Healthy Skepticism Library item: 2049

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Publication type: news

Chippaux J.
Pharmaceutical colonialism in Africa
Le Monde Diplomatique 2005 Aug 13
http://mondediplo.com/2005/08/11pharma

Abstract:

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.

Keywords:
Africa trials

Notes:

Ralph Faggotter’s Comments: Multinational companies are naturally attracted to parts of the world where local regulatory agencies and laws protecting workers and citizens are weak or absent.
This is no less true for companies seeking to undertake drug trials.

Full text:

Pharmaceutical colonialism in Africa

Le Monde diplomatique, August 2005
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 Translated by Donald Hounam

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 sus-pen-sion. Trials were also halted in Cameroon (February
2005) and Cambodia (August 2004) (1), but continue in Thailand,
Bot-s-wana, 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 super-vision, 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
develop-ing 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 respons-ible 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.

Africas 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 Nigerias 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 Cameroons 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 Cameroons national ethical committee. As Fabrice Pilorgi 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 declar-ation 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 pathol-ogies, 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 industrys 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 regu-lations
(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. Kourilskys 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 Africas 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.

Notes:

(1) Compliment denqujte, 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 Picoul,
+ 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 lithique devient
immorale, Pour la Science, Paris, 2004.

(9) See the report to the French prime minister, Philippe Kourilsky
and Genevihve Viney, Le principe de pricaution, Odile Jacob and
Documentation frangaise, 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)]