Saturday, August 14, 2004

Antidepressant Suicidality Data Review

The Food and Drug Administration will be holding a two-day conference to review data on the incidence of suicidality in children and adolescents who take antidepressant medication in research studies.  The meetings will take place on Sept. 13 and 14, at an Holiday Inn in Bethesda, MD.  According to FDAAdvisorycommittee.com:

The meeting is being held as a follow-up to a Feb. 2 meeting where advisory committee members expressed concern about the high degree of variability and lack of categorization of events believed to be suicide related.

FDA’s preliminary review of over 4,000 pediatric patients from clinical trials of several antidepressants identified 109 cases as “possibly suicide related.”

Since the Feb. 2 meeting, “experts in pediatric suicidality, assembled by Columbia University, have independently classified these reported events, and FDA has conducted an analysis of these data,” a Federal Register notice slated for publication Aug. 4 states.

The Columbia group employed a standardized methodology to categorize events into “suicidal,” “non-suicidal,” and “indeterminate.” The suicidal category has three subdivisions: “suicide attempt,” “suicidal ideation,” and “suicidal behavior without injury.”

“The committees will consider the results of FDA’s analysis of these independently classified events and will consider what further regulatory action may be needed with regard to the clinical use of these products in pediatric patients,” the Federal Register notice reports.

Interested persons can view the meeting via webcast, but it costs $145 per day for the privilege.  I will be curious to see what they say.  Whatever the conclusion, it will be controversial.  The methodology used is reminiscent of the 2000 Florida recount, with "indeterminate" events playing the role of pregnant chads.