Managing Editor's Note: Below is a detailed "weekend read" from Martin Walker, who has covered the GMC Hearing since its start. Grab of mug of coffee or a cup of tea and enjoy.
By Martin Walker
Part Two of Counterfeit Law: A Tale of Two Trials
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 similar independence?
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.
(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, Volume II of Silenced Witnesses.
(9) Celia Forrest on her son Adam, in Adam, Volume II of Silenced Witnesses
(10) Deborah Heather on her son Andrew, in Being the Voice of my Child, Volume II or Silenced Witnesses.
(11) Polly Tommy on her son Billy, in Futures for Billy, Volume II of Silenced Witnesses.
(12) Richard and Jan Crean on their son Thomas in Disgusterous!, Volume II of Silenced Witnesses.
(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.