FDA debates youth suicide, anti-depressant link

April 16, 2004|By Julie Bell | Julie Bell,SUN STAFF

Thomas Woodward's oldest child was 17 when she hanged herself in the family garage after seven days on the anti-depressant Zoloft. He believes the drug and the government bear partial responsibility for her death.

"This was such a total shock," Woodward, of North Wales, Pa., said of the day last summer when he found his daughter Julie and grabbed her cold body, too late to help. "We knew right away she was not capable of this. This was not her."

Like a number of other family members who testified before a U.S. Food and Drug Administration advisory committee earlier this year, Woodward believes a new generation of popular anti-depressants has contributed to suicide. But though the allegation was raised nearly 13 years ago, when a different generation of families came forward making similar claims about adults on Prozac, the FDA seems no closer today to resolving the issue.

"I don't think we're going to find a definitive answer," Dr. Robert Temple, the FDA's medical policy director, said of the agency's latest effort to analyze data from clinical trials of anti-depressants in children.

That's a worrisome prospect for the millions of patients prescribed these drugs - and more ammunition for critics of the FDA. Despite a recent FDA request that manufacturers strengthen warning labels, skeptical members of Congress are demanding to know more about how the agency has evaluated the safety of anti-depressants.

Yesterday, the chairman of the House Energy and Commerce Committee threatened hearings on reports that the agency muzzled a scientist who concluded that there was a link between anti-depressants and suicide.

"There are troubling questions of whether FDA supervisors inappropriately suppressed significant information that would have been of consequence to their own advisory committee, not to mention the public," said Rep. Joe Barton, a Texas Republican and the committee chairman.

FDA officials concede that the scientist was not allowed to testify about his conclusions - but said it was because others in the agency disagreed with him.

"He would have been presenting an agency conclusion, and there isn't an agency conclusion," Temple said. "That's a way to get people concerned when they wouldn't be."

Although the FDA continues to study the risk among adults, the emotional pitch of the debate has been elevated by the fact that children are taking more anti-depressants. People 17 years old and younger accounted for nearly 11 million of the outpatient prescriptions dispensed for 10 popular new-generation anti-depressants in 2002, or about 7 percent of the total, according to the latest FDA-compiled figures.

Growth in that market is occurring even though clinical trials have shown that just one drug, Prozac, is effective in treating major depression in children. Even then, critics say, Prozac has shown only a minor benefit over a placebo.

Gauging safety

Also, general practitioners who prescribe many of the drugs often have little follow-up time with patients and might not notice side effects.

The FDA gauges safety and effectiveness largely by relying on studies that pharmaceutical companies conduct and share with the agency. But drug makers aren't required to release the results of all clinical trials, and critics argue they often keep negative ones a secret.

That's part of the problem, say some experts.

"As far as I'm concerned, the FDA has badly mismanaged this for 15 years," said Dr. Joseph Glenmullen, a Harvard Medical School clinical instructor and author of the book Prozac Backlash. "We absolutely need congressional hearings."

The House Energy and Commerce Committee launched its inquiry last month to determine what - and when - the FDA had learned about the safety and effectiveness of anti-depressants in children.

About the same time, Sen. Charles E. Grassley of Iowa asked the FDA to explain why it refused to let its principal analyst on the issue, Dr. Andrew Mosholder, present his conclusions on the safety of anti-depressants during its advisory panel's February hearing.

The Los Angeles Times has cited internal FDA documents showing that the analyst found children who took the drugs were twice as likely to be involved in suicide-related behavior as those who did not.

Additionally, Connecticut Sen. Christopher J. Dodd and nine colleagues - including Maryland Sen. Barbara A. Mikulski - have asked the FDA to provide information about the human testing of anti-depressants in children.

Some patients and members of consumer organizations said the drugs had been helpful and cautioned the FDA about scaring patients into avoiding them.

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