By MICHAEL D. LEMONICK
TIME
TIME magazine asks whether antidepressants are a Prescription for Suicide?
Shannon Baker, whose 12 year old daughter, Kara Jaye-Anne Otter, committed
suicide when she had been on the antidepressant Paxil for seven months,
recalls: "I was told the worst side effects would be flulike symptoms."
The Los Angeles Times describes how Kevin Rider who was prescribed an SSRI,
was found shot to death at the age of 14. "Not long before his death, Kevin
Rider was caught climbing on a neighbor's roof in the middle of the night -
a bizarre stunt, like nothing the boy had ever done before, said his
mother." "Here I thought I was such a good mother, and I listened to a
doctor over my own son. I'll feel guilty about that for the rest of my
life."
Story here
lthough the life-threatening risks of the new SSRI antidepressants have
been known for years to a small, select group of researchers-soon after the
launching of Prozac (the first SSRI antidepressant)- most doctors who
currently prescribe the drugs don't have a clue about the potentially
explosive effects these drugs produce in some children and adults. Neither
doctors nor the public know that most clinical studies remain unpublished,
hidden in the drug manufacturers secret files. They are hidden because the
results contradict the claims made both in direct consumer ads and in the
peer-reviewed literature-these drugs have NOT been proven either safe or
effective. According to Dr. Martin Teicher, a senior Harvard researcher at
McLean Hospital who was first to publish case reports linking suicide and
Prozac, an internal Eli Lilly study of adults taking the drug showed "a
substantially greater incidence of suicide attempts in people in the study
receiving Prozac than in people receiving placebo or other
antidepressants."
For recent scientific analyses of the evidence since Dr. Teicher's 1990
article, see: http://www.ahrp.org/risks/SSRIsuicide0204.html
FDA's failure to warn doctors and the public about drug-induced
life-threatening adverse effects has encouraged doctors to prescribe these
drugs with abandon. The author William Styron referred to "the promiscuous
prescribing" of SSRIs by doctors who are uniformed about the potentially
life-threatening risks.
Change is likely to come only through congressional intervention.
Congressman James Greenwood has taken the first step toward protecting
children by requesting drug manufacturers to provide the unpublished data.
See his Feb. 3 letter at:
ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)
Contact: Vera Hassner Sharav
Tel: 212-595-8974
e-mail: [email protected]
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.
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.
Nonsense, say scientists who favor sharing such data. The reason some
studies remain unpublished is that the drug companies don't like to admit
negative results. According to Dr. Martin Teicher, a researcher at McLean
Hospital outside Boston who has published case reports linking suicide and
Prozac use, an internal Eli Lilly study of adults taking the drug showed "a
substantially greater incidence of suicide attempts in people in the study
receiving Prozac than in people receiving placebo or other
antidepressants."
But that study wasn't published, he says, while research showing no
increase in suicide attempts was. Says Dr. Richard Harrington, an expert in child
and adolescent psychiatry at England's University of Manchester: "It's very
important that things get peer reviewed. There is no question about that.
But if you have to make decisions about giving drugs to children, you might
sometimes have to go on unpublished reports."
Starting this week, the FDA will try to make sense of it all: the studies,
published and unpublished; expert testimony from both sides; and the
personal stories of ordinary people like Mark Taylor, 19, wounded in the
Columbine school shootings by Eric Harris, 18, who was taking the
antidepressant Luvox at the time. The agency could come to a decision by
next summer, but it might not be as well informed as some would like. The
truth, suspect many psychiatrists, is complicated: SSRIs help some people
and hurt others.
Says Teicher: "To figure out what impact [SSRIs] have on a side effect like
suicidal thoughts that might only affect a couple of percent - or even less
than 1%-of people in a study, you need a much, much larger study." And,
says Teicher, nobody is doing those studies yet. Besides, argues Koplewicz,
SSRIs are most often prescribed for kids by pediatricians or family
practitioners, not by experts in child psychiatry. "We need to train these physicians
properly," he says, "not ban drugs that are clearly effective."
Reported by Melissa August/Washington, Helen Gibson/ London, Hilary
Hylton/Austin and Sora Song/ New York
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