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Committee members pushed for the patient attachment after hearing
dozens of bereaved relatives describe physicians who they said had
cavalierly prescribed antidepressants to children for a whole range
of conditions that the drugs were never intended to treat and then
failed to warn patients about the risks.
"If I heard nothing else from the public, it was that they want
to be warned," said Jean Bronstein, a nurse from Sunnyvale, Calif.,
who serves as a consumer representative to the advisory
committee.
Advocates who have argued for years that antidepressants are
over-used and often dangerous said that they were pleased with the
committee's recommendations.
"That they voted for a black box is more than I ever would have
hoped for," said Sara Bostock, 58, of Atherton, Calif. Ms. Bostock's
25-year-old daughter, Cecily, stabbed herself in the throat after
being prescribed an antidepressant.
The members of the committee who opposed the addition of
black-box warnings to the drugs' physician-information sheet said
they did so because they feared such warnings would discourage
physicians from treating depressed youngsters.
Dr. Matthew V. Rudorfer, a panel member from the National
Institute of Mental Health, said that 15 percent of teenagers with
untreated depression commit suicide - a much greater risk than that
presented by the drugs themselves, he said. And another panelist
from the institute, Dr. Daniel Pine, noted that one-on-one talk
therapy has been found in a landmark study to work no better in
treating depression in teenagers and children than placebos. In that
study, published this summer, Prozac was more effective by some
measures than either talk therapy or placebos.
To some, such results, however meager, mean that these drugs can
help. But others point out that most other studies, many of them
smaller, have shown that the drugs do not work.
In comments after the hearing, Dr. Temple of the F.D.A. said he
hoped that the committee's decision would help dim the controversy
that has swirled around the agency for much of the year.
The agency held a similar hearing in February in which top agency
officials treated with skepticism findings from numerous clinical
trials that the drugs may lead some patients to become acutely
suicidal.
Weeks after the hearing, leaked documents showed that a top
safety reviewer at the agency, Dr. Andrew Mosholder, had concluded
that the drugs did cause some patients to become suicidal and that
the drugs' risks outweighed their benefits in children and
teenagers. Top officials were forced to admit that Dr. Mosholder's
testimony at the February meeting was canceled because of his
views.
Senate and House committees initiated investigations. More leaks
ensued. Agency officials insisted that they simply needed time to
undertake a more thorough review of the studies. That review was
completed last month with conclusions nearly identical to Dr.
Mosholder's original analysis.
In comments after the meeting, Dr. Temple said that the agency,
which has already said it will consider label changes for
antidepressants, said it would decide on those changes within a few
months.
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