Editorial Note: This post is by Leonie Fennel. It’s one of two involving Leonie.
Last week, Dr Ben Goldacre gave a public lecture in the Royal College of Surgeons in Dublin (organised by the 3U Partnership and the very lovely Dr Ruth Davis). Dr Goldacre is a doctor, academic, campaigner and writer; he is also a psychiatrist and self-professed nerd. I was eager to hear what he had to say, not least as the subject-matter was ‘Bad Trials’ – so off I toddled to Stephen’s Green with a friend in tow, a psychotherapist. He, like me, has a personal interest – he has witnessed first-hand the devastation that can be caused by nothing more than a GP’s farraginous prescribing. He is also a very kind, funny, charming companion, so I was delighted to have any excuse to meet up with him. I’d also say he’s a handsome chap but the husband I abandoned for the day wouldn’t be too impressed.
Having read Goldacre’s ‘Bad Pharma’ book, we were both curious to hear what he had to say. Incidentally, he once called my English friend Fid a ‘Smeary Conspiracy Theorist’ – so apart from guaranteed entertainment, I wasn’t too sure what else to expect. In fact, his talk was fast-paced and as excitable as he is – he hops around like a Duracell bunny on speed and lets out intermittent roars, which effectively kick-starts the heartbeats of anyone not paying attention. Nevertheless, he attempts to make data and statistics fun, a nigh-on impossible task.
Needless to say, as the subject concerned ‘bad-trials’, he specifically mentioned GlaxoSmithKline’s notorious Study 329, although bizarrely managed to do so without mention of GSK (usually both are referenced synonymously). He seemed like an amicable chap and was quite happy to answer questions afterwards in the Q & A session.
I was interested to explore his views on Study 329 and asked his opinion on why the BMJ took a year (of much wrangling) to publish Le Noury et al’s reanalysis of it – and did he think it had anything to do with the BMJ’s clinical editor being married to a partner in Ropes and Gray, the same law-firm hired by GSK to defend the action brought by the US Dept. of Justice, where Study 329 was a central element.
Goldacre said that he didn’t know and didn’t care – that fraud and Conflicts of Interest were not of interest to him. He asked what the fixation with Study 329 was, as it was just one of the many trials where data was misrepresented?
He expressed the opinion that everyone knew from early on that the original study 329 was flawed and nobody really relied on it. I sincerely doubt that the authors would agree with him on that, but he is entitled to his opinion. The oddity as the photo shows he was talking about outcome switching which is what happened in this originally well-designed trial.
He went on to say that the reanalysis (Restoring Study 329: efficacy and harms of paroxetine and imipramine in treatment of major depression in adolescence) was nothing new. It only did what had largely been done before and confirmed what everyone actually already knew.
Expressing my concerns that Study 329 was still not retracted, he asked what I wanted to happen, that all papers that are re-analysed and found wanting, be retracted? Erm, yes!
My friend, the dishy therapist, then said that wasn’t the crucial point being that 329 harmed so many children? Ben said once people have informed consent, they can make their own choices – like this is a common practice. He pushed Ben on the now-common practice of problematizing distress, with Ben suggesting that people need to be careful not to push their own biases onto others.
It struck me as odd that BG seemed disturbed by the discussion turning to study 329 – yet he had specifically brought it up himself. I thought it even odder that he didn’t give the re-analysis by Le Noury et al any credit at all. I got the distinct impression that while his forte may be in data and stats, the enormous numbers harmed by these fraudulent trials were given little consideration.
How can anyone say that people can make an autonomous choice to take a drug, when the (usually ghost-written) studies are manipulated to give positive results, while hiding serious harms?
The mammoth undertaking by Le Noury et al deserves huge recognition for exposing just this – that truly informed consent is impossible unless the full facts are provided.
Editor’s Note: Ben Goldacre has taken exception to this characterization. He comments below. His tweets on the issue can be found BG tweets
I’m unsure what world Ben Goldacre lives in?
The reanalysis “was nothing new, only doing what had largely been done before and confirming what everyone actually already knew.”?
Why then is Seroxat still prescribed to teens off-label?
Unless, of course, BG has evidence that it’s not prescribed to children and adolescents any more?
Sincerely,
The Smeary One
Did Uncle Ben really write ‘Bad Pharma’, or was it ‘ghostwritten’ by someone else? Cognitive dissonance arises from reading Leonie’s post above…
Meanwhile, this morning, Nemeroff’s mate Pariante (King’s College, London) has claimed a new blood test for inflammation, which identifies who should be treated ‘more aggressively’ for depression (i.e. more drugs).
Wonder who funded this self-aggrandising little BS exercise, then? Psychiatry’s ‘endless promissory note’, a phrase coined by Szasz, rolls endlessly on…
I’ll plait spider’s legs if this test is ever used by any clinician.
http://www.bbc.co.uk/news/health-36459679
Walter
What an entertaining read – thanks Leonie. I would have loved to be there to hear you and your hunk ( means the same when used in Ireland I hope!) cornering Dr BG. Would have enjoyed seeing him squirm and then try to deflect your questioning, even more!
After the entertainment of your writing came the seriousness of what went on. Did he just expect the audience to accept every statement of his as the truth? If so, having you there certainly put paid to that idea of his didn’t it. So he thinks that nothing new came out of the years of hard work that went into producing Restoring Study 329? To me, that sounds like sour grapes more than even an ounce of truth. Does he truly believe that patients have all the necessary information to give ‘informed consent’ before ingesting drugs pushed by their GPs? If so, I would say he has a lot to learn!
One thing is for sure, if he had his audience eating from the palm of his hand up to a point, then your spitting out of his precious comments may well have woken the audience to the fact that not ALL professionals think in this way. Also, that not ALL non-professionals are that gullible either!
Looking forward to your next instalment now. Can’t wait to be entertained!
I am sick to death of hearing smug academics apologize for this infamous Paxil study by saying “everyone” knew it wasn’t very good and “nobody” really relied on it anyway. I hope Dr. G. can explain that to Tracy Eisen, who was put on Paxil as a teenager (at least a decade after Study 329) and Kristina Gehrki, whose daughter was also put on the drug and died by suicide. Both women wrote to the BMJ to applaud the publication of that paper taking apart this study once and for all:
http://rxisk.org/study-329-stories/
If it’s really true that the medical-academic elite and their corporate sponsors “knew” this study was a piece of poop for TWENTY years — then all the more shame on them! Why did they not bother to inform the rest of us? It’s even worse than their airy dismissals of the Chemical Imbalance or Serotonin Theory of depression. Which they all say “nobody who was anybody” really believed, lo these last THIRTY years.
Nobody — except for your doctor and mine. And your teachers, and your judges and politicians, and the local talk-show hosts, and the cop on the corner, and your next-door neighbor. A relentless, orchestrated chorus that left us ordinary patients surrounded.
But then again, in the eyes of these people we are Nobodies. Teens like Tracy are apparently super-Nobodies. Not even people — just a revenue stream. And the “health education” put out for us and are doctors is apparently what George Orwell called Prolefeed. It doesn’t have to be true. Just useful — to our natural superiors, I guess.
Remember that the next time you read the latest Prolefeed from WebMD or Sanjay Gupta or USA Today. Or the Journal of Child and Adolescent Psychiatry.
And, I thought I had problems with G; SK upper management
They, BG +++ GSK are wilfully turning a ‘blind-eye’ to Club329, but, the last laugh as with All Legal Rights will be when All Trials is forced to remove GlaxoSmithKline, hook, line and sink’er from its shop windows and B G.lax will probably say “you winsome, you lose some”..
Nice; Part 1, Leonie..
“Pseudoscientists and pharmaceutical frauds beware: gladiator of rationality Dr. Ben Goldacre is set to slaughter peddlers of scientific misinformation this September.
http://www.eventfinda.co.nz/2016/an-evening-with-ben-goldacre/auckland
“What better immunisation from pseudoscience and misinformation than the shots of verbal vaccination from the doctor himself, Dr. Ben Goldacre? The doctor will see us in September.
Er..
GSK @GSK 16m16 minutes ago
Delighted to be in the @FT Responsible Biz Report. We believe ‘how’ is as important as ‘what’ when running a biz
Er..
New Zealand Doctor @NZDoctor_news
Author of Bad Science and Bad Pharma, Ben Goldacre, is presenting in Auckland http://www.eventfinda.co.nz/2016/an-evening-with-ben-goldacre/auckland … #alltrials
17h
This blog on Dr Healy’s website simply misrepresents what I said on Study 329 and medicalisation of mood.
I record all Q&A sessions in case people misrepresent what I say.
Here is a recording of that evening. The discussion misrepresented in this blog is at 11 minutes.
https://drive.google.com/open?id=0BzeHCsdbbqFxT2tUUDMzR25fTVU
I think it would be good if you included a link to this, in the text of your blog post, so that people can hear what I actually said.
I’ve popped the audio on SoundCloud to make it easier for people to hear how Dr David Healy is simply misrepresenting what I said.
https://soundcloud.com/ben-goldacre/ben-goldacre-dublin-qa
I think it would be appropriate for this audio to be embedded in the post above.
Earlier on today Ben Goldacre tweeted as below claiming that Dr David Healy has misrepresented my views on medicalization of depression and Study 329. The post it should be noted was by Leonie Fennel.
The tweet contains a soundcloud recording of the Q & A
https://twitter.com/bengoldacre/status/740228336467779586
I have listened and everyone else should too. I think it shows that Leonie has been more than fair in her representation of what Ben has said about Study 329 – I think his views on this are both wrong and unfortunate. They are not going to help the cause he claims to support.
The representation of his views on medicalization and linked to this on informed consent I believe are also fair. The way this played out was complex but essentially what he is saying appears to boil down to the fact that he would feel he needs to put aside any views he might have on whether depression or whatever is treated with pills or not and show people the ghostwritten articles on trials whose data has been sequestered and not even regulators have gotten to see and if there appears to be a benefit from treatment in these “adverts” and people want to take the drugs as a result – who is he to stand in the way.
Everyone should listen to this Q & A and Retweet and favorite it
David Healy
Seems that Dr. Ben could do with a few lessons in reading and comprehension!
I think it’s very telling that Dr David Healy is unwilling to put the full audio of what I said in the body of the blog he has published above. Here it is, again.
https://soundcloud.com/ben-goldacre/ben-goldacre-dublin-qa
I don’t think this post or discussion is a reasonable reflection of what I’ve said about Study 329 (or medicalisation) during that talk, that Q&A, in blogs, books, or anywhere else.
Study 329 was risible, I regularly use it as an example of outcome switching myself, including in the lecture described above.
I absolutely do also think that we already knew, a decade before “Restoring Study 329”, that Study 329 was negative. This is thanks to the heroic work of Jon Jureidini, which showed Study 329’s outcomes were switched, paroxetine had no benefits, and only harms. That epic, magnificent paper on 329 was published back in 2008:
http://www.csun.edu/~lmchenry/documents/ClinicalTrials.pdf
The “Restoring” paper was a great exercise, it was clearly a gigantic amount of work, but it’s also true that its findings largely repeated what Jureidini had already heroically showed a decade earlier. To my mind the biggest take-home was more excellent updated documentation on, for example, GSK’s risible responses to Jureidini, and the laughable circus around people defending the paper. There was, of course, the opportunity to create more media coverage about this one case. That is truly great.
BUT: I genuinely do think there’s a risk in focusing on single trials, when discussing widespread structural problems in medicine. It can create the misleading impression that these are one-off episodes, rather than recurring themes.
Outcome switching is terrifyingly prevalent, a Kamal and I discuss here (with extensive reference to Study 329):
http://compare-trials.org/blog/are-your-results-unusual-or-how-often-are-outcomes-switched/
A third of trials have discrepancies on their primary outcomes:
http://download.springer.com/static/pdf/257/art%253A10.1186%252Fs12916-015-0520-3.pdf
If there have been 500,000 RCTs to date, then we have 150,000 misreported RCTs to get angry about.
If interested, you can read what I said about Study 329 in Bad Pharma here. As it happens I also set out the basic design of RIAT and re-analysis of misreported RCTs in this section of the book (top right page) in 2012.
https://goo.gl/photos/c598CuYbVf5MqZFc7
If I was writing it today, I think I’d use a different example, for one reason: to avoid being seen to always discuss the same example. Maybe I’d use Jon Jureidini’s excellent 2015 work on CIT-MD-18, which shows exactly the same thing, on a different drug, and a different trial: outcome switching, and a drug that was misrepresented as working in children, in a trial that was flagrantly misreported.
http://content.iospress.com/articles/international-journal-of-risk-and-safety-in-medicine/jrs717
That’s my personal view on the optimum strategy for challenging a broken culture in medicine: use as many different examples as possible, and always emphasise that the problems are systemic not anecdotal. I think that’s reasonable to voice. I don’t think it’s reasonable or constructive for anyone to take that thought and use it to pretend that I am somehow unconcerned by the misreporting of Study 329 by GSK and the original study authors.
Study 329 was dire. Talking about its flaws is a very good thing to do. It is just not unique, and in my view, strategically, it is important to constantly emphasise to the public, professionals, and policymakers that this is about tens of thousands of flawed trials, not one. That’s just my view.
This gets more and more interesting.
1. BG now claims to have invented RIAT amongst everything else.
2. BG seemingly doing some outcome switching on audio clips he wants put up
3. BG claims his discovery of outcome switching is the new Moses bringing tablets down from the mountain moment
4. Notwithstanding this, BG claims Jureidini had pointed out outcome switching in Study 329 within minutes of it being published – then puts reference to paper 7 years later
5. BG seems to think everyone else should think outcome switching is the key thing, when at least 50% of the value of Restoring Study 329 is about adverse events – nothing to do with primary outcomes or their switching
6. BG claims Study 329 was a dire and risible study – when GSK think its wonderful, Marty Keller et al to this day think it was wonderful – and Nardo, Jureidini, Le Noury, Tufanaru, Raven, Abi-Jaoude and Healy all think it was a well designed study.
7 I’ve been more concerned about structural problems in the system than BG for a longer period of time, focussed mainly on access to the data. BG in contrast through AllTrials is linked to a proposal that would prevent the data from being accessed and scrutinized properly – in the way that was done in Study 329 – and has been done in no other study to date.
Outcome switching looks like bait and switch to distract attention from the key concern – adverse events.
David Healy
I think you’re right about the bait-and-switch. Sure, outcome switching is bad. Drugs that don’t do what they promise — that are ineffective against the problem they treat — are indeed a problem. But why? First, they are expensive; they waste money that could be spent on other things. Second, and even more important, they can do real harm to our physical and mental health.
You will get far more rewards for sticking to the first problem (not to mention being courted by drugmakers who tout the “greater efficacy” of their latest product, which they assure you is well worth the dizzying cost). Ben Goldacre has built a very interesting database that seems to focus mainly on which districts of the English NHS are prescribing more expensive drugs when cheaper ones might do as well.
You will NOT get those rewards by focusing on the damage that’s being done to human health — although that issue is far more important and pursuing it will probably have a greater impact on reducing economic waste. In particular, you can’t be jolly friends with GSK or any other corporation whose prime directive is to sell its products.
I think Goldacre’s slide, shown in the picture, says it all. Looking at it, you would think the Paxil study was problematic only because it made an “ineffective” pill — one “not significantly better than placebo” — look better than it was. In fact, for a very significant group of patients Paxil was WORSE than placebo, and might well have been fatal if they hadn’t been in a closely supervised setting.
And if you can’t address the larger question of “medicalization” then the whole effort is hamstrung. Some of these kids needed other, non-drug-centered kinds of support to deal with their problems. Some maybe didn’t need any “mental-health services” at all. Both groups were sold short, and possibly exposed to significant harm as well.
Thanks again Leonie, You have again reported a serious subject in your wonderful inimitable style. Although I believe Ben probably started out with the intention to “first do no harm” His “stand up” type routine was different and encouraging a few years ago and his enthusiasm for change was obvious. I even read his book Bad Pharma. Unfortunately change is slow. Whilst he punctuates his message with the adverbs “crap” and “shit” of a younger generation he is getting older and no further along the road to his Utopia in health/medicine despite his breathless enthusiasm. I was not impressed by his assertion that the BMJ was/were not the “Bad Guys” followed by a long ramble about 329 being a known chestnut for close to 20 years.This amounted to his total dismissal of the work involved in the reanalysis of the fraudulent reporting of the original study. The original SKB study was important because it was probably more responsible than any other for the increase in diagnoses of depression. This was followed by an expanding market for the pharmaceutical companies with the subsequent glib reference to side effects of the “medication” as side effects of the “illness”. Down through the years as a result of the fraud that was 329 there have been hundreds of thousands of human tragedies. However, Ben in his stand up comic guise asks you if you want the tens or hundreds of thousands of other /fraudulent studies dissected/retracted along the same lines as 329. He appears to be perplexed as to why 329 is so important to you as it isn’t to him. He doesn’t care. He’s not interested. When he asks you who you want to retract it, is he being genuine or stupid or is he playing to an adolescent gallery, is he expecting guffaws and sniggers when he points out to you that BMJ didn’t write study 329?
The recording is quite difficult to follow so I hope I haven’t misjudged anyone. Ben gets a lot of laughs, I realize this is his style but he needs to seriously answer serious questions not do waffle and piffle. Otherwise I could misjudge him and think he is profiting and being evasive and noisy.
Great to see all the comments. It seems I have kicked a hornet’s nest, so to speak. However, I stand over my words and there are a few points I’d like to clarify..
1. I’m not sure why Ben Goldacre is accusing David Healy of misrepresenting him – I wrote this blog, as has been pointed out to him.
2. I did not like BG accusing me of misrepresenting him and the recording proves I did no such thing. I think this is more to do with a personal spat with Healy than anything I’ve written, but good to see Study 329 being discussed.
3. I was well aware the Dublin talk was being recorded and also that Goldacre has a history of heated altercations on social media when he’s in disagreement. I think he’s happy to ‘misrepresent’ a misrepresentation.
I’m so looking forward to doing part 2 (If David still lets me).
Leonie
I probably agree with Ben Goldacre about the whole conflicts of interest thing not being that interesting. I don’t think it’s a root cause, certainly not on the level of individuals. Yes it’s a bad thing that shouldn’t be happening, but it should be seen as a symptom rather than a cause. Find and treat the cause rather than the symptoms – now there is a novel concept I wish my doctor would explore.
But this fits in quite well with my current perception of Ben Goldacre’s ‘activism’. There never seems to be any consequences of all this bad pharma – the only examples seem to be already banned products or commercial failures – things that have already been caught in the net one way or another. But a leading psychotropic or even god forbid a statin causing someone problems – that’s not really up for discussion. A major study like 329 was badly flawed, but didn’t cause any damage as it was effectively caught by the system…. That’s all I’m hearing when I listen to that recording. That type of argument is not really new – certainly not to anyone here.
So we have this flawed process that Ben Goldacre among many others have discussed over the years – yet when someone pops their head up to say that this or that popular drug is causing them some nasty side effects, Ben and his establishment mates start shouting about Smeary Conspiracy Theorists, anecdotal nonsense and how none of it can be true because there is no evidence.
There is no evidence that… It’s from the stock library of excuses for everything these days. How to tell a lie without technically telling a lie. You’re just as likely to hear that from the US press secretary when we talk about civilian casualties from a drone strike, or the spokespersons of the junk food industry when we talk about obesity, or from apologists for the energy industry when we talk about the environment.
What these people are really saying is “while looking for evidence that we are right, we didn’t find any evidence that we are wrong”. Ahh ok then, my problems must instead come from my numerous character flaws, my pathetic malfunctioning body and my limited intelligence.
But I can’t help thinking that despite Ben’s belief that it’s all old news, we still don’t know very much about the dangers of anti-depressants and young people. Just the other day I read this in the DM.
http://www.dailymail.co.uk/news/article-3629448/Teenage-girl-killed-opportunity-commit-suicide-bedroom-celebrating-Christmas-family-friends.html
What puzzles me about this is there isn’t one mention of the drugs being a possible cause. Of course I can’t say, despite the similarities with my own experiences, if the AD’s contributed to her death, but I can certainly say that it is more than possible and fits the profile – at least going by the descriptions in this article of the times leading up to this tragic event.
The top rated comment by a country mile (copy and paste response no doubt) is this….
“If you’re reading this and feeling low, go talk to someone please. It’s always workable, go see your GP or tutor, or speak to a friend or relative. There’s is always another route.” Up votes 1581 – Down votes 30.
Did it not occur to the commenter or the 1500+ people that agree, that this poor young girl WAS getting help and she WAS talking to people about it. Is it not possible that on this occasion that the problem lay elsewhere? If so, do we have any evidence that backs that theory up? Apparently not going by this article and the vast majority of the comments.
Not surprisingly, the worst rated comment is this…
“Why did the dr prescribe antidepressants to someone with suicidal thoughts? Increased suicidality is one of the more common side effects in young people”
A poorly framed comment, but one with much more relevance to the article than the best rated comment given what we supposedly know about the dangers of antidepressants and teenagers.
It looks to me that the medical establishment have learnt bugger all from study 329 and the public and pretty much everyone else are further away from being properly informed than ever.
I was supposed to be taking a break but I have inadvertently sucked into this debate, which I must say- is quite fascinating. In my opinion Leonie’s article was measured and tame in its response to Ben’s coverage of Paxil (Seroxat) study 329 and the ‘medicalization of human distress’ in his lecture and Q and A. This issue (‘the medicalization of human distress’), along with the pharmaceutical industry’s insatiable appetite for profits for its shareholders above human life, are among the two most important aspects to all of this. In fact, without these two driving forces, Paxil study 329 wouldn’t have happened because Paxil study 329 was a commercial enterprise- the purpose of which was to aim to sell Paxil (Seroxat) to depressed under-18’s. Indeed, GSK, at the time, were desperately trying to get a license to treat teens, and kids, with Seroxat- despite the many tens of thousands of complaints from concerned Seroxat to BBC Panorama at the time.
Ben doesn’t seem to see the big picture (I have noticed this before in previous debates/controversies with him). He is so fixated on facts, stats and numbers, that he fails to see that what he is discussing has a real world affect on (potentially) billions of people. Paxil Study 320 is notorious for many reasons, but not least because it shows that we cannot trust pharmaceutical companies, in particular GSK.
GSK have proven time and time again, that they are devious, and that they have absolutely no regard for human life, despite their various PR stunts.
In my opinion, Ben, was used by GSK, and is still used by GSK. GSK joined Alltrials for publicity – nothing more- nothing less. I think they see a naivety in Ben, or perhaps a gullibility, which (despite his obviously extremely ‘book-smart’ brain in terms of assessing and translating complex ideas into easily digestible concepts) is all too obvious to see for those who are tuned into these things.
GSK have a few drugs coming on stream, and judging by their track record- we can’t trust them, their trials, their PR, or their how they spin the data to us. GSK’s business model is based upon releasing drugs into the public domain and dealing with the side effects/casualties/deaths etc afterwards (usually in the form of lawsuits). They even make a huge profit on the defective drugs like Seroxat and Avandia. Any lawsuits that follow are factored into their legal war-chest- they never lose out. However, for the dead patients, or the damaged ones, there is no recourse. Ben never discusses the real world damage to patients- he discusses faults in the data but not faults in the ethics in regards to corporate manslaughter of patients with dangerous drugs..
Will it take another Seroxat, or Avandia, for Ben to wake up and see what he’s dealing with?
Will it take another Department of Justice fine for GSK? Will it take another serious fraud squad investigation? Before Ben wakes up from his ego-slumber?
I fear it might…
There’s a lot more I could say, but I might do a blog post and express my thoughts there instead…
I was interested to read Leonie’s blog (thanks!) and now I have also had chance to hear Ben Goldacre’s question-time answers, I follow with a tale:
There is it seems a shipwreck in the shallow but turbulent waters of what is deceptively known as evidence-based medicine. The ship’s emblem, on the now tattered grubby orange flag at the top of the mast, is still just visible within inches of the water-line. With faded glory it reads: GSK 329, and stands as a warning to other ships venturing to travel in these waters.
There are many other grounded wrecks within the muddied waters of EBM; for the most part, invisible like ghosts lurking beneath the surface that seem to strike in the dead of night. These are waters where people have knowingly sailed on the word of the respected ancient mariners: “These waters are safe” they have repeatedly called, as they promised hope and safe passage. Yet, most tragically, despite the confidence of the ancient mariners, even children have died within these waters and families have been left devastated.
There was discord about what should be done. “There are so many wrecks, surely we can’t remove them all” – exhorted one experienced mariner who was well-familiar with that particular coast line. But others insisted: “Simply removing GSK 329 will not make these waters safe, all the wrecks should at least be charted and if possible removed.”
But as you and I realise – even this was not going to make their navigation through and around EBM safe. “Ah, but people should be allowed to make their choices” it was said, “if they choose to sail this way, that’s up to them.” And then a rather wise ancient mariner stood among the disaffected crowd as he spoke slowly and thoughtfully: “Yes, the wrecks should be mapped so all can be warned – and where possible removed. But we mariners must take the initiative, and correct the old mariner’s tale that these waters and the ships in them are as safe as we make out. Unless we do this, tragedy after tragedy will continue to follow.”
As one of the authors of the RIAT restoration of Paxil Study 329 who was around for the whole process, I don’t actually know the answer to Leonie’s question about why it was so hard to get our paper published. I don’t know if a Conflict of Interest had anything to do with that, but in a way, that’s the whole point – when there’s a significant Conflict of Interest, you can’t ever really know. It’s a variable that can’t be evaluated. So her question stands whether it can be answered or not. Should the original Study 329 report be retracted? That’s not in our hands. My choice would be that it should never have been published in the first place.
I certainly agree with Ben that Study 329 is not a stand-alone example. They are legion. And I’m glad he mentions Jureidini et al’s recent paper deconstructing the Citalopram in Adolescent Depression study
[full text at http://content.iospress.com/articles/international-journal-of-risk-and-safety-in-medicine/jrs717%5D.
With 329, we ultimately had the full data to work with. In CIT-MD-18, they didn’t, but they had the subpoenaed documents that show the background deceit in living technicolor. Both illustrate what we called “a priori protocol” deviation and Ben calls “outcome switching” as the method to distort the truth. They had a hell of a time getting published too
[see http://1boringoldman.com/index.php/background-notes/%5D
– a narrative of their story. There’s another recent paper that’s less well known but equally important, that was equally hard to get published – Cosgrove et al’s paper on the Vortiozetrine Clinical Trials, Under the Influence: the Interplay among Industry, Publishing, and Drug Regulation. They had neither data access nor subpoenaed documents, but using other sources including regulatory documents, they were able to show this same kind of ghost-management in a contemporary, in-patent drug. It’s an excellent paper, but not directly available online
[full text on ResearchGate https://www.researchgate.net/publication/295077256_Under_the_Influence_The_Interplay_among_Industry_Publishing_and_Drug_Regulation click on “Read the full publication”].
These misreported studies are indeed everywhere, but the few that can be definitively demonstrated are still hard to come by.
One thing I personally learned in the writing process for Restoring 329 had to do with adverse events. I knew about the efficacy issues with 329 before we got full data access. But even with the Complete Study Report [CSR] and Individual Participant Data [IPD], the extent of the harms weren’t apparent until we had the raw Client Report Forms [CRFs] in our hands. Distortions in the efficacy analysis are easier to see and to demonstrate. But the harms are much more important, central, and require a lot more digging. Prescribing an ineffective medication isn’t good. But prescribing a potentially harmful medication without having a full deck of cards is a nightmare for both prescriber and patient.
Ben Goldacre and the rest of us that are preoccuppied with this topic have known about Study 329 for a long time for sure. And for that matter, we know how common the deceit in Clinical Trial articles of psychoactive drugs has become in general. For us, Study 329 is a paradigm. But that’s not true at large, in spite of Jon Juriedini and his colleagues making it abundantly clear for years. The purpose of our RIAT Study was to prove that point and anchor it firmly in the mainstream medical literature. And even if publishing it was a hard road [and it definitely was], I’m appreciative that the BMJ put our Restored Study 329 into the medical record, full text on line, for the world to see. For me at least, it is an icon for something huge that has shamed our profession. I hope there will be many more to follow. As Ben said in his TED talk, “Sunshine is the best disinfectant.”
Ben is worried that the focus on Study 329 might detract attention from the ubiquity of this kind of misleading publication. I certainly hope not. But if that’s a possibility, it’s all the more reason for all of us to stick to the task – AllTrials, RxISK, COMPare, RIAT, the bloggers, the presentations, the journals with integrity, Data Transparency, YODA, these comments, etc, everybody else dedicated to the fact that an open and accurate scientific literature is a bottom line requirement. The misreporting is so widespread that here’s room for all of us…
I apologize for the typos in my comment. But these links didn’t make the trip and need correcting. The %5D at the end makes them fail [it’s interpreted as “]”]. These should work…
… Citalopram in Adolescent Depression study – full text at
http://content.iospress.com/articles/international-journal-of-risk-and-safety-in-medicine/jrs717
With 329, we ultimately had the full data to work with. In CIT-MD-18…
… They had a hell of a time getting published too
http://1boringoldman.com/index.php/background-notes/
– a narrative of their story. There’s another recent…
mea culpa
This is all very lovely.
From a “Seroxat is not the best disinfectant” point of view, may I ask how all the litigants feel when GlaxoSmithKline is paraded in front of our noses as Clinically Transparent by All Trials when Ben Goldacre and Crew know full well that they are not…?
I agree with you Annie. GSK have no interest in transparency or their victims – rather, they’re using AllTrials as a smoke and mirrors exercise.
Another issue is the huge inconsistency between what the statisticians are saying and what the actual prescribers are saying. I live in a country where a leading psychiatrist, Professor Ted Dinan, has publicly stated (following a possible zoloft-induced suicide), that he is ‘not aware of any convincing evidence linking Sertraline to suicidal behaviour’ and that ‘the public should have no concerns about these drugs’. http://www.irishexaminer.com/ireland/health/family-calls-for-more-research-into-anti-depressants-153706.html So what good are the stats to the victims?
I do not need brilliant mathematicians to tell me that Annie and Bobby have suffered immeasurably from Paroxetine; that Stewart died by the same paroxetine; that Shane and Kevin’s deaths were caused by Citalopram; that Brennan died from taking Escitalopram; that Woody died by Sertraline; that Jake died by Fluoxetine; et cetera, et cetera.
How can families ever get justice when the expert findings are contradicted so readily by Pharma, prescribers and dubious experts who dig their heals in in the face of wrongdoing, such as in the 329 debacle? Remember “Nobody Pinned Anything on us”.
In my opinion, the battle to make actual evidence-based medicine possible, would be far easier if all (independent) experts were as outspoken as you all. Otherwise, what’s the point of being a pharmacological or statical genius? The victims are screaming at this end, now the other end needs to step up. No one has been as outspoken as David Healy, who despite his brainpower, has made huge strides in bringing these two ends together.
I can’t get past the “smeary conspiracy theorist” comment. When people survive things as horrendous as the kinds of drug reactions we’ve had on SSRIs (including med sys denial), it’s only natural that we would express outrage in whatever ways possible.
BG appears to overlook the real people who have suffered and continue to suffer real consequences. He and GSK heartily congratulate themselves for supposedly fixing things for future, hypothetical customers (and shareholders) while blithely stepping over (and in Bob’s case, on) those who have borne and continue to bear the full consequences of industry behavior.
Perhaps his only objective is to repave the road for industry, though it might make sense to clear it of bodies first.
Thanks for stirring the pot, Leonie. Can’t wait for part 2.
It’s akin to a stance of “shit happens”.
Thalidomide causing all sorts of defects – shit happens.
Paxil causing a multitude of problems; birth defects, induced suicide, horrific withdrawals – shit happens.
Citalopram causing induced suicide and homicide, birth defects, horrific withdrawal – shit happens.
The list goes on and on.
It’s almost as if BG has forgiven the perps behind the designs of these trials and offered them yet another chance to show if they can behave.
In short, GSK sold a lie and hundreds of thousands, possibly millions, who were duped into believing that Paxil (Seroxat) was safe and effective (“Remarkable efficacy”)
Yes, we bleat on and on about Study 329, yes, we totally understand that it is not the only flawed trial putting patients at risk. What we don’t do is accept that those who masterminded 329 should be given another chance to prove themselves, we don’t accept that they will ever be transparent.
An apology would have been nice but GSK only ever apologise when they are forced to. Let’s face it, the only reason they have opened their doors (slightly) is because they were forced to via American litigation.
I lost 19 months of my life to Seroxat withdrawal, but hey ho, shit happens, huh?
I’m lucky – I’m still here to write about it, unlike the countless others who have died as a result of induced suicide – but, hey Ben, shit happens, right?
Bob Fiddaman
The Smeary Conspiracy Theorist.
Yes, Bob.
It really is time to have complete honesty here and be completely upfront about the devastation resulting from Seroxat.
I have been commenting on David Healy’s blog since its inception as have you and some others.
This is such a sordid tale of GlaxoSmithKline refusing point blank to allow any of us a voice for the horrors of withdrawal from Seroxat, the months bedridden, the anorexia, the hyperventilation, and, in my case a few acts of appalling violence upon myself which included gas ovens, exhaust pipes, knives, ropes and ending with swallowing 28 beta blockers in a rather horrific bid to stop the overwhelming agony from this horrendous drug.
I am also still here to talk about it.
It was all a long time ago, it happened to me on July 21, 2002.
Despite my protestations to my gps and a psychiatrist, I was further engaged in duplicity from these people.
Despite being completely honest to my child’s headmaster, as my child became naturally anxious about her mother and her own situation with bullying from her classmates re her mothers attempted suicide from Seroxat, this headmaster decided that we were not worthy of attending his school and my child was alienated from anything resembling a normal life, at this time.
It was all so horrific, I almost lost my mind and we ran away from our lives.
However, things settled down and suddenly finding myself alone and in a strange place, not of my making, I had to make us comfortable and do some pitiful jobs to make ends meet.
Living only with my daughter, because of the shame and guilt forced on me by dishonest medics, every day was a painful reminder that darling Naomi had been hurt and her education destroyed by Seroxat and people who first and foremost put themselves first over our three lives.
It was a complete tragedy.
I am including a recent interview with Sir Andrew Witty who for reasons only known to himself has decided to shut this appalling episode of Paroxetine out of his life.
He also has colleagues who have done the same.
I don’t think it is possible that I could ever engage with someone like Ben Goldacre who I knew from the start was only ever interested in Ben Goldacre.
The stance he is taking is shocking, with the element of being a traitor to us and to my mind this is utterly unforgivable on his part.
Bob, you have made plenty of videos showing the dead bodies from Paroxetine and you are a genuine and passionate advocate of all things Horrific from Paroxetine.
To this end, I have included one of the videos you made which was inspired and very, very funny. Sometimes all we can do is laugh because if you didn’t you would probably completely lose the plot.
The smeary conspiracy theorist……..Well, done, Robert Fiddaman
Bob Fiddaman
The Smeary Conspiracy Theorist.
The bodies are talking..Mornings with ‘Maria’
GSK @GSK 6h6 hours ago
Gr8 interview, @MariaBartiromo Amazing what you covered in 6 minutes!
• • GSK @GSK 5h5 hours ago
#ICYMI our CEO was interviewed by @MariaBartiromo this morning covering a wide range of topics. @MorningsMaria
GlaxoSmithKline CEO on drug prices, R&D in fight against Zika
GlaxoSmithKline CEO Andrew Witty on innovation in the pharmaceutical industry, efforts to reduce the price of medication, why he wants the U.K. to remain in the E…
video.foxbusiness.com
http://video.foxbusiness.com/v/4932726320001/glaxosmithkline-ceo-on-drug-prices-rampd-in-fight-against-zika/?#sp=show-clips
Gr8 interview, @Andrew Witty Amazing what you left out in how many years?
………..in fight against Paxil
The bodies are talking
Mornings with ‘Bob’
https://www.youtube.com/watch?v=OQWGGcRTCis
Inspired…oh, smeary, one:)
I’d just like to plead that we don’t lose sight of the enemy in these situations by picking apart the valid concerns of both sides. As I tell my family all the time, life outside this house is challenging enough without bring the fight indoors. GSK, among other pharma giants, have all the time and money to sit back and play divide and conquer. Let’s not give them them ground in what will likely be a long battle. Keep up the good work, all of you.
Harold
What do you make then of GSK’s many links to Ben G and in the light of that his apparent efforts to act like Study 329 never existed?
DH