From the Editor: Second Thoughts - Pharmaceutical Executive

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From the Editor: Second Thoughts


Pharmaceutical Executive


Patrick Clinton
A day or two after the shootings at Virginia Tech, the newspapers carried an account of an important new study in the Journal of the American Medical Association. It was a week of shock, grief, and not a little morbid fascination, and I suspect that not many readers took notice. That's too bad, because the JAMA study and the coverage of Seung-Hui Cho cast genuinely useful light on each other.

The study, conducted by a team led by Jeffrey Bridge, associate professor of pediatrics at Ohio State University and an investigator at the Columbus Children's Research Institute, was a review of 27 published and unpublished trials of second-generation antidepressants

(including selective serotonin reuptake inhibitors, or SSRIs) in patients younger than 19. Their findings—no real surprise—were that the drugs were effective in treating anxiety and obsessive-compulsive disorder in young patients, and modestly effective in treating major depression. And though they caused an increase in suicidal thoughts, it happened to only about one patient in 100, half the rate FDA had previously estimated. The benefits, it appeared, outweighed the risks.

Overall, Bridge told a reporter from the Web site http://Foodconsumer.org/, "Our findings mean that antidepressants should be considered as a first-line treatment option for pediatric depression and anxiety disorders."

It's not that different from what FDA and its advisory committee have already said. But have doctors and patients actually understood what they've been hearing for the past few years?

I'd vote no, based on another recently published journal article, this one from the April issue of Archives of General Psychiatry. The study, by Quintiles' Amir Kalali and colleagues, looks at how antidepressant use was affected by FDA's black-box warning for antidepressants and the process that led to it. The results were striking: After FDA's February 2004 hearings on SSRIs, prescriptions for the drugs for children and adolescents started dropping each month through September 2004—the total drop was 18.6 percent. At that point, the prescription rate stabilized for six months, then began a slow rise.

Now, a drop in the use of a particular class of drugs isn't necessarily a bad thing, but in this case, as doctors turned away from SSRIs, they doubled their use of buproprion, an atypical antidepressant that carries exactly the same black-box warning. And though I can't prove it, my gut tells me that the prescription drop wasn't just squeezing out overutilization; it was taking drugs away from patients who needed them.

If you doubt that, consider this: During the same time that pediatric use of SSRIs dropped more than 18 percent, the suicide rate for children and adolescents rose at almost exactly the same pace—18 percent.

It's important to be cautious with the data. The rise in the suicide rate may prove to have no relation to the drop in the use of antidepressants. But I bet it doesn't. I expect that in a year or so, the public will finally get around to saying, How could we have been so wrong? Why did we spend so much time thinking about the risks of the drug and so little thinking about the risks of not taking it? What's wrong with a drug-safety system that misleads us so badly?

At least I hope that's what people start asking. You can't build a sound system of public health on the single pillar of avoiding drug risk. As we've learned again in recent weeks: Sometimes failure to treat can kill.

Patrick Clinton Editor-in-chief


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