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."
