E-DRUG: Pharmaceutical colonialism in Africa
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[crossposted with thanks from Afro-nets; thanks to Philippa for spotting! WB]
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 rele-
vance of the drugs to the needs and the pathology of the conti-
nent. 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 clini-
cal trials in Nigeria. But in March 2005 serious ethical short-
comings caused their suspension. Trials were also halted in Cam-
eroon (February 2005) and Cambodia (August 2004) (1), but con-
tinue in Thailand, Botswana, Malawi, Ghana and the US.
In 2001 30 Nigerian families sued another US pharmaceutical com-
pany, Pfizer, in New York over trials of Trovan, an antibiotic
to combat meningitis. In the course of the study, during an epi-
demic 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 compa-
nies 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 al-
most 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 Nurem-
berg code, adopted after the trials of Nazi doctors in 1947. But
the postwar spread of medical ethics was slow to encompass phar-
maceuticals, and regulation only developed in reaction to scan-
dals 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 tri-
als 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 be-
tween 1957 and 1962; a powder, Morhange, poisoned 145 infants
and killed 36 in 1972. Scandals such as these led to the regula-
tion of clinical trials. But not until 1988 did the Huriet-
Serusclat law lay down an authoritative code of ethics - im-
plicit recognition that clinical trials had been conducted ille-
gally for two decades.
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 consid-
erations 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 fa-
vourable 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 organi-
sation 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 preven-
tion or medical follow-up, which did not worry Cameroon's na-
tional ethical committee. As Fabrice Pilorgé 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 commit-
tees have sprung up across Africa, but can still lack the neces-
sary expertise and funding (6).
Not only does Africa have its own pathologies, but conditions
under which drugs are administered and their side effects moni-
tored are problematic. It is reasonable to ask whether any tri-
als 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 poli-
cies that would allow them to have real control over the activi-
ties of profit-driven drug companies.
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 sub-
jects. 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 simi-
larly ignored. If the trial confirms that it prevents HIV trans-
mission, 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 con-
dom. Experience in malaria prevention demonstrates the impossi-
bility 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 coun-
tries, 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 those rules.
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 ef-
fectiveness 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 Rau-
wolfia, 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 ac-
cessible, 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 de-
cisions about trials, oversee and carry them out, allowing de-
veloping countries to make independent use of clinical research.
(1) Complément d'enquête, 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 tab-
let that does not contain the active ingredient.
(6) See the Pan-African bioethics initiative website
(7) See Patrick Trouillet, C. Battistella, J. Pinel, Bernard Pé-
coul, « Is orphan drog status beneficial to tropical disease
control? », Tropical Medicine and International Health, Oxford,
1999, 4, p. 412-420.
(8) Philippe Kourilsky, Vaccination : quand l'éthique devient
immorale, Pour la Science, Paris, 2004.
(9) See the report to the French prime minister, Philippe
Kourilsky and Geneviève Viney, Le principe de précaution, Odile
Jacob and Documentation française, Paris, 2000.