November 30, 2005

Kids and the Speed Patch

This week's big shindig at the Food and Drug Administration involves treating teenagers with attention deficit disorder with a Ritalin skin patch. On Friday, the Psychopharmacologic Drugs Advisory Committee will hear evidence supporting this new way to administer the drug from Shire Pharmaceuticals and Noven Pharmaceuticals.

The committee will be chaired by Dr. Wayne Goodman of the University of Florida Medical School, even though he had to receive a special waiver to sit in judgment of Shire's application. The University of Florida has hundreds of thousands of dollars in contracts and/or grants with Shire and its direct competitors.

By doing a little digging, I discovered that Shire over the past two years awarded Dr. Regina Bussing, who is the chief of child and adolescent psychiatry at Florida, at least $44,000 to study the next big thing in treating kids with ADHD. Guanfacine hydrochloride (it apparently doesn't have a trade name yet) reputedly has the same effect as Ritalin without being a stimulant. Bussing has also done work for Shire testing Adderall on kids. (The tests on the skin patch were led by psychiatrists at another university.)

Should Dr. Goodman be allowed to vote or even participate at Friday's meeting? On the one hand, his own research over the past few years has been mostly funded by the Veterans Administration and the National Institutes of Health, although he did receive a large number of small grants from various drug companies earlier in this decade. On the other hand, is he likely to take a hard line stance against Shire, even if the evidence warrants it? After all, the company has a close relationship with one of his colleagues down the hall.

Here's my take on those questions: We shouldn't have to ask them. When the FDA leaves scientists with conflicts of interest on federal advisory committees, the agency inevitably taints the public's perception of the integrity of the process, especially those who have real concerns about the wisdom of giving powerful drugs to kids who can't sit still for the tedium of high school work.

Posted by gooznews at November 30, 2005 10:35 PM