belief that some countries should start paying for
their own vaccines. The third campaign was the 'magic bullet'
approach which promoted new and improved vaccines fi
nanced by private foundations in the so-called "Childhood
Vaccination Initiative (CVI). The CVI was created in 1997 to
solve the sustainability problem faced by many vaccine initia
tives. Global industry and public monies worked together
within its programme. The emphasis was placed on develop
ment and products instead of health systems. A year later, the
CVI was damaged by donor tensions and concerns about the
weakening of the UN system. Commercial interests started to
14

dominate CVI. The programme itself received criticism for
focusing on technical solutions.
Industry's interest in vaccines: magic bullets

Today vaccination policies seem to have shifted towards
public-private 'partnerships' and away from equity. The Director
General of the WHO has come out strongly in favour of public
private ventures to treat infectious diseases. Health has become
an economic asset and is no longer primarily seen as a
basic human right. In vaccination programmes the focus now

appears to be creating markets for new vaccines Achieving
equity in access to a limited number of essential vaccines, the
objective of the EPI does not seem to be the primary objective
any more. The notion of market failure and the lack of new
vaccines are attractive ideas for the pharmaceutical industry as
it can play a leading role in 'supporting' the development of
new vaccines.
Industry is keen to develop new vaccines, although only an
estimated 74% of the world's children are covered by current
vaccine programmes1. The population already reached by
vaccination programmes is a huge potential market for new
vaccines and there is more profit in it than in trying to reach the
remaining 30%-40% that currently receives no vaccines. (The
74% figure hides the fact that some countries still have only 40%
coverage.) Pharmaceutical companies want to expand the number
of vaccines included in the EPI. Currently, six generic antigens
are used in it. Sixty percent of the vaccines are produced locally
so an inexpensive generic alternative is available and used. Now
companies and donors are looking for new magic bullets - new
vaccines - that will prevent more diseases. Such an approach is
much more attractive to donors than working to reach the
children still not receiving the basic mix of vaccines.
New vaccine campaigns

Since the beginning of 2000, there have been three new
approaches to address vaccines:
15

The Global Alliance for Vaccines and Immunisations
(GAVI, largely supported by the Bill & Melinda Gates Founda
tion)
The Children's Vaccine Programme (CVR also funded by
the Gates Foundation)
UNICEF's Global Fund for Kids Vaccines (GFKV)
Today vaccination policies seem to have shifted towards
public-private 'partnerships' and away from equity.
These initiatives have overlapping goals. The Gates Foun
dation has donated hundreds of millions of dollars towards the
first two funds for a five-year period. (Interestingly, this support
will be facilitated by the NGO PATH, which coincidentally
happens to be based in Seattle, near the headquarters of Gates'
company, Microsoft.) Unlike earlier vaccine campaigns, these
initiatives spend little time discussing sustainability. Instead
there is a great deal of talk about the need to create new
systems and new vaccines. Critics have raised concerns that
these private initiatives reduce local capacity to produce vac
cines. The fact that GAVI and the other programmes will work
with newly developed vaccines generated by multinational
firms could cause people to believe that locally produced
vaccines have lower quality. It is also important to note that in
initial disbursements of GAVI only 10% goes towards health
systems support. Ninety percent goes towards new vaccines
such as hepatitis B. This may change in the future, but it is
indicative of the emphasis of support to vaccination programmes.
GAVI is an interesting case study to analyse. One can see
where its financial support comes from, but who runs its Board?
At present, its Board comprises some of the most influential
international actors involved in public health today. The current
members include four renewable members2.
• The Bill and Melinda Gates Foundation
• UNICEF
• The World Bank Group
• WHO
16

In addition, it has eleven rotating members which include
various stakeholders:
• Three Northern (OECD) governments (Canada, The Neth
erlands, Norway)
• Two developing country governments (Bhutan, Mali)
• One OECD industry (Aventis Pasteur)
• One developing country industry (Center for Genetic
Engineering and Biotechnology (CIGB))
• One foundation (The Rockefeller Foundation)
• One NGO (PATH /Bill & Melinda Gates Children's Vac
cine Programme)
• One research institute (US National Institutes of Health
(NIH))
• One technical health institute (US Centers for Disease
Control)
Such a large initiative involves benefits and risks. GAVI's
advantages include the increased resources brought to the
vaccine issue and its cost-effectiveness. Some of the initiative's
negative consequences include the reinforcement of donor
dependence, a skewing of health programmes, a large empha
sis on creating markets, the weakening of UNICEF's indepen
dence, a lack of sustainability for traditional vaccines suppliers
and technical transfer, greatly reduced transparency, and limited
involvement by developing countries and consumers. One has
to wonder what will happen to this initiative after its five years
of funding has been used.
There is a great need for more consumer voices to be
heard on this issue. Vaccination policy has changed rapidly
during the past few years and consumer input has been lacking.
We must start asking critical questions about such public-private
interactions to ascertain the long-term consequences for public
health. In such a high-profile area as vaccines, participants
including donors, governments, and industry have a clear
17

vested interest. Consumer voices need to make sure that the
public health interest is represented as well.
[1] GAVI: Global Immunization Challenges: One in four chil
dren is excluded, taken from GAVI website 23/3/01, http:/
/ w w w . vaccinealliance.org/reference/
globalimmchallenges.html.
[2] GAVI Board members as of 23/3/01.

UNSAFE INJECTION & HEPATITIS B

It is estimated that children and adults who are ill or
hospitalised, including those infected with HIV, are often ex
posed 10-100 times to injections. An average of 95% of all
injections are curative, but the majority of which were judged
to be unnecessary. At least 50% of injections were unsafe in 14
of 19 countries (representing five developing world regions) for
which data were available. Five studies attributed 20-80% of all
new hepatitis B infections to unsafe injections, while three
implicated unsafe injections as a major mode of transmission of
hepatitis C. In conclusion, unsafe injections occur rou
tinely in most developing world regions, implying a
significant potential for the transmission of any blood
borne diseases. Unsafe injections currently account for
a significant proportion of all new hepatitis B and C
infections. This situation needs to be addressed immediately,

as a political and policy issue, with responsibilities clearly
defined at the global, country and community levels.1
12 billion intramuscular injections are administered world
wide each year, and that about 90% of these are given for
curative indications. The risk of transmission from needle injury
is about 30% for hepatitis B virus (HBV) and about 3% for
hepatitis C virus (HCV), he said. “The incidence of viral
hepatitis in a given population is a good indicator of the
effectiveness of hospital infection control and injection
18

safety practices in that setting,” Margolis said. “A signifi
cant proportion of cases of viral hepatitis is iatrogenic.”

(iatrogenic means a disease introduced by the doctor).
Epidemiological studies have shown that the risk of
hepatitis B in adults is significantly associated with a history of
injections received in hospitals, dental offices, and clinics and
other outpatient settings. In some parts of the world, it is
said, 50% of cases of hepatitis B infection in adults are
directly related to a history of receiving intramuscular
injections while only about 15% of cases are attributed
to sexual transmission. In children in developing coun
tries, a history of injection is a predominant risk factor
for both hepatitis B and hepatitis C infection. 2

“Roughly 12 billion injections are given each year glo
bally,” said Dr. Keith M. Sabin, an epidemiologist with the
division of HIV/AIDS prevention of the Centres for Disease
Control and Prevention. “We estimate that 75 percent of these
12 billion injections are not necessary,” he added, quoting the
World Health Organisation (WHO) figures. ”So, 9 billion unnec
essary injections are being administered globally at a rough cost
of 50 cents a shot,” Sabin said. “Some $4.5 billion is being
wasted annually on these unnecessary injections.” 3
Injections - a dangerous engine of disease

- Unsafe injection practices are a powerful engine to trans
mit blood borne pathogens, including hepatitis B virus
(HBV), hepatitis C virus (HCV) and human immunodefi
ciency virus (HIV). Because infection with these viruses
initially presents no symptoms, it is a silent epidemic.
However, the consequences of this silent epidemic are
increasingly recognized.
Hepatitis B virus

- HBV is highly infectious and causes the heaviest burden
of disease: unsafe injections account for 33% of new
HBV infections in developing and transitional countries
for a total of 21.7 million people infected each year.
19

Hepatitis C virus

- Unsafe injections are the most common cause of HCV
infection in developing and transitional countries, causing
two million new infections each year and accounting for
42% of cases.
Human immunodeficiency virus

- Globally nearly 2% of all new HIV infections are caused
by unsafe injections with a total of 96000 people infected
annually. In South Asia up to 9% of new cases may be
caused in this way. Such proportions can no longer be
ignored.
Fear of HIV is a powerful motivation to engage patients
and healthcare workers in safer injection practices. 4

Samisen L, Kane A, Lloyd J, Zaffran M, Kane M. Unsafe
injections in the developing world and transmission of
blood borne pathogens: a review. Bulletin World Health
Organ. Geneva, Switzerland 1999;77(10):789-800.
2) David S. MacDougall. International Association of Physi
cians in AIDS Care.
Third International
Conference on Thera
pies for Viral Hepati
tis. Monday, Decem
ber 13, 1999, Maui,
Hawaii.
http://
www.iapac.org/conferencesZictvh91213.html.
3) The Times of India On
Line. Saturday 7 April
2001.
4) Unsafe injection prac
tices - a plague of
many health care sys
tems. WHO.

1)

20

MEDICINES NOT TO INJECT

In general it is better never to inject the following :
1. Vitamins : Rarely are injected vitamins any
better than vitamins taken by mouth. Injections are
more expensive and more dangerous. Vitamins taken
by mouth as well as injections, cost less and are not
dangerous. Do not inject vitamins! It is better
to swallow them - preferable in the form of
nutritious foods.
2. Liver extract, vitamin B12 and iron injec
tions (such as Imferon). Injecting these can cause abscesses
or dangerous reactions. Ferrous sulphate pills will do more
good for most anaemia.
3. Calcium, injected into a vein is extremely dangerous, if not
given very slowly.
4. Penicillin. Nearly all infections that require penicillin can
be effectively treated with penicillin taken by mouth. Use
injectable penicillin only for dangerous infections.
5. Chloramphenicol or Tetracycline. These medicines do
as much or more good when taken by mouth.
Intravenous (I.V.) solutions. These medicines be used
only for severe dehydration and given only well trained per
sons. When not given correctly they can cause dangerous
infections or death.

If you want vitamins, buy eggs
or other nutritious foods
instead of pills or injections

NO

YES
21

Misleading promotion

Misleading advertisements have flooded the market and
only deceived the consumer to undergo hepatitis B vaccination.
A certain degree of fear has been instilled in the public mind
regarding how important it is for one to get vaccinated or else
die of cance of liver. The companies seem to have achieved a
great deal of success in inducing fear among the general public.
DAF-K has collected some such misleading advertisements.
Here are some of them. DAF-K has written to the drug
companies and to the Karnataka State Drug Controller,
Bangalore. If it does not get a postive reply from the concerned
company, then it plans to seek justice in the court of law
Some examples of such advertisements :

KILLS
more
Beonle
<
n a aay man
AIDS kills in a year.

Henalilts B Is preventable.
Consult your Doctor,

This advertisement by the lead
ing multinational company SKF (now
known as Glaxo Smith Kline or GSK) is
promoting that hepatitis B kills more
people in a day than AIDS in a year.
This is totally misleading and unscien
tific

Another misleading advertisement
by the same company. At the out set it
is unethical to show pictures of chubby
children for such a advertisement. In
When acquired fa childhood
tend to s^f ia-35 coke^umck like fact such pictures capture the imagina
cinhcsis and liver cancer
tion of parents and almost give them
the feeling that there own children may
’ ■): i...
get effected. The use of children for
promoting a drug is considered to be
It is preventable. unethical as standards set by certain
Consult your Doctor. groups campaigning for consumers in
Europe.

Hepatitis IS

22

Hepatttls-B

The 2nd largest
cause of cancer

This is another misleading pro
motion by the drug company
Wockhardt. This company has not re
plied to DAF-K’s letter dated 7th Feb
ruary, 2004.

Letter from Healthskeptism

6th February 2004
Gopal,
Thank you for contacting us!
The advertisement uses an emotive picture that exaggerates
the effect of hepatitis B on the liver compared to what happens for
many people.
The promotional claim is ambiguous. I can think of 10 pos
sible meanings. (Meanings 1) and 3) below depend on the fact that
people sometimes get HIV positive status without signs and
symptoms confused with AIDS.)
The promotional claim could be taken to mean that:
1) more people die within a day of being infected by hepatitis B
than within a year of being infected with HIV.
2) more people die within a day of being infected by hepatitis B
than within a year of developing AIDS.
3) the proportion of people with hepatitis B infection who die is
higher than the proportion of people with HIV who die so that
if 1,000 people had hepatitis B and 1,000 had HIV then the
number with hepatitis B who die each day would be more than
those with HIV who die each year.
23

the proportion of people with hepatitis B infection who die is
higher than the proportion of people with AIDS who die so that
if 1,000 people had hepatitis B and 1,000 had AIDS then the
number with hepatitis B who die each day would be more than
those with AIDS who die each year.
5) the absolute number of people who die each day from hepatitis
B each day is higher than the absolute number who die from
AIDS each year.
These claims could be taken as referring to India only or to the
world as a whole so that doubles the list of 5 above to make 10
possible meanings.
It would be good to ask GSK which meaning or meanings did
they intend and what if there evidence to support those meanings. If
there are any meanings that they did not intend do they have any
evidence from pre-testing the advertisement to show that people
would not interpret the advertisement in that way?
I hope that is understandable and helpful.
Dr Peter R. Mansfield,

4)

Healthy Skepticism,
34 Methodist Street,
Willunga SA 5172 Australia.
www.healthyskepticism.org
peter(a)healthyskepticism.orq
Ph/Fax +61 8 8557 1040

24

A LETTER TO HEALTH MINISTER FROM DAF-K

57, Tejaswinagar,
Dharwad 580 002
0836-2461554
drdabade@sancharnet.in

DRUG ACTION FORUM-KARNATAKA
1 January 2004
To,
Smt Sushma Swaraj,
Union Minister for Health & Family Welfare,
Ministry of Health & Family Welfare,
Government of India,
Maulana Azad Road,
New Delhi 110 011
Drug Action Forum-Karnataka is a committed group of citizens
voluntarily involved in bringing awareness among consumer regard
ing Rational Drugs Promotion and Policy.
We learn from the media reports that Government of India is
planning to implement hepatitis B vaccination as a part of its
Universal Vaccination Programme in a phased manner in all districts
of India. We express our grave concern on this issue because of the
following reasons:1. Lack of resources:- To vaccinate all newborn with hepatitis B
vaccine and to implement which would cost Rupees 1250 million
annually for the hepatitis-B vaccine alone, at the rate of Rupees
50 per new born for the 25 million annual births in India. If this
is compared with the budget in the year 2000-2001 of Rupees
1250 million allotted by the Government of India for its National
Tuberculosis Programme and Rupees 1050 million for Malaria
control. Tuberculosis & Malaria are obviously major killers in
India.
It is necessary to address these questions in a developing
country like India, where financial resources is always a constraint.
Secondly, in any case, modern health care management should
consider cost efficacy and effectiveness of any healthcare
intervention paid through public money.
25

2.

Absence of epidemiological basis:- The quoted study, by

medical bodies has been that of S.PThyagaran et al, which puts
the carrier state in India at 4.7%. This is not acceptable, as it
suffers from errors as per Phadke Anant & Kale Ashok. Actually
the epidemiological HBsAg carrier rate works out to be 1.42%.
Based on low carrier rate alone, it is clear that the Universal
Strategy is invalid in India.
Therefore we would like to suggest:-

That Government of India take up the Selective Vaccination
Strategy, in which the pregnant women be screened for HBsAg
and vaccinate such newborn only if mother is positive. It has
been observed that the cost efficacy of this Selective Vaccination
Strategy, (around Rupees 5227), is much greater, than Universal
Vaccination Strategy, (around Rupees 9260) for protection from
HBeAg (hepatitis B e antigen). Secondly, to cover all the
pregnant women and their newborn in a year, the total annual
cost of the programme for Universal and Selective vaccination
for a cohort of 10,000 would be Rupees 5,00,000 and Rupees
1,15,000 respectively.
A detailed write up on the issue titled “Hepatitis B
vaccination in India - a controversy” has been enclosed for your
kind reference and perusal.
2. That the Government should regulate the promotional material
of the vaccine manufacturers, which has been misleading the
common man. We enclose one such advertisement from a
vaccine manufacturer and we believe that there are several such.
Only effective regulation on the part of the Government can stop
this.
We hope that you will look into this matter urgently as it is an
important public health issue and if you need more information we
would be happy to provide you the same.
Yours sincerely,

1.

(Dr Gopal Dabade)
Attachments :
1) Hepatitis B vaccination in India - a controversy.
2) Misleading advertisement by drug company SKF; about hepatitis
B vaccine.
26

FIRST LETTER TO THE DRUG COMPANY ABOUT MISLEADING
ADVERTISEMENT FROM DAF-K

57, Tejaswinagar,
Dharwad 580 002
0836-2461554
drdabade@sancharnet.in

DRUG ACTION FORUM-KARNATAKA
29th December 2003
To,
Smith Kline Beecham Pharmaceuticals,
Devanhalli road,
Off Old Chennai Road,
Post Box Number 2,
Bangalore 560049.
Drug Action Forum-Karnataka is a concerned and committed
group of citizens voluntarily involved in trying to bring awareness to
the consumer regarding Rational Drugs promotion and policy.
I am here with enclosing advertisements by your company for
the vaccine hepatitis B. These advertisements are totally misleading
and are an unscientific way of promoting this vaccine. It is unfortu
nate that such advertisements often lead to gross misuse of a drugs
(vaccine in this case) for unnecessary indications.
Drug Action Forum-Karnataka appreciates that hepatitis B vac
cine is a useful vaccine for public health problems, as long as it is used
properly. But your company has attempted to create a wrong impres
sion that hepatitis B is greater public health problem than HIV/AIDS.
It is well know that HIV/AIDS is an important public health problem
and your company attempts to belittle it because you have a vaccine
for hepatitis B.
We urge you to withdraw the advertisements immedi
ately and seek an public apology (by advertising in popular
dailies). We hope to hear from you within a fortnight, if not we will
be compelled to take the issue to concerned authorities.
Hoping to hear from you soon.
Yours sincerely,

(Dr Gopal Dabade)
Copy to : State Drug Controller, Palace Road, Bangalore 560001.
27

REMINDER LETTER FROM DAF-K TO DRUG COMPANY

57, Tejaswinagar,
Dharwad 580 002
0836-2461554
drdabade@sancharnet.in
DRUG ACTION FORUM-KARNATAKA
13th January, 2004
By Regd. Post with Acklodgement due

To,
Smith Kline Beecham Pharmaceuticals,
Devanhalli road,
Off Old Chennai Road,
Post Box Number 2,
Bangalore 560049.
Dear Sir I Madame,
Drug Action Forum - Karnataka is a collective action group in
raising awareness among the general public on rational use of
medicines and vaccines.
We had written earlier to you in our letter dated 29th December
2003 regarding a misleading promotional material from your com
pany addressed to the lay person about vaccine hepatitis-B. In this
advertisement you had claimed that hepatitis-B kills more people in
a day than HIV/AIDS in a year. We had suggested that you should
withdraw the advertisement and seek an public apology for advertis
ing in such a manner.
It is unfortunate matter that you have not bothered even to
reply to our letter dated 28th December 2003
*.
This letter dated 11th
January 2004 is a final warning to you and if we do not get a suitable
reply from you within a fortnight, then we will be compelled to take
the issue to court to seek justice on behalf of the consumers. I hope
wiser council will prevail upon you and that you will act soon.

Hoping to hear from you soon.
Yours sincerely

(Dr Gopal Dabade)
Copy to : State Drug Controller, Palace Road, Bangalore 560001
28

REPLY FROM KARNATAKA DRUG CONTROLLER

GOVERNMENT OF KARNATAKA
(DRUGS CONTROL DEPARTMENT)

Office of the Drugs Controller,
for the State of Karnataka,
Palace Road, Bangalore.
Date : 19th Jan, 2004.
To M/s. Smith Kline Beecham Pharmaceuticals,
Devanhalli Road,
Post Box No.2,
Bangalore 560 049

DCD/23/DMR/2003-04

Sir,
Sub : Drugs & Magic Remedies (Objectionable
advertisement) Act, 1954 and Rules
thereunder.
Ref : Letter dated 15 Dec’ 2003 of Drug
Action Forum, Karnataka.

With reference to the above, please find herein enclosed
a copy of advertisement and letter sent by the Drug Action
Forum, Karnataka.
You are directed to submit your comments.
Yours faithfully,

Drugs Controller
Copy to Dr. Gopal Dabade, Drug Action Forum, Karnataka, 57,
Tejaswinagar, Dharwad 580 002 for information.
29

REPLY EROM DRUG COMPANY
jjr GlaxoSmithKline
GlaxoSmithKline

BY COURIER

Pharmaceuticals Limited

30th January 2004
Regd. Office: Dr. Annie Besant Road,
Drug Action Forum
Worli,
57, Tejaswinagar
Mumbai 400030.
Tel: 022-2495 9595
Dharwad 580 002 Karnataka.
Fax: 022-2495 9494
Dear Sir,
We refer to your letter dated 13th January 2004 received by us
in Mumbai on 28th January 2004 possibly because the same is ad
dressed to SmithKline Beecham Pharmaceuticals India Limited [SBPIL]
at the Bangalore factory address. You may recall that SBPIL merged
with Glaxo India Limited in the year 2001 and is now known as
GlaxoSmithKline Pharmaceuticals Limited [GSK].
It is stated in the said letter that you had previously addressed a
letter to us on 28th December 2003 regarding 'misleading' promotional
material from our Company addressed to lay persons about the vac
cine Hepatitis B. We would like to state that we have not received your
letter of 28th December 2003 nor have we received from you the 'mis
leading' promotional material / advertisement referred to by you in your
letter under reply. Without being able to refer to the material in respect
of which the allegation is made, it is difficult for us to comment in any
detail on the same.
Despite the lack of the material referred to, we have investigated
the matter and would like to state that no such promotional material/
advertisement as referred by you has been released by SBPIL or GSK
during the past five years at least. Unfortunately, we have not been
able to confirm whether any such promotional material was issued more
than five years ago, since there have been many changes in the erst
while SBPIL following the merger. It is possible that the promotional
material that is being referred to is very old, at least more than 5 years.
However, to allow us to comment more in detail, we would request you
to forward to us a sample of the said promotional material/advertisement or inform us where the same can be seen so that we can take up
the matter at the earliest.

30

As a responsible Company ethically promoting its products, we
do not make any claim that is not factually correct. In the circumstances,
we reiterate once again that GSK has made no such claim as men
tioned by you in the aforesaid letter and in the event the promotional
material referred to by you is in fact issued by our predecessor Com
pany, we will certainly take steps to withdraw the same if they are still in
existence.
Yours faithfully,
GlaxoSmithKline Pharmaceuticals Limited
(Mrs. S. Patel)
Senior General Manager
Legal & Secretarial
cc: State Drug Controller, Palace Road, Bangalore 560 001.

AND DAF-K’S REPLY

DRUG ACTION FORUM-KARNATAKA
57, Tejaswinagar,
Dharwad 580 002
0836-2461554
drdabade@sancharnet.in
4th February, 2004

To,
Mrs S K Patel
Senior General Manager
Legal & Secretarial
GlaxoSmithKline Pharmaceuticals Limited
Regd. Office: Dr Annie Besant Road, Worli
Mumbai 400 025.
Dear Mrs Patel,
Thanks for your letter dated 30th January 2004, which was
received on 2nd February 2004.
31

Drug Action Forum-Karnataka had earlier written to your
company in the address that were mentioned in your web pages. It
is only now through your letter we learn about this contact address.
So from hence forth all correspondence of Drug Action ForumKarnataka will be addressed to the same.
Apart from our letter the Karnataka State Drug Controller in
letter dated 19lh January 2004 number DCD/23/DMR/2003-04 has
mentioned about Drug Action Forum-Karnataka’s complaint and
written to your company to respond to. the same. We fail to
understand as to how you have not received all these letters.
None of your advertisements mention the date on which it was
released. So it is just impossible to know when your company
released the grossly misleading advertisement for promoting hepatitis
B vaccine. So we from Drug Action Forum-Karnataka suggest that
YOUR COMPANY SHOULD MENTION DATE OF RELEASE ON
ALL ITS ADVERTISENMTS ATLEAST IN FUTURE, so that consum
ers would know when it was released.
As per your request I am enclosing the copy of the advertise
ments. We not only want you to withdraw these advertisements but
your company should seek public apology (by issuing an adver
tisement in the form of statement) for having advertised the

same.
Yours faithfully

(Dr Gopal Dabade)
cc : State Drug Controller. Palace road, Bangalore 560001
Commissioner Food & Drug Administration, Griha Nirman
Bhavan, Bandra (East), Mumbai 400051

-32

SECOND RESPONSE FROM DRUG COMPANY

GlaxoSmithKline

19th February 2004
Drug Action Forum,
57, Tejaswinagar
Dharwad 580 002
Karnataka.

GlaxoSmithKline
Pharmaceuticals Limited
Regd. Office: Dr. Annie Besant Road,
Worli,
Mumbai 400030.
Tel: 022-2495 9595
Fax: 022-2495 9494

Dear Sirs,

We refer to your letter dated 4th February 2004 forwarding to us
samples of material said to have been released by the former Smith
Kline Beecham Pharmaceuticals India Limited [SBPIL] in connection
with Hepatitis B vaccines.
On examining the material forwarded by you, we would state
that it is incorrect to say that the said material is a "grossly misleading
advertisement", as the contents of the same were factually and medi
cally correct at the time the said material was released. As mentioned in
our earlier letter, the material was probably released by the former SPBIL
many years ago. At that time, the statement made in the material was
factually correct as can be verified by you. We send herewith copies of
material furnished by our Medical Department to substantiate this posi
tion.
It is not apparent from the material sent by you as to where the
same was "advertised" as mentioned in your letter under reply. Since
these materials were released by the former SBPIL several years ago,
we are surprised to note that you have been able to obtain the material
at this time. We request you to let us know as to where the said material
is still available to enable us to take appropriate action.
If the said material is still in circulation, we will make our best
efforts to ensure that the same is withdrawn. We once again assure you
that as a responsible Company, we do not issue any promotional mate
rial that is either false or misleading to our consumers. The question of
releasing any advertisement for a public apology therefore cannot arise
since the said promotional material has not been released by us and

33

does not continue to be in circulation. Moreover, as indicated above,
the said material is factually correct.
We trust that in the circumstances, you will treat the matter as
closed.
Yours faithfully,

GlaxoSmithKline Pharmaceuticals Limited
(Mrs. S. Patel)
Senior General Manager
Legal & Secretarial
Encl:a/a.
cc: State Drug Controller, Palace Road, Bangalore.

REPLY FROM DAF-K

;

57, Tejaswinagar,
Dharwad 580 002
0836-2461554
drdabade@sancharnet.in

i

drug action forum-karnataka
8th March 2004

-■■■-

To,
Mrs S Patel,
Senior General Manager,
Legal & Secretarial,
GlaxoSmithKline Pharmaceuticals Limited,
Regd Office: Dr Annie Besant Road,
Worli,
Mumbai 400 030

Dear Sirs/Madame,
This is in reply to your letter dated 19th February 2004, which
was received on 26th February 2004.
DAF-K’s Scientific Committee has gone through the material
34

that has been sent by you, which your letter mentions is to substan
tiates the position that is in the advertisement Unfortunately in
general the material is unscientific. Most of it is correspondence
between individuals or some of it even being advertisements. One
particular article is from Readers Digest, which you are perhaps
aware is not a scientific journal. The lone scientific article from Indian
Journal of Medical Sciences, volume 57, number 9 of September
2003 by DD Banker, does not mention that hepatitis B kills more
than HIV/AIDS.
It is important to note (as mentioned in your letter dated 19th
February 2004) that now your company find the advertisement
irrelevant as you want to withdraw the same. One wonders how an
advertisement issued by your former company some time ago could
turn out into one not so now. How does your company substantiate
this?
To sum up we do not find any evidence either then or now to
state that the advertisement is correct and we are more convinced
than ever that it is a totally gross misleading and unscientific
promotional material. The material is thus factually incorrect.
To your specific question as to where we found the advertise
ment, we admit that it was found in a hospital in our small home
town. But that is not the complete picture, as 1 am sure your
company would have distributed this grossly misleading advertise
ment throughout the country. So this specific question of yours
should be directed to your Medical Representatives, who would be in
a better position to answer this question.
We are also surprised about the mention in your letter that the
“material was probable released by the former SPBIL many years
ago”. As mentioned in our DAF-K’s previous letter dated 4th February
2004, none of your advertisements mention the date on which it was
released. So it is just impossible to know when your company
released the grossly misleading advertisement for promoting hepatitis
B vaccine. So we from Drug Action Forum-Karnataka suggest that
YOUR COMPANY SHOULD MENTION DATE OF RELEASE ON
ALL ITS ADVERTISENMTS ATLEAST IN FUTURE, so that consum
ers would know when it was released. Given this state of affairs one
would like to know how you derive at the conclusion that it was
released “many years ago”. Though we raised this issue in our letter
35

dated 4,h February 2004, your letter dated 19th February 2004
unfortunately does not address it.
• The claim in your letter that the advertisement was not
released by your company, is truly shocking. It is also not clear from
your letter if you are making this statement because it was released
by your former company SBPIL. But we know that it was issued by
SBP1L, with whom Glaxo has got merged now. And needless to point
out that the present company GSK is fully responsible for all the
previous deeds of SBPIL.
Let us assure you and your company that we are more than
eager to close the matter and give it a decent burial, provided your
company seeks a public apology (by issuing an advertisement in
the form of statement), instead of writing endlessly and meaninglessly that your company is a responsible company, and does not
issue any promotional material that is false.
We trust that this letter clears your doubts and will put sense
in your actions.
Yours faithfully,
(Dr Gopal Dabade)
CC to;- Commissioner Food & Drug Administration, Griha Nirman
Bhavan, Bandra (East), Mumbai 400 051.
- Karnataka State Drug Controller, Palace Road, Bangalore
560 001

36

LETTER FROM DAF-K TO ANOTHER COMPANY
57, Tejaswinagar,
Dharwad 580 002
0836-2461554
;
drdabade@sancharnet.in

DRUG ACTION FORUM-KARNATAKA
7,h February 2004
To,
Wockhardt Limited,
Wockhardt Towers,
Bandra Kurla Complex,
Bandra East,
Mumbai 400 051
Sir/Madame,
Drug Action Forum-Karnataka is a concerned and committed
group of citizens voluntarily involved in trying to bring awareness to
the consumer regarding Rational Drugs promotion and policy.
I am here with enclosing advertisements by your company for
the vaccine hepatitis B. This advertisement is misleading and is an
unscientific way of promoting this vaccine. It is unfortunate that such
advertisements often lead to gross misuse of a drugs (vaccine in this
case) for unnecessary indications.
Drug Action Forum-Karnataka appreciates that hepatitis B
vaccine is a useful vaccine for public health problems, as long as it
is used properly. But your company has attempted to create a wrong
impression about hepatitis B.
We urge you to withdraw the advertisements immedi
ately and seek an public apology (by advertising in popular
dailies). We hope to hear from you within a fortnight, if not we will
be compelled to take the issue to concerned authorities.
Hoping to hear from you soon.
Yours sincerely,

(Dr Gopal Dabade)
CC to : - Commissioner Food & Drug Administration, Griha Nirman
Bhavan, Bandra (East), Mumbai 400051
37

Reproduced from BMJ towards fair use;
Should immunisation against hepatitis B take priority
over provision of clean drinking water?(Statistical Data
Included)
British Medical Journal, July 17, 1999, by Jacob M Puliyel

EDITOR — The World Health Organisation has suggested
universal immunisation with hepatitis B vaccine. [1] The Indian
Academy of Paediatrics has recommended vaccination to paedia
tricians in the country and to the government; paediatricians have
in turn been recommending it. The cheapest Indian vaccine costs
360 rupees (5.21 [pounds sterling]) for three doses.
The India Development Report 1997 suggests that a third of
the population earn less than 57 rupees (83p) per capita per
month. [2] The main causes of death in India are diarrhoea,
respiratory infections, and malnutrition.
Does the World Health Organisation really want universal
immunisation with hepatitis B vaccine to take priority over the
provision of clean drinking water? At what stage of development
of a country’s infrastructure does the prevention of hepatitis B by
vaccination take priority? Is there any study about this? We would
like to be rid of this vermin, but the Pied Piper must be paid.
[1] Hoofnagle JH. Towards universal vaccination against hepatitis
B. N Engl J Med 1989;321:1333.
[2] Parikh KS, ed. India development report 1997. Delhi: Oxford
Press, 1997.

Jacob M Puliyel Head
Department of Paediatrics,
St Stephen’s Hospital,
Delhi 110054, India
puliyel@del6.vsnl.net.in
COPYRIGHT 1999 British Medical Association
COPYRIGHT 2000 Gale Group
38

•

Subject: AFRO-NETS > Hepatitis B vaccination or clean
water ?

•

From: “Jacob M. Puliyel” <puliyel@del6.VSNL.NET.IN>

•

Date: Sat, 13 Feb 1999 11:18:11 -0500 (EST)
Hepatitis B vaccination or clean water ?

Source: e-drug@usa.healthnet.org (modified)
Dear everybody,
The WHO has. suggested universal immunisation with
Hepatitis B vaccine in countries with intermediate prevalence.
The Indian Academy of Paediatrics has dutifully recommended
it to paediatricians in the country and to the government.
Paediatricians have in turn been advising the vaccine. The
vaccine costs about Rupees 750 for 3 doses.

The India Development Report 1997 (Ed. Kirit S Parikh
Oxford Press Delhi 1997) suggests that a third of the population
earn less than Rupees 57 per capita per month. The major
killers here are diarrhoea, respiratory infections and malnutri
tion. Basic amenities like safe drinking water are not available
to the majority.
Does the WHO really want universal immunisation with
Hepatitis B as a priority over the provision of clean drinking
water? At what stage of infrastructure development in a country
does Hepatitis B prevention by vaccination take priority? Is
there any study about this?

How does one compute the cost effectiveness of Hepa
titis B vaccination. One way to compute cost-effectiveness
would be to look at the cost of a liver transplant and the cost
of vaccinating n number of people to prevent the need for that
transplant. If the cost of the latter is less than the former it can
39

be called a cost-effective intervention. But surely the WHO is
aware of the ground realities in developing countries.
Liver transplant is not an option for 99.99% of the
population. For one person dying of liver failure hundreds of
others die of diarrhoea. The interventions (like provision of
clean drinking water) required to save these hundreds would
cost a fraction of what is required for Hepatitis B vaccines.

Is it right that developing countries are advised to spend
their meagre resources on this expensive Programme of univer
sal immunisation with Hepatitis B vaccine?
The WHO is manned by the best brains in the world.
There must be very sound reasons for their recommendation.
I am however curious to know their reasoning. I put my
question to them via e-mail. I have not heard in reply. Probably
the e-mail did not reach the right person.

I wonder if any one can help with the answers.
Jacob M. Puliyel

Head, Department of Paediatrics

St Stephens Hospital

Tis Hazari Delhi 110054, India
mailto:puliyel@ndf.vsnl.net.in
Send mail for the ‘AFRO-NETS’ conference to ‘afronets@usa.healthnet.org’.
Mail administrative requests to ‘majordomo@usa.healthnet.org ’.

For additional assistance, send mail to: ‘owner-afronets@usa.healthnet.org ’.

40

Date :

To,
Union Minister for Health & Family Welfare,

mpomx

xm

mx H

po

> mh

m cn > m

r

Ministry of Health & Family Welfare,
Government of India,

Maulana Azad Road, .

New Delhi 110 011
We learn from the media reports that Government of •
India is planning to implement hepatitis B vaccination as a
part of its Universal Vaccination Programme in a phased
manner in all districts of India. We express our grave
concern on this issue because of the following reasons:-

O Lack of resources:- To vaccinate all newborn with
hepatitis B vaccine and to implement which would
cost Rupees 1250 million annually for the hepatitis-B
vaccine alone, at the rate of Rupees 50 per new born
for the 25 million annual births in India. If this is
compared with the budget in the year 2000-2001 of
Rupees 1250 million allotted by the Government of
India for its National Tuberculosis Programme and
Rupees 1050 million for Malaria control. Tuberculosis
& Malaria are obviously major killers in India.
O Absence of epidemiological basis:- The quoted
study, by medical bodies has been that of
S.PThyagaran et al, which puts the carrier state in
India at 4.7%. This is not acceptable, as it suffers
from errors as per Phadke Anant & Kale Ashok.
Actually the epidemiological HBsAg carrier rate works
out to be 1.42%. Based on low carrier rate alone, it
is clear that the Universal Strategy is invalid in India.
Therefore we would like to suggest:-

> That Government of India take up the Selective
Vaccination Strategy, in which the pregnant women
41

H LU <
Cd

H X
LU

CL

Yours sincerely,

CO LU

We hope that you will look into this matter urgently as
it is an important public health issue and if you need more
information we would be happy to provide you the same.

U LU <

> That the Government should regulate the promotional
material of the vaccine manufacturers, which has
been misleading the common man. We enclose one
such advertisement from a vaccine manufacturer and
we believe that there are several such. Only effective
regulation on the part of the Government can stop
this.

CL

be screened for HBsAg and vaccinate such newborn
only if mother is positive. It has been observed that
the cost efficacy of this Selective Vaccination Strategy,
(around Rupees 5227), is much greater, than Univer
sal Vaccination Strategy, (around Rupees 9260) for
protection from HBeAg (hepatitis B e antigen). Sec
ondly, to cover all the pregnant women and their
newborn in a year, the total annual cost of the
programme for Universal and Selective vaccination for
a cohort of 10,000 would be Rupees 5,00,000 and
Rupees 1,15,000 respectively.

)

Name:Address:-

< CL LU DC

(

T LU DC LU

42

DRUG ACTION FORUM-KARNATAKA

Drug Action Forum - Karnataka is a registered under
Karnataka registration society act and is a group that is
committed to Rational Drug Therapy and Policy.
Drug Action Forum - Karnataka believes that drugs and
vaccines should be made available to people that:> can meet the health requirements,
> are only essential,
> are safe and
> the cost is within the reach of people.
DID YOU KNOW ABOUT
THE DRUG SITUATION IN INDIA?

>
>

>
>

>

>

World Health Organisation’s list of Essential Drugs is
only 372.
But there are around 80,000 formulations in our
country.
Most of them are unessential and some even hazardous.
Common public health problems in India are
Tuberculosis, Malaria, HIV/AIDS. But there is no drug
price regulation on these drugs for these Public Health
problems.
The Drug policy of our country is prepared by Ministry
of Petroleum & Chemicals. The Health Ministry has
nothing to do with it.
The drug price control is by Ministry of Commerce.

OBJECTIVES OF DRUG ACTION FORUM - KARNATAKA

□ Conduct studies on unessential and hazardous drugs in the
Indian market.
□ Bring it to the notice of people through various medias.
□ Publish a bulletin three times a year.
□ Bring out publications on such issues.
□ To explain lay person about Indian Drug policy and Health
policy.
□ Conduct trainings on such issues.
□ To promote the concept of “Health for All”, as stated in the
World Health Organization documents.
□ To support and involve in People Health Movements.
□ To collect information on these issues and disseminate it to
people.
□ Join hands with like minded national and international
organisations.
HOW CAN YOU INVOLVE

0 Actively involve in all Drug Action Forum - Karnataka’s
programmes.
© Purchase, distribute and sell DAF-K’s publications.
0 Talk to your family doctor and local chemist about the
issues involved Rational Drugs.
0 Donate your time, energy and money for the cause of
Rational Drugs campaign.

This booklet “Instead of looking at the issue of health
as a human right it appears to have become an
economic asset and the focus appears to be on
creating markets for new vaccines.”

- Dr. H Sudarshan, President, Karnataka Society for
Rational Drug Use (KSPRUD),
Printed at .Vasant Printing Works Kayannagar, Dharwad.

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