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The accusation that Wakefield’s research is fraudulent is in regard to a single 1998 Lancet Publication he co-authored, titled: “Ileal-lymphoid-nodular hyperplasia, non-specific colitis, and pervasive developmental disorder in children”. The focus of that study was gastrointestinal dysfunction in children with autism, not vaccines and autism. The Lancet paper states:“We identified associated gastrointestinal disease and developmental regression in a group of previously normal children, which was generally associated in time with possible environmental triggers… Onset of behavioural symptoms was associated, by the parents, with measles, mumps, and rubella vaccination in eight of the 12 children, with measles infection in one child, and otitis media in another.”“We did not prove an association between measles, mumps, and rubella vaccine and the syndrome described. Virological studies are underway that may help to resolve this issue…We have identified a chronic enterocolitis in children that may be related to neuropsychiatric dysfunction. In most cases, onset of symptoms was after measles, mumps, and rubella immunization. Further investigations are needed to examine this syndrome and its possible relation to this vaccine.” An addendum states: “Up to Jan 28, a further 40 patients have been assessed; 39 with the syndrome.” -https://www.thelancet.com/journals/lancet/article/PIIS0140673697110960/fulltextIn 2003, a freelance journalist by the name of Brian Deer accepted an assignment for the Sunday Times, having been hired by Paul Nuki who stated “I need something big on MMR” as “litigation was pending in the High Court over alleged damage to children from the MMR vaccine.” Subsequently Deer consulted MLI (Medico-Legal Investigations, a firm that provides “a confidential service for the pharmaceutical industry and health sectors”. -MLI ) who assisted him “in strictest confidence -MLI” to craft the allegations. Between 2006 and it’s demise in 2013, MLI was funded entirely by the Association of British Pharmaceutical Industries (ABPI), acting as its “police force”. According to MLI’s chairman, 26 of the 27 doctors against who MLI initiated GMC proceedings, were found guilty of “research related matters.” MLI worked closely with “health authorities.” Among its services to Pharma clients was designing complaints to initiate GMC investigations. MLI served as:“Liaison between GMC and complainants during the build-up to the disciplinary hearing; Completion of case and final preparation for hearing under the auspices of the solicitors acting for the prosecution…” -MLIOn February 25, 2004 Deer solely filed a formal complaint against 3 of the 13 study authors (Andrew Wakefield, John Walker-Smith, and Simon Murch) with the GMC fitness to practice panel, stating:“I write to ask your permission to lay before you an outline of evidence that you may consider worthy of evaluation with respect of the possibility of serious professional misconduct on the part of the above named registered medical practitioners.” -Brian DeerThe GMC case against Dr. Wakefield and his two co-defendants on behalf of Brian Deer, alleged that vulnerable children were subject to research under the guise of clinical care. When the GMC case was subjected to genuine judicial review in 2012 at the appeal of Dr. Walker-Smith, the GMC allegations collapsed. After a thorough assessment of all the evidence and testimonies, the High Court determined that there was no evidence to support the allegations. The significant GMC determinations against the study were overturned. The GMC had the opportunity, but chose not to appeal the severe censure by the High Court. The attorney representing the GMC acknowledged that GMC had no additional evidence to substantiate its guilty verdicts. The High Court decision, therefore, became irrevocable. Despite adjudication of the GMC principal allegations against the infamous Lancet Study, the case continues to be mis-portrayed to the public as a valid GMC verdict.The GMC case was built on a central false premise; namely, that the Lancet clinical observation study, was commissioned by the Dawbarns law firm, paid for by the Legal Aid Board (LAB), and conducted under Project 172-96, to support a lawsuit. The GMC panel conflated two different studies. The study (project 172-96) that Dr. Wakefield, Dr. Murch, and Professor Walker-Smith were accused of performing had been approved, and was slated to be conducted AFTER the (Lancet) pilot study. However, as was adjudicated by the High Court, the Lancet observational case series was NOT Project 172-96:The key allegations & GMC fitness to practice panels’ determinations followed by the 2012 High Court adjudication are as follows:(1) “The children described in the Lancet paper were admitted for research purposes under Project 172-96; the purpose of the project was to investigate the postulated new syndrome following vaccination. The Lancet paper failed to state that this was the case, and the Panel concluded that this was dishonest, intentional and irresponsible.” -GMC“The Panel has heard that ethical approval had been sought and granted for other trials and it has been specifically suggested that Project 172-96 was never undertaken and that in fact, the Lancet 12 children’s investigations were clinically indicated and the research parts of those clinically justified investigations were covered by Project 162-95. In the light of all the available evidence, the Panel rejected this proposition.” -GMC“Serious professional misconduct [alleged by GMC] in relation to the Lancet children was in part founded upon its [GMC] conclusion that the investigations into them were carried out pursuant to Project 172- 96. The only explanation given for that conclusion is that it was reached ‘in the light of all the available evidence’, that was an inadequate explanation.” -Justice Mitting.“None of the five clinicians involved in the investigation of the Lancet children who gave evidence to the panel considered that they were following Project 172-96. None of the children fitted the hypothesis to be tested under Project 172-96,” -Justice Mitting“None of the children fitted the hypothesis to be tested under Project 172-96, in that none of them had both received a single or double vaccine. Project 172-96 was never undertaken.” -Justice Mitting(2) Children were subjected to invasive tests “that were not clinically indicated” – e.g., spinal taps and endoscopic procedures such as colonoscopies and biopsies – for research purposes under 172-96. -GMC“Project 172-96 was never undertaken and that in fact, the Lancet twelve children's investigations [including procedures] were clinically indicated and the research parts [directed by Wakefield] of those clinically justified investigations were covered by Project 162-95 [the general permission given to Professor Walker-Smith in September 1995].” -Justice Mitting“As Miss Glynn [from GMC] concedes, the reasons for the panel’s findings that colonoscopy, barium meal and follow through and lumbar puncture were not clinically indicated are wrong,” and “the finding that a lumbar puncture was not clinically indicated was not open to the panel and was wrong”. -Justice Mitting.(3) The study lacked ethics committee approval. -GMC“It was a clinically driven investigation which did not require Ethics Committee approval,” -Justice Mitting(4) “Some [4] of the children were not routine referrals to the gastroenterology department, in that they lacked a history of reported gastrointestinal symptoms and had been referred for investigation of the role played by the measles vaccination or the MMR vaccination in their developmental disorders.” -GMC“The [GMC] findings that the referrals of four children were not routine because the referring doctors did not mention intestinal symptoms in their referral letters was factually accurate as to the contents of the referral letters, but of no significance. In each case, Professor Walker-Smith elicited gastrointestinal symptoms at his outpatients clinic. The finding that all four children “lacked a history of gastrointestinal symptoms” is wrong unless the panel intended only to refer to the contents of the referral letters. -Justice Mitting“The panel’s finding that the description of the patient population [histories] in the Lancet paper was misleading would only have been justified if its primary finding that all of the Lancet children were referred for the purposes of research as part of Project 172-96 is sustainable. Because, for the reasons which I have given, it was not, this aspect of its findings must also fall.” -Justice Mitting.“In every case investigations were followed by a discharge letter prepared by Dr. Casson which set out a diagnosis of the child's condition and by a recommendation for treatment”. “The discharge notes were appropriately amended.” -Justice Mitting.(5) The description of the children’s diagnosis in the Lancet paper and the description of the referral process as “consecutively referred” was “inaccurate,” and “irresponsible”. -GMC“This [Lancet] paper does not bear the meaning put upon it by the panel. The phrase “consecutively referred” means no more than that the children were referred successively [to the Department of Paediatric Gastroenterology], rather than as a single batch. The words did not imply routine referral.” -Justice Mitting“It [GMC] put its stretched meaning of the wording of part of the paper into his mouth and then found [entered a decision against him] that it was irresponsible and misleading. This was not a legitimate finding.” -Justice Mitting.(6) [Wakefield Caused] “blood to be taken from a group of children for research purposes at a birthday party, which the Panel found to be an inappropriate social setting. He behaved unethically in failing to seek Ethics Committee approval; he showed callous disregard for any distress or pain the children might suffer, and he paid the children £5 reward for giving their blood.” -GMCOne blood sample each was taken from these developmentally normal, healthy children for research purposes, to serve as controls, for comparison with autistic children with bowel disease. Each of the parents had been contacted prior to the party; they were fully informed, and each gave permission (some of the parents were medical doctors). The blood was taken by a qualified, experienced medical professional, not Dr. Wakefield; the equipment used was appropriate, sterile and the type commonly used.As for Dr. Wakefield’s failure to obtain approval from the Research Ethics Committee (REC) for the taking of blood from these children: first, according to the National Research Ethics Service, “Not all research conducted within the UK requires approval from an NHS REC”. Dr. Wakefield testified that it was his “understanding at that time was that such approval was not necessary unless the subjects of the research were National Health Service patients.”(7) “Dr. Wakefield accepted monies totaling £50,000 procured through Mr Barr, the Claimants’ solicitor to pursue research under Project 172-96.”The sworn testimony of Mr. Martin Else, Head of the Royal Free Hampstead NHS Trust, confirms that the £50,000 from the Legal Aid Board was held in a separate Special Trustees account (account G106). The money was not paid to Dr. Wakefield; it was first submitted to the UCL medical school, and then transferred by Dean Ari Zuckerman to the Special Trustees account. It was not used until the Lancet study had been completed. The Royal Hospital General Trust fund paid the salary of a lab technician during the 2 years in which the Lancet study was conducted (1996-1998). The technician was not paid with the money provided by Legal Aid Board.(8) “Dr. Wakefield failed to disclose to the Editor of the Lancet his involvement as the inventor of a patent relating to a new vaccine for the elimination of the measles virus (Transfer Factor) which he claimed in the patent application, would be a treatment for inflammatory bowel disease (IBD). He did not accept that the invention was envisaged as an alternative vaccine to MMR…He acknowledged that he had envisaged the use of transfer factor for at least a proportion of the population, and that he had a financial and career interest in its success, but he insisted that there was a reasonable argument for non-disclosure. The Panel considered that his actions and his persistent lack of insight as to the gravity of his conduct amounted to serious professional misconduct.” -GMCDr. Wakefield suggested to the administrators that the Royal Free Hospital School of Medicine could generate capital by developing biotechnology patents. This patent was submitted in collaboration with the Royal Free. Patent law requires strict confidentiality: any disclosure of information related to a patent will result in loss of legal protection for the patent. The patent for “Transfer Factor” was NOT for a competing measles vaccine; transfer factor cannot stimulate the production of protective measles antibodies. The patent was for a proposed antidote treatment against adverse reactions to the vaccine. However, it was not tested nor developed.(9) “Dr. Wakefield failed to disclose to the Ethics Committee and to the Editor of the Lancet his involvement in the MMR litigation.” -GMCKnowledge about his work in preparation for a class action lawsuit by the UK government sponsored Legal Aid Board, was known to his co-authors, to administrators of the Royal Hospital, and to Dr. Richard Horton editor-in-chief of the Lancet. Justice Mitting quotes from a letter dated November 6, 1996, written by Dr. Wakefield to Professor Walker-Smith about “the legal aspect of these cases and the litigation being proposed by Dawbarns”. As noted above, Dr. Horton was well aware of the planned litigation as proven by his correspondence in 1997 with the attorney who was slated to file the lawsuit. Furthermore, the lawsuit was the subject of an article in The Independent as early as Nov. 27, 1996.The High Court ruled in regard to the GMC’s case against the authors; “there was distortion of evidence, inadequate analysis, inadequate and superficial reasoning and explanation, inappropriate rejection of evidence, ‘flawed’ and ‘wrong’ reasoning, and ‘numerous and significant universal inadequacies’…. Fundamental errors…that go to the heart of the case. They are not curable. The panel’s determination cannot stand.”-Justice Mitting.“Both on general issues and the Lancet paper and in relation to individual children, the panel's overall conclusion of serious professional misconduct was flawed…[there was] inadequate and superficial reasoning and, in a number of instances, a wrong conclusion… the medical records provide an equivocal answer to most of the questions which the panel had to decide”. “The panel’s determination cannot stand. I therefore quash it.” -Justice Mitting. (March 7, 2012).“Mr Justice Mitting called for changes in the way General Medical Council fitness to practise panel hearings are conducted in the future saying: "It would be a misfortune if this were to happen again." -BBC News http://www.bbc.com/news/health-17283751The High Court records quoted above were found at the British and Irish legal information institute: http://www.bailii.org/cgi-bin/markup.cgi?doc=/ew/cases/EWHC/Admin/2012/503.html&query=Walker-Smith+and+GMC&method=booleanSome have been critical of the study for failing to conform to the scientific standards of a controlled clinical trial. But the authors never claimed it was a randomized clinical trial; it was a case series; “It wasn’t supposed to be “a scientific sample” or a statistical measure of anything.” - Dr. Walker-SmithOthers have criticized Dr. Wakefield for “making inductive statements on the basis of 12 cases.” Viewed from a non-contentious historical perspective, this study is an example of how scientists identify a new condition based on a small number of patients. For example, Dr. Leo Kanner was the first scientist to identify the condition of “early infantile autism” in 1943. The basis for this identification was his case series involving 11 children. And Dr. Hans Asperger’s paper (1944) described 4 cases of “autistic psychopathy” which laid the foundation for the recognition of Asperger’s syndrome. These small studies are considered seminal works. More recently, a paper in a journal published by the BMJ Group (2004) described findings of cerebral changes in 9 infants who underwent diffusion tensor imaging.In any regard, The Lancet 12 study was ultimately correct in its findings of an association between gastrointestinal dysfunction in children with autism. It is now well documented that GI problems are often a co-morbid condition in these children. Unfortunately, the Lancets retraction of “Wakefield’s” study has created serious implications in the medical profession and has come at a significant cost to children with autism. For more than two decades these children have not been able to receive care for their co-morbid GI conditions, pediatric physicians are not willing to diagnose GI dysfunction in these patients due to the stigma associated with the Lancet study, these children have been neglected by a paralyzed medical profession, and left to suffer without warrant from untreated and debilitating GI symptoms indefinitely.

In many instances the onset of autism symptoms in children begins with a typically developing child who, following vaccination has a “normal” vaccine reaction such as high fever, rash, hives, vomiting, and lethargy that persists for several days, upon recovery from acute vaccine reaction symptoms new behaviors are present that are consistent with autism. The child does not appear to fully recover from the reaction or return to their previous self, thus the onset of autism is often described as “sudden” or “overnight” and in these cases onset is accurately attributed to occurring during the period of vaccine reaction symptoms. In some cases the autism symptoms progress over time and worsens, while in other cases a partial recovery is made. As long as the onset of autism symptoms continue to simultaneously occur during the same period as a vaccine reaction the real world experience that vaccines contribute to autism will persist regardless of scientific studies.Additionally, the vaccine studies currently available are of poor quality. The best study the scientific community currently has to offer disproving a link between vaccination and autism is a meta-analysis performed by medical student LE Taylor, titled; “Vaccines are not associated with autism: an evidence-based meta-analysis of case-control and cohort studies.”In this analysis, Taylor compiled 6 MMR studies (Madsen, Uchiyama, Destfano, Mrozek-Budzyn, Smeeth, Uno Y) and 4 Thimerosal studies (Andrews, Verstraeten, Hviid, Price). It is asserted in the public domain that the analysis includes 1.2 million children, however two of the studies (Hviid, Madsen) counted all the children born in Denmark between 1990 and 1998, meaning the authors of the meta-analysis double counted those children. There were only about 500,000 total births in Denmark between 1990 and 1998, according to the individual studies included in Taylor.The Cochrane Collaboration is comprised of 53 review groups at research institutions worldwide, they reviewed three of the studies included in Taylor;Madsen et. al. 2002 https://www.nejm.org/doi/full/10.1056/NEJMoa021134 “A population based study of MMR vaccination and autism”Cochrane Findings; “Because of the length of time from birth to diagnosis, it becomes increasingly unlikely that those born later in the cohort could have a diagnosis i.e. there was extensive under-counting of autism cases in the MMR group.” [Not only was this paper fatally flawed in design, but it was conducted illegally. Madsen, Thorsen and their team did not have the legally required ethical clearances to access the data they used in this study. In addition, Thorsen has been legally indicted for fraud over miss-use of research funds.]DeStefano et. al. 2004. https://www.ncbi.nlm.nih.gov/pubmed/14754936 “Age at First Measles-Mumps-Rubella Vaccination In Children With Autism And School-Matched Control Subjects: A Population-Based Study In Metropolitan Atlanta. (Co-author Dr. William Thompsons’ has denounced his own study, his public statement declares he and his colleagues wrongly omitted findings of a statistically significant correlation between vaccines and autism in this study).Cochrane Findings; “DeStefano provided inadequate explanations for missing data…excluded more than a third of cases”.Smeeth et. al. 2004 https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(04)17020-7/fulltext “MMR Vaccination and Pervasive Developmental Disorders: A Case-Control Study”.Findings; The study assessed the association between exposure to MMR and the onset of autism and other PDD based on data from the UK’s General Practice Research Databased (GPRD) studies (Black 2003; Smeeth 2004) the precise nature of controlled unexposed to MMR and their generalisability was impossible to determine.Regarding the Verstraeten study,; Verstraeten et al. (2003). “Safety of thimerosal-containing vaccines: a two-phased study of computerized health maintenance organization databases.”It was wrong for Taylor to use this study as evidence to assertion that vaccines do not contribute to autism, as Verstraeten has previously pointed out in a letter published in the April, 2004 issue of Pediatrics, stating while his team had “found a positive association between thimerosal and certain outcomes in Phase I, these findings could not be replicated in the second phase. The perception of the study changed from a positive to a neutral study ―Surprisingly, however, the study is being interpreted now as negative by many. The article does not state that we found evidence against an association, as a negative study would. It does state, on the contrary, that additional study is recommended, which is the conclusion to which a neutral study must come.”Two of the studies (Andrews, Hviid) actually ascertained an asinine conclusion that Thimerosal has a protective effect on children;Andrews et al. (2004) “Thimerosal exposure in infants and developmental disorders: a retrospective cohort study in the United kingdom does not support a causal association.”The "protective effect" of organic mercury exposure found in young children was biological implausible. According to this study, higher thimerosal exposure at 4 months of age reduced the risk of ADD and unspecified developmental delay by at least 20 percent compared to children with lower exposures. There is no biological evidence to suggest that a known neurotoxin like ethylmercury can be beneficial to neurodevelopment. Validation exercises found that 20% of the diagnoses were invalid or questionable. The authors state; "This lack of specificity is a limitation of the study because it biases against findings an association."Hviid et al. (2003). “Association Between Thimerosal-Containing Vaccine and Autism”The data in this study show that mercury is beneficial to infant children. Those in the thimerosal group had a relative risk of 0.85 for autism, compared with the mercury free group, suggesting a substantial protective effect for thimerosal. This finding is suspicious, and runs counter to all knowledge, science and common sense.Giving more weight to the group of medical students that authored Taylor et.al. over the Cochran Collaborations following reviews is ridiculous;2003 MMR Cochrane review findings regarding MMR/autism studies; https://www.sciencedirect.com/science/article/pii/S0264410X03002718The external validity of the studies was low. Descriptions of the study populations, response rates, vaccine content and exposure - all important indicators of generalizability - “were poorly and inconsistently reported.”“Because the vast majority of ASD cases cannot be accurately sub-classified, if there is a subset of individuals with autism syndrome triggered by exposure to vaccines, our ability to find it is very limited in the absence of a biological marker”.“A lack of unexposed children is another limitation. The committee noted that they had previously called for studies to enroll children whose families opted against the MMR vaccine, but so far, this type of study has been difficult to do with sufficiently large numbers”.“There was a lack of clarity in reporting and systematic bias which made it impossible to compare the various studies through quantitative synthesis of data”.“There were general difficulties in ascertaining adequate numbers of unexposed children due to the high uptake of vaccines and the extent of vaccination programs. This is a methodological* problem likely to be encountered in all comparative studies of established childhood vaccines”.There was a “lack of adequate description of exposures (vaccine content and schedules in all studies”.“The failure of any study to provide descriptions of all outcomes was a recurring problem”.“Some reports offered inadequate explanations for missing data, accepting as ‘adequate’ explanations such as ‘nonresponse to questionnaire’ and ‘no medical records unavailable.”“There were inadequate and inconsistent descriptions of reported outcomes, limited observation periods and selective reporting of results. All of these problems contributed to the reviewers’ decision not to attempt pooling data by study design”.“There was only limited evidence of MMR’s safety compared to single component vaccines from studies with a low risk of bias. The few studies least likely to be affected by systematic error pointed to a likely association with increased febrile convulsions in the first two weeks post-vaccination”.“There was a moderate-to-high probability of bias in all but one of the cohort studies”.“MMR could contribute to autism in a small number of children because the epidemiological studies lacked sufficient precision to assess rare occurrences.”They also noted that it was possible that epidemiological studies would “not detect a relationship between autism and MMR vaccination in a subset of the population with a genetic predisposition to autism”.“We found limited evidence of safety of MMR compared to its single-component vaccines…external validity of included studies was also low. In addition, inadequate and inconsistent descriptions of reported outcomes (a well-known problem), limited observation periods (maximum 42 days), and selective reporting of results…As MMR vaccine is universally recommended, recent studies are constrained by the lack of a non-exposed control group…“We were unable to include a majority of the retrieved studies because a comparable, clearly defined control group or risk period was not available. The exclusion may be a limitation of our review or may reflect a more fundamental methodological dilemma: how to carry out meaningful studies in the absence of a representative population not exposed to a vaccine universally used in public health programs. Whichever view is chosen, we believe that meaningful inferences from individual studies lacking a non-exposed control group are difficult to make.”The 2005 Cochrane Review overall conclusions regarding MMR safety studies; “We could not identify studies assessing the effectiveness of MMR that fulfilled our inclusion criteria. A lack of clarity in reporting and systematic bias made comparability across studies and quantitative synthesis of data impossible.” The MMR studies were “largely inadequate… incomplete… [and suffered from] high risk bias. We found only limited evidence of the safety of MMR compared to its single component vaccines from studies that had a low risk bias”. Ultimately, due to the absence of any credible evidence disproving an association with MMR/vaccination, the reviewers were left with the only assertion they could make...that mass vaccination is the evidence for MMR safety. http://onlinelibrary.wiley.com/wol1/doi/10.1002/14651858.CD004407.pub2/full2012 Cochrane Review of studies comprised of 14,700,000 children identified the same lack of evidence credibility as the 2005 study review. “There was a lack of adequate description of exposure (vaccine content and schedules) in all cohort studies. Another recurring problem was the failure of any study to provide descriptions of all outcomes monitored. “The design and reporting of safety outcomes in MMR vaccine studies, both pre- and post-marketing, are largely inadequate… The methodological quality of many of the included studies made it difficult to generalize their results.” In other words post-marketing surveillance was not adequate to show that mass vaccination is evidence of MMR safety, contrary to their 2005 conclusions.The study that was touted as a “fraud” by the GMC in 2010 was subjected to legal adjudication in 2012 under High Court rule. Subsequently, the GMC could not support their allegations under legal scrutiny and the allegations against the paper were overturned by Justice Mitting. The accusation that Wakefield’s research is fraudulent is in regard to a single 1998 Lancet Publication he co-authored, titled: “Ileal-lymphoid-nodular hyperplasia, non-specific colitis, and pervasive developmental disorder in children”. The focus of that study was gastrointestinal dysfunction in children with autism, not vaccines and autism. The Lancet paper states:“We identified associated gastrointestinal disease and developmental regression in a group of previously normal children, which was generally associated in time with possible environmental triggers… Onset of behavioural symptoms was associated, by the parents, with measles, mumps, and rubella vaccination in eight of the 12 children, with measles infection in one child, and otitis media in another.”“We did not prove an association between measles, mumps, and rubella vaccine and the syndrome described. Virological studies are underway that may help to resolve this issue…We have identified a chronic enterocolitis in children that may be related to neuropsychiatric dysfunction. In most cases, onset of symptoms was after measles, mumps, and rubella immunization. Further investigations are needed to examine this syndrome and its possible relation to this vaccine.” An addendum states: “Up to Jan 28, a further 40 patients have been assessed; 39 with the syndrome.” -https://www.thelancet.com/journals/lancet/article/PIIS0140673697110960/fulltextIn 2003, a freelance journalist by the name of Brian Deer accepted an assignment for the Sunday Times, having been hired by Paul Nuki who stated “I need something big on MMR” as “litigation was pending in the High Court over alleged damage to children from the MMR vaccine.” Subsequently Deer consulted MLI (Medico-Legal Investigations, a firm that provides “a confidential service for the pharmaceutical industry and health sectors”. -MLI ) who assisted him “in strictest confidence -MLI” to craft the allegations. Between 2006 and it’s demise in 2013, MLI was funded entirely by the Association of British Pharmaceutical Industries (ABPI), acting as its “police force”. According to MLI’s chairman, 26 of the 27 doctors against who MLI initiated GMC proceedings, were found guilty of “research related matters.” MLI worked closely with “health authorities.” Among its services to Pharma clients was designing complaints to initiate GMC investigations. MLI served as:“Liaison between GMC and complainants during the build-up to the disciplinary hearing; Completion of case and final preparation for hearing under the auspices of the solicitors acting for the prosecution. Completion of case and final preparation for hearing under the auspices of the solicitors acting for the prosecution…” -MLIOn February 25, 2004 Deer solely filed a formal complaint against 3 of the 13 study authors (Andrew Wakefield, John Walker-Smith, and Simon Murch) with the GMC fitness to practice panel, stating:“I write to ask your permission to lay before you an outline of evidence that you may consider worthy of evaluation with respect of the possibility of serious professional misconduct on the part of the above named registered medical practitioners.” -Brian DeerThe GMC case against Dr. Wakefield and his two co-defendants on behalf of Brian Deer, alleged that vulnerable children were subject to research under the guise of clinical care. When the GMC case was subjected to genuine judicial review in 2012 at the appeal of Dr. Walker-Smith, the GMC allegations collapsed. After a thorough assessment of all the evidence and testimonies, the High Court determined that there was no evidence to support the allegations. The significant GMC determinations against the study were overturned. The GMC had the opportunity, but chose not to appeal the severe censure by the High Court. The attorney representing the GMC acknowledged that GMC had no additional evidence to substantiate its guilty verdicts. The High Court decision, therefore, became irrevocable. Despite adjudication of the GMC principal allegations against the infamous Lancet Study, the case continues to be mis-portrayed to the public as a valid GMC verdict.The GMC case was built on a central false premise; namely, that the Lancet clinical observation study, was commissioned by the Dawbarns law firm, paid for by the Legal Aid Board (LAB), and conducted under Project 172-96, to support a lawsuit. The GMC panel conflated two different studies. The study (project 172-96) that Dr. Wakefield, Dr. Murch, and Professor Walker-Smith were accused of performing had been approved, and was slated to be conducted AFTER the (Lancet) pilot study. However, as was adjudicated by the High Court, the Lancet observational case series was NOT Project 172-96:The key allegations & GMC fitness to practice panels’ determinations followed by the 2012 High Court adjudication are as follows:(1) “The children described in the Lancet paper were admitted for research purposes under Project 172-96; the purpose of the project was to investigate the postulated new syndrome following vaccination. The Lancet paper failed to state that this was the case, and the Panel concluded that this was dishonest, intentional and irresponsible.” -GMC“The Panel has heard that ethical approval had been sought and granted for other trials and it has been specifically suggested that Project 172-96 was never undertaken and that in fact, the Lancet 12 children’s investigations were clinically indicated and the research parts of those clinically justified investigations were covered by Project 162-95. In the light of all the available evidence, the Panel rejected this proposition.” -GMC“Serious professional misconduct [alleged by GMC] in relation to the Lancet children was in part founded upon its [GMC] conclusion that the investigations into them were carried out pursuant to Project 172- 96. The only explanation given for that conclusion is that it was reached ‘in the light of all the available evidence’, that was an inadequate explanation.” -Justice Mitting.“None of the five clinicians involved in the investigation of the Lancet children who gave evidence to the panel considered that they were following Project 172-96. None of the children fitted the hypothesis to be tested under Project 172-96,” -Justice Mitting“None of the children fitted the hypothesis to be tested under Project 172-96, in that none of them had both received a single or double vaccine. Project 172-96 was never undertaken.” -Justice Mitting(2) Children were subjected to invasive tests “that were not clinically indicated” – e.g., spinal taps and endoscopic procedures such as colonoscopies and biopsies – for research purposes under 172-96. -GMC“Project 172-96 was never undertaken and that in fact, the Lancet twelve children's investigations [including procedures] were clinically indicated and the research parts [directed by Wakefield] of those clinically justified investigations were covered by Project 162-95 [the general permission given to Professor Walker-Smith in September 1995].” -Justice Mitting“As Miss Glynn [from GMC] concedes, the reasons for the panel’s findings that colonoscopy, barium meal and follow through and lumbar puncture were not clinically indicated are wrong,” and “the finding that a lumbar puncture was not clinically indicated was not open to the panel and was wrong”. -Justice Mitting.(3) The study lacked ethics committee approval. -GMC“It was a clinically driven investigation which did not require Ethics Committee approval,” -Justice Mitting(4) “Some (4) of the children were not routine referrals to the gastroenterology department, in that they lacked a history of reported gastrointestinal symptoms and had been referred for investigation of the role played by the measles vaccination or the MMR vaccination in their developmental disorders.” -GMC“The [GMC] findings that the referrals of four children were not routine because the referring doctors did not mention intestinal symptoms in their referral letters was factually accurate as to the contents of the referral letters, but of no significance. In each case, Professor Walker-Smith elicited gastrointestinal symptoms at his outpatients clinic. The finding that all four children “lacked a history of gastrointestinal symptoms” is wrong unless the panel intended only to refer to the contents of the referral letters. -Justice Mitting“The panel’s finding that the description of the patient population [histories] in the Lancet paper was misleading would only have been justified if its primary finding that all of the Lancet children were referred for the purposes of research as part of Project 172-96 is sustainable. Because, for the reasons which I have given, it was not, this aspect of its findings must also fall.” -Justice Mitting.“In every case investigations were followed by a discharge letter prepared by Dr. Casson which set out a diagnosis of the child's condition and by a recommendation for treatment”. “The discharge notes were appropriately amended.” -Justice Mitting.(5) The description of the children’s diagnosis in the Lancet paper and the description of the referral process as “consecutively referred” was “inaccurate,” and “irresponsible”. -GMC“This [Lancet] paper does not bear the meaning put upon it by the panel. The phrase “consecutively referred” means no more than that the children were referred successively [to the Department of Paediatric Gastroenterology], rather than as a single batch. The words did not imply routine referral.” -Justice Mitting“It [GMC] put its stretched meaning of the wording of part of the paper into his mouth and then found [entered a decision against him] that it was irresponsible and misleading. This was not a legitimate finding.” -Justice Mitting.(6) [Wakefield Caused] “blood to be taken from a group of children for research purposes at a birthday party, which the Panel found to be an inappropriate social setting. He behaved unethically in failing to seek Ethics Committee approval; he showed callous disregard for any distress or pain the children might suffer, and he paid the children £5 reward for giving their blood.” -GMCOne blood sample each was taken from these developmentally normal, healthy children for research purposes, to serve as controls, for comparison with autistic children with bowel disease. Each of the parents had been contacted prior to the party; they were fully informed, and each gave permission (some of the parents were medical doctors). The blood was taken by a qualified, experienced medical professional, not Dr. Wakefield; the equipment used was appropriate, sterile and the type commonly used.As for Dr. Wakefield’s failure to obtain approval from the Research Ethics Committee (REC) for the taking of blood from these children: first, according to the National Research Ethics Service, “Not all research conducted within the UK requires approval from an NHS REC”. Dr. Wakefield testified that it was his “understanding at that time was that such approval was not necessary unless the subjects of the research were National Health Service patients.”(7) “Dr. Wakefield accepted monies totaling £50,000 procured through Mr Barr, the Claimants’ solicitor to pursue research under Project 172-96.”The sworn testimony of Mr. Martin Else, Head of the Royal Free Hampstead NHS Trust, confirms that the £50,000 from the Legal Aid Board was held in a separate Special Trustees account (account G106). The money was not paid to Dr. Wakefield; it was first submitted to the UCL medical school, and then transferred by Dean Ari Zuckerman to the Special Trustees account. It was not used until the Lancet study had been completed. The Royal Hospital General Trust fund paid the salary of a lab technician during the 2 years in which the Lancet study was conducted (1996-1998). The technician was not paid with the money provided by Legal Aid Board.(8) “Dr. Wakefield failed to disclose to the Editor of the Lancet his involvement as the inventor of a patent relating to a new vaccine for the elimination of the measles virus (Transfer Factor) which he claimed in the patent application, would be a treatment for inflammatory bowel disease (IBD). He did not accept that the invention was envisaged as an alternative vaccine to MMR…He acknowledged that he had envisaged the use of transfer factor for at least a proportion of the population, and that he had a financial and career interest in its success, but he insisted that there was a reasonable argument for non-disclosure. The Panel considered that his actions and his persistent lack of insight as to the gravity of his conduct amounted to serious professional misconduct.” -GMCDr. Wakefield suggested to the administrators that the Royal Free Hospital School of Medicine could generate capital by developing biotechnology patents. This patent was submitted in collaboration with the Royal Free. Patent law requires strict confidentiality: any disclosure of information related to a patent will result in loss of legal protection for the patent. The patent for “Transfer Factor” was NOT for a competing measles vaccine; transfer factor cannot stimulate the production of protective measles antibodies. The patent was for a proposed antidote treatment against adverse reactions to the vaccine. However, it was not tested nor developed.(9) “Dr. Wakefield failed to disclose to the Ethics Committee and to the Editor of the Lancet his involvement in the MMR litigation.” -GMCKnowledge about his work in preparation for a class action lawsuit by the UK government sponsored Legal Aid Board, was known to his co-authors, to administrators of the Royal Hospital, and to Dr. Richard Horton editor-in-chief of the Lancet. Justice Mitting quotes from a letter dated November 6, 1996, written by Dr. Wakefield to Professor Walker-Smith about “the legal aspect of these cases and the litigation being proposed by Dawbarns”. As noted above, Dr. Horton was well aware of the planned litigation as proven by his correspondence in 1997 with the attorney who was slated to file the lawsuit. Furthermore, the lawsuit was the subject of an article in The Independent as early as Nov. 27, 1996.The High Court ruled in regard to the GMC’s case against the authors; “there was distortion of evidence, inadequate analysis, inadequate and superficial reasoning and explanation, inappropriate rejection of evidence, ‘flawed’ and ‘wrong’ reasoning, and ‘numerous and significant universal inadequacies’…. Fundamental errors…that go to the heart of the case. They are not curable. The panel’s determination cannot stand.”-Justice Mitting.“Both on general issues and the Lancet paper and in relation to individual children, the panel's overall conclusion of serious professional misconduct was flawed…[there was] inadequate and superficial reasoning and, in a number of instances, a wrong conclusion… the medical records provide an equivocal answer to most of the questions which the panel had to decide”. “The panel’s determination cannot stand. I therefore quash it.” -Justice Mitting. (March 7, 2012).“Mr Justice Mitting called for changes in the way General Medical Council fitness to practise panel hearings are conducted in the future saying: "It would be a misfortune if this were to happen again." -BBC News http://www.bbc.com/news/health-17283751The High Court records quoted above were found at the British and Irish legal information institute: http://www.bailii.org/cgi-bin/markup.cgi?doc=/ew/cases/EWHC/Admin/2012/503.html&query=Walker-Smith+and+GMC&method=booleanSome have been critical of the study for failing to conform to the scientific standards of a controlled clinical trial. But the authors never claimed it was a randomized clinical trial; it was a case series; “It wasn’t supposed to be “a scientific sample” or a statistical measure of anything.” - Dr. Walker-SmithOthers have criticized Dr. Wakefield for “making inductive statements on the basis of 12 cases.” Viewed from a non-contentious historical perspective, this study is an example of how scientists identify a new condition based on a small number of patients. For example, Dr. Leo Kanner was the first scientist to identify the condition of “early infantile autism” in 1943. The basis for this identification was his case series involving 11 children. And Dr. Hans Asperger’s paper (1944) described 4 cases of “autistic psychopathy” which laid the foundation for the recognition of Asperger’s syndrome. These small studies are considered seminal works. More recently, a paper in a journal published by the BMJ Group (2004) described findings of cerebral changes in 9 infants who underwent diffusion tensor imaging.In any regard, The Lancet 12 study was ultimately correct in its findings of an association between gastrointestinal dysfunction in children with autism. It is now well documented that GI problems are often a co-morbid condition in these children. Unfortunately, the Lancets retraction of “Wakefield’s” study has created serious implications in the medical profession and has come at a significant cost to children with autism. For more than two decades these children have not been able to receive care for their co-morbid GI conditions, pediatric physicians are not willing to diagnose GI dysfunction in these patients due to the stigma associated with the Lancet study, these children have been neglected by a paralyzed medical profession, and left to suffer without warrant from untreated and debilitating GI symptoms indefinitely.