Shaken – not Stirred

My eldest son has Juvenile Myoclonic Epilepsy that is marvelously under control due to the golden combination of the right medication in the proper dose, along with strict and compliant adherence.

So it came as somewhat of a shock at the end of last month when the FDA issued an altert to health care providers on the “Risk of Suicidal Thoughts and Behavior with Antiepileptic Medications.”

Here is a link to the FDA alert:

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01786.html

As with many recent FDA risk communications initiatives, the unintended consequences may very well outweigh the need for the communication.

To that end I recommend to you an article from the New York Times, “Making Sense of the Great Suicide Debate.”

According to the article, “Many doctors who treat epilepsy patients said they were bewildered by the recent reports and concerned that regulators were scaring patients away from valuable medications based on limited evidence ... In the case of the epilepsy drugs, the F.D.A. found 4 suicides among some 44,000 people taking the drug in 199 studies, and none among some 28,000 on placebo.”

Here is a link to the complete article:

http://www.nytimes.com/2008/02/10/weekinreview/10carey.html?_r=1&ref=health&oref=slogin

The regulatory policy issue at play here is FDA risk communications and the important (and mostly unaddressed) question of unintended consequences.

Is it important for the FDA to communicate with health care providers and patients (and parents of patients) when relevant safety data becomes available? Yes. But is the agency weighing the risks and benefits of such communications with the appropriate finesse – as they do when they review a drug application – that’s the question.

And it’s a good question for the FDA’s new Risk Communications Advisory Committee to consider when they meet for the first time on February 28.