Posted by jrbecker on August 3, 2004, at 9:12:09
something to watch since this has indirect implications for upcoming drug approvals (e.g., Cymbalta). Lilly also announced today that it would make available all of the company's sponsored clinical trials. That story is posted further below...
http://www.reuters.com/newsArticle.jhtml?
type=healthNews&storyID=5850500Antidepressant Safety Review Set for September
Mon Aug 2, 2004 06:44 PM ET
WASHINGTON (Reuters) - A U.S. advisory committee will meet in September to once again consider whether antidepressants raise the risk of suicide in children and teenagers, regulators announced on Monday.The Food and Drug Administration will present a new analysis of antidepressant data and ask the panel if more research or regulatory action is needed, according to a notice to be published in the Federal Register.
FDA officials are trying to determine if widely used antidepressants such as Prozac make children or teenagers suicide-prone, or whether the disease itself is responsible.
The advisory panel of outside experts considered preliminary data in February and urged stronger warnings to the public while the FDA probed further. In March, the agency urged close monitoring of antidepressant patients for signs of worsening depression or suicidal thoughts.
Agency officials, meanwhile, asked Columbia University experts to look at reports of suicidal behavior among children who took antidepressants during clinical trials. Many of the reports were vague and difficult to interpret, FDA officials have said.
The FDA's analysis of the Columbia team's assessment "is in the works," Dr. Robert Temple, FDA's associate director for medical policy, said in an interview.
He said he did not know whether the FDA would release its analysis ahead of the Sept. 13-14 advisory committee meeting.
"We'll try to let people see what we have as soon as we can," Temple said.
Some lawmakers and other critics have questioned whether the FDA tried to keep secret one agency reviewer's conclusion that the drugs were linked to a higher suicide risk. FDA officials have denied the charge.
Some also have asked why the FDA has taken longer to act than British authorities, who have advised doctors not to prescribe most of the drugs known as selective serotonin reuptake inhibitors to anyone under 18.
© Reuters 2004. All Rights Reserved.
http://reuters.com/newsArticle.jhtml?type=topNews&storyID=5858024
Eli Lilly to report results of trials via registry
Tue Aug 3, 2004 08:27 AM ET
NEW YORK, Aug 3 (Reuters) - Drugmaker Eli Lilly and Company (LLY.N: Quote, Profile, Research) on Tuesday said it will disclose the results of all its clinical trials through a publicly available registry.
The move comes amid criticism drug companies may hide negative results of clinical trials of their drugs and follows a lawsuit by New York Attorney General Eliot Spitzer against rival GlaxoSmithKline (GSK.L: Quote, Profile, Research) . Spitzer claimed the company suppressed information about its antidepressant Paxil.Glaxo, which denied the allegation, said it would create an electronic database to make data from its trials accessible. Lilly said it will begin posting results of all human trials and announce the initiation of all late-stage trials.
Lilly said it will disclose results of early, mid-stage and late-stage trials once a drug has been approved. For trials conducted after the drug has been approved, the company will release results as soon as possible but no later than one year after the trial has been completed.
© Reuters 2004. All Rights Reserved.
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thread:373554
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