F.D.A. Links Drugs to Being Suicidal

BETHESDA, Md., Sept. 13 - Top officials of the Food and Drug Administration acknowledged for the first time on Monday that antidepressants appeared to lead some children and teenagers to become suicidal.

Dr. Robert Temple, director of the F.D.A.'s office of medical policy, said after an emotional public hearing here that analyses of 15 clinical trials, some of which were hidden for years from the public by the drug companies that sponsored them, showed a consistent link with suicidal behavior.

"I think that we now all believe that there is an increase in suicidal thinking and action that is consistent across all the drugs,'' Dr. Temple said, summarizing the agency's presentation to a special advisory committee. "This looks like it's a true bill.''

The acknowledgement, made after the hearing, comes a year after the agency suppressed the conclusions of its own drug-safety analyst, Dr. Andrew Mosholder, who first found a link between the drugs and suicide in teenagers and children. Agency officials wrote in internal memorandums that Dr. Mosholder's analysis was unreliable, and they hired researchers at Columbia University to re-analyze the same data. That study recently reached conclusions nearly identical to Dr. Mosholder's.

The testimony came before an advisory committee of 31 independent experts that the F.D.A. has charged with making a recommendation about the labeling and use of antidepressants in children and teenagers.

Family members of suicide victims at the hearing angrily denounced agency officials for the delay in admitting the risk of antidepressants in children. The British health authorities decided in December to ban the use of most antidepressants in children and teenagers.

Mathy Milling Downing of Laytonsville, Md., whose 12-year-old daughter hanged herself in January, said: "Candace's death was entirely avoidable had we been given the appropriate warnings. "The blood of these children is on your hands.''

Agency officials said that they had no regrets about the months of study. "I don't think the data were at that time reliable,'' Dr. Temple said. "Scaring people needlessly" or overdoing a warning is worrisome, he added.

The most popular pills are Zoloft, made by Pfizer; Paxil, made by GlaxoSmithKline; and Prozac, made by Eli Lilly & Company. In 2002, nearly 11 million children and teenagers were prescribed antidepressants.

The risk of suicide among patients given the pills is very small. If 100 children and teenagers are given antidepressants, 2 or 3 will become suicidal who otherwise would not have had they been given placebos, agency officials said. None of the children in the trials committed suicide, but some thought about or attempted suicide, researchers found.

In March, the agency required antidepressant manufacturers to include on labels a warning that therapy with antidepressants could lead some patients, both adults and children, to become suicidal. The committee must decide whether this warning is strong enough or whether the drugs should be banned for children. The advisory committee is expected to make a decision on Tuesday. The F.D.A. normally follows recommendations of its advisory committees.

It is a complex task. Most studies of the drugs have failed to show that they have any effect on depression in children and teenagers. But the drugs have proven effective in adults, and studies suggest that teenage suicide rates have dropped in countries where use of antidepressants is widespread. A large study of depressed teenagers conducted by the National Institute of Mental Health recently found that Prozac was far more effective in treating depression in children and teenagers than was talk therapy.

Several speakers noted that clinicians would have almost nothing to offer depressed teenagers and children if antidepressants were banned. Suicide is the third leading cause of death among teenagers, trailing only homicide and accidents. Without treatment, many more teenagers will die, several experts said. If the committee suggests an even stronger warning, some patients will resist therapy and could perhaps die, some speakers said.

The issue has roiled the agency and is likely to transform the way the drug industry markets its products. Committees in both the House and Senate have begun investigations following disclosures that Dr. Mosholder's analysis had been suppressed.

The New York State attorney general Eliot Spitzer, filed suit against GlaxoSmithKline, charging the drug maker with fraud for failing to disclose the results of clinical trials of Paxil that found no benefit while promoting the drug to physicians. The company settled the suit this summer by promising to disclose the results of all of its clinical trials of its marketed products dating back to 2000.

Editors of the nation's top medical journals have said they will not to accept for publication trials that have not been publicly registered, and legislation is expected to be offered in both the House and the Senate requiring the disclosure of the results of all major drug tests on humans.

For some bereaved parents, Monday's hearing was a chance to take drug makers and the F.D.A. to task.

Mark and Cheryl Miller of Overland Park, Kan.,, told the committee that their 13-year-old son, Matthew, had committed suicide seven months ago while taking Zoloft.

"Why haven't parents like Cheryl and myself and countless others been told the truth?'' Mr. Miller asked.

But others said that antidepressants had helped millions. Dr. Suzanne Vogel-Sibilia of Beaver, Pa., said that she had brought her 15-year-old son, Tony, to the hearing to represent what she said were the vast majority of patients who had been helped by the drugs.

"Please help me preserve my future," Tony told the committee. "Don't take away my medication."

Claims that antidepressants cause patients to become acutely suicidal have been made since 1991, just three years after Prozac was introduced. But drug makers and regulators long dismissed these claims, saying they were anecdotal reports without any basis in rigorous clinical trials.

Then last year, GlaxoSmithKline announced that tests of Paxil had found that teenagers and children who took the pill were more likely to become suicidal than those given placebos. The announcement was quickly followed by a similar one from Wyeth, the maker of Effexor, another antidepressant. Suddenly, the anecdotal reports were being confirmed by clinical trials.

Still, just how the drugs may lead some people to become suicidal remains the subject of fierce debate. Many of those at the hearing said that the pills had brought a change in the personalities of their friends and relatives. Alice Erber said that Paxil caused her 21-year-old son, Jake Steinberg, to throw himself in June from the 24th floor of a Manhattan office building.

But Dr. Temple speculated that some people taking the pills become suicidal because they are actually getting better. As their depression improves, he said, they gain the energy to act on suicidal thoughts that their illness had suppressed.

"I think the work is cut out for us tomorrow,'' Dr. Wayne Goodman, chairman of the advisory committee, said at the end of Monday's hearing.

Ritalin is a stimulant like methamphetamine or other antidepressants.

So what? (except that you use the phrase "methamphetamine or other antidepressants". Neither Ritalin nor methamphetamine is used as an antidepressant in children--or any adult that I've ever seen. SSRI's, tricyclics, tetracyclics, MAOIs--yes they are still used some--atypicals, etc. in adults. I never even saw them used as antidepressants back 35 years ago when we were homogenizing rat brains to determine biogenic amine level changes or testing rat pee for VMA for the few antidepressants that WERE available). I wasn't arguing any efficacy or salutary benefit for Ritalin--I'm against it.

My objection is to the ridiculous statement that if one has taken Ritalin, one may not own a firearm. That makes the people with real arguments look like they are on the stupid side.

By the way, the "D", or decongestant portion, in your Allegra-D or Claritin-D, etc. is a stimulant also; according to the reasoning I object to, those would prevent one from owning a firearm. Sheesh.

I talked to her MD yesterday for quite some time. Her sessions with her therapist are going to be twice a week while she is transitioning into the meds. I am more than willing to see how she does on them, and I have high hopes that it will make her feel better.....just want to be cautious..

I wish you the very best. You've got a difficult decision to make. I think that the primary thing is to keep talking with her and her doctor and observe her very, very carefully. I've known people who've been on these kind of meds for a long time and they can make a difference. But they are not kids. I think parents are the one who are on the scene and must make the call. It's the most difficult part of parenting. I hope all goes well for your daughter and your family.

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