Doctor's research finds link between MMR vaccine, autism
By Cynthia T. Pegram
Lynchburg News and Advance
Sunday, May 25, 2003
On the screen was a photo of a toddler, smiling.
The next photo was of a pale child, a few years older with no expression. “The lights in this child’s life had effectively gone out,” said Dr. Andrew Wakefield, describing the first autistic child he’d seen. Wakefield was one of five speakers at a Saturday conference sponsored by the Central Virginia Autism Group. The audience of more than 100 included parents, therapists, teachers, speech therapists and others in related fields. Autism is a disorder that ranges from mild to severe and impairs a child’s ability to process sensory information, creating problems in learning and behavior.

The autistic child first treated by Wakefield, a British gastroenterologist, sent him on a research journey that has taken him away from the established medical opinion about autism as a neurological disorder. His research links the MMR (Measles, Mumps, Rubella) vaccine with autism. His detractors say if there was credible evidence the vaccine would be off the market. Wakefield described how the child’s mother said her son was developmentally normal until he had his MMR vaccine at 15 months old. Then the autism appeared, and with it severe bowel problems. She wanted him examined for bowel disease, but doctors had repeatedly told her “he’s autistic. They’re bound to have bowel problems.”
The circular logic made no sense.

That was more than five years ago. Since then Wakefield has studied bowel disease in children with autism. He has identified an inflammatory condition that seems to be linked to the MMR vaccine, which at that time contained a mercury preservative. His team’s first findings on 12 children were published in The Lancet, a British medical journal, and for the first time brought to light on-going parental concerns about the vaccine and changes in their children. Wakefield lost his job after refusing to back down from the findings and now continues research with several other teams, finding evidence that argues against traditional public health practices using vaccines. His latest findings implicate the measles virus used in the vaccine. Wakefield says that the children with the inflammatory disorder in the bowel also include those with other developmental disorders.

“It suggests the spectrum of biological disorders … may have a common link,” he said. The inflammation is throughout the intestines, he said. The only other viral infection with such an impact, he said, is in AIDS. “Clearly these children don’t have HIV infection,” he said. “But they have all the features of a chronic viral disease of the intestine.” How does that create the problems of autism? The damaged membrane of the intestine, he explained, can’t act as an efficient barrier to harmful molecules which can then enter the blood stream. Wakefield said that it was the parents who saw the connection between the vaccine and the changes in their children “The parents were right,” he said. “The medical profession, to a man and to a woman, virtually, was not. That is a lesson in humility.”

Autism is very complex, said Dr. Mary Megson, a Richmond pediatrician, who has more than 2,000 patients who have autism and other disabilities. “I think autism is caused by having a genetic predisposition and then an environmental event which disconnects major metabolic pathways in the body,” she said. Megson is having some success treating autism with vitamin A, which is best absorbed as an oil molecule but most often found in other forms in today’s diet. As she researched vitamin A, she found it affected cell growth differentiation, cell repair, vision, immune function, genetic expression and modulating metabolism. “Sounds like a list of areas affected by autism, doesn’t it?” she asked, rhetorically. “The first child I treated was a fifth-grader with no language,” she said. “I put him on just the RDA, the recommended dietary requirement of vitamin A in the form of oil molecules — cod liver oil. Three weeks later, when I walked into the room, he was telling his mother ‘leave me alone, I can get up on the table by myself.’”

Having an active practice, she began evaluating visual function and family history that might relate to vitamin A, such as night blindness. And she found it. She now believes that many autistic children have vision without the ability to perceive the shading that gives form and shape to objects. Something blocks the metabolic pathways so the production of normal vision doesn’t happen. As a result, the child sees the world in a bizarre pattern and blobs of color that make little sense. Vision is just one of many pathways that can be affected. The DPT vaccines were first given in 1943, she said. Autism is now growing at an extraordinary rate. “We have a huge increase,” said Dr. Elizabeth Mumper, a Lynchburg pediatrician. Of special concern to her is the amount of mercury that children got with their vaccines prior to the late 1980s and early 1990s. Mercury is toxic to the brain. Although each vaccine was well within the guidelines for mercury exposure, children got several vaccines in one visit to the doctor. As a result, some were getting 125 times the “safe” exposure levels on a single day. Although the goal was to make sure the children were protected from five or six deadly infections they might catch, the unintended consequence was the very high mercury level, so high that damage could be predicted to occur, if it had been known. Babies were getting very small doses, she said, “but we were giving them to very small people.” Although much of the conference was highly technical, it didn’t seem to daunt anyone. “It is complicated,” said Willmer Price, parent of a 3½-year-old autistic child. “Autism itself is complicated. So there is no one answer to any of the problems.”
ä Contact Cynthia Pegram at cpegram@newsadvance.com or (434) 385-5541.

 

Testimony of Dr Andrew J Wakefield MB MS FRCS FRCPath
Committee on Government Reform
June 2002
  http://www.house.gov/reform/hearings/healthcare/02.06.19/index.htm
Mr Chairman and members of the Committee,
Before bringing you up to date with the research linking MMR vaccine to regressive autism I will put the record straight with respect to Dr Gershon' s testimony last year on the molecular detection of measles virus in the laboratory of Professor O'Leary. Dr Gershon's testimony was false in relation to a number of assertions, whether or not his testimony constituted perjury or simply sloppy science. It is not my wish to take up valuable time in this hearing with the details of Dr Gershon's unacceptable errors. All correspondence and raw data have been provided to the ranking majority and minority members. Merely by way of illustration, he stated that tissues from experimental animals not infected with measles virus were positive in Professor O'Leary's lab. In fact they were all entirely and consistently negative on repeat testing. Dr Gershon's behavior was a disgrace. I would level the same charge at anyone who relies or has relied in any way upon this testimony. I am not surprised that Dr Gershon turned down the offer to appear before this committee. Had he done so, I am sure he would have enlightened the Committee, somewhat belatedly, as to any proprietary rights his wife might have in the Merck chickenpox vaccine patent.

The current sate of the science:
The association between MMR vaccine, autism and intestinal inflammation was first suggested by my group from the Royal Free Medical School in 1998 in a paper published in the Lancet. The same research team, in collaboration with Professor John O'Leary and Dr Simon Murch from the Royal Free Hospital, has since shown in a comprehensive series of eight peer-reviewed scientific studies that the major findings of our original study were correct. These papers are listed as an appendix. The sum of the research by my group and our collaborators, taken together with additional work by independent physicians and scientists in the United States has now confirmed the following facts.

1. Children with regressive autism and intestinal symptoms have a novel and characteristic inflammatory disease of their intestine (1-4).

2. This disease is not found in developmentally normal control children(2-4).

3.  This disease is entirely consistent with a viral cause (5-8).

4.  This disease may be the source of toxic damage to the brain (9).

5.  Measles virus has been identified in the diseased intestine in the majority of children with regressive autism studied, precisely where it would be expected if were the cause of the intestinal disease (5,8).

6. These children, who suffer the same pattern of regressive autism and intestinal inflammation, come from many countries including the US and Ireland where they have been investigated and biopsied independently.

7.  Measles virus has been found in only a small minority of developmentally normal children (5).

8. The measles virus in the diseased intestine of autistic children is from the vaccine (11).

9.  Children with regressive autism appear to have an abnormal immune response to measles virus (1a,2a)

These findings are entirely consistent with parental reports that their normally developing child regressed into autism following exposure to MMR vaccine (1,11).

Confirmation of intestinal findings
Other researchers in the US have confirmed the presence of intestinal inflammation in children with regressive autism (3a & see testimony of Dr A.Krigsman MD) and, independently, the link with measles virus in children who were given the MMR vaccine (12,13). Measles virus sequencing Most significantly, a study due to be presented at the Pathological Society of Great Britain and Ireland, in Dublin at the beginning of July has confirmed that the measles vaccine virus is present in the diseased intestinal tissues of children with regressive autism. The Dublin researchers headed by Dr John O'Leary, Professor of Pathology at Trinity College Dublin, examined viral genetic material from intestinal biopsies taken from 12 children with gastro-intestinal disease and an autistic spectrum disorder. The viral genetic material had already been identified as measles in a study published in January in Molecular Pathology. Using state of the art molecular science the samples from these twelve children have now been characterised as from vaccine strain measles virus. This investigation continues. These data constitute a key piece of evidence in the examination of the relationship between MMR vaccine and regressive autism.

Re-challenge and biological gradient effects for MMR/MR vaccines A further key piece of evidence comes from examination of "re-challenge" and "biological gradient" effects for possible vaccine-related adverse events. Re-challenge refers to a situation where re-exposure of an individual to an agent (e.g. vaccine) elicits a similar adverse reaction to that seen following the initial exposure. The secondary reaction associated with re-challenge may either reproduce the features associated with the primary challenge, or may lead to worsening of the condition that was provoked or induced by the initial exposure.

During the course of our clinical investigation we have observed that some children who received a second dose of MMR, or boosting with the combined measles rubella (MR) vaccine, experienced further deterioration in their physical and/or behavioural symptoms following re-exposure. In a report of April 2001, the Vaccine Safety Committee of the US Institute of Medicine (IOM) stated that, in the context of MMR vaccine as a possible cause of this syndrome, "challenge re-challenge exposed would constitute strong evidence of an association"[1]. In the context of adverse vaccine reactions, a biological gradient refers to an increasing severity of, or increased risk of developing, a particular disease outcome. More severe bowel disease in children with regressive autism who had received more than one MMR/MR would be an example of this. We have undertaken systematic evaluation of re-challenge and biological gradient effects in children with regressive autism who have undergone investigation at the Royal Free Hospital.

  "Exposed" - children with normal early development & regressive autism who had received more than one MMR/MR - were compared with age and sex matched "unexposed" - children with normal early development & with regressive autism who had received only one MMR but otherwise similar baseline characteristics to the exposed group. Comparisons included: secondary (2o) developmental/behavioural regression; 2o physical deterioration, prospective, observer-blinded scores of endoscopic & microscopic disease severity.

In a preliminary analysis exposed children scored significantly higher than unexposed children for secondary regression on the basis of analyses performed at the different levels, including :(i) parental history excluding those whose secondary regression occurred following publication of the 1st suggested MMR-autism link in 1998; and, inclusion of only those for whom independent corroborative evidence of secondary regression was obtained from the records;
(ii)            secondary physical symptoms;
(iii)            presence of severe ileal lymphoid hyperplasia; and,
(iii)            presence and severity of acute mucosal inflammation.
No measures of disease were worse in unexposed than exposed children.

These data identify a re-challenge effect on symptoms and a biological gradient effect on severity of intestinal inflammation that provide evidence of a causal association between MMR and regressive autism in these children.

I have repeatedly requested a meeting with Sir Liam Donaldson the UK's Chief Medical Officer to discuss the situation. His response has been to refuse to meet, but instead to demand that we send him the children's samples. He has provided absolutely no indication, in terms of scientific protocol, how he would proceed to analyse these samples. He has, as far as I am aware, no ethical approval for analysing these samples. He may be reassured to know that independent testing is being conducted and that as part of the litigation process in the UK, the Defendants are being provided with identical samples for independent analysis.

The last seven days have seen a report, in the journal Clinical Evidence, publicised as "new research" disproving any links between autism and the MMR vaccine.  The authors specifically excluded clinical research into bowel disease, immune disorders and other documented features of autism that may relate to a viral cause. They do not cite any of our publications beyond the initial study of 12 children in 1998. In fact, the Clinical Evidence paper was no more than a review of the epidemiological studies, including the Davis study that will be critically reviewed during this hearing, that have already been dismissed as irrelevant by an independent review commissioned
by the Institute of Medicine in the US.
Key Publications by Wakefield/O'Leary  groups
1.        Wakefield AJ, Murch SH, Anthony A, Linnell J, Casson DM, Malik M, et al. Ileal LNH, non-specific colitis and pervasive developmental disorder in children. Lancet 1997; 351: 637-641.
2.        Wakefield AJ, Anthony A, Murch SH, Thomson M, Montgomery SM,Davies S, et al. Enterocolitis in children with developmental disorder.American Journal of Gastroenterology 2000; 95:2285-2295
3.        Furlano RI, Anthony A, Day R, Brown A, McGavery L, Thomson MA, et al. Colonic CD8 and ?d T cell infiltration with epithelial damage in children with autism. Journal of Pediatrics  2001;138:366-372
4.        Torrente F, Machado N, Ashwood P, et al. Enteropathy with T cell infiltration and epithelial IgG deposition in autism. Molecular Psychiatry 2002;7:375-382
5.        Uhlmann V., Martin CM., Shiels O., Pilkington L., Silva I.,Lillalea A. Murch SH., Wakefield AJ., O'Leary JJ. Potential viral pathogenic mechanism for new variant inflammatory bowel disease. Molecular Pathology. 2002;55:1-6
6.        Kawashima H., Takayuki M., Kashiwagi Y., Takekuma K., Hoshika A.,Wakefield AJ. Detection and sequencing of measles virus from peripheral blood mononuclear cells from patients with inflammatory bowel disease and autism. Digestive Diseases and Sciences. 2000;45:723-729
7.         Wakefield AJ and Montgomery SM. Measles, mumps, rubella vaccine:through a glass, darkly. Adverse Drug Reactions & Toxicological Reviews 2000;19:265-283.
8.         Wakefield AJ and Montgomery SM. Autism, viral infection and measles mumps rubella vaccination. Israeli Medical Association Journal 1999;1:183-187
9.        Wakefield AJ, Puleston J., Montgomery SM., Anthony A., O'Leary JJ., Murch SH. Review article: the concept of entero-colonic encephalopathy, autism and opioid receptor ligands. Alimentary Pharmacology and Therapeutics 2002; 16: 663-674
10.    Shiels O., Smyth P., Martin C., O'Leary JJ. Development of an allelic discrimination type assay to differentiate between strain origins of measles virus detected in intestinal tissue of children with ileocolonic lymphonodular hyperplasia and concomitant developmental disorder. Pathological Society of Great Britain and Ireland. Journal of Pathology. 2002 .A20
11.    Wakefield AJ, Anthony A. Clinical characteristics of children with autism and entero-colitis comparing recipients of one and more than one measles-containing vaccine (submitted). Publications by others
1.      a. Singh V., Lin S., Yang V. Serological association of measles virus and human herpesvirus-6 with brain autoantibodies in autism. Clinical Immunology and Immunopathology. 1998:89;105-108
2.      a. Singh VK. Neuro-immunopathogenesis in Autism. 2001. New Foundations of Biology. Berczi I & Gorczynski RM (eds) Elsevier Science B.V. pp447-458
3.      a. Horvath K, Papadimitriou JC, Rabsztyn A, Drachenberg C, Tildon JT. Gastrointestinal abnormalities in children with autism. Journal of Pediatrics 1999; 135: 559-563

[1] Stratton K., Gable A., Shetty P., McCormick M. Immunization Safety Review: Measles-Mumps-Rubella Vaccine and Autism. National Academy Press. Washington DC. 2001. www.iom.edu/imsafety

http://www.garynull.com/Documents/AutismFinnishStudy.htm

Autism: A Recent Serious Rise in Finland

F. Edward Yazbak, MD, FAAP
K. Yazbak, BA, MA


There have been several published and frequently quoted studies from Finland concerning the safety and efficacy of the combined measles, mumps and rubella vaccines (MMR). Some of these studies were joint efforts by the Departments of Pediatrics and Public Health at the University of Helsinki, the National Public Health Institute and the National Research and Development Center for Welfare and Health. The studies were often supported by grants from the vaccine manufacturer.

The two first studies, by Peltola et al, were published in The Lancet in 1986, four years into a large and extensive National Vaccination Program. Both were of limited scope and interest. (1,2) The next publication whose main author was also Professor Peltola of the Department of Pediatrics appeared in the New England Medical Journal in 1994. It was comprehensive and detailed: The elimination of indigenous measles, mumps, and rubella from Finland by a 12-year, two-dose vaccination program. (3)

It essentially stated that over a period of 12 years, 1.5 million of the 5 million people in Finland were vaccinated, that coverage exceeded 95 percent, and that the program using two doses of combined live-virus vaccine had eliminated indigenous measles, mumps, and rubella from Finland. The study also stressed that no deaths or persistent serious problems were directly attributable to vaccination and that the most frequent complication requiring hospitalization was acute thrombocytopenic purpura, which occurred at a rate of 3.3 per 100,000 vaccinated persons. Autism and irritable bowel disease (IBD) were never mentioned.

A subsequent report "Explosive School-based Measles Outbreak. Intense Exposure May Have Resulted in High Risk, Even among Revaccinees" (4) by Mikko Paunio (Department of Public Health, Helsinki University), Professor Peltola and others was published in the American Journal of Epidemiology in 1998. It has received less attention, and has rarely, if ever, been mentioned during the present, and intense, MMR debate. It essentially stated  "That high levels of measles vaccination coverage have not always prevented outbreaks"
· "That those infected later at home had high measles risk, even if they were revaccinees"
· "That when siblings shared a bedroom with a measles case, a 78 percent risk (seven out of nine children) was observed among vaccinees"
· "That vaccinees had approximately 2 days' shorter incubation time than unvaccinated persons" and
· "That vaccinated and unvaccinated students were equally able to infect their siblings".

The study concluded that protection against measles might not be achievable, even among revaccinees, when children are confronted with intense exposure to measles virus.

In February 1998, Andrew Wakefield published in The Lancet his well-known study (5), which described specific gut changes in autism and raised for the first time, the possibility of a link between MMR vaccination and late-onset or regressive autism. Dr. Wakefield drew no conclusions but simply called for more research.

In a prompt response, Peltola and Associates contributed a research letter to The Lancet, which was published in May 1998 (6). Since then all vaccine authorities have been assuring everyone that MMR vaccination has not been associated with autism and IBD in 3 million vaccinees followed up for 14 years. This Peltola letter and a study from the UK by Brent Taylor et al (7) have become the main arguments used by Wakefield's opponents to neutralize his on-going research and findings.

The "damage control" nature of the research letter from Finland is clearly apparent in its very own title: No evidence for measles, mumps, and rubella vaccine-associated inflammatory bowel disease or autism in a 14-year prospective study. This obviously is misleading. The study terminated in 1996, two full years  before Wakefield published his original findings and when he was specifically questioned, Professor Peltola stated that the study had not been designed to identify autism as a complication.

In the letter, Professor Peltola reported that about three million doses of the combined live-virus vaccine [MMR or Virivac Merck, West Point, PA, USA] had been administered in Finland between 1982 and 1996. He also listed the adverse events reported shortly after vaccination and their follow-up. The study, which was supported by a grant from Merck, did not investigate or report complications, which started weeks or months after vaccination. Again, Autism and IBD were not suspected to be, in any way related to MMR vaccination before 1998, and had not once been mentioned in the original 1994 publication.

In the same issue of The Lancet (Volume 351, Number 9112, 02 May 1998)  Andrew Wakefield responded to Peltola and refuted each of his statements. He also highlighted the fact that "In the five year period to 1991, there was a 300% increase in the numbers of Crohn's Disease in Finland, an extraordinary observation that remains unexplained (Gastroenterology 1997, 1417; 112:A-732)". In his conclusion, Dr. Wakefield stated that "The authors have failed to address the issue raised in our study and this ad hoc retrospective and fundamentally irrelevant report contributes nothing to the scientific debate surrounding this issue. Neither does it mitigate the failure to have conducted prospective, long term safety studies of MMR vaccine."

Two years later, Dr. Wakefield notified the authorities, several months in advance of his forthcoming publication Measles, Mumps, Rubella Vaccine: Through a Glass, Darkly (8) to allow them time to prepare for any possible fall-out. This precipitated the production of yet another Finnish paper (9), which detailed the more serious adverse events of the same study. This latest contribution by Dr. Annamari Patja (with Professor Peltola listed last) was also supported in part by a grant from Merck. Patja stated that there were only 173 "potentially serious reactions claimed to have been caused by MMR vaccination" among the 1.8 million individuals who received some 3 million doses of MMR vaccine. All occurred within four weeks from vaccination and several of them were followed longitudinally till 1996. They included one death, 77 neurological, 73 allergic, and 22 miscellaneous reactions. Some 45% of them, according to the authors, were probably caused or contributed by some other factor. Minor adverse events among 437 vaccinees were listed casually but were excluded from further analysis. According to Dr. Patja, "Idiopathic thrombocytopenic purpura was also excluded because it has been analysed previously", this in spite of the fact that thrombocytopenic purpura following MMR vaccination was the most frequent complication requiring hospitalisation. (3) The references as to the absence of autism and IBD were clearly added on in
rather unrelated paragraphs. The study was promptly and thoroughly criticized by Welsh in Scotland, Shattock in England and us (10) and is receiving less attention now.

What has been most intriguing is that neither Patja in December 2000 nor Peltola in May 1998 ever mentioned the incidence of autism in Finland during the duration of their MMR study or since. One would have certainly expected that they would have, if indeed they had examined autism and its relationship to MMR. But they NEVER did.

What is more disturbing is that Dr. Patja appears to have ignored a recent study from Oulu University (11) which describes an impressive rise in autism in Northern Finland, similar in magnitude to that in other Western countries. This study by Kielinen et al was submitted for publication in November 1999 and was published in the journal of European Child & Adolescent Psychiatry in 2000. All professionals reporting on the specific subject of autism, in a country with only 5 million people should have been aware of its results.

The Kielinen study included all children born between 1979 and 1994 in the northern Provinces of Oulu and Lapland (which represent 1/8 of the total population of Finland), and who were therefore 3-18 year old on December 31, 1996 when the Peltola study ended.The authors personally reviewed records from all selected cases of autism, to determine that they fulfilled the present criteria of ICD-10 and DSM-IV. Their careful review revealed a cumulative incidence of autism in Northern Finland of 12.2/10,000 an alarming increase when compared to the previously reported incidence of 4.75/10,000 in 1991. (12) More concerning is the fact that the increase in younger children, all born in the second half of the MMR campaign, was even more spectacular. The cumulative incidence in the 5-7 age group specifically was 20.7/10,000 or more than 1 in 500 children. It certainly is possible but rather unlikely that such an increase is due to better diagnosis. A label as ominous as autism is not imposed lightly in a country where each and every disability becomes immediately the sole responsibility of the State. In fact, as in the United States, these are probably conservative figures.

The reported increased incidence in the younger age group is of particular concern as it could indicate an accelerating increase in autism overall. Equally concerning is the fact that there are no incidence studies from the rest of Finland where the exact increase in autism remains a mystery. There is NO REASON to think that it will be less impressive than in the northern provinces. A similar situation just took place in the Unites States. In 1999, the California report (13) was the first detailed documentation of an autism explosion. Since then, alarming autism rates have been reported in all states. (14,15)

A fortunate aspect of autism in Northern Finland (if one dares put autism and fortunate in the same sentence) is the fact that almost 50% of children in the Kielinen study had a tested IQ above 70. This is remarkable because many tests are based on verbal abilities, which are less adequate in  children with autism and do not represent their real functional level, as the authors pointed out.

Generally speaking in the past, only one fifth of children with autism had IQs of 70 and above. Of late, higher ability and performance are being reported in increasing numbers and seem to be more prevalent in children with late-onset autism. If this is truly so, then one must consider a trigger that may affect the child after a period of normal development. In Finland the MMR vaccine has to be examined, before it is ruled out. absolving it, a priori, when independent longitudinal studies of its safety are lacking, is reckless.

It is unconceivable that a disease affecting more than 1 in 500 children has received so little attention. Autism is the present and real epidemic in Finland and Peltola, Patja and their talented associates should turn their attention to it, instead of spending their time defending the MMR vaccine. It should be easy to interview parents of affected children and to ask them if they believe there is an autism-vaccine connection. The Government of Finland should initiate and finance studies in which every aspect and every possible cause of autism are scrutinized. It is unlikely that the vaccine manufacturer will fund or support such studies.

References

1. Peltola H, Karanko V, Kurki T, et al. Rapid Effect on Endemic Measles, Mumps and Rubella of Nationwide Vaccination Pro-gramme in Finland. Lancet 1986; 1:137-9

2. Peltola H, Heinonen OP et al Frequency of True Adverse Reactions to Measles-Mumps-Rubella vaccine: a double-blind placebo-controlled trial in twins. Lancet 1986; 1: 939-42

3. Peltola H, Heinonen OP, Valle M, Paunio M, Virtanen M, Karanko V, Cantell K. The Elimination of Indigenous Measles, Mumps, and Rubella from Finland by a 12-year, two-dose vaccination program. N Engl J Med 1994; 331: 1397­402. )

4. Mikko Paunio, Heikki Peltola, Martti Valle, Irja Davidkin, Martti Virtanen, and Olli P. Heinonen. Explosive School-based Measles Outbreak. Intense Exposure May Have Resulted in High Risk, Even among Revaccinees. Am J Epidemiol 1998;148:1103-10

5. A J Wakefield, S H Murch, A Anthony, J Linnell, D M Casson, M Malik, M Berelowitz, A P Dhillon, M A Thomson, P Harvey, A Valentine, S E Davies, J A Walker-Smith. Ileal-lymphoid-nodular hyperplasia, non-specific colitis, and pervasive developmental disorder in children. Lancet 1998; 351: 637-41

6. Heikki Peltola, Annamari Patja, Pauli Leinikki, Martti Valle, Irja Davidkin, Mikko Paunio. No evidence for measles, mumps and rubella vaccine-associated inflammatory bowel disease or autism in a 14-year prospective study. Research letters: Lancet: Volume 351, Number 9112, 02 May 1998

7. Taylor B, Miller E, Farrington P, Cetropoulos M, Favout-Mayaud JL, Waight P. Autism and measles, mumps, and rubella vaccine: no epidemiological evidence for a causal association. Lancet 1999; 353: 2026-29.

8. Wakefield AJ, Montgomery SM. Measles, Mumps, Rubella Vaccine: Through a Glass, Darkly. Adverse Drug Reactions and Toxicology Review,. 2000,19 (4) 1-19.

9. Patja A., Davidkin I., Kurki T., Kallio M., Valle M., Peltola H Serious adverse events after measles-mumps-rubella vaccination during a fourteen-year prospective follow-up. Paed. Infect. Dis.J. 19 1127-1134 (2000)

10. Yazbak FE, Yazbak K.An Unconvincing Finnish Study.libnt2.lib.tcu.edu/staff/lruede/Fin2.html

11. Kielinen M, Linna S.-L, Moilanen I. Autism in Northern Finland; European Child &Adolescent Psychiatry 9:162-167 (2000)

12. Vinni I, Timonen T Behavioral Analytical Point of View. Finnish Association for mental Retardation, Helsinki (1991)

13. Changes in the population of persons with Autism and Pervasive Developmental Disorders in California's Developmental Services system : 1987 through 1998. A report to the legislature
www.dds.ca.gov./autismreport.cfm

14. Yazbak FE Autism 99: A National Emergency.www.garynull.com/Documents/autism_99.htm

15. Yazbak, FE Autism 2000: A Tragedy. www.garynull.com/Documents/autism_2000.htm F. Edward Yazbak, MD, FAAP Kathleen Yazbak, BA, MA TL Autism Research
E-mail: TLAutStudy@aol.com

These personal observations may not represent the views of organizations to which we belong.

Copyright 2001
 

The MMR Controversy: An Investigation. Part One

      [By Melanie Phillips. First published in the Daily Mail, UK.  Thanks to Philip & Chareline Gibbs.]

http://www.femail.co.uk/pages/standard/article.html?in_article_id=171316&in_
page_id=169  and http://www.melaniephillips.com/ where the next two articles can be accessed
on day of publication.

      He has been mocked, denounced and driven from his job. To the medical and political establishment, he is an outcast and an enemy. But Andrew Wakefield, the doctor at the heart of the furore over the MMR vaccination, believes he is on the brink of vindication.

       It was Dr. Wakefield, a gastroenterologist then working at the Royal Free hospital in London, who first made the devastating claim that the triple jab for measles, mumps and rubella can provoke both autism and bowel disease in a small proportion of children. His theory, which exploded into the public arena in 1998, spread alarm among parents everywhere.  The British and international medical authorities united to dismiss it, scorning his research as worthless and insisting that the vaccination was perfectly safe. Report after report was published to rebut his findings, with MPs and Ministers -- including Tony Blair -- joining the chorus that there was no cause for concern.

       According to Mr Wakefield, his life was made impossible. His funding started to dry up, professional collaborations were broken off, and researchers were allegedly bribed or threatened not to have anything to do with him.  Realising his work was imperilled, he felt obliged to leave the Royal Free. Now, however, Mr Wakefield has evidence that he thinks will prove he was right all along.  His new research -- which has yet to be published in a medical journal -- focuses on booster MMR jabs, which are given to children around the age of  four to reinforce the original injection given at around 15 months.

       Among the children in Wakefield's study, those given the booster jabs suffered a dramatic deterioration in both behavioural problems and bowel symptoms.  After the booster, he claims, one child stopped growing for 18 months and another failed to develop at all for five years. There was also a significant increase in acute bowel inflammation in the majority of children who received the second jab.

       Such evidence from re-vaccination is potentially explosive. Symptoms appearing after one jab might be put down to coincidence -- the key counter-claim by Wakefield's critics.  But if the same symptoms clearly worsen after a second jab, this argument becomes much harder to sustain.  Indeed, such evidence would seem likely to reignite the whole MMR debate. The American Institute of Medicine said that evidence from a booster would constitute a strong case that the vaccine and the symptoms ascribed to it were linked.  The report's author, Dr Kathleen Stratton, told me: 'If such evidence could be well documented -- and so far it hasn't been -- then it would be extremely useful and would certainly provide much more confidence that there is something there to be looked at.'  Her caveat is important, for one thing is certain: Wakefield's new evidence will be subjected to the most ferocious scrutiny by the many doctors and scientists who think that his previous claims are based on bad science.

       There are strong arguments on both sides. Experienced and principled figures are convinced that MMR can be trusted. On the other hand, Wakefield is not a lone voice; other experts, and independent evidence, now support him.  For example, Dr Ken Aitken, a neuropsychologist and autism expert in Scotland, has already performed preliminary research that helps back up Wakefield's new 'booster' study, showing that children who already had developmental problems get significantly worse after a second jab.

       Dr Aitken also found that one of the key problems the youngsters display is incontinence -- which is not common among classically autistic children, but indicates a more catastrophic disintegration. The whole row has been fuelled by an apparent huge rise in the incidence of autism across the western world.

       Yet this, too, is the object of the most intense controversy, with experts in violent dispute over whether there really are more children with autism or whether the diagnostic goalposts have simply been moved. These are profoundly important arguments. But the whole debate has been tainted by the extraordinary behaviour of some of MMR's key supporters, and the sheer recklessness with which dissenting voices have been ignored.  As we are about to see, utterly inconclusive studies have been paraded as proving that MMR is safe. Warnings that the jury is still out, and that more research is needed, have been suppressed.

       Key roles in adjudicating on the controversy have been handed to individuals with financial links to the drug manufacturers. Concerns have been voiced that some expert evidence may have been coloured by personal antagonism towards Mr Wakefield.  Most worryingly of all, it can now be revealed that warnings over an early strain of MMR were knowingly disregarded -- only for it to be suddenly withdrawn after it was found to have a potentially fatal side-effect. The fact that children were falling ill was not picked up for more than two years.

       Now, with the government still piling on the pressure for every child in the country to be vaccinated, parents need more than ever to know the truth about this whole affair.  Is it safe for their children to have the triple jab or not? Are single vaccines safer? Whom should they trust: the small group of researchers sounding the alarm or the medical establishment?  This series, which continues in the Mail tomorrow, is an attempt to cut through the propaganda that is clouding those vital questions. AUTISM is a poorly understood disorder, characterised by withdrawal and isolation from the world, along with strange habits and compulsions. These can include ritualistic hand-flapping, rocking, absence of eye contact, self-injury and consuming interest in inanimate objects.   But the symptoms displayed by children whose parents link their disorder with MMR also include serious bowel disease, loss of language, excessive thirst, recurrent respiratory problems, allergies and food intolerance.

       Such a list goes far beyond our current understanding of either autism or bowel disease. And how these two conditions could be connected to one another, let alone to MMR, is one of the most vexed questions of all.  What remains clear is that the level of suffering among the parents of these children is immense. Their lives have been turned upside down, and their efforts are nothing short of heroic.  Some have given up careers to care for their children. Many have little sleep as their children are up for much of the night.  David Thrower of Warrington, Cheshire, has to watch his 15-year-old son Oliver all the time in case he damages himself or anything else.  Rosemary Kessick of Peterborough says of her 14 -year-old son William: 'He is not violent but if he picks something up he doesn't understand he has to put it down, and he breaks everything. 'We've been through several sets of furniture. He gets behind an armchair and starts throwing it. He cannot come into the kitchen at all because he would damage someone.'  Both David Thrower and Rosemary Kessick insist their sons were totally normal before receiving the MMR jab.

       They are two of more than 1,000 parents -- all of whom believe their children were injured by the vaccination -- who are pressing claims for compensation against three drug companies in a class action that will come to the High Court next year.  It promises to be an epic confrontation, and the stakes are enormous. If the parents win, the damage to public confidence in vaccination policy will be incalculable. If they lose, the medical establishment will use the case as final proof that MMR is safe.

       The establishment's case rests on what is known as epidemiological evidence. Rather than examining particular instances -- individual children thought to have been harmed by MMR -- this looks at patterns of disease in the general population.  So far, all such studies have concluded that there is no evidence of any link between MMR and autism or bowel disease. For some, that is enough to settle the argument.  'If the claimed link isn't evident in the population studies, it isn't likely to be a major factor,' says Brent Taylor, professor of community child health at London's Royal Free hospital, and a former colleague of the dissident Dr Wakefield.

       'The research that suggests there's a link has been questioned by every reputable reviewer I know, and they have all dismissed it,' says Pat Troop, the Government's Deputy Chief Medical Officer. 'This evidence is overwhelming.'  But the idea that epidemiology settles this argument is over-optimistic. For this research prompts more questions than answers.   Every one of these studies is either not equipped to address this particular issue, or has been criticised by other experts as flawed, or deals with questions which miss the point.  For example, much has been made of two Finnish studies, one of which looked at the effects of MMR on groups of twins, while the other looked at 1.8 million children over a 14-year period.

       But neither of these was designed to pick up autism or bowel disease. The Medical Research Council's own review of autism research dismissed them as unhelpful to the issue.  Similar importance has been attached to a study by Brent Taylor and his colleagues of autistic children in North London in 1999. It set out specifically to discover whether MMR was responsible for a  higher rate of autism or bowel disease than had occurred before vaccination.  This study, however, has been criticised as poorly executed and unreliable. The eminent Canadian epidemiologist, Professor Walter Spitzer, says its sample was too small to provide any meaningful conclusions.  Moreover, he says it could not establish the rate of regressive autism -- when a child develops normally and then suddenly starts to lose skills -- because it had no control group by which to measure it.

       Regressive autism is a recurrent theme in stories of children allegedly harmed by MMR, so this is a crucial omission. Professor Spitzer makes the same criticisms of later studies by Brent Taylor, too.   He also fiercely criticises Professor Taylor for not releasing his raw data for independent scrutiny, even when requested to do so by the American Congressional committee which is holding hearings into the MMR controversy. In response, Taylor insists he has refused on legal advice that to release the data might compromise patient confidentiality.

       James Roger is a medical statistician who is sceptical of Andrew Wakefield's theory. Nevertheless, he outlined serious limitations to the Taylor study at a meeting in 2000 of the Royal Statistical Society.  The key problem, he says, is that it relied on clinical case notes – the records kept by doctors while they are treating a patient. James Roger believes these would not have provided an adequate contemporary record, as the doctors were unlikely to have charted the symptoms from when they first appeared. Even if they were eventually told the full story, they might not record it in their notes.

       'Diagnosis often does not take place for two to three years after the parent first becomes concerned,' says Roger. 'Some parents become concerned early, others later, and doctors do not tend to write long family histories.'  Yet research based on case notes continues to be held up as proof that fears over MMR are groundless.  One example, published last year in the prestigious New England Journal of Medicine, was based on the medical records of more than half a million children in Denmark. It found that vaccinated children were no more likely to be diagnosed autistic than those who had not had the jab.

       Some newspaper coverage suggested that this might be a definitive verdict. But these medical records simply won't have told us the full story.   It is one of the main contentions by Andrew Wakefield and many parents that doctors often brush aside both the children's symptoms and the parents' concerns.  'Retrospective studies like this are meaningless,' says Wakefield. 'You go through the clinical records of the autistic children who have inflammatory bowel disease and there isn't a single mention of gastro-intestinal problems.  'And because regressive autism was very unusual, the doctor mainly ignored the mother when she reported regression.  'Many parents say when they made a connection to the vaccine, they encountered great hostility from paediatricians who noted them down as difficult and didn't listen to them.'  Other widely cited epidemiological studies which are said to disprove a link, such as work carried out by the child psychiatrist Eric Fombonne – an adviser to the drug companies that make MMR -- suffer from this same limitation of using health records.  None of the studies clinically examined the children or talked to their families.

         PROFESSOR Brent Taylor robustly dismisses such criticism. A large number of international bodies has accepted his work without demur, he says. 'We looked at a wide range of clinical notes and other health professionals' records,' he says. 'I can't imagine that such symptoms would be ignored.'  But another claim is laid against him: that he is not a dispassionate commentator on this issue.  Not only has he been for two years a member of the Joint Committee for Vaccination and Immunisation, the government's vaccine advisory body whose reputation would be shredded if MMR was shown to be unsafe; in addition, Wakefield appears to have caused Taylor concern well before the controversy erupted into general view.  In a letter written on December 8, 1997, to a consultant paediatrician who asked about vaccine safety, Professor Taylor wrote: 'There is as yet no satisfactory, validated research data linking MMR and any medical condition.

       'There is a zealot surgeon in our adult gastroenterology department who thinks that MMR is the cause of all the problems of the Western world but with a particular down on Crohn's disease (a form of bowel disease) and, in a difficult to understand association, with autism.   'Both Crohn's disease and autism, of course, often present during the second year and therefore any health interventions get the blame. There is a group of rather unscrupulous sounding lawyers in King's Lynn who are encouraging families to sue.'  Professor Taylor denies this means his subsequent studies are biased. 'I think I can hold personal opinions and still be a dispassionate scientist,' he says.  The use made of such studies by others is another matter again. Although official bodies reviewing the evidence have in general said that the case for a link to autism has not been proved, their conclusions also suggest that the jury is still out.

       Yet their equivocal findings have been falsely presented by the Government and the medical establishment as proof that MMR is safe.  The US Institute of Medicine, for example, was dismissive of both Andrew Wakefield's evidence and the epidemiological studies.  It concluded from this: 'The evidence favours rejection of a causal relationship at the population level between MMR vaccine and ASDs (autism spectrum disorders).'  However, it went on to add a crucial rider: 'The committee notes that its conclusion does not exclude the possibility that MMR vaccine could contribute to ASD in a small number of children because the epidemiological evidence lacks the precision to assess rare occurrences of a response.'  In other words, although the link between MMR and autism could not be stood up in terms of the general population, it might be happening at an individual level.

       As a result, the Institute of Medicine recommended that the issue receive continued attention. Yet the British Government uses this report, among others, to say 'there is no link'. Another example of such distortion involves the Committee on the Safety of Medicines (CSM). In 1999, the committee sent questionnaires to parents who were suing the drug companies over the alleged damage to their children from MMR, and to their doctors.

       Only some questionnaires were returned, and the committee whittled this number down even further. It decided that the quality of the information was extremely variable, and insufficient to permit meaningful analysis. The committee said it could find nothing that gave it 'cause for concern about the safety of MMR vaccines'. Nevertheless, 'it was impossible to prove or refute the suggested associations between MMR vaccine and autism or IBD (irritable bowel disorder)'. In other words, given the available evidence, the committee was saying that the question was still open.  Yet in January 2001, the Department of Health issued a press release after a 'further review' quoting the committee's chairman, Professor Alasdair Breckenridge, as saying: 'MMR vaccine is very safe. There is no question mark whatever over its licensing.'  The Chief Medical Officer, Professor Liam Donaldson, was equally categorical.  'MMR remains the safest way to protect our children,' he said.

'Concerns that have been raised relating to autism and Crohn's disease are considered by the CSM and other expert bodies nationally and internationally to have been refuted.'  But they hadn't been. Indeed, the Committee on the Safety of Medicines had expressly said it was impossible to refute them. The way in which such absence of evidence has been persistently misrepresented as proof that all is well led Dr Peter Fletcher, a former assessor to the committee, to protest in a letter to a clinical periodical. He wrote: 'The readers of this journal may ponder the curious turn of events which has now led to the Department of Health, the Medicines Control Agency, the Committee on Safety of Medicines and other eminent bodies citing negative studies as absolute evidence of safety.'  The most protracted and bitter battle, however, took place over a review of autism research by the Medical Research Council. This was begun after the then Health Minister Tessa Jowell met Mr Wakefield and the parents back in 1997.

       The Medical Research Council first set up an ad hoc committee. According to one of its members, autism specialist Dr Ken Aitken, this concluded that there was insufficient evidence to say there was definitely a problem.  'We agreed it needed more investigation,' he said, 'but there was not sufficient evidence to change the policy. But Sir Kenneth Calman, (the then Chief Medical Officer), then issued a press release at variance with this conclusion, in which he said there was no problem.'  Dr Aitken believes that Sir Kenneth’s statement was bound to mislead the public. 'I was concerned that Andrew Wakefield had been given very short shrift,' he says. The Medical Research Council then set up a bigger review which became mired in argument between the experts and the lay members.

       The review had been originally set up expressly in response to MR Wakefield's concerns. Yet lay member Rosemary Kessick, whose son William has suffered so badly since his MMR jab, says there was an immediate volte-face. 'The first thing we were told was that MMR was not in the committee's remit. On the contrary, their premise was, if MMR wasn't causing autism, then what was?'  This is quite remarkable. The committee's eventual report discussed selective evidence about MMR in a show of objective analysis -- yet, in truth, it had ruled it out from the start.  The main dispute, however, arose over a perceived conflict of interest. A number of expert members on the Medical Research Council's panel turned out to be advisers to the drug companies defending the law suit being brought against them by the parents.

       As far as Rosemary Kessick was concerned, this turned the review into a farce. 'I didn't see how this could possibly be independent,' she said. According to the MRC's research strategy manager Dr Peter Dukes, the panel responded to the row by bringing on additional members. 'In the end, there was a broad consensus by the lay group that the process was fair,' he said. Mrs Kessick does not agree, and insists that the lay members were excluded from the decision-making. 'They said the lay members would only be observers and not contribute to the final report,' she said. 'It was outrageous.'  The final report itself is a notably equivocal document. Having found flaws in a number of the studies it considered, the MRC panel concluded that 'the current epidemiological evidence does not support the proposed link' of MMR to autism.

       However, an earlier draft of the report -- which I have read – places rather more emphasis on crucial caveats which in the final report are far less prominent. Referring to the reviews by the MRC and the Institute of Medicine, as well as by the American Academy of Paediatrics and the Irish Department of Health and Children, the draft observed that these had unanimously concluded that a causal link between MMR and autism was 'neither proven nor disproven'. The final report merely said that the link was ‘not proven’. The report also acknowledged the finding of these studies that, although the epidemiological evidence did not support the proposed link, it 'could not exclude the possibility that a very small number of children are affected differently from the large majority'. It added that 'more extensive research would be necessary to provide the consistency and biological plausibility required to establish a casual link between viral infections and autism'.  In its early draft, the Medical Research Council plainly concluded that the jury was still out on a link between MMR and autism, and more research was needed.

       By the final, published version, this conclusion was all but buried. Many believe the only way to resolve this whole controversy is through fresh, undisputed clinical research. 'We don't think any more epidemiological studies have any purpose,' says Judith Barnard of the National Autism Society. 'They are a very blunt tool and do not pick up very rare occurrences. 'Scientists funded by the statutory agencies are firmly of the belief that Wakefield's studies are bad science. So we want to see more research by other people. And not, as the Medical Research Council is now doing, looking at more patient records, but more physiological studies.'  Since the Medical Research Council funds such studies, I asked its strategy manager Dr Dukes why this wasn't being done. 'We have not received any specific proposals to look at the effects of MMR,' he said. 'No scientists have approached us.' But I have spoken to one highly regarded autism researcher who was one of a group that did offer the MRC precisely such a proposal, but which was unaccountably turned down flat. And this researcher says there have been others.

       Now the government has given the National Institute for Biological Standards and Control £300,000 to try to replicate Wakefield's research.   But the scientist who heads the institute, Dr Phil Minor, is being paid to advise GlaxoSmithKline, makers of the MMR vaccine, in the forthcoming law suit.  And one of his colleagues, Dr Mohammed Afzal, leader of the Institute's MMR programme, has been giving free legal advice to law firms representing the companies involved in the case. This may be one reason why the government has serious problems in regaining public confidence in the safety of MMR. Parliamentary answers two years ago listed six members of the Joint Committee for Vaccination and Immunisation, and seven members of the Committee on the Safety of Medicines, who had declared financial or other interests in the drug companies involved.

       According to parent David Thrower, more recent data issued by the committee on the Safety of Medicines reveals that 19 members of these two committees now have such interests.  PERHAPS the greatest cause for concern lies in the history of MMR in Britain. In 1992, the particular type of  MMR being used was withdrawn, as it was discovered that the Urabe strain of mumps vaccine in the mix was causing an alarming amount of aseptic meningitis, a disease that can kill infants. The Department of Health switched to an alternative MMR vaccine made by a different manufacturer.  But it had known of concerns about Urabe before it first introduced that vaccine in 1989. Months previously, Canada had suspended its use of the Urabe-strain MMR after discovering the risk of aseptic meningitis, and switched to an alternative vaccine. But the Department of Health went ahead nevertheless and introduced it into the UK.

       Dr Elizabeth Miller, head of the vaccines division of the Public Health Laboratory Service, was involved in eventually identifying the Urabe risk in Britain.  Although the Department of Health knew about the Canadian evidence before it introduced the Urabe vaccine here, she said, the risk was considered low at one in every 100,000 doses. It was also unclear at the time, she said, whether the alternative vaccine posed a similar risk. Nevertheless, she said, the department identified Urabe strain MMR as something for which surveillance needed to be introduced. So paediatricians had to complete a card every month saying whether there had been any adverse reactions.

       This surveillance ran for two to three years. A few cases of aseptic meningitis were reported, but the risk worked out at about one in 250,000, even rarer than the reports from Canada. But amongst these cases, there appeared to be a cluster in Nottinghamshire where the risk was much higher. So Dr Miller conducted a study identifying every case of aseptic meningitis.  'We linked this to the vaccine records and found many cases of aseptic meningitis linked to the vaccine that had not been picked up,' she said.  As a result, in 1992 Urabe-strain MMR was suddenly withdrawn in the UK and replaced with the type of MMR vaccine used today.  The revelation of this débâcle poses some extremely urgent questions. Why did the department introduce Urabe-strain MMR, knowing there to be a question mark over its safety?  Was this not tantamount to gambling with the health of Britain's children? What price the government's vaccine safety surveillance when it failed for two to three years to detect the risk eventually picked up by Dr Miller?  How can we be sure there are no other adverse effects from the current vaccine, when doctors accept that the normal surveillance system fails to unearth most adverse reactions?  Above all, how can we trust the Department of Health's assurances that MMR is safe, when the original vaccine safety trials failed to spot the risk of aseptic meningitis from the Urabe-strain mumps component?  When I put these questions to Dr Miller, her reply was not altogether reassuring.

       'It is recognised that pre-licensing trials are not likely to pick up rare events,' she said. 'So you either say you will never introduce the vaccine, or do so with post-licensing surveillance once it is there. 'You need to strike a balance between saving lives through new vaccines and saving lives by safe vaccines. The cost would have been to have children dead from not having the vaccine.'  This may be so, but it makes glaringly clear the risks inherent in any vaccination programme. The government says repeatedly that MMR is the safest way to protect our children. But why should we trust them when they got it so badly wrong before?  Tomorrow, I will look at the extraordinary way in which warnings about MMR have been brushed aside by the medical authorities, and how Andrew Wakefield and his fellow researchers have refused to be silenced.

COMMENTARY - Editorial

MMR, Experts And A Question Of Trust
The lead Editorial in The UK Daily Mail today following the first part of Melanie Phillips investigation.
 

Doctors turn on each other as MMR debate rages again

Architects of autism study embroiled in bitter dispute

Sarah Boseley, health editor
Saturday November 1, 2003
The Guardian

The long-running controversy over the MMR vaccination turned unexpectedly into an extraordinary public battle of words yesterday between two doctors responsible for the research paper which began the scare five years ago. Andrew Wakefield and Simon Murch, both gastroenterologists at the Royal Free medical school in London, have taken very different paths since their paper was published in the Lancet in February 1998.  Dr Wakefield continued public backing for his hypothesis that the MMR triple jab could be responsible for rising rates of autism among children has made him a hero to many parents seeking a reason for their children's distressing condition, but rendered him virtually a pariah to most of the medical establishment.

In contrast, Dr Murch and his team have kept a low profile.

All that changed yesterday, however, when Dr Murch published a strongly worded letter in the Lancet stating that there was no evidence of a link and warning of the likelihood of a measles epidemic because of the low rate of vaccination, which is down to 61% in some parts of London. Dr Wakefield immediately responded by alleging that Dr Murch had acted only because he was under pressure from his medical bosses.

"I have been there. I have done it," said Dr Wakefield on Radio 4. "His laboratory is under threat. He has failed to gain due promotion. He has been strongly advised to withdraw from scientific publications that involve any mention of my name or association with MMR and bowel disease.

"If that is not an infringement of academic freedom and certainly an implied threat, then I don't know what is." Dr Wakefield accused "the hierarchy of the Royal Free and the medical school" of creating the pressure. The school issued a statement describing his allegations as "simply absurd". "The school believes that Dr Murch's rejection of any association between MMR and autism is his considered professional judgement as a paediatrician and a researcher," the statement said.

"In addition, the Royal Free Hampstead NHS Trust completely refutes the suggestion that the trust is considering withdrawing treatment from children. The trust intends to continue to provide this important service and has no plans to reduce or withhold treatment from these children." Dr Murch told the Guardian that it was not true he had been passed over for promotion. There had been talk of moving the lab, he said, but it did not happen and "it would not have been a matter of us losing space. It was nothing whatsoever to do with MMR".

While he did not want "to have a pop at Andy", whom he respected, he added: "Andy should know better than anybody that I can't be bullied by anyone. "I would never sell out the kids that I look after by peddling something that wasn't true. That would be a disgrace." The dispute has once again left parents confused about what to believe. But according to Dr Murch, his views have never changed. They have simply not been reported under the same banner headlines as Dr Wakefield's, he said.

He and other consultants involved in the initial research wrote a letter to the Lancet in May 1998 backing the continued use of the MMR, but no one took much notice. The controversy began more than five years ago, when the Royal Free doctors identified a particular sort of bowel inflammation in children brought to their clinic who had developmental difficulties. The February 1998 paper was based on 12 of the children. In eight cases, parents or doctors reported that symptoms of autism developed after the MMR jab. In one case, they were said to have developed after the child had had measles. The team at the Royal Free hypothesised that the measles virus could conceivably be the link between the gut problems and the autism.

That valid scientific theory in need of investigation was soon turned into a cause célèbre, however.

Some of the doctors involved now think the dramatic press conference at the Royal Free to launch the paper was a mistake. Dr Wakefield's views that MMR was to blame overshadowed the cautious noises being made by some colleagues. He drew the spotlight by stating publicly that he thought parents might be well advised to give children the jabs separately. Although the paper stated that it "did not prove an association between measles, mumps, and rubella vaccine and the syndrome described", the scientific uncertainty got lost in the ensuing panic.

Dr Murch and his team have quietly continued to research the links between bowel disease and autism, and have managed to establish a connection. One of his reasons for speaking out is that he felt his results were being distorted by the anti-MMR camp to make them look as though they bolstered the case for the jab causing autism. They do not, he said. "I got fed up at the data we had generated in our labs being presented at these revivalist meetings in the US," he said.

Dr Wakefield has continued to focus his own work on the individual children with bowel problems whose parents believe developed autism after the vaccination.  He cites Dr John O'Leary, professor of pathology at Trinity College, Dublin, who says he has found vaccine strain measles virus in samples from the gut of the 12 children initially studied. Further research will be published today, he says, in the Journal of Clinical Immunology. But although the papers keep coming, Dr Wakefield is in a scientific bunker. "The problem is that he thinks there is a big conspiracy and people are selling out around him. He thinks if he stands still and holds firm, history will vindicate him," said Dr Murch.

Careers and controversies

Andrew Wakefield is a former surgeon who became a gastroenterologist and a research fellow at the Royal Free, where he set up the inflammatory bowel diseases study. He was the first named author on the controversial 1998 Lancet paper which was a collaboration between various specialities at the Royal Free and which took his theory substantially further. The paper projected him into the limelight. He was the only one of the 12 authors to suggest that the MMR should be given as separate vaccines. More and more parents brought autistic children to him and he became the focus of compaigners against the combined vaccination.

But Medical Research Council scientists concluded that there was no proof for or against a link between bowel disease, autism and MMR. By mutual agreement, his job at the Royal Free was terminated. He and his wife Carmel, who is also a doctor, went to the United States, but no permanent position materialised and they returned to the UK. Simon Murch is a lecturer and consultant paediatric gastroenterologist at the Royal Free and University College school of medicine in London. He runs the academic centre for paediatric gastroenterology. He is a full-time consultant caring for children with gut and bowel problems, while doing as much research as he can.

Dr Murch was one of 12 authors of the February 1998 Lancet paper, and one of three who wrote to the Lancet the following May to stress their commitment to the MMR vaccination for children. He was moved to write to the Lancet, he says, because the vaccination take-up has dropped so low that an epidemic seems inevitable, and because the research his team was publishing was being wrongly used to argue against the safety of the MMR.  Those who want to climb the academic ladder need to bring in large grants for new research. He has wanted to spend time in the clinic with his young patients. He has respect for Dr Wakefield's convictions and did not want to be pitted against him.
 

http://www.thisislondon.com/news/articles/9305535?source=Evening

Double standards claim over MMR
By Isabel Oakeshott, Evening Standard, Health Correspondent
24 February 2004

Health chiefs stand charged with hypocrisy today after accusing a leading MMR scientist of "mixing spin and science". The Government claims Dr Andrew Wakefield had a conflict of interest when he produced a study suggesting a link between the vaccine and autism, because he was paid £55,000 by lawyers to investigate whether MMR was safe. Chief Medical Officer Professor Sir Liam Donaldson described the work as "poor science" and Prime Minister Tony Blair seized on the revelations to call for an end to the debate over the vaccine's safety.

But autism campaigners today revealed that at least 19 experts on government-appointed committees, which declared the vaccine safe, also had conflicts of interest. Some of the doctors and scientists have shares in drugs firms that make the jabs, and others received research grants from them. More than a dozen experts from the Committee on Safety of Medicines and the Joint  Committee on Vaccination and Immunisation - which produced reports stating that the vaccine was safe - are named by the campaigners.

They include:

Dr Phil Minor, who has been paid to advise MMR vaccine distributor GlaxoSmithKline on a legal case brought by families who say their children were damaged by the vaccine. Professor Henry Dargie, Professor John Smyth and Professor Jonathan Cohen, who worked as consultants to GlaxoSmithKline. Dr David Goldblatt, who was an "occasional member of expert panels" for GlaxoSmith-Kline and MMR supplier Aventis Pasteur. Non-personal interests include "industrial support" from the drugs company. Dr Colin Forfar and Dr Michael Donaghy, who have shares in GlaxoSmithKline.

Professor David Nutt, who has been a consultant for Glaxo-SmithKline and is also a shareholder in the company.

Bill Welsh, of the anti-MMR group Action Against Autism, said: "If the Government wants to start looking for conflicts of interest, they only have to look at their own house. The number of experts on their so-called independent panels who have stakes in drugs companies is incredible.

"It is rank hypocrisy for them to criticise Dr Wakefield over the funding he received."

The row highlights the links between scientists and doctors and pharmaceutical giants, which fund thousands of research studies each year. Today politicians described the links as a "major problem" and called for more independence in medical research. Labour MP David Hinchcliffe, chairman of the Commons health select committee, said: "This whole debate has exposed the way in which research is compromised by the commercial realities of funding. I think this is becoming
a great difficulty."


 

TAINTED RESEARCH:  What's good for Wakefield is good for the rest, too

Our thoughts have turned to Dr Andrew Wakefield, whose research findings of a possible link between the MMR vaccine and autism have been discredited. As you may recall, a Sunday Times journalist discovered that a few of the 12 children in Wakefield's study programme were also taking part in a different study being funded by the Legal Aid Board.  The consequence of all this, according to the journalist who was acting as judge and jury, was that  Wakefield's conclusions were tainted, and suspect.

So why have we started thinking about Dr Wakefield again?  Well, we happened on a new study that found that 40 per cent of all studies published in two medical journals in 2001 had conflicts of interest.  They were either directly funded by the drug company whose drug was being tested, or some of the researchers were in the employ of the drug company concerned. This would seem to be a clearer case of discredited research than anything undertaken by Dr Wakefield.

But have these studies been similarly dismissed?  Perhaps we just missed it.

(Source: Journal of Internal Medicine, 2004; 19: 1).

Killing the Messenger
From Floyd Tilton
Dr. Andrew Wakefield Fired and Hired
UPDATE: Dr. Andrew Wakefield, has been hired the International Child Development Resource Centre (ICDRC) in Florida as its Director of Research. Dr Wakefield told reporters, "The autism world is in crisis with the number of children affected skyrocketing. Not only does the medical establishment have no answers, it appears that it doesn't want toask the right questions. ICDRC breaks that mould. It holds tremendous potential and it will be an honour for my team and I to help realise that potential."

The Director of ICDRC, Dr. Jeff Bradstreet, said Dr Wakefield's decision to join them was wonderful news and would complete a "world-class" research team of specialists with expertise in all aspects of autism.

Dr Wakefield is investigating the possibility that the MMR vaccine, which combines live measles, mumps and rubella viruses in one shot, may cause bowel problems in some children which lead to autism.

Dateline: 12/05/01

Dr. Andrew Wakefield, the autism researcher who found the a potential link between the Measles - Mumps - Rubella vaccine (MMR) and autism has been fired by the Royal Free Hospital in London. Ironically, this news comes one day after a researcher at Harvard University substantially replicated the results of Wakefield's research, the first step at proving a hypothesis to be true according to the scientific method.

Dr. Timothy Buie, a pediatric gastroenterologist from Harvard/Mass General Hospital who has been conducting independent research similar to that reported by Dr. Wakefield in Great Britain. According to his findings, which came about as the result of over 400 gastrointestinal endoscopies with biopsies, as well as evaluation of digestive enzyme function in children diagnosed with autism and finding a connection, the chronic inflammation of the intestinal tract observed by Dr. Wakefield is present in a significant number of cases, although the incidence was noted to be less frequent in his group.

Buie announced his findings during the Oasis 2001 Conference for autism in Portland, Oregon. His findings are leading him to conduct more research into dietary treatments for autism, including gluten free - casein free diets for autistic children. His findings have also been supported by research done at the University of Maryland, by Dr. Karoly Horvath and others, who obtained essentially similar results to those found by both Wakefield and Buie.
Click on page two for more of Wakefield's comments and thoughts.

Dr. Andrew Wakefield Fired, Part Two
Dr. Wakefield, who is recognized by many in the autism community worldwide as an authority on autism, told parents involved in his research, "I realise now that everything that has happened to me was inevitable from the beginning. If you offend the system, then the system will take its revenge." As a result, parent and Autism groups around the world are reacting with horror to the termination of Dr. Wakefield by the hospital.

Now, at the time when his research has been validated by independent researchers in other countries, Wakefield finds himself on the outside looking in, at least as far as the Royal Free Hospital is concerned. While he still will have access to patients that were under his program, according to a message that he sent to concerned parents. Always the optimist, despite the jabs made at him by many in the medical community, Wakefield said, "One great benefit of this arrangement is that I shall no longer have to spend a considerable amount of time in distracting political negotiations with the Medical School and will be able to devote 100% of my effort to the research."

It brings to mind the story from mythology in which the messenger who brought news of the defeat of the army in battle, was killed for delivering unpleasant news to the king. His death, however, did not change the fact that the battle was lost. In Dr. Wakefield's case, the medical establishment may have tried to kill the messenger, but the message did not change. It remained constant, and has now been validated by others.

 

Making a connection
Cynthia T. Pegram
cpegram@newsadvance.com
Tuesday, February 22, 2005
A Lynchburg pediatrician is within about a year of completing research on potential links between autism and a common childhood vaccine.

The research is set up to reproduce or refute the clinical work of Dr. Andrew Wakefield, the lead author in published findings in a 1998 British medical journal that stirred worldwide debate. The article raised the issue of parental concern that a possible link between autism and inflammatory bowel disease was triggered by childhood vaccines. Early results from the local research confirm a high percentage of gut disease in Lynchburg-area children with autism. “We’re still working on the research,” said Dr. Elizabeth Mumper, who is working with Dr. Michael H. Hart of Roanoke, a pediatrician specializing in diseases of the intestine. “In terms of the presence of gut disease, we have essentially replicated their (the British team’s) findings.”

Autism, once considered a rare disorder, has dramatically increased worldwide since the late 1980s. It affects a child’s development in social and language skills, as well as behavior. Mumper said samples of tissue from 30 autistic children show within a few percentage points the presence of a marker for gut disease, which Wakefield found. Samples from about 20 non-autistic children have also been obtained - and that’s been the most difficult part.

“The controls have been hard to come by,” said Mumper. “We have very stringent criteria, and the parents have to consent to their child having two extra biopsies taken when they’re going in (for endoscopic examination) for some other reason.” Now about 27 months into the study, Mumper said it likely will take three years to complete. Tissues samples from the autistic children and the non-autistic children will undergo molecular level analysis, but no one will know those findings until they are complete. “In order to have a meaningful scientific study,” said Mumper, “you have to compare your case population to a set of healthy controls. If we’re trying to say that autistic kids have more bowel disease … we have to be able to compare that to a control population.
 
“The controls are kids that ordinarily would have qualified to be endoscoped anyway because they have something like vomiting or constipation.” Mumper and Dr. Mary Megson, a Richmond specialist in developmental pediatrics, are referring the cases. Both work with autistic children. “We asked the parents if they could be part of the research. I don’t think any of the autism parents turned us down. They were all very much interested in contributing further the science of gut disease/inflammatory bowel disease in autistic children.”

Wakefield spoke in Lynchburg several years ago at an autism conference. His conclusions of a vaccine-autism link have been challenged worldwide. He has written that fragments of the measles virus can be found in the lymph tissue in the bowel. Any causal link between vaccines and autism is rejected by the federal Centers for Disease Control and Prevention, the Institute of Medicine, and the American Academy of Pediatrics.

Those prestigious groups say that Wakefield’s conclusions and research were flawed and his findings could not be replicated - a keystone of scientific proof. Most of the members of that first research team have backed away from the conclusions he still holds. Whatever the trigger in autism may be, Mumper is convinced that bowel disease “is clearly a huge factor” in autism. When treating inflammatory bowel disease, said Mumper, “their autism symptoms get better.”

Mumper, who works with the nonprofit Defeat Autism Now of the California-based Autism Research Institute, speaks nationally on autism. She authored chapters in the new Lippincott Williams and Wilkins book “Pediatrics.” The chapters are on autism and also autoimmune and allergy issues seen in autism. She considers that autism occurs because of a “genetic predisposition for some type of trigger - an environmental trigger or an infectious trigger. “The study we’re doing is to try to further identify what some of those triggers might be.” Mumper said some autistic children have variations in their biochemistry that impairs a process called methylation, which takes place at the molecular level and plays out in every body system.

The altered biochemistry makes some children vulnerable to environmental triggers, which creates inflammatory bowel disease. Wakefield’s 1998 article cited parents’ beliefs that their children had changed after the measles-mumps-rubella (MMR) vaccine. Mumper said that as a pediatrician, she worried that “in a genetically susceptible subset of kids, that we may have hurt them unwittingly by giving them MMR vaccines at a time they were vulnerable.” She said in the mid-1990s, “we had a big push to catch up on immunizations. “And the thought was that if they’ve just been on antibiotics, it’s OK to go ahead and immunize them.
“The result - we immunized kids who were slightly sick. We immunized kids who had diarrhea, which is a risk factor for not handling a live viral vaccine well. We immunized kids who were on antibiotics.”

Most children did fine, she said, but in retrospect, “in a sub- population of kids, they did not do well.” “After years of getting histories from parents from many parts of the country, many of them give the story that they seem to have a child who got bad bowel disease and simultaneous autistic symptoms temporally related to the MMR vaccine.”But that doesn’t mean the vaccine caused the autism, she said. “I want to make that clear. But, that’s why we’re doing the study, to look and see if we do have evidence of the (vaccine) virus being there.”

This story can be found at
: http://www.newsadvance.com/servlet/Satellite?pagename=LNA/MGArticle/LNA
_BasicArticle&c=MGArticle&cid=1031781113173&path=

 

Dr Andrew Wakefield

In an article published on June 20, we referred to allegations printed in The Sunday Times relating to Dr Andrew Wakefield. The allegations related to two studies conducted by Dr Wakefield into the link between the Measles, Mumps and Rubella vaccination and the onset of autism.

The Sunday Times alleged that the nature of the funding of one of the studies could potentially have affected the outcome. We have been informed that defamation proceedings have been commenced against The Sunday Times in connection with this article. We would like to make it clear that there was in fact no conflict of interest nor was Dr Wakefield personally paid to undertake the study as was alleged.

Furthermore we wish to clarify that the studies were carried out under proper ethical authorisation. Finally we accept that the subjects of the studies were selected through appropriate NHS referrals. We apologise to Dr Wakefield for any distress caused and at his request have paid an appropriate sum to selected charities.

http://www.cambridge-news.co.uk/news/region_wide/2005/07/16/9508081d-0052-4f6d-8679-28f63e6ac5c3.lpf
 

MMR: The Facade Cracks

      The Daily Mail, UK
http://www.melaniephillips.com/articles/archives/001580.html

      Ever since the MMR controversy burst upon a bemused world back in 1998, the battle lines have been very clearly drawn. In one camp is Andrew Wakefield, the gastro-enterologist who started the whole furore when he claimed to have discovered a new syndrome in children combining autistic symptoms with a new type of bowel disease.   The affected children’s parents believed that this was the result of their triple measles, mumps and rubella jabs. Mr Wakefield took their fears seriously and suggested that, for the sake of prudence, children should be vaccinated with single jabs rather than MMR.

      In the uproar that has ensued ever since virtually the entire medical establishment, headed by the Department of Health, has lined up in the opposite camp to denounce Mr Wakefield’s claims in the most vitriolic terms as ‘junk science’ with no substance to them whatsoever. MMR, said all these experts with one voice, had been proved to be safe.    As a result, Mr Wakefield’s reputation has been systematically trashed and his research is said to be discredited. Yet many parents remain concerned. Only about 70 per cent of children are being vaccinated with MMR, raising fears of epidemics of measles, mumps and rubella. Indeed, as figures published yesterday revealed, in some areas a few as one in ten children has the triple jab.

      Yet as the controversy deepened, there was never a chink in the united front the health department presented to the world. It painted the anti-MMR camp as a bunch of hysterical and grasping parents desperate to blame someone for the inexplicable tragedy that had befallen their children, and exploited by a cranky and irresponsible doctor who was putting the health of the nation’s children at risk by terrifying parents into avoiding giving them the MMR jab.

      At the very core of the department’s case was its assertion that all the evidence was on its side. There had been no serious corroboration of Mr Wakefield’s claims and all reputable studies had shown MMR to be safe. There was simply no scientific case to answer.  Now, however, that united front has been shattered. A former senior Government medical officer has broken ranks to say that, on the contrary, the evidence suggests that for a small proportion of children MMR is not safe and that the Government is guilty of ‘utterly inexplicable complacency’.

      The person who is saying this cannot easily be dismissed. Dr Peter Fletcher, a former Chief Scientific Officer at the Department of Health in the late 1970s, is a former medical assessor to the Committee on the Safety of Medicines and had responsibility for deciding whether new vaccines were safe. For years, therefore, he was at the very heart of the vaccine policy-making and regulatory establishment. If anyone knows how to assess all the available evidence on such matters, he surely does.

      But now just look at what he has said. Having agreed to be an expert witness for lawyers of the affected children, he had studied thousands of documents relevant to the MMR issue. And these, he found, revealed ‘a steady accumulation of evidence’ from scientists around the world that the MMR jab was causing brain damage in certain children.  The clinical and scientific data that was now accumulating that MMR could cause brain, gut and immune system damage in a small proportion of vulnerable children was, he said, ‘far too much to ignore’.  In other words, Mr Wakefield’s evidence was in the process of being corroborated. What price, then, the health department’s insistence that such corroboration didn’t exist?

      Other assertions by the medical establishment were similarly shredded. They had tried to explain away the ten-fold leap in autism and related brain damage in children over the past 15 years as a statistical illusion arising from improved diagnosis. But according to Dr Fletcher there was ‘no way’ this could add up – and it failed to address the additional ‘extremely worrying increase’ in inflammatory bowel disease and immune disorders among children in this period. ‘It is highly likely that at least part of this increase is a vaccine-related problem’, he said, questioning why the government wasn’t taking ‘this massive public health problem’ more seriously. Why indeed? Dr Fletcher himself has suggested the answer: that there are very powerful people who have staked their entire reputations and careers on proving Andrew Wakefield wrong -- and they are willing to do
almost anything to protect themselves.

      This was a remarkable allegation from someone who was himself at the very heart of that particular establishment. But it is clear to anyone who has studied the evidence – as Dr Fletcher has done – that the bland assurances of the Government are simply not supported by the facts that they claim back them up.

      While Mr Wakefield is being subjected to a witch-hunt, and while the parents of the affected children are scandalously denied legal aid to pursue the court case which may well have finally brought to light the truth about MMR, those powerful people in the medical establishment are continuing to misrepresent the evidence. In particular, they claim that epidemiological studies show it is safe. But these studies are based on population-wide surveys too large and insensitive to get at the truth. This is because, for the vast majority of children, the vaccine poses no problem at all. Only a very small proportion are said to have been badly affected, possibly through a combination of environmental or genetic factors. Population-wide studies are considered unlikely to pick up small numbers like this.

      Worse still, the evidence has actually been distorted. Take, for example, the recent study by the respected Cochrane Library, which was said to have proved that Mr Wakefield was wrong. In fact, far from saying MMR was safe the study said explicitly that the evidence for its safety was not good enough.

      Dr Fletcher himself has previously protested at such misrepresentation. In 2001 the Government’s Chief Medical Officer, Professor Liam Donaldson, said concerns over the safety of MMR were considered by the Committee on the Safety of Medicines and other expert bodies to have been refuted. But in fact, the CSM had expressly said it was impossible to refute them and that the question was still open.

      In a letter to a clinical periodical Dr Fletcher noted ‘the curious turn of events which has now led to the Department of Health, the Medicines Control Agency, the Committee on Safety of Medicines and other eminent bodies citing negative studies as absolute evidence of safety.’       No-one listened. He also said at that time that the MMR safety trials conducted before its introduction in Britain were inadequate.

      No-one listened.
      Instead, the relentless drive to introduce more and more vaccines continues. This week, the Government is reported to be planning to announce yet another jab for babies, this time against pneumococcal meningitis. Vaccination plays a vital role. But are we yet sure that we understand the full effects of so many vaccines on immature immune systems?

      Now the Chancellor has urged all parents to vaccinate their children with MMR. Yet we still don’t know the truth about this vaccine. The pieces of this most complex of scientific jigsaws have not yet fallen into place.   What is clear is that the assertions made by the government about its proven safety, and about the absence of any evidence that might cause concern, are simply not true. Dr Fletcher’s intervention is devastating. As he says, if it is proved that MMR does cause autism after all, this will become one of the greatest scandals in medical history.    Are they listening now?

 

July17, 2006
Scared UK Docs Won't Charge Wakefield

"The General Medical Council has indicated that it will not proceed with charges against Dr Andrew Wakefield, who first suggested a link between the triple jab and autism. Dr Wakefield has been strongly backed by the parents of autistic children allegedly damaged by the vaccine, who refused to condemn his actions when interviewed as part of the inquiry. Last night the families claimed the investigation had been used to discredit his work and prevent further study into the risks of the vaccine." - The Daily Mail, UK

BL Fisher Note:

It has been eight long years since British gastroenterologist Andrew Wakefield, M.D. and colleagues from the Royal Free Hospital in London published an article in The Lancet urging further scientific investigation into the possible link between MMR vaccine, inflammatory bowel disease and autism in some children. Ever since, Wakefield has been subjected to a vicious personal and professional smear campaign at the hands of public health officials and medical doctors in Britain, the U.S. and Canada, who have no tolerance for scientific investigation into the biological mechanisms for vaccine injury and death.

Britain's General Medical Council (GMC), which is the equivalent of a self annointed Medical Supreme Court, has publicly been conducting an "investigation" for the past two years into whether Andrew Wakefield should be convicted of "professional misconduct" and have his medical license taken away. For the sin of trying to prevent healthy children from regressing physically, mentally, and emotionally after MMR vaccination into autism, the GMC has been determined to make sure he cannot find ways to help autistic children recover from MMR vaccine induced autism.

Now, at the eleventh hour, just before Andrew Wakefield was to have his day in court and publicly defend himself against nearly a decade of baseless charges by those seeking to silence him, the doctors in charge of the GMC have put their collective tails between their legs and run. Just like a common street bully, who blindsides an innocent with a sucker punch in the dark, doctors inside and outside of government and industry are too chicken to stand ground and fight in the light of day. The GMS has apparently figured out it won't stand a chance fighting Wakefield under the bright lights of the media it has duped and exploited in order to hide the child victims of one-size- fits all vaccine policies that end up targeting the genetically vulnerable for sacrifice.

It does not matter anymore what the GMC and doctors in charge of the mass vaccination system in the US and countries around the world do or do not do to Andrew Wakefield. His legacy is already written in the hearts and minds of the people whose children he has saved and will save from a lifetime of pain.


MMR row doctor who defied Government 'in the clear'
Daily Mail, U.K.
July 15, 2006

By SUE CORRIGAN and SALLY BECK


The doctor at the heart of the MMR vaccine controversy may not face charges of misconduct despite a 20-month investigation which has devastated his professional reputation. The General Medical Council has indicated that it will not proceed with charges against Dr Andrew Wakefield, who first suggested a link between the triple jab and autism.

Dr Wakefield has been strongly backed by the parents of autistic children allegedly damaged by the vaccine, who refused to condemn his actions when interviewed as part of the inquiry. Last night the families claimed the investigation had been used to discredit his work and prevent further study into the risks of the vaccine.

Dr Wakefield first suggested a link between the triple vaccine for measles, mumps and rubella and autism and bowel disease in 1998, after carrying out tests on 12 children admitted to the Royal Free Hospital in London with serious bowel disorders. He proposed that parents be offered three single injections. The Government denied there was a problem with the vaccine and it became a politically sensitive issue after senior Labour figures, including Tony Blair, refused to disclose if their children had received the jab. Dr Wakefield was ostracised by the medical establishment and has since moved to
America.

In late 2004 the GMC announced it was launching an inquiry into allegations of serious professional misconduct against Dr Wakefield and two former colleagues. It centred on claims that autistic children admitted to the hospital with serious bowel problems were subjected to "unnecessary and invasive", tests.
 Smear campaign

However, the children's parents are understood to have staunchly defended the doctor's actions, praising him as the first to take their concerns seriously. It was also claimed Dr Wakefield's research had not been valid because he failed to disclose a £50,000 grant from the lawyers of parents attempting to sue MMR's manufacturers for their children's disorders. Dr Wakefield has consistently argued that the grant was for separate research.

Nearly two years later the GMC has not drawn up any formal charges against Dr Wakefield and no date has been set for a public hearing, at which scientific arguments for a link between MMR and autism would have been aired. GMC spokeswoman Jo Wren said there is now "no guarantee", there will ever be a hearing. New figures released last week revealed that more than one in 100 children in the UK suffer from autism - far higher than previously thought. Last night Rosemary Kessick, the mother of an autistic boy whose treatment is part of the investigation, accused the GMC of allowing itself to be used as part of a deliberate Government campaign to smear Dr Wakefield and prop up public confidence in MMR.

"Hundreds of autistic children with the serious bowel disease first identified by Dr Wakefield have been unable to get any treatment in the UK, and the drawn-out GMC investigation has played a major role in this disgraceful state of affairs," she said. "It is deeply disturbing that Dr Wakefield's research findings and personal integrity have been so damagingly called into question on the basis of draft charges that may, in the end, simply be dropped."

Last night Dr Wakefield confirmed that no charges had been filed to date