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Lawmakers open probe of FDA
Agency accused of barring safety data on antidepressants

Rob Waters, Special to The Chronicle

Wednesday, March 31, 2004
San Francisco Chronicle
Chronicle Sections

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Republican leaders from committees in the House and Senate have opened inquiries into whether officials of the Food and Drug Administration prevented an FDA medical officer from presenting a safety review on antidepressants and suicidal behavior by children to an agency advisory committee last month.

The Chronicle reported on Feb. 1 that the medical officer, Dr. Andrew Mosholder, was prevented by FDA managers from presenting to the committee his finding that several leading antidepressants appear to increase the risk of suicidal thoughts and actions among children.

"We want to know whether Mr. Mosholder was in any way prevented from sharing all the information that he gathered with the advisory committee," said Rep. James Greenwood, R-Pa., chairman of the investigations subcommittee of the House Energy and Commerce Committee. "That's why we're bringing him and his management team in for interviews, so we know exactly what happened here."

After the story appeared, the FDA began an investigation aimed at identifying the people who provided information to The Chronicle, according to FDA and congressional sources.

Susan Cruzan, a spokeswoman for the FDA, said she could neither confirm nor deny whether such an investigation was in process, adding that the agency would review the congressional requests and respond promptly.

The Senate Finance Committee has also gotten involved. The panel's chairman, Sen. Charles Grassley, R-Iowa., sent a letter last week to Health and Human Services Secretary Tommy Thompson requesting information on the withholding of the report and on the possible FDA internal investigation into the source of information provided to The Chronicle. The letter noted that members of his staff had confirmed that Mosholder was not allowed to present his report to the advisory panel.

Grassley's letter also noted that Mosholder "was given a so-called script to read," explaining why he would not be presenting his findings.

The committees want to interview Mosholder and several of his colleagues and to review documents and memoranda relating to the removal of his review from the committee's agenda, according to lawmakers on both panels.

Grassley said in an e-mail to The Chronicle that he was "very troubled" by allegations that the FDA's Office of Drug Safety withheld critical information from parents and doctors about the potential risks of these drugs.

"We are talking about kids here, and public safety," Grassley said. "Even more troubling is the possibility that the FDA started an investigation to find out which staffer let the public know about this possible link. From what I know now, that person or persons might deserve a medal."

Mosholder's analysis is thought to be similar to the conclusion reached by British regulators, who in December issued a public health warning telling doctors to stop prescribing most leading antidepressants to children. The British warning noted that the drugs had not been proven effective in reducing depressive symptoms among young patients and appeared to increase the risk of suicidal behavior.

Last week, six weeks after hearings in which parents recounted the suicides of their children and pleaded with the FDA to take action, the agency announced it was asking drugmakers to place warnings on the labels of leading antidepressants. The warnings would advise doctors to closely monitor patients for suicidal behavior after they begin antidepressant treatment or change their dosage.

Vera Sharav, president of a patients' advocacy group, was not satisfied. "They issued the warning because they had to save face under pressure," said Sharav. "However, the warning equivocates, claiming there's no evidence proving the suicidal effect of these drugs when the FDA has embargoed a report that would show the opposite. The FDA has been a party to a coverup."

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