In the first part of Counterfeit Law I looked at the verdict of the General Medical Council's Fitness to Practice Panel in the case of Dr Wakefield, Professor Murch and Professor Walker-Smith, and what followed it. In part two I looked at the evidence given by the expert witnesses in relation to what the prosecution claimed was research carried out on the twelve autistic children cited in the Lancet paper. There is no doubt that these claims were the centre of the case, however, this kernel was deceptively wrapped in a mass of lesser charges like a wood hidden by the trees.
All these subtle and apparently lesser strands of the case changed and metamorphosed during the hearing as the historical circumstances and present day evidence came together. These cocooning lesser charges were always very important because they added a taint of deceitfulness, dishonesty and in one instance apparent stupidity to the character of otherwise honourable professionals; they helped uphold the central charge of experimenting on autistic children.
The peripheral issues in the hearing were: 'the lack of declared conflict of interest in the Lancet paper' (1) , the 'blood samples taken from children', 'research ethics committee approval for the Lancet paper 'study' and 'the administration of Transfer Factor'. The charges around these issues might be termed 'padding', for if looked at individually we see that they could hardly exist as stand-alone charges, it is only when they satellite around more major charges that they gather weight and energy (2). None of the arguments in the whole 'Wakefield affair ' changed more organically or showed such dissonance as those around the suggested undeclared conflict of interest held by Dr Wakefield at the time of the publication of the Lancet paper and none it transpired could have been so easily refuted in a court of law or a genuine enquiry by the unfolding evidence. This last part of Counterfeit Law looks at the conflict of interest issue and the role of Dr Richard Horton, editor of the Lancet medical journal.
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Horton's description of the conflict of interest issue, although in the last analysis deceptive, was simple: Wakefield, he said on finishing the case review paper for publication in the Lancet, failed to add, and therefore hid from him, from the Lancet and from the public the information that he had received funding from the then Legal Aid Board (later to become the Legal Services Commission) to carry out research, that would aid his expert witness testimony on behalf of the parents of vaccine damaged children (3).
This accusation of conflict of interest was developed and extended by the GMC prosecutors, so when proffered in the Hearing it had become baroque. Ultimately the prosecution narrative was that Wakefield had hidden his conflict of interest in a paper that was the fraudulent conclusion of a disguised research study carried out on healthy autistic children with the intention of fixing a result that showed MMR caused autism. The 'fixed' results of this research study were to be used by the solicitor Richard Barr in the parents claim against pharmaceutical companies, so making pots of money for all parties while helping Wakefield in his Jihad against vaccine manufacturers.
The issue of conflict of interest has become increasingly important over the last decade and it is the centre of a great deal of debate within the scientific community (4). Concern has arisen especially because increasingly, highly paid 'scientific' witnesses acting as experts for corporations, not claimants, particularly in environmental, industrial production and high technology damage cases, have been found to lean towards the defence. There is an old legal rubric about witnesses - ‘There is’ it goes, ‘no property in a witness’ and expert witnesses in particular are meant to do their research and give their evidence for, and to, the independent 'court'.
The Legal Aid Board or the more recent Legal Services Commission in England does give funding to lawyers acting in claimant's cases. It does not, however, represent private interests but is an agency of the state that funds research of many different kinds. The contemporary test for conflict of interest is whether or not readers of the research might perceive there to be a conflict. Ultimately this perception can only be exercised if authors state possible conflicts; therefore the first subsidiary offence in the conflict of interest calendar has to do with declaration of such conflicts.
It is generally recognised that the regulation of interest conflicts in research, has changed from being lax - almost none existent - twenty years ago, to more clearly defined. One of the central rules which dictates declaration of conflict of interest is that the reported research must be related to any projects undertaken with payment or other involvement with parties who might be seen to gain from the research (5).
The Lancet paper was a case review paper recording findings of a clinic work-up on twelve children. The prosecution in the GMC hearing and the more general campaign against Dr Wakefield, only got near to getting away with their fraudulent accusations over conflict of interest, because they claimed that the Lancet paper represented the conclusions of a research study that set out to evaluate the link between MMR and autism. The prosecution, had to maintain that the Lancet paper was the conclusion of a research study because rules about research ethics committee approval and such things as conflict of interest apply to research studies and not necessarily to case review papers - especially a decade and a half ago. Apart from many other considerations, this explanatory paragraph from Professor Michael Siegel should be seen as important:
'It is important to note that the research must be directly related to the testimony (in expert witnesses) in order for there to exist a conflict of interest. If I am testifying that an individual's smoking caused his or her lung cancer, then there is no reason why all of my research related to smoking must include a conflict disclosure. However, if my research relates specifically to the issue of lung cancer causation by smoking, then a conflict disclosure would be in order.' (6)
If Dr Wakefield had given evidence in the parents claim against pharmaceutical companies on behalf of their vaccine damaged children, his evidence would have been about any link between MMR and autism. However, the case-review Lancet paper was not about that, was not a study and did not try to prove anything. Dr Wakefield was quite clear in his evidence at the GMC hearing, that had he begun or finished for publication any research which looked at the relationship between MMR and regressive autism he would have clearly stated any perceived conflict of interest. This is, however, yet another example of how, in the GMC trial, the burden of proof was deceptively shifted to the defence - that the absence of any declared conflict of interests showed that Wakefield had them but had deliberately hidden them from the Lancet editor, so proving his guilt.
A notable case of undeclared conflict of interest that was exposed relatively recently was that of the late Sir Richard Doll, the world acclaimed public health epidemiologist. In 1989, Doll published an important paper on Vinyl Chloride and brain cancer in production workers. The paper had been suggested to him by Brian Bennett, the Medical Advisor to ICI UK, a major producer of vinyl chloride. Bennett had originally sought the advice of the US Chemical Manufacturers Association about whether or not Doll should be involved. Agreeing to Doll's involvement, they provided him, not only with payment for the research but also all the industry data upon which to base his research.
The research paper produced by Doll concluded that although there was a an increased risk of brain cancer amongst vinyl chloride workers, that increase was not related to exposure to vinyl chloride. Bennett had advised Doll of the journal that would publish the paper but before Doll submitted the paper, he absolved himself of responsibility for any declaration of conflict of interest by writing to Bennett asking if he should disclose payment received from major vinyl chloride companies. Bennett wrote back to him saying that this was unnecessary. Consequently Doll’s lucrative involvement with the Chemical Manufacturers Association and particularly one of its major members, Monsanto, remained a secret until 2005 (7).
When this story emerged for a second time, two years later in 2007 on the front page of the Guardian, those who supported Doll, the Chief executive of the Medical Research Council, the director of the Wellcome Trust, the President of the Royal Society, the President of the Academy of Medical Science (8) and the chief executive of the Cancer Research UK, all scions of industrial science, wrote a letter to the Guardian pointing out why Doll had not needed to state his conflict of interests. Although their argument that the paper was published pre-rules about declaration had some validity, the fact that Doll had clearly been aware of his obligation to make a declaration, is shown by his apparently sincere inquiry, not of the journals editor, but of Bennett. Over and above this, there were no ifs or buts about the matter, Doll had, for whatever reason, determinedly kept secret a series of funding and methodological links with the industry that he had researched. Nevertheless Doll’s paper is still today used by industry as the 'proof' that there is no link between the production of vinyl chloride and brain cancer.
The dispute over Wakefield's conflict of interests continued between 1998 and 2010 and became one of the main factors in a finding of dishonesty against him by the Panel of the GMC Fitness to Practice Hearing. While everyone else involved in the prosecutorial campaign against Wakefield constantly developed and extended the case against him, Richard Horton, despite disguised forays into more general aspects of the issue and anodyne propagandizing support for MMR, appeared to focus in his more serious public utterances almost solely on the conflict of interest issue. The fact is, he had to do this because he had published Wakefield's paper in his journal and unless serious criticism were to befall him, he had to choose an issue to 'expose' that reflected solely on Dr Wakefield and not upon his editorship of the Lancet.
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Parents first began to make contact with the Royal Free Hospital in the early nineteen nineties. Their children suffered from a range of conditions; most had bad bowel problems, constant diarrhoea and were in pain; many of them had begun to regress into shades of ASD. Some of the parents anecdotally reported that their children's problems had begun soon after they had received their MMR vaccination. These parental anecdotes were flagged up, as they should have been by conscientious clinicians and researchers as an area of possible future research.
The children of parents who made contact with Dr Wakefield in his capacity as head of the Experimental Gastrointestinal Unit, were passed to Professor Walker-Smith for clinical evaluation (9). In those cases, where suspected IBD was linked to regressive autism, even Professor Walker-Smith, with a long experience of paediatric gastroenterology, could not reach a diagnostic conclusion. Other than the fact that the children appeared to have Inflammatory Bowel Disease and had regressed into autism, it was difficult to garner any more diagnostic information. It was odd for IBD to appear so quickly especially in young children, and it was even more odd for young children who had been developing well to suddenly regress into autism.
Faced with this kind of diagnostic conundrum especially in the field of public health, doctors all over the world do the same thing. They create a protocol that includes a variety of tests and procedures covering as many bases as possible. In essence this is detective work that the doctors hope will ultimately uncover a diagnosis leading to a treatment.
In 1997, Dr Wakefield, in his capacity as a research worker, began writing up a case review of the first twelve children who had been examined at the RFH. The idea of the paper was to give other doctors in other hospitals an early warning about the condition. Sticking to the academic rules of case review papers, children with similar presentations who had sequentially attended the hospital were included in the report. The children were admitted as inpatients for short periods so as to undergo tests and clinical procedures.
Although, when they left the hospital some children were given advice on remedial treatments, none of them received treatment for the root cause of their conditions because this was still not known. Such case review papers, which are not the writing-up of research but which record clinical observations, did not need research ethical committee approval in 1997/8, and some do not today.
However, during procedures such as colonoscopy, small samples are clipped from parts of the body under observation; if these biopsy samples are intended to help with diagnosis, research ethics committee are often asked for approval, especially if the intention is to stored for future research. The approval covering the taking of samples from any child patients, application 162/95 was a 'blanket' approval that had been obtained by Professor Walker-Smith from Guy's hospital and brought with him to the Royal Free.
The writing of this first case review paper was almost entirely the work of Dr Wakefield as he was head of the unit and the senior researcher. The reason why twelve other authors had to be attributed on the paper was because all these specialists had played some part in the evaluation of all, many or a few of the children. In the GMC farrago, Miss Smith, the prosecutor, tried to show that apart from Dr Wakefield, Professor Murch and Professor Walker-Smith, all the other authors were makeweights whose names had been added to the paper virtually without their consent.
Dr Wakefield submitted the first draft of the paper to the Lancet in May 1997 and it was finally published in February 1998. Its publication was accompanied by a press briefing organised by Professor Zuckerman, the Dean of the University attached to the RFH. During the preparation of the press briefing Zuckerman agreed with Wakefield that given the possibility that MMR was not completely safe for all children it would be a good idea to advocate single vaccines (10). When a journalist at the press briefing asked what parents were to do given the contention that the triple vaccine might not be safe for some children, the question was fielded by Zuckerman to Wakefield. Wakefield answered in the manner agreed, that it might be a good idea to return to single vaccines until research at the Royal Free had clarified the position.
This call by Wakefield for parents to return to the single vaccines - translated by the media into a call by Wakefield for parents not to vaccinate their children - became the story of the press briefing and effectively ended Dr Wakefield's research career in England. With this statement, he had threatened the profits of the vaccine manufacturers, derailed successive governments combined vaccine policy and become a public health pariah. From the day of the press briefing, his career began to unravel, and in 2002 he left England to do research in the United States of America.
* * *
One of the enduring questions about the GMC hearing is why the onslaught against Dr Wakefield began in 2004 a full six years after the publication of the Lancet paper. The most straightforward reason for this interregnum was that from 1992 lawyers and claimants had been pursuing a civil action against three pharmaceutical companies. Any attack on Wakefield a prospective expert witness, would have been seen as a clear breach of sub-judice. The first thing that the pharmaceutical companies had to do was bring an end to the civil action (11). This they managed in 2003 when the government withdrew legal aid from the parents, who appealed to no avail against the decision in 2004.
In the years between 1998 and 2003, however, the pharmaceutical companies and the government prepared the ground for a post-civil action assault on Wakefield. In 1998 Brian Deer began work with an oddly titled Sunday Times article about Margaret Best and other whooping cough claimants. 'Vanishing victims' supported Wellcome's (later GSK) whooping cough vaccine and derided the expert witnesses appearing for the parents. (12)
At some point in the five-year lay-off, Dr Richard Horton was commissioned to write two pro-MMR books, one destined to be published in the wake of Deer's 2004 exposé of Dr Wakefield. Behind the scenes arrangements were also being made for Sir Crispin Davis, Horton's manager at Elsevier, the Lancet publishers, to be moved onto the board of GSK in 2003, seemingly to mind Horton during the crisis that was about to overtake the Lancet. This intervention of GSK in the Lancet, should have been enough to end the journals reputation and raise the most serious questions about Horton's role as editor. Finally, from 2003, it appears that Brian Deer began to construct a specific case against Wakefield that could be progressed through the GMC.
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Despite their facile nature, the two books Horton wrote between June 2003 and June 2004 were rushed to print by Granta a mainstream liberal documentary and fiction publisher. The 2003 book was titled Second Opinion and was a book of general medical concerns that contained a single chapter on the MMR conflict. The second book, MMR Science and Fiction: Exploring the Vaccine Crisis, is a paean of praise to MMR and a subcutaneous assassination of Wakefield.
In Second Opinion Horton recounts how the Lancet's publication of Wakefield's case review paper, unleashed a tide of reaction against him personally. How he was telephoned by the former president of the UK’s Academy of Medical Sciences 'in a fury about the publication of a paper that raised questions about MMR'. The only past President that fits the bill is Sir Peter Lachmann, the founder President of the Academy, 1998-2002. Horton must truly have been annoyed at getting phone calls from his fellow Fellows in the Academy of Medical Sciences; readers of my last essay will remember that Sir Peter Lachmann had telephoned him on another occasion, threatening his job if he published a paper on the health dangers of GM potatoes. Sir Peter was to be a prosecution witness with Horton and Sir Michael Rutter at the forethcoming GMC Hearing. Horton seems to have joined these two high-flying drug company-linked academics as a founding Fellow of the AMS (13) without paying any heed to the old adage 'if you lay down with dogs, you get up with fleas'; or were his protestations just a pantomime?
In the book, Horton spins the Department of Health line that single vaccines were not licensed in Britain (14) at the time that the Lancet paper was published and when Dr Wakefield advised parents to chose them: 'for all practical purposes (it was) a recommendation to parents not to have their children vaccinated at all since the components were not available separately in the U.K.' In fact this is completely wrong. The truth was that in an attempt to bully through their combined vaccine policy, soon after the Lancet paper, the government moved on companies importing the single vaccines, withdrawing licenses, and coming down heavily on practitioners who advocated them, so helping deny UK parents freedom of choice.
In the book, Horton introduces many of the hoary old chestnuts that became staples in the ongoing barrage against Wakefield. However, he says as well that Wakefield’s work opened up a new field of science - the relationship between the brain and the intestine - in the aetiology of autism. Even here, though, he was unable to leave the matter without throwing a gratuitous spanner into the works, maintaining that no one had replicated Wakefield's work - work that Wakefield had not actually produced!
'... Not one person or group has confirmed the original findings in the Lancet paper'.
While this statement might well have been true of the large scale epidemiological studies manufactured and re-presented by the Department of Health, and its related bodies, that looked at how many cases of autism appeared in large samples of vaccinated vs. unvaccinated children, it was not true of small clinical studies or case reviews which took as their starting point children who presented with serious bowel problems and regressive autism; the actual subject of the Lancet case review paper.
Horton concludes the chapter in Second Opinion with the lessons to be learned from this 'sad affair', which has left 'Wakefield’s reputation unfairly in tatters, virtually unemployable in the UK for the work he wanted to do.'
Unless Horton is intellectually compromised, which I suspect he is not, he is disassembling throughout this book and the next one, for he emerges shortly down the line with Deer and Harris, as one of those most responsible for the destruction of Dr Andrew Wakefield's career.
* * *
Horton's public re-engagement with Wakefield's paper, came almost six years after the Lancet paper's publication and was triggered by Brian Deer who, out of the blue, called up all the actors in the drama a week before he was about to publish his 'exposé' in the Sunday Times.
A PR consultant friend had been helping take the heat off Wakefield following the publication of the Lancet paper. (15) Between December 2003 and January 2004, he was contacted by Deer who asked for an interview with Wakefield. Deer said he was planning to publish a story about the Lancet paper in the Sunday Times, the patchy details that Deer gave about this imminent publication were enough to send Wakefield hot foot from Texas to London in February 2004.
Wakefield made this trip without any of his documents referring to the period of the Lancet paper. In fact, both Professor Simon Murch and Professor Walker-Smith, also called to an urgent meetings with Deer, were as well thrown back on their memory of events that had occurred six to eight years before. From this point onward, Deer and Horton appeared to play the traditional urban masque of 'good cop, bad cop', as they extracted statements from the three doctors.
Wakefield flew into England at dawn on Tuesday 17th February and in the few hours he had left before any meetings began, he gathered what information he could lay his hands on. Horton had also made arrangements with Deer for Deer to brief him and the Lancet staff at the offices of the Lancet that morning. While Andy was answering questions and defending himself against Deer's accusations with representatives of the Sunday Times, including Paul Nuki, the newspaper’s ‘Focus’ editor, at an office in Mayfair, Deer was at the Lancet.
Paul Nuki, a journalist at the Sunday Times from 1993 until 2007, is the person originally thought to have given Deer the job of finding something on MMR for the Sunday Times (16). He is the son of Professor George Nuki, who was coincidentally a member of the Committee for the Safety of Medicines for a period in the late 1980s, when the CSM was considering the Pluserix MMR vaccine, for safety. Pluserix was taken off the market by the British government in 1992 after it was found internationally to have caused serious adverse reactions. (17)
Having also pressurized Murch and Walker-Smith to meet with Deer at the Lancet offices, in the afternoon, Deer was there with Evan Harris - whom Horton later describes as a 'shadowy presence' - and presented, Horton says, a five hour seminar on Wakefield's corruption. Horton later described the presentation as 'gripping' and the allegations it contained 'devastating'.
Horton's objectives in acting as an administrative secretary for Deer have never been explained. As the editor of the Lancet, a fairly conservative medical journal, why did Horton give Deer the audience he did? After all Deer was a relative unknown 'medical' reporter without any connections with above board health or medical organisations. If Deer wanted to raise issues about a single paper authored by thirteen highly respected medics, why didn't Horton simply point him in the direction of the Lancet letter pages?
In fact it was Horton who launched the pre-publicity for Deer and the Sunday Times and he seems to have known the game plan from 'early doors'. Apparently gob-smacked by the revelations of Wakefield's unethical adventures at the Royal Free, Horton immediately set himself up as a contemporary Poirot with medical leanings. The next day he dragged Deer to the Royal Free Hospital to conduct interviews. In the afternoon of that day, a vehement Deer and a smooth Horton, amongst friends at the post Wakefield Royal Free, pressed Murch, Walker-Smith and Wakefield, the three 'suspects' into the writing of self-incriminating statements that appeared to support Deer's story about the origins of the 1998 Lancet paper. These statements were then added to Deer's Sunday Times article and later surfaced at the GMC being put to the defendants as 'confessions'.
Despite clearly wanting to damage Wakefield, Horton's diplomatic public account of his sleuthing at the RFH, suggested that he had found Deer's case to have been damaged by these enquiries. In fact, according to Horton, it was beginning to look as if some of Deer's accusations were ill-founded.
Despite appearing to be privately seeking the truth about Wakefield's paper and still apparently chummy with him, immediately following Deer's intervention and apparently still lacking verified information, with Deer's article ready to appear in the Sunday Times, Horton stepped out onto the boards to give a very public evening and early morning media show. (18)
On Friday February 20th Horton went on national television and accused Dr Wakefield of hiding a serious conflict of interest from him and the Lancet. To believe this, Horton would have also had to believe that the paper he published was not a case review paper but the result of a full-blown research study; this he didn't believe. Horton evidently saw nothing wrong with scuppering Wakefield's work on television before any 'evidence' had been verified, either in the Sunday Times or, more importantly, within the scientific or academic community. In his second book, published in October 2004, MMR: Science and Fiction, Horton's approach can be seen as much deeper and subtler than Deer's'.
Horton repeats what he said on the BBC television news:
If we knew then what we know now we certainly would not have published the part of the paper that related to MMR, although I do believe there was and remains validity to the connection between bowel disease and autism'.
The only problem with this statement is that no part of the paper was about MMR. The paper simply reported that in eight out of the twelve children parents or GPs had noted a coincidence of the vaccination and the onset of the child's illness, suggesting that this coincidence should be the subject of further research.
Horton's retrospective and unevidenced remarks were to get stronger 'in other interviews' (20)
'There were fatal conflicts of interest in this paper ... in my judgement it would have been rejected ... I called Wakefield's work on the link between the MMR vaccination and autism, "fatally flawed." ' (21)
In the book, Horton goes on to reflect on the Media coverage the following day, feigning surprise at its 'aggressive' nature:
'Medical journal raps MMR report doctor' said the Daily Express. 'Lancet in attack on MMR doc', proclaimed the Daily Mirror. 'MMR doctor criticised,' announced The Times. 'Lancet MMR report invalid, says editor,' reported the Daily Mail. (22)
'A whirlwind of innuendo ensued, which caught all of us in its wake. Evan Harris, the MP who had mysteriously joined Brian Deer at the Lancet's offices, called for an independent inquiry into Wakefield's research. Put on the back foot by the sudden escalation in media interest and by Harris's call for a public inquiry, Britain's Health Secretary, John Reid, urged the General Medical Council to investigate Wakefield, 'as a matter of urgency'. Even Prime Minister Tony Blair jumped into the debate, saying, 'There is no evidence to support this link between MMR and autism.' (23)
The following morning, Horton appeared on the Today radio news programme.When questioned by John Humphreys about MMR, he declared that the vaccine was 'absolutely safe.'
On Sunday the 22nd February, Deer's 'exposé' ran in the Sunday Times. The article opened the flood gates for all the vaccine establishment riffraff, evidently rehearsed and waiting in the wings, to speak their one line parts.
Professor Liam Donaldson, the chief medical officer, took the opportunity to have his Bram Stoker moment, 'Now a darker side of this work has shown through, with the ethical conduct of the research'. On the Independent Television news, Prime Minister Tony Blair took the opportunity to make a remark which could have been a reflection on his own judgement in the weapons of mass destruction debacle; 'I hope now that people see the situation is somewhat different from what they were led to believe.'
On Monday 23rd, all the newspapers were full of Horton's story, less so of Deer's, because he worked for another newspaper, and because no one could be certain that his information wouldn't invite libel actions. As the hyenas circled Wakefield's prostrate body, developing what was to become the case of the GMC prosecution, Evan Harris MP, who had never made any declaration of interests, vested or otherwise, came to be more frequently mentioned. Harris was a member of the House of Commons Science and Technology Select Committee, a group that since 1997 had aggressively lobbied on behalf of corporate science against environmental dangers and alternative medicine.
Despite his apparent polite empathy with Wakefield and despite his approach being far subtler than Deer's or Harris's, Horton is quite venomous. Generally speaking his tone in MMR: Science and Fiction, is that of an emotionally challenged recidivist who, caught for the umpteenth time reaching his hand into a gentleman's coat pocket, says with bare faced confidence: 'Really gov I ain't done nowt wrong, was this gent 'ere left his wallet hanging from his pocket, inviting me to relieve 'im of it.'
Even in the introductory pages of MMR: Science and Fiction, Horton takes great delight in putting the boot in:
The Vaccine Guide by Randall Neustaedter looks innocuous enough. It is a book with a sober academic cover that can be found in most bookstores. I bought my copy in June 2004, at a cafe close to University College London. But as soon as the reader turns the cover they will enter a world of striking half truths, gross errors of omission and astonishing manipulation of fact. On the first page, you will read this: 'The vaccination campaign has traded infectious diseases of childhood for chronic autoimmune diseases that afflict both children and adults.' One of those gratefully acknowledged by Neustaedter is a doctor called Andrew Wakefield. (24)
As my eight year old son, too young to read between the lines, might say belligerently: 'And ...?'. To an astute adult, however, the 'and' is clear, 'And Dr Andrew Wakefield is a willing party to these "striking half truths, gross errors of omission and astonishing manipulation of fact".' Interesting as well how Horton manages to distance himself from Dr Wakefield, referring to the man whose papers he has edited, sent to peer review and then published, and in the company of whom he has practiced medicine at the same hospital, as 'a doctor called Andrew Wakefield.' If Horton was ignorant of the part he was playing in a Big Pharma conspiracy then I'm a Dutchman.
As he rolls on describing the Tsunami of media criticism that descended on Wakefield, he almost fails to mention Brian Deer's article, which appeared on Sunday February 22nd in The Sunday Times, MMR Research Scandal (25). The only part of the article Horton quotes is a little snippet about himself: 'Medical insiders now wonder if he [Horton] can survive the scandal that has damaged the Lancet'. Horton quotes this, obviously distancing himself yet again from Deer, but also adds a softer quote, 'Meanwhile, he [Deer] was described as "one of Britain's top investigative journalists".'
Horton's solution to the crisis that enveloped him personally in 2004, was to call for a 'partial retraction' of the Lancet paper. The part Horton suggested needed retracting was the interpretation that might be thought by readers to claim that MMR was responsible for autism. Although Horton managed to convince some 10 of the authors that this 'partial retraction' was a valuable contribution to the scientific debate, Dr Wakefield, Peter Harvey and Dr John Linnell refused to lend their name to this retraction and wrote to the Lancet explaining why there was no conflict of interest and why, in the absence of a causal interpretation attributable to MMR in the Lancet paper, there was nothing to withdraw.
Horton's 'fiddling while Rome burned' did not placate Harris and other members of the Commons Science and Technology Committee who said that there was no such thing as a partial retraction. When Horton accompanied his Elsevier boss, Crispin Davis, who was within weeks to be made a GSK board member, to a meeting of the UK parliament Science and Technology Committee on 1st March 2004, Harris and other members of the Committee were vituperative, scolding Horton for being a wimp, a man without the strategic intelligence to straightway 'retract the whole paper'.
* * *
The next opportunity that Horton had to pursue the cause of the vaccine companies came when he was called by the GMC prosecution to give evidence against Dr Wakefield. On the day he assumed the chair vacated by Professor Zuckerman, Horton, who refrained from repeating President Chávez's words 'I can still smell burning' when following President Bush to the podium at the UN, stuck to his basic public view that while there was nothing wrong with the science of Wakefield's paper, there was everything wrong with his approach to conflict of interest. Horton performed throughout his evidence like Blondin on a high wire above Niagara while Miss Smith, the prosecutor, stretched herself out below him; an infinitely flexible and safe Olive Oyl.
Attending the GMC hearing and writing it up for the parents, I have to admit to having misjudged Horton. Like a very capable actor, he managed to present a likeable liberal self to the hearing that I now think was actually light years away from his real character. He slithered through his evidence for the prosecution as if he was best friends with everyone in the room and would walk a mile out of his way to help any number of old ladies across busy roads. Horton was tall and fit looking, wearing a casual but well cut charcoal black suit, he exuded the cool of well educated Brits and a younger Michael Cain. Of course, it probably helped that Miss Smith treated him like a long lost son, every question noticeably caressing his ego.
According to Horton his enquiry into Deer’s allegations left him sure that at least one of Deer’s most serious accusations was completely fictitious. From that point onwards it appeared that he gave impeccable evidence for the defence. In fact, he rose to a level of praise for Dr Wakefield the like of which any campaigner had heard only from parents. If the prosecution was expecting him to say that the paper was full of poor science, they must have been surprised when he said the absolute opposite. The Lancet paper was an excellent example of a ‘case series’. Such a case review was a standard and entirely reputable way of reporting on a possible new syndrome. He likened it to how the first cases of HIV/AIDS were reported in the early 80s and how the variant CJD issue broke more recently. He said unequivocally that the science still stood and that he 'wished, wished, wished' that the clock could be turned back and the paper considered in the light it was first presented without everything that followed.
However, when it came to Wakefield's deliberately hiding his conflict of interest, Horton suddenly turned on Wakefield. Throughout this part of his evidence Horton tried desperately to shore up the idea that Wakefield had kept secrets from him and the Lancet. In response to a question by Miss Smith as he was being led through his evidence, Horton said:
'To my knowledge in February 1998 and during the peer review process going back into 1997, I was completely unaware of any potential litigation surrounding the MMR vaccine. I was not aware of the involvement of a firm of solicitors Dawbarns ... I was not aware of any other relationship between Dr Wakefield and Dawbarns and Richard Barr. When I read those statements I saw this as something that was triggered by the paper ...' (26)
'To my knowledge in February 1998 and during the peer review process going back into 1997, I was completely unaware of any potential litigation surrounding the MMR vaccine.' (27)
'I was not aware of the involvement of a firm of solicitors Dawbarns.' (ibid)
'I was not aware of any other relationship between Dr Wakefield and Dawbarns and Richard Barr.' (28)
Horton told the Panel that he understood Wakefield’s agreement with the legal aid board to carry out a study on a small number of children happened after the publication of the Lancet paper. Although this statement is a 'cover-up' which plays a significant part in Horton's story that he had no knowledge of Wakefield's involvement in Legal Aid Board funding of research for Dawbarns, prior to publication of the Lancet paper, it actually reflects the truth. It is directly contrary to the prosecution case that the Lancet paper was the report of an illicit study carried out with Legal Aid Board funding that attempted to prove that MMR caused autism.
Horton, in fact, dug a very deep hole, jumped in it and then proceeded to bury himself; he could only do this. If the case review paper was in fact a case review paper and its science was sound, then not only did the majority of the fraudulent prosecution case collapse but Horton must as well be arguing for the defence that the Legal Aid Board funded research which had not yet been carried out and there was therefore no conflict of interest. This was in fact the case and had this line of Horton's been pursued by counsel for the defence it would have done the prosecution immense damage. However, no one probed Horton's self-serving inconsistency, nor did the defence seek to seriously undermine his assertions that he had no knowledge of Wakefield's involvement with either Dawbarns, Richard Barr or the Legal Aid Board, prior to the publication of the Lancet paper.
Defence council did spend a considerable time cross-examining Horton about the lack of declaration of ‘conflict of interest’ issue. At the end of a long session, the worst that Horton appeared willing to sensibly adduce was that Dr Wakefield was genuinely surprised that there was the need for him to reveal funding from the Legal Aid Board.
Horton seemed happy to say that Dr Wakefield had been honest by his own lights and he had not declared any conflict of interest because he genuinely believed - and believes still - that there was no conflict to be declared. While Horton personally disagreed with Dr Wakefield’s interpretation of this, as did Professor Simon Murch and Professor Walker-Smith, he acknowledged clearly that it could be seen as a matter of opinion and not a reflection on Dr Wakefield’s honesty. But then, Horton knew that if Wakefield was found 'guilty' of hiding a conflict of interest, he would be adjudged dishonest. For such a polite boy from the academic 'hood'. Horton remained as solid as it appeared possible, on the matter of conflict of interest.
* * *
During the life of the GMC hearing, after Horton had given his evidence, on February 29th 2008, Carmel Wakefield, unpacking overflowing filing cabinets transported from London to Texas where the Wakefields had settled, found a series of documents which told the full story of the state of Horton's knowledge of Wakefield's role in the civil action and his involvement with the Legal Aid Board a year before the publication of the Lancet paper.
At the time Wakefield submitted the final draft of his paper to the Lancet, Richard Horton and Richard Barr, the lawyer from Dawbarns, the company handling the parents civil action, were embroiled in an argument. In March, the Lancet had received a letter from a Dr B.D. Edwards; the letter brought to Horton's attention the fact that text and tables from various Lancet papers were being reproduced in a Dawbarns Fact Sheet, sent to parents (29). Sarah Quick of the Lancet noted Edwards' letter in a memo to Horton marked “urgent” on 19th March 1997.
B.D. Edwards was actually a member of the Medicines Control Agency (MCA) (later to become the MHRA), the agency responsible for the licensing and safety of drugs in the UK. Clearly the copyright of Lancet published material did not come within the remit of the MCA and Edwards had written his letter on personal notepaper. We should perhaps understand that with a major civil action in the pipeline, pharmaceutical interests would already be operating a harassment and an intelligence gathering strategy against the lawyers and defendants involved.
Barr wrote to Horton explaining Dawbarns’ position in a faxed transmission of 3rd April 1997. In the coversheet of this fax Barr wrote that the 'Fact Sheet and other originals' had been sent by post. As far as Horton's knowledge about the civil action, Wakefield's involvement in it, and the granting to Dawbarns of Legal Aid for the action, Barr's letter contained much information. The letter makes it clear that Barr was involved in litigation related to possible damage to children following MMR and MR vaccinations. Barr refers to exchanges he had had with Wakefield and the latter’s permission for Barr to quote, in the Fact Sheet, from papers authored by him. Barr refers to pressure from the MCA and the Department of Health to him from quoting from the Lancet in the Fact Sheet.5
Oddly, Horton responded to Barr in April 1997 denying him permission to use material from the Lancet in the Fact Sheet. Oddly, because this was a clear act of obstruction by Horton; in this slight matter he was evidently siding with the pharmaceutical company defendants in the case that Barr was building. On 16th April 1997 Barr responded by seeking an appeal to the Lancet’s Ombudsman. Horton replied saying that he would be happy to refer the matter to the Lancet’s Ombudsman.
Although Barr wrote to Horton on 29th April 1997 asking to be put in touch with the Ombudsman, Horton didn't answer until 12th June 1997. Barr subsequently corresponded with the Lancet’s Ombudsman Professor Sherwood. Sherwood arbitrated in favour of Lancet tables being removed from the Fact Sheet but short quotes from the Lancet remaining.
This correspondence on these dates are proof of the fact that from March 1997 Horton was aware of the civil action being organised by Barr at Dawbarns, and that Dr Wakefield was involved. But of greater relevance than these things was the fact that Horton had then the case-review paper written by Wakefield and twelve other clinicians at the RFH and he must have known without any shadow of a doubt that this paper was not the result of a 'study' and that no legal aid funding, or any other kind of funding, except the personal time and the NHS salary and facilities of Dr Wakefield at the RFH had been needed to correlate the clinical presentation of the twelve children.
Very quickly after publication of the Lancet paper, the Lancet received a letter from a Dr Rouse. (30) The general tone of this was reminiscent yet again of a pharmaceutical company strategy to destabilise Wakefield's paper. The original letter to the Lancet from Rouse was entitled: 'Vaccine adverse events: litigation bias might exist.' In the letter Rouse provides direct quotes from what is described as a 48 page: 'Vaccine Fact Sheet' prepared by Dawbarns solicitors. Dr Rouse repeats from the fact sheet the information that Dawbarns are working with Dr Andrew Wakefield of the Royal Free Hospital who is investigating 'Inflammatory Bowel Disease', and that a sheet is available from Dawbarns offices, written by Dr Wakefield if anyone needs information about persistent stomach problems (including pains, constipation or diarrhoea) following vaccination.
Dr Wakefield replied to this letter in the Lancet of May 2nd 1998. Rouse's use of the novel term ‘litigation bias’ again drew attention to Wakefield's work in light of the way it was being viewed by the pharmaceutical companies. In fact, the use of this term was the subtle beginning of what was to develop into the 'conflict of interest' strand of the prosecution case. More importantly Rouse's letter and Wakefield's response to it makes it crystal clear that immediately after publication of the Lancet paper, the issue of conflict of interest was aired in the Lancet.
* * *
Word got around, and from the 29th of February 2008, it was clear to everyone involved in the case that at the end of the defence case, Horton would be recalled and roasted over hot coals. The new evidence once aired would destroy a major support for the prosecution case. In fact, it was unlikely that the prosecution would survive in the matter of conflict of interest, because Horton was their major witness on the matter. When the issue of Horton's recall was mooted, I felt we were finally about to see some deft legal footwork that would end or at least diminish the whole charade. I wrote the following in my report:
Suddenly on Friday 14th November 2008, when everything was almost all over and people were wondering where they had left their macs and umbrellas, one of the hearings small subterranean volcanoes erupted. I almost missed its beginning when it went from criticism to what passes at the GMC for a full-blown row in about 90 seconds.
I was first conscious of the fact that Miss Smith was in her usual sotto voce style - as if she didn't really want anyone else to know what she was saying - talking about Dr Horton being recalled to give rebuttal evidence.
Now Miss Smith was on her feet explaining in very sensitive and sympathetic terms why getting Dr Horton to Euston Road this century was a logistic feat similar to the one that faced Hannibal in 203BC during the second Punic War. In order to impress the Panel and assume the moral high ground, Miss Smith detailed Dr Horton's itinerary in the days after the hearing that was to resume on January 12 2009. Horton's diary included what Miss Smith seemed to think was a clincher. On one day, pride redolent in her voice, Dr Horton was in 'Palestine', 'launching a session in relation to health on the West Bank'. This was very laudable and it made me suddenly aware that the whole prosecution team must have always been constant supporters of the cause of the Palestinian people. I also wondered whether Dr Horton's visit to the West Bank had anything to do with his relationship with Mr Blair, who was then Middle East Envoy.
Anyway, it was quite apparent from Miss Smith's litany of Dr Horton's important political and humanitarian work, that fitting in to give evidence at the GMC hearing was not only small potatoes but indescribably difficult. Miss Smith attacked the problem as if all the parameters of it were settled and taken for granted; it was, undoubtedly the hearing that had to fit in with Dr Horton and not Dr Horton who could fit in with the hearing.
Miss Smith even had the length of Dr Horton's evidence decided and in one particular defence of him, she said something like: 'Well, Dr Horton's evidence will take about 50 minutes, he should be able to fit that in ...' To be honest, it might have seemed to the casual observer that Miss Smith wasn't trying very hard to get Dr Horton to the hearing. This idea was supported by a seemingly quite angry Kieran Coonan, who spluttered that it was obviously impossible for the defence to come to any conclusions about how long Horton's evidence would take because all they had so far produced - after having sight of the new evidence that utterly contradicted his first statement - was an unsigned statement i.e. a rough draft of what Horton might say but without the authority of his signature. 'We have', Mr Coonan said, 'been waiting since day 69 (it was then day 108) for a signed statement '. It occurred to me later that the last thing Horton would want to do was place a new signed statement in the public domain, especially when it became apparent that in the new statement, Horton was claiming total amnesia for everything, including the LAB funding, research at the RFH, the parents court case and Wakefield's role as an expert witness, prior to the publication of the 1998 paper..
Mr Coonan's evident dissatisfaction was as nothing compared with that of the Legal Assessor, who when asked to contribute to a solution about the timing of Horton's appearance said quite dryly, 'I haven't even seen the unsigned statement, so it
is hard for me to make any decisions'. On this, Miss Smith did one of her little turns that so endeared her to us, a little aside that carries with it great natural humour and drollery. Holding up the two pages of the statement for the Legal Assessor, sitting twenty feet away, to 'see' she said, 'This is Dr Horton's statement', before returning it to her table.
Alas the whole firework display spluttered out when it was decided that behind the scenes talks would resolve the matter of recalling Dr Horton. These talks must have concluded in either an agreement or a stale-mate because Horton never appeared to be cross examined on his new amended statement and the hoi polloi were never any the wiser about this important conflict of evidence.
* * *
During the writing of this essay, every time I have typed his name, I have almost typed 'Sir Richard Horton'. Whether this is because the Richard is close to the name of one of Horton's heroes, Sir Richard Doll, a supreme exponent of interest conflict, or whether it is because Horton's Herculean work on behalf of pharmaceutical medicine in the Wakefield case will inevitably gain him a knighthood, I'm not sure.
At a time when every other concerned health care academic in the country was trying to find a way of prizing apart the drug companies from doctors and medical journals, the prospective 'Sir' Richard Horton had gained his next toe-hold on the slippery pole. It was announced in February 2008 that he had been chosen to chair a working party set up by The Royal College of Physicians (RCP) and the drug industry in an attempt to create a better relationship between doctors and the drug companies.
In a letter inviting submissions Dr Horton and Ian Gilmore, president of the RCP, said: 'There are barriers perceived to exist between the industry, the NHS and academic medicine that inhibit a truly dynamic and productive relationship between the key players, working in the best interests of patients'. Perceived or real, perhaps Dr Horton might agree with the first and Dr Wakefield with the second.
Following the verdict of the GMC Fitness to Practice Panel in January 2010, Richard Horton claimed that the Lancet paper was completely compromised and rescinded it from the historical record. (31)
(1) Wakefield AJ, Murch SH, Anthony A, Linnell J, Casson DM, Malik M, et al. Ileal-lymphoid-nodular hyperplasia, non-specific colitis, and pervasive developmental disorder in children. Lancet 1998;351:637-41.
(2) The prosecution argument that confused 162/95, the research ethics committee approval granted to Professor Walker-Smith at his previous hospital and which he took with him to the Royal Free, was deliberately conflated by the prosecution to cover a non-existent research project which they said had resulted in the Lancet paper of 1998. This was a very important aspect of the case, however, it was sprung on the defence by the prosecution at the hearing and had no real provenance except in the speculative imagination of Brian Deer who did not give evidence to the GMC hearing
(3) There were 13 authors of the Lancet paper. None of them declared any interests and yet the prosecution, aiming to discipline Wakefield alone - despite trying him with two other defendants - never once brought this matter up.
(4) This edition of the American Journal of Industrial Medicine is a good introduction to conflict of interest in industry and environmental legal cases .Egilman David, Tweedale Geoffrey, McCulloch Jock, Kovarik William, Castleman Barry, Longo William, Levin Stephen, Bohme Susanna Rankin. P.W.J. Bartrip's attack on Irving J. Selikoff. Am J Ind Med. 2004 Aug;46(2):151–155.
The blog of Professor Michael Siegel, a physician who specialized in preventive medicine and public health in Boston, Massachusetts, gives a good break down of the does and don'ts of conflict of interest rules.
(7) Walker. M. J. Company Men Part Two: Sir Richard Doll: Death, Dioxin and PVC. 2005. http://www.medicalveritas.com/images/00208.pdf
(8) For a run down on the Academy of Medical Science, See Counterfeit Law Part II http://www.ageofautism.com/dr-andrew-wakefield/
(9) The first patients had to be put on hold because Walker-Smith was working out his time at Guys Hospital. A few cases had to wait for a longish period until Walker-Smith came on post.
(10) During the GMC hearing, Zuckerman maintained that the use of the word 'monovalent' used twice in a letter to Wakefield, was a typing error made by his inefficient secretary. It should, he claimed in evidence have read, 'polyvalent'.
(11) See Counterfeit Law Part II. http://www.ageofautism.com/dr-andrew-wakefield/
(12) Deer had already begun to suggest in this long article that the whooping cough vaccine damage cases that were brought into court by the expert witness were shown either not to be ill or ill from other causes. In 1998, Deer was evidently already rehearsing the arguments that the GMC prosecution would use against Dr Wakefield's 12 Lancet paper children.
(13) ibid, Counterfeit Law Part II. http://www.ageofautism.com/dr-andrew-wakefield/
(14) See postings at the BMJ and on Age of Autism by John Stone and others.
http://www.bmj.com/cgi/eletters/340/feb02_4/c644. Professor Trisha Greenhalgh
February 23, 2010 Trisha Greenhalgh's Competing Interests in Wakefield Case.
(15) In this last section of the essay I have drawn in part on the unpublished writing of Carmel Wakefield.
(16) See John Stone on AOA. March 03, 2010. Brian Deer Hired to "Find Something Big" on MMR
(17). The story of the Urabe strain mumps virus is a complicated story. MMR containing Urabe strain had been found to create serious adverse reactions in Canada, and withdrawn from the market even before it's introduction in Britain. See The Urabe Farrago by this author.
(18) Later Deer was to threaten Horton with a civil action on the grounds that he broke their agreement to keep confidential the information in Deer's Sunday Times story until after it's publication.
(19) Richard Horton, MMR: Science and Fiction, exploring the vaccine crisis. Granta Books. London. 2004.
(20) ibid. MMR: Science and Fiction
(21) ibid. MMR: Science and Fiction
(22) ibid. MMR: Science and Fiction
(23) ibid. MMR: Science and Fiction
(24) ibid. MMR: Science and Fiction
(25) The Sunday Times, February 22 2004.
(26) See Horton’s evidence, Day 17 GMC hearing
(27) ibid GMC Hearing
(28) ibid GMC Hearing
(29) This fact sheet was an edition dated 16th July 1997.
(30) Original letter from Dr Rouse to Lancet of 9th March 1998.
(31) Another Wakefield authored papers from a journal also owned by Elservier, Neurotoxicology was also rescinded.
Martin J Walker is an investigative writer who has written several books about aspects of the medical industrial complex. He started focusing on conflict of interest, intervention by pharmaceutical companies in government and patient groups in 1993. Over the last three years he has been a campaign writer for the parents of MMR vaccine damaged children covering every day of the now two year hearing of the General Medical Council that is trying Dr Wakefield and two other doctors. His GMC accounts can be found at www.cryshame.com, and his own website is, www.slingshotpublications.com.