Panel to debate safety of antidepressants

Some on FDA committee want stronger warning on suicide risk in youths

September 12, 2004|By NEW YORK TIMES NEWS SERVICE

When the Food and Drug Administration opens an advisory committee hearing tomorrow into the safety of antidepressants, several committee members will push for tougher warnings saying that a child or teenager given the drugs may become suicidal in the first weeks of therapy, they said in interviews.

"I want the warning strengthened," said Dr. Richard Gorman, a member of the committee and a pediatrician from Ellicott City. "I would also like the pharmaceutical companies to send out letters to doctors saying that, in kids, this stuff doesn't work."

Dr. James McGough, another committee member and a professor of clinical psychiatry at the University of California, Los Angeles, also said he wanted stronger warnings.

For more than a year, agency officials have struggled to find the appropriate balance between warning patients about the possible suicide risk of antidepressants and reassuring those patients that drug therapy can be an effective and safe remedy.

Along the way, the agency has been the object of intense scrutiny and criticism, in part because its own employees, reflecting differences outside the agency, have disagreed about the appropriate course. A safety reviewer for the agency, Dr. Andrew Mosholder, wrote memorandums recommending that doctors be discouraged from prescribing the drugs for children; his bosses thought him alarmist and barred him from speaking about his conclusions at a public meeting in February.

Mosholder is scheduled to speak at the hearing tomorrow, and this time agency officials have said they will allow him to do so. The committee has about 30 members.

But to bolster its point that there could be grave consequences if patients are afraid to seek drug therapy, the agency has also scheduled speakers to discuss the devastating effects of depression among teenagers and children.

In 2001, 1,611 teenagers committed suicide, making it the third-leading cause of death among 15- to-19-year-olds. By age 18, one out of five teenagers has suffered a period of intense depression, studies show.

Still, agency officials will also discuss the results of 22 clinical trials of antidepressants showing that teenagers and children given the pills were almost twice as likely to become suicidal as those given placebos. And few of the trials show that the drugs cured depression any better than placebos.

The studies were sponsored by drug companies and were largely kept secret from the public. The controversy surrounding the trials has led most pharmaceutical companies to promise to make public the results of all future human trials, and it has spurred Congress to propose requiring that all human trials be disclosed on government Web sites.

Other tests may also prove crucial to the committee's deliberations. The most important is one financed by the National Institute of Mental Health that found that Prozac was far more effective than talk therapy, or one-on-one counseling, in ameliorating the symptoms of depression in teenagers and children. Another study recently published in The Journal of the American Medical Association found that those taking antidepressants were most likely to become suicidal in the first nine days of treatment. After that, the risk of suicide, which is rare in any case, declines sharply.

Together, the two studies suggest that the benefits of taking Prozac far outweigh the risks and that the risks can be managed if patients are observed closely in the first two weeks of therapy, several experts said.

"This study shows that the drug is definitely worth the risk," said Dr. Thomas R. Insel, director of the National Institute of Mental Health. "And after all the work that went into the study, the clear results we got out of it, I would hate to see those findings ignored."

The committee will also hear from family members of those who committed suicide while taking antidepressants. In the past, the heartbreaking anecdotes have led many committee members to push for stronger warnings than agency officials originally suggested.

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