Wednesday, May 16, 2007

Antidepressants need more scrutiny

Antidepressants need more scrutiny
Some studies are at odds with the Star Tribune's enthusiasm for this group of drugs.
May 16, 2007

The child, who according to press reports hanged herself shortly after watching Animal Planet from her father's lap, did not have an illness associated with suicide. Yet following a spike in agitation while on the drug, she felt so compelled to end her own life that she apparently needed to bend her knees to bring about death. At age 12.

Having sat through the December 2006 FDA hearing on an updated label for the drugs, I thought the recent editorial seemed like much of the media assessment of the issue -- distressingly stenographic and remarkably uncurious about an issue that involves the health of millions of Americans, and one in which little is as it appears.

In just one of its many surprisingly immodest endorsements of the drugs, the editorial suggested that "the serotonin-lifting medications have worked wonders for millions of Americans caught in the life-crushing grip of depression." If antidepressants' serotonin-lifting properties were indeed their mechanism of action, one surely would not wish to scare users away.

But it is entirely possible that lifting serotonin has nothing to do with the drugs' effectiveness. In 2002, after obtaining data through the Freedom of Information Act, psychologists Irving Kirsch and Thomas J. Moore published a much-cited meta-analysis of the entire FDA database of SSRI clinical trials in the journal Prevention and Treatment.

They found that most studies of antidepressants had failed to prove they worked, and in those that did, 80 percent of the drugs' benefit was replicated in test subjects taking a placebo. The remaining difference, the authors determined, was an antidepressant effect so small it would have equaled the amount of improvement in mood one gets from a good night's sleep.

The Star Tribune's editorial quoted studies suggesting that only a small number of suicides or suicidal acts are related to antidepressants. According to David Healy, author of "Let Them Eat Prozac" and former secretary for the British Association for Psychopharmacology, patients often drop out of studies when they become suicidal, thereby lowering the incidence on paper of the effect.

Critical readers can even find cause for suspicion in the recent and much-touted Journal of the American Medical Association meta-analysis, which found that benefits slightly exceeded risks in antidepressants for children and adolescents. All but three of the 27 studies included in the meta-analysis were published drug studies. Drug companies often find something different in the studies they choose not to submit for publication.

According to a 2003 Swedish review in the British Medical Journal, "without access to all studies (positive as well as negative, published as well as unpublished) ... any attempt to recommend a specific drug is likely to be based on biased evidence." By 2004, Lancet editor Richard Horton would conclude that "journals have devolved into information laundering operations for the pharmaceutical industry."

There may indeed be "no reason to be fearful" of antidepressants, as the Star Tribune argued. It seems at times, however, that the real parties sowing fear on this issue are the defenders of antidepressants. The critics of the drugs are merely asking for the opportunity, when agreeing to take a medication, to offer consent that is fully informed.

Paul Scott is a Rochester writer and the author of "Bitter Pill," an article in the current issue of Minnesota Monthly about Minneapolis-based antidepressant safety advocate Kim Witczak.

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