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 She became withdrawn, refusing to see friends, and remembers asking her mother to get her a couple of boxes of paracetamol, thinking, “I’m going to have to take all these tablets,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.

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.

 

 

Family double death horror

I’ve just seen this terrible story in the Daily Mirror:

A father is believed to have returned home yesterday evening to find his two young children murdered and his wife with her wrists slit.

Emergency services were called to the home in Wandsworth, south west London, but the 10-week-old baby boy and one-year-old girl were pronounced dead at the scene.

A post mortem is due to take place today although reports have suggested the children showed no signs of injury and may have been smothered.

A woman in her mid-30s, believed to be the man’s wife, was arrested over the deaths and is being questioned by detectives today.

She is understood to have self-harmed but did not require hospital treatment.

Police are believed to be investigating the possibility that the mother was suffering from post-natal depression.

In cases like this, I believe one of the first things to establish is what (if anything) the woman was being treated with for her depression…

The authorities simply must start to take notice about this issue and the public deserves to know if there is a connection between acts of extreme violence and drug treatment – I believe that antidepressants can cause extreme violence.

All too often in the past, it seemed that the only other people in the world who would ever begin to entertain the possibility were people such as Michael Moore and Dr Peter Breggin in the USA – and in England David Healy, Andrew Herxheimer and David B. Menkes, who co-authored a paper on the subject in 2006 – Antidepressants and Violence: Problems at the Interface of Medicine and Law.

If you want more information, then you can read follow up with these links (or just type ‘Violence’ in the search box on the left of your screen:

What made Raoul Moat do it

Nebraska shooting – antidepressant connection yet again?

Lost in translation – were Anti-Depressants Involved In Finland School Massacre?

A brief history of school shootings

The Finland Massacre

SSRI stories

Antidepressants and violence

As I’ve said, there has to be a proper investigation into this issue – and I believe that the drug companies (such as Glaxo) know the problem exists, but have done nothing about it as it would have affected their profits.

 

Glaxo – a simple challenge for you…

It’s been a while since I wrote anything as I’ve been very busy with my day job.

Happily, others have continued to write – I’ve just read a post over at Seroxat Suffers about Glaxo in New Zealand and the Patient Information Leaflet that comes with Aropax (Seroxat).

According to Glaxo (only in New Zealand, though):

Depression is longer lasting or more severe than the low moods that everyone has from time to time. It is thought to be caused by a chemical imbalance in parts of the brain.

AROPAX corrects the chemical imbalance and so helps relieve the symptoms of depression.

Sorry, but I have to throw the gauntlet down to Glaxo on this one… I think in 2012 it’s fair to say that the chemical imbalance story has been discredited completely.

But, Glaxo, if you can tell me what the correct level of Serotonin is in a human brain, then I’ll listen.

If you can measure how much Serotonin I currently have in my brain, then I’ll listen.

If you can then demonstrate how much 20mgs of Seroxat will raise my brain serotonin level by, then I’ll listen.

But the problem is that Glaxo can’t do any of those – the idea of a ‘chemical imbalance’ causing depression – and even the term ‘SSRI’ – was invented by marketing and PR companies, simply to sell a drug.

To use a technical term, it’s complete bollocks.

 

 

More from David Healy

I’ve just been reading David Healy’s new blog and there are a couple of things I think that you really must have a look at.

Firstly, there’s a very personal article about alcohol and SSRIs – here’s a taster:

It’s crazy that patients have to get together on the internet to compare their side effects and discuss their problems because there is nowhere else to go. It has made me look to other people’s experiences for information now regarding drugs as they seem to be more accurate and honest in their findings than companies, regulators or doctors.

I didn’t realize until I came off the medication how bad I was. I feel ashamed and guilty for what I put people through. I have lost my job, had to move home, have a criminal record and lost the respect of family and friends. This could all have been avoided if there had been proper warnings in place and effective communications between different authorities.

I want to tell my story as a warning to anyone who may be craving alcohol on SSRIs. I also want to tell people that sometimes it’s a mistake to leave it to the experts. And finally I want to tell doctors that your patients can often see that the information you are getting is wrong — we don’t blame you for this, we just want you to listen to us.

I have written about alcohol craving in the past and you can read it here.

Secondly, there is a draft paper,  Antidepressants for takers – written by Dr. David Healy, Dr. Jo Lenoury and Dr. Dee Mangin.

Here’s what’s covered:

DRUGS AND CHEMICALS
WHAT STUDIES HAVE BEEN DONE ON THESE DRUGS?
WHAT DATA UNDERPIN THE USE OF THESE DRUGS?
HAS ANYONE ACCESS TO ALL THE DATA?
WHAT PUBLICATIONS ARE THERE ON THE USE OF THESE DRUGS?
HOW GOOD ARE THE STUDIES?
ARE THERE ANY PROBLEMS IF MY DOCTOR KEEPS TO RECOGNIZED GUIDELINES?
DO ANTIDEPRESSANTS WORK?
WHAT DO ANTIDEPRESSANTS DO?
WHAT OVERALL IMPACT WILL ANTIDEPRESSANTS HAVE ON HOW I FUNCTION?
ARE THE EFFECTS OF ANTIDEPRESSANTS DOWN TO PLACEBO?
ACUTE TRIALS & CHRONIC TREATMENT
WHEN SHOULD I TAKE TREATMENT?
ARE THERE ANY PROBLEMS WITH TREATMENT COMBINATIONS?
WHAT WILL GET ME BETTER IF I DON’T TAKE PILLS?
MYTHS ABOUT ANTIDEPRESSANTS
WHAT DO YOU KNOW OF MY PROS & CONS?
WHAT ARE MY OPTIONS?
WHAT HAPPENS IF I DON’T TAKE TREATMENT?
DO THE PEOPLE IN THE STUDIES OF THESE DRUGS RESEMBLE ME?
HOW DO YOU KNOW WHICH ANTIDEPRESSANT TO GIVE ME?
HOW LONG DO I HAVE TO BE ON TREATMENT?
WHAT ARE THE RISKS?
THE RISKIEST RISKS
HOW LIKELY ARE LISTED SIDE EFFECTS OF ANTIDEPRESSANTS TO HAPPEN?
WHAT UNACKNOWLEDGED RISKS CAN REASONABLY BE SUSPECTED?
PERIODS OF RISK
DO ANTIDEPRESSANTS CAUSE PROBLEMS?
STOPPING?

That’s Antidepressants for takers – if you ask me it sums up Seroxat Secrets in 15 pages!

The story of SSRI stories

This interview is taken from David Healy’s new blog and is all about SSRI stories – an incredible resource, built over many years by Rosie Meysenburg…

The body of evidence that is presented would lead any sane person to think there’s something wrong here and there has to be urgent research undertaken into the unwanted effects of antidepressants – but for some reason the regulators (such as the FDA & the MHRA) and the drug industry seem happy to bury their respective heads in the sand and pretend nothing is wrong.

Rosie Meysenburg’s story

For anyone interested in the effects of drugs, the website SSRI stories has been an inspiration. Rosie Meysenburg, its creator, was recently diagnosed with cancer and is terminally ill. The story of how she came to create SSRI stories shows what people can do to hold the powers that be to account.

—David Healy


DH:          How did you get started with SSRI stories ?

RM:          I had spent ages trying to quit smoking. Eventually, in 1992, my doctor persuaded me to try Prozac. I took it for eight weeks during which time my behavior got stranger and stranger and I ended up in hospital. I had no idea what caused the problem until my husband, Gene, suggested it might be the Prozac. So I called the Mental Health Association here in Dallas and asked, “Do you know anyone else who has had a reaction to Prozac? Is there somebody I could talk to?” She said, “Oh, we have a number here for the Prozac Survivors Support Groups.” So she gave me their number and I called them. They talked to me for a long time on the phone and sent me a ton of literature. Well I couldn’t believe it — there were testimonies from Dr. Teicher and others.

I had a manic reaction to Prozac taken for smoking cessation.

I got my medical records and they showed the doctors thought I had a manic reaction to Prozac although I don’t think it was manic; I think it was more nutty. I was angry about the fact that they knew it was the drug but hadn’t told me but there wasn’t too much I could do then — this was 1993. After that I wrote a letter to the FDA which they used in Motus vs. Pfizer — a letter that asked if they could put the same warning on their package insert as Germany had.

Then the Internet started in 1997 and I sat down and I went through the phone book and I called practically every physician in the city in which I lived. I’m a determined person. I asked them if I could find anything about Prozac on the Internet that would show that it could cause harm would they be interested? About 22 of them said yes they would be. I went into Alta Vista — the search engine before Google — I typed in Prozac. There wasn’t too much else you could type in except Zoloft and Paxil. And sometimes I’d put “plus suicides” or “plus murder” whatever and I came up with all kinds of things. This is how I started my message board — it was to these people and some of them were very interested, which kept me going.

Then Mark Miller who lost his 13-year-old son to a Zoloft-induced suicide became involved. He put up a website for Ann Tracey — I didn’t really know who she was. I found her on the Internet and so I sent her some emails and she wrote back. She said, “The Zoloft suicides? Can you find a phone number for these people, Rosie?” So I had a domain where you can find phone numbers and I found them and she called them and told them what had happened to their children. We had a whole list of phone numbers. We did that until about 2004.

Ann started pursuing another line of business although she still tried to find time to help on the SSRI cause. But then the FDA announced online — we watched the FDA announcements like a hawk — a meeting concerning antidepressants/suicide and children. We had about 25 names of parents of children who had committed suicide.

The FDA was astounded.

I think the FDA was astounded. They started out with the five minutes they were going to give to each parent to present their case. Then they went to three minutes and finally two minutes. I mean the FDA has these meeting every day and two or three people show up for issues like how many nuts should we put in the cookies? If you’re allergic to peanuts, what should the warning be? I think by law they are required to put an FDA meeting notice in one newspaper and they happened to put it in the Arlington, Virginia, newspaper because my husband Gene talked to a man whose son had committed suicide who saw the FDA announcement in the newspaper and then pretty well everybody came from either finding out about it by themselves or from contact through Ann Tracey, Mark Miller, or myself.

So we went to the 2004 meeting and the FDA placed a black box warning regarding suicidality and children under the age of 18, and then in 2006 that same black box warning for the 24-year-olds and under. I looked at my computer in my saved box and I had 1,000 messages; probably 300 were suicides and another 250-300 were murders, and then there were assaults and all kinds of different things.

DH:          When was this?

RM:          This was May 2006. I had over 1,000 media articles regarding antidepressants and murder, murder-suicides, suicides, assaults, school shootings, road rage, air rage, etc. My husband Gene set up the initial database for me.

“Thank you. I understand now what happened.”

I spent probably 20-25 hours a week doing that and the rest of time I spent with family and friends. I posted every post that’s up there. Can you believe it — 4892! Curious the way I feel about SSRI Stories. On the contact page for SSRI Stories everybody thanked me. I said to Gene that there will be a lot of people just saying, “Oh you’ve got to be kidding me; this cant be true.” Instead I’ve received these emails from the contact page of SSRI Stories with people saying “Thank you. I understand now what happened to my brother or my sister.”

When I first started my message forum I got a threatening letter from somebody when I had my own name up there, although I still kept up with my message board. Now that I’m dying I guess I’m less worried about them beating up on me over Prozac you know. I used to be worried about all these shooters out there but now I don’t care who knows my name.

Now that I’m dying I guess I’m less worried about them beating up on me over Prozac.

I am pretty sure FDA have ignored SSRI Stories. But when I look at the stats, Homeland Security goes in there quite a bit and looks at some of the cases. A lot of people are coming in from the military. The big thing I’ve had is people making comments on sections because my stat counter gives the web address. For instance one comment said, “My friend John Smith didn’t know why we were having all these school shootings and he went into SSRIs Stories and now he knows why.” I think it’s helped raise awareness, and I see a lot of people making comments because they come up in the stat counter with the URL or their website and I can click on their website and they’ll say things like, “Have you seen SSRI stories? It’s unbelievable but I think it’s true.” Stuff like that.

So I don’t know how many people have actually looked at SSRI Stories. As far as the index goes we’ve had maybe 300,000 or 400,000 people look at it, which isn’t a lot but which is still quite a bit. On the individual stories we’ve had close to 1 million people looking at them. It seems like in the individual stories approximately one out of every four people will go from the individual story into the index or cover page.

more people are being injured out there by this than we realize

But I can’t really say what kind of impact SSRI Stories has had. What I feel is that more people are being injured out there by this than we realize. Someone I know told me he has a neighbor on one side just died on Paxil and Zoloft, while on the other his neighbor just died on Celexa. Before that neighbor died she said she thought the police were taping her and she had begun to drink heavily and to act crazily.

DH:          Did your friend not know your work and warn his neighbors?

RM:          Well he only found out afterward. He could see the personality of one of his neighbor’s change but he didn’t know for sure and he felt he couldn’t go into it in-depth because this was his neighbor and he was embarrassed. Beside even when I was on Prozac I failed to spot the connection.

One day I went up to the bank and there was a lady there. She began talking about Prozac to me and she said that when she was on Prozac she killed her dog and then, right there at the bank counter, she started crying. I said “Why did you kill your dog?” and she said that he’d become incontinent and all of a sudden on Prozac she got aggravated with that so she took him to the vet and had him put to sleep. And then she started crying. She said her dog was her best friend. And I said to her, “ What was it about the Prozac that made you do this?” And she said it made her more aggressive. It makes you more unfeeling and more aggressive. Of course, she only had her dog put to sleep. I’m not saying she committed a major crime. Her pet was incontinent. He was probably old and would have died soon anyway but the point is that this is happening to a lot of people.

He burned down 10 churches and…will spend the rest of his life in jail.

About two or three months ago there was a case in a town near Dallas where a 20-year-old man, who was taking Champix and Prozac at the same time, went around in the middle of the night and burned down 10 churches.  No one of course had been killed because the churches were empty but the jury gave him life in prison. This article on SSRI stories talks about Prozac and Champix and it does say the perpetrator blamed the Champix because he didn’t know if he’d actually done it or if he’d dreamed it. But you see the Prozac can cause you to kind of go into a manic rage also and out of this you get a pyromania, or a kleptomania or nymphomania, and then on the Champix he was kind of like in a dream state. Anyway he’s 20 years old and will spend the rest of his life in prison.

DH:          Why did the issue of people becoming violent get your attention?

RM:          Well because you know in United States it’s always been a tradition not to print suicides. The only way you can tell is if they have a little clue in the obituary or if it says “he died suddenly.” Whereas, the UK and other countries do print suicides. They’ll say “committed suicide.” That’s why I have so many cases from people in Australia and Canada of suicides but very few from the US. However if it’s a controversial suicide or suicide of a famous person, people will want to know what happened to them, and then they’ll print it because everyone will say “Oh my gosh, this famous actor died. How did he die?” But I’m just talking about ordinary people who aren’t high profile. Also the big problem in the US is the drug advertising and of course the media is dying. Some of the newspapers have gone out of business — the only thing that keeps them alive is the drug ads.

The US has lost Freedom of the Press in an unusual way.

The U.S. has lost Freedom of the Press in an unusual way. The newspapers and TV cannot mention that the perpetrator was on an SSRI because the media is afraid the pharmaceutical companies will pull their ads.

DH:          Why do you think people are so reluctant to think that the drugs may be causing a problem?

RM:          I think it’s because they don’t ever stop to think that it might be the medication. I mean in the sense that I was on Prozac for nine weeks while I was losing my mind but I never once thought of the Prozac. My husband, Gene, was the one who finally figured out what was happening to me.

Why are we so slow to finger the drug?

DH:          Why are we so slow to finger the drug?

RM:          Because we’ve never really had a prescription drug before that’s caused so much violence and murder and mayhem. We’ve had the antibiotics for years and, of course, the illegal drugs. They were mostly made illegal because they were addictive, but we often think they cause psychosis, especially cocaine and methamphetamines. Pretty potent. However none of the school shooters were on those illegal drugs. That’s something.

DH:          Why, given so many school shootings being linked to these drugs, do you think the coin hasn’t dropped? What is it about the United States that makes people so reluctant to think the drugs could be responsible?

RM:          They say that in United States anybody who wants to can have a gun. So they blame the guns. And we did have one school shooting where the person was not on an SSRI in Kentucky and reporters write about this case all the time but neglect to mention the other school shooting. Strange. In Columbine, that second kid Dylan Klebold’s records were sealed, so nobody knows his toxicology. But you know there have even been 3 or 4 girls that did these shootings. And not all of the 65 school deaths were shootings — some were stabbings. And nobody seems to catch on. I don’t want to say nobody because while I go to my other stat counter, Go-stats, I’m amazed at the number of people that have typed in the words “antidepressant plus school shootings,” but there’s nobody in power seeing this.

Bill O’Reilly says there is an epidemic of women school teachers molesting their male students.

Bill O’Reilly, a famous TV talk show host, says there is an epidemic of women school teachers molesting their male students. He says that his program receives at least one report a week. SSRI Stories has 16 media articles of women school teachers who molested their male students while on medications for depression. One case, in Canada, was even a “won” case in the sense that the jury decided the SNRI Effexor had caused this type of weird nymphomaniac behavior.

We have won 29 legal cases so far, that we know about. If you go into SSRIS stories cover page and click on won cases you can see them all there. About 8 were homicides and 12 were murder attempts. One was an air rage case in a diplomat from England. There was a very early Zoloft case and a murder that was won 1994 that I found in the archives. Nobody had heard about it. It happened in South Carolina. So that means at least 29 judges or juries have decided to acquit on the grounds that the antidepressant caused the criminal behavior.

The other thing that gets me about these SSRIs is, not only do people become violent, they become extremely violent especially the women. They become so terribly violent they will stab somebody 200 times. There was the case in England of the man who stabbed his wife 200 times and then walked next door and stabbed his neighbor’s furniture another 200 times. So this is what’s kind of scary about it. We have about six people on death row here in United States, I think four of them are women who killed their children while they were on Prozac or Zoloft or something. One was a physician’s wife out in California and she killed her three children and then tried to kill herself and didn’t die and now she’s on death row.

DH:          Do you think there’s anyway for us to raise the profile of these cases and create a resource for people to get help?

RM:          That’s another bothersome issue — nobody’s put up a list of attorneys or physicians or anything. I did ask one or two people to help me post but nobody wanted to — they’re all so busy. Everyone’s so busy and it takes a lot of time. I can’t do the kind of work it would take to set up a list of physicians or attorneys but in future time somebody might be able to set that up.

the more I got into it the more sorry I felt for the perpetrators

When I first got caught up in the SSRI debacle I felt so sorry for the victims — people that were murdered or committed suicide. But the more I got into it the more sorry I felt for the perpetrators. So many of them were so young. Ben Garris was a young boy at the age of 15 who took Zoloft and it made him suicidal so they placed him in a prestigious hospital, Shepherd Pratt, and switched him to Prozac. He told them that he felt violent and they wrote in the hospital notes that he felt violent but they said he was being manipulative. He told me in his letter that he also told them to protect the other patients because he felt so violent. But they didn’t write that in the notes. Anyway he ended up killing a nurse who was on duty there. He got life in prison without the possibility of parole. So he was 16 when he went to prison and he’ll be there until he dies.

And there was a 13-year-old girl in Iowa who killed her great aunt. Stabbed her to death. She was on Prozac. She was given life in prison and the reason I knew it was that my sister sent me the article from the Des Moines Register that said she was on Prozac and that she was the youngest person to be sentenced to life in prison in Iowa. These are just some of the cases of the children.

DH:          Have you had any help from any group or anyone?

RM:          When I first started thinking about setting up SSRI Stories on the Internet, I sent a prototype of the way SSRI Stories would look to Sara Bostock who had lost her beautiful talented daughter to a Paxil-induced suicide. Sara believed that the prototype needed to have a “movable database,” and she hired a computer person to fix the prototype. She also paid for the server for over five years and helped me by posting 200 of the stories that I had saved in my computer. She even invented the name “SSRI Stories.” She believed in SSRI Stories and this gave me the energy I needed to carry out the work on the website. So SSRI Stories owes a lot to her and also to Ann Tracy for her early work.

But, no, other than these two people and my husband being my technician, nobody has come forward to help. There are other people doing a lot of work on psychotropic drugs but they are worn out themselves keeping different sites going. One person did write to me offering to help but I don’t know anyone who can keep up with SSRI stories because of changes in Google.

I don’t know anyone who can keep up with SSRI stories because of changes in Google

For years I went into Google and it said up above images, “Google News,” etc. I would click on Google News Advanced Search. Then when I clicked on Google News I would type in the word “antidepressant” and for that day it would say, for example, March 1, 2010, two hours ago something about an antidepressant that maybe killed somebody. I would quickly scan that to see if it was one of our cases. Then that would say four hours ago, six hours ago, and I could do that day till I was done with that day. I would type in “antidepressant” and “antidepressants,” and “anti-depressant” and “anti-depressants,” and I could get it all for that day. Then I’d type in “medication plus depression,” then I’d type in “medication plus depressed,” and “medication,” and so on. And I’d type in Prozac, Zoloft, Paxil, Celexa — there were nine of them I typed in — and they would come up one hour ago, three hours ago from all over the world. That was what was amazing.

Now when you go to Google news and type in the word “antidepressant” it will come up first of all with Wikipedia. Then it will say four days ago, then two days ago, then six hours ago — it’s 18 times as much work. With just one person trying to do it and then getting sick, it’s got to be too much. Before I was sick, when they changed that, I went ahead and set up a Google alert. Do you know what Google alerts are? I would type in “antidepressant plus murder” and I would type in my email address and have them send me a Google alert for “antidepressant + murder.” That’s an email that they sent to me personally. I was able to work off that for about eight months. I would probably get about 75 of those a day, most of them didn’t have anything to do with antidepressants plus murder. They’d say someone was murdered back in 1910 or something but too bad they didn’t have antidepressants then.

I would have to go through a lot of those that said nothing but then all of a sudden I would come across one that did — that’s how I came across the case of the schoolteacher who was acquitted of molesting a minor male student because of her Effexor usage. After that I typed into Google “Effexor + teacher,” “Prozac + teacher,” “Celexa + teacher,” etc. Then I’d get into a lot of things like a teacher says Effexor is a great drug for whatever.

DH:          How old were you when you created SSRI stories?

RM:          Well I’m 74 now, and I put up my first 1000 cases that I’d saved for 10 years in 2006 — so I was 69. I was in good health then.

DH:          What did you work at?

RM:          I was a music teacher. I went to Catholic University of America in Washington and then transferred to Drake University and got my bachelor of music education in Iowa. I taught for three years and then moved to Omaha where I met Gene. We got married and moved to Houston, Texas. He worked on the moon shot back in 1963, 1964. We lived there till 1968 and then we moved to Dallas. I got in touch with Andy Vickery of Houston over the Sargeant Steven Christian case here in Dallas. So I knew Andy Vickery and Rick Ewing before I even put up my message board.

DH:          You’re a former music teacher who at the age of 69 creates SSRI stories. What could other people do to make a difference?

RM:          Well I think other people should be watching the personalities of people.

watch the personalities of people.

If they see a sudden change in the personality of somebody they’ve known for years they need to ask them “Are you on a medication?” If you ask a person “Are you taking a drug?” they often think you mean an illegal drug. So it’s a very delicate question to ask. I think when a family has a person who starts on a medication and their personality changes, they don’t realize it is the medication causing this. They just think that the illness is getting worse.

We have so many cases where, “Well, he started on Prozac and his illness was getting worse so we took him to the doctors and he doubled the dose.”

We have all kinds of cases like that. So I think people need to be aware of what SSRIs can do and how they can cause this personality change.

DH:          What you’re answering though is what we need to do about this group of drugs. What I’m asking is what can people do to change the system? You’ve been an extraordinary example to people of what they could be doing.

RM:          I wish that there was a group working on the SSRIs because it’s affecting so many people — perhaps as many as one out of three. There is a WEB MD article on SSRI Stories that states that one out of three people may become worse on antidepressants and even become bipolar. I mean in some the effects are just mild personality changes, they get kind of grumpy you know. But there are ones that are serious, I don’t know how often that happens, but it’s a lot.

Another thing is that the suicide rate has not really gone down in the United States. It declined a little in the 1990′s because of the good economy but the government statistics from the years 2005 to 2007 shows it’s gone up for all ages except 24 — the Black Box warning worked!

terrible things are happening

And terrible things are happening to these poor wounded warriors in Iraq and Afghanistan. They’re giving these kids antidepressants and sending them out in battle where they’re committing suicides and homicides and everything. That man from Sherman, Texas, that went into the clinic in Bagdad and shot five people dead. Remember that one? He was on PTSD drugs, one of them an antidepressant, and they had just changed his dosage the day before. Also, what was the psychiatrist taking who shot and killed 14 American soldiers at Ford Hood, Texas? They did mention in Gulf News that he was the type of psychiatrist who tended to medicate himself.

Some of the atypical antipsychotics like Seroquel and Risperdal can also cause violence and that should be brought out too. And then there’s Chantix, which has so many cases of violence. How many people are taking Chantix? Probably not very many. It’s just for people who want to quit smoking. One person did say to me, and it was a doctor, that yes Prozac is number two on the list in that recent article by Tom Moore, but everybody takes Prozac. In other words he was thinking because of the number of people, there isn’t really a problem. I said well what about Chantix, and he just nodded in a puzzled fashion. Physicians tend to be skeptical.

DH:          Why?

The physician does not recognize what’s happening

RM:          This is what I’ve noticed from the people who have contacted me through SSRI stories. The physician does not recognize what’s happening. The patient is started on Prozac. They go to the physician and the physician says, “How are you feeling?” “Oh I feel tremendous, I feel great.” That’s wonderful, but what’s happening then is that person is going home and they are deviant, they’re divorcing their husband or wife and they’re taking off on a motorcycle — I’m not kidding this is a true story — to go to Florida and live with some beach bum who tends bar. They’re leaving their two children behind and their husband and the doctor didn’t have a clue. Because they said they felt great. That’s what’s so weird.

A lot of people type in “SSRIs and divorce.” I’m amazed the number of people who do that, or “Zoloft ruined my marriage” — I can remember that from many people. Somebody else typed in something like “Paxil made me crazy.” Those are the people who are reaching SSRI Stories, but who are they? They’re just the man in the street and not any powerful group. So we need a group to work on all of these different angles, the divorce, the hypomania, the pyromania, the kleptomania, nymphomania — I think that’s what’s happening to these woman schoolteachers. What they don’t realize is that people who go into mania and hypomania have an increased libido.

It’s the children that disturb me the most.

But it’s the children that disturb me the most. There is a post on SSRI Stories about a 15-year-old girl who was forced by her father to take Paxil and then to double the dose. A few days later she slit her younger brother’s throat and buried him in the back garden. I cannot imagine a young girl doing this. These are some of the really tragic cases and they are being hidden.

This why I can’t read mystery stories anymore. If I wanted to read something, I will read a comedy. Every time Gene and I went to the movies or out with friends to movies we would go to comedies. I would have to see a comedy because I would sit all day long and find those cases and I needed relief from this. All I can say is that we need some group that’s big and powerful who will pick up all the different angles there are in SSRI Stories.

Six and a half years on… and what has the MHRA done to clean up its act?

Nothing is the short answer.

Below are extracts from The House of Commons Select Committee Report of March 2005 on the The Influence of the Pharmaceutical Industry… March 2005 – that’s a long time ago and the UK drugs regulator, the MHRA, has still made none of the changes recommended.

The Select Committee summed up:

“The MHRA, like many regulatory organisations, is entirely funded by fees from those it regulates. However, unlike many regulators, it competes with other European agencies for fee income… dangers of the present arrangements…. During this long inquiry we became aware of serious weaknesses in the MHRA. Worryingly, in both its written and oral evidence the Agency seemed oblivious to the critical views of outsiders and unable to accept that it had any obvious shortcomings, except those that could be remedied by more transparency. The Agency’s attitude to its public health responsibilities suggested some complacency and a lack of requisite competency, reducing our confidence in its ability to undertake the reforms needed to earn and deserve public trust.

The consequences of lax oversight is that the industry’s influence has expanded and a number of practices have developed which act against the public interest.”

Download the full report here, in the meantime here are a few choice extracts:

Page 4: The industry is by no means solely to blame for the difficulties we describe. The regulators and prescribers are also open to criticism.

Page 8: The industry is hugely influential ….Its influence in Parliament is extensive. The Annex lists the All-Party Groups the pharmaceutical industry supports.

Page 4: The regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), has failed to adequately scrutinise licensing data and its post-marketing surveillance is inadequate. The organisation has been too close to the industry, a closeness underpinned by common policy objectives, agreed processes, frequent contact, consultation and interchange of staff. We are concerned that a rather lax regime is exacerbated by the MHRA’s need to compete with other European regulators for licence application business.

Page 5: The Government, like the MHRA, has tended to assume that all is for the best… In view of the failings of the MHRA, we recommend a fundamental review of the organisation

Page 30: The MHRA is unusual in being one of few European agencies where the operation of the medicines regulatory system is funded entirely by fees derived from services to industry

Page 31: The MHRA relies on company data, presented as a series of detailed assessment reports, in its decision whether or not to licence a drug. Raw data is very rarely analysed.

Page 49: The consent forms do not inform patients that the raw data may be maintained by the industry, not made available to the general public or even reviewed by the regulatory authorities.Much of the criticism was essentially of the lack of transparency and the difficulties for doctors and others in assessing the research which is undertaken.

Page 52: The major impetus for greater transparency with medicines came from a lawsuit brought in August 2004 by the New York State Attorney General against GSK, alleging the company had concealed negative clinical trial results. As part of the settlement, GSK agreed to set up a public register of all clinical trials on all of its drugs.This breached a longstanding
convention, vigorously upheld by the regulators, whereby clinical trial results
were regarded as company property and commercially confidential.

Page 52: Too many problems appear to persist unnoticed or unacknowledged by the organisations that are central to the co-ordination, conduct and review of the clinical trials.

Page 78: The relationship between the industry and the MHRA is naturally close. There are regular interchanges of staff, common policy objectives, agreed processes, shared perspectives and routine contact and consultation. Many of the senior staff of the MHRA have previously worked with the industry …Overwhelmingly, the different parties appeared to speak the same language, with companies determined to observe the letter of the law and the regulators determined to uphold it.

Page 79: Such closeness provides the basis of the trust that the MHRA said it relied on as an integral part of the regulatory process.239 The MHRA Chairman suggested that trust underpinned the stance of the MHRA towards the companies they regulate. We inferred that this extended to the routine acceptance of companies’ summaries of the results of tests on their drugs as true reflections of the raw data on which they were based.

Page 79: Trust is critical in the relationship between regulators and industry. However, at the heart of this inquiry are the concerns of those who believe that the MHRA is too trusting. Trust should be based on robust evidence; …The evidence indicated that the MHRA examined primary (raw) data on drug effects only if it suspected some misrepresentation in the summary data supplied. It was argued that such trust in regulated companies goes too far: reliance on company summaries is neither sufficient nor appropriate, in the absence of effective audit and verification of data that companies provide. …Denial of access to information held by the [MHRA] puts the interests of pharmaceutical companies ahead of those of patients and prescribers. This is particularly indefensible in the light of evidence that regulatory agencies, supposedly established to protect the public, are acquiescing in biased later publication of the information they hold.

Page 79: Regulatory inertia was clearly illustrated through publication of the findings of the UK’s first ever public investigation into a drug safety problem:

Page 82: In setting up the review of SSRI antidepressants, the MHRA/CSM responded to another long-standing concern about regulatory activity: the possible conflicts of interest of regulators.

Page 83: user reports of often serious problems had been systematically discounted or ignored.

Page 85: In evidence to this Committee, Mr Brook expressed concerns about the influence of the industry on drug regulation, specifically the perceived threat by MHRA staff of legal entanglement resulting from regulatory action: …every time we made difficult decisions there was always this issue of: ‘We have got to be very careful because the pharmaceutical companies will sue us if we get this wrong; they will take us to court and take us through legal processes’; and it was very clear that the MRHA officials were very mindful the whole time of that dimension, to my view, more than the dimension of public health and public responsibility of the public.

Page 87: Further concerns, relating to the MHRA’s reliance on company summaries of data, rather than raw data are discussed elsewhere.

Page 96: A statement to the effect that heart problems were associated with Celebrex was issued by the MHRA in December 2004. In the statement, the Agency made it clear that it had not seen the actual data from the drug company but that its advice was based on information from Pfizer’s website.

Page 98: The regulatory authority, which is responsible for controlling much of the behaviour of the industry has significant failings. Lack of transparency has played a major part in allowing failings to continue. The traditional secrecy in the drug regulatory process has insulated regulators from the feedback that would otherwise check, test and stimulate their policies and performance. Failure can be measured by the MHRA’s poor history in recognising drug risks, poor communication and lack of public trust. Regulatory secrecy also underpins publication bias, and other unacceptable practices. The closeness that has developed between regulators and companies has deprived the industry of rigorous quality control and audit.

Page 102: Thirdly, procedures for investigating complaints about breaches of regulations are too slow, poorly enforced and weakly sanctioned.

Page 103: The MHRA does not routinely examine raw data submitted with the licence application but is dependent on summaries provided by the applicant. The Expert Working Group on SSRI’s report of December 2004 showed that summaries of information may not provide the detail required to assess drug risks adequately.

Page 106: The publication of misleading promotional material is a criminal offence and the punishment should befit such a status.

Page 106: The MHRA, like many regulatory organisations, is entirely funded by fees from those it regulates. However, unlike many regulators, it competes with other European agencies for fee income… dangers of the present arrangements….During this long inquiry we became aware of serious weaknesses in the MHRA. Worryingly, in both its written and oral evidence the Agency seemed oblivious to the critical views of outsiders and unable to accept that it had any obvious shortcomings, except those that could be remedied by more transparency. The Agency’s attitude to its public health responsibilities suggested some complacency and a lack of requisite
competency, reducing our confidence in its ability to undertake the reforms needed to earn and deserve public trust.

Page 117: The MHRA should put in place systematic procedures to randomly audit raw data.

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