Harnissing the Power of the Placebo

Placebos drive drug companies crazy. Before they can market a new medicine they have to prove that it works better than an inactive sugar pill, also known as a placebo. In Europe they frequently call placebos "dummy pills."

The FDA won't approve a medicine until clinical trials demonstrate effectiveness. To rule out the power of expectation or suggestion, neither the investigator nor the volunteers taking the medicine know which subjects are getting the real deal and which ones are taking the dummy.

For reasons that are not completely understood, placebos are powerful medicine. They can banish warts, relieve depression, ease heartburn, calm a cough and help people with insomnia get a good night's sleep. They can even ease pain.

The very act of taking a pill--even a placebo pill--can recruit the brain's own chemical messengers to block pain receptors. This response has been known for years, ever since a nurse in World War II ran out of morphine and noticed that the soldiers who got a saline shot she offered as a pain reliever seemed to do surprisingly well.

For decades, scientists thought of this placebo response as a quirk of "mind over matter." They even suspected--wrongly, as it turns out--that placebo responders were a little weird, either neurotic or particularly suggestible.

Now, though, drug companies need a better understanding of the placebo effect. It has been getting in their way. That's because it can be hard to prove a new medicine really does work significantly better than a dummy pill.

Take antidepressants, for example. When Prozac first received approval from the FDA, it was a new type of medicine to combat depression. The drug was heralded as an important advance in fighting mental illness. A cover story in Newsweek magazine reflected the popular opinion that Prozac was a wonder drug.

Many years later, however, researchers uncovered a puzzling secret. They looked at both published and unpublished data submitted to the FDA for six popular antidepressants (Prozac, Celexa, Effexor, Serzone, Paxil and Zoloft). They found that these highly successful and pricey antidepressants worked barely better than placebos in clinical trials (PLoS Medicine, Feb., 2008). The authors concluded, "the overall effect of new-generation antidepressant medications is below recommended criteria for clinical significance."

Part of the problem was that the placebo response was so strong. In some trials, 80 percent of the improvement could be attributed to the placebo effect.

Drug companies have found that it is becoming more difficult to demonstrate that their new medicines actually work better than dummy pills. It's not just drugs that affect mood. New medications for Parkinson's disease and inflammatory bowel disease (Crohn's) have failed to establish their superiority over placebo.

Doctors and drug companies may need to rethink their understanding of placebos. If the human body can respond so convincingly to suggestion, then perhaps healers should be using that innate human capacity. Rather than consider such responses as a problem to be overcome in the course of drug development, perhaps it is time to look at new ways to harness the power of the placebo response.