A nationwide survey this year suggested that as many as half of U.S. doctors prescribe a fake treatment -- or placebo -- at least once a month. Adam Kolber suspects that his dermatologist is one.
Kolber visited the doctor because after his bug bites had faded, the itching didn't. The dermatologist proffered a small bottle of lotion and said it ought to provide relief. He didn't explain why, Kolber recalls.
Sure enough, the itching stopped after he applied the lotion, and Kolber, a law professor who has written about placebos, suspects that the doctor's assurance of relief, not any ingredient in the lotion, is what scratched his itch.
"Something like itching has a very strong psychological component," Kolber says.
Doctors have known about the placebo effect, a product of the interaction between mind and body, for decades. They've seen patients' discomfort diminish after taking a sugar pill or getting an injection of saltwater. Placebos work only as long as patients don't know they're fake, research suggests. But is it ethical for doctors to deceive patients by not telling them?
The American Medical Association says no, but the survey found that one in 20 doctors who prescribed placebos explicitly described them as such to patients. The survey, which was published in the journal BMJ in October, has helped fuel debate about whether their potential to make patients feel better outweighs doctors' responsibility to be truthful.
In addition, the survey found that most doctors who prescribed placebos, no longer able to obtain innocuous sugar pills, actually were using real drugs not proven effective in treating patients' complaints. These "impure placebos," such as antibiotics and sedatives, could be doing more harm than good.
"Until 1960, a physician in any hospital in the United States could order a placebo," says Harvard scientist Ted Kaptchuk, who has long studied the placebo effect and co-wrote the report about the doctor survey. Doctors even could specify what color sugar pill they wanted, he says.
"It was routine care until really the end of the '60s," when the civil rights revolution led to an increased emphasis on patient autonomy and informed consent. Increasingly, effective treatments became available, which reduced doctors' reliance on placebos.
Today, the only sugar pill on the market is cherry-flavored Obecalp (spell it backward), which is aimed at children. (Some critics wonder whether parents who dispense Obecalp might be contributing to a whole new generation of pill-poppers.)
For clinical trials only, drug companies make placebos that look identical to their products, so neither the researchers nor the participants know who's getting a placebo and who's getting the real thing.
Studies have shown repeatedly that placebos are effective in treating health complaints with a strong psychological component, such as pain, depression, constipation and erectile dysfunction.
"The more vague the complaint, the more room for the mind to affect perception," Kaptchuk says. Placebos can't cure cancer -- "the mind has power, but it's not a superpower"-- but given the right setting and the right complaint, they might work as well as proven drugs, he says.
Acupuncture plus attention
In a study published in the May issue of BMJ, Kaptchuk and colleagues examined the placebo effect in patients with irritable bowel syndrome.
The researchers compared no treatment, placebo acupuncture (using "needles" that appeared to pierce the skin but actually retracted into a hollow handle) and placebo acupuncture plus extended interaction with friendly acupuncturists coached on what to say and how to say it.
The sham acupuncture was better than no treatment but not as effective as sham acupuncture plus the attention of a practitioner. Patients who received both the sham acupuncture and their acupuncturist's attention did as well as patients in trials of drugs used to treat irritable bowel syndrome, researchers say.
Apparently, "such factors as warmth, empathy, duration of interaction and the communication of positive expectation might indeed significantly affect clinical outcome," the authors write. In other words, bedside manner seems to play an important role in the placebo effect.
"There's not a doctor I don't talk to who says, 'Yes, part of my role is to be a priest and to have this healing function,' " says Arthur Caplan, director of the Center for Bioethics at the University of Pennsylvania.
Yet, while "we're very superstitious and open to all kinds of magical inputs in our lives" -- think lucky underwear on Game Day -- "we seem a little more surprised when it pops up in a place like medicine."
In an e-mail Kolber cites in "A Limited Defense of Clinical Placebo Deception," Paul Arnstein, a Boston College associate professor of community health, refers to placebo use as one of medicine's "dirty little secrets." Kolber published the article in January in the Yale Law & Policy Review.
A survey of 466 internists at three Chicago medical schools reported last year in the Journal of General Internal Medicine found nearly all 231 respondents believed placebos can make patients feel better, and almost half said they had prescribed a placebo. Only 12% said they thought placebo use in routine medical care should be prohibited.
This year's nationwide survey of 1,200 U.S. internists and rheumatologists echoed those findings. Nearly two-thirds of the 679 respondents said they believed prescribing placebos was "ethically permissible." Nearly half said they had prescribed placebos more than once a month.
Both surveys found little use of pure placebos, namely sterile saltwater shots or sugar pills. Instead, doctors said they prescribed antibiotics (which treat only bacterial infections) for viral infections, sedatives, vitamins, pain relievers and doses of other drugs too small to have a therapeutic effect.
"They're basically relying on the symbolic value of the pill," says Rachel Kermen, lead author of the Chicago survey and a physical medicine resident at the Rehabilitation Institute of Chicago. "There should be ways to avoid the potential dangers of using something that has real chemicals in it." She suggests stocking pharmacies with sugar pills.
Ezekiel Emanuel, co-author of the national doctor survey, acknowledges that "we should be worried" when doctors prescribe real drugs as placebos. But pure placebos need to be taken seriously, says Emanuel, bioethics chairman at the Clinical Center of the National Institutes of Health.
"If there's power here, and there's not much harm here, I think we're faced with the challenge: Well, what's the downside?" he says. "We need some serious ethical reflection and probably a little more data."
For example, he says, his team now plans to ask patients what they think about placebos.
'May undermine trust'
Emanuel's doctor survey was conducted six months after the AMA House of Delegates adopted an ethics policy prohibiting the use of placebos without patients' knowledge. Like the physicians who responded to the surveys, the AMA defines placebo more broadly than a sugar pill.
"A placebo is a substance provided to a patient that the physician believes has no specific pharmacological effect upon the condition being treated," according to the AMA's 2-year-old policy. "In the clinical setting, the use of a placebo without the patient's knowledge may undermine trust, compromise the patient-physician relationship and result in medical harm to the patient."
Law professor Kolber says the AMA went too far. No cases of medical malpractice suits filed by patients who learned their doctors had deceived them by prescribing a placebo have been published, he says. But the AMA's ethics policy could change that: "The AMA may have just created liability for its doctors by creating this industry norm."
Imagine, though, says AMA board member Ardis Hoven, if you discovered your doctor, without telling you, had prescribed pills for which there was no evidence of effectiveness against your pain.
"Unless you're upfront with a patient, you're going to get into an area of trust erosion, and that is something I can't afford to lose with my patients," says Hoven, a Lexington, Ky., infectious-disease specialist.
Doctors could still cover themselves, she says, by telling a new patient they might surreptitiously prescribe a fake treatment to harness the placebo effect.
"Open-ended consents usually aren't ... taken very seriously, but I think in that case, you could do it," Caplan says. One problem, he says: Patients would always be trying to guess which treatments were placebos.
So doctors should just tell them the truth, an approach that, not surprisingly, leaves some placebo researchers skeptical, Oskar van Deventer says.
Doctors could capitalize on the scientific evidence that while sugar pills are inert, the placebo effect they evoke is real, van Deventer, an engineer, reasons in an article in the September issue of Medical Hypotheses. He says he came up with the idea of full disclosure after talking with some friends in pharmaceutical sales.
"At least part of the placebo effect is the attention from the doctor, the effect of being taken seriously, the effect that there's medical research behind it," van Deventer said in a phone interview from his home in Leidschendam, Netherlands.
"Even though it's absolutely fake, the effect could still be there."
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