Following last week’s post, Club 329: Part 1, Ben Goldacre went into orbit claiming his views on medicalization and Study 329 had been misrepresented. He offered a SoundCloud as evidence. The link can be found in the comments after the last post. Seems to me Leonie got the content of the Q & A right.
In the course of listening to the BG SoundCloud though something else came into view. Leonie began questioning him about the links between one of the BMJ editors and the law firm Ropes and Gray who had represented GSK in the Department of Justice case that led to a $3 Billion fine for GSK. This didn’t seem to worry Ben. He’s not worried about Conflict of Interest – nor am I. His view on Fraud is unclear.
There was something else in the recording that caught my interest. BG didn’t figure the question of BMJ taking over a year to publish Study 329 was an issue. You couldn’t possibly make out that BMJ are the bad guys in the business of suppressing good science, he said. If anything they have a reputation for being too sanctimoniously obsessive about research integrity.
As BG says people react differently to things. If you and he were both facing a course of treatment, some piece of trial data about a drug might speak to him and not you and vice-versa. Maybe the Study 329 story doesn’t speak to him and others of you out there – doesn’t give you a feel for GSK or BMJ.
Perhaps a completely different story will work for those of you to whom Restoring Study 329 doesn’t speak.
Six months into a tortured year long review process for Restoring Study 329, something odd happened. On February 9 2015, I was approached by the BMJ:
I’ve long been interested in the controversy over the role of serotonin in mental illness and wonder if you would like to write an editorial for us on: “What is the evidence that serotonin plays a role in depression?”
More than happy to think about doing this for you. But I probably need to make something of a pre-conflict of interest conflict of interest statement, which you will need to consider.
The idea of serotonin in depression is inextricably linked to the marketing of the SSRIs. There is vanishingly little evidence that serotonin is involved in depression – but I can probably put more evidence on the table for its role than almost anyone can.
The idea of a role for serotonin in depression has been an extraordinary marketing trope – one that is critical to perceptions when it comes to the way the role of SSRIs in suicidality and birth defects is viewed. Because of this latter aspect and my role in some of these debates many people viewing an editorial by me would probably have a blood boiling moment. That’s just viewing the existence of an editorial – might not be too bad if they read it.
BMJ decided to run with it, but then seemed to have a crisis. They got back to me with an extensive conflict of interest declaration and there was a considerable delay after I got this back to them before anything else happened. Given all the fuss BMJ were making about Conflicts of Interest on Restoring Study 329, it was difficult not to think there was some link.
Finally they ran with the editorial but had difficulties with the title. So, So Long and Thanks for all the Serotonin became Serotonin and Depression. The Marketing of a Myth. It did well in terms of impact factor despite the fact that Sense about Science, with which Ben Goldacre is closely linked and which kicked off AllTrials with him, mobilized to get dissing comments about it from the Royal College of Psychiatrists and others.
Sense about Science spends a good deal of time mobilizing responses to material that might seem not supportive of corporate interests – see the Sense about Science series of posts to which BG also took exception.
But there is a more interesting story behind this one that I only know about by accident.
A short while before the BMJ approached me, I had been sent an article – on the Myth and Marketing of Serotonin. It was a very good read. At least as good as mine if not better. One of the authors asked what I thought about the possibility of BMJ being interested. I said I thought it was unlikely.
Despite my advice, the authors went ahead and submitted anyway – on February 7 2015. They got a quick reply.
We are in the process of commissioning an editorial for The BMJ, looking specifically at the role of serotonin in depression, and so you will be able to send in a rapid response to that directly.
When dealing with BMJ you can get the feeling they (the editors) are using authors to run their own agenda. You might get in touch with a draft article on Access to Clinical Trial Data and they get back saying “sorry we’ve just had something else from someone else on this topic”. The something else when it appears a good deal later turns out to be a neutered version of what needs to be said.
Many people figure journals shouldn’t have an agenda. In fact the first medical journal, the Lancet, began with an agenda – against food adulteration. The later appearing BMJ ran its own campaign against nostrums – around 1900. These campaigns put these journals at considerable risk of reprisals. BMJ sees itself under its current editor as on a mission. It’s more recent campaigns, far from putting the journal at risk, have been for Evidence Based Medicine and Against Overdiagnosis, along with AllTrials to which pharma has signed up.
Whatever the BMJ mission its not a mission to tackle adverse events – the modern equivalent of adulteration or nostrums. It was close to paralyzed in the case of Study 329 by having to conceded a drug might have a side effect.
The educational articles BMJ runs on most drugs contain little or no mention of adverse events. While it published Restoring Study 329 after a gun was put to its head, its educational articles on antidepressants play down any risk of suicide, are comfortable with giving antidepressants to children, never mention withdrawal, and deny links to birth defects.
But here’s the rub. The article that was better written than mine was written by Leonie Fennel and Maria Bradshaw – neither of whom have healthcare or neuroscience backgrounds. Both write like angels. Leonie was a hairdresser before a family tragedy mobilized her to find out more about the drugs that led to the death of her son and others. The latest version can be accessed on ResearchGate and an earlier version is attached here.
You’d have to think BMJ couldn’t cope with the idea of a hairdresser joining the club. Only credentialed nerds need apply.
Leonie’s input along with that of people like Anne Marie Kelly who have done so much to establish the role of SSRIs in promoting alcoholism proves again and again – and is the inspiration behind RxISK.org – that motivation counts for more than expertise.
When my article came out, Sense about Sense mobilized against it – having been sent a copy by BMJ, with whom they, BG and GSK are part of an AllTrials coalition.
Parts 3 and 4 to come.
Copyright © Data Based Medicine Americas Ltd.
The theme here seems to be ‘academics only please’.
I was recently chastised on Facebook for posting links to antidepressant related news items (including my own work) – Apparently, I have become ‘obsessed and addicted’ to bad news.
The friend in question refuses to read such links, citing that they are too dark and depressing. Each to their own, I guess.
My knowledge on antidepressants was also questioned – of course, it will be, just as the academic qualities of Mrs Scissorhands, Leonie Fennell, will be questioned.
I think it’s safe to assume that patient advocates, myself included, didn’t choose this path ~ it chose us. Our journeys are similar but, of course, not identical. We, or a loved one fell foul of a regulatory and pharmaceutical system that was designed to prod us with a stick should we ever question the safety and efficacy of prescription drugs.
I’ve said it before, and for the purpose of this comment I’ll say it again. If I wanted to know about the quality of food served in a restaurant, I’d ask for customer opinion and not that of the chef, management or staff. The customer (consumer) is best placed to offer an opinion.
It’s my experience, through 10 years of blogging, that there are certain academics who feel we (who have been affected by harmful medications) don’t really have a voice because we never went through the process of the travelling to University to learn about medicine. We get the pat on the head, or (like Jofre) the tickle under the chin, when we question experts – if they are not patting or tickling they are name calling.
They, unlike us, must be right because they have studied hard to get where they are today.
We are told by regulatory authorities and pharmaceutical companies that our stories are anecdotal, which is basically an unofficial yellow card.
When we fight the system, or ask questions, we are labelled as ‘vexatious’ or ‘conspiracy theorists’ – What would he/she know, he/she is just a hairdresser or Land Rover worker.
Truth be told, I could walk in to any GP surgery and educate a doctor on SSRi’s, in particular, Seroxat.
I’ve had many emails over the years from people (patients) who read my work and then pass my findings on to GP’s – these patients get back to me telling me that their GP’s have told them, “You don’t want to believe everything you read on the Internet”
Ho hum, you don’t want to believe everything you read in the JAACAP either, Doc.
Patients, ex-patients and those who have experienced loved ones struggle at the hands of antidepressants have a vital role to play but it was, and still is, always going to be difficult to explain to healthcare professionals and academics that we may just know more than what they do when it comes to adverse events related to this group of medicines.
I’m not a number cruncher like BG but I do know that potentially 329’s ‘small classroom of suicidal kids (Benbow) was a lot more than the 20 or so that first springs to mind when thinking of small sized classrooms.
Perhaps, BG can take a look at these numbers and then approach GSK and ask them why they allowed this to happen, moreover, why they have never offered an apology.
The Devil is in the Details – http://fiddaman.blogspot.co.uk/2015/09/alastair-benbow-devil-is-in-details.html
Anyway… what do I know!
I agree with Bob Fiddaman on this and I am glad that Dr Healy has decided to follow up the last post with this one. The issues here need airing.
But there’s no point in repeating my view when I have already done a blog post that can be read here
Thanks to Truthman30 for sharing that extended quote from Ben Goldacre’s book Bad Pharma, published in 2012. If you can’t read the whole thing, skip down to this line:
“It gets much worse than that. These children weren’t simply receiving a drug that the company knew to be ineffective for them; they were also being exposed to side-effects …”
It ain’t the last word on the Seroxat/Paxil/Paroxetine scandal, for sure. But it’s a whole lot better than the perspective he laid out in Dublin. Having strained to take in the Soundcloud recording of the latter, I can only wonder: Where-oh-where has the Old Ben gone?
Prior to GSK’s public embrace of AllTrials, described by Ben Goldacre as a “cartwheel moment,” it seems like he understood pretty well that “outcome switching” and “limited efficacy” were NOT the biggest problems with paroxetine in children – not by a long shot. He also didn’t mind pointing out that our safety systems were “full of loopholes” which GSK had “cheerfully exploited.”
The new focus — well, as long as patients are informed that the average reduction in depression rating scales was modest, who am I to butt in? — is very different. It’s far more suitable to his growing partnership with GSK. It’s even more ideally suited to his activities around statins, if the Amazon promo for his upcoming book (and the Sponsored Links for Crestor and Livalo offered by Amazon UK to US customers) are any guide:
Thank you Johanna,
I thought it was particularly interesting to analyze and juxtapose Ben’s views pre- ‘the GSK/Alltrials coalition’- and then after. The passage that you quote is very telling indeed.
Up to 2 million prescriptions were written for Paxil (paroxetine/Seroxat) in the US alone (on the backs of off label promotion/study 329 citation/and the literal -monetary prostitution- of doctors/psychiatrists and academics to GSK at the time).
According to GSK spokesperson, Alastair Benbow,- a small class of kids in about a school of about a thousand would have these effects (of suicide self harm etc from Paroxetine/Seroxat).
…If you imagine a school of more than a thousand children, all of whom are deeply troubled by depression. Less than a small class size would have these suicidal thoughts or attempts”
Therefore if we translate that into the risk exposed to children in the US alone (and we estimate that there’s around 30 in a class on average), that means about 30 in a thousand kids could be put at risk of suicide/self harm from Seroxat/Paxil. That’s 3 in every one hundred, or one in very 33 or thereabouts. Or, 10 in every 330, or 100 in every 3300, or 1000 in every 33,000, or 10,000 in every 333,000 or 100,000 in every 3 million. With two million prescriptions in the US, globally that figure could easily have been 3 million kids at risk who were exposed to Paroxetine.
That’s a hell of a lot of kids at risk , and that’s just in the US. This drug was prescribed globally, not just to under-18’s, but to young adults (who GSK also admit there is a risk in – in under 29/25). We know that this drug is extremely harmful in all age groups.
Any company that puts kids at risk in this manner should be disbarred from trading… period…
The last thing we should be doing is trusting a company that engages in this sort of thing, yet that’s exactly what Alltrials has done, and therefore in light of all of this- Ben Goldacre’s praise and admiration for Glaxo CEO Andrew Witty, is not just nauseating, it’s disturbing…
Isn’t it amazing how hundreds – or even thousands – of us have gone through the same type of experiences :- . suffered adverse reactions to SSRIs
. watched family or friends suffer adverse reactions to SSRIs
. reported adverse reactions to SSRIs to GPs
. reported adverse reaction and damage by SSRIs to psychiatrists pushing
more and more drugs to relieve the lingering problems
and yet, NOT ONE OF US seems to be believed?
Whatever our role in society, the lowliest of us must have a right to be LISTENED to and to be BELIEVED. Without the trust of professionals in us lowly ones and our ‘truths’ then their ideas and findings are lost on us too. Their work, surely, depends on our trust. How long can that trust hold when we have to confront their negativity so often?
I cannot understand why so few professionals are willing to listen let alone believe and act upon what we have to say. They are supposed to be the ‘educated elite’ but seem to behave with such a closed mind that it beggars belief. Were the numbers who claim ‘adverse reactions’ very few, then that would sort of justify their non-interest (although each single case is, of course, of grave concern) but here we are, in droves, shouting out – not for our own sakes so much but for future users – and yet they fail us.
One thing is for sure, WE WILL NOT STOP SHOUTING however long it takes to convince them of the reality of such events. God forbid that a member of their families suffer in the ways that we have seen, for it is certain that, if they did, they would have no hesitation in changing their minds then.
Tickled Pink with Leonie, the hairdresser; beautifully coiffed, compared with academically qualified, academic, with the image of a 1970s scruffy intellectual
Reading the Horrific and Tear-jerking story by Dear Dr. Doctor, and his daughter, over on Rxisk.org, it is impossible to balance Ben Goldacre, Alltrials, Sense about Science and the BMJ with much credibility
Despite their own Pain and Loss, Leonie Fennel and Maria Bradshaw are the true heroes of the hour, diligently recognised by David Healy
When the Whole World Relayed the Message to my own daughter, that Seroxat Had Nothing To Do With *It*, I was very afraid that I could have lost her forever
If she had not been *intellectually developed* at 9 years old, this might well have been the Case
I had to leave her alone in a not nice property, with no friends, no school, no life and I was Scared that she might Kill Herself
She didn’t talk to me, she was mono syllabic, she had no enthusiasm
This was our Worst Journey in the World
How we *held hands* again after all this should be a lesson for all those Wanabee Amateurs in the World of what is more or less a rather stilted, hidden agenda of ‘nothing to do with me, guv’ led by that world renowned orator, Sir Andrew Witty
It came from his lead, it trickled down the throats of all those individuals who have made many wrong decisions and many wrong calls like a thick black blood oozing down from the nasal cavities to the stomach
Dear, Dr. Doctor, take a bow..
The Journey with no end, I need not have under estimated my Heroic Child…..but, the fact that I had to and seeds of doubt were sown was a complete miscalculation by Andrew Witty, Ben Goldacre and even the pert and pretty, Fiona Godlee…
I wrote this little narration early this morning with no reference to any comments subsequently left and I must say that Bob and our invisible, visible Truthman tell the truth that courses through my veins..
Truly excellent article from Leonie Fennell and Maria Bradshaw – “When doctors mislead; the chemical imbalance lie.” Exactly right tone, development of the subject, critically correct references and solidly based from start to finish.
I do hope it has been submitted elsewhere? If not, I’d strongly recommend it being blogged where-ever greatest impact can be reached – it deserves it – great work.
Its all the FDA’s Fault…Geeks talk Clinical
….a BiG.retweet frenzy
Because the @US_FDA have never once issued a fine for anyone failing to post results #AllTrials https://twitter.com/eturnermd1/status/742823626173382660 …
View on Twitter
Geeks talk Clinical
I am the co-chair – along with GSK’s Chief Medical Officer Murray Stewart – of the GSK scientific review board, and we review all the clinical trials that are proposed. Our default position is that we use innovative statistical approaches and adaptive clinical trial design as the starting position. If the team proposes not to do it, then I think we would ask them, “Why not?”
We are quite innovative in our design of clinical trials. We try to learn during our early trials – we have interim analyses, drop arms or add arms based on the data – it is much more an iterative process. We also try to capture the patient experience in the best way possible.
Less important to see $$$3 Billion Fines for Paxil from the Department of Justice than it is from the FDA?
And still *at it* with *Innovative* Clinical Trial Spin, those good people at GlaxoSmithKline leading the way in *The Alltrials Videos*
GSK @GSK 3h3 hours ago
We’re using new tools to develop meds with real patient benefits. Our chief immuno officer discusses #leadingscience
Geeks Talk Clinical..
GlaxoSmithKline is to pay $3bn (£1.9bn) in the largest healthcare fraud settlement in US history.
Thank you for the kind comments. The chemical imbalance myth/lie/fraud is a particular bugbear of mine because I totally believed in it. To my eternal shame, when I drove my son to the doctor, I had never heard of ghost-writing, switching outcomes or ‘marginally better than placebo’. I assumed the doctor knew what he was waffling about and was educated in what he was prescribing. Sadly I was wrong. Shane died 17 days after a prescription for Citalopram (prescribed for a relationship break-up).
I should probably point out that I am a mature (oft- immature) student in the Royal College of Surgeons, the college where Ben Goldacre held his talk. I absolutely love it – the college itself is Ireland’s largest medical school and the fabulous building is steeped in history. The lecturers are second to none and the students are an eclectic bunch of very opinionated and friendly souls – what’s not to love? However, this RCSI tweet shows that even medical schools can be unwitting participants in pushing misinformation on the masses – “mental health difficulties are chemical imbalances in your brain – its not as simple as saying ‘Im not feeling great”. https://twitter.com/rcsi_irl/status/527542590925991937
While I have asked twice for this tweet to be taken down, once on my first day (not very clever) and again a few months later, it is still there for all to see. So while some experts say that the chemical imbalance theory of depression was just an ‘urban legend’, this tweet from a highly-respected medical school shows the exact opposite.
I think Goldacre makes it fairly clear what he thinks about side effects on his own blog. Warning. You may experience boiling blood if you read this little piece of extremism.
Everyone is having Kittens – not one bit surprised.
If anyone was on the fence about Goldacre and his intentions, his nocebo explanation for Statin side effects should clear that up for you fairly quickly. Thankfully he doesn’t get much support down below in his own comments section, and reading between the lines I think he took a more flak from some heavy hitters than maybe he was expecting too.
So what will the new Statins book be about? I genuinely can’t wait…Will he go all in for Statins and try and argue for them being a miracle drug, despite the cholesterol myth on the way to becoming chemical imbalance 2.0? Or will it be an attempt at a climbdown from his 2014 ‘its all in everyone’s head’ stance?
Oh I so hope I am alive 20 years from now when Ben says- ‘Anyone who was anyone knew about the Cholesterol myth all along – it was just a useful metaphor’.
If Ben’s thinking on adverse events becomes mainstream then we would all be in much bigger trouble than we are now. I am beginning to think this guy in conjunction with GSK and Sense about science is a match made in hell for those concerned about adverse events. Ben wants us to completely ignore reality and just live by the numbers – numbers he and his like control and that we can never question. Orwellian if you ask me.
Here is verse 2 of Radiohead’s song ‘The Numbers’ from their latest album. Fits like a glove and always leaves me with a smile.
We call upon the people
The people have this power
The numbers don’t decide
Your system is a lie
A river running dry
The wings of a butterfly
And you may pour us away like soup
Like we’re pretty broken flowers
We’ll take back what is ours
Take back what is ours
Neil is right about the Nocebo effect – it only needs BG to make a big fuss about this, and every possible CNS drug side effect will be attributed to all of us who claim to have been affected by these drugs. Chemical psychiatry could have a field day over the nocebo – cue for multiple peer-reviewed papers on how ‘anti-psychiatry’ are responsible for ‘harm’ towards patients who have failed to take their very necessary drugs…
Whatever happened to BG between writing ‘Bad Pharma’ and now? Did he find that he was beginning to be seen as a ‘heretic’ by his colleagues? Did he find he was being cold-shouldered by those he had considered as ‘friends’? Heaven forbid, someone may have even described him as a ‘smeary conspiracy theorist’ – the usual response towards anyone who points out how blatantly corrupt Big Pharma is. Is he desperately now trying to pull back from the edge? Re-establish his ‘establishment credentials’? Please do tell Ben, we’d love to hear…
Anyone wanting realistic information on statins might look at Dr Malcolm Kendrick’s website. A Scot living in Macclesfield, and yet another inspirational individual from the Celtic fringe, blogging to protect us from the horrors of EBM.
More Hairy Stories..
Hot off the Press
Doctor who admitted falsifying drug trials is remanded in custody
Hot off the Press (via Neil)
“But as i said above, anyone who has side effects from a treatment, which they feel outweigh the benefits, can simply stop taking that treatment.”
JP Sand said,
March 27, 2014 at 8:25 pm
Ben, it is Ben right?
Being of a curious mind, I just clicked on the YouTube video link that you posted above.
I must say, at first I was delighted to see a rather odd character tottering across the stage in a floral frock and a frizzled head of hair. I thought, oh my, Susan Boyle has come to sing us a song. Then, she balled up her tiny fists and shrieked that she was going to “skull-fuck” us with her “data cock”.
I rubbed the sleep out of my eyes, and then I saw more clearly: THAT’S NOT SUSAN BOYLE, THAT’S BEN GOLDACRE!
Still, the resemblance is uncanny.(See here:
By the way, if I were an epidemiologist, I’d wash your mouth out with soap.
• Ben Goldacre said,
March 29, 2014 at 10:00 pm
Observational data overstates side effects, randomised trial data should give a more accurate estimate, but probably underestimates side effects for the reasons we explain in our paper, and for the extra reason i explain above. You feel you had side effects. As a matter of principle, in a world full of doctors giving readers health advice, I’ve decided not to do that, and to focus on explaining evidence instead. For similar reasons i wouldn’t content on your personal experience of side effects. But as i said above, anyone who has side effects from a treatment, which they feel outweigh the benefits, can simply stop taking that treatment.
• Ben Goldacre said,
July 3, 2014 at 6:35 pm
You’re mistaken. The benefit for each individual from statins depends on their preexisting cardiovascular risk. I have no idea what your cardiovascular risk is (and I don’t want to know, since I’m not your doctor) so I’ve no idea what benefit you would get, it may well be rather large.
Well done Leonie, having suffered the truth you are speaking out…You are a witness to the dangers of SSRIs…“When you listen to a witness, you become a witness.”
― Elie Wiesel – survivor of Auschwitz…
Many of us are not University educated (although you have changed that) but we are people who have suffered the dangers, the trauma, the broken down selves of dangerous drugs. We are more knowledgable than the University Graduates today.
Leonie, as for the Royal College of Surgeons, be careful – they are the doctors of yesterday, today and tomorrow who are wholly owned by Big Bad Pharma so take what you can in but believe me they are simply the Pharma players of tomorrow.
To change that, we need to highlight, question Pharma vested interests in Colleges, Universities and Governments.
I admire you for your whole story on what happened to your lovely son and how this hairdresser mother rose up to clear his name and raise awareness…you have indeed come a long way.
On the other hand there is me – just a mother, but worked at PA level to doctors, solicitors, Banks, as well as whilst raising my children worked in pubs, shops, took in wonderful students for summer from Spain, Italy and Brazil for many years, many of whom were children of Doctors, Pharmacists etc. Somewhere along the line as coming across as a passive separated Mom – the Medical Cartel felt they had an easy target..me being “The Good Patient” believed every word from Saintly Medical Cartel – from 2009 – 2011 my gut feeling was telling me something was wrong…Here I was that good patient suffering from ill health no matter what prescription I was given from “good doctor”. My children, by now in their University Studies on Science and Medical (Nursing) would not listen to Mom going on again about “it must be the medication”. God Bless them they studied so hard to learn the opposite of what I was quickly learning by my own health going down. “Mom stay off that internet, doctors do not prescribe what is not good for you, listen to the doctors, Mom, you are becoming paranoid about doctors and medicines”…what could I say to my darling educated children…I was simply Mom.
Soon I began to realise whilst I have educated my three children to Science and Medicine and now they want me…I know that Irish healthcare played on the fact that I would not upset my children’s studies.
My wonderful children believe in the “chemical imbalance”. My youngest is doing a Masters out of Ireland in Science and what is good/bad in Medicine.
It breaks my heart to know that my own University educated children do not realise the dangers of Healthcare today.
I thank Dr David Healy for his Blog and Posts – many of which describe my story…if it was not for his blog posts and Dr Peter Goestche’s posts I would have believed I am indeed paranoid – If only I had been paranoid about doctors and medicine – I may have saved myself a lot of torture and health breakdown.
Despite many medical and Pharma injuries – with further experiments done on my body by the Mad Science of Doctors who do Harm in the name of Pharma Profit Margins..I have to play the mother who is simply “a little bit silly” for daring to question doctors. My children have constantly said to me “Mom, you question doctors, they have studied for years to do good for patients”.
In conclusion I have persisted unkownst to my children until very recently on “pushing” Gardai to take a case under the Irish Criminal Health Act of 2012 where I was further injured under anaesthetic for a foot operation. It took over 2 years for Gardai to take a Statement and submit it to DPP. I learnt recently that HSE (Irish Healthcare as in NHS) and Gardai edited my Statement and removed the two Consultant names from my Statement.
At present day I have been advised by DPP that they can only deal with Statements through Gardai (Irish Police) – I am still waiting for that up to date Statement to be taken.
Everyone at present states – “Would you go see a doctor, you sound stressed”….
Thank you Leonie and all who are involved in exposing the dangers and suffering of Patients…