TEENS AND ANTI-DEPRESSANTS Congress grills FDA about secretive stance

The FDA defended its decisions to keep trial results from the public.
LOS ANGELES TIMES
WASHINGTON -- Members of Congress on Thursday accused the Food and Drug Administration of suppressing information, for as long as eight years, about the increased risks of suicidal thought and behavior in children and teenagers taking anti-depressants.
"There is something terribly rotten at the FDA," said Rep. Peter Deutsch, D-Fla. "No agency charged with protecting public health should have behaved with such indifference."
During a House subcommittee hearing on the FDA review of clinical trials involving the widely prescribed drugs, the legislators also criticized FDA officials for withholding information from clinical trials about the lack of benefit for children from most anti-depressants.
"The FDA knew about the lack of efficacy in these clinical trials several years ago, and nothing has been done to change labels to inform doctors, patients and parents," said Rep. Greg Walden, R-Ore., who chaired the hearing of the House Energy and Commerce oversight and investigations subcommittee.
Defended decisions
FDA officials defended their decisions to keep data gathered in clinical trials from the public.
"The higher-ups felt the data weren't ripe for presentation," said Dr. Robert Temple, a director at the FDA's center for drug evaluation and research.
Temple said agency officials were worried about scaring young patients away from the drugs.
"Having untreated depression is risky, too," he said.
About 1,600 teens -- many of them suffering from depression -- commit suicide each year, according to the FDA.
The FDA is under intense congressional scrutiny for its failure to move more quickly to warn doctors and parents about the increased risk of suicidal behavior in children on anti-depressants.