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Experimenting With Fairness

First World standards for Third World drug trials provoke moral quandaries.

Paragraph 30 of the World Medical Associationís Helsinki Declaration doesnít seem like the formula for starting a hullabaloo. Itís just a small part of a nonbinding international declaration of ethical principles for conducting medical research on humans. It doesnít directly require the pharmaceutical industry to provide free antiretrovirals to Botswana, nor does it call for raiding private medicine cabinets.

Nonetheless, paragraph 30 has stirred an increasingly testy debate over drug trials in developing countries. Pharmaceutical companies and some researchers want very much to water down its message; activists and doctors in developing countries want to strengthen it. Debate over the paragraph has now morphed into a dispute over the industrialized worldís responsibilities for reducing the gross inequalities in worldwide health care.

According to paragraph 30, written as part of a 2000 revision of the Helsinki Declaration, after the completion of a study like a drug trial, “every patient entered into the study should be assured of access to the best proven prophylactic, diagnostic,and therapeutic methods identified by the study.” Someone living, say, in the West African republic of Burkina Faso and participating in a successful study for a new cancer drug should get the treatment shortly thereafter—even if that subject received only placebos during the trial. Critics of the directive want to reduce the burden of company sponsors to “reasonable, good faith efforts,” as recommended in a 2001 U.S. National Bioethics Advisory Commission report.1

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The World Medical Association recently tabled debate over revising the item. But an in-house committee is analyzing the matter, and numerous interested parties are primed to chime in when the dialogue restarts in a couple of months. Written in 1964 and revised only five times since, the Helsinki Declaration lacks the force of law but is the most important document guidinginternational medical research. Many countries cite it as the founding principle of their codes, and other countries, like Israel, have adopted the declaration wholesale into their laws.2

The core justification for paragraph 30 is found in the declaration itself: companiesand researchers have a moral responsibility toward people who put their bodies on the line for science. Paragraph 5 states, for example, “In medical research on human subjects, considerations related to the well-being of the human subject should take precedence over the interests of science and society.”3 The world, in the eyes of many, is moving toward a system of medical maquiladoras, and the people in developing countries need to benefit maximally from the tests, particularly if they canít afford the drugs for which they serve as guinea pigs. “Changing paragraph 30 would shortchange people here,” says Aasim Ahmad, a doctor in Karachi, Pakistan, who believes that medical research has brought his country nothing but exploitation.

Proponents of loosening the requirement see paragraph 30 as a tangle of contradictions and ambiguities. It could slow research and drive medical experiments out of developing nations where, at the least, they are currently bringing up standards, bringing in knowledge, and helping to create drugs that will ultimately benefit everyone.

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1  U.S. National Bioethics Advisory Commission (April 2001) Ethical and Policy Issues in International Research: Clinical Trials in Developing Countries, cited in World Medical Association Ethics Unit (2003) Documentation for the Preparation of Note of Clarification on Paragraph 30 of the Revised Declaration of Helsinki. World Medical Association: 11.

2  World Medical Association Ethics Unit (2002) Chapter 4: The Declaration of Helsinki. World Medical Association: 16.

3  World Medical Association (June 10, 2002) World Medical Association Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects. World Medical Association.

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