Lyam David-Kilker was born on 24 October 2005, the second son of Michelle David and Miles Kilker of Bensalem, Pennsylvania. At birth he seemed like a normal, happy, healthy infant, but all that soon changed. His breathing was labored, and he became lethargic and lost his appetite. His parents took him to the doctors, who delivered devastating news. Lyam was born with multiple cardiac defects: a hole in his atrial septum, a hole in his ventricular septum, along with transposition of the great arteries—the same condition which afflicted Christiane and Amery’s son Daniel. Lyam required two open-heart surgeries and spent the first six months of his life in the hospital.
Shortly before conceiving, Michelle David had been prescribed Paxil for mild anxiety and occasional panic attacks, and she continued to take the drug throughout her pregnancy. After Miles Kilker heard a commercial message on television for the law firm linking Paxil to congenital heart defects, Michelle called the number and was referred to Sean Tracey, a personal injury lawyer from Houston.
During the trial, the plaintiff’s lawyers cited a couple of 2001 emails to GlaxoSmithKline from a woman (not Michelle David) who had taken Paxil while pregnant. The woman’s name was redacted from all court documents. The first email from her, dated 31 May, read:
“My name is [redacted]. I was diagnosed with panic disorder about four-and-a-half years ago. Since that time I’ve been taking Paxil, which is truly a miracle drug. I’ve been panic-free with this drug and have been able to go on with a normal life.
“I was married in October of 2000.My husband and I found out we were pregnant at Christmas time. I was so excited. I love children. The only problem is that I carried the baby to six months gestation and then had to have a termination.
“The doctors diagnosed my son with Truncus arteriosis. They said he would not lead a normal childhood and would most likely not make it through the open heart surgery that he would need as soon as he was delivered (if he was able to make it to that time). To say the least, I was absolutely distraught with this news.I thought this was something that I did, was because I stayed on the Paxil for selfish reasons.
“I wanted to know if you could direct me to any information you might have of any woman that has taken Paxil and still had healthy babies. My husband and I are ready to try again to get pregnant in the next month or two. I am so nervous. I don’t want to stop taking my miracle pill. But, then again, if there is a chance that this might hurt or affect the baby I want to know upfront. And I will somehow stop taking it for the time being.
“Please contact me as soon as possible. I love everything this drug has done for me. I am so thankful that your company had this available for me.I just want to continue to have a normal life and have the child that I always wanted. Please contact me as soon as possible.
“Please don’t forget about me,Thank you.”
“Thank you for your inquiry. We are attaching a copy of our current product information for Paxil. Please review the section on use during pregnancy. Further questions about your treatment should be directed to the physician, pharmacist or healthcare provider who has the most complete information about your medical condition. Because patient care is individualized, we encourage patients to direct questions about their medical condition and treatment to their physician. We believe that because your physician knows your medical history, he or she is best suited to answer your questions.
“Our drug information department is available to answer any questions your physician or pharmacist may have about our products. Your healthcare professional can call our drug information department at 1-888…”.
Congenital malformations associated with this drug
At that time, the prescribing information for Paxil made no mention of the number of reports of congenital malformations associated with this drug, and it was company policy not to tell doctors, patients, or pharmacists, either.
On 1 June, the mystery woman wrote again:
“This response is in regards to an e-mail that I had sent you previously. I was asking to see if you have any or are in the process of any clinical trials for women who are currently on Paxil and pregnant. I wanted to find out information to see how many women were on Paxil during pregnancy and if they were able to successfully have healthy babies.
“I am in no way insinuating your product did this to my child. I love the product, and I don’t think I could have gotten through my panic attacks without the wonderful help of this miracle drug. I just want to start to try and get pregnant again soon. I do not want to put my unborn child through anything that would hurt him/her.
“Please, if you do not have this information, where is this information held? Does anyone do studies like this?Please, any information you may give me would be great.Thanks again for your help.”
GSK responded to the mystery woman’s query by certified mail, asking her to sign a form authorizing the release of her medical records to GSK. The letter never reached her—it was returned as “undeliverable” by the US Postal Service. GSK apparently made no further efforts to communicate with her, although they did send a Medwatch report to the FDA, stating that “mother’s concurrent medications and medical conditions were not specified.” An internal GSK document, dated 13 June 2001, stated the link between Paxil and the cardiac defects suffered by the mystery woman’s unborn fetus was “almost certain.”
Lawyers for GSK argued that somebody must have checked the “almost certain” box by mistake. The jury didn’t buy it, and on 29 October 2009 awarded $2.5 million to Lyam Kilker.
Lyam survived, but hardly unscathed. For the rest of his life he will suffer from high blood pressure and diminished energy, and he will need repeat surgeries to replace the grafts covering the holes in his heart.
On 2 July 2012, the United States Department of Justice announced that GlaxoSmithKline had agreed to pay $3 billion to settle claims of illegal marketing of its products, including Paxil—the largest such payout in history. The same day the settlement was announced, the value of GSK shares rose 1.3%.
David Healy is a Professor of Psychiatry at Bangor University and the author of Pharmageddon, and he also testified as an exert witness at the Kilker trial. In a telephone interview he blasted SmithKline Beecham for not following up on early indications that paroxetine could cause birth defects. “They didn’t do what they ought to have done, do the kind of studies that they ought to have done.” He likened their attitude to that of tobacco company executives confronted with evidence of the harm their product could cause: “Let’s not look too closely at this.”
The mystery woman was later identified as Joanne Thomas, and she subsequently filed a wrongful death suit against GSK. On 27 November 2013, the Common Pleas Court of Philadelphia ruled against her on the grounds that the developing fetus (whom she called Ryan) had not reached the age of viability when the pregnancy was terminated. The certificate of fetal death listed Ryan’s gestational age as 21 ¬Ω weeks, whereas 3 days before the pregnancy was terminated, a cardiologist estimated Ryan’s age at 22 weeks. According to Pennsylvania law, a fetus is not considered “viable” until the age of 23 weeks.
Next: Part 4: “Patient safety is our highest concern”
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.
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.
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.
A Key Largo man who prosecutors say severely beat his wife with the stock of a shotgun in 2015 and then engaged in a rolling gun battle with police — wounding one officer — changed his not-guilty plea to insanity due to what he says is withdrawal from the anti-anxiety medication Paxil.
And his wife has gone from a witness for the prosecution to a defense witness.
Honour Schminky, wife of Robert Schminky — charged with four counts of attempted first-degree murder, two counts of battery on law enforcement officers and a misdemeanor of discharging a gun in public — declined to comment when asked outside the Plantation Key courthouse about the case Tuesday morning. A trial has tentatively been scheduled for July.
Robert Schminky’s attorney, Hal Schuhmacher, filed the change of plea on Friday in Monroe County Circuit Court. Chief Assistant State Attorney Mark Wilson said Tuesday that his office will hire its own psychiatrist to evaluate Schminky.
“Insanity is an all-or-nothing proposition,” Wilson said.
Palm Beach psychiatrist Dr. Stefan Rose is expected to testify that Schminky, 59, suffered from amnesia on Jan. 21, 2015, “due to Paxil discontinuation syndrome” when he beat his wife with the shotgun so savagely that it broke several of her ribs and the gun’s stock. Schminky fired the weapon into the ground twice as Monroe County Sheriff’s Office deputies responded to the couple’s Buttonwood Drive home shortly before midnight.
According to court documents, Schminky then sped off in his Lexus SUV. Deputies chased as Schminky led them north up County Road 905 while firing pistol rounds at them. He then turned around and pulled into the Circle K gas station parking lot that splits County Road 905 from the 18-Mile Stretch of U.S. 1 — the two roads that lead in and out of the Keys.
Two Sheriff’s Office cruisers and a Florida Highway Patrol car driven by Cpl. Christine Gracey corralled Schminky’s vehicle. Schminky rammed Gracey’s car and the two vehicles became temporarily locked together. Rather than give up, police say Schminky opened fire, shooting a total of 31 rounds. One bullet entered Gracey’s car and two shattered the blue lights on top of the vehicle.
Schminky also fired at deputies. One round grazed Sheriff’s Office Sgt. Sidney Whitehouse’s leg. Schminky managed to free his Lexus and drive away. While her car was stuck to Schminky’s, Gracey said she did not feel it was safe to return fire because two Sheriff’s Office cars were on both sides of her cruiser. But when Schmiky backed up, she fired one shot at his fleeing vehicle.
Gracey was awarded the FHP’s Medal of Valor in May 2015 for her courage under fire. She was also awarded the department’s Purple Heart medal because the gunshot fired into her car caused her to suffer hearing damage.
After the skirmish at the Circle K, Schminky drove to St. Justin Martyr Catholic Church near mile marker 105.5. He reportedly fired several shots at Deputy Nestor Argote and ran off but soon was captured by Argote and Detective Barney Sajdak.
In the Lexus, officers found a .44-magnum revolver with six empty shell casings, and six shells apparently from a .40-caliber semiautomatic handgun, according to the 2015 arrest affidavit.
A British doctor who campaigned for the public to be warned about increased suicide risk in young people taking antidepressants has said that US drug regulators should consider including adults in warnings.
David Healy, a psychiatry professor at Bangor University, called for the warnings after GlaxoSmithKline (GSK) was ordered to pay $3m (£2.34m; €2.75m) to the widow of a US man who killed himself shortly after starting generic paroxetine.
The jury in the case of Stewart Dolin, a 57 year old attorney, concluded that GSK had failed to properly warn the public about the increased risk of suicide when taking paroxetine. The jury reached its verdict after lawyers for Dolin’s widow, Wendy, presented evidence in the Chicago federal court suggesting that GSK knew that paroxetine posed a risk to adults but had concealed or manipulated data.
Dolin stepped in front of a train in July 2010 shortly after starting a generic version of paroxetine that was sold by Mylan Pharmaceuticals. Mylan was originally named in the lawsuit but was later dismissed because of regulations and a Supreme Court ruling that a generic company cannot be sued if the brand name company does not first change product labelling.
Warnings about the increased risk of suicidal thoughts and behaviour in children and young adults were added to the labels of antidepressants in the US and Europe more than a decade ago.1 In the US, however, labels do not warn of these risks for anyone over 24 years old.
Many consumers have tried to hold drug makers responsible for suicides in adults without success. But the legal team representing Wendy Dolin argued that GSK had artificially inflated the number of suicides and suicide attempts that occurred among people who were given a placebo during clinical trials of paroxetine. They said that this alleged move made the antidepressant look better by comparison, since it appeared to minimise the risk of suicide associated with the drug.
The lawyers also argued that GSK had used averages for all selective serotonin reuptake inhibitors (SSRIs) to demonstrate that paroxetine did not raise the risk of suicide in adults aged over 24. Court documents also indicated that paroxetine displayed a much higher risk than all but one of the SSRI drugs.
Wendy Dolin declared the verdict “a great day for consumers.” After the verdict she told the Chicago Tribune, “This for me has not just been about the money. This has always been about awareness [of] a health issue, and the public has to be aware of this.”
Healy, who spearheaded the campaign to upgrade suicide warnings on antidepressants and testified as an expert witness on behalf of Wendy Dolin, said that the findings in the case should prompt the US drug regulator to review the evidence on SSRIs and suicide risk in adults.
“When it becomes so clear cut that a jury finds there is a problem, it suggests the evidence is strong enough to look at the issue,” Healy told The BMJ. “If it’s that clear to the average man on the street, and the FDA [the US Food and Drug Administration] doesn’t do something about it, we have an odd situation.”
GSK, which markets paroxetine under the brand name Paxil in the US, has said that it will appeal the verdict. “GSK maintains that because it did not manufacture or market the medicine ingested by Mr Dolin, it should not be liable,” it said in a statement. “Additionally, the Paxil label provided complete and adequate warnings during the time period relevant to this lawsuit.”
GSK added, “The scientific evidence does not establish that paroxetine causes suicide, suicide attempts, self-harm, or suicidal thinking in adult patients. In 2007, FDA revised the labelling for the entire class of SSRI drugs (including generic paroxetine and Paxil). The label includes statements that studies did not show an increased risk of suicidality (attempts or ideation) in adults over the age of 24, and that there appeared to be a protective effect in adults over 64.”
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.
Day 5 – Dolin Vs GSK Paxil Induced Adult Suicide – Chicago.
There was a startling revelation today in the Dolin Vs. GSK trial: Attorneys representing widow Wendy Dolin showed the ratio of Paxil-induced suicidality in adults is a staggering 8.9. It is not 6.7, as previously claimed and reported by Glaxo. The 6.7 figure is astoundingly high in itself, but the 8.9 ratio is flabbergasting!
Plaintiff witness, Dr. David Ross, said this figure is ‘astounding.’ What you should remember here is that GSK’s 1989 drug application for Paxil said the suicidality odds ratio was 2.6.
Over the years as GSK’s lies were uncovered and more bodies were buried because of Paxil, GSK later changed the Paxil-induced suicide rate to 6.7. But today the world knows the actual Paxil-induced suicidality figure for adults is 8.9. This number is almost a nine-fold increase in adult Paxil patients experiencing suicidal thoughts, suicidal thinking and completed suicide–thoughts that are created by akathisia and other adverse reactions to Paxil and not by any underlying pre-existing condition.
Today at the trial, expert witness, Dr. David Ross, who worked for the FDA for ten years, testified extensively. While working at the FDA, Dr. Ross was responsible for reviewing new drug applications (NDA’s), i.e., he oversaw the statistics.
His evidence started with 6 points about GSK’s responsibilities (or lack of…)
1. Paxil is associated with an increased risk of suicidal behavior in adults beyond the age of 24. 2. GSK was not upfront about Paxil’s suicidal behavior risk. 3. In 2010, GSK had the ultimate responsibility for the Paxil label. GSK was responsible for ensuring the Paxil label did not contain any false, misleading, or inaccurate information about safety. 4. Federal regulations required GSK to warn doctors that Paxil induces adult suicidal behavior, starting in 1992. 5. GSK could have warned doctors by changing the Paxil label. There is no evidence the FDA would have stopped GSK from issuing a Paxil-specific warning in the non-class labeling sections. In fact, the FDA specifically invited GSK to discuss such changes. 6. GSK did not warn doctors of the true Paxil-induced suicidal behavior risks for adults beyond the age of 24.
Dr. Ross further reiterated to the jury what David Healy previously stated: that the responsibility for accurate drug labeling lies with the product manufacturer and not with the FDA. Dr. Ross added, “…the FDA does not do drug trials, we only know what we are shown.” He added, “You have to rely on the drug company.” He also informed the jury that the FDA’s annual budget is $1.3 billion, most of which comes from drug companies.
Another striking statement Ross shared with the jury was, “The FDA is in charge of enforcing the law, and GSK is in charge of following the law.”
Today’s evidence clearly shows that GSK has not followed the letter of the law enforced by the FDA.
Attorney Brent Wisner from Baum Hedlund asked Dr. Ross if he thought GSK’s label regarding adult suicide was adequate. Dr. Ross answered, “No.” and further added, “It was false and misleading and remains so today.”
Ross also told the jury that if he saw a nearly 9-fold increase in suicide in a drug (any drug) that he “Would not prescribe the drug.” In fact, Ross would categorize a 9-fold increase of any drug as a “frequent adverse event on labeling.”
He also told the jury that the term “Emotional lability” that GSK used instead of suicidality, “conceals what is really going on.”
Remarkably, two GSK employees, along with a third author who received funding and/or similar perks from GSK, published a medical journal paper stating Paxil actually reduced suicide in adults. Ross told the jury that he believed this published paper which contains obvious statistical errors should be retracted. The published article, “Reduction of suicidal thoughts with paroxetine in comparison with reference antidepressants and placebo”, by Montgomery, Dunner, and Dunbar was then used by GSK reps to promote the safety of Paxil in adult patients to prescribing doctors, even though GSK knew it was the complete opposite!
Indeed, it was a very bad day for GSK. The standard “Objection!” was lamely shouted out by King & Spalding’s resident Jack-in-the-box, Andrew Bayman, more times than I care to recall. The majority of his objections were overruled by the Honorable Judge Hart.
I’ve long been a critic of both the British and American drug regulators (the MHRA and FDA). Despite ten years of successful blogging, I’m never too old to learn something new, even when the new information is quite tragic: Today I, and the jury learned that drug companies such as GSK hold medical regulators by the balls. Drug companies provide information (to include false data from faulty clinical trials) and medical regulators have to accept drug company information as the truth. GSK should expect ramifications from global regulators after today’s evidence. An almost 9-fold increase in suicidal behavior in adults taking Paxil is appalling, particularly when we know that, for years, GSK continues to claim there is no causal association between suicide and adults taking Paxil.
This lopsided relationship has terrible ramifications for mental health authorities and suicide nonprofits who unconcernedly take drug company hush money. For years both have claimed antidepressants are a safe and effective treatment for a variety of possible ailments (anxiety, OCD, adult depression, e.tc.) A nearly 9-fold increase in suicidality strongly suggests that both mental health and mental health nonprofits have been duped by the pharmaceutical industry, along with prescribing doctors, medical regulators, and an unsuspecting public.
Just think folks: GSK even tried to get a license for Paxil to be prescribed to children after they knew of the Paxil-induced suicide increases in adults!
Nice ethical company, huh?
I’ll leave the last words to today’s witness, David Ross. The former FDA Medical Advisor was asked if he prescribed Paxil to his patients. Amid the objections from King & Spalding’s Andrew Bayman, he answered, “No. I don’t believe that it works and I don’t believe that it’s safe.”
Trial continues tomorrow.
For now, it’s time for a Guinness, in honour of Stewart Dolin.
There was an interesting article, about Paroxetine and older adults, which appeared in the Guardian in 2003.
A woman called Italia Sudano (an Italian born/British resident) was apparently used as a Paroxetine (Paxil/Seroxat) guinea pig, by her GP (doctor) without her consent. Her doctor was (allegedly) paid by GSK too, and this was also all done without Sudano’s knowledge. The doctor in question, Dr Robert Adams, was struck off by the GMC (General Medical Counsel) after he was found guilty, of not just unethically pimping out his patients to GSK, but also for using several other patients as guinea pigs for various other drug companies and drugs too (not to mention making thousands of pounds in the process).
This case, is disturbing, and also remarkable, but what is stranger still is- how we heard nothing more about it, apart from the report in the Guardian at the time.
The reason why I bring this case up is, currently GSK are being sued in a court in the US by Wendy Dolin, for the death of her husband, Stewart Dolin, in a ‘Paxil Induced Suicide‘ case. The Dolin case centers on GSK’s dodgy Paroxetine trials, and in my opinion, Paroxetine should never have been licensed in the first place. GSK admit that Paroxetine is dangerous for under 18’s, however, many of us who have taken the drug, are highly aware that all ages can suffer from Paroxetine’s dangerous side effects. Side effects such as akathisia, de-personalization, volatility, suicidality etc are common among all age groups (GSK just don’t give us the full facts).
It would be interesting to find out- What data did GSK obtain from cases such as Sudano’s? Were the results of these (highly unethical) live human guinea pig trials ever seen by anyone outside of GSK? Will GSK present the findings in court, in cases such as Stewart Dolin’s? Were GSK receving data from any other GP’s in relation to Paroxetine testing on patients (with or without their consent) at the time, before it, or any time since? If so, what exactly was GSK trying to study by gleaning data from the case of a 72 year old Woman put on Paroxetine, without her consent, or knowledge , from her dodgy doctor? Did Italia Sudano take a legal case against her doctor? If so- did GSK provide information as to the significance of their Paroxetine testing on her?
Sunday 9 February 2003 01.24 GMT First published on Sunday 9 February 2003 01.24 GMT
When Italia Sudano went for a check-up with her GP, Dr Robert Adams, she was in good health. Her husband had died a few months earlier and her blood pressure was a little high.
Yet nothing could have prepared Sudano, 72, for the nightmare that was to follow and the discovery of a trail of greed and fraud that went right to the heart of the medical profession.
She was astonished to discover that her trusted GP had been using her as a guinea pig by giving her tablets which had not been medically approved. Worse still, he was being paid to do so by a pharmaceutical company.
An investigation by The Observer has revealed that many doctors are risking their patients’ health by subjecting them to medical trials without their knowledge.
Over the next few weeks Adams asked Sudano to return for more blood tests. By the end of the second month her arms were black and blue. Her son, Joe, said they looked as though they had been slammed in a door. She said: ‘At one point I asked if he was selling my blood.’
Little did Sudano know how close to the truth her comment was. On her last visit, Adams took a bottle of pills from the top drawer of his desk and suggested Sudano take one a day. While she thought it strange she wasn’t being given a prescription, she trusted her doctor.
But within hours of swallowing the pill, she could hardly walk because she was so dazed. Her face had swollen up badly and she was in considerable pain.
She stopped taking the tablets and complained to Hertfordshire Health Authority. This sparked an investigation that led to one of the largest cases of medical research fraud ever uncovered in Britain.
It emerged that over the previous five years Adams had earned more than £100,000 from drug companies, including the European giants AstraZeneca, GlaxoSmithKline and Bayer. They were all paying him to test their new drugs on his patients. Like Sudano, many of his patients had never given their consent and had no knowledge they were being used as human guinea pigs in a medical trial. Patients with no symptoms were given drugs and others who needed proper medication were given placebos. Adams was receiving almost £1,000 for each patient.
Last month Adams was found guilty by the General Medical Council (GMC) of serious professional misconduct and suspended for 12 months. The GMC’s lawyer described it as ‘assault’ and Sudano is now looking to sue Adams.
GlaxoSmithKline was using Adams to study its anti-depressant Paroxetine, but had to cancel the trial at a cost of hundreds of thousands of pounds.
The drugs industry talks of bad apples and the odd errant doctor milking the system but insists that trials using GPs are essential for medical advances and that payment to doctors for the extra work involved is ethically correct.
But an investigation by The Observer suggests the problem of GPs using patients as guinea pigs without their consent is more widespread. Some 3,000 doctors each year are paid by drug firms to sign up their patients to tests and on average 15 patients are needed for each trial. With doctors picking up £1,000 per patient, drug companies are spending £45m on getting doctors onside. There is no suggestion the companies are implicated in moves to carry out the tests by doctors on patients secretly.
Medical fraud experts estimate that one per cent of all drug trials involve fraud, including failure to get proper consent from patients. This means hundreds of patients a year are being given unapproved and potentially dangerous drugs without their knowledge.
The Observer has discovered that in the last five years the GMC has taken action in a dozen cases involving GPs undertaking fraudulent research. Examples include:
· Dr Vasu Agrawal from Chigwell, Essex, removed samples of womb from menopausal women as part of a trial into a new hormone replacement drug called Divina Nova. Agrawal failed to tell the women they were testing a drug that could have serious side-effects. Agrawal, who forged signatures on consent forms, received almost £6,000 from Orion Pharma International.
· Dr Paul Chima from Edinburgh is estimated to have received more than £200,000 from a range of pharmaceutical companies for testing their new drugs for angina, asthma, high blood pressure and depression. He failed to warn patients of possible side-effects and offered one a £2,000 bribe not to give evidence against him.
· Dr James Boschler from south London was given £22,500 from Bayer and Solvay Healthcare. He claimed to have signed up 36 patients, but 25 of the consent forms were discovered to be forgeries.
The country’s foremost investigator of medical research fraud is Peter Jay, the former Metropolitan Police detective chief inspector who arrested serial killer Dennis Nilsen. Since 1996 Jay has run MedicoLegal Investigations, an independent body, and has taken 12 doctors to the GMC.
Jay is investigating six further cases, including one involving a GP in Manchester. Dr Mark Northfield is alleged not to have obtained consent from patients for entering them into trials to test drugs manufactured by Bayer and Roche to treat high blood pressure and heart problems. Northfield is contesting the allegations before the GMC professional conduct committee.
Jay said: ‘While the industry has become more alert to the problems over the last decade there is still clearly a worrying and persistent problem in research fraud involving doctors. This is not just an issue of patient safety, but a problem that might lead to bad drugs being approved or good drugs failing to be approved.’
The Observer’s revelations of the continuing problem of research fraud have sparked calls for industry guidelines to be toughened up. David Hinchcliffe, the Labour chair of the House of Commons Health Select Committee, described the situation as bordering on ‘scandalous’ and said his committee would look into the issue.
He said: ‘The relationship between the drug firms and the medical profession is one that needs to be thoroughly investigated. It is extremely worrying that patients’ trust is being abused by doctors who are more interested in making money from the pharmaceutical industry.’
Dr Evan Harris, health spokesman for the Liberal Democrats, suggested that doctors involved in trials should be subject to on-the-spot inspections and that a patient’s consent to take part in a drug trial should be given outside the GP’s surgery, for example to a research officer acting for the firm.