Shaken – not Stirred

  • by: |
  • 02/11/2008
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:

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:

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.

Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

Blog Roll

Alliance for Patient Access Alternative Health Practice
Better Health
Biotech Blog
CA Medicine man
Cafe Pharma
Campaign for Modern Medicines
Carlat Psychiatry Blog
Clinical Psychology and Psychiatry: A Closer Look
Conservative's Forum
Club For Growth
Diabetes Mine
Disruptive Women
Doctors For Patient Care
Dr. Gov
Drug Channels
DTC Perspectives
Envisioning 2.0
FDA Law Blog
Fierce Pharma
Fresh Air Fund
Furious Seasons
Gel Health News
Hands Off My Health
Health Business Blog
Health Care BS
Health Care for All
Healthy Skepticism
Hooked: Ethics, Medicine, and Pharma
Hugh Hewitt
In the Pipeline
In Vivo
Internet Drug News
Jaz'd Healthcare
Jaz'd Pharmaceutical Industry
Jim Edwards' NRx
Kaus Files
Laffer Health Care Report
Little Green Footballs
Med Buzz
Media Research Center
More than Medicine
National Review
Neuroethics & Law
Nurses For Reform
Nurses For Reform Blog
Opinion Journal
Orange Book
Peter Rost
Pharm Aid
Pharma Blog Review
Pharma Blogsphere
Pharma Marketing Blog
Pharmacology Corner
Pharmaceutical Business Review
Piper Report
Prescription for a Cure
Public Plan Facts
Real Clear Politics
Shark Report
Shearlings Got Plowed
Taking Back America
Terra Sigillata
The Cycle
The Catalyst
The Lonely Conservative
Town Hall
Washington Monthly
World of DTC Marketing
WSJ Health Blog