FDA's Indictment of Psychiatric CME

As covered in the business section of Tuesday’s New York Times , an FDA advisory committee has accused the agency of doing too little to warn physicians about the dangers of prescribing newer antipsychotics to children.

The committee reviewed data showing that more than 389,000 children and teenagers were treated last year with Risperdal, the majority of them 12 years old or younger. Risperdal is one of five newer atypical antipsychotics, drugs which comprise the bulk of antipsychotic prescriptions to both adults and children in the U.S.

While the atypicals have been extravagantly profitable for drug companies, a series of recent studies have shown that they are no more effective than older generic antipsychotics, and that some incur a higher risk of weight gain and blood lipid abnormalities. The most recent of these studies focused specifically on children with schizophrenia and schizoaffective disorder. In that study, the atypical drugs Risperdal and Zyprexa were no more effective than the generic molindone, and the children on the newer agents suffered significant weight gain—13 pounds on Zyprexa and 9 pounds on Risperdal over only 8 weeks of treatment. Molindone caused less than a pound of weight gain.

So who is to blame for the excessive enthusiasm for atypical antipsychotics in children? The FDA says: “Not us.” When asked why physicians were not learning enough about side effects, Thomas Laughren, the director of the agency’s division of psychiatry products, said that the FDA has done its job by requiring appropriate warnings on the drug labeling. According to the article:

"Dr. Laughren of the F.D.A. said the agency could do little to fix the problem. Instead, he said, medical specialty societies must do a better job educating doctors about the drugs’ side effects."

Hmmm. Now that is going to be a tall order, considering that over half of all medical education courses in the U.S. are funded by drug companies. The medical specialty societies reap millions per year in “industry supported symposia,” which are CME courses certified by the medical societies, paid for by drug companies, and which are subtle advertisements for the sponsor’s drugs.

What is the FDA doing about this corruption of medical education? Absolutely nothing. Instead, they have given this responsibility to an agency called the ACCME. The ACCME is independent of the FDA, and is funded almost entirely by organizations that have a vested interest in continued drug company funding of CME. Because of this, it has presided over an incremental approach to regulation that has moved at glacial speed. Meanwhile, children on antipsychotics are becoming obese.

It is time for the FDA to get involved in regulating doctors’ education. I suggest that they immediately form a task force to investigate why the ACCME is moving so slowly to get industry influence out of medical education.

Let’s get real about this issue. Our health, and our children’s health, are at stake.