Falling in step with an Administration that ignores facts, data, scientific analyses and the scientists who perform/assess them, the FDA not only ignored findings from clinical trials but the warnings of one of their own scientific advisors, even going so far as to prevent his testimony at an earlier hearing. Are we feeling any safer yet?
BETHESDA, Md., Sept. 14 - Federal drug regulators should warn physicians and patients in the strongest possible terms that antidepressants not only cause some children and teenagers to become suicidal but most have also failed to cure their depression, a federal advisory committee voted Tuesday.
The committee voted 15 to 8 that the Food and Drug Administration should mandate that the drugs contain "black box" warnings on the sheet of information that physicians review when prescribing drugs. This type of warning is in boldface type, surrounded by a black border and placed at the top of a drug's warning label.
The agency held a similar hearing in February in which top agency officials treated with skepticism findings from numerous clinical trials that the drugs may lead some patients to become acutely suicidal.
Weeks after the hearing, leaked documents showed that a top safety reviewer at the agency, Dr. Andrew Mosholder, had concluded that the drugs did cause some patients to become suicidal and that the drugs' risks outweighed their benefits in children and teenagers. Top officials were forced to admit that Dr. Mosholder's testimony at the February meeting was canceled because of his views.
Senate and House committees initiated investigations. More leaks ensued. Agency officials insisted that they simply needed time to undertake a more thorough review of the studies. That review was completed last month with conclusions nearly identical to Dr. Mosholder's original analysis.