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Jan. 14, 12:42 EDT |
Health
officials torn on ethical use of placebos |
Fierce
debate erupts in wake of revision to Helsinki declaration |
Susan
Okie
SPECIAL TO THE STAR |
WASHINGTON - THE USE of placebos - inert, dummy medicines - as a tool
for evaluating new drugs has ignited a fierce ethical debate in the wake
of a revision to a key international medical document.
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 |
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