House Energy and Commerce Committee To Investigate FDA Over Antidepressant Concerns

Rep. Joe Barton (R-Texas), chair of the House Energy and Commerce Committee, last week said that his committee will investigate whether FDA "fully disclosed the disagreement among its scientists about whether antidepressants might be linked to suicide in children," the AP/Albany Times Union reports (Neergaard, AP/Albany Times Union, 4/16). According to unnamed FDA sources, medical officer Andrew Mosholder planned to present a preliminary report that found selective serotonin reuptake inhibitors may increase the risk of suicide in children at a Feb. 2 public meeting. A senior FDA official said that Mosholder did not present the report because the results were not finalized. After its meeting, the advisory committee recommended that FDA issue stronger warnings to physicians about the potential link between SSRIs and suicidal behavior in children. FDA in March issued a public health advisory that calls for new warning labels on 10 different antidepressants -- which included both SSRIs and other antidepressants -- to include detailed warnings about the potential risk of suicidal behavior in patients who take the medications (California Healthline, 4/6). In a letter to Congress released Thursday, FDA officials said that Mosholder's data were presented at the meeting by his supervisor. However, top officials did not want Mosholder to present his findings because "the appearance that [Mosholder's findings are] an agency determination ... might lead patients who were actually benefiting from the use of these drugs to inappropriately discontinue therapy," the letter said. But Barton said, "There are troubling questions of whether FDA supervisors inappropriately suppressed significant information that would have been of consequence to their own advisory committee, not to mention the public." Robert Temple, chief of drugs for FDA, said that it is not uncommon for scientists in the agency to disagree and that agency scientists "were given a clear picture of that disagreement and the data behind it." Temple added, "Nobody should think we're shrinking from this -- we raised it" (AP/Albany Times Union, 4/16).

The Washington Post on Sunday examined how antidepressants that "have never shown benefits for depressed children in clinical trials have some of the largest increases in prescription rates." According to the Post, the number of children being treated with antidepressants "has soared over the past decade," with prescriptions for antidepressants for children increasing 50% between 1998 and 2002. The Post reports that supporters and opponents of antidepressant use in children "present the issue in black-and-white terms," but the data from clinical trials that test the drugs in children "paint a complicated picture." In addition, "experts starkly disagree on the statistics" from the trials, the Post reports. Former NIH Director Steven Hyman, provost at Harvard University, said that antidepressants "are by and large efficacious, but they are only moderately efficacious," adding, "A lot of clinical trials for antidepressants fail. Partly that's the difficulty of trials in a waxing and waning disease, but we also need drugs of greater intrinsic efficacy." Jane Garland, head of the mood and anxiety disorders clinic at Vancouver-based British Columbia Children's Hospital, said, "When a patient takes a medicine or a family physician or a pediatrician prescribes medicine, their understanding when they hear this medicine works is they believe, 'My child will recover from depression.'" However, Garland said that "the data says they are not going to get any better than on a placebo. They will have some improvement in symptoms, which is a good thing, but it means there is clearly more than medication needed for treatment" (Vedantam, Washington Post, 4/18).