Lethal FDA Warning

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The willful blindness of the Food and Drug Administration (FDA) -- its overcautious reluctance to approve new drugs -- has led to historic declines in new drug approvals, which will cost lives in years to come.

A more immediate tragedy, though, is FDA's refusal to withdraw its off-putting "black-box" warning label on antidepressants for teens.

A new study confirms that the disastrous rise in teen suicides -- first noted in last year's analysis of 2004 data -- persisted in 2005, albeit to a lesser degree. Most experts agree the first such rise in decades was due largely to FDA-generated publicity in late 2003 about drugs for depression causing "suicidality" -- self-destructive thoughts.

No actual suicides occurred in these FDA evaluations, only thoughts about suicide. Yet this hubbub was shortly followed by the FDA's mandate of a "black-box" warning label on Prozac and other antidepressants often prescribed for teens suffering from the real agony of depression.

Studies done over the ensuing years confirmed the obvious: Fewer prescriptions were written for these safe and effective drugs -- and those written were likelier to come from psychiatrists instead of the pediatricians and family doctors these troubled youngsters had always relied upon for treatment. Why? Primary caregivers were spooked by the new skull-and-crossbones-like warnings on the medicines, even though the drugs had been effective and well-tolerated. Always fearful of lawsuits anyway, family docs decided in large numbers that "better safe than sorry" would apply -- and referred their young patients to specialists, creating another hurdle in the path of effective treatment.

To any objective observer, the cause-and-effect pattern was clear: Baseless FDA warnings of "suicidality" plus black-box warnings led to a decline in physician prescribing (and parental acceptance) of safe and effective antidepressants -- and the rate of teen suicide rose to a historic, and tragic, degree. Defensive FDA talk last year about a "chance spike" in teen suicides is refuted by these new data, which confirm a real increase (while prescriptions continue to lag).

Experts in teenage depression continue to petition the regulators to remove the warning label. Amazingly, despite the statistical evidence of more than 600 needless young deaths for the years 2004-05 -about 1 each day -- FDA spokeswoman Sandy Walsh said, "We never intended to discourage appropriate prescribing."

She went on to imply that valuable habits were encouraged in doctors by the warning label despite all those deaths: "It's still good advice to monitor patients starting treatment."

I am confident that doctors prescribing drugs that are powerful but potentially dangerous (as many beneficial drugs are) know how to monitor depressed patients better than does Ms. Walsh, though her gratuitous advice is appreciated.

If she actually wanted to benefit public health, perhaps she should stop lecturing doctors and instead tell her bosses at the FDA that the time is long past when the inappropriate warning label on antidepressants should be removed. Every day it remains -- frightening parents, teens and doctors -- costs a youngster his or her life. These are real lives, not hypothetical ones.