text:
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 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.
Isn't it ironic that an anti-depressant killed someone?
prozac & paxil have many more horror stories on the internet than zoloft. I don't know why.
On the surface, yes, but then if you know the science behind them you might get angry.
Serotonin, an important chemical produced in the brain, is considered essential for relaxation, concentration, sleep and calmness. Its lack or suppression can lead to severe mental disturbances and even violent behavior. To make serotonin the body requires adequate levels of magnesium, tryptophan and vitamin B-6, nutrients which the USDA says American diets are severely deficient in, but which medical doctors rarely run tests for -- even when they prescribe medications which affect serotonin levels (which includes "anti-depressants," and which is often!).
There are about 200,000 deaths a year because of prescription (legal) drugs, including the homicides and suicides from "serotonin re-uptake inhibiters" and other so-called anti-depressives (in contrast to about 20,000 deaths a year in the U.S. because of illegal drugs).
Most American medical doctors have taken no more than 5 hours of nutrition classes in medical school if any at all, but they are subjected to dozens and dozens of presentations by pharmaceutical company representatives on patent medications every year. So it should be no wonder why more and more people look elsewhere for advice on real nutrition.
I all most hung myself trying to read that!
FReepmail me if you want on or off my health and science ping list.
Very interesting. Thank you.
a nutritional deficiency would explain certain food cravings in depressed people and even women with PMS who are now offered repackaged antidepressants.
-- and even when just taking supplements for those missing nutrients may have been all that is required.
Amendment X to the Constitution of the United States, together with Article I, Section 8, prohibits the U.S. Congress from involving itself in cabbage pricing, education, health care, personal safety, campaign financing, most criminal law, toilet capacity, the banning of amino acid supplements (specifically, tryptophan) and thousands of other things it has gotten away with (so far). (see http://lcweb2.loc.gov/const/constquery.html)
Do you have any reputable links?
I lost my son, Jeff, (17) in Feb of 1999 due to major depression (suicide). He was on Zoloft, and it made it worse, I am certain. God, I miss my son! I wish the FDA would get it's act together regarding anti-depressants.
I don't think these goofy MD's care. When I went to see my OBGYN he just gave me lexapro for post partum, Never bothered to see about lifestyle changes or therapy. and the crazy thing was that he knew the last thing I wanted was drugs and for the next 6 months I went through h***. Thank GOD I am off and doing well.
The simplest way to think about SSRIs is this: They give the patient back his energy before they give him back his mood. Many, many people who have both moderate to severe depression and suicidal ideation are literally too depressed to kill themselves. They want too, but they're too detatched to even be bothered to go through with an attempt. Once you start them on an SSRI, there is a short period of time, roughly one to six weeks, where they medication will be effective enough to give the patient some of his energy back, but not effective enough to relieve the underlying depression. Obviously, in those who are already thinking about suicide, this can be an extremely dangerous period of time, because it gives them a window in which they'll have both the desire to kill themselves and the wherewithall to go through with it.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.
The solution, however, is incredibly simple: All patients with even the slightest hint of suicidal ideation (like the subject of this article) should be monitored 24 hours per day for the first few weeks after being started on an SSRI. You don't have to lock them up for the duration, but you can't just toss the bottle of pills at your kid and continue with your daily routine during this time.
Assuming this article is telling the truth about what occurred (a giant if, given the source), the doctor should have made this very clear to the parents. But in any case, for all the bloviating in the MSM about this issue over the last few months, the reality is that doctors and scientists have known that SSRIs act this way for pretty much as long as they've been in existence. The only reason these medications are getting black box warnings is because there are so many doctors and parents out there that simply don't want to take any responsibility any more.
No. They sometimes have devastationg effects on some people even in small doses. Most of them require a weaning-on period. Sometimes they throw you into a severe agitated state which I can only describe as a preview of hell.
Some depressed people cannot tolerate anti-depressants. Sometimes if you have anxiety or comorbidity, a transquillizer works better. Take care of the anxiety and the depression lifts because you are able to get out and do more things comfortably.
I will never take another drug without doing extensive research on the anxiety/panic/depression newsgroups to see the various reactions people have towards them.
We have a tendency to trust doctors which is fine (to a point) with psyiological drugs but can be deadly when dealing with brain chemistry altering drugs.
People going on anti-depressants should be watched carefully for increased anxiety/agitation/tremors/behavorial changes. If you have a negative reaction, it sometimes takes quite a while to resolve. A lot of people cannot articulate what they are feeling. Outwardly they seem better because they seem to have more energy and "sound" better but inwardly they are in terrible danger.
Some people can almost effortlessly go on to anti-depressants and when get the chemicals built up with positive transformative effects. For others it is a recipe for disaster. I would imagine it is even worse for younger people who are more volatile anyway and don't know what to expect and trust their doctors because things like antibiotics work in such a life-saving manner. It is not the same with psychological meds.
They used to put you in the hospital and monitor your reactions, blood pressure etc. Now they write you a script and send you out the door and tell you to come back in a month or so. In the meantime, anything can happen.
Yes it is.
The list of what the USDA has said is depleted in the food supply is in one of my many bookshelves, and I don't know where it is right off, and I'm tired. I do recall that they said magnesium barely meets the RDA's (but various nutritionists claim the RDA's are ridiculously low in this, in B-6 and in some other nutrients).
FWIW, I do respect the Life Extension people and their obsession with data ( http://www.lef.org/ ). Some people say their research should be discounted since they have products to sell. I say anything funded by government and universities should therefore be doubly-discounted since they have tyranny to sell and tenure to buy. In any case, let the buyer beware, ESPECIALLY when anyone claims to be unbiased.
Does anyone know if Zoloft has a similar affect on adults?
Prayer for the both of you. Condolences.
Where did your lack of trust in Doctors first originate to place such trust in the Internet?
Because they made so many mistakes in my treatment over the years. They just have to make an educated guess about what might work for you. Can you say "guinea pig"? They don't really know and just start trying a drug and switching to another or a combo until they find something that seems to work. Sometimes if you are on a drug long-term, it quits working. Sometimes a drug only does half the job but it is better than not being able to function at all.
I was once put on a drug (mao inhibitor). I woke up about 8 times a night, felt like laying down in the park and finally lost control of my bladder. I had to threaten to get a lawyer if I had to take any more of that. How many sick people have the courage to take on a powerful doctor? They have the power to throw you in a state hospital if you don't cooperate in taking your meds and the courts back them up.
It depends on the illness. People with schizophrenia are particularly at the mercy of their doctors.
I suffer with anxiety/depression with some ocd behavior which is difficult to treat.
In the beginning, I took whatever they dished out without questioning any of it. Neither did my family because everyone is frightened of and for a family member who suffers from psychological disorders. And everybody trusts doctors.
I shudder to think what they are doing to some helpless people who are unable to articulate what is going on inside or are in nursing homes, etc. People should *always* have a second or third opinion and *never* trust one primary care giver, even if there can be some conflict over professional turf in the process.
My apologies. I'm so tired I'm not thinking (not that tiredness has that much to do with it). Nomatter whether the USDA is basing their assumptions on Americans eating 5 servings of fresh fruits and vegetables a day or not, and nomatter whether my recollection of what they had to say is accurate or not, the point really is: MD's SHOULD test each referenced patient for those nutrients from which serotonin is made BEFORE they make THEIR hurried decisions, whether they are to prescribe nutrient supplements, prescription meds or whatever.
As far as which nutrients the body needs to actually synthesize serotonin is concerned, I'm sure a minimal amount of Googling will get you there. Sorry to be so brusk (before my head hits the keyboard!).
Did anybody give thought that these people might be killing themselves caused they ARE depressed?
For anyone on antidepressants, ritalin, or other psycotropic drugs, or if considering taking them please visit www.breggin.com
I'm sorry about your loss.
I've been on anti-depressents for many years myself and it's hard to decide if I'm better off on the meds than off them.
As long as parents are "looking for a miracle" (as the parents in the article put it), and as long as doctors are making quick & easy profits, no one has any motivation to look into the *behavioral* and *alternative* treatments for depression available. Of course, as the article also says, many of the things which *cause* teenagers to be depressed are considered "unchangeable" (when in actuality they are NOT.)
I just checked the precautions for a number of SSRIs. All of their precautions included watching for suicidal tendencies or suicidal ideation. The distinction between adolescence and adulthood is somewhat arbitrary. Suicide is the worst outcome of untreated depression. I would be wary for about the first 6 weeks that someone started taking a SSRI to be on the safe side. I'm always leary about adverse drug reactions.
Both of you make excellent points - the key here seems to be that these drugs for many people may be *too dangerous* in the first month or so without hospitalization. But insurance companies won't pay for 4-6 weeks of hospitalization (they usually provide only 10 days or so.) Obviously for some it's not enough.
Perhaps. But my son was prescribed paxil for anxiety and tried to kill himself. He wasn't depressed.
The particular side effect of restlessness/agitation seems to be the precursor.
Doctors make mistakes so the Internet is more appealing to you?
Personally I am taking Paxil, because I explained to my Doctor that I have been having trouble sleeping since my aortic dissection surgery.
I felt that the 20mgs was too strong for me and I self medicated to 10mgs and with the approval of my Doctor all is well.
Point being, if you are dissatisfied with treatment by your doctor, why would you go to the Internet for comfort in knowing that your treatment would be better?
Unless of course, for some personal reason you have a distaste for proved medical service I would recommend that you seek another Doctor before going to the Internet when it is your health that is at stake.
I'd be happy if Dr's would mention that restlessness/agitation is a MAJOR warning sign. I was told about insomnia, I was told about appetite problems. No one mentioned restlessness.
I was still trying to find out from my child's teacher what she meant by "having difficulty controlling himself, physically" meant when my son tried to kill himself in her classroom.
Someone realy ought to redo "Bowling for Columbine" exposing the real reason those boys did what they did. Moore goes to such bizarre lengths to prove America is a violent culture and guns are evil and Charlton Heston is the devil. the truth is much simpler: The 2 Columbine boys were on a combanation of Prozac and Ritalin, which has been proven in a Cornell study to produce feelings of rage, persecution and paranoia, with violent tendencies at a rate 100x that of Prozac or Ritalin alone.
There is a good story though...Lexapro has changed my life for the better and the lives of others I know.
Was there some studies showing that the number of suicide has steadily decreased since SSRI as introduced?
From the article:
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.''
Little bit late there with that, aren't you, bow-tie daddy and soft-bowed-blouse mommy?
Sounds strange that the suicide is attributed to merely one week of medication. It is counterintuitive: one would think that much greater exposure would be needed for serious side effects. Seems like the case was worse than garden variety depression.
Currently using Wellbutrin, which doesn't have the side effects that Zoluft has, but has done nothing but make me amgry and irritable.
I will bet that the good Dr. was getting rewards (kickbacks) for the number of scripts per week!
Not a word in the article about dopamine - and interactions w/ sleep, dopamine, and these drugs.
Should be.
Incredible read.
Not at all. I wouldn't self-medicate from the internet. I sought out discussion groups because I have known a lot of people with problems and mine is different from anyone I have ever known until I found the internet discussion groups and found out that people who have both depression and anxiety can have serious problems going on anti-depressants. I never knew that before and no doctor ever told me that specifically.
I wouldn't have said anything at all in this discussion, but I kind of wanted to warn readers that some drugs that work great for some people are disasters for others, and the doctors don't know for sure until they try them on you.
I shouldn't have said doctors make mistakes. It is a trial and error process in most cases with these meds, and most doctors do the best they can.
The only reason I said anything at all is that I don't want anyone else to go through some of the things I have been through. Sometimes you have to assert yourself with your doctors and stop taking things that are affecting you adversely and look for something more suitable.
Sometimes tranquillizers will get you over the hump, but they are really pushing the SSRI's right now for some reason. You cannot go off them cold turkey but have to taper off.
a) Sources for this?
b) What is Prozac prescribed for IN TEENAGERS anyway?
My heart goes out to you. Having two little girls I can't comprehend how you feel.
However that doesn't matter to these people. There is too much money in it for them to worry about little things - like your son. These bastards in the FDA are setting themselves up for cushy jobs at Eli-Lilly etc after they oversee the drugs the same companies put out. A personal experience with a surgical tool company opened my eyes to the fact that there are people who will sit in an office and let people get blinded, maimed or killed for a decent salary. It was an ugly revelation.
Trial lawyers and punitive damages do have a place. The corporate veil for some circumstances has to be limited.
God Bless You.
No one has accused anyone of being a Scientologist yet
Actually that stat is meaningless. It is the relative rate that is an issue. Children who take antidepressant do kill themselves at a higher rate. It has been argued and denied for years. Now the major drug companies are putting warnings on their product. Irrational and homocidal behavior is next.
Absolutely true.
When I was on Zoloft, my doc told me the effects wouldn't kick in until the 4th week or so. It sounds as if the "therapy" session, followed by girlfriend issues, pushed him over.
My concern with these drugs are side effects that are not listed. Both Zoloft and Prozac can cause huge weight gain. The argument is that it happens to such a small percentage of people, that the companies don't need to list it. I put on almost 100 pounds in only 2 1/2 years before they attributed it to the Zoloft (my thyroid quit at the same time, so I was doubly hit) I went off Zoloft and lost 30lbs in 3 weeks!!! Since then, everyone I speak to mentions that they gained weight while on these drugs as well. (BTW, I'm still losing the weight. About 30 lbs to go. I'm in year 3 of taking off. I DO NOT RECOMMEND THIS DRUG TO ANYONE!!! It's weird, but acupuncture did wonders for me)
This is still not a recognized side effect.
Re: Your quote from the article from Dr. John Mann:
In the interest of full disclosure, Dr. Joseph John Mann of Columbia is a paid consultant and expert witness in court cases for both Glaxo and Pfizer. Dr. Mann testified on behalf of Glaxo in the Schell case mentioned in this article. It's the only case lost at trial over this issue.
Dr. Mann has also received funding from Eli Lilly to promote the safety of antidepressants.
I find that quite interesting because I have an irrational, inherent distrust of folks who don't like their first, given name.
Before you made that statement, overall, I thought the article was pretty good, balanced and comprehensive. Now, I'm wondering.
I'm glad you are. In reading your comments in the threads you've put up on this issue, including our exchange on a recent thread, I've sensed that you're struggling with this. Good luck in your journey.
Although I'm sure most will laud this article as balanced, there's plenty wrong with it IMO....mainly factual omissions such as the one I pointed out.
Please address any omissions that you find.
I thought the struggle was obvious. Primum, non nocere. Translate Latin. First, do no harm.
Any corrections are always appreciated.
Disclaimer: Opinions posted on Free Republic are those of the individual posters and do not necessarily represent the opinion of Free Republic or its management. All materials posted herein are protected by copyright law and the exemption for fair use of copyrighted works.


text:
Study to Assess Neuroinflammation and Neurocognitive Function in Patients With Acute Hepatitis C and Chronic HIV Co-Infection - A Positron Emission Tomography (PET) Study
Recruitment status was Recruiting
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Subtle changes to the brain, which doctors find difficult to detect through conversation or examination, may occur in patients with HIV and/or hepatitis C infection. It is not currently known whether the brain is affected in early (or acute) hepatitis C.
This study plans to evaluate what happens to the brain in patients with HIV and early hepatitis C. The investigators will be comparing 3 groups of individuals:
- Group 1: Individuals with HIV infection and acute (early) hepatitis C infection
- Group 2: Individuals with HIV infection
- Group 3: Healthy volunteers
Individuals wishing to take part will complete a series of tests assessing different aspects of their brain including:
2 brain scans using different technology:
- Magnetic resonance imaging (MRI) brain scan with spectroscopy
- CT PET brain scan
- A computer game test which measures brain function
- 2 short questionnaires
Results of these tests will be analyzed and compared between 3 groups.
Condition |
Acute Hepatitis C HIV HIV Infections |
Study Type: | Observational |
Study Design: | Observational Model: Case Control Time Perspective: Prospective |
Official Title: | A Prospective Case-control Study to Assess Neuroinflammation and Neurocognitive Function in Patients With Acute Hepatitis C and Chronic HIV Co-infection - a PET Study |
- Association of 11C-labelled PK11195 uptake using PET with acute HCV and HIV infection [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Association of CNS metabolite ratios and neurocognitive performance with acute HCV and HIV infection. Association between patient characteristics and 11C-labelled PK11195 uptake using PET, CNS metabolite ratios and neurocognitive performance. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Estimated Enrollment: | 40 |
Study Start Date: | June 2009 |
Estimated Study Completion Date: | September 2011 |
Estimated Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
Groups/Cohorts |
HIV positive men with acute HCV infection
HIV positive men who do not have acute HCV
Healthy controls
Ages Eligible for Study: | 25 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
HIV positive men with acute HCV infection
Inclusion Criteria:
- HIV-1 antibody positive for at least 12 months
- Acute HCV (Blood HCV PCR positive with negative PCR within past 8 months)
- HCV genotype 1
- Ability to give informed consent
- Aged > 25 years
- Male
- Abbreviated Mental Test Score of at least 8/10
Exclusion Criteria:
- Evidence of established cirrhosis or encephalopathy
- Commencing or any change to HIV medications within 12 weeks
- Active opportunistic infection
- Taking anti-depressants or any psychoactive medications within past 4 weeks
- Use of benzodiazepines within past 4 weeks
- Recent significant head injury
- Established dementia
- Alcohol dependence or recreational drug misuse
- Untreated early syphilis
- Hepatitis B infection (HBsAg positive)
- Pregnancy
- Unable to give informed consent
- Any contraindication to MR scanning
Please refer to this study by its ClinicalTrials.gov identifier: NCT00959166
United Kingdom | |
St Mary's Hospital | Recruiting |
London, United Kingdom, W2 1NY | |
Contact: Lucy J Garvey firstname.lastname@example.com | |
Principal Investigator: Alan Winston | |
Sub-Investigator: Lucy J Garvey |
Principal Investigator: | Alan Winston | Imperial College London |
No publications provided
Responsible Party: | Dr Alan Winston, Imperial College, London |
ClinicalTrials.gov Identifier: | NCT00959166 History of Changes |
Other Study ID Numbers: | 09/H0712/17 |
Study First Received: | August 13, 2009 |
Last Updated: | May 25, 2010 |
Health Authority: | United Kingdom: Research Ethics Committee |
Keywords provided by Imperial College London:
Acute hepatitis C HIV Neurocognitive function Neuroinflammation |
Additional relevant MeSH terms:
Hepatitis Hepatitis A Hepatitis C Infection Digestive System Diseases Enterovirus Infections |
Flaviviridae Infections Hepatitis, Viral, Human Liver Diseases Picornaviridae Infections RNA Virus Infections Virus Diseases |
ClinicalTrials.gov processed this record on May 04, 2015

subset: commoncrawl


text:
FedEx Desktop Availability
As of September 20, 2014, FedEx Desktop will no longer be available for download. For more on FedEx tracking options please click here.
FedEx Desktop monitors shipment status and sends notifications directly to your desktop. If you regularly track shipments and need to frequently check their status, FedEx Desktop is your solution. Best of all, it's easy to install and simple to use!
With FedEx Desktop, you will be able to:
- Manage your time more efficiently by knowing when to expect shipments.
- Easily access your shipment information from your desktop.
- Become more proactive by having another channel to monitor shipment exceptions.
Do you have a fedex.com login? If not, please register now. |
In order for FedEx Desktop to operate, your system must comply with the requirements set forth by the FAQ section of this page. Without limiting the information set forth at such page, FedEx Desktop is intended to operate on the following operating systems: Microsoft® Windows 2000, Windows XP or Windows Vista. Macintosh PowerPC® or Intel® processor, Mac OS X v.10.4 or 10.5.
Without limiting any other requirements at the page set forth above, in order for FedEx Desktop to operate, your system must contain certain other Adobe programs and files ("Adobe Programs"). In order to ascertain whether the Adobe Programs are on your system, your system will be scanned. If you agree to such scan, please click the "Install now" button. If you do not agree to such scan, you must click the "Cancel" button and the installation process will terminate.
If the scan indicates that a required Adobe Program is missing, those programs and/or files may be downloaded to your system. All such programs and/or files are provided by Adobe Systems Incorporated ("Adobe") and are subject to and governed by your license agreement(s) with Adobe.
FedEx Desktop will not operate if the required Adobe Programs are not operating properly on your system. The FedEx Desktop End User License Agreement (EULA) does not permit use of FedEx Desktop on a different system. If you attempt to download or install FedEx Desktop on another system, you may damage that system and/or data located on it. FedEx assumes no responsibility or liability, and disclaims all responsibility and liability, for any damages and liability (including, without limitation, loss of programs and/or data) arising from or relating to (a) the scan; (b) your use of FedEx Desktop on either a different system or a system without the required Adobe Programs operating properly; or (c) the installation, operation, maintenance, or support of a Adobe Program(s) and/or your use (or inability to use) any Adobe Program(s). If you do not agree to the foregoing, you must click the "Cancel" button and the installation process will terminate.
By clicking "Install now", I have read the foregoing and agree to the scanning and/or downloading of required Adobe Program(s).
TrackAdd important or critical shipments to FedEx Desktop. FedEx Desktop will remember your shipments and provide you automatic shipment updates until delivered. |
Tracking historyFedEx Desktop remembers any shipment you add to the application, providing you easy access to your shipment information. |
Drop shipment placards to your desktopDrag and drop important shipments to the desktop. Shipments parked on the desktop will receive automatic shipment updates until delivered. You can also view more detail shipment information by clicking on each shipment. |
SearchSmart search functionality allows you to search shipments by tracking number, nicknames, etc. |
Shipment notificationsPop-up messages will notify you when shipments are delivered or when selected exceptions occur. |
FiltersYou will be able to filter by clearance delays, shipment exceptions, delivered shipments, etc. providing easier navigation and access to shipment information. |
Nickname shipmentsNickname your shipments so you can easily identify them via FedEx Desktop. No more hassle trying to remember tracking numbers. |
E-mail notificationsYou can choose to e-mail tracking results, exception updates and delivery updates in order to keep your customers informed. |
- What is FedEx Desktop?
FedEx Desktop is a free tracking application that enables you to track shipments and display each shipment status directly on your desktop. This tracking application will monitor the status of your shipments and automatically notify you of critical events that affect your shipments.
- Why am I getting an Unavailable message that says "the service has been temporarily disabled"?
You may be seeing this screen for one of two reasons:
- FedEx is experiencing an outage.
- FedEx is upgrading the FedEx Desktop service and it is temporarily unavailable. The message will go away once the upgrade is complete.
- You are running an older version of FedEx Desktop.
- If you are running an older version of FedEx Desktop, this message indicates that your installed copy of FedEx Desktop has expired and can no longer be automatically updated. In that case, please see "Why has my version of FedEx Desktop expired?" below.
- To check for the version of FedEx Desktop that you are running, navigate to the following area within the tool: Help > About FedEx Desktop.
- FedEx is experiencing an outage.
- Why has my version of FedEx Desktop expired?
A new version of the application has been created since your original download. The previous version is no longer supported. You will need to upgrade in order to continue using the product.
- How do I upgrade my version of FedEx Desktop?
You must now uninstall and then reinstall the application to continue using the product.
- How do I uninstall FedEx Desktop?
- Windows
Select Start < Settings > Control Panel
Open the Add or Remove Programs panel
Select FedEx Desktop
Click the Change/Remove button. - Mac OS X
Drag the application to the trash. - Linux
Launch the system package manager (e.g. Synaptic on Ubuntu), search for FedEx Desktop and mark it for removal. You may need to click the button Apply or Accept to remove the application. - For more assistance with the uninstall process please call your corresponding Customer Service number.
- Windows
- How will I be made aware of future version upgrades of FedEx Desktop?
If at any time after you login you are prompted to upgrade your version of Adobe or FedEx Desktop, accept the upgrade. After a certain period your offer to upgrade will expire. At that point you will have to follow the manual process to uninstall and reinstall the application as described above.
- System Requirements
File size: 2 MB
File name: FedEx Desktop.exe
Estimated download time:
Dial up: 22 minutes – 56 KB
Broadband: 1 minute – 1 MB
CPU speed: Intel© Pentium© 400 MHZ
System memory (RAM): 256 MB
3-5 MB hard-disk spaceThis application will work on Microsoft® Windows 2000, Windows XP SP2 or above or Windows Vista. It will also work on Macintosh PowerPC® or Intel® processor, Mac OS X v.10.4 or above. Flash 22.214.171.124 or higher is also needed to run the application.
Internet connection is required to get automatic shipment updates.
- List of Features
FedEx Desktop offers the following features:
- Automatic shipment download for FedEx InSight® users
- Add tracking numbers
- View tracking details
- Tracking history
- Drop shipment placard to your desktop
- Automatic shipment updates
- Add shipments to a watch list
- Remove shipments from the application
- Shipment notifications
- Visibility of selected shipment exceptions
- Nickname shipments
- Graphical shipment progression bar
- Advanced search options
- Local data purge
- Access to fedex.com
Automatic shipment download for FedEx InSight® users
FedEx Desktop has added benefits for FedEx InSight users by automatically pulling shipments to the desktop once logged in. If you do not currently have access to FedEx InSight and would like enhanced visibility within FedEx Desktop, please register here.
Add tracking numbers
You can manually add tracking numbers by putting one tracking number at a time in the "add tracking number" box and pressing enter or clicking the "Track" button. Manually adding tracking numbers brings up a tracking detail page that shows detailed information about the shipment and all associated information related to this package. When the detail page is closed down, you will find that the tracking number has been added to the application. FedEx Desktop will remember your shipments and provide you automatic shipment updates until the shipment is delivered.
View tracking details
Click the tracking number to view the tracking details. You may also access the following from the Details screen:
Associated Shipments
Click this tab to view a list of the associated shipments for a multiple-piece shipment, including the master tracking number. To view details for an associated tracking number, you must add each associated tracking number individually to FedEx Desktop.
Click this tab to send e-mail exception and delivery updates regarding the shipment to yourself and others.
Click this link to enter and save notes specific to a tracking number. These notes are visible only to you and can be used when performing a Search.
Tracking history
FedEx Desktop remembers any shipment you add to the application, providing you easy access to your shipment information. It will store up to 3,600 shipments. To remove a shipment from the application, simply click on the remove shipment icon on the tracking number you would like to remove.
Drop shipment placard to your desktop
You can drop shipment placards to your desktop by selecting the frame of a specific tracking number and dragging it on to the desktop. This will help you isolate the shipments that are most important to you. FedEx Desktop will provide automatic shipment updates until the shipment is delivered.
You may remove the shipment placard by clicking on the close placard icon.
Automatic shipment updates
Shipment information is regularly updated if you have continuous Internet connection. The right bottom corner of the application displays the last updated time. You can also request an update by clicking on the last updated time.
Add shipments to a watch list
You can add shipments to your watch list at any time by simply clicking on the star icon. The star icon will turn yellow which denotes that the shipment has been added to the watch list.
You can access all the shipments that have been added to the watch list by selecting "Watch list" from the Advanced drop down. To remove a shipment from the watch list, simply click on the star again.
Remove shipments from the application
To remove a shipment from the application, simply click on the remove shipment icon on the tracking number you would like to remove.
Nickname shipments
You can nickname your shipments by clicking on the pencil icon. This will bring up a box to add a nickname to that particular shipment. After you nickname your shipment, the application will show the new name along with the tracking number. You can use the same nickname on multiple shipments. You will be able to easily identify and find this shipment by using the search capability within FedEx Desktop.
Shipment notification
You will receive pop-up messages to notify you when shipments are delivered or when selected exceptions occur. To change the shipment notification settings, go to "Settings" and select the pop-up messages you prefer.
Visibility of selected shipment exceptions
Shipments that encounter exceptions are highlighted in red to advise you when an excpetion occurs. Clicking on the tracking number will bring up the details screen, which will show more information on the shipment exception.
You can also easily view your shipment exceptions by selecting "All excpetions," "Clearance delays" or "Delivery exceptions" from the Advanced drop down.
Graphical shipment progression bar
This bar represents the progress of the movement of your shipment. The different bars are:- Shipment initiation – FedEx received shipment information from sender
- Pickup – FedEx has possession of shipment
- In transit – Shipment is in transit to its final destination
- Delivered – Shipment has been delivered
Advanced search options
FedEx Desktop allows you to find any shipment in your list, using the tracking number, customer reference, nickname or any other shipment data source. You can search all shipments, or narrow down the search by choosing a specific category. Once information is entered into the search box, a list is presented with those records that match the search criteria.
Local data purge
FedEx Desktop will write data to the hard drive of your computer. It will store up to 3,600 shipments to the hard drive. At any time, select "Purge data" from within settings to remove this local data, which includes all history, settings and shipments. You can also remove each shipment individually by clicking on the remove shipment icon.
Access to fedex.com
FedEx Desktop provides you easy access to fedex.com. From the "Help" menu within the application, you will be able to navigate to the following pages within fedex.com:- FedEx home page
- Ship with FedEx
- Get rates and transit times
- Find FedEx locations
- FedEx Small Business Center
- Business and document services
- What do I need in order to use FedEx Desktop?
In order to use FedEx Desktop, you will need a fedex.com login. If you do not already have one, go to the fedex.com Login Registration page. You can also click on the "Register now" button from the log-in screen of FedEx Desktop. Once you register, you will receive an e-mail with your registered user name and password.
- Why Register?
FedEx considers the security of your shipment information a top priority and therefore, registration is required for visibility to shipment information. After you register, you can get timely and accurate status of your shipments. You can receive proactive notifications about critical shipping events and possible actions to speed the delivery.
- How do I download FedEx Desktop?
Click the Download button from FedEx Desktop page. A window will open asking you to accept FedEx terms and conditions. Once you read and accept the terms and conditions by clicking the "Install now" button, it will automatically evaluate your desktop applications and system capabilities and download Adobe® AIR™ and then FedEx Desktop.
Note: FedEx Desktop download process verifies what version of Flash is available and automatically offers a one step or two step download process depending on the result. If you do not have the latest Flash version (18.104.22.168 or higher), on FedEx Desktop page, you will be provided with two links - one for Adobe® AIR™ and one for FedEx Desktop. You will have to install Adobe Air first, then download FedEx Desktop. - I want to uninstall FedEx Desktop. How do I do that?
From Windows® Start menu, click on Control Panel. Select Add/Remove Programs. Scroll down the list until you find FedEx Desktop. Click Remove button to uninstall. (Please consult Windows® help information on how to do this).
- Is FedEx Desktop safe to use? Will it introduce any viruses into my system?
FedEx Desktop is safe to use. It does not contain any type of "malware." The only information the application contains is FedEx tracking information.
- How can I disable FedEx Desktop from automatically starting every time I log in to my computer?
To disable FedEx Desktop from automatically starting, simply follow these instructions:
1. From the Tray Menu, right click on the FedEx Desktop icon.
2. Click on "Auto-start FedEx Desktop" to disable the auto-start option.
You can also disable the "Auto-start" option by following these instructions:
1. From the main FedEx Desktop screen, click "Options" then "Settings"
2. Un-check the box for "Auto-start FedEx Desktop"
3. Click "Save" - Is FedEx Desktop storing all shipment data in my computer?
FedEx Desktop will write data to the hard drive of your computer; however, will display details for up to 300 shipments via the display of your desktop. At any time, select "Purge data" from within settings to remove this local data, which include all history, settings and shipments . You can also remove each shipment individually by clicking on the remove shipment icon.
- I minimized the application. Where has it gone?
If you "Exit the application" the icon in the system tray will disappear. To re-open the application, click on the desktop icon.
- I'm getting a lot of shipment pop-up messages. How can I stop them?
The shipment pop-up messages were designed to notify you when shipments are delivered or when selected exceptions occur. To change the shipment notification options, go to "Settings" then select the pop-up messages you prefer.
- What if I forgot my password?
If you have forgotten your password, click on the "Forgot your user name or password?" link on the log-in screen of FedEx Desktop. You will be asked for your user ID and the e-mail address you used when you registered with FedEx. Select "e-mail current password." Once you complete the required fields and click continue, we will e-mail your current password.
- How can I change my password?
If you would like to change your password, click on the "Forgot your user name or password?" link on the log-in screen of FedEx Desktop. You will be asked for your user ID and the e-mail address you used when you registered with FedEx. Select "change password," answer your reminder question successfully and reset your password.
- Should I worry about the security of my account information if I download this application?
FedEx understands the importance of protecting the privacy of customer information. Your shipment information is password protected and FedEx does not sell customer information or give it to outside parties unless required by law. Please note, it is not advised to run this application on a public computer.
- Is there a way for FedEx Desktop to automatically add my shipments?
Sign up for FedEx InSight®! FedEx Desktop has added benefits for FedEx InSight users by automatically pulling shipments to the desktop once logged in. If you do not currently have access to FedEx InSight and would like enhanced visibility within FedEx Desktop, please register here.
- Once I download the application, will I be able to see my shipments?
If you are currently a FedEx InSight® user, FedEx Desktop will automatically pull shipments that you were authenticated to view and that are currently viewable via FedEx InSight. If you have more than 300 active shipments in FedEx InSight, you willl only see shipment exceptions, if they occur, in FedEx Desktop. (note: FedEx InSight displays shipments from the time that FedEx picks up the shipment until four days after proof of delivery. If there is no proof of delivery, shipments are displayed for 15 days from the ship date.)
If you are not a FedEx InSight user, you will not see all your shipments. However, you will be able to manually add shipments to the application. FedEx Desktop will remember your shipments and provide you automatic shipment updates until the shipment is delivered. - What does the four segment bar near the top of each tracking frame represent?
The bar represents the progress of the movement of your shipment. They are:
- Shipment initiation – FedEx received shipment information from sender
- Pickup – FedEx has possession of shipment
- In transit – Shipment is in transit to its final destination
- Delivered – Shipment has been delivered
- How can I see details about a specific shipment?
By clicking on the tracking number, the application displays shipment details in a separate window.
- What kind of shipments can I track using FedEx Desktop?
You can track any FedEx Express®, FedEx Ground®, FedEx Freight® and FedEx Custom Critical® shipment as long as you have a valid tracking number.
- Is there a maximum number of shipments stored in FedEx Desktop?
FedEx Desktop will store up to 3,600 shipments; however, will display details for up to 300 shipments via the display on your desktop. At any time, select "Purge data" from within settings to remove your shipments from FedEx Desktop. You can also remove each shipment individually by clicking on the remove shipment icon.
- How can I filter my shipments?
From the Advanced tab, you can filter by watch list, all exceptions, clearance delays, delivery exceptions, delivering today, undelivered and delivered shipments.
- How do I find a specific shipment?
From the Advanced tab, enter the tracking number, reference number, nickname, notes or any other data element found in the shipment record to the "Search my shipment" box to find your shipment.
- What number should I call for questions regarding my shipment status?
Please call the Customer Service number here for questions regarding your shipment.
- Where can I get help on downloading the application?
Please call the Customer Service number here for questions regarding your shipment.
- Covered Code Information
The Application contains Covered Code (as defined in the Mozilla Public License, version 1.1 ("MPL") which are provided subject to MPL:ant, asdoc,frameworks/javascript,frameworks/locale,frameworks/projects, and frameworks/themes. In accordance with and subject to the MPL, you are entitled to a source code version of such Covered Code. The source code to such Covered Code is available from Adobe Systems Incorporated ("Adobe") through their website and located at: www.adobe.com


text:
You are a fan of plinking hosting ? Come to discover the best forums plinking hosting on the internet and share your experience with a community fan of plinking hosting . You can also build a forum plinking hosting and create your online discussion.
Free forum : This forum is for karaoke host and people that love to sing. A place to share revelvent information relating to the legal and ethical operation of karaoke hosting. Also, a place to ask and answer questions that are revelent to karaoke in
free, forum, karaoke, this, host, people, that, love, sing, place, share, revelvent, information, relating, legal, ethical, operation