POST 00836E : PHARMACEUTICAL COLONIALISM IN AFRICA
28 September 2005
The article below was originally published in the "Monde diplomatique" of
June 2005, and August for the English edition. It was sent by Anthony
Battersby (mailto:[email protected]
). Quite interesting though a little
long, it has no direct link with vaccination apart from Anthony's comments.
However, vaccines are also clinically tested and would it surprise anyone
if some protocols were questionable?
It seems that the English version is not identical to the French so those
who can or would like to read the original can consult TechNet archives in
French, message 00264F.
It is obvious that Internet has had and will have further impact on many
aspects of human life. Some is positive and some the opposite. In a very
short time Internet has reproduced human nature in an electronic microcosm,
with all its greatness as well as its worse vicissitudes. The role of
Internet as described by Anthony seems to me quite positive.
Pharmaceutical colonialism in Africa
[crossposted with thanks from Afro-nets]
Le Monde diplomatique
August 2005 - AFRICA FILE
Big drug companies are conducting clinical trials in Africa with no
consideration for ethics, the health of patients or the relevance of the
drugs to the needs and the pathology of the continent. Nobody is testing
traditional medicine to see if it works, and how.
by Jean-Philippe Chippaux*
NOVOFIR is an antiviral drug developed by the United States bio-
pharmaceutical company Gilead Sciences to combat Aids. The US government
and the Bill and Melinda Gates Foundation paid for the organisation Family
Health International to carry out clinical trials in Nigeria. But in March
2005 serious ethical shortcomings caused their suspension. Trials were also
halted in Cameroon (February 2005) and Cambodia (August 2004) (1), but
continue in Thailand, Botswana, Malawi, Ghana and the US.
In 2001 30 Nigerian families sued another US pharmaceutical company,
Pfizer, in New York over trials of Trovan, an antibiotic to combat
meningitis. In the course of the study, during an epidemic in 1996, 11
children out of 200 died and others suffered brain damage and paralysis (2).
The developing world is now a place where pharmaceutical companies ignore
ethical considerations and the health of patients. Without the informed
consent of their subjects, who receive only the most basic information and
usually inadequate therapeutic supervision, they conduct clinical trials
with limited benefits to specific patients or the local population as a whole.
Before any new medicine is approved and marketed, it must go through
formal, rigorous clinical trials designed to establish tolerance and assess
its effectiveness. It is estimated that almost 100,000 such trials are
carried out worldwide each year, 10% of them in developing countries and 1%
in Africa. During the 1990s the number of foreign trials financed by US
public and private funding reportedly rose from 271 to 4,458 (3).
The concept of evidence-based medicine, using statistics and testing, has
prevailed in the West since the end of the 19th century (4). The first
formal statement of ethics was the Nuremberg code, adopted after the trials
of Nazi doctors in 1947. But the postwar spread of medical ethics was slow
to encompass pharmaceuticals, and regulation only developed in reaction to
scandals and accidents.
International declarations extended and refined the code: the 1964 Helsinki
declaration defined the main ethical principles of medical research and the
1981 Manila declaration dealt with clinical studies in developing
countries. They insist that trials should be confidential, and that those
conducting them should be competent and should protect their subjects,
whose consent they have secured. These were only recommendations and no
sanctions were proposed.
An antiseptic, Stalinon, killed 102 patients in France in 1955; thalidomide
was responsible for 12,000 foetal abnormalities between 1957 and 1962; a
powder, Morhange, poisoned 145 infants and killed 36 in 1972. Scandals such
as these led to the regulation of clinical trials. But not until 1988 did
the Huriet-Serusclat law lay down an authoritative code of ethics -
implicit recognition that clinical trials had been conducted illegally for
Bypassing ethical principles
Africa's few medical and pharmaceutical regulations date from the colonial
era and are now obsolete or ill-adapted to current circumstances. There is
increasing danger that ethical considerations will be ignored as drug
companies relocate tests to a continent where costs can be five times less
than in developed countries. Since African disease rates, especially
infectious ones, are higher and symptoms have not been weakened by repeated
intensive treatments, epidemiological conditions are more favourable for
trials. The weakness of local health structures generates a docile patient
pool, making the process easier.
Africa is a perfect environment in which to circumvent ethical principles.
During the trials of Trovan, there was no formal consultation with the
Nigerian authorities or Nigeria's ethical committee about the information
given to families involved or about securing of their consent. The tests of
Tenofovir on 400 Cameroonian prostitutes between July 2004 and January 2005
failed to meet ethical requirements. Tenofovir reduces transmission of SIV,
the equivalent in monkeys of HIV. The manufacturers decided to conduct
trials among a high-risk group - sex workers in a country with a high rate
of HIV infection - to find out if it might work on human beings.
Only information in English was given to the volunteers, many of whom were
French-speaking and illiterate. The anti-Aids organisation Act Up-Paris and
Cameroon's Network for Ethics, Rights and Aids (Reseau Ethique Droit et
Sida), claim that some of the women thought they were receiving a vaccine.
Those who were given a placebo (5) did not receive any advice on Aids
prevention or medical follow-up, which did not worry Cameroon's national
ethical committee. As Fabrice PilorgÃ© of Act Up points out: "There is an
obvious conflict of interest between offering prevention and testing a
preventive medicine - the test is only valid if the women are exposed and
become infected." A recommendation made by the World Medical Association in
the Helsinki declaration was that ethical committees should examine the
experimental protocol before any study, checking that it is relevant and
appropriate to the social and economic context in which it is to be
conducted. Over the past decade, such committees have sprung up across
Africa, but can still lack the necessary expertise and funding (6).
Not only does Africa have its own pathologies, but conditions under which
drugs are administered and their side effects monitored are problematic. It
is reasonable to ask whether any trials conducted there are relevant to
African needs. Out of 1,450 new medicines marketed between 1972 and 1997,
only 13 were for tropical diseases (7). Since trials are determined,
financed and organised by the pharmaceutical industry, decisions as to
which drugs should be tested and how are inherently biased. African
governments find it difficult to develop clear, coherent policies that
would allow them to have real control over the activities of profit-driven
The mismatch between the poverty of developing countries and the power of
the medical industry exacerbates the conflict between scientific and
commercial interests. By the end of the 1990s the pharmaceutical industry's
global turnover ($480bn) was greater than the GDP of all the countries of
sub-Saharan Africa ($380bn).
Scientifically, it is possible to justify the trial of Trovan on the
grounds that it allowed the effectiveness of the drug to be tested under
consistent conditions on a suitable number of subjects. But the study
overlooked the fact that the cost of the product and the limited chances of
its commercialisation without state subsidy make its use in Africa highly
unlikely.The appropriateness of Tenofovir in an African context was
similarly ignored. If the trial confirms that it prevents HIV transmission,
it will be marketed as a prophylactic against Aids. But it is not a
realistic one in a continent that struggles to treat its sick and to
promote the cheap and more widely available condom. Experience in malaria
prevention demonstrates the impossibility of persuading healthy people to
take medicine every day for the rest of their lives, especially if it is
expensive. Some conclude that trials of Tenofovir were done in developing
countries, among prostitutes, to secure quick, clear results without
administrative complications or excessive costs.
Some scientists, such as Philippe Kourilsky, director of the Pasteur
Institute in Paris, maintain that the health crisis in the third world is
so urgent that it justifies the relaxation of regulations (8). But to
override the precautionary principle under which the harm trials cause
would demand their regulation despite the absence of scientific consensus -
because of cost would imply that different criteria apply to different
parts of the world (9). In the rich world all that matters is that the
product works. Among the poor, safety would be subordinated to the ability
to pay, forcing them to make do with what they can afford, whatever the
result of trials.
The result is strategic imperialism, which imposes rules upon the poor
without their consent. Kourilsky's insistence that it would be "ideological
imperialism to apply the rules of the rich to those who are not in a
position to endorse them" permits an unacceptable relativism. Third
parties, especially those who make the rules, cannot decide who can endorse
If they are to meet their health needs, Africans must be able to conduct
their own trials. The issue is all the more important since it affects
traditional medicine, which is cheaper and more widely accepted. Clinical
tests proving the uselessness or effectiveness of these traditional
remedies could enhance heritage and allow an indigenous pharmaceutical
industry to emerge. There are many African plants with reputed
anti-infection, anti-inflammatory and diuretic properties that might be
used against infections, rheumatism, hypertension or cardiac insufficiency;
some might prove as important as quinine extracted from cinchona bark,
aspirin from the willow, reserpine from an African Rauwolfia, and
anti-cancer agents that have been derived from the Madagascar periwinkle.
Only drugs that meet Africa's needs should be tested there. They should
satisfy specific criteria determined by their potential use. They should be
effective and, given the inadequacy of local mechanisms to monitor side
effects, harmless. They should be accessible, and easy to distribute,
prescribe and administer. They should have a long shelf-life and encourage
patient adherence to treatment, compensating for weaknesses in the health
system. But the priority is to allow local communities to make their own
decisions about trials, oversee and carry them out, allowing developing
countries to make independent use of clinical research.
(1) ComplÃ©ment d'enquÃªte, France 2, 17 January 2005.
(2) The case remains unresolved.
(3) US department of health & human services, Washington, 2001.
(4) See Harry M Marks, "The Progress of Experiment: Science and Therapeutic
Reform in the United States", 1900-1990, Cambridge University Press, 2000.
(5) To verify the effectiveness of the drug, those participating are
divided into two groups, one of which receives a dummy tablet that does not
contain the active ingredient.
(6) See the Pan-African bioethics initiative website
(7) See Patrick Trouillet, C. Battistella, J. Pinel, Bernard PÃ©coul, "Is
orphan drug status beneficial to tropical disease control?", Tropical
Medicine and International Health, Oxford, 1999, 4, p. 412-420.
(8) Philippe Kourilsky, "Vaccination : quand l'Ã©thique devient immorale",
Pour la Science, Paris, 2004.
(9) See the report to the French prime minister, Philippe Kourilsky and
GeneviÃ¨ve Viney, Le principe de prÃ©caution, Odile Jacob and Documentation
franÃ§aise, Paris, 2000.
* Jean-Philippe Chippaux is a doctor and director of research at the
Institute of Development Research at Dakar in Senegal. He is the author of
"Pratique des essais cliniques en Afrique" (IRD Editions, Paris, 2004)
This valuable and interesting article has omitted the impact of the
internet to disseminate information world-wide.
I was in Northern Nigeria as a part of a team reviewing immunisation
services just after the Pfizer debacle. One of the effects reported to us
was that thanks to information gleaned from the internet people were
becoming sceptical about the probity of activities they saw as being
instigated by foreigners beyond those immediately associated with the
trial. This provided fertile ground for the suspicions which arose over
polio eradication a couple of years later, which were again fueled by
information (much of it spurious) gathered from the internet.
The internet does make it possible for people in countries like Nigeria to
see that they are being treated differently and for many that is not
acceptable. The recent discussion over Thiomersal is an example. The
arguement goes, if it is not good enough for the rich why should it be good
enough for the poor. The disparities between the poor and the rich are now
much more visible to the poor because of the internet.
The actions of the pharmaceutical companies will not pass unnoticed for
long and will have a negative impact on other health interventions unless
those interventions are seen by the population to be relevant to their
needs. Information from the internet may help them to define those needs.
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