AMA: It's not OK to use placebos deceptively

Las Vegas -- Physicians may use placebos only if patients agree, and doctors should never resort to placebos for their own convenience or to mollify a difficult patient, says a new ethical policy the AMA House of Delegates adopted at its November Interim Meeting.

The new measure defines a placebo as "a substance provided to a patient that the physician believes has no specific pharmacological effect upon the condition being treated" and says that deceptive use of placebos in a clinical setting "may undermine trust, compromise the patient-physician relationship and result in medical harm to the patient."

It is not only patients' trust that is undermined, but their care could be delayed or their condition misdiagnosed if physicians rely on deceptive placebo use, said Robert M. Sade, MD, chair of the AMA's Council on Ethical and Judicial Affairs.

According to the adopted council report, there is evidence suggesting that patients can benefit from a placebo even when they are aware it is being used. The report says physicians could explain to patients that a better understanding of their condition can be achieved by evaluating different medications, one of which could be a placebo. The council report also says doctors may use placebos, with patients' consent, in single-patient controlled studies known as N-of-1 trials.

The policy was first proposed at the June Annual Meeting but referred after several physicians testified about successes with undisclosed placebo use. At the November Interim Meeting, Michael E. Greene, MD, a Macon, Ga., family physician, talked about a doctor he knew who would deal with elderly, comfort-seeking patients by using three inert, different-colored pills of supposedly varying strengths.

"It works," Dr. Greene said. "I saw it time and time again. And I'm tired of being told that everything I do is unethical."

Regina M. Benjamin, MD, a family physician and council member speaking for herself, asked fellow delegates to put the shoe on the other foot. "As physicians, we're all going to become patients at some point in our lives," she said. "How would we feel if, after the fact, we were told by our physician that we were given a placebo? How many of us would like that idea?"

In the final tally, 64% of delegates voted to adopt the new policy.

Other policies adopted

If a pharmacist or pharmacy chain refuses to fill a patient's valid prescription, the prescription should be returned to the patient, and prescribing physicians should be notified, a newly modified AMA policy says. This strengthens an already existing AMA policy that calls for legislation requiring pharmacists or pharmacy chains to fill valid prescriptions or provide immediate referrals.

The urgency of the policy, first proposed at the June Annual Meeting, has diminished somewhat since the Food and Drug Administration earlier this year approved over-the-counter sales of the emergency contraceptive pill, marketed as Plan B, for women 18 and older.

Delegates also voted to amend the AMA's ethical opinion on confidentiality to clarify doctors' legal and ethical obligations. The amended language says that when the law requires physicians to disclose confidential patient information, they should notify their patients. Also, the opinion says, doctors should only "disclose the minimal information required by law and advocate for the protection of confidential information and, if appropriate, seek a change in the law."

Lastly, the AMA Foundation gave Cherry Hill, Colo., bioethicist Fredrick R. Abrams, MD, its Isaac Hays, MD, and John Bell, MD, Award for Leadership in Medical Ethics and Professionalism. Dr. Abrams founded the Center for Applied Biomedical Ethics at Rose Medical Center in Denver, the first U.S. community-hospital center for the study of ethical issues.

"Dr. Abrams foresaw the need for formal education in bioethics among practicing physicians, and his continued encouragement ultimately led to the formation of the AMA's Educating Physicians on End-of-Life Care program," AMA Foundation President and board Trustee Peter W. Carmel, MD, said in a statement.