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Doubts About Medicating Kids
Pressure is mounting to ban or curtail the use of
antidepressants on children. An FDA panel heard evidence this
week.
by Gregory M. Lamb, The Christian Science Monitor, February 5,
2004
For more articles like this
visit
https://www.bridges4kids.org.
Personal
tragedies and scientific evidence are combining to call into
question the use of powerful antidepressant drugs on children
and teens.
Pressure has been building for months to ban or curtail their
use. Recent scientific studies have found a link between the use
of these drugs and suicidal tendencies among children. In
December, Britain banned the use of some antidepressants on
patients under 18. The fallout from a hearing called by the Food
and Drug Administration (FDA) this week is ratcheting up the
pressure for some kind of action on this side of the Atlantic.
"Until I went to the conference, I felt I would be out of step
with my colleagues not to" prescribe these drugs, said Lawrence
Diller, a pediatrician from Walnut Creek, Calif., in a telephone
interview after the hearing. Parents and even children
themselves expect to be given a pill today, he says. But "I
think pediatricians are going to be much more careful after
hearing about this," by either writing fewer prescriptions or
monitoring the children more closely.
Dr. Diller - author of the book "Should I Medicate My Child?" -
was one of several physicians and researchers who testified at
the hearing outside Washington Monday. The advisory panel also
heard from numerous grieving parents and relatives whose
children had either killed or injured themselves or others while
taking prescription antidepressant medications. Meanwhile, one
presentation from researchers showed the drugs to have little or
no more effectiveness than placebos - sugar pills.
The FDA had been planning to issue a report on the drugs next
summer. But the advisory panel urged the FDA to act now to warn
doctors and parents. While the warning wouldn't place a ban on
prescribing such drugs, it would caution both physicians and
parents to watch for signs that the drugs might be having a
harmful effect.
"Our sense is that we would like, in the interim, the FDA to go
ahead and issue stronger warning indications to clinicians
regarding possible risks of these medicines," said Dr. Matthew
Rudorfer, a scientist at the National Institute of Mental Health
and the chairman of the FDA advisory committee. "We think such
warnings are required to elevate the level of concern and
attention that practitioners use in prescribing them.... We want
to put a speed bump in the road."
About 40 relatives of children who had taken antidepressant
drugs testified at the hearing that they believed the prescribed
drugs had had tragic consequences.
Parent Sara Bostock, said that after two weeks of taking Paxil
her daughter fatally stabbed herself with a kitchen knife. "To
die in this violent and unusual fashion ... led me to believe
Paxil must have put her over the edge," Ms. Bostock said.
Another parent, Mark Miller of Kansas City, Mo., said his
13-year-old son, Matt, hanged himself after taking seven Zoloft
pills. "You have an obligation today ... [to prevent] this
tragic story from being repeated over and over again," he said.
Two parents testified that they thought the drugs had helped
their children and urged the FDA not to ban them.
Diller and others are also concerned that scientific studies
about the drugs have either been suppressed or misinterpreted.
Diller says he spoke in his testimony about his "loss of faith
in my academic colleagues to generate accurate information and
opinions that I feel I can trust because of the extremely
intimate link between researchers and the drug industry."
After such revelations, he says, one might expect closer
regulation of the medical profession. But "we don't have to
worry about regulation of doctors because the government has
been bought off and so has the public by the drug industry," he
says. "The ads directed to consumers convince everyone that life
is simply, you know, neurotransmitter bubbles going from one set
of synapses to another. The lobbying of the drug industry is
legendary - and this is a doctor speaking."
Another testifier, David Antonuccio, a psychologist at the
University of Nevada Medical School in Reno, was part of a team
that analyzed 12 studies (published and unpublished) on
antidepressants and children. "Our conclusions were that the
advantages of the antidepressants in children were so small and
so trivial as to be clinically insignificant," Dr. Antonuccio
said by telephone after the hearing. They certainly do not
"warrant any increased risk, let alone increased risk for
suicidal behavior.
"We don't think the benefits warrant [even] some of the [lesser]
side effects, which are quite common, including agitation,
insomnia, and gastrointestinal problems."
His team's preliminary analysis of available studies shows that
"placebos duplicate 90 percent of the drug response," which
suggests that the drugs' benefit is primarily psychological.
Less risky strategies such as "exercise, cognitive-behavior
therapy, depression-management skills, sports, or just good
parenting" should be considered first, he says, adding that,
speaking as a father of a 5-year-old, "this is a really
important issue when it comes to protecting our children."
Britain cited health risks when it banned six brands of
antidepressants for children under 18. In the United States,
only Prozac has been deemed effective by the FDA in treating
children for depression, but doctors are legally free to
prescribe other antidepressants and have been doing so
routinely.
In October the FDA alerted doctors to reports of suicidal
tendencies found among children participating in clinical tests
of antidepressant drugs. Wyeth, the pharmaceutical company that
makes the antidepressant Effexor, had warned doctors in August
that its drug caused an increased risk of suicidal behavior in
children.
Antidepressants are heavily advertised by drug companies to the
general public and are used to treat depression,
obsessive-compulsive disorder, social phobias, and anxiety
disorders.
The drugs are classed as SSRIs or selective serotonin reuptake
inhibitors. Millions of prescriptions for them are written each
year. The FDA says that more than 10 million children and teens
17 and under took antidepressants in 2002. The drugs under
review by the FDA are known by the brand names Remeron, Serzone,
Effexor, Wellbutrin, Celexa, Luvox, Paxil, Zoloft, and Prozac.
The Pediatric Research Equity Act of 2003, signed into law last
November by President Bush, provides the FDA with authority to
require studies of the effects of pharmaceutical products
specifically on children to ensure that they are both safe and
effective.
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