ntidepressant 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