Internal memos and a secret government report about the negative effects of antidepressants in children—suppressed by the US Food and Drug Administration—have surfaced publicly.
The Alliance for Human Research Protection, a national network dedicated to ensuring ethical standards in medical research, published the documents on 26 July.
The published documents confirm earlier news accounts that a government expert with the FDA's Office of Drug Safety, Dr Andrew Mosholder, found that children taking antidepressants were twice as likely to become suicidal as children taking placebo. He reportedly urged the agency to follow the lead of British health authorities by warning doctors that the risks of the newer antidepressants, except fluoxetine, might outweigh the benefits when used in children.
The leaked documents show his data and conclusions. The FDA has subsequently acknowledged to the BMJ that Dr Mosholder was prevented from presenting his report at an advisory committee meeting on 2 February and was told that if he was asked any questions during the meeting he could respond to queries only by using a prepared script approved by his supervisors.
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The Alliance for Human Research Protection, a national network dedicated to ensuring ethical standards in medical research, published the documents on 26 July.
The published documents confirm earlier news accounts that a government expert with the FDA's Office of Drug Safety, Dr Andrew Mosholder, found that children taking antidepressants were twice as likely to become suicidal as children taking placebo. He reportedly urged the agency to follow the lead of British health authorities by warning doctors that the risks of the newer antidepressants, except fluoxetine, might outweigh the benefits when used in children.
The leaked documents show his data and conclusions. The FDA has subsequently acknowledged to the BMJ that Dr Mosholder was prevented from presenting his report at an advisory committee meeting on 2 February and was told that if he was asked any questions during the meeting he could respond to queries only by using a prepared script approved by his supervisors.
The FDA's response?
The FDA has launched a criminal investigation to find out which employees leaked Dr Mosholder's report. Meanwhile the suppression of the report has triggered Congressional investigations by Senator Charles Grassley, who has interviewed employees in the agency's Office of Drug Safety, where Dr Mosholder worked.
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