OPINION
Depressing news on depression
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.
New York Times Editorial 23 April 2004
28 April 2004
http://www.nytimes.com/2004/04/23/opinion/23FRI1.html?ex=1083297600&en=9fa027f970d30129&ei=5062&partner=GOOGLE
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