Food and Drug Administration officials were forced before a House committee to defend their choice not to respond with precautionary measures despite mounting evidence from as early as 1996 that antidepressants could be causing increases in suicidality (both suicidal ideation and suicide attempts) in children. Rebukes for the FDA's failures came from both sides of the aisle at the Sept. 23 hearing as lawmakers reprimanded the FDA officials for failing to protect the public health. According to testimony given by senior officials from the FDA's Office of Drug Evaluation before the House Committee on Energy and Commerce, the FDA had been on notice since the mid 1990s most clinical trials have shown that antidepressants are no more effective than placebos in treating child depression but decided nonetheless forestall strong warnings on the use of antidepressants in children. Testimony also revealed FDA senior officials may have suppressed and softened the conclusions of one of their senior medical investigators, Dr. Andrew Mosholder, who last year found a 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 Dr. Mosholder's conclusions. FDA officials rationalized their decision to suppress the information by saying they did not want the advisory committee to think 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. 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. Several House members 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. After seeing the full results this September, the advisory committee voted 15-8 in favor of recommending 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 members 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 promised only that the FDA would look at the rationales of the votes when weighing the decision. In response to the findings of the clinical trials on children, the FDA is now planning to look at thousands of adult clinical trials to see if the same increased risk of suicidality exists in the adult population.