Use of Placebos Ignites Ethics Debate Officials Argue They Shouldn't Be Used If Treatment Exists

Article excerpt

WASHINGTON -- Researchers, ethicists and health officials attending a conference at the National Institutes of Health this week defended the use of placebos -- inert, dummy medicines -- as an essential tool for evaluating new drugs, and said giving them to patients in a study often can be justified even when there already is a treatment that works.

"There has been a great shift taking place about placebo use," said Sissela Bok, a philosopher and senior fellow at the Harvard Center for Population and Development Studies. "What is clear is that the ethical issues are nowhere near resolved."

Giving placebos to study participants has ignited a fierce ethical debate, after last month's revision of a key international medical document to declare their use unethical whenever the disease being studied already has an effective treatment.

The Declaration of Helsinki was revised to state that experimental therapies always should be tested against "best current" treatments and that placebos should be used only when no treatment exists.

The changes were made after controversy arose over studies conducted in Africa and Asia of experimental treatments to prevent pregnant women from transmitting the AIDS virus to their infants. An effective treatment already was in routine use in industrialized countries, but was unavailable in the countries where the research took place. Some study participants were given placebos.

Many officials were alarmed by changes to the declaration.

"Because a couple of very smart, caring people get together somewhere, they don't speak for humanity," said Stephen Straus, director of the National Center for Complementary and Alternative Medicine, which co-sponsored the conference.

There is widespread consensus in the research community that using placebos is unethical whenever withholding an effective treatment would place study participants at risk of death or lasting disability. …


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