 |
|
| Jan. 14, 12:42 EDT | |
| Health officials torn on ethical use of placebos | |
SPECIAL TO THE STAR |
|
|
The Declaration of Helsinki now states that using placebos is unethical whenever the disease being studied already has an effective treatment. ``There has been a great shift taking place about placebo use,'' says 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.'' The revised Declaration of Helsinki states that experimental therapies always should be tested against ``best current'' treatments and that placebos should be used only when no treatment exists. The revision came 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 is in routine use in industrialized countries but unavailable in the countries where the research took place. Some study participants were given placebos. Although a three-day November conference at the National Institutes of Health (NIH) originally intended to examine the science of the ``placebo effect'' - the observation that people suffering from various conditions often improve when given a dummy medicine - much of the discussion focused on the ethics of placebo use in research. Many participants expressed alarm over the revised Helsinki declaration. ``Because a couple of very smart, caring people get together somewhere, they don't speak for humanity,'' said Stephen E. Straus, director of the National Center for Complementary and Alternative Medicine, which co-sponsored the conference. ``Very reasonable people can disagree, and the stakes are very high.'' 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. Certain kinds of medicines - including antibiotics, cancer chemotherapy drugs and prescriptions to treat diabetes - are rarely tested against placebos. But placebos have played a crucial role in evaluating the effectiveness of many other drugs, including treatments for high blood pressure, depression, allergies, pain and anxiety. The ``placebo effect'' is much stronger for some diseases than for others. For example, in studies of depression, placebos are about 75 per cent as effective as antidepressant drugs. In pain studies, they work about 50 per cent as well as active pain-relievers. But they don't shrink tumours or cure infections. Scientists, health officials and ethicists disagree on what kinds of studies involving placebos may justify subjecting patients to various degrees of risk or suffering and on whether such choices are best made by study participants, researchers or supervisory bodies. The revised Helsinki declaration would bar using placebos to evaluate a new drug for hay fever or migraine, explains Robert Temple, director of medical policy at the U.S. Food and Drug Administration's research centre. But testing such a medicine against another drug approved to treat such conditions generally doesn't measure its effectiveness as well as testing it against a placebo. ``There are a lot of trials where the (participating) person isn't giving anything up and wants to be in the trial,'' Temple says. ``The declaration bars them, too. I think that's paternalistic.'' Forbidding the use of placebos ``rules out development of all new therapies for conditions for which there are proven therapies,'' says Robert J. Levine, an ethicist and professor of medicine at Yale University. If researchers had followed such rules in the past, he adds, drugs currently used to treat high blood pressure or stomach ulcers never would have been developed because of the existence of older, less-effective treatments. Levine and Temple, among others, argue that subjecting studies to scrutiny by institutional review boards and informing prospective participants of the risks and benefits of a study provide sufficient safeguards. But Kenneth J. Rothman, a professor of epidemiology at Boston University, defends the revised Helsinki declaration, saying the interests of the individual patient always should supersede the desires of science, society or ``the rogue investigator who would diminish the rights of the patients in favour of some other goal.'' Bok says the thorniest ethical dilemmas involve research carried out in poor countries with the goal of developing affordable treatments, such as the recent controversial AIDS studies. The challenge ``is how to grant full respect to human subjects of placebo research and, at the same time, full concern for the needs of populations. I think we're only at the beginning of efforts to do that.''
THE WASHINGTON POST |
|