Friday, April 16, 2004

The New York Times > Washington > Expert Kept From Speaking at Antidepressant Hearing:
"Top Food and Drug Administration officials admitted yesterday that they barred the agency's top expert from testifying at a public hearing about his conclusion that antidepressants cause children to become suicidal because they viewed his findings as alarmist and premature"…

Recent studies have shown that children given antidepressants are more likely to become suicidal than those given placebos. But the studies have lead to different interpretations by psychiatrists. The refusal by drug companies to publish the studies has worsened the confusion. Internal agency documents obtained by The New York Times show that federal health officials are divided, too.

Dr. Andrew D. Mosholder, an agency epidemiologist, was the man charged with analyzing 22 studies involving 4,250 children and seven drugs. In a carefully argued, 33-page memorandum, he concluded that children given antidepressants were almost twice as likely as those given placebos to become suicidal.

He urged the agency to discourage doctors from prescribing to children all antidepressants except Prozac. Prozac is the only antidepressant proven effective in treating depressed children, and its studies showed no link with suicide, Dr. Mosholder wrote. Dr. Mosholder's conclusions mirrored those made by British health authorities.

But Dr. Mosholder's supervisors, Drs. Mark Avigan and Anne Trontell, wrote memorandums disagreeing, according to the documents.

"In particular, we disagree that the data are sufficiently robust to advocate preferential use" of Prozac in children, Dr. Trontell wrote.

Health officials convened a special advisory committee on Feb. 2 to offer guidance on how the agency should respond to the studies. As the agency's principal reviewer, Dr. Mosholder was scheduled to speak. He was removed from the agenda, Dr. Temple said.

Senator Charles E. Grassley, a Republican from Iowa and chairman of the Senate Finance Committee, said he was investigating whether the agency inappropriately suppressed crucial findings. Representative Joe L. Barton, a Republican from Texas who is chairman of the House Energy and Commerce Committee, said he was also investigating.

"It would have been very wrong for the F.D.A. to withhold any information it had about unintended consequences that might result from the use of antidepressants, especially for children and adolescents," Mr. Grassley said.

http://www.nytimes.com/2004/04/16/politics/16DEPR.html

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