hen 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 can become
suicidal in the first weeks of therapy, they said in interviews.
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"I want the warning strengthened," said Dr. Richard Gorman, a
member of the committee and a pediatrician from Ellicott City, Md.
"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.
Dr. Mosholder is now 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, some 1,611 teenagers committed suicide, making it the
third leading cause of death among 15- to-19-year-olds. By the age
of 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 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 mandating 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 quite 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."
But studies are only part of the story. As it did in earlier
proceedings, the committee will hear from family members of those
who committed suicide while taking antidepressants. In the past, the
heartbreaking anecdotes have shaken many committee members and led
them to push for stronger warnings than agency officials originally
suggested.
That dynamic may play out again. The agency has already promised
to include in the inserts in antidepressants' packaging a summary of
its analysis of the 22 trials. Two agency officials acknowledged
privately that the committee was also likely to press the agency to
strengthen the labels' suicide warnings. The F.D.A. generally
follows the recommendations of its advisory committees. In the only
recent public testimony by agency officials regarding the
controversy, Dr. Janet Woodcock, the agency's acting deputy
commissioner for operations, explained before a House subcommittee
on Thursday why the agency had refused to bar doctors from
prescribing most antidepressants to children, as British health
authorities did late last year.
The British decided on the prohibition because, authorities there
said, none of the drugs except Prozac had proved beneficial in
fighting depression in teenagers and children, and several studies
appeared to show that they may increase the risk of suicide. With no
benefit to recommend the drugs, the British concluded that they were
not worth their risks.
By contrast, Dr. Woodcock said the F.D.A. was keenly aware that,
without antidepressants, physicians had few tools with which to
treat pediatric depression. And she said that the agency's decision
to force all of the drugs to include a general warning about the
risk of suicide was an appropriate course.
"This is what we know," she said. "We have several positive
trials with Prozac. We know these drugs are effective in adults. We
know they have not been effective in some trials, in a number of
trials." She later added: "And we know the information about
suicidality. That is the state of the science."
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