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Friday, September 24, 2004

House Committee Finds FDA Failed to Warn Public About Danger

FDA officials have had indicators that antidepressants could increase suicidality in children since as early as 1996, according to testimony given in front of the House Energy Commerce Committee yesterday by senior officials from the FDA’s Office of Drug Evaluation. However, rather than acting with caution, the FDA chose to forestall strong warnings on the use of antidepressants in children, despite the fact that most clinical trials have shown that antidepressants are no more effective than placebos in treating child depression. Rebukes for the FDA’s failures came from both sides of the fence yesterday as lawmakers reprimanded the FDA officials for failing to protect the public health of Americans.

Testimony also revealed that FDA senior officials may have suppressed and softened the conclusions of one of their senior medical investigators, Dr. Andrew Mosholder, who found last year a strong connection between antidepressants and suicidality in children. The FDA did not let the doctor present his findings in front of an advisory committee meeting in February, but rather had another doctor present the results of the clinical trials without the Dr. Mosholder’s conclusions.

The FDA rationalized their decision to suppress the information by saying that they did not want the advisory committee to think that the findings were the FDA’s official conclusions. “We thought it was potentially dangerous to the public to present a premature conclusion to the public,” stated Dr. Robert Temple, director of FDA’s Office of Drug Evaluation I. Several congressmen questioned why the advisory committee, comprised of medical professionals, would not be able to understand the complexities and uncertainties of the study even if the general public could not.

“What was the harm in allowing Mosholder an opportunity to present his data?” asked Committee Chairman Joe Barton. FDA did not allow Dr. Mosholder to present his results until September, after his findings were corroborated by outside experts at Columbia University and by an FDA medical examiner.

After seeing the full results this September, the advisory committee voted 15-8 for strong “black-box” warnings on antidepressants. The House committee repeatedly accused the FDA of weakening past recommendations of the advisory committee and questioned whether the FDA would actually follow the most recent recommendations. Though Dr. Temple promised a decision on the warning label within a few days, the committee certainly did not get the reassurance that they were looking for: “I’m not predicting that we won’t go with the black-box warning,” Temple responded. At the same time, he also indicated that he did not believe that the 15-8 vote was a clear majority and that the FDA would look at the rationales of the votes when weighing the decision.