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



 
 
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  #1  
Old April 20th 10, 11:57 AM posted to misc.health.alternative,misc.kids.health,sci.med,sci.med.nursing
john[_5_]
external usenet poster
 
Posts: 822
Default How the GMC Framed Doctors Wakefield, Walker-Smith and Murch

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.

  #2  
Old April 20th 10, 12:06 PM posted to misc.health.alternative,misc.kids.health,sci.med,sci.med.nursing
john[_5_]
external usenet poster
 
Posts: 822
Default How the GMC Framed Doctors Wakefield, Walker-Smith and Murch

http://www.ageofautism.com/2010/04/h...nd-murch-.html

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

1. Introduction

In 1998 the Lancet published a short case series of 12 autistic children
admitted to the Royal Free Hospital (RFH) in London for treatment of bowel
symptoms.1 The paper was one of the first to bring to the medical
community's attention an unexplained association between autism and bowel
disease, describing the children's clinical findings and noting that parents
timed the onset of eight of their children's conditions from the MMR
vaccination. Twelve years later the General Medical Council, the UK medical
regulator, concluded that the way the three senior authors of the paper --
Dr Wakefield, and Professors Walker-Smith and Murch -- had researched and
written the paper amounted to serious professional misconduct, especially in
the way the children were selected and subject to invasive investigations,
in the doctors' unethical research practices and Dr Wakefield's failure to
disclose his conflict of interest. In the sanctions stage of the hearing
that began in April 2010 the prosecution is recommending that Wakefield and
Walker-Smith are erased from the register of medical practitioners and that
Murch is suspended.

Following evidence from the prosecution and defence in the largest and most
expensive hearing in the GMC's history, the fitness to practice (FtP) panel
faced the apparently small issue of deciding which of two ethical approvals
applied to the 1998 Lancet paper: approval 162-95 in 1995 or approval 172-96
in 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 this
one 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. The
defendants, however, referred to 162-95 as the appropriate approval.
Accepting approval 172-96 would shift the entire findings of fact, in effect
changing the goalposts.

Ethical approval 162-95 was a short letter from the EC to Walker-Smith
allowing him to take two additional mucosal tissue samples for research from
the bowel of children undergoing a colonoscopy to investigate their clinical
condition. The team could thereby obtain further research data on a child's
condition in addition to clinical data. The approval was generic and applied
to children being treated by Walker-Smith. This included the Lancet case
series of 12 children with autism and gastroenterological symptoms, a study
describing clinical symptoms for which no research protocol was needed as
the children were admitted for treatment -- ie they would be subject to the
same tests whether or not they were included in the research study. The case
series did not research the impact of new treatments or diagnostic
procedures which would require more rigorous ethical approval. The use of
colonoscopy and other procedures to investigate clinical conditions was a
matter for the doctors' clinical judgment. The approval set the start date 5
September 1995.

In cross examination the chair of the Ethics Committee in 1995 and 1996
conceded that no EC approval was required to write up a retrospective case
series for a journal. The children were admitted consecutively on the basis
of clinical need, their clinical conditions investigated and written up in
accordance with approval 162-95. The 12 children were referral by their GPs
or local consultants. That ethical approval was granted was stated at the
end of the paper.

The prosecution acting on behalf of the GMC, who brought the case against
the doctors, argued that 172-96 (and the associated research protocol) was
the only approval governing the Lancet case series. Ethical approval
1972-96, for a study of 25 children, provided a different set of conditions:
the start date for including the children, 18 December 1996; the illnesses
the children must have and the vaccinations received to qualify; and the
bureaucratic procedures to be followed -- consent forms lodged, who had
responsibility for ordering investigations, who was the lead researcher,
etc.. These conditions of approval represented the armoury the prosecution
would use to knock down the defendants' simpler conditions, with the start
date the most powerful piece taking first shot. If the Lancet paper couldn't
stand up to the start date -- that the children could only be admitted after
18 December 1996, not after 5 September 1995 -- then everything else would
fall, including the contention that the children were selected for treatment
on the basis of clinical need.

The summary of the panel's conclusions on findings of fact shows that the
panel 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 done
under approval 162-95. Most surprisingly the panel gives no reasons for
rejecting 162-95. In one move the Lancet series became a research 'project'
and not a treatment exercise, in which clinical interventions on severally
disabled children (eg colonoscopies and lumbar punctures) were done for
research purposes even though clinically indicated for the treatment of sick
children with serious and unexplained symptoms. In its only reference to
162-95 in the summary, the panel misleadingly refers to it as a 'project'
(p.3), whereas the approval was generic covering the clinical practice of
taking additional samples from colonoscoped children for research purposes
such as the Lancet case series and other descriptive case series were they
to be undertaken.


2. Key findings based on 172-96

Start date and ethical approval

By selecting the start date of 18 December 1996, the prosecution could show
that 7 of the 11 children (one of the 12 was a US patient and excluded from
the proceedings) were accepted for the research before the start date and so
without ethical approval. For example, Wakefield was charged 'that Child 2
was investigated under a project without the approval of the EC in that it
was not research covered by any EC application other than that for Project
172-96 and...contrary to the conditions of approval for Project 172-96 Child
2 had been enrolled into the project before 18 December 1996' (p.14) - a
phrase repeated ad nauseam for seven children and in almost all cases for
the same set of charges against each of the three doctors. Using 172-96, the
panel was able to frame the facts so that Dr Wakefield's statement in the
Lancet paper that the study was ethically approved was 'dishonest,
irresponsible, contrary to [his] duty to ensure that the information
provided by [him] was accurate' (pp.48-9). Had 162-95 been duly acknowledged
these charges would have fallen.

Inclusion criteria
Applying the inclusion criteria of 172-96 meant that the 11 children did not
qualify for the project as they failed to meet them, namely 'enteritis and
disintegrative disorder following measles/rubella vaccination' (p.8).
Instead they were described in the Lancet as autistic and vaccinated with
MMR. By failing to adhere to these inclusion criteria for each child,
Wakefield was admonished for having 'failed to comply with [his] duties to
the EC as a named Responsible Consultant' (eg see p.14). Again these
criteria were replicated for each of the three doctors.

However, look closely at the changing diagnoses among the children's doctors
as reported in the summary and you realise how precarious the diagnosis of
autism is even among experts. For example, child 6's GP offers an initial
diagnosis of autistic syndrome in August 1996; whereas three months later
the psychiatrist working with the research team suggests Asperger's Syndrome
as the most likely diagnosis (pp. 24-5). It is well known that autistic
spectrum disorders are diagnosed differently by different doctors. Yet true
to their ideological ends, the GMC prosecution forced the facts when the
reality was far from clear.

Research not treatment
By accepting approval 172-96, the Panel was asked to judge that the children
were being admitted for research and not treatment. Placed within the 1996
framework, the Lancet paper was no longer a case series of children
undergoing clinical treatment but a research project subject to far stricter
approval. Consequently each doctor was charged with carrying out
interventions on the children for research purposes alone for which they had
no approval.

Interventions not clinically indicated
The most serious implication of judging the doctors' actions according to
research criteria alone was that, in a UK climate of heightened child
protection, they were found to have 'caused' interventions not clinically
indicated and 'contrary to the clinical interests of the child'. Yet,
although the doctors claimed 172-96 was not the appropriate approval, the
answer to question 11 on the 172-96 protocol and pro forma stated that 'all
the procedures and the majority of the samples are clinically indicated'.

The consequence of using 172-96 was that facts allowable under the 1995
approval were excluded, specifically testimony from parents of eight of the
Lancet 12 saying that their children were being treated for serious clinical
needs by the three doctors who exercised deep professional concern
throughout.3 Their evidence submitted by letter to the GMC was disallowed.


2. Selecting the children for the research

The prosecution used a conventional referral model in deciding how the
doctors should have selected the children for the Lancet study. Any
departure from this model was denounced as unethical, thereby
institutionalising, 14 years after the 1996 approval, a 'correct' process
for which there was then no authority. For the Panel a case series is 'a
routine process in which the investigators had played no active part'
(p.45). Ethical research involves the researcher playing a passive role in
the referral process, as patient is passed from GP to consultant and finally
to the medical researcher, with the parties necessarily sharing an
understanding of the patients' condition. The researcher is involved in the
final but not the initial selection of patient/research subjects.

The summary gives examples of parents initiating contact with Dr Wakefield
and his willingness to talk to them. However, far from his behaviour being
held up as a model of the caring professional, the panel concluded that
these communications constituted 'a biased selection of patients in the
Lancet paper' (p.47), in which, to take the example of child 12, Dr
Wakefield 'was actively involved in the referral process' in that he was 'in
written and telephone contact with Mrs 12' (p.34). The panel contrasts these
findings with the Lancet case series' own account of 'children consecutively
referred to the department of paediatric gastroenterology'4 and concludes
that 'The description of the referral process in the Lancet paper was
therefore irresponsible, misleading, contrary to [Wakefield's] duty to
ensure that the information in the paper was accurate' (p.46).

The Lancet paper admits the possibility of 'selection bias in a
self-referred group' that characterised part of the referral process.5
Nonetheless, despite the element of self-selection, the referral process for
the case series conformed to the conventional methods. For example, the GMC
summary of findings describes the referral process in the 11 cases where
GP's or local consultants consistently wrote referral letters to Professor
Walker-Smith. Each child was processed down the referral line in the
established way, even though a study of new symptoms would require that a
process of pre-referral negotiation should take place, whereby Dr Wakefield
communicated with local GPs, consultants and parents to establish the nature
of the child's symptoms and to explain to all parties what the research
entailed. The GMC denounced the negotiation that the parties to the referral
exercised in order to reach agreement on issues such as the clinical
conditions of the patient, what treatment is or is not available and what
benefit the research might bestow on the patient.

The GMC applied an outmoded model of medical research to Wakefield et al's
work, with yet again profound implications for the three doctors and for
research ethics more widely, in ways that impede future research into
autism, bowel disease and vaccine safety. To describe the ethically
responsible search for patient subjects for a research programme into
unexplained symptoms as 'fishing expeditions', to use the prosecutor's
words, is a travesty of the research ethics involved, a demeaning and
cynical account of the lengths to which caring doctors went in their concern
for patients and parents, and a cruel impediment to research that could
benefit seriously ill children.


3. The Lancet paper controversy: ask no questions

The GMC used approval 172-96 to censure the doctors for having written the
Lancet paper because of its subsequent impact on MMR take-up. The panel
accused Wakefield thus: 'You knew or ought to have known that your reporting
in the Lancet paper of a temporal link between the syndrome you describe and
the MMR vaccination had major public health implications, would attract
intense public and media interest'.

Wakefield is blamed for having raised questions of the MMR that have been
central to the lives of the autism community since the 1990s, and the
question many parents have asked, whatever conclusions reached: did the MMR
cause my child to become autistic? The GMC sought to censure Wakefield et
al's independent and critical scientific research into the association
between autism and bowel disease which raised legitimate questions and
recommended further research about the role of MMR in the onset of these
condition.

Further, 172-96 was used to conflate two studies, different in conception
and funding: the Lancet case series and the Legal Aid Board study on behalf
of autistic child litigants claiming damages from MMR manufacturers. The
Panel was 'satisfied that the project 172/96 document is substantially the
same as the protocol sent to the LAB by Mr Barr [the solicitor representing
the child litigants alleging MMR damage] in June 1996' (p.11). By framing
the two studies in this way, the panel could claim that Wakefield's LAB
funding 'constituted a disclosable interest' that should have been disclosed
to 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 unexplained
symptoms which could impede research into much needed new treatments
medical scientists will avoid researching autism, related bowel diseases and
especially vaccine safety, for fear they will be treated like the three
doctors and endanger their careers
independent research into vaccines could become a no-go area in medical
science, apart from research undertaken or sponsored by commercially-driven
pharmaceutical manufacturers and government. Parents considering vaccinating
their children would, more than ever before, have only official product
information to rely on with no access to independent advice

Conflict of interest

The GMC argued that Wakefield should have disclosed a conflict of interest
in that he was also receiving money from the LAB to research the role of the
MMR in the onset of autism and bowel disease in 1500 sick and disabled
children claiming damages against three manufacturers for injuries allegedly
caused by the MMR. The GMC used a third party test, whereby conflict of
interest rests on what other people would perceive as a conflict, so that
Wakefield 'had a duty to disclose to the Editor of the Lancet any
disclosable interest including matters which could legitimately give rise to
a perception that [he] had a conflict of interest' (p.44), claiming that
this understanding of conflict of interest prevailed in the scientific
community in 1997. The GMC failed to report the Lancet's guidelines that:
'The conflict of interest test is a simple one. Is there anything . . . that
would embarrass you if it were to emerge after publication and you had not
declared it?'.6 Here a subjective test rather than third party test is used
which places the onus on the author(s) to judge if they would be embarrassed
were a conflict of interests to emerge.

If approval 162-95 had prevailed, the Lancet paper would have been seen as a
descriptive case series, as the authors contended, entirely different from a
legal aid funded study seeking to establish if a causal link exists between
the MMR and autism/bowel disease.

Whilst the GMC has made much of the ethical failings of Dr Wakefield, which
in their view would support a case for serious professional misconduct
against him, no acknowledgement is given to the fact that in the case of Dr
Wakefield, his legal aid funded study was done in support of litigation for
severally sick and disabled children. From the GMC's point of view there is
no difference between conflict of interest in this case and conflict where
doctors fail to disclose funding sources from profit-making bodies such as
pharmaceutical companies or fail to disclose that an academic publication is
part of a programme in support of the development of commercial products.


Conclusion: ethics and ideology

That the panel reduced a complex multitude of facts to a core set of facts
that accorded with 172-96, in the longest and most complex GMC hearing ever,
should have caused alarm bells to ring. This reduction alone should signal
that the process of reaching conclusions was driven by an ideological agenda
which rendered complexity a choice between two ways of ordering the facts,
namely between ethical approvals 162-95 and 172-96. For the defence, 162-95
appealed to the panel’s understanding of how researchers conducted a small
case series which reported findings of an association between autism and
bowel disease; and for the GMC prosecution and panel, 172-96 appealed to an
ethical argument that simplified complexity into pre-digested and highly
selective findings of fact. The reliance on the 1996 ethical approval as the
exclusive means of framing the facts points to the presence of an
ideological agenda in the hands of the GMC, prosecution and panel, and shows
how 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 the
case to the GMC, the GMC and sections of the press, in particular the Sunday
Times journalist Brian Deer who submitted the original complaint and
evidence in 2004, which served as the template for the GMC's preliminary
investigation, the prosecution's case and the panel's conclusions - a
template which they followed to the letter.




 




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