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Letter in the Lancet Responding to an Article on HIV/AIDS Prevention Trials

This letter, by Health Research Group Deputy Director Peter Lurie, M.D., MPH, and Director Sidney Wolfe, M.D.,  appeared in The Lancet on May 29, 1999.

Sir- The so-called consensus statement on perinatal HIV prevention trials [1] is the first of several attempts to greatly undermine existing protections for human trial participants, especially in as much as they relate to the rights of participants from developing countries. At present, there are also attempts to weaken the Declaration of Helsinki and to rewrite the ethical guidelines of the Council of International Organisations of Medical Sciences (CIOMS). Ethical guidelines on HIV vaccine trials from the United Nations Programme on HIV/AIDS are also being produced and may have similar results. Should some or all these changes take place, trial participants in developing countries will be left less protected as research in those countries increases.

These initiatives are concerned with expanding the use of placebos from that which the Helsinki document allows: “in any medical study, every patient-including those of a control group, if any-should be assured of the best proven diagnostic and therapeutic method”.[2] The CIOMS document strikes a similar chord. In direct contrast, the proposed revisions to the Helsinki Declaration, for example, would allow placebos whenever the condition being studied does not lead to death or disability, even if an effective therapy exists. [3]

The draft Helsinki revision, like the UNAIDS vaccine trial draft document, [4] consigns trial participants in poor countries to second-class medical treatment by permitting effective treatments to be denied them on the basis of their poverty: “[the patient] will not be denied access to the best proven diagnostic, prophylactic or therapeutic method that would otherwise be available to him or her [emphasis added]”.[3]

The consensus statement strikes similar themes. Despite two randomised, placebo-controlled trials showing the effectiveness of zidovudine in reducing perinatal HIV transmission, and three more that have been completed since the workshop participants convened, the writers insist that “there are circumstances [no antiretrovirals available nor likely to be in the short term] in which a no-antiretroviral comparison may be ethically justified”. What happened to the Hippocratic oath, in which physicians undertake to “look upon [God’s] offspring in the same footing as my own brothers”?

Like much else in the world economy, research is increasingly becoming globalised. From the brief history of globalisation we have already learned that, where there are no strong protective measures, industries and governments will ride roughshod over human rights and public health concerns. Now is the time to strengthen protection for human beings, not to convene a series of groups whose apparent intention is to weaken them.

[1] Perinatal HIV Intervention Research in Developing Countries Workshop Participants. Consensus statement: science, ethics, and the future of research into maternal infant transmission of HIV -I. Lancet 1999; 353: 832-35.

[2] Declaration of Helsinki, 48th World Medical Assembly, Somerset West, Republic of South Africa, October, 1996.

[3] World Medical Association. Proposed revision of the World Medical Association Declaration of Helsinki (undated document).

[4] Guidance document on ethical consideration. in international trial. of HIV preventive vaccine. (draft). Joint United Nation. Programme on HIV/AIDS, November, 1998.