FDA Tried To Tailor Report On Antidepressants
Congressional panel says critic was told to alter documentsSep 24, 2004 | Washington Post A Food and Drug Administration medical officer was told by top agency officials to delete material on the risks of antidepressant drugs from records he was submitting to Congress and then to conceal the deletions, according to documents released Thursday at a hearing on Capitol Hill.
A bipartisan panel of Congress members said the FDA also repeatedly prevented Andrew Mosholder from disclosing his conclusions that the medications increase the risk of suicidal thoughts and behavior among children, potentially delaying the issuance of a public warning. During the daylong hearing, the representatives repeatedly accused the agency of obfuscating the risks, slowing action and subjecting Mosholder to harassment.
The disclosures added a new dimension to a year-old controversy over the use of antidepressant drugs in children, which led a government advisory panel to recommend last week that the FDA require a strongly worded "black box" warning on the medications. While depression itself is known to increase the risk of suicidal behavior, two FDA analyses, including one by Mosholder, have concluded the drugs may double the risk of suicide among some children.
After revelations that Mosholder was asked not to present his findings at a public forum in February led to an outcry, the agency's internal investigative arm told Mosholder he might be subject to disciplinary action, the documents showed. He was asked whether he had leaked his findings to the media and denied doing so.
He then prepared a sworn statement about his findings and stated he had been targeted by the internal inquiry. When investigators working for Senate Finance Committee Chairman Charles Grassley, R-Iowa, sought a copy of his records, Donna Katz of the FDA's Office of Chief Counsel urged him to delete material from the statement and submit a cleaned-up version.
Investigators from Grassley's committee, as well as the House Energy and Commerce subcommittee on oversight and investigations, which held a hearing Thursday, have said they were outraged to learn that Mosholder had been the subject of an internal inquiry and disciplinary threats.
The hearing produced new demands from congressional members who wanted to know why the FDA did not respond sooner to concerns about the widely used antidepressants. Mosholder said he had found as early as last September that drugs such as Paxil, Zoloft and Effexor were associated with an increased risk of suicide among children.