for CryShame. www.cryshame.com
Dr Wakefield's defence was finished on Monday April 7. The day, however, became a day of reckoning. Kieran Coonan had come right up to the GMC fitness to practice hearing with his route map and parked the car in front of professor Zuckerman's address before driving up to honk his horn outside Richard Horton's vacated and collapsing premises.
The public gallery and the press room were full. The ending of the Wakefield defence and the evidence of rebuttal presented by Wakefield against the prosecution's two most vulnerable witnesses, evidently worried the prosecution, and the mid morning break saw Dear Brian giving media colleagues a lecture on the real case, which only he knows. A crowded press room heard the story that I have overheard twice now about the rumour mill. According to Brian, the whole case is a fantasy dreamed up by parents desperate to find a cause for their children's autism and led by a charismatic but remorseless quack concerned only with image and reputation.
Brian, however, faced real opposition after his short lecture, in the person of Jane Bryant of the One Click Campaign. Used to dealing with the heavyweights of the ME underworld, Jane didn't blanch before Dear, harrying him with constant questioning about who paid him and who he was working for. He was, he said only a journalist doing his job, researching Dr Wakefield and his colleagues at the Royal Free Hospital, he didn't know anything about autism or the causes of autism, he had just been investigating Wakefield. However, people like ‘the dribbling idiot' - I noticed that his colleagues looked bemused as he gestured towards me - have said that there is a definite link between MMR and autism without any proof. Of course I have never said any such thing and Brian had to be saved from Jane Bryant by the GMC Press officer.
Inside the hearing where charges and evidence really matter, Wakefield was able, for the first time, to give his rebuttal evidence against Professor Zuckerman and Dr Richard Horton. It had always been clear that Zuckerman was protecting his back when he gave evidence and Dr Wakefield was able to present evidence that showed not only that Professor Zuckerman had arranged the press briefing for the Lancet paper about which he so bitterly complained, but that he also supported Wakefield in his position that the government should revert to monovalent, that is single vaccines, until research at the Royal Free was concluded.
Kieran Coonan introduced a part of a DVD made by the University during the press briefing; the sound was so bad that only a practiced lip-reader could gain anything from it. (I have to say that this was actually indicative of a downhill pattern in relation to sound in the hearing. I am slightly sceptical about a public hearing that the public cannot hear because the participants speak in an exactly opposite direction to their microphones). Fortunately the panel were provided with a partial transcript of the press briefing. Watching the reportage, we saw Dr Wakefield suggesting in the most reasonable manner that to avoid a possible continuing public health crisis, it might be better to return to the single vaccines for a period. Professor Zuckerman seemed to support this position.
The defence introduced a series of letters which showed that though the whole team at the Royal Free were not completely in agreement over the role of MMR, or any public discussion over it, there was at least knowledge of the fact that Dr Wakefield would pursue his position on the single vaccines at the press briefing and on this matter he had the solid support, at least of Professor Roy Pounder his line manager.
What one could hear from Professor Pounder's contribution to the press briefing was particularly moving because he spoke from a principled position, laying considerable emphasis on the fact that whatever happened on a macro level, adverse reactions were of enormous consequence to individual children and their parents. Pounder had written to the DoH telling them of the course the press briefing would take and suggesting that they should be well stocked with single vaccines in case their press briefing and the publication of their paper turned parents towards single vaccines.
It was clear from the evidence presented in the lead up to the press briefing and the briefing itself, that Dr Wakefield had voiced major concerns about the safety and testing record of MMR. This is not something that has come out during the GMC hearing, so far, perhaps because the defence didn't want to put to much weight on it.
Dr Horton's Grave Error
Mr Coonan had actually started the morning with Dr Richard Horton filling in the gaps in the evidential picture in the period prior to the publication of the Lancet paper.
It had been clear from Dr Richard Horton's evidence for the prosecution earlier in the hearing that he wanted to appear to be pleasing everyone. He was flirtatious with Miss Smith - and she with him - while at the same time finding it hard to agree with her. And when it came to the defence, Horton did everything but roll on his back and offer his tummy for tickling while giving evidence to exonerate Dr Wakefield.
There was, however, one point upon which Dr Horton did not behave distractedly; a point on to which he hung despite a stormy cross examination from Mr Coonan at his most amiable. This was the matter of Dr Wakefield's conflict of interest; whether the fact that Dr Wakefield's receipt of £55,000 from the legal aid board should have been declared in his 12 child case review paper published in the Lancet .
On this matter, although his position was whittled down by Coonan, Horton remained as solid as it appeared possible for such a polite boy from the academic ‘hood. Despite everything that was thrown at him, relating to the date of the publication and the relative moral and ethical value of conflict of interest declarations at that or any other time, Horton stood firm.
Whether or not this was because he had previously declared that he never would have published Wakefield's paper had he known about his receipt of money from the Legal Aid Board, or whether having voiced his disagreement with the majority of Brian Deer's criticisms of Wakefield's paper, this was the only sticking point that remained with him, we do not know. On this issue, however, he was dogged. Mr Coonan found it easy enough to nudge him off balance on the very edges of the matter, such as the ‘early' date of the paper and the matter of whether expert witnesses had to make declarations in their academic work at that time, but on the core of the matter, the conflict of interests represented by Wakefield's apparent receipt of the legal aid money, Horton was cement.
For those of you who are unfamiliar with the process of a GMC fitness-to-practice hearing, they are to all intents and purposes like a hearing in any British law court. They assume almost the same shape even if acted out within a different, less oppressive architecture and thank god, without all the theatrical costumery. Each witness is sworn in, either stating a religious conformity or making a civil declaration. The importance of this is obvious and the same rules relating to perjury – the making of a false oath - apply as do in the court of law.
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Dr Andrew Wakefield first began negotiating the publication of ‘the Lancet' paper that was to appear in early 1998, in June 1997. At this time he sent two papers in to the Lancet, one entirely on the science of any link between measles virus and Inflammatory Bowel Disease (IBD) and the other a more narrative review of twelve cases referred to the Royal Free Hospital in sequence. The science paper was not published because 2 out of 3 peer reviewers turned it down.
Wakefield knew about the Lancet's rules governing conflict of interests, in October 1997, however, he received a new ‘guidelines' document from Richard Horton the Lancet's editor. The test governing conflict of interests was stated very simply and involved disclosing anything that might cause embarrassment if it became public at a later date.
There were two issues that might have appeared superficially to provoke embarrassment, if they were not declared in the published ‘Lancet paper'. These were, so it was said, the fact that Dr Wakefield had received £55,000 from the Legal Aid Board in order to undertake research that might result in proving the biological link between IBDBowel, regressive autism and the MMR vaccine. Second that Dr Wakefield had agreed to be an expert witness in legal claims by parents against manufacturers of the MMR vaccine.
In relation to the £55,000, the prosecution had always maintained, wrongly, that this money was paid directly to Dr Wakefield so that he might carry out research. In fact, the £55,000 was paid in two parts, to another research worker at the Royal Free Hospital. The money was banked with and dispensed by, the Special Trustees of the Hospital and was never actually touched by Dr Wakefield.
There was a study planned for the instructing solicitor of parents claiming on behalf of their vaccine damaged children, for which Dr Wakefield and his team would have been funded by the Legal Aid Board. However, at the time of the ‘Lancet paper', this study was not underway. Because the prosecution failed to properly research the different projects that were being planned or carried out, their evidence wandered round in the dark for a good percentage of their case.
With respect to Dr Wakefield declaring his putative appearance as an expert witness at some future date; it was actually never to happen. There has been a great deal of divisive debate about this matter in science circles although unfortunately those who have approached the subject appear to have little knowledge of the law.
There is a legal rubric that I have always liked although it has evident faults, ‘There is' it goes, ‘no property in witnesses'. The rubric is most true in relation to ‘expert' witnesses, for such witnesses are guided by their knowledge, their science and their intellect and are answerable to the court and not to the solicitors who present them. Although it is easy to spot a committed ‘professional' witness whether they appear for the defence or the prosecution, most experts have to prove their science before the jury and the opposing council just as they have to proved it in peer reviewed journals.
Appearing as an expert witness in a case is not something which should have to be declared. However, it would always be most correct to declare any appearance as an expert if one had received money directly from either the defendants or the prosecution at any time. In the past the Legal Aid Board has not represented private interests and it bankrolled research of many different kinds on behalf of both defence and prosecution - for private investigators, all kinds of forensic experts, psychiatrists, crash reconstruction experts and weapons experts as well as many other ‘experts'.
Finally, we have to see the accusation that there was no disclosure of either of these factors, in the light of two other factors; the time in which the paper was written and published and the approach of the journal's editor. Clearly, journal editors should play a considerable part in policing and regulating their own journals and thereby adequately forewarning contributors of their house style.
A notable case that arose relatively recently, illustrating a number of these points is that of the late Sir Richard Doll . In 1988, Doll published an important paper on Vinyl Chloride and brain cancer in production workers. His path to the completion of this paper was dogged by vested interests. The paper had been suggested to him by Brian Bennett, the Medical Advisor to ICI UK, the major British producer of vinyl chloride. Bennett had originally sought the advice of the US Chemical Manufacturers Association about whether or not Doll should be involved. When they agreed on his involvement, they provided Doll, not only with payment for the research but also all the industry data upon which to base his research. The paper produced by Doll concluded, in line with industry thinking that there was no relationship between vinyl chloride production and brain cancer amongst workers. Bennett had advised Doll on the journal that would publish the paper, the Scandinavian Journal of Work, Environment and Health, before Doll submitted the paper, he wrote to Bennett asking if he should disclose payment from the major vinyl chloride companies for research funding. Bennett wrote back to him saying that this was unnecessary. Doll's lucrative involvement with the Chemical Manufacturers Association and its major member Monsanto, remained a secret until 2003. (Walker, Martin J. Sir Richard Doll: Death, Dioxin and PVC. 2003. http://www.whale.to/v/walker_doll.html )
When this story emerged two years later on the front page of the Guardian, those who supported Doll, continued to defend him absolutely. In this case of course, 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 very industry that he had researched. Nevertheless Doll's paper on vinyl chloride is still today used by industry as the standard assessment of any link between the production of vinyl chloride and brain cancer.
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When Richard Horton appeared before the GMC hearing in 2007 to give evidence, the defence relied upon his answers in cross examination to put together a picture of when he first knew of Dr Wakefield's involvement with Richard Barr of Dawbarns the lawyer who handled the case for the MMR claimants. Since Horton's cross examination, however, papers have come to light which identify more exactly the time Horton first knew of Dr Wakefield's involvement with Dawbarnes and the Legal Aid Board. This new information castes doubt on the veracity of Richard Horton's evidence to the GMC.
In 1995 Dawbarns solicitors were appointed by the Legal Aid Board to manage the claims arising from immunisation with the MMR combined live vaccine. As part of their efforts to learn and inform their clients about the vaccine, Dawbarns through Richard Barr and Kirsten Limb prepared a factsheet about the vaccine which they distributed primarily to their clients. Over time this factsheet grew in size as more information and research came to light.
Whilst it was intended primarily for clients, requests for copies came from medical practitioners, from the pharmaceutical industry and even from the government departments charged with looking at vaccine safety. The factsheet attempted to present the situation fairly, but it was not uncritical of the lack of information and what appeared to be misinformation provided by the government in vaccine issues.
In the first quarter of 1997 a Dr B.D. Edwards, a member of the Medicines Control Agency (MCA) wrote to Dr Richard Horton, bringing to his attention the fact that text and tables from various Lancet papers were being reproduced in the Dawbarns Fact Sheet. Consequently Ms Limb received a phone call from Sarah Quick of the Lancet on 19 th March 1997. In that telephone conversation Miss Quick said that Dawbarns should apply for retrospective permission to reproduce the Lancet material. She indicated that there should be no problem about granting permission.
Richard Barr wrote to the Lancet explaining Dawbarns' position in a letter on 3 rd April 1997 . The letter makes it clear that Barr worked for Dawbarns solicitors and that he was involved in litigation related to potential damage to children following exposure to MMR and MR vaccines. In the letter, Barr references Wakefield's work on MMR and autism and draws Horton's attention to this work. Barr took Horton directly to the text that describes his working relationship with Dawbarns.
Also in this letter Barr refers specifically to exchanges he had with Wakefield and the latter's granting of permission to Barr to quote, in his Fact Sheet, papers published previously by Wakefield in the Lancet.
When Horton responded to Barr denying him permission to use material from the Lancet in the Fact Sheet, Barr sought the intercession of the Lancet's Ombudsman . Correspondence then ensued between Barr and Horton and Barr and the Lancet about Barr's access to the Lancet ombudsman. Eventually the Lancet Ombudsman ruled that given the not-for-profit nature of the Dawbarns newsletter publication the tables and other references in the Factsheet could remain.
This relatively protracted exchange between Horton and Dawbarns that included reference to Dr Wakefield and a number of statements about Wakefield's interests in the legal cases, ended while the Lancet paper was being discussed and sent out to peer reviewers. It would appear highly unlikely that being involved in a contentious exchange with Richard Barr and Dawbarns, Horton could possibly have forgotten that Dr Wakefield was involved with the solicitors pursuing research on MMR and autism.
In March 1998 a month after the publication of the Lancet paper, the Lancet published a letter from a Mr Rouse, the letter suggested that the ‘Lancet paper' might have introduced ‘litigation bias'. Rouse made a couple of completely wrong statements in his letter to the Lancet and it was clear that the major point of it was to open the attack on Dr Wakefield that hinted at all kinds of secret associations with lawyers and campaigning organisations.
Wakefield answered this letter from Mr Rouse and made clear his interests in the legal cases. So, even if Horton and others claim not to have known of any apparent conflict of interests prior to the Lancet paper's publication, it was stated within a month of this publication.
The reason why no one had thought to bring up the matter of conflict of interest at the time of the paper, was that everyone involved knew about Dr Wakefield's contact with the Legal Aid Board. The first public disclosure of his acting as an expert witness had occurred in November 1996 and it was known at that time by all the senior staff of the university.
The major critics of the Lancet paper did not make a developed view of their criticism of the paper known until some six years after its publication when Brian Deer attacked Dr Wakefield in the Sunday Times in 2004. Following Deer's Sunday Times report, Horton publicized a tectonic shift in his opinion of Dr Wakefield, the Lancet paper and conflict of interest. After apparently, superficially at least, defending the paper for six years, Horton claimed to now regret publishing it, suggesting that it was ‘fatally flawed', in February 2004 Horton told the BBC:
In my view, if we had known the conflict of interest Dr Wakefield had in this work I think that would have strongly affected the peer reviewers about the credibility of this work and in my judgment it would have been rejected.
From this time also, Horton was to claim that a much more complex rule was actually in force with respect to conflict of interest declarations in any published papers in the Lancet . The position was not now one in which embarrassment might occur, but where readers might have the ‘perception' that there were undeclared conflicts of interest. This of course was a whole new ball-game and Dr Wakefield found it almost impossible to argue this oddly existential idea; how could one gauge anothers perception.
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When Dr Horton attended the GMC fitness-to-practice hearing in 2007. He came to it as an independent witness whose conscience had been troubled by what appeared to be a grave ethical blunder on the part of Dr Wakefield who had failed to disclose serious conflict of interests.
However, Horton appears to have been playing a very deep game, for it transpired that not only had he known about Dr Wakefield's interests in the legal cases a year before the publication of the Lancet paper, but perhaps more worryingly, although he appeared to find in favour of Wakefield when he ‘investigated' Deer's Sunday Times accusations, he seems to have been more or less happy to discuss Wakefield's downfall behind the scenes. In his book, MMR Science and Fiction , he reveals how in 2004 he was asked to help a confused GMC in the prosecution of Wakefield .
The GMC seemed nonplussed by the Health Secretary's urging the GMC to investigate Wakefield as a matter of urgency. In truth they had not a clue where to begin. At a dinner I attended on 23 February 2004, one medical regulator and I discussed the Wakefield case. He seemed unsure of how the Council could play a useful part in resolving any confusion. As we talked over coffee while the other dinner guests were departing, he scribbled down some possible lines of investigation and passed me his card, suggesting that I contact him directly if anything else came to mind. He seemed keen to pursue Wakefield, especially given ministerial interest. Here was professionally led regulation of doctors in action - notes exchanged over liqueurs in a beautifully wood-panelled room of one of medicine's most venerable institutions."
‘New evidence', discovered recently in filing cabinets ‘lost' when the Wakefield's moved to North America, which form the basis for the account above about Horton's early knowledge of Wakefield's involvement with Dawbarns and the legal cases, throws quite a different light on Horton's testimony at the GMC hearing in 2007. Leading Horton through his evidence in chief, Ms Smith put it to him:
‘Looking at the wording of the sentence you referred to “only one author has agreed to evaluate a small number of these children on behalf of the legal aid board” you say you took that to mean since publication of the paper and we are now some three or four months on from publication of the paper'.
Horton answers ‘Yes'.
Horton confirmed to the Panel that he believed Wakefield's agreement with Richard Barr, to evaluate a small number of these children happened after the publication of the Lancet.
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 rather than the paper being in some senses a culmination of events up to February 1998.
Can Horton simply have forgotten the discussion and exchange of letters that had occurred in 1997? He does in fact go to extreme lengths to deny any knowledge that he knew Wakefield was involved with the solicitors for the complainants in the vaccine damage case. While he was being led through his evidence in chief by Miss Smith he made a number of bald statements which are hard to reconcile with our knowledge now of what happened prior to the publication of the Lancet paper.
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.”
Brining these matters up on this last day of the defence case, one could see clearly that the defence believed that the evidence of Dr Richard Horton before the GMC panel, left something to be desired. The truth, maybe?
While this bombshell evidence could well be front page news in any major criminal or civil trial, in a fitness-to-practice case organised by the Government against an important British research doctor, the ‘news' is not ‘news' but some kind of esoteric information, too complex for journalists to reconstruct for the public consumption. What could easily be expressed in any other circumstance as ‘Defence questions the memory of Journal editor's evidence in vaccine case' is passed over as some baroque curlicue in a lengthy conundrum of a case.
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Dr Wakefield's defence case and Kieran Coonan's route map, ended with a brief glance at the prosecution charge that Dr Wakefield brought medicine and the medical profession into disrepute by telling a funny story about blood being taken from children at a birthday party. This particular charge doesn't really bear commenting upon in an age when pharmaceutical company executives are not brought personally to account for the thousands of deaths caused by their products. Bringing medicine into disrepute – I should coco.