FDA Resisting Antidepressant Probe-Lawmakers
Sep 9, 2004
By Lisa Richwine
Source: Yahoo News
WASHINGTON (Reuters) - Republican lawmakers on Thursday charged the U.S. Food and Drug Administration (news - web sites) with hindering a congressional probe into whether the agency suppressed a possible link between antidepressant use and suicidal behavior in youth.
Rep. Joe Barton (news, bio, voting record), chairman of the U.S. House Energy and Commerce Committee, said the FDA (news - web sites) 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 (news, bio, voting record), a Colorado Democrat.
Rep. Bart Stupak (news, bio, voting record), a Michigan Democrat, said "the integrity of our drug safety system is being questioned, and I believe rightfully so."
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 Paxil. Only Eli Lilly and Co.'s Prozac, sold generically as fluoxetine, is approved for treating pediatric depression.
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 national database.
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 (news, bio, voting record) of Florida.
