Guinea Pigs in a Giant Marketing Experiment Posted by Rob Schneider at 03/24/06 07:01 PM

On February 9, an advisory committee of the FDA recommended a black box warning for on stimulants used to treat attention deficit disorder, citing heart dangers particularly for adults. There's more news this week.

On March 23, a NY Times story reported:

Stimulants like Ritalin lead a small number of children to suffer hallucinations that usually feature insects, snakes or worms, according to federal drug officials, and a panel of experts said on Wednesday that physicians and parents needed to be warned of the risk.

On March 23, a pediatriac advisory committee recommended that, at least for kids, that ADHD drugs not contain a black box warning on heart risks, though a strengthened label.

"It was a realistic recommendation," Dr. Karen Ballaban-Gil, a professor of clinical neurology and clinical pediatrics at Albert Einstein College of Medicine in New York City, said of Wednesday's action. "A black box warning is a little too aggressive, but clearer labeling is always a good thing."

Dr. Robert Temple with FDA's CDER office commented on the need for further study on potential risks:

"We still have to come to grips with some of the recommendations made at the drug safety committee one-and-a-half months ago, but that pertained mostly to adults," Temple said. "It was quite a satisfactory meeting that answered many of our questions, but we still have much work to do on adults."

So, what about potential risks for kids? Will further study be a priority for the FDAl? With large numbers of children taking ADHD medicines, driven by agressive drug company marketing efforts to doctors and parents, doesn't this argue for the best information and far stricter FDA oversight?

After the February 9th panel recommended a black box warning the NY Times opined:

Last week's recommendation by a federal advisory panel that stimulants like Ritalin should carry a strong warning about their dangers was a brave effort to slow the drug promotion juggernaut that frequently drives use beyond reasonable bounds.

Drug companies' bottom lines have pushed marketing beyond any level we or any other country have ever experienced.

We are guinea pigs in an experiment drug companies are conducting on us. But not guinea pigs testing new medicines. Instead we're part of a giant marketing experiment that advertises powerful -- and potentially dangerous-- medicines like advertising for time shares, sliced bread, or exercise machines, but with unknow consequences for public health.

Wonder how advertising could possilby cause harm to public health? Think Vioxx.

comments (1)

1 Posted by Heather at 03/29/06 02:34 PM

I would like to some studies done on the effects these drugs have on young adults, like college students. Being a college student myself, I am around people on these drugs used to pull all-nighters. I haven't heard anything about hallucinations, but are there any long-term effects that won't come into fruition until later in life? I would be interested to see something about this.