Tagged: Paxil

Father Forgives His Dead Daughter’s Boyfriend For Her Paroxetine (Seroxat/Paxil) Induced Murder ..


Quite an amazing story about a truly tragic ‘paroxetine induced murder’ that occurred in the Netherlands. I look forward to the book.

The capacity of the human heart to delve deep into the depths of compassion never ceases to inspire.

From the Guardian:

https://www.theguardian.com/lifeandstyle/2017/may/26/experience-i-made-peace-with-my-daughters-killer

Experience: I made peace with my daughter’s killer

This is not about forgiveness. What happened cannot be changed; this is our way of dealing with it

Eddy Hekman
Eddy Hekman: ‘At 5am, two police officers came to the house and we learned what had happened.’ Photograph: Judith Jockel for the Guardian

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.

As told to Gordon Darroch. Do you have an experience to share? Email experience@theguardian.com

 

 

 

 

 

 

How FDA Avoided Finding Adult Antidepressant Suicidality (Dr Peter Breggin- Mad In America)


https://www.madinamerica.com/2017/05/how-fda-avoided-finding-adult-antidepressant-suicidality/

How FDA Avoided Finding Adult Antidepressant Suicidality

Peter Breggin, MD

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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.”

The studies that the FDA relied upon for adults over age 24 were dismally flawed and untrustworthy compared to the ones used for children. According to the FDA at the 2006 hearings:

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.

13 Ways That GSK Hid The Seroxat/Paxil Suicide Signal…


Seroxat/Paxil/Aropax (Paroxetine) : The Anti-Depressant that makes you want to kill yourself!..

 


https://davidhealy.org/change-in-chicago-whose-problem/

Change in Chicago: Whose Problem?

May, 24, 2017 | Reply

Stewart Dolin’s Doctor Says (about Paxil) : ““I don’t trust the labeling,” he said. “I don’t trust the company, to be honest.”…


And why would he?

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…..”


https://davidhealy.org/change-in-chicago-dr-welby-on-the-witness-stand/

Change in Chicago:  Dr. Welby on the Witness Stand

May, 15, 2017 | 8 Comments

Dr David Healy Recounts His Experiences Of The Dolin Paxil Trial..


Dr David Healy recounts his role in securing a victory against GlaxoSmithKline in the Stewart Dolin Paxil trial…

Compelling reading..

More on the Dolin trial in later posts..


https://davidhealy.org/change-in-chicago-playing-go/

Change in Chicago: Playing Go

May, 8, 2017 | 1 Comment

Long Term Seroxat/Paxil User: ” the only reason I am on the drug is because I am dependent upon it. And that is not good enough.”…


https://www.theguardian.com/society/2017/may/06/dont-know-who-am-antidepressant-long-term-use

‘I don’t know who I am without it’: the truth about long-term antidepressant use

Prescriptions have doubled in a decade, but very little is known about the effect of taking SSRIs for years and years. Is it a lifesaver or a happiness trap?

Noma Bar illustration of bird in cage shaped like a pill
Long-term side-effects of taking antidepressants are sometimes ignored or misunderstood. Illustration: Noma Bar

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?”

A Seroxat box and pills
Pinterest
By 2003, worldwide sales of Seroxat, manufactured by GlaxoSmithKline, were worth £2.7bn. Photograph: Alamy

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.

prozac
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Prozac. Photograph: Getty Images

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’

By Simon Hattenstone

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.

Are you a long-term user of antidepressants? Tell us about your experiences

  • If you are affected by the issues raised in this piece, contact the Samaritans here.

Mad In America: Wendy Dolin Takes on GlaxoSmithKline And Wins — For Now at Lea


Wendy Dolin Takes on GlaxoSmithKline And Wins — For Now at Least

Jim Gottstein, JD

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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:

  1. Duty of care owed by the defendant to the plaintiff;
  2. Breach of that duty; and
  3. The breach of duty proximately caused an injury.

See, Memorandum Opinion and Order (Order), page 8.

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.

Ed Silverman: Dear Scott Gottlieb: Add new warnings to Paxil labels. You may save a life…


A little too late for many, however good to see someone of Ed Silverman’s character speaking out about the scandal of Seroxat/Paxil.

https://www.statnews.com/pharmalot/2017/05/01/paxil-suicide-warning-fda/?s_campaign=fb&utm_content=buffer12cb5&utm_medium=social&utm_source=facebook.com&utm_campaign=buffer

 

D

ear Dr. Gottlieb,

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.

Dr David Healy Blogs About The Stewart Dolin Trial Verdict… (well worth reading)


https://davidhealy.org/change-in-chicago-the-dolin-verdict/

Change in Chicago: The Dolin Verdict

May, 1, 2017 | Reply

Wendy Dolin: “…GSK would stop at nothing to intimidate me…”


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.


http://fiddaman.blogspot.ie/2017/04/exclusive-interview-with-wendy-dolin.html

Tuesday, April 25, 2017

Exclusive: Interview With Wendy Dolin

Wendy Dolin

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.

Interesting.

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.

Links

What is Akathisia? (Short Educational Video)

MISSD

Baum, Hedlund, Aristei & Goldman

Rapoport Law Offices, P.C

Dolin Vs GSK Paxil Trial Court Transcripts

Dolin v. GSK Paxil Trial Exhibits



Dolin Vs GSK Blog Coverage

Dolin v GSK – Opening Arguments

Dolin Vs GSK – Day Two – “Jack-In-The-Box”

Dolin vs GSK – Healy ‘Rocks Da House’

Dolin Vs GSK – JP Garnier Video Deposition

Dolin Vs GSK – The Dunbar Tape

Dolin Vs GSK – Day 4 – Slam Dunk

Dolin Vs GSK – 8.9 Suicide Increase For Adult Paxil Users

Dolin Vs GSK – Day 6 – Ass Kicking Semantics

Dolin Vs GSK – Day 7 – Abraham Lincoln

Dolin Vs GSK – Day 8 – Get to the Point, Todd!

Dolin Vs GSK – Glenmullen Nails It!

Dolin Vs GSK – “Babes”

Dolin Vs GSK – Wendy’s Cross and GSK’s Petition

Dolin Vs GSK – Robert “Bling Bling” Gibbons

Dolin Vs GSK: Suicide Prevention Warning “Futile”, Claims GSK Exec

Dolin Vs GSK : Jury shown List of the Dead in Paxil Clinical Trials

Dolin Vs GSK: Last Man Standing & The Return of Dr. Healy

Dolin Vs GSK: Closing Arguments

Dolin Vs GSK – The Verdict