By MARC K. SIEGEL
May 12, 2007 -- CONGRESS may soon increase the Food and Drug Administration's oversight of pharmeceuticals. I certainly don't think we should simply trust what drug companies tell us, but I have my worries about the FDA, too.
Why? Consider one of my patients. Last year, the teen was in trouble - fighting with both parents during an ugly divorce and becoming severely depressed and violent. He'd had a fistfight with a relative and been expelled from his school
This year, he is not dead or in prison, but back in school. He's a much happier person who has been helped greatly by psychotherapy, time to heal his emotional wounds - and the anti-depressant Zoloft.
I can't say that he would have committed suicide without the medication, but the chances of his downhill spiral continuing would have been much greater. And the pill most certainly did not increase his chances of taking his own life.
Yet the FDA recently opted to impose its most serious "black box" warning on the prescription of anti-depressants to those aged 18 to 24. This sends the wrong message about drugs that are often life-saving.
What has led to these new warnings? An analysis of the use of 11 anti-depressants in 77,000 patients in this age group - which found an increased risk not of suicide but of suicidal thoughts for one patient in a thousand.
This number is quite small - and the FDA has a history of overestimating this kind of risk. It instituted a black-box warning against use of anti-depressants in children and younger adolescents in 2004. But a recent study in The Journal of the American Medical Association showed that the presence of "suicidal thoughts" in this group is less than half what the FDA had thought.
Is there any science behind the fears of these useful meds? Dr. John Mann, director of neuroscience at the New York State Psychiatric Institute and an expert on suicide, notes that starting an anti-depressant can occasionally remove inhibition and fear of death - "the person is no longer indecisive, and suicide may ensue."
But this theory is really a justification for careful observation by a trained professional like a psychiatrist, not for irrational fear of the drug. Any patient taking a drug for the first time may experience unexpected side effects, so early surveillance is always warranted.
And, while some caution about tiny theoretical risks may be in order, a growing fear of these drugs is hurting actual patients.
The pediatric warnings were instituted in March 2004; since then, the number of prescriptions of the common SSRI anti-depressants written for those under 19 has dropped by more than 10 percent. Meanwhile, childhood and adolescent suicides rose by nearly 20 percent in 2004 over the prior year. Fewer anti-depressants, that is, were followed by more suicides.
I worry that we'll now see that trend continue with the extension of the warnings to older patients. Worse, suicide grows more common among older teens, so the loss of life with the new warnings could be that much greater.
Warnings are only useful when they protect us against something dangerous. With untreated depression, the danger of suicide is far greater than the risk of the drugs that prevent it.
Dr. Marc K. Siegel is author of "False Alarm."