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F.D.A. Links Drugs to Being Suicidal


Published: September 14, 2004

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TIMES NEWS TRACKER

  Topics

Alerts
Food and Drug Administration


Drugs (Pharmaceuticals)


Children and Youth


Suicides and Suicide Attempts



(Page 2 of 2)

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.

"If he had not taken Paxil, he would be alive today,'' Ms. Erber said.

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.


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