A Suicide Side Effect?
What parents aren't being told about their kids' antidepressantsJan 4, 2004 | San Francisco Chronicle
"Angela had been just pushing through and pushing through," says her mother, Sara.* "She mustered all her strength and courage to face the chemo and to be sick all the time." By the end of the summer, with the most intense part of her treatment behind her, she was worn out and discouraged. "She started to feel overwhelmed and depressed."
She began seeing a therapist and talked openly about her feelings. But after a few weeks her depression had not lifted, and Angela asked about going on antidepressants.
It took six weeks for the Reich's insurance company to approve a psychiatrist, and by then Angela was in a deep funk. "She was not wanting to get out of bed in the morning," Reich recalls. "She couldn't do her homework. She said it felt terrible to live like this, but then she would say, 'I don't want to die, I don't want to hurt myself.' I remember sitting across from her at the kitchen table and tears pouring from her eyes and her saying 'This is so hard.' "
The psychiatrist prescribed Paxil, a selective serotonin reuptake inhibitor (SSRI) similar to its famous predecessor, Prozac. On a dose of 5, then 10, then 15 milligrams a day, Angela soon started feeling better. Five weeks after she began taking the medication, Angela and her mother met with the psychiatrist, who suggested another boost in dosage. "He said she's doing well now; she could be doing even better on 20 milligrams," Reich remembers. She was hesitant, but Angela wanted her old life back and thought it made sense to try. The next day, she started on the higher dose.
Restless Legs, Sleepless Nights
Within days, Reich says, her daughter was acting strangely. The first change was Angela couldn't keep her leg still. "She'd be sitting in a chair and her knee would be jerking up and down." She became irritable and had more trouble sleeping. Her parents would ask about her restless, jerking leg and she would snap at them to leave her alone.
When Reich left on a business trip, Angela called her three or four times a day and begged her to come home early. When she returned, Angela "burst in my room and hugged me," Reich says. "She kept saying, 'Mommy, I'm so glad you're home.' She was scared, like she couldn't cope. She said she dreaded going to bed because she had so much trouble sleeping. She'd lay there thinking and her thoughts got darker and became unbearable."
That night, Reich shared her daughter's bed but Angela slept little and was still wound up in the morning. When her mother tried to get her ready for a piano lesson, she said she wasn't going. "She looked funny and had a weird smile on her face," Reich remembers. "I knew something was wrong. I looked around the room and saw some pill bottles. I asked if she took any pills and she said 'Yes.' "
Under questioning, Angela told her mother she had taken four tablets of the sleeping pill Ativan. Then Angela ran to the bathroom, locked the door, and started going through pill bottles. Her father, Jim, smashed the door open and snatched a bottle of Benadryl from her hands. She ran to her purse, seized a bottle of Tylenol and began shoving pills in her mouth. Her mother grabbed her, pinned her arms, and marched her to the car, as Angela's younger brother watched.
Reich drove straight to a nearby hospital. One block from the house, Angela turned to her mother. "She said 'Mom, I don't know why I did that. It was like something took me over.' And I said 'I know, it wasn't like you. But I will keep you safe.' "
At the emergency room, the staff administered charcoal to absorb the drugs, then transferred Angela to a psychiatric hospital. The next day, the hospital psychiatrist called Reich. "He told me it was a drug-induced suicide attempt," she said, related to the increased dosage of Paxil.
Neither Angela, Sara nor her husband, Jim, an internal medicine doctor, knew Paxil might carry a risk of triggering suicidal thoughts or actions. Aside from a generic statement that depressed people are more likely to attempt suicide, there is no mention of such a risk in Paxil's prescribing information.
England Acts, United States Follows
The risk Paxil may pose to children and teenagers burst into the news this summer, when British regulators issued a warning urging doctors not to prescribe the drug to children. They were acting on new data presented to United States and British authorities showing that among 1,100 children enrolled in clinical trials of Paxil, those taking the drug were nearly three times as likely to consider or attempt suicide as children taking placebos. "There is an increase in the rate of self-harm and potentially suicidal behavior in this age group," said a statement from the British Medicines and Healthcare Products Regulatory Agency (MHRA). "It has become clear that the benefits (of Paxil) in children for the treatment of depressive illness do not outweigh these risks."
Nine days later, the FDA issued a similar warning and announced that it would conduct a detailed review of pediatric trials of Paxil, a review soon broadened to include seven other antidepressants, including top sellers Prozac, Zoloft and Effexor. In August, Wyeth Pharmaceuticals warned doctors that its drug, Effexor, triggered hostile behavior or suicidal thinking in children at twice the rate as the sugar pills taken as placebos.
Then, last month, the MHRA announced that it was urging doctors to stop prescribing a group of six antidepressants, including Paxil, Zoloft and Effexor because they caused an increase in suicidal thoughts and actions. "These products should not be prescribed as new therapy for patients under 18 years of age with depressive illness," wrote Gordon Duff, chairman of the MHRA's Committee on Safety of Medicines, in a "Dear colleague" letter to British physicians.
Prozac, the only SSRI approved for use in depressed children, was not included in the new warning. The British review did not find a significant increase in the risk of suicide-related events among children taking the drug.
The British and American warnings were a stunning turnaround that left thousands of parents whose children are using the drugs wondering whether their children were at risk. But it was also long-sought vindication for a small group of researchers, family members and lawyers who have been arguing for years that antidepressants cause some people to become violently unhinged. They say they've been frustrated in getting this word out to the public, in large part because of the FDA's unwillingness to confront and control the drugmakers.
The FDA's warning about a possible suicide risk from Paxil left Sara and Jim Reich feeling furious, betrayed, and ready to sue. "Had I known there was a threefold increased risk of suicide among kids taking Paxil, I would not have allowed my daughter to go on that drug," said Jim. In fact, Jim has prescribed the drug himself and is outraged that the Physician's Desk Reference, or PDR the drug bible for doctors, based on FDA-approved prescribing information says nothing about Paxil's suicide risk.
The British and American warnings also raised some troubling questions: How did drugs that have been widely promoted as nearly risk-free, and that are commonly prescribed by pediatricians and child psychiatrists, come to be seen as potentially dangerous? What should parents whose children are taking them do about it? And just how effective are these drugs that can sometimes cause such serious problems?
An Uncontrolled Experiment
Since 1987, when Prozac became the first SSRI on the market, America's love affair with antidepressants has worked its way down the age ladder. Between 1987 and 1996, the use of antidepressants and other psychotropic medications by children and adolescents tripled, with most of that increase occurring after 1991, according to a recent study in the Archives of Pediatric and Adolescent Medicine. By 1996, the study found, 6 percent of American children and teenagers were taking psychotropic medications, one-third of which were antidepressants.
Biological solutions to behavioral problems were becoming increasingly acceptable, even fashionable. "I think there's been a revolution in the way people think about behavior," says Lawrence Diller, a behavioral pediatrician in Walnut Creek. "The idea that children's behavior is the product primarily of their genetics and biochemistry was promoted by American psychiatry and hijacked by the drug industry. It's simply become more acceptable to see behavior as a reflection of an imbalance in chemistry rather than an imbalance in life."
The phenomenal growth in antidepressants prescribed to children leaves many doctors and therapists uneasy. Diller, who has written about his misgivings in two books ("Running on Ritalin" and "Should I Medicate My Child?"), cautiously prescribes antidepressants to some children, but says the new data about a possible link to suicide is making both him and some parents think twice. "It hasn't caused me to stop using SSRIs, particularly in teenagers, but I think it's another reminder that our information is incomplete."
To understand how we got here, it's important to know a bit about the drug- approval process. When a drug company applies to the FDA for approval to sell a medication, it must demonstrate that the drug is safe and effective for a particular population, such as adults, and a specific condition, such as depression. Once the drug has been cleared by the FDA and is on the market, doctors are free to prescribe it to anyone for any reason. "Off-label" prescribing, is quite common; the only real restriction is that drug companies cannot market drugs to unapproved groups. From 1987, when Prozac was first approved for adults, until early last year, when Prozac became the first SSRI approved for use in depressed children 7 and older, all antidepressants used by depressed children were prescribed off-label.
The widespread use of antidepressants by children, critics say, amounts to an uncontrolled national experiment. The prescribing physicians are often pediatricians or family doctors with little or no training in psychopharmacology. The drugs are frequently given in the absence of therapy or other interventions. The subjects of the experiment children are too young to give meaningful consent. There is little understanding of the long- term effect these medications have on the architecture of children's developing brains. And the evidence that the drugs are effective is less than impressive.
When Prozac was approved for depressed children last year, it was on the strength of two controlled trials. One, published in 1997 in the Archives of General Psychiatry, found that after eight weeks, 56 percent of kids taking Prozac showed some improvement, according to the clinicians who evaluated them, compared with 33 percent of the kids in the placebo group. But 69 percent of the kids taking Prozac still had significant symptoms of depression. Clinical trials of Paxil, Zoloft and Effexor found those drugs to be no more effective than placebos in treating depressed children.
Perhaps the most notable finding from clinical trials of antidepressants is how many children respond well to placebos as many as 59 percent in some studies. This high placebo response rate is a common finding in pediatric drug trials, in which children are generally seen once or twice a week by clinicians, says David Healy, an internationally known psychopharmacologist from the University of Wales College of Medicine who has emerged as a prominent critic of drug company practices. "This suggests that simple support can help children in many cases," Healy says.
SSRIs: Cleaner and Safer?
In the years since 1987, SSRIs have developed a reputation for being largely free of serious side effects, vastly improved over the older generation of so-called tricyclic antidepressants. In some respects, this is true: Distressed patients who attempt to kill themselves by overdosing are unlikely to succeed; they can usually tolerate the pills. And patients taking tricyclics are more likely to suffer from constipation, urinary retention, blurred vision and dry mouth.
But SSRIs cause sexual problems at fairly high rates, as well as insominia, nausea, dizziness and other side effects. Studies also have not found them to be more effective than the older pills at relieving symptoms of depression. "The SSRIs have sold themselves very heavily as safe and clean drugs compared to the old antidepressants," says Healy. "Well, it's not clear that they're safer, and it's not clear that they cause fewer side effects."
One side effect of SSRIs, recognized for at least 15 years, is a sensation called akathisia, a restless agitation that ranges from jitteriness to a sensation described by some people as "jumping out of their skin." Healy believes akathisia is the principal trigger for impulsive violence in some people taking SSRIs. "They became anxious, agitated, terrified, unable to sleep at night and restless," he says the symptoms that plagued Angela Reich.
There have long been signs that SSRIs sometimes cause these reactions, which drug manufacturers have tried mightily, and largely successfully, to keep out of the public eye and off the labels. This issue first arose a couple years after Prozac went on the market, amid a raft of media reports about grisly acts of murder and suicide. The most notorious event took place in 1989, when Joseph Wesbecker went on a shooting frenzy, killing nine fellow workers of a Louisville, Ky., printing plant before turning his gun on himself. Wesbecker, who had a history of mental problems, was taking Prozac. No one could prove Prozac caused his rampage, but by early 1991, some 350 suicides of Prozac patients had been reported to the FDA, according to one former FDA official. Those reports, which occurred outside the context of scientific clinical trials, were dismissed as anecdotal and sensational by company officials.
Harder to dismiss, though, was a study published by Harvard researcher Martin Teicher and two colleagues in the American Journal of Psychiatry in 1990 about six patients who developed "violent suicidal preoccupation" after taking Prozac for two to seven weeks. "It was also remarkable how violent these thoughts were," the authors reported. "Two patients fantasized, for the first time, about killing themselves with a gun," they wrote, while one placed a loaded gun to her head, another had to be restrained to prevent self- mutilation, and another fantasized about killing himself in a gas explosion. None of the patients was suicidal when they started taking Prozac, the researchers reported, and their fixation with violence and death abated when they stopped.
Similar symptoms were noted the next year in a paper in the American Journal of Child and Adolescent Psychiatry about six children ages 10 to 17 who developed "intense self-injurious ideation or behavior" while taking Prozac. After three weeks on the drug, one 14-year-old girl, who had been depressed but never suicidal, began cutting and otherwise injuring herself. She told hospital staff, "I'm just waiting for the opportunity to kill myself, " and chanted, "Kill, kill, kill; die, die die; pain, pain, pain," according to the paper. The Yale University authors noted the complexity of reaching any conclusion about the cause of these events since the children all had lengthy histories of psychiatric difficulties that put them at risk for suicide. They also noted that many children taking Prozac become agitated, restless, and disinhibited and developed insomnia to boot.
A 1998 paper by Roger Lane, a scientist at Pfizer, the maker of Zoloft, stated that "all SSRIs have the rare potential to cause akathisia." In its most extreme form, Lane wrote, patients may feel that "death is a welcome result."
Lane also warned that akathisia can sometimes be mistaken for worsening depression, prompting some doctors to increase the dosage and the danger. Healy agrees. "[Doctors] have been educated to think that SSRIs take four, five, six weeks to work," he says. "But they can cause problems long before that."
In response to the Teicher paper and the growing media furor connecting Prozac to acts of violence and suicide, the FDA in September 1991 convened an extraordinary special hearing of its Psychopharmacological Drugs Advisory Committee. Speakers told of family members who committed suicide or homicide while on Prozac and begged agency officials to ban or restrict the drug. But representatives of Eli Lilly, maker of the blockbuster drug, backed by FDA and academic researchers, argued that suicide is an inherent risk among depressed patients. The Lilly officials presented figures from the company's clinical trials database suggesting that people on Prozac were at no greater risk of suicide than people taking placebos.
Committee members voted unanimously in Lilly's favor, and Prozac remained on the market. No warning that the drug might induce violent or suicidal urges in some people was added to its label.
'Cooking the Books'
The Prozac suicide controversy, and the huge number of suicide reports that were streaming into the agency, reverberated inside the FDA, where two other SSRIs, Paxil and Zoloft, were being considered for approval. The FDA medical officer charged with reviewing Paxil's safety and efficacy data was Martin Brecher, now an executive with the British pharmaceutical company Astra Zeneca. "The reports of successful suicide were coming in in bunches," he said in a recent deposition. "It was extraordinary, especially in comparison to other annual reports where, you know, you had 20 reports of a cold and maybe two reports of some liver enzyme elevations and here you are with 20 deaths in a report."
Because Paxil and Zoloft were members of the same chemical class as Prozac, the FDA asked officials at SmithKline Beecham (the predecessor to GlaxoSmithKline) and Pfizer, Zoloft's maker, to submit reviews on the drugs' effect on suicidal behavior of patients. Brecher called Thomas Donnelly, a SmithKline Beecham executive, and asked him to prepare such a report. In an internal company memo uncovered in a lawsuit, Donnelly described his conversation with Brecher, noting that the FDA "does not see it as a real issue but rather as a public relations problem."
What happened next is controversial. Critics charge that the company manipulated data to diminish the apparent suicide risk among Paxil users and submitted it to the agency. One of the harshest critics is an unlikely plaintiff's attorney in San Rafael, a self described conservative Republican and retired Navy officer named Don Farber.
Farber, who has spent the better part of the past five years suing Glaxo- SmithKline and other drug companies, is one of a handful of lawyers handling such cases. His first case involved a San Jose man, Reynaldo Lacuzong, who, in 1996, drowned his two children and himself in a bathtub three days after he began taking Paxil. After the suit was filed, GlaxoSmithKline and the surviving Lacuzong family resolved the case with an undisclosed settlement.
The same thing has happened in dozens of other cases of alleged SSRI- induced suicide or violence; few cases ever go to jury. In June 2001, however, a case did. Three years earlier, Donald Schell, a 60-year-old Wyoming man, killed his wife, daughter and granddaughter three hours after taking two tablets of Paxil given to him as samples by his internist. Surviving family members sued GlaxoSmithKline, and the jury awarded them $6.4 million for the wrongful deaths of their relatives.
"[The company] knew there was a small group at risk and Don Schell was one of those vulnerable people," the family's attorney, Andy Vickery told the jury. Farber makes the same argument: Drug companies have an obligation to warn doctors and patients that these drugs can pose a threat to some people.
"If there was a warning that said 'Caution: this drug may cause suicide in some people,' then doctors are going to know about it," Farber says.
Instead of warning people, Farber charges, Glaxo-SmithKline tried to hide the true numbers. "They cooked the books," says Farber during a recent interview. "They cheated on the results. And the FDA is part of this."
Farber says the company manipulated the figures. Documents obtained by The Chronicle show that in its initial application to the FDA, the company reported that out of 2,963 adults taking Paxil during clinical trials in the United States or other countries, seven patients killed themselves and 42 attempted suicide. But in a review submitted in April 1991, in response to Brecher's request, the seven suicides had dropped to five and the 42 attempts had gone down to 40.
At the same time, the number of attempted suicides by patients taking placebos doubled from three to six in the later review. The 1991 review also acknowledges that two suicides and two suicide attempts charged to placebo occurred during a one-week "washout" period that came before the start of the study. During that period, subjects were taken off any drugs they had been using to get the drugs out of their system. Experts say it is inappropriate to count events during the run-in period as placebo events.
Company officials admit there were errors made in reports filed with the FDA, but deny any attempt to mislead. "There were unfortunately some inconsistencies in how the data on suicide attempts was presented to FDA," says GSK spokeswoman Mary Anne Rhyne. "When we became aware of this, we went back and looked at the clinical trial data again. GSK did not intentionally submit any erroneous or misleading information to FDA. The suicide data submitted to FDA explicitly identified when events occurred during the placebo run-in period. FDA had all this information right from the beginning."
Farber contends that these small shifts in numbers make a big difference in suicide rates. He claims that a close look at the data reveals that only one placebo patient out of 554 attempted suicide, while 49 patients out of 2,963 taking the drug committed or attempted suicide - a ninefold difference.
Rhyne disputes this analysis. "The randomized, placebo-controlled data shows no statistically significant differences in suicides or suicide attempts between Paxil and placebo," she says.
Drug Firms and the FDA: Too Close?
For its review of all pediatric trials of antidepressants, the FDA is reanalyzing the data to determine whether reports of suicidal ideation among children were categorized properly. Critics are concerned that this reanalysis may minimize the apparent suicide risk to the benefit of drug companies, and contend that the agency has a long history of protecting the industry. They point to company memos, uncovered through legal actions, that reveal a sense of confidence within the companies that the FDA was on their side. Memos from Eli Lilly executives described one FDA official, Paul Leber, as "our defender" and cautioned that faxes should not be sent to him unless he knew they were coming so he could receive them personally.
Other memos suggest Lilly officials went to great lengths to conceal any hints that Prozac might trigger suicide. Consider this line from a 1990 memo to Lilly executive Leigh Thompson written by Claude Bouchy, a Lilly official in Germany, in response to a request to change the description of an event from "suicidal ideation" to "depression." Bouchy writes: "Hans [a fellow Lilly employee] has medical problems with these directions and I have great concerns about it. I do not think I could explain to the BGA [the German FDA], a judge, to a reporter, or even to my family why we would do this, especially on the sensitive issue of suicide and suicidal ideation."
Critics charge that the pro-industry stance of FDA officials prevented a more thorough examination of the role antidepressants may play in triggering suicide and violence in some users. They also charge that many American psychiatric researchers have been compromised in their ability to look objectively at this issue because they are so dependent on funding from pharmaceutical companies.
The FDA's Thomas Laughren rejects the notion that his agency is protecting drugmakers. "The goal here is to get to the truth," he says. For the review of pediatric trials of antidepressants now under way, the agency is bringing in a panel of experts as judges. "We're taking all the cases and having them reclassified blindly," he says. "They'll be looking at all the information that is relative to the question of suicidality and they will not know the drug assignment."
As the agency reviews the data, experts will debate a core question: how to reconcile reports of antidepressants triggering suicidal behavior with other studies that suggest that these drugs reduce suicide rates. A paper published in the October Archives of General Psychiatry found that regions of the country where the use of antidepressants by children increased the most also tended to have the greatest drop in suicide rates.
Could antidepressants lower the suicide risk in some people while raising it in others? "It's entirely possible that both things are true," says Mark Olfson, a professor of clinical psychiatry at Columbia University and lead author of the Archives paper.
David Healy says the drugs simply have different effects on different people. "My hunch is that, just as with adults, there is a group of children who are suited to the pills and do very well on them and an equally large group of kids who are not." Among those who don't do well, Healy says, are some who get much worse.
One thing most experts seem to agree on is that patients, especially children, should be monitored closely for side effects from the day they start taking the drugs. "They may be more anxious or have unusual thoughts they've never had before," Healy says. "They may think about harming others or themselves." Healy also suggests asking children if they've had strange dreams, nightmares or thoughts since they started taking the drug. "The other thing to look out for," he says, "is the opposite effect: Kids who become absolutely fearless, they just don't feel anxious at all."
On Feb. 2, nearly 13 years after the 1991 Prozac hearings, an FDA advisory committee will once again hold a hearing about the risk of suicide by people taking antidepressants, this time focusing on the risk to children and teenagers. The meeting will come too late to help 17-year old Julie Woodward of North Wales, Pa.
In July, Julie began attending a two-week group therapy program at nearby Horsham Clinic. A break-up with a boyfriend and conflicts with her parents had left her feeling withdrawn and in a struggle to maintain good grades. One condition of attending the program was taking antidepressants, Tom Woodward says. He and his wife didn't really like the idea, but were told they were "essential to treatment" and "very benign."
On day three of the program, Julie began taking 50 milligrams of Zoloft, and that night came the first signs of unusual behavior. Julie and her mother had a small dispute, and Julie roughly shoved her mother, an out-of-character act, Woodward says.
During the next few days, Julie became more edgy and withdrawn. On the evening of day six, she told her parents she wanted to stay home alone. But when they looked for her later that night, they couldn't find her. The next day, her father found her body hanging in the garage. One week after starting on Zoloft, she had taken her life.
When the FDA hearing comes, Tom and Kathy Woodward plan to testify, as do Jennifer Tierney and her daughter, Jame, of Kernerville, N.C. The Tierneys' story exemplifies another part of the antidepressant story: withdrawal.
All SSRIs have been reported to cause withdrawal problems in some patients who stop taking them. Paxil and Effexor, however, seem especially likely to trigger withdrawal symptoms, probably because they exit a user's body more rapidly. "Paxil has been linked to more reports of withdrawal symptoms than any other drug in clinical history," says Karen Barth, an attorney with Baum- Hedlund, a Los Angeles firm that is representing some 3,000 people who have suffered withdrawal problems on Paxil.
Jame Tierney was 14 when she was prescribed Effexor to ease migraines she'd been suffering from for years. She started with Effexor and other drugs, but gradually went off the others. She enjoyed eight good months of reduced headache pain. Then the migraines worsened and her neurologist doubled the dose. Within two weeks, her personality began to change. "She became the most angry, combative, raging child you've ever seen," says her mother. "I'd never seen her like this and I had no idea why."
Jame was also unhappy and depressed. "I was hopeless, and I thought suicide was the only way out," she recalls. "I had violent thoughts and tendencies that I'd never felt before." She contemplated killing herself and made one attempt to cut her wrists.
She remained on 150 milligrams and in a raging misery for a full year, functioning at school but isolating herself in her room. Then her mother learned Effexor wasn't a headache drug but an antidepressant, unapproved for children, which can sometimes cause serious side effects. Over the objections of the neurologist, Jame tried to taper off the drug.
Her personality quickly returned to normal, but she suffered terrible withdrawal symptoms constant vomiting, headaches, muscle aches and disequilibrium that kept her out of school for months. Finally, on advice from a California doctor, she began taking vitamin and enzyme supplements. After six months, the withdrawal symptoms ended and her headaches are now a rare event. Her bout with depression, which she experienced only on Effexor, also came to an end.
While Jame was weaning herself from Effexor, Angela Reich was trying to get off Paxil. Her dose was cut to 15 milligrams a day while she got through the next round of chemo. She lowered her dosage to 12.5 mgs, then 10, then 7.5, 5, and 2.5 over four weeks. Finally, on Jan. 24, she took no Paxil. That's when the side effects began.
"She couldn't sit up, she had trouble walking, and she was dizzy," Sara recalls. "She couldn't walk straight, and she had this zapping, this electrical feeling in her arms."
The restless akathisia was gone, but Angela was uncomfortable, depressed, and irritable "really irritable," her mother says. One night, Angela nearly flipped out. She ran into the living room, screaming, and started grabbing books off the shelves and heaving them. "She tore them up and said she hated them, she hated us and she hated the people around her," Sara says. "Then she grabbed for some knives." Her father restrained her and held her until she calmed down. But the whole family was shaken. "I started to feel like 'Oh my God, my kid has gone insane,' " Sara says.
Somehow Angela and her family got through the next month, and she gradually started to feel normal. She went off to college in September and is doing well, her parents say. Best of all, as this article was going to press, she got another negative biopsy report on her cancer.
Angela didn't want to talk about her Paxil experiences with a reporter "It's just too painful," her mother explained. But she did want to join the lawsuit that Baum-Hedlund is pursuing against GlaxoSmithKline. "She wants to prevent anyone else from going through this kind of nightmare. She wants to save other people from suffering like she suffered."