Keeley Schwindt was a high school freshman who became
moody and angry, and one day swallowed a massive dose of aspirin to see
what would happen.
Kevin Rider was a cerebral 12-year-old who
gradually lost interest in his schoolwork and pleasure in his precious Boy
Scout activities.
Like millions of boys and girls beginning
adolescence, they were diagnosed with depression, and their parents
decided to put them on medication.
Soon Schwindt, of Garden City,
Kan., was thriving, playing on the basketball team, later heading off to
college. Last year, at age 19, she won a teen beauty pageant, and her
parents believe antidepressants helped saved the girl's life.
Rider, of Orem, Utah, wasn't so fortunate. He had good and bad
stretches on the medication. One day, at age 14, he was found dead with a
gunshot wound to the head, an apparent suicide that his mother, Dawn
Rider, blames on the drugs. "He was not at all a suicidal person, not at
all," she said. "The drugs ended his life."
In public hearings
today a panel of experts convened by the Food and Drug Administration is
set to address the underlying question: Could the same drugs that doctors
say have helped make life more enjoyable and fulfilling for millions also
increase the risk of suicide in some children?
The hearings come
weeks after health officials in England effectively banned doctors from
prescribing a range of antidepressants to children, citing concerns over
suicide risk. As the debate heats up in this country, some psychiatrists
say that the uncertainties could vastly alter the treatment of depression
in American minors.
"The potential implications of this are
enormous, because FDA decisions carry so much weight in terms of what
medications are available to patients and families," said Dr. James
McCracken, director of child and adolescent psychiatry at UCLA's
Neuropsychiatric Institute. McCracken said concerns over suicide "are
genuinely confusing to many doctors who've used these drugs for some time
and are comfortable with them. To suggest that the drugs may be harmful
for kids is an about-face that is very hard to understand."
The
debate is over how to interpret research on SSRIs (selective serotonin
reuptake inhibitors), the popular class of antidepressants that includes
Prozac, Paxil and Zoloft. All agree that a risk of suicide shadows any
treatment for depression. It's not just that the disease itself puts a
person at increased risk, psychiatrists say; it's also that effective
therapy can lift mood and energy level just enough to prompt someone to
action.
Nonetheless, U.S. government researchers who reviewed
adult studies of SSRIs decided in the early 1990s that the medications had
mostly minor side effects and did not increase suicide risk. Subsequent
trials of drugs such as Prozac, Paxil and Zoloft in children and
adolescents suggested to most psychiatrists that the drugs were safe and
effective in younger patients too.
But no law compels drug
manufacturers to publish all the relevant information on a drug, and often
negative findings are withheld. In recent years, a raft of previously
unpublished information has emerged from SSRI trials in children —
convincing some scientists that the drugs are not as safe and effective as
initially portrayed.
"What you're seeing is one of the greatest
divides in medicine, between what published articles and their authors
say, and what the data actually show," said Dr. David Healy, director of
the North Wales Department of Psychological Medicine in Britain. Healy is
one of several researchers who contend that authors of industry-sponsored
SSRI trials in children have made the drugs look better than they really
are. In one trial, he said, researchers masked serious side effects by
noting vaguely that some children became "emotionally labile
[changeable]," when actually the youngsters reported thoughts of taking
their own lives, what's known as suicidal thinking.
In its warning
on SSRI use in children last December, the British Medicines and
Healthcare Products Regulatory Agency, Britain's version of the FDA, cited
evidence of a twofold to threefold increase in suicidal thinking with some
of the drugs — from about 1.5% to 3% or more, in some trials. (The agency
exempted Prozac from this warning, but the drug is not licensed for use
for children or adolescents in England.)
Yet Dr. Graham Emslie, a
psychiatrist at the University of Texas Southwestern Medical Center in
Dallas, who has conducted dozens of SSRI trials in children, said this
evidence amounted to little more than scattered case reports. Emslie heads
a task force of specialists reviewing data from some 2,000 children in
antidepressant trials. Late in January, the group reported that "taking
SSRIs or other new generation antidepressant drugs does not increase the
risk of suicidal thinking or suicide attempts."
"It's very hard to
interpret single case reports without investigating them more thoroughly,"
Emslie said. "I've been doing these kinds of studies for more than 10
years now, and I've never seen any of these problems" of suicidal
thinking.
Many members of the task force have received drug company
funding for research. They deny that those arrangements bias their
judgment. They also point out that thoughts of suicide are not the same
thing as the act itself, and that no child committed suicide during the
trials. The dark thoughts need to be taken very seriously, they said; but
the teenage years are often colored with morbid fantasies, even in those
who are not clinically depressed.
Dr. Jane Garland, a psychiatrist
and director of the Mood and Anxiety Disorders Clinic at BC Children's
Hospital in Vancouver, Canada, has noticed that a small number of children
in her practice have an "odd" reaction to SSRI medications. "Generally
speaking, if you're really suicidal, the antidepressants will make you
less so," she said. "But then there's this subgroup of young patients who
aren't suicidal who take the drugs and report this odd and sudden onset of
obsessive suicidal thinking. They say, 'I think I'm losing my mind,' and
'I don't want to feel this way.' "
Rider, the Utah mother, who is
scheduled to testify in Washington today, said this described what
happened with her son. "He was telling me the drugs made him feel strange,
he said he didn't like what they did to him, and all along I took the
advice of our doctor" to continue the medication, she said. "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."
Already,
many parents of troubled youngsters who might benefit from treatment with
SSRIs are weighing the possibility, however remote, of an increased risk
of suicidal thinking.
Deborah Gongora, 30, a mental health patient
advocate in Victorville, has two children prone to depression, 14-year-old
David and his sister, 12-year-old Devin. David has struggled with bouts of
depression since grade school, but recently has found some relief in group
and individual counseling sessions, without antidepressants.
Devin
has tried talk therapy too, but doesn't like it or find it helpful. "With
her, right now, I believe antidepressants are the right thing to do," said
Gongora. "I was depressed myself at her age. I was suicidal, so I know
what it looks like. For me, the most important thing is having an open and
honest relationship with her, so I have some idea what she's thinking. If
a child is depressed and contemplating suicide already, you have to do
anything to stop them."
Some signs of suicidal thinking are
obvious, child psychiatrists say: talking about death; total withdrawal
from friends; giving away prized possessions. A sudden increase in drug or
alcohol use also can be a warning. Mock attempts, and actions such as
Kansas teenager Schwindt's experiment with aspirin, are ominous. So is
erratic, wildly uncharacteristic behavior. 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.
Those doctors who believe that suicidal thinking is a
risk with some SSRIs say that reaction is most likely to occur within the
first two weeks of starting on the antidepressant or if the patient quits
the drug suddenly. For now, the only thing all sides agree on is that
researchers need to focus directly on the possible link between SSRIs and
suicidal thinking, rather than leaving the subject open to debate.