YSM 85-3

BIOETHICS
able for a clinical trial to use a placebo as
a control — a question that has sparked
explosive debate within the bioethics community
for decades.
“Undivided Loyalty”
The relationship between the physician
and the patient is at the heart of the placebouse
debate. Physicians are bound by a legal
concept called the fiduciary obligation,
which calls for the physician’s undivided
loyalty to the interests of the patient. Therefore,
is it possible for a physician to give a
patient a placebo while still upholding this
obligation? If a physician conducts a clinical
trial knowing that half of the patients will
be given nothing more than a sugar pill, is
the physician truly fulfilling his or her duty?
The short answer, most bioethicists say, is
that it depends on the situation.
Use of placebo control groups has been
the gold standard of clinical research
since the 1960s. Courtesy of Tulane.edu
According to Levine, the use of a placebo
as a control is unquestionably ethical under
certain circumstances. One circumstance
arises when testing a therapy for a condition
for which there is no proven treatment. “If
there’s no medication out there that anyone
thinks is any good, then it is considered ethically
acceptable to give half of the patients
a placebo,” Levine said.
On the other hand, there are some circumstances
under which it is clearly unacceptable
to use placebos. If researchers are
testing a new therapy for a serious condition
that has a known effective treatment, it is
not considered ethical to give placebos to
any of the patients. “This would be considered
a serious violation of the fiduciary
obligation,” Levine said. If, for example, a
researcher were conducting a clinical trial on
a new medication that might prevent heart
attacks, they should not give any of the
trial participants a placebo if there already
existed a reasonably effective medication for
that purpose. Because use of a placebo in
such a situation could cause death or permanent
harm to participants, the researcher
would be obligated to test the performance
of the new drug by comparing it to that of
the known treatment.
Other examples, however, are not so
straightforward. Levine points to hypertension,
commonly known as high blood
pressure, as an example of a condition for
which the acceptability of placebo use is less
clear. Over time, untreated hypertension can
be deadly, increasing the risk for conditions
such as heart attack, stroke, and kidney
failure. Yet in the short-term, it is unlikely
to be fatal for individuals who are otherwise
healthy and are under the observation of
experienced doctors. Therefore, is it ethical
to use placebo controls when testing new
medications for hypertension?
Levine claims that, in these situations, it is
ethical to use placebos, provided that a few
conditions are met. First, the placebos must
only be used in individuals with a conditions
so mild that they are unlikely to develop
serious complications. Second, all trial participants
must be monitored carefully, and
withdrawn immediately from the trial at the
first sign of adverse effects. Finally, the trial
must only be conducted over a short period
of time — on the order of months, rather
About the Author
Dr. Levine believes that placebo use
in research on conditions like hypertension
is acceptable if certain
precautions are taken. Courtesy of
TheSurvivorsClub.org
than years. “We do these sorts of trials
under circumstances where nobody’s going
to get into serious trouble,” Levine said.
Above all, Levine stresses the importance
of acknowledging the complexities
of human research ethics. “Almost everything
you read in the papers is sound-byte
ethics,” he says. “Things are virtually never
as simple as they appear to be in the media.”
The complicated issues raised by the ethics
of placebo use force physicians to tackle
difficult questions about their responsibilities
to their patients, the place of scientific
research in society, and the moral duties that
bind us together as human beings.
Bridget Kiely is a freshman in Calhoun College planning to major in Molecular,
Cellular, and Developmental Biology.
Acknowledgements
The author would like to thank Dr. Levine for sharing his expertise concerning
placebo use in bioethics.
Further Reading
• Levine, Robert. “Placebo controls in clinical trials of new therapies for conditions
for which there are known effective treatments.” The Science of the Placebo: Toward
an Interdisciplinary Research Agenda. Ed. H. Guess, A. Kleinman, J. Kusek
and L. Engel. London: BMJ Books, 2002.
www.yalescientific.org April 2012 | Yale Scientific Magazine 13