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Pharmaceutical colonialism in Africa

http://victoria.indymedia.org/news/2005/08/42909.php

Pharmaceutical colonialism in Africa

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,...

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 (. 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.

( 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)]
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