Formal complaint letter sent to European Spine Journal

 

Dear Editor

I am writing as regards the recent publications by Albert et al (1, 2) in the European Spine Journal (ESJ).   These are the undisputable facts of the case:

-          Both Albert et al studies were submitted and all authors declared no conflict of interest in 2012 (1, 2)

-          Two authors (Albert and Manniche) are company directors of both ‘MAST MEDICAL EDUCATIONAL SERVICES LIMITED’ and ‘MAST MEDICAL CONCEPT LIMITED’

-           ‘MAST MEDICAL EDUCATIONAL SERVICES LIMITED’ and ‘MAST MEDICAL CONCEPT LIMITED’ were both incorporated in April 2010

-          The ESJ’s guidelines on conflict of interest state “Conflict (if none, “None” or describe financial interest/arrangement with one or more organizations that could be perceived as a real or apparent conflict of interest in the context of the subject of this article)"

 

These are some undisputable facts from the recent correspondence in the ESJ:

 

-          The Journal has been made aware of the undeclared conflicts of interest of two authors (Albert and Manniche) relating to the two studies  (as stated (3))

-          The ESJ has allowed the lead author to publish a response to the ‘ No conflict of interest?’ letter which refuses to acknowledge that being a director of a limited company whose work directly relates to the results of the studies is a conflict of interest (“there was no conflict of interest to declare” (4) )

-          The ESJ Editor has not acknowledged that the authors have failed to declare their conflicts of interest (5)

 

Therefore in conclusion I would like to lodge a formal complaint to the ESJ because of the failure to enforce your own clear guidelines on conflicts of interest.  This has been manifest by:

 

1.      The ESJ has issued no corrections to the two studies to include the conflicts of interest of the two authors (Albert and Manniche)

2.      The lead author has published a peer reviewed letter  in the ESJ denying that a conflict of interest is a conflict of interest

3.      The Journal has not at any point (Editorial by Editor and invited Editorial) acknowledged that the two authors failed to declare these conflicts of interest

 

If the ESJ is of the opinion that two authors being MAST company directors does not constitute a conflict of interest, then I would be interested to see how this stance could possibly be justified using the Journal’s guidelines?

 

I would like to make it clear that unless adequate action is now taken by the Journal, I shall be taking this case to COPE,

 

Kind regards

 

1.         Albert HB, Lambert P, Rollason J, Sorensen JS, Worthington T, Pedersen MB, et al. Does nuclear tissue infected with bacteria following disc herniations lead to Modic changes in the adjacent vertebrae? European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society. 2013;22(4):690-6. Epub 2013/02/12.

2.         Albert HB, Sorensen JS, Christensen BS, Manniche C. Antibiotic treatment in patients with chronic low back pain and vertebral bone edema (Modic type 1 changes): a double-blind randomized clinical controlled trial of efficacy. European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society. 2013;22(4):697-707. Epub 2013/02/14.

3.         Dean BJ, Davies BM. No conflict of interest? European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society. 2013. Epub 2013/07/16.

4.         Albert HB. Answer to the Letter to the Editor of Benjamin John Floyd Dean et al. entitled "No conflict of interest?" concerning "Antibiotic treatment in patients with chronic low back pain and vertebral bone edema (Modic type 1 changes): a double-blind randomized controlled trial of efficacy" by Albert HB et al., Eur Spine J (2013) 22:697-707. European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society. 2013. Epub 2013/07/17.

5.         Aebi M. Editorial. European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society. 2013. Epub 2013/07/26.

 

Oh Dear - European Spine Journal humiliates itself further!

 

It seems that the European Spine Journal thinks that the more it ignores something, the more likely it is to go away, alas this is not the way in which the real world works.  The Editor of the Journal has waded into the debate with some rather confused and illogical words.  It seems the those who dare criticise a clear undeclared business interest directly relating to the study results are 'moral preachers'!  I would say that those who point out the failings of peer review in an objective manner are simply fair honest people who are trying to see science done in the right way, both ethically and morally:

" With a statement as well as an answer to one of the letters to the editors by the principal author (H. A.), the European Spine Journal reacts on numerous accusations mainly from self-nominated moral preachers of the lay press that it has published the two papers without checking the disclosed ‘‘no conflict of interest’’ statement."

The Editor completely ignores that fact that the authors failed to declare a clear conflict of interest:

 "As Editor of the journal, my reply is twofold:

 1. The quality and the originality of research are not less, even if the author has a so-called ‘‘conflict of interest’’, more so when this ‘‘conflict of interest’’ has nothing to do with the process of research.

 2. Every author who wants to publish a paper in the European Spine Journal has to sign a ‘‘no conflict of interest’’ statement before the paper is accepted for publication. The European Spine Journal has neither the capacity nor the size to check the truth of every author’s statement. Here, we have to rely on the honesty of the authors. If an author is not honest and lies to the journal, then this is his/her own responsibility."

In response to point 1, it is entirely irrelevant as the conflict of interest was NOT disclosed at the time of submission, if it had been there would be no problem.  Sadly for the authors it was not declared and this changes the situation completely, an undeclared conflict of interest directly relating to the study content is a clear case of 'research misconduct'.  The authors signed 'no conflict of interest' when two of them had a clear conflicting business interest with MAST Medical.

In response to point 2, it is fair that the Journal missed the conflict of interest initially, I have never said this was their fault, the authors need to take the blame for this.  However the problem is that it has been subsequently pointed out to the Journal by my letter that a clear conflict of interest was not declared by the authors.  The Journal has since failed to acknowledge this failed declaration and has not issued any form of correction to include the previously undeclared conflicts of interest; the Journal has also allowed the author to deny the conflict of interest is even a conflict.  Finally there is some appalling condescension in the final paragraph:

"The journal can only ban such an author from future publishing in the European Spine Journal and in severe cases the journal may publicly announce the withdrawal of the publication in question. However, such a decision has to be proportional and is only justified when the conflict of interest manipulates the methodology and results, in other words, the quality and the honesty of the research data. This is clearly not the case in the two papers of H. Albert et al. It is not up to the lay and public press to make themselves the judges about content, which is geared towards a selective community, in this case the spine research community."

It is the Journal's job to make it clear to ALL readers when authors have a conflict of interest relating to the study content.  In this case the European Spine Journal has dismally failed to do this, having been clearly informed of a clear conflict of interest of the authors by my letter.  The Journal has failed to apply its own guidelines on conflicts of interest, which are remarkably clear on this.  Scientific research should be open to anyone to read and clear conflicts of interest should be declared honestly so that any reader is aware of the circumstances surrounding the research.  The Journal has failed dismally on this issue and instead prefers to launch attacks against those who dare objectively criticise their clear governance failings.

The BMA ignores its members

The BMA has recently entered negotiations on the junior doctor contract, and for the first time in quite a few years they have surveyed their members for their opinion.  Strangely the BMA has never asked its members for their opinion on working hours before. The survey was analysed by Ipsos Mori but the questions were all crafted by the BMA:

"The questions were designed by the BMA (without input from Ipsos MORI) and covered working hours, pay, quality of life and training, as well as key demographics such as gender, region, grade and speciality."

The BMA press release focused on the dangers of extra hours and based this on weak anecdote, while it completely ignored the key and striking finding that so many junior doctors want the EWTD hours limit increased:

"Many felt that the limit should be raised to better reflect reality." and "While some respondents felt that 48 hours average per week was an acceptable limit of working hours, others mentioned a need to increase the working hour limit. Broadly similar numbers of respondents expressed either view."

Notably it is interesting that the BMA survey is rather flawed methodologically, something that is inevitable when individuals try to survey, but when an organisation with the money and infrastructure of the BMA does a survey, is this acceptable?:

"This means that the responses are not representative of the population of any audience as a whole. The findings cannot therefore be extrapolated to the overall populations."

So the BMA has spent a lot of time and money on a survey, and they claim the results are pretty meaningless. So how on earth can they justify hyping up the dangers of extra hours based on weak anecdote, while completely ignoring the views of 'many' on wanting to work more hours.  Not impressive.  There were some other key findings including the need for better shift patterns and for key elements of training to be part of the contract.  But overall I can't help but think that this was a massive missed opportunity?

The cynic in me feels that this was very deliberate from the BMA.  They wanted a woolly qualitative survey as this was something which could be used to neatly ignore all the opinions that they dislike, the weak methodology allowed for this wiggle room and it is very convenient for them.  The hypocrisy of their selective use of anecdote is truly breathtaking; either the survey is too weak to rely on and they should not have hyped up the dangers of extra hours, or they should have given fair coverage to the huge numbers who want more hours.  The BMA's biased and selective use of the results is an insult to their membership.  It is however telling that despite the BMA's spin, many doctors are deeply unhappy with the EWTD hours limit and want more hours.

The European Spine Journal appears to support research misconduct

The 'antibiotics for back pain' story broke several weeks ago to a huge amount of media hype, in fact the vast majority of coverage was very positive, there was very little context and caution thrown into the mixture at that early stage.  A huge reason for this media fanfare was the orchestrated PR campaign conducted by the authors and MAST Medical directors, not mutually exclusive groups as we have since discovered.  In fact one MAST Medical company director, Peter Hamlyn, was widely quoted in the media stating:

"This is vast. We are talking about probably half of all spinal surgery for back pain being replaced by taking antibiotics,"

He also claimed the research was worthy of a Nobel prize.  Strangely there was no mention in the media of Hamlyn's conflict of interests as a MAST company director, perhaps the media were told but just didn't mention it, who knows?  MAST Medical consists of two limited companies which were formed in 2010 and whose business depends on the results of the two Albert et al studies published this year in the European Spine Journal.  So two of the authors had clearly failed to state a clear conflict of interest relating to their roles as company directors of the MAST firms, and at this early stage it was not clear how much the Journal knew.

One might have thought that the ranting of a lone blogger and a very balanced piece in the BMJ by Margaret McCartney would not have ruffled the feathers of the authors and the Journal, however recent events have shown this appears not to be the case. I wrote to the journal to express my grave concerns that the two authors did not declare their blatant conflict of interest regarding MAST Medical, one would have thought that the Journal and authors would quickly apologise and correct the studies to include this conflict of interest.  Alas not, what we have seen has been a blustering piece of orchestrated obfuscation that wouldn't look out of place in a Kafka novel.

The Journal has come out with guns blazing and has refused to acknowledge that the authors' positions as company directors of firms whose business directly relates to the subject matter of the published studies are a conflict of interest.  It is strange as this stance from both the lead author and the Journal clearly contradicts their own guidance on conflicts of interest.  The Journal has not enforced its own guidelines by allowing the lead author's flimsy response to be published, while the Journal has published an editorial that has gone on the offensive:

".....the importance of this should not be lost amidst the negative, unstructured and unscientific response to this study....This mass media launch has led to a very widespread and negative feedback in the lay and specialist medical media. Obviously, this is an unregulated, opinionated repository for often extreme opinions, but there must be significant reputational risk both to the scientists, the commercial organisation in London and to the spinal community in general from some of these widely read internet resources (see http://ferretfancier.blogspot.co.uk/2013/05/antibiotics-for-back-pain-conflicts-of.html, and http://theconversation.com/zit-bacteria-causing-back-paina-spotty-hypothesis-14060). In addition, there has been a cynical response from the respected medical press [17] although a subsequent article gave a slightly more tempered response [18]."

It is utterly incredible that the editorial dares claim talk of 'reputational risk' to the authors and their businesses that stand to profit from their studies, as if this is some kind of smear campaign against them, rather the opposite in reality.  Strangely the editorial makes no mention of the MAST Medical PR campaign and its role in intentionally creating the media fanfare.  The authors and their companies have put their own reputations at risk because they have failed to declare a clear conflict of interest to the Journal, and now the Journal is stepping on some very dodgy ground indeed by backing up the unprofessional and unethical stance of the authors.  Their actions constitute a form of research misconduct and in order to attract attention away from this they are going on the attack, and trying to paint those who dare make objective criticism as crazed extremists.  

The lead author's response to my letter is nothing but obfuscation, she talks of a limited company as just an 'idea' and paints herself as a sorry victim of an 'attack'.  It is amusing that pointing out a clear undeclared conflict of interest is deemed an attack by Albert, it seems to me to be nothing other than fair objective criticism that she should properly address.   In reality the lead author is a MAST company director and is trying to take attention away from her failure to declare this as a conflict of interest by going on the attack.

This whole sorry sage demonstrates many important points.  Firstly digging a hole deeper is never a good option, it is far more sensible to admit an error when one is made.  Secondly the process of peer review is only as good as those managing it.  Thirdly those who go on the aggressive attack are often doing so because they are in a very weak defensive position.  I will not let this drop and it is important that the authors/Journal are not allowed to get away with this blatant refusal to declare a clear conflict of interest.  It is important for science that peer review is not abused in this manner, and to do this one must freely speak out the objective truth without fear.  Sadly this story looks set to run and run.

Laughable response from 'antibiotics for back pain' author

These are the simple facts:

1. Two authors (Albert and Manniche) were named MAST company directors in 2010.

2. 'Antibiotics for back pain' study submitted to European Spine Journal in 2012.

3. No conflicts of interest declared in submission by both authors despite the fact that this company could potentially directly profit as a result of the study's findings.

The author's letter has just been published in the European Spine Journal and it states:

"The study was conducted from 2007 and the last one year control was carried out in late 2009. After the independent statistical analysis was done, the paper was written and then sent to the first Journal in 2010."

It is irrelevant when the study was sent to the first journal, the author is obfuscating in the extreme, it was submitted to the ESJ in 2012, 2 years after both authors were named MAST company directors.  The second justification for the undeclared conflicts of interest are:

"Since the company was nothing but ‘‘an idea’’ until after e-pub, there was no conflict of interest to declare."

Actually the company was more than 'idea', it was a proper limited company when the paper was submitted.  It is worth going back the the ESJ's guidelines on conflict of interest, it makes the author's claim look flimsy to say the least:

"Conflict (if none, “None” or describe financial interest/arrangement with one or more organizations that could be perceived as a real or apparent conflict of interest in the context of the subject of this article)"

The conflict is perceived, real and apparent in the context of the subject of the article.  The author does continue to obfuscate by digressing into details about the MAST company and try to paint herself as the 'disheartened' victim of an attack.  Sadly this is completely irrelevant, MAST is a company and she is a director of this company, and she should have declared this.  If the intentions of the company are benevolent, then why not simply declare it as the conflict of interest which it still is?

It is breathtaking, dumbfounding and utterly farcical that the author feels she can justify the failing to declare her clear conflicts of interest, she is clearly in breach of the ESJ's clear guidelines on this very topic.  The Editor's failure to enforce these guidelines and allow the publication of this laughable defence speaks volumes.  The Journal appears to value publicity over ethics and standards.  

The author and ESJ would have done better to simply apologise and admit the undeclared conflicts of interest.  Instead they have tried to justify the overtly unjustifiable, they have aggressively defended the blatantly incorrect, they have obfuscated and they continue to do all this.  Personally I am not impressed with this at all and it is precisely this kind of behaviour that makes an absolute mockery of peer review.  To be accused of 'attacking' the author for daring to point out a clear undeclared conflict of interest is rich, to say the least.  I am just pointing out clear objective facts which the author and European Spine Journal continue to ignore.

Antibiotics for back pain - the saga continues

A series of articles have appeared on the ESJ in response to the 'antibiotic for back pain' study by Albert et al.  There are three letters to the Editor, two of which are mine, and one of these points out the clear undeclared conflicts of interest of the authors.  There is also an editorial, it's worth reading yourself to reach an opinion of course, but it does appear to be a rather aggressive and blustering defence of the journal's stance and actions.  There are some sentences that simply don't make great sense:

"Against this background, it seems that a mass media launch in the United Kingdom, Europe, and North America with the story rapidly being taken up around the world, offering a ‘‘cure’’ for back pain propagated from a private clinic in London, should be considered unwise"

While the way in which the Editorial glosses over the conflict of interest issue is interesting, to say the least:

"One of the authors of the Southern Denmark papers has a commercial link with this organisation and addresses this conflict of interest elsewhere in this edition of the European Spine Journal."

This is factually wrong, actually 2 of the authors are named company directors of MAST Medical firms as I have stated on this blog.  The Editorial strangely doesn't  mention that one of the Albert/Manniche's business partners in the MAST MEDICAL companies, Peter Hamlyn, was directly involved in creating the media fanfare and mass hysteria:

"This is vast. We are talking about probably half of all spinal surgery for back pain being replaced by taking antibiotics" (Peter Hamlyn of MAST Medical in Guardian)

There is thus a complete failure of the Editorial to even notice that the massive media fanfare was instigated by the author/s and their very well rehearsed PR campaign, involving their business partners such as Peter Hamlyn.  The bizarre accusations levelled at bloggers like myself made me crack up:

"This mass media launch has led to a very widespread and negative feedback in the lay and specialist medical media. Obviously, this is an unregulated, opinionated repository for often extreme opinions, but there must be significant reputational risk both to the scientists, the commercial organisation in London and to the spinal community in general from some of these widely read internet resources (see ferret fancier, and the conversation). In addition, there has been a cynical response from the respected medical press [17]although a subsequent article gave a slightly more tempered response [18]."

The irony of the 'unregulated' and 'opinionated repository' is highly amusing given the completely unregulated freedom of peer reviewed journals to do precisely that!  Margaret McCartney is labelled 'cynical' for daring to question undeclared conflicts of interest!  I would like to personally thanks Margaret for her work on this as I feel without her pressure the Journal may well have buried a lot of this criticism. The Editorial simply tells us what is right near the end and again makes no mention of the authors' and MAST Medical's PR being the prime reason for the media fanfare that ensued:

"We believe that the surgical and scientific communities should have a tempered and objective response to these publications."

The overall point is simple.  Two authors were named company directors of firms that stood to directly profit from the results of research,and this was not declared when the articles were submitted, despite that fact that both authors were named company directors two years before the articles were even submitted!  The author/s have a lot of explaining to do and I struggle to see how they can dig their way out of this hole they have created for themselves.  The Journal also failed to pick up this undeclared conflict and appears to still be in denial on the issue.

The Journal has not behaved impressively either, this sort of aggressive defensive posturing doesn't do them any favours at all.  The Editorial contains basic factual errors and ignores the way in which the media fanfare was MAST Medical driven. The attempt to smear those, including myself, who have attempted to expose the truth is weak.  I suggest that the 'reputational risk' to the scientists is 100% self inflicted, the failure to declare serious conflicts of interest is a major professional failing that the Journal should be taking far more seriously.  The fact that these conflicting interests were undeclared had a major impact on the way in which the research was reported, and interpreted by doctors and patients alike.  This should be acknowledged at the very least.

ps I must also say that it is a remarkable coincidence that the Editorial is written by John O'Dowd and Adrian Casey, the latter of whom happens to work at the same private hospital at which Peter Hamlyn (MAST Medical Academy) also works!  Just chance I presume

The Shape of Privatisation (Training) Review

Anyone involved in medical training should be keeping a very close eye on the GMC's 'independent' review 'The Shape of Training'.  I may turn out to be completely paranoid and misguided on this piece of work, but it does appear to me that the review has already made up its mind and that the 'consultation' is nothing more than a pathetic sham.

It is worth having a read through the 'evidence so far', if one can call it 'evidence' that is.  Sadly the literature review is a biased piece of highly selective cherry picking, and then much of the other 'evidence' (opinion) gathering seems focused on reinforcing the Review's predetermined outcomes.  In life if one asks a silly question, then one gets a silly answer and this is exactly what this review is doing.  The logic of the review is sadly lacking:

"Most participants supported a move towards broader based, general training after the Foundation Programme. As the number of patients with multiple morbidities increases, we will need doctors with sufficient breadth of knowledge to provide appropriate care to these patients."

This is a spurious point as doctors who have been adequately trained for 2 years post registration should not need yet more generic 'broad based' training to be generally competent.  Overall the review ignores the massive failings in training today such as inadequate experience gained due to shoddy regulatory processes, and is proposing a complex solution to a problem that would be better addressed by direct fixation, not the creation of a misleading theme in order to indirectly fudge the problem.

I would be ashamed to produce such a biased 'review'as the Shape of Training review has done, the negative impacts of competency based methods that have been regularly outlines in peer reviewed journals are completely ignored, and the low quality evidence to fit the review's preconceived ideas is cherry picked.  The predetermined goals are highlighted by this kind of biased statement in the review:

"Most agreed that at the end, doctors should receive a Certificate of Generalist Training (CGT), which could

be followed by further generalist or specialty training through credentialing. "

This idea of a CGT is ludicrous.  The review should be addressing the rank inconsistency and inadequacy of Foundation training, so that doctors are generally competent post registration, not creating yet more waste and bureaucracy by pushing through reform to create a service providing monkey post-CGT grade.

The preconceived nature of the review is confirmed when the review states that there are only 3 paths ahead: 1) sub consultant grade of dumbed down post-CGT monkeys 2) slight changes to current system (best option but will clearly be ignored) 3) sub consultant grade of dumbed down post-CGT monkeys with credentialing.  The best option (2) will be ignored because it will make "it more difficult to emphasise the importance of generalists to care in the future" - an incoherent illogical explanation that makes little sense to anyone with half a brain cell.

The Shape of Training review is MMC part 2 - it is clear that the nature of the training reforms have already been decided by those in Whitehall and that the imperative is to create a cheaper dumbed down medical workforce that will be far easier for the new privatised NHS to bully and exploit.  It is a G4S style solution, shiny on the outside but completely devoid of quality on the innards.  The sub consultant grade is coming, the government wants to kill the properly trained consultant grade who are empowered by quality training and a CCT.  It is yet more command and control from the government, aided by the GMC, and it will not be good for doctors or patients.  I fear for medical training when it is being run by those who are prioritising the needs of cowboy profiteers over patients.

Government to phase out use of' 'water' after independent review

The fluid of death, 'water', has been responsible for numerous deaths in recent years. Not only that, but numerous injuries, damage to property and houses, as well as erosion of river banks have been down to this ghastly 'deathly' fluid.  Many of our esteemed national newspapers and broadcasters have been engaged in a noble campaign to ban this lethal liquid.  It is also important to remember that water in it's even more lethal solid form 'ice' is responsible for even more death and misery, just think of skiing injuries, mountaineering deaths, the use of ice blocks as weapons, boats sunk by icebergs and many more great examples.

The government have used their wise knee tendons to react in the only way they know, they have crafted some brilliant policy based on this marvellous media campaign based on knowledge and benevolence.  It must be added that it is merely coincidental that such news stories sell a lot of papers and this industry thrives upon reckless ignorant scaremongering.  Water must be banned, it must be outlawed, we simply cannot allow this fluid of death to carry on killing, maiming and destroying.  There were floods in the bible, there was the Titanic, there have been murdering Tsunamis all over the planet, water is evil scum, it must be eradicated.

The government are not serving their own interests here, they are acting in the public interest, the fact that it will lead to a boost in their popularity amongst the Daily Mail reading fraternity is another huge coincidence that I shall simply ignore as I hate water, it has to go.  The practicalities of such beneficial water banning reforms are unclear but it will definitely be cost effective, think of the amount of money wasted on our deathly water based infrastructure, think of the money wasted on our sea defences, on maintaining our beaches and rivers.  We need dryness, we need safety, we want utopia, we read the Daily Mail, it is possible.  The oceans need draining, the sky needs clearing, the rivers emptying, just think of our children for goodness sake!

I love this country, and I love the Daily Mail and Telegraph, the way in which government policy is driven by this expert and knowledgeable analysis is a great example of democracy in action.  I am only disappointed that the MMR wasn't banned in similar fashion, the evidence was there that it harmed and the government ignored it, how very reckless and short sighted that was.  Anyway well done David Cameron and his lovely chums, they are serving the public interest with their selfless benevolence, even they will suffer as a result of the water reforms, their water trough will have to be replaced by some caviar provided by G4S........