We Have Known This For 20 Years …


Psychiatry and the drugs industry have tried to suppress the reality of severe side effects for decades.. many people have been harmed because of this..


Antidepressant withdrawal symptoms severe, says new report

Existing guidance that symptoms are minimal leads to misdiagnosis and ‘harmful long-term prescribing’

 

https://www.theguardian.com/society/2018/oct/02/antidepressant-withdrawal-symptoms-severe-says-new-report

 

Half of all those taking antidepressants experience withdrawal problems when they try to give them up and for millions of people in England, these are severe, according to a new review of the evidence commissioned by MPs.

Guidance from the National Institute of Health and Care Excellence (Nice), which says withdrawal symptoms “are usually mild and self-limiting over about one week” urgently needs to be changed, say the review authors.

Dr James Davies from the University of Roehampton and Prof John Read from the University of East London say the high rate of withdrawal symptoms may be part of the reason people are staying on the pills for longer. They cannot cope, so carry on taking the drugs, or their doctors assume they have relapsed and write another prescription.

The review was commissioned by the all-party parliamentary group for prescribed drug dependence and follows a long debate about the Nice guidance, which critics say is out of date.

Modern antidepressants of the SSRI class, such as Prozac (fluoxetine) and Seroxat (paroxetine), were marketed in part on their safety. Studies showed that when taken alone, overdoses were rarely fatal, which was not the case with benzodiazepines. Also, stopping the drugs was said to be easier.

There have been plenty of anecdotal accounts of withdrawal symptoms, which include dizziness, vertigo, nausea, insomnia, headaches, tiredness and difficulties concentrating. But the Nice guidance said in 2004 that the withdrawal symptoms were slight and short-lived and was re-adopted without further evidence in 2009. It is similar to the US guidance, which says symptoms usually resolve within one to two weeks.

The review, published in the journal Addictive Behaviors, focused on 14 studies of antidepressants that had relevant data on withdrawal symptoms. The studies, which were diverse, showed that between 27% and 86% of people suffered from them, with a weighted average of 56%.

Antidepressants are now some of the most commonly prescribed drugs in the UK and US, say the authors. “In the UK, usage has risen since 2000 by 170%, with over seven million adults (16% of the English adult population) being prescribed an antidepressant in England alone last year,” says the review.

About half of antidepressant users have been taking the pills for longer than two years. In England, that is 3.5 million people – 8% of the population. In the US, 13% of the population (37 million adults) were on them by 2011-2014, official data shows. Half have been taking them for five years or more.

“This new review of the research reveals what many patients have known for years – that withdrawal from antidepressants often causes severe, debilitating symptoms which can last for weeks, months or longer,” said Dr James Davies.

“Existing Nice guidelines fail to acknowledge how common withdrawal is and wrongly suggest that it usually resolves within one week. This leads many doctors to misdiagnose withdrawal symptoms, often as relapse, resulting in much unnecessary and harmful long-term prescribing.”

The review includes comments from some of the studies where antidepressant users were interviewed about their experiences of trying to wean themselves off the pills.

One spoke of “horrible dizzy spells and nausea whenever I lower my dose”. Another said: “The withdrawal effects if I forget to take my pill are severe shakes, suicidal thoughts, a feeling of too much caffeine in my brain, electric shocks, hallucinations, insane mood swings … kinda stuck on them now coz I’m too scared to come off it.”

Sir Oliver Letwin MP, chair of the parliamentary group, said: “This systematic review provides important new data on antidepressant withdrawal which will be considered by Public Health England as part of their current review into prescribed drug dependence. The data suggests that existing medical guidelines in this area should be urgently updated to reflect the fact that antidepressant withdrawal is much more common, severe and long-lasting than previously stated. Furthermore, we hope that other medical bodies will take note of this new research, and update their own guidance accordingly.”

Nice said it is looking again at its guidance. “In July 2018, the committee met and concluded that the current evidence base needs updating to include research from July 2016 onwards. Nice agrees,” said Paul Chrisp, director of the Centre for Guidelines at Nice. “It is important that the final recommendations are based on the most up-to-date evidence possible. In addition to updating the existing evidence reviews, we will include new work on patient choice and a focus on shared decision making.

“We hope the final guideline will allow people with depression to be offered the best treatments and reach joint decisions about their care that reflect their preferences and values.”

This article was amended on 3 October 2018 to clarify how overdosing on SSRI antidepressants differs from overdosing on benzodiazepines.

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While Wendy Burn Plays Mind Games… People Die…


“…Half of all those taking antidepressants experience withdrawal problems when they try to give them up and for millions of people in England, these are severe, according to a new review of the evidence commissioned by MPs….

https://www.theguardian.com/society/2018/oct/02/antidepressant-withdrawal-symptoms-severe-says-new-report


A recent study touted in the media claims that up to 30% of people on SSRI antidepressants might experience severe withdrawal symptoms. This isn’t news to me, or the millions of people who have experienced severe withdrawal symptoms, and it isn’t news to the researchers, authors, bloggers, journalists, critical psychiatrists, documentary film makers, bereaved parents of SSRI tragedies, psychologists etc- but to the royal college of psychiatry, it seems to be.

Or is it?

It’s been known for at least 16 years in the mainstream UK (since around the time of the BBC’s Secrets of Seroxat documentary) that SSRI’s have a risk of serious withdrawals, however it seems that psychiatry, and psychiatrists (such as Wendy Burn) has been actively deflecting anything that would make SSRI’s look bad ever since.

Wendy (the Royal college of Psychiatrist’s UK president) seems to see her role not as a patient advocate as such, but more of a guardian of the psychiatric paradigm, and even the dogs on the street know by now- the psychiatric paradigm is owned by the Pharmaceutical industry, and has been for some time. Therefore, perhaps Wendy knows not who-or what- she really serves?

(or maybe she knows all too well?)

Wendy, claims that the study -touting 30% will experience severe withdrawals- is not scientific, and that also, we must

 

“…Remember this is a selected group, not randomly chosen. Terrible for those affected and we must try to help them but it is not 30% of everyone who ever takes an antidepressant…”

https://twitter.com/wendyburn/status/1049758874612506625


Let’s stop for a minute and consider that Wendy is correct (and she might be correct), let’s consider that it is not 30% of people who will have severe withdrawals, let’s bring down our guesstimate to 5% (a really low conservative guess) and let’s apply that to the real world.

A recent article in the UK press said that up to one in 6 people at any time in England will be on an SSRI drug.

….with over seven million adults (16% of the English adult population) being prescribed an antidepressant in England alone last year,” says the review….”

https://www.theguardian.com/society/2018/oct/02/antidepressant-withdrawal-symptoms-severe-says-new-report

That’s seven million adults in the UK. All on SSRI drugs.

If we take the most conservative estimate of 5%, not the 30% that has been touted in the media, and which Wendy of the college of psychiatrists, says is not an accurate number. Let’s go down by 25% to 5% as our most conservative estimate.

5% of 7,000,000 is

350,000

That’s 350,000 people who could be experiencing debilitating withdrawals, withdrawals so severe that they are ill for months, sometimes years. A Withdrawal so severe and horrific that they can’t work, they lose relationships, jobs, their lives, personalities, health and so on. Some might be in such pain from the severe withdrawal that they kill themselves. I felt that way on Seroxat, the despair in a severe Seroxat withdrawal is beyond words.

It’s Stephen King level horror… and then some.

There are no official guidelines for helping those in severe withdrawals, no supports, and outdated advice from NICE. Many people will be left alone in agony and some will die because of it.

But Wendy doesn’t see any of this as a problem.

She doesn’t see that severe withdrawals are a serious problem, and that denial of them is also a problem..

She doesn’t see conflicts of interest between psychiatry and pharma as a problem either.

Perhaps people like Wendy are the problem?

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Seroxat Addict Speaks Out..


https://www.dailymail.co.uk/health/article-6228645/Now-doctors-wake-dangers-patients-hooked-depression-pills.html

Now doctors MUST wake-up to the dangers of patients hooked on depression pills

  • For 18 months the Daily Mail has been campaigning for patients addicted to pills 
  • Now, a major report proves that millions of people are affected by the affliction 
  • Here, Jonathan Gornall details the compelling stories of two typical sufferers  

Stevie Lewis went to see her GP for help with insomnia after struggling with the pressures of starting up a business consultancy. The 41-year-old from Bristol hoped she’d be given something to help her sleep.

‘But to my surprise the doctor announced that I was on the edge of clinical depression — what my mother’s generation would have called a nervous breakdown,’ she recalls.

And instead of sleeping tablets, she was given a prescription for paroxetine, a type of antidepressant known as a selective serotonin reuptake inhibitor (SSRI), thought to work by increasing the level of a mood-enhancing brain chemical, serotonin.

Hooked: Stevie Lewis, from South Wales, went to see her GP for help with insomnia - but was told she was on the cusp of clinical depression...and given addictive anti-depressants

Hooked: Stevie Lewis, from South Wales, went to see her GP for help with insomnia – but was told she was on the cusp of clinical depression…and given addictive anti-depressants

‘I was completely shocked, not least when he told me I had a chemical imbalance in my brain,’ says Stevie, who now lives in Rogiet, South Wales. ‘I thought very carefully about whether I should take this drug, but in the end I did, because I believed him — he was my doctor.’

However, her shock at being prescribed an antidepressant was nothing compared with the horror that awaited her when she tried to wean herself off paroxetine.

Stevie did not know this was the start of a 20-year battle to extricate herself from the grip of a drug she never needed, during which she would struggle with appalling side-effects that doctors refused to acknowledge were caused by withdrawal, dismissing them as a return of her original symptoms.

Antidepressants, she was told emphatically, weren’t addictive and she could stop taking them whenever she felt like it. But when she tried, she found herself running a gauntlet of horrific side-effects, including extreme anxiety and an irrational terror of everyday acts, objects and places. At times, she felt she might be going mad.

But, as revealed in the Mail today, a major new study suggests that far from losing her mind, Stevie, like millions of patients, was indeed experiencing drug withdrawal.

The review, one of the largest ever carried out of studies investigating the incidence, severity and duration of reactions to antidepressant withdrawal, concludes that the phenomenon is not only real, but ‘more widespread, severe and long-lasting’ than doctors have been led to believe by years of guidance from the National Institute for Health and Care Excellence (NICE).

Stevie endured a 20-year battle to extricate herself from the grip of a drug she never needed

Stevie endured a 20-year battle to extricate herself from the grip of a drug she never needed

The new research was carried out on behalf of the All-Party Parliamentary Group for Prescribed Drug Dependence, and is published in the journal Addictive Behaviors.

Researchers looked at 23 studies published over the past 20 years and concluded that 56 per cent of all patients on antidepressants suffer withdrawal symptoms, of which 46 per cent said their symptoms were severe.

The authors estimate that in England alone, where one in six adults takes antidepressants, 4 million people may experience symptoms when withdrawing from the drugs, and around 1.8 million may experience these as severe.

They also found that it’s ‘not uncommon for patients to experience symptoms for several weeks, months or longer’, with some having debilitating symptoms for years.

These findings, say the authors, make a nonsense of the NICE guidance, which advises prescribing doctors that while withdrawal symptoms ‘can be severe’, they are ‘usually mild and self-limiting over about one week’.

The current guidance from NICE ‘is not only out of date but doesn’t respect the evidence base’, says James Davies, co-author of the new paper and a reader in medical anthropology and mental health at the University of Roehampton.

And the personal cost to patients is incalculable. Dr Davies suggests the faulty guidance is causing ‘many doctors to misdiagnose withdrawal symptoms, often as relapse, resulting in unnecessary and harmful long-term prescribing’. That’s because when people come off antidepressants and then experience withdrawal, ‘the doctor looks at the NICE guidelines and concludes it can’t be withdrawal’.

Fact: 56 per cent of all patients on anti-depressants suffer withdrawal symptoms - of which 46 per cent said their symptoms were severe

Fact: 56 per cent of all patients on anti-depressants suffer withdrawal symptoms – of which 46 per cent said their symptoms were severe

‘Patients are regularly having their withdrawal reactions either denied, ignored or, most concerningly, misdiagnosed as a relapse in their condition, at which point the drugs are reinstated.’

As a consequence, the length of time people are kept on the drugs has doubled since the guidelines were issued in 2004.

Dr Davies suggests that the existing guidelines have contributed to the doubling over the past decade of the number of adults in England on antidepressants — an escalation he describes as nothing less than ‘a public health crisis’.

It’s important to note that many people say these medications have helped them. However, there is no scientific proof that the drugs do so by reversing a ‘chemical imbalance’. There is also evidence that, for most, they’re no more beneficial than placebos.

‘But unlike placebos, they cause side-effects and withdrawal problems,’ says Dr Davies.

The new review of evidence has been submitted to Public Health England, which is conducting a review into prescription pill dependency, set up in January after a campaign backed by the Mail.

It’s also been sent to NICE, whose current guidance is based chiefly on a paper presented at a psychiatric symposium on ‘antidepressant discontinuation syndrome’ held in Phoenix, Arizona, in the U.S. in December 1996, which was funded by drugs company Eli Lilly.

‘The understanding of anti-depressant withdrawal was significantly shaped by that symposium,’ says Dr Davies. But neither that paper nor a later one relied upon by NICE ‘cites a single source that supports the one-week claim’.

‘We’ve looked very thoroughly for the evidence to support the NICE advice, and there isn’t any,’ adds John Read, a professor of clinical psychology at the University of East London and co-author of the new paper. ‘There’s no way they can put out the same advice again once they’ve read this.’

Dr Joanna Moncrieff, a psychiatrist and leading critic of the overuse of antidepressants, welcomes the research and says it’s imperative NICE updates its guidance.

‘This paper shows that official documents and the psychiatric profession have not taken this issue seriously, not put enough effort into researching it and not wanted to face up to the problems that these drugs can cause,’ she says.

‘We’re giving people these drugs for years on end and we haven’t bothered to work out what happens to them, how that affects the body, and what happens when people stop them. That seems just outrageous, a terrible situation.’

WHAT THE NEW RESEARCH COULD MEAN FOR YOU…

The new research casts doubt on the official view that withdrawal symptoms from antidepressants are usually mild and short-lived, as set out in NICE guidelines and in a recent statement from the Royal College of Psychiatrists (RCP), which said: ‘In the vast majority of patients, any unpleasant symptoms experienced on discontinuing antidepressants have resolved within two weeks’.

In fact, as many as half of patients will experience withdrawal symptoms, with nearly half of those suffering severe effects, the new research has found. ‘We are very much hoping that our research will influence the direction of NICE’s new guidance,’ says Dr James Davies, one of the authors.

Professor John Read, a psychologist and the report’s co-author, adds: ‘We want NICE to acknowledge that antidepressant withdrawal is more common, long-lasting and severe than current guidelines state, and to oblige doctors to warn patients.’

Change may be on its way, though. In comments on the new research Professor Wendy Burn, the RCP’s president, said ‘antidepressants are an effective, evidence-based treatment’ which were ‘a life-saver for many people’.

She adds: ‘But not enough research has been done into what happens when you stop taking them. As this review shows, for many people the withdrawal effects can be severe, particularly when antidepressants are stopped abruptly.

‘We are pleased that Public Health England is prioritising dependence on, and withdrawal from, prescribed medicines as an area of review, and welcome NHS England’s referral to NICE asking that they do the same.’

Many, she believes, would not start taking antidepressants if they knew the battle they might have to get off them. ‘There are lots of people who contact me who have struggled to get off this medication and feel so angry that this was not highlighted to them.

‘This data is now there, and both doctors and patients need to be much more cautious about starting antidepressants in the first place, because it is quite clear that getting off them is not easy for a substantial number of people.’

Among them Stevie Lewis. She decided to come off paroxetine for the first time after taking it for about five months, but within a few days began to suffer ‘tremendous nausea and dizziness’, which lasted for two weeks.

She had no idea it had anything to do with the drug — neither did her doctor, who diagnosed labyrinthitis, an inner-ear disorder affecting balance. In fact, dizziness is a well-documented side-effect of suddenly stopping antidepressants.

In March 1998, Stevie went reluctantly back on the drug after suffering three miscarriages and the death of her mother. ‘Looking back, all I really needed was grief counselling,’ says Stevie, now 63. ‘It’s absurd, given what I’d gone through, that someone could suggest I was feeling low because of a chemical imbalance in my brain.’

After a year back on paroxetine, Stevie again decided to quit — ‘but this time I just couldn’t do it’.

Every time she tried, a few days later she’d feel highly anxious and tearful, developing insomnia. Her doctor said it was anxiety disorder and told her to stay on the pills.

It was only in 2002, when she made contact with a support group online, that she realised she’d become dependent on the drug and was experiencing withdrawal from it.

‘It had been a shock to be told I was on the edge of a nervous breakdown, and then another to be told I had a chemical imbalance in my brain — now I was a prescription junkie,’ says Stevie.

What Really Killed Dolores O’ Riordain?


“….IRISH rock star Dolores O’Riordan (46) drowned in the bathtub of her London hotel room while more than four times over the drink driving limit.

The revelation came as a London coroner’s court held an inquest into the death of The Cranberries lead singer and mother of three.

Westminster Coroner Dr Shirley Radcliffe returned a verdict of accidental death with the singer having drowned due to alcohol intoxification

Ms O’Riordan was found dead in bedroom 2005 at the Hilton hotel on Park Lane in London at 9am on January 15….”

https://www.independent.ie/irish-news/courts/were-just-glad-it-is-over-family-of-dolores-oriordan-as-coroner-records-her-death-as-accidental-37289371.html

 

The death of Irish singer Dolores O’Riordain (from the Cranberries), is yet another celebrity demise that leaves us with more questions than answers. I’ve written about Dolores before (see here); in that post from 2014, I asked was Dolores on psychiatric drugs? As it turns out, according to the inquest into her death, she certainly was. She had four anti-depressants in her system at the time of her death (by drowning in a bath tub), and a high level of alcohol. Her death was recorded as accidental and alcohol was considered the culprit. She was also under the care of two psychiatrists; both quite well renowned.

“…Trinity College Dublin (TCD) psychiatrist, Dr Seamas O’Ceallaigh, and US psychiatrist Dr Robert Hirschfeld were treating Ms O’Riordan…”

If, as the article suggests, Dolores was receiving the best psychiatric mental health care available, then why did she die? Surely, if you could afford the best health care, your life should be extended not diminished? that’s usually the way it works right?

Not so, with psychiatric treatment.

Pulitzer prize nominated journalist- Robert Whitaker’s ‘anatomy of an epidemic‘ explains in detail why those who receive psychiatric care (mostly in the form of drug treatments) have shortened life spans and increased disability and disablement.

When someone gets diagnosed with a ‘mental illness’ – In Dolores’s case- Bi-Polar, it usually send them down a trajectory of psychiatric medication regimes, which can last for years, even decades. The multiple side effects from psychiatric drugs can end up being more of a problem than the original diagnosis. Often times the side effects can mimic psychiatric illnesses, leaving the person in a much worse state than if they weren’t on the drugs. It’s very hard to come off psychiatric drugs too, even if you want to, and due to their toxicity, many people are poor metabolizers of them anyhow, which means that the drugs build up in the liver, causing many physical and mental side effects to exacerbate over time.

It’s interesting to note also, that 4 anti-depressants were found in Dolores’s system at the time of her death. Why on earth would her psychiatrists prescribe her 4 different anti-depressants? This is a recipe for disaster. It’s this kind of poly-pharmacy that often kills, maims or disables psychiatric drug users because of the various interactions between the medications. I took Seroxat for a few years in my twenties, and it was a horrific experience, it changed my personality, made me unruly, aggressive, act out of character etc (these are all common well known side effects of Seroxat and other SSRI anti-depressants) so I can only imagine what it feels like to be prescribed multiple psychiatric drugs.

It seems Dolores’s story follows the same path as many of those who are prescribed psychiatric drugs over a long period of time. Usually the psychiatric diagnoses comes from a trauma. In Dolores’s case, she was sexually abused in childhood, and she became anorexic, it’s unclear when she was diagnosed with bi-polar, but it seems it was in young adult-hood or thereabouts. It’s safe to assume that she had been medicated for years because of this diagnosis. Once entered into this system of drugging it’s very difficult to get out of it, a lot of the time those who are prescribed psychiatric drugs over long periods of time, end up in a bad way.

This begs the question, who is responsible for her untimely death? Who is responsible for the prescriptions of multiple, mind-bending, personality changing, multiple-side effect psychiatric anti-depressant drugs that she was prescribed?

“…Dr Andrews conducted the toxicology tests and found Ms O’Riordan had a blood alcohol concentration of 330mg and urine alcohol concentration of 397mg.

Traces of four medications used to treat depressive disorders were found in her system but all bar one was within the low therapeutic range.

That fourth drug was found in only a slightly elevated range….”

What were the four medications used to treat depressive disorders that she was prescibed? and why were her psychiatrists not monitoring her and her prescriptions? why was she left alone in such a state with access to multiple psychiatric medications? were the psychiatrists tracking her reactions to the meds she was prescribed over the years?

One of Dolores’s psychiatrists was US psychiatrist Dr Robert Hirschfeld. When you google Hirschfeld, it’s interesting that the third link that comes up is from a blog from an ex-patient of his who seems not too happy with Hirschfeld’s apparent long links to psychiatric drug manufacturers.

See here –

https://depressionintrospection.wordpress.com/tag/robert-hirschfeld/

“….Here’s a nice little tidbit. The questionnaire was “adapted with permission from Robert M.A. Hirschfeld, M.D.” So as an uninformed patient reading this (which I was at the time), I’m thinking, “Oh, this must be legit since they got permission from a doctor to use this checklist.”

There’s more than meets the eye here.

“….On the surface, Dr. Hirschfeld seems like an awesome doctor – and he very well may be. Dr Hirschfeld’s bio from the University of Texas Medical Branch at Galveston (UTMB) extols the “Professor and Chair” of its psychiatry deparment. He has history of working with various national organizations such as the National Depressive and Manic-Depressive Association,  National Institute of Mental Health (NIMH), and National Alliance for Research on Schizophrenia and Depression (NARSAD). He’s written all kinds of articles and blah blah blah. He’s considered a leader in his research of bipolar disorder.

In fact, because Dr. Hirschfeld is so great, he’s a member of pharmaceutical boards and has acted as a consultant for pharmaceutical companies, according to ISI Highly Cited.com. Some of our favorite guys appear here: Pfizer, Wyeth, Abbott Labs., Bristol-Myers Squibb, Eli Lilly, Forest Labs, Janssen, and – lookee here! – GSK…..”

Most people don’t realize that bio-psychiatrists, like the ones who treated Dolores, are not concerned with helping their patients deal with trauma of personal problems. They are fixated on the brain of the ‘mentally ill’ person and not their emotions, or feelings. They treat the brain, not the person. I didn’t realize this myself, until I came off psychiatric drugs some years ago, and researched psychiatry and the drugs industry. I was absolutely shocked and appalled when I realized that psychiatrists were beholden to the drugs industry and saw no problem with selling themselves to the industry to make money. I was shocked to see that drug companies have been hiding side effects for years with many of their drugs, and that many tens of thousands of people’s lives were being destroyed due to the over-medicalization of human distress.

Ultimately, alcohol was deemed responsible for her untimely death, however it would seem to me that psychiatric drugs were a massive factor also. Anti-depressants don’t mix well with alcohol, I know this from personal experience, they also can make people crave alcohol sometimes, (to take the edge off). Of course- psychiatrists and the drug’s industry play down these side effects- they play down all side effects, because it’s in their interest to keep you, and everyone else, on these drugs. It’s not in your interest, it’s in theirs.

It seems to me that Dolores was just another victim of a psychiatric system that is completely corrupted by the pharmaceutical industry, and sees patients as mere fodder. It’s very easy to entrap vulnerable people in this system of continual over-diagnoses, mis-diagnosis and drugging, and it seems that Dolores fell foul of the all too usual trajectory of :

Trauma = Psych Diagnoses = Psychiatric drug regime= lifetime of side effects= personality changes= polypharmacy= death.

This system has to change, vulnerable people like Dolores deserve better.

 

 

 

Is Giving Anti-Depressants To Teens A bad Idea ?


“..The study looked at the average effect of anti-depressants rather than how they worked for individuals, and the researchers said the findings might not apply to use of the drugs over the longer term…”

 

Great documentary from the acclaimed ‘the doctor who gave up drugs’ series (see below), about the dangers of anti-depressants in kids. It has been established for a long time now that SSRI anti-depressants are unsafe for kids, but what about their use in the adult population?

Interesting segment from David Healy discussing the raw data on Seroxat in teens (see first video below). It was because of the actions of people like David Healy that Seroxat was never officially approved for use in teens in the UK. If Glaxo had gotten their way, it’s possible that Glaxo would have pushed Seroxat for a licence for kids in the UK. This would have meant more SSRI induced teen suicides.

The most interesting segment for me was the part with Andrea Cipriani, the researcher who recently analyzed a meta-analysis of studies on SSRI’s, which made waves in the media not too long ago.

Back in February, Cipriani (see second video down) said that ‘anti-depressants are effective for moderate to severe major depression in adults’. However as Dr David Healy points out, the studies that Cipriani made his analysis on, were mostly ghost written articles.

Cipriani did not study the raw data, therefore his analysis is inherently skewed. He doesn’t mention this in the many media articles he appeared in to promote this study.; he only addresses it because David Healy brought it up. It seems to me that doctors like Cipriani are merely agents of PR for psychiatry (and indeed by default then- the drug companies) than patient advocates. Every few years psychiatry needs to re-establish its dominance of the mental health paradigm.

It’s just marketing.

Why do academics like Cipriani not demand to see the raw data from the drug companies?

Why do they mislead the public?

Why does Cipriani (and indeed Carmine Pariante) not mention also that his analysis was based on very short term studies (and that these studies are not raw data studies), and that safety and effectiveness in long term use in adults has not been established? (This despite the fact that people end up on these drugs for years, sometimes decades).

I feel also that any time Carmine Pariante is interviewed on TV he should be forced to mention his links to drug companies:

His links to GSK  alone are shameful considering GSK’s vast criminality and harm to consumers and patients over the decades.

“…Dr Carmine Pariante has received Funds for a member of staff and funds for research. Professor Pariante’s research on depression and inflammation is supported by: the grants ‘Persistent Fatigue Induced by Interferon alpha: A New Immunological Model for Chronic Fatigue Syndrome’ (MR/J002739/1) and ‘Immunopsychiatry: a consortium to test the opportunity for immunotherapeutics in psychiatry’ (MR/L014815/1; together with GSK), from the Medical Research Council (UK); the National Institute for HealthResearch (NIHR) Mental Health Biomedical Research Centre in Mental Health at South London and Maudsley NHS Foundati on Trust and King’s College London; by Johnson & Johnson as part of a programme of research on depression and inflammation; and by a Wellcome Trust led consortium that also include Johnson & Johnson, GSK and Lundbeck…”

 

I don’t trust Andrea Cipriani, I don’t think he is being honest.

I also don’t trust Carmine Pariante either, however I think he is more misguided than anything else.

Anti-depressants don’t save lives.

Doctors like David Healy save lives.

Doctors like Pariante and Cipriani help drug companies to extinguish them..

 

 

People Write Into People’s Pharmacy About Paxil/Seroxat Suicide..


“….One person wrote about her son: “He was a 35-year-old young man with everything to live for, good job, happily married, no financial problems. He was experiencing some anxiety and chest pains and saw a doctor, who prescribed Paxil. Three days later, my son committed suicide. Something needs to be done to stop this from happening to others….’’

http://www.journalnow.com/zzstyling/pharmacy/people-s-pharmacy-can-antidepressants-lead-to-suicide/article_227a9814-b1e1-52af-ad03-25ee0c20f223.html

Myth Busting New Post On SSRI Dangers From AntiDepAware..


The royal college of psychiatry UK would have you believe that anti-depressants are nothing but a positive thing for mental health patients. They’d have you believe that these pills are relatively harmless, mostly effective, and that the benefits outweigh the risks. They’d like you to think that SSRI’s are ‘saving lives’ and ‘helping millions’. They don’t want you to know that some people might become homicidal, aggressive, volatile or even commot murder because of them.

They don’t want you to know the truth, because the truth about side effects undermines the psychiatric profession and its ideology and power (and we can’t have that now can we?).

Well, the website Antidepaware does want you to know the truth about SSRI’s, check out the new post from the Antidepaware website here…

 

http://antidepaware.co.uk/great-myth-buster/

The Great Myth Buster

On Wednesday July 26th, BBC showed a thoughtful, well-researched Panorama documentary called A Prescription for Murder?. The programme was directed and introduced by Shelley Jofre (left), who, several years ago, exposed The Secrets of Seroxat.

Most of the recent documentary was devoted to the so-called “Batman killer” James Holmes (right), a neuroscience graduate who shot dead 12 people and injured 70 in a Colorado cinema in 2012. He had been taking the SSRI antidepressant Sertraline (Zoloft), along with Clonazepam, a benzodiazepine.

In the run-up to the programme, two significant interviews were published. In the Sunday Times on July 23rd, Katinka Blackford Newman (left) was interviewed by Oliver Thring.

Katinka, who was one of the principal researchers on the Panorama documentary, was the author of The Pill That Steals Lives. At its launch a year ago, I was privileged to have met David Carmichael, who had travelled from Canada.

In 2004 David (right), who had never shown any symptoms of psychosis before being prescribed Seroxat, strangled his 11-year-old son Ian. He was judged to be “not criminally responsible on account of a mental disorder” for murdering his son and, in 2009, he received an absolute discharge. Caroline Scott’s interview with David was published in the Daily Mail on the day before the documentary was shown.

Another guest at the launch of Katinka’s book was Leonie Fennell, who had travelled from Ireland. In 2009, Leonie’s son, 22-year-old student Shane Clancy (left) fatally stabbed his ex-girlfriend’s new boyfriend, injured two others, then died after stabbing himself 19 times. Shane had no history whatsoever of violence, self-harm or mental instability of any sort. However, a few weeks before the tragedy, Shane had gone to see a doctor as he was feeling low after breaking up with his girlfriend, and was prescribed the antidepressant Citalopram (Celexa). At Shane’s inquest, the jury decided that Citalopram had probably caused Shane’s death and thus rejected a suicide verdict.

Although most of the Panorama documentary was devoted to James Holmes, both David and Leonie appeared in short interviews with Shelley Jofre.

But, before the documentary had even been shown, the Science Media Centre orchestrated a campaign of mis-information and denigration against the programme. Among the psychiatrists enlisted to provide “expert comments” were Allan Young (right) and Carmine Pariante, both of whom have financial links to pharmaceutical companies that make antidepressants. Moreover, the two professors are employed by Kings College, London, which recently welcomed the UK managing director of Pfizer (makers of Sertraline) on to its board.

Another contributor was Wendy Burn (left), the new president of the Royal College of Psychiatrists, who also wrote an article for The Times, published the morning after the broadcast, entitled “Stop this dangerous scaremongering over antidepressants”.

There was little criticism of the programme after it had actually been shown.

But then, on Twitter, the Royal College of Psychiatrists (@rcpsych) announced that Wendy Burn and Carmine Pariante would be holding an hour-long Q and A session on August 3rd, using the hashtag #ADsMythBuster (right). It seemed as if the college’s intention was to use Twitter to “bust” what they regarded as “myths” surrounding antidepressants.

The questions started to come in well before the session, but no replies were tweeted before the appointed hour.

It wasn’t long before the first myth was busted by Wendy and Carmine. The surprise was that this particular myth had been perpetrated for many years by their colleagues, as well as other prescribers: “The old idea that ADs correct a chemical imbalance in the brain is an over-simplification and we do not support this view.”

I felt optimistic, and asked, to no avail: “Now that you’ve busted the “chemical imbalance” myth, are you going to bust the “no causal link with violence” myth next?

Alas, it was not to be. This was the nearest we would get to a proper myth buster during the hour. Before long, the assertion that “ADs do have measurable biological effects; increasing new brain cells & reducing stress hormones” produced a number of retorts, both serious and light-hearted, from those who found this quite difficult to believe.

Asked about withdrawal, the reply was: “Not everyone gets withdrawal symptoms. You must come off ADs slowly over 8-12 weeks with support of your doctor.” This response was queried by a participant, who was told: “Everyone is different & you need to plan this with your doctor. Most people are okay with 8-12 weeks to reduce and stop”.

Somebody asked about the best ADs for a mother to use before and after birth and was told: “Preferred choice are SSRIs esp Fluoxetine in pregnancy & Sertraline in breastfeeding”. The questioner was not told that the best option was to avoid antidepressants altogether during this period.

When a question was asked about whether antidepressants can be used to treat bi-polar, the reply was “Yes they can, but preferably with a mood stabiliser”. Aine O’Beirne (left) was quick to retort: “You say use SSRIs to treat Bipolar when SSRIs are one of the causes of Bipolar epidemic”.

To a question about side-effects causing sexual problems, the reply was: “Yes they are common with SSRIs, usually improves but if not discuss with your doctor”.

And when they were asked about the length of treatment, the professors answered: “Patients are taking ADs for longer according to the correct guidelines for treatment & this is a good thing”.

The reply to a question about the record high numbers of antidepressants prescribed was: “We believe it’s because more people are coming forward & reduced stigma – this is a good thing”.

The person who asked about the benefits of taking antidepressants was told: “Sadness improves within days, new studies show that improvement is faster than we originally thought – within weeks”.

And to the person whose antidepressants weren’t working, the answer was: “There are recommended combinations of ADs & other meds for patients who don’t respond”.

To a question about the link with violence, Wendy and Carmime (right) stuck with the ridiculous line: “In adults there is no evidence ADs increase hostility & aggressiveness”. This prompted my question: “Did you actually watch “Panorama” last week?

I asked several questions, and received replies to two of them. The first, about sanctioning members for not following NICE Guidelines, elicited the response: “The guidelines are guidelines not the law, we encourage people to follow them”.

In the other, I asked “Is it acceptable to compel somebody to take ADs in order to be given sickness benefit?”. The reply, “Nobody should be forced to have any treatment to be given sickness benefit”, gave me encouragement, although this message needs to be passed on to the guilty GPs.

It was obvious that only a small proportion of questions could be answered, but I had a feeling that the more difficult ones were avoided in favour of those for which pre-prepared replies were available.

One of the most frustrated participants was Lucy Johnstone (left), who submitted the three questions that had the most re-tweets, but never received an answer to any of them. Eventually, to the question “Why are rocketing prescribing levels not reducing rates of depression and suicide, if the drugs are effective?”, Lucy commented: “71 retweets & 88 likes. Deserves an answer”.

A complete list of questions and answers has been compiled by James Moore, while Aine has published a selection on Storify.

The following day, the overriding impression was that if the College saw their “MythBuster” session as a PR exercise, then they had failed. The reaction of Fiona French (right), writing in the BMJ, was typical: “The online support community submitted many, many intelligent and probing questions. The responses were few in number and lacking in substance. We were advised that the Royal College ‘thinks’ the benefits of antidepressants outweigh the harms but no supporting evidence was provided.”

My contribution was to suggest that: “Next time @rcpsych need an #ADsMythBuster, they should call @PGtzsche1.”

I was, in fact, referring to Professor Peter Gøtzsche (top), one of the world’s most knowledgeable and influential professors in this field. In September 2015, I attended a conference in Copenhagen which Peter had organised. The theme of the event was Psychiatric drugs do more harm than good. I wouldn’t have expected the Pharma-influenced Royal College of Psychiatrists to agree, but the arguments were compelling.

In January 2014, Dr David Healy (left) published an article on his website which Peter had written, and in which he blew apart 10 myths that GSK, Lundbeck, Eli Lilly, Pfizer, etc would like us to believe. Here is Peter’s article:

At the Nordic Cochrane Centre, we have researched antidepressants for several years and I have long wondered why leading professors of psychiatry base their practice on a number of erroneous myths. These myths are harmful to patients. Many psychiatrists are well aware that the myths do not hold and have told me so, but they don’t dare deviate from the official positions because of career concerns.

Being a specialist in internal medicine, I don’t risk ruining my career by incurring the professors’ wrath and I shall try here to come to the rescue of the many conscientious but oppressed psychiatrists and patients by listing the worst myths and explain why they are harmful.

Myth 1: Your disease is caused by a chemical imbalance in the brain

Most patients are told this but it is completely wrong. We have no idea about which interplay of psychosocial conditions, biochemical processes, receptors and neural pathways that lead to mental disorders and the theories that patients with depression lack serotonin and that patients with schizophrenia have too much dopamine have long been refuted. The truth is just the opposite. There is no chemical imbalance to begin with, but when treating mental illness with drugs, we create a chemical imbalance, an artificial condition that the brain tries to counteract.

This means that you get worse when you try to stop the medication. An alcoholic also gets worse when there is no more alcohol but this doesn’t mean that he lacked alcohol in the brain when he started drinking.

The vast majority of doctors harm their patients further by telling them that the withdrawal symptoms mean that they are still sick and still need the medication. In this way, the doctors turn people into chronic patients, including those who would have been fine even without any treatment at all. This is one of the main reasons that the number of patients with mental disorders is increasing, and that the number of patients who never come back into the labour market also increases. This is largely due to the drugs and not the disease.

Myth 2: It’s no problem to stop treatment with antidepressants

A Danish professor of psychiatry said this at a recent meeting for psychiatrists, just after I had explained that it was difficult for patients to quit. Fortunately, he was contradicted by two foreign professors also at the meeting. One of them had done a trial with patients suffering from panic disorder and agoraphobia and half of them found it difficult to stop even though they were slowly tapering off. It cannot be because the depression came back, as the patients were not depressed to begin with. The withdrawal symptoms are primarily due to the antidepressants and not the disease.

Myth 3: Psychotropic drugs for mental illness are like insulin for diabetes

Most patients with depression or schizophrenia have heard this falsehood over and over again, almost like a mantra, in TV, radio and newspapers. When you give insulin to a patient with diabetes, you give something the patient lacks, namely insulin. Since we’ve never been able to demonstrate that a patient with a mental disorder lacks something that people who are not sick don’t lack, it is wrong to use this analogy.

Patients with depression don’t lack serotonin, and there are actually drugs that work for depression although they lower serotonin. Moreover, in contrast to insulin, which just replaces what the patient is short of, and does nothing else, psychotropic drugs have a very wide range of effects throughout the body, many of which are harmful. So, also for this reason, the insulin analogy is extremely misleading.

Myth 4: Psychotropic drugs reduce the number of chronically ill patients

This is probably the worst myth of them all. US science journalist Robert Whitaker demonstrates convincingly in “Anatomy of an Epidemic” that the increasing use of drugs not only keeps patients stuck in the sick role, but also turns many problems that would have been transient into chronic diseases.

If there had been any truth in the insulin myth, we would have expected to see fewer patients who could not fend for themselves. However, the reverse has happened. The clearest evidence of this is also the most tragic, namely the fate of our children after we started treating them with drugs. In the United States, psychiatrists collect more money from drug makers than doctors in any other specialty and those who take most money tend to prescribe antipsychotics to children most often. This raises a suspicion of corruption of the academic judgement.

The consequences are damning. In 1987, just before the newer antidepressants (SSRIs or happy pills) came on the market, very few children in the United States were mentally disabled. Twenty years later it was over 500,000, which represents a 35-fold increase. The number of disabled mentally ill has exploded in all Western countries. One of the worst consequences is that the treatment with ADHD medications and happy pills has created an entirely new disease in about 10% of those treated – namely bipolar disorder – which we previously called manic depressive illness.

Leading psychiatrist have claimed that it is “very rare” that patients on antidepressants become bipolar. That’s not true. The number of children with bipolar increased 35-fold in the United States, which is a serious development, as we use antipsychotic drugs for this disorder. Antipsychotic drugs are very dangerous and one of the main reasons why patients with schizophrenia live 20 years shorter than others. I have estimated in my book, ‘Deadly Medicine and Organized Crime’, that just one of the many preparations, Zyprexa (olanzapine), has killed 200,000 patients worldwide.

Myth 5: Happy pills* do not cause suicide in children and adolescents

Some professors are willing to admit that happy pills increase the incidence of suicidal behavior while denying that this necessarily leads to more suicides, although it is well documented that the two are closely related. Lundbeck’s CEO, Ulf Wiinberg, went even further in a radio programme in 2011 where he claimed that happy pills reduce the rate of suicide in children and adolescents. When the stunned reporter asked him why there then was a warning against this in the package inserts, he replied that he expected the leaflets would be changed by the authorities!

Suicides in healthy people, triggered by happy pills, have also been reported. The companies and the psychiatrists have consistently blamed the disease when patients commit suicide. It is true that depression increases the risk of suicide, but happy pills increase it even more, at least up to about age 40, according to a meta-analysis of 100,000 patients in randomized trials performed by the US Food and Drug Administration.

Myth 6: Happy pills have no side effects

At an international meeting on psychiatry in 2008, I criticized psychiatrists for wanting to screen many healthy people for depression. The recommended screening tests are so poor that one in three healthy people will be wrongly diagnosed as depressed. A professor replied that it didn’t matter that healthy people were treated as happy pills have no side effects!

Happy pills have many side effects. They remove both the top and the bottom of the emotions, which, according to some patients, feels like living under a cheese-dish cover. Patients care less about the consequences of their actions, lose empathy towards others, and can become very aggressive. In school shootings in the United States and elsewhere a striking number of people have been on antidepressants.

The companies tell us that only 5% get sexual problems with happy pills, but that’s not true. In a study designed to look at this problem, sexual disturbances developed in 59% of 1,022 patients who all had a normal sex life before they started an antidepressant. The symptoms include decreased libido, delayed or no orgasm or ejaculation, and erectile dysfunction, all at a high rate, and with a low tolerance among 40% of the patients. Happy pills should therefore not have been marketed for depression where the effect is rather small, but as pills that destroy your sex life.

Myth 7: Happy pills are not addictive

They surely are and it is no wonder because they are chemically related to and act like amphetamine. Happy pills are a kind of narcotic on prescription. The worst argument I have heard about the pills not causing dependency is that patients do not require higher doses. Shall we then also believe that cigarettes are not addictive? The vast majority of smokers consume the same number of cigarettes for years.

Myth 8: The prevalence of depression has increased a lot

A professor argued in a TV debate that the large consumption of happy pills wasn’t a problem because the incidence of depression had increased greatly in the last 50 years. I replied it was impossible to say much about this because the criteria for making the diagnosis had been lowered markedly during this period. If you wish to count elephants in Africa, you don’t lower the criteria for what constitutes an elephant and count all the wildebeest, too.

Myth 9: The main problem is not overtreatment, but undertreatment

Again, leading psychiatrists are completely out of touch with reality. In a 2007 survey, 51% of the 108 psychiatrists said that they used too much medicine and only 4 % said they used too little. In 2001–2003, 20% of the US population aged 18–54 years received treatment for emotional problems, and sales of happy pills are so high in Denmark that every one of us could be in treatment for 6 years of our lives. That is sick.

Myth 10: Antipsychotics prevent brain damage

Some professors say that schizophrenia causes brain damage and that it is therefore important to use antipsychotics. However, antipsychotics lead to shrinkage of the brain, and this effect is directly related to the dose and duration of the treatment. There is other good evidence to suggest that one should use antipsychotics as little as possible, as the patients then fare better in the long term. Indeed, one may completely avoid using antipsychotics in most patients with schizophrenia, which would significantly increase the chances that they will become healthy, and also increase life expectancy, as antipsychotics kill many patients.

How should we use psychotropic drugs?

I am not against using drugs, provided we know what we are doing and only use them in situations where they do more good than harm. Psychiatric drugs can be useful sometimes for some patients, especially in short-term treatment, in acute situations. But my studies in this area lead me to a very uncomfortable conclusion:

Our citizens would be far better off if we removed all the psychotropic drugs from the market, as doctors are unable to handle them. It is inescapable that their availability creates more harm than good. Psychiatrists should therefore do everything they can to treat as little as possible, in as short time as possible, or not at all, with psychotropic drugs.

At least Wendy Burn and Carmine Pariente admitted the first of Peter Gøtzsche’s myths. I look forward to a time when Myths 2-10 are dispelled by those who are at present prescribing a ridiculously high and ultimately harmful number of antidepressants.

* I am not comfortable with the phrase “happy pills”, but I have left the original text intact. It is possible that, in this context, the phrase emanates from a literal translation from Danish.

Related Articles:

More Harm than Good

Hope in Copenhagen

Mental Health Disability: the Antidepressant Connection

Suicide Prevention: a Conflict of Interest

Paxil (Seroxat) And The Dangers Of Suppressing Medical Research..


https://www.vox.com/the-big-idea/2017/8/1/16012946/clinical-trial-research-public-transparency

 

 

A surprising amount of medical research isn’t made public. That’s dangerous.

Dan Kitwood / Staff

When the results of clinical trials aren’t made public, the consequences can be dangerous — and potentially deadly.

Consider the case of the anti-depressant Paxil, produced by the drug company SmithKline Beecham (now part of GlaxoSmithKline). GSK got approval from the FDA in 1999 for treatment of depression in adults, but not in teenagers. That meant that while doctors could prescribe the drug to adolescents — a so-called “off label” prescription — GSK could not promote the drug to doctors for that purpose.

But the company did just that, according to criminal and civil complaints filed by the Justice Department and a suit by then-New York Attorney General Eliot Spitzer. What’s more, the Justice Department claimed, GSK selectively and misleadingly released information about three studies it had conducted of the drug: It hired a consulting company to write a journal article that played up evidence from one study that the drug worked better as a treatment for pediatric depression than a placebo, played down (better) evidence from the same study that it hadn’t, and soft-pedaled the side effects.

These side effects included suicidal thoughts and actions.

It buried two other studies, the Justice Department noted, in which Paxil had failed to show efficacy in treating depression.

In the end, GSK paid the US government $3 billion in fines for illegal and misleading promotion Paxil and other drugs, and, in 2004, the FDA required manufacturers to put a “black box” warning label on Paxil and other antidepressants about the potential risks of increased suicidal thoughts and actions when used in children and teenagers.

In 2015, researchers published a second look at the data and clinical study reports underlying the study GSK had relied on for promoting Paxil’s use in adolescents. They affirmed the drug “was ineffective and unsafe in this study.” This was part of a much bigger problem afflicting drug research, they said: “There is a lack of access to data from most clinical randomised controlled trials, making it difficult to detect biased reporting.”

You might think a crisis of that scope, involving teenage suicide and billions of dollars, would rouse the scientific establishment to make sure that the results of all clinical trials be made public. But it didn’t happen. Despite public campaigns, and even legal requirements, many clinical trials still report results publicly late or not at all. What, if anything, will prod researchers — and universities and drug companies — to act?

The issue at stake here isn’t the FDA’s approval process. The FDA makes drugmakers go through an intensive application process before it deems new drugs or medical devices safe and effective. When drug companies seek FDA approval for a drug or device, they aren’t allowed to cherry-pick which results they report. The agency requires that companies submit plans outlining all trials they’ll submit for approval, and scrutinizes the trial results (even conducting its own statistical review). But the FDA does not ensure that all of those trial results also enter the public view.

That means doctors and researchers trying to get a full picture of a drug’s effects are out of luck.

During the Paxil legal battles, there was not yet a law in the United States requiring that clinical trials publicly share their results. What is remarkable is that today there is such a law — yet researchers and companies often ignore it.

Some researchers do share their trial results through journal publications. However, one synthesis of studies on the topic found that from one quarter to one half of clinical trials are never published — or are published only years after trials end. In that same report, from 2012, new research found that roughly half of all trials funded by the National Institutes of Health remained unpublished 30 months after the end of a trial (though 68 percent were ultimately published at some point). The reasons for delays and non-publication vary, from researchers’ lack of interest in reporting negative results — the infamous “file drawer problem” — to constraints on the time of researchers.

Progress on transparency legislation

The research transparency movement has been gaining steam, but still can’t declare victory. A 1997 federal requirement mandated that researchers register some trials in a public database (those pertaining to serious or life-threatening diseases). Then in 2005, an association of medical journals started requiring that any study published in one of their publications be registered in an online database before the time of first patient enrollment. That didn’t guarantee results would be made public, but it at least provided an incentive to researchers to make some information about the trial available.

A few years later, an even bigger shift occurred. Congress passed the FDA Amendments Act of 2007, which required that “applicable clinical trials” register and publicly report results within one year of trial completion. (The requirement excluded some trials, such as Phase 1 trials of drug safety as opposed to efficacy.) The site ClinicalTrials.gov, run by the National Library of Medicine, had started posting general information about trials in 2000 — so sick people could sign up, for example — but now became the place where those results were posted. And the law included a penalty: Those who failed to report on time could face fines of up to $10,000 per day.

Yet nearly a decade later, it’s clear that many researchers and institutions basically ignore the law. They report trials late or not at all, but the FDA has yet to levy a fine. An investigation by the health journalism organization STAT, published in December 2015, looked at about 9,000 trials across 98 institutions, from 2008 to 2015. Of trials that were required by the FDA to report their results, 74 percent of industry trials were either not reported or reported late. The figure, maybe surprisingly, was even worse for academic institutions: 90 percent late or unreported.

By STAT’s calculation, if the FDA had enforced the law using the $10,000-per-day day fine, it could have collected over $25 billion since 2008, funding the agency several times over.

And the thrust of STAT’s conclusions has been echoed by other investigations. (After the Paxil episode, GSK, for its part, has been posting trial results to the company website; it also fares better than many other companies and institutions in several recent transparency scorecards.)

A medical culture too comfortable with non-publication and non-reporting

Why hasn’t the FDA enforced the 2007 law on publicizing results, and why hasn’t it levied financial penalties?

One reason, according to several of those that I spoke with, including Deborah Zarin, director of ClinicalTrials.gov, is that the 2007 law contained ambiguity about some of the requirements, including which trials were subject to the law.

Jennifer Miller, founder of Bioethics International, agrees that some researchers have been, at least till very recently, uncertain about whether the 2007 law applied to their trial. The language used in the law to describe applicable studies included the phrase “controlled clinical trials,” and there was some uncertainty about which trials would count as “controlled.” “How can you impose fines on an ambiguous law?” Miller said.

Researchers I spoke to emphasized, however, that clinical trial results are not just a legal issue: It’s an ethical matter, too. Regardless of the law, shouldn’t reporting results be part of the culture of doing clinical trials?

If so, there’s a problem with the current culture. Researchers are rewarded primarily for publishing as much as possible in the highest-ranked journals that they can, says Joseph Ross, an associate professor of medicine at Yale and an associate editor at JAMA Internal Medicine. “There’s no clear incentive for investigators to have a member of their staff do everything required by ClinicalTrials.gov. It gets deprioritized because it is a substantial amount of work, and investigators don’t put it at the top of their list.”

Competition may play a role. Someone who is running a trial might think: “My competitor has similar molecules in the pipeline, why should I tell them why it failed so that they don’t pump money into it?” says Tomasz Sablinski, co-founder of the drug development firm Transparency Life Sciences, who was previously with the pharmaceutical company Novartis.

How to change the norms, so that there’s an internal commitment to reporting results from researchers and institutions? Steven Goodman, an associate dean and professor of medicine at Stanford, notes that it will be important for institutions to provide education to researchers on how to report results, and pay for staff support.

AllTrials, a nonprofit organization founded by medical doctor and public intellectual Ben Goldacre, took on the mission of pushing for clinical trial transparency. AllTrials, which started in the UK and also has a campaign in the US, thinks the laws don’t go far enough: None of the regulations governing clinical trial reporting require sharing results retroactively (that is, before the laws are passed), which leaves many results for already-approved drugs unreported.

Goldacre also collaborated with a web developer and scientist, Anna Powell-Smith, to create the automatically updated Trials Tracker. The tracker scans ClinicalTrials.gov and PubMed to identify how many clinical trials have been reported by companies and institutions with 30 clinical trials or more. After working on transparency for many years, Goldacre believes “naming and shaming” is the main thing that will really grab the attention of those who haven’t reported their trials.

Momentum seems to be gathering, although the Trump administration’s commitment to the cause remains uncertain. In September 2016, Health and Human Services, which oversees the FDA, issued a “final rule” clarifying and expanding the requirements of the 2007 law: It specifies what was meant by “controlled clinical trials,” among other things. (“All interventional studies with prespecified outcome measures.”) The rule also expands the scope of the requirement to include results from certain trials of new drugs and devices which haven’t yet been approved by the FDA.

The National Institutes of Health (NIH) also announced a policy in September 2016 requiring that all its grant recipients publicly report their clinical trial results. The NIH policy and HHS final rule took effect on January 18. Will the organizations ramp up pressure to comply with the law, and will researchers take this obligation seriously? It’s too soon to say.

The obligation to research participants

One reason to care about whether clinical trial results are shared is that hundreds of thousands of patients have put themselves on the line as research subjects. We owe it to them not to let the information their participation enabled get stuck in a file drawer.

“If we made a pact with a person to enter into this experiment, then we have an ethical and scientific obligation to have the results out there, no matter what happened,” said Stanford’s Goodman.

Everyone who conducts a clinical trial should report their results, whatever the outcome. It’s the law, and it’s past time that it was followed. When researchers fail to do so, we should point that out early and often — for the sake of public health.

Stephanie Wykstra is a freelance writer and consultant with a focus on research transparency. She has recently worked with nonprofits including AllTrials USA and Robert Wood Johnson Foundation. Twitter: @Swykstr.

What Did They Prescribe Chester Bennington?


Petrusich-Chester-Bennington-1

 

http://www.eonline.com/news/868229/the-dark-side-of-linkin-park-s-chester-bennington-alcoholism-and-depression-inspired-and-plagued-singer-shadowing-his-massive-success

 

“…Meeting his second wife helped pull him out of a period of “absolute self-destruction,” he told Bullz-Eye.com in 2009 while promoting Out of Ashes. “I don’t know when to stop when I’m in that mode. I’ll go through a gallon of Jack Daniels and down some antidepressants in one night and keep on going. I just hated my life at one point. I loved my band, career and friends, but when I got home from tour, I couldn’t deal with stuff. I would just begin drinking.”

 

RIP Chester..

 

https://www.theguardian.com/music/2017/jul/21/chester-bennington-obituary

Chester Bennington obituary

Vocalist with the band Linkin Park whose sound was emblematic of the nu-metal genre

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Linkin Park’s Chester Bennington dies aged 41

The death of Chester Bennington, vocalist with the rap and nu-metal band Linkin Park, at the age of 41, curtails a brilliantly successful career that brought a string of awards and multimillion-selling albums and singles. Linkin Park enjoyed enormous and immediate acclaim with their debut album Hybrid Theory (2000), released on Warner Bros after the band had been rejected by several labels. The combination of Mike Shinoda’s rapping and Bennington’s soaring, impassioned singing became the band’s instant focal point, with the group’s metallic thunder enhanced by edgy electronic treatments. Their sound became emblematic of the nu-metal genre, alongside like-minded artists such as Korn and Limp Bizkit.

Hybrid Theory sold nearly 5m copies in its first year and to date has sold more than 20m, and reached No 2 on the US chart and No 4 in the UK. The singles Crawling, One Step Closer and In the End became radio favourites, receiving heavy airplay on MTV, and in 2002 Crawling won a Grammy for best hard rock performance. The album Reanimation (2002) comprised remixes of Hybrid Theory songs plus additional material, and was another international multimillion-seller.

When the band released Meteora in 2003, following intensive touring in the US, including dates with their own multi-artist Projekt Revolution tour, it shot to the top of the US and UK album charts and spawned a fresh batch of hit singles, including Somewhere I Belong, Breaking the Habit and Numb, the last of these an anthem of Bennington’s disconnection from the world. The album went on to sell more than 10m copies. In 2004, Linkin Park teamed up with Jay-Z on the EP Collision Course, mixing rap with metal; the track Numb/Encore, splicing together the band’s Numb with Jay-Z’s Encore, went to 20 on the US singles chart and 14 in the UK. In 2005 it won a Grammy for best rap/sung collaboration.

But while his music provided a cathartic outlet, Bennington had experienced an assortment of emotional and drug-related issues since childhood. He was a close friend of Chris Cornell, the lead singer of Soundgarden, who killed himself in May, and wrote a heartfelt posthumous letter to Cornell. Bennington was found dead at his home in California on what would have been Cornell’s 53rd birthday.

Bennington was born in Phoenix, Arizona. His mother, Susan Elaine Johnson, was a nurse, and his father, Lee Russell Bennington, a police detective who often worked on child abuse cases. They divorced when he was 11, after which his father gained custody of Chester. He had two older sisters and an older half-brother, Brian. Since his father often worked double shifts, Chester frequently found himself at home alone. He fell into a pattern of drug and alcohol abuse, and, he once told Metal Hammer magazine, “dropped so much acid I’m surprised I can still speak. I’d smoke a bunch of crack, do a bit of meth and just sit there and freak out. Then I’d smoke opium to come down.”

His emotional state was further affected by the fact that he suffered sexual abuse by an older friend between the ages of seven and 13. “It destroyed my self-confidence,” he told Kerrang! in 2008. “Like most people, I was too afraid to say anything. I didn’t want people to think that I was gay or that I was lying.” He was also bullied at school.

He found some respite in drawing and songwriting, and was a fan of Depeche Mode and Stone Temple Pilots. At 17 he moved in with his mother, and worked at Burger King while attempting to become a musician. His first group, Sean Dowdell and His Friends?, made a three-track cassette in 1993, after which Bennington and Dowdell formed the alternative-rock band Grey Daze, who released three albums during the 1990s.

Bennington married Samantha Olit in 1996, quit Grey Daze in 1998 and moved to Los Angeles to further his musical career. He auditioned for a band called Xero, and when he was hired as vocalist he completed the original line-up of what then became Linkin Park (a pun on Lincoln Park in Santa Monica), alongside Shinoda, Brad Delson, Dave Farrell, Rob Bourdon and Joe Hahn.

In 2005 Bennington put together a side project, Dead By Sunrise, featuring musicians from Orgy and the Street Drum Corps and comprising songs he considered “darker and moodier than anything I’d come up with for the band”. In 2009 they released their only album, Out of Ashes, which scraped into the US Top 30.

Linkin Park returned in 2007 with the album Minutes to Midnight, co-produced with Rick Rubin and marking a deliberate step towards a more mainstream rock sound. This delivered the big hit singles What I’ve Done, Bleed It Out and Shadow of the Day, which all scored heavily in the American alt and rock charts. New Divide, from the soundtrack compilation album Transformers – Revenge of the Fallen (2009), gave them another major hit. Their subsequent albums, A Thousand Suns (2010) and Living Things (2012), saw sales falling way below their earlier peaks, but they still delivered big hit singles including The Catalyst, Waiting for the End and the anthemic Burn It Down.

In 2013 Bennington joined Stone Temple Pilots after they fired the vocalist Scott Weiland, and, after recording the EP High Rise, stayed with them until 2015. “I got to create and perform with one of the greatest rock bands of our generation, that had so much influence on me growing up,” he said afterwards. He was back with Linkin Park for The Hunting Party (2014), on which they tacked back towards a heavier rock sound. One More Light (2017) was, by comparison with the group’s original sound, virtually a pop record. “It’s a great record, we love it,” insisted Bennington to hostile critics, and the album shot to the top of the US Billboard chart.

Bennington had tackled his addiction issues with some success, admitting falling off the wagon in 2005 when he divorced, but getting clean again in 2006 when he married Talinda Bentley, a schoolteacher and former model. In the run-up to the release of One More Light, he seemed optimistic and positive, saying that he had shaken off the depression he had felt two years earlier. “I know exactly who I am, I know exactly what I’m made of and I’m totally happy with it,” he said.

He is survived by Talinda and their children, Tyler Lee, Lily and Lila; by a son, Draven Sebastian, from his first marriage; and by two sons, Jaime and Isaiah, from a relationship with Elka Brand.

Chester Charles Bennington, singer and songwriter, born 20 March 1976; died 20 July 2017

 

Watch The Full Panorama Documentary ‘A Prescription For Murder’ Here…


Is it possible that a pill prescribed by your doctor can turn you into a killer? Over 40 million prescriptions for SSRI anti-depressants were handed out by doctors last year in the UK. Panorama reveals the devastating side effects on a tiny minority that can lead to psychosis, violence, possibly even murder. With exclusive access to psychiatric reports, court footage and drug company data, reporter Shelley Jofre investigates the mass killings at the 2012 midnight premiere of a Batman movie in Aurora, Colorado. Twenty-four-year-old PhD student James Holmes, who had no record of violence or gun ownership, murdered 12 and injured 70. Did the SSRI anti-depressant he had been prescribed play a part in the killings? Panorama has uncovered other cases of murder and extreme violence which could be linked to psychosis developed after the taking of SSRIs – including a father who strangled his 11-year-old son. Panorama asks if enough is known about this rare side effect, and if doctors are unwittingly prescribing what could be a prescription for murder.

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