The truth about long-term antidepressant use

A great piece today in the Guardian by . Good to see such a comprehensive piece of reporting in the mainstream media.

This what you and I know has happened to many of us, but at the same time GSK continues to deny is a major health crisis because of Seroxat (and other SSRIs). In the UK, as the High Court action moves ever closer to trial, GSK and their expensive legal team still have their collective head in the sand – at least that’s their public stance. I believe that for many years GSK has known about the problems Seroxat causes while you take it, about the terrible problems people have withdrawing from the drug and also about the long-term problems ‘survivors’ are left with for the rest of their lives.

Here’s the article:

Sarah never planned to take antidepressants for 14 years. Three years after she began taking them, when she was 21, she went to her GP and asked to stop: 20mg of Seroxat a day had helped her live with anxiety and panic attacks, but she began to feel uncomfortable about being on medication all the time. Her doctor advised her to taper down her medication carefully.

At once, “I was a mess,” she says. “I thought I was losing my mind. My appetite completely went. I lost the best part of two stone. I was anxious constantly. My mouth was dry. It was difficult to sit and be calm.” She became withdrawn, refusing to see friends, and remembers asking her mother to get her a couple of boxes of paracetamol, thinking, “I’m going to have to take all these tablets, because I can’t live like this.”

Sarah’s doctor encouraged her to go back up to 20mg. “Within a week, I was much better. I feel anger when I look back. That wasn’t me relapsing, that was withdrawal. But I was so unwell, I didn’t stop to think, ‘I’ve never had this before.’ I truly thought it was me. Now the only reason I am on the drug is because I am dependent upon it. And that is not good enough.”

Prescriptions of SSRIs (selective serotonin reuptake inhibitors), the most common type of antidepressant, have doubled in the past decade. There are now more than 70m prescriptions dispensed in the UK in a year, the “greatest rise” of any drug in the last year, according to NHS research. But while the side-effects of starting and then withdrawing from these drugs are reasonably well known (the patient information leaflet accompanying the SSRI Seroxat is six pages long), there is very little research into the long-term effects of using antidepressants.

Last year, an all-party parliamentary group began hearing evidence as to whether there is a link between a measurable rise in mental health disability claims – 103% between 1995 and 2014 – and that in antidepressant prescriptions. (Claims for other conditions fell by 35% in the same period.) “We need to have a serious rethink about current levels of prescribing, because it may well be that the drugs are in fact contributing to the disability burden,” Dr Joanna Moncrieff, a consultant psychiatrist and senior lecturer at University College London, told the committee.

Reports both anecdotal and clinical have included side-effects such as constant pain, an altered sense of smell, taste or hearing, visual problems, burning hands and feet; food or drug intolerances and akathisia (the medical term for a deep inner restlessness). When a patient begins tapering down their dosage, these effects are generally ascribed to the drug leaving their system; if it is long after withdrawal is supposed to be over, however, patients are often disbelieved (according to the drug companies, withdrawal should take just two weeks for most people, though they acknowledge that for some it can be months).

Professor David Healy, director of the department of psychological medicine at Cardiff University and author of 22 books on psychopharmacology, believes that antidepressants are overprescribed. “If you go into your average doctor – if you’ve been off the drug for half a year or more – and you complain [of a range of symptoms] and say, ‘I think it’s caused by this pill I was on’, he or she would say, ‘It’s been out of your body for months. You’re neurotic, you’re depressed. All we need to do is put you on another pill.’”

GPs, Healy says, are “relying on your word, and if it’s a choice between believing what you say and relying on what drug companies say to them, they [tend to] believe the drug companies”. Healy, who has been a consultant for, and expert witness against, most of the major pharmaceutical companies, has long argued that long-term side-effects are routinely ignored or misunderstood.

But many experts believe these drugs do more good than harm. “Most of the people I see who have moderate to severe depression benefit from them,” says Daniel Smith, a professor of psychiatry and researcher into bipolar disorder at the University of Glasgow. For some, medication can be no less than “transformative. It can get them through a really critical period of their life.”

However, when it comes to long-term impact, especially after a person stops taking SSRIs, Smith says it can be hard to work out which symptoms relate to the drug use and which to the underlying conditions. “There’s obviously an issue of cause and effect. How can we be certain the SSRI caused it? Depression affects libido and sexual interest. How much [of the reported effects] is depression and/or anxiety symptoms coming back?”

SSRIs have been around for more than 40 years, but grew in popularity in the late 1980s and 90s after pharmaceutical company Eli Lilly launched fluoxetine, otherwise known as Prozac. Time magazine put the drug on its cover twice, asking, “Is Freud finished?” and describing SSRIs as “mental health’s greatest success story”. In 2001, a landmark report on a clinical trial into paroxetine (sold as Seroxat in North America and Paxil in the UK), called Study 329, concluded that it demonstrated “remarkable efficacy and safety”. Study 329 led directly to a massive increase in prescriptions: by 2003, worldwide sales of Seroxat (manufactured by GlaxoSmithKline) were worth £2.7bn.

But concerns were raised about the study –the US food and drug administration (FDA) officer who reviewed the data disagreed with the findings, calling it a failed trial – and in 2015 the British Medical Journal published a re-evaluation. Seven authors went through as many of the thousands of individual case reports as they could, and found not only that “the efficacy of paroxetine… was not statistically or clinically different from placebo”, but that “there were clinically significant increases in harms, including suicidal ideation and behaviour”. The original study reported 265 adverse reactions; the BMJ found 481. The re-evaluation also found that psychiatric responses were grouped together with “dizziness” and “headaches”, rather than given their own category. In 2003, the UK banned the use of Seroxat by anyone under 18; and in 2004 the FDA required a “black box warning” on all antidepressants, its strictest level of patient warning.

“Patient safety is our number one priority,” a GlaxoSmithKline (GSK) spokesperson tells me. “We believe we acted responsibly in researching paroxetine, monitoring its safety once it was approved and updating its labelling as new information became available.”

Many SSRI users report blunted emotions, even long after they have ceased taking pills, and an impact on sexual function. “They should be called anti-sex drugs rather than antidepressant drugs,” says Jon Jureidini, a child psychiatrist of 30 years’ standing, a professor of psychiatry and paediatrics at the University of Adelaide and co-author of the BMJ study, “It’s more reliably predictable that they’re going to get rid of sexual function than it is that they’re going to get rid of depression.” Again, some people find this persists long after they cease taking the drug. One person I spoke to, Kevin, had taken Prozac for six months when he was 18; now 38, he hasn’t had an erection since.

Last September, Healy and colleagues published a further examination of the data gathered for Study 329. This data followed the trial participants for six months after they started taking paroxetine (the “continuation phase”) and while they were tapered off it. GSK, which in 2004 published a clinical study report, had argued that “the long-term safety profile of paroxetine in adolescents appears similar to that reported following short-term dosing”. Healy and co, however, concluded that the “continuation phase did not offer support for longer-term efficacy”. More alarmingly, they found that the taper phase, when patients were being taken off the drugs, was the riskiest of all, showing a “higher proportion of severe adverse events per week of exposure”. This, they said, opens up the risk of a “prescribing cascade”, whereby drug side-effects are thought to be symptoms, so are treated with further drugs, causing further side-effects and further prescriptions – thus increasing the risk of long-term prescription drug-dependency.

In October, the British Medical Association published its response to a two-year fact-finding exercise into long-term use of psychoactive drugs. It noted that while benzodiazepines, z-drugs, opioid and antidepressants are “a key therapeutic tool”, that their use can “often lead to a patient becoming dependent or suffering withdrawal symptoms… the evidence and insight presented to us by many charity and support groups… shows us that the ‘lived experience’ of patients using these medications is too often associated with devastating health and social harms”; it was therefore, the report concluded, a “significant public health issue”.

The BMA made three key recommendations: first, and most urgently, that the UK government establish a 24-hour helpline for prescribed drug dependence; second, that it establish well-resourced specialist support units; and third, that there should be clear guidance on prescription, tapering and withdrawal management (they found the current approach to antidepressants, in particular, to be inconsistent: too many patients were suffering “significant harm”). There are also increasingly urgent calls for studies into long-term effects that are not funded by drug companies, because, Moncrieff says: “We don’t have very much data. This research is really important, but hasn’t been done. It’s a massive blind spot. It’s extraordinary – or maybe, given the pressures and interests at work, not extraordinary at all – that it hasn’t been filled.”

In March this year, members of the BMA, along with MPs and researchers from Roehampton University, went to parliament to lobby Public Health England, armed with research estimating that there are 770,000 long-term users of antidepressants in England alone, at a cost of £44m to the NHS per year (a figure that does not account for the cost of GP appointments, or the impact of side-effects, withdrawal effects and disability payments).

“I think you have to adopt a very conservative approach,” says psychiatrist Jon Jureidini. “These are brain-altering drugs, and our overall experience with brain-altering drugs of all kinds is that they tend to have a detrimental effect on some proportion of people who take them long term. All we know about the benefits is from short-term symptom-reduction studies. The careful prescriber needs to say, ‘Well, in balancing the likely benefits and harms, I need to be very cautious about how much benefit I’m expecting, and I need to be very generous about the possibility that the harms might be more than they appear to be.’”

Quite a few long-term users, such as those I spoke to below (and who wished to be anonymous), would agree.

‘Tapering off is the hardest thing I’ve ever done’: Sarah, 32; has taken Seroxat for 14 years I was prescribed Seroxat when I was 18, the year I started university. I grew up with a disabled sister, so things at home were very stressful, and I had a history of anxiety and panic attacks. I had counselling, but the problems persisted, so I went back to the GP. I don’t remember everything that was said, but there was no conversation about side-effects.

Within the first two weeks of starting Seroxat, I remember I was sitting in the front room watching TV when out of nowhere I had this intense feeling of heat, like an electric shock. It started in my hands, went all the way up my arms and through to my head.

The GP said it was probably just my body getting used to the drug. And after a few weeks the weird sensations did ease off. I had a fabulous time at university. I still had panic attacks, and there were certain situations I would avoid – as I still do – so it wasn’t a wonder drug, but there were no major problems.

But in 2006 I tried to come off it. There were a couple of Panorama documentaries about the side-effects and I was starting to become concerned. The GP said, “That’s fine, but do it gradually, over three weeks.”

I immediately became incredibly unwell. I thought I was losing my mind. I was going to work, but it was difficult to get through the day. My mouth was so dry, I was constantly drinking water. I had bizarre thoughts – not hallucinations – that were frightening or distressing. I had a strong sense of detachment from reality.

Eventually, the doctor said, “Look, you coming off is obviously not working: we need to get you back to 20mg.” Within a week I was much better.

A few years later, when I realised my mental health was getting worse, even though I was on the medication, I started to do some research, reading case studies about withdrawal. I find it so offensive when a GP says, “This is who you are.” I didn’t have these symptoms 10 years ago. I didn’t have this sense of detachment. I saw various psychiatrists. They just kept saying, “The drug is safe, you need to be on it.” A couple of others told me the reason I was having these problems was because I wasn’t taking enough. Another said, “If you were diabetic, you’d take insulin and you wouldn’t have an issue. Why are you so bothered about taking this drug?”

I’ve been on it since I was 18, so I don’t know who I am without it, as an adult. Who knows? I might have all kinds of problems, but I need to know I’ve tried. Tapering off is the hardest thing I’ve ever done. It’s taken me three years just to get from 20mg to 5mg. I’m no longer with my partner – we were together for six years. I believe Seroxat has played a part: it affected my moods, it made my anxiety worse and, by necessity, I’ve had to be selfish, really. I don’t want to say all my problems are to do with Seroxat, because they’re not. But I do believe that it has caused me harm.

‘I don’t have much of an interest in interacting romantically or physically with the opposite sex’: Jake, 24; took SSRIs for eight years I had been dealing with symptoms of OCD and anxiety for a lot of my childhood. It’s in my family, affecting two siblings and one parent. I was prescribed Zoloft when I was 12; I took a variety of SSRIs, Zoloft to Prozac to Lexapro, and then two others, for eight years.

Did they help? You know, I can’t really tell you, because I got through school. I got high marks, I had a lot of friends. So, in that sense, they must have helped. That’s the thing: for people with major depression, it’s easy to say, this has a measurable effect. But I kept taking them just because that’s what I’ve always done.

I went to university right out of school. I did very poorly. I had a bit of a breakdown, isolating myself, not sleeping. I was still on medication. I came home and enrolled at a community college. That was my worst period – I was very depressed. And I started to think, “I’ve been on these medications a long time. I’m not doing well – why not get off them?” I don’t recommend this at all to anyone, but I stopped going to a psychiatrist and took myself off.

For months I had trouble sleeping. I was jittery. I had brain zaps. My anxiety was pretty ramped up. I would feel numbness in my extremities – generally my arms. My psychiatrist told me these were just normal withdrawal symptoms, and they’d be gone in four to six weeks: “Anything you feel beyond that is your anxiety and depression returning.” Basically, if you still feel anything beyond this window that the medical community has established, it’s all in your head.

Eventually I went back to school full-time, and I remember doing OK, feeling somewhat better.

I’ve now been drug-free for four years. What’s lasted are the sexual side-effects. They were definitely worse in withdrawal than they had been on the drug, even though I didn’t really realise or understand it at the time, primarily because I started to take SSRIs at 12. While my brother took the same medicine over the same period and had a normal sexual life, I had a lack of sexual interest. I had erections, and I have regularly masturbated my entire life. But I don’t have much of an interest in interacting romantically or physically with the opposite sex.

I didn’t even start thinking about sex until a couple of years ago. It’s almost like I woke up one day and thought, “OK!” I started getting these windows – days or weeks – when normal sexual feelings would appear. But they’re new to me and I don’t know what to do about them. And because I don’t know what to do, I get anxious, and the anxiety kills any feeling – and then I’m anxious because I’ve lost all my feeling.

Online, I’ve come across a big asexual community. Some also took antidepressants; I think there are a lot of people like me out there. I’d like to think that if I keep going to counselling and sleeping and eating properly, I can rectify these things.

In the end, it’s about pros and cons. If you’re lying in bed and can’t get up, is it better to function? If it was up to me, I’d say that, barring extreme circumstances, nobody under 18 should be prescribed these things. Your brain develops around them. Drug companies should be thinking of the long-term effect on people who can’t even consent.

‘If I missed a dose, I’d get shocks down the side of my body’: Chris, 43; has been taking Seroxat for 26 years I was originally prescribed Seroxat for mild anxiety about my GCSEs. It was 1991, about the time GlaxoSmithKline released Seroxat. I was one of the first people to be given it.

I was prescribed 20mg, the basic dose, to start with. It helped me: I got through school, I went to uni, I went to work. But I had side-effects from the off: profuse sweating, low libido. I’m quite a placid person, but I became aggressive. I never suffered, in the beginning, with the suicidal thoughts that people talk about now, but what I did notice was that if I missed a dose – especially after eight years of taking it – I’d get shocks down the side of my body. I’d be nauseous, my limbs would become weak. I’d be in a constant state of confusion and was very impatient. I couldn’t communicate well with people. I said this to the doctor, and he said, “We’ll up the dose to 40mg.” That was 1998.

The 10 years after that weren’t too bad. I managed to work, as a sales rep, for 18-20 years. But by 2012, by which time I was up to 60mg, I had tried on numerous occasions to withdraw. I tried to go back to 20mg, but my words became slurry, so the doctor put me back up to 60mg.

By the time I was 38, even that wasn’t enough. I tried to take my life. The doctor wouldn’t prescribe a higher dose. I couldn’t do my job, I couldn’t concentrate, I couldn’t drive. A psychiatrist once said to me that coming off Seroxat is harder than quitting heroin. That really hit home.

I have now been unable to work for four years. I’m still seeing a psychiatrist. I’ve also been diagnosed with fibromyalgia: constant tiredness, aches in the neck, and in the lower back and lower limbs. I’m 43 and still live with my mum and dad.

I also have no libido. Since the age of 30, I have had no feelings in that regard whatsoever. I have had relationships, but they’ve all failed. I haven’t been in a relationship for 10 years, which is a long time to go without sex, but I just don’t get the urge.

I don’t really have emotions, to tell you the truth. The drug takes your emotions away. I’m sort of existing, not living.

And when the drugs do work…

‘I wanted to be able to feel good when good things were happening, bad when bad things were happening’ 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”.

I would try to come off the pills and felt rubbish again – not more rubbish than before, but the same. So I returned

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.

Yes, I know it has been a while…

I’m just in the process of looking back at my time on Seroxat and my withdrawal from it. I can’t say what for at the moment, but watch this space….

Looking back at my blog I can remember how important it seemed at the time to use the internet to get the message out there that there were problems with Seroxat. Of course, over the past 11 years we have come to understand that there are problems with many SSRIs and other drugs. There are also problems with the way big Pharma goes about its business – from rigging drug trials to marketing unsafe drugs to the public.

I’m lucky, I have been able to move on in my life and I leave this blog on the internet to help anyone who is suffering the same way I did in the hope it may be able to help in some small way.

Back in 2005/2006 there was a only handful of us who were using the internet to warn of the problem of Seroxat. Happily now there are far more people and organisations that write about this subject and I hope it’s more widely known by the general pubic and medical professionals alike.

If you haven’t visited these sites, you should:

Leonie Fennell

Dr David Healy

AntiDepAware

GSK: Licence to (K)ill

The Pill that Steals

There’s a trial going on the US at the moment – the crux of the matter in Dolin Vs GSK is whether or not Paxil (Seroxat) caused Stewart Dolin to kill himself whilst under Paxil’s influence – and just what GSK did to hide the truth about the dangers of their drug.

The trial is being covered the mainstream media and by Bob Fiddaman on his blog, and below here are some links to the story so far.

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

I think that both Bob and I enjoy watching GSK squirm, but what’s important from a wider perspective is the way that a trial brings previously secret information into the public domain. Each trial that takes place opens the curtains a little wider.

I hope that the trial will bring closure for Stewart Dolin’s widow, Wendy. What GSK and their lawyers always forgets is that are real people and real tragedies at the sharp end of the unsafe drugs they choose to bring to market and make huge profits from.

There’s also an action nearing trial in the UK at the moment, and as I wrote previously: The publicity of a High Court hearing will mean the mainstream press  will be free to report on ALL the evidence presented. Now… I’m thinking that this will mean a lot of GSK documents that have until now remained secret will become very public knowledge. You see a case like this, while common in the USA, is unheard of in the UK and the publicity it will generate will be huge. And all those once-secret documents and the information they hold will be available the world over for future claimants to use. I think a whole new raft of claims will be kick-started in the USA alone. I wonder what GSK’s share price will look like after all this? And how institutional investors will view a company that breaks the law and lies & cheats its way to profit?

In the 21st century, ethos & culture – the way a company actually operates and conducts its business – are as important to a PLC as having a blockbuster product to sell. Ethos & culture are intrinsic parts of a modern corporate brand, going way beyond the generic, meaningless mission statement that we see from GSK “…to help people do more, feel better, live longer”.

I’d like to finish on a personal note. Perhaps, after all these years, I’m getting nearer to closure. For me, that simply means people will believe what happened to me was real.

More importantly, I hope that Doctors will understand what happened to me was real – and perhaps then we can start to help others who are going through the horrors of withdrawing from Seroxat/Paxil today.

Feeling very humble this morning

Last night I was out on the town – well not really, more like out at Waterston’s in High Street Kensington for the official launch of – The Pill That Steals Lives – a new book by Katinka Blackford Newman.

Of course the book is one thing (and I think you should go and buy a copy) but for me the highlight of the evening was meeting so many people who are campaigning to raise awareness of the problems that anti depressants can cause.

I say problems, but in reality the stories I heard were beyond belief and so very harrowing that I all I could do was to sit there quietly in tears… I urge you to read David Carmichael‘s story. It seems I got away with it. What I went through was nothing compared to what happened to some.

The pain and suffering in the room last night was matched only a sense of quiet anger and frustration. Anger at the drug companies for not stepping up and admitting what’s wrong with their ‘product’ and doing something about it, and frustration that we still don’t have our voices heard above the noise that is generated by the establishment. I was humbled by the great work others have done and continue to do.

And speaking of getting our voices heard – please have a look at AntiDepAware – it’s a great resource that we should all be supporting.

In the UK, the good news is that it looks like GSK want to go court. I for one think this would be a fantastic thing – the chance to bring everything out in the open and re-ignite the whole SSRI debate and put a spotlight on the arguments about what’s wrong with their entire business model – from the way they fix drug trials – to the way they market their drugs – to the suffering they have caused. A trial in the High Court in London will ensure our voices are heard.

I’m ready – bring it on.

 

 

Seroxat Group action – latest news

Great news about the Seroxat Withdrawal Group Litigation in England… we are on our way to trial! AT LAST!!

I’m sure if you read Bob Fiddaman’s blog you know already – see here – but I thought I’d wait until we had passed the time limit for GSK to appeal Mr Justice Foskett’s judgement to proceed with the Seroxat Withdrawal Group Litigation. That time has passed and there was no appeal… we are on our way to trial! AT LAST!!


If you happen to be one of the group claimants and you HAVE NOT received forms from Fortitude Law in the past 2 weeks, then you should contact Fortitude Law via email at lcorr@fortitudelaw.uk or telephone on 0203 667 3775 without delay.


I think I’ll say it again, just because I can … ‘Judgment has been received from the Honourable Mr. Justice Foskett to proceed with the Seroxat Withdrawal Group Litigation’. 

I think there must be quite a few people on the other side who really thought this had gone away, but I can tell them now to look out – it hasn’t gone away and it’s all too real. I’ve said before that, for me, a trial is the only to resolve this issue

The publicity of a High Court hearing will mean the mainstream press  will be free to report on ALL the evidence presented. Now… I’m thinking that this will mean a lot of GSK documents that have until now remained secret will become very public knowledge. You see a case like this, while common in the USA, is unheard of in the UK and the publicity it will generate will be huge. And all those once-secret documents and the information they hold will be available the world over for future claimants to use. I think a whole new raft of claims will be kick-started in the USA alone. I wonder what GSK’s share price will look like after all this? And how institutional investors will view a company that breaks the law and lies & cheats its way to profit?

In the 21st century, ethos & culture – the way a company actually conducts its business – are as important to a PLC as having a blockbuster product to sell. Ethos & culture are intrinsic parts of a modern corporate brand, going way beyond the generic, meaningless mission statement that we see from GSK.

I’d like to finish on a personal note. Perhaps, after all these years, I’m getting nearer to closure. For me, that simply means people will believe what happened to me was real.

More importantly, I hope that Doctors will understand what happened to me was real – and perhaps then we can start to help others who are going through the horrors of withdrawing from Seroxat/Paxil today.

 

 

What is GlaxoSmithKline still hiding from us – what is so important about the missing 9 pages?

Last week news broke in the New Scientist that Glaxo’s own researchers had been responsible for “an inappropriate analysis” of clinical trials that “obscured” suicide risks associated with Seroxat/Paxil for 15 years (see the court documents released last month).

Not until 2006 did GSK alert people to raised suicide risks associated with the drug, marketed as Paxil and Seroxat.

An analysis of internal GSK memos and reports, which were released to US lawyers seeking damages, suggests that the company had trial data demonstrating an eightfold increase in suicide risk as early as 1989. Harvard University psychiatrist Joseph Glenmullen, who studied the papers for the lawyers, says it’s “virtually impossible” that GSK simply misunderstood the data.

Glenmullen’s report rests on documents obtained by lawyers in Los Angeles, who are bringing around 30 cases against GSK linking suicides and suicide attempts to the use of Paxil. The report was under seal at a district court in Sacramento, California, until 18 January, when the judge agreed to make parts of it public.

Read that last sentence again – “… the judge agreed to make parts of it public…”

What was released to the public was 83 pages of Dr Glemullen’ report – 9 pages have been withheld.

Over now to United States Senator Chuck Grassley, I think.

Senator Grassley has written to Mr. Christopher Viehbacher, President of GlaxoSmithKline (United States) asking for the missing nine pages. The full letter is here.

Part of it reads:

It is my understanding that 9 pages of Dr. Glenmullen’s report are not available publicly. Accordingly, please respond to the following questions and request for information. Please repeat each enumerated question and follow it with your response.

1. When did GSK first learn that Paxil was associated with an increased suicide risk?

2. When did GSK first report to FDA that Paxil was associated with an increased suicide risk?

3. When did GSK first notify patients and doctors that Paxil was associated with an increased suicide risk? Please provide all pertinent documents and communications.

4. Please provide the Committee with the complete, unredacted version of Dr. Glenmullen’s report. Along with that report, please provide the appendix and all documents that are referred to in the report, in the order that they are referenced.

5. Please provide the Committee with the accompanying children and adolescents report.

Now, I think at this point we should turn to Professor David Healy.

As an expert witness in the Schell/Tobin case, Professor Healy had been granted access to Glaxo’s archives and made shocking discoveries, so much so that on the 7 June 2000, he wrote to Dr June Raine of the UK’s Licensing body the MHRA.

“… All of their [GSK] healthy volunteer studies were supposed to have been made available to me but not all were. Of the ones that were missing there was trace correspondence left in once indicating that the investigator had never witnessed such a level of problems in a study with healthy volunteers. Another study was a single dose study which in a dose dependent fashion yielded a 75% rate of severe adverse events most of which involved the central nervous system. There were other disturbing indications from one of the other missing studies”.

“My testimony in this case also bore witness to sealed studies and other unreported data. It commented on the Montgomery Baldwin Study which yielded a projected rate of 45 suicide attempts in a group of recurrent brief depressive disordered patients on paroxetine per annum versus 12 on placebo. The figures were not statistically significant in great part one has to suggest because the company had terminated the study early. This termination and subsequent non-publication I would imagine the jury will have found and others will find significant.

In conclusion, Professor Healy wrote:

I think what will also be clear is that SmithKline Beecham recognised the presence of withdrawal syndromes in their volunteers from the early to mid 1980s. That withdrawal syndromes occurred at a much higher rate than occur on benzodiazepines. Nevertheless they applied for and have received from you and other regulators a licence to claim that their drug is effective in the prophylaxis of depression and these claims have been based on designs which almost certainly are designs better suited to show the presence of a withdrawal syndrome than designs suited to demonstrate prophylaxis in depressive disorders. A great number of people have in recent years been told that when they begin to feel ill on discontinuing treatment that this is the recrudescence of their mood disorder rather than a discontinuation syndrome from their drug. I would imagine that a great many such people and others on their behalf will feel extraordinarily let down and angry when faced with the evidence that I’ve been faced with”.

Anyone see a pattern forming here?

Senator Grassley has given GlaxoSmithKline until February 14 to respond to his letter…

GlaxoSmithKline hid suicide risks in clinical trial data… what do you think?

This from The New Scientist.

AN INAPPROPRIATE analysis of clinical trial data by researchers at GlaxoSmithKline obscured suicide risks associated with paroxetine, a profitable antidepressant, for 15 years, suggest court documents (897kb, requires Acrobat Reader) released last month. Not until 2006 did GSK alert people to raised suicide risks associated with the drug, marketed as Paxil and Seroxat.

An analysis of internal GSK memos and reports, which were released to US lawyers seeking damages, suggests that the company had trial data demonstrating an eightfold increase in suicide risk as early as 1989. Harvard University psychiatrist Joseph Glenmullen, who studied the papers for the lawyers, says it’s “virtually impossible” that GSK simply misunderstood the data – a claim the company describes as “absolutely false”.

Glenmullen’s report rests on documents obtained by lawyers in Los Angeles, who are bringing around 30 cases against GSK linking suicides and suicide attempts to the use of Paxil. The report was under seal at a district court in Sacramento, California, until 18 January, when the judge agreed to make parts of it public.

The analysis focuses on the “washout” phase preceding a trial, when subjects stop taking most or all medications to avoid confusion with results from the trial itself. Because the washout occurs before patients randomly receive either the drug or the placebo control, adverse events during this time can’t be attributable to the trial and so are seldom if ever included in final results.

However, GSK researchers submitting data on Paxil to the US Food and Drug Administration in the late 1980s and early 1990s included suicides and suicide attempts from the washout period in the results for the placebo arms of trials, but not from the Paxil arms. Glenmullen alleges that these extra “placebo” suicides negated suicides attributed to Paxil in the trials, making the drug appear safer than it really was. He says that if the washout results had been excluded, the data would have showed that Paxil increased eightfold the risk of suicidal behaviour in adults.

GSK spokeswoman Mary Anne Rhyne says inclusion of the washout data “was intended to present the full picture of events that occurred in all phases of the clinical trials – starting from the time patients were enrolled, before they were randomised”. She says that even without the washout data, Paxil still came out as safe as the placebo in this trial. She accused Glenmullen of incorrectly analysing the data to reach the opposite conclusion, but didn’t respond to a request for numerical proof that Glenmullen’s verdict was wrong.

Glenmullen suggests that the FDA would have acted differently had the use of the washout data been made more explicit. Rhyne says that material still under seal shows the FDA to be fully aware of how the washout data was being used. But Glenmullen quotes Martin Brecher, the FDA official who reviewed Paxil’s safety, as agreeing during a pre-trial hearing that the use of the washout data was “scientifically illegitimate”.

Independent researchers say it was wrong to use washout data as GSK did. “I can’t imagine circumstances in which it would be appropriate,” says Bruce Psaty of the University of Washington in Seattle.

IN AN UPDATE FROM PHARMALOT: Chuck Grassley of the Senate Finance Committee has just written Glaxo seeking nine pages that weren’t made available with the unsealed documents. Here is the letter.

Seroxat increases suicidal thinking – it’s official – but what about addiction and withdrawal?

Seroxat increases suicidal thoughts – it’s official, or at least it will be official
from October this year. But only if you’re 25 years old or younger…

… if you’re older, even by a month or just a day, then you’re safe – so they
tell us and GlaxoSmithKline always tells us the truth, don’t you agree?

But no mention of withdrawal or addiction.

WARNINGS of the dangers of suicidal thoughts and behaviour are to be
included in the packages of anti-depressants in the UK. Warnings will be
carried in the patient information leaflet in the packets from October this
year.

The direction was issued yesterday (Tuesday) by the Government’s
Medicines and Healthcare Products Regulatory Agency. (MHRA)

A notice has been sent to drug manufacturers. It mentions a review by
the Food and Drugs Agency in America, which looked at bupropion,
citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine,
mirtazapine, nefazodone, paroxetine, sertraline and venlaxfaxine.

The review found no risk of higher sucidality in the general
population but said younger people were at higher risk and that there
were no differences in the risk between antidepressant classes.

A statement released by the MHRA says that the wording of warnings has
been agreed by the EU as has the time table for implementation.

The agreed wording reads:

“Thoughts of suicide and worsening of your depression or anxiety
disorder. If you are depressed and/or have anxiety disorders, you can
sometimes have thoughts of harming or killing yourself. These may be
increased when first starting antidepressants, since these medicines
all take time to work, usually about two weeks but sometimes longer.

You may be more likely to think like this:

If you have previously had thoughts about killing or harming yourself.

If you are a young adult.

Information from clinical trials has shown an increased risk of
suicidal behaviour in young adults aged less than 25 years with
psychiatric conditions who were treated with an antidepressant.

If you have thoughts of harming or killing yourself at any time,
contact your doctor or go to a hospital straight away.

You may find it helpful to tell a relative or close friend that you
are depressed or have an anxiety disorder and ask them to read this
leaflet. You might ask them to tell you if they think your depression
or anxiety is getting worse or if they are worried about changes in
your behaviour.”

The news was greeted as a victory by anti-drugs campaigner, Janice
Simmons, a grandmother from Great Stukeley in Huntingdon.

Mrs Simmons told The Hunts Post on Tuesday: “I’ve won. This is the
result of eight years’ work. Warnings of suicidal thoughts and
behaviour will now be carried on all anti-depressants.”

Mrs Simmons, 57, began her campaign after she discovered that her
second husband, John had been prescribed Seroxat years before she met
him and since become addicted to anti-depressants. Her help-group –
the Seroxat User Group – has had tens of thousands of hits on its
website. Mrs Simmons has gathered information from across the world.
She has begun a dossier of case histories of tragic effects on people
who have been prescribed anti-depressants.

This year she had a meeting with the Prime Minister, Gordon Brown to
discuss the problem. However, she has always conceded that the drugs
can help some people.

One of the issues Mrs Simmons discussed with Gordon Brown was the
length of time (four years) that the MHRA has taken to investigate
allegations against the manufacturer of Seroxat, GlaxoSmithKline
.

It is alleged that the drugs giant withheld information that Seroxat
could cause suicide in under 18s. The allegations have always been
denied and GSK has said that Seroxat was never licensed for children.

Too little too late is what I say

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