Placebos: What place do they have in medicine?
Placebos: What place do they have in medicine?
Honesty is foremost ethical concern
There are several ethical questions surrounding the American Medical Association's policy prohibiting physicians from giving substances they believe are placebos to their patients unless the patient is informed of and agrees to use of the substance, according to a 2012 report from the Hastings Center.1
Irresponsible use of placebos could harm patients by preventing them from getting more effective treatment, acknowledges Anne Barnhill, the report's author and a lecturer for the Department of Medical Ethics and Health Policy at the University of Pennsylvania in Philadelphia.
"Undisclosed use of placebos might violate a patient's autonomy because the patient doesn't have the opportunity to give informed consent," she says. "However, not all ethicists agree that undisclosed placebo use is always a violation of patient autonomy."
Trust is biggest issue
Matthew Wynia, MD, MPH, director of the American Medical Association's Institute for Ethics and an assistant clinical professor at the University of Chicago Hospitals, says that being honest with patients is "absolutely critical, and that holds true when dealing with the use of a placebo."
If patients learn they were given a placebo without their knowledge, this might erode the patients' trust in their individual doctor and also in doctors more generally, says Barnhill.
The patient might feel "duped into taking a 'fake' treatment, or that his doctor is a quack, and the patient might consequently lose trust in his doctor," says Barnhill. "On the other hand, the patient might think that a doctor who uses placebos is really cutting edge, or savvy, about mind-body connections."
Given that the doctor doesn't know what patients will conclude in these cases, the most cautious approach to protecting the patient's trust in medicine is for the doctor to tell the patient whether the treatment is commonly considered a placebo, says Barnhill.
Wynia agrees. A physician telling a patient he or she was given a medication when the patient actually got a placebo, such as a saline injection instead of a narcotic for a migraine headache, would be an "egregious practice," he says.
"I suspect that this has gone down substantially," says Wynia. "The value that people place on honesty and shared partnership is so much higher now than it was 30 or 40 years ago," he says. "It's a rare patient these days that would tolerate a doctor they thought was lying to them."
How big is effect?
There is also some debate as to whether the placebo effect exists, says Wynia, noting that if a particular drug is compared with a placebo and both groups of patients get better, this isn't necessarily the result of the placebo effect.
"To really test the placebo effect, you would have to compare it against a 'no treatment' arm," he says. "If you are only comparing a placebo versus a drug, there is a chance that all you are witnessing is regression to the mean."
Of the few studies that have been done with treatment, placebo, and no treatment arms, says Wynia, "it doesn't look like the placebo effect is very large at all. It could be that people are using things as placebos in the belief that the placebo effect is very important, when in fact it may not be."2 (See related stories on non-deceptive practices and what constitutes a placebo, below.)
- Barnhill A. Clinical use of placebos: Still the physician's prerogative? Hastings Center Report 2012;3:29-37.
- Hrobjartsson A, Gotzsche PC. Is the placebo powerless? An analysis of clinical trials comparing placebo treatment with no treatment. N Engl J Med 2001;344:1594-1602.
Anne Barnhill, Lecturer, Department of Medical Ethics and Health Policy, University of Pennsylvania, Philadelphia. Phone: (215) 898-7136. E-mail: [email protected].
Charlotte Blease, PhD, Faculty, School of Politics, International Studies and Philosophy, Queen's University, Belfast, Northern Ireland, UK. E-mail: [email protected].
Matthew Wynia, MD, MPH, FACP, Director, The Institute for Ethics and Center for Patient Safety, American Medical Association, Chicago, IL. Phone: (312) 464-4980. E-mail: [email protected].
Non-deceptive options do exist
"It's often argued that patients would be less trusting of their doctors if they later discovered that their physician had intentionally prescribed a placebo," says Charlotte Blease, PhD, faculty at the School of Politics, International Studies and Philosophy at the Queen's University Belfast in Northern Ireland, UK.
"Theoretically at least, gone are the days of paternalism in medical practice, whereupon physicians were not obliged to be fully honest about the treatment choices available to patients," she says.
Nowadays, failing to allow patients to make fully informed, autonomous decisions about the treatments available to them, including allowing patients to choose not to be treated, is considered "not only to be unethical but unlawful," says Blease.
While it's usually assumed that for a placebo to work it must involve deception on the part of the medical professional, this isn't necessarily the case, says Blease, pointing to a 2010 study that concluded that open-label placebos may be an effective treatment for irritable bowel syndrome.1
"This, at least, opens up the possibility of 'non-deceptive' placebos in clinical practice," Blease says.
If a physician is uncertain about whether a treatment is going to work for a particular patient, he or she may give the patient the option of comparing the results of the treatment with a placebo for a period of time and tracking his or her symptoms.
"That is personalized medicine. It shows respect for the patient and engages them in treatment," says Matthew Wynia, MD, MPH, director of the American Medical Association's Institute for Ethics.
Ethical gray area: What is a placebo?
When most people hear the word "placebo," they probably think of sugar pills, but some bioethicists argue that even the physician's ability to listen and show empathy could fit the definition.
In fact, there are lots of "gray areas" with regard to what constitutes a placebo, according to Charlotte Blease, PhD, faculty at the School of Politics, International Studies and Philosophy at the Queen's University Belfast in Northern Ireland, UK.
In a recent paper, Blease argued that it may be better to use the term "positive care effects" rather than "placebos." "The term placebo seems to conjure up the rather simplistic notion of sugar pills," she explains.1
While an American Medical Association's policy requires doctors to tell patients if they believe a treatment is a placebo, it doesn't doesn't explicitly address cases in which the doctor disagrees with the consensus view about whether a treatment is a placebo, notes Anne Barnhill, a lecturer for the Department of Medical Ethics and Health Policy at the University of Pennsylvania in Philadelphia.
"Doctors might wonder, in those cases, 'Must I report the consensus view about a treatment, or may I just tell the patient what I believe?'" she says.
One kind of "gray area" case is when a physician offers a treatment that he or she believes is effective for the condition being treated, but the physician doesn't know whether it works because it has a specific effect on the condition being treated or whether it works via the placebo effect, says Barnhill.
"Another 'gray area' case is when a physician offers a treatment that she believes has a specific effect on certain conditions," she says. "But for the condition she is now trying to treat, she is unsure whether the treatment has a specific effect or is effective at all."
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