Courts are not a place you can make jokes. I started off with a confident pitch:
If you owe a bank a million pounds, you have a problem but if you owe the bank a billion …
I didn’t get much further. It felt like several GSK lawyers popped up, addressing the judge with words to the effect that he’s talking about banking your honor, this is not his area of expertise. The judge accepted their objections and I didn’t get to complete the analogy.
Nobody knew what I was talking about anyway – pounds? What are pounds?
Judge Hart also ruled out the following image. So the jury never got to see it.
A lot of my testimony centered on working through each of the ways to hide the data listed here. The exhibit couldn’t be shown but this is what was covered – in some ways too well. There were documents showing correspondence between GSK and FDA on many of these points leaving the jury wondering whether GSK or FDA were more to blame.
Many of the things that were done were shocking. GSK and other companies dumped withdrawal related suicidal acts into the placebo arm of trials, inflating the risks of placebo and breaching FDA regulations in the process. A good deal of this was so blatant that the jury must have been left wondering whether FDA reviewers were asleep or out to lunch.
Suicidal events were coded under the heading of emotional lability. When a journalist and lawyers independently spotted this coding trick and it became a public issue, emails circulated within FDA asking what emotional lability actually was, and where it had come from. But Andy Bayman for GSK could show the jury the documents sent into FDA which showed suicidal events clearly coded as emotional lability. This naturally cast doubt on whether FDA could have been as ignorant of what was going on as FDA head honchos later claimed to be.
Another egregious trick was the use of patient exposure years. This gives rise to the Space Shuttle fallacy. If you calculate lives lost per miles traveled the Space Shuttle may be the safest means of transport in the universe. But it takes a brave person to go on one.
This is because in terms of exit from and entry to earth’s atmosphere the shuttle is highly risky – just like antidepressants where its the starting and stopping that are the problem. GSK and other companies continued some people who were happy as clams on their paroxetine for lengthy periods of time and mixed these with the patients having difficulties to dilute the problem. All of sudden, per year on treatment, the antidepressants looked safe. This is a legitimate approach for some problems but not for this one.
Another trick was putting suicidal events in a neurological category that also included dizziness and headache. These happen so commonly they drown out the signal from suicidal events.
Every time a maneuver like this was exposed, GSK looked bad. They looked like they owed the jury and the public money – a million dollars. The problem is though, they hold all the data. No one could give the jury the data from these GSK trials and say “here you are – its not rocket science – you work out what this data shows”.
While this is the case GSK effectively owe us Billions and its us who have the problem. They own us. And don’t seem to be under any onus to stop owning us.
But GSK interrupted my efforts to lighten the jury’s day by making this remark. A Court is not a place for this kind of thing.
Copyright © Data Based Medicine Americas Ltd.
I remember there being a joke about this in Graham Greene’s ‘Our Man in Havana’ where the hero solves his insolvency by selling drawings he’s made of vaccuum cleaners to British intelligence, claiming that they are military installations, and perhaps this is GSK’s model – I don’t know whether Greene or Getty got there first. But also, perhaps worth observing that unlike the USA the British civil service have the problem licked – unless your are as wealthy as Getty the Legal Aid Agency will prevent you getting to court.
Amazing how they get away with it, surely this ‘concealing of side effects’- resulting in harms to patients- amounts to corporate manslaughter in some instances?
GSK: $$$ 3 BILLION
“In November 2012 GSK pleaded guilty and agreed to pay $3 billion, the biggest fine in corporate history. The next year, the number of prescriptions for paroxetine in the United States increased by 3%.”
Medicine’s Most Infamous Clinical Trial
Correspondence with GSK
Witty did not respond at all whilst in orbit .. he didn’t have a problem, Houston ..
Wendy Dolin: $3M in Chicago
Whose Problem .. no emotional liability on starting and stopping ..
Who cares in Sweden
4 hrs ·
Din läkares frågeformulär om depression
är skapade av läkemedelsbolag.
Det är inte ett skämt!
Your Doctor’s questionnaire on depression
Are created by pharmaceutical companies.
It’s not a joke!
Well, Annie, by now you almost certainly know I care in Sweden. I wish more would too, and preferably as loud and with authority as dr. Healy.
But that video has been out there for some years now, and despite it’s truth and sometimes skocking content, nothing has changed.
The elderly female psychiatric professor emeritus depicted in the video still runs “Psychiatry Sweden” with an iron hand, still denying that anything bad comes from her beloved pills, like this quote on SSRI’s in general from 2017:
(my translation, plus check the relation to the Dolin-trial facts about suicides)
-“Furthermore an increase in suicidal behaviour and self destructive behaviour have been reported. In the placebo-controlled studies though, no completed suicides has been reported”
The quote is from the 2017 version of the pharmacists book on pharmaceuticals, and the quote refers to using SSRI’s as a first line treatment for anxiety.
The guidelines for treatment of anxiety is co-authored by her husband, he is also a professor in psychiatry, and together, well, they are “loud” promoters of the pills we discuss here.
Off topic: nice to see you included the original swedish text. All the dots over the letters are in the right place, copy and paste works magic ; )
Not sure whether this dovetails in any way with the post, but I was rung up and asked to give an interview to the media this week on our experience of suicide and our belief of the link between RoAccutane and suicides. As there’s been a flurry of news re this drug again this week in the papers following yet more suicides, there seems to be renewed interest in hunting for evidence of its causal link to suicides. Roche (like the FDA) must have the evidence hidden away somewhere, and the parental anecdotal evidence is legion, their combined appalled voices getting louder in solidarity as each month passes. The interviewer asked me what I thought of some new study just out (didn’t catch the name of it, or research body) saying there is again no proven link between suicides and isotretinoin because how can you know what goes on in a person’s mind relating to other factors in their life which might make them want to end it. In other words, how long is a piece of string? Funny how we are getting a study like this coming out just now in defence of RoAccutane, and Jeremy Vine on BBC Radio 2 speaking up for RoAccutane with Dr Ellie (Somebody), a GP who always comes out in its strong defence. Beware the Distracting Hand again, the smoke screens, whilst the scientific evidence, like GSK’s remains hidden. You BET they owe us billions, and yes, it’s ruined our lives so it IS our problem, because they have all the dosh and all the power, for now. But the writing on the wall is getting larger and the clamour of the rabble is getting louder. Humanity will only stand for so much, and then they’ll break down the barricades and kidnap the evidence. Wait and see.
My apologies, it was the BBC’s expert GP Dr Sarah Jarvis who spoke on BBC Radio 2 on 22nd May 2017, just after 1pm. She used words like ‘RoAccutane works VERY VERY well’ for some people, but others can get severe depression. She didn’t mention suicide at all. Later she said RoAccutane is FANTASTIC, and when a telephone caller rang in to say she’s nervous about using this drug in case the acne comes back after stopping it Dr Sarah Jarvis said she’d recently been chatting to a dermatologist colleague about this and he’d said in 70 – 80% of those he’d prescribed it to, (or it may be, of those he’d read about who take it) it doesn’t come back after one course of RoAccutane.
She did advocate a Mediterranean diet, lower sugar and processed foods, she also strongly wanted people to stop using antibiotics. She was against sun bathing because of the risk of skin cancer. Another caller said she had at last got rid of her acne in her 30s by having attended a seminar on acne given by dermatologists who recommended RoAccutane, so she went along to her private hospital, saw the Consultant Dermatologist there, was prescribed RoAccutane, and after, I think she said 9 months, her acne had cleared, so she is delighted. There was no anti-RoAccutane view seriously expressed, except that a woman needs to have triple contraceptive measures in place (reasons why were not explained). At the start of the interview Dr Sarah Jarvis gave the main reasons why we get acne, saying 80% of teenagers get it but for some it persists later in life and hormones can influence this. But she also insisted that stress doesn’t affect acne! But stress surely affects hormone levels? So stress MUST affect acne, and anecdotally we KNOW it does.
She went through other topical treatments and said they dried up and stripped the top layer of skin and that could be a problem for people. All in all, I’d say this was a pretty good but subtle promotion for RoAccutane-isotretinoin as the alternative case about the danger of suicide was not spelt out even handedly. Jeremy did open the piece by saying there is a new Report out saying one in five people with acne reported having considered suicide, but this suicide word was not mentioned again. It ties in though with what I was asked earlier this week with reference to some new Report, ie ‘didn’t I agree that it was the acne that was causing the suicides, or other factors in people’s lives and not RoAccutane.’
We have seen Dr Sarah Jarvis on BBC tv last year, telling us how safe SSRIs are and that those who report problems have mental issues themselves anyway so we should take their complaints with that in mind, ie with a pinch of salt. Beware the Distracting Hand again, folks. Subtle but effective. Remind yourselves of Dr Jarvis’ paid links with the pharmaceutical industry. She did a jolly good job for ROCHE in that interview, without making it obvious…
Dr J yet again…
She’s in need of a personally dedicated website to bring her to account – no ad hominem attacks, no lies, just a factual resume laid out online of what she has said, and who she has taken funding from.
Anyone googling her name, the ‘alternative’ site appears, and she (and other KOLs) might begin to get the message – ‘You cannot hide your links and then claim to be some sort of balanced authority on these drugs’.
You are bang on right Walter! It’s the certainty with which she sounds off about everything. We found a comment somewhere from someone in 2009 I think, a nutritionist, complaining to the BBC because at that time Dr J was saying that diet made absolutely NO difference to skin health. Now she’s at least admitting that a Mediterranean diet is a good idea, but she’s also doing the big hurrah for RoAccutane at the same time.
Just been speaking to another parent in our group bereaved by RoAccutane, who has heard of yet 2 more deaths in the Havant, Portsmouth area in recent weeks, on top of the two in Colchester. All in our group feel such fury and desperation all at once. The nonsense Dr J is putting out just compounds this.
Why do the BBC keep rolling her out, when so many complain about her? We just can’t understand it. Is she paying for a slot with them? Or does Big Pharma control the BBC like everything else? Talk about propaganda!
Walter, I have just opened my copy of ‘Good Housekeeping’ for July and there is Dr J again (using a photo I’d guess was taken at least 10 years ago) as ‘Ask SARAH’, ‘Dr Sarah Jarvis answers your health questions this month’….. one topic is ‘bone density checks’ (DH may be interested).
So, Dr J is the BBC expert and now a very well respected women’s magazine expert, one wonders whether she and Big Pharma -to whom she is happily connected – are running a propaganda cartel. Needless to say I shall be cancelling my subscription to ‘Good Housekeeping’ with immediate effect. I can’t trust their advice any more.
There are many tricks of the trade of coverup. Whilst here on your blog Dr Healy, it is about the drug trade within Pharma. We have had many examples of the crime of Pharma drugs with Shane Clancy tragic murder/suicide and Jake Glynn’s suicide both had been on Pharma prescribed drugs by the medical profession. Both families were left without answers and suffered greatly. This is because the Pharma industry is protected in the UK and Ireland and Departments of Health really do not give a damn.
The above post reminds me of the words of Gandhi:
“First they ignore you, then they ridicule you, then they fight you, and then you win.”
― Mahatma Gandhi
I suffer Pharma’s ridicule & medical cartel violation of my body at every turn but tonight I want to talk about Pharma’s Medical Devices. Both the HSE & NHS have refused to take on board the harm of Morcellators, Mesh and many more devices. Dr Amy Reed and her husband Dr Hooman Noorchasm only came across Morcellators when Amy suffered the consequence of such. I phoned Health Products Regulatory Authority about Morcellators about 2 years ago. I was told that whilst Morcellators had been recalled worldwide by J & J they, the HPRA, were advised that Irish ones are safe. Yes Pharma are still using the Leprauchan gaffs in Ireland and seemingly the UK.
Dr Amy Reed, 44 years old, mother of 6 children, the youngest being 4, died last night.
The following is her story with the support of her husband also a doctor Hooman Noorchasm.
May she Rest in Peace.
GlaxoSmithKline’s New CEO Is Off to a Good Start
The other priorities the new CEO highlighted were a stronger focus on execution and on improving the value of the pipeline and a desire to shift the culture of the company to be more disciplined and performance oriented.
None of these pronouncements is particularly shocking
What incoming CEO wouldn’t want to improve a company’s execution, culture, and the value of its assets?
May 27, 2017
Father Forgives His Dead Daughter’s Boyfriend For Her Paroxetine (Seroxat/Paxil) Induced Murder ..
“The label said paroxetine, which is a selective serotonin reuptake inhibitor (SSRI), and as a psychologist I knew there are risks associated with it.”
“the appeal court ruled that he had been in a psychotic state.”
We continue to visit and support Samarie. It’s not about whether we forgive him. What happened can never be erased, for him or for us. I can understand people thinking it’s unbelievable that we can even look each other in the eye, but this is our way of dealing with it. I’ve never thought it was the wrong decision.
Furthermore, GSK, just as they did at trial, are blaming Stewart’s doctor for prescribing Paxil and also the FDA for apparently refusing to update the suicide warning on Paxil.
GSK are also, it appears, blaming the judge for not properly instructing the jury.
The motions states, “In contrast, the Court denied GSK a fair opportunity to cross-examine Plaintiff’s experts for bias and to present relevant evidence. In addition, Plaintiff had the final word at trial with expert testimony that went far beyond any proper “rebuttal.” These many errors resulted in extraordinary prejudice to GSK, jury confusion, and ultimately a verdict unsupported by the weight of the evidence. A new trial is required.”
“13 WAYS GSK USED TO HIDE THE SUICIDE SIGNAL”.
This invaluable consolidation of the deliberate deception methodology in clinical trials is both powerful and disturbing.
I am at a loss to conceptualise how knowledge and awareness of such deliberate
data-deception of prescribers (and the resultant deception of patients) can be effectively made available to GPs.
There appears to remain amongst many prescribers an unquestioning belief and acceptance of clinical trials validity.
As a result there is a continued deception of patients by the perpetuation of the chemical imbalance hoax.
Denial that SSRIs and psychotropic drugs can cause akathisia and bizarre changes in personality and behaviour, leading to violence, suicidality and then misdiagnosis as emergent psychiatric disorder, and/or completed suicide.
Refusal to listen to genuine reports of PSSD, despite advocacy for their use in
“voluntary chemical castration of selected sex offenders”.
There is surely a case for AWARENESS OF FRAUD IN CLINICAL TRIALS TRAINING to be addressed at medical school and during vocational training for general practice.
From arrival at medical school, and throughout General, and Specialist Professional Training, we became increasingly aware of a “ethical duty” to afford respect to our medical colleagues.
Surely unquestioning adherence to such a demonstrably dangerous duty must be challenged and moderated if this knowledge, skills and awareness void –
( a void which prevents prescribers from listening to, and acting safely upon reports from patients and families detailing serious SSRI/psychotropic ADRs) – is to be addressed?
WATCH: Does My Bias Look Big In This? Talk by @DrDavidHealy
Published on 31 May 2017
A talk by Professor David Healy on clinical trial bias and the flaws of evidence-based medicine (EBM). The talk was presented at University College London for the ‘Your Health, Your Evidence 2017’ conference on behalf of EBM+ on 3rd May 2017.
What transparency means to me ..
Elevating trust, transparency, and integrity in reporting the results of industry sponsored research.
GSK 15m15 minutes ago
We know that #transparency matters, but what does it mean? Here’s what some of our leaders think: http://gsk.to/2qEok0r #ThursdayThoughts
Take the Pledge
I pledge to support the timely, accurate, complete, balanced, and transparent reporting of industry-sponsored research results in adherence with appropriate guidelines and ethical standards: 1) to ensure practitioners have access to full information when making treatment decisions for their patients; and 2) to foster a culture of mutual respect, understanding, and trust among authors, the pharmaceutical industry, and medical journals/editors to facilitate this process.
Why Transparency Matters
GlaxoSmithKline: Public Disclosure of Clinical Research
Count Me In
“To me, transparency means that information is shared in a clear and understandable way”
Chief Medical Officer
GSK attempt to ‘derail’ with objections ..
GSK said its experts would have told jurors that Dolin’s method of self-destruction was not uncommon for Chicago in 2010, as there was a cluster of train suicides in summer 2010 set off by a high-profile rail suicide in May that year. Further, the experts would have testified that when white, middle-aged men, like Dolin, kill themselves, they often do so more violently than other demographic groups.
GSK asks for new trial over claims its anti-depressant labeling contributed to lawyer’s suicide
by Dan Churney |
May 31, 2017, 11:18am
One of the numerous miscues Hart committed, in GSK’s view, was to bar GSK’s expert witnesses from testifying against plaintiff’s claim the “hallmark” of suicides caused by Paxil-paroxetine, was their violent nature.
According to GSK, in the instructions, Hart “misled” the jury about the drug maker’s duty to warn users and the FDA’s role in label contents, as well as failed to explain the requirements of a “failure-to-warn” claim.
Problem Areas ..
“white pills in western markets”
Former Glaxo chief Andrew Witty was famous for his attempts to move away from “white pills in western markets”
MHRA Seek Payment For Info on Deadly Drugs
“A cynic might conclude that more zeros make it easier to capture the attention of investors.”
Annie, I guess this is about to become an interesting battle don’t you agree? We all know that Bob will not give up without a fight to the bitter end for the truth – hidden as it is at the moment. His reply to the MHRA is just magnificent. Can’t wait to see their next move – no doubt other obstacles will present themselves in due course. I’ve no doubts either that Bob, being well used to overcoming obstacles, will tackle whatever they manage to throw in his way!
Also of interest is James Moore’s latest podcast showing that Tapering Strips (for safe reduction of some ADs and APsych. medications, with more in the pipeline) are already available in the Netherlands. UK users of these meds are urged to have a chat with their GPs if having difficulty with reductions using standard, available tablet strengths.
Things seem to be on the move – let’s hope that Roche have a change of heart regarding Ro Accutane soon too Heather.
BOB FIDDAMAN @Fiddaman 1h1 hour ago
So nice to know that one of King & Spalding’s biggest and wealthiest clients, GlaxoSmithKline, may now have someone to oversee any future criminal behaviour of theirs.
Discussing the group’s approach, Wray told Law 360, “It’s kind of a ‘keep calm and tackle hard’ philosophy.”
Wray said, “We’re more known for calmly and quietly diffusing a crisis or making matters go quietly away and keeping things in the middle of the road.”
“Don’t you think if these medicines caused suicide someone would have spoken up?” ~ Andy Bayman – King & Spalding.
Challenging the industry norm ..
BOB FIDDAMAN @Fiddaman 10h10 hours ago
Replying to @GSK
Why was the compensatory award originally put in place?
Head of Anti-bribery and Corruption, Sanctions and Export Controls Centre of Excellence, GSK
The other David, speaks up at Kings College, London and is the story that needs to be retold and retold … about Paxil ..
He could never have seen this coming.
Expert Click ..
“The Seventh Circuit’s ruling is a significant achievement because it confirms that drug manufacturers are answerable for their misdeeds in a jury trial and will no longer be granted immunity under the guise of preemption. The ruling is not only a victory for the Masons, but a victory for all consumers of pharmaceutical drugs.”
The appeal was briefed and argued by Bijan Esfandiari of Baum, Hedlund, Aristei & Goldman
(Summary: Paxil’s manufacturer, GlaxoSmithKline (Glaxo) has lost its bid for immunity from suicidal behavior lawsuits. A Federal Court of Appeals in Chicago rejected Glaxo’s attempt to throw out a case arising from the suicide of a 23-year-old university student who was taking Paxil at the time she died. Her parents claim that Glaxo failed to warn that Paxil causes suicidal behavior.
Glaxo argued that FDA approval of a drug should shield its manufacturer from fault even when the company learns of harmful negative reactions after FDA approval. This theory, known as “preemption,” asserts that FDA approval “preempts” or nullifies any lawsuits against a drug. If Glaxo had succeeded, it would have made it extremely difficult for other injured consumers to seek compensation in Court.
In a unanimous opinion, the Court of Appeals rejected Glaxo’s arguments and refused to give immunity to drug manufacturers. The Court confirmed that injured consumers should be allowed to have their claims tried in a court of law and manufacturers must be held accountable for failing to disclose harmful negative reactions to their drugs—the manufacturers retain their obligation to warn of risks even after the FDA approves the drug for marketing.)