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Education Reporter

Antidepressants Don't Work for Most Patients
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One of the largest studies yet of modern antidepressant medications concluded that the drugs have no effect on most patients who take them. The study looked at data from 47 clinical trials submitted to the Food and Drug Administration (FDA). Researchers concluded that the drugs had a clinically significant effect only on a very small subgroup of patients, those who were the most severely depressed. The study appears in the online journal Public Library of Science Medicine (PLoS).

The 47 clinical trials tested the four best known antidepressants: Prozac, Serzone, Paxil, and Effexor. These trials, some published and some unpublished, had been submitted to the FDA to support licensing applications for the drugs.

Irving Kirsch, the PLoS study's lead author, summarized his team's results: "There seems to be little reason to prescribe antidepressant medication to any but the most severely depressed patients, unless alternative treatments have failed to provide a benefit. This study raises serious issues that need to be addressed surrounding drug licensing and how drug trial data is reported."

The published studies are generally more positive about the drugs' effects than the unpublished studies. According to the PLoS analysis, pharmaceutical companies routinely withhold negative data on these drugs from doctors and the public, although they must present the data to the licensing authorities.

A report in the New England Journal of Medicine in January reached a similar conclusion. Of all studies of antidepressant drugs, about one-third are never published, and almost all of the unpublished studies report that the drugs are not effective. "Selective publication can lead doctors to make inappropriate prescribing decisions that may not be in the best interest of their patients and, thus, the public health," the Oregon Health and Science University research team warned. They also found that in some of the published studies, the final drafts "spun" the results to make them seem far more positive than the Oregon team judged them to be.

Antidepressants are the most commonly prescribed drugs in the United States. Doctors issued about 118 million prescriptions for them in 2005. Prescription of the drugs for children and teens has proved especially controversial. The FDA has officially approved only Prozac for children, but doctors commonly prescribe other antidepressants for them as well. All antidepressants now carry "black box" warnings advising patients and doctors that the drugs can cause suicidal thoughts or behavior in children, teens, and young adults up to age 24. Studies have shown that children on these medications have about a 4% chance of developing suicidal thoughts or behaviors, compared to a 2% chance among children taking placebos. Testing of the effects of these drugs on children has been extremely limited compared to testing of their effects on adults.

"Although patients get better when they take antidepressants, they also get better when they take a placebo, and the difference in improvement is not very great. This means that depressed people can improve without chemical treatments," said PLoS researcher Irving Kirsch in a statement. Exercise, counseling, and therapy are among the non-pharmacological treatments that research has shown can help some people cope with depression. (The Independent, 2-26-08; MSNBC, 2-26-08, 1-16-08)

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