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Keywords : Africa, Clinical trials, Ethics

A recent article in the New England Journal of Medecine, entitled “A new Colonialism ? Conducting Clinical Trials in India” (3) denounces a new government policy there that amounts to opening the door to various abuses in clinical trials. Criticism from a number of quarters has been voiced against some clinical tests conducted by Western pharmaceutical companies in countries of the developing world. Up to the 1990s, such trials were performed in the developed world, on people drawn from their population. Today, however, about a quarter of such research is conducted in the third world, and the trend is accelerating. The Washington Post even speaks of a “human body hunt”. Scandalous, isn’t it ? Looks like “another instance of the poor being abused by the rich”! Thinking further, however, isn’t responsibility shared for this state of affairs ? Are not the countries in the South who have signed such research agreements guilty of failing to exercise due caution or even of complicity in actions that potentially violate the laws ?

Under a project to develop a preventive treatment for AIDS, an NGO, Family Health International (FHI) and Gilead Laboratories have been conducting tests on prostitutes in Douala, Cameroon. Both organizations are accused of using these women as “guinea-pigs”, and disregarding their rights, and the project has given rise to legitimate controversy. The prostitutes were given a tablet of tenofovir (Viread*) to test its possible effectiveness in preventing contamination by the HIV. No medical treatment was given to those of the women who were already infected with AIDS. Local administrative officials have proclaimed their good faith in the matter, arguing “the need to distinguish and avoid mixing up ethical and humanitarian aspects” (4). Properly speaking, such an incomprehensible and irresponsible position is dumbfounding !

The same study is currently conducted in Ghana (Tema), in Botswana, and in Malawi.

Cambodia is a small country ; a poor country among the poorest in the world, bled to its knees by a domestic genocide in which a quarter of the population was herded off to mass graves ; a country still torn apart by political battling over power, but it said “no” to this operation which some African countries have agreed to establish. How can we explain that Cameroon, Ghana, Botswana and Malawi have agreed so easily to this operation ? Did the prestige and label of the Bill and Melinda Gates Foundation facilitate acceptance ? The Indian decision may be related to India’s adoption of an unbridled so-called “market” economy free of social and political controls, a version of “economic liberalism” propounded by the Chicago School of economics whose flaws have been pointed out by the Nobel prize-winner in economic science J. Stiglitz (5) ; it appears that the same recipe, perceived as a cure-all, is being applied in Africa.

However, the example set by Cambodia sweeps away the underlying financial-cum-economic arguments. Lack of information, the shortage of technical capabilities among African medical practitioners are very likely to have been contributing factors to the establishment of such a research station and especially acceptance of its mode of operation. Given the persistent identity problems in Africa, a lack of self-confidence may also be considered as a possible cause. African governments, no doubt, are partly to blame, but the responsibility of the African scientific elite cannot be swept under the carpet either. How are we to explain, otherwise, that 60 % of 260 “research papers”, according to a researcher who is a member of the Ethics Committee of Cameroon, are “pirates” (unauthorized) ?? (4) Is this due to lack of precautions, to corruption or to social inhibitions ?

JP Chippaux, a researcher at Institut de Recherche pour le Développement (IRD), is the author of « The Practice of Clinical Trials in Africa », a book (2) in which he defines, as follows, a number of ethical criteria for conducting clinical research :
– Social or scientific value (a measure of operational efficiency);
– scientific validity;
– selection of research subjects (including a pertinent choice of sample population and the protection of vulnerable or exploitable groups);
– a good risk-to-benefit ratio;
– independent evaluations (including an evaluation of possible conflicts of interest)
– respect for the research subjects (right to withdraw from the research at any time without incurring penalties-ensuring the confidentiality of data-subject security-communication of results to participants).

African traditional societies, based on a customary hierarchical system of communal kinship and government or guidance by elders has imploded as a result of the unavoidable and forcible intrusion of the modern world. The traditional fabric of society can no longer be a backbone for resistance. In this context, as societies are speedily being transformed, roles are redistributed in a disorderly fashion and on a commercial, even mercantile, basis, which is by nature unstable and opportunistic. The means used to get to the top of the social ladder ignore ethical rules. Money, even filthy money, is dominant. The participants in the macabre dance around dying people are no doubt short-sighted politicians, guided by what a political analyst, JF Bayart (1), has perceptively called their “stomach”. But they are not alone. For cases such as medical trials show other participants and social groups. Among these the elite, made up of scientific and other leaders who, too often, have given up the fight. Let us remind ourselves that the end, however worthy, does not justify the means.

The responsibility of members of the scientific and intellectual elite is to remain constantly attentive, looking not only into the distance but also at their doorstep to detect, alert, point out the potential dangers facing the larger Community. This is especially necessary in the field of medicine.

  1. BAYART JF. L’État en Afrique. La politique du ventre, Ed. Fayard, Paris,1989
  2. CHIPPAUX JP. La pratique des essais cliniques en Afrique, Editions IRD, Paris, 2004
  3. NUNDI S. GULHATI CM. A new Colonialism ? Conducting Clinical Trials in India. N Engl J Med 2005; 352:1633-36
  4. SIEWE A in J.A. L’Intelligent no. 2300, Feb 6 to 12, 2005
  5. STIGLITZ J. Globalization and its discontents, WW Norton Ed, New York, 2002

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ISSN: 1992-2647