AFRICA FILE
Pharmaceutical colonialism in Africa
http://mondediplo.com/2005/08/11pharma

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
biopharmaceutical 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 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 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 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 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 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 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 developping 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 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 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 developping countries to make independent use of
clinical research.
Translated by Donald Hounam

* 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)

(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 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 Pécoul,
« Is orphan drog status beneficial to tropical disease control ? »,
Tropical Medecine 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.