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HEALTHY
FUTURE?
HAS
Health Action International
What is H Al?
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Health Action International
What is HAI?
Health Action International (HAD is an informal network of some 100
consumer, health, development action and other public interest
groups involved in health and pharmaceutical issues in 60 countries
around the world. HAI has active participants in Africa, Asia, Europe,
Latin America, North America and the Pacific region.
HAI believes that all drugs marketed should:
— meet real medical need;
— have therapeutic advantages;
— he acceptably safe;
— offer value for money.
In 1988 the World 1 lealth Organisation (W! IO) calculated that of (he 5
billion people in the world, between 1.3 and 2.5 billion have little or
no regular access to essential drugs. At the same time it is estimated
that as many as 70% of the drugs on the global market arc inessential
and/or undesirable products. HAI supports the Essential Drugs Policy
of the WHO which concentrates on the supply and use of some 250
drugs considered to be the most essential. HAI also believes that the
problem of the enormous numbers of inappropriate and ineffective
products must be tackled.
HAI recognises that access to appropriate medicines is only one
element of health care and that a significant improvement in world
health will be achieved only if the problems of poverty, poor
sanitation, and malnutrition are addressed.
IIAI works through research, education, action campaigns and
dialogue. IIAI publications arc used by health workers, government
drug regulatory agencies and consumers around the world. Research
undertaken by HAI’s participants contributes to belter education
about drugs, and is the foundation for campaigns calling for stronger
regulations on the production, distribution, marketing and use of
drugs. IIAI participants organise and participate in educational and
training seminars in many parts of the world. Special attention is
given to the use of medicines by women and to the development of
user information. IIAI participants are active in monitoring promotion
practices, supporting efforts to establish national drug and health
policies, and encouraging the supply of essential drugs.
In the few years since its foundation the HAI Network has
achieved successes at both international and national level.
HAI’s contribution has been important in areas such as
these:
achieving a gradual improvement in the advertising
standards of many of the major multinational
pharmaceutical companies;
- promoting the essential drugs concept and in winning
both political acceptance and public understanding of
rational drug use;
- establishing an international network which has become
accepted as the group protecting the interests of users
of medicines;
- campaigns leading to regulatory action in various
countries to;
• ban harmful antidiarrhoeals,
• stop the inappropriate use of high dose hormonal
drugs,
• end the use of anabolic steroids as growth stimulants
for children...
-
...many examples can be given but much work remains to
be done.
HAI works at many different levels: with health workers in many
countries; with academics and trainers; with government officials and
national health associations; with regional decision making bodies
such as the Commission of the European Community (EEC); with the
pharmaceutical industry; and at the international level. HAI
participants have taken part in many consultations and discussions
organised by the WHO as part of its Revised Drug Strategy and been
active in mobilising support for the WHO Action Programme on
Essential Drugs and Vaccines.
HAI Europe
HAI participating groups in Europe work in three overlapping areas:
— in partnership with HAI groups in other regions,
campaigning, providing information, facilitating
fundraising, and mobilising support;
— raising awareness in Europe of drug issues in
developing countries;
— promotion of rational drug use in Europe through
research, policy advocacy, public education and debate
with industry.
In 1988 HAI groups in Europe set up the independent 11 Al Europe
Foundation whose principal objective is “to raise and distribute
funds...to support worthwhile initiatives which reflect HAI ideals and
objectives - and in doing so, to extend and strengthen the HAI
network”. The Foundation has a Board of Trustees and an Advisory
Board of health workers, development workers and academics,
including pharmacologists, who give advice and support to the
coordinating team and help guarantee the standard of project work.
IIAI-Europe
J. van Lennepkade 334-T
1053 NJ Amsterdam
The Netherlands
Tel:(31 20) 833684
Fax:(31 20) 855002
HA! Clearinghouse/Action for
Rational Drug Use for Asia (ARI)A)
c/o Consumers International
Box 1045, 10830 Penang, Malaysia
Te!:(60 4) 2291396
Fax: (60 4) 2286506
AIS Latin America
c/o Accirin para la Sahid
Aptdo. 126
Chimbote, Peru
Te!:(51 44) 321601
Fax: (SI 44) 321484
Problem drugs
All HAI Europe’s activities involve drugs. Though aware that
pharmaceuticals are only one element of health care - that in
developing countries, for instance, poverty, malnutrition and lack of
clean water are the major causes of ill-health - network participants
share a common concern that drugs can kill as well as cure, and often
consume a large proportion of a country’s health budget.
HAI’s expertise in dnigs manifests itself in many different forms. But
whether the work involves pressing for the banning of a dangerous
product, researching the effects of particular types of drugs on
women, lobbying government officials, raising funds for overseas
groups, running training workshops or formulating policies, it is
always driven by the principles that all drugs should meet real
medical need, have genuine therapeutic advantage, be acceptably
safe and offer value for money.
The Problem Drugs pack looks at dangerous, ineffective, irrational,
inappropriate and needlessly expensive pharmaceuticals, like
anabolics and growth stimulants, providing a campaign tool which
has been widely distributed and translated. It is being followed up by
a scries of similar campaign reports on such topics as Antibiotics the wrong drugs for diarrhoea, and Peddling placebos, which
analyses ineffective and sometimes harmful cough and cold remedies.
In response to requests from members of the HAI network in
developing countries, a different, more academic report was
produced on' the painkiller dipyrone ("an unacceptably dangerous
drug which we do not need”). Although banned.or severely restricted
in more than 20 countries, it is widely sold elsewhere despite adverse
effects which can include agranulocytosis (elimination of while
blood cells which are an important defence against invading
bacteria), and shock.
The booklet, published by IIAI Europe and BUKO Pharma-Campaign,
a West German coalition of development action groups, reviews
dipyrone, surveys products around the world which contain the
ingredient (its many names make it hard to track down), and presents
a bibliography of articles, reports and reviews of dipyroneinvaluable for countries in which the only information available to
doctors and regulatory authorities comes from the companies.
Getting a specific drug withdrawn from the market can be, literally,
life-saving work. But it can be like playing skittles - even if one goes
down the game goes on. So HAl increasingly tries to counterbalance
the companies' partial promotional material and incentives by getting
its message about rational drug use to consumers, prescribers and the
media. The emphasis is on drug policy rather than particular products.
■: ■.
Impaired mental
menial iiertnesj,"memdly'andi
. ,. v . ...conlUalon.,,^^^
A 1987 Sandoz leaflet from Pakistan
which promotes Hydergine
(co-dergocrine mesylate) as a 'brain
|onjc,
What people say about hai’s Problem Drugs pack
its findings, particularly with '
respect to the developing
countries, are disquieting'
-• Doctor from Zimbabwe.g
. Good technical quality and
' presentation. Easy to read, xr ’
- British Medical Journal, 24 May
1986
'These materials are an
excellent support base to
reflect on a problem which has
been little noticed by most
Third World countries.’
- Journalist from Chile
'the right document in all
aspects' .
— Doctor from Department of
Pharmacology, University of
Khartoum
'very useful and easy to
understand’
- senior lecturer In medical sociology,
New Zealand
’gives us Information which
cannot be obtained from
manufacturers'
- Tanzania Bureau of Standards
'easy to understand, very'
helpful; should be given to all
local health workers because
they aren’t told about the risks
and side effects of all drugs'
- West German doctor
'Good design and the contents
are easy to read. The details
are easily understood.’
- Health educator, Peru
'the information is good, broad
and easy to understand'
' - Clba-Gelgy, Venezuela'Aj,^./..
■
■
■ "■
'■
■; The pack Is being used:
- ' amongmedlcaland
paramedical workers in'1':?':
\ West Germany
A1' '
. - J'as the basis for radiox$ij-:;.
■
programmes in Peru and
Zambia •
TX
- . as the basis for newspaper
or magazine articles in
Bolivia, Chile,-India, PeruT
and Zambia
';;
. - ■ In the preparation of aX'yf’
/
practical guide
■. \'yr A prescribing in Bollvla’^-fefr,
''.' to train primary health Vyc
.„
workers in Brazil,^*:;
Honduras; India,1 Mexico,.
•jyi.'and the Philippines
\
for health education by the’;.
I:,.!.'. National Population
Bureau; Nigeria^r^y^n,’-.
.;.:,T-\^'as the basis for University T.
vyu-y level courses Iri^^^-yr
■. /vy pharmacology In Brazil; Ip?.
pharmacy,1'medicine and
'
dentistry and postgraduate'. .
' 'q'.y pharmacy'and medicine ;
’. .courses in Sudan; In'-’v'X1.;;
'
medical sociology In they
'
..
to help Improve drug
registration In Sudan.y';^;--]’'
Drugs Too Few And Too Many
Cutting a path through what has
been called the "therapeutic jungle"
- the huge number of
pharmaceutical products, the
confusion over nomenclature and
the uncertain status of many of them
- is a key aim of Health Action
International.
One way of doing the job is to
eliminate drugs which are medically
inessential or undesirable. A study
financed by USAID in 1981
concluded that as many as 70 per
cent of the drugs on the world
market fell into these two cateaories.
"It cannot be said that the more
drugs the better; national lists
with thousands of drugs have
no advantage over more
limited lists."
— WHO and UNICEF, But some drugs
are more essential than others. 1986
"I would be willing to bet that
we could get along with about
half the number of
prescriptions that are written
each year."
- Or J. E. Goyan. Dean of the School
of Pharmacy. University of
California. San Francisco and past
Commissioner of the US FDA, 1980
So many countries, and millions of people, are spending vast
amounts of money every year on medicines which, at best, leave the
patient's condition unaltered or. at worst, are hazardous. (A survey in
Sweden showed 10.000-15,000 patients admitted to hospital every
"The flood of new drugs in recent years has provided many dramatic
improvements in therapy, but it has also created a number of problems of
equal magnitude. Not the least of these is the 'therapeutic jungle', the term
used to refer to the combination of the overwhelming number of drugs, the
confusion over nomenclature, and the associated uncertainty of the status
of many of these drugs."
- Goodman & Gilman. The Pharmacological Basis of Therapeutics
year for treatment for drug
side-effects.) Excessive purchases
are encouraged by manufacturers
whose promotional strategies are
determined largely by profit rather
than by health considerations. The
Wall Street Journal reported:
"The very survival of a drug
company in today’s highly
competitive marketplace often
depends as much on a company's
marketing talents as it does on the
quality of its medicine."
Promotion can be aimed at
persuading consumers that certain
useless medicines, such as many
cough mixtures, are good for them.
Or it may take the form of
unfounded claims about the benefits
of a product, such as the promotion
of certain antihistamines or vitamin
products as appetite stimulants. Or
getting doctors, who often rely on
industry sources for drug
information, to change their
prescribing habits.
"Vie often encounter patients
who have sold off their last
valuable assets in order to be
able to purchase prescribed
medications, as is the case for
the young girl whose parents
sold off land in order to be able
to purchase the 14 different
medicines that were prescribed
for the treatment of her bloody
dysentery."
- Dr Michael Bennish, Research
Associate, international Centre for
Diarrhoeal Disease Research,
Bangladesh; 1987
“Companies who peddle drugs
unrelated to real health care
must be exposed and excluded
from the market. Advertising
must be controlled in the
common good. This is
draconian but where health
means money and profit there
is no other better way.”
- Barry Desmond, Minister for Health
and Social Welfare, Ireland, from a
speech given at the opening of the
12th World Conference on Health
Education, Dublin, 1 Sep 1985
In an effort to tackle the problem, which is particularly dangerous in
countries where unbiased drug information is scarce and drug
regulatory authorities are weak or non-existent, the World Health
Organization encourages countries to draw up their own essential
drugs lists.
“The majority of Zairians in Kinshasa, the capital of Zaire, obtain their
medicines from small neighbourhood health clinics and/or pharmacies. A
survey of 25 health clinics and 37 local pharmacies revealed that the
multinational drug companies had a great impact on the quality of treatment
offered by these clinics and pharmacies. Accordingly, these facilities
routinely lacked essential drugs, such as antiparasitics and antibiotics,
while they stocked hazardous and expensive drugs such as
aminopyrone-dipyrone drugs.... It is apparent that the multinational drug
firms exert a major and adverse influence on the quality and cost of health
care in Kinshasa."
- Harold Glucksberg and Jack Singer, “The multinational drug companies in Zaire: Their
adverse effect on cost and availability of essential drugs", International Journal of Health
Services, Vol. 12. No. 3.1982, pp.381-387
The advantages are that:
— a careful selection of drugs can be made based on the
best information and on real needs
— correct dosages are easier to remember, which increases
safety
— wastage is reduced because there is less switching from
one drug to another
— ordering, storage and distribution are all easier to
manage
— it becomes easier to collect reliable data on drug
consumption and on side effects.
Many countries have adopted essential drug lists, often in the face of
fierce opposition from industry, for example in Bangladesh. A
number of countries, including Britain and The Philippines, have
taken steps to reduce the drug jungle, by encouraging generic drugs
instead of their brand-name counterparts. When Norway moved to
reduce the number of pharmaceutical preparations on the market, the
health authorities stated: "The basic aim of a drug policy is to ensure
that effective and safe drugs of good quality are available to meet the
health needs of the country.”
A reduction of products on the market often increases the quality of
health care because it means that people spend their money on better
drugs rather than wasting it on ineffective or inappropriate
medicines. A rational drug policy is of vital importance in countries
where many people have little or no access to druss — it can be a vital
step in making drugs affordable and
available.
"The industry should shoulder
much of the blame for the
Another way of contributing to a
current inappropriate and
more rational use of drugs is to
excessive use of medicines in
ensure that better information about
developing countries. And it
must produce more convincing
products is available - for drug
arguments to support its thesis
regulatory authorities, health
that the [1981] voluntary code
workers, patients and the general
of practice of the International
public. The Bangladesh Expert
Federation of Pharmaceutical
Manufacturers Associations
Committee found that such
(designed to protect
information was the key to being
consumers against unethical
able to dismiss a large number of
drug promotion) is working. It is
encouraging to see that the
ineffective and potentially harmful
industry is showing concern,
products and to concentrate on the
but it must show its critics that
supply of more useful products.
this is more than skin deep.”
It is important that the information
about drugs is independent. The
reliance of health workers on
information provided by the industry
has created major public health
problems, such as the growing
resistance of microbes to antibiotics.
Both prescribers and consumers
have to learn that some illnesses do
not require medication and that
when a drug is required one is often
enough. All too often heavy
marketing techniques have
encouraged consumers and
- Richards, T., editorial, British
Medical Journal, 24 May 1986
“While the boldface ad
advocates 'blind' use of their
product, the fine print
embodies the spirit of
conservative practice. This
classic double message, i.e.,
'use our product without
hesitation’ and 'use our product
only with great caution', is
typical of many drug company
circulars containing prescribing
information.’’
- Marc Lappe. When Antibiotics Fail,
1986
prescribers alike to think that the newer and more complicated a
treatment is the greater the chance of a cure.
General health education is also required - for example, to combat
myths which help perpetuate the “pill for every ill” approach. A
rational drug policy must be part of an integrated approach to the
planning of health care. Even the most rational drug policy will not
solve health problems arising from poverty or lack of sanitation and
clean water.
Policies which foster the rational use of drugs are not against
pharmaceutical companies. As Charles Medawar of Britain’s Social
Audit commented: “We've got to have a flourishing industry. If the
industry were producing drugs which people needed, and if the
industry were promoting them responsibly, I wouldn't for a moment
argue that it shouldn't make money out of that."
European Community exports
West Europe is proud of its record in protecting the public from
dangerous products. If a developing country sells a badly-made toy
which comes apart and injures a child, or exports groundnuts with
traces of mould, up go the howls of protest and the import barriers.
Yet the European Community is still unwilling to keep its side of the
trade bargain by insisting that pharmaceutical companies based in its
member states export to developing countries only medicines good
enough for their own domestic markets.
Approximately one out of every four drugs exported from West
Germany to the Third World, for example, has never been sold in
West Germany itself or have not been marketed there for at least 15
ycais. These exports include 87 pharmaceutical products that have
been withdrawn from the West German market.
Analysis of drugs sold by West German companies in
Third World countries In 1988
Total
1273
rational drugs*
505 (of which 159 are essential drugs)
irrational drugs" 768 (of which 439 are combination drugs)
irrational drugs not sold
in the frg in 1988 300 (of which 87 were withdrawn in the frg
within the last 15 years)
‘drugs suitable for the treatment of particular diseases or symptoms according to
clinical pharmacological standards
“drugs intended for the treatment of particular diseases or symptoms which are
not suitable for (his purpose because of bcncfil/risk considerations according to
clinical pharmacological standaids
This double standard docs not slop there. Some Community
exporters send drugs to developing counit ies which have not even
been considered lor registration because they contain {national
combinations of ingredients — such as chloramphenicol and
streptomycin. Not only is (he indiscriminate use ol antibiotics
breeding resistance among harmful micro-organisms but, when sold
as a treatment for diarrhoea, streptomycin and chloramphenicol tire
medically inappropriate. Even a harmless combination can be
dangerous in a developing country because it may divert a
purchaser’s only available money from a genuinely needed drug or
another form of therapy.
The policy of one standard for the rich world and another for the
poor also applies to drug information. Some products arc marketed in
developing countries with fewer warnings about side-effects than
appear on the accompanying literature in Europe. There arc also
differences in the claims made for efficacy in different parts of the
world. These discrepancies arc potentially hazardous because they
eliminate the possibility of making an accurate assessment of the
risk-benefit balance on which the safely of any drug depends.
HAI is campaigning Io correct these anomalies. Il is also supporting
programmes which help developing countries establish their own
registration and control systems and to set up legislative frameworks
for the import of pharmaceuticals. There is no justification for failing
- Cartoon try Paddy Alton
10 guarantee the honesty and safety of (he Community’s
pharmaceutical exports immediately. But there is additional cause for
swill action: regulations covering standards within the industry after
the introduction of the Community’s “single market” by the end of
1992. have not yet been decided. Whatever is agreed, however, will
have a direct impact on pharmaceutical exports, valued at USS
12,400 million a year, about 30 per cent of the total production of
EEC-based companies. The 11 At campaign aims to sec the
introduction of export regulations which guarantee:
— acceptably safe, efficacious and good quality drugs
— an end to the esport of banned or unlicensed substances
— provision offull and up-to-date information
— public accessibility to specified data on exported drugs.
Important battles have been won. In 1986 a report by Euro MP Mrs
Mary Banotti, called for by the European Parliament, clearly set out
the ease for action. She pointed out that Third World dependence on
drug imports made international standards on drug quality and use
imperative, particularly as many countries had not yet been able to
establish effective and independent systems of control.
t
i
Parliament has called for a strengthening of the European
Commission’s proposals on the issue. The Council of Ministers has
ruled that domestic manufacturing licenses covering quality are
required for exports loo. A crucial committee of the Parliament
adopted most of (he HAI-supported amendments to the Commission’s
proposals.
But final success slipped from IIAI’s grasp when a Parliamentary
vole in favour of the amendments just failed to secure (he necessary
absolute majority in spite of winning very broad support within the
European Parliament.
So (he snuggle for equity continues. National groups affiliated to IIAI
will carry on lobbying their countiy's Euro Ml’s; IIAI representatives
j
;
i
will attend endless meetings of parliamentary committees and talk to
officials, researchers will be encouraged to dig out vital facts on the
extent to which banned products arc exported, information on the
campaign and on specific dings will be exchanged between HAI
Europe and groups in the Third World, the marketing activities of the
pharmaceutical companies will be monitored, the media will be
briefed.
It all takes time and money and effort. But 11 Al is determined to see
that West Europe gives meaning to the rhetoric in favour of a safe
and rational drugs policy - for everyone in (he world, not just for
Europeans.
Drug Donations
“Surely people with no drugs must be thankful for anything they
are given.”
HAI together with the Christian Medical Commission is asking
people to look critically at the common practice of donating
unwanted drugs for use in developing countries.
In many developing countries scarce financial resources and
problems obtaining foreign currency make it difficult to ensure die
supply of imported dings. The WHO estimates that between a quarter
and a half of the world’s population lack access to basic essential
drugs. When confronted with a problem of this size it is not
surprising that some organisations have started to organise the
collection of drugs for donation to the Third World.
The plans are well intenlioned, but in practice drug donations often
cause tremendous problems in the recipient country:
— the drugs are often an ill-assorted collection of small
packages of different drugs directed mainly towards
treatment of diseases common in the west;
— the information on the packets is often in a language not
understood by local pharmacy staff;
— the dosage forms vary as do the expiry dates - in fact not
infrequently the drugs are already expired oh arrival;
— forward planning becomes impossible if the drug supply
depends on unpredictable donations.
Defective products In drug donations to Sudan (1983-87)
Expired
Chloroquine phosphate (8 million tablets)
Piperazine adipate (500,000 tablets)
'Mascom Delux' tablets (haeinatopoiectic, nutritive tonic)*
'Infectomycln Trochensalt’ (amoxycillin dry suspension)*
'Decaris' (levamisole) 100,000 tablets
Aluminum hydroxide suspension (decomposed)
'Flagyl' (metronidazole) tablets
'Reverin’ powder for injection (roliletracycline)
Banned
'Citramon' (contained phenacetin) 378,000 tablets"
'Entero-Vioform' tablets (clioquinol)
'Juvelon S' capsules (vitamin E)
Not registered
'Light Force SR’ tablets (vitamin C, minerals, Pacific kelp)
'Melakelfin' tablets (sulphapyrazine and pyrimethamine)
'Calcium Resonium’ powder (calcium polystyrene sulphonate)
'ProSobee' liquid (milk-free nutritive)
'Pyralgin' tablets (dipyrone)
Liquid (Korean)***
'Complexon III’ powder (EDTA)
‘besides being expired, these products were not registered in Sudan
“label in Russian
‘“this product had its label entirely in Korean, it was also expired
Source: Lancet, 5 Mar 1988, p.539
In short the collected drugs arc often inappropriate to the needs of the
people who receive them, and up to 80% of.such donations have Io
be disposed of on artival. The soiling and safe disposal of large
quantities of unwanted drugs can present pioblcnis which stretch the
lime and resources ol the health centres and hospitals receiving the
donations.
Not all donations ate ill conceived but one of the problems is that
many people simply do not realise the complexity of the issues
involved. HAI and the Christian Medical Commission are trying to
change this. Together they have worked Io develop and promote the
CMC Guidelines for donors and recipients of drugs. If these
Guidelines arc followed (hen drugs will be donated in a limited and
sensible way which ensures that those al the receiving end get useful
and needed drugs of high quality and accompanied by appropriate
information. Organisations at the receiving end of drug donations are
being encouraged Io use the Guidelines as a basis for requesting
drugs.
IIAI-Curope is working Io ensure that the Guidelines are publicised,
discussed and integrated into (he policy of donor agencies in Europe.
It At participating groups in France have taken this up as a major issue
and organised national seminars for those involved ill development
organisations. Similar activities are being organised in other
countries. Slowly people arc beginning to realise that, however good
the intentions tire, indiscriminate drug donations can be just another
form of “dtug dumping.”
The CMC Guidelines are just another expression of the importance of
rational drug policy - what a health facility needs is a regular and
reliable supply of a limited number of appropriate drugs, together
with the information necessary Io use them properly. The concept is
simple but winning acceptance for it is not easy.
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Defective donated drugs being burned. (Photo: World Council of Churches,
Christian Medical Commission)
Women and pharmaceuticals
For Ellen ’1 I loen it started with a letter in a newspaper. The writer
pointed out that while concern was being expressed about the effects
of hormones in cattle-feed, the writer’s mother had been given the
same hormone during pregnancy, in the form of diethylstilbestrol
(DES). Ellen’t I loen discovered that her mother had also taken the
synthetic oestrogen, as had millions of other women around the
world. Not only did the mothers face an increased likelihood of
breast cancer, but their daughters and to a lesser extent their sons
were al risk from a range of effects which included a rare type of
vaginal or cervical cancer, pregnancy problems and testicular
abnormalities.
Ellen ’l 1 loen recalls: “Without planning a campaign in I lolland, we
found we were in the middle of one. Initially, doctors were unwilling
to help. They said ‘It’s not really a problem. You’re the only ones.’
That’s the message a beginning group always gets." There are DES
action groups in several countries whose main aim is to identify and
support people who have been exposed to DES and to create
awareness about the effects of DES exposure. The groups are also all
pressing for a complete ban on “a dangerous, ineffective
pharmaceutical with long-term adverse reactions".
Campaigning has given the groups an expertise in drugs affecting
women’s reproductive system, which forms an important part of (he
work of 11 Al Europe’s Women and Pharmaceutical Campaign. They
are even monitoring the development of new drugs, such as
contraceptive vaccines, because as Ellen't lloen points out, with the
effects of DES still surfacing, “we don’t want the whole cycle to start
again.”
The danger is real, partly because in the contraceptive field
administrative and medical convenience (ends to take precedence
over the needs and wishes of (he users. Governments with a strong
commitment to reducing the pace of population growth, for example,
favour permanent or long-lasting methods of birth control and lend to
play down the seriousness of side-effects.
In any case, several studies have indicated that women lake more
drugs than men and, as the chief health care providers for the family,
buy more. The marketing of many drugs is also targeted at women tranquillisers, for example, which are the subject of a 11AI study
following reports from Asian groups of widespread misuse in
factories, service industries and among teenage girls.
yay.isan
W KUS! IMA BUANA
Illustration from an
information leaflet
about implants
produced by the
Indonesian group,
Yayasan Kusuma
Buana. Illustration
by Yan Mintaraga.
Predictably, initial resistance to (he campaign was based on a fear
that its work was based on a radical feminist rather (han a medical
perspective and that its research, coming from women’s groups, was
bound to be insufficiently thorough. But the campaign has already
proved its ability to pose awkward questions about the hazards of
high-dose Lil’ (oestrogen/ progesterone) drugs leading to their
banning in India; about the link between breast cancer and (he Pill;
about (he effects of long-lasting hormonal contraceptives. This work
reflects the overall 11 Al thrust of increasingly looking at categories of
drugs and the context in which they are used rather than simply
concentrating on problem dings.
The emphasis is on the careful assessment of safely issues and the
vital importance of the provision of unbiased evidence so that
women are enabled to make a rational choice. The work also takes
special account of the environment in which drugs are used, which
leads to questioning of health care systems, the policies of family
planning programmes, and the information and communication
capabilities of health care providers.
A strong and close partnership between groups in developing
countries and those in industrialised countries is at the heart of the
effective campaigns organised by the women and pharmaceuticals
network.
But always the key point is to keep asking questions from a women’s
perspective. As Ellen’t 1 loen can confirm, the failure of scientists
and doctors to take this step in the past has led to the creation of
completely unnecessary women’s illnesses on a vast scale.
ORDER FORM
Please send me the following publications:
No. of
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Publication
Unit Cost
D.F1.
Problem Drugs Pack (A.Chetley)
30.00 *
Information pack on various categories of
problem drugs and special prescribing needs for women,
children and the elderly. Highlights examples of unethical
& double standards in marketing. Special loose-leaf
sections for teaching and campaign work
(HAI 1994)
Problem Drugs (book form) (A.Chetley)
Bound version of above Pack (ZED Books 1995)
40.00
Medicamentos Problema (A.Chetley)
Spanish translation, book version
of Problem Drugs Pack
(AIS 1995)
30.00
Statement of the International Working Group on
Transparency and Accountability in Drug Regulation
Report of international working group on origins,
scope and effects of secrecy in drug regulation
(HAI/Dag Hammarskjold Foundation 1997)
Available in English, French and Spanish
Please state language preference
5.00
International Journal of Risk and Safety in Medicine
50.00
Special Issue featuring papers from international authors
on how secrecy and lack of transparency and accountability
in drug regulation lead to undermining of public health
(IOS Press 1997)
Power,Patents and Pills
Seminar Report on the consequences of GATT/WTO
for public health and access to essential drugs
(HAI 1997)
15.00
Dipyrone: a Drug No One Needs
Critical review of dipyrone incl.bibliography
and list of brand name products containing dipyrone
(HAI-Europe/BUKO 1989)
20.00 *
Total
D.F1.
No. of
copies
Publication
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D.F1.
Total
D.F1.
German and Swiss Drug Supplies to the Third World
(R. Hartog & H. Schulte-Sasse)
A critical analysis of drug exports
(HAI-Europe/BUKO/Dec. de Berne 1990)
30.00
—
A Healthy Business (A. Chetley)
Traces the campaign for a more rational use of drugs
and examines the response of the industry to its critics
(ZED books 1990)
35.00 *
—
The Provision and Use of Drugs
in Developing Countries (A. Harden et al.)
Annotated bibliography of studies on drug use.
Includes a review of policy implications
(University of Amsterdam/HAI 1991)
32,50 *
—
Promoting health or pushing drugs ?
A critical examination of marketing of pharmaceuticals
(HAI-Europe 1992)
15.00 *
—
5.00
Med-Sense
A new HAI product promoting critical attitudes towards
5 boxes cost 20.00
medicines and encouraging the rational use of drugs.
10 boxes cost 25.00
Comes in the form of a pill box. Available in
English, French, Spanish, Dutch; limited numbers
available in Germany, Flemish, Russian, Latvian,
Lithuanian, Polish. Please state language preference . . .
(HAI-Europe 1992)
Primary Health Care and Drugs 30.00 *
Global Action towards rational drug use
A detailed examination of the implementation of
primary health care based on proceedings of an international
conference in Bielefeld, Germany in September 1990
(BUKO/HAI-Europe 1991)
Exposed: Deadly Exports (B. van der Heide)
The story of European Community exports of banned
or withdrawn drugs to the Third World
(WEMOS 1991)
20.00
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copies
Publication
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D.FL
Total
D.Fl.
Power and Dependence (C. Medawar)
37,50
Discusses safety of medicines from a consumer
perspective with special reference to benzodiazepine
tranquillisers
(Social Audit 1992)
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—
Publication
"For Health or Profit ? Medicine, the Pharmaceutical Industry
and the State in New Zealand" by Peter Davis.
Review of pharmaceutical industry influence in prescribing methods
in New Zealand, showing global problems involved in current
treatment methods.
(OUP, 1992)
Cost
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15,=
—
"Drugs Policy in Developing Countries" by Najmi Kanji et al.
Study on implementation of rational drugs policies in developing countries
and future strategies to achieve the WHO’s Essential Drugs concept.
(Zed Books, 1992)
10,=
—
"Secrecy and Medicines in Europe"
Report on the EMEA, transparency in pharmaceutical information for
consumers, and the influence of E.U. registration system.
(National Consumers Council, 1994)
10,=
"From Policy to Practice:
The future of the Bangladesh National Drug Policy" by A. Chetley
Independent assessment of the achievements of the Bangladesh
National Drug Policy after 10 years implementation, with prospects
for future improvements in supply and use of medicines.
(IOCU, 1992)
10,=
—
—
"Health and Disease in Developing Countries" by Kari S. Lankinen et al.
Health issues and specific diseases are investigated from the wider
perspective of development in general, and includes strategies for
international cooperation.
(Macmillan, 1994)
35,=
—
"A Healthy Balance ? Women and Pharmaceuticals"
An international collection of articles on women and drugs covering:
drugs in pregnancy, psychotropics, contraceptive research, quality
of care, STDs and medicalisation of women’s lives.
(Women’s Health Action Foundation, 1995)
25,=
"Deception by Design Pharmaceutical Promotion in the Third World" by Joel Lexchin
Exposes double standards employed by the pharmaceutical industry
in their marketing and promotional practices in developing
versus industrialised countries.
(Consumers International (CI ROAP), 1995)
25,=
—
Video "What is HAVf'''
.
Explains aims^tTachievementsjjftfieHAI network in its global
campai°rjJi5r the rationaprse^f drugs.
In English, French^tnd'Spanish on one tape.
,(XlS Bolivians)
"What do women look for when choosing a contraceptive ?"
Poster on Women and Drug Promotion
Illustrates adverts of unethical promotion of contraceptives;
gives guidelines on good contraceptive provision & usage.
(HAI-Europe, 1995)
Press Kit for HAI pack on Problem Drugs
Set of feature articles on: children & drugs; antidiarrhoeals;
antibiotics; dipyrone; Norplant; tranquillisers.
Includes illustrations of irrational promotional materials,
and extracts of facts, figures, and quotes.
5,=
(5 for 15,=)
5,=
BRIEFING PAPERS (free of charge)
—
"Immunological Contraceptives: designed for populations not people"
(HAI/WHAF, 1994)
Describes research to develop a new type of birth control based on the immune
system and assesses the implications for women’s health and rights.
"Self-regulation or Self-Deception ?" (HAI, 1994)
Commentary on the 1994 revision of the IFPMA Code of Pharmaceutical
Marketing Practices.
—
"Essentials for Health: Ensuring Equitable Access to Drugs" (Panos, 1994)
Briefing document prepared for health delegates to the World Health Assembly on
the vital role of the WHO’s Essential Drugs concept, the role of National Drug
Policies, marketing practices, and rational use of drugs in general.
—
Set of 4 postcards (HAI 1993 and 1994)
Features various aspects of rational drug use.
HAI Information pack (HAI 1996)
Background information on the work of the HAI network, its aims and activities
on current themes of pharmaceutical issues.
"HAI News"
Newsletter featuring international health issues and news from HAI groups worldwide.
Produced 6 times per year by the HAI office in Penang, Malaysia.
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action and other public interest
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HAI-LIGHTS February 1997
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New book announcement
Fragile Economies, Flooded Markets
Networking for Rational Drug Use in Africa
Health Action International announces the publication of its report on the
HAI Eastern Africa training workshop "Promoting Rational Drug Use in
the Community" which was held in Nairobi, Kenya from 14-19 March,
1997.
While pharmaceuticals can play a key role in improving health, their benefits remain largely
unknown to millions of African consumers. Instead, drugs often contribute to serious health
problems on the continent due to misdiagnosis, incorrect self-medication and poor quality of
drugs. Many Africans lack access to the most essential drugs, and scarce resources are often
spent on ineffective and expensive treatments.
Discussing ways to address these problems was the theme of HAI's Eastern Africa Regional
Training Workshop. The six-day meeting brought together consumer advocates and
pharmaceutical experts from Eritrea, Ghana, Kenya, Sierra Leone, Tanzania, Uganda,and
Zambia to determine ways to promote the essential drugs concept and to identify problems
hindering rational drug use. This report summarises the participants' presentations, conclusions
and plans for the future.
The training workshop in Nairobi marks the start of the HAI Africa programme. Further
regional training sessions are scheduled to be held in Southern Africa and in Francophone
Africa during 1998.
Copies of the report on the first of these regional workshops can be obtained from the
HAI-Europe office. Price including postage: NLG 35.00.
Please contact:
HAI-Europe
Jacob van Lennepkade 334-T
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The Netherlands
Tel: +31 20 6833684 Fax: +31 20 6855002 E-mail: hai@hai.antenna.nl
HEALTH ACTION INTERNATIONAL IS AN INFORMAL NETWORK OF OVER 200 CONSUMER, HEALTH, DEVELOPMENT ACTION AND OTHER PUBLIC INTEREST
GROUPS INVOLVED LN HEALTH AND PHARMACEUTICAL ISSUES IN 70 COUNTRIES AROUND THE WORLD, HAI ACTIVELY PROMOTES A MORE RATIONAL USE OF DRUGS
ALL DRUGS MARKETED SHOULD MEET REAL MEDICAL NEEDS, HAVE THERAPEUTIC ADVANTAGES, BE ACCEPTABLY SAFE .AND OFFER VALUE FOR MONEY.
Other coordinating HAI offices:
HAI/ARDA/CI-ROAP, PO Box 1045, 10830 Penang, Malaysia. Tel: (+60) 4 2291396 Fax: (+60) 4 2286506 E-mail: ciroap@pc.jaring.my
AIS Latin America:Oficina de Coordinacion AIS LAC, Aptdo. 41-128, Lima, Peru. Tel./fax: (+51) 1-3461502 E-mail:ais@amauta.rcp.net.pe
HA
7/i\v
w
FOR IMMEDIA TE RELEASE: 25 April 1997
Health Action International
HAI-Europe
HAI Report Examines Impact of Trade Agreements on Consumers’ Access to
Jacob van Lennepkade 334 T
1053 NJ .-Amsterdam Drugs
The Netherlands
tel: +31 (0) 20 683 36 84 In the HAI publication, Power, Patents and Pills released today, a number of consumer
fax:+31 (0) 20 685 50 02 representatives suggest that intellectual property agreements made by the GATT and
E-mail: hai@hai.antenna.nl
World Trade Organization (WTO) may have negative implications for the health of
many consumers and could limit or deny them access to pharmaceuticals, particularly
essential drugs.
This unique report is drawn from presentations made at a one-day seminar held in
Bielefeld, Germany last year. The meeting was a direct response to the resolution passed
at the 49th World Health Assembly in 1996 which called on the World Health
Organization (WHO) to report on the impact of the WTO’s work regarding national
drug policies and essential drugs and to make recommendations for collaboration
between the two organizations.
Power, Patents and Pills highlights some consumer concerns regarding international
trade agreements. The report includes summaries of the following presentations:
An Introduction to GATT and WTO by Dr. Zafar Mirza, Association for Rational
Use of Medication, Pakistan
Trade and Pharmaceutical Policies-A US Perspective by James Love, Center for the
Study of Responsive Law, USA
WTO/GATT and Medicines: WHO’s Perspective by Dr. Colette Kinnon, WHO
The TRIPs Agreement and Pharmaceutical Policies by Adrian Otten, WTO
Heads-TNCs Win, Tails-South Loses or the GATT/WTO/TRIPs Agreement by
Dr. K. Balasubramaniam, HAI Regional Office for Asia and the Pacific
HAI believes that access to essential drugs should be the guiding principle used to assess
the impact of intellectual property rights on pharmaceuticals. HAI calls for alternative
models to patent protection to be put forward and for public discussion on research and
development decisions. The organization believes countries should be able to interpret
intellectual property agreements to give the greatest benefit to their consumers.
HAI has created an international working group on the WTO to ensure that rational
drug policies prevail and that the WTO becomes more transparent. This publication is
part of HAI’s international campaign on GATT/WTO and the implications for essential
drugs policies.
FOR MORE INFORMATION, contact:
Elizabeth Hayes, Publications & Information Officer
Jacob van Lennepkade 334-T
1053 NJ Amsterdam
The Netherlands
tel: (+31-20) 683 3684
fax: (+31-20) 685 5002
-E-mail: HAI@HAI.-ANTENNA.NL--------------------------------------------------------------------
HEALTH ACTION INTERNATIONAL IS AN INTORMAtfNETWORK OF OVER 200 CONSUMER. HEALTH, DEVELOPMENT ACTION .AND OTHER PUBLIC INTEREST
GROUPS INVOLVED LN HEALTH .AND PHARMACEUTICAL ISSUES IN 70 COUNTRIES .AROUND THE WORLD, HAI ACTIVELY PROMOTES A MORE RATIONAL USE OF DRU
ALL DRUGS MARKETED SHOULD MEET REAL MEDICAL NEEDS, HAVE THERAPEUTIC ADVANTAGES, BE ACCEPTABLY SAFE AND OFFER VALUE FOR MONEY.
Other coordinating HAI offices:
HAI/ARDA/CI-ROAP, PO Box 1045, 10830 Penang, Malaysia. Tel: (+60) 4 2291396 Fax: (+60) 4 2286506 E-mail: ciroap@pc.jaring.my
AIS Latin America:Oficina de Coordination MS LAC, Aptdo. 41-128, Lima, Peru. Tcl./fax: (+51) 1-3461502 E-maiLais@amauta.rcp.net.pe
HAILIGHTS
HAI-Europe, February 1997, Vol. 2, No 1
Secrecy in Drug Regulation:
Fighting for the Right to Know
by Ellen't Hoen
How can health professionals and consumers
make responsible decisions about drugs when so
much information about the products they
prescribe and use remains hidden from the
public's view? In this article, Ellen ’t Hoen,
Coordinator ofthe International Society of Drug
Bulletins (ISDB) andformer HAI staffmember,
explains some of the issues at stake and some of
the efforts being made to promote greater
transparency
and accountability
in
drug
regulation.
Each year, new drugs are launched that take their place
with the thousands of drugs already being used by consumers.
A great deal of the information gathered during clinical trials
and the entire research and development process is never
released when a drug is approved. More surprising, many
countries’ national drug regulatory agencies do not explain
why a particular drug is denied approval, suddenly withdrawn
from the market after years of use, or why an application for a
new indication is refused. Even when drugs stay on the
market, much of the data gathered on adverse drug reactions
is also kept out of die public's reach.
Some countries such as the United States and Sweden have
a tradition of “freedom of information” and make a great deal
of drug information available to the public. However, many
other countries invoke secrecy when asked to provide
information on drug regulatory decisions. Sometimes secrecy
is viewed as a way of avoiding possible panic among consumers
who might not understand technical data. At other times it is
an easy answer to the difficult problem of finding the resources
and staff necessary' to handle such information requests. Some
agencies fear the power of commercial interests affected by
their decision-making and, often, there is simply no legal
mandate to reveal such information, even if the agency would
like to be more open. All of these factors contribute to the fact
that a great deal of important scientific data on research, safety
and drug utilisation is kept from researchers and the public.
Health Action International-Europe and the Dag
Hammarskjold Foundation brought together drug policy
experts in late 1996 to explore the problems caused by secrecy'
in drug regulation and to look for ways to increase
transparency, both nationally and internationally. The
meeting’s participants emphasised that national and regional
drug regulatory' agencies must act primarily' to protect the
public interest, regardless of the other commercial and
political interests at stake. They' felt that regulators should also
be accountable for the decisions they make. And while
acknowledging that there are certain situations in which
industrial business secrets should be protected, die
participants felt that this justification is now used in
discriminately and urged commercial secrecy be defined and
limited. The group’s views on the need for greater
(Continued on page 2)
Bn This issue...
[
1
Secrecy in drug regulation:
Fighting for the right to know
4
Drug policy
5
Promotion
7
Rational drug use
8
Campaigns
9
Drug information
10
Upcoming meetings and events
11
Publications
HAI-LIGHTS February 1997
Secrecy in Drug Regulation:
Fighting for the Right to Know
(From page 1)
transparency can be found in die recently' published
document, Statement of the International Working Group
onTransparency and Accountability in Drug Regulation'.
Building the case against secrecy
Secrecy has been an issue on HAl’s agenda since 1991.
During diat year, die UK Committee on the Safety of
Medicines withdrew the drug triazolam (Halcion®) from the
UK market on the basis of evidence it had. However, die
reason behind this decision was not made known to the public
or the medical profession.-' Charles Medawar’s book Poorer and
Dependence. Social Audit on the Safety ofMedicine' broadened the
discussion and brought the issue to the attention of more
European partners. The book which focuses on tranquillizers
argues that levels of drug injury will remain unacceptably high
until decision-makers are made more accountable.
As a next step, the UK’s National Consumer Council
(NCC), Social Audit, The Campaign for Freedom of
Information and others joined forces in an initiative to
promote greater public access to drug regulation information
by sponsoring “The Medicines Information Bill”. The
proposed legislation would have required the Medicines
Control Agency to publish detailed information related to the
suspension of a licence; given the public the right to see all
safety information, the advice of the Committee on the Safety
of Medicines, inspection reports of manufacturing plants and
narrowed the scope of section 118 (the secrecy clause) so that
only genuine manufacturing secrets and sensitive information
about unlaunched products could be withheld.4 While the bill
passed two readings, it was opposed by the government and
pharmaceutical industry' and never came to a vote. The British
manufacturers threatened to boycott die UK drug regulatory'
system if the bill passed.
At the HAI-Europe annual meeting in 1992, participants
adopted a resolution on secrecy in medicines control. The
resolution stated “Secrecy' in medicine regulation is pervasive,
largely unnecessary, and an obstacle to health. Lack of
information limits freedom of choice, reduces scientific
credibility and inhibits constructive participation.”
Groups around Europe also watched in amazement as the
details of a serious Italian corruption scandal unfolded.
Professor Duilio Poggiolini, head of the Italian medicines
division and President of the European Committee for
Proprietary Medicinal Products (CPMP) was tried and found
guilty' of accepting large amounts of money' and gifts from
pharmaceutical companies in exchange for speeding up
registration procedures, allowing favourable price deals and
changing the indications for certain products. Many large
HAI-LIGHTS February 1997
pharmaceutical companies were involved in this corruption
scandal which also raised questions about the absence of
procedures to investigate administrative malpractice at the
European Medicines Evaluation Agency.5
Similar questions were raised in 1993 by the NCC in its
report Balancing Acts, conflict of interest in the regulation of
medicine. It pointed out that the Medicines Control Agency
which approves and removes prescription drugs from the
market is financed by drug companies. In addition, it found
that 14 of the 21 members of the Medicines Commission
(which oversees the work of the agency) had personal financial
links with drug companies.6 A 1994 NCC report focused on
many key’ issues regarding European Union drug regulation
and its lack of openness. The report says “Our conclusions
contain many questions. And until we have access to more
information these questions are likely’ to remain unanswerable
by those whom they' most affect - patients and consumers.”7
Secrecy shows itself in another form when companies
refuse to provide information about drugs to prescribers who
want to ensure safe use. The drug bulletin, Drug Disease
Doctor, described attempts to obtain information about the
excipients of 130 popular oral liquid brand preparations. The
authors wrote to the medical directors of 56 companies. After
a reminder letter was sent 27 (48%) replied of which sixrefused to give the information, six offered other reasons for
not furnishing information (e.g. the product was no longer in
production) and 15 (27%) provided information on thirty'
products. The rest of the companies (52%) did not respond.
The authors commented that “It raises questions about the
quality' of the products used by non-responders. Refusals and
no response was obtained from many’ well known
multinational companies.... It is clear that the message of
‘greater transparency’ is yet to reach the pharmaceutical
companies in developing countries.”8
Secrecy in Europe
Faced with national systems tliat encourage secrecy’, many
people hoped that the newly established European Medicines
Evaluation Agency (EMEA) in London would break the
tradition of secrecy. HAI partners were promised great
improvements in this area once the EMEA opened its doors.
However, while the agency’s doors opened in January’ 1996,
not too much else appears to be open there.
The prediction tliat European regulation would provide
the answer to the demand for greater access to information
prompted the European Drug Bulletins (a sub-group of ISDB)
to test whether this was actually’ true. They learned that
European Public Assessment Reports (EPARs) are available as
retrievable files on the Internet. However, questions about
how the reports arc actually’ put together, the basis for the
decisions and how the scientific committees reach their
conclusions remain secrets. The EME/\ implied that it might
be possible to obtain the full text of clinical trials, the names of
experts, copies of the CPMP expert report, copies of the
minutes regarding the CPMP discussion on the clinical
evaluation of a drug and the reasons for rejecting a new drug
or a new indication application. The EMEA did acknowledge
the important role of drug bulletins and offered to organise a
joint workshop on EPARs and drug information. This is
scheduled to take place during 1997.
benefits of openness and the risks caused by excessive secrecy.
In the few months since its release, the statement on secrecy
prepared in Uppsala has generated a great deal of support and
action. For example, the French drug bulletin La revue
Prescrire has distributed hundreds of copies of the statement to
advocate the need for greater openness at the national and
international level and discussed the issue at its annual
“Golden Pill” award ceremony which highlights innovative
drugs. The statement and articles describing the history of
secrecy and the particular problems it causes in both
developing and developed countries will soon appear in the
InternationalJournal of Risk and Safety in Medicine.
The publication of the EPAR has also brought to light
problems of consistency with patient information leaflets. One
example is the drug toremifene (Fareston®) which was
approved in 1996 for treatment of hormone-dependent
metastatic breast cancer. The patient information leaflet
however says the drug is used for the treatment of “a certain
type of breast tumour in women who have had their
menopause”. This information differs substantially from the
scientific information published in the EPAR. The CPMP,
the EMEA’s scientific committee approved this inaccurate
patient information regarding the indication. Reports in the
pharmaceutical press suggest that the wording resulted from a
dispute between members of the CPMP about whether or not
the word “cancer’ should appear in patient information
leaflets. HAI has asked the EMEA to reverse this decision.
However, the EMEA has refused to do so citing the labelling
directive which says “certain therapeutic indications shall not
be mentioned in the package leaflet, where the dissemination
of such information might have serious disadvantages for the
patient.”1' How the scientific committee came to the
conclusion that failing to mention the correct indication for an
anti-cancer drug can be disadvantageous to a woman with
breast cancer remains a well-kept secret.
Copies of the statement have also been sent by HAI groups
to officials in the Ministries of Health and drug regulator}'
agencies. The Peruvian Ministry of Health has told HAIEuropc that it believes the problems of secrecy need to be
discussed in the context of the medicines law which will soon
be debated in the national Parliament. HAI will advocate the
need for transparency at an upcoming meeting of European
drug authorities at which it has been asked to discuss
transparency and accountability.
Other groups and networks such as INRUD, the
Cochrane Collaboration and MaLAM have circulated the
document. Electronic conferences on essential drugs and
freedom of information have also generated support for the
document’s principles. The statement is now being used as
background material in courses around the world.
For more information about initiatives taking place in
your country or region and to learn more about the
international campaign, contact the HAI-Europe office.
In 1996, the European Parliament adopted a resolution on
industrial policy for the pharmaceutical sector. In it, the
Parliament called for proposals by the Commission to disclose
data from trials carried out in connection with drug
authorisations. The resolution also proposed that
governments and licensing authorities make available
complete summaries of the clinical evidence which causes a
drug to be authorised or withdrawn. The resolution also
insisted that the EMEA take on a wider duty of disclosure and
called on the Commission to ensure that patients’
representatives participated in its board of management and
scientific committees.10
1
Copies of the statement are note available in English, French, Spanish anil
Portuguese. They can be obtainedfree ofchargefrom the HAI-Europe office.
2
"The sudden trithdratnal of Triazolam-reasons and consequences. Drugs and
Therapeutics Bulletin. Vol. 29, .Vo. 23, 11 Nov. 1991.
3
Copies of Charles Medawar's book Paster and Dependence: Social Audit on the
Safely of Medicine can be obtained through the HAI-Europe office. Contact the
office for ordering details.
4
House of Commons, Press release front Giles Radice, "Bill to end unucceptablc
secrecy about safety of medianes", December 7, 1992.
3 't Horn, E. 'Corruptieskeletten in Italiaanse Geneesmiddelenkast', [Corruption
Breaking the grip of secrecy
Today, the number of groups and individuals working for
greater transparency is growing and so are the issues
addressed. HAI partners are looking at other areas of policy
that have an impact on consumers’ health and the
development of rational drug policies but where transparency
and accountability are lacking and consumers have little or no
voice. Examples include the work of the World Trade
Organization, drug pricing, and the harmonisation of drug
regulation.
HAI, ISDB and others are working to make regulators,
consumers, patients and other interested groups aware of the
skeleton in Italian medicine cabinet! Ttjdschrift voor Gezondheid en Politick
{Journal on Health and Politics! 2/94. p. 21
6 National Consumer Council, Balancing Acts, conflict ofinterest in the regulation
ofmedicine, Sept. 1993. London
7 Secrecy and Medicines in Europe. National Consumer Council. 9/94. London.
Ref. PD 32/04/94.
S
Diksbit, R K. and N. Diksbit. "Lick of information about excipients used in
brand products. Drug Disease Doctor, Vol. 9. No. I. I996,pp. 13-14.
9 Article 7.32, Directive 92/27/EEC.
10 European Parliament. Report on the Communication from the Commission to
the Council and the European Parliament on the outlines ofan industrial policy
for thepbarmacetiticalsector in the European Community. A4-l>IO4/96/partA.
o
HAI-LIGHTS February 1997
Drug policy
CALL FOR BETTER DATA
ON CLINICAL TRIAL COSTS
A report assessing data from
more than fifty US governmentsponsored clinical trials and tax
credits from eleven years of orphan
drug development charges that
industry calculations on costs may
be exaggerated or biased. The
article questions the findings of a
paper produced by the former US
Office of Technology Assessment
(OTA) which used industry figures
to estimate the average out-of
pocket expenditures for one drug’s
clinical trials to be USS24.5 million (in 1995). When risk of
failure adjustments were factored in the expected cost per
approved drug totalled USS54.8 million. Using public data on
58 government-funded clinical trials, the Washington-based
Center for Study of Responsive Law, came up with a much
lower figure. It found the average clinical trial costs to be
approximately USS7 million. Risk-adjusted expected costs
were then calculated at USS16.1 million—less than thirtv
percent of the OTA/industry estimates. The study’s author,
James Love, stresses that tax credit data on orphan drug
development shows that companies reported spending only
USS3.2 million on human-use clinical trials per approved
drug. Such a low figure suggests that the government has
played a large role in funding clinical trial work on the sixty
orphan drugs that have been approved during the last five
years. Love believes the difference between his estimates and
those of the OTA report are due to three main factors:
possible unclaimed tax credits by industry, the government’s
central role in funding research on orphan drugs and inflated
cost estimates by industry. The article emphasises that much
of the data needed to determine the actual cost of such drug
development remains outside the public domain and in the
files of pharmaceutical companies. The report calls for greater
disclosure of such financial data so that policy makers can have
a better idea of actual research and development costs. Copies
of die full article can be obtained from the HAI-Europe office
or on the web at http:/Avww.essendal.org/cpt/pharm/market
letter, html. (Marketletter, 13/1/97) •
FRENCH GROWTH HORMONE SCANDAL
Although the French government banned the use of
growth hormone collected from cadavers in 1985, the central
pharmacy' of the Paris Hospital Union kept delivering this
product into 1986.
HAI-UGHTS February 1997
A recent French magazine article revealed that while
hospital pharmacies destroyed their stock after the US and
then France banned the product, the central pharmacy
continued to distribute the product until all of its stock was
gone to avoid financial losses. The ban was imposed when
experts determined that human growth hormone carries the
risk of transmitting Creutzfeldt-Jakob disease (CJD). Today
fifty French children have been diagnosed with the disease—
the world’s largest number. While earlier investigations found
senior health officials guilty of "killing by negligence” after
making errors in using the product in 1984 and 1985, these
new findings may bring a heavier charge of “killing by
poisoning” against the officials due to their disregard of the
ban. {The Lancet, Vol. 349, 18/1/97) O
THE RETURN OF THALIDOMIDE?
After playing a major role in removing thalidomide from
the international market in 1961, the US Food and Drug
Administration (FDA) is now considering its use for a number
of conditions, despite its known teratogenicity'. A recent FDA
committee discussed die drug’s success in treating forms of
leprosy, lupus and some AIDS-related conditions among
other indications. In light of this fact, the agency has called
upon industry to speed up trials on the drug.
At the same time, the FDA is concerned that the drug may
be used by women of childbearing age in whom it has been
shown to cause severe birth defects even when used in small
doses. Committee members have called for informed consent
procedures and legislation that would limit its use. They also
want to require women of childbearing age to use birth control
and undergo pregnancy tests while using die drug. (Scrip, No.
2182, 19/11/96) •
EUROPEAN EXPORT POLICY CRITICISED
Three European NGOs (ReMeD, PIAIED and Wemos)
have published a study describing the current export
legislation now being used in 17 countries. In their study,
“The Drug Trade Between European and Developing
Countries: the Regulatory Systems’ Efficacy, Problems and
Perspectives” they point out problematic loopholes that exist
in current legislation.
The publication encourages the adoption of new measures
to ensure better quality control of drugs exported from
Europe. It also stresses the need for greater transparency
regarding information on poor quality, imported drugs for
health workers in developing countries. The authors argue
scientific evidence that others have submitted to the FDA or
other regulators. This is an important dispute for unpatented
drugs (such as the cancer drug Taxol) many of which were
invented through government-funded research. I he dispute
in Argentina signals the US government’s tietermination to
fight for legal policy before the World Trade Organization
that would require less developed countries to adopt
restrictive policies for the marketing of generic drugs under
the Trade-Related Intellectual Property (TRIPs) agreement.
A copy of the full letter sent by the Center for Study of
Responsible Law is available on the Internet at
http://www.essential.org/cpt/pharm/reg tration.html. •
that importing countries need clear, detailed information
about restrictions and the quality of drugs sent from Europe in
order to make informed decisions regarding drug regulation in
their own country'.
Copies of “Les changes de Medicaments Entrc Pays
Europeens ct Pays en Developpement: efficacite des systemes
de regulation, problemes et perspectives” is available in
French for 50FF plus postage from ReMeD, 35 rue Davie],
75013 Paris, France. Those interested in receiving an Englishlanguage summary should contact the HAI-Europe office. •
US CONSUMERS PUSH FOR LESS
RESTRICTIVE TRADE ON DRUGS
ALBANIA ALLOWS FOREIGN LANGUAGE
LABELLING
In February' 1997, consumer advocates wrote to US
President Clinton asking him to reconsider trade sanctions
against Argentina. The dispute concerns data submitted by
pharmaceutical companies to the US Food and Drug
Administration (FDA) and other regulators, concerning the
efficacy’ and safety of a pharmaceutical product. Argentina
recently enacted legislation which permits Argentinan
regulators to rely upon the evidence that pharmaceutical
companies have submitted to the FDA and other regulators
when determining whether or not a drug can be marketed in
Argentina. The US wants Argentina to wait five years or more
before it will permit generic companies to rely upon the
Albania’s drug regulatory agency has announced that it
will now allow labelling and patient information as well as
registration data to be written in either English or Italian.
Representatives from other regional drug agencies disagreed
with dais decision and urged the Albanian government to insist
upon having all information translated into Albanian.
However, a staff member from the Albanian National Centre
for Drag Control stated that if the country insisted upon this
rule, drug companies would not register their products in
Albania, denying consumers access to needed drugs.
(Scrip, No. 2192,24-27/12/96) ©
Promotion
NEW DIRECTIONS IN DRUG PROMOTION
on a specific illness are sponsored by industry either openly or
with well disguised funds. Such patient groups claim to
represent the consumer’s voice but may actually play an
important role in marketing a drug. Such groups help
companies raise awareness about new drags before they’ are
even launched, they often argue for decreased controls on
licensing and pricing and they provide a “trustworthy'”
endorsement for a product. The Internet is also a new source
of almost unlimited possibilities for promoting drags. Many
companies already’ have their own web site where information
about their products can be easily obtained bv consumers.
To receive a copy’ of the full article, contact the HAI-Europe
office. @
Thwarted by some national or regional restrictions on
direct advertising, pharmaceutical companies have developed
new ways to promote their products. HAI contacts David
Gilbert and Andy Chetley examined the new trends in drag
promotion in the UK (and world-wide) in their article “New
Trends in Drug Promotion”(a more detailed version of the
article will appear in an upcoming issue of HAI News).
Increased industry' involvement in symposia, publications and
continuing education efforts are only' some of the better
known promotional tools now being used by pharmaceutical
companies. However, newer, more subde methods include
“patient education” material often in the form of glossy'
brochures. available to consumers interested in learning more
about a particular health problem and current treatments. The
authors point out that some companies have taken such efforts
a step further and produced “educational” videos on particular
health problems which patients can order to view at home.
Others supply a toll-free number to call to receive more
information about a health condition and treatment options.
In addition, a growing number of patient groups campaigning
GREEK CONSUMERS FIGHT BAD ADVERTISING
A Greek court has nded that diet pills sold bv the Slim
company contained misleading advertising claims. The Greek
Consumer Association (EKPIZO) brought the case against
the firm because the diet pills were advertised as completely
o
HAI-L1GHTS February 1997
GOVERNMENTS BEGIN TACKLING
INTERNET PROMOTION
For the first time, the VS Food and Drug Administration
(FDA) has issued a letter objecting to promotional material
placed on a pharmaceutical company's home page. A letter was
sent to The Liposome Company (TLC) in December 1996 for
claims made on behalf of an amphotericin B lipid complex
injection called Abelcet. The agency charged the company
with using false and/or misleading claims to promote the drug.
The company has answered that it thought the web site would
mostly be used by investors and therefore they did not include
all of the precautionary language put forward by the FDA.
(Scrip. No. 2198, 17/1/97)
In a similar action, the UK Department of Health has
informed the company Quality Health, Inc. that it is
conducting illegal activity and could face prosecution for its
advertising of prescription-only medicines on the Internet.
The company now advertises 14 different drugs to treat such
problems as epilepsy, acne, depression and Alzheimer’s
disease. (.Vetrx Update. European Pharma Law Centre, Ltd.,
No. 55) O
herbal, absolutely safe and available without a prescription.
Examination of the pills found that they contained iodine and
some additives that could leatl to adverse effects in some users.
The company had also claimed that the Greek Pharmaceutical
Organization had approved the pills’ distribution, which was
not true. The court also ruled that tights sold by die firm said
to make feet thinner had no “bio-magnetic effect” and were
simply ordinary tights.
ADVERTISING TO CONSUMERS:
WHO BENEFITS?
The court ordered the company to pay damages because of
the misleading claims. For more information about the case,
contact: EKPIZO, Legal Department, Valtetsiou 43-45, GR10681 Athens, Greece, tel: (+30) 1 330 0673, fax: (+30) 1 330
0591. •
CANADIAN DOCTORS OBJECT TO
SELLING DATA
As more indirect advertising for prescription drugs is made
to consumers, supporters of the trend suggest that consumer
involvement through such advertising will lead to better
health outcomes. Although there is a lack of data on this
question, Joel Lexchin, a HAI member and President of
MaLAM, has made predictions based upon current
advertisements of non-prescription drugs and advertisements
directed at doctors.
The Canadian Medical Association has adopted a set of
principles on prescribing data after learning that this
information was being sold by pharmacists and
pharmaceutical companies for marketing purposes.
Emphasising that most of the physicians were completely
unaware that their prescribing data was being collected and
sold, the association has demanded that doctors give informed
consent for these activities to take place and stated that they
have the right to refuse cooperation in such a scheme. The
principles point out that while doctors often benefit from
receiving feedback about their prescribing habits, this type of
data collection is done strictly for marketing reasons and adds
nothing to the quality' of patient care. The statement of
principles calls for assurances that the collection and sale of
such data in no way invades the privacy of patients. If doctors
choose to take part in this data collection, the association
demands that the doctors have the right to view the
information collected about them, free of charge. (Prescriber
Profile Principles, 4/9/96) •
In his article “Consequences of Direct-to-Consumer
Advertising of Prescription Drugs” Lexchin reveals that a
1993 survey of advertisements for OTC drugs in Canadian
magazines found 51 drug advertisements of which 39%
included major violations of existing advertising guidelines
and 24% contained minor errors. The case for prescribers was
not found to be much better. A 1991 Canadian study looked at
111 different advertisements in 14 professional journals and
found that risks were only mentioned 53% of the time while
benefits were highlighted 91% of the time. Of those that did
mention risk, 94% did so in terms of the absence of side effects
or risk regarding the drug. Lexchin also emphasises that
previous studies have also shown doctors’ prescribing is
negatively affected by advertising. That is, the more they
depend upon commercial sources of information, the more
irrational their prescribing. Surveys from the US, where
dircct-to-consumer advertising is allowed, have shown
consumers often demand a particular drug they have read
about. One study found that 84% of doctors would consider
HAI-LIGHTS February 1997
o
such a patient request for a drug and 16% said they would be
likely to prescribe it based upon the patient’s demand. Based
on studies such as these, Lexchin is not positive about the
consequences of dircct-to-consumer advertising. In
conclusion, he stresses that the need to provide consumers
with adequate information about possible treatments is not
fulfilled through advertising. Objective, clear information is
the key to informing consumers about health choices, not
promotion. Faced with the coming reality of direct consumer
advertising in Canada, Lexchin sees prescribers playing a key
role in providing full information about drugs so that
advertising does not lead to poorer prescribing. Copies of die
complete article can be obtained from Joel Lexchin, 121
Walmer Road, Toronto, Ontario M5R 2X8, Canada, tel: (+1416) 964 7186, fax: (+1-416) 923 9515, e-mail:
joel.lexchin@utoronto.ca. •
Rational Drug Use
PRESCRIBE GIVES "GOLDEN PILL" AWARD
Boehringer Mannheim’s drug Digidot® received praise
from the French drug bulletin La revue Prescrire for providing
a real therapeutic advance in treating life-threatening digitalis
intoxication. During a ceremony attended by more than 150
industry representatives and press, five odier drugs were also
honoured for their contribution to therapy and six companies
were commended for the information they provided to the
bulletin. O
PRACTICAL PHARMACY NEWSLETTER
LAUNCHED
After three years working as a pharmacist in Tanzania,
Georgina Stock realised that many pharmacists in developing
countries lack practical information about drugs. In response,
she has started a newsletter for pharmacy workers who want to
learn more about good drug management. Entitled Practical
Pharmacy for Developing Countries, die newsletter consists of
easy-to-read information on basic aspects of pharmacy work.
It is directed at staff who have received formal training in
pharmacy as well as those who have not. Readers arc also
encouraged to write about problems they have encountered in
their own work experience. The newsletter is supported by
ECHO International Health Senices and has covered such
issues as drug donations, drugs in pregnancy, rational
prescribing, good manufacturing guidelines, problems
regarding
expired
drugs
and
drug
advertising.
Those interested in learning more about the newsletter should
contact:
Georgina
Stock,
Heatherlands,
Lydford,
Okehampton, Devon EX20 4AU, United Kingdom or e-mail:
G.F.Stock@bristol.ac.uk •
HAI plans new activities in Africa
As part of a new project in Africa, HAI has planned a
regional training seminar and workshop in Eastern Africa.
The meeting will be held from 15-19 March 1997 in
Nairobi, Kenya in conjunction with a conference organised
by CISS International (Community Initiative Support
Services). Similar workshops and training sessions are
planned for Southern Africa and Francophone Africa later
this year and in 1998. HAI-Europe members who have
contacts in these areas are encouraged to contact the HAIEurope office to suggest names of possible participants for
the workshops and future activities.
introduction of generic drugs within Africa’s private sector.
The cards carried messages promoting the benefits of generic,
essential drugs for African consumers. The continent's
growing private pharmaceutical sector has raised concerns
about access to essential drugs and generics. The devaluation
of the area’s currency has also hurt availability of essential
drugs. For more information, contact: ReMeD. 35 rue Daviel.
75013 Paris, France. •
FRENCH CONTEST ON GENERICS
Health workers from more than twenty countries took
part in a postcard competition held in Africa by the Paris
based group RcMeD. The contest was aimed at promoting the
HAI-LIGHTS February 1997
14 formulated especiallv for children. The World Health
Organization does not recommend the use of 41 of these drags
and the remaining 20 are of unproven efficacy. After analysing
the visits of 113 children with diarrhoea to pediatricians, it
found that anti-diarrhoeal drags were prescribed to 93
children (83%). Fifty-six children received a prescription for
one drug, 29 for two drags, 7 children received three
prescriptions anti one child received four. A copy of the
French study can be obtained for 70FF from PLMED, 24 quai
de la Loire, 75019 Paris, France. O
ANTI-DIARRHOEALS COMMONLY PRESCRIBED
FOR CHILDREN IN FRANCE
Childhood diarrhoea is a common problem in France that
leads to many medical consultations and hospital stays. In a
study on the use of anti-diarrhoeals by children, the group
PIMED found that many children receive ineffective or
sometime dangerous drugs to treat this condition. French
prescribers can choose between 61 types of anti-diarrhoeals.
Campaigns
DUTCH PROZAC GROUP TAKES ELI LILLY TO
COURT-AND LOSES
rather than entering into an honest debate with them.” At
present, Van Meerendonk has not yet decided if he will appeal
the ruling.
A Dutch court has decided that the pharmaceutical
company Eli Lilly does not have to retract its claim that the
Dutch chapter of the US-based Prozac Survivors Support
Group, Inc. (PSSG) is linked to the Church of Scientology.
HAL groups wanting to receive more information about
the court case and its background are encouraged to contact
Frank van Meerendonk. Prozac Survivors Support Group, tel:
(+31-13) 528 5631. O
This claim was made against the group in a letter the
company circulated to a number of Dutch newspapers last
year. The letter was sent days before the group’s founder,
Frank van Meerendonk, was to testify' as an expert in a murder
case possibly involving the use of Prozac. In it, the company7
complained about the negative publicity7 that Prozac had
received (often from the PSSG) and cast doubts on the
character of the Dutch PSSG by tying it to the Scientologists.
The Scientology7 Church has taken an active role during the
past few y’ears in publicising the dangers that have been related
to the anti-depressant’s use.
PROMOTING EVIDENCE-BASED PRACTICE
The UK-based King’s Fund has started a thrcc-year
programme to explore how the growing amount of research
findings can be used to improve health services for consumers.
The project, entitled “Promoting Action on Clinical
Effectiveness (PACE)’’ will examine issues that need to be
included in the assessment and implementation of research
data. The programme’s work will he carried out in 16 local
projects, two from each of the new regional Health
Authorities in England and will involve medical and nursing
staff. The projects will focus on different health subjects such
as stroke prevention, post-operative pain control and low back
pain, among others. For more information about the
programme or to receive a copy of its quarterly bulletin,
contact: David Gilbert, King’s Fund Development Centre,
11-13 Cavendish Square, London W1M OAN, United
Kingdom, e-mail: d.gilbert@Kehf,org.uk •
Van Meerendonk, who became director of the Dutch
chapter in 1995, sued the company for this action. He has
strongly7 denied that the PSSG works with the Scientology7
Church though he openly admits that, on one occasion, he
discussed die drag with members of the group as part of his
philosophy7 to meet with any and all groups involved with
Prozac. However, he has said “This was when 1 was still
warning the Dutch public in an individual capacity after my
own devastating experience with the drag. This was years
before 1 joined the PSSG." After the court case ended, die
Scientology Church issued a press release confirming Van
Meerendonk’s words.
...AND INFORMED CHOICE
As part of the Promoting Patient Choice initiative, the
King’s Fund is studying the information given to patients with
ten specific clinical areas including sub-fertility, hip
replacement and cholesterol screening and management. I he
purpose of the project called “Materials for Informed ChoiceEvaluation” (MICE) is to collect the available information
given to patients and assess it utilising patient focus groups and
subject specialists. This second group will use a quality7 criteria
checklist Such a review aims to identity the extent and nature
The judge’s ruling stated dial due to die fact that the US
based PSSG had received some indirect support from the
Scientology7 Church when it first started, Eli Lilly could not be
blamed for making the same link with the Dutch group. After
the verdict was announced, Van Meerendonk said “It is more
than amazing that the judge found for Eli Lilly. It has used this
'Scientology7 tactic’ for years. It’s a shame that the company7
prefers to silence victims of its drug through a smear campaign
HAI-UGHTS February 1997
o
prospective trial participants. The Cochrane Collaboration
strongly encourages other health research bodies to include
consumers in their work too. Those interested in learning
more about the Cochrane Collaboration’s consumer network
should contact its coordinator, Hilda Bastian at the Australian
Cochrane Centre, fax: (+61-8)370 3539 or e-mail:
hilda.bastian@flinders.edu.au
(Summarised from “The contribution of consumers and
patients in clinical research" by .Andrew Hcrxheimer. A full
copy of the original text is available from the HAI-Europe
office.) •
of patient information materials that can contribute to shared
clinical decision-making. A report on the project’s findings
will be published in mid-1997. For more information about
the PACE and/or MICE project, contact David Gilbert at the
address given. O
INVOLVING CONSUMERS IN
HEALTH RESEARCH
A'lost clinical research studies answer questions posed by
researchers or their industry sponsors. Where does that leave
consumers who have their own questions and concerns about
health issues? Until recently, consumers had very little say in
determining which questions should be answered by medical
research, rhe Cochrane Collaboration, an international
network that systematically reviews research data on a variety
of health topics, wants to change that. According to the
organisation’s policy, each of its review groups must include
consumer representatives as well as scientific experts. This is
done in an effort to ensure that patients’ perspectives are
included in even' review. Lay members of these teams play a
crucial role in ensuring that research participants understand
a study’s design, their role, any risks or inconveniences
involved, and the expected benefits to them and future
patients. In order to make sure that these points are well
understood, the Collaboration believes that consumers must
be actively involved in preparing the information given to
MEDIA AIDS GERMAN CAMPAIGN
During the past two years, BUKO Pharma-Kampagne has
strongly criticised the German pharmaceutical company Byk
Gulden regarding its promotion for certain drugs. Despite this
action, rite company has refused to respond to the
organisation’s charges—until now. A recent television
programme on the marketing of irrational drugs in developing
countries highlighted the marketing of one of its products
used to treat diabetes in Mexico. The drug contains
phenphormin, an ingredient which was taken off the German
market in 1978 due to its dangerous side effects. Publicity
caused by the programme has led the company to promise to
replace this ingredient in the drug. {Pharma Brief, No. 10.
12/96) ©
Drug Information
rarely you may find you feel dizzy or your mood changes for
no reason.” In comparison, under “psychological changes” the
drug’s data sheet mentions “anxiety, hallucinations and
paranoid reactions." CA also found
consumers had the right to be
confused when confronted with
instructions such as those listed
in the migraine drug Aligralevc’s
“common trigger factors
to avoid where possible.”
These included "Physical
(fatigue/over-exertion/
relaxation); Psychological
(anxicty/depression/excitement/shock/worry); Medical
(the Pill/menstruation).” As one
participant concluded “It’s very
difficult. It says ‘over-exertion’
and ‘relaxation’. I don’t know
which one you should be
avoiding. It’s contrary, isn’t
it? And you can hardly avoid
UK RESEARCH SHOWS RELIABLE CONSUMER
INFORMATION LACKING
Consumers are not receiving the information they need
about medicines, reports the UK’s Consumers’ /Association
(CA). After surveying more than 2,000 consumers, CA
researchers found that a great deal of consumer information is
of poor quality or written in a way that makes it difficult for
users to understand. Technical jargon, unattractive layouts
and confusing text were some of the biggest problems noted in
the ten prescription drug patient leaflets that were also
scrutinised as part of the study. A-ATien experts were asked to
review the leaflets, many reported that they seemed to be
written by the company’s staff without any input or testing by
consumers. CA later discovered that only half of the
pharmaceutical companies do in fact test their information
material on potential users. /Another common complaint was
that important information about adverse effects was missing
as well as information on how to use a drug. When experts
compared the patient leaflets to the data sheets used by
physicians some startling differences were found. For
example, the leaflet for the antimalarial Lariain states “very
o
HAI-LIGHTS February 1997
Since it started in 1992. more than 5,000 people have used
this information senice. Approximately forty percent request
information on possible side effects. More than half of the
callers have noticed an undesirable effect and want to know if
it could be due to their drug therapy. Most of the phone calls
involve medication used for a long period of time. The most
common types of drugs asked about affect die central nen'ous
system, the heart and circulatory system, and women’s and
men’s reproductive health. In discussions, many doctors and
pharmacists in Switzerland have said that patients using drugs
for a long period are well informed about their medication.
The telephone sendee suggests this is not always the case.
menstruation, can you?" Copies of the full article can be
obtained from the I lAI-Europe office. •
NETWORK OF DRUG INFORMATION CENTRES
At a recent meeting promoting the work of drug
information centres, an international network called
INDICES was established. The group plans to set up an
electronic network of individuals and organisations working in
drug infonnation or at drug information centres. Those
interested in participating in this discussion group should send
their e-mail address to: Leesette Turner at e-mail:
hamis@iafrica.com or fax: (+27) 21 451 158, tel: (+27) 21 461
4219. Postal inquiries should be sent to: 26A Mannion Road,
Oranjezicht 8001, South Africa. •
For more information about the SDIC telephone service,
contact Markus Fritz, SDIC/SMI, Postfach 124, CI 1-4007,
Basel, Switzerland, tel: (+41-61)692 5140, fax: (+41-61) 692
8711 and e-mail: 100604.204@compusen'e.com O
HOW TO PROVIDE CONSUMERS
WITH BETTER INFORMATION?
Upcoming Meetings & Events
The increasing role that consumers play in their own
health care plus the fact that many medicines are available
without a prescription has led to a crucial need for
independent drug information for consumers. In their article
“Should drug information be an integral part of health care?”
11A1 members Elina Hemminki and Andrew Herxheimer
examine the underlying problems that keep such information
out of consumers’ reach. Faced with an overwhelming amount
of commercial information and professional interests that
want to keep drug information in the hands of prescribers, the
task is not an easy one. The authors argue that simply
producing more objective infonnation will not solve the
problem either. Flooded with such information, consumers
may soon believe that drug treatment is the only answer to
most medical problems. One possible alternative is to make
drug information a part of health care and to regulate it strictly
just like other types of health care. Copies of the full article can
be obtained from the HAI-Europe office. •
15-19 March
HAI Eastern Africa training session and workshops
Nairobi, Kenya
1-4 April 1997
"International Conference on
Medicines" Chiang Mai, Thailand
Use
of
In September 1997, the University of Amsterdam will
offer an advanced international programme in medical
anthropology entitled the Amsterdam Master's in Medical
Anthropology (AMMA). The programme takes twelve
months to complete and is targeted at social scientists,
physicians and other health professionals who wish to
acquire skills in medical anthropological theories and
research methods. The course is also available on a parttime basis. Modules on gender, chronicity, infectious
disease and psychiatry are also open to applicants who do
not wish to follow the full curriculum. For further
information please write to:
DIALLING FOR ANSWERS
A drug without reliable and complete information is
useless. The telephone service of the Swiss Drug Information
Centre (SDIC/SMI) aims to avoid this problem by providing
consumers with independent drug information. Consumers
can call the SDIC and be connected with a pharmacist who
will immediately answer their questions about a drug. In
complicated cases, the pharmacist calls the patient back with
the needed information. The SDIC collects and reports little
known side effects to the national drug authority’s
pharmacovigilance department. It has become a recognised
partner in this work by the drug authority.
HAI-LIGHTS February 1997
Improving
University of Amsterdam
Faculty of Social Sciences
Medical Anthropology Unit
Attn. Dr. Ria Reis
AMMA Programme Manager
Oudezijds Achterburgwal 185
1012 DK Amsterdam
The Netherlands
Tel: (31) 20 525 2670
Fax: (31) 20 525 3010
E-mail: amma@pscw.uva.nl
e
a
Publications
O Statement of the International Working Group on
Transparency and Accountability in Drug Regulation
(Available in English, French, Spanish and Portuguese)
The statement summarises the main arguments against
secrecy in drug regulation and advocates a regulator}' system
which emphasises public health and which is open to scrutiny.
To order copies, please contact the HAI-Europe office.
O A Guide to NGO Essential Drugs Policies
While many NGOs support WIIO’s essential drugs concept,
few involved in buying or distributing drugs have actually
integrated it into their own practice. This discussion paper
highlights the need for Europe-based NGOs to work with the
essential drugs list when planning their policies on drug
selection and distribution. The Guide describes how to
develop an essential drugs policy, how to use it when dealing
with drug donations and where to obtain further information
about rational drug use. Copies can be obtained from the
HAI-Europe office.
Medicines m Pregnancy, 3rd edition, Australian Drug
Evaluation Committee Commonwealth Department of
I lealth and Family Services
This publication provides important information for health
professionals who must decide how to manage medical
conditions in pregnant patients or women who plan to become
pregnant. Experts agree that pregnant women should be
careful about the use of any drug during their pregnancy and
should only use them if absolutely necessary and no alternative
treatment is possible. To help point out possible risks, the
booklet categorises the known harmful effects that many types
of drugs can have on the developing baby, including birth
defects. It also discusses the crucial period during pregnancy
when certain drugs are particularly dangerous. Free copies are
available from the HAI-Europe office.
• Health Information Centres in Europe: What is their
status? How should they develop
(Eds.) M. Bonati & G. Tognoni.
This is a report of a workshop that brought together various
players involved in the provision of health information. The
participants included regional drug information centre staff
members, drug bulletin editors, academics and consumer
advocates. The papers highlight the current constraints in
providing accurate, independent health information while also
pointing out the various approaches that can be taken to
inform consumers and health professionals. Copies of the
report can be ordered from the Institute Mario Negri, Via
Eritrea 62, 20 157 Milan, Italy, tel: (+39) 2 390 141, fax: (+39)
2 332 000 49 or e-mail: Mother_Child@IRFMN.mnegri.it
• European Drug Index
Health professionals must frequently identify drugs
originating from other countries. This reference guide,
assembled by the European Society of Clinical Pharmacists,
provides a list of drug trade names and their active principles
for products on the market in more than twenty European
countries. Information is also included about dosage forms,
strength, main therapeutic application and country of origin.
Copies can be ordered in book form (USS175) or as a CD
ROM (USS255). For more information, contact: Amsterdam
Medical Press, PO Box 9332, 1800 GH Alkmaar, The
Netherlands, fax: (+31-72) 520 1438
O An IIIfor Every Pill
This brochure developed by HAI for last year’s World Health
Assembly contains a number of recent examples of unethical
and misleading promotion. The flyer can be used to support
campaigns on ethical promotion. Free copies can be obtained
from the HAI-Europe office.
Publication Clearance
HAI-Europe is offering a number of older network
publications at almost no cost to HAI-Europe members.
Copies of the following books can be obtained from the
office for free (plus postage costs). Titles are available only
in English unless noted otherwise. Those interested in
receiving books, should contact the office for more details.
(Only a limited number of copies are available. Books are
not meant for resale.)
Antibiotics: the wrong treat
Peddling placebos
ment for diarrhoea
A. Chetley, 1989
A. Chetley 1987
(English, French and Spanish)
Drugs and world health
C. Medawar/Social Audit,
1984
A Question of control
Women's perspectives on the
development and use of
contraceptive technologies,
Wemos, HAI, 1992
fewer drugs, better therapy
BUKO, 1988
Marketing fertility
Wemos, 1989
(English and Dutch)
Diz- urx.
05505
HAI-LIGHTS February 1997
To subscribe:
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participants in the HAI-Europe network. A subscription to this
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HAI-Lights is produced by the HAI-Europe office
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Design: Bea van der Heijden & Marit van Vliet
HAI-LIGHTS February 1997
©
HAI-LIGHTS
HAl-Europe, July/August 1997, Vol. 2, No 2-3 - Double Issue
The Ties That Bind: Drug Industry Sponsorship
Increased competition for public funds and dwindling budget
allocations have put pressure on a number of European and
North American patients groups and public health institutions,
such as hospitals, to accept pharmaceutical industry support for
their work. What are the implications ofthis trendfor the quali
ty of work provided by these organisations? Will it lead towards
favouring the company which provides sponsorship? While such
funding decisions are not made easily and are sometimes backed
by guidelines regarding the use and acknowledgement of such
funding, many NGOs feel uneasy about such “partnerships”. In
fact, to avoid any possible conflict of interest or loss of indepen
dence, HAI member groups have stated that they will not accept
industry funding for their work. In preparation for a briefing
paper on new trends in drug promotion, HAI Lights now takes
a closer look at this new promotional tool used with increasing
success by industry and its possible consequences for public
health.
ly independent from the pharmaceutical industry and raise
their necessary funding through membership fees and/or
public grants. However, others may receive funding from a
company with the specific goal of promoting a product or
policy. It is often difficult for the public to discover a group’s
link with industry without a lot of investigation. Such spon
sorship may or may not be disclosed at public meetings or in
informational publications.
by Lisa Hayes and Barbara Mintzes
In many European countries, national budgets for health
and social services have been reduced in recentyears as a result
of fiscal restraint policies. As a consequence, many non-profit
health groups have faced cutbacks or total funding cuts. Many
groups which might not have considered industry funding in
the past now feel forced to consider it.
Other groups have relied on industry funding for years.
Yet industry sponsorship takes on many different forms and is
sometimes hard to spot. Most of it can be divided into three
main categories: non-profit groups that accept industry fun
ding, patient and health groups actually created and directed
by industry and health facilities accepting “charitable” gifts
from drug companies.
In This Issue...
1
Cover story: The Ties That Bind
6
Drug policy
8
Promotion
10
Rational drug use
13
Campaigns
Industry sponsorship of patient groups
Patient groups often start out as small-scale, grassroots
organisations created by people with a disease who wish to
reach out to others in the same position in order to share
experiences and to provide emotional support and information.
They frequently act as advocates for better health care and are
typically voluntary organisations. Such patient groups can
provide a valuable channel of understanding and expertise in
obtaining appropriate medical care. Often they are complete
I 14
o
Drug information
16
Upcoming meetings and events
17
Publications
HAI-LIGHTS July/August 1997
Does such sponsorship mean that the information
Industry-controlled organisations
provided to consumers may be altered in order to present
Scrip reported that the US-based advocacy group, The
possible drug treatment options in a positive light? In Canada,
Foundation on Economic Trends accused the pharmaceutical
the Infertility Awareness Association reprinted information
company, Genentech, of using a private charity, the Human
provided by its sponsor, the drug company Serono, in a
Growth Foundation, “to help ‘recruit’ thousands of healthy
newsletter sent out to its members. Information on the
children of short stature for potential treatment with its
fertility drug, elomiphene, included the statement that “The
human growth hormone (HGH) Protropin.” ’ The charity,
occurrence of hot flashes is not a side effect, but rather an
whose Board included employees from Genentech and Lilly
indication that the drug is working.”1 In the UK, a patient
and which received most of its funding from these two
booklet on infertility produced by Women’s Health Concern,
companies, approached city educational officials and offered
an organisation receiving industry funding, also includes
height screening for all children. As a result, tens of thousands
information on elomiphene? The booklet clearly lists hot
were screened. If they were found to fall in the bottom fifth
flushes as a potential side effect among others. However, it
percentile for their age group, their parents received a letter
goes on to reassure women that “Most women do not
advising them to see their doctor. They were told that if the
experience any side effects. If they occur,
short stature resulted from a medical
none are serious but include..."' Such
condition, a treatment was available.
According to the Foundation for
information differs significantly from the
advice of the UK Committee on Safety of
Economic Trends, neither the schools
"Because patient associations
Medicines, included in the British
nor the parents were told about the
are so intent on gathering and
National Formulary (BNF) which states,
financial links between Genentech,
passing on to their members
“The CSM has recommended that
Lilly and the Human Growth
elomiphene should not normally be used
Foundation.
information about drugs under
for longer than 6 cycles (possible
development, they have
increased risk of ovarian cancer in
In Canada, Glaxo began giving a
patients treated for longer than
large amount of funding to the
become useful vehicles for
recommended)”.4
Canadian Migraine Association which
pharmaceutical companies for
had been inactive for years, according
The listed side effects given in the
to the company’s former director of
disseminating information
BNF include visual disturbances and
patient education. Unsurprisingly, the
about new medicines at a
funding was granted as the company
ovarian hyperstimulation, both of which
pre-launch stage."
prepared for the release of its new
require immediate drug withdrawal.
migraine
treatment,
sumatriptan.
However, the Women’s Health Concern
Public meetings on migraine were held
booklet only lists “hot flushes, mild
in the association’s name but were, in
headaches and occasional abdominal
fact, organised by the company as part of a pre-launch,
discomfort most pronounced at mid-cycle” as side effects. The
promotional campaign. When the association began to
booklet’s text also mentions nothing about the increased risk
complain about the company’s heavy-handed involvement,
of multiple births following use of elomiphene. In addition,
Glaxo simply found another needy group, the Canadian
the publication makes no mention of the fact that the
Association of Neuroscience Nurses and started giving them
organisation receives pharmaceutical industry funding.’
funds and held meetings in their name. The company’s global
sales for the drug in 1995 were US $600 million, a generous
In an article appearing in Pharmaceutical Visions, an
reward for such promotional efforts."
industry magazine, Sean Mihno wrote: “Because patient
associations are so intent on gathering and passing on to their
"No strings" gifts
members information about drugs under development, they
A new trend in the UK is the growing use of industry
have become useful vehicles for pharmaceutical companies for
sponsorship when government health budgets are slashed.
disseminating information about new medicines at a pre
The UK Drug and Therapeutics Bulletin held a seminar on the
launch stage.’”'He notes that Merck collaborated with the UK
topic in June and invited three speakers to explain why they
National Osteoporosis Society in the pre-marketing of
had decided to accept industry sponsorship". A main theme
Fosamax (alendronate) and Zeneca worked closely with
brought out in each of the presentations was the lack of
groups focusing on schizophrenia and respiratory diseases,
funding available through the country’s National Health
“on educational projects in preparation for the launch of its
Service (NHS). As a result, doctors and other health
anti-asthma drug Accolate and its schizophrenia treatment
professionals expressed frustration at the fact that their
Seroquel.”
facilities were literally falling down around them due to an
advanced state of disrepair while they had no resources to fix
or improve them. Enter industry. For example, Glaxo
HAI-LIGHTS July/August 1997
o
illustration: Thea Boonstra
giving and personal attention will lead to some sort of
reciprocation.
This translates into action: when a medical representative
comes to a physician’s office, they’ will be seen."
Wellcome donated £1.75 million to King’s College Hospital
in London so it could build a spacious new pharmacy.
Michael Cross, General Manager of Clinical Diagnostic
Services at the hospital denied that the company’s generous
donation had any influence on the staffs prescribing habits. In
another example, SmithKline Beecham rebuilt the pathology
facilities at West Middlesex University Hospital. A group of
pathologists approached the company after the hospital
announced that it would close the facilities due to their poor
physical state. The £3.5 million laboratories have just opened
five miles away from the hospital and will be used for non
urgent pathology work, plus clinical trial research for industry'.
One of the hospital’s pathologists, Dr. Penelope Thorpe,
pointed out that the pathologists working at the hospital will
remain employees of the hospital while the new laboratory's
staff of 150 will be employees of SmithKline Beecham."1
Industry's motivation
According to research on promotional trends done by'
David Gilbert and .Andrew Chedey', there are a number of
reasons why' pharmaceutical companies give funds to patient
groups:1-’
• Patient organisations help companies spread awareness
about new drugs at a pre-launch stage that assists in
preparing the market
• They' act as a direct channel to consumers that bypasses
prescribers
• Such groups provide a more credible endorsement of a
product than could be achieved if the information came
directiy' from the company, and
• These organisations can help industry argue in favour of
fewer controls on drug licencing and pricing.
Do such gifts necessarily undermine the integrity and
credibility of health care institutes and professionals?
Speaking at a similar panel discussion on industry sponsorship
organised in Toronto, Canada by' The National Network on
Environments and Women’s Health in May, Joel Lexchin,
President of the Medical Lobby for Appropriate Marketing
(MaLAM), stressed that companies provide sponsorship in
order to set up a particular atmosphere with health care
professionals. “The message is ‘the pharmaceutical companies
are your friends—y'ou can rely on them—they do all these nice
things for you”, he suggested. As a result, when a more directsell situation appears, there is an expectation that all that gift
Importantly,
information
produced
by
patient
organisations is not subject to the same regulations as that
directly disseminated by a drug company - even when the
group receives pharmaceutical industry’ funding. For example,
a patient group can leg-ally’ recommend an unapproved drug
use or make claims about a product not yet on the market in a
newsletter or brochure while the company may’ not.
o
HAI-LIGHTS July/August 1997
colleagues (members, colleagues in the European
institutions?)
• Will the relationship with industry' negatively’ influence
colleagues in their ability to promote public health?
• Is it likely that industry would use this relationship to
negatively influence colleagues in the promotion of public
health?
While guidelines such as these are commendable, these
criteria have no real value if they' are not critically applied by'
groups. Industry-sponsored organisations might want to
consider having their publications and information services
critically assessed by outside organisations that are
independent of industry’.
.Marc Czarka, director of pharmaceutical affairs for Eli
Lilly in the Benelux stated this year that Lilly funds the
American Psychiatric Association and that it helped create and
sponsors the Belgian League of Depression in cooperation
with other pharmaceutical companies. The reason why?
Czarka said “It’s useful for us because, unlike American law,
European law does not allow us to talk directly to potential
patients. The league does it for us.” ”
The impact on public health
Does such sponsorship actually damage consumers’
health? That, of course, depends on who you ask. Patient
groups that accept sponsorship firmly deny it and emphasise
the opposite: Taking such funds allows them to get on with
their important health work. However, there are many
potential hazards attached to accepting such hinds, not the
least of which is a fundamental conflict of interest between
representing patients’ interests and receiving funding from
companies whose commercial interests are dependent on
those patients.
What the future holds
Drug industry sponsorship is not an issue that will go away'
soon. As national health authorities and funders face budget
squeezes, it is likely to become a more common dilemma. Hie
UK examples described in this piece are one illustration of
how government health authorities arc developing more
complex and far-reaching “partnerships” with industry that
can have an effect on the ways consumers are informed about
health issues and what they are told.
Patient groups, hospitals and health institutes with
financial links to a particular drug company or industry in
general need to look critically at the role they play. They may
unwittingly end up being used for promotional purposes. If
their work aims to spread awareness of a disease so that more
people seek a particular drug treatment, or if they endorse
specific products or present positively biased drug
information, they are involved in drug promotion not
information dissemination. This definition is given by the
WHO Ethical Criteria for the Promotion of Medicinal Drags
which calls promotion: “all informational and persuasive
activities by manufacturers and distributors, the effect of
which is to induce the prescription, supply, purchase and/or
use of medicinal drugs.”1'1
HAI believes that consumers have the right to
receive independent, objective information about
treatment options which allows them to make
informed decisions about their health. Any drug
company sponsorship of a health group or
facility in essence compromises this principle and
is therefore not in the public's interest.
One positive development is the recent trend to provide
objective information for health professionals. Independent
drug bulletins, national committees and hospital boards are
acknowledging the growing need to establish and publicise
treatment guidelines and produce independent drug bulletins
which assess the pros and cons of different drug treatments
and make recommendations. Such publications stake their
credibility on complete financial independence from the
pharmaceutical industry'. However, much of this information
remains out of reach for consumers and consumers continue
to play a minimal role in determining the approach taken or
the priorities for information provision.
The response from NGOs
In the face of tightening budget possibilities and criticism
about industry sponsorship, some European NGOs have
started to develop critical guidelines to help their members
facing the dilemma of industry funding. The Brussels-based
European Public Health Alliance (EPHA), a broad coalition of
health groups, has some members that are dependent upon
industry funding, while others are strongly opposed to it. Ln
late 1995, its members met to discuss the potential conflicts
caused by industry sponsorship. The EPHA adapted the
discussion into general guidelines for members contemplating
whether or not to accept industry funding. Its guidelines
include the following questions for NGOs to ask themselves
before they accept industry sponsorship:1’
The advocacv role played by patient organisations and the
health care services provided by' public health institutions
fulfills an important role that needs to be valued.
To keep patient groups and health facilities independent,
there needs to be national political will and sufficient
resources to support NGOs and health services so that they
• Will the relationship with industry compromise the
organisation’s ability' to promote its aims and objectives
responsibly and sincerely?
• Will the relationship with industry negatively influence
HAI-LIGHTS July/Auqust 1997
o
can carry out their work in an adequate, productive envi
ronment. There is a real danger that industry sponsorship will
slowly erode the objective, informational role now carried out
by NGOs and health care providers. One solution proposed
by Gilbert and Chetley' in their research on promotion is the
creation of an independent fund providing resources to pro
duce high quality consumer information about drugs.1'' This
type of initiative could be paid from a proportion of industry
revenue now earmarked for consumer education.
Another possibility could be for consumer groups to esta
blish “blind trusts” as a way to accept industry' money' without
compromising their independence. Furthermore, patient
groups should feel obliged to list their sources of funding in all
of their publications and at public meetings so that people rea
ding information or taking part in meetings can be aware of
potential conflicts of interest.
References
1.
2.
Personal Communication.
Scammell, G. Infertility. No. 10 in a series, Women's Health
Concern, UK, 1992.
3.
4.
Ibid.
British Medical Association and Royal Pharmaceutical Society
of Great Britain, British National Formulary 33, 3/97, p. 319.
5.
6.
Scammell, G. Infertility, 1992.
Milmo, S. "A matter of patients". Pharmaceutical Visions,
1996, 5:1; 68-72.
7.
8.
"Questions on US growth charity" Scrip 1960, 8/10/94, p. 19.
Nainggolan, L. "Carving a niche in the migraine market" Scrip
Magazine, 6/97, p. 20.
9.
Drug and Therapeutics Bulletin Seminar, "The Challenge of
Industry Sponsorship in the NHS" 11/6/97, London.
10.
Dinsdale, P. "Glaxo Wellcome to work with UK health
authority" Scrip, No. 2243, 24/6/97, p. 5.
If sponsorship is first given in a small amount for a see
mingly’ unrelated project, who will later object when funding
is made available for a campaign or project that more closely
corresponds to the company’s interest? At the Drug and
Therapeutics Bulletin seminar, Dr. Alike Whiteside, Director of
the Alacclesfield Primary' Care Centre explained that when the
centre, located near Alanchester, decided to accept a small
grant from the firm Zeneca, it justified it on the grounds that
no Zeneca products were prescribed at the facility’. A company
spokesman at the seminar said the company had chosen to
help fund part of the centre’s budget because it had a factory
located just outside the town and is die community’s largest
employer. Does it matter that none of the company's drugs is
currently used by the clinic? As Lexchin suggested, doesn’t the
company’s funding of the centre provide a “partnership" fee
ling for the doctors working there that could lead to conflict of
interest?
11.Ford, A. R. "Panel debates thorny issue of pharmaceutical fun
ding", Canadian Women's Health Network Newsletter (to be
published).
12.
Gilbert, D. & A. Chetley. "New trends in drug promotion".
Consumer Policy Review, 6:5, 9-10/97; 165.
13.
Thomson, C. "Woke up this morning feelin' so blue Took an
antidepressant but what'll it do?
The Bulletin, 6/5/1997, p. 25-31.
14.
World Health Organization, Ethical Criteria for Medicinal
Drug Promotion" Geneva, 1988.
15.
Taken from "Commercial sponsorship and NGOs" European
Public Health Alliance, p.4
16.
Gilbert, D. & A. Chetley. "New trends in drug promotion"
p. 165.
In an age when consumers are encouraged to make more
decisions about their own healthcare, too often the quality' of
information available to them is low or highly promotional in
nature. Until consumer education is given greater attention
and concern, individuals will continue to be placed at a disad
vantage when making decisions about their health and treat
ment options. HAI and its members have a crucial role to play
in supporting critical, independent information and pointing
out both obvious and hidden drug promotion.
Lisa Hayes is Publications and Information officer at the HAI-
Europe office. Barbara Mintzes is a former HAI-Europe staff mem
ber. She is now pursuing her PhD in epidemiology’ at the University
of British Columbia in Vancouver, Canada.
o
HAI-LIGHTS July/August 1997
Drug Policy
WHO CALLS FOR EXTENDED ESSENTIAL
DRUGS POLICY
In the 1997 World Health Report, WHO calls for the
extension of the essential drugs policy to industrialised
countries. This position has met with extreme criticism from
the pharmaceutical industry which does not want the concept
applied to the private sector. V\T1O maintains that the most
efficient way to ensure that consumers around the world have
access to essential drugs is through standard treannent
protocols and lists of drugs for different types ol health care.
Such a structure would enable better drug supply, proper staff
training and lay the basis for reimbursement measures. In the
report, WHO emphasises “essential drugs are not for poor
countries only, or for rural areas only. The concept of essential
drugs is just as valid in developed countries, in teaching
hospitals, and in health insurance schemes.”
(Scrip, No. 2233. 20/5/97) •
In response to the criticism, the country’s Auditor-General
has promised to carry out an audit of the agency’s drug
approval process.
(The Globe and Mail, 28/5/97)
CALL TO RESPOND ON EMEA OPENNESS
The European Medicines Evaluation Agency (EAIEA)
recently asked interested groups to respond to proposals
included in its consultation document on transparency and
access to documentation.
HAI and the International Society of Drug Bulletins
(ISDB) both drafted replies to the document which included
suggestions to improve the EMEA’s policy on transparency.
These comments were drawn up in consultation with a
number of their European and international contacts.
confidential
HAI and ISDB both believe that a great deal of
information submitted to the agency is veiled by secrecy.
Often it is withheld from the public according to broad
definitions of confidentiality. A much more specific definition
of commercial confidentiality is needed in order to ensure that
only legitimate trade secrets and confidential personal
information are protected. In their replies, both organisations
also highlighted the need for greater representation by
consumers and public health groups at the EMEA. At present,
only one consumer organisation is recognised by the agency as
opposed to a much greater industry presence. HAI and ISDB
have also pointed out the danger of introducing significant
charges for access to information. The organisations fear that
such action could place important information beyond the
reach of non-profit organisations.
FORMER EMPLOYEES CRITICISE CANADIAN
DRUG REGULATORY PROCESS
Managers working for the Canadian drug regulatory
authority, the Health Protection Branch of Health Canada,
have been accused of dismissing drug reviewers’ concerns
about safety and going ahead to approve drugs anyway,
according to recent articles appearing in the national press.
One example highlighting the problem was a memo written by
the acting head of the veterinary drug department
summarising a promise to a manufacturer to go more easily on
the company for its next drug submission. The memo states,
“I told him 1 would make up for the rough time he’s had with
Revalor-H when we review his next submission.”
One outspoken critic of the agency’s behaviour is Dr.
Michelle Brill-Edwards who resigned from the agency in 1996
because she felt agency managers brushed aside her concerns
about the potentially dangerous side effects of the drug
nifedipine and other calcium-channel blockers. As part of the
Coalition of Canadians for Accountable Government, she
believes that the regulatory agency failed to take safety
concerns into account because of the country’s decision to de
regulate the pharmaceutical sector and the growing emphasis
placed on cost recovery. “It’s becoming more and more
evident that the department considers that the client of Health
Canada is not the Canadian citizen, who has a right to know
about the benefits and risks of a drug. They consider the client
to be the [pharmaceutical ] industry,” she said.
HAI-LIGHTS July/August 1997
The EMEA has now circulated copies of all the comments
received in an interim report. .As only a small number of
responses were sent, the agency has decided to invite further
comments from interested groups. A member of the European
Parliament has called for a workshop on transparency which
will be held later this year. This will include ISDB and HAI
and other interested parties, national regulatory authorities
and the EMEA. For more information about the workshop or
to receive a copy of the consultation replies, contact the HAIEurope office. •
______________
o
WHO'S NAKAJIMA TO STEP DOWN
IMPROVING THE USE OF MEDICINES
Ihe Director General of the World Health Organization,
Dr. Hiroshi Nakajima has announced that he will not run for
re-election when his second term expires next spring. The
names of a number of possible candidates have already begun
to circulate including former Norwegian Prime Minister Gro
Harlem Brundtland and the WHO’s regional director for
Africa, Dr. Ebrahim Sabra. The new Director General will be
elected during the World Health Assembly next May. O
More than 250 researchers, policy makers, consumer
advocates and health managers from 46 countries met in
Chiang Mai, Thailand in April for the “First International
Conference on Improving Use of Medicines”. The meeting
was held to examine various strategies used to improve drug
use in developing countries, to develop policy guidelines and
strategies and to signal future areas for research.
DUTCH DEMAND COST-EFFECTIVENESS
STUDIES
Ihe Dutch National Health Insurance Council
(Ziekenfondsraad), which oversees reimbursement for
medications, has declared that expensive, new drugs should
undergo cost-effectiveness studies funded by drug companies
before they are added to the reimbursement list. Such dings
would be placed on a temporary' list while their manufacturer
carried out the tests. If cost-effectiveness was shown, the drug
would be added to the country’s reimbursement list. Those
not meeting cost-effectiveness standards would be taken off
the list. All drugs eligible for reimbursement would be
reviewed again in two years’ time. The national
pharmaceutical association, Nefarma, has continued to oppose
the government’s idea to carry out cost-effectiveness studies,
arguing that no clear guidelines exist.
(Scrip, No. 2228, 2/5/97) O
UK PHARMACISTS JOIN YELLOW CARD
SCHEME
Starting in April, UK hospital pharmacists have been
encouraged to report any' adverse drug reactions to the
country’s Medicines Control Agency (MCA) on its wellknown “yellow card” form. The agency' decided to extend the
programme to hospital pharmacists in the hope of increasing
the information it receives about adverse drag reactions. At
present, medical doctors, dentists and coroners are expected to
report adverse reactions. The MCA is planning a number of
regional seminars on the reporting system for community
pharmacists as well. These pharmacists have been specifically
targeted to provide information about adverse effects related
to over-the-counter medicines anti herbal products, products
most doctors do not report on.
(Current Problem!: in Phannacavigilance, Vol. 23, 2/97) O
During the conference, participants highlighted the need
to inform and empower consumers who play a crucial role in
improving the way medicines are used. It was stressed that
while many different educational approaches have been taken.
most have not been scientifically' evaluated and documented.
The participants agreed that this should be an area of priority
in the future.
All of the meeting’s presentations and recommendations
will be available shortly through the WHO Action
Programme on Essential Drug’s (DAP) internet home page
(http://www.who.ch/programmes/dap/DAP_Homepage.html )
DEPO PROVERA APPROVED IN CANADA
After being denied approval twice, Upjohn and Pharmacia
finally gained approval for the injectable contraceptive Depo
Provera last April. The reason for the turnabout? Strong,
persistent lobbying by the pharmaceutical companies. Lack of
public information about the planned approval also played a
part. Before earlier decisions, a coalition of women’s health
organisations, groups representing the handicapped, native
women’s groups and mental health associations had raised
concerns in the press about both healdt risks and die potential
for abuse. This time, there was no public outcry because the
first public announcement about this application came from
Health Canada after the drag had already been approved.
During earlier submissions, objections had been raised
regarding the drug’s.possible link with an increased incidence
of breast and cervical cancer in women under the age of 35.
Those concerns have not disappeared. In fact, the director of
Canada’s drug regulatory agency, the Health Protection
Branch of Health Canada, confirmed that the approval was
not based on any new scientific evidence. Instead, the
committee asked to reconsider the drag application concluded
that Depo Provera carried a risk for breast cancer that was
“similar to other hormonal contraceptives” and, therefore,
safe enough.
Many women’s health groups in Canada have reacted with
dismay at the approval. The drag was already available in
HAI-LIGHTS July/August 1997
Canada for use in treating endometriosis and some types of
cancer. Many physicians had already begun prescribing the
drug for use as a contraceptive following its approval in the US
in 1992.
(DES Action Canada newsletter, no. 50, 1997) •
fastest for reviewing and approving drugs. Solid peer review is
another victim of the system’s growing need for quick
regulator}- review. While industry has gained increased access
to EU regulators under the new system, the authors point out
that little is being done to promote greater transparency and
accountability towards EU consumers. Consumers, health
professionals and science all stand to lose from the extensive
secrecy that protects much of die data submitted to EU
regulators. To receive a full copy of the report contact the
HAI-Europe office. •
EU HARMONISATION: AT WHAT PRICE?
How does the harmonisation of European drug licensing
procedures affect the assessment of drug safety and
effectiveness by regulators? This is the subject of a new study
by two UK researchers, John Abraham and Graham Lewis.
After conducting 77 interviews with national drug regulators,
representatives of the pharmaceutical industry and staff from
consumer organisations, the authors have highlighted the
impact that such harmonised measures may have upon safety
and efficacy standards. They have also examined the policies’
consequences for industry and consumers, transparency and
the future of national drug regulator}’ systems. This report,
“The Interaction Between European Drug Regulation and
Toxicological Science” warns that increasing pressure to meet
drug agency budget shortfalls through industry fees has forced
national authorities to try and position themselves as the
END OF EU CONSUMER ADVERTISING BAN?
During the Fourth Conference of Medicines Agencies
held in The Hague, The Netherlands in April, a
representative of the European Commission’s pharmaceutical
unit, industry directorate (DG III) stated that the EU plans to
reconsider its earlier decision to ban direct-to-consumer
advertising of prescription-only drugs. While no additional
information was given during the meeting, it was suggested
that it might not be justified to continue to forbid such
advertising.
(Scrip, No. 2233, 20/5/97) •
Promotion
BELGIAN RESEARCHERS EXAMINE PROZAC’S
POSSIBLE SIDE EFFECTS
Researchers distributed questionnaires to five hundred
general practitioners and more than three hundred group
practices throughout Belgium asking if the doctors had
personally seen side effects possibly linked to the drug
fluoxetine (Prozac). Of the eighty doctors who responded,
eleven reported severe side effects not mentioned in the
package insert used in Belgium, The Netherlands and
Luxembourg. The adverse effects mentioned included
patients’ feeling that they were going to die, severe
nervousness, aggressive behaviour and suicide attempts. When
Eli Lilly, the drug’s manufacturer, heard about the study, it
sent letters to all Belgian doctors questioning the study’s
scientific basis and suggesting that it would take legal action
against the researchers. As a result, the researchers believe
many doctors chose not to take part in the survey. Later, the
company did take the head researcher, Dr. Robert
Bourguignon, to court citing the damage that could be caused
by the study’s negative effect. However, the court ruled in
favour of the researcher. According to published reports, the
HAI-LIGHTS July/August 1997
legal manoeuvres of the company have not caused Dr.
Bourguignon to back away from the controversy. As he stated
in one interview, “Lilly systematically threatens people who
express a negative opinion about Prozac. This increases the
suspicion that something is not right.”
Questions about the drug’s possible side effects have also
been raised in the Belgian federal Parliament by MP Thierry
Detienne of the Ecologists Party. During a debate held on the
issue, Detienne called on the Belgian government to report any
new possible adverse effects linked to the drug’s use in the
country. He also requested that the information accompanying
the drug explicitly mentions its potential risks, especially in the
light of the large number of prescriptions written for it. AVliile
acknowledging that prescribers were free to give tlic product to
the patients they thought needed it, Detienne said die
government had a responsibility to ensure that all of the
information on fluoxetine sent to doctors mentioned its
potential side effects. He found it unacceptable that
promotional materials sent to doctors exaggerate the drug’s
safety and efficacy.
(Correspondence received)
o
Canadian women between the ages of 45-54 and 15% between
the ages of 55-64 had professional occupations in 1990.
THE REAL MESSAGE BEHIND
HT ADVERTISEMENTS
Mintzes’ study found that the hormone therapy
advertisements promoted an image of well-being, exemplified
by youthful, healthy, white professionals. As such therapies do
not stop or reverse aging or bring about happiness, she warned
that this provides a misleading image of the benefits of
hormones. T he lack of indications or warnings within the
advertising text was also a common cause of concern. The
prescribing text is usually published on another page or in
small, hard-to-rcad typeface. The Canadian advertisements
had all been pre-screened by the Pharmaceutical Advertising
Advisory' Board before publication. The study recommended
better regulation of the images and slogans allowed in
pharmaceutical advertising to prevent undue medicalisation of
menopause. A copy' of the complete study can be obtained
from the HAI-Europe office.
A study done by MAI contact Barbara Mintzes examined
the way menopausal and post-menopausal women in Canada
and the UK are represented in advertisements for menopausal
hormone therapies. All advertisements for hormone therapies
appearing in late 1996 and early 1997 were cut out of issues of
five Canadian and three British journals sent to general
practitioners and obstetrics/gyneacology specialists. Twelve
individuals were asked to complete a questionnaire about the
woman pictured in each advertisement without knowing the
source of the image. The average estimated age of the women
was forty, about ten years younger than the average age at
menopause in Canada and the UK. In addition, the reviewers
thought more than three-quarters were “professional
women”, although, in contrast, only about one-fourth of
HAI WELCOMES AFRICA PROJECT
COORDINATOR
In July,
Jannes van
coordinator of
HAI's
der Wijk began work as
new three year
project for
promoting rational drug use in Africa. Jannes is a
medical doctor who has just completed a Master's
degree in public health in The Netherlands. He joins the
HAI staff after working as the head of Medicins Sans
Frontieres's mission in the Democratic Republic of Congo
(formerly Zaire) where, among other duties, he was
responsible for setting up an extensive drug supply
programme. Previously, he held the position of medical
director at a mother and child clinic in Niger. Much of his
time is now being spent preparing the second regional
workshop for Africa which will take place in South Africa
in early 1998. HAI contacts working with groups in Africa
or interested in learning more about the project can
reach him through the HAI-Europe office and via e-mail
at: jannes@hai.antenna.nl.
o
HAI-LIGHTS Juiy/August 1997
Rational drug use
years' work on the subject had not found a single agent that
provided increased protection against STDs compared with
contraceptives already available on the market. Participants
also challenged the relevance, acceptability and availability of
microbicides in many culmral settings. The use of commercial
sex workers in trials of microbicides was also criticised, as their
semi-legal status may make it more difficult for them to refuse
to participate in a trial, raising concerns about the ethics of
informed consent.
However, in light of the risk of contracting STDs/HIV
and many women’s strong desire to have children, the
participants saw a real need for a non-contraceptive
microbicide.
THE REASONS BEHIND REPORTING
The Uppsala Monitoring Centre recently conducted a
pilot study to investigate why some doctors report adverse
drug reactions while others do not. zVll of the national centres
taking part in the WHO monitoring programme were asked
to send letters to twenty doctors who had reported side effects.
The letters asked doctors to explain why they had decided to
file an adverse reaction report. In total, responses were
received from twelve countries involving 177 case reports.
The main reasons given for sending a report to the national
centre included wanting to contribute to medical knowledge,
reporting a previously unknown reaction, finding a reaction to
a new drug, always reporting adverse reactions, knowing of a
link between the drug and the reaction, and witnessing a
severe reaction.
Those taking part in the Rotterdam meeting agreed that
microbicides were not a first-choice treatment to prevent
STDs and HW in The Netherlands because of the
population’s general acceptance of condoms. Some also said
that free availability of such agents might lead to their misuse
by certain groups, such as migrant sex workers, who are
pressured by clients not to use condoms. The participants
called for more social research focusing on the risk
perceptions of future, possible users. They also said that
women and health activists need to play a greater role in the
design of this research.
The Uppsala centre plans to use the findings of the pilot
survey to encourage adverse reaction reporting among all
doctors. A copy of the full research article “Reasons for
Reporting Adverse Drug Reactions—Some Thoughts Based
on an International Review” can be obtained from the Uppsala
Monitoring Centre, Box 26, S-751 03 Uppsala, Sweden, tel:
(+46-18)17 48 50, fax: (+46-18)50 78 40 or e-mail:
who.drugs@who.pharmasoft.se
(Uppsala Reports, 5/97) •
The meeting preceded an international conference on the
practical and ethical considerations involved in microbicides
research held in Washington during April. This meeting
brought together women’s health advocates, clinical
researchers, social scientists, ethicists and drug regulators.
The report of this symposium will be published by the end of
this year. Copies of this report and an English-language
summary’ of the Rotterdam meeting ‘Women’s Visions on
Safer Sex: Assessment of 10 Years of Research into
Microbicides’ can be obtained from:
WHAF, P.O. Box 94263, 1009 AG Amsterdam,
The Netherlands, tel: (+31-20)665 2002, fax: (+31-20)6653002 or e-mail: 101526.250@compuserve.com •
THE FUTURE OF MICROBICIDES RESEARCH
The Women’s Health Action Foundation brought
together approximately twenty Dutch and Belgian women’s
health groups in Rotterdam to assess the progress resulting
from ten years of microbicides research. Microbicides are
agents, usually in the form of creams or jellies, that are
inserted into the vagina to protect women against HIV or
other sexually transmitted disease (STD) infections.
At the meeting, participants discussed the fact that
researchers conducting a long-awaited study on the use of
microbicidal agent nonoxynol-9 in Cameroon recently
reported that this treatment provided no extra protection
against HIV and other STDs. However, the researchers stated
that the rate of HIV infection appeared to decrease through
counselling, condom use and treatment for other STDs.
This package of additional services was provided to the
trial participants as part of the research project for ethical
reasons.
MENOPAUSE AND MEDICINE
Is menopause primarily a medical or a social and biological
event? This was the main question posed at “The Menopausal
Transition: A Different View”, an international symposium
held in Leiden, The Netherlands duringjune. The conference
was organised by Professor Eylard van Hall of Leiden
University’s Department of Obstetrics and Gynaecology.
Speakers, who came from a variety’ of disciplines, examined
not only how women experience menopause, but also
historical and recent marketing of menopause as a medical
The participants discussed the implications of this study’s
results and others for further microbicides research. The
group questioned whether research should continue as ten
HAI-LIGHTS July/August 1997
©
event. The evidence for long-term post-menopausal use of
hormones for disease prevention was critically evaluated.
Interestingly, as Elina Hemminld pointed out, a study in
Sweden showed that women doctors in that country were
much more likely to use menopausal hormone therapies than
women in the general public: 88% of post-menopausal
gynaecologists used hormones as compared to 24% of post
menopausal non-medical women.
A Dutch general practitioner, Dr. Sips, examined the
evidence for widespread bone mineral density testing and
offers of hormones to prevent bone fractures from
osteoporosis if women were found to have low bone density.
He was highly critical of the value of these diagnostic tests, in
large part because they are not able to predict very well who
will or will not develop an osteoporotic fracture. His best
estimate was that about five percent of fractures would be
prevented with widespread testing and treatment. The
evidence for heart disease prevention is also inconclusive
because it comes from observed differences in heart disease
rates among women who chose to take hormones and women
who did not. The problem is that heart disease was a
contraindication to hormone use during the period of many of
these observational studies.
A US epidemiologist, Shanna Swan, examined the
evidence for cancer risks with long-term hormone use. The
evidence here as well is in large part inconclusive, except for
the well-documented association between long-term use of
estrogens alone and a higher risk for endometrial cancer. The
growing evidence of an increased risk for breast cancer is
controversial: like heart disease prevention it comes from
observational studies. However, current long-term users
appear to be 20-30% more likely to be diagnosed with breast
cancer than tvomen who have never used menopausal
hormones.
Graham Dukes examined the reasons drug companies
chose to market menopausal hormones in the late 1960s and
early 1970s. He emphasised the strong commercial pressures
for continued diversification and expansion by hormoncproducing companies which had grown rapidly as a result of
the contraceptive pill’s success. Ingar Palmlund reviewed the
way advertisements have portrayed menopausal women
during the last thirty years: in the 1970s and early 1980s the
image was one of a harassed, anxious woman who needed to
take hormones to feel better. In the 1990s, it is of a youthful,
vibrant woman who is healthy and alive because she takes
hormones. Full proceedings from the meeting have been
published in the Journal of Psychosomatic Obstetrics and
Gynecology 1997, 18:2.
(From B. Mintzes, Conference Report, to be printed in the
Journal of Risk and Safety in Medicine) •
Free access to MEDLINE
The US National Library of Medicine has announced
that access to the medical information database,
MEDLINE, is now available for free through internet.
The web address is: http://www.nlm.nih.gov
CONSUMERS AND TECHNOLOGY
ASSESSMENT
Consumers have an active role to play in assessing health
care technology and targeting new areas of research, stressed
Catherine Hodgkin during her presentation at the
International Society of Technology Assessment in Health
Care (ISTAHC) meeting in Barcelona held in May.
Consumers can do much more than act as cases or studies in
technology assessment, she emphasised, they can also play an
active role as vital informants and interested partners. In order
for consumers to benefit fully from technological advances,
the}' need to be informed about technology' options so that
they can make good decisions and help ensure
implementation. Consumer representatives should also be
supported to enable consumer participation on such issues as
setting the agenda. Such involvement will help lead to the
implementation of effective, evidence-based policy' and
improved health.
(C. Hodgkin presentation “Integration of stakeholders in
the health technology assessment process”) •
BROMOCRIPTINE USE IN THE NETHERLANDS
A WHAF-sponsored study on the use of breastmilk
suppressants in The Netherlands suggests these drugs are
being prescribed less often each year. Exploratory research
carried out by the University of Groningen at VVHAF’s
request looked at two regional databases as well as one
national registry that contained prescribing data for
pharmacies in the community. The number of prescriptions
written for lactation suppressants within these databases has
decreased since 1994.
Qualitative research done with a small number of
prescribers and women found that doctors who still prescribe
the drugs see infant death in the broadest sense as the most
pressing reason to prescribe it. Other reasons include if the
mother is ill, has undergone breast surgery or if non-drug
options do not seem to relieve the symptoms. At the same
time, the study says that Dutch doctors are now less likely to
provide a prescription to women who simply' do not want to
breastfeed.
The prescribing data analysed showed that bromocriptine
remains the most commonly prescribed lactation suppressant
WEAL TAHAI-LIGHTS July/August 1997
first time they had questioned the claims made in industry
advertisements. The Association "DRUGS" plans to follow up
this seminar by hosting a meeting aimed at teaching Moldovan
consumers more about the drugs they use. It will emphasise
that both prcscribers and consumers are responsible for using
medicines wisely.
in the country today. Currently, two lactation suppressants
are on the national market, bromocriptine (Parlodel) and
cabergoline (Dostinex).
In 1994, the use of bromocriptine was brought under
scrutiny when the US FDA and many other countries took
action to remove this indication due to deaths and serious side
effects related to the drug's use as a lactation suppressant.
Despite efforts by national consumer and health groups, the
Dutch regulator}' authorin’ chose not to remove the
indication. Regardless of reports from other countries, the
agency concluded that the risks involved in Dutch women’s
use of the drugs was too low to demand such action because
few women used lactation suppressants.
For more information about the seminars, contact: The
Association "DRUGS", #90 Moscow Avenue 13/3, Kishinev,
Moldova 2068, fax: (+3732) 738 330 or e-mail:
natalie@drugs.moldova.su O
rhe views and experiences of the few women who took
part in the study varied widely. What became clear, however,
was that the women were not well informed about lactation
suppressants before they had to make a decision about using
them. The study recommends that women receive
information about non-drug solutions and lactation
suppressants during the early months of their pregnane}’. The
report also calls for information provision to midwives and
post-partum nurses. To receive a copy of the full report (in
Dutch), contact: Women’s Health Action Foundation at the
address already given.
(The use of lactation suppressants in The Netherlands, L. Vos,
Univ. Of Groningen, 6/97) •
Natalie Tchebotarenko promotes the essential drug concept in
Moldova
ESSENTIAL DRUGS DISCUSSION IN MOLDOVA
Pharmacologists and hospital doctors came together at a
recent seminar sponsored by the Association “DRUGS” to
discuss the creation of a national drug list in Moldova and the
use of WHO’s ethical criteria on drug promotion in order to
promote rational drug use. The seminar’s participants agreed
that such an essential drugs list was needed to ensure that
doctors prescribed safe, effective and inexpensive drugs for
patients. It was also seen as a good way to make generic names
better known to Moldovan prescribers. Earlier research done
in the country had shown that many doctors are unfamiliar
with generic names as they rely heavily on industry promotion
for their information about drugs.
BNF NOW ON LINE
An electronic version of the British National Formulary
(BNF) is now available. Popular demand from readers has led
the BNF to produce a version of its text that can be used easily,
accessed at the moment when drugs are being prescribed or
dispensed. The electronic text version, called eBNF, allows
viewers to obtain information about a particular drug as well
as interaction data. The electronic version is being further
developed so that it can be used with electronically held
patient records. There are also plans to link the eBNF to other
electronic resources such as drug bulletins and textbooks.
Aggressive drug promotion was another issue tackled
during the meeting. Some suggested that medical
representatives convince the directors of health institutions to
use their products through gifts or other benefits. The
WHO’s Ethical Criteria on the Promotion ofMedicinal Drugs are
not well known. The seminar group concluded that such
criteria need to be adopted and followed by companies
operating in Moldova. During the meeting, the doctors were
given current drug advertisements to analyse following the
principles set out in the ethical criteria. For many, it was the
HAI-LIGHTS July/August 1997
For more information about the eBNF, contact the British
National Formulary, c/o The Royal Pharmaceutical Society of
Great Britain, 1 Lambeth High Street, London SEI 7JN,
United Kingdom. •
©
Campaigns
NO TO NORPLANT, UNLESS...
A group of Dutch NGOs campaigning on women’s
reproductive health has launched a publication rejecting
Norplant as a first-choice contraceptive and demanding that
minimum conditions be met before it is used by any women in
the country. Now available in English as well as Dutch, the
document highlights the risks and possible coercion associated
with its use, user dissatisfaction, the danger of further
medicalisation if women experience adverse effects, and the
need for a reliable system of provision and removal. The
publication’s creators, including the NGOs WHAF and
Wemos, have disseminated these recommendations on
minimum conditions to groups and policy makers in The
Netherlands in the hope of informing decision-makers and
doctors about the medtod before it reaches the market. An
English-language version has been sent out to more dian 150
women’s organisations and concerned health care providers,
particularly groups in Central, Eastern and Southern Europe.
Other NGOs in countries where Norplant is already marketed
are encouraged by the authors to use the Dutch document in
their own discussions about the method. To obtain a copy in
English, contact WHAF at the address given. O
Moldovan doctors carried out by the Association “DRUGS”.
The group is now working to establish an independent
committee of experts to deal with donations entering the
country'. They plan to translate the inter-agency Guidelines far
Drug Donations and inform doctors about the committee's
work. For more information, contact Association "DRUGS”
at the address already given. •
DUTCH DONATIONS TO ROMANIA
The Dutch health and development NGO Wemos
organised a one-day seminar on Pharmaceutical Aid to
Romania late last year so that Dutch NGOs and Romanian
health professionals could discuss ways to improve the quality
of drug donations sent to Romania. More than 60 participants
took part in the meeting which resulted in a lively exchange of
ideas and experiences highlighting both donors’ and
recipients’ views on donations. The meeting concluded with
recommendations that mirror the inter-agency Guidelines on
Drug Donations issued by WHO last year. Copies of the
seminar report can be ordered by contacting Mark
Raijmakers, Wemos, Postbus 1693, 1000 BR Amsterdam, The
Netherlands, tel:( +31 -20)420 2222, fax: (+31-20)620 5094, or
e-mail: Wemos@tip.nl •
INFORMATION FOR DES SONS
Although less is known about the health risks men face due
to their mothers’ use of diethystilbestrol (DES) while
pregnant than the health risks for women, a new booklet sets
out solid, easy-to-understand information on the most
commonly asked questions. Published jointly by the US
National Cancer Institute, the National Institute of Child
Health and Human Development and the National Institutes
of Health, the booklet, DES Sons, emphasises why it is
important to find out if one has been exposed to DES before
birth, the known health problems associated with such
exposure and where to find help. Copies of the booklet can be
ordered from DES Action in the US. For more information on
how to order, contact: DES Action-USA, 1615 Broadway,
#510, Oakland, CA 94612, USA, tel: (+1-510)465-4011 or email: DESACT@WELL.COM •
IMPROVING DONATIONS IN MOLDOVA
Donated drugs arriving in Moldova are often not used due
to inefficient distribution and because labelling and package
inserts are often in a foreign language according to a survey of
PRESCRIRE FIGHTS FOR GREATER OPENNESS
La revue Prescrire, the independent drug bulletin based in
Paris, has called on the French Medicines Agency and
politicians to explain the excessive secrecy surrounding the
agency’s actions. The bulletin has accused the agency of
withholding important information from the public. During
the past few years, the journal has been denied access to expert
reports and the minutes of scientific committee meetings
explaining the agency’s decisions.
The recent, sudden withdrawal of three French generics is
die latest example of the absurd consequences resulting from
the lack of transparency in the drug regulatory decision
making process. Three generic drugs from GNR-Pharma and
Jumer (diltiazem GNR, piroxicam GNR and piroxicam
Jumer) were taken oft’the market in December 1996. Prescrire
approached the manufacturers and the medicines agency to
find out if the withdrawals were due to clinical incidents or any
other events. GNR-Development and Jumer explained to
Prescrire that the action had been taken for the following
reason: "This measure was decided in collaboration with the
medicines agency, following a review of the different files or
HAI-IIGHTS July/August 1997
supporting the application for marketing authorisation:
certain clinical data obtained several years previously were no
longer in keeping with current requirements for generic files."
To date, the French Medicines Agency has published
nothing on the subject and has refused to respond to
Prescrire’s request for written information about the decision.
However, high-level staff members have confirmed, off the
record, that these provisional withdrawals resulted from a
review of the files, undertaken at the initiative of an outside
body which was not identified. It seems that some checks made
at sites where studies were done revealed abnormalities in
assessment of bioequivalence which were not in keeping with
current requirements.
For more information, contact Ellen ‘t lloen, Ln revue
Prescrire, P.O. Box 459, 75527 Paris Cedes 11, France, tel:
(+33-1) 492 37 290, fax: (+33-1)480 78732 or e-mail:
106041.2744@compuserve.com •
A number of HAl-Europe contacts and drug anti health
agencies now operate a website giving information about
their current work. Look for these organisations on the
world wide web:
BUKO: http://users.aol.com/suednetz/epo/epo.htm
DES Action USA: http://www.desaction.org
DES Action Canada: http://www.web.net/~desact
HAI: http://www.haiweb.org
WHO: http://www.who.ch
WHO's Action Programme on Essential Drugs:
http://www.who.ch/programmes/dap/DAP_Homepage
.html
FDA: http://www.fda.gov
To have your website listed, please send the address to the H/l IEuropc office and we will publish it in a forthcoming issue.
Drug Information
Addressing a group of more than two hundred pharmacists
at the 4th European Conference on Drug Information held in
Amsterdam during May, Ellen ‘t Floen, Coordinator of the
International Society’ of Drug Bulletins (ISDB) stressed the
need for consumers to receive high-quality
drug information, ‘t Hoen pointed out that
as patients are requested to take more
responsibility for their own health, they
also have the right to participate more
actively in their own health care. This
situation calls for good communication on
the part of prescribers and pharmacists so
that consumers have access to information
about medicines and so they can put
companies’ promotional claims into
context.
The presentation also outlined the
fundamental difference between drug
information and promotion. A number of
ISDB members such as La revue Prescrire
in Paris are monitoring the information
that prescribers receive about drugs to
make sure that it is credible. For the past
six years, Prescrire has assembled a group
of general practitioners and hospital
pharmacists to monitor the behaviour of
medical representatives and to judge the
HAI-LIGHTS July/August 1997
accuracy’ of their claims. An assessment of the project during
1991-97 found that drug indications were extended or changed
in approximately one-fourdi of the visits. The suggested
dosages did not match the data sheet one-sixth of the time.
Importandy, side effects, contraindications and interactions
were not mentioned during more than three-quarters of the
meetings.
illustration: M arit van Vliet
CONSUMERS' NEED FOR INFORMATION
Ellen ‘t Hocn also stressed the crucial role played by
pharmacists. They play a double role as information provider
and business owner. Sometimes, one role loses to the other as
a recent survey carried out by the Consumers’ Association
(CA) in London suggested. CA sent researchers posing as
customers to ten pharmacies around the country to check on
the depth ofinformation provided by pharmacists. In total, 14
out of thirty times the wrong drug was sold for a health
problem. In six of the 14 cases this was done despite the fact
that the customer gave information that should have alerted
the pharmacist that the drug could pose risks. In 15 out of 30
cases, the pharmacist did not refer the customer to a physician
although this should have been done.
In conclusion, ‘t Moen emphasised that pharmacists need
to cooperate with doctors on behalf of consumers. To do so,
both groups must respect each other’s role and not be blinded
by unfair stereotypes. She said both doctors and pharmacists
were in important positions to encourage regulatory agencies
to define medicine as “the drug plus adequate supporting
information”, not just the chemical entity' itself. At present,
while regulators scrutinise drugs before allowing them on the
market, the information supplied with them receives much less
consideration.
(From the presentation by' E. *t Hoen, “Drug Information
and the Public”, 4th European Conference on Drug
Information) O
HIGHLIGHTING THE CONSUMER'S INTEREST IN
CLINICAL TRIALS
The interest of patients taking part in a clinical trial should be
respected and protected in a number of ways, argues Andrew
Herxheimer in a recent article entitled “Clinical trials and
consumers” which appeared in Consumer Policy Review.
Patients asked to take part in clinical trials must receive
balanced, understandable information about its purpose and
method. They should also be given adequate time to make a
decision about participating in it. Herxheimer also suggests
that clinical trials could be improved if organisations taking
part in health research included consumer representatives. In
addition, trial participants arc often denied access to trial
results after the trials’ conclusion. This raises an ethical
dilemma that needs to be addressed. Herxheimer calls on
ethics committees to ensure that trial participants receive a
copy of the completed study report written in a manner which
they can understand. He also calls on researchers to try to
publish all clinical trial results or at least to make the
conclusions available to the public. Such public access to
information would enable consumers to help publicise trial
results and increase pressure to reveal disappointing as well as
positive conclusions about results with a proposed treatment.
For a copy of the complete study, contact Consumer Policy
Review, Consumers’ zkssociation. Castlemead, Gascoyme
Way, Hertford X, SGI4 ILH, United Kingdom.
tel: (+44-645)830 115 or e-mail: cpr@which.net
(“Clinical trials and consumers”, Consumer Policy Review,
5-6/97)
O
The HAI-Europe office is sad to report that one of its long
standing contacts, Debbie Khudabux, died recently at her
home in Brighton, England.
’ Debbie became an active part of the HAI network in 1991
when UK groups launched a national campaign against
I secrecy in drug regulation. As a staff member of the National
Consumer Council in London, she worked closely with other
UK HAI contacts and the HAI-Europe staff in Amsterdam to
lobby for greater openness in the country's drug regulatory
system.
Those who knew Debbie remember her as an extremely
positive, intelligent and warm person. She will be greatly
missed by many in the network.
|
HAI-LIGHTS July/August 1997
Ji
Upcoming Meetings & Events
Ad Hoc Working Group on Cross Border
Advertising, Promotion and Sale of
Medicinal Products using the Internet
3-5 September, WHO, Geneva
This meeting has been called based upon a resolution
passed at the last World Health Assembly recognising the
increased use of the internet to advertise and sell drugs. The
working group plans to discuss the issue and report on it to the
WHO Executive Board and next year’s World Health
Assembly. Contacts interested in providing comments in
preparation for the meeting, should contact the HAI-Europe
office. •
Pharmacovigilance Meeting
24-27 September
An international conference on developing effective
communications in pharmacovigilance is being co-sponsored
by
the
Uppsala
iMonitoring
Centre,
EQUUS
communications, WHO and the University of Verona’s
Institute of Pharmacology. The meeting will be held in Erice,
Sicily, Italy. For more information, contact the conference
organisers at tel: (+44-171) 274 8724, fax: (+44-171)733 3600
or e-mail: equus@direcon.co.uk •
HAI Seminar on the World Bank
26 September
HAI-Europe will host a one-day seminar on World Bunk
Pharmaceutical Policies and Access to Essential Drugs in Oslo,
Norway. The seminar will focus on the World Bank’s current
policy on pharmaceuticals, implementation of national loans
and the extent to which these policies are influencing the
direction of international drug polity.
Those interested in learning more about die seminar should
contact the HAI-Europe office. •
HAI-LIGHTS July/August 1997
HAI-Europe Annual Meeting
26-28 September
Members of the HAI-Europe network will be meeting in
Oslo, Norway to discuss their work, joint campaigns and plans
for the coming year. All HAI members from the region are
encouraged to attend. For more information about the
meeting, contact the HAI-Europe office.
World Consumer Conference
3-7 November
This is the 15th World Consumer Congress hosted by
Consumers International. This year, the meeting will take
place in Santiago, Chile. Its theme will be “Empowering
Consumers for the 21st Century: Consumers in Civil
Society.”
For more information about tire meeting, contact:
Consumers’ International, Regional Office for Latin America
and the Caribbean, Casilla 9635, Santiago, Chile,
tel: (+56-2)335 1695, fax: (+56-2)231 0773 or e-mail:
xvcong@entelchile.net.
The programme and more details can be found on its website:
http://www.consumersinternational.org •
Publications
O Le Prix tin Bien-Etre (The Price of Well-Being)
by Edward Zarificn, Editions Odile Jacob 1996, 282 pages,
FF 130
Wliy does France consume more tranquillisers, sleeping pills,
anti-depressants and neuroleptics than other European
countries? Are French people more troubled or more
frequently mentally ill than their neighbours?
No, replies Edward Zarificn, author of Le Prix tin Bien-Etre
(The Price of Well-Being). The underlying problem is the
way the slightest emotional or social problem has been
mcdicalised. Zarifien published this book, an adaptation of his
report to the Ministry of Health on the overconsumption of
psychotropic drugs in France, to raise public awareness of the
problem. He discusses the problems of the bias towards drug
treatment found in GPs and psychiatrists’ education, the lack
of independence of teachers and opinion leaders, and the
important role of the pharmaceutical industry' in continuing
medical education.
La Revue Prescrire praises Zarifien’s passionate, lucid style of
presentation. He is highly' critical of the way psychiatric
disease categories have been expanded and of the shifting
boundary between what is considered normal and
pathological. He also speaks of the transformation of the
psychiatric clinic into a clinic for “target symptoms”, a
mechanistic and reductionist view of mental illnesses based on
symptomatic treatments rather than on a more complete view
of the individual.
The recent treatment of depression is presented as a case in
point. The image presented in the press is of a problem with
an exclusively’ medical solution. We are told repeatedly' that
“depression is a real illness”, implying the need for medical —
or to be more precise, pharmacological — treatment.
To order a copy of the book (in French) contact: 1’Appel du
Livre, 105, rue de Charenton, 75012 Paris, France; or fax:
(+33-1)43 07 50 80.
(Review by Barbara Mintzes)
O Managing Medicines: Public Policy and Therapeutic Drugs
by Peter Davis, Open University Press, 1997, (hardcover £45,
paperback £14.99)
This book addresses a broad range of policy issues related to
drugs. Peter Davis seeks to place the policy questions in a
broad context which helps us to understand the cultural, social
and economic and political significance and power of
medicines. In one chapter entitled “Science, consumers and
the law” particular attention is paid to the issue of
transparency arguing that consumers and their advocates lack
“the essential information that is required for rational decision
making...at the level of personal action or wider policy
debate.” In a final chapter, possible future policy' options are
considered
using
scenarios
representing
different
combinations and directions. In this way, Peter Davis hopes to
stimulate a more explicit and clear sighted debate about
choices in the area of pharmaceutical policy.
(Review by Catherine Hodgkin)
O Drugs for the Elderly (second edition)
(Ed. Leo Offerhaus), WHO Regional Publications, European Series,
No. 71, World Health Organizauon-Copenhagen, 1997, 145 pp.,
SFr. 32
More than ten y'ears ago, the European office of WHO
published two small books on the rational and appropriate use
of drugs in the two extremes of life: in y'outh and old age. They
are no longer available and the people who have written them
are scattered over the earth. As the world population is rapidly’
greying and drug problems in old people now account for
quite a lot of suffering and unnecessary hospital admissions,
the need for new unbiased information sources seemed quite
urgent. Though a number of comprehensive and expensive
text books have been written for hospital physicians, hardly
any information on the rational use of drugs in old age has
been available to doctors in primary health care. The original
text from 1985 formed the basis of the revision, but each
chapter has been thoroughly updated. In addition, the revised
manuscript was critically reviewed by primary health care
HAI-LIGHTS July/August 1997
ph\sicians. As 1 have been asked to recommend my “own”
book 1 have to be modest and clearly state that the first edition
was excellent; we in Copenhagen have only tried to make the
second edition even better and we tried to add a more pan
European flavour to it. A list of relevant books and
publications has been added and the drug index has also been
updated. I sincerely wish to see this little book in the pockets
of all interested general practitioners, geriatricians and other
doctors employed in hostels and hospices for old people.
(Review by Leo Offerhaus)
More languages for secrecy statement
The International Working Group's Statement on
Transparency
and
Accountability
in
Drug
Regulation has now been translated into German
• All We Need is Transparency:
The Trade in Medicinal Drugs between Europe and Developing
Countries, 14 pp., ReMeD, PLMED and Wemos.
Health authorities in developing countries are routinely
confronted with bad quality imported drugs. The quality of
imported drugs is closely related to the strengths and
weaknesses of existing legislation governing the trade in
medicinal drugs.
A recent study carried out by HAI contacts, Reseau
Medicament et Developpement (ReMeD), Pour une
Information Medicale Ethique et le Developpement
(PLMED) and Wemos examines the efficacy of drug export
legislation in 17 European countries, including all EU
countries, Norway and Switzerland. It also looks at regulatory
aspects controlling the pharmaceutical markets in 17
developing countries. It identifies some of the strengths and
weaknesses found in the legislation involving both imports and
exports. Plus, it highlights the need to introduce new measures
to control the quality of drugs sent from Europe.
and Italian as well as English, Spanish, French and
Portuguese. Copies of all versions can be obtained
from the HAI-Europe office.
• Fragile Economies, Flooded Markets:
Networkingfor rational drug use in Eastern Africa
The full French report can be ordered from ReMeD, 35 rue
Daviel, 75013 Paris, France for 50 FF plus postage. Copies of
a summary in English are available from the HAI-Europe
office or from Wemos, Postbus 1693, 1000 BR Amsterdam,
The Netherlands.
Report of the HAI Eastern Africa Regional Training Workshop, 1519 March 1997, Nairobi, Kenya, NLG 15 (reduced rate for groups in
developing countries)
During the course of five days, HAI contacts from five Eastern
Africa countries described the pharmaceutical situation in
their countries and proposed ways to promote rational drug
use in the region. The result is a new report illustrating the
important and creative work already being done by groups in
the region and their plans for the future. Those wishing to
order a copy of the workshop report should contact the HAIEurope office.
• InternationalJournal of Risk and Safety in Medicine:
Secrecy in Drug Regulation, IOS Press, NLG 50, (reduced rates for
groups in developing countries)
The journal issue explores the problems caused by
unnecessary secrecy in drug regulation. Its contents include
information never published before on the detrimental role
secrecy has played in the registration of such drugs as the
hypnotic triazolam (Halcion) and the contraceptive implant
levonorgestrel (Norplant). It also includes articles on the
tradition of secrecy in drug regulation, the striking differences
in information available from national drug regulatory
agencies, how secrecy influences the reporting of side effects ,
the way it affects regulators in developing countries and
Eastern and Central Europe and its influence on international
harmonisation initiatives now underway.
• Power, Patents and Pills:
An examination of GA1T7WT0 and essential drugs policies,
HAI-Europe, 32 pp., NLG 15 (reduced rate for groups in developing
countries)
A number of international trade agreements have far-reaching
implications for public health. At a one-day seminar on
GATT, the World Trade Organization, pharmaceutical
policies and essential drugs organised in 1996 by HAI-Europe
and BUKO Pharma Kampagne, participants explored the
consequences of the GATI' and WTO for public health and
access to pharmaceuticals, especially essential drugs. This
HAI-LIGHTS July/August 1997
book summarises the presentations and discussions made at
that meeting.
Copies are available from the HAI-Europe office.
©
The journal’s contents are based upon the papers presented at
a meeting of drug policy experts co-organised by H Al and the
Dag Hammarskjbld Foundation which explored the origins
and consequences of secrecy in drug regulation. Copies arc
available from the HAI-Europe office.
• Reproductive Rights in Practice:
A Feminist Report on the Quality of Care
(Eds) Anita Hardon and Elizabeth Hayes, ZED Books/Wl IAF,
1997, US$22.50
To what extent are women and men’s reproductive rights
respected around the world? Has family planning come to
mean little more than population control? These questions are
discussed in a new book published jointly by the Women’s
Health Action Foundation and ZED Books. Authors from
eight countries, Kenya, Nigeria, Thailand, Bangladesh,
Mexico, Bolivia, Finland and The Netherlands describe the
provision of family planning. They appraise the quality of care
and adherence to reproductive rights in different family
planning settings within each country. While the picture they
paint is disturbing and often surprising, the authors put
forward recommendations for change designed to improve die
way contraceptives are offered and provided to women and
men in a wide variety of cultures.
Copies of the book can be obtained from WHAF, P.O. Box
94263, 1009 AG /Amsterdam, The Netherlands, tel: (+3120)665
2002,
fax:
(+31-20)665-3002
or
e-mail:
101526.250@compuserve.com
• Monitoring Family Planning and Reproductive Rights:
A Manual for Empowerment by Anita Hardon, Ann Murua, Sandra
Kabir and Elly Engelkes, ZED Books/WHAF, 1997, USS 22.50
This handbook was written as a companion to the report just
described. It provides a framework for researching family
planning provision in different cultural settings. The book
shows NGOs and other health researchers how to design and
carry out such a project and provides indicators for quality
assessment. It is the first methodology handbook of its kind
and employs a step-by-step approach in covering all of the
elements needed to design, carry' out and analyse such a study.
Copies of this manual can also be obtained through WHAF at
the address given.
• International Conference on National Medicinal Drug
Policies—The Way Forward
Australian Prescriber, Vol. 20, supplement 1, 1997, ISSN 0312-8008
This report contains the proceedings of the conference on
national drug policies held in Australia during October 1995.
The meeting’s theme was “Can a comprehensive approach to
national medicinal drug policy meet both health and economic
needs?” It brought together more than three hundred people
from fifty countries to discuss equity of access to medicine,
rational use, quality' and the role of the pharmaceutical
industry. From the days’ presentations and discussions, clear
recommendations for action were developed.
A limited amount of copies is available from the HAI-Europe
office.
HAI-LIGHTS July/August 1997
To subscribe:
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office to support the work of Health Action International and
participants in the HAI-Europe network. A subscription to this
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rational use of drugs who wish to subscribe to HAI-Lights can do so
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Contributors to this issue: John Abraham, Babet Bonemeijer, Robert
Contributions are welcome for future issues.
Bourguignon, Pat Cody, DES Action Canada, MP Thierry Detienne,
Please send information to the following address:
Rose de Groot, Bas van der Heide, Andrew Herxheimer, Catherine
HAI-Europe, Jacob van Lennepkade 334-T,
Hodgkin, Ellen't Hoen, Annemarie Jurg, Joel Lexchin, Frank van
1053 NJ Amsterdam, The Netherlands
tel. (+031-20) 683 36 84, fax (+31-20) 685 50 02
e-mail: hai@hai.antenna.nl
\_______________________ —-----------------------------------------------
HAI-LIGHTS July/August 1997
Meerendonk, Barbara Mintzes, Leo Offerhaus, Mark Raijmakers,
Natalie Tchebotarenko and Jannes van der Wijk.
Design: Marit van Vliet
HA! believes that all drugs marketed should meet real medical need, have real therapeutic
advantages, be acceptably safe and offer satisfactory value for money.
Health Action International is an informal cooperating network of some 100 consumer, development action and other public interest
groups worldwide. The HAI network works to further the safe, rational and economic use of pharmaceuticals worldwide; to promote the full
implementation of the World Health Organisation's Action Programme on Essential Drugs and to look for non-drug solutions to the
problems created by impure water and poor sanitation and nutrition.
;
HAI
Health Action .International
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