UPDATE 3-U.S. FDA resisting antidepressant
Thu Sep 9, 2004 06:33 PM ET (Adds
lawmaker, FDA comments)
By Lisa Richwine
WASHINGTON, Sept 9 (Reuters) - Republican lawmakers on Thursday
charged the U.S. Food and Drug Administration with hindering a
congressional probe into whether the agency suppressed a possible
link between antidepressant use and suicidal behavior in youth.
Rep. Joe Barton, chairman of the U.S. House Energy and Commerce
Committee, said the FDA has been uncooperative during the
committee's seven-month inquiry.
"Unfortunately, over the last several months, the committee has
been met mostly with stonewalling, slow-rolling and plain
incompetency from the FDA," said Barton, of Texas.
The committee asked for all documents that raised questions about
antidepressant use in children, but an FDA employee decided to limit
the records sent, Barton charged.
If necessary, "we will send committee staff to the FDA with the
(U.S.) Capitol Police ... and we will go through the files
ourselves," he said at a committee hearing.
Dr. Janet Woodcock, FDA's acting deputy commissioner for
operations, said the agency provided the requested documents and
"will make every effort to cooperate with the committee."
She also said committee staff had declined invitations to review
records at the FDA but were still welcome to do so.
Lawmakers said the FDA and drug makers neglected to alert the
public quickly about potential links between antidepressants and
suicidal behavior in youth, and about studies that failed to show
most of the drugs worked in kids.
"Parents are frantic. Their children are depressed, and they are
under the illusion these drugs will work," said Rep. Diana DeGette,
a Colorado Democrat.
Rep. Bart Stupak, a Michigan Democrat, said "the integrity of our
drug safety system is being questioned, and I believe rightfully
Woodcock said the FDA had released all the information it was
legally permitted to make public.
An FDA letter to drug maker Wyeth, released by the House
committee, urged the company not to include a warning about
"hostility and suicide-related adverse events" to a section about
pediatric use on the label for antidepressant Effexor.
FDA officials felt that language would be confusing and preferred
a more general statement that was being added to other
antidepressant labels, Woodcock said.
Questions about a possible link between the depression drugs and
suicidal behavior arose last year when regulators reviewed studies
of children who took GlaxoSmithKline Plc's (GSK.L: Quote,
Paxil. Only Eli Lilly and Co.'s (LLY.N: Quote,
Prozac, sold generically as fluoxetine, is approved for treating
The FDA has not concluded if there is a link, but last month said
it would update antidepressant labels to include information from
various studies. A panel of outside experts convened by the FDA
meets next week to discuss the issue.
The controversy has prompted calls for better disclosure of
clinical trials that yield unfavorable results.
Drug company executives told the panel they were making more data
public. Several firms have put data on their Web sites, and an
industry group is setting up a database.
Major medical journals said this week they would not publish
results from any clinical trials that were not registered in a
Some lawmakers are developing legislation to make reporting of
trial results mandatory.
"The industry should make every effort, or Congress will come
down with a registry," said Republican Rep. Cliff Stearns of
Florida. (Additional reporting by Susan Heavey; Editing by Chizu
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