OBJECTIVE: To determine if there is evidence for a causal relationship between acute encephalopathy followed by permanent brain injury or death associated with the administration of further attenuated measles vaccines (Attenuvax or Lirugen, Hoechst Marion Roussel, Kansas City, MO), mumps vaccine (Mumpsvax, Merck and Co, Inc, West Point, PA), or rubella vaccines (Meruvax or Meruvax II, Merck and Co, Inc, West Point, PA), combined measles and rubella vaccine (M-R-Vax or M-R-Vax II, Merck and Co, Inc, West Point, PA), or combined measles, mumps, and rubella vaccine (M-M-R or M-M-R II, Merck and Co, Inc, West Point, PA), the lead author reviewed claims submitted to the National Vaccine Injury Compensation Program. METHODS: The medical records of children who met the inclusion criteria of receiving the first dose of these vaccines between 1970 and 1993 and who developed such an encephalopathy with no determined cause within 15 days were identified and analyzed. RESULTS: A total of 48 children, ages 10 to 49 months, met the inclusion criteria after receiving measles vaccine, alone or in combination. Eight children died, and the remainder had mental regression and retardation, chronic seizures, motor and sensory deficits, and movement disorders. The onset of neurologic signs or symptoms occurred with a nonrandom, statistically significant distribution of cases on days 8 and 9. No cases were identified after the administration of monovalent mumps or rubella vaccine. CONCLUSIONS: This clustering suggests that a causal relationship between measles vaccine and encephalopathy may exist as a rare complication of measles immunization.
Source: Pediatrics. 1998 Mar;101(3 Pt 1):383-7.
The Sunday Times last weekend resumed its witch-hunt against Andrew Wakefield, the gastro-enterologist who warned against the possible risks to children of the MMR vaccine following a paper he wrote in the Lancet in 1998. In this paper, he described a new childhood syndrome which he called autistic enterocolitis, which suggested a connection between a new type of bowel disease and autistic spectrum disorder and reported the fact that some of the parents of the children in the study thought there was a connection between these symptoms and the MMR vaccine. The titanic furore which subsequently engulfed Wakefield, in which virtually the entire medical establishment turned on him, effectively forced him out of Britain and has resulted in his being investigated by the General Medical Council for serious misconduct.
The campaign against Wakefield in the Sunday Times has been led by journalist Brian Deer. Last weekend, the paper published a two-page ‘investigation’ and a front-page spin-off story alleging that
confidential medical documents and interviews with witnesses
have established Wakefield had
changed and misreported results in his research, creating the appearance of a possible link with autism…
amidst various other lurid charges. Deer claimed that his ‘investigation’ was
confirmed by evidence presented to the General Medical Council
What the Sunday Times did not report was that the GMC investigation into Wakefield was triggered by a complaint from… Brian Deer, who furnished the allegations against him four years ago. He has thus been reporting upon the hearing into his own complaint. Since when has a reputable paper published a story by a reporter who is actually part of that story himself — without saying so – and who uses information arising from the disciplinary hearing which he himself has instigated and which is investigating allegations he himself made in the first place?
Wakefield has issued a detailed refutation of Deer’s allegations, reported here. I reproduce his response below in full ( for clarity, I set out Wakefield’s responses to Deer in bold type and identified by the letter W).
W: Below is a list of the allegations made by Brain Deer against me, received on Friday 6th February 2009, 2 days prior to his publishing in the UK’s Sunday Times newspaper.
Dear Dr Wakefield,
I’m directed by editors managing my investigation of the MMR matter for The Sunday Times to inform you that we intend to publish further on this topic, and particularly on your role in it. It is now some five years since I first sought to discuss with you your work, and I’ve made numerous attempts to do so. As you will appreciate, the safety of children by means of vaccination is an unparalleled issue of public interest and concern.
As you will know, not least as a result of our concurrent attendance at the General Medical Council fitness to practise hearing into your conduct, I’m now extremely familiar with the precise medical histories, diagnoses and so forth of the children enrolled for your study, published in the Lancet on 28 February 1998. Based on this knowledge, and other sources of information, including the cooperation of families enrolled in your research, I must put to you, for your response, a number of serious matters.
(1)That you repeatedly, and without justification, changed and misreported findings from those children for publication in the Lancet.
I cite, for instance, three children who you represented as having regressive autism, who in fact had Asperger’s disorder, or in one of those cases PDAS, which are not regressive and involve no loss of language or other basic skills. You claim that the paper is a series of “previously normal” children, but medical records – which you had a duty to read and understand – show that some five of the 12 children were subject to concerns prior to vaccination, and were not “normal”. Other children, who you claimed to have suffered their first “behavioural symptoms” within days of vaccination, in fact had none for months. In the cases of some 8 children – two thirds of the total – you changed normal histopathology results to abnormal results, in a so-called “research review”, despite claiming that the series was merely a clinical report.
W: The diagnoses reported in the Lancet were accurate based upon the information provided to the clinicians and review of the available records. (I) Where there was considered to be a pre-existing developmental problem, this was accurately reported in the Lancet paper. (II) This is not the place to get into a detailed discussion on developmental regression which is still a subject of debate
experts in child development and is certainly not something about which Deer has any expertise.
It is a matter of fact that I did not play any part whatsoever in making the microscopic diagnoses of inflammation on any biopsy from any child investigated at the Royal Free Hospital. Intestinal tissues were examined, and the children’s pathology documented, by two doctors (not me) employed in the Department of Histopathology who were experienced in bowel disease, using an agreed protocol to ensure rigor and consistency . These doctors were co-authors on the paper. The same tissues were reviewed by Professor Walker-Smith and his team. I merely entered the documented findings into the Lancet paper. I did not “change” any findings as alleged. The paper was then reviewed by the relevant authors prior to submission to the Lancet in order to confirm that the diagnoses were correct. The findings reported in the Lancet are, in the opinion of the relevant authors, correct. This is a matter of record at the GMC.
(2) That, without justification, you omitted parental links to MMR in the case of one quarter of the children, in order to reach your unsubstantiated claim in the paper that problems came on within days.
Contrary to your claim that the parents of 8 of 12 children linked MMR to their child’s problems, in fact the parents of 11 of the children made this connection whilst at the Royal Free. The additional, unreported, children are Child Five, Child Nine and Child Twelve. Their parents said that problems came on between one and four months after MMR, and their hospital records, which you had access to (and in one case wrote), show this. Through the device of their omission, you contrived to create the appearance of a clearcut temporal link between MMR and autism, when there was none such. Furthermore, by their omission, you contrived to create the appearance that these children were routine clinical cases passing through the hospital, when in fact, as you knew, they were recruited, marshalled and referred in collaboration between you, JABS and a solicitor. As such, they were bound to blame MMR when they came to the hospital.
W: This is a particularly tortuous argument that reflects Deer’s grasp (or lack of it) on both the scientific process and the evidence. Parents of 8 of the 12 children made the link between MMR vaccination and onset of symptoms contemporaneously. Other parents made the link retrospectively, that is, some years later. We reported on those 8 who made the link at the time of their child’s deterioration and excluded those who made the link later in order to remove any bias associated with recall that may have been prompted by, for example, media coverage. To have done otherwise would have been potentially misleading.
In fact, when all of the medical and parental records were made available via the GMC many years later, it became apparent that one further parent had made the link with MMR contemporaneously, but had remained silent on this at the request of her husband because it had led to doctors dismissing their concerns about their child’s medical problems on the basis that they were “just looking for something to blame.” This in itself is a telling indictment of how a possible cause risks being overlooked because of the prejudice of some physicians.
The second part of this allegation, which is dependent upon the fallacy in the first part, is nonsense. The route by which the children came to the Royal Free was one driven by clinical need and had nothing whatsoever to do with the lawyer Richard Barr. The facts of this matter and in particular the route by which the children came to be seen by Professor Walker-Smith, have been reported to the GMC. This allegation – one which Deer has rehashed in spite of the evidence – has no basis in fact.
It need hardly be stated again after so many occasions in the GMC but the leading, primary and principal reason all twelve children ended up at the Royal Free, was that they had bowel or ‘stomach’ problems. The matter of vaccination was brought up by parents because they thought that it was relevant to the clinical diagnosis.
(3) That the paper you wrote and published in the Lancet was a device, assisting you in obtaining money from the Legal Aid Board.
I draw to your attention your prior contractual undertaking with Mr Barr, and your joint undertaking to the Legal Aid Board to attempt to find a “new syndrome”. This latter undertaking was entered into before any of the children were admitted to the Royal Free, or you could ever have known of any syndrome. Eighteen months later, you would declare that you had found precisely such a syndrome, based on the 8/12 temporal link, and an alleged coincidence of regressive autism and inflammatory bowel disease. The records show that neither of these are valid. Without the public ever suspecting, the route by which you reached this claim required the wholesale changing and misreporting of data. Following your claims, to which you attached the reputations of 12 other, generally unwitting, doctors, you successfully extracted substantial sums of money from the legal aid fund, not least for the business Unigenetics, of which you were a director, and for yourself personally. We have previously reported that the Legal Services Commission says that you pocketed more than £435,000, plus expenses. The amounts you received increased as the scare you created continued: the grossest possible conflict of interest.
W: Deer is wrong on all counts. The purpose of the contract with Mr Barr was to conduct a scientific study to look for measles virus proteins in the bowel of children (initially those with Crohn’s disease and later, to include those with autism and intestinal symptoms (such as abdominal pain and diarrhea) that required endoscopic examination and biopsy. On the other hand, the clinical basis for the investigation of the autistic children has been established by my pediatric colleagues – two of the most experienced pediatric gastroenterologists worldwide – beyond any reasonable doubt.
Deer has completely missed the point; the “syndrome” that we have accurately and reproducibly described is the combination of autistic regression, swelling of the lymph glands in the last part of the small intestine (ileum) and inflammation of the colon. Any association of this syndrome with MMR vaccine remains to be confirmed and, in contrast with Deer’s claim, the syndrome does not require any temporal link to MMR vaccination at all. This has been made clear to the GMC.
The children who turned out to suffer from the “syndrome” were referred as early as May 1995, long before I had ever heard of Richard Barr or vaccine litigation. Deer is aware of this fact.
Any payment that I received over the course of working for more than 7 years as a expert to the UK courts in the MMR litigation – substantially less than the sum Deer claims – was donated to an initiative to build a new center for the investigation and care of patients with inflammatory bowel disease at the Royal Free. This matter is described in more detail in a forthcoming essay by Bill Long, access to which will be posted in due course at http://www.drbilllong.com/index.html.
I resigned from Unigenetics and was not involved in the dealings of this company with the Legal Aid Board.
Finally, I did not “create” a scare but rather, I responded to a scare that parents brought to my attention. To have ignored their concerns would have been professional negligence.
(4) That, additional to the above, in recent years you have reviewed your changes and misreportings in the Lancet, and yet you have neither withdrawn your claims in the paper, nor sincerely and publicly apologised for your conduct, as you should have done.
As a result of the GMC hearings, you have been supplied with all the documentation, and, indeed, were last year taken by counsel through the changes and misreportings. There can be no question that you know the precise details of these children. Particularly given outbreaks of measles, widely reported in UK media most recently today, and the appalling burden of guilt laid on the parents of autistic children who believe it was their own fault for vaccinating their child, you had an absolute duty to come forward at the earliest opportunity and make the position clear. You have not done so, but indeed continue to display the paper’s claims on your website, and to campaign against MMR.
W: The evidence presented by me to the GMC described precisely and accurately the basis of the findings reported in the Lancet. The absence of any ‘misreporting’ is a matter of record both in my oral testimony and in that of my clinical colleagues. There is absolutely nothing either to withdraw or to apologize for in this matter. It is, however, a tragedy that the continued misrepresentation of the facts has had a negative impact on the ability of affected children to get access to the care that they so desperately need.
(5) That, overall, you created the appearance of a possible link between MMR and autism, when you knew, or should have known, that there was no reasonable basis for this in the histories of those children, and, as a result have caused immense and growing harm, unnecessary concern and waste of public money.
In summary, not one of the 12 children is free of serious doubt as to the manner in which their case has been reported by you. Indeed, there is no real evidence that any of the children were as you reported in the Lancet. When lack of evidence of previous normality, lack of evidence of regression, lack of evidence of inflammatory bowel disease, and lack of any temporal link as you describe, are taken into account, there was no basis in the records for your claim to have discovered any new syndrome at all.
W: Based upon the parental histories of regression in their children after MMR vaccine, the known link between measles and brain damage including autism (III)and the findings in the children, there was and continues to be every reasonable basis for suspecting a possible link between MMR vaccination and autistic regression.
The reporting of the children in the Lancet paper is an accurate account of the clinical histories as reported to Professor Walker-Smith and his clinical colleagues. The normality or otherwise of the children’s development was evident in the medical history taken by these clinicians, and backed up by the Health Visitor’s (IV) contemporaneous record of the respective child’s development. The claim to have detected a possible new syndrome was valid and, in contrast with Deer’ false claim, is supported by confirmation of the original findings by others. (V)
As you will see, the issues we raise with you are not the same as the charges you face before the GMC, although the fitness to practise hearings have, as expected, yielded important insights and evidence. It is clear that, particularly in the context of measles outbreaks in the UK, US, Europe and now Australasia, it is important that the public be urgently informed of the true position at the earliest possible date.
W: On the contrary, the issues raised by Deer are, in many respects, identical to those raised by him on previous occasions. One can only imagine that, as the evidence has emerged at the GMC, the fallacy of Deer’s original allegations has become clear. The timing and content of Deer’s latest allegations and the published article, his behavior at the GMC hearing (See “The Incident” by Martin Walker (VI) ), and recent admissions of failings in the area of vaccine safety by the US National Vaccine Advisory Committee, suggest a degree of desperation on the part of Deer and those with whom he is working.
Measles outbreaks are preventable, immediately, by offering to parents with entirely valid concerns about the safety of MMR vaccine, a choice of single measles vaccine; not to do so is unethical and puts the vaccine policy, “our way or no way”, before the wellbeing of children.
There is absolutely no question of the continuing investigation and treatment of these children coming to a halt because of this or any other kind of subversive tactic.*
It is remarkable how so many commentators take at face value the claims being made by Wakefield’s detractors, and how many recycle the misrepresentions of easily verifiable facts – such as what the Wakefield paper actually said – which his detractors disseminate. For more context, read this new paper by Wakefield et al which points out, among other things, the suspect nature of much of the research upon which the claims that MMR has been proved beyond a shadow of doubt to be safe are based:
Most critics fail to reference the authoritative Cochrane review of these studies—exclusively non-clinical—which dismissed most of the “major studies” upon which the IOM relied as being of insufficient quality to merit consideration. This includes the work of Eric Fombonne [133], of which the review said, “the number and possible impact of biases in this study was so high that interpretation of the results was difficult” [134]. Further, in an extraordinary paper, “Tale of Two Cities” [135], Dr. Fouad Yazbak uncovered how Dr. Eric Fombonne mixed data from two Canadian cities, Montreal and Quebec City, to create the misleading impression that autism had gone up when MMR uptake was falling [136]. Dr. Yazbak’s investigation showed that when autism and MMR uptake rates in the same city (Montreal) were compared, both went up [135].
More importantly, however, data that have been represented to the public as showing no association between MMR and autism in fact show just the opposite. A case in point is the CDC’s own study looking at age-at-first-MMR vaccination and autism risk [137]. The study found a statistically significant association between younger age at MMR vaccination and an increased risk of autism. This risk was greatest in the most recently vaccinated children. Why? The age at first MMR vaccination has gone down over time [138, 139]
And also, on the original vaccine safety trials:
The deficiencies in vaccine safety studies were later reinforced by the systematic analysis of Dr. Thomas Jefferson and colleagues from the Cochrane Collaboration, an internationally respected body that provides independent scientific oversight. They wrote, “The design and reporting of safety outcomes in MMR vaccine studies, both pre and postmarketing is largely inadequate” [134]. In an interview with Richard Halvorsen for his book The Truth about Vaccines, [155] one of the lead authors of the Cochrane review left no doubt as to his true feelings when he said, “The safety studies of MMR vaccine are crap. They’re the best crap we have but they’re still crap” [156].
I have written about the Wakefield MMR affair here, here, here, here, here,here,here and here. I have read much of the relevant research, spoken to dozens of parents, interviewed several of the dramatis personae in the history of this vaccine and consulted experts on both sides. Like everyone else, I await the conclusion of the GMC hearing and have no idea how that will end. But I note the fact that, in relation to the most incendiary allegation against Wakefield — that he used the children who figured in the Lancet paper to further an undeclared and pre-existing paid study in connection with the parents’ law suit to prove that something was wrong with MMR — the first of these children was referred to him in 1995, while he did not undertake the study in question until two years later. The parents themselves told me, when I wrote about this in 2003, that they had gone to Wakefield in desperation because no other doctor would take seriously their perception that something untoward and catastrophic had gone wrong with their child’s gut and that this was somehow connected to an inexplicable developmental problem in the child– and they had heard on the grapevine that there was a gastro-enterologist at the Royal Free Hospital who was prepared to listen.
I stand by everything I have written and the conclusions I have previously reached: that the clinical jury is still out on the risks of MMR; that the epidemiological research on which the claims are based that it has conclusively been proved to be safe is at best methodologically inadequate and at worst has been misleadingly spun; that although any link to MMR remains unproven, Wakefield’s Lancet findings of a new clinical syndrome have been replicated; and that far from being, as it is claimed, conclusively disproved, his concern that while the vast majority of children have no side effects from MMR a small proportion may be vulnerable through the impact of the vaccine on some kind of pre-existing vulnerability looks ever more plausible.
I note that – unreported in the UK mainstream media – there have been two significant developments in the US. The first was the Hannah Poling case, which I first commented upon here and in which, in a landmark ruling, the US Court of Federal Claims, Office of the Special Master conceded a vaccine injury to a child from Georgia who, having been developing normally until she received nine simultaneous vaccinations including MMR, subsequently developed serious brain and body disorders. The court ruled that
the vaccinations [Hannah Poling] received on July 19, 2000 significantly aggravated an underlying mitochondrial disorder, which predisposed her to deficits in cellular energy metabolism, and manifested as a regressive encephalopathy with features of autism spectrum disorder.
We don’t know which of these nine vaccines triggered this catastrophic reaction. But the significance of this case is that it established for the first time that a hitherto unknown problem with a child’s cellular system caused a catastrophic reaction in that child to a vaccination schedule, including delivery of the already multiple MMR, that has produced no ill-effects in other children.
The Poling case was almost certainly behind the remarkable comments made by Dr Bernardine Healy, the former head of the National Institute of Health, who told CBS News last year:
The government has said in a report by the Institute of Medicine, and by the way I’m a member of the Institute of Medicine—I love the Institute of Medicine—but a report in 2004 basically said ‘do not pursue susceptibility groups—don’t look for those patients—those children who may be vulnerable.’ I really take issue with that conclusion. The reason why they didn’t want to look for those susceptibility groups was because they were afraid that if they found them, however big or small they were, that that would scare the public away….there is a completely expressed concern—that they don’t want to pursue a hypothesis because that hypothesis could be damaging to the public health community at large by scaring people. First of all, I think the public’s smarter than that. The public values vaccines. But more importantly, I don’t think you should ever turn your back on any scientific hypothesis because you’re afraid of what it might show.
…When I first heard that there was a link between autism and vaccines, I thought that was silly. Really, I tended to dismiss it just on the superficial kind of reading, just reading what was in the papers, no offense to the media—so when I first heard about it I thought ‘well, that doesn’t make sense to me.’ The more you delve into it, if you look at the basic science, if you look at the research that’s been done in animals, if you also look at some of these individual cases, and if you look at the evidence that there is no link, what I come away with is the question has not been answered …I think that the public health officials have been too quick to dismiss the [autism link to vaccination] hypothesis as irrational.
It is of course precisely Wakefield’s concern that the MMR vaccine might, in a small proportion of cases, trigger a catastrophic reaction in a child with an as yet unknown pre-existing vulnerability. For that he is being hung out to dry – and any discussion about his concern is being suppressed by the intimidatory tactic of blaming anyone who says he might have a point for the reported rise in measles cases. As has been said over and over again from the very start, that problem could have been totally avoided if the government had provided single measles jabs. It refused — because it was determined not to concede any ground over multiple vaccines and so decided instead to play for the highest possible stakes in destroying Andrew Wakefield. It is the Department of Health – which never flags up similar concerns about the rise in cases of autistic spectrum disorder — that is responsible for the rise in measles cases.
Truly, health policy and a show trial straight out of Kafka.
Update: An American court looking at three further test cases has ruled that there is no proven link between the MMR vaccine and autism. The judges said parents had been misled by doctors who were guilty of ‘gross medical misjudgment’ and had peddled ‘speculative and unpersuasive’ theories. Campaigners have claimed the ruling was a politically driven reaction to the Poling case.
*Notes:
I) Health Visitor checks: a routine regular developmental and physical in-home assessment of children by the National Health Service in the UK
II) Lancet 1998:351; 637-41
III) Deykin EY, MacMahon B, Viral exposure and autism. Am J Epidemiol, 1979;109:628–38. Ring A, Barak Y, Ticher A, et al. Evidence for an infectious etiology in autism. Pathophysiology, 1997; 4:91–96.
IV) Health Visitor checks: a routine regular developmental and physical in-home assessment of children by the National Health Service in the UK
V) Gonzalez, L., et al., Endoscopic and Histological Characteristics of the Digestive Mucosa in Autistic Children with gastro-Intestinal Symptoms: A Preliminary Report. GEN Suplemento Especial de Pediatria, 2005;1:41-47. Balzola, F., et al., Panenteric IBD-like disease in a patient with regressive autism shown for the first time by wireless capsule enteroscopy: Another piece in the jig-saw of the gut-brain syndrome? American Journal of Gastroenterology, 2005. 100(4): p. 979- 981. Krigsman A et al. http://www.cevs.ucdavis.edu/Cofred/Public/Aca/WebSec.cfm?confid=238&webid=1245 last accessed June 2007) (paper submitted for publication)
VI) http://www.cryshame.co.uk//index.php?option=com_content&task=view&id=113&Itemid=192
Source: The Spectator, by Melanie Phillips, 11 February 2009.
