Friday 26 May 2017 14.00 BST Last modified on Saturday 27 May 2017 00.10 BST
My daughter Renske met her boyfriend Samarie on the train. She was heading from the Netherlands to Switzerland; he was an asylum seeker from Benin. They got chatting and exchanged phone numbers. That was how it started. They had a good relationship. He was attentive and they were very respectful towards each other. They spent holidays with me and my wife Lieuwkje.
Just before midnight on 13 April 2011, I saw on the news that a girl had been killed in Baflo, where Renske lived. About an hour later, they showed a picture of the scene, and I recognised her flat. I called the police and said, “I think my daughter is the victim of the incident in Baflo.” At 5am, two officers came to the house and we learned what had happened.
Samarie had picked up a fire extinguisher in the hall and beaten Renske to death. When an officer tried to arrest him, he grabbed his pistol and shot him dead. Samarie was then shot by police five times and taken to hospital. I couldn’t believe it; in the two years that we’d known Samarie, I had never seen him lose his temper. It was so far removed from the man we knew that we couldn’t make sense of it. It was immediately clear to my wife and I that he needed help, and we wanted to try to be there for him; to understand what had happened.
Initially, I thought it was connected to Samarie’s asylum claim. The day before the killing, his final appeal had been rejected and he was told he was being deported. Five weeks later I went to his flat and found a strip of pills. I knew Samarie was taking antidepressants, but I didn’t know what sort. The label said paroxetine, which is a selective serotonin reuptake inhibitor (SSRI), and as a psychologist I knew there are risks associated with it. From talking to Samarie’s psychiatrist, I discovered that he was reducing his dose. I read that in a small number of cases there have been severe side-effects to SSRIs, including outbursts of extreme violence, usually when the dose is being changed.
After a month or two, we contacted his lawyer, but we couldn’t see Samarie because he was still in the prison hospital. We wrote him a letter and he replied saying how sorry he was. In September we visited him for the first time. We wanted to see for ourselves that he was genuinely remorseful. Samarie came into the room in tears, and he and my wife Lieuwkje hugged each other. I shook his hand. We didn’t talk a lot. He was still limping from his injuries.
From then on, we visited once a month. At first, we talked about what had happened with Renske. He said he’d been in a state of anxiety all day and had tried to get help. They had an argument and she tried to stop him walking out; that was when he hit her. When I asked if he had an explanation, he said: “No, you know how much I love her.” The visits allowed us to bear the grief together; it was our way of coping.
The idea of writing a book together came to me in 2014 after Samarie’s trial. He was sentenced to 28 years in prison for double murder. I thought, the circumstances of my daughter’s death are so extraordinary that I need to find a way to put it in words. Renske was a caring, modest young woman. She and Samarie had dreamed of living together one day. As well as losing her, we had lost them as a couple.
Samarie’s sentence was reduced on appeal to five and a half years. Instead of premeditated murder, he was found to have diminished responsibility for the killing of Renske and partial responsibility for the death of the police officer; the appeal court ruled that he had been in a psychotic state. He has now completed his sentence, and been transferred to psychiatric care.
We continue to visit and support Samarie. It’s not about whether we forgive him. What happened can never be erased, for him or for us. I can understand people thinking it’s unbelievable that we can even look each other in the eye, but this is our way of dealing with it. I’ve never thought it was the wrong decision.
Doctors often tell patients that antidepressants can only cause suicidal behavior in children and not in adults. Many publications also make the same claim. The false claim is based on the FDA-approved Black Box Warning for antidepressants that warns about an increased rate of suicidality in children, youth and young adults taking antidepressants, but not in adults over age 24. The Black Box Warning specifically summarizes, “Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24.”
“Due to the large number of subjects in the adult analysis, almost 100,000 patients, the adjudication process was left as the responsibility of the sponsors [the drug companies] and was not overseen or otherwise verified by the FDA. This is in contrast to the pediatric suicidality analysis in which the FDA was actively involved in the adjudication (p. 14).”
In addition, the FDA also announced at the 2006 hearings on antidepressant-induced adult suicidality that it did not require a uniform method of analysis by each drug company and an independent evaluator as required with the pediatric sample.
Thus, the FDA was comparing somewhat good apples (the pediatric studies) to rotten apples (the adult studies), while making them seem comparable. The child studies showed that antidepressants can cause suicidality — the adult studies (after age 24) showed nothing other than FDA collusion with the self-serving drug companies. As I have described in my books and scientific articles, drug companies routinely manipulate their data on suicide to avoid any causal connection to their drug (see for example my 2006 paper about GSK and Paxil).
In the case of Eli Lilly, here are two memos by employee Claude Bouchey (pages 2 & 3 of document) written to the hierarchy of the company in which he expresses guilt and shame about changing official investigator reports of Prozac-induced suicide attempt to misleading terms like “overdose” or “depression.”
Ironically, the FDA controlled and monitored the original pediatric studies precisely because the drug companies on their own failed to find any risk of antidepressant-induced suicidality in any age group. Why would the FDA assume these same self-serving drug companies, left on their own again, would spontaneously begin for the first time to conduct honest studies on the capacity of their products to cause adult suicidality?
Furthermore, even in the rotten-apple adult studies, despite the drug company’s manipulations, Paxil (paroxetine) turned out to be causally associated with increased suicidality in depressed adults in an internal FDA review of the data. As a result, in 2006 the FDA then forced the maker of Paxil, GlaxoSmithKline (GSK), to write a “Dear Doctor” letter to all healthcare providers confirming the Paxil/suicidality causal link in adults.
In April 2006, the FDA also made the drug company put a warning in its Full Prescribing Information (label or package insert) about the risk of Paxil causing suicidality in adults with depression; but GSK convinced them to drop it in subsequent years.The warning appeared in the Physician’s Desk Reference (PDR) only once in 2007.
Meanwhile, there are many studies showing that antidepressants do cause suicidality and suicide in adults.
Next time you hear someone say that the FDA studies only showed increased suicidality in children and young adults as opposed to adults, remember that the adult studies, unlike the pediatric studies, were not controlled, monitored or validated by the FDA. This is one more example of the extremes the FDA will go to in order to protect drug companies and their often lethal products.
It was bad enough to find out that antidepressants cause suicidality in children. The drug companies and their minions complained mightily. The FDA and the drug companies were not going to allow a repetition of sufficiently unbiased studies that might conclude that adults are also vulnerable to antidepressant-induced suicide.
Courts are not a place you can make jokes. I started off with a confident pitch:
If you owe a bank a million pounds, you have a problem but if you owe the bank a billion …
I didn’t get much further. It felt like several GSK lawyers popped up, addressing the judge with words to the effect that he’s talking about banking your honor, this is not his area of expertise. The judge accepted their objections and I didn’t get to complete the analogy.
Nobody knew what I was talking about anyway – pounds? What are pounds?
Judge Hart also ruled out the following image. So the jury never got to see it.
A lot of my testimony centered on working through each of the ways to hide the data listed here. The exhibit couldn’t be shown but this is what was covered – in some ways too well. There were documents showing correspondence between GSK and FDA on many of these points leaving the jury wondering whether GSK or FDA were more to blame.
Many of the things that were done were shocking. GSK and other companies dumped withdrawal related suicidal acts into the placebo arm of trials, inflating the risks of placebo and breaching FDA regulations in the process. A good deal of this was so blatant that the jury must have been left wondering whether FDA reviewers were asleep or out to lunch.
Suicidal events were coded under the heading of emotional lability. When a journalist and lawyers independently spotted this coding trick and it became a public issue, emails circulated within FDA asking what emotional lability actually was, and where it had come from. But Andy Bayman for GSK could show the jury the documents sent into FDA which showed suicidal events clearly coded as emotional lability. This naturally cast doubt on whether FDA could have been as ignorant of what was going on as FDA head honchos later claimed to be.
Another egregious trick was the use of patient exposure years. This gives rise to the Space Shuttle fallacy. If you calculate lives lost per miles traveled the Space Shuttle may be the safest means of transport in the universe. But it takes a brave person to go on one.
This is because in terms of exit from and entry to earth’s atmosphere the shuttle is highly risky – just like antidepressants where its the starting and stopping that are the problem. GSK and other companies continued some people who were happy as clams on their paroxetine for lengthy periods of time and mixed these with the patients having difficulties to dilute the problem. All of sudden, per year on treatment, the antidepressants looked safe. This is a legitimate approach for some problems but not for this one.
Another trick was putting suicidal events in a neurological category that also included dizziness and headache. These happen so commonly they drown out the signal from suicidal events.
Every time a maneuver like this was exposed, GSK looked bad. They looked like they owed the jury and the public money – a million dollars. The problem is though, they hold all the data. No one could give the jury the data from these GSK trials and say “here you are – its not rocket science – you work out what this data shows”.
While this is the case GSK effectively owe us Billions and its us who have the problem. They own us. And don’t seem to be under any onus to stop owning us.
But GSK interrupted my efforts to lighten the jury’s day by making this remark. A Court is not a place for this kind of thing.
Why would anybody trust GSK? Would you trust a felon?
The Dolin trial opened a can of worms about Paxil/Seroxat, suicidality and akathisia which GSK would rather remained tightly in the can. It’s too late now though, the worms are already out…
See Dr. David Healy’s excellent new post about wider implications of the Stewart Dolin Paxil induced suicide trial.
“……The regulatory history of Paxil and the other SSRI’s was almost Byzantine. For years they carried no warnings of a risk for suicide. In 2004, after thousands of troubling reports, a Black Box warning was finally issued for children and adolescents. A number of medical experts felt the warning should apply with equal urgency to adults.
However, in 2007, the FDA decided on a uniform warning for all antidepressants, old and new. This was the “24 and under” label attached to both brand-name and generic Paxil in 2010. This suited GSK just fine. The FDA invited the company to discuss whether additional warnings were needed for Paxil, but GSK never took them up on it.
More importantly, it never fully shared with the FDA—and still less with doctors in the community—what it knew about the real risks of its product. In fact, GSK had known since 1989 that its drug could trigger akathisia, an agonizing combination of physical restlessness and emotional turmoil that could lead to suicide. The risk applied to both teenagers and adults; at least twenty suicides had occurred in patients on Paxil in clinical trials, the majority of them in people over age thirty…..”
Editorial Note: This is part three in the Change in Chicago series covering the Dolin trial and its implications. Like part 1 it is written by Johanna Ryan – The Dolin Verdict and Playing Go.
By twenty-first century American standards, Stu Dolin’s medical care was close to ideal. That’s a hard idea to swallow, given what happened to him in the end, but it’s true. The real paradox is why it wasn’t enough to save him – and how his doctor became a victim as well.
In June 2010, while taking a generic version of the antidepressant Paxil, Dolin jumped in front of an oncoming subway train in downtown Chicago. His family was convinced that the medication had caused his suicide. Last month, a federal jury agreed. They found GlaxoSmithKline (GSK) liable for Dolin’s death, and awarded $3 million to his widow Wendy – two million for her own loss, and one million for Stu Dolin’s own suffering in his last week of life.
Few people succeed in suing the drug company when a loved one dies from the effects of his medication. It’s far more common to sue the prescribing doctor. Plenty of lawyers are willing to take on a malpractice insurer with limited loyalty to the doctor, and a lively interest in a reasonable settlement. To face off against a multinational corporation with an unlimited war chest, which will fight like hell for the reputation of its product, is something else entirely.
An even bigger barrier is something called the Learned Intermediary Doctrine. Under American law, drug companies have no obligation to level with you, the patient, about the potential hazards of the drug. Their only obligation is to tell your doctor about those risks. He or she is then expected to function as a “learned intermediary” – a sort of educated bodyguard who will tell you what you need to know, in language you can understand, and see to it that no harm comes to you. The drug’s official label (that enormous, technical document folded up and stuffed into the drug package) is written with your doctor, not you, in mind.
But what if that official label does not tell the whole truth about the drug’s hazards? That was the situation faced by Martin Sachman, M.D., Stu Dolin’s family doctor, who became a key witness in the Dolin lawsuit.
Marcus Welby M.D. – the old-school family doctor
That’s not Martin Sachman in the picture at the top of today’s blog – it’s Robert Young in the title role of Marcus Welby, M.D., the popular prime-time TV drama from the 1970’s. To most of us, Dr. Welby represents the family doctor we wish we could have – the one our parents had in the good old days. He was a settled presence in the neighborhood; he’d known you and your family for years. You could go to him for advice on just about anything, and you tended to trust what he told you.
For Dolin, Marty Sachman was that kind of doctor. Since about 2005, Sachman has had what’s known as a “concierge” practice. For an annual fee of about $2,000 (over and above their usual insurance costs), patients can get something close to a Marcus Welby level of care from a doctor of this type. They can be reached on weekends, may even make house calls from time to time, and you’re almost never limited to a ten-minute appointment.
Sachman had been Stu Dolin’s doctor for at least ten years. He was also a close personal friend. (That’s unusual enough these days that attorneys rushed to assure the jury there was nothing “unethical” about it. A generation or two ago it was fairly common, especially in small towns.) Often, faced with a difficult medical decision, there’s one question we really want to ask the doctor: Would you give the same advice to a loved one or a best friend, if they were in my shoes? Mostly, we don’t have the nerve to ask. Stu Dolin was lucky enough to know the answer would be yes.
A Job For A General Practitioner
Most family doctors take that Learned Intermediary business fairly seriously. It’s one reason why they refrain from handling “specialty” drugs for complex or serious conditions, which may require expert management. Chemotherapy for cancer; biologic drugs for Crohn’s disease, MS and other autoimmune disorders – those are best left to specialists.
When he began practicing medicine in the 1980’s, Sachman explained, antidepressants were in that category. The older ones were more problematic, with more side effects, and were reserved for people with relatively severe symptoms. Rather than try to treat such patients himself, he’d refer them to a psychiatrist.
This changed when Paxil, Prozac and the other SSRI drugs came out in the early 1990’s. They were depicted as being safe enough to be handled by general practitioners, and a reasonable option for patients whose troubles didn’t warrant seeing a psychiatrist. By the mid-2000’s, this had become the first-line option for dealing with both depression and anxiety.
As Dr. Sachman saw it, if a patient had mild to moderate depression in response to some trouble or stress in his life that was a “reactive” depression for which he could prescribe SSRI’s. If they had serious problems with sleep and appetite, a slowed-down or unusually agitated appearance, and an inability to function in daily life, that was true “clinical depression,” and they should see a psychiatrist.
Dr. Sachman knew Stu Dolin well, and the anxiety he complained of in June 2010 did not alarm him. Stu was just going through “one of his stress periods, on account of his work responsibilities. He seemed to be getting through it like he did the other times.” Dr. Sachman’s diagnosis was situational anxiety. A drug like Paxil could help people get through a rough period like this. The condition was fairly benign—and like the overwhelming majority of his colleagues, he considered Paxil to be a fairly benign drug.
A “Warning Label” that failed to warn
By 2010, the official label for Paxil gave physicians no reason to doubt that assessment – at least for adult patients. It warned that any antidepressant could trigger agitation and suicidal impulses in children and youth up to the age of 24. However, it also stated that “short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24,” and showed lowered suicidality in those over 65.
The warning added two more crucial sentences:
“Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality or unusual changes in behavior.”
As psychiatrist Joseph Glenmullen told the jury, this label effectively blinded doctors to the risks faced by adults: “What this tells me as a practicing psychiatrist is that if I’m treating a 57-year-old patient, and I put them on Paxil, Paxil couldn’t make them worse. Paxil couldn’t make them suicidal.” If they did feel worse, said Glenmullen, “it would be, and it says explicitly, their depression or other underlying psychiatric condition.”
Worst of all, he said, “if the patient gets worse and it might be the drug, what do you do? You take them off the drug to see. If they get worse and it couldn’t be the drug but it’s the depression, what do you do? You increase the drug, which is going to worsen the risk. So it’s very dangerous.”
The regulatory history of Paxil and the other SSRI’s was almost Byzantine. For years they carried no warnings of a risk for suicide. In 2004, after thousands of troubling reports, a Black Box warning was finally issued for children and adolescents. A number of medical experts felt the warning should apply with equal urgency to adults.
However, in 2007, the FDA decided on a uniform warning for all antidepressants, old and new. This was the “24 and under” label attached to both brand-name and generic Paxil in 2010. This suited GSK just fine. The FDA invited the company to discuss whether additional warnings were needed for Paxil, but GSK never took them up on it.
More importantly, it never fully shared with the FDA—and still less with doctors in the community—what it knew about the real risks of its product. In fact, GSK had known since 1989 that its drug could trigger akathisia, an agonizing combination of physical restlessness and emotional turmoil that could lead to suicide. The risk applied to both teenagers and adults; at least twenty suicides had occurred in patients on Paxil in clinical trials, the majority of them in people over age thirty.
A Doctor Taken Hostage
Thanks to GSK, that information never reached Marty Sachman. If it had, he testified, he would never have prescribed Paxil for Stu Dolin. There were plenty of other options—other drugs, and non-drug strategies – for treating situational anxiety. Because of the warning label, he said, he had never prescribed Paxil to a patient under 25; the benefits didn’t seem worth the risk. He had a few adult patients who seemed to do well on Paxil; if they had been on it for several years and wanted to continue, he would refill it. However, in the seven years since Stu Dolin’s death he had not written a single new Paxil script: “I don’t trust the labeling,” he said. “I don’t trust the company, to be honest.”
Marty Sachman’s anguish—and his sense of betrayal—was apparent to everyone in the courtroom. Physicians like himself, he said, “rely on truth and honesty from pharmaceutical companies, and to falsify information or hold back information is totally criminal. How can we treat people effectively and safely if we can’t depend on that?” They couldn’t. Instead, he had prescribed a drug, and a patient had died. That alone would have been traumatic for any honest doctor; that the patient was his best friend made it devastating. It was not like being a Learned Intermediary; it was more like being a hostage.
So what about the average Joe?
Dr. Sachman never got the chance for a follow-up visit with Stu Dolin; within six days of starting Paxil, he was dead. If he had, it’s just possible he could have spotted his longtime patient’s real problem. Maybe even stopped the Paxil. We’ll never know.
In 2010, the year Stu Dolin died, doctors wrote 259 million antidepressant prescriptions. For most patients, who don’t have access to anyone remotely resembling Dr. Welby, the situation is even scarier. They may get a script for an SSRI in a ten-minute encounter with an overworked stranger, based on a checklist left in the waiting room so that every patient can be “screened” for depression. The potential number of doctors taken hostage – and patients tossed overboard – is hard to imagine.
I have to think genial old Marcus Welby, M.D. wouldn’t stand for it. What about us?
Editorial Note: This is a second post in the Change in Chicago Series looking at the Dolin trial and its verdict. There will be two more in the series.
Being cross-examined in a legal case involving Pharma is rarely fun. The lawyers will have done their homework in spades. As one of them put it to me once: Dr Healy, I have read everything you have ever written. Looking straight at him, I was quite prepared to believe this included every email I’d ever written. Between raking over an expert’s financial affairs, and private lives and any view ever expressed on anything, the assault on the expert can take any shape and rarely involves an engagement with the “science” of the issue. The results can be bloody.
In a deposition in the Dolin case two years previously that was supposed to be about the science of paroxetine, after a quick hour on the science, Dr Tamar Halpern and Bob Glanville for GSK spent nine hours instead picking over my relations with Betsi Cadwaladr University Health Board, my dealings with all sorts of people before finally producing several large binders containing every post on this and on the RxISK blog – something like 800,000 words and 500 blog posts, fishing fro statements to snag me on.
At trial, Andy Bayman, GSK’s lead lawyer made a show of presenting me with two huge binders of prior depositions and testimony. I didn’t have the wit to count up all the words and pages and hours of testimony but it was likely 10,000 plus pages, a million plus words and over 3000 hours worth of being grilled under oath. The usual tactic is to pick out a phrase deep in the folder and triumphantly present that to the Court as representative of “your views Dr Healy”.
This is where any prior use of irony, or jokes, or effort to take the views of those who have an opposite point of view to mine into account can become a liability.
One trick is just to ask: “Did I read that correctly Dr Healy” – and move quickly on. In Dolin I had what I thought was a minor triumph when Andy Bayman tried this and I had the wit to respond “No”. This was something he didn’t expect, particularly as he had all the words correct. I explained that he’d missed the note of irony.
Overall the cross in Dolin didn’t seem to be too bad. Mr Bayman was more than averagely pleasant – it seemed. He didn’t argue too much when I seemed to score points – as I thought. At the end some of those on the plaintiff’s team congratulated me on having done a good job – but they probably say that to all witnesses. Several people reading the transcript later commented on a job well done but they were supporters to begin with.
So, after the trial was over, I turned to the closing arguments from both sides with interest. What would Andy Bayman say? I was a little surprised to begin with. Surprise turned to consternation. What was this – it seemed like someone called David Healy was the prize witness for GSK. Again and again they quoted that nice Dr Healy as saying FDA knew of the problem decades previously. Dr Healy showed you that FDA saw exactly what GSK had done and you didn’t hear him mention any quibbles.
A lot of the points I thought I had scored with looked like own goals. No wonder Andy Bayman didn’t contest some of what I thought were my most effective shots. No wonder he was so nice.
The full transcripts and exhibits are available on the Baum Hedlund website and will be on SSRI stories.
In trials like the Dolin trial, the plaintiff’s team try to make sure the jury blames GSK rather than the man himself or his doctor. At the end of this trial, they thought they had done a good job and the jury might not be out for much more than a few hours. The jury was out for days. And when they came back it became clear they were wrestling on the issue of who to blame. But Stewart Dolin wasn’t in the frame. Nor was his doctor. The dilemma was whether FDA were more culpable than GSK.
This was like playing Go, where it can look like the black counters on the board have white encircled until white puts down one more piece and all of a sudden it wins.
As someone who knows Andy Bayman, I was interested to see what Andy Vickery would make of what had happened. Vickery is a Houston lawyer who in 2001 won the Tobin case – a first ever verdict against a pharmaceutical company for a behavioral effect of one of their drugs – which should have led to a Black Box Warning for Adults on Antidepressants. He might say he was “just a lil ol’ country lawyer, but momma Vickery didn’t raise no fools … But it would be tongue in cheek if he did.
In the end, the Jury got it right. They usually do. The citizens who decided the Dolin Paxil suicide case in Chicago last week held GSK accountable for the wrongful death of Stewart Dolin, by all accounts a very good man. And, although the verdict was only a fraction of the daily profits that GSK garnered from Paxil during its lengthy monopoly money patent protected marketing days, the verdict still holds the company that made those billions of dollars in profits — the company that had both the legal authority and moral responsibility to change the label — liable for damages.
But it was not easy. By all appearances, the Jury struggled at length with the beguiling arguments of GSK’s very talented lead counsel, Andy Bayman. He told them that the FDA were a “neutral group of scientists” who did not have a “dog in this fight.” And that the FDA had “spoken loudly” on the issue of SSRI induced suicide. It was excellent advocacy, but a sleight of hand.
The truth is that the FDA stuck its head in the sand on this issue when it was first raised regarding Prozac in 1990, and, with the exception of a minor nod for the protection of pediatric patients in 2004, it has kept its head in the sand. In this respect, I share Mr. Bayman’s perspective that the FDA has, indeed, “spoken through its silence.” The FDA’s abysmal abdication of its duty to protect patients was, indeed, another “proximate cause” of Stewart Dolin’s death. Its “silence” killed Stewart Dolin.
BUT, the FDA is immune from suit. To be sure, the FDA could argue that one of the reasons that it was silent is that GSK “cooked the books” on Paxil suicidality. There is ample evidence to support that. But the “whole truth” is that the FDA had plenty of information which should have caused it to act proactively and to protect the American populace, and it willfully neglected its duty to do so.
The issue first arose in 1989 in the wake of a scientific study by two highly credentialed Harvard neuropsychopharmacologists. They cited 6 cases in which Prozac was the likely precipitating cause in adult suicide attempts, and they posited a “biologically plausible” explanation for how and why that happened.
In response, the FDA assembled an ostensible “blue ribbon” panel to advise it. It was a total farce. Several of the panel members had to obtain “waivers” of their extensive ties to Big Pharma in order to serve at all, and the Chairman of the Committee wore a bullet-proof vest at the public hearing because he feared a family member of an SSRI suicide victim might shoot him!
When a citizen’s group petitioned the FDA to take action, to require warnings, it said, not now, but if ever there is a “court judgment” we will sit up and take notice. Our law firm provided that verdict in June of 2001 in the Tobin case in Wyoming. After hearing all of the scientific evidence from both sides, the Jury specifically found that “Paxil can cause some people to commit homicide and/or suicide,” that it had caused the four deaths in issue there, and that damages for those deaths were $8MM. Our principal expert was Dr. David Healy (who also testified on behalf of Mrs. Dolin, and who has been grossly and unfairly maligned by GSK for years).
In the wake of our 2001 verdict, the FDA could and should have required full, robust warnings. But they did not. Three years later they required “Black Box” warnings for pediatric patients, but, although the adult data was almost exactly the same, they permitted the drug companies to phrase the warnings as if to appear that they did not apply to adults over the age of 24.
Stewart Dolin was 57. And Mr. Bayman used the FDA’s “silence” and its pathetic endorsement of the “pediatric” only warning to good purpose. He argued effectively that the FDA has “never said” that Paxil causes suicide and that it had taken “no action” for the last 10 years (since it finally received all of the adult data regarding SSRI suicidality). In this, he was right. The FDA has taken “no action.” Shame on them! Andy Bayman was also on target when he said that Dr. Healy “laid the blame at the FDA’s feet.” He did so because the FDA was wrong all along!
Many, many good people have died because the FDA stuck its head in the sand on this issue. It should now pull its head out of the sand, and hang it in total shame.
Saturday 6 May 2017 08.30 BST Last modified on Saturday 6 May 2017 20.51 BST
Sarah never planned to take antidepressants for 14 years. Three years after she began taking them, when she was 21, she went to her GP and asked to stop: 20mg of Seroxat a day had helped her live with anxiety and panic attacks, but she began to feel uncomfortable about being on medication all the time. Her doctor advised her to taper down her medication carefully.
At once, “I was a mess,” she says. “I thought I was losing my mind. My appetite completely went. I lost the best part of two stone. I was anxious constantly. My mouth was dry. It was difficult to sit and be calm.” She became withdrawn, refusing to see friends, and remembers asking her mother to get her a couple of boxes of paracetamol, thinking, “I’m going to have to take all these tablets, because I can’t live like this.”
Sarah’s doctor encouraged her to go back up to 20mg. “Within a week, I was much better. I feel anger when I look back. That wasn’t me relapsing, that was withdrawal. But I was so unwell, I didn’t stop to think, ‘I’ve never had this before.’ I truly thought it was me. Now the only reason I am on the drug is because I am dependent upon it. And that is not good enough.”
Prescriptions of SSRIs (selective serotonin reuptake inhibitors), the most common type of antidepressant, have doubled in the past decade. There are now more than 70m prescriptions dispensed in the UK in a year, the “greatest rise” of any drug in the last year, according to NHS research. But while the side-effects of starting and then withdrawing from these drugs are reasonably well known (the patient information leaflet accompanying the SSRI Seroxat is six pages long), there is very little research into the long-term effects of using antidepressants.
Last year, an all-party parliamentary group began hearing evidence as to whether there is a link between a measurable rise in mental health disability claims – 103% between 1995 and 2014 – and that in antidepressant prescriptions. (Claims for other conditions fell by 35% in the same period.) “We need to have a serious rethink about current levels of prescribing, because it may well be that the drugs are in fact contributing to the disability burden,” Dr Joanna Moncrieff, a consultant psychiatrist and senior lecturer at University College London, told the committee.
Reports both anecdotal and clinical have included side-effects such as constant pain, an altered sense of smell, taste or hearing, visual problems, burning hands and feet; food or drug intolerances and akathisia (the medical term for a deep inner restlessness). When a patient begins tapering down their dosage, these effects are generally ascribed to the drug leaving their system; if it is long after withdrawal is supposed to be over, however, patients are often disbelieved (according to the drug companies, withdrawal should take just two weeks for most people, though they acknowledge that for some it can be months).
Professor David Healy, director of the department of psychological medicine at Cardiff University and author of 22 books on psychopharmacology, believes that antidepressants are overprescribed. “If you go into your average doctor – if you’ve been off the drug for half a year or more – and you complain [of a range of symptoms] and say, ‘I think it’s caused by this pill I was on’, he or she would say, ‘It’s been out of your body for months. You’re neurotic, you’re depressed. All we need to do is put you on another pill.’”
GPs, Healy says, are “relying on your word, and if it’s a choice between believing what you say and relying on what drug companies say to them, they [tend to] believe the drug companies”. Healy, who has been a consultant for, and expert witness against, most of the major pharmaceutical companies, has long argued that long-term side-effects are routinely ignored or misunderstood.
But many experts believe these drugs do more good than harm. “Most of the people I see who have moderate to severe depression benefit from them,” says Daniel Smith, a professor of psychiatry and researcher into bipolar disorder at the University of Glasgow. For some, medication can be no less than “transformative. It can get them through a really critical period of their life.”
However, when it comes to long-term impact, especially after a person stops taking SSRIs, Smith says it can be hard to work out which symptoms relate to the drug use and which to the underlying conditions. “There’s obviously an issue of cause and effect. How can we be certain the SSRI caused it? Depression affects libido and sexual interest. How much [of the reported effects] is depression and/or anxiety symptoms coming back?”
SSRIs have been around for more than 40 years, but grew in popularity in the late 1980s and 90s after pharmaceutical company Eli Lilly launched fluoxetine, otherwise known as Prozac. Time magazine put the drug on its cover twice, asking, “Is Freud finished?” and describing SSRIs as “mental health’s greatest success story”. In 2001, a landmark report on a clinical trial into paroxetine (sold as Seroxat in North America and Paxil in the UK), called Study 329, concluded that it demonstrated “remarkable efficacy and safety”. Study 329 led directly to a massive increase in prescriptions: by 2003, worldwide sales of Seroxat (manufactured by GlaxoSmithKline) were worth £2.7bn.
But concerns were raised about the study –the US food and drug administration (FDA) officer who reviewed the data disagreed with the findings, calling it a failed trial – and in 2015 the British Medical Journal published a re-evaluation. Seven authors went through as many of the thousands of individual case reports as they could, and found not only that “the efficacy of paroxetine… was not statistically or clinically different from placebo”, but that “there were clinically significant increases in harms, including suicidal ideation and behaviour”. The original study reported 265 adverse reactions; the BMJ found 481. The re-evaluation also found that psychiatric responses were grouped together with “dizziness” and “headaches”, rather than given their own category. In 2003, the UK banned the use of Seroxat by anyone under 18; and in 2004 the FDA required a “black box warning” on all antidepressants, its strictest level of patient warning.
“Patient safety is our number one priority,” a GlaxoSmithKline (GSK) spokesperson tells me. “We believe we acted responsibly in researching paroxetine, monitoring its safety once it was approved and updating its labelling as new information became available.”
Many SSRI users report blunted emotions, even long after they have ceased taking pills, and an impact on sexual function. “They should be called anti-sex drugs rather than antidepressant drugs,” says Jon Jureidini, a child psychiatrist of 30 years’ standing, a professor of psychiatry and paediatrics at the University of Adelaide and co-author of the BMJ study, “It’s more reliably predictable that they’re going to get rid of sexual function than it is that they’re going to get rid of depression.” Again, some people find this persists long after they cease taking the drug. One person I spoke to, Kevin, had taken Prozac for six months when he was 18; now 38, he hasn’t had an erection since.
Last September, Healy and colleagues published a further examination of the data gathered for Study 329. This data followed the trial participants for six months after they started taking paroxetine (the “continuation phase”) and while they were tapered off it. GSK, which in 2004 published a clinical study report, had argued that “the long-term safety profile of paroxetine in adolescents appears similar to that reported following short-term dosing”. Healy and co, however, concluded that the “continuation phase did not offer support for longer-term efficacy”. More alarmingly, they found that the taper phase, when patients were being taken off the drugs, was the riskiest of all, showing a “higher proportion of severe adverse events per week of exposure”. This, they said, opens up the risk of a “prescribing cascade”, whereby drug side-effects are thought to be symptoms, so are treated with further drugs, causing further side-effects and further prescriptions – thus increasing the risk of long-term prescription drug-dependency.
In October, the British Medical Association published its response to a two-year fact-finding exercise into long-term use of psychoactive drugs. It noted that while benzodiazepines, z-drugs, opioid and antidepressants are “a key therapeutic tool”, that their use can “often lead to a patient becoming dependent or suffering withdrawal symptoms… the evidence and insight presented to us by many charity and support groups… shows us that the ‘lived experience’ of patients using these medications is too often associated with devastating health and social harms”; it was therefore, the report concluded, a “significant public health issue”.
The BMA made three key recommendations: first, and most urgently, that the UK government establish a 24-hour helpline for prescribed drug dependence; second, that it establish well-resourced specialist support units; and third, that there should be clear guidance on prescription, tapering and withdrawal management (they found the current approach to antidepressants, in particular, to be inconsistent: too many patients were suffering “significant harm”). There are also increasingly urgent calls for studies into long-term effects that are not funded by drug companies, because, Moncrieff says: “We don’t have very much data. This research is really important, but hasn’t been done. It’s a massive blind spot. It’s extraordinary – or maybe, given the pressures and interests at work, not extraordinary at all – that it hasn’t been filled.”
In March this year, members of the BMA, along with MPs and researchers from Roehampton University, went to parliament to lobby Public Health England, armed with research estimating that there are 770,000 long-term users of antidepressants in England alone, at a cost of £44m to the NHS per year (a figure that does not account for the cost of GP appointments, or the impact of side-effects, withdrawal effects and disability payments).
“I think you have to adopt a very conservative approach,” says psychiatrist Jon Jureidini. “These are brain-altering drugs, and our overall experience with brain-altering drugs of all kinds is that they tend to have a detrimental effect on some proportion of people who take them long term. All we know about the benefits is from short-term symptom-reduction studies. The careful prescriber needs to say, ‘Well, in balancing the likely benefits and harms, I need to be very cautious about how much benefit I’m expecting, and I need to be very generous about the possibility that the harms might be more than they appear to be.’”
Quite a few long-term users, such as those I spoke to below (and who wished to be anonymous), would agree.
‘Tapering off is the hardest thing I’ve ever done’:Sarah, 32; has taken Seroxat for 14 years
I was prescribed Seroxat when I was 18, the year I started university. I grew up with a disabled sister, so things at home were very stressful, and I had a history of anxiety and panic attacks. I had counselling, but the problems persisted, so I went back to the GP. I don’t remember everything that was said, but there was no conversation about side-effects.
Within the first two weeks of starting Seroxat, I remember I was sitting in the front room watching TV when out of nowhere I had this intense feeling of heat, like an electric shock. It started in my hands, went all the way up my arms and through to my head.
The GP said it was probably just my body getting used to the drug. And after a few weeks the weird sensations did ease off. I had a fabulous time at university. I still had panic attacks, and there were certain situations I would avoid – as I still do – so it wasn’t a wonder drug, but there were no major problems.
But in 2006 I tried to come off it. There were a couple of Panorama documentaries about the side-effects and I was starting to become concerned. The GP said, “That’s fine, but do it gradually, over three weeks.”
I immediately became incredibly unwell. I thought I was losing my mind. I was going to work, but it was difficult to get through the day. My mouth was so dry, I was constantly drinking water. I had bizarre thoughts – not hallucinations – that were frightening or distressing. I had a strong sense of detachment from reality.
Eventually, the doctor said, “Look, you coming off is obviously not working: we need to get you back to 20mg.” Within a week I was much better.
A few years later, when I realised my mental health was getting worse, even though I was on the medication, I started to do some research, reading case studies about withdrawal. I find it so offensive when a GP says, “This is who you are.” I didn’t have these symptoms 10 years ago. I didn’t have this sense of detachment. I saw various psychiatrists. They just kept saying, “The drug is safe, you need to be on it.” A couple of others told me the reason I was having these problems was because I wasn’t taking enough. Another said, “If you were diabetic, you’d take insulin and you wouldn’t have an issue. Why are you so bothered about taking this drug?”
I’ve been on it since I was 18, so I don’t know who I am without it, as an adult. Who knows? I might have all kinds of problems, but I need to know I’ve tried. Tapering off is the hardest thing I’ve ever done. It’s taken me three years just to get from 20mg to 5mg. I’m no longer with my partner – we were together for six years. I believe Seroxat has played a part: it affected my moods, it made my anxiety worse and, by necessity, I’ve had to be selfish, really. I don’t want to say all my problems are to do with Seroxat, because they’re not. But I do believe that it has caused me harm.
‘I don’t have much of an interest in interacting romantically or physically with the opposite sex’: Jake, 24; took SSRIs for eight years
I had been dealing with symptoms of OCD and anxiety for a lot of my childhood. It’s in my family, affecting two siblings and one parent. I was prescribed Zoloft when I was 12; I took a variety of SSRIs, Zoloft to Prozac to Lexapro, and then two others, for eight years.
Did they help? You know, I can’t really tell you, because I got through school. I got high marks, I had a lot of friends. So, in that sense, they must have helped. That’s the thing: for people with major depression, it’s easy to say, this has a measurable effect. But I kept taking them just because that’s what I’ve always done.
I went to university right out of school. I did very poorly. I had a bit of a breakdown, isolating myself, not sleeping. I was still on medication. I came home and enrolled at a community college. That was my worst period – I was very depressed. And I started to think, “I’ve been on these medications a long time. I’m not doing well – why not get off them?” I don’t recommend this at all to anyone, but I stopped going to a psychiatrist and took myself off.
For months I had trouble sleeping. I was jittery. I had brain zaps. My anxiety was pretty ramped up. I would feel numbness in my extremities – generally my arms. My psychiatrist told me these were just normal withdrawal symptoms, and they’d be gone in four to six weeks: “Anything you feel beyond that is your anxiety and depression returning.” Basically, if you still feel anything beyond this window that the medical community has established, it’s all in your head.
Eventually I went back to school full-time, and I remember doing OK, feeling somewhat better.
I’ve now been drug-free for four years. What’s lasted are the sexual side-effects. They were definitely worse in withdrawal than they had been on the drug, even though I didn’t really realise or understand it at the time, primarily because I started to take SSRIs at 12. While my brother took the same medicine over the same period and had a normal sexual life, I had a lack of sexual interest. I had erections, and I have regularly masturbated my entire life. But I don’t have much of an interest in interacting romantically or physically with the opposite sex.
I didn’t even start thinking about sex until a couple of years ago. It’s almost like I woke up one day and thought, “OK!” I started getting these windows – days or weeks – when normal sexual feelings would appear. But they’re new to me and I don’t know what to do about them. And because I don’t know what to do, I get anxious, and the anxiety kills any feeling – and then I’m anxious because I’ve lost all my feeling.
Online, I’ve come across a big asexual community. Some also took antidepressants; I think there are a lot of people like me out there. I’d like to think that if I keep going to counselling and sleeping and eating properly, I can rectify these things.
In the end, it’s about pros and cons. If you’re lying in bed and can’t get up, is it better to function? If it was up to me, I’d say that, barring extreme circumstances, nobody under 18 should be prescribed these things. Your brain develops around them. Drug companies should be thinking of the long-term effect on people who can’t even consent.
‘If I missed a dose, I’d get shocks down the side of my body’:Chris, 43; has been taking Seroxat for 26 years
I was originally prescribed Seroxat for mild anxiety about my GCSEs. It was 1991, about the time GlaxoSmithKline released Seroxat. I was one of the first people to be given it.
I was prescribed 20mg, the basic dose, to start with. It helped me: I got through school, I went to uni, I went to work. But I had side-effects from the off: profuse sweating, low libido. I’m quite a placid person, but I became aggressive. I never suffered, in the beginning, with the suicidal thoughts that people talk about now, but what I did notice was that if I missed a dose – especially after eight years of taking it – I’d get shocks down the side of my body. I’d be nauseous, my limbs would become weak. I’d be in a constant state of confusion and was very impatient. I couldn’t communicate well with people. I said this to the doctor, and he said, “We’ll up the dose to 40mg.” That was 1998.
The 10 years after that weren’t too bad. I managed to work, as a sales rep, for 18-20 years. But by 2012, by which time I was up to 60mg, I had tried on numerous occasions to withdraw. I tried to go back to 20mg, but my words became slurry, so the doctor put me back up to 60mg.
By the time I was 38, even that wasn’t enough. I tried to take my life. The doctor wouldn’t prescribe a higher dose. I couldn’t do my job, I couldn’t concentrate, I couldn’t drive. A psychiatrist once said to me that coming off Seroxat is harder than quitting heroin. That really hit home.
I have now been unable to work for four years. I’m still seeing a psychiatrist. I’ve also been diagnosed with fibromyalgia: constant tiredness, aches in the neck, and in the lower back and lower limbs. I’m 43 and still live with my mum and dad.
I also have no libido. Since the age of 30, I have had no feelings in that regard whatsoever. I have had relationships, but they’ve all failed. I haven’t been in a relationship for 10 years, which is a long time to go without sex, but I just don’t get the urge.
I don’t really have emotions, to tell you the truth. The drug takes your emotions away. I’m sort of existing, not living.
And when the drugs do work…
‘I wanted to be able to feel good when good things were happening, bad when bad things were happening’
I suppose I was a depression snob. A purist. Why should I take antidepressants? Yes, there was something rubbish about crying all the time, not functioning, being unable to answer simple questions because of the fug in my head. But, hey, at least I was true to myself.
My depression went back to my late teens. I didn’t like to think of myself as depressive, because depressives were losers. And I didn’t think I fitted the bill: I was pretty funny and able, and I could get girlfriends. I guess most depressives don’t think they fit the bill.
It might have been genetic. My dad had paralysing depression, and so did his father. As a young boy, I’d spent three years off school with encephalitis – an inflammation of the brain that is often fatal. Survivors are often left with depression.
I remember as a teenager being on holiday in Greece with friends. The weather was gorgeous, and I thought, “Why can’t it piss down, because then at least I’d have a reason to feel this way?”
That is what I always craved – objectivity. To be able to feel good when good things were happening, to feel bad when bad things were happening. I hated the fact that my feelings rarely correlated to what was going on in my outer world.
In my 20s, I got by. I held down a good job, fell in love, had kids, made friends, had a pretty good life. But things came to a head when my best friend killed herself. I’d find myself weaving in between traffic wondering what the impact would be like. I took a period off work and gratefully accepted my Prozac prescription.
Things had changed since I first rejected them. Prozac looked cool (lovely green-and-white pills) and rock bands wrote great songs about it (even if REM’s Shiny Happy People was supposed to be dystopic). After telling people I was off work with depression, I ended up feeling like a priest at confessional. It turned out that virtually everybody I knew was a depressive and pilling their way out of it; now it was “our secret”.
Initially, Prozac made me feel sick. And then magically, after a couple of weeks, I felt lighter, as if something had been lifted. I could hear questions properly, answer logically, enjoy a sunny day.
My partner said I was transformed. Occasionally, I would try to come off the pills and felt rubbish again – not more rubbish than I had before, but the same. So I returned, and after a while, I thought, “What’s the point of even thinking about coming off the pills if they make life work for me?”
There are times now when I wonder if I weep and fret and withdraw too much, and whether I’m becoming immune to the Prozac. But on balance I think not, because life is still so much better than it was.
If Prozac was no longer working for me, would I stop taking it? Probably. Would I stop taking antidepressants full stop? I doubt it. I’d simply look for another super pill.
In July of 2010, Stewart Dolin, a partner at the mega law firm Reed Smith, jumped in front of a subway train in Chicago, killing himself. He was apparently suffering from akathisia caused by the so-called antidepressant drug paroxetine. The brand name for paroxetine is Paxil, but Stewart was given a generic version manufactured by Mylan.
Stewart’s widow, Wendy, sued GlaxoSmithKline (GSK), the manufacturer of Paxil, and Mylan, on the grounds that the paroxetine caused Stewart to commit suicide. The case came to trial on March 14th and ended on April 20th with a $3 million verdict for Wendy and their children. The trial itself was gripping, with excellent coverage by Bob Fiddamen:
Since Bob did such a great job, I am not going describe the trial except to say that it exposed GSK lies and the morally bankrupt conduct of GSK, its attorneys and expert witnesses. GSK knew Paxil caused adults to commit suicide and hid that from the Food and Drug Administration (FDA) and doctors. The trial transcripts can be found here and exhibits here.
This is one key to the case, because there is a legal principle shielding drug companies called the “Learned Intermediary Doctrine” which establishes that the doctor, with access to full information, recommended the prescription-only drug after carefully weighing the risks and benefits. The primary official way that doctors are told about the risks of a drug is through the FDA-approved “label.” The drug manufacturer can also issue what is called “Dear Doctor” letters alerting them to risks.
But if the drug manufacturer withholds information, then one can get over the Learned Intermediary hurdle. That is the crux of this case. The argument is that because the manufacturer did not tell the doctor about the substantial risk of suicide, the Learned Intermediary Doctrine does not apply. Ms. Dolin’s top-notch legal team from Baum Hedlund (well known for taking on drug companies, especially over antidepressants) and David Rappaport established that GSK did not inform the FDA or doctors that Paxil caused people to commit suicide, thus getting over the Learned Intermediary hurdle. In fact, GSK still denied it. Cases against drug companies for withholding important information are not unusual.
However, Wendy Dolin faced another really big problem, which was that Stewart took the generic version of Paxil, manufactured by Mylan. Wendy sued Mylan, but Mylan was prohibited from providing any information other than the approved FDA label. How can Mylan be liable for not telling doctors something that it is prohibited by law from telling them? For that reason, Mylan was held to not be liable and dismissed from the case. Wendy also sued GSK, but GSK argued, “Hey, we didn’t manufacture the drug Mr. Dolin took so we can’t be liable.” This is a classic Catch-22. The generic drug manufacturer isn’t liable because it was prohibited from giving any additional information and the original manufacturer isn’t liable because it didn’t sell the drug. And, indeed, the judge ruled that GSK could not be held for product liability since it wasn’t its pill that caused Stewart’s suicide.
This is where excellent lawyering came in. R Brent Wisner of Baum Hedlund and local counsel David Rappoport came up with what I think is a brilliant argument based on what is called common-law negligence. The elements needed to establish negligence in Illinois are:
Duty of care owed by the defendant to the plaintiff;
The judge held that GSK owed a duty to warn doctors (but not consumers) of the risks of which it knew, or should have known, satisfying the first requirement. This duty is not tied to the branded Paxil, manufactured by GSK, but is applicable to the generic versions as well. This allowed the case to go to the jury where the dishonesty of GSK was put on full view.
The jury was charged with determining whether GSK was negligent in failing to warn the doctors and then, if so, did that negligence cause Stewart to commit suicide. The judge instructed the jury as to what negligence and proximate cause mean, as follows:
“Negligence” as used in these instructions means the failure to do something which a reasonably careful person or corporation would do, or the doing of something which a reasonable careful person or corporation would not do under circumstances similar to those shown by the evidence. The law does not say how a reasonably careful person or corporation would act under those circumstances. That is for you to decide.
As used in these instructions, “proximate cause” means that cause in the natural or ordinary course of events produced the death of Stewart Dolin. It need not be the only cause, nor the nearest or last cause. It is sufficient if it combines with another cause resulting in Stewart Dolin’s death.
The entirety of the judge’s instructions to the jury can be found here.
Then, the jury indeed found GSK negligent in not informing doctors of the suicide risk and this negligence caused Stewart’s death. In order to get there, the jury had to believe Stewart’s doctor that he would not have prescribed the paroxetine if he had known about the risk, or would have monitored him.
Frankly, in the overall scheme of things, the $3 million verdict is not that large. Stewart was a successful partner in a big law firm, presumably making a lot of money. But Wendy Dolin’s lawsuit was never about the money. Bob Fiddaman published an interview with Wendy after the verdict that is quite worthwhile reading. I direct your attention to it especially for her description of the awful tactics of intimidation perpetrated by GSK’s lawyers. The other thing about Wendy’s interview that I would draw attention to is her description of the importance of the ruling on generics:
I knew from the moment this lawsuit was filed that GSK was always concerned that this was a generic drug. . . . It has been suggested that GSK wants to take this case to the Supreme Court because they are so afraid of what this guilty verdict means. As it stands, the legal ramifications for this verdict are so damaging for pharmaceutical companies that reaching the Supreme Court is very possible.
For sure, holding drug companies liable for failure to warn about risks with their drugs even after they have gone generic is a good thing. Actually, I think drug companies have an incentive to do this to depress generic sales in favor of new drugs that are still on patent and therefore subject to monopoly pricing. In fact, it has been a longstanding pattern that the real risks of drugs do not get revealed until they come off patent. This case, if sustained on appeal, gives even more incentive for the drug companies to diss their drugs after they come off patent.
We will have to see where this goes, but for sure it is a big victory for exposing the truth. Baum Hedlund and David Rappaport deserve kudos for taking this case and pursuing it so effectively.
As you inch closer to becoming the new head of the Food and Drug Administration, your list of challenges must be swelling. Here is one more item to add: Whether to insist on a stronger warning label for the antidepressant Paxil.
For the past decade, Paxil’s label has not carried any information indicating the drug poses a statistically significant risk of suicidal behavior for anyone over 25. Yet there is scientific evidence that such a risk is real (see table 16 on page 26). A jury in Chicago recently decided that that a label warning could have prevented the death of a 57-year-old man who killed himself while taking a generic version of Paxil.
For public health reasons, the FDA should pursue a warning.
“Even recognizing the limitations of the data (found in the relevant analysis), it’s hard to understand [why] the increased risk of suicidal behavior, or attempts, is not in the label,” said Dr. David Kessler, a former FDA commissioner and now a professor at the University of California, San Francisco, School of Medicine.
Here’s the backstory: Paxil is one of several antidepressants known as an SSRI, a group that includes Prozac and Zoloft. For many years, the drugs were mired in controversy over whether they increased the risk of suicidal behavior and thoughts. The FDA eventually ordered the companies to warn of such a risk for children and young adults.
But what about issuing a warning for adults older than 25? The opportunity was bungled.
Back in 2006, GlaxoSmithKline — which makes Paxil — actually offered to revise its label to indicate a risk existed for adults. But the FDA nixed that in favor of a class-wide warning, limited to children and young adults, for all SSRI drugs. This blunted the effect of the data Glaxo had submitted to the FDA — which showed that adults on Paxil faced a much higher risk than those on all but one other antidepressant.
Instead, the FDA suggested the company could submit a supplemental warning and schedule a meeting for review. This never happened because Glaxo did not follow up (see page 127). As a result, the Paxil labeling never included information about a risk to adults.
For its part, Glaxo does not deny that its studies showed an elevated risk for adults. But the company contends that it properly conveyed all the appropriate data to the FDA and says it was the agency’s call to create a common, class-wide label instead of developing a warning more specific to Paxil.
Now, let’s fast forward to a federal courtroom in Chicago, where documents detailing these developments have been filed.
A five-week trial recently took place over a legally complicated, but significant, question — whether consumers who suffer harm after taking a generic drug should be allowed to sue the company that makes the brand-name version of the medication. In this instance, the man who committed suicide took a generic version of Paxil, made by Mylan.
Glaxo was named in the lawsuit because Mylan had to use its label on the generic. Federal regulations do not allow generic companies to independently change labeling after learning of potential risks, unless a change has already been made to the corresponding brand-name drug. That regulation was upheld in 2011 by the Supreme Court.
As a result, consumers sometimes seek to hold brand-name drug makers responsible for injuries they suffer while taking generics, although more than 100 such cases have been tossed out by courts around the country. Only two survived and one is being appealed. This time, Glaxo was the loser and was ordered to pay $3 million to the man’s widow.
The company, however, plans to appeal, which raises the possibility that not much, if anything, will change. Meanwhile, countless adult Americans will continue to be prescribed a generic version of Paxil that does not contain a warning about the risk of suicidal behavior.
But this should not be the end of the story.
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Most consumers may not realize this, but drug makers legally own the right to the labeling on their medicines. Yes, the wording is developed during talks with the FDA, but a company can certainly consider adding an additional warning.
Glaxo “had the option to go further, but chose not to do so,” said Dr. David Healy, a Bangor University psychiatry professor who helped spearhead a campaign to upgrade suicide warnings on antidepressants, and who served as an expert witness on behalf of the widow in the recent trial.
Perhaps Glaxo bet it would not face lawsuits from consumers who took the generic. Nonetheless, the possibility of harm has existed all this time. And that is something the FDA should have realized. (An FDA spokeswoman told me the agency would not comment.)
So, Dr. Gottlieb, as you look over your to-do list, consider the lack of information in the Paxil labeling. And move to fix it. You might save a life.
Editorial: This series of posts on Stewart Dolin’s death interrupts a series on how to bring about change . This is not inappropriate as law suits are one of the few ways to bring about change. This post in the series is by a Chicagoan – Johanna Ryan who has been tracking the case since it was filed first.
How a Chicago jury got it right
On April 20, a federal jury in Chicago awarded $3 million to the widow of a man who threw himself in front of a downtown subway train seven years ago. Stewart Dolin’s suicide, they concluded, was not the result of depression, anxiety or the stresses of his job as a corporate lawyer. Rather, it was his medication that had led to his death: a generic version of paroxetine or Paxil, the blockbuster antidepressant made by GlaxoSmithKline (GSK).
Paxil is one of a class of antidepressant drugs known as selective serotonin reuptake inhibitors or SSRI’s. These have become some of the most commonly prescribed drugs in America and worldwide, offered to treat a wide range of emotional ills from grief to social anxiety. But while many people find them helpful, they have long been known to make some patients irritable and anxious.
In extreme cases, this can advance to a state known as akathisia – an intense emotional turmoil and physical restlessness that can be so unbearable as to trigger suicide in those who suffer from it. That’s what Wendy Dolin, Stewart’s wife, insisted had happened to her husband. After listening to the evidence for six weeks, the jury agreed.
They also agreed that GSK had known all about the risks of akathisia and suicide posed by Paxil, but had failed to warn prescribers. As Dolin lawyer Michael Baum put it: “GSK has known for two decades that Paxil can cause people of all ages to commit suicide … GSK not only hid the risk, but stuck its head in the sand and ignored countless suicides that occurred in its clinical trials.”
Generic drugs and the Catch-22
Wendy Dolin’s victory also challenges an enormous Catch-22 in the current state of the law. A 2011 decision of the U.S. Supreme Court had barred consumers from suing the manufacturer of any generic drug for failure to warn of its hazards. That’s because by law, the generic pill must not only contain the same ingredients as the brand-name version – it must also carry the same warning label issued by the drug’s original brand-name developer. Yet because they do not produce the generic tablets, GSK and other drug companies have insisted they can’t be liable for any harm done on account of a false or misleading label.
However, in 2014 the Chicago court ruled that this would leave patients without any legal protection, and allowed Wendy Dolin to pursue a case against GSK. The entire pharmaceutical industry will be keenly interested in GSK’s appeal.
What happened to Stu Dolin?
At 57, Stu Dolin had been a corporate lawyer for over thirty years. He was a senior partner in the multinational firm of Reed Smith, earning about a million a year. He and Wendy had been together since their senior year in high school and were still inseparable; their two adult children were both doing well and close to their father. Stu Dolin worked hard but also loved travel, sports and hanging out with his family and a circle of close friends. He seemed anything but depressed.
At 57, Dolin was also not supposed to be at risk for problems related to Paxil. In 2004, the FDA had imposed a Black Box warning label on Paxil and other SSRI’s, alerting doctors to a risk of suicide in children and teens. The warning was later applied to all antidepressants and extended to patients up to age 24. However, based on the evidence submitted by GSK and other drug manufacturers, no warning was issued for adults.
In the summer of 2010 Stu Dolin began seeing a counselor for anxiety linked to job stress. He had sought help for similar problems once or twice before. Two years into the Great Recession, there was plenty of stress to go around in Chicago’s financial district. However, a fellow Reed Smith partner and longtime friend testified that Dolin’s anxiety was nothing all that out of the ordinary. His counselor worked with him on relaxation and problem-solving techniques; she did not see him as a man at risk of suicide.
His family doctor, another old friend, prescribed Paxil. Dr. Sachmann didn’t think Stu needed to see a psychiatrist; it was a garden-variety case of stress. However, within two days of beginning the Paxil, those who knew Stu Dolin saw unsettling changes. His moods swung from happy and confident one moment, to agitated or weepy the next. His wife Wendy recalled that he didn’t seem like himself. For the first time, he asked his counselor for an emergency session; she was concerned enough to call him the next morning and urge him to ask Dr. Sachmann for some tranquilizers to calm him down. That same day, after a business lunch, he walked down to the Blue Line subway station where a fellow passenger noticed him pacing back and forth in an agitated manner. When the train arrived, he threw himself in front of it.
The Dolin jury and the March for Science
If Paxil really posed that kind of danger, argued GSK attorney Andrew Bayman, why hadn’t anyone spoken out? His implication was clear: This was an established drug, a staple of modern medicine. Surely it must have been vetted by reputable scientific experts. If the jury couldn’t see that, perhaps they were just blind to the science.
Two days after the verdict, on Earth Day, 40,000 people rallied in downtown Chicago against what they saw as attacks on science itself by the new team in Washington: dismissing global warming as a Chinese hoax, blaming autism on the measles-mumps-rubella vaccine, and taking aim at public science budgets from the EPA to the National Institutes of Health. Clearly, nothing might garner more sympathy for GSK than to paint itself as another victim of “anti-science hysteria.”
More than a few Americans, long urged to blame the nation’s woes on other people’s frivolous lawsuits, might buy that claim. “Sorry for the woman’s loss but this is truly an example of when juries go bad,” commented one Chicago Tribune reader. “We all suffer with giant health premiums and drug costs because of ignorant juries and greedy lawyers,” another wrote. “Wonder why he was so depressed?”
They might be surprised to learn that the jury’s verdict was based less on the speeches of hyperventilating trial lawyers than on a six-week immersion in the science of clinical trials, antidepressants, statistical significance and drug regulation. If anything, the jurors’ efforts could have earned them a place on the podium at the March for Science.
They heard Dr. David Ross, a former senior regulatory scientist with the Food and Drug Administration (FDA) testify that “GSK was not upfront” with FDA reviewers about Paxil’s suicide risks. Dr. Ross explained that the FDA does not test new drugs on its own, but relies on studies conducted by the companies themselves: “We only know what we are shown.” GSK’s analysis of its own clinical trials pointed to 8.9 times the rate of suicidal behavior in depressed patients on Paxil compared to those taking a placebo. However, Dr. Ross testified, the company had misrepresented the results so that the increased odds of suicidal acts on Paxil appeared to be just 1.8, which reassured FDA that the difference was not significant.
They heard Dr. David Healy, an expert on the SSRI class of drugs from the UK, explain that psychiatry had known for fifty years that antidepressants could cause agitation and suicide in some patients. SSRI’s carried higher risks than older drugs, with violent suicidal acts being noticeably more frequent. Based on his own experience conducting clinical trials, Healy showed jurors the methods GSK had used to conceal the suicide risk – in particular, inflating the number of suicides and suicide attempts in trial subjects taking placebos, which made Paxil look safer by comparison than it actually was. He also explained how clearly suicidal behavior could be coded under misleading terms such as “emotional lability.”
They heard Dr. Joseph Glenmullen, a clinical psychiatry professor at Harvard Medical School who reviewed Dolin’s treatment records, testify that his original anxiety symptoms were quite different from the drug-induced akathisia he had shown in the days before his suicide. Glenmullen testified that he was 100% certain that Paxil, not job stress, had caused Dolin’s suicide – but the drug’s labeling would have led his doctor to believe that this could not occur in a middle-aged man.
GSK’s own experts may have sealed its fate
Certainly GSK was not cheated of its own opportunity to bring on the science. Yet time and again its own employees and retained experts were forced to concede the Dolin team’s main points. Dr. Anthony Rothschild, a purported expert in “psychological autopsies,” was unable to convince jurors that Stu Dolin’s suicide was due to his underlying mental illness. He did, however, inform them that he had testified for GSK in about 20-30 prior Paxil death cases – he had lost count of the exact number.
Dr. John Kraus, a senior GSK scientist, and Dr. Geoffrey Dunbar, its former CEO, both admitted that the company’s misclassifying of “placebo suicides” had made its Paxil safety data misleading. Yet both men had published the data in medical journals which had never been corrected, along with submitting it to the FDA. Finally, faced with the twenty known and two possible suicides on Paxil during clinical trials, Dr. Kraus reluctantly conceded that 80% of the victims were over thirty. Whatever they had told the FDA, the risks of Paxil could not be confined to adolescents – and GSK knew it.
What happened to Stu Dolin, attorney David Rapaport told the jury, could have happened to anyone. The tragedy was that it could have been prevented, if Dolin and his doctor had been told of the potential risks. After six weeks of testimony, the jury was convinced: The science should have mandated a warning.
Where will Wendy Dolin’s victory lead?
Four years ago the Dolin family founded MISS-D: the Medication-Induced Suicide Foundation in Memory of Stewart Dolin. They plan to step up the great educational work they’ve already begun to make sure that other families don’t suffer the same fate. “None of us here are anti-drug. That’s not the issue,” she told the press. “But we are patient advocates and we hope that people will start asking better questions.”
For David Healy, the time has come for the FDA and other regulators to consider changing that label to extend the suicide warning to adults. “If it’s that clear to the average man on the street, and the FDA doesn’t do something about it, we have an odd situation.” Considering that as many as one in five American adults may take these drugs, “odd” is putting it mildly.
Reading through Bob Fiddaman’s latest post (an interview with Wendy Dolin)- I can’t help but be struck by Wendy’s admirable bravery and courage in the face of a continual onslaught of attempted character assassinations and intimidation towards her by GlaxoSmithKline.
To say that GSK (and the money hungry, blood thirsty lawyers, academics and doctors on their payroll) are abhorrent, reprehensible and sociopathic, would be putting it very mildly.
In my opinion, GSK behave in an utterly evil manner.
They hid the side effects of Paxil (Seroxat) through manipulation of their clinical trials and data. They failed to warn properly of the dangers of Paxil induced Akathisia and suicide. They were found responsible (and liable) for Stewart Dolin’s death in a US court of law. Furthermore, despite GSK’s lawyers relentless attempts to undermine Wendy (plus her family and friends), and the attacks on Stewart’s memory, she maintained her dignity and resolve.
Her moral and ethical strength is remarkable.
GSK could learn a lot about humanity from Wendy Dolin.
Read Bob’s latest post (below) for a poignant and moving interview with Wendy.
Wendy Dolin’s name has been cemented in history, as has that of her late husband, Stewart Dolin.
Her victory against pharmaceutical giant, GlaxoSmithKline, was never simply about Paxil causing the death of an adult. Many people in my circles already knew Paxil can and does cause akathisia and death among people of all ages. But GlaxoSmithKline and its paid experts have played down this truth for many years. Other pharmaceutical companies that manufacture SSRIs, (Pfizer-Zoloft, Eli Lilly-Prozac, etc.) have also actively concealed that akathisia is a serious adverse side effect of their products.
Wendy’s husband needlessly died as a result of GlaxoSmithKline failing to warn about akathisia. Furthermore, GSK failed to warn that akathisia can lead to suicide.
I started writing about Wendy’s case two years ago. I never knew back then the impact it would have on me as a writer, a consumer, and a human. It was inevitable that our paths would cross. Most of the stories on my blog feature real people harmed by drugs the pharmaceutical companies call “antidepressants.” These people are not fictional characters; their loved ones are not simply statistics. All are real people who, as a result of corporate greed and deceit, lost a family member. I have personally met the majority of the families featured on my blogs, families who, through no fault of their own, have been left devastated by unimaginable, avoidable deaths. These courageous family members are left to pick up the pieces of a life obliterated by the pharmaceutical industry and its incestuous relationships with medicine regulators, such as the FDA and MHRA.
My own personal belief is that pharmaceutical CEO’s and executives should be imprisoned for withholding important safety information from consumers, particularly when withholding such critical information leads to suffering and/or death. This was surely the case in Dolin Vs GlaxoSmithKline. I also believe experts called to defend products in pharmaceutical litigation should be imprisoned if the evidence they produce at trial is shown to be false and if it is deemed perjury. One only has to look through the court transcripts in this case to see several statements by experts that were simply untrue.
Wendy, her family and close circle of friends, have remained dignified throughout the trial and pre-trial. On the other hand, the tactics of GlaxoSmithKline’s hired attorneys, King & Spalding, has been nothing short of repugnant. If their pre-trial tactics were legal, then the legal system needs a complete overhaul. Wendy’s interview today shares some of the shenanigans GSK pulled years ago before the trial began.
I have a particular disdain for King & Spalding, probably more so than GlaxoSmithKline. That disdain has been strengthened after interviewing Wendy and, of course, after being present during the first two weeks of this trial.
I think it’s safe to assume King & Spalding don’t like me either. I can live with that safe in the knowledge that I am, in essence, trying to do part of a job coroners should be doing. I try to give the dead voice. King & Spalding, it appears, not only try to stifle the voices of the living, but they also try to suppress and manipulate the voices of the dead.
I’m really proud of Wendy and her children, just as I am of others who take on the mighty pharmaceutical industry, be it through lawsuits, blogging or other advocacy work. It’s a dark, seedy world. I should know, I’ve been writing and researching about Big Pharma for more than ten years.
~ Bob Fiddaman
Here’s my interview with Wendy Dolin.
Congratulations on last week’s successful trial against GSK. You worked tenaciously since filing the case in 2014. I imagine today’s feelings of victory are bittersweet for you and your family. Many people are unaware how traumatic the pre-trial process can be when challenging pharmaceutical companies and their attorneys. Can you share your experiences?
I knew when I filed this lawsuit, it was going to be a very difficult process. But I was unprepared for the sheer number of depositions and subpoenas GSK demanded. I was told this was a record number of requests. I understood the need for certain information, but it became very clear early on that GSK’s goal was to send a powerful message to me: That is, when you have the audacity to challenge GSK, all attempts will be made to harass everyone you care dearly about. GSK also repeatedly tried to humiliate me. For example, depositions that should have been a few hours became eight hours in an attempt to wear people down. GSK asked the same question over and over and over again hoping to manipulate, confuse and take people’s comments out of context.
Some of the irrelevant but personal questions GSK asked me included, “How many times do you go to temple? Are you dating anyone? Who are my partners at work?” They even requested Stewart’s high school transcripts. All were totally irrelevant and useless questions posed by attorneys from King and Spalding and Dentons. They were calling my friends, not identifying themselves and trying to get people to somehow say terrible things about my relationship with Stewart. There was nothing to say, of course, and GSK’s attorneys just embarrassed themselves. It became a joke amongst my friends as to who would be called next and who did GSK think they were dealing with that they thought their sweet talking female attorney was somehow going to get information?
All of these questions were offensive, but what is truly the most offensive and egregious act was showing my children Stewart’s therapy notes during depositions. As a therapist, as a mother and a compassionate human being, I am aware there was no purpose to have done such. I have talked to therapists, physicians and pharmaceutical lawyers and all agree there was nothing gained by this other than to show me that GSK would stop at nothing to intimidate me.
So, let me get this straight, attorneys for GSK telephoned your friends to try and dig up dirt on you? What sort of questions were they asking your circle of friends?
The good news regarding the phone calls is that most of my friends very shortly into the conversations realized something wasn’t quite right, and therefore they shortly ended the conversations. They asked “Do you know Wendy and Stewart Dolin?” or “What can you tell us about Wendy and Stewart Dolin’s relationship?” Most people said, “Whose side are you on?” To which, GSK attorneys replied, “You could be getting a subpoena, and that is not a very pleasant experience, so maybe you would like to tell us now what you know before the subpoenas arrived.” Several of the people GSK attorneys contacted were never, ever going to receive subpoenas but as part of my deposition, GSK wanted to know who were our closest friends and who were we with the weekend before Stewart died. What also was interesting is that GSK attorneys called my friends on their cellphones rather than their landlines. I never gave out any numbers. I don’t know for sure, but I think perhaps GSK’s attorneys naively thought they would somehow catch my friends off guard and get more info.
Thank you. The word akathisa is relatively unknown to many. Can you tell me when you first heard the word and how it related to Stewart’s death?
After Stewart, died nothing made sense. On Friday, August 13th a friend called me and said, “akathisia killed Stewart.” And of course, I replied, “What?” She suspected early on that she thought Stewart’s death was related to Paxil since that was the only thing that was different in his life that week. When I first heard the word, akathisia, I was walking my dog at the time. When I got home and wrote the word down, I decided to google “akathisia, Paxil, and suicide.” All of a sudden this wealth of information appeared. One of the first articles that appeared was one by Dr. Peter Breggin titled “How GlaxoSmithKline Suppressed Data on Paxil-Induced Akathisia: Implications for Suicidality and Violence.” Then another article showed a connection between SSRIs and suicide and violence and included a definition of akathisia. It listed characteristics of akathisia. For the first time, what didn’t make sense now became perfectly clear. Stewart’s physical inner and outer restlessness, agitation and anxiety that I observed his last week of life now made sense. It was in this article that I first had the revelation that the drug I thought Stewart was ingesting to deal with his work related stress and anxiety instead created suicidal thoughts and actions, both of which he did not have previously.
The article went on to state that Akathisia is so terrible, “Death Can Be A Welcome Result.” This is an actual quote by Dr. Roger Lane, the chief medical officer for Pfizer. Pfizer makes Zoloft, which like Paxil, is also a SSRI. It was at that moment I knew I needed to do something to help protect others and improve public health. How can this devastating drug side effect not be unknown to most health care professionals or patients?
After learning about akathisia, did you research attorneys who might help you seek justice?
I was told that Baum Hedlund was the best law firm in the country regarding pharmaceutical litigation. I was told very early on by Baum Hedlund that the generic issue would be a large hurdle.
Moving on to MISSD. Can you tell me what MISSD is all about and why it was important to create this organisation?
When Stewart died, I wanted to start an organization to raise awareness regarding akathisia. It is incredible how the organization name came to me. So many people were saying to me how awful it is when someone dies so young and how much they will miss their loved one. I kept hearing the name “miss.” That’s how the name MISSD came to me. It stands for The Medication Induced Suicide Prevention and Education Foundation in Memory of Stewart Dolin.
After choosing the name, I gathered together close friends and family and was privileged to have the incredible Kim Witzcak as a board advisor. I have the best and most dedicated board. Since akathisia is what killed Stewart and very few people had ever heard of it, including health care providers, we decided our mission would be to educate the public regarding akathisia. The mission of MISSD is simple: To educate the public that when starting, stopping or changing a dosage of a medication like SSRI’s, the drug side effect akathisia can occur. MISSD highlights the symptoms of akathisia and what to do if you are experiencing akathisia. We are a non-profit organization and take no money from pharmaceutical companies. This is important to note because many nonprofits do take money from the pharmaceutical companies and I believe this can create an unethical relationship.
MISSD presents at local, national and international conferences. We have created a booth and have exhibited in conference halls at too numerous to count. Last year our organization created an animated video about akathisia which has received almost 15,000 hits. In addition to the educational booth, pamphlets have been produced in English and Spanish that communicate the warning signs of akathisia, and we also have power point presentations. Two months ago my incredible board members and I presented at Loyola University Graduate School of Social Work.
MISSD is obviously near and dear to my heart. MISSD has saved lives and provided comfort to many people who have experienced such terrible loss. We have a “Share” link on our MISSD website, and I keep seeing similar stories posted over and over again. They always start out “My loved one was fine, and then, gone, out of the blue, with no explanation.” In the middle of the trial, a woman texted me stating her husband ended his life after starting Paxil. I believe he was prescribed Paxil not for depression, but in an attempt to deal with side effects from chemotherapy. As I keep hearing these real stories, it makes me more determined to spread the word of MISSD.
We are particularly interested in working with military groups given that the military suicide rate is at a record high. MISSD believes there is a correlation between the number of drug cocktails our veterans are prescribed and the increases in suicide and suicidality. In March, MISSD helped sponsor an event called “K9’s for Veterans” where I talked to more than 400 military vets and their family and friends regarding akathisia. After I had spoken, so many people came up to me and said thank you. They said, “that happened to me” or “It happened to someone I know.” MISSD is important to my board and me because it is helping prevent needless deaths. We are all so proud and thankful for our supporters who have helped us make a positive impact. I believe MISSD is the first organization in the world to raise awareness about akathisia. We are a safe patient advocacy group. When we all realized Stewart’s death could have been prevented, MISSD was our way to take action. Our knowledge of akathisia became a defining moment in all of our lives. We had to share this side effect so that the public can be better informed than we were. What sort of response have you had from the launch of MISSD, have you come across any opposition from regulators or pharmaceutical companies? No opposition from any regulators. At one point in my lawsuit, GSK wanted information on my board members, donators and GSK attorneys (either Andy Bayman or Todd Davis) presented print outs from our MISSD website. They wanted MISSD to be explored. Judge Zagel promptly stated MISSD was out of the lawsuit. The fact that GSK was worried about MISSD was gratifying because it confirmed we were shedding light on a subject they preferred to keep hidden.
The recently released MISSD video surely helps spotlight akathisia. What has been the overall response from the video?
Fantastic. We realized that if we were going to present to schools, hospitals, etc., we needed a powerful educational tool. We wanted a tool that was simple, short, and to the point. The video is creative and state of the art. Wherever we show the video, it is always very well received. It has been incredibly gratifying how well we have been received by the public. I think this is due in part because MISSD is not anti-drug, it is simply dedicated to raising awareness of akathsia and saving lives. Our mission resonates with so many people. Everything MISSD does is done very professionally, and we are viewed as a very important safe patient organization. Our initial fundraiser was primarily attended by friends, family members and associates of our board members. This is no longer the case. Today MISSD events are well attended, and I meet many new people for the first time at every event. They explain that they first found MISSD online as an important resource after their loved one died from prescription drug-induced akathisia. The families of akathisia victims who attend MISSD events come from all backgrounds and all parts of the country. We usually have more than 300 people at each event.
You’ve had many people visit Chicago from across the world, some of them also have tragic stories regarding the loss of loved ones due to prescription drug-induced akathisia. When did you realise the extent of this problem?
When Kim Witczak presented the Selling Sickness conference in Washington, D.C. in 2013, I met many people, such as Mathy Downing and Sara Bostock, who lost loved ones to akathisia. This was important as I started to realize I was certainly not alone.
Later when I spoke in Copenhagen with Kim and Mathy and met Steffini Lynch and Leonie Donnelly, it further emphasized this was a universal problem. Recently as the MISSD presence has expanded, I realize that through our website many people have come to Chicago to MISSD events and found comfort and support from the mission of MISSD.
The jury unanimously agreed that GlaxoSmithKline is liable for not updating the Paxil label regarding the increased suicide risk created when adults take Paxil. In essence, the jury stated they believe, after hearing all the evidence presented by both sides, that Paxil caused Stewart’s suffering and death. Furthermore, the jury believes GlaxoSmithKline knew about these potential risks yet failed to warn consumers. During the trial it came to light that 22 patients died in Paxil clinical trials, 20 of these died by suicide, and the other two deaths are suspected to be suicides. All 22 victims were taking Paxil at the time, and 80% of these patients were over the age of 30. GSK likes to argue that it was an “illness” that caused these deaths and not Paxil. What would you say to the surviving family members of these clinical trial victims if you had a chance to meet them?
That is a great question because it brings up so many issues. GSK talks at length about underlying illness. Yes, there are people that kill themselves because they have had a lifelong history of mental health issues. They struggle and medications have been life-saving in many situations. However, when you talk to love ones of people who died from akathisia you hear from many of them that the drugs were prescribed for issues such as insomnia, test anxiety, or situational stress. The drug companies seem to want to pathologize what it means just to be human.
During the trial, my sister sat through opening arguments and texted me, “I don’t know who they are talking about.” GSK tried to create a view of Stewart that quite frankly didn’t exist. But specifically, regarding prescription drug-induced suicides, I would tell the surviving family members to realize the death was not the fault of their loved one. People sometimes say that when someone ends their life, it was their choice. I am not sure that that is a correct statement either. But death by akathisia is not a choice. It is not a suicide. It is a fatal drug reaction.
Additionally, I would tell surviving family members to get involved. There is a favorite quote of mine from the anthropologist Margaret Mead, “Never doubt that a small group of thoughtful, committed citizens can change the world; indeed, it’s the only thing that ever has.” Talk to others, spread the word regarding akathisia, contact government agencies. As we learned from this lawsuit, GSK blamed the FDA; We need to be proactive and contact our regulatory agencies to say inadequate warnings are just not acceptable. What this lawsuit has shown is that akathisia is a real, legitimate adverse drug reaction. The public needs to be aware of akathisia signs and symptoms.
Do you have any advice for consumers who are considering pharmaceutical industry litigation?
I think the person has to be aware that this process is emotionally and physically difficult. In addition to having the necessary courage and conviction, it is imperative to have top lawyers. My lawyers from Baum Hedlund and David Rapoport were incredible. They are professional and highly knowledgable. But they are also amazing human beings who understand the injustice that was done to Stewart. Our work together felt less like a lawsuit and more like a personal journey and commitment shared by all of us.
We know Glaxo is appealing the verdict. This means the funds the jury award for Stewart’s avoidable death and suffering will be held until the appeal process is finished. There have been a few online comments left on media articles in which a few posters have suggested this trial is just about money. How do you respond to people who suggest such?
I always want to respect people’s divergent opinions, and I can understand from the outside looking in one interpretation of the lawsuit might be that is about money. However, this notion is furthest from the truth. I would hope these individuals actually understood what critical information was highlighted in this trial because this information affects their lives as well as Stewart’s. I hope people would educate themselves regarding drug safety, drug studies, the role of the FDA, generics, etc. The vast majority of people have had very, very positive reactions to the verdict. There will always be people who disagree, and that is their prerogative.
I knew from the moment this lawsuit was filed that GSK was always concerned that this was a generic drug. I was told before we even went to trial, that, if GSK lost, they would appeal. In fact, I believe there was a lawyer in the courtroom for GSK that was there for the sole purpose of gathering information to start the appeal process. Appeals take several years and, of course, I could lose on appeal. It has been suggested that GSK wants to take this case to the Supreme Court because they are so afraid of what this guilty verdict means. As it stands, the legal ramifications for this verdict are so damaging for pharmaceutical companies that reaching the Supreme Court is very possible. That could take 5-7 years.
Clearly this case has never been about money. For me, it has always been about awareness, highlighting akathisia and ultimately changing the black box warning to include all ages. If those individuals who think this case is about money actually read the entire articles, they would learn about MISSD and all the work I do to increase akathisia awareness. While I am eternally grateful to the generosity of our supporters, I have also used my own resources to help educate the public about akathisia. I do this in honor of Stewart and to help others avoid similar tragedy.
Thank you, Wendy. Please, if there is anything you want to say to the readers of my blog, feel free to do so.
I am so grateful to the overwhelming support of many people from all over the world. A special thanks to you, Bob, for all you have done over the past years to raise awareness of drug side effects, specifically akathisia, and my lawsuit. You have devoted so much of your time and resources to this case, and I am eternally honored by your efforts. You are remarkable. Thank you so much.