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H E A L T H / M E D I C I N E
Prescription For Suicide?
British authorities say some antidepressants can be
deadly for kids. Now the FDA is investigating
By MICHAEL D. LEMONICK
Monday, Feb. 09, 2004
Kara Jaye-Anne
Otter, 12, had been on the antidepressant Paxil for seven months
when she committed suicide. "I was told the worst side effects would
be flulike symptoms," recalls her mother, Shannon Baker. "But after
three weeks she had begun to cop an attitude. Her grades started
falling. Then she didn't care what she looked like, and she was
fighting with everybody." Baker says her daughter developed rashes
and dark circles under her eyes and had trouble sleeping. Then, on
June 7, 2001, Kara pinned a note to her chest reading, "By the time
you find me I'll be dead. I love you with all my heart. Don't worry,
Jesus is with me." She hooked a bungee cord onto a plate hanger on
the wall, wrapped the cord around her neck and pulled against it
until she passed out. Within minutes she was dead.
Baker is convinced Paxil is what killed her daughter, and that's
what she'll tell a U.S. Food and Drug Administration panel meeting
this week in Bethesda, Md. For years a small but vocal group of
patients and doctors have insisted that certain antidepressants,
including Paxil, Zoloft, Prozac and other medications known as
selective serotonin reuptake inhibitors (SSRIs), carry an
unacceptable risk of antisocial behavior and suicide in kids who
take them. Many clinicians and most pharmaceutical companies
disagree. Major depression is a dangerous illness that in itself can
lead to suicide, and they insist that the benefits of these drugs
outweigh the risks. But drug firms also refuse to release all their
research — some of which tends to undercut their claims. "It's a
real shell game here," says Vera Sharav, president of the Alliance
for Human Research Protection, an advocacy group.
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The issue is coming to a head. By last December, the British
Medicines and Healthcare Products Regulatory Agency, the equivalent
of the FDA, had declared Celexa, Effexor, Lexapro, Luvox, Paxil and
Zoloft (but not Prozac) too risky for kids under 18. Two weeks ago,
a task force of the American College of Neuropsychopharmacology
fired back, saying that despite the risk of potentially serious side
effects, it's riskier to withhold the drugs.
Now comes the FDA probe, which began with an investigation of
Paxil launched in the fall of 2002. Last June the FDA cautioned
doctors against prescribing the drug to young people because of a
possible increase in suicidal thinking. In October the FDA issued a
broader public-health advisory alerting physicians that in clinical
trials, Paxil, along with about half a dozen other antidepressants,
wasn't any more effective than a placebo at treating depression in
kids. Indeed, no antidepressant other than Prozac has been formally
approved for young people. But that's not the same as a ban. Once a
drug is legal, doctors can prescribe it at will.
The British, on the other hand, actually banned the use of Paxil
(under the drug's British trade name, Seroxat) for kids last June,
and went on to ban the others in the following six months. Why the
difference, when British authorities were looking at the same data
as the FDA? One reason is that most studies on effectiveness aren't
really definitive. They don't prove one way or the other whether the
drugs work significantly better than placebos — and the Brits went
with the more conservative interpretation. That, argues Dr. Graham
Emslie, co-chair of the American panel and the author of several
studies on SSRIs, is shortsighted. "A failure to show effectiveness
is not the same as proving ineffectiveness."
Moreover, he argues, the evidence linking SSRIs to suicide is
very weak. Autopsies on people who have taken their lives show that
most victims hadn't taken an antidepressant, or had taken an
overdose, in the hours before their death. The British cited
"suicide-related events," not actual suicide, as the reason for the
ban — and there's obviously a big difference. "About 2 million teens
in the U.S. have clinical depression," says Dr. Harold Koplewicz, a
psychiatrist and director of the NYU Child Study Center. "But 3
million kids have suicidal thoughts. They seem to be part and parcel
of the adolescent experience." And, he points out, only a fraction
of either group actually attempts suicide.
Finally, say critics, the British medical authorities looked at
the evidence in an unsophisticated way. Many of the unpublished
studies they reviewed came from the drug companies themselves, and
at least some of those had been carried out for a very specific
purpose. Under FDA rules, any company that tests its medications on
young people at the FDA's request wins an extra six months' worth of
patent protection, whether or not the results are positive. Since
these studies were done for financial gain and weren't reviewed by
independent scientists, they probably shouldn't be given full
weight. Making them public, as activists demand, might muddy the
waters rather than help families make informed decisions.
From the Feb. 09,
2004 issue of TIME magazine
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