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Collier Schorr for The New York Times
Thirteen-year-old Matt Miller killed
himself shortly after he started taking Zoloft. His
parents and those of other teenage suicides recently won
a victory when the F.D.A. issued a strong warning about
adolescent use of antidepressants. |
ooking
back, Mark and Cheryl Miller would have done a lot of things
differently with their 13-year-old son, Matt. They probably
would never have left Lenexa, Kan. They would have sent him to a
different school, and they certainly would have chosen a
different therapist. But most of all, they wouldn't have given
him Zoloft. ''It's not a pleasant thing living with the thought
that you had a hand in your son's death,'' Mark Miller told me
recently. ''Making him take those pills was done out of love for
Matt, but it was still the wrong thing to do.''
 |
We were on our way back from Mark and Cheryl's
Wednesday-night Bible-study class. I was riding with Mark, who
had come straight from the advertising agency where he works as
a vice president and creative director. A young-looking 55, with
neatly combed hair and wire-rimmed glasses, he was wearing a
striped Polo button-down and pressed blue jeans. A few minutes
later Mark eased his white Volvo into the garage of their home,
a meticulously decorated two-story Tudor in Overland Park, Kan.
The Millers moved here from Lenexa, like Overland Park a suburb
of Kansas City, in the summer of 1996, though they'd been
talking about relocating for years. They liked Lenexa, but Mark
was doing well, and they could afford a bigger house in a more
upscale neighborhood.
Their new home was only 30 minutes away from their old one,
but it meant a new school district for their two children. Their
15-year-old, Jenny, was going to be a freshman in high school
and was nervous about the move. Her 12-year-old brother, Matt, a
slight, fair-haired boy who wore skateboard-style clothing, was
excited. As a Cub Scout, he had built the fastest pine-wood
derby car in his age division, and he was looking forward to
taking flying lessons at a flight school near their house when
he turned 14.
School started, and Jenny was doing fine. She tried out for
the drill team, and while she didn't make it, she did meet some
new friends at the auditions. Things were a little harder for
Matt at Harmony Middle School. First of all, it was big; the
Overland Park area had become very popular in recent years, and
Harmony had been forced to temporarily accommodate 700 students,
nearly twice as many as it had been designed to. Starting in the
seventh grade also put Matt at a disadvantage, as most of his
classmates had already been together for a year. Though he was
small for his age, Matt was popular with the girls. Still, he
was clinging to his old friends more tightly than the Millers
had hoped. On weekends, Mark and Cheryl often found themselves
driving him to and from Lenexa.
For a while, the Millers thought Matt was just going through
a normal period of adjustment; a few months in, though, they
noticed a change. ''At the beginning of the school year, Matt
was getting calls from girls all the time,'' Cheryl, a petite
woman in a stylish gray jacket and black pants, told me. ''But
around Christmas we saw things weren't connecting for him as
well. The kids weren't letting him in. He started getting quiet,
withdrawn.'' The Millers' theory is that the other boys were
jealous. ''We think some of the guys were blocking him out
because all of the girls were calling him,'' Mark said. ''He
probably crossed somebody with someone's girlfriend.''
By midwinter the signs were more pronounced. His grades were
falling. Always an A-B student -- he had excelled in math in
particular -- he now had a D and an F. In February, Matt was
caught forging his father's signature on several midterm
progress reports. The Millers were called to the school for a
conference. As the second semester continued, Matt's problems
multiplied. One of his teachers reported that Matt was breaking
pencils in class and failing to interact with his classmates.
Several instances of ''unsatisfactory conduct'' were brought to
the attention of the principal.
In April, the school put Matt in a special-needs class for an
hour every afternoon. Neither his attitude nor his behavior
improved, though he did start going steady with a girl in May.
Around that time, a counselor at Harmony suggested to Mark and
Cheryl that they seek therapy for Matt during the summer. The
Millers, who knew by now that Matt was unhappy though they
weren't sure why, thought this was a good idea. They were eager
to help Matt while school was not in session; that way, he could
start fresh in the fall. They initially wanted Matt to see a
social worker recommended by the school, but their insurance did
not cover that therapist. In the end, they chose a psychiatrist,
telling themselves that this might be for the best in case
medication was required. Matt didn't want to go. ''He said to
me, 'Mom, I'm not crazy,''' Cheryl recalled. Mark added: ''I
remember telling him, 'Matt, this is good.' We would all love to
pay someone to help us work through our problems.''
On June 30, 1997, the Millers took Matt to see Dr. Douglas
Geenens, a child psychiatrist referred to them by Matt's
primary-care physician. In addition to the doctor and the
Millers, both Mark and
Cheryl remember there being two other people in the room, who
Dr. Geenens explained were his trainees. Matt sat silently for
almost the entire 50-minute session. Cheryl did most of the
talking, sketching
out Matt's emotional deterioration since the start of the
calendar year.
Matt's next appointment with Dr. Geenens was scheduled for July
21, a Monday. Mark and Cheryl recalled the details for me: Matt
took a 30-minute test for attention deficit disorder and spent
15 minutes
filling out a Children's Depression Inventory form, a standard
tool for measuring depression in kids. At the end of the
session, Dr. Geenens suggested that Matt try Zoloft. He gave the
Millers three sample bottles with seven 50-milligram tablets in
each and told them to make sure that Matt took one a day. The
Millers had never heard of it. ''The only thing I was aware of
was Prozac,'' Cheryl told me. ''I asked him why are you
prescribing Zoloft?'' Dr. Geenens answered that Zoloft was newer
and more refined than Prozac. Cheryl asked if there were any
possible side effects. Dr. Geenens said they should be on the
lookout for stomachaches or insomnia. The doctor had no
appointments available until the middle of August, but he wanted
the Millers to call in a week and let him know how Matt was
doing.
Two days later, Mark took the kids to visit his mother at her
apartment in Sioux City, Iowa. Their plan was to spend a few
days there, then bring Mark's mom back to Overland Park for the
weekend --
they had tickets to a play in Kansas City -- before dropping her
back home on their way to a family vacation on a lake in
Wisconsin. Matt spent much of his time in Sioux City swimming in
the pool at his
grandmother's apartment complex. They came back on Friday and
all went out to dinner. ''He was sitting across from me, and I
remember asking him to quit stomping on my feet,'' Cheryl told
me. ''I think back to that now -- he couldn't sit still.'' At
lunch after church a couple of days later, Matt's grandmother
also noticed that he seemed restless and agitated.
The Millers were leaving early Monday morning for Wisconsin. On
Sunday night, July 27, at around 11:30, Matt was still on the
phone with his girlfriend. Mark went to his son's room to tell
him to hang
up and go to bed. ''I didn't yell at him, but I was firm,'' Mark
recalled. Matt threw the phone down and angrily slammed the door
in his father's face, something he'd never done before. Mark
went back to his room and asked Cheryl if he should go back in
and talk to him. Cheryl thought they ought to wait until
the morning. ''He's finally just getting settled,'' she told
Mark. ''We don't want to rile him up again.'' When Cheryl went
in to wake Matt up the following morning, she found him hanging
by a belt from a laundry hook in his closet.
It didn't take long for Mark's thoughts to turn to the Zoloft:
''It was the only thing that had changed that week. What else
could we attribute it to? He's on a new medication, and he takes
his life.'' When he spoke with Dr. Geenens later that morning,
Mark asked if there was something in the drug that might have
triggered suicidal behavior. The doctor told him that he wasn't
aware of anything.
At the time, there wasn't much reason for Dr. Geenens to have
known otherwise. Over the course of the past two years, however,
the debate over whether antidepressants, particularly those
known as S.S.R.I.'s -- selective serotonin reuptake inhibitors
-- can trigger suicidal behavior in teenagers has migrated from
the margins of the medical community to the front pages of
newspapers. Adding to the controversy was public outrage at
revelations that a number of pharmaceutical companies had
deliberately withheld damning information about S.S.R.I.'s --
specifically, data from clinical trials that suggested that
these drugs were both more dangerous and less effective for
adolescents than millions of consumers had been
led to believe.
Beneath the rancor was a complicated question. Patients who were
being prescribed antidepressants were, by definition, vulnerable
to suicidal behavior; it was difficult to determine where the
effects of depression ended and the effects of the drug began.
What's more, psychiatrists had been aware for decades that the
risk of suicide increases when patients first start emerging
from depression. Rollback, as this is known, is thought to be
caused by a depressed patient's energy level rising ahead of his
or her mood. No longer lethargic but still deeply unhappy, for a
brief period some patients who had been too apathetic before to
harm themselves now had the wherewithal to do so. Were patients
taking S.S.R.I.'s experiencing rollback? Or was there something
specific about S.S.R.I.'s that triggered suicidal impulses?
Things came to a head this fall with the F.D.A.'s affirmation of
a link between antidepressants and suicide ''ideation,'' or
suicidal thoughts, in adolescents. Now all antidepressants,
including S.S.R.I.'s like Prozac, Zoloft, Paxil, Lexapro, Luvox
and Celexa, must carry a black-box warning label, the regulatory
agency's
strongest kind, making a possible suicide link explicit and all
but ensuring a significant decrease in their use among young
people. Far from providing closure on this complicated issue,
though, the F.D.A. ruling may ultimately raise more questions
than it answers.
Many child psychiatrists, who as a group have come to rely on
S.S.R.I.'s to treat adolescent depression, seem to think the
F.D.A. overreached. Studies have shown that one out of every 20
teenagers has suffered at least one bout of severe depression in
his or her life, and adolescent depression can be especially
difficult for doctors to manage. Teenagers are often resistant
to psychotherapy, and unlike adults, who can quit a job or leave
a marriage that might be aggravating their unhappiness,
adolescents are almost always stuck with their lots. Doctors who
treat young people -- child psychiatrists, pediatricians and
general practitioners alike -- were wary of tricyclics, the
previous generation of antidepressants, because of the risk of
overdose. (The difference between an effective dose and a lethal
one could be as small as six tablets.) But it is much harder to
OD on S.S.R.I.'s. While the F.D.A. has approved only Prozac for
depression in children and adolescents, doctors are free to
prescribe any of these drugs ''off label'' for a patient group
not specified on the packaging. And they have: between the early
90's and 2001, the prescription rate of antidepressants for
those under 18 more than tripled. In 2002, 11 million
antidepressant prescriptions were written for children and
adolescents in the United States. Doctors recommended the drugs
primarily to treat depression, but also for other emotional
problems, from anxiety to shyness to obsessive- compulsive
disorder.
The pharmaceutical companies are clearly making a product that
most psychiatrists consider critical to treating depressed
adolescents. Not prescribing these drugs may very well pose a
greater threat than prescribing them. Studies have shown that
areas in which antidepressant use among young people is
widespread have experienced a dip in teenage suicide rates;
according to Dr. John Mann, a suicide
expert at Columbia University, fewer than 20 percent of the
4,000 adolescents who commit suicide in America each year are
taking or have ever taken antidepressants. ''It would be
ludicrous to think that antidepressants could actually
contribute to suicide in the United States in any kind of
significant way,'' Mann told me. ''The vast majority of teen
suicides are actually committed in the absence of
antidepressants.''
The F.D.A. was essentially forced to strike a balance between
the cost of the few and the good of the many. Did the agency
give too much weight to the few? ''For a family who has lost a
child shortly after going on Prozac or some other S.S.R.I., I
don't know what I can say to them,'' Dr. John Walkup, a child
psychiatrist in Baltimore, told me. ''But it's dangerous to make
public policy based on rare and tragic events.'' Still, as Mark
and Cheryl Miller will tell you, it's no less dangerous to
ignore them.
In the months after Matt's death, the Millers confronted a sort
of grief that most parents cannot begin to imagine. Both of them
took a month off from work. They started every day with an
early-morning walk around a lake near their house. They talked
about Matt and all of the things they might have done
differently. Jenny made the drill team that fall, and the
Millers attended every Friday-night football game to watch her
perform at halftime. They found that they felt better when they
were out of the house, so they took lots of weekend trips and
visited family members on Thanksgiving and over Christmas. They
also went out with friends and colleagues as much as possible.
''We both strived for normalcy again, which we knew would never
be quite the same,'' Mark told me. Always religious people, the
Millers immersed themselves even deeper in Christianity and met
weekly with a Christian grief counselor.
But Mark was also hunting for answers. He soon found what he was
looking for, or rather whom. During one Internet search, he
happened across the Web site of Ann Blake Tracy, author of
''Prozac: Panacea or Pandora?'' a self-published 424-page screed
against S.S.R.I.'s. Unless you are desperate, as most people
typing words like ''suicide'' and ''antidepressants'' into
Google most likely are, Tracy's Web site does not invite
lingering. A picture of her in what looks like an out-of-focus
70's yearbook photo is surrounded by text that is the online
equivalent of someone yelling outside the gate of the White
House -- angry black-and-red type interrupted with WARNINGS
about the dangers of going off these drugs cold turkey, and
invitations to ''click here'' to read more personal horror
stories.
Even among the most ardent opponents of S.S.R.I.'s, Tracy is an
extremist. When I met her this fall, she told me that she began
her campaign against antidepressants in 1989, when two friends
in Salt Lake City, both Mormons, became alcoholics shortly after
going on Prozac. Since then, she has come to believe that
antidepressants have played a role in just about every
high-profile act of violence the world has seen, from the death
of the Princess of Wales (''When Princess Di was killed,'' she
said, ''I called the police in Paris and said you've got a
driver on Prozac'') to the 1999 shootings at Columbine High
School to the terrorist attacks of Sept. 11. But as an early
anti-S.S.R.I. activist, Tracy was a godsend to families like
the Millers, who were relieved to discover someone who could
vindicate their hunch about these drugs.
Mark pulled Tracy's number from her Web site and called her.
After hearing Matt's story, she steered Mark to some other
sources, and he continued his research. He soon learned that the
possibility of a link between S.S.R.I.'s and suicide had first
been raised many years earlier by two Harvard Medical School
psychiatrists, Dr. Martin Teicher and Dr. Jonathan Cole, in a
paper published in early 1990 in The American Journal of
Psychiatry titled ''Emergence of Intense Suicidal Preoccupation
During Fluoxetine Treatment.'' The doctors observed that six of
their adult patients experienced ''intense, violent suicidal
preoccupation'' within two to seven weeks of starting on
fluoxetine, the generic name for Prozac, the first of the
S.S.R.I.'s to reach the American market.
Teicher and Cole didn't want to overstate the significance of
their findings -- five of the six patients had entertained
thoughts of killing themselves at some point earlier in their
lives -- but the onset of suicidal thinking had occurred so
suddenly after the beginning of treatment that a prospective
link was hard to
ignore. ''The purpose of this report is to suggest the
surprising possibility that fluoxetine may induce suicidal
ideation in some patients,'' the doctors wrote, reporting that
the phenomenon appeared in about 3.5 percent of their patients
taking the drug.
About a year later, Dr. Robert A. King, a child and adolescent
psychiatrist at the Child Study Center at Yale Medical School,
noticed something similar in several of his patients between
ages 10 and 17. Dr. King had prescribed Prozac for 42 of his
young patients suffering from obsessive-compulsive disorder (but
not depression), 6 of whom experienced what he later described
in The Journal of the American Academy of Child and Adolescent
Psychiatry as ''self- injurious ideation or behavior'' --
behavior that none of them had ever experienced before. This was
too small a sample to rule out the possibility of coincidence,
but large enough for Dr. King to conclude that a narrow, still
poorly defined group of patients on Prozac do seem to experience
a range of adverse side effects from restlessness to
self-destructive acts.
In September 1991, the F.D.A. convened a committee of 10
psychiatrists and psychologists to weigh in on the issue. After
listening to hours of testimony from victims, depression experts
and mental-health professionals, the panel decided that more
research was needed but that for now there was no ''credible
evidence'' of a link.
To Mark, this hardly sounded like a clean bill of health. Other
things troubled him as well. He learned, for instance, that the
F.D.A. had never approved Zoloft as a pediatric antidepressant
-- and indeed that the drug's maker, Pfizer, had not been
compelled to prove that it was safe for young people. He read
about a phenomenon known as akathisia, or activation, a state of
extreme agitation that can be induced by some psychotropic
medications and can cause patients to behave in an
uncharacteristically violent manner, which seemed to describe
perfectly Matt's condition before his suicide.
Armed with this new information, Mark contacted Matt's
psychiatrist, with whom he hadn't spoken since the morning of
his son's death, and suggested that they meet. Mark knew that
most psychiatrists would also have prescribed antidepressants
for Matt, but he wanted to encourage the doctor to reconsider
his approach to these drugs. To that end, he brought along all
of his S.S.R.I. files. They ordered iced teas, and Mark
said a short prayer asking that they honor Matt in their
approach to this very difficult meeting. He began by telling Dr.
Geenens that he and Cheryl blamed themselves for being too quick
to embrace a ''solution in a bottle'' to Matt's unhappiness.
''We wanted a miracle,'' Mark said to the doctor, ''and we were
willing to accept anything offered which promised an end to his
depression, and to our agony.'' Mark explained to Dr. Geenens
that he and Cheryl wanted him as a partner, not an adversary,
and
urged him to join their anti-S.S.R.I. cause by using his
professional influence to encourage other physicians to exercise
restraint when it came to antidepressants. In Mark's
recollection, Dr. Geenens was
polite but visibly uncomfortable. When the hour-and-15-minute
meeting was over, Mark didn't get the feeling the doctor was
going to change his prescription habits, let alone enlist in
their fight against
antidepressants. ''He was relieved to know I wasn't planning a
malpractice suit,'' Mark later reflected in an e-mail message to
Ann Tracy. (Dr. Geenens did not respond to phone calls seeking
comment.)
Mark and Cheryl did, however, decide to sue Pfizer. The next
time Mark saw Dr. Geenens, two years had passed and the doctor
had just given his deposition in the case. By this point, any
lingering hopes that Dr. Geenens might emerge as an ally had
long vanished. Not only had the doctor not responded to letters
from the Millers' lawyer; he had also signed an affidavit for
Pfizer in which he maintained that he had relied solely on his
own professional judgment when prescribing Zoloft for Matt. At
his deposition, Dr. Geenens also acknowledged that he was a
member of Pfizer's Speakers Bureau, and that he gave -- and was
still giving -- on the order of 50 Pfizer- sponsored talks a
year for between $300 and $750 each.
By the time of Matt Miller's death in 1997, there had been
hundreds of adult antidepressant lawsuits focusing on both
violence and suicide, the vast majority of which were either
dismissed or resolved out of court. Drug makers are rarely eager
to settle these cases, largely because they don't want to
encourage the small cadre of trial lawyers who make a living
suing them. At the same time, the publicity involved with going
to court, in addition to the risk of confronting a guilty
verdict, is even less appealing. A result is a
great many 11th-hour settlements. Indeed, as of 1997, only one
antidepressant case, that of Joseph Wesbecker, a former employee
at a printing plant in Louisville who went on a shooting spree
about a
month after starting to take Prozac in 1989, had ever gone to
trial.
For all of the adult suits, however, there had been relatively
few adolescent cases before Miller v. Pfizer Inc. Unlike
product-liability lawsuits, which focus on whether a particular
item malfunctioned, it's the psychic state of an individual that
is contested in S.S.R.I. lawsuits. For the parents of that
individual, the prospect of subjecting themselves to a grueling
emotional autopsy of their lost child can be too much to bear.
The Millers agonized over the decision to sue Pfizer, waiting
until August 1999, two years after Matt's death and fewer than
24 hours before the statute of limitations would expire, before
finally filing the papers. They knew that pursuing the case was
going to require considerable financial and emotional
investments. While their lawyer was working on contingency, Mark
had to cover all of the court fees, which would run into the
tens of thousands of dollars. ''We knew it was going to be
painful, that we were going to be reopening all sorts of
wounds,'' Mark told me, reflecting on the decision now. ''I
don't regret it. I don't think I'd be able to live with myself
if I didn't feel like we had done everything we could for
Matt. But I would tell anyone who asks me, don't do it. It's not
worth it.''
Mark and Cheryl hired Andy Vickery to represent them. A stocky
and excitable Georgia-born, Yale-educated plaintiff's lawyer who
wears black cowboy boots under his dark suits and drives a
Jaguar,
Vickery has handled little besides antidepressant cases for the
past decade. This preoccupation has not made for the most stable
existence. A few years ago, after a devastating defeat at the
hands of Eli Lilly & Company -- ''The verdict came down on
Good Friday, and I felt like I'd been crucified'' -- and a
succession of costly dismissals, Vickery almost lost the
ranch-style house he and his second wife bought and renovated in
Houston's tony Tanglewood section, a few blocks away from former
President Bush.
But there have been some big victories since. In addition to
dozens of settlements -- the out-of-court agreements always
stipulate that the terms remain undisclosed -- Vickery took
GlaxoSmithKline to
court on behalf of the relatives of Donald Schell, who went on a
violent rampage hours after starting on the company's S.S.R.I.
Paxil, murdering his wife, his daughter and his granddaughter
before turning
the gun on himself. In 2001 a Wyoming jury ordered the company
to pay $6.4 million to Schell's relatives, 40 percent of which
went to Vickery, who paid off his mortgage.
Like any good trial lawyer, Vickery has internalized his
clients' traumas and converted them into a cause. ''We're on the
right side, we've been on the right side all along and now the
world is starting to realize that we are on the right side,'' he
told me in his office in a Houston skyscraper last month. ''I've
believed it
from the bottom of my heart all along.''
The basic facts of the Miller case looked compelling to Vickery.
It was a violent suicide, which fit the pattern he had observed
in previous antidepressant cases. Also, Matt had hanged himself
from a low-hanging hook; all he had to do was lower his feet to
the floor and he would have saved himself. To Vickery,
this suggested a sudden, drug-induced mania. ''Matt Miller went
from zero to 60 and hanged himself in a way that took Herculean
effort,'' he told me.
Miller v. Pfizer Inc. was Vickery's second adolescent suit and
his first suit against Pfizer. He had tangled with enough drug
companies to know it wasn't going to be easy, but he soon found
himself grappling with a uniquely ferocious enemy. In addition
to interviewing virtually everyone whom Matt had come into
contact with in the year leading up his death, Pfizer burrowed
deep into Mark and Cheryl's private life. The company's lawyers
deposed the Millers' pastor and grief counselor, and subpoenaed
the handwritten journal that Cheryl kept after her son's suicide
as well as their daughter Jenny's diary. Pfizer even hired Park
Dietz, a forensic psychiatrist and an expert in autoerotic
asphyxiation, to file a report contending
that Matt's suicide may have been a case of masturbation gone
awry. Among the numerous other possible causes Pfizer raised
during the pretrial proceedings, according to Vickery, was
Matt's relationship with his father. Malcolm Wheeler, Pfizer's
lead attorney, ''said in open court that Matt Miller hated his
father,'' Vickery said. ''That's as low a blow as I've ever seen
by any lawyer. . . . They are subhuman. I hate Pfizer.''
Pfizer doesn't think much more of Vickery. ''Andy is a very
clever, articulate guy,'' Wheeler told me recently. ''But he
just throws stuff out there, and unless you compel him to
provide the backup data and calculations, he'll just talk you to
death.''
The Millers' story of Matt's life, until its abrupt end, is one
of a more or less normal adolescent boy experiencing more or
less normal adolescent problems. The Pfizer lawyers set out to
build a
counternarrative. In the thousands of pages of depositions and
expert-witness reports, there are moments when it seems that the
Millers might not have grasped the depth of their son's
emotional problems. ''Matt Miller was a very, very tragically
disturbed child who just didn't get help in time,'' as Wheeler
put it.
That said, many of the details that Pfizer's lawyers brought out
can be seen either as a serious indication of severe emotional
problems or as standard teenage acting out. The only thing
that's truly beyond dispute is that the emotional life of an
adolescent boy is virtually impossible to parse.
Matt was clearly having trouble making friends at Harmony Middle
School. One of his guidance counselors testified that other
students described him as ''weird,'' and noted that Matt had a
tendency to alienate the more popular kids and to pick on the
less popular ones. Still, a good deal of his behavior seems
fairly typical for an attention-seeking teenage boy, things like
baiting other students, joking about defecation, drawing lewd
pictures. Matt's special-needs instructor, Roxana Rogers,
recalled Matt breaking into tears during a conversation in the
hallway because he felt so much pressure at home to be
''perfect,'' also not an entirely unusual sentiment for the
child of ambitious upper-middle-class parents.
Yet there were hints of violence and self-destructiveness as
well. Matt was disciplined several times at school, once for
hitting a classmate with a chain, another time for supposedly
threatening a fellow student with a piece of a plastic mirror.
Rogers once saw Matt banging his head against his locker and
remarked in her deposition that he shuffled his feet and walked
around the classroom at inappropriate times -- which sounds a
lot like the sort of restlessness that Cheryl observed the week
he was on Zoloft.
There was every indication that Matt was depressed. He scored a
13 on the Children's Depression Inventory, which Dr. Geenens
considered ''significant'' and indicative of moderate
depression. There was also evidence that he had talked about
taking his own life before doing so. Chad Brownel, Matt's only
close friend at Harmony, said that Matt mentioned suicide
''hundreds of times'' during the six months that they'd known
each other. And toward the end of the school year, when Roxana
Rogers asked Matt about his plans for the summer, Matt said that
if his parents sent him away to camp, he would kill them and
then kill himself. Rogers considered the remark and his behavior
problematic enough to call his mother and schedule a meeting.
What's more difficult to determine is whether Matt would have
acted on these thoughts had he not taken Zoloft. Suicidal
ideation is common among depressed adolescents, but completed
suicides are rare; some child psychiatrists have come to see
suicide attempts more as appeals for help than as expressions of
a determination to die. One question on Matt's Children's
Depression Inventory asked him to choose one of the following:
''I do not think about killing myself''; ''I think about killing
myself, but I would not do it''; ''I want to kill myself.'' Matt
answered that he thought about killing himself but would not do
it.
After going on the medication, Matt told his friend Chad that
the pills were giving him insomnia. Chad also noticed that Matt
seemed ''a little more wild'' and more energetic. Instead of
watching ''Beavis and Butt-head'' or playing the video game
Mario Kart, which they usually did, Matt wanted to ride bikes to
Taco Bell. Matt could have been going through rollback, a
relatively common reaction in the early stages of treatment. Or
he might have been experiencing activation, the dangerous side
effect that Mark had read about online. Was it the Zoloft per
se? Or was Matt's suicide a tragic by-product of the process of
getting better?
Those were questions for the jury to wrestle with. But before
Miller v. Pfizer Inc. could go to trial, Vickery had to show
general causation -- in other words, that S.S.R.I.'s cause some
people to become violent or suicidal. He had done this in all of
his previous antidepressant cases. There had been no shortage of
hard-fought battles -- for the drug makers, causality was their
first line of defense -- but he had never failed to clear that
hurdle.
Vickery turned to Dr. David Healy, an expert witness whom he had
used several times before, to present the court with proof of a
plausible link between S.S.R.I.'s and suicide ideation. A
specialist in psychological medicine at Cardiff University in
Wales, Dr. Healy had first warned about the potential for
suicidal acts among patients on antidepressants in 1990. Since
then he has published several provocative academic books on the
subject, most recently ''Let Them Eat Prozac''; as a frequent
expert witness in S.S.R.I. cases, Dr. Healy has spent quite a
bit of time rooting around in the basements of drug companies
searching for suppressed information on antidepressants.
Conversely, the drug companies have spent quite a bit of time
and money attacking Dr. Healy's bona fides and trying to
discredit his research as ''junk science.''
The judge appointed two independent medical experts to evaluate
Dr. Healy's work. Dr. Healy submitted his data to the court. The
experts were flown to Kansas City. Over two days of hearings,
they raised questions about Dr. Healy's methodologies, and the
judge ultimately barred his testimony. Without it, the Millers
had no proof of a causal link. Their case was dismissed before
it had even begun.
Last February, six months before the F.D.A. acknowledged a link
between S.S.R.I.'s and suicidal thoughts, a Kansas appeals court
affirmed the ruling. By this point, Vickery had spent more than
$200,000 on the Millers' suit. One final, long-shot option
remained: the Supreme Court.
Mark and Cheryl's lawsuit may have been foundering, but they
were finally making some headway in their public campaign
against S.S.R.I.'s.
Not long after Matt's death, Mark helped Ann Tracy create a Web
site for her nonprofit group, the International Coalition for
Drug Awareness, where families with similar experiences could
post their
stories and learn more about the side effects of
antidepressants. He soon found himself at the center of a
growing community of ''survivors.'' For several years, this
loose network of families tried vainly to draw attention to
their cause; but then in late 2003, when the Medicines and
Healthcare products Regulatory Agency -- the U.K.'s equivalent
of the F.D.A. -- advised against the use of all S.S.R.I.'s
except Prozac in patients under 18, the outside world suddenly
became interested.
The British decision had been the unintended consequence of
GlaxoSmithKline's request to market Seroxat -- known as Paxil in
the United States -- to children with social phobias and O.C.D.
As part
of the application process, GlaxoSmithKline submitted what it
believed to be all the data required for approval. The M.H.R.A.,
however, wanted to see more, specifically all of the company's
trials on Paxil and adolescent depression, many of which had
never been published.
The trials were submitted, and the British regulatory agency did
not like what it saw. Not only did the data suggest that Paxil
caused an increased suicide risk in children; several of the
trials also failed to demonstrate that the drug performed any
better than a sugar pill. Within a matter of weeks, the M.H.R.A.
publicly announced that Paxil should not be used in children.
Not long after came the broader warning against all
antidepressants except Prozac.
By this point the F.D.A. had also seen GlaxoSmithKline's
unpublished Paxil data and was deep into an investigation of its
own. Over the summer of 2003, the regulatory agency warned
doctors against using Paxil in children under 18, and in the
fall of that year it publicly acknowledged that it couldn't
''rule out'' the possibility that a number of other
antidepressants might also increase the risk of suicide in
adolescents.
For the most part, though, the F.D.A. approached the issue
more gingerly than its British counterpart. Agency officials
wanted to see additional data before taking any further action.
The problem was that no large-scale studies existed. Until they
did, the F.D.A.'s only option was to combine a number of small,
disparate trials conducted by drug makers in the late 90's and
try to draw some meta- conclusions. None of those trials had
been designed to assess suicide risk, but for the time being
they were all that the agency had to go on.
In late 2003, the F.D.A. asked the pharmaceutical companies for
all relevant information on every so-called adverse event in
each of these pediatric antidepressant trials. A group of
independent researchers from Columbia University was
commissioned to review the 427 cases the companies produced.
With the help of a separate team of suicide experts, the
Columbia researchers set about classifying them as suicidal or
not.
It was not an easy task. There wasn't a single successfully
completed suicide among the cases provided, which meant that the
researchers had to decipher suicidal thoughts or actions based
on brief, vague narratives. Also, the information the
researchers were given was often misleading. For instance, one
child had taken 11 pills impulsively before going to school;
this was classified a medication error. Another had wrapped a
cord around his neck; this was labeled ''hostility.'' At the
same time, relatively harmless acts -- including a girl slapping
herself in the face -- had been listed as ''suicidal.'' But the
biggest challenge was a theoretical one. ''There's a lack of
conceptual clarity about how you even define a suicide
attempt,'' said the principal investigator of the Columbia team,
Kelly Posner. Self-mutilation, for example, is common among
depressed children, but how can you know whether it was done
with suicidal intent?
The F.D.A. did not want to issue a ruling until the Columbia
group finished, but one F.D.A. drug-safety analyst, Andrew
Mosholder, did not want to wait. Mosholder was assigned to
review GlaxoSmithKline's Paxil trials many months earlier and
noticed that a number of events that looked a lot like suicide
attempts had been subsumed under the euphemistic term
''emotional lability.'' Since then he had conducted his own
analysis on several antidepressants and determined that children
on them were almost twice as likely to
experience suicidal thoughts or exhibit suicidal behavior as
those taking placebos. Mosholder wanted to go public, but the
F.D.A. wouldn't allow it, out of concern that his conclusions
would only further fan the flames.
Mosholder's findings were soon leaked to The San Francisco
Chronicle. Before long, the story was splashed across the
nation's newspapers. Families like the Millers had a new hero, a
would-be whistle-blower who had been silenced by his own
government.
The publicity surrounding Mosholder's conclusions also piqued
the interest of several politicians, most notably Senator
Charles Grassley of Iowa, who wondered if the F.D.A. might be
deliberately suppressing information about the dangerous side
effects of antidepressants. Tom Torlakson, a state senator in
California whose niece had committed suicide after starting on
Celexa, convened his own hearings on the issue. In New York,
Attorney General Eliot Spitzer sued GlaxoSmithKline for
concealing vital information from the public about the safety
and efficacy of Paxil. (The two parties settled, with the
company agreeing to pay $2.5 million to New York State.)
In the middle of September, with the Columbia study complete,
the F.D.A. convened hearings on the issue. The anti-S.S.R.I.
lobby was galvanized; dozens of families came to Maryland to
tell their harrowing tales. (Only one mother rose to defend the
drugs.) Kathleen Bodnar spoke about her 21-year-old daughter --
Torlakson's niece -- who threw herself in front of a BART train
in San Francisco last spring, shortly after being prescribed
Celexa. A number of families blasted the drug makers for
suppressing data and chided the F.D.A. for not taking stronger
steps earlier. ''The blood of these children is on your hands,''
Mathy Downing, who found her 12-year-old daughter hanging from
the valance above her bed in January, a few days after taking
100 milligrams of Zoloft, told the panel.
But for all of the impassioned testimony, the most important
presentation came from an F.D.A. medical reviewer, who offered
his analysis of the long-awaited Columbia review. The risk of
depressed children engaging in suicidal acts was 1.78 times
greater for those who had been treated with antidepressants than
for those who had been given placebos. At the end of the
hearings, the panel voted to add to all antidepressants
black-box warnings cautioning that the drugs can trigger
suicidal behavior in adolescents. ''A 'BLACK BOX'! -- Wow,''
Mark wrote in a mass e-mail message to fellow survivors. ''Could
we
have ever guessed they would go this far?''
When I visited Mark and Cheryl in late September, they were
optimistic that the F.D.A. ruling would breathe new life into
the their lawsuit against Pfizer. ''The whole summary judgment
was granted based on us not being able to prove that there is
evidence of suicidality,'' Mark told me. ''Now the F.D.A. has
basically validated our position.''
A couple of weeks later, though, the Millers' five-year battle
with Pfizer was over. The Supreme Court declined to review their
case.
The black-box warning seems sure to put off parents, not to
mention doctors, who will now have to assume a greater share of
the responsibility when prescribing these drugs. ''A black box
is scary,'' Dr. Walkup, the Baltimore psychiatrist, told me.
''In order for you to go against it, you've got to summon a
certain amount of courage.''
While many child psychiatrists are unlikely to change their
attitude toward S.S.R.I.'s, most pediatricians and general
practitioners, who until now have written the bulk of these
prescriptions, no doubt will. This could mean a lot of untreated
children. There are only 7,400 child and adolescent
psychiatrists in
America; even in areas with high per-capita concentrations, the
average wait to see one is six weeks. There is also the matter
of cost. Many child psychiatrists charge steep hourly rates that
are only partly offset by health insurance providers.
For doctors who don't have much experience with S.S.R.I.'s,
prescribing them for adolescents does seem daunting. Teenagers
can't always be counted on to take their pills, and as with many
medications, sudden withdrawal from S.S.R.I.'s can be dangerous.
Perhaps an even bigger challenge is teasing out bipolar from
unipolar depression, a critical distinction given that
S.S.R.I.'s can trigger mania in a small number of bipolar
adolescents. Even for those children who do respond well to
S.S.R.I.'s, finding the right dose -- and, in some cases, the
right combination of drugs -- can be tricky. Some children
metabolize medicine more quickly than adults, others more
slowly.
Still, over the past few months I have spoken with a number of
teenagers (and their parents) whose lives have been saved by
antidepressants. ''Had it not been for these two medications, I
would not be here,'' Kristen Conklin, a 21-year-old graduate
student at Widener University in Pennsylvania, told me. Conklin
started taking Wellbutrin five years ago after a failed suicide
attempt. A year later, her doctor added Effexor as well. ''I can
look back on my life now and know that if I had to feel that way
again, I probably would think it's a smart idea to commit
suicide. It took some time to figure out what works, but they
have helped me in ways that I can't even begin to explain.''
The numerous antidepressant success stories have none of the
drama of the comparatively few failures, but that doesn't
necessarily make them any less important. Conklin's
psychiatrist, Dr. Peter Kahn, told me that he and many of his
colleagues have known from the beginning that S.S.R.I.'s are
potent drugs. They always start with low doses and raise them
gradually -- their mantra is ''start low, go slow'' -- and
supervise their patients closely, particularly in the first few
weeks after beginning treatment. (Kahn makes sure that all of
his patients have his cellphone number.)
Child psychiatrists have an almost universal faith in
S.S.R.I.'s; the problem is that there isn't much clinical data
to support their conviction. Why? One explanation is that the
limited number of studies that have been done on adolescents and
antidepressants were almost all substandard. Most of them were
conducted in response to a 1997 Congressional act intended to
encourage drug makers to undertake more pediatric trials.
Companies could extend their patents for a drug for six months
by testing it on
children -- whether the trial demonstrated that the drug worked
or not. There was, in other words, a powerful incentive to do
the trials, but no incentive to do them well. Among other flaws,
patients were enrolled at multiple sites in a number of
different countries, which made quality control very difficult.
In clinical parlance, the trials were susceptible to a lot of
''noise,'' factors that obscure rather than illuminate the
effects of a given drug.
A much more carefully conducted Prozac study was published this
year in The Journal of the American Medical Association. The
results pleased defenders of S.S.R.I.'s: 61 percent of the
patients treated with Prozac improved, compared with only 35
percent of those given sugar pills. ''This study should put to
rest doubt about whether these drugs work in teenagers with
severe depression,'' said one of the report's authors, Dr.
Graham Emslie. (While the study was sponsored by the National
Institute of Mental Health, Emslie has received money from a
number of drug companies in the past.) What the study didn't do
is put to rest concerns about suicidal side effects. No patients
in the control group tried to commit suicide, while six of those
treated with Prozac did.
More trials are under way now, but it may be years until the
F.D.A. will have enough fresh data to revisit the subject. Until
then, doctors will have to decide whether they want to go up
against a black-box warning. And parents will have to decide
whether they want to trust their doctor's judgment.
Jonathan Mahler, a contributing writer for the magazine, last
wrote about Lt. Cmdr. Charles Swift, a military lawyer defending
a
suspected Qaeda member at Guantanamo. His book, ''Ladies and
Gentlemen, the Bronx Is Burning,'' will be published in April by
Farrar, Straus & Giroux.
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