Placebo Ban Reconsidered

Just 6 months after laying down new rules that would restrict the use of placebos in clinical trials, the World Medical Association (WMA) has been forced to reconsider its policy. Yesterday, the group announced that it is undertaking an "internal investigation" that may lead to a retreat from a firm stance it adopted in October 2000.

At its general assembly meeting in Edinburgh last fall, the WMA approved a complete overhaul of the "Declaration of Helsinki," a set of ethical principles to guide medical research on humans. In the most dramatic change, the document stated that researchers should avoid using placebos if they can. The revisions said that patients in clinical trials should always be given either an experimental therapy or the best available current therapy (Science, 20 October 2000, p. 418).

Several experts in clinical research strongly objected to the approved rewording. A key regulatory official at the U.S. Food and Drug Administration (FDA), Robert Temple, argued that the WMA policy would make it difficult to test certain new drugs, particularly psychoactive drugs, because their efficacy is difficult to measure without a placebo group. In public remarks, Temple suggested the FDA might ignore the new rule. Some European leaders also complained, says WMA secretary-general Delon Human; they claimed that the new rule had prompted ethics reviewers to delay important clinical trials that included placebos.

At a March meeting in Pretoria, South Africa, Temple and other critics urged the WMA to reconsider its policy. Now, the WMA is following up the complaints with an internal review, held from 3 to 6 May in Divonne, France. "We intend to investigate whether the guidelines are likely to restrict good, ethical research in any way," Human says. "We will consult widely." Then, if the WMA finds evidence to support the critics, the matter will go to the WMA general assembly this fall for final action--and possibly, another revision of the Declaration of Helsinki with more relaxed guidelines on placebo use.

Related sites

Text of the Declaration of Helsinki, revised in October
Conference proceedings of the March meeting in Pretoria
The World Medical Association