Wednesday, April 18, 2007

Thanks, FDA

New article in JAMA, that says that antidepressants are not be bad for teens after all. They do indeed cause a slightly increase in suicidal thoughts, but no increase in actual suicide attempts, and gee, they help people recover from their psychiatric illness. See the following press release:

According to a new study, conducted by the Center for Innovation in Pediatric Practice (CIPP) at Columbus Children's Hospital and published in the April 18 issue of The Journal of the American Medical Association (JAMA), there is more information for parents about the risks and benefits of antidepressant treatment for children with depression and anxiety disorders.

The Children's Hospital study found the overall benefits of antidepressants in treating pediatric major depressive disorder (MDD), obsessive-compulsive disorder (OCD) and non-OCD anxiety disorders (ANX) in children 19-years-old and younger clearly out-weigh the risks of suicidal thoughts and attempts associated with these medications.

"Although our findings regarding suicidal thoughts and attempts are in the same direction as the Food and Drug Administration (FDA) meta-analysis, we found a much lower overall risk and we added analyses of the potential benefit of these medications," said lead author Jeff Bridge, PhD, CIPP principal investigator and assistant professor of pediatrics at The Ohio State University College of Medicine. "This is good news for parents because it gives them more information for discussions with their family's physician about their child's treatment options."

This is one situation where FDA labeling did NO GOOD for the health of the American public or for primary care doctors trying to treat them. A Black Box label was put on all SSRI anti-depressant medications that treatment of mood disorders with medications may cause in increase in suicidal thoughts. It was strongly recommended to discuss this (as with all black box warnings) with patients when prescribing. What it did was to prevent most reasonable parents from being able to accept such a medication for their children, for fear of suicide. What it also did was to scare the crap out of primary care docs trying to help the overwhelmingly huge number of Americans who suffer from psychiatric illness.

Lawyer: "But doctor, didn't you read the black box label?"
Doctor: "I did, but I was more concerned about leaving this patient's mood disorder untreated. There's a three month wait in my community for anyone to get in to see a pyschiatrist, so I have to make treatment decisions that I'd rather not make."
Lawyer: "But doctor, didn't you read the black box label?"

What would have made sense is for the FDA to wait 6 months to look at some outcomes, ie actual suicide rate, as quoted above.

This for me is something akin to the current RotaTeq situation. The FDA is asking doctors to discuss the theoretical risks of intussuception with parents. It's a great conversation. "There's a new vaccine that I would like to give to your 2-month old baby. A few years ago, we had another vaccine against this common diarrheal illness that was killing healthy babies, but we don't think this one is doing that. We're just not sure yet." And we wonder why some parents won't vaccinate.

It's irresponsible of the FDA to put out this half-assed information and drop it in the lap of primary care. If there was truly no difference in the number of intussuception cases in vaccinated and unvaccinated children, why the warning?

So far, I haven't given a single RotaTeq dose. I'll probably regret my decision if I have a baby that gets very sick from Rotavirus. What's a doc to do?

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