Washington -- 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
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.
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