How the GMC Framed Doctors Wakefield, Walker-Smith and Murch
By Martin Hewitt

http://www.ageofautism.com/2010/04/h...rch-.htmlApril 20, 20101. IntroductionIn 1998 the Lancet published a short case series of 12 autistic childrenadmitted to the Royal Free Hospital (RFH) in London for treatment of bowelsymptoms.1 The paper was one of the first to bring to the medicalcommunity's attention an unexplained association between autism and boweldisease, describing the children's clinical findings and noting that parentstimed the onset of eight of their children's conditions from the MMRvaccination. Twelve years later the General Medical Council, the UK medicalregulator, concluded that the way the three senior authors of the paper --Dr Wakefield, and Professors Walker-Smith and Murch -- had researched andwritten the paper amounted to serious professional misconduct, especially inthe way the children were selected and subject to invasive investigations,in the doctors' unethical research practices and Dr Wakefield's failure todisclose his conflict of interest. In the sanctions stage of the hearingthat began in April 2010 the prosecution is recommending that Wakefield andWalker-Smith are erased from the register of medical practitioners and thatMurch is suspended.Following evidence from the prosecution and defence in the largest and mostexpensive hearing in the GMC's history, the fitness to practice (FtP) panelfaced the apparently small issue of deciding which of two ethical approvalsapplied to the 1998 Lancet paper: approval 162-95 in 1995 or approval 172-96in 1996. For the doctors, however, this one year's difference was momentous,even after 15 years of passing. The entire case would be won or lost on thisone decision.The GMC prosecution claimed that 172-96, granted by the RFH Ethics Committee(EC), was the only ethical approval for the Lancet case series. Thedefendants, however, referred to 162-95 as the appropriate approval.Accepting approval 172-96 would shift the entire findings of fact, in effectchanging the goalposts.Ethical approval 162-95 was a short letter from the EC to Walker-Smithallowing him to take two additional mucosal tissue samples for research fromthe bowel of children undergoing a colonoscopy to investigate their clinicalcondition. The team could thereby obtain further research data on a child'scondition in addition to clinical data. The approval was generic and appliedto children being treated by Walker-Smith. This included the Lancet caseseries of 12 children with autism and gastroenterological symptoms, a studydescribing clinical symptoms for which no research protocol was needed asthe children were admitted for treatment -- ie they would be subject to thesame tests whether or not they were included in the research study. The caseseries did not research the impact of new treatments or diagnosticprocedures which would require more rigorous ethical approval. The use ofcolonoscopy and other procedures to investigate clinical conditions was amatter for the doctors' clinical judgment. The approval set the start date 5September 1995.In cross examination the chair of the Ethics Committee in 1995 and 1996conceded that no EC approval was required to write up a retrospective caseseries for a journal. The children were admitted consecutively on the basisof clinical need, their clinical conditions investigated and written up inaccordance with approval 162-95. The 12 children were referral by their GPsor local consultants. That ethical approval was granted was stated at theend of the paper.The prosecution acting on behalf of the GMC, who brought the case againstthe doctors, argued that 172-96 (and the associated research protocol) wasthe only approval governing the Lancet case series. Ethical approval1972-96, for a study of 25 children, provided a different set of conditions:the start date for including the children, 18 December 1996; the illnessesthe children must have and the vaccinations received to qualify; and thebureaucratic procedures to be followed -- consent forms lodged, who hadresponsibility for ordering investigations, who was the lead researcher,etc.. These conditions of approval represented the armoury the prosecutionwould use to knock down the defendants' simpler conditions, with the startdate the most powerful piece taking first shot. If the Lancet paper couldn'tstand up to the start date -- that the children could only be admitted after18 December 1996, not after 5 September 1995 -- then everything else wouldfall, including the contention that the children were selected for treatmenton the basis of clinical need.The summary of the panel's conclusions on findings of fact shows that thepanel chose approval 172-96 'in the light of all the available evidence'(p.3),2 rejecting the defendants' claim that the Lancet case series was doneunder approval 162-95. Most surprisingly the panel gives no reasons forrejecting 162-95. In one move the Lancet series became a research 'project'and not a treatment exercise, in which clinical interventions on severallydisabled children (eg colonoscopies and lumbar punctures) were done forresearch purposes even though clinically indicated for the treatment of sickchildren with serious and unexplained symptoms. In its only reference to162-95 in the summary, the panel misleadingly refers to it as a 'project'(p.3), whereas the approval was generic covering the clinical practice oftaking additional samples from colonoscoped children for research purposessuch as the Lancet case series and other descriptive case series were theyto be undertaken.2. Key findings based on 172-96Start date and ethical approvalBy selecting the start date of 18 December 1996, the prosecution could showthat 7 of the 11 children (one of the 12 was a US patient and excluded fromthe proceedings) were accepted for the research before the start date and sowithout ethical approval. For example, Wakefield was charged 'that Child 2was investigated under a project without the approval of the EC in that itwas not research covered by any EC application other than that for Project172-96 and...contrary to the conditions of approval for Project 172-96 Child2 had been enrolled into the project before 18 December 1996' (p.14) - aphrase repeated ad nauseam for seven children and in almost all cases forthe same set of charges against each of the three doctors. Using 172-96, thepanel was able to frame the facts so that Dr Wakefield's statement in theLancet paper that the study was ethically approved was 'dishonest,irresponsible, contrary to [his] duty to ensure that the informationprovided by [him] was accurate' (pp.48-9). Had 162-95 been duly acknowledgedthese charges would have fallen.Inclusion criteriaApplying the inclusion criteria of 172-96 meant that the 11 children did notqualify for the project as they failed to meet them, namely 'enteritis anddisintegrative disorder following measles/rubella vaccination' (p.8).Instead they were described in the Lancet as autistic and vaccinated withMMR. By failing to adhere to these inclusion criteria for each child,Wakefield was admonished for having 'failed to comply with [his] duties tothe EC as a named Responsible Consultant' (eg see p.14). Again thesecriteria were replicated for each of the three doctors.However, look closely at the changing diagnoses among the children's doctorsas reported in the summary and you realise how precarious the diagnosis ofautism is even among experts. For example, child 6's GP offers an initialdiagnosis of autistic syndrome in August 1996; whereas three months laterthe psychiatrist working with the research team suggests Asperger's Syndromeas the most likely diagnosis (pp. 24-5). It is well known that autisticspectrum disorders are diagnosed differently by different doctors. Yet trueto their ideological ends, the GMC prosecution forced the facts when thereality was far from clear.Research not treatmentBy accepting approval 172-96, the Panel was asked to judge that the childrenwere being admitted for research and not treatment. Placed within the 1996framework, the Lancet paper was no longer a case series of childrenundergoing clinical treatment but a research project subject to far stricterapproval. Consequently each doctor was charged with carrying outinterventions on the children for research purposes alone for which they hadno approval.Interventions not clinically indicatedThe most serious implication of judging the doctors' actions according toresearch criteria alone was that, in a UK climate of heightened childprotection, they were found to have 'caused' interventions not clinicallyindicated and 'contrary to the clinical interests of the child'. Yet,although the doctors claimed 172-96 was not the appropriate approval, theanswer to question 11 on the 172-96 protocol and pro forma stated that 'allthe procedures and the majority of the samples are clinically indicated'.The consequence of using 172-96 was that facts allowable under the 1995approval were excluded, specifically testimony from parents of eight of theLancet 12 saying that their children were being treated for serious clinicalneeds by the three doctors who exercised deep professional concernthroughout.3 Their evidence submitted by letter to the GMC was disallowed.2. Selecting the children for the researchThe prosecution used a conventional referral model in deciding how thedoctors should have selected the children for the Lancet study. Anydeparture from this model was denounced as unethical, therebyinstitutionalising, 14 years after the 1996 approval, a 'correct' processfor which there was then no authority. For the Panel a case series is 'aroutine process in which the investigators had played no active part'(p.45). Ethical research involves the researcher playing a passive role inthe referral process, as patient is passed from GP to consultant and finallyto the medical researcher, with the parties necessarily sharing anunderstanding of the patients' condition. The researcher is involved in thefinal but not the initial selection of patient/research subjects.The summary gives examples of parents initiating contact with Dr Wakefieldand his willingness to talk to them. However, far from his behaviour beingheld up as a model of the caring professional, the panel concluded thatthese communications constituted 'a biased selection of patients in theLancet paper' (p.47), in which, to take the example of child 12, DrWakefield 'was actively involved in the referral process' in that he was 'inwritten and telephone contact with Mrs 12' (p.34). The panel contrasts thesefindings with the Lancet case series' own account of 'children consecutivelyreferred to the department of paediatric gastroenterology'4 and concludesthat 'The description of the referral process in the Lancet paper wastherefore irresponsible, misleading, contrary to [Wakefield's] duty toensure that the information in the paper was accurate' (p.46).The Lancet paper admits the possibility of 'selection bias in aself-referred group' that characterised part of the referral process.5Nonetheless, despite the element of self-selection, the referral process forthe case series conformed to the conventional methods. For example, the GMCsummary of findings describes the referral process in the 11 cases whereGP's or local consultants consistently wrote referral letters to ProfessorWalker-Smith. Each child was processed down the referral line in theestablished way, even though a study of new symptoms would require that aprocess of pre-referral negotiation should take place, whereby Dr Wakefieldcommunicated with local GPs, consultants and parents to establish the natureof the child's symptoms and to explain to all parties what the researchentailed. The GMC denounced the negotiation that the parties to the referralexercised in order to reach agreement on issues such as the clinicalconditions of the patient, what treatment is or is not available and whatbenefit the research might bestow on the patient.The GMC applied an outmoded model of medical research to Wakefield et al'swork, with yet again profound implications for the three doctors and forresearch ethics more widely, in ways that impede future research intoautism, bowel disease and vaccine safety. To describe the ethicallyresponsible search for patient subjects for a research programme intounexplained symptoms as 'fishing expeditions', to use the prosecutor'swords, is a travesty of the research ethics involved, a demeaning andcynical account of the lengths to which caring doctors went in their concernfor patients and parents, and a cruel impediment to research that couldbenefit seriously ill children.3. The Lancet paper controversy: ask no questionsThe GMC used approval 172-96 to censure the doctors for having written theLancet paper because of its subsequent impact on MMR take-up. The panelaccused Wakefield thus: 'You knew or ought to have known that your reportingin the Lancet paper of a temporal link between the syndrome you describe andthe MMR vaccination had major public health implications, would attractintense public and media interest'.Wakefield is blamed for having raised questions of the MMR that have beencentral to the lives of the autism community since the 1990s, and thequestion many parents have asked, whatever conclusions reached: did the MMRcause my child to become autistic? The GMC sought to censure Wakefield etal's independent and critical scientific research into the associationbetween autism and bowel disease which raised legitimate questions andrecommended further research about the role of MMR in the onset of thesecondition.Further, 172-96 was used to conflate two studies, different in conceptionand funding: the Lancet case series and the Legal Aid Board study on behalfof autistic child litigants claiming damages from MMR manufacturers. ThePanel was 'satisfied that the project 172/96 document is substantially thesame as the protocol sent to the LAB by Mr Barr [the solicitor representingthe child litigants alleging MMR damage] in June 1996' (p.11). By framingthe two studies in this way, the panel could claim that Wakefield's LABfunding 'constituted a disclosable interest' that should have been disclosedto the EC (p. 11) and stated in the Lancet paper (p.49).The potential consequences for research of the GMC's judgement are that:doctors will revert to a referral process for patients of unexplainedsymptoms which could impede research into much needed new treatmentsmedical scientists will avoid researching autism, related bowel diseases andespecially vaccine safety, for fear they will be treated like the threedoctors and endanger their careersindependent research into vaccines could become a no-go area in medicalscience, apart from research undertaken or sponsored by commercially-drivenpharmaceutical manufacturers and government. Parents considering vaccinatingtheir children would, more than ever before, have only official productinformation to rely on with no access to independent adviceConflict of interestThe GMC argued that Wakefield should have disclosed a conflict of interestin that he was also receiving money from the LAB to research the role of theMMR in the onset of autism and bowel disease in 1500 sick and disabledchildren claiming damages against three manufacturers for injuries allegedlycaused by the MMR. The GMC used a third party test, whereby conflict ofinterest rests on what other people would perceive as a conflict, so thatWakefield 'had a duty to disclose to the Editor of the Lancet anydisclosable interest including matters which could legitimately give rise toa perception that [he] had a conflict of interest' (p.44), claiming thatthis understanding of conflict of interest prevailed in the scientificcommunity in 1997. The GMC failed to report the Lancet's guidelines that:'The conflict of interest test is a simple one. Is there anything . . . thatwould embarrass you if it were to emerge after publication and you had notdeclared it?'.6 Here a subjective test rather than third party test is usedwhich places the onus on the author(s) to judge if they would be embarrassedwere a conflict of interests to emerge.If approval 162-95 had prevailed, the Lancet paper would have been seen as adescriptive case series, as the authors contended, entirely different from alegal aid funded study seeking to establish if a causal link exists betweenthe MMR and autism/bowel disease.Whilst the GMC has made much of the ethical failings of Dr Wakefield, whichin their view would support a case for serious professional misconductagainst him, no acknowledgement is given to the fact that in the case of DrWakefield, his legal aid funded study was done in support of litigation forseverally sick and disabled children. From the GMC's point of view there isno difference between conflict of interest in this case and conflict wheredoctors fail to disclose funding sources from profit-making bodies such aspharmaceutical companies or fail to disclose that an academic publication ispart of a programme in support of the development of commercial products.Conclusion: ethics and ideologyThat the panel reduced a complex multitude of facts to a core set of factsthat accorded with 172-96, in the longest and most complex GMC hearing ever,should have caused alarm bells to ring. This reduction alone should signalthat the process of reaching conclusions was driven by an ideological agendawhich rendered complexity a choice between two ways of ordering the facts,namely between ethical approvals 162-95 and 172-96. For the defence, 162-95appealed to the panel's understanding of how researchers conducted a smallcase series which reported findings of an association between autism andbowel disease; and for the GMC prosecution and panel, 172-96 appealed to anethical argument that simplified complexity into pre-digested and highlyselective findings of fact. The reliance on the 1996 ethical approval as theexclusive means of framing the facts points to the presence of anideological agenda in the hands of the GMC, prosecution and panel, and showshow in the end the 3 doctors were framed according to this agenda.This agenda, like all ideology, points to what the panel expressly denied,that the hearing was orchestrated by the government, who recommended thecase to the GMC, the GMC and sections of the press, in particular the SundayTimes journalist Brian Deer who submitted the original complaint andevidence in 2004, which served as the template for the GMC's preliminaryinvestigation, the prosecution's case and the panel's conclusions - atemplate which they followed to the letter.