Study 329: Conflicts of Interest
Email from Fiona Godlee (Editor of The BMJ) to RIAT July 6th 2015
Re: Study 329
Dear Dr Jureidini,
Many thanks for your letter. I quite understand you concerns. You are right to say that there are few or no precedents against which to compare this article. We ourselves are feeling our way, both with the RIAT process since this is the first full RIAT research paper we will publish, and with the specific challenges posed by this particular study and you as the paper’s authors. I want to stress that we are proceeding in good faith with the clear aim of publishing the article as soon as possible provided we can do so safely. …
All best wishes
Fiona Godlee FRCP
Editor-in-Chief The BMJ
The path to publication
BMJ state that it takes on average 8 weeks from submission to publication of an article. The review process for Restoring Study 329 took a year, with a three month review process involving six reviewers to begin with, and then a further four reviews in a four month process, leading to a provisional acceptance in March that was withdrawn.
Ultimately there were seven versions of the article. All versions and all reviews and responses are available on Restoring Study 329 (See Study329.org – timeline to publication).
At the time of this email from Fiona Godlee it was far from clear that the BMJ were committed to publishing the paper.
Conflicting interests
The Lancet and BMJ were among the earliest medical journals. They began in Britain in the early nineteenth century with a public health brief.
Public Health began in an effort to contain contagious diseases. No one knew what lay behind epidemics of plague, smallpox, cholera and typhus. The problem might lie in abattoirs that sat in the middle of towns in those days or in the unhealthy constitutions of those who became ill. A lot of powerful interests were at stake.
In the absence of effective treatments, the public health movement stimulated a revolution by focusing on the environment and changes to it rather than on the individual. Removing the handle on the Broad Street pump offered a wonderful symbol of its mission to prevent disease rather than intervening to treat when it it was often too late.
While there might be nervous abattoir owners on one side, in the late nineteenth and early twentieth century public health science and politics and business were largely on the same side. The new science created opportunities for new research based businesses. Establishing that bacteria caused infections opened up the prospect of vaccines and antibiotics and helped the growth of the insurance industry. The wealth that came with these new industries lifted many out of poverty and in this way helped health just as much as they hygiene helped by preventing diseases.
The conflicts of interest at that point lay, as they had done since Galileo, between science and religious or political beliefs – between the evidence that vaccination helped and those who for religious or political reasons were opposed to vaccination or to people being forced to take vaccinations.
Twentieth century conflicts
With the development of bacteriology and the demonstration that bugs caused infections and the hunt for a Magic Bullet, the focus drifted back from preventing disorders to treating individuals. This environment is fine if you take your pills – antibiotics, antidepressants, statins whatever.
This development was linked to another. Because the development of modern science was so interlinked with the development of modern industry, industry were among the earliest to embrace “research”. Long before the Cochrane Collaboration began systematic reviews, the lead industry were systematically collecting all articles in the lay or scientific press about the effects of lead, in order to monitor the threat to their business and to be able to assess what lead blood levels might “wash” with the public and politicians. The industry also supported scientists in research projects to minimize problems. But minimization of problems did not mean doing studies to determine the lowest blood lead level at which biological effects became apparent. It meant studies that would minimize problems to industry.
Lead is not on the radar these days for people in the way it once was or in the way that it and other heavy metal poisonings probably still should be. The epidemiology of schizophrenia for instance shows an initial emergence of this disease in the nineteenth century and a more recent decline and this rise and fall parallels lead usage and lead levels. Dementia and a range of other diseases like cancer likely stem from environmental sources that have a basis in industrial pollution.
In part because the tobacco industry’s famous aphorism Doubt is our Product crystallized a modus operandi for all modern corporations, there is some awareness today that an increasing amount of “scientific” research is done to muddy the waters on questions of environmental induced diseases. This is a use of data against Science, a capturing of the Appearances of Science.
Dwight Eisenhower in a famous address in 1961 just before he left presidential office caught some features of this new world: “In holding scientific research & discovery in respect as we should, we must be alert to the equal and opposite danger that public policy could become the captive of a scientific and technological elite.”
Female genital mutilation
The situation we now have is something like as follows. You want to submit an article to our Journal on the benefits of Female Genital Mutilation? You must declare your “conflict” and we might decide not to publish no matter how good your data looks because this looks like data marshaled in support of a belief system rather than science proper.
This example is not all that far-fetched. Many books and articles routinely carry claims about the supposed results of studies demonstrating the health benefits of circumcision (MGM), about which all men have a conflict.
Whatever anyone’s beliefs about FGM and MGM, at the end of the day the power of science lies in an acceptance that we resolve issues with data. The idea that pharmaceutical companies can hang onto data by Force Majeure is the antithesis of science.
The new biology, pharmacology and trials-ology risks undoing Galileo and putting the individual back at the center of the universe. We can’t randomize environments but we can randomize individuals and if some drug produces a difference in a situation the simplest and most profitable conclusion will usually be that we have corrected a defect in the individual.
The new biology, pharmacology and trials-ology risks undoing the Bible even. The script is being rewritten to tell the story of a vulnerable Goliath, who while laboring away at making the medicines critical to all of us, and providing jobs, is at increasing risk from an unscrupulous and unethical David.
While there is the occasional headline such as a former editor of the BMJ resigning an honorary post from Nottingham University because it took money from the tobacco industry, the new rules of the game are as outlined by Fiona Godlee – anyone who has attempted on the basis of data to challenge a pharmaceutical company about the adverse effects their drugs cause must ipso facto be deemed to have a Conflict of Interest on a par with someone presenting data apparently showing health benefits from FGM.
The BMJ and NEJM reserve the right not to publish material like this, on the basis that while we are committed to resolving issues on the basis of data, anyone who has accessed data on this issue or in this fashion clearly has some strange belief system and must be deemed to be suspect – unlike companies like Pfizer whose actions follow the data in a disinterested fashion.
Medication time
What’s really going on is that journals are scared of industry. This is partly because the leading figures in medicine have become minions concerned more for the health of industry than the health of people and there is no-one who is likely to back up a journal willing to take a tough stand.
There is another reason. While data might really be new data – previously unavailable – the BMJ are scared that if they feature it they will be put out of business. Journals are a business that feeds on science rather than part of science.
These journals are caught in a 1960s style double-bind. They are dealing with a Nurse Ratchet, who writes friendly letters on first name terms to the journal’s Editor – Dear Fiona – but who has made it clear she will sue and put them out of business if they don’t play ball at medication time.
Close to the last thing a journal is willing to do today is feature any article about the biggest public health issue of our day – the biggest source of environmental toxicity – the morbidity and mortality caused by treatment.
In the face of a complex situation like this, the temptation as Daniel Kahneman told us 40 years ago is to resort to the Fundamental Attributional Error which is to look for who to blame. But rather than blame the powers that might house-arrest them (as happened to Galileo), the BMJ, along with society’s new religious authorities, locate the problem in Galileo – the person attempting to produce the data.
In the case of Study 329 there also appeared to be a desperate hunt for some box to tick that would make BMJ fireproof, some proof that the scurvy knaves behind the Restoration of Study 329 were adhering to some protocol that would make the results objective and definitive – exactly the opposite message to the message of the final article which is that the results are provisional and that objectivity as regards what these drugs do for good and for bad arises from having the data out there so they can be contested.
Science involves getting data into the public domain where it can challenge beliefs. But decades ago BMJ and other journals gave up on any attempt to access the clinical trial data behind the claims being made.
Now BMJ are signed up to an AllTrials coalition that includes GSK and is against Data Access.
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Yes..absolutely…yes..absolutely
Who needs a Journal signed up to Alltrials…it seemed good at the time, I think she needs to reconsider….
May I go back to Walter and the last post…..
I liked your comment following the link. It was kind, gracious and forgiving.
Actions speak louder than words…and sometimes all it takes is a bit of encouragement from one person to another…..to get some sort of ball rolling…………..
Are you just an intelligent bystander or have you taken drugs yourself when you describe yourself as a ‘psychiatric survivor’?
I think the majority of people need to totally reconsider their position.
How obvious does it have to get while they all become so politically correct….saving their own skins and bacon………..put on the spot never got worse….
So, far, I have seen nothing loyal to patient’s interests apart from…….
Walter K on October 17, 2015 at 2:45 pm said:
Peter
Your blog is honest, refreshing and gives wonderful insight into the richness of Scottish culture. I have been coming here for a while now. My name is Walter, and I am a psychiatric survivor.
The woman I loved was born in Scotland in the same year as you were, and her father was a don at the University of Stirling. Several years ago, her SSRI dosage was increased, and over a few weeks she changed from a kind and wonderful woman, into a cold-hearted and hostile alien who I no longer recognised. I felt as if she had been the subject of an experiment by Dr Josef Mengele, and that she had been slowly buried alive. A few months after she abandoned me, she resumed the relationship with the man whose emotional abuse of her had caused her to seek psychiatric ‘help’ in the first place. She remains in that ghastly zombified condition.
So few doctors speak out like you do, about the corrupting influence of the drug industry on healthcare. There are thousands of us out here, whose lives have been unravelled by this diabolical arrangement. The few of you give hope to the many of us. I just thought I’d let you know.
Thank you for all you have done.
Walter.
Annie – thank you for your kind comments, I’ve only just read this.
I’ve never taken drugs myself, although I was tempted to seek emotional oblivion when my GP, an otherwise kind and intelligent woman, tried to prescribe me Citalopram when I found myself in a very dark place after my ex-partner disappeared. I had loved her passionately, and I grieved for her as if she had died; I don’t think there was a day in 2013 that I did not weep for her.
We hit our fifties, our life seems good, and we think we are well-informed because we read a broadsheet and listen to R4 every day, but we miss the nuances…and then one day, a trapdoor opens beneath our feet and we fall into a foul, fetid drug-strewn pit we never knew existed. So, shocked and bewildered, we look online, and find only horror piled upon horror, and no Morpheus and no Trinity to help us. Only all-powerful Mr Smith: Big Pharma and chemical psychiatry in the ascendancy, harming more and more victims, and a desperate rearguard action by a few ethical doctors and journalists and bloggers, derided and ridiculed as conspiracy theorists and reactionaries.
As I gained knowledge, in those early months, googling relentlessly at 3AM, my grief preventing sleep, a second horror confronted me: I now have a strong (unspoken) suspicion about why my youngest son has learning difficulties, because for most of her adult life, my ex-wife was on SSRIs (and her own sister is a senior partner in a GP practice).
So what are we to do? How can we oppose or expose this horror? How can we prevent more unwitting people from falling into this hideous trap? If 65,000 people contacted Panorama after Shelley Jofre’s expose on Seroxat, that suggests that hundreds of thousands may have suffered SSRI ADRs. If just 1% of such a number came together, as law abiding activists, to form something along the lines of a grassroots-run ‘League against chemical psychiatry’…and not just to oppose psychiatry, but also to offer support to those who have suffered as a result of iatrogeny.
Yours in hope,
Walter
Dear Walter
Excellent reply.
You are upset and I’m sorry and I completely understand.
If you read Comments, Rxisk site, you are very lucky you didn’t swallow what was offered to you. If you had, you might have gone through/going through most of which is addressed by intelligent people who are describing very detailed accounts.
Some of us are left in complete limbo:
Tinnitus which is not tinnitus
Sleep which is not sleep
Nervous reactions to normal problems
Perpetual fear of minor stuff going wrong
Criticism which can send you into spasms
This is some of our legacy from the ‘jokers’ doctors whose instinctive reaction is to belittle us and because of that scorning, ridicule, or, even, kind, sympathetic, do nothing to address the worlds most endemic problem.
Doctors today have no place in modern medicine and the sooner they realise that and we can get rid of them and replace them with modern doctors learning about modern medicine, the better.
This is not going to happen in our lifetime.
The whole culture of all these new drugs means that the every day gp, is a useless, worthless, spineless critter.
You can walk into one of thousands of medical outlets and you will never get a systematic uniform opinion of any worth whatsoever on Seroxat, Librium, Diazepam, Statins, Aspirin….the list is endless.
Thank you for being a rare breed of observational intelligence.
Annie
http://withdrawal.rxisk.org/discussion/protracted-withdrawal/
Great blog post…
however, a very disheartening too.
I honestly feel that it’s close to impossible to affect real change in respect to challenging the pharmaceutical industry, particularly a giant Goliath like GSK, but that shouldn’t stop us from documenting all this for future generations…
I think your blog will be referenced in future generations as a touch stone for information on how it all went very wrong…
The corporatization of human health, people’s lives, and the world generally, will be our undoing…
Eisenhower’s speech (as you infer being highly apposite to the medical industrial complex) also warns ‘we must guard against the acquisition of unwarranted influence, whether sought or unsought, by the military industrial complex. The potential for the disastrous rise of misplaced power exists and will persist’. This places medical science in a highly politicised, subjective context and yet expects us all to have blind faith in its claim to objectivity and benevolent aims. What a morass of contradictions!
Perhaps we should reflect also on the words of Andrei Sakharov, who described the biologist Lysenko (father of the disastrous bio-agricultural experiments that almost destroyed Russian farming) as being accountable for inter alia ‘adventurism, for the degradation of learning, and for the defamation, firing, arrest, and even death of many genuine scientists’. (Birstein, 2001, The Perversion of Knowledge: The True Story of Soviet Science). Or maybe not…Sakharov was eventually exiled for speaking out for political truth and scientific objectivity though, of course, this was under an authoritarian regime, unlike…..
I’m beginning to think we’d be much better of without these journals, and the plethora of ‘peer-reviewed’ literature that is being used to impose an ever-increasing amount of questionable medical interventions in our lives.
The way it seems to work is a pharmaceutical company dreams up a product, runs ‘clinical trials’, gets the (biased?) results published in the ‘peer-reviewed’ literature, then presents data to the ‘regulator’, which provides a rubber stamp of approval, and voila another product in the marketplace, and the ‘regulator’ gets its cut too via ‘fee for service’ payments. So the pharma companies, the academics involved in trials, the journals publishing the papers behind paywalls, the ‘regulators’, and the doctors who are the frontline sales force, all benefit from this cosy arrangement.
And when it comes to vaccines they’ve really worked the system to the hilt, particularly in those countries where vaccines are being made compulsory to access financial inducements and/or access to childcare and schooling (e.g. Australia and the US).
Sure, maybe some vaccines are justifiable for serious, easily transmitted diseases. But things have now gotten way out of hand and vaccines and revaccinations for all manner of ailments are being added to vax schedules.
The United States can take a bow for facilitating the current flood of vaccine products as it provided vax manufacturers with protection from liability in the 80s. I bet Volkswagen wish they had such a good deal…
And when a vaccine doesn’t work, e.g. pertussis, the proposed solution is another revaccination. In Australia pertussis vaccination is now recommended for babies (x 3 shots), 18 months olds, 4 year olds, teenagers, pregnant women for every pregnancy, anybody involved with a baby. And yet studies are indicating the acellular pertussis vaccine may actually be causing new strains of the disease to develop(1), and spreading the disease via vaccinated individuals(2). What is going on here?
References:
(1) In March 2012, The Conversation reported on a new strain of whooping cough that appears to be resistant to vaccination i.e. “A team led by scientists at The University of New South Wales believes the emerging strain of the Bordetella pertussis bacterium may be evading the effects of the widely-prescribed acellular vaccine (ACV) and increasing the incidence of the potentially fatal respiratory illness, according to a study published in The Journal of Infectious Diseases”. See Vaccine-resistant whooping cough takes epidemic to new level: https://theconversation.com/vaccine-resistant-whooping-cough-takes-epidemic-to-new-level-5959 In The Conversation article, Professor Lyn Gilbert, a Professor in Medicine and Infectious Diseases at the University of Sydney, said there was a range of ways scientists might tackle the new strain of whooping cough, including administering “more boosters of the current vaccine”. The question is, how does increasing the numbers of ‘boosters’ of the current vaccine protect against the new strain? Also see my email enquiries on this matter to Professors Lyn Gilbert and Ruiting lan in December 2012: http://users.on.net/~peter.hart/Whooping_cough_enquiry.pdf which did not receive a response. Also see Octavia, S. et al. Newly Emerging Clones of Bordetella pertussis Carrying prn2 and ptxP3 Alleles Implicated in Australian Pertussis Epidemic in 2008-2010. JID 2012:205 (15 April). Brief Report: http://jid.oxfordjournals.org/content/early/2012/03/14/infdis.jis178.full.pdf+html and Sharp rise in cases of new strain of whooping cough. UNSW Australia Newsroom, 21 March 2012: https://newsroom.unsw.edu.au/news/health/sharp-rise-cases-new-strain-whooping-cough
(2) See for example FDA study helps provide an understanding of rising rates of whooping cough and response to vaccination. FDA News Release, 27 November 2013: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm376937.htm and Jason M Warfel et al. Acellular pertussis vaccines protect against disease but fail to prevent infection and transmission in a nonhuman primate model. PNAS, 22 October 2013: http://www.pnas.org/content/111/2/787.full.pdf
“the specific challenges posed by … you as the paper’s authors” – this is enormously concerning. “…the story of a vulnerable Goliath, who while laboring away at making the medicines critical to all of us, and providing jobs, is at increasing risk from an unscrupulous and unethical David” indeed. Also greatly worrying is BMJ’s signing up to AllTrials.
Thank you so much for highlighting complex and critical issues.
Well this puts us right back into biblical territory: “Ye blind guides, which strain at a gnat, and swallow a camel!” “And why beholdest thou the mote that is in thy brother’s eye, but considerest not the beam that is in thine own eye?”
Both are from the Book of Matthew in which Jesus upbraided the timid and conventional authorities in his own community. Those scribes and Pharisees of course were just trying to survive under the rule of an emperor with a two-by-four in his eye, and with unlimited resources to hunt down his critics. Some blatantly sold out to the empire, while others tried to walk a fine line, doing the best they could while being careful not to challenge the empire TOO openly. A lot like today’s medical journals.
Well, in the end, the BMJ DID publish this paper, and for that I’m glad. Just as in the end they refused loud calls from the worst of today’s Pharisees to retract that paper showing statins were more likely to harm than help the majority of patients who take them. In both cases they dithered and sweated for months, but finally stood up for what’s right. More than most of their colleagues have done.
In the land of the blind, the one-eyed woman is a visionary, I guess …
EMA speaks to Georgia…
http://1boringoldman.com/index.php/2015/10/21/some-clarity/
Adelaide speaks to UK…
http://study329.org/bmj-press-release-and-materials/
BMJ speaks to RIAT…
After some eloquence of import>
>Someone else spoke…
ben goldacre @bengoldacre 5h5 hours ago
MEDICAL DATA DORKS anyone got a nice structured dataset that maps between UK and US drug names? it’s for a thing.
A Bridge too Far?
Is flip pant the new decorum for gla so mit line and will be em jay admit to split loyalties?
Back from the drivinguscrazy.se film festival – my journey to activism has begun.
And it’s needed, dr. Healy Points to numerous issues, in psychiatry as a whole but even more so concerning the drugs they use.
So now I’ve personally met Whitaker, David Cohen and John Read. I watched Peter Kindemann give a speech. They all seem like intelligent and good people, all aware of a needed shift in direction for psychiatry.
But, yes there is a but, all these names have been fighting for change for so long, why should I engage in a fight where change is the last Word that comes to mind?
The BMJ shows the behaviour of a scared dog seeking affirmation with its owners for its behaviour. When confronted with a new breed of science, that aims to give any and all peer-reviewers the same access to data, the BMJ themselves start to ask for the authors to “revise” their conclusions. But it’s THEIR conclusions, let the readers build their own when they have access to the same data????
They way I understand this is that when a scientist back in the 80′, 90’s and 00’s put forward his conclusion, no one could verify this with root-level data???
And now when they can, the journal asks the authors to withhold their bold claims???
I’m sorry, but this is academic nonsense at the SAND-PIT level again!!!
/Ove 2015
Er…
It is not as obviously fatal as many physical illnesses
Er…
http://www.economist.com/news/leaders/21676771-fine-words-mental-health-should-be-matched-money-researchbut-not-just
Er…
Simon Wessely @WesselyS 1 hr1 hour ago
Well done @TheEconomist for leader on #mentalhealth and specifically research funding. Fortunately they want more http://www.economist.com/news/leaders/21676771-fine-words-mental-health-should-be-matched-money-researchbut-not-just …
David Healy
4 hrs • Twitter •
The entire 12-month history of #Study329 pre-publication review (all 7 drafts) is here:
Just a little something, for the Irish to get their teeth into………
https://twitter.com/hashtag/GSKIrelandIMPACT?src=hash
I would like to see evidence that there is a *conflict of interest*– across the board. Where is the *proof* that anyone of these for profit industries has an interest in protecting “patient’s’ from harm? or in identifying and correctly treating the underlying, root cause of a “patient’s” suffering.
I don’t see the *conflict*– just various degrees of willingness to chalk up harm done as a necessary component of progress–, or rather, collateral damage in the quest to profit from the suffering of others.
Aw, *motives* of interest to change tack slightly….21 at 12/12
Hide-and-go-seek…with Mickey
http://1boringoldman.com/index.php/2012/12/21/hide-and-go-seek/#comment-233379
Catch 22 at 12/12
Nice picture of Seroxat
http://www.thetimes.co.uk/tto/science/article4596979.ece
Clinical Cloud
http://www.thetimes.co.uk/tto/opinion/leaders/article4596984.ece
Calling #AllTimes readers to provide full links
Thank you