Drug makers, however, have received notification from the FDA alerting them to the fact that they must now implement suicide assessment analysis in their clinical trials.
The impetus for this important change came as a result of research conducted by Columbia University’s psychiatry department, under the direction of Kelly Posner, Ph.D. In 2004, the FDA learned that some children taking anti-depressants had become increasingly suicidal, but the FDA remained unconvinced of a definitive link between anti-depressants and suicidal ideation until the Columbia studies confirmed it. Similar studies with a French obesity drug – rimonabant – also motivated the agency to develop a clear policy on testing for psychiatric side-effects. Now, the agency embraces a Suicidality Classification Project.
According to the New York Times, “there are two reasons that the F.D.A. for years was inattentive to the psychiatric effects of new medicines. First, distinguishing between mental problems that spring from a disease and those that result from its treatment is often difficult. For antidepressants, many researchers suggested that suicidal behaviors resulted because, as patients’ depression lifted, they suddenly had the energy to carry out previous suicidal thoughts. Second, drug side effects are often first identified in clinical trials when multiple doctors treating hundreds of patients record similar problems in trial notes. But terms to describe depression or suicidal thoughts can vary widely, making them hard to discern.”
Some related stories include:
-Tamiflu, Relenza Side Effects Need Listing
- Tamiflu And Relenza Should Have Psychiatric Side Effects Warning, Say Regulators
- FDA: Weight-Loss Drug Could Cause Suicidal Thoughts
-Ritalin, Concerta possibly linked to psychiatric problems
On a related note, representatives Henry A. Waxman, John D. Dingell, Frank Pallone, Jr., Rosa L. DeLauro, and Edward Markey, and Senators Edward M. Kennedy, Patrick J. Leahy, and Christopher J. Dodd, are skeptical about a new Food and Drug Administration (FDA) proposal because it appears that it is designed to shield pharmaceutical corporations from consumer lawsuits.
A statement posted on Waxman’s House Oversight and Government Reform Committee states that the “FDA’s proposed rule would amend the regulations that permit companies to promptly update their drug and device labels with new safety information without waiting for FDA approval. These regulations serve the vitally important public health function of ensuring that patients and healthcare providers are made aware of safety risks associated with their medical products at the earliest possible moment.”
In a letter to the FDA, also available on Waxman’s site, the lawmakers assert that “We are concerned that the intent of this proposal is to protect companies in the pharmaceutical and device industry from being held liable for marketing products they know are unsafe” and that “such a policy change comes at the expense of consumers and violates the mission of the FDA.”
Shrinking the News is a column written by Peter Sheehy, who earned a PhD from the Department of History at the