Editorial Note: It was tempting not to run a post today for fear it might get lost in the wash of the Clinton-Trump debate. But today is the fourteenth anniversary of the day FDA issued an approvable letter for Paxil for children, as well as the fifty-fourth anniversary of the 1962 FDA Act that created the playing field on which Study 329 happened. It’s also World Mental Health Day. Freud might have been amused.
Study 329 recruited its last patient in 1997. The data was analyzed in 1998. Faced with the results, the plan was to pick out the good bits and publish them. This meant never publishing the Continuation Phase – the 24 week extension to the Acute Phase of Study 329. The good bits of the Acute Phase became the Keller et al 2001 paper – possibly now the most famous clinical trial publication of all time.
The Continuation Phase was published for the first time by Le Noury and colleagues in September 2016 – eighteen years later. It is available HERE along with reviews from JAACAP – not the journal in which it was published.
Among the most interesting findings are those from the Taper Phase. Publishing the Acute Phase only meant that the Taper Phase vanished. Whatever way the data are cut, whether in terms of all severe adverse events, or behavioral adverse events or suicidal adverse events the picture remains the same – the taper phase of this trial was the riskiest period for those on active treatment. This will come as no surprise to many who have learnt the hard way after the event. Others like Bruce Springsteen do not yet seem to have put two and two together – see Born to Withdraw.
The years 1997 and 1998 may be as important as the data. The Moneybags image above, an internal SmithKline Beecham image from 1997, brings out how the issue was viewed within the company. SmithKline were at the time under intense pressure from Lilly and Prozac, with Lilly running adverts for Prozac like the one below.
The material accompanying adverts like this specifically targeted Paxil – Seroxat, the drug that was Prozac’s most direct competition. This is an unusual thing for a pharmaceutical company to do. They have to be on solid ground. It was also deeply cynical in that Prozac also causes dependence and withdrawal but with the right study its long half life can appear to make this problem disappear.
SmithKline’s response was maybe even more cynical. For women worried about getting pregnant and possible risks to their unborn baby, the short half life of paroxetine and being able to get off it quickly was a blessing. If you were on Prozac, the implicit message was you were “fucked”.
Extraordinarily in the face of this – twenty years ago – most doctors and regulators affected not to notice anything. Were they being adults trying to ignore children squabbling in the back of the car, or were they like terrified kids in Jurassic Park trying not to draw the attention of the Tyrannosaurs sniffing the air around them?
Most doctors still affect surprise at the idea SSRIs might come with withdrawal problems. Regulators since 2002 know very clearly about the problems but have decided to leave any communication of these issues in company hands.
It needs an anthem from someone like Bruce Springsteen to find the millions of people whom “Progress” has left washed up on a shore they never wanted to be on. An anthem to put the island on which they have been Shipwrecked on the map.Share this:
Copyright © Data Based Medicine Americas Ltd.
Watching the sunset on top of the ferry, listening to Don’t Get Me Wrong by the Pretenders and thinking of you.. <3 love you.
Bang up the volume…..
Email from darling daughter this morning..I had this cassette in my car years before she was born and years after she was born and I still have the cassette.. considering her life was completely destroyed by Seroxat with the odious headmaster, the suicidal mother, the avenging doctors and so on……I am constantly awestruck by her memories and generosity of spirit……
Christine Ellen "Chrissie" Hynde (born September 7, 1951)
Annie (born 13 September, 1951)
Thank Yooooooo..The Pretenders
“…washed up on a shore they never wanted to be on.”
The Boss, himself, would be proud of that line.
oh my goodness.
Thank you for exposing this.
It sure is a stark contrast from the propaganda of ‘discontinuation symptoms are mild and short-lived’.
In reality it is anything but.
This is beyond. criminal.
The “Moneybag” graphic at the top is extraordinary. To judge by the tags, it was unearthed in a court proceeding.
Was it put out by one of GSK’s rivals — or by GSK itself?
Mu understanding its an internal SmithKline document. It was once confidential but no longer.
I always thought the “Where’s my Paxil” image was quite telling.
GSK has provided us with plenty that we’ve seen and heard, over the years, which made our lips curl, but I feel that this graphic image is the most insulting yet! How could anyone, working for the company, not feel a pang of conscience at the thought that their bosses cared not a fig about ANYTHING other than gathering further full moneybags, repeatedly supplied by the unfortunate and unsuspecting public?
Retaliation by means of music sounds a fantastic idea to me – what’s Gareth Malone up to at the moment? – he’d soon whip up a “Seroxat Survivors’ Symphony plus vocals” I’m sure!
Podcast on BMJ drawing attention to Study329
An A. to put the island on which they have been Shipwrecked….. on the Map.
A.nother….for the Map..’Data’ Based Medicine…(User Karma:3)
October 11, 2016 at 3:00 am
TRM123 ( User Karma: 1 ) says:
That is of course, thanks to valid, not fraudulent evidence based medicine.
October 10, 2016 at 7:41 pm
TRM123 ( User Karma: 1 ) says:
This is surely the most powerful and the most discomforting revelation of the brutal and ruthless tactics of egregious pharma-marketing to date.
Forty years as a doctor, and my naivety in considering drug companies to be ethically based and patient focused is a cause of profound regret.
Thank you RxISK.org and those dedicated to evidence based medicine.
But your honesty is helpful to those like us whose pens still write these prescriptions daily. A reminder. I see horrible horrible withdrawal from all psychotropics and am learning how not to attribute it all and throw more meds at it.
ben goldacre @bengoldacre 14h14 hours ago
ben goldacre Retweeted OpenTrials
OKAY KIDS we are trying to build a GIANT tool filled with ALL the data on ALL the trials. It’s here. NOW GO PLAY.
Disclaimer: This is an early beta prototype. If you find any error, with data or functionality, please let us know via this page.
Study to evaluate the efficacy and safety of Paxil® Tablets in children and adolescents with Major Depressive Disorder
Suits..on the Map
Incentives and Corruption publication launch
VP and Head of Global Ethics and Compliance Strategy, Planning and Operations, GSK
Transparency International UK challenges corruption, strengthens integrity, and fights for a fair society based on the rule of law. @anticorruption UK chapter
Transparency Int’lUK @TransparencyUK 3h3 hours ago
Still time to register! #Incentives and #Corruption event tonight with @CharlesMCotton @Mazars_UK & @GSK
As a key driver of corrupt and unethical behaviour
Transparency International UK
Organiser of Incentives and Corruption publication launch
Transparency International (TI) is a global movement sharing one vision: a world in which government, politics, business, civil society and the daily lives of people are free of corruption. Transparency International UK (TI-UK) is the UK national chapter of this movement.
Trickling in..on the Miap
October 12, 2016 at 10:25 am
Stephen Gilbert ( User Karma: 6 ) says:
I often wonder what the people who work for drug companies are like. I’m talking about the upper echelon, the supervisors and movers and shakers and the CEO’s. They know what the effects of their drugs truly are, they know how people’s lives will be destroyed by taking their products, and yet they sit back and put money bag symbols on the information dealing with the drugs. They hide adverse information from studies that have been cooked to make the drugs they want to push look fine and dandy. How cold and ruthless is that?
They create toxic drugs. They send out their drug reps to push these things to uninformed GP’s and to get nursing homes to give things like Haldol to residents who are not as compliant as they should be. They convince an entire nation that everyone is “sick” and “mentally ill” or “depressed” with their direct to consumer advertising. They convince the FDA, which is supposed to protect us, to ok drugs that cause harm. They are manipulative and deceitful and they must be laughing all the way to the bank with their dividends that total in the billions.
How much longer are we going to put up with it?
October 11, 2016 at 11:43 am
Someone Else ( User Karma: 0 ) says:
Absolutely, the antidepressants have withdrawal effects:
“Commonly reported symptoms include flu-like symptoms (nausea, vomiting, diarrhea, headaches, sweating), sleep disturbances (insomnia, nightmares, constant sleepiness). Sensory and movement disturbances have also been reported, including imbalance, tremors, vertigo, dizziness, and electric-shock-like experiences in the brain, often described by sufferers as “brain zaps”. Mood disturbances such as dysphoria, anxiety, or agitation are also reported, as are cognitive disturbances such as confusion and hyperarousal.”
And today’s doctors think these symptoms of antidepressant discontinuation syndrome are symptoms of “bipolar.” Even though it states quite clearly in the DSM-IV-TR:
“Manic-like episodes that are clearly caused by somatic antidepressant
treatment (e.g., medication, electroconvulsive therapy, light therapy) should not count
toward a diagnosis of Bipolar I Disorder.”
What a shame today’s mainstream medical community, the psychologists, and the psychiatrists are all so stupid, they can’t even read their own DSM. Plus, they harbor “delusions of grandeur” they “know everything about the meds.” My experience was the only thing today’s psychiatrists know how to do is create “psychosis,” via anticholinergic toxidrome poisoning, while misdiagnosing this as numerous made up and scientifically invalid DSM disorders.
Where’s my malpractice check?
October 11, 2016 at 8:41 pm
Alex ( User Karma: 0 ) says:
“Where’s my malpractice check?”
I think a bunch of us are wondering about this.
Annie, thanks for bringing these comments to our attention.
So, it seems like there’s a few, just a few, physicians in America waking up to the disgraceful malpractice that’s been proliferating for so long.
When, oh when, are we going to start getting similar admissions from UK based doctors, I wonder?
Jane, I am a UK psychiatrist. I see this a lot.Everyday. I have chosen to work at a GP facing team so that I can stop as much of this nonsense as I can.Drops and oceans come to mind. I am also think that over reliance on medication or the blind faith that it can do a lot comes from not having skills other than prescribing.
I like this quote from the ‘Retired Physician’:
“Forty years as a doctor, and my naivety in considering drug companies to be ethically based and patient focused is a cause of profound regret”.
HOW is it the profound naivety of SO MANY of the medical profession continues and continues ?
WHY is ‘profound regret’ not spreading like a plague?
We should be re-naming the ‘profession’ Storks not Doctors. Heads in the sand or what?
Picking up on Annie’s quote from Stephen Gilbert (User Karma : 0) about what people who work for drug companies are like, and keeping in mind the Money Bags image at the start of this post, I can admit that I do know one of them a little, socially. I know and have liked her parents very much for several years? I used to go to a weekly group of ladies who ‘knitted’ at their home but feel I can go no more. I couldn’t bear to listen to the glowing reports of this really nice ( and if you met her, you’d agree that she was indeed really really nice) woman who travels round the world to lecture to doctors about drugs, the large salary she was earning for so doing, and how clever she is. She has a Pharmacology Degree. I wanted to talk to her directly about what she does and asked her mother if I could ring her to arrange this, so that I could ask her about the drugs our son was prescribed. Her mother says she is not a ghostwriter but is much more important than that, and works for an agency dealing with various drug companies. But she also said (rather dismissively)that her daughter was far too busy to meet me.
I don’t go to the ‘knitting’ group any more. I can see that I am ‘uncomfortable’ to be around. I just cannot listen to the glowing parental reports of the stellar rise of the daughter and the enormous salary she earns from Big Pharma. The worst thing is, the young woman IS nice. But does she ‘know what she does’? Apart from the massive earnings she gets? Does she worry about the ethics of Big Pharma? I frankly don’t think she can allow herself to think too deeply. I guess she rationalises it all to herself, as using her writing and presentation skills in doing good for humanity controlling disease etc. I miss the knitting group, but not the boiling inside…..
Knit One, Purl One…
The guest blog below was written by medical professionals involved with INANE, whose membership recently unanimously agreed to support the AllTrials campaign.
The International Academy of Nursing Editors (INANE) is a loosely organized group of editors
We were pleased to have Ben Goldacre
It is likely that most nurses as well as most physicians are unaware of depth and breadth of the gaps in the scientific literature with regards to clinical trial results.
A PLUS for US
Precursors to suicidality and violence on antidepressants: systematic review of trials in adult healthy volunteers
inspired by David Healy’s work.
Abstract Objective: To quantify the risk of suicidality and violence when selective serotonin and serotonin-norepinephrine reuptake inhibitors are given to adult healthy volunteers with no signs of a mental disorder.
Anam Cara Retweeted
GSK @GSK 13h13 hours ago .@AnamCaraSupport – Supporting parents after the death of a son or daughter #GSKIrelandIMPACT
Anam Cara @AnamCaraSupport 12h
@GSK thank you for a fantastic evening at #GSKimpact 2016 awards…. Delighted winners
Some ‘geesk’ nerve..
$11.9 Million Paxil Suicide Verdict: The Inside Story
By Peter Breggin, MD
I testified that the psychiatrist’s actions were worse than practicing medicine negligently—he was not practicing medicine at all. He was more like a vending machine. I further testified that this was callous disregard, especially since he admitted to knowing that the drug had dangers associated with it, including suicide, and yet asked no information about the patient, did not come in to see him, and ordered no special supervision.
Restarting him on Paxil 30 mg, when most of the drug was out of his system, caused akathisia (agitation with hyperactivity) and suicide. I also found that the doctor and the psychologist were negligent in several other ways, including their failure to evaluate the patient and to order careful monitoring.
As a medical expert in a product liability case against GlaxoSmithKline, the manufacturer of Paxil, I had discovered from the company’s secret files that Paxil frequently caused severe psychiatric adverse reactions during the first few doses.
IMPORTANT PRESCRIBING INFORMATION
Dear Healthcare Professional:
GlaxoSmithKline (GSK) would like to advise you of important changes to the Clinical Worsening and Suicide Risk subsection of the WARNINGS section in the labels for PAXIL (paroxetine HCl) and PAXIL CR (paroxetine HCl Controlled-Release Tablets).
2013-04-26 — Dr. Jureidini writes to GSK CEO Sir Andrew Witty. The letter states: I write to you as the CEO of GlaxoSmithKline in regard to an on-going complaint about a fraudulent journal article
Thank You for Sharing These Outstanding Scripts..Follow that Bob..
Submission to parliament regarding suicide prevention in UK
A very exciting development!
Timothy Moss ·
Brilliant achievement. Appalling harms. Prescribers still refer to the mythical “chemical imbalance”. Deconstruction of Pharma funded and controlled clinical trials shows gathering evidence of academic misconduct. (See Study 329. 2016)
Yes Annie – and now the Victoria Derbyshire programme on BBC2 is discussing antidepressant use/ problems as well as this petition and its aims this week, on October 19th. The petition has over 1000 signatures to date. James Moore, the person who set up the petition on Change.org is appearing on the programme and asking us to respond via Twitter etc.
to pre spond
We don’t know how much research this Victoria Derbyshire has done and I would hope that she does a little more than This Morning did with Katinka when interviewers did not bat an eyelid at her claims and the doctor was awful..
She has two whole days to research Anti-depressants before (terrifying) James.
She could do a crash course by reading the Pill that Steals Lives, cast her eye over David’s Blog and RxISK, chug through SSRI Stories, and, so on.
One thing, is quite clear, it is the Doctor’s nonsensical prescribing of overtly dangerous psychotropic drugs and failure to know how to Taper and Monitor that allows the likes of Seroxat to live in its vacuum and he’s on a hiding to nothing for Manufacturers of Ads to relinquish their legally scrutinised PIL leaflets with a nod and a wink to doctors..
James has caught the imagination and he is to be much congratulated.
A pre quell and a se quell to Victoria; a ‘line’ on ‘broadcast’..
We know all about the before and the after..
.Smoke and Mirrors
by Frederick Ernst, Ph.D.
You might be interested to see the email I sent to Victoria Derbyshire yesterday:
If others want to write its: firstname.lastname@example.org
Dear Victoria Derbyshire
I am pleased to learn that, on Wednesday 19 October, you will be facilitating some publicity for the important subject of the very serious harm caused by psychiatric drugs – benzodiazepines, anti-depressants and anti-psychotics.
As well as the awful withdrawal problems these cause, I want to emphasise my concern for the hugely unrecognised, very serious and tortuous condition of AKATHISIA. Like many others, I was struck with this terrible condition within 48 hours of starting on an SSRI anti-depressant. It was an indescribable horror.
This happened several times to me over the course of about 7 years but each time the prescribing doctor and consultant psychiatrist failed to recognise Akathisia and instead prescribed additional, harmful medications and wrongly diagnosed me with a serious mental condition.
Eventually, whilst researching about one specific side effect on the internet, I discovered the truth about these harmful medications and learnt that my rapidly worsening condition was not a symptom of my own mental decline but was caused by the very medication that was supposed to be helping me.
It is a very alarming fact that many doctors are not true to the hippocratic oath of ‘Do No Harm’ and are, instead, causing an awful lot of harm.
This happens A LOT and it is a HUGE, HUGE SCANDAL.
Please publicise this as much as possible
Well done, Jane, this is very good..
We rarely receive a voice when this sort of thing comes up and it comes up rarely…time for a deluge of emails to Victoria.
Katinka did her interviews alone and extremely eloquently, but, this time round, time for a change, an opportunity..
I don’t know the readership of David’s blog, but, he does have 957 friends on facebook, may be a few could step up to the plate..
Other blogs have their friends, we have our friends, composing hats on..today..
My drug dealer was a doctor, doctor
Had the plug from Big Pharma, Pharma
He said that he would heal me, heal me
But he only gave me problems, problems
My drug dealer was a doctor, doctor
Had the plug from Big Pharma, Pharma
I think he trying to kill me, kill me
He tried to kill me for a dollar, dollar
19 October 2016
I am passing on some much needed support for Claims that Anti-depressants do cause aggression/violence/suicide/akathisia on starting, when the dose is increased or when the drug is restarted.
I know all about this from personal experience of an SSRI and which led to the above situations.
I was subjected to a gross amount of ill-founded accusations from doctors because I was wrongly prescribed an SSRI which led to two hospital emergency admittances and copious amounts of benzodiazepines and beta-blockers from cold turkey cessation of the particular SSRI.
The amount of personal discrimination coming my way because I was on an SSRI was completely unfair and put me in a life threatening situation which should never have occurred if I had been tapered, monitored and treated in a fair and compassionate way.
To this end, I would point you in the direction of:
Katinka Newman has listed her Media interviews on her site and her blog contains Permanently and Temporarily Stolen lives for your perusal.
The above two websites are most important, involved with the dangers of Psychotropic Drugs.
Akathisia as a side effect is very much played down from Pharmaceutical companies as this is the side effect that can claim lives.