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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
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
"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
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