Sometimes a placebo is the way to go

Key Points

Scientists have long known of the "placebo effect," when positive clinical outcomes are caused by treatments not known to bring about such results. It is usually explained as the effect of a positive expectation-patients given a fake or ineffective treatment often improve simply because they expect to improve.

In the study, a placebo was defined as a treatment whose benefits derive from positive patient expectations and not from the physiological mechanism of the treatment itself. Sixty percent of doctors indicated they would recommend a sugar pill for patients with chronic pain if it had been shown to be more effective than no treatment.

This raises several ethical and legal issues. The American Medical Association recommends that patients have full knowledge of treatments recommended by their doctors. State laws require that patients with capacity be given sufficient information about any proposed treatment so they can make an informed decision to consent or refuse.

The inherent catch-22 is the likelihood that the placebo effect would be undermined if patients were explicitly told they were getting a dummy pill.

One possible solution is to document the reasons why orthodox prescriptions may be insufficient, and why the patient's best interests might be served by the use of a placebo. Some states don't require physicians to share information with a patient if the information would damage the patient. These exceptions to the necessity of informed consent are envisioned for use with patients whose morbidity might deteriorate if told about potential bad outcomes. This reasoning could be extended to cover situations involving placebos.

If you use any exception to the necessity of informed consent, you would be well-advised to document your reasoning in case your judgment is questioned later. If you are prescribing something other than a sugar pill, there may be side effects, interactions with other drugs, and patient expenses.

Those factors raise the likelihood of a litigable problem. If the patient has a bad result and files suit, you will have to explain to a jury's satisfaction why you took an unorthodox course.

Further, since patients have access to their own records in some manner in virtually every state, the "placebo effect" would be compromised once the patient reads his own records.

The fact that ethical and legal issues are raised does not necessarily mean that prescribing placebos is an inherent evil. Many patients seek additional pain medications, and many exhibit some hypochondriacal symptoms. Some patients demand the latest high-end, TV-propelled drug. Short of recommending a psych evaluation, the easiest solution that conforms to the "Do no harm" principle may be a placebo.

The author is a healthcare attorney in Mt. Kisco, New York, specializing in risk-management issues. She can be reached at lj@bestweb.net. Malpractice Consult deals with questions on common professional liability issues. Unfortunately, we cannot offer specific legal advice. If you have a general question or a topic you'd like to see covered here, please send it to memalp@advanstar.com
.