Tagged: SSRI

Sinead Describes Her Experiences After Being Prescribed Paroxetine (Paxil/Seroxat) In 2001…


It makes me sad to think how many other poor souls were duped down the psych drug route at the same time I was..

How different would life have been for us had we not been poisoned by Paroxetine?

The following podcast is from James Moore’s fantastic podcast series..

Check them out.

 

 

“Please don’t forget about me”: Antidepressants and birth defects “I was absolutely distraught”


Good coverage on this site of SSRI -Paxil/Seroxat (antidepressant) induced birth defects scandal.

This is the third of a three part series from the Canada Free Press.

See the website (here) for more..


Part III: “Please don’t forget about me”: Antidepressants and birth defects

“I was absolutely distraught”


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.

Part I: “Please don’t forget about me”: Antidepressants and birth defects
Part II: A gigantic uncontrolled experiment
Part III: I was Absolutely Distraught

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.”

GSK responded:

“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…”.

Continued below…



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.”

 

Continued below…



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”


Patrick D Hahn — Bio and Archives |Patrick D Hahn is an Affiliate Professor of Biology at Loyola University Maryland and a free-lance writer. His writing has also appeared in Biology-Online, Loyola Magazine,Popular Archaeology, Natural News,Canada Free Press, and the Baltimore Sun.

Shocking Seroxat Stories From The Recent Guardian Article On SSRI’s..


I was lucky I got off Seroxat (Paxil) when I did. I was almost 4 years on it, and every minute of that four years was a minute too long for me. I can only imagine how horrible it must feel to be on Seroxat for ten years or more. In a recent Guardian article on SSRI’s, the long term use of SSRI drugs was examined, and some of the stories about Seroxat were very sad. These drugs are highly toxic and dangerous. Seroxat is hell in a pill. One poor guy has been taking Seroxat for 26 years. That is simply horrendous and his doctor should be ashamed.

The side effects are absolutely appalling on Seroxat and it is almost impossible to come off without experiencing extremely debilitating withdrawals.

My heart goes out to all these people trapped on SSRI’s. Long term usage of these drugs has not been studied and even very short term use can be dangerous.

Here are some examples of Seroxat horror stories from the Guardian article, however there must be many thousands more who can’t speak out though, that’s the bigger tragedy….

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

‘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…”


“….I have been on seroxat since 1996, my dose has been 50mg daily for over a decade. I was prescribed it for depression, five years’ ago I was diagnosed with bipolar and told seroxat is not recommended as it can increase the likelihood of manic episodes. In about 1996 I was told I was neurotic because I reported that if I missed a few days’ meds I would get electric shocks deep inside my brain and inside my body. I have tried tapered reduction of my dose several times, mostly at the insistence of GPs (prior to my bipolar diagnosis) and once during my pregnancy in 2007. Those were the scariest periods in my life, I have never felt so physically and mentally ill.

In 2007 I found myself calculating the drop to hang myself and looking for a suitable spot in the house. It wasn’t at all like my ‘normal’ suicidal feeljngs, this was a strong compulsive urge, I can’t even explain it properly. Hanging is not a method I have ever contemplated during other periods of suicidal ideation. As far as I can see I need to take these meds for the rest of my life, trying to even reduce them is too terrifying to contemplate. Since taking them I have also become a severe bruxist and have destroyed most of my teeth through grinding and clenching. Whether this is a side effect of seroxat or not I don’t know but it is very tiresome and painful…”


“…I was on SSRIs for around 25 years continuously. After being on Seroxat for around 15 years my GP got concerned, and told me the long term effects of that drug were unknown, and that I should change to something else. I went on to Sertraline, which was equally effective against the dysthymia I suffered from. That is a relatively unknow variant of standard depression which is not as serious but is chronic, and it never lets up, which is why I was on the pills continuously for all that time.

I never once assumed the pills were any sort of cure – they aren’t. They are just a stop gap, a mental “sticking plaster” if you like. They can keep you functioning – sort of – so you can earn a living. But they leave you with little emotions and turn life in a sort of grey mush.

I tried out a whole variety of different therapies over the years, including standard psychodynamic counselling, gestalt, psychosynthesis, mindfulness, bodywork, hypnotherapy, and creative writing as well as keeping up an exercise programme. None of those things worked in the slightest for me – though I learnt a lot in the process and probably fixed a few other less pressing problems. I eventually came across spirit release therapy (google it) which did work.

Coming off the antidepressants once the depression was cured still took about 6 months. I tried a 4 week programme initially, but felt ill and just went back to my normal dose. A very slow withdrawal fixed it – which involved chopping up standard 50 and 100mg pills into smaller chunks with a stanley knife!…”


“…I only took Seroxat for 6 months, and coming off that was about half of that timescale. I didn’t like it, I have a gap in my memory of my time taking it, and it was horrible to come off. I’m glad I didn’t take it for very long. That was a number of years ago though. More recently I’ve had Citalopram (also not fun to cut down); Mirtazapine (easier to come off than SSRIs), and I’m currently taking Sertraline. A part of me wonders if any of them are helping me much. I was told by a Psyc nurse a few weeks ago that my moods should be more stable than they are, so it’s possible that I don’t have depression alone but something else.
What that may be is difficult to discover. Unfortunately getting anywhere with NHS mental health services is like wading through thick treacle in the dark while a force 9 gale is blowing at you. As others have said, antidepressants just deal with some of the symptoms, they don’t fix the problem….”


“…I have taken a few anti-depressants over the years and I have mostly positive things to say, except I wouldn’t touch Paxil (seen a few people have a tough time on that) and there was one which I forget the name of, but it made so ill the first night I took one, I would rather be depressed that feel that unwell, so I didn’t take one more! I have taken Prozac for 4 months – apart from killing my sex drive, it saved my life, like opening dark-room curtains to show a beautiful garden outside in sunlight, the effect was so dramatic. Don’t remember coming off being a problem, but it was 20+ years ago.
I took Wellbutrin to stop smoking and it worked amazingly well and I came off it after 2 months (haven’t smoked since) and still fondly remember the boost to my libido that first month (almost tempted to try again). Coming off wasn’t a problem. I do recall the constipation being incredible but managed it with prunes and extra water everyday! Seriously.

I took Citalopram for a year to deal with a bit of anxiety and high-stress, only 20mg and when I came off it suddenly, not tapered, I did get weird brain zaps but only for 2 weeks. I came off as I wanted to conceive and didn’t want to be on drugs…”


“…I was prescribed Seroxat for chronic melancholic depression, within a month I started to have suicidal thoughts, not good when I also take high doses of morphine…”



“…I wish I could take SSRIs, but the nightmares that come with them make it impossible. Three to five horrendous scenarios every night are just too much for me. My days are slightly better but my nights are hell….”

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.

BMJ: US drug regulators should consider adding adults to SSRI suicide warning, says campaigner


http://www.bmj.com/content/357/bmj.j2050
News

US drug regulators should consider adding adults to SSRI suicide warning, says campaigner

BMJ 2017; 357 doi: https://doi.org/10.1136/bmj.j2050 (Published 25 April 2017) Cite this as: BMJ 2017;357:j2050

  1. Ed Silverman

Author affiliations

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.”

References

Glaxo’s Last Mudslinging Act At The Stewart Dolin Paxil Trial..


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“….Next came the issue of Rothschild’s cozy relationship with GlaxoSmithKline. In the Dolin case alone, Rothschild has been paid approximately $165,000 for his testimony.

Rapoport pressed Rothschild further and asked him about previous cases where GSK has called him as an “expert” witness.

When asked how many times GSK has hired him as a witness in Paxil death cases, Rothschild couldn’t seem to count that high. “Going back 15 years, I can’t give you an exact number, but it’s probably in the neighborhood of 20 or 30.”…”

-Bob Fiddaman:

http://fiddaman.blogspot.ie/


Two weeks ago, I decided to take a blog-break due to some health issues which I need to try to attend to. I still intend to pull back from blogging, as blogging about this stuff can be exhausting at times, however I feel It’s important to highlight the Stewart Dolin Paxil induced suicide trial currently ongoing in the US.

It seems to me that Glaxo’s case in defending Paxil, has been more of a masterclass in mudslinging as opposed to a legitimate defense of their drug. They seem to think that if they hire every pharma-whore they can find available and get those pharma-whores to sling mud at Stewart Dolin’s character, then that will be enough to sway the jury that it was not Paxil which caused Stewart to kill himself.

Pretty pathetic on Glaxo’s part, in my opinion.

Bob Fiddaman has been covering the Dolin trial on his blog for a few weeks, and his last two posts show just how desperate Glaxo are to deny that Paxil (seroxat) can cause suicide and akathisia.

It is simply astounding how GSK can try to defend Paxil/Seroxat in court on the premise that Paxil doesn’t cause suicide or akathisa, while at the same time, they admit in their PIL’s (Patient information leaflets) that Paxil can induce suicidal thoughts/ideation, akathsia and changes in behavior etc.

You can’t have it both ways, but it seems that isn’t going to stop Glaxo from trying.

One of Glaxo’s so called ‘experts’ in the Dolin trial is Dr Anthony Rothschild. Rothschild has apparently been defending GSK’s Paxil/Seroxat in possible Paxil induced suicide cases for many years.

I wonder how much money Dr Rothschild has made over the last 15 years defending Paxil? If he got over 150,00 dollars for one appearance, and he has done 20 to 30, for Glaxo, then perhaps defending Paxil alone has made him a millionaire?

You’d have to wonder too, does Dr Rothchild care about the wellbeing of those prescribed SSRI’s like Paxil?, does he care about the truth of the side effects of these drugs seeing the light of day? or does he care more about the hundreds of thousands of dollars he receives per court appearance from GlaxoSmithKline? and the monetary grants and honoria he receives from the drug industry?

I think astute readers will come to their own conclusions about that.

Seroxat/Paxil does cause Akathisia, I experienced it myself, and so have many others. Paxil/Seroxat does cause suicidal behaviors, I experienced this too, and so have many others. GSK are proven liars, fraudsters, felons and criminals. Anyone who takes blood money from them- to defend their drugs in cases where their drugs have caused harm- does not have the public’s best interest at heart.

Furthermore, greedy doctors on a drug company’s pay-roll certainly don’t have their patients’ interests at heart.

Dr Rothschild (and those of his ilk) make an absolute mockery of the medical Hippocratic oath..

“First do no harm”..

See Fid’s post here for more

 

Seroxat/Paxil Lawsuit Shows That Seroxat Increases Suicide Risk Over 800 Percent…


http://www.naturalblaze.com/2017/03/pivotal-lawsuit-shows-widely-used-antidepressant-increases-suicide-risk-over-800-percent.html

Pivotal Lawsuit Shows Widely Used Antidepressant Increases Suicide Risk Over 800 Percent

suicideBy Annabelle Bamforth

A trial is currently underway in Illinois as a widow seeks to hold pharmaceutical manufacturer GlaxoSmithKline accountable for improper labeling and minimizing a potentially serious side effect of a well-known antidepressant.

Paroxetine is a widely prescribed antidepressant and anti-anxiety drug under the class of drugs known as selective serotonin reuptake inhibitors (SSRIs). Paroxetine is most commonly known as the brand name of Paxil, manufactured by GlaxoSmithKline (GSK). 

Since 2012, Wendy Dolin has been engaged in a legal battle against GSK following the suicide of her husband, Stewart Dolin. Wendy says that in the summer of 2010, Stewart was prescribed a generic version of Paxil for anxiety issues related to work. According to Wendy, Stewart Dolin complained of becoming increasingly anxious and restless and was unable to sleep while taking the drug. On July 15, 2010, less than one week after beginning this medication, Stewart committed suicide by walking in front of a train.

Wendy began searching for answers in the wake of her husband’s suicide and said she learned that he had been displaying signs of akathisia, a disorder characterized by an individual’s inability to relax or sit still. Psychiatrist Joseph Glenmullen said in 2006 that “Patients have described [akathisia] to me as listening to nails scratching on a black board 24/7, or your bones rattling like tuning forks. It is this inner agitation that is by far the most dangerous.” In 2012, Wendy filed a legal complaint against GSK seeking to hold the manufacturer liable for her husband’s death. The complaint noted that “a scientist working for another SSRI manufacturer, Pfizer, wrote in a 1998 medical journal article that the suicidal impulses resulting from akathisia may be explained as a feeling that ‘death is a welcome result’ when the ‘acutely discomforting symptoms of akathisia are experienced on top of already distressing disorders.’”

The critical issue in Wendy Dolin’s lawsuit is not simply paroxetine itself. It’s no secret that lawsuits against pharmaceutical companies are usually complicated under most circumstances, but this case is particularly notable as a tragic example of the gray area of liability when a patient is prescribed a generic drug, as well as the problems between the FDA and drugmakers that exist when it comes to publishing safety labels for patients and doctors.

It’s important to distinguish that Stewart Dolin was not prescribed the brand of Paxil, but a generic brand of paroxetine that was manufactured by another company, Mylan. Brent Wisner, Wendy Dolin’s attorney, described the issue as a “donut hole of liability” in which both the generic and the original manufacturer deny responsibility. “That’s where you have the generic maker on one hand saying, ‘We don’t know about these risks. We can’t be held responsible for them… plus, we can’t change the label,’” Wisner said according to an NBC investigative report. Winner added that “the brand name makers are saying, ‘Well, we didn’t make the pill.’”

Generic drugs are often prescribed in place of specific brands, mainly to save costs, as generic drugs cost far less than brand names on average. In Illinois, where the Dolin family resided, “state pharmaceutical laws actually require such a substitution unless a doctor has advised against it. Some of the few courts that have sided with plaintiffs in generic-drug injury cases have also highlighted this conundrum for generic-drug plaintiffs,” according to a Law360 report on Wendy’s case.

Wendy and Wisner claim that the warning label that was given to the generic brand was “factually incorrect and misleading.” In their lawsuit, they allege that “the paroxetine label in existence at the time of Stewart Dolin’s death did not warn of the drug’s association with an increased risk of suicidal behavior in adults despite GSK’s knowledge of a statistically significant 6.7 times greater risk in adults of all ages. In fact, the label stated the opposite – that the suicidality risk did not extend beyond the age of 24.” Stewart Dolin was close to 57 when taking paroxetine.

The lawsuit alleges that GSK whitewashed the suicide risks of Paxil in its data given to the FDA. The complaint explains that in 1989, GSK”s “Integrated Summary of Safety Information,” required to gain approval from the FDA, included a presentation identifying the number of suicide and suicide attempts during clinical trials. The suit alleges that GSK’s summary “skewed the statistical analysis of the data presented and obscured the true risk” by including suicide attempts “of placebo patients that had taken place in the placebo run-in (or wash-out) phase” before the clinical trials began. “Run-in” or “wash-out” refers to a time period of removing any other drugs in a trial participant’s system; any “adverse events” that take place during those periods are not appropriate or generally accepted for inclusion in calculations during clinical trials, the suit claims.

The Cook County Record reports that while those warning labels on Paxil and paroxetine were approved by the FDA, GSK said it was not allowed by the FDA to include an additional warning of a “statistically significant increase in the frequency of suicidal behavior in patients treated with paroxetine.” GSK claims that the FDA wanted to maintain homogeneous warnings among all antidepressants.

However, U.S. District Judge James Zagel noted that GSK “never asked for a formal meeting, nor did it seek additional labeling regarding Paxil-specific data” in a February 2016 ruling, and further wrote that “Moreover, GSK never sent a separate supplement and declined the FDA’s invitation for a meeting to discuss the inclusion of … the adult warnings.”

The trial against GSK is in progress and is expected to last a few weeks. Bob Fiddaman, a blogger and author who has written extensively about his own experiences with paroxetine, has been covering the developments of the trial. Fiddaman wrote that a “startling revelation” was unveiled on March 22nd:

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.

Fiddaman wrote that Dr. Ross, who worked for the FDA for ten years, offered lengthy testimony. Fiddaman points out that Dr. Ross discussed the problematic relationship between the FDA and drug manufacturers. The FDA relies heavily on the accuracy of the data that is provided by drug companies, which is problematic when the companies present arguable data.

GSK’s argument has summarily been that they do not bear liability because the drug that was prescribed to Stewart Dolin was not manufactured by Mylan, not GSK. The company has stated that “we remain consistent in our stance that since GSK did not manufacture or market the generic paroxetine ingested by Mr. Dolin, it should not be held liable in this trial.”

Annabelle Bamforth writes for TheFreeThoughtProject.com, where this article first appeared.

GSK Can’t Ax Out-Of-Staters From Ill. Paxil (Seroxat) Suit, Court Says


GSK Can’t Ax Out-Of-Staters From Ill. Paxil Suit, Court Says

http://www.law360.com/articles/833842/gsk-can-t-ax-out-of-staters-from-ill-paxil-suit-court-says

Law360, Boston (August 29, 2016, 5:06 PM EDT) — GlaxoSmithKline LLC had enough purposeful contacts with Illinois during clinical trials for the antidepressant Paxil for it to face claims from out-of-state residents that the company failed to warn that the drug could cause serious birth defects, a state appeals court ruled Friday.

The First District Appellate Court of Illinois, Fifth Division, ruled that the standard for a showing that a defendant’s conduct was “arising from” its contacts with the state was “lenient and flexible,” giving the state courts jurisdiction over the pharmaceutical giant. The decision in an interlocutory appeal upholds the trial court’s denial of GSK’s dismissal bid.

“In light of the lenient and flexible ‘arising from’ and ‘related to’ standard, plaintiffs meet the low threshold of a prima facie showing that their claims arose from defendant GSK’s Paxil trials in Illinois,” the appeals court said.

In the suit, eight minors from six states — Illinois, Florida, Colorado, Virginia, Michigan and Wisconsin — said that they suffered catastrophic birth defects because their mothers were taking GSK’s Paxil. The label failed to warn them of serious birth defects that the drug could cause, the plaintiffs said, and that was the result of inadequate clinical trials, 18 to 21 of which occurred in Illinois via 17 Illinois doctors. That meant that the claims arose directly out of or were related to GSK’s purposeful contacts with Illinois, the plaintiffs argued.

GSK argued that Illinois did not have jurisdiction over the out-of-state plaintiffs.

“GSK is disappointed by the court’s decision and is considering its options,” the company said in an emailed statement Tuesday.

Tor Hoerman, whose firm represented the plaintiffs, said in an emailed statement: “This decision is entirely in line with existing precedent of the Illinois Supreme Court and Appellate Court. … Drug makers who conduct inadequate or manipulated clinical trials in Illinois should not be surprised that they can be sued in Illinois for that conduct.”

In trying to have the suit dismissed as to the out-of-state plaintiffs, GSK said that its clinical trials occurred in 44 states and foreign countries, too attenuated for personal jurisdiction in one state where it’s not headquartered. Its alleged acts or omissions in Illinois were not the “but for” cause — in other words, GSK said, the plaintiffs couldn’t show that the harm would not have occurred but for what GSK did in Illinois.

In addition, GSK argued, the plaintiffs weren’t study subjects there, and the out-of-state plaintiffs didn’t take Paxil or suffer injuries in Illinois.

The children and their mothers argued that GSK had meaningful contacts with Illinois through its clinical trials of Paxil, during which they said it failed to track 18 pregnancies, one of which resulted in a heart defect. According to Friday’s decision, GSK employs 16,323 people in the U.S., including 217 who reside in Illinois, and from 2000 to 2006, GSK had between 79 and 121 employees marketing Paxil in Illinois.

They did not have to prove that any act was committed in Illinois, but just make a prima facie showing, the defendants said.

In a ruling Friday, the appeals court sided with the plaintiffs.

“The quality of defendant GSK’s relationship with Illinois can hardly be characterized as random, attenuated or the like; the contacts with Illinois, over the course of two decades, were purposeful and directed,” the appeals court ruled.

The plaintiffs, and the judges, used some of GSK’s own statements to show that the case could continue. In a declaration, GSK said that the principal Paxil investigators had “little or no input into or control over the study design protocol or analysis of the aggregate data collected from all study sites.”

“As plaintiffs argue, the word ‘little’ invites the inference that the physicians had some degree of input into, and control over, the clinical trials, or else the word would have been omitted,” the appeals court said. Absent further guidance in the record, we ‘resolve in favor of the plaintiff any conflicts in the pleadings and affidavits.’”

Judges Robert E. Gordon, Bertina E. Lampkin and Eileen O’Neill Burke sat on the panel for the First District.

GlaxoSmithKline is represented by Dentons.

The plaintiffs are represented by Ken Brennan of TorHoerman Law LLC.

The case is M.M., a minor, et al. v. GlaxoSmithKline LLC et al., case number 1-15-1909, in the Appellate Court of Illinois, First District, Fifth Division.

–Editing by Mark Lebetkin.

Update: This story has been updated to include a comment from GSK.

Dr Peter Breggin: $11.9 Million Paxil Suicide Verdict: The Inside Story


https://www.madinamerica.com/2016/10/11-9-million-paxil-suicide-verdict-inside-story/

$11.9 Million Paxil Suicide Verdict: The Inside Story

No one expected a very large award, let alone $11.9 million, in this suicide malpractice case involving the antidepressant Paxil (paroxetine). The jury verdict on September 15, 2016 was gratifying and encouraging (Family of Pennsylvania jail suicide victim awarded $11.9M$11.8M Federal Medical Malpractice Verdict For Prison Inmate’s Suicide). It demonstrates that the judicial system and the public are becoming increasingly aware of the hazards of psychiatric drugs, including their capacity to make people behave in ways that are harmful to themselves and others, and contrary to their past behavior and character.

Great success seemed unlikely in this case. To begin with, suicide malpractice suits are very difficult to win. Juries understandably want to hold people responsible for their behavior when they kill themselves. I was going to testify that a single dose of Prozac 30 mg was the main cause of his suicide, a conclusion that other experts would vigorously challenge.

In addition, the case was in an area of the country where juries are conservative about giving monetary awards to plaintiffs. It was in the U.S. District Court for middle Pennsylvania in the city of Scranton.

Juries also tend to look askance at claims made on behalf of people in jail.  Mr. Mumun  Barbaros, the deceased victim, was in his fourth day of incarceration, awaiting release on bail. The judge did not allow the jury to know the nature of his alleged crime or the charges against him, and I was not permitted to comment on them. If allowed, I would have testified that Paxil-induced disinhibition drove him to vandalize the property of a man in a competing business.

Some people are also less sympathetic to naturalized citizens with strong ties to their countries of origin. Mr. Barbaros was a Bulgarian who became a citizen, but his wife and children spent only part of the year with him and he sent back large amounts of his earnings from his tavern to his extended family back home.

Finally, the case had scientific complexities that the jury had to understand.

The defendants were the independent healthcare provider to the jail, PrimeCare, and several of its personnel or contractors assigned to the jail. Mr. Barbaros had been taking Paxil for anxiety for many years, along with the sedating antidepressant trazodone to help him sleep.

At the time of his arrest, Mr. Barbaros reported that he needed his medication.  Due to a series of errors upon the part of the healthcare personnel, his request for medication went unfilled for four days.  By the second and third day, Mr. Barbaros develop headaches and hypertension, and his chronic stomach problem worsened, but no one attributed these symptoms to withdrawal. However, his intake evaluation and contacts with healthcare providers documented an absence of suicidal thoughts and revealed no great distress.

When the staff finally confirmed Mr. Barbaros’ medications, a licensed practical nurse (LPN) from the jail phoned the psychiatrist on call and asked him to prescribe the Paxil 30 mg and trazodone 100 mg. The LPN did not offer the doctor any information about Mr. Barbaros, such as his age, the reason he was taking the medications, how long he had been taking them, and how long he had been without them in jail. The psychiatrist, in turn, did not ask the nurse any questions, but simply authorized the drugs.

I testified that the psychiatrist’s actions were worse than practicing medicine negligently—he was not practicing medicine at all. He was more like a vending machine. I further testified that this was callous disregard, especially since he admitted to knowing that the drug had dangers associated with it, including suicide, and yet asked no information about the patient, did not come in to see him, and ordered no special supervision.

Following his first morning dose of the Paxil, Mr. Barbaros was seen for a routine evaluation by a staff psychologist in the mid-afternoon. At this point, Mr. Barbaros was drastically changed. He was no longer a man who conversed easily and showed no signs of significant stress, anxiety or depression. According to the psychologist’s deposition, Mr. Barbaros now looked extremely anxious and like a “cornered rat,” spoke very little, made poor eye contact, and looked hunched over and withdrawn. In the psychologist’s scantily written report, his only diagnosis was “rule out depression,” an entirely new diagnosis for Mr. Barbaros.

I attributed these drastic changes in Mr. Barbaros’ condition to the impact of the large dose of Paxil. The psychologist had not checked to see what medications Mr. Barbaros was taking. He did not check the medical record and therefore did not know that his current severely anxious and withdrawn state was entirely new for him during his incarceration.  He did not ask his patient if he was suicidal.

In my direct examination, I testified that restarting the patient on his regular dose of Paxil 30 mg, despite a hiatus of at least four days without the medication, was a direct cause of the suicide later on the same day. Restarting him on Paxil 30 mg, when most of the drug was out of his system, caused akathisia (agitation with hyperactivity) and suicide. I also found that the doctor and the psychologist were negligent in several other ways, including their failure to evaluate the patient and to order careful monitoring.

I further explained that Paxil (paroxetine) is a selective serotonin reuptake inhibitor (SSRI) antidepressant. All antidepressants can cause suicidal and homicidal behavior, especially those like the SSRIs that routinely cause stimulation or activation, including akathisia, agitation, insomnia, disinhibition, emotional lability, hypomania and mania, and a general worsening of the patient’s condition. Of all the antidepressants, Paxil was the only one to show a statistically significant association with suicide in depressed adults in the short and deeply flawed clinical trials used for FDA approval of the drug.

To back me up, I brought a number of documents, including a 2006 letter from the manufacturer to all healthcare providers admitting to the association between Paxil and suicide in depressed adult patients, and further warning that this risk might apply to patients with other diagnoses. I also brought a copy of the 2006 Full Prescribing Information for Paxil that carried the same warning about suicide in adults, before the drug company got the FDA to delete it in later editions. I had written about the subject of medication-induced suicide in my book, Medication Madness: The Role of Psychiatric Drugs in Cases of Violence, Suicide and Crime.

One of the more dramatic moments in my testimony came on the first series of questions during cross-examination. When I began reviewing the case, I was asked to focus on Mr. Barbaros’ medical record going back approximately six years to the time when his primary care doctor had started him on Paxil 10 mg, apparently without difficulty, and then raised it gradually to 20 mg and then 30 mg. To be thorough, I examined all the remaining extensive medical records and came upon something remarkable buried within them that had previously escaped attention.

The day after his first dose of Paxil 10 mg, Mr. Barbaros became so anxious that he thought he was having a heart attack and sought immediate help at a local medical clinic separate from his primary care physician who prescribed the Paxil. That clinic referred him to a cardiologist on an emergency basis who evaluated him and found no physical disorder. These doctors treated Mr. Barbaros’ anxiety with prescriptions for a benzodiazepine tranquilizer.

Mr. Barbaros had experienced a very severe anxiety reaction to his first dose of Paxil, but it apparently never entered his mind that Paxil was causing it. From the medical record, it looks like he never told the emergency clinic or the cardiologist he had recently started taking Paxil and he never told his primary care doctor, when he returned for follow up later on, that he had been so anxious that he went to a cardiologist and received sedative tranquilizers. It is very common for individuals to fail to realize that their acute psychiatric emergencies are being caused by their psychiatric medication.  I call this phenomenon “medication spellbinding” or intoxication anosognosia.

As a medical expert in a product liability case against GlaxoSmithKline, the manufacturer of Paxil, I had discovered from the company’s secret files that Paxil frequently caused severe psychiatric adverse reactions during the first few doses. I had published an article about this in the hope of alerting people to the risk. This earlier work of mine enhanced the credibility of my discussion.

So… when I was asked at the beginning of cross-examination to explain why Mr. Barbaros would have such a bad reaction to being restarted on Paxil since he never had a bad reaction to being started many years earlier, I had an unexpected answer. I could reply and document from the medical records that, in fact, he had a drastic psychiatric reaction to the original 10 mg dose but no one recognized that it was related to the Paxil. The defense attorney was so flummoxed by my revelation that he never even asked to see the relevant medical records. The cross-examination then went on for an unexpectedly long time, requiring me to come back a second day. The defense probably was hoping that the jury would forget the revelation I had disclosed in the first few minutes.

The jury not only found that PrimeCare and several of its practitioners and staff had been negligent, they further concluded that the company and most of the individual defendants acted with deliberate indifference to Mr. Barbaros’ medical needs.

Despite a vigorous challenge by the defendants’ attorneys, the judge qualified me as an expert in psychiatry, psychopharmacology and the specific drug Paxil. In the trial, other experts testified for the plaintiffs concerning the nursing care and administrative policies of the healthcare provider, as well as the violent method of Mr. Barbaros’ death by gagging himself.

The jury award included $2.8 million for negligence, $1.06 million for federal deliberate indifference and $8 million for punitive damages. The case is Ponzini et al. v. Monroe County et al., case number 3:11-cv-00413, in the U.S. District Court for the Middle District of Pennsylvania. The attorney for the plaintiff was Brian Chacker of Philadelphia. He worked extraordinarily hard and with great diligence on the case.

I do believe that the success of this case reflects greater awareness within the public and the judicial system concerning the dangers of psychiatric drugs.

The Paxil/Seroxat Study 329 Story In 2016: Project Censored : Downplayed stories illuminate larger patterns in inequality, spying, the environment and corporate influence ..


http://www.sfreporter.com/santafe/article-12640-project-censored.html

Crisis in Evidence-Based Medicine

The role of science in improving human health has been one of humanity’s greatest achievements, but the profit-oriented influence of the pharmaceutical industry has created a crisis situation. That research simply cannot be trusted. Burying truth for profit is a recurrent theme for Project Censored. The top story in 1981 concerned fraudulent testing from a single lab responsible for one-third of the toxicity and cancer testing of chemicals in America. But this problem is much more profound.

“Something has gone fundamentally wrong,” said Richard Horton, editor of The Lancet, commenting on a UK symposium on the reproducibility and reliability of biomedical research: “Much of the scientific literature, perhaps half, may simply be untrue. Afflicted by studies with small sample sizes, tiny effects, invalid exploratory analyses and flagrant conflicts of interest, together with an obsession for pursuing fashionable trends of dubious importance, science has taken a turn towards darkness. … The apparent endemicity of bad research behavior is alarming.”

Horton’s conclusion echoed that of Marcia Angell, a former editor of the New England Journal of Medicine, who went public in 2009.

A classic case was Study 329 in 2001, which reported that paroxetine (Paxil in the United States and Seroxat in the United Kingdom) was safe and effective for treating depressed children and adolescents, leading doctors to prescribe Paxil to more than 2 million US children and adolescents by the end of 2002 before being called into question. The company responsible (now GlaxoSmithKline) agreed to pay $3 billion in 2012, the “largest healthcare fraud settlement in US history,” according to the US Department of Justice.

Nonetheless, the study has not been retracted or corrected, and “none of the authors have been disciplined,” Project Censored points out. This, despite a major reanalysis which “‘starkly’ contradicted the original report’s claims.” The reanalysis was seen as the first major success of a new open data initiative known as Restoring Invisible and Abandoned Trials.

While Project Censored noted one Washington Post story on the reanalysis, there was only passing mention of the open data movement. “Otherwise, the corporate press ignored the reassessment of the paroxetine study,” and beyond that, “Richard Horton’s Lancet editorial received no coverage in the US corporate press.”

Source: The Lancet 385, no. 9976, 2015; Cooper, Charlie, “Anti-Depressant was Given to Millions of Young People ‘After Trials Showed It was Dangerous,’” The Independent, 2015; Boseley, Sarah, “Seroxat Study Under-Reported Harmful Effects on Young People, Say Scientists,” The Guardian, 2015.