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Pharmaceutical Drugs Marketing Myth: Depressing News on Depression

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Depressing News on Depression
New York Times

Published: April 23, 2004

Antidepressant drugs are being widely administered to children and adolescents despite increasing concern that the benefits have been oversold and some potentially dangerous side effects minimized. The jury is still out on whether the modest benefits of some of these drugs outweigh the small risks they impose. But the escalating debate makes us wonder, uneasily, whether doctors have been dispensing the pills far too cavalierly despite a dearth of evidence to support their value.

The issue that has dominated recent discussion is whether the most commonly prescribed antidepressants increase the risk of suicide in children and adolescents. British health authorities have cautioned against using most of them in children under 18, and a top expert at the United States Food and Drug Administration considers most of the drugs too risky. But the F.D.A. as a whole is not yet convinced that the risks outweigh the potential benefits.

Not a single participant in trials of the drug has actually committed suicide, and there is uncertainty as to whether all the events classified as suicide attempts or suicidal thoughts were really what they seemed. The F.D.A. has contracted for an evaluation of the evidence by outside experts. For now, the agency is simply urging doctors to monitor their patients closely and is seeking stronger warning labels for 10 antidepressant drugs.

It is extraordinarily important to get the final judgment right. Depression, left untreated, is a major cause of suicide, and there is ample testimony from many young people and their doctors that the pills are vital for their well-being even if the overall evidence of effectiveness is weak. It remains to be determined whether, on balance, it is riskier to give the drugs or to withhold them.

What seems most astonishing is the skimpy evidence that these drugs work at all in most young patients. All the antidepressant drugs were approved for marketing based on clinical trials in adults, but once they were on the market, doctors were free to prescribe them for any patients and any purpose. Under a federal law that was drawn up to coax drug companies into studying the effects of their drugs in young people in exchange for an extension of patent rights, the major manufacturers studied their antidepressants in patients under 18. So far, only Prozac has shown enough evidence of effectiveness and safety to win approval from the F.D.A. and British health authorities. The discouraging results underscore the need to test all drugs in children that will be used in children because the effects are often different from those found in adults.

Many leading psychiatrists are convinced that the drugs have value in young people, based on what they deem positive results from some studies. But a critical evaluation by Australian researchers in a recent British Medical Journal article concludes that the authors of the largest published studies "have exaggerated the benefits, downplayed the harms, or both," possibly because of financial ties to the pharmaceutical industry.

Clearly, the companies and medical experts who believe that antidepressants can help young patients have a lot more work to do to make their case. The issue would seem important enough for the government, perhaps through the National Institute of Mental Health, to finance a large and well-designed study to get a definitive answer.



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