Expert Kept From Speaking at Antidepressant Hearing [View All]

[depakid]

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.

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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.

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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.

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Dr. Mosholder found that 108 of the 4,250 children had done something that merited being called suicidal. He divided the cases into those who were given drugs and those given placebos and found that children given drugs were almost twice as likely to become suicidal as those given placebo. The agency declined to make Dr. Mosholder available for an interview.

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Unlike the FDA, Britian's MHRA had no trouble banning Paxil and other SSRI's from being prescribed to children and adolescents- and Glaxco-Smith-Kline is a British company. Thier lead researcher sent an open letter to the FDA summarizing their analysis.

This only makes the FDA's suppression of evidence at the behest of PhRMa all the more OUTRAGEOUS.