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The Lancet should Reinstate the Andrew Wakefield Paper

The-lancet-illustrationBy Martin Hewitt

In the wake of the High Court judgment on Professor John Walker-Smith’s appeal against the decision of the General Medical Council (the UK regulatory body for doctors) to delicense him, what should now happen to the retracted paper he co-authored with Dr Andrew Wakefield? The decision lies with The Lancet editor, Dr Richard Horton. But what are the grounds for reinstating the paper as a properly conducted clinical investigation into 12 children with autism and bowel disease admitted to the paediatric gastroenterology department at the Royal Free Hospital (RFH) London in the mid-1990s? The paper was the focus of the GMC’s trial of the three senior authors on charges of serious professional misconduct which led to the delicensing of Walker-Smith and Wakefield.

Background

Few academic articles have been dogged by the controversy attending the now retracted  Lancet Paper ‘Ileal-lymphoid-nodular hyperplasia, non-specific colitis, and pervasive developmental disorder in children’ since its publication in February 1998. (Another link to retracted paper here.) In seeking to avert controversy The Lancet published an editorial accompanying the paper to warn against drawing the wrong conclusions that the paper had established that the MMR caused autism and bowel disease. The paper, which went through several cautious redrafts, said it "did not prove an association between measles, mumps, and rubella vaccine and the syndrome described”, adding that “Virological studies are underway that may help to resolve this issue”.

On publication the RFH took the exceptional step of holding a press conference to launch the paper in the hope of preventing the media and public from concluding that the MMR was unsafe and to avert a collapse in MMR take-up. When Dr Andrew Wakefield the lead writer was asked by the press if he would personally support the three-in-one MMR vaccine, he responded by advising parents to choose the single measles, mumps and rubella vaccines spaced out at intervals. Whilst his comments were seized on by the press as evidence that the MMR was unsafe and by the medical establishment as highly irresponsible, his answer accorded with official government policy. At the time the government vaccination schedule offered the choice between MMR and the three separate vaccines, in accord with the Department of Health's express policy when the MMR was launched in 1988.

In March 1998, the then UK Medical Officer of Health convened a conference of selected experts under the auspices of the Medical Research Council to discuss the paper with Wakefield. One question asked was how the case series of 12 children with autism and bowel disease was selected. Thus began a further controversy that challenged the paper’s statement that the children were “consecutively referred to the department of paediatric gastroenterology” and sought clarification of its statement that “Intestinal and behavioural pathologies may have occurred together by chance, reflecting a selection bias in a self-referred group”. To many medical researchers it appeared that the child patients had been selectively chosen as a result of parents contacting Dr Wakefield to produce a biased sample.

The controversy reignited in February 2004 when the Sunday Times’ published the findings of a five-month investigation by freelance investigative journalist Brian Deer into the paper’s research and ethics. Deer’s articles continued up to January 2011 and were then followed by further articles in the British Medical Journal. When Deer first presented The Lancet with his findings four days before publishing his first Sunday Times article, the journal began its own investigation publishing a summary of Deer’s allegations and responses by the three lead authors Dr Wakefield, Professor John Walker-Smith and Dr (now Professor) Simon Murch and by the Royal Free and University College Medical School. The Lancet summarised Deer’s allegations: the investigations, some highly invasive, did not have ethical approval; the study was completed under cover of an entirely different approved study; the children were selected by invitation from Wakefield and Walker-Smith to the parents, constituting selection bias and contrary to the paper’s claim about consecutive referrals; and the Lancet children were part of a legal-aided and funded research project to investigate the feasibility of litigation for vaccine damages.

Having considered the responses of the senior authors and the medical school The Lancet judged that the first three allegations were unfounded. However, on the last allegation concerning Dr Wakefield’s involvement with a separate LAB-funded study from The Lancet study, it concluded that “the perception of a conflict of interest nevertheless remains. This funding source should, we judge, have been disclosed to the editors of the journal.” Nonetheless the paper was not retracted.

Henceforth The Lancet paper entered into a period of unprecedented controversy much deeper than before, driven by the Sunday Times investigation and the personal involvement of Brian Deer, who used his website to make claims far beyond those made in the Sunday Times at the same time. Three days after Deer had published his first article, he sent a 6-page email to the GMC outlining the above allegations with the additional claim that Wakefield had committed scientific fraud. In effect this not only instigated the 3 year GMC investigation that led to the fitness to practice hearing begun in 2007, but also outlined the trajectory Deer was to follow in his serious attacks on Wakefield’s reputation in the Sunday Times and on his website, and from 2011 onwards in the British Medical Journal. Currently both Deer and the BMJ appear to have adopted an expedient silence as they await the result of Wakefield's forthcoming libel action against them in Texas.

The final stage of controversy began with the GMC fitness to practice hearing of the three doctors which culminated on January 2010 with findings of serious professional misconduct against them. In July the GMC recommended the sanction against Wakefield and Walker-Smith of erasure from the medical practice register, to be applied on appeal to the High Court. For Wakefield an appeal was not feasible as the Medical Protection Society, the insurance fund providing legal cover for doctors accused of offending medical regulations, withdrew its support and he was unable to finance the appeal himself. He was thereby struck off. However Walker-Smith’s appeal was heard by Justice Mitting in the High Court in London in February 2012.

On 2 February 2010 The Lancet fully retraction the paper "from the published record" on the grounds that “several elements of the 1998 paper by Wakefield et al are incorrect, contrary to the findings of an earlier investigation [see above]. In particular, the claims in the original paper that children were 'consecutively referred' and that investigations were 'approved' by the local ethics committee have been proven to be false”. The statement hints at other concerns. We know from The Lancet’s earlier investigation that the editor formed the view that Dr Wakefield should have declared a conflict of interest regarding his involvement in a separate legal-aided study. But, being a separate issue from Walker-Smith’s appeal, this does not form part of Mitting's judgment. Wakefield himself has claimed throughout that the legal-aided study was for different scientific purposes than those pursued in the Lancet paper.

The Mitting Judgment and the Lancet paper

Having digested much of the hearing's 149 days of submissions and evidence and many other related papers, and heard Queens Counsels for Walker-Smith and the GMC, on 7 March J Mitting quashed all charges against the Professor.

Inevitably the thorough and irrevocable negation of the charges against Walker-Smith and of the GMC’s legal case, based on its deep misunderstanding of The Lancet paper, raises an important question of the status of the Wakefield et al paper, which is still listed as retracted, to which we now turn.

There is no doubt that the Mitting judgment goes to the heart of the way the GMC exercised its regulatory powers in this case. He outrightly criticises the "universal inadequacies" and "inadequate and superficial reasoning" of the disciplinary panel's approach, and recognised the personal suffering the GMC had inflicted on Walker-Smith. "It would be a misfortune if this were to happen again" he concluded on delivering his judgment.

More specifically, the Mitting judgment rejects the two fundamental grounds the GMC gave for finding the three doctors guilty of serious professional misconduct and so undermines The Lancet‘s argument for retraction based on these grounds; out go the claims that the patients were not consecutively referred to the department of paediatric gastroenterology and that the investigations did not have ethics committee approval.

 

On the issue of referral, J Mitting rejects the GMC’s charge against Walker-Smith that a consecutive referral meant “a routine referral to the gastroenterology department...in which the investigators had played no active part”. Mitting says, "Thus construed, this paper does not bear the meaning put upon it by the panel. The phrase 'consecutively referred' means no more than that the children were referred successively, rather than as a single batch, to the Department of Paediatric Gastroenterology. The words did not imply routine referral.” Moreover, he notes that “The general reader of that paragraph would note the author’s [Dr Wakefield's] caution about the possibility of selection bias in the self-referred group. Taken together with the comments already cited made about the temporal coincidence of the onset of symptoms and MMR vaccination in the case of eight children, the author has made it clear that this was not a routine referral. It was a referral generated by the concerns of parents about a possible link” (para 157 here).

On the issue of whether the paper had ethical approval, Mitting’s findings are more complex. First he rejected the GMC’s view that the paper was research. Summarising, he says, “At the heart of the GMC’s case against Professor Walker-Smith were two simple propositions: the investigations undertaken under his authority on eleven of the twelve Lancet children were done as part of a research project – Project 172-96 – which required, but did not have, Ethics Committee approval; and they were clinically inappropriate“ (9). However, contrary to the GMC’s position, Mitting concludes that the investigation was clinically driven. Addressing the inadequate thinking of the GMC’s fitness to practice panel, he concludes that “What the panel’s stated reasons do not do, however, is to justify its conclusion that the investigations were for the purposes of [research] Project 172-96 and not for the purpose of a developing clinical project.” On the panel’s findings on the individual Lancet children, he says, “The detailed findings of the panel...did not fill the obvious gaps in its general conclusions.... In no case did it address the indications in the medical notes which supported the oral evidence of the clinicians that they were undertaking a programme of diagnostic and therapeutic investigations, not research; or give adequate reasons for rejecting that account in the case of each individual child” (148). In relation to the individual children, Mitting found clear evidence that they were referred for clinical reasons and not for research.

Secondly, on the question of paper’s approval, the GMC had found that the paper was governed by research approval 172-96, which set a start date for the investigation of 18 December 1996 and that children included in the study should have Disintegrative Disorder and be vaccinated by Measles Mumps vaccination – conditions that the investigation had not followed. However, contrary to the GMC, Mitting found that the panel had given no grounds for saying the paper was approved by 172-96: “On any view, that was an inadequate explanation of the finding" (20). Further Mitting notes that a letter of 11th November 1996 from Professor Walker-Smith to Dr Pegg, chair of the ethics committee, “contained an unmistakeable implied statement: that investigations under Project 172-96 had not yet begun" (17). The investigation was undertaken for clinical reasons and not covered by approval 172-96. In conclusion the paper was a case series of 12 children and did not require research ethics approval.

On the issue that the children did not have the approved condition Disintegrative Disorder and the Measles Mumps vaccination, Mitting concludes that “The only ground upon which [the panel] found that the investigations lacked Ethics Committee approval was that child 7 did not meet the inclusion criteria because he had had MMR vaccination and had not been diagnosed with disintegrative disorder.  Those findings were correct, but could not have justified a finding of serious professional misconduct.  As far as I know the reason for including the first criterion has never been explained.  The second was treated by gastroenterologists in the clinical team as shorthand for a disorder on the autistic spectrum" (138).

The finding that the children were admitted for clinical reasons also puts paid to GMC allegations that the children were subject to inappropriate invasive procedures and that the study did not comply with 172-96’s administrative requirements for start date, consent forms, etc.. (For a AoA discussion of these requirements go here.) The GMC prosecution trick was to claim that the paper was covered by approval 172-96, and thereby to introduce a set of conditions that would condemn the doctors were 172-96 accepted as the appropriate approval. In the light of Mitting’s judgment, this trickery is now out in the open and the GMC's attempt to shift the goal posts declared null and void. However, the current injustice is that these spurious charges still apply to Dr Wakefield and Professor Simon Murch unless the GMC recants and accepts that in the light of Walker-Smith’s successful appeal they must now withdraw these charges on the grounds of consistent justice for all three doctors.

 

On the paper's approval status, Mitting concludes that the statement in the paper – that “Ethical approval and consent: Investigations were approved by the Ethical Practices Committee of the Royal Free Hospital NHS Trust, and parents gave informed consent.” – was "untrue and should not have been included" (153). He notes that this was a change made to the previous draft which stated “This clinical investigation has been approved by the Ethical Practices Committee of the Royal Free Hospital NHS Trust” ‒ itself inaccurate as a clinical paper would not need ethical committee approval. In focusing on Walker-Smith's case alone, as was his brief, J Mitting appears to ignore the fact that ethical approval 162-95 ‒ giving Walker-Smith generic approval to take two additional tissue samples for research from children undergoing clinical colonoscopy ‒ applied to the paper. The published statement of approval refers to 162-95. When examined by his QC on 49th day of the GMC hearing, Dr Wakefield clarified his reasoning for publishing the approval statement. He responds in the negative to the question, "Were you, from your standpoint, at any stage seeking ethical approval in respect of what you have described as 'the clinical elements'?" (page 19). In short ethical approval was not necessary for a clinical study. However, when asked about his research responsibilities for the paper, Wakefield explains, "In respect of what I was doing, which was research, then ethical approval would have been required. And, when asked "Did you have it?", says "Yes, I did...Under 162/95".

Conclusion

Mitting’s judgment should allay The Lancet editor’s concerns based on the GMC's now fallacious findings on the children’s referral and the paper’s ethical approval. However, Mitting raises a new, and we have argued mistaken, concern about the ethics approval statement printed in The Lancet. Mitting’s findings apply to Walker-Smith and not to Dr Wakefield who has not had the opportunity to appeal the GMC's findings and sanctions. Mitting accepts that the paper was for clinical purposes and we know from Wakefield's testimony that, although this is the case, generic approval 162-95 also applied. Even if this proved not to be correct, it would be unreasonable to make this a serious sticking point for continuing the paper's retraction after Mitting's judgment.

Further clarification on the findings against Wakefield and Murch must await the GMC’s publication of ‘lessons learnt’ from the Mitting’s judgment. Further clarification of the paper’s now highly questionable retraction status awaits The Lancet editor's decision. A Facebook site is now available for the public to register their disquiet with The Lancet over the paper’s status [here]. If the ethical questions that have hung over the paper since publication are now resolved, then the paper should be restored to its original position as a peer reviewed paper reporting legitimate research.

An entirely different matter concerns The Lancet's role as an archive of past scientific papers and its duty to maintain an intact history of advances in medical science, whether or not these publications were subsequently proved wrong and superseded by new scientific findings. Some Lancet readers may continue to argue that the paper's findings ‒ on bowel disease in autistic children and the temporal association between MMR and the onset of behavioural symptoms ‒ remain invalid and that this is sufficient reason for it to remain retracted. However, whatever the validity of these findings, it would clearly undermine The Lancet's scientific role if it allowed a paper to remain retracted which had played an important role in the development of medical knowledge of autism and bowel disease and which remains a significant point of focus and debate for subsequent studies. Not only would it introduce new grounds for retracting the paper – initially retracted for ethical and not scientific reasons – but it would detract from the Lancet’s longstanding status, since it was founded in 1823, as a guardian of scientific development and a record of the different turnings medical science has taken in advancing knowledge and treatment.

 

Comments

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Wow!
the Earth revolves around the sun inspite of the Diet of Worms and burning of papers, and the GI is involved some how with immunity, MMR and autism inspite of a retraction of a science paper.

The human race just never really grows up does it.

"....falsified research stands unretracted–including the work of authors who actually went to prison for fraud!

Richard Borison, MD, former psychiatry chief at the Augusta Veterans Affairs medical center and Medical College of Georgia, was sentenced to 15 years in prison for a $10 million clinical trial fraud but his 1996 US Seroquel® Study Group research is unretracted. In fact, it is cited in 173 works and medical textbooks, misleading future medical professionals.

Scott Reuben, MD, the 'Bernie Madoff' of medicine who published research on clinical trials that never existed, was sentenced to six months in prison in 2010. But his 'research' on popular pain killers like Celebrex and Lyrica is unretracted. If going to prison for research fraud is not enough reason for retraction, what is?

....More than 50 ghostwritten papers about hormone therapy (HT) written by Pfizer’s marketing firm, Designwrite, ran in medical journals, according to unsealed court documents on the University of California–San Francisco’s Drug Industry Document Archive. Though the papers claimed no link between HT and breast cancer and false cardiac and cognitive benefits and were ghostwritten by marketing professionals not doctors, none has been retracted."

http://www.counterpunch.org/2012/04/27/why-are-these-fraudulent-papers-unretracted/

I was able to be present on a couple of occasions at Professor Walker-Smith's Royal Courts of Justice appeal.
It was clear from the very beginning that the judge had an excellent knowledge of what had gone on at the GMC, but more importantly what had gone on at the Royal Free Hospital. (All completely right and proper obviously). It is a shame that those who deserted the Professor and retracted the Lancet Paper were not present at the Appeal to hear Justice MItting quash the charges against JWS.
I would also like to say that I completely agree with John Stone's comment.

If I were a fly on the wall in Judge Mitting's Chambers,I'd imagine that he would now have some views with regard to the events,which led to a witch hunt of those academics, whom dared investigate those with acquired or late onset autistic like symptomology and gut problems. A pre determined course of action was planned by certain UK immunisation mandarins against both parents and those academics,in which huge resources,earmarked to investigate the initial findings,which might have involved immunisation, were used instead in a campaign to stifle and damn any further research.I would now hope that Martin Hewitt's excellent article will encourage an investigation into the chain of events,which led to the ending of research,involving those UK Colindale mandarins, a certain Murdoch journalist,The Lancet,a former Lib democrat MP,a shady far left science media group and the now discredited GMC.

Ottschnaut's comment is just plain stupid. Gillies work was an attempt to rebuild faces after the Great War. READ the paper before denigrating it. If you can't understand the paper, read a review, try this one:

http://english.siu.edu/Resources/HaroldGilles.pdf

I'm sure Mark Struthers will not have to 'eat his hat' but I include a selection for him 'just in case':-
ullam.typepad.com/ullabenulla/2006/04/edible_hats.html

In their initial response, following the Professor Walker-Smith High Court appeal, the GMC assured Justice Mitting that they are in the process of 'reforming' their doctors' disciplinary hearings. In future, these hearings are to be handed over to a newly created 'independent' organisation. Yes, I'm as cynical as everyone else about this, BUT the GMC was already thoroughly discredited, even before the scathing published Mitting verdict, which quashed all the GMC findings against JW-S, and had some harsh words to say about the GMC's 'inadequate and superficial' examination of the 'evidence'.

There will be quite a few 'behind the scenes' inquiries and actions taking place, although the chances of these being made public are slim. Professor Murch, who faced more or less identical charges to Professor Walker-Smith, and was admonished by the GMC, and is still employed as a clinician within the NHS, will be looking for a restoration of his 'good name' since this slur on his reputation will have dented his career prospects. I imagine Professor Murch's legal insurance company will be looking for all of their expenses back too!!

I will eat my hat if the editor of the Lancet reinstates the paper, the case series report by Wakefield et al. Restoring the paper is obviously the right action to take, the honourable and decent thing to do. However, honour, decency and doing what is right are not part of the ethic of the British medical establishment. My hat is safe.

Gillies HD. Paraffin wax in facial surgery . Lancet 1919; 2: 174-174.

It's amazing what Lancet doesn't retract versus what they do. The article above is a scholarly treatise on injecting hot wax into patients faces for cosmetic effect, published in early 1900s and still part of Lancet proud heritage. That is, not retracted.

Maybe Wakefield is too evidence based to be included in this assemblage of medical curiosities posing as a journal....

Martin Hewitt implies that the GMC are to publish the 'lessons learnt' from the Mitting's judgement. If the GMC publish anything on the matter, let alone anything meaningful, I'll eat my hat.

If "The Lancet" retracted the paper, were they able to without any reason/s??? Perhaps a rubber stamp "Retracted."

If "The Lancet" wasn't required to give a reason/s, therefore shouldn't they be able to reinstate the paper without any reason/s??????? Perhaps a rubber stamp "Reinstated."

Elizabeth Gillespie

I believe there are five other MMR papers with the same basic conclusions written by five other scientists in five different countries.

I am sure there is a simple way to locate them and link to them for the non-believers...

"Lancet" has lost all scientific credibility in the past two decades, as it is mainly involved in advertising pharmaceuticals and in censoring out legitimate and important research. I would not trust any paper published in Lancet anymore.

Keep up the good work and good writing Martin. I have written to Horton but as yet have not received any reply.

Thank you. This is a very helpful synopsis of Judge Mittings findings regarding GMC subversion of truth.

Thank you Martin Hewitt for explaining so clearly and precisely the chain of events which led to complete distortion of the facts by the media and the GMC concerning this case. And also for highlighting part played by journalist Brain Deer. So much credibility was attributed to him; it makes this whole sorry episode sound like a bad joke. What medical qualifications did he have? You have presented factual reasoning as to why this paper should be reinstated. We can only wait now to see what transpires.
MMR is STILL an unsafe vaccine and proper safety trials have not been carried out.
Good luck to Dr Wakefield’s libel action In Texas.

Thank you Martin for demonstrating meticulously that the only reasons now for the retraction of the paper are political bullying and cowardice. This falsification of history shames the scientific community and shows why they are completely bought out, and can no longer be trusted. The science we get from now on is the science our political masters choose that we pay for, and God help the next generation.

John

Just because it's been retracted doesn't mean we can't read it: http://www.vaccinesafetyfirst.com/pdf/LANCET%20pdf.pdf

Thank you Martin.

It is very important that the paper get reinstated as soon as possible. My son’s bowel disease and that of many others has been patently ignored here in Minnesota, simply because they also have autism.

As mentioned by an earlier commenter, many gastro docs may want to help, but the fear of being “Wakefielded” is a very powerful force. The rest of them just refuse to help on the basis that they are too damn lazy to read and think for themselves about the evidence that they are given as an excuse to keep our “difficult cases” out of there offices.

I look forward to the day that I can drive 12 miles to see an Autism Gastrointestinal specialist instead of 1200 miles. This will never happen until at the very minimum, the Lancet paper is reinstated. The next on my wish list is Dr. Wakelfield’s day in court and watching Brian Deer and Fiona Godless squirm as they are forced to admit to their mistakes.

My son is getting better but has a way to go. Working with Dr Krigsman he went from 60 pound 14 year old to a 120 pound 15 year old – no change in diet or consumption. If Deer and all the others involved in the demonization of Dr. Wakefield had allowed research to move honestly forward since the publication of the paper, what treatments might have been developed? How many children would not have had to live years and years in pain?

The Lancet should definitely hear from us that they owe it to science and to their own history to rectify this mistake, but the people running the show at the Lancet are not the only “guardians” who have hijacked scientific development for their own selfish motives.

I concur with Patricia, I just tried to access the Facebook page, but at this time it's not a link.

Cannot access that Facebook Lancet page link, it doesn't work. Another one please? The time for a sustained protest to reinstate the paper is now. Great article.

Horton speaks with forked tongue. A forcible challenge to his position is long overdue.

An excellent and well reasoned account by Martin Hewitt. The ethical approval 162-95, as Mr Hewitt points out, enabled the Royal Free clinicians to take two EXTRA biopsies to be used for purely research purposes. The clinicians required NO ethical approval for carrying out invasive or other diagnostic scopes and scans. This was a normal part of their duties as clinicians.

As I write I am looking at my Grandson's Royal Free consent form, signed by my daughter in 1998, which makes it clear that the extra biopsies are for purely research purposes. The form also states that parents can refuse permission and this would in no way adversely affect their childrens'clinical care and treatments at the Royal Free. I cannot see how this could ever be construed as unethical,even by a medical ignoramus like Brian Deer. This form was clearly included in all of the Lancet 12 childrens' casenotes.

The GMC panel can perhaps be forgiven for being fooled by QC Sally Smith's 'sleight of hand' over the two ethical approvals, where she 'led' Professor Booth into stating the LAB and Lancet research studies were the same, but there is NO excuse for Deer OR his Murdoch and BMJ publishers.

Thanks for an excellent detailed and thorough analysis of the work undertaken by a dedicated team trying to unlock the enigma of autism by doing what should be consistently followed through to this day. That children need to be reexamined at a tertiary level and that the underlying physiology that drives their condition be investigated and reported without fear.

Science and medicine hopefully will answer this question in the near future. Whatever the primary causation may be I feel one could look back at the Walker-Smith Wakefield paper and see that this was indeed the beginning of many of the answers people have sort over the following 13 year interval.

Science asks questions medicines addresses patient need both were done with honesty and care. Andy's entire hypothesis of causation and John Walker-Smith's Gastrointestinal findings could be completely wrong , but that is not what science and medicine is about. It is the honest process ... that is of the greatest importance.

Wikipedia defines a "bloody shirt" thus:

"Waving the bloody shirt also has been used to define someone who brings up a past injustice or mistreatment in history to justify or cover up an injustice being committed in the present."

For too many .. and .. for too long .. the "bloody shirt" of Dr. Wakefield has been used to "cover up an injustice being committed in the present".

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