The Placebo Debate: Is It Unethical to Prescribe Them to Patients?

By Elaine Schattner

Pills, liquid, or powder with no treatment value can be harmful to the doctor-patient relationship, which is predicated on a mutual trust, some say

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You might wonder, lately, if placebos can confer genuine health benefits to some people with illness. If you're reviewing a serious publication like the New England Journal of Medicine, you could be persuaded by results of a recent article on giving placebos to asthma patients in a randomized clinical trial. The topic has blossomed since 2008, when PLoS One reported on the use of mock treatments, without concealment, in people with irritable bowel syndrome. In that small study, participants experienced symptomatic relief even though they knew they were getting bogus remedies. Now, upon perusing the New Yorker, you might be mesmerized by Michael Specter's intriguing story on the history of placebos and burgeoning, research-minded attention to this highly-debatable subject at the intersection of health care, science, and medical ethics.

One area of consensus is the centricity of semantics in the discussion. How doctors define a placebo varies. In this light, any outcomes -- good, bad, or negligible -- ascribed to a placebo effect would depend on the term's meaning. According to the NIH-sponsored Clinical Trials website, a "placebo is an inactive pill, liquid, or powder that has no treatment value." But investigators in the field -- and skeptics too -- wonder about a gray zone where doctors prescribe low-dose or seemingly innocuous treatments but don't call these placebos. Perhaps the mystery lies in science -- how these can affect the mind's expectation of relief and, sometimes, harness hidden-but-powerful aspects of the doctor-patient relationship.

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"It's a complicated issue," suggests Frank Miller, Ph.D., a bioethicist at the NIH. His group surveyed internists and rheumatologists around the U.S. about their attitudes toward placebos. "Most think it's ethically acceptable. But it depends on the circumstances," he recounts. "They rarely will give a so-called inert placebo like a sugar pill, or an injection of saline solution," he says. "But frequently they'll prescribe certain kinds of treatments that are unlikely to work other than by a placebo response," he recounts. For example, a primary care physician might prescribe a multivitamin for a patient who feels tired. "He'll give it even if there's no reason to think the patient has a vitamin deficiency." That would be an "impure placebo," he explains.

A subtler, more realistic instance is when an older man takes saw palmetto for urinary difficulty, Miller says. Randomized studies have discredited this herbal compound for men with symptoms linked to an enlarged prostate. "It's a benign treatment," he says. "You can buy saw palmetto in health food stores, or on the Internet. And it's cheap," he adds. "It might help just as much as an expensive, prescription drug like Flomax," he adds. "I don't think there's anything wrong with recommending it, but you have to be honest about the evidence," he said.

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"It's unethical for a doctor to give a patient a placebo" says Dr. Harriet Hall, a retired family physician who writes critically about alternative and complementary approaches to medical care. "It involves deception," she emphasizes, "Lying is wrong, and if doctors start lying to patients, it destroys the trust. And that's a bad thing."

"There's a fine line," she considers. "Sometimes a doctor deceives himself by finding an excuse to give a drug that really isn't indicated," she says. If a doctor thinks a patient has a viral infection, but goes ahead and prescribes an antibiotic, they're giving that drug like a placebo, just to make the patient feel better. "And it may work," she adds. "It's a slippery slope."

"Placebos can make people feel better," she admits. "But the effect is small, temporary, and inconsistent, and doesn't have any objective effect on the disease process. Rather than giving a placebo, doctors should aim to enhance effective treatments with placebo effects by giving the patient more time, attention, and confidence," she wrote.

Hall takes issue with the NEJM report on placebos in treating asthma. In that study, patients received a medical inhaler, a placebo inhaler, sham acupuncture, or no treatment, she explains. "The people who got placebos felt better, but their lung function was not improved," she says. And that's where the danger lies: "Asthma can be fatal. If the patient's lung function is getting worse but a placebo makes them feel better, they might delay treatment until it is too late."

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"Deception is unethical," says Ted Kaptchuk. He directs the Harvard-affiliated, NIH-funded Program in Placebo Studies based at Boston's Beth Israel Deaconess Hospital. "But we've shown that even if you don't conceal it, a placebo can be powerful," he says. "It changes patients' perceptions about what they're experiencing."

Kaptchuk, who practiced acupuncture for years, stands out among the faculty at Harvard Medical School because he lacks a typical doctoral degree. Nonetheless, he's immersed himself in medical science, published in academic journals, and won significant grant support for his work. He considers clinical trials a top priority. There are two key issues for placebo research, he says. First, we have to verify that there is a demonstrable benefit in a particular clinical situation. "Then, where there is a placebo effect, the question is, 'how do we transfer the effects of a dummy pill into practice?'," he asked. "And how can we explain this to a wary group of doctors?"

"There's got to be transparency," Kaptchuk emphasizes. He is senior author of the NEJM asthma report. For that investigation, the patients underwent detailed psychological evaluations before enrolling. Each participant was told that if they received an inhaler, they would also get a sham treatment at some point during the protocol, he confirms.

"The role of placebos is limited," he acknowledges. They can't affect the underlying disease mechanisms in conditions like hypertension or arrhythmias, he considers. But they can influence subjective symptoms like pain and depression, hot flashes, and insomnia. "Those can be modified by some of the ritual aspects of giving medicine," he says. "So even if it's hard to apply placebos to cancer or heart disease, they might be useful for helping patients with pain and depression."

"It's weird," Kaptchuk concludes. "There are reasons why I thought placebos might work." Not all have panned out. "We should examine what are the ingredients in a doctor-patient relationship that can be modified or altered," he says. "By adding a supportive, warm, and empathic relationship to a dummy injection, we got much greater effects. That tells you something about medicine."

Image: Triff/Shutterstock.

This article available online at:

http://www.theatlantic.com/health/archive/2011/12/the-placebo-debate-is-it-unethical-to-prescribe-them-to-patients/250161/