U.S. government health advisers considered Monday whether strong warning labels were needed on antidepressants because they have been linked to suicidal tendencies among children who take them.
Among the witnesses was: Dr. Andrew Mosholder, the Food and Drug Administration epidemiologist who last summer stumbled across the link and was prevented from testifying about it during a meeting last February.
Mosholder asked for clarification from British-based GlaxoSmithKline and received data in May 2003 that suggested a link between the company's drug Paxil and increased suicidal actions among children taking the antidepressant. Last June, the FDA issued a public warning about the drug. In July, FDA asked all antidepressant manufacturers to resubmit clinical trial data.
Independent experts, working with Columbia University, were asked to review the research. This summer, the Columbia reanalysis came to conclusions that backed Mosholder.
Dr. Russell Katz, director of FDA's division of neuropharmacological drug products, acknowledged the firestorm prompted by preventing Mosholder from testifying last February, when FDA advisory panels met.
"As you know, Dr. Mosholder did not present these conclusions in the February meeting," Katz said. "There has been, since that meeting, considerable public discussion and controversy."
Katz said the reason for barring Mosholder's testimony was straightforward: Errors in early analysis could wrongly paint antidepressants as dangerous or safe, either mistake having the potential for "disastrous consequences."
The joint panel will weigh the benefits of nine drugs given to depressed children against the risk the same remedies may increase suicidal thoughts and suicide attempts among those youths. The panel could suggest regulatory actions, such as enhanced warning labels, if it finds there is in fact a link.
"Nothing, in my experience, is more tragic than the loss of a child from suicide," Dr. Wayne Goodman, chair of the FDA psychopharmacologic drugs advisory committee, said during opening remarks. Goodman said the panel will likely not have all the data it would like, but will issue a recommendation late Tuesday based on what is known now.
For the second time in seven months, 73 family members will reopen painful wounds to prod the agency to issue more strident warning labels on antidepressants they blame for their children's deaths.
A congressional panel peppered industry representatives with questions at a hearing last week and has sought e-mail, phone messages and other internal FDA agency correspondence to determine whether there was an organized cover up.
The majority of medicines children take are prescribed off-label, meaning they are not specifically designed or approved for use in children, said Dianne Murphy, director of FDA's office of pediatric therapeutics.
Because of new legislation, since 1998 drug companies have conducted more clinical trials involving children. Some 100 pharmaceutical products subjected to 200 studies found that about one-quarter of the time, the FDA changed the dose, found a new adverse reaction that occurred only among children or found the drugs didn't work in kids at all.
Murphy said the new data strongly push for changes to clinical trials to tease out why children respond to drugs differently than adults. "We will need to change some of our trials as we move forward," she said.
Diane Wysowski, an FDA epidemiologist in the division of drug risk evaluation, said with "so much at stake" larger, randomized controlled trials of sufficient length are needed.
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