ichelle Van Syckel was one of those teenagers who did
everything -- played the clarinet and basketball, loved to travel, was an
honor-roll student for five years. But, after moving to a new town, Van
Syckel had trouble making friends, became irritable, and eventually
stopped eating.
Doctors diagnosed her with anorexia and depression, eventually
prescribing Paxil, a close relative of Prozac and one of the most popular
antidepressants on the market. Rather than improving, though, Van Syckel
became suicidal, at one point cutting ''DIE'' into her abdomen with a
razor.
''I wasn't always this insane,'' Van Syckel wrote in a poem. ''I don't
see an end to this long and winding road. . . . Tomorrow doesn't look too
great but maybe I'll be happier.''
Now, Van Syckel's family is suing both her doctors and GlaxoSmithKline,
the maker of Paxil, charging that her downward spiral into depression was
made dramatically worse by the very medication prescribed to treat it. The
case, part of a growing body of evidence linking Paxil to suicidial
thoughts and actions in a small percentage of the children who take it,
could have far-reaching implications for the treatment of depression in
adolescents.
''I never felt helpless prior to Michelle being on medication,'' said
her mother, Lisa Van Syckel.
GlaxoSmithKline's head of clinical development and medical affairs, Dr.
Alan Metz, said ''we have some evidence'' that Paxil is effective in
children. Children on Paxil who experience suicidal thoughts ''is a
relatively small number of patients,'' said Mary Anne Rhyne, a spokeswoman
for GlaxoSmithKline. ''We think there is more research that needs to be
done.''
But the Van Syckel case and others like it have prompted regulators to
act. In June, the US Food and Drug Administration, in an unprecedented
decision, recommended that doctors stop prescribing Paxil to new patients
under the age of 18 and advised parents to consult a doctor if their
children are currently taking Paxil.
Not long before the FDA's announcement, its British counterpart took a
strong stance against Paxil, advising doctors not to prescribe it to
children after reviewing clinical trial data of about 1,000 children on
the drug who had a 1 1/2 to three times greater risk of having suicidal
thoughts. But the FDA is more equivocal, waiting to deliver the final word
on Paxil while it reviews the data, leaving parents and doctors agonizing
over what to do next.
''This is something we are actively working on,'' said an FDA
spokesperson. ''Until we finish our review, we won't have a final decision
on this issue.''
But psychiatrists fear the controversy surrounding Paxil could scare
families from getting what is sometimes the best possible treatment.
''This just puts families in a difficult spot,'' said Dr. William
Beardslee, chairman of the department of psychiatry at Children's Hospital
Boston.
Doctors may become more reluctant to prescribe Paxil to children as
well, knowing that it could cost them personally if something goes wrong.
A Wyoming family won a $6.4 million dollar lawsuit against GlaxoSmithKline
in 2000 after a man taking Paxil shot his wife, daughter, and
grandaughter. The jury found there was enough scientific evidence to find
Paxil primarily responsible for the violence.
''Doctors I know felt more vulnerable [after FDA action],'' Beardslee
said. ''We're prescribing medications for a terrible disease and suddenly
the approval was withdrawn. It left us as physicians feeling very puzzled.
If we can't trust the FDA, what can we trust? No physician alone has
resources to look at all medications. That's what we have the FDA
for.''
The controversy occurs at a time when Paxil has emerged as the drug of
choice to treat teenage depression. Although the company says national
figures are not available, in Massachusetts, about 1,000 children under
MassHealth, the state's Medicaid insurer for low-income people, are
currently taking Paxil, out of about 3,700 children on Zoloft, Paxil, and
Prozac.
''It seems like over the last few years I've encountered more and more
kids coming into our practice that are on Paxil,'' said Dr. Bruce Black,
director of Comprehensive Psychiatric Associates in Wellesley and a paid
speaker for GlaxoSmithKline five years ago. ''I'm sure [the FDA's
decision] is going to put a significant damper on this. It will pretty
much shut it down.''
Paxil, a selective serotonin reuptake inhibitor, or SSRI, from the same
family as Prozac and Zoloft, works by boosting concentrations in the brain
of serotonin, a chemical that is key to mood regulation. Some doctors
prefer it over Prozac because the body metabolizes it more quickly.
Paxil was celebrated upon its FDA approval in 1992, like other SSRIs,
as the cure-all for depression, a debilitating disease affecting 18.8
million Americans, up to 2.5 percent of children and 8.3 percent of
adolescents. It was one of the biggest sellers last year for
GlaxoSmithKline with $2.5 billion in sales and the second most commonly
prescribed antidepressant in the United States.
But drugs that boost serotonin levels in the brain could actually
encourage the behaviors they are supposed to prevent. Soon after Prozac's
approval in 1987, doctors noticed their Prozac patients feeling so
uncomfortable they wanted to jump out of their skins. This excessive
physical and emotional agitation, called akathisia, some doctors believe
could lead some patients to act on suicidal thoughts. In 1991, an FDA
advisory panel decided there was no link between antidepressants like
Prozac and suicide tendencies in adults.
Dr. Christopher Lamb, director of child psychopharmacology at Cambridge
Health Alliance, said these side effects can happen with drugs like Prozac
and Paxil early on in treatment or when the dosage is changed, although
''it's hard to separate what is the side effect and what is just the
illness.''
Some psychiatrists, however, say the side effects, while serious, are
not reason enough to stop prescribing SSRIs to children.
''Medication can be extremely helpful and even lifesaving for some
children,'' said Dr. David Fassler, a child and adolescent psychiatrist in
Burlington, Vt.
Far from saving Michelle Van Syckel's life, however, the drug, her
family said, nearly killed her. Within days of taking Paxil, Van Syckel
felt ''extremely nervous and anxious,'' according to court documents.
Instead of withdrawing the medication, her doctors increased the dosage
and within weeks Van Syckel became confrontational, verbally abusive, and
started cutting herself. Her mother said the most striking change in the
normally tolerant teenager was her rabid racism, ''calling kids s---s and
using the n word.''
Understanding why youths like Van Syckel could be more susceptible to
these side effects requires more data, doctors say, but companies rarely
conduct clinical trials on children, leaving doctors to guess what drugs
work best for young people.
In fact, Prozac is the only antidepressant approved for children, with
studies demonstrating its effectiveness in young people. But even without
approval, a drug like Paxil can still be prescribed to children. Once the
FDA approves a drug for a certain group of patients with particular
condition, doctors are free to prescribe it to whomever they feel might
benefit, including children and conditions the FDA did not consider.
Parents should not take their children off Paxil or other
antidepressants, according to the FDA, since patients can sustain severe
withdrawal symptoms if the drugs are stopped abruptly. Psychiatrists have
fielded more calls from concerned parents since the announcement, but
Black sees this as medical progress.
''This is going to push people to be a little more thoughtful, and
that's a good thing,'' Black said.
Doctors eventually took Van Syckel off Paxil. Three years later, her
mother said she is almost completely back to normal and will be off to
college soon.
But the scars remain. Van Syckel may not remember threatening her
mother with an axe or screaming racial slurs, but the cuts on her body
will not disappear.
''My advice to parents is, when you take your child to a psychiatrist
and their first suggestion to you is, `We've got this new medication,' run
for the hills,'' said Lisa Van Syckel. ''Because they have no desire to
help a child; only to medicate them and get them out of their hair.''
Katherine Lutz can be reached at
lutz@globe.com.
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