AMA: Ethics Council's Stance on Placebo Therapy Sirs Unease

CHICAGO, June 16 - Is is not proper for clinicians to use placebo therapy in everyday practice without telling patients first, according to the American Medical Association's ethics council.

A report by the Council on Ethical and Judicial Affairs (CEJA) said that it is unethical for a physician to use a placebo in the guise of therapy without the "knowledge and cooperation of the patient."

But many physicians in the AMA's House of Delegates, which met here, took great umbrage that the council would put the use of placebo therapy, without giving patients notice, outside the realm of ethical behavior. Their lengthy vocal protests, demanding that the council reconsider its opinion, suggested that placebo therapy is common in everyday practice.

When the AMA House of Delegates disagrees with a CEJA report it cannot amend it but can ask the council to reconsider, which is what happened in this case. Priscilla Ray, M.D., a Houston psychiatrist who chairs the council, said the group would attempt to fine-tune language but the ethics of the issue were not likely to be modified.

The net result is that CEJA will resubmit its placebo report to the AMA House at its interim meeting in November or at the annual meeting next June. If the AMA signs off on the report, the placebo opinion will be codified in the Code of Medical Ethics, which is updated annually.

The CEJA report dealt only with the use of placebo in clinical practice, not the use of placebo in clinical trials.

Randomized placebo-controlled trials often report a benefit for patients randomized to placebo and in some trials that effect is greater than the benefit of active treatment. This, it seems, had led some physicians in clinical practice to prescribe the placebo rather than a drug or device that is therapeutically active. And that is an ethical slippery slope, according to the council.

"In clinical trials this is not an issue because patients are aware that they may receive an active treatment or they may receive a placebo," said Dr. Ray. Moreover, in clinical trials placebo use is closely monitored by institutional review boards, she said.

The sticky issue for CEJA was the use of placebos in everyday medical practice.

Richard Wiseley M.D., an AMA delegate from Toledo, Ohio said there is a "strong historical precedent for the use of placebo in clinical practice." But Dr. Wiseley and other physicians who testified during a hearing on CEJA's placebo report argued that the value of the placebo could be diminished or "nullified" if the patient were informed that the pill or treatment had no known clinical value.

Robert Sade, M.D., a thoracic surgeon from Charleston, S.C., and the vice-chair of CEJA, responded that keeping the patient in the dark had the potential to "undermine the trust of the patient."

Dr. Sade said that a permissible single-patient clinical trial approach may be useful in making a diagnosis when the physician is faced with significant clinical uncertainty. Patients should be told that they will be alternately be given a substance that is "not pharmacologically specific for the condition being treated" but may be helpful and in any case will not worsen the condition.

CEJA also came down against using placebos as an expedient to mollify a difficult patient.

Michael Williams, M.D., a neurologist at Johns Hopkins, who represents the American Academy of Neurology in the AMA House, said he doesn't use sugar pills-"actually I don't know where you get those sugar pills"-but he sometimes uses a sham procedure. "I treat many patients with normal pressure hydrocephalus," he said. "These patients have shunts that I can adjust. Sometimes a patient will ask for an adjustment, when I'm not sure that an adjustment is clinically indicated."

In those cases he said he sometimes tells the patient that he is going to try something but he doesn't give specific details to the patient. Instead, he tells the patient that he is either going to adjust the shunt or he is going to leave the pressure adjustment unchanged. "But I do tell them that there is a possibility that that the treatment will be active and I assure them that they won't be harmed by the treatment," he said. He then tells patients that they should "simply concentrate on the effect and tell me what occurs."