Counterfeit Law: And They Think They Have Got Away With It
By Martin Walker
Denying the experience of Parents
The Place of Sir Michael Rutter in Industrial Science
Rutter's evidence against Dr Andrew Wakefield
The Deconstruction of Professor Rutter
Part Three: Houdini Horton
February 21, 2010
Part of me isn't surprised by this apparent new development (the resignation of Dr Wakefield from Thoughtful House). The simple math of Thoughtful House's board suggests that there will be at least one or two people of caliber and integrity, who know that all the cranksite stuff about a witch-hunt, sinister forces and all that shit, are just that: shit. Wakefield has been nailed, absolutely fairly, properly, but belatedly, with no hidden agendas or vested interests. Apart, that is, from the public interest.
Brian Deer February 18, posted on Respectful Insolence
Occasionally I look at how my reputation is faring on the internet. There, amongst pages about my writing and campaigning over the last thirty years, is Brian Deer's character assassination of me, Liar for Hire, (1) whenever I see this, I spend a few moments checking reality. I go back to the beginning and remind myself that it began with the parents: ordinary, able, loving and honest individuals whose lives and children were suddenly plunged into the maelstrom of inflammatory bowel disease, regressive autism and other forms of vaccine damage.
Despite the fact that many of these parents knew that their children's illnesses began following the MMR vaccination, in Britain some of the best healed professional people, as well as some of the seediest like Brian Deer, have closed ranks on them, denied vaccine damage and tried to erase both parents and children from the organic life of British society.
Worse still, some of these people, such as the GMC prosecuting counsel, have accused the parents sotto voce of a sly plot, a vendetta to enrich themselves by suing vaccine manufacturing pharmaceutical companies, either that or diagnosed in them a kind of Munchausen's syndrome by proxy, as a result of which they forced their children upon Dr Wakefield. In the midst of this moral crime wave, amongst academics, regulators and medical profiteers, amongst media, science and political personalities, Dr Wakefield emerged as a kind of hero; a lone voice that put his faith in science and scientific method, a good doctor whose reputation was dragged through the fake mud of a Hollywood film set.
The battle over the moral character of Dr Andrew Wakefield has for the moment become a stumbling block on the road to recovery and treatment of the children adversely affected by vaccines. Inevitably the most difficult of decisions is now presented to parents: do they cold shoulder the advancing political reality and draw in their wings around the nest to protect their children or do they immerse themselves in politics and put the diagnosis and treatment of their damaged children on hold? - Perhaps there is a way to do both things simultaneously.
I would contend from my relatively privileged position, that the first strategy will walk us all into the snows of oblivion like blind beggars in a Bruegel’s painting. The second strategy will set us on a path of energetic confrontation with our enemies, but every marginal victory will help the children. There is no doubt in my mind which battle needs to be won in order for us to reach back and tighten our grip on the hands of the damaged children. Now more than ever we have to win the political battle in the public arena.
* * *
My last two posts have been about corrupt detail of the GMC hearing; I have written them as part of my reality check. In times when even the strongest and most committed feel weakness like a nausea, travelling back can reassure us of the manipulation that has taken place. As a writer, of course, I am used to the details of my work getting lost in the slipstream of a struggle. As days go by, things that are important in context get jammed on the towpath and we find it difficult to keep the overall picture in view.
At the end of August 2008, I wrote an essay, (2) In the Interests of Conflict. In it I tried to bring-up the issues of conflict of interest to the heart of the GMC hearing and lay it at the feet of the Panel Chairman Dr Surendra Kumar. I consider conflict of interest massively important, because this is the hidden mechanism by which corporate science manipulates reality. This is the secret armoury of funding and public relations that hides in the bunkers beneath an apparently level playing field.
The whole battle against Dr Wakefield and the parents has been shot through with conflict of interest, some of which might be refuted, some of which might be made to appear trivial and some of which might be dismissed as coincidental. I believe, however, that my essay about the Panel Chairman, like some of John Stone's investigative work, raised irrefutable issues that should have brought the GMC hearing to a juddering halt.
* * *
In the late nineteen eighties, at roughly the same time that the MMR vaccine was introduced by the British government, Dr Andrew Wakefield took up a post at the Royal Free Hospital. He was a well-respected gastroenterologist charged with the task of heading a new department of experimental gastroenterology. One of the areas he was to research was the increase in Crohn's disease amongst young people. Wakefield, who had travelled from Canada where he had been researching bowel transplantation, would win awards for his work on the aetiology of Crohn's disease.
In 1992, the British government backhandedly admitted that two of the three types of MMRs they had introduced in the late 1980s had been dropped following serious adverse reactions created by the Urabe strain of mumps virus used. Thousands of children, principally in Canada, Japan and Britain, were made ill by this vaccine. However, in Japan and Canada parents of vaccine damaged children were quickly compensated. In Britain, a morally bankrupt Department of Health sided with the pharmaceutical industry to claim that the adverse reactions suffered by these children were so slight as to be of no consequences. (3)
By 1993, parents seeking help with one aspect of MMR's adverse reactions, a novel new condition of Inflammatory Bowel Disease (IBD) followed by regressive autism, began to attend the Royal Free Hospital. As these children began presenting there, Dr Wakefield contacted the DH to inform the head of vaccine and immunology Dr David Salisbury that he considered MMR could be creating a public health crisis and asked for a meeting. It took Salisbury almost six years to arrange such a meeting.
In 1992, the parents of MMR vaccine damaged children began preparing a legal
claim against three pharmaceutical companies. By the end of the 1990s the number
of parent claimants attached to this lawsuit had grown to around 2,500 and Dr
Wakefield had been assigned by the claimants' lawyers to give expert evidence
for the parents. In 1998 the Lancet published the case review paper and
later that year Deer wrote the first of a series of articles character
assassinating previous expert witnesses who had appeared for vaccine damaged
claimants and casting doubt upon other cases of vaccine damage claimants.
In 2004 after a decade of organisation and legal finessing, , the first batch of claimants cases, were due to come before the High Court. However, in a move to support the pharmaceutical companies and deny thousands of parents their rights under civil law, legal aid was withdrawn from all the cases. Under a post-industrial New Labour government, a century of civil law enabling citizens to sue powerful interests was snatched from the people.
2004 was the fulcrum year, the year when the legitimate legal claims of citizens against three pharmaceutical companies were turned on their head and a zealous, immoral and criminal campaign was begun by the government and the pharmaceutical companies to wipe out all reports of vaccine damage and anyone who might stand as an expert on this issue. Only months after Deer's Sunday Times attack on Dr Wakefield, Dr Richard Horton whose line manager at Elsevier the Lancet's publisher was Sir Crispin Davis also a board member of GlaxoSmith Kline, published a pulp fiction paperback which lauded the absolute safety of MMR.
* * *
Immediately after Brian Deer's 2004 article in the Sunday Times and following the instructions of John Reid, the then Secretary of State for Health, Deer submitted his papers as a complaint against Dr Wakefield to the General Medical Council. The journey of Deer's speculative and shoddily researched article to the GMC prosecution is crammed with abuses of the legal process, I detail some of them below before I discuss what I believe to be the most important issue of conflict of interest.
Since 1988, there have been two ways in which cases arrive at a Fitness to Practice Hearing at the GMC. There is the official route, by which a complaint made by a patient or relative can be filtered by readers and preliminary hearings to arrive in front of a panel, and there is the unofficial route by which cases promoted by the Association of British Pharmaceutical Industries (ABPI) arrive. This second path, made available by the GMC to Big Pharma, gives control to the industry over cases involving doctors who might be carrying out research for the industry which results in unethical behaviour, or damage to trial subjects or patients, or finally those cases of doctors who might have embarked upon research or treatments which threatens the competitiveness of pharmaceutical products. These cases are researched, investigated and then legally formulated in conjunction with GMC lawyers by a private detective agency solely funded by the pharmaceutical industry named Medico-Legal Investigations (MLI). While cases prepared internally by the GMC have resulted in mixed findings over the last two decades, cases prepared by the pharmaceutical industry usually result in guilty verdicts.
Neither the GMC nor its hearings make statements about the origins of cases that are brought against doctors, unless of course this is evident from the presentation of the complainant in the hearing. In the Wakefield, Murch and Walker-Smith hearing, the GMC consistently denied that Brian Deer was the complainant in the case and claimed spuriously that the case against the doctors had been brought by the GMC itself. As the defence lawyers approached the case as if it were any 'normal' case, the hearing never approached the issue of who had investigated and assembled the information of the case. However, we know from a number of sources that in investigating his case against Dr Wakefield, Brian Deer was helped by MLI. In the past MLI have used complainant journalists to progress cases into the GMC.
GMC Fitness to Practice Hearings, are constructed to all intents and purposes, like criminal or civil trials that take place in jury trials. To some extent this sets them aside from the usual extra-legal tribunals, such as those that deal with issues like unfair dismissal. It is, however, the way in which the hearings differ from a proper trial that must concern us; these differences are startling. The first and perhaps most seminal difference is that while the judiciary in Britain is separated from the political executive, the GMC acting as the prosecuting authority pays for the employment of all parties, other than the defence, including the jury (Panel), in any hearing.
In a real criminal trial, which the Wakefield hearing tried to emulate, all the investigation prior to charges being brought are carried out by the police. Over time such investigations have become trammelled by rules and regulations, such as the judges rules in Britain and the Miranda ruling in the US.
It is interesting that although the GMC lawyers gathered a series of unproductive and dubious prosecution statements from a whole variety of people, they depended quite heavily for their information of the three defendants, not just upon their evidence but on written statements obtained under threat by Brian Deer and Dr Richard Horton. None of the defendants had access to lawyers when they were pressured into making these statements. All three doctors answered questions put to them by Deer, under the threat that the Sunday Times was about to break a story that would ruin them, with a sincere desire to help put together a complete story of the work that had been done at the RFH. None of the doctors knew that what they said would be used against them in a legal hearing.
When it comes to the structure of the court, this tries to mimic a real court. There are defence counsel and prosecutors, there are defendants and a 'jury' called a Panel, there is a Legal Assessor to the Panel who tacitly takes the place of a judge in advising them. The difference between a real judge and the Legal Assessor is that one of the real judge's most skilful tasks is to advise the jury in public session on what weight should be placed on the evidence. In the GMC hearing the Legal Assessor had no such role; God knows how the Panel understood or contextualised the evidence they heard over two and a half years. It is clear by the ultimately shambolic verdict that the Panel failed or refused to grasp the most basically transparent defence evidence, upon which nearly all the verdicts rested, that 'the Lancet paper' was only a case review report and not a 'study' or 'trial' of any kind. Such defence evidence had to be agreed by the Panel because they had to allow the defence the benefit of the doubt on any unproven allegations.
In the proper court, not only are the jurors chosen from the population at random, but the counsel for either side are allowed peremptory challenges, to ascertain any kind of bias in the jurors that might apply specifically in relation to the case being heard. In Britain, this right to peremptory challenge has been completely eroded over the last decades, ending with the 1988 Criminal Justice Act. However, in an important case, involving for instance a police officer charged with causing a death, the judge will usually warn the jury of conflict of interest and ask anyone who has been a police officer or who had a relative who was a police officer or anyone who worked in a civilian capacity within a police station to declare this. Having concluded these tests, the jury themselves chose their foreman or woman in camera and this person helps the other jurors negotiate their verdicts and offers them to the court.
In the case of a GMC prosecution, the Panel consists of professional jurors paid per day by the GMC, the prosecuting authority. Any conflict of interest they might have had were reflected only in cursory notes about their roles outside the GMC, displayed on the GMC web site. In relation to the specific case, none of the Panel were asked about whether they agreed with mass vaccination, whether or not they or any of their relations had autistic children or for that matter what their employment was prior to offering themselves as Panel members. There was no elected foreperson of the jury because the GMC imposes a Panel Chair. Again, details of the Chair's interests are noted on the GMC's web site, with no particular sharpness or alacrity. The Panel Chairman and any other Panel members might take the advantage of making a declaration at any time during the hearing.
In the Wakefield, Murch, Walker-Smith hearing, the GMC first chose a Professor Dennis McDevitt as Panel Chairman, however, campaigners forced the GMC to make McDevitt stand down when they made public the fact that in 1988, McDevitt had been a member of the very JCVI committee that had agree the safety of Pluserix MMR, manufactured by Smith Kline & French (now GlaxoSmithKline). In fact, following serious adverse reactions, this vaccine was belatedly withdrawn in 1992. A number of the children who suffered adverse reactions to Pluserix were claimants in the court case for which Dr Wakefield had been asked to give expert witness evidence. Nor only this, but McDevitt had received research funding from both Glaxo and Smith Kline French before both companies joined to become GlaxoSmithKline the MMR vaccine manufacturers. Even the GMC was unable to get away with such a high level of duplicity and conflict of interest.
The question that preoccupied me during the first three months of the GMC Fitness to Practice Hearing was this: if the GMC had gone to these lengths to shoo-in the first clearly biased Chair of the Panel, having been found out, were they likely to just give up and enter a second 'clean' candidate for Panel Chair? I had serious doubts, so I began researching an essay to see if superficially Dr Kumar had any vested interests.
It should be understood that the Panel Chair in GMC hearings is the most influential member of the jury, the person most in need of neutral and independent thinking, a person, like all other jury members, who has to be free from any taint of bias or preconception about the guilt or innocence of the defendants. It goes without saying that the GMC, the prosecuting agency in this case, was duty bound to summon all its resources in testing all panel members in this hearing in great detail in order to discover and make public any possible conflicts of interests.
* * *
Anyone who took the trouble to go to the GMC web site and look at the declarations of possible panel members, could have ascertained that Dr Kumar was connected to the following organisations:
Principal General Practitioner. President, British International Doctors Association (formerly ODA). Interests: Medical Defense matters & Medico-politics. Member: General Practitioner's Committee (BMA), UK National Screening Committee (Dept of Health). Fellow: Royal College of GPs (FRCGP). Fellow BMA. Member Independent Review Panels of MHRA (Medicine & Health Care Regulatory Agency). Member of Clinical Executive Committee (CEC) of Halton & St Helens PCT. Member of Medical Protection Society.
The above list is as far as the GMC 'Conflict of Interest' policy takes us in the case of Dr Kumar. In fact, this list is woefully inadequate as one of Conflict of Interests and, in fact, discloses nothing specifically that might lead defence counsel to embark upon more detailed enquiries about Dr Kumar. However, I considered that this superficial review of Dr Kumar's involvement in the medical culture of the GMC, needed in such a sensitive case to be thoroughly investigated.
That Kumar's conflict of interests were not seriously probed or challenged was mainly the fault of the defence counsel, who throughout the case appeared to want to be polite and accommodating in relation to the prosecution. One can only assume that from the beginning of the case the defence lawyers denied the politics of the case and stuck doggedly to what they considered their 'legal' brief.
I have had considerable experience of defence lawyers in political cases, working as a Mackenzie friend throughout the 1970s and 1980s. The problems always begin with defence lawyers isolating the case from its social and political context. From the beginning, Dr Wakefield had considerable political support that should have been mobilized as a defence campaign which the lawyers kept informed. Instead, Wakefield's solicitors and counsel swore Wakefield to secrecy and convinced him that the hearing was an easily winnable legal battle. Meanwhile, Brian Deer and the Sunday Times, the pharmaceutically controlled lobby groups, blog sites and tabloid newspapers continued a relentless campaign against him well beyond the legal detail of the hearing.
Perhaps more important than this, while the Chairman of the panel intoned that the hearing was nothing to do with vaccination, the government pressed on with its very public vaccine programme which made it appear that vaccination was a matter of life or death and anyone who stood in its way was possibly a murderer. Dr Wakefield's case was a political case and the lawyers should have seen this and refused to play ball without the most intense public investigation of such things as conflict of interest. As it was, the defence entered the hearing exuding bonhomie and acting as if the whole matter was just a terrible misunderstanding.
It was very noticeable that at the beginning of this hearing in 2007, there was no structured mechanism for introducing conflict of interest information, all of which should have been provided by the GMC and been the basis for challenges by defence council. Dr Kumar did make an almost mute point of telling the hearing, in general terms and quite hastily, that he had previously sat on committees that were part of the Medicines Control Agency (MCA). (4) It was also the case that at any point in the hearing when a named person known to Dr Kumar, or a particular place of work, cropped up, he told the hearing that he knew or had worked in the vicinity of this person or this location. (5)
In looking at what might be considered Dr Kumar's vested interests that might have been declared at the start of the Wakefield, Murch and Walker-Smith fitness to practice hearing, I have concentrated on four areas: Kumar's previous involvement with the GMC, his work on two committees of the MHRA, his work for the Department of Health, his work as Chairman of the British International Doctors Association (BIDA), and the previously declared information about shareholdings in GSK.
* * *
Between 1999 and 2005, it was recorded that Dr Kumar was a consistent activist within the GMC, the prosecuting authority in this case, and had, as he made clear in his list of posts and affiliations on the GMC site, prior to 2004 been a GMC council member and served on the following committees: the 'registration committee', the 'health committee', the 'professional conduct committee', and the 'racial equality and diversity committee'. As an Associate of the GMC since 2003, he has also been a panel member on 'fitness to practice' hearings.
We have to bear in mind that the Panel in these cases is the jury, a small group of individuals capable of bringing in a verdict of dishonesty, that stands to a doctor with as much authority as the finding in a criminal law trial. Clearly the jury should be absolutely untainted by any involvement with either the defendants, the prosecutors or the many central issues of the case. In this case we have to consider whether being so intimately involved with the GMC it is possible that Kumar might have been au fait with the GMC's position on the prosecution of Dr Wakefield. His choice as Chairman was in effect no different from the Crown Prosecution Service, the English prosecuting authority, ensuring that one of its staff was on a jury in a criminal trial.
Since the late 1990s, Dr Kumar had been involved in two British medicines regulatory bodies, the Medicines Control Agency (MCA) and its main committee, the Committee on the Safety of Medicines (CSM). The MCA became the Medicines and Health Care Regulatory Agency (MHCRA) and in 2005 the CSM became the Commission on Human Medicines. Dr Kumar was definitely on the CSM in 1998 and this is the committee membership that he alluded to at the beginning of the hearing. (6) Members of this committee discussed the safety of drugs and vaccines.
Following the restructuring of the MCA after it became the Medicine and Health products Regulatory Agency (MHRA), Dr Kumar sat on two of this body's most influential committees. The Independent Review Panel for Advertising (IRPA) and the Independent Review Panel for Borderline Products (IRPBP). (7) Both the advertising of pharmaceutical products and the definition of what is a medicine are two of the hottest topics presently involving pharmaceutical companies in Britain and the first group is certainly relevant in relation to the advertising of MMR. Both the IRPA and the IRPBP has a policy of members declaring personal and non-personal interests. (8)During 2003, 2004 and 2005, and through 2006 into 2007, when the GMC hearing began, the MHRA records show that Dr Kumar held shares in GSK.
On hearing of the MHRA for the first time, it might seem to many people that it is a 'normal' government regulatory agency. Few people would guess that the MHRA, while being the most important regulatory body for medicines in Great Britain and the organisation which, for example, processes Yellow Cards that notify the DH of averse reactions to drugs, is actually a trading company completely subsidised by the pharmaceutical industry.
The MHRA took over from the MCA in 2003. The MHRA is a Government Trading Fund that might just as well be called a business or a corporation. A Trading Fund is an almost entirely separate economic entity that earns money by the provision of services and, like any kind of company, it must balance the books at the end of each year. However, unlike a number of other Government Trading Funds, which provide services, earn money and accept fees from diverse ‘beyond government’ sources, the whole of the MHRA income is provided by one funding source; the pharmaceutical industry. Further, a percentage of staff and executives of the agency, have come into it from the pharmaceutical industry. It is therefore not surprising that, funded and partly staffed by the industry, its policies are shaped to please this sector. When considering conflict of interests, the workings of the MHRA have to be seen in light of the fact that the agency is completely beholden to the pharmaceutical industry.
Dr Kumar sits on the UK National Screening Committee that is chaired by the Chief Medical Officer for Scotland and advises Ministers and the National Health Service (NHS) in all four UK countries about all aspects of screening policy and implementation. Screening programmes are of immense importance to the contemporary drugs industry as the ongoing embittered battle over the Gardasil vaccine against human papillomavirus (HPV) for pre-pubescent girls is showing.
The Department of Health (DH), a central aspect of the NHS has been at the very forefront of the battle against Dr Andrew Wakefield. Anyone seeking information about MMR from the DH web site was at the time of the start of the hearing directed through links to Brian Deer's web site and, apparently speaking for the New Labour government and the DH, Deer gives his version of the crimes of Dr Wakefield. The DH gives no links to other web sites of a similar kind and there is not the slightest attempt at balance. (9)
If at the time I wrote my essay An Interest in Conflict, you had gone to 'MMR the facts' via the NHS site and put Brian Deer in the search box, the site would have served you 50 items which mention Deer's work. The first item was this:
'MMR news: 14-Nov-04: Sunday Times: MMR scare doctor planned rival vaccine. Doctor whose work provoked a worldwide scare over MMR failed to reveal that he was developing his own commercial rival to the vaccine.' 'MMR scare doctor planned rival vaccine, Sunday Times - Brian Deer.' 'It has emerged that a patent was filed on behalf of Dr Andrew Wakefield for a measles vaccine and other products that would have stood a better chance of success if public confidence in MMR’s safety was undermined. To read the full Brian Deer article in the Sunday Times, please visit Times Online'.
Now, the fact is, despite it being promulgated by the lobby groups, the Sunday Times and the government, this story promoted by the NHS is not true. Of all the allegations made by Brian Deer, this is one of the most apparently prejudicial while being completely untrue. The 'competitive vaccine' referred to was Transfer Factor, which Dr Wakefield experimented with in the hope that it might help children overcome serious adverse reactions to measles and other vaccines. The GMC enquiry was so little enamored of this 'evidence' that it dismissed it almost entirely, concentrating instead on whether or not Dr Wakefield, or either of the other two defendants were acting ethically in prescribing Transfer Factor to one child who was recorded in the Lancet paper.
Looking briefly at another connection between the NHS, Brian Deer's web site and the GMC hearing, if you travelled to Brian Deer's web site through the NHS 'MMR News' you would have found an analysis of the Lancet paper by a Professor Trish Greenhalgh. This off-the-cuff analysis repeats almost word for word the prosecution case put by the GMC. The fable suggests that the Lancet paper case-series review, was in fact a badly conducted full blown research project organised to prove that MMR caused autism in vaccinated children.
Greenhalgh's explanation of the Lancet paper (10) is quite
extraordinary in that it followed the line of Deer and the GMC rather than the
paper itself. Greenhalgh’s interview answers give a very clear view of how Dr
Wakefield's detractors, from the beginning, tried to portray the Lancet
paper as the record of a full-blown study, rather than a short 'case series
review'. They also give us an insight into the case that the GMC began
prosecuting and how this case was broadcast by the NHS and the DH.
So the happy coincidence of Dr Kumar's involvement at a relatively high level in the NHS, although it might be dismissed as purely co-incidental, would appear inevitably to prejudice his view of the Lancet study if we understand that the NHS and the DH was from the beginning promulgating the GMC's prosecution view of Dr Wakefield's work.
To show how far up the system the honesty paralysis went within the NHS, at the beginning of the GMC hearing, we might quote John Stone:
After the publication of Brian Deer's story the Chief Medical Officer, Sir Liam Donaldson remarked to the BBC Today Programme (23 February 2004 - three years before the GMC trial began): 'Now a darker side of this work has shown through, with the ethical conduct of the research and this is something that has to be looked at'. On the same day the Prime Minister said to ITV [commenting on Brian Deer's article]: 'I hope now that people see the situation is somewhat different from what they were led to believe'. (11)
Since 2002, Dr Kumar has been the National President of the British International Doctors Association (BIDA). Prior to that he was, from 1990-1996, the General Secretary of the organisation. BIDA was established in the United Kingdom with the objectives of promoting the interests of Ethnic Minority Doctors and Dentists working in the United Kingdom. However, what doesn't become clear on the BIDA web site, unless you look closely, is the fact that the organisation is funded not only with membership fees but also by pharmaceutical companies. BIDA's magazine is also subsidised by drug company advertising. This information is declared by Dr Kumar in his conflict of interest declaration for the MHRA but not for the GMC.
Not only is it the case that anyone adjudicating in the Wakefield fitness to practice hearing has had from the beginning the power to raise or lower the price of vaccine manufacturers shares, there is inevitably a question that has to be answered about the individuals' commitment to that company and how these shares were obtained, were they given as payment by the company or bought from them?
* * *
I can remember that morning clearly. We had returned to the hearing after one of those interminable delays and I was staying not far across the Euston Road in the Indian Student YMCA. I had a cheap down to earth room without anything resembling breakfast, and was not in any sense looking forward to yet another day in the hearing. Over the last break I had managed to finish the essay about the conflict of interests inherent in the hearing and particularly those of the Panel Chairman. I suppose that I was slightly apprehensive; on a previous occasion I had released an essay during a break, only to return to find Brian Deer raging against me outside the GMC building.
I went into the building, feeling as always somehow dwarfed by the architecture of post-modern humiliation, chatted to the funereally dressed young woman behind the polished granite desk, picket up my name tab on a red lanyard, stepped with experienced precision through the automatically opening glass half door turnstile to the lift. The lift was a place of concern for by this point you had passed through the cordon sanitaire of the GMC foyer and could well come face to face with one of the prosecution team, or a panel member.
The third floor that morning seemed eerily quiet and it was from that point onwards that I began to suspect the worst. Sitting in the outer lounge I glanced through the Daily Telegraph and got a cardboard cup of green tea from the machine. I eventually slipped through the glass doors into the carpeted corridor and then into the four rows of chairs that constituted the public gallery. I sat down, got out my pen and notebook, placed my coat over the back of the chair and sat quietly waiting.
Usually when the defence lawyers and the defendants came in, they glanced in my direction, after all I had attended as many days of the hearing as they had and I was considered a familiar face. On that day, there was a long wait before anyone came into the hearing room and the lawyers particularly, although sometimes smiling slightly, kept their heads down. As the last members of the panel entered the room, the Legal Assessor, a neat piggy faced man, was still in animated conversation with Dr Wakefield's counsel. It was then that I knew that something was about to happen and that something might involve me; after all I was the only outsider there.
Everyone took their seats and the little man with the pink face pulled at his cuffs, looked into the still air in front of him and then launched into me.
A judge in real life, the Legal Assessor described my essay as an 'unhelpful intervention', adding, 'if this person thought that he was helping anyone he was mistaken'. Of course, in saying this, he entirely missed the point, I have no interest in 'helping anyone', just in speaking up for the parents and their vaccine damaged children and, the more abstract cause of 'justice'.
The assessor, however, employed by the GMC, was more pragmatically concerned than I was. One of his objections to my essay was:
If anybody thought that they were helping anyone, they were not because it has involved lawyers having to read and consider it, it will have involved unnecessary expense, unnecessary work and possibly even unnecessary concern.
Inevitably my mind rolled back over the junk journalism that Deer had produced during the hearing, including a long article that newly accused Dr Wakefield of fixing the results of his research. One of my worst crimes, it appeared, was that I had made the intervention with my essay 'at this point in the hearing', that is, after a year of the prosecution's prevaricating, repetitious time wasting.
The best that can be said is that this was considerably unhelpful and entirely inappropriate at this stage in these proceedings.
He implied that, had I made my observation about Dr Kumar's conflict of interest at the beginning of the hearing, it would have been considered in a more kindly light.
The Assessor made the point that Dr Kumar had declared his conflicts of interests at the beginning of the hearing. Of course, neither the legal assessor or anyone else involved, could have read from the transcript Dr Kumar's exact words when, during the hearing, he explained that he held shares in GSK, the vaccine manufacturer.
The Assessor went on to accuse me of a criminal act for which unfortunately his tribunal was unable to prosecute me.
Unfortunately, this is not a court of law and does not have the benefit of contempt law, otherwise I might give firmer advice to the Panel as on how to deal with such interventions. The Panel members who were shown this of course were concerned about the propriety of their position. It is an entirely unhelpful intervention.
For the rest of the day I caught Kumar leaning forward slightly and glancing
side-stares at me, still the only person in the public gallery, as if he were
reminding himself of my features. I wondered what he was thinking and was amazed
at the seeming effrontery embodied in those glances.
As I was writing for CryShame, the parents' organisation at this time, the Chair of CryShame, Allison Edwards, following this cover-up by the Panel chairman and the Legal Assessor, supported my attempts to get the GMC to make a clear statement about their conflict of interest policy. After an exchange of correspondence, the GMC admitted that they didn't actually have such a policy.
Brian Deer, clearly primed by someone to reply to my relatively academic finding of Dr Kumar's GSK shares, responded with a vitriolic personal attack:
Some of the latter (parents), in their pain, have now turned nasty: with
me as a target for their hatreds. Although almost literally a handful of people,
and some with no link to MMR or autism at all, they've insinuated themselves
among affected British families and are causing distress with false allegations.
Among these is a claim that my Sunday Times and Channel 4 investigation - which
nailed the scare and helped to restore public confidence - was covertly
supported by the drug industry.
A string of recent outings for this sickening falsehood are authored by a 61-year-old graphic artist called Martin Walker, who apparently lives in Spain, but last year surfaced at the mammoth hearings of the GMC in London. He claims to be a "health activist", and, although generally of little consequence, is a relentless peddler of smear and denigration, with a track record of latching onto the vulnerable. These he beguiles - like he's their new best friend - and then, if past form is a predictor for the future, attempts to sell them self-published books. (12)
* * *
Returning finally to myself and my 'reputation', I feel that Deer's execrable writing above hopefully does him more damage than it does my reputation and it goes without saying that, though I value my reputation quite highly, it is dust in the wind compared to the monumental reappraisal that the parents of vaccine damaged children have had to effect in their lives since they were struck by this manufactured tragedy.
What astounds me now more than anything has nothing to do with any sense of personal hurt, but the sustainability of the gross lies told by Deer and his criminal contemporaries in the government and corporations. Since the verdict against Dr Wakefield, Professor Murch and Professor Walker-Smith, Deer has affected the most odious and duplicitous persona, hailing himself as the promoter of the parents' cause and expressing empathy with them after their painful victimisation by Dr Wakefield.
That political forces in Britain are able to air brush out a whole society of vaccine damaged children and their parents while censuring the academic history of a man who speaks out for them, is quite extraordinary. I spend days now wondering how we might reassert the presence of the parents and their children, making public the crimes of those centrally involved. (13) Were it not for the fact that I know this struggle is for the future of science, justice and the chimera that we call democracy, I would be tempted to move on.
Recently on television I watched an interview with an Italian anti-mafia judge and marveled, not for the first time, at the moral strength of such people. The British legal community is so desperately lacking in individuals of moral standing that no one has stepped forward to challenge the corruption with which the pharmaceutical mafia and the corporate State are mocking science, justice and the parents of vaccine damaged children. In the case of Dr Wakefield, the GMC has brought the legal and regulatory process into utter disrepute, raising the age-old question of Quis custodiet ipsos custodes? Who guards the guards?
(2) All my essays over the period of the Wakefield case were published in Medical Veritas, Volume 6, Issue 1, April 2009.
(4) As related below, in 2003, the Medicines Control Agency (MCA) became the Medicines and Healthcare products Regulation Agency (MHRA).
(5) This practice coincides with a note about spontaneous declaration that I
was sent by the GMC after making an enquiry about their policy:
There are, however, occasions relating to Fitness to Practise hearings when a conflict, or potential conflict, of interest may arise and which would not be recorded in the Register of Interest. This would include occasions where the doctor appearing before the panel, or a witness, was known to one of the panelists or where one of the panelists had prior knowledge of the events that led to the doctor's appearance before the panel. You will appreciate it is impossible to list such conflicts in the Register of Interests. The procedure on those occasions is that panelists are required to declare those interests as soon as they are aware of them. Panelists are usually able to declare such interests in advance of the start of the hearing but there are instances where conflicts only become apparent during the course of a hearing e.g. as the evidence is adduced or when a witness is called.
(6) 1998 Summary of the Meeting of the Committee on Safety of Medicines held on 11th February 1998.
(7) The Medicines (Advertising and Monitoring of Advertising) Amendment Regulations 1999, SI No. 267, came into force on 5 April 1999 and completed the implementation of Directive 92/28/EEC. Regulation 13 and the Schedule contain a procedure for a review of the Health Minister's preliminary decision on whether an advertisement complies with the Medicines (Advertising) Regulations 1994, as amended ("the Regulations"). The Health Ministers proposed that the review would be undertaken by an Independent Review Panel.
(8) 2005, Independent Review Panel for Advertising: Declaration of members
current personal and non-personal interests.
(9) http://www.dh.gov.uk/en/Publichealth/Healthprotection/Immunisation/index.htm ....to.... MMR Explained ... to... http://www.mmrthefacts.nhs.uk/
[MMR news]: Analysis of the 1998 Lancet Wakefield paper
Professor Trisha Greenhalgh explains why the Wakefield 1998 Lancet paper should never have been published on scientific grounds.
(11) Cited by John Stone in his bmj response: http://www.bmj.com/cgi/eletters/328/7438/528#56300
(12) The majority of Deer's attack on me and my rebuttal are published in Medical Veritas.
(13) One way everyone can help is by buying copies of the first two Silenced Witnesses books in which the parents tell the stories of their vaccine damaged children.
March 13, 2010
The oath taken when in the witness box is no less solemn or important. Often the only evidence given in a case is that of a single Constable and on it the Magistrate has to decide the issue. The greatest care, therefore, must be exercised to avoid any statement which is not strictly true. Never keep anything back, on the other hand never enlarge on nor exaggerate the evidence. State your plain story in simple terms, remembering that on your plighted word depends the liberty of a fellow citizen.
Instruction to Recruits into the Liverpool City Police
from the Deputy Head Constable. 1919
In Britain today, especially in relation to vaccines, the pharmaceutical industry has managed to completely disappear both the history and the idea of serious pharmaceutical adverse reactions. The past is like a raked-over garden, the pharmaceutical companies have re-written the history of law, medicine and democracy to make the public believe that no one has ever suffered an adverse reaction from a vaccine. This mirage is evidently helped by the fact that there has been only one in-court decision against the pharmaceutical companies on vaccine damage since the second world war. (1).
In the presentation of the new pharmaceutical reality, even the case of thalidomide, a drug that was advertised as being 'outstandingly safe' is now heralded as a fine example of how pharmaceutical companies admit to their errors, accidents and organised disasters; like a fake wall of remembrance on a Hollywood film set. The truth about thalidomide is that the involved multinational chemical and pharmaceutical companies put up massive obstruction, obfuscation and prevarication, in a wholesale attempt to evade responsibility for the damage it did.
In a series of international trials the defendants were able to find scientists from all over the world to come forward and give evidence that there was 'no proof ' thalidomide had damaged anyone. The German branch of the trial against Chemie Grunenthal, the original producers of the drug, began in 1968. Six years of preliminary investigations were followed by two and a half years of court proceedings, and the case finally concluded without a verdict in December 1970.
The trial in Germany was marked by constant melodrama by the defence counsel who crowded the court, continually demanding that certain defendants were freed because of illness. Expert witnesses for the claimants were consistently accused of having vested interest - despite the fact that most of the expert witnesses for the defence either worked for the company whose executives were on trial or were good friends of theirs and despite the fact that one of the defence counsel had until only a few months before the trial been in the dock as one of the accused.
The defence brought a number of expert witnesses, including a Professor Chain from Britain. They argued that there was no scientific proof that thalidomide caused teratogenic effects of any kind. In what remains one of the great books about pharmaceutical and chemical companies denying 'adverse reactions' to drugs, Thalidomide and the Power of the Drug Companies, (2) Sjostrom and Nilsson have the following to say about the evidence of these expert witnesses - it is worth repeating at length:
'To everyone's surprise, Chemie Grunenthal was able to produce certain medical experts who claimed that the hypothesis that thalidomide caused abnormalities was unproven. At a time when the impact of the thalidomide disaster had caused the medical authorities of most civilized countries to tighten their legislation for drug control considerably; when the teratogenic action of thalidomide was included in elementary textbooks for medical students as a horrifying example of the teratogenicity of a drug in man; when the intake of thalidomide in the sensitive period of pregnancy was considered sufficient reason for legal abortion in Sweden; when scientists all over the world were working jointly in cooperation with the controlling authorities and pharmaceutical industries to prevent a repetition of what had happened; when at international meetings on medical science no single voice had every been raised against Lenz's interpretation; when drug companies all over the world in the West and the East had included the testing of drugs for teratogenicity as a standard procedure for testing drug toxicity; when the Astra company who manufactured the drug in Sweden under license from Grunenthal had admitted in the trial in Sweden that thalidomide was to be regarded as teratogenic in man; and when finally, the English manufacturers, Distillers, had agreed to pay compensation to the parents of malformed children in an out-of-court settlement, nobody would have expected a professor of anatomy from the university of Gottingen (Erich Blechschmidst), a Professor in pathology (Karl Ferdinand Kloos), a professor of orthopaedics from the medical faculty of Aachen (Anton Hopf) and a professor of forensic law (Gerhard Rommeney) from Berlin, to stand up in the Casino in the small town of Alsdorf in Nordrhein-Westfalen and claim that it had never been shown that thalidomide caused foetal damage'.
Since the thalidomide case, the drugs companies in Britain have fought desperately to keep themselves out of court.
In April 2003, lawyers in Britain acting for one and a half thousand parents
whose children had been damaged by vaccines since the introduction of MMR in
1988, received a letter from the Legal Aid Board. The letter explained that in
the case being brought against three pharmaceutical companies, Merck,
GlaxoSmithKline and Aventis-Pasteur, which had taken just over a decade to
assemble, and that had Dr Andrew Wakefield acting as an expert witness for the
parents, would have its legal Aid funding rescinded. In Britain this was
tantamount to a deathblow to the parents case.
The defendants were divided into groups claiming against a wide variety of disabilities caused by different aspects and different types of MMR. The strongest cases appeared to be those children who had suffered very serious bowel problems after being vaccinated and who had consequently experienced regressive autism. These cases, certainly on the word of the parents and that of Dr Wakefield, who had researched the bowel disease, appeared clear cut.
Had the case reached court, it would have been the first case against pharmaceutical interests to arrive there for three decades. Even if it had been over quickly and even if the companies had won, the case would undoubtedly have cost the pharmaceutical companies involved dearly in both money and reputation. As well with a wide range of adverse reactions to the MMR vaccination, there can be no doubt that the cases would have dragged on for many years. One of the most serious matters that a full court hearing would have raised, however, was who was responsible for paying out claims; vaccines in England were after all a central aspect of the government's public health programme.
In June 2004, just a few months after the Appeal against the withdrawal of legal aid was turned down in the High Court - by a judge whose brother was a non executive member of the GlaxoSmithKline board - the General Medical Council (GMC) served papers on Dr Andrew Wakefield commanding him to appear before them with a view to facing charges, included those of dishonesty. The eighty odd major and minor charges that were eventually to be listed against Dr Wakefield and replicated against Professor Simon Murch and Professor Walker-Smith, were all based, in essence, upon one Sunday Times article written by a pro-MMR journalist who had a history of writing in support of GlaxoSmithKline vaccines. The main core of the allegations rested on a single 'case review' paper that cited the cases of twelve children seen clinically at the London Royal Free Hospital and published in the Lancet in 1998.
From the perspective of the pharmaceutical companies, now free of the threatened civil action, this reversal of trials was strategically brilliant. With the help of the GMC such a 'trial' could be dragged out over years, the right person was in the dock, and joy of joys, not a single penny in payment would come from the profits of pharmaceutical companies. Every penny of the millions of pounds that the 'trial' would cost would by discretely lifted from the pockets of hard working medical practitioners by their professional regulatory body without discussion.
But perhaps the greatest sense of warmth that exuded from the plan was that if Dr Wakefield was found guilty, he would be shown publicly to be a dishonest rogue; if he were found not guilty on some charges, the medical world would anyway walk round chunnering-on about smoke and fire. And while pharmaceutical puppeteers might move around advising on the direction of the prosecution, they need never break cover, or indeed make a single public statement.
Before moving on to look at some of the evidence that was and was not given, in this faux trial at the GMC, lets compare the two 'trials'. The first case was progressed by the parent claimants of thousands of vaccine damaged children, those people the law is there to protect and care for. The second case was brought by the General Medical Council also there to protect injured patients, but in this case triggered by one journalist, who made no declaration of conflict of interest and who was not to actually appear as a witness. Ostensibly the case was brought in the name of thousands of doctors who pay the GMC to keep their profession 'clean'.
The first witnesses in the real trial would have been a select group of parents whose clinical cases showed most clearly that their children had changed from their normal development to have horrendous bowel problems and regressive autism. The first witnesses in the GMC 'trial' were to be the General Practitioners who had first seen the damaged children. These children were apparently not ill but simply autistic, they had not been examined clinically but used as research subjects. This switch from the weight of proof being with the 'full-time' parents of vaccine damaged children, to reside with peripherally involved local medics, led inevitably to the dilution of the case that the parents would have presented of their seriously vaccine damaged children.
The second group of witnesses in the first real trial would have been a small group of expert witnesses, including Dr Wakefield; they would have argued that the serious bowel problems experienced by the vaccine damaged children, were novel and extraordinary and were most probably caused by an environmental trigger. In the second 'trial' there were also to be expert witnesses, even the same expert witnesses that the defence might have brought in the real trial; unfortunately however, the expert witnesses for the claimants in the second trial were in the dock. They still gave their evidence, it just didn't carry much weight because they were now the accused parties!
A last comparison relates to the content of the argument used in both cases. In the first real trial, the claimants would have argued that their children developed terrible bowl problems and a number of other adverse reactions soon after their MMR vaccination; that their children had been developing normally but then began to regress into autism; the expert witnesses would then have given evidence as to how this might have happened. The pharmaceutical company defendants in this case would have had a huge problem in managing the burden of proof. Although they might have argued persuasively that it was unlikely that serious bowel problems could lead to ASD, they would have had difficulty in cross examining parents about the temporal and physical onset of their children's bowel problems. At least a half of the claimants case would have been proved by parents experience before the jury made up their minds about the second half of the case, on the basis of the scientific evidence of the expert witnesses.(3) However, thirty years ago, in the last round of whooping cough vaccines, the pharmaceutical company defendants did win a major victory when they persuaded the court that the scientific rather than experiential evidence should be argued first.
In the second 'trial' run by the GMC, still continuing after almost 3 years, the defendants narrative hasn't changed, the children are still at the heart of the defendants case, they argue that when the children came to them they had terrible bowel problems and that many of them had also slipped into regressive autism and that these children were only ever examined clinically in order to find a diagnosis. The GMC prosecution however sets about severing any connection via bowel problems, between MMR and ASD. In fact this is easy, because some of the children's GP's say that they didn't actually see any evidence of IBD. Some of them also make the point that they were in no way equipped to find evidence of IBD.
The next bullet fired from the prosecution gun, after their attempt to show that none of the children were actually suffering from IBD, was to have the general practitioners be absolutely sure that the children they saw were autistic. The prosecution expert witnesses were then able to make a definite case on two main points; that the children were autistic, and the children did not show any special symptomatic picture that looked like IBD. This later argument became a belt and braces argument, because the expert witnesses argued that autistic children often have bowel problems anyway. As the prosecution argued that the children did not suffer IBD, they also had to argue that any tests carried out on the children were not related to a suspicion of IBD, but were experiments carried out on disadvantaged autistic children, by the defendants, without the knowledge of the parents, without ethics committee approval with the sole intention of making pots of money in suing the vaccine manufacturers. Had the parents presented evidence about the signs of IBD and the onset of regressive autism, the whole prosecution house of cards would have collapsed.
One of the most startling, bizarre and indeed horrific aspect of this 'bogus' GMC trial was hearing doctors and legal prosecutors arguing that not only were the children not ill - only autistic - but that testing autistic children diagnostically with such preliminary tests as lumber puncture and colonoscopy was barbaric. The truth of the matter was as plain as the well-sculpted nose on the hard face of Miss Smith, the principal prosecutor: the prosecution did not want any doctors, anywhere, to even partially suggest that prior to regressing into autism, these children had suffered a major environmental challenge.
At the end of the day the GMC prosecution case relied almost entirely on three unfounded suggestions. First the suggestion that Dr Wakefield and the other two defendants had tested and conducted procedures on the children that were not clinically necessary; that the 1998 Lancet case review paper was the result of illicit non-ethical committee approved experimentation on children; and finally the two most senior expert witnesses, Professor Sir Michael Rutter who argued that these children were first and foremost autistic and Professor Ian Westercot Booth who argued that had the children showed signs of IBD, which they did not, any such condition could have been explored using non-invasive tests.
There were of course other related matters in the GMC trial that were thrown into the case like confetti in order to ensure a common view of Dr Wakefield as a criminal of note. There was conflict of interest; the accusation that Dr Wakefield developed a competing measles vaccine; that someone treated one child with Transfer Factor and finally that Dr Wakefield callously and injuriously took blood from children so that he could use these samples as controls; but even more importantly - in telling a joke publicly about obtaining the blood samples, he brought medicine into disrepute. (4)
The main body of the evidence given by the prosecution referred to the 12 children cited in the Lancet case review paper. However, the proposition that the 12 Lancet children had been experimented on for an illicit research project carried out without ethics committee approval and often without parental consent and written up in the Lancet, was a complete fabrication. The Lancet paper told the clinical presentation and diagnostic enquiries of 12 children who had arrived at the Royal Free Hospital consecutively in the mid 1990s. The paper did not represent a study of any kind, nor did the clinical examination of the children or the reporting of these examinations, require ethical committee approval.
I would like now to look at the kind of evidence that parents might have given had they been called by the defence. I want to do this through the statements given by parents in the two Silenced Witnesses books that I have edited and published. These parents and these children are not the ones cited in the Lancet paper but seven self selected parents, who describe a small number of the many children who arrived at the Royal Free after the first twelve but showed a similar presentation. (5) I have used the stories of these children because in theory at least, the twelve Lancet children's cases have never been placed in the public domain, as whole narratives.
* * *
That morning before Jack got his vaccine he was in good health, but I recall that in the three months prior to receiving the MMR vaccination he had been suffering from a cough and a high temperature. The doctor advised us that Jack could develop a high temperature, may be a bit under the weather and may need nursing after the MMR vaccine.
After Jack had the MMR vaccination, I remember holding him for most of the day. He was a bit clingy and unwell and needed medication to keep his temperature down. I noticed a bad reaction to the vaccine around twelve hours later at about one in the morning when Jack seemed very distressed and cried for a period of time. A cry that was different from his normal cry and I rubbed his back because I thought he may have wind, but he also felt floppy.
Two days later I was out with Jack and he had another prolonged crying fit
as if he was in real pain, so I brought him home immediately, gave him something
to bring down the temperature he had developed and for the pain. Again Jack
settled. Jack went to the doctor seven days after receiving the MMR and I
explained that he was not his normal self; he was listless, crying, suffering
from wind, diarrhoea and occasional fever.
Within a month of receiving the MMR around early summer, John and I realised that Jack was beginning to deteriorate quite significantly. He stopped responding when my husband or I called his name, he had a gaunt almost stunned look upon his face and he would stare at things. He became anxious and his behaviours started to change. He would sit and constantly flip the pages of a book over and over again and when we tried to intervene to slow down and look at pictures or read from the book he would get upset and seem to need to get back to what he was doing previously.
His lack of speech, playfulness, attention, focuses and habitual activities became more worrying. Again this was pointed out to our GP, family and others whom I came in contact with. Before he had the vaccine Jack would say ‘teddy’, ‘light’, and 'mum' and mimic his favourite programme ‘go go power rangers’. After the MMR vaccine Jack was virtually silent. He stopped responding to his name and began to withdraw completely. This was the beginning of a search to obtain a proper diagnosis. (6)
* * *
In these early months, David gave good eye contact and interacted with us all. He was a joy to me because we could not have been closer. I was not going to miss one moment of David’s first year. I stopped breast-feeding when he was just over 11 months. David was a calm happy baby. He took his first unaided steps at about this time.
At the age of 13 months and 3 weeks on 5th July 1994, I took David to the Doctor’s surgery. He was checked over by our GP to see if he was well. His eczema was not considered a problem and the same Health Visitor, who had visited us regularly, administered his MMR, his first and only dose of Merck’s MMRII. Job done, we left the surgery.
That following weekend on the 9th July, the family were all present at my parents' house for a garden party. There were many guests and we thought it safer for David to be put in his pram, while I tended the Bar-B-cue. Two things were apparent about David on this day. Firstly, my Aunt saw him struggling to get out of his pram reigns with what she describes as almost manic determination. When he was finally ‘released’ we saw what we thought was the cause of his upset, DIARRHOEA, in capital letters, bright yellow soft mushy stools.
David’s stools were always mushy from that day onwards, with no solid form at all. A short while later the stools were checked for what was described as ‘bugs’ but nothing was found so it was put down to ‘toddler diarrhoea’. (It was still given this title when David was 6 years old and the condition continued).
Within a short time, we began to notice the development of strange behaviours that accompanied the diarrhoea. What speech he had gained began to deteriorate. He developed a phobia to his toothbrush and if he caught sight of it he would give a high-pitched scream. In the early days of David’s regression, late 1994-1995 I could not believe that my son, who had once done everything so well and so easily suddenly was not able anymore. Babies do not regress for no apparent reason and perhaps that is why it just wasn’t covered in the baby books. I later read that it is extremely rare for a young child to loose speech unless they have experienced a serious illness or trauma and David had had nothing, not even a mild temperature in his first year.
In 1995 I had to stop taking him with me to school to collect his sister because he started to ‘run away’ from me if he was out of his reigns. I had to chase him across the playground through crowds of children and parents on numerous occasions. He also stopped talking to us. The odd words that he did still speak became shorter, Ribena became 'bena'. Instead of telling us what he wanted he would lead us by the hand to whatever he wanted and use my finger to touch the object. He lost the ability to cry and it was replaced by the high-pitched scream.
The diarrhoea continued, approximately 3 times a day. Every time it occurred the bright yellow or pale brown smelly mushy stools would ooze out of his nappy and stain his clothes. (7)
* * *
Josh was born on the day he was due, 13th December 1992, after a normal delivery. He weighed 8lb 11oz. The midwives all called him a little bruiser, he was very chunky and looked muscular, he looked gorgeous in his little bodysuit. I decided to breast feed Josh; he took to this and fed very well, on several occasions he put on 1lb a week. After six weeks when my milk did not seem to be satisfying him, I put Josh on the bottle to which he took immediately. Now Josh was sleeping right through the night, we couldn't believe it; at two his brother was still waking up.
Josh developed normally and reached all his milestones as expected, he sat
unaided at just over six months, and although he was the slowest to walk at 11
months, I didn't consider that to be late. By 11 months Josh was saying single
words such as 'Mamma', 'Dada', 'Ta', 'Gone', 'Juice' and 'Bye'.
Josh had his MMR vaccine at 13 months; on the evening of the vaccination he had a high fever so we gave him Calpol. The following morning he woke with severe diarrhoea, it had leaked all through his baby grow and onto his cot bedding. This was bright yellow and then changed to what I can only describe as being like Oxtail soup. This continued for five days, he then became constipated. Prior to the MMR he had opened his bowel every day, sometimes twice a day.
We began to notice changes in him, my happy contented little boy now seem to always be miserable and upset and would scream and cry for no apparent reason; he no longer liked to be picked up and cuddled. He seemed to not like to be touched, and changing his nappy was a nightmare, anyone would have thought I was hurting him. He became withdrawn.
How could our little boy have changed so quickly within four weeks of having the MMR vaccine? Josh’s behaviour was what I can only describe as 'odd', I put this down to his constipation, but soon began to realise that there was more to it. He became obsessed with light switches and would climb on chairs and tables to get to them, turning the light on and off. It was the same with door handles and opening and closing doors. He was getting a lot of enjoyment from this repetitive behaviour and clearly had to do it. It was now a real struggle to get any eye contact with him; before he loved posing for the camera, he now ignored any camera that was pointed at him.
It was now six weeks since his MMR vaccine and we had heard no language from him for at least two weeks. The single words he had gained had vanished and he made no attempt to say anymore. At his 18-month assessment concerns with his behaviour, poor interaction, little eye contact and a total loss of speech were noticed. He was still only opening his bowel once a week, I was being told not to worry as all children are different with their toilet habits. Anything I said about MMR was completely ignored; it was as if I hadn't spoken. (8)
* * *
From the very first day following the MMR vaccination Adam changed dramatically. His first reaction was recorded by visiting nurses on the 6th day following the vaccination as being miserable and out of sorts. On the 8th day, Adam had loose stools, was vomiting, had a rash and was feverish. He continued to have pronounced measles symptoms for over six weeks and he also developed an ear infection. The visiting Community Paediatric Sister identified the symptoms as a reaction to the MMR vaccination. Her notes recorded on 15th April 1994 include 'mother and respite nurse appear to have measles from Adam’s MMR'. On 29th April 1994 she recorded 'Rash still evident on face from measles, appetite not improved'.
This period marked the beginning of a long-term change in Adam. The measles symptoms were followed by general malaise, intermittent fevers and rashes, temperature control problems and profuse cold sweats, which continued for over 15 months. Even today, Adam has cold sweats - some nights drenched - and I know that he is heading for a viral episode, it’s as though his body cannot fight it off, it just lies below the surface like a malignant viral breath, not something tangible and obvious that I can fight, nothing that the doctors take seriously.
Frighteningly, Adam also became very withdrawn, and lost interest in
everything. Within days he became a different child, losing many skills he had
previously acquired. The behavioural changes were very apparent during the
summer although I thought he was lethargic and withdrawn because of his illness.
I therefore paid more attention to his physical symptoms at that time and
concentrated on trying to restore him to full physical health. At this time,
Adam's physiotherapist, described him as being like a totally different child.
She could not engage with him and he had no motivation; it was as if she were
not there. She had been a fixture in his life since he was born, she called him
her little Rangers fan, due to a green and white stripy outfit, and he loved
her. Now, she no longer existed for him.
By September 1995, the behavioural changes were more pronounced, Adam seemed to be regressing, he had no interest in communication, and he spent hours every day gazing at his hand, holding it up in front of his face and moving his fingers. He was in a world of his own. He craved gluten and casein foods such as pasta, bread, soft cheese, milk and fromage frais, and by the summer of 1996 these were actually the only foods he would eat. Before the MMR vaccination, Adam had been eating a range of foods including fish, meat, chicken, vegetables and fruit. (9)
* * *
At eighteen months Andrew received the MMR vaccine and five days afterwards
he had what can only be described as a bout of chronic diarrhoea. A few weeks
later he was vomiting and had developed a rash on his torso, which the GP
suspected was measles; this I found alarming! There followed a vast array of
medical complaints, eczema, conjunctivitis and tonsillitis. At this time
diarrhoea was part of our everyday life with up to seven bowel movements a day.
A referral was made to a pediatrician who requested tests for thyroid function,
a stool test and one for coeliac disease; every test came back normal.
Although the doctors were trying very hard to find the cause of Andrew’s bowel condition we were becoming very frustrated. We noticed Andrew was not responding to us when we called his name; unbeknown to us he was showing signs of autism.
Andrew was referred by an audiologist to a consultant paediatrician, who looked over the coming year at Andrew’s behaviour. In March of 2000 we were devastated to be told that Andrew was autistic. Our first thought was that the bowel condition came first, autism second, although we did feel that the two things could be connected.
Everyday the nauseating smell of diarrhoea filled our house. I think that over time we began to get used to it. Tests for Andrew followed, one after the other, referrals followed by the problem of getting Andrew into a special educational needs school. (10)
* * *
So on the 30th May 1997 at 13 months old, Billy had the MMR.
That night Billy developed a high fever, we gave him Calpol and put him to sleep in his cot with his beloved drinking cup of milk; he was now on cow’s milk straight from a carton, slightly warmed. The next day he was restless, he cried a lot and maintained a fairly high temperature. That evening I went to check on him and he was lying in his cot shaking uncontrollably. He seemed cold. I grabbed a blanket and wrapped him tightly and held him close.
My sister, Rosie raced over to sit with Bella while Jon and I dashed to Kingston Hospital. In the car I held him tighter and tighter, Jon kept talking to him, 'It’s OK son, we’ll get you some help.'
'He needs a massive course of antibiotics, he’s probably had a reaction to his jab, it’s quite common. In future don’t wrap him up; you should have stripped him off and let him cool down', said the hospital doctor.
We watched our little boy sitting on the examination table, shaking, his teeth chattering. His cheeks, tummy, tops of his arms and legs were scarlet. Another young doctor came in and gave him a jab of yet more antibiotics. “Take him back to the doctors if he is still like this in 48 hours”, they said.
Well, guess what, he was, and we were prescribed a 6-week course of antibiotics ‘to really blast everything out’. Billy was vomiting so much on the antibiotics now; he couldn’t even drink his milk without projectile vomiting.
Billy deteriorated fast; he lost the few words that he had. Within a week he started to reject most foods, he only wanted Weetabix, milk, apples and his bread sticks. We tried to encourage him to eat vegetables, meat, and all the foods he used to love so much. He would throw his head back against the chair, banging it repetitively and screaming this new high pitch scream. He lost a lot of weight and eventually his hair started to fall out. But the very worst part of all of this was his diarrhoea. It was frightening; it was liquid and endless; it seeped through any nappy and into everything.
I took him back to the doctor.
“Does he eat lots of apples?” he asked.
“Yes, he loves them”, I replied.
“Good. Don’t worry, it’s perfectly normal, just toddler diarrhoea, keep him hydrated.”
When Billy was 18 months old, the Health Visitor turned up for his routine check. After asking Billy to, 'Brush Dolly’s hair', 'Point to his nose', and 'Pick up a book', it was blatantly obvious that Billy had a serious problem. (11)
* * *
Thomas had his triple jab on 12th June at age 13 months. Supplied by Meriux Immravax, Batch no D1400. The impact was not immediate, but over the next two weeks Thomas started to lose his spark. He just slowed down, slept a lot more, and started to get more grumpy.
Something was clearly wrong, we had been to the doctors and given the usual
re-assurances: growing phase, typical boy, don’t worry he will soon be babbling
ten to the dozen. We felt we needed to push for more medical investigations.
Jan already had a clear view on the cause. Something had changed and gone dramatically wrong at around 14 months, at around the time of the triple jab.
Finally there were so many other things that were going wrong with Thomas. Things that were not included in the definitions of autism that we had researched. Why did Thomas keep falling over. Why did he perspire so much at night, and often sleep for very long periods. What about the excessive drinking of apple juice and Ribena. Why did Thomas gorge on certain foods, breaded products especially: it would not be unusual for Thomas to consume 5 packets of crisps in one go. What about the grey eyes, the pot belly and the explosive poo’s?
I remember coming home from a two-week business trip to the States. I arrived to find Jan in the hall, trying to wipe excrement off the walls of the stair well. Thomas had not made it upstairs and had one of his many 'explosions'. None of this fitted the autistic label. (12)
* * *
Denying the experience of Parents
The fact that the GMC chose not to present the parents at the prosecution of the three doctors showed conclusively that they were not interested in conducting an honest enquiry but instead were bent upon a trial and ultimately a finding of guilt. It has been suggested that it was the responsibility of the defence to bring the evidence of the parents to the tribunal and in part this is true. However, it was clearly not possible for the prosecution to present anything near a True Bill having refused to acquaint the Jury with a major portion of the information pertaining to the charges. In a real trial in a court of law, rather than a fixed professional regulatory tribunal, it would have been impossible for the prosecution to proceed without presenting all the evidence, however detrimental it was to their case. (13)
In the case of the GMC v Wakefield, Murch and Walker-Smith, although it has been consistently stated by Brian Deer, for instance, that what was done to the children by the doctors was terrible, the GMC was not only unwilling to articulate the route of any complaint to the hearing, but purposefully made invisible the 'victims' upon whose cases they traded during the hearing.
Having disappeared a good portion of the evidence, the prosecution pursued its case about the children solely through the two expert witnesses Sir Michael Rutter and Professor Booth. The entirely circumstantial evidence of these two men was used by the prosecution to bring in a guilty verdict against Dr Wakefield. Their evidence had nothing to do with the facts of the twelve children cited in the Lancet paper, for neither of them knew anything of factual note about the condition of the children. Their evidence went entirely to what they themselves might have done if presented with such children in a hospital setting. Because, however, the prosecution presented the experts with a distorted picture of the children's illnesses the great majority of the evidence of both experts was beside the point.
* * *
The Place of Sir Michael Rutter in Industrial Science
Professor Sir Michael Rutter is Britain's foremost expert on the genetic, hereditary and psychological causes of autism. He sees autism as an aspect of mental illness that might be treated with drugs. He gives no credence to the view that ASD can be caused by environmental factors. Because he holds these views Sir Michael is inevitably close to the pharmaceutical companies that promote drugs for psychiatric conditions. He was signed up as an expert witness by GSK in the run-up to the parents' civil action.
David Sainsbury's term in office as the Under Secretary of State responsible for science, a position granted him in exchange for his donations to New Labour both before and after their victory in the 1997 election, spawned a cabal of industry orientated scientists who having first organised within the Royal Society with the help and guidance of Sainsbury's department, went on to set up and become part of the Science Media Centre, Sense About Science, and the Academy of Medical Sciences (AMS), while rejuvenating the British Association. With the influence and money available to the Department, Sainsbury cultivated, placed and honoured a series of scientists and non-scientists, capable of bringing industry into the heart of government.
These individuals and institutions have been the ones principally organising against Dr Wakefield on behalf of pharmaceutical companies in Britain. One of the stars in Sainsbury's firmament of proselytizing industrial-academic organisations is the Academy of Medical Sciences (AMS). The AMS is a relatively small and select new science club, the base from which industrial science now send out its troops to attack unbelievers.
Although the AMS was only set up in 1998, Sainsbury while in office as Minister of Science promoted it as if it were on a par with the Royal Society, which was founded in the eighteenth century. As the biggest drug, chemical and bio-tech companies poured money into it, its leading representatives began to describe it as one of the leading and most renowned academic and scientific institutions in Britain.
'The Academy of Medical Sciences is one of the five learned academies in the United Kingdom, alongside the Royal Society, Royal Academy of Engineering, the British Academy and, in Scotland, the Royal Society of Edinburgh.' (14)
Although the AMS has insisted on the pretence that it is 'independent', this
word is never defined. The truth is that the organisation has never come close
to being independent in any form. Although while he was in post Sainsbury
promoted the Academy, pushing research work through it, benefit from its
representation was always a one way traffic; promoting industry without
reference to the lay-public.
When in 2003 the Sainsbury initiated Brain Science, Addiction and Drugs Foresight exercise on addiction and behaviour modification, recommended the next psychiatric black arts drugs, cognitive behaviour enhancing substances, Sainsbury, whose family funds a number of mental health projects, passed the recommendations on to the AMS, for industry take-up. He then portrayed this in 2005 to the parliamentary Science and Technology Committee as a kind of public consultative arrangement.
'We have asked the Academy of Medical Sciences to do a similar project in that area. I think overall we are pushing forward that agenda on public engagement pretty strongly.' (15)
Outside of his Ministerial post, Sainsbury then promoted cognitive behaviour enhancing substances, in partnership with the pharmaceutical industry, just as he had promoted genetically modified food in partnership with Monsanto as if their development and use, without any reference to the precautionary principle, was a foregone conclusion.
The power that the AMS has within the industrial world of bio-technology and pharmaceutical medicine was seen in 2008, when one of the longest running academic drug fronts, the Novartis Foundation, previously the Ciba Foundation, shut up shop and threw in its lot with the Association, a merger that was completed in 2010, when the AMS moved into a new multi-million pounds building in Portland Place.
Coincidentally, three of the witnesses called by the GMC prosecution, who
did the most damage to Dr Wakefield in the GMC hearing are embedded in the AMS.
Professor Sir Michael Rutter, Professor Peter Lachmann and Dr Richard Horton,
the editor of the prestigious medical journal the Lancet, are all founding
members of the AMS, each of them having been made fellows in 1998 when the
academic drugs front was first set up.
Lachmann was also on the scientific advisory board of SmithKline Beecham (now GSK), which invests heavily in biotechnology. At the height of the row over GM crops and Arped Puztai, Lachmann, then the first President of AMS (1998 - 2002) and three others wrote a Blimpish letter to the Times (Times December 4 2002), attacking Puztai from their new ensconcement in the Academy.
Not only Horton himself but the apparently independent Lancet is deeply involved in the AMS. In September 2008 the Forum held a one day workshop on 'Benefits and Harms of new medicines'. The workshop was supported by only two funders GSK and the Lancet (16). In 2004 when the most serious attack was carried out against Dr Wakefield by Brian Deer an the year that Horton published his book claiming the absolute safety of MMR, the Lancet's manager at Elsevier was Sir Crispin Davis, who also sat on the Board of GSK.
Funders of the AMS include amongst many: AstraZeneca, Chiron Vaccines, Department of Health, GlaxoSmithKline, Medical Research Council (MRC), NHS Education for Scotland, Roche, Sanofi Pasteur, the Lancet, the Wellcome Trust and Wyeth. The AMS has a Forum that decides upon and pursues academic scientific projects. Funders include the Association of British Industries (ABPI), Astra Zeneca, GSK, the MRC, Merck Sharp & Dohme, Pfizer, Wellcome, Wyeth, the Health Protection Agency and Hoffmann La-Roche.
* * *
Rutter's evidence against Dr Andrew Wakefield
As she led him through his evidence, Miss Smith made a point of revealing
that Sir Michael was primed as an expert witness for Merck in the claim for
compensation taken by the parents against the MMR manufacturers. In turn Rutter
made the point, quite strongly, that the case never actually got to court. At
the end of his evidence, when it was suggested by the Chairman of the Panel that
Rutter ‘acted for’ the pharmaceutical company in the compensation case, Rutter
bridles at the term, telling the Panel that he was an independent expert. One
presumes that experts for the claimants might legitimately lay claim to such
With the possible exception of Professor Zuckerman, Rutter was to become the first real witness for the prosecution. He was an ideological witness, anything but independent, one who was not giving evidence to fact, but rather, agreeing with the prosecution critique of the behaviour, the methods, the language and the professionalism of the three doctors being tried.
Like Professor Booth who came after him, Rutter was to end up giving expert evidence, with a broad brush, on the work of the whole gastrointestinal department at the Royal Free Hospital. This despite admitting at least three times during his evidence that he knew nothing about gastrointestinal medicine. Perhaps even more oddly, at the end of his evidence, he assures the Panel of one thing: he could not, he said, criticise the gastrointestinal work carried out in the department and his view in sum was simply that the neuro-psychiatric aspect of the ‘work up’ on the children was lacking.
This is not something that the defence wanted to argue about. In the main, the majority of the children had already been diagnosed with a disorder on the autistic spectrum before they arrived at the Royal Free. And even though a psychologist did interview a number of the children, the authors of the Lancet paper were quite definite about what they were writing about: a new syndrome which linked inflammatory bowel disease (IBD) to various behavioural disorders, the onset of which a number of parents suggested coincided with their children’s MMR or MR vaccination.
Through a Thursday, Friday and the whole of Monday, Miss Smith presented, for the third time, the whole of the prosecution case; turning from her reading every ten minutes or so to let the Professor reassuringly nod his acquiescence with her case. Rutter was equally uncreative in the presentation of his evidence. It was as if Miss Smith and he were in a three-legged race, both completely of one mind. Rather than elaborate on the various pillars of the case, Professor Rutter simply agreed wholeheartedly, and sometimes enthusiastically, with the propositions put by Miss Smith.
‘It was odd’, he agreed, to this and that. ‘It certainly wasn’t the way he would have done it’, he shook his head, to that or this. Miss Smith segued into a repeat trawl through the cases reported in the Lancet paper. After discussing ethics committee approval, Miss Smith picked up each case one by one and travelled through referral, hospital induction, invasive procedures - particularly in respect of lumbar puncture - lack of consent for, and lack of notes with respect to, involvement in research. Miss Smith bore witness to the howlers, sins, crimes and simple gaffes of Dr Wakefield, in the measured voice of a teacher explaining elementary arithmetic.
Certain matters are not deemed worthy of comment by the prosecution. One such matter is the real, rather than prosecution-sanitised, condition of the children and the crisis of coping and caring which the parents were, and still are, faced with daily. An understanding of the severity of the children’s gastrointestinal condition was absolutely essential to a realistic understanding of the work of Dr Wakefield and others at the Royal Free in the mid 1990s. The prosecution, however, avoided this, as did Professor Rutter, who not being a gastroenterologist had not the faintest notion of the children's medical condition.
While the whole of the prosecution case settled on the twelve children reported in the Lancet paper, no one has made mention of the fact that in the five years between 1993 and 1998 and for some years afterwards, hundreds of parents made their way to the gastrointestinal unit at the Royal Free. They went there often with their own determination, because this was the only collection of doctors in the whole of the UK who were dealing with the public health crisis which had occurred following the introduction of the various MMR or MR products after 1988.
The Deconstruction of Professor Rutter
Oddly, It was not Dr Wakefield who bore the brunt of Rutter's evidence because he had not instructed others to, or himself, carried any 'invasive procedures'. In terms of argument, what Hopkins, Professor Murch's counsel, was able to do, was to make it clear to the panel that much of what Professor Rutter claimed during his evidence-in-chief was little more than personal opinion. Perhaps even more exactly, it was personal opinion heavily biased towards the neuro-psychiatric axis of the arguments around autism.
He began his cross examination by rescuing Dr Wakefield from the isolated corner into which Professor Rutter and Miss Smith had painted him. Hopkins made it clear that there were actually four hospital departments involved in the clinical work of caring for the children who attended the Royal Free. That there were a number of ‘responsible consultants’ making decisions from day to day about treatment and investigations.
Although Hopkins laid siege to each strand of Rutter’s evidence, his strategy was most pronounced when dealing with the matter of lumbar punctures. From the beginning the prosecution has made the case that the use of lumbar puncture, as a diagnostic aid on children, especially children with any kind of autistic disorder, was an abomination akin to torture. Rutter, however, when speaking on lumbar punctures, was at best a reluctant witness. At his most transparent, he was happy to admit that in cases of disintegrative disorder or regressive autism lumbar puncture was necessary in order that encephalopathy could be confirmed or disregarded.
It was apparent that Rutter was concerned at having made this admission and he tried to lessen its force and its use to the defence by claiming that next to none of the cases in the Lancet paper could be shown to have a disintegrative disorder and in other cases lumbar punctures should not be used as a general investigation.
Very gradually, Hopkins introduced papers to the tribunal from Professor Chris Gilberg who has carried out clinical research in Sweden. Hopkins described him as having been an expert in autism for 33 years and pointed out that in the mid 1990s Gilberg was considered a leading authority. But unlike Rutter, Gilberg was in favour of using lumbar puncture.
Rutter began contesting Gilberg’s work, suggesting that he had made a number of mistakes in his career, having evinced arguments which had proved to be wrong or fallacious. This defence came across as the expression of professional jealousy and not as scientific evidence.
Hopkins turned the ratchet up a notch with each paper that he put to Rutter. As the papers mounted, so did their authority and so did the number of authors who favoured the use of lumbar puncture as a primary biomedical investigation. Besieged, Rutter was thrown back on the odd argument that while this might be the case in the rest of the world, in Britain it was not considered an acceptable practice.
Gradually, Hopkins began to develop a more important argument relating to the legitimization of bio-medical investigations. By introducing the idea of the medical work-up in cases of autism, he made it apparent that there was, is and historically always had been, a serious conflict between two schools of thought on the diagnosis and description of autism. These two schools are on the one hand those who believe in an almost entirely psychiatric approach and those who believe that a whole battery of biomedical investigation should be carried out in an attempt to find a medical explanation of autism. While neither of these schools of thought were exclusive, the psychiatric partisans had held sway almost without argument for the last thirty years. This school was, in fact, only now beginning to accept that there might be environmental factors involved in autism. While Gilberg cited the supposition that one in three cases were based upon a ‘medical’ condition, Rutter would agree only to a possible one in ten ratio.
While presenting Gilberg’s papers, Hopkins drew attention to one of his primary suggestions, that there was a serious lack of comprehensive biomedical work-up in autistic cases. The gap between Gilberg and Rutter, and therefore between the Royal Free team and an entrenched psychiatric view of autism, was obviously considerable.
Following the Gilberg papers, Hopkins moved on to deal with a few more of Professor Rutter’s expert views, such as his half-hearted support for the inclusion of bowel pathology in diagnosing cases, and more simple things, such as his views on the patient consent form used by the Royal Free team.
At the end of Mr Hopkins’ cross examination, it was difficult to imagine that the panel had not received the message that Professor Rutter was far from independent in his view of Dr Wakefield’s research. At 2.00 pm on the same day, Mr Miller, counsel for professor Walker-Smith got to his feet. Of the three barristers, Mr Miller appears on the surface to be the most sympathetic. However, seeing him in action it is easy to understand that his introductory bonhomie is simply a distraction. It was never more so than in his dealing with Professor Rutter. After the exchange of a few pleasantries, Mr Miller plunges straight into the heart of his cross examination.
Mr Miller puts it to Professor Rutter that the case-series reported in the Lancet was not the study ‘172/96’, which he and Miss Smith have made the core of the prosecution case. As the argument developed, with Mr Miller putting it to Professor Rutter that the children in the Lancet paper had clearly been treated on the basis of clinical need and not as research subjects, for the first time Rutter’s response became uncertain. He said, ‘My impression is that this is research’.
Mr Miller was positively cruel in his repost, ‘This is the danger of poring over the documents!’ This comment went deep in to the shaky prosecution case and revealed what appeared to be a massive schism in both the prosecution reasoning and the paper work.
Mr Miller drove his point home. In answer to Rutter’s assertion that the children do not represent a homogeneous group, like good research subjects, Mr Miller replies, ‘No one ever went out to look for these specific types of children’.
And on the matter of the research consent forms which Professor Rutter and the prosecution have been adamant are missing from the patient notes, Mr Miller was again scathing. ‘You also say that there are no research forms in the children’s notes; was this because there was no research?’
When Professor Rutter realised what had happened, I would not have been surprised if he had addressed Miss Smith with the words, ‘This is another fine mess you’ve got me into’. To his credit, however, Professor Rutter seemed to suffer the cross-examination in good heart, he continued to protect the prosecution case while sounding almost as if he recognised that, for the moment at least, he was on the losing side.
So there we had it. Research project 172/96, the project that the prosecution maintained had led to the Lancet paper, was actually a quite different project, that had nothing to do with the clinical work that had generated a review of 12 consecutively referred initial cases; cases seen at the Royal Free on the basis of clinical need. Once this had been exposed, one could not help wondering how Miss Smith could continue with a large part of her prosecution. One also had to wonder what the defence had left to throw at Professor Rutter on the next day’s cross-examination. Professor Rutter now appeared to be an expertless expert. He had been softened up by Mr Hopkins and then knocked out by Mr Miller. All the counsel on the defence table seemed to finish their day with eyes averted from prosecution counsel and the expert witness as if embarrassed by the enormity of the prosecution’s mistake.
At the end of cross-examination by the defence, Rutter’s entire case lay in tatters on the floor, and he was left repeating an earlier criticism that ‘the investigations were done without consulting with the other specialists (the psychiatrists and neurological specialists)’. Making the point even more specifically, he said, nearing the end of his cross examination, ‘follow-up is lacking on the neurological, psychiatric side. My criticisms are on the brain side and not on the gut side’.
With this final criticism it appeared, to me at least, that the whole case for bringing Professor Rutter as an expert witness was brought into question. To hear Rutter say that he had no criticisms of the gastrointestinal side of the work, but only the lack of psychiatric and neurological aspects of research or patient care, was to invoke the words of Mandy Rice Davies in the trial of Stephen Ward, ‘Well, he would say that, wouldn’t he’. There can be little doubt, however, that this personal and professional bias was very far away from anything vaguely resembling damning, or even ‘expert’ evidence against Dr Wakefield.
* * *
Professor Booth followed Professor Rutter as an expert witness. He is a gastroenterologist. Not only was Professor Booth not capable of commenting upon the psychological or autistic dimension of the cases but his gastrointestinal appraisal, although expert, could not have been more conservative. By leaving out a whole series of aspects that concerned the doctors working at the Royal Free, his expertise in gastroenterology failed completely to match the more complex cross disciplinary approach that imbued the work of the Royal Free team and specifically the research of Dr Andrew Wakefield.
Although manifestly a consummate professional, with his patients at heart, Professor Booth showed himself to be the very kind of highly qualified clinical practitioner whose safe conservatism probably led to parents with vaccine damaged children seeking out more positive and investigative clinical attention from other practitioners. His diagnostic vision never seemed to stretch further than the most prominent and primary gastrointestinal symptom presented by the children in the Lancet paper. He frequently commented on the fact that this or that child had constipation, or a typical type of diarrhoea, and one got the feeling that this could have been the beginning and end of the diagnostic work undertaken by him in such cases.
Professor Booth’s mental frame of reference appeared to be almost exactly opposite to that of Dr Wakefield and the gastrointestinal team at the Royal Free. Whereas the latter was expansive, interdisciplinary and creative, Professor Booth’s approach appeared to be single-symptom orientated, mono-disciplinary and conservative in its references.
For this reason alone, Professor Booth was a witness who contributed next to nothing to the overall picture of the prosecution. Nor did he further our understanding of the medical practice, or, from the prosecution’s point of view, the supposed criminality of the doctors at the Royal Free. His answer to almost everything was the most conventional answer. What one does not do, he emphasised constantly, is anything unconventional. His evidence steered well clear of any mention of MMR, or vaccine strain measles virus, and he said almost nothing about autism.
Despite the fact that autism did not come within the scope of either his evidence-in chief or his cross examination, at the end of his evidence, he gave a stunningly forceful answer to a panel member who asked him whether disintegrative disorder - so far accepted by everyone during the hearing as being a type of autism – was a product of inflammatory bowel disorder or a neuro-psychiatric disorder. The question was awkwardly put, but even so, the answer to it lay at the centre of the hearing. Ensuring that the panel member stayed in the dark, Booth answered her with an utterly dogmatic response, saying: ‘It is a neuro-psychiatric disorder.' Gladly straying beyond the remit for his expert evidence, Booth answered without faltering as if he had been eagerly awaiting the question.
Booth not only agreed with anything that Miss Smith put to him, but did so in a heavy and ponderous manner, adding a varnish of wrongdoing to simple and often quite uncertain matters. Late in the morning, Booth introduced a radical new note into the evidence, which although it had always slept uncomfortably beneath the surface of the prosecution, had found no one brave, or ill-informed enough, to adopt it. It had frequently been suggested that parents were the motivating force in the referral of patients from GPs to the Royal Free. In Booth’s evidence, this idea was embroidered and built upon. What he termed ‘parent objectivity’ – as if the very matter of being a parent was now one of scientific learning – might, he suggested, be skewed, with parents forcefully pushing the need for invasive investigations against the beleaguered clinician’s better medical judgement. In Booth’s rather bizarre world-view, the desperate parents of children with (psychologically induced) autism, had been willing to offer up their children for all kinds of damaging procedures.
Booth labeled the parents as just short of hysterical for searching unstintingly for a diagnosis and treatment of their children’s condition. Unlike the other witnesses, who had vaguely floated this notion, Booth made it an ideological tenet and he was to repeat it on a number of occasions. Although these remarks were introduced with the caveat ‘this is not to blame anyone’, according to him, parents were ‘vulnerable’ individuals willing to go to any lengths to find out what was causing their children’s (non-medical) pain and (non-medical) ill health. This evidence was, of course, particularly inexpert given that only one of the parents had given a statement to the prosecution.
This concept introduced a new and considerably different perception of the three doctors on trial. Parallel with the idea of vulnerable patients, or parents, runs the idea of exploitative doctors. This, then, was the prosecution getting the ‘parents complaints’, non-existent in reality, into the hearing via the back door. It could be deduced from Booth that the GMC was bringing the case on behalf of parents and children who had been led up the garden path by – and the motivation was never entirely clear – ‘non evidence based’ practitioners at the Royal Free.
Miss Smith spent almost three days again going through the case of each Lancet child with Professor Booth. This was the fourth time that she had performed this act and she was rightly confident in her presentation. We can simply list the other areas in which Booth agreed with Miss Smith in her criticisms of Dr Wakefield and sometimes of Professor Walker-Smith and Professor Murch, which arose mainly during the prosecution review of the children’s cases.
Blood-screening tests should always be done before planning colonoscopies.
The Royal Free team definitely appeared to be involved in research rather then clinical work.
Dr Wakefield frequently appeared to overstep the boundaries of his research employment. Dr Wakefield frequently overstepped his job description.
Dr Wakefield should have had no part in admitting or helping get patients referred from GPs to the Royal Free.
Many of the children were not suffering from disintegrative disorder as suggested by the protocol for project 172/96. Many of the children reported in the Lancet study did not fulfill inclusion criteria for project 172/96.
On occasions it appears that Dr Wakefield actually ordered an investigation.
The team went further than initial/past diagnoses of diarrhoea or constipation to carry out more invasive tests which were rarely indicated.
It is unusual to send a child patient to a tertiary clinical centre hundreds of miles away from their home.
Should Dr Wakefield have been ‘working with children’ when he had no paediatric qualifications.
In a number of cases Professor Booth saw no reason for follow-up investigations.
Professor Booth did not consider it ‘normal’ for a consultant to personally contact a GP, neither he nor any of his colleagues ever did this.
Dr Wakefield should have sought extra Research Ethical Committee approval for the prescription of a novel treatment. (This referred to some of the invasive procedures and prescriptions, but most particularly to ‘transfer factor’).
Dr Wakefield’s taking of blood samples for controls at his son’s birthday party Professor Booth considers ‘deeply disturbing’ and ‘utterly repellant’.
During his cross examination, Professor Booth showed himself radically adept at countering specific questions. Booth argued every question or statement that was put to him by Mr Miller and Mr Hopkins. Although he managed to argue the defence to a stale-mate it is difficult to know whether his strategy actually won him friends. Getting into such personal arguments with counsel is like dancing naked at a psychiatric convention to prove your sanity. It is unlikely that you will gain much advantage from it, except by virtue of respect for your audacity.
It is hard to tell whether Booth embarked upon this strategy of argument because he opposed the medical practices at the Royal Free, or because he is naturally an argumentative person. As time went by it became evident that Booth had come to the GMC to argue, to the point of irrationality, against the work of the Royal Free gastrointestinal team. He made this view clear, not just with reasoned quiet disputation but with free ranging argument that, to paraphrase Professor Rutter, ‘smelt like’ pure bloody mindedness. On the lighter side, his evidence resembled nothing so much as a medical version of The Office.
Both Mr Miller and Mr Hopkins cross examination focused on a small and contained number of specific points.
Was Dr Wakefield carrying out research or was he involved in clinical work?
Were the children reported in the Lancet paper treated in accordance to a research protocol or on the basis of clinical need?
What were the usual procedures used to diagnose IBD in children?
Did the children in the Lancet paper present problems of sufficient seriousness to merit investigation by colonoscopy?
Were screening tests carried out to determine whether the children had signs of IBD prior to colonoscopy?
Did the literature endorse the use of colonoscopy?
Is it useful for a doctor to have a check-list of symptoms in mind when examining children who might be suspected of having IBD?
These seminal questions of the prosecution were restricted to the proper parameters of Professor Booth’s evidence, however, the tides of his evidence lapped on shores miles away from these more focused matters. Before going in detail through his approach to the cross examination, I would make reference to just one matter. Seemingly of a new generation of orthodox physicians, Professor Booth repeated whenever he could the expression ‘evidence-based medicine’; not once did anyone ask him what he meant by this.
I would make two points in relation to this absurd assumption that either Professor Booth or the GMC prosecution supported ‘evidence based medicine’. First, it is palpably obvious that neither of the expert witnesses knew anything at all about the real condition of any of the twelve children upon whose diagnosis and treatment they were commenting. At a distance of over ten years, with restricted notes and the absence of any record of conversations between doctors at the Royal Free and parents, Professor Booth, gave guesstimates, over three days, as to what he would have done in ‘this situation’. It is difficult to imagine anything further from the reality of ‘evidence-based medicine’.
Although Booth’s strategy of arguing about everything carried him through his evidence, and clearly disrupted the defence, he came unstuck on two occasions and was led into ridiculous overcompensation. Both these seminal arguments had to do with the place of colonoscopy in the diagnosis of IBD, a clearly essential component to formulating treatment. Nearing the end of a long day on Wednesday 17th. Mr Miller cross examined Professor Booth on a position paper, The Porto Criteria, which had been formulated by the IBD Working Group of the European Society for Paediatric Gastroenterology, Hepatology and Nutrition, and was termed a ‘Medical Position Paper’ and described as representing ‘recommendations for diagnosis’.
When Mr Miller put ‘…the criteria for inclusion of colonoscopy in investigations of children suspected of having IBD…’ from the Porto paper to Professor Booth the professor was unable to think quickly enough and deny their validity. The paper was very strong in suggesting that colonoscopy was ‘essential’ as a diagnostic aid in cases of children who might have IBD. In agreeing to sentences of the criteria as they were read to him by Mr Miller, Booth almost scuttled the prosecution boat.
In the night, someone must have whispered in his ear, for the next morning, when again confronted with the Porto Criteria, Booth denied them all plausibility. It was clear that someone had helped him find an argument. Now, while still agreeing with the separate criteria and their importance in diagnosis, he claimed that the document in which they were embedded had no validity at all. According to Booth such amateur papers, in this case written-up by 25 or so specialists, were clearly biased in favour of the authors opinions and had no authority. They had, said Professor Booth, been overtaken by objective systematic reviews that scrutinized many papers and articles, coming to a completely independent view of what was considered best practice.
This view was clearly claptrap. However, unfortunately for the defence lawyers, a GMC fitness to practice hearing is not the place to argue sociology, methodology or science. I will briefly make a couple of points which could have been used by the defence in other circumstances. Firstly, the position paper was simply that. The consensual position of 25 practicing clinicians. It existed as a guide for anyone in the society who thought that it made sense. Secondly, it is not possible to arrive at an objective consensual view by systematic review in circumstances where there is major conflict. What does emerge from such work is the dominant and orthodox view that is usually the most conservative reduction; not necessarily the right conclusion or the most creative view.
The second of Booth’s pratfalls also grew from his attempt to extricate himself from his previous days agreement with the Porto criteria. Now, under cross examination from Mr Hopkins, Booth developed a theme that he had been warming to throughout his evidence and which suited most completely his bizarre argumentative disposition. In order to deny the symptomatic criteria for the use of colonoscopy in the investigation of suspected cases of IBD, Booth denied that what he called ‘tick lists’ were of any use. If he had left this view as a general remark, in the way that Professor Rutter might, there can be no doubt that it might have held some meaning. Unfortunately for all those who had to listen, Booth became involved in a repetitive incantation that claimed not only were all these listed symptomatic criteria in the Porto document known to every practicing gastroenterologist, but checklists were useless without the experiential skill of the physician who could asses and balance the various items on the list. When Booth made deep incursions into this argument, he began to sound quite barmy because of course no one had ever suggested that these lists should be used by first time amateur practitioners, say the next door neighbour, who had decided to carry out a helpful colonoscopy. Everyone had taken it for granted that it was experienced doctors who diagnosed IBD and then decided whether or not colonoscopies were a necessary investigation.
It was clear from the beginning of Professor Booth’s evidence that he and the doctors practising at the Royal Free had completely different approaches and were looking for quite different things in their patients.
While those at the Royal Free were of the opinion that an extensive and cross disciplinary ‘work-up’ was of the essence in attempting to diagnose and therefore treat the very serious illnesses of the children concerned, Professor Booth, no less professionally, believed that a gastroenterologist should be mainly concerned with first symptomatic manifestations, best diagnosed and treated without invasive investigations; an approach, as Mr Miller put to Professor Booth in cross examination, that might be described as ‘wooden’.
* * *
So there in the evidence of the General Practitioners, non of whom knew anything at all about the behaviour of Dr Wakefield at the Royal Free Hospital nor anything specific or specialised about IBD, and the two expert witnesses, Sir Michael Rutter and Professor Booth, we see the full extent of the case against Dr Wakefield on the matter of whether he carried out non clinical research on the 12 Lancet children cited in the Lancet paper.
'But surely', I hear you cry, 'there must have been other evidence!' There wasn't. What there was, however, was a mass of innuendo, prosecution assertions, haphazard asides and Deerisms (defined as un-researched and usually defamatory statements made by Brian Deer) which tended to make it look as if Dr Wakefield and the other two defendants were men of evil design. In the GMC Fitness to Practice Hearing against Dr Wakefield, Professor Murch and Professor Walker-Smith it might be said that the Prosecution argued a good case completely unsupported by evidence and using the untruthful premise that the Lancet case review paper was a botched and illegitimate piece of research carried out by mercenary doctors at the behest of hysterical parents who wanted to prove that MMR caused autism. When one considers that the British Government, the GMC, the Sunday Times and the pharmaceutical industry dragged this burning case from the ashes of the parents claim heading for the high court and remodelled it into a Phoenix of vaccine damage denial, we can only be amazed, not just at the cruel inhumanity of those involved but also at their strategic brilliance.
(1) The case of Margaret Best and Kevin, her whooping cough vaccine damaged son. There have been out-of-court settlements but always on pharmaceutical company terms.
(2) In Britain law firms, taking defence cases or claimants cases in civil actions, were until recently totally dependent upon state aid to pursue the case. More recently the state has cut back drastically on Legal Aid, so making it impossible for many poorer individuals or groups to be involved at all in the legal system. British lawyers have shown no desire to get involved in pro bono cases on a no win no fee bases, instead preferring to let wrongly accused defendants and damaged civil claimants go to the wall.
(3) Up until the time of the last whooping cough vaccine claims trials, the parents told their stories, the defence cross-examined them and the jury, after also having heard the expert witnesses believed or disbelieved them.
(4) In fact, Dr Wakefield did not take the blood samples in question, they were taken by a fully qualified nurse.
(5) Silenced Witnesses first volume and Volume II: The Parents' Story
(6) Joan Cambpell on Jack in A belief in Angels, volume One of Silenced Witnesses.
(7) Deborah Nash on David, In The Presence of Strangers, the first volume of Silenced Witnesses.
(8) Heather Edwards on Josh in Suffering in Silence, Silenced Witnesses Volume II: The Parents' Story
(9) Celia Forrest on her son Adam, in Adam, Silenced Witnesses Volume II: The Parents' Story
(10) Deborah Heather on her son Andrew, in Being the Voice of my Child, Silenced Witnesses Volume II: The Parents' Story
(11) Polly Tommy on her son Billy, in Futures for Billy, Silenced Witnesses Volume II: The Parents' Story
(12) Richard and Jan Crean on their son Thomas in Disgusterous!, Silenced Witnesses Volume II: The Parents' Story
(13) The prosecution did bring one parent to the hearing. However, they got her to give evidence under false pretences, telling her that she would be giving evidence for Dr Wakefield when in fact she was being called by the prosecution.
(14) From their web site.
(15) Uncorrected transcript of oral evidence - to be published as HC 490-i House of Commons minutes of Evidence taken before science and technology committee OST scrutiny 2005. Wednesday 19 October, Lord Sainsbury of Turville.
(16) Annual Report and Financial Statements 31st March 2009.
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.
March 28, 2010
Counterfeit Law, Part Three: Houdini Horton
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.
* * *
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.
* * *
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.
* * *
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 forthcoming 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
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
(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.