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The Antidepressant Dilemma (long read)
NY Times ^ | November 21, 2004 | JONATHAN MAHLER

Posted on 11/20/2004 7:07:55 PM PST by neverdem

Looking 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