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Andrew Wakefield on the Today Show

24 May

Andrew Wakefield appeared on the US TV show “Today” in an interview with Matt Lauer. Mr Wakefield has just been erased from the medical register in the UK for his actions in regards to his research while at the Royal Free Hospital in London.

Much of the time is given over to taped footage from Matt Lauer’s Dateline episode on Mr Wakefield, leaving little time for the interview. Mr. Wakefield’s points were nothing new. First is his claim that his work has been replicated in five countries. It hasn’t. His second point is that the US government has been “secretly” settling vaccine-autism cases since 1991.

This was a big talking point a year ago, just not by Mr. Wakefield. At that time people were reviewing vaccine court cases for awawrdees who have ASD’s. Consider this post by David Kirby from last June:

And, more than 1,300 vaccine court cases were already paid out for encephalopathy and seizure disorders. We will soon learn how many of those children also have an ASD, though I can confirm now that it appears to be far, far higher than the1-in-150 rate reported by CDC.

There hasn’t been much discussion of that in many months. Apparently they have given this talking point to Mr. Wakefield. I was expecting something–some “hook”–that would make it worthwhile for Mr. Wakefield to be on the Today Show. Something interesting, not just a new book. I would find it odd if this is it. This information is not Mr. Wakefield’s work and has been sitting on a shelf for some time. A year ago we were told the results would be “soon”.

While we are discussing this, the idea that the government has been “secretly conceding” autism/vaccine cases is nonsense. The information they are talking about are in the decisions of the vaccine court–publicly available to anyone with WestLaw access. Many of the cases are publicly available on the vaccine court’s website–that’s how Kathleen Seidel at Neurodiversity.com got the information and first broke the story that, yes, autistic kids have been compensated in the past. See “a not so hidden History“.

The “US Government acknowledges that vaccines cause autism” argument gets even stranger when you consider that Mr. Wakefield is speaking. The US Government, through the vaccine court, declared in three separate test cases (for example, the Cedillo case) that Mr. Wakefield’s hypotheses on MRR/measles virus/persistent infection/autism are wrong. Not just wrong, “not even close”. The idea that Mr. Wakefield would use the decisions of the court to defend himself is amazing in its brazenness. “Amazing in his brazenness” is pretty much expected from Mr. Wakefield.

With that rather long introduction, here is the interview:

http://www.msnbc.msn.com/id/32545640

Visit msnbc.com for breaking news, world news, and news about the economy

Addendum:

Mr. Lauer still doesn’t get the problem with Mr. Wakefield’s conflicts of interest. First, it is not just the money he was receiving to fund his research. Mr. Wakefield deflects criticism by claiming that the funds were for a different study. Mr. Wakefield was a paid expert in the litigation, contracted before the Lancet paper and the press conference. It doesn’t matter what studies he had ongoing and where this was funded, he was severely conflicted.

Second, while this didn’t come up in the Today Show interview, this is a defense Mr. Wakefield and his supporters rely upon: the concept that Mr. Wakefield didn’t claim the

What he did was to call for the suspension of the triple-vaccine. His statement was very irresponsible:

INTERVIEWER: But if you say there’s at least a question mark over it now, should the vaccine continue to be administered while you’re investigating?

DR ANDREW WAKEFIELD: I think if you asked members of the team that have investigated this they would give you different answers. And I have to say that there is sufficient anxiety in my own mind of the safety, the long term safety of the polyvalent, that is the MMR vaccination in combination, that I think that it should be suspended in favour of the single vaccines, that is continued use of the individual measles, mumps and rubella components.

The Panel has determined that Dr Wakefield’s name should be erased from the medical register

24 May

The following is taken from a GMC press release.

This case is being considered by a Fitness to Practise Panel applying the General Medical Council’s Preliminary Proceedings Committee and Professional Conduct Committee (Procedure) Rules 1988

Date: 24 May 2010

Dr Andrew Jeremy WAKEFIELD

Determination on Serious Professional Misconduct (SPM) and sanction:

The Panel has already given its findings on the facts and its reasons for determining that the facts as found proved could amount to serious professional misconduct.

It then went on to consider and determine whether, under Rule 29(1) of the General Medical Council Preliminary Proceedings Committee and Professional Conduct Committee (Procedure) Rules Order of Council 1988, the facts as admitted or found proved do amount to serious professional misconduct and if so, what, if any sanction it should impose. It has accepted the Legal Assessor’s advice in full as to the approach to be taken in this case, and has looked at each doctors’ case separately but, when considering whether Dr Wakefield is guilty of serious professional misconduct, has looked at the heads of charge found proved against him as a whole. It has not confined its consideration to the heads of charge; it has also had regard to the evidence that has been adduced and the submissions made by Ms Smith on behalf of the General Medical Council. On behalf of Dr Wakefield, no evidence has been adduced and no arguments or pleas in mitigation have been addressed to the Panel at this stage of the proceedings. In fact Mr Coonan specifically submitted:

“……we call no evidence and we make no substantive submissions on behalf of Dr Wakefield at this stage.” “…I am instructed to make no further observations in this case”.

Nevertheless, the Panel considered the totality of the evidence in Dr Wakefield’s case including the reference dated 27 October 1995, from Professor Leon Fine, the then Head of the Department of Medicine at the Royal Free Hospital, when reaching its decision at this stage, having been asked to consider that as part of Mr Coonan’s submissions at Stage 1.

Serious professional misconduct has no specific definition but in Roylance v General Medical Council [1999] Lloyd’s Rep. Med. 139 at 149 Lord Clyde, in giving the reasons of the Privy Council, said:

“Misconduct is a word of general effect, involving some act or omission which falls short of what would be proper in the circumstances. The standard of propriety may often be found by reference to the rules and standards ordinarily required by a medical practitioner in the particular circumstances…”

Lord Clyde went on to say:

“The misconduct is qualified in two respects. First, it is qualified by the word ‘professional’ which links the misconduct to the profession of medicine. Secondly, the misconduct is qualified by the word ‘serious’. It is not any professional misconduct which will qualify. The professional misconduct must be serious.”

The Panel has acted as an independent and impartial tribunal and exercised its own judgement on these matters. It has borne in mind the relevant GMC guidance at the time, namely the 1995 Good Medical Practice and, in so far as the findings relate to events after 1998, the 1998 Good Medical Practice. It has considered what has been adduced and submitted on behalf of the doctors about the standards and procedures which were prevalent at that time.

In considering Dr Wakefield’s case, the Panel has also taken into account the passage of time before these matters were brought before it and the length of time this case has taken. It noted that the multiple sittings were for a variety of reasons including professional commitments of the Panel and requests from Counsel for reasons such as illnesses, accidents, unavailability of witnesses and preparation time.

The Panel has noted Dr Wakefield’s previous good character and taken into account everything it has heard including his qualifications, experience and standing within the profession, with patients and the parents of patients.

The Panel considered the conduct of Dr Wakefield whilst he was registered as a medical practitioner and employed by the Royal Free Hospital Medical School in 1996 and 1997, initially as a Senior Lecturer in the Departments of Medicine and Histopathology. Later, from 1 May 1997 he was a Reader in Experimental Gastroenterology and an Honorary Consultant in Experimental Gastroenterology at the Royal Free Hospital.

The Panel has already found proved that Dr Wakefield’s Honorary Consultant appointment was subject to a stipulation that he would not have any involvement in the clinical management of patients. On five occasions (child 2, 4, 5, 12 and 7) he ordered investigations on children, when he had no paediatric qualifications, and in contravention of the limitations on his appointment. The Panel considered this alone constituted a breach of trust of patients and employers alike.

In February 1996 Dr Wakefield agreed to act as an expert in respect of MMR litigation. In relation to the Legal Aid Board (LAB), the Panel found that Dr Wakefield accepted monies totalling £50,000 procured through Mr Barr, the Claimants’ solicitor to pursue research. A costing proposal had been submitted by Mr Barr to the LAB containing detailed information provided by Dr Wakefield, and Dr Wakefield ought to have realised that Mr Barr would submit it to the LAB.

The costing proposal set out costs in respect of the investigation of five children. It covered each child’s four-night stay in hospital with colonoscopy, MRI and evoked potential studies. Dr Wakefield admitted that the funding subsequently provided by the Legal Aid Board had not been needed for these items because these costs were borne by the National Health Service as the patients were being admitted as NHS patients.

The Panel found that Dr Wakefield had a duty to disclose this information to the Legal Aid Board via Mr Barr. It was dishonest and misleading of him not to have done so. The Panel concluded that his intention to mislead the Legal Aid Board was sufficient on its own to amount to serious professional misconduct.

The Panel also found that in respect of £25,000 of LAB monies, Dr Wakefield caused or permitted it to be used for purposes other than those for which he said it was needed and for which it had been granted. In doing so he was in breach of his duties in relation to the managing of, and accounting for, funds.

In September 1996 Dr Wakefield made an application to the Ethical Practices Sub-Committee of the Royal Free Hospital (Ethics Committee) seeking approval for a research project involving 25 children. This was approved by the sub-Committee as Project 172-96. He named himself as one of the three Responsible Consultants, thereby taking on the shared responsibility for the information given in support of his application; for ensuring that only children meeting the inclusion criteria would be admitted to the study; that conditions attached to the Ethics Committee approval would be complied with; and that children would be treated in accordance with the terms of the approval given.

In respect of Research and Ethics Committee approval, the Panel had regard to the particular ethical guiding principles with regard to conducting research on children. It rejected Dr Wakefield’s overall contention that Project 172-96 was never undertaken; that all the investigations carried out on the children were clinically indicated and that the research elements of the project were covered by another Ethics Committee approval.

The Panel concluded that the programme of investigations that these children were subjected to was part of Project 172-96. It further determined that the conditions for approval and the inclusion criteria for that project were not complied with. The Ethics Committee’s reliance on the probity of Dr Wakefield as a Responsible Consultant was not met.

With regard to nine of the eleven children (2,1, 3, 4, 6, 9, 5,12 and 8) considered by the Panel, it determined that Dr Wakefield caused research to be undertaken on them without Ethics Committee approval and thus without the ethical constraints that safeguard research. Ethical constraints are there for the protection both of research subjects and for the reassurance of the public and are crucial to public trust in research medicine. It was in the context of this research project that the Panel found that Dr Wakefield caused three of these young and vulnerable children, (nos. 3, 9 and 12) to undergo the invasive procedure of lumbar puncture when such investigation was for research purposes and was not clinically indicated. This action was contrary to his representation to the Ethics Committee that all the procedures were clinically indicated. In nine of the eleven children (2,1, 3, 4, 9, 5,12, 8 and 7) the Panel has found that Dr Wakefield acted contrary to the clinical interests of each child. The Panel is profoundly concerned that Dr Wakefield repeatedly breached fundamental principles of research medicine. It concluded that his actions in this area alone were sufficient to amount to serious professional misconduct.

The results of the research project were written up as an early report in the Lancet in February 1998. Dr Wakefield as a senior author undertook the drafting of the Lancet paper and wrote its final version. The reporting in that paper of a temporal link between gastrointestinal disease, developmental regression and the MMR vaccination had major public health implications and Dr Wakefield admitted that he knew it would attract intense public and media interest. The potential implications were therefore clear to him, as demonstrated in his correspondence with the Chief Medical Officer of Health and reports which had already appeared in the medical press. In the circumstances, Dr Wakefield had a clear and compelling duty to ensure that the factual information contained in the paper was true and accurate and he failed in this duty.

The children described in the Lancet paper were admitted for research purposes under a programme of investigations for Project 172-96 and the purpose of the project was to investigate the postulated new syndrome following vaccination. In the paper, Dr Wakefield failed to state that this was the case and the Panel concluded that this was dishonest, in that his failure was intentional and that it was irresponsible. His conduct resulted in a misleading description of the patient population. This was a matter which was fundamental to the understanding of the study and the terms under which it was conducted.

In addition to the failure to state that the children were part of a project to investigate the new syndrome, the Lancet paper also stated that the children had been consecutively referred to the Department of Paediatric Gastroenterology with a history of a pervasive developmental disorder and intestinal symptoms. This description implied that the children had been referred to the gastroenterology department with gastrointestinal symptoms and that the investigators had played no active part in that referral process. In fact, the Panel has found that some of the children were not routine referrals to the gastroenterology department in that either they lacked a reported history of gastrointestinal symptoms and/or that Dr Wakefield had been actively involved in the process of referral. In those circumstances the Panel concluded that the description of the referral process was irresponsible, misleading and in breach of Dr Wakefield’s duty as a senior author.

The statement in the Lancet paper that investigations reported in it were approved by the Royal Free Hospital Ethics Committee when they were not, was irresponsible.

Subsequent to the paper’s publication, Dr Wakefield had two occasions on which he could have corrected the content of the Lancet paper yet both times he compounded his misconduct.

First, in a published letter in response to correspondents who had suggested that there had been biased selection of the Lancet children, Dr Wakefield stated that the children had been referred through the normal channels, a response which was dishonest and irresponsible. He provided an inaccurate statement which omitted relevant information when he knew that the description of the population in the study was being questioned by the scientific community.

Second, at a meeting of the Medical Research Council, the Chair, Professor Sir John Pattison referred to the seriousness and importance of the implications of Dr Wakefield’s research and its major public health implications. At that meeting and on the issue of bias in generating the series of cases, Dr Wakefield stated that the children had come by “the standard route”, a response which was dishonest and irresponsible.

Regarding the issues of conflicts of interest, Dr Wakefield did not disclose matters which could legitimately give rise to a perception of a conflict of interest. He failed to disclose to the Ethics Committee and to the Editor of the Lancet his involvement in the MMR litigation and his receipt of funding from the Legal Aid Board. He also 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 also claimed in the patent application, would be a treatment for inflammatory bowel disease (IBD).

Even before the publication of the Lancet Paper, eminent professionals had expressed concerns about the LAB funding to Dr Wakefield and potential conflicts of interest. Dr Wakefield rejected these views. With regard to non-disclosure to the Ethics Committee, Dr Wakefield did in evidence accept that the Legal Aid Board funding should have been disclosed, but said that his involvement in the litigation need not, especially because of his interpretation of the questions in the application form. He said no question was asked which related to that matter and therefore felt no need to disclose. In evidence to the panel he stated:

“The form is set out expecting certain answers to specific questions and no such question exists. Therefore, since it was not asked, it was not answered.”

However, given the importance of an Ethics Committee’s reliance on the probity of an applicant, the Panel determined that this was a failure by Dr Wakefield and his actions amounted to serious professional misconduct.

With regard to the non-disclosure to the Lancet the Panel accepted evidence from the Editor of the Lancet, as to the importance of this issue. The Lancet published clear guidance in relation to the conflict of interest test that the applicant should apply and the need to discuss any issues arising from it with the Editor. The Lancet test was: “Is there anything that would embarrass you if it were to emerge after publication and you had not declared it?” Dr Wakefield chose not to declare or discuss any conflict of interest with the Editor. He stated that he was able to reconcile his position, was not embarrassed by it, and was quite proud of the position he had taken on behalf of the Lancet children.

Dr Wakefield was insistent that his involvement with the new patent had not given rise to any prior need to disclose. Despite the clear terms of the patent, 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 said that it did not cross his mind to disclose it, and even with hindsight he insisted that there was a reasonable argument, as he put it, 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.

In relation to the administration of Transfer Factor to Child 10, the Panel noted the admitted background of Dr Wakefield’s involvement in a company set up with Child 10’s father as Managing Director, to produce and sell Transfer Factor. Around the same time, Dr Wakefield inappropriately caused Child 10 to be administered transfer factor. The Panel accepted that information as to its safety had been obtained and that the approval to administer Transfer Factor to one child was granted in the form of “Chairman’s approval”, “on a named patient basis” in a letter from Dr Geoffrey Lloyd, Chairman of the Medical Advisory Committee at the Royal Free Hospital. Nonetheless the Panel found that Dr Wakefield was at fault because the substance was given for experimental reasons, he did not cause the details to be recorded in the child’s records, or cause the general practitioner to be informed, and he did not have the requisite paediatric qualifications.

Dr Wakefield’s actions were contrary to the clinical interests of Child 10 and an abuse of his position of trust as a medical practitioner. The Panel considered these to be serious departures from the standards of a registered medical practitioner and concluded that these amounted individually and collectively to serious professional misconduct.

Dr 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. He then described the episode in humorous terms at a public presentation and expressed an intention to repeat his conduct. When giving evidence to the Panel, Dr Wakefield expressed some regret regarding his remarks. The Panel was concerned at Dr Wakefield’s apparent lack of serious consideration to the relevant ethical issues and the abuse of his position of trust as a medical practitioner with regard to his conduct in causing the blood to be taken. The Panel concluded that his conduct brought the medical profession into disrepute.

Dr Wakefield defended the ethical basis for the taking of blood at a birthday party contrary to the experts who gave evidence to the Panel and who strongly condemned this action. The Panel determined that his conduct fell seriously short of the standards expected of a doctor and was a breach of the trust which the public is entitled to have in members of the medical profession. It concluded that this behaviour amounted to serious professional misconduct.

The Panel has borne in mind the principles guiding a doctor as set out in the relevant paragraphs of 1995 Good Medical Practice which relate to providing a good standard of practice and care, good clinical care, keeping up-to-date, abuse of professional position, probity in professional practice, financial and commercial dealings, and the general principles of conflict of interest, followed by particular provisions as to the way in which research must be conducted. The 1998 Good Medical Practice, relevant to Dr Wakefield’s conduct at the birthday party, lists the duties of a doctor in providing a good standard of practice and care, keeping up-to-date and the issue of research and the absolute duty to conduct all research with honesty and integrity.

In all the circumstances and taking into account the standard which might be expected of a doctor practising in the same field of medicine in similar circumstances in or around 1996-1998, the Panel concluded that Dr Wakefield’s misconduct not only collectively amounts to serious professional misconduct, over a timeframe from 1996 to 1999, but also, when considered individually, constitutes multiple separate instances of serious professional misconduct.

Accordingly the Panel finds Dr Wakefield guilty of serious professional misconduct.

In considering what, if any, sanction to apply, the Panel was mindful at all times of the need for proportionality and the public interest which includes not only the protection of patients and the public at large, but also setting and maintaining standards within the medical profession, as well as safeguarding its reputation and maintaining public confidence in the profession. It bore in mind that the purpose of sanctions is not punitive, although that might be their effect.

The Panel noted the submissions of GMC Counsel that the appropriate and proportionate sanction would be erasure in light of his serious and wide-ranging misconduct. However the Panel accepted the Legal Assessor’s advice that this was only a submission on behalf of the GMC and it was for the Panel to make up its own mind. Dr Wakefield’s counsel did not make any substantive submissions on his behalf.

The Panel went on to consider whether it should, pursuant to Rule 30(1), postpone the case. It received no submissions in this regard and so went on to determine whether it was sufficient to conclude the case without making a direction or with an admonition.

The Panel made findings of transgressions in many aspects of Dr Wakefield’s research. It made findings of dishonesty in regard to his writing of a scientific paper that had major implications for public health, and with regard to his subsequent representations to a scientific body and to colleagues. He was dishonest in respect of the LAB funds secured for research as well as being misleading. Furthermore he was in breach of his duty to manage finances as well as to account for funds that he did not need to the donor of those funds. In causing blood samples to be taken from children at a birthday party, he callously disregarded the pain and distress young children might suffer and behaved in a way which brought the profession into disrepute.

In view of the nature, number and seriousness of the findings the Panel concluded it would be wholly inappropriate to conclude the case without making a direction or with a reprimand.

It next considered under rule 31 whether it was sufficient to direct that the registration of Dr Wakefield be conditional on his compliance during a period not exceeding three years with such requirements as the (Panel) may think fit to impose for the protection of members of the public or in his interests. Conditions have to be practicable, workable, measurable and verifiable and directed at the particular shortcomings identified. The Panel concluded that Dr Wakefield’s shortcomings and the aggravating factors in this case including in broad terms the wide-ranging transgressions relating to every aspect of his research; his disregard for the clinical interests of vulnerable patients; his failure to heed the warnings he received in relation to the potential conflicts of interest associated with his Legal Aid Board funding; his failure to disclose the patent; his dishonesty and the compounding of that dishonesty in relation to the drafting of the Lancet paper; and his subsequent representations about it, all played out against a background of research involving such major public health implications, could not be addressed by any conditions on his registration. In addition, the Panel considered that his actions relating to the taking of blood at the party exemplifies a fundamental failure in the ethical standards expected of a medical practitioner. It concluded that conditional registration would not mark the seriousness of such fundamental failings in his duty as a doctor.

The Panel next went on to consider whether it would be sufficient to suspend Dr Wakefield’s registration for a period not exceeding twelve months. Dr Wakefield has demonstrated a persistent lack of insight and has insisted in many instances on his ethical propriety: in the context of the referral process and the treatment of the children in the research project in which he was engaged; in the context of the funding of the project; with regard to the terminology of the Lancet paper; with regard to his non-declaration of interests; with regard to not acting in the best clinical interests of the Lancet children and with regard to obtaining blood from children at a birthday party.

The Panel noted that the sanction of suspension may be appropriate for conduct that falls short of being fundamentally incompatible with continued registration; where there is no evidence of harmful deep-seated or attitudinal problems; and where there is insight and no significant risk of repeating behaviour. Although these points have been set out in the GMC’s Indicative Sanctions Guidance which was published subsequent to these events, the Panel considered that the guidance outlines the type of sanction appropriate to the gravity of misconduct and that the same principles are applicable to Dr Wakefield’s actions at the material times. The Panel considers that Dr Wakefield’s conduct in relation to the facts found falls seriously short of the relevant standards and that suspension would not be sufficient or appropriate against a background of several aggravating factors and in the absence of any mitigating submissions made on his behalf. Dr Wakefield’s continued lack of insight as to his misconduct serve only to satisfy the Panel that suspension is not sufficient and that his actions are incompatible with his continued registration as a medical practitioner.

Accordingly the Panel has determined that Dr Wakefield’s name should be erased from the medical register. The Panel concluded that it is the only sanction that is appropriate to protect patients and is in the wider public interest, including the maintenance of public trust and confidence in the profession and is proportionate to the serious and wide-ranging findings made against him.

The effect of the foregoing direction is that, unless Dr Wakefield exercises his right of appeal, his name will be erased from the Medical Register 28 days from when formal notice has been deemed to be served upon him by letter to his registered address.

Dr Wakefield is presently not subject to any interim order on his registration. The Panel will hear submissions on whether an immediate order of suspension should be imposed upon him pending the outcome of any appeal, first from Ms Smith on behalf of the General Medical Council and then from Mr Coonan on behalf of the doctor but will do that at the conclusion of the reading of all three determinations.

Dr. Simon Murch and the GMC: free to continue unrestricted medical practice

24 May

Below is the finding of the GMC in the “Determination on Serious Professional Misconduct and sanction”

Bottom line:

Taking all of the above into account, the Panel concluded that Professor Murch demonstrated errors of judgement but had acted in good faith and that any professional misconduct on his part, such as his failing in duties of research governance and performing colonoscopies that were not clinically indicated, could not reach the threshold of serious professional misconduct because of the circumstances in which he found himself.

Accordingly the Panel found that Professor Murch is not guilty of serious professional misconduct.

In these circumstances it was therefore not necessary to consider a sanction and Professor Murch is free to continue unrestricted medical practice

The determination is presented in full below:

____________________
his case is being considered by a Fitness to Practise Panel applying the General Medical Council’s Preliminary Proceedings Committee and Professional Conduct Committee (Procedure) Rules 1988

Date: 24 May 2010

Professor (formerly Dr) Simon Harry MURCH

Determination on Serious Professional Misconduct (SPM) and sanction:

The Panel has already given its findings on the facts and its reasons for determining that the facts as found proved could amount to serious professional misconduct.

It then went on to consider and determine whether, under Rule 29(1) of the General Medical Council Preliminary Proceedings Committee and Professional Conduct Committee (Procedure) Rules Order of Council 1988, the facts as admitted or found proved do amount to serious professional misconduct and if so, what, if any sanction it should impose. It has accepted the Legal Assessor’s advice in full as to the approach to be taken in this case, and has looked at each doctors’ case separately but when considering whether Professor Murch is guilty of serious professional misconduct, has looked at the heads of charge found proved against him as a whole. It has not confined its consideration to the heads of charge; it has also had regard to the evidence that has been adduced and the submissions made by Ms Smith on behalf of the General Medical Council. On behalf of Professor Murch, it was submitted although he made errors of judgement, that not every error of judgment is misconduct, or wilful misconduct and as such, could and should not be considered to be serious professional misconduct.

Serious professional misconduct has no specific definition but in Roylance v General Medical Council [1999] Lloyd’s Rep. Med. 139 at 149 Lord Clyde, in giving the reasons of the Privy Council, said:

“Misconduct is a word of general effect, involving some act or omission which falls short of what would be proper in the circumstances. The standard of propriety may often be found by reference to the rules and standards ordinarily required by a medical practitioner in the particular circumstances…”

Lord Clyde went on to say:

“The misconduct is qualified in two respects. First, it is qualified by the word ‘professional’ which links the misconduct to the profession of medicine. Secondly, the misconduct is qualified by the word ‘serious’. It is not any professional misconduct which will qualify. The professional misconduct must be serious.”

The Panel has acted as an independent and impartial tribunal and exercised its own judgement on these matters. It has borne in mind the relevant GMC guidance at the time, namely the 1995 Good Medical Practice and, in so far as the findings relate to events after 1998, the 1998 Good Medical Practice. It has considered what has been adduced and submitted on behalf of Professor Murch about the standards and procedures prevailing at that time. The Panel has borne in mind the principles guiding a doctor as set out in the relevant paragraphs of 1995 Good Medical Practice which relate to providing a good standard of practice and care; good clinical care; keeping up to date; abuse of professional position; and the provisions as to research.

When determining whether the relevant conduct amounts to serious professional misconduct, the Panel considered all the evidence including issues of probity, honesty, medical ethics, the clinical interests of patients, the approach to research, appropriate clinical standards, Professor Murch’s attitudes to those issues in his practice generally and the views of the other experienced practitioners in the relevant field.

The Panel has borne in mind the Legal Assessor’s advice that Professor Murch is a man of good character, not just in the sense that he has no previous findings recorded against him by the GMC, but also in that he was professionally competent and highly regarded in his chosen field of practice at that time. It has taken into account his qualifications, experience and standing within the profession, with patients and the parents of patients, together with the testimonials submitted by colleagues, patients, and associates, relevant to the question of serious professional misconduct, and in the knowledge of the findings made by this Panel against him. In accordance with the Legal Assessor’s advice it has taken into account his own evidence and submissions made on his behalf about why he did what he did, or omitted to do whatever it is said he should have done, as well as the testimonial and other relevant mitigating evidence. The Panel heard positive evidence of Professor Murch’s clinical ability, integrity and the respect in which he is held, by witnesses called by the GMC at the fact finding stage. The Panel also heard further evidence of his good character in oral and written testimonials. He was described as a leader in his field with international recognition of his skill in paediatric gastroenterology in general and performing colonoscopies on children in particular. He has been Professor of Paediatrics and Child Health at the Clinical Sciences Research Institute at Warwick Medical School in Coventry since 2005.

In considering Professor Murch’s case, the Panel has also taken into account the passage of time before these matters were brought before it and the length of time this case has taken. It noted that the multiple sittings were for a variety of reasons including professional commitments of the Panel and requests from Counsel for reasons such as illnesses, accidents, unavailability of witnesses and preparation time.

The Panel considered the conduct of Professor Murch whilst he was registered as a medical practitioner and employed by the Royal Free Hospital Medical School as a senior lecturer and held an honorary consultant contract with the Royal Free Hampstead NHS Trust. Having completed his training under Professor Walker-Smith, he had become senior lecturer and an honorary consultant in March 1995, first at Queen Elizabeth Hospital for Children in Hackney and the Medical College of St Bartholomew’s, then in September 1995 at the Royal Free Hospital. The Panel acknowledges that at the material times he was at the beginning of his consultant career. Professor Murch’s academic work involved research projects relating to paediatric gastroenterology, and his clinical work involved advice and treatment relating to sick children. The Panel also noted that he and another colleague were responsible for undertaking colonoscopies on children at the Royal Free Hospital.

The children described in the Lancet paper were admitted for research purposes under a programme of investigations for Project 172-96, the purpose of which was to investigate a postulated new syndrome following vaccination. The Panel rejected the contention that Project 172-96 was never undertaken. It found that Professor Murch was, along with Dr Wakefield and Professor Walker-Smith, named as a Responsible Consultant in the application for Project 172-96, to the Royal Free Hospital Ethics Committee, and thereby took on the shared responsibility for the research governance of the application; for ensuring that only children meeting the inclusion criteria would be admitted; that conditions attached to the Ethics Committee approval would be complied with; and that the children would be treated in accordance with the terms of the approval given.

The Panel also accepted the expert evidence that Responsible Consultants who sign up to research are individually responsible and have a duty to ensure such research governance. The principles of research ethics and governance and in particular, the guiding principles with regard to children, require a doctor to conduct research within ethical constraints. An ethics committee, in performing its regulatory function, has a right to expect probity from applicant doctors. The Panel is aware of Professor Murch’s membership of the Ethics Committee at the material time. It noted that he had only been a committee member for a few months and had not received any formal training but nonetheless concluded that he would have been aware of such responsibility.

In relation to what became known as Project 172-96, Professor Murch had concerns about its nature from an early stage. He said he was surprised to find a copy of Dr Wakefield’s Proposed Clinical and Scientific Study paper in his pigeon-hole, on returning from holiday in July 1996. He said this:

“The document was produced by Dr Wakefield… and …he took from [a planning meeting in May 1996] the clinical plan and inserted it into a document of his own.”

It prompted Professor Murch to consider if this altered the nature of the proposed investigation of the children:

“… this document caused some discussion …we also then wondered whether that changed the essential nature of what we were intending to do from clinical to research, and therefore we asked Professor Walker-Smith, and he was utterly clear about this … that at some stage Dr Wakefield may be wishing to do his research when he was in a position to do so, but that the investigation of the children was entirely a clinical matter, so he very clearly differentiated these two strands. This is a document that was written by a researcher that effectively picked up on a clinical approach that we were doing and appended to that a large superstructure of speculation based around something we had not discussed.”

He further stated in his evidence:

“I discussed with Professor Walker-Smith the nature of what we were to do and he was entirely clear on this: that …these were clinical admissions …I made my decisions in entire good faith …If the Panel decide we made an error of judgment, then we made an error of judgment.”

The Panel considered that his evidence on this matter went to the issue of insight.

The Panel found that all eleven of the Lancet children underwent a programme of investigations for research purposes without Ethics Committee approval and that Professor Murch failed to comply with his duties as a Responsible Consultant, to ensure adequate research governance. However it attached significant weight to the fact that Professor Murch demonstrated that he took the responsibilities of a Responsible Consultant seriously when he brought to an end, in or around late February 1997, the practice of undertaking lumbar punctures for the group of children as a whole because he could not draw any clear inference that a child might have a regressive neurological disorder of sufficient severity or clinical suspicion to make such a procedure reasonable on clinical grounds. He stated in evidence:

“…I took the steps which … led to the termination of 172-96. I felt that on the first occasion I had been called upon to act in my capacity as Responsible Consultant I had indeed acted responsibly, and this had the consequences of preventing the study going ahead.”

Professor Murch’s involvement with the project was subsidiary to, and more limited than, that of Dr Wakefield and Professor Walker-Smith. He had sought and obtained guidance and reassurance as to the nature of the study from two senior respected colleagues: Professor Walker-Smith and Dame Sheila Sherlock, Emeritus Professor of Medicine at the Royal Free Hospital, eminent in her field, whom, the Panel heard, “many senior academics would turn to for guidance and advice.” Further, Professor Murch knew that Professor Walker-Smith had confirmed his view on the clinical justification for the investigations in a letter dated 11 November 1996 to Dr Pegg, Chairman of the Ethics Committee.

The Panel accepts that in all the circumstances, Professor Murch’s actions in respect of research governance could not amount to serious professional misconduct.

Regarding the clinical care of the children, the Panel has found that Professor Murch undertook colonoscopies which were carried out in pursuance of a programme of investigations for research purposes on Child 2, 1, 4, 5, 12 and 10. In all but Child 10 this investigation was not clinically indicated. However, notwithstanding that he had a responsibility to ensure that the procedure he carried out was indeed clinically indicated, the Panel acknowledge that in respect of five of the children, 2, 1, 5, 12 and 10, the initial decision to colonoscope had been made by Professor Walker-Smith. The Panel noted that in the case of Child 4, Professor Murch was not the consultant responsible for the child’s admission and therefore his responsibility remained that of a colonoscopist only.

In respect of five of the children upon whom he performed colonoscopies, Child 2, 1, 4, 5 and 12, his conduct was contrary to the clinical interests of that child. He has fully acknowledged his responsibilities as a colonoscopist and said this about what he perceived to be the purpose behind the investigations:

“I think our whole ethos was to try to determine what was causing the illness in the child and to see whether we could do anything about it.”

Professor Murch’s first opportunity to see the children was after they had been admitted into hospital for about ten minutes on the morning of the colonoscopy procedure itself, for which the children had already been rigorously prepared. The Panel accepted Professor Murch’s evidence that, “time for decision making is inevitably pretty limited” and that it would have been impractical to undertake a full assessment of each child again before the colonoscopy. The Panel accepted Professor Murch’s evidence that the pre-colonoscopy assessment would usually involve assessing whether the child was clinically well on the day, that his or her condition had not changed since admission to hospital, and assessing whether the bowel preparation had been administered satisfactorily.

The Panel took into account that Professor Murch had, along with his colleagues, received information from Dr Wakefield of the purported histories of regression and significant bowel problems of the children. They all agreed that colonoscopies were appropriate in the circumstances. Professor Walker-Smith saw a number of the Lancet children in outpatients and took the decisions that they should be admitted into hospital for further investigation whilst Professor Murch did not see any of these children in outpatients nor decide that they should be admitted. He relied on the expertise and judgment of Professor Walker-Smith:

“I had complete faith in Professor Walker-Smith’s diagnostic ability. He was the paediatricians’ paediatric gastroenterologist.”

The reassurance that Professor Walker-Smith gave about the clinical basis for the investigations was also expressed in the application of Project 172-96:

“… in view of the symptoms and signs manifested by these patients, all of the procedures and the majority of the samples are clinically indicated.”

The Panel acknowledged that Professor Murch’s status within the department at the time of events in 1996, was that of a relatively junior consultant and that he would attach significant weight to the opinion he was given by Professor Walker-Smith.

The Panel accepted the expert evidence of Professor Booth, that a colonoscopist would have a low threshold for carrying out a colonoscopy that had been requested by a more senior colleague who had many more years of experience in assessing children. The Panel also accepted that it could not criticise Professor Murch for making an assumption that an investigation was clinically indicated if ordered by Professor Walker-Smith as it is appropriate to “respect the skills and contributions of your colleagues”, as indicated in the 1995 edition of Good Medical Practice.

The Panel concluded Professor Murch acted in good faith albeit it has found he was in error. His actions, although comparable to professional misconduct in respect of undertaking procedures which were not clinically indicated, were mitigated by the fact that he was under a false impression that they were clinically indicated and this could not reach the threshold of serious professional misconduct.

In relation to the Lancet paper, Panel has found that Professor Murch was not a senior author of that paper.

The Panel noted that in the press briefing held at the Royal Free Hospital immediately prior to publication of the Lancet Paper, Professor Murch spoke to the findings. Professor Zuckerman, the Dean of the Royal Free hospital at the time, in giving evidence to the Panel, testified that Professor Murch vigorously presented the view that the findings in this research were not sufficient to advise discontinuation of the MMR vaccine. Professor Murch was also instrumental in the retraction of the interpretation that had been placed on The Lancet article by the media. In dealing with the repercussions of the Lancet paper and their possible impact on public health policy, the Panel considered that Professor Murch behaved professionally and responsibly.

The Panel wishes to point out that it did not use personal mitigation to downgrade what would otherwise amount to serious professional misconduct to some lesser form of misconduct. Nevertheless, the Legal Assessor advised that evidence of potential mitigation might be relevant to the seriousness of the misconduct under examination; and that in this case there is an overlap. The Panel accepted that advice. When considering the issues of probity, honesty, medical ethics, the clinical interests of patients, the approach to research and appropriate clinical standards, the Panel noted from the evidence as a whole, including some of the testimonial evidence, that Professor Murch was regarded as a very cautious, gentle endoscopist. Furthermore, it was not out of the ordinary for him to be involved in a comprehensive set of investigations of complex conditions using an extensive protocol, which was a common method of working within the Department at the Royal Free Hospital.

Taking all of the above into account, the Panel concluded that Professor Murch demonstrated errors of judgement but had acted in good faith and that any professional misconduct on his part, such as his failing in duties of research governance and performing colonoscopies that were not clinically indicated, could not reach the threshold of serious professional misconduct because of the circumstances in which he found himself.

Accordingly the Panel found that Professor Murch is not guilty of serious professional misconduct.

In these circumstances it was therefore not necessary to consider a sanction and Professor Murch is free to continue unrestricted medical practice

Dr. Andrew Wakefield, turning disgrace into publicity.

24 May

The decisions from the General Medical Council on what actions will be taken on Doctors Andrew Wakefield, John Walker-Smith and Dr. Simon Murch for improper actions already found proven in previous hearings. In advance material for his book, even Dr. Wakefield has been stating that he will be struck off the register: “In the pursuit of possible links between childhood vaccines, intestinal inflammation, and neurologic injury in children, Wakefield lost his job in London’s Royal Free Hospital, his country of birth, his career, and his medical license.”

This is one place where I would agree with Dr. Wakefield. The idea that he’s about to lose his license seems a safe enough bet to just admit it as already having happened.

Dr. Wakefield has decided to quite literally defend him self in the court of public opinion, rather than the hearing room. As Mike Stanton points out in Andrew Wakefield’s Farewell, Dr. Wakefield did not call any of the families involved in the his research in his defense. Instead he relies on the rallying cry, “no family has ever complained…”

Brian Deer, in his recent article Weeping wounds of the MMR scare addresses this rallying cry:

Even some of those involved in his research now tell me they have had enough of his antics. “Please let me know if Andrew W has his doctor’s licence revoked,” emailed the father of Child 11. “His misrepresentation of my son in his research paper is inexcusable. His motives for this, I may never know.”

Dr. Wakefield will not appear before the GMC to hear the verdict. Rather, he will be in New York to appear on TV, where Matt Lauer of the Today Show will interview him. This may be the high water mark in Dr. Wakefield’s publicity campaign, which has included direct-to-youtube interviews with Dr. Mercola (whose runs probably the most trafficked medical misinformation website, if I may state my opinion), another made-for-internet interview, and a future interview on internet radio (10pm to midnight). This in addition to his keynote talk at an anti-vaccine rally to be held this week.

He may also be up for the first knighthood ever given out by AutismOne, at least in the wishful thoughts of his supporters.

In other words, he is moving from side show of the autism research community to center ring in his own circus.

Dr. Andrew Wakefield to join Dr. Arthur Krigsman in clinic independent of Thoughtful House?

20 May

Dr. Andrew Wakefield gives an interview in a recent story in the Austin Statesman, Censured doctor says he’ll resume autism research in Austin.

Dr. Wakefield is the primary doctor behind the idea that the MMR vaccine causes autism. His initial paper suggesting this link has been retracted by The Lancet, and the General Medical Council ruled that he was dishonest in his research efforts and showed a callous disregard for his subjects. He expects to lose his license when the GMC finishes the second phase of their action against him next Monday.

According to Dr. Wakefield, this will be the “final effort by the mainstream medical establishment to silence him and stop his research.”

I am at a loss for how this could silence him or stop his research. Dr. Wakefield resides in the United States and has for some time. Even when he was doing research in the United Kingdom, he was not working in a capacity to use his medical license (at least to my understanding).

The interview continues–

“Now that they have come to their determination, I will make absolutely sure the truth comes out,” Wakefield said. “I think I am in a position to encourage people to take a more serious look at the kinds of projects I am considering,” such as researching the long-term health of children who have been vaccinated and those who have not been vaccinated.

Again, I am at a loss. Why has Dr. Wakefield waited until he lost his license, something which he does not use, to make sure that the truth comes out? I would also question whether he is in a position to be taken seriously.

Dr. Wakefield is further quoted:

“Vaccine safety is built upon the confidence of the public u2026 and I’m not prepared to (compromise) that,” he said Wednesday, adding that he hopes people will read the book and “make up their own minds about what is real and what isn’t real.”

Dr. Wakefield is not prepared to compromize the public’s confidence in vaccines?

I am, yet again, at a loss for words.

On the subject of Dr. Wakefield’s future efforts:

Wakefield said he resigned from Thoughtful House so he wouldn’t be a distraction from its work. He said Thoughtful House was getting away from a focus on gastrointestinal issues and autism. Krigsman posted a message to former Thoughtful House patients saying their records would be forwarded to him, and they could see him at a “new, independent” office in Austin where Wakefield said he would do research similar to what he did at Thoughtful House.

US Court of Appeals denies vaccine court case

14 May

The first of the vaccine court autism cases has been denied by the United States Court of Appeals, Federal Circuit. The Vaccine court (or, more accurately, the U.S. Court of Federal Claims) grouped the autism claims into an “Omnibus”, something like a class action case, where evidence to prove vaccines cause autism was presented in a few “test cases”, rather than hearing all the cases individually. The Omnibus Autism Proceeding heard six test cases, three on the theory that the MMR vaccine causes autism and three on the theory that thimerosal (a mercury containing perservative) causes autism.

The appeals decision is for the test case of Yates Hazelhurst, one of the MMR test cases. The case was summarized by the Special Master who decided the case:

[P]etitioners assert that the measles component of the MMR vaccine causes an immune dysfunction that impairs the vaccinee’s ability to clear the measles virus. Unable to properly clear the measles virus from the body, the vaccinee experiences measles virus persistence which leads to chronic inflammation in the gastrointestinal system and, in turn, chronic inflammation in the brain. Petitioners argue that the inflammation in the brain causes neurological damage that manifests as autism.

The Special Master (essentially the Judge in the vaccine court) denied the claim. The family appealed to the Court of Federal Claims, who upheld the decision. The recent decision is from the United States Court of Appeals, Federal Circuit, making this the second appeal affirming the original decision.

The family appealed on the basis, as the appeals judge put it:

On appeal to this court, the Hazlehursts argue that the special master improperly relied on certain evidence that should have been excluded and disregarded other evidence that should have been considered.

The MMR theory for autism causation relies on the notion that the measles virus from the vaccine persists in the guts of children. This, in turn relies on research by Dr. Andrew Wakefield’s team and in particular, the Unigenetics laboratory. The government brought in a witness, Dr. Stephen Bustin, to refute the validity of the results from the Unigenetics lab. Dr. Bustin’s testimony and level of expertise were very clear in showing that the Unigenetics results were faulty.

The special master found that Dr. Wakefield’s work had been largely discredited within the scientific community and that none of the studies indicating the presence of measles virus in autistic children had been successfully replicated by an accredited laboratory independent of Dr. Wakefield or Unigenetics. In particular, the special master found that Dr. Wakefield’s early 1990s research on persistent measles infections was reviewed by the Medical Research Council of the United Kingdom and found to lack important controls and sufficiently specific reagents for detecting measles virus. She also found that Dr. Wakefield’s subsequent research was dismissed by the scientific community as methodologically unsound. In that regard, she noted that 10 of 12 co-authors on Dr. Wakefield’s controversial 1998 article in the medical journal The Lancet subsequently retracted their support for the article’s conclusion that there is a potential causal link between the MMR vaccine and autism.

The Special Masters allowed the petititioners (including the Hazelhursts) time to rebut Dr. Bustin’s testimony, through cross examination and through documentation from the UK MMR litigation. The petitioners did not avail themselves of this opportunity.

Over objection, the government sought to introduce Dr. Bustin’s reports and testimony regarding the Unigenetics laboratory, which, by that time, had gone out of business.[ 2 ] The special master in the Cedillo case provisionally admitted the evidence. The three special masters in the omnibus proceeding then deferred decision on whether to rely on that evidence and stated that they would “favorably consider joining in a request” by the petitioners “for the release of relevant reports” from the UK litigation. The record remained open for more than a year following the Cedillo hearing to afford the petitioners sufficient time to present rebuttal evidence, to conduct additional cross-examination of Dr. Bustin, and to obtain documents from the British court. However, none of the petitioners recalled Dr. Bustin for further questioning or applied for access to any of the materials from the UK litigation.

The Hazelhurst’s argued that evidence should have been allowed that was not. In particular, they argued that some unpublished results demonstrate the persistent measles theory.

The special master further concluded that the unpublished and preliminary findings of the Walker group should not be accorded significant weight. She observed that Dr. Hepner had declined to “draw any conclusions about the biological significance” of the investigators’ findings and had testified that negative controls were not included with each experimental run. The special master also noted that the petitioners’ experts based their opinions on the characteristics of the “wild-type” measles virus, as opposed to the vaccine-strain measles virus, which is far less virulent and replicates poorly in the human body.

In the end, the appeals judge ruled that there was no reason to overturn the original decision:

Because we find no error in the special master’s consideration of the evidence, we also find no error in her decision to discount Dr. Corbier’s opinion that the MMR vaccine caused Yates’s autism. By Dr. Corbier’s own admission, his opinion depended heavily on the reliability of the scientific studies purporting to show measles virus persistence in autistic children.

Compensation under the Vaccine Act is limited to those individuals whose injuries or deaths can be linked causally, either by a Table Injury presumption or by a preponderance of “causation-in-fact” evidence, to a listed vaccine. The special master concluded that the Hazlehursts’ evidence failed to demonstrate the necessary causal link, and the petitioners have not identified any reversible error in the special master’s decision reaching that conclusion.

The petitioners now have the choice of appealing to the U.S. Supreme Court. As noted above, the Supreme Court hears cases which help define laws and this does not appear to be such a case. It would seem unlikely, then, that the Court would agree to hear this case. If so, this is the end of the appeals for the Hazelhurst’s in their case against the U.S. government. The next step would, then, be to take their case to civil court against the vaccine manufacturers. Such cases have not been successful so far. Civil cases require a higher level of evidence and expertise than the vaccine court. Having failed in the Federal Court, where the rules are more favorable to the petitioners, it would seem a difficult battle to win the case in civil court.

Review of Frontline’s The Vaccine War

29 Apr

The Vaccine War has aired. Judging by the responses, one might consider it a success. Pro vaccine groups like Every Child By Two were telling people to watch it. The Autism Science Foundation “highly recommends” watching it. On the other side, the organizations represented by the Age of Autism blog (Generation Rescue, the National Autism Association, SafeMinds, the Autism Research Institute and TACA) are very upset. Jenny McCarthy has gone to the Huffington Post with her side of the story, as has Dr. Jay Gordon, whose entire interview was cut from the program.


An unofficial (and incomplete) transcript is here.

That all said, I both appreciated the program and had my fears realized. In this case, my fears were that people would be given a platform to spread misinformation. And it happened. Jenny McCarthy and others made statements that were, in my view, misinformation. But, I appreciated the fact that Frontline took the time to counter much of the misinformation with actual experts discussing real science.

Frontline describes the show as:

In The Vaccine War, FRONTLINE lays bare the science of vaccine safety and examines the increasingly bitter debate between the public health establishment and a formidable populist coalition of parents, celebrities, politicians and activists who are armed with the latest social media tools — including Facebook, YouTube and Twitter — and are determined to resist pressure from the medical and public health establishments to vaccinate, despite established scientific consensus about vaccine safety.

I think the show accomplished this. There was some cost in terms of allowing Generation Rescue’s misinformation message in TV once again. But, this time, this time they are the problem.

If you watch the introductory 2 minutes of this video, you will get some idea of how the show is presented

Parents, both pro vaccine and not, activists, public health workers and researchers like Dr. Offit telling various sides of the story, with the narrator tying it together.

Narrator: Tonight on Frontline: They’re hailed as medicine’s greatest triumph: conquering smallpox, diphtheria, polio and more. But today, some Americans question if all those vaccines are worth the risk.

The show is in four segments. The titles for these segments should, again, give you an idea of the tone of the show.

1. A visit to Ashland, Oregon. In some American communities like this one, parents are hesitating to vaccinate their children, despite their doctor’s advice.

2. Eroding faith in vaccines. Skeptics target Paul Offit, inventor of the rotavirus vaccine. And many parents are wary of vaccines because they no longer see the diseases.

3. Fearing vaccine risks, especially autism.. Vaccine skeptics like celebrity Jenny McCarthy have organized a community of parents concerned about a vaccine-autism link.

4. The science that launched the movement. A British doctors ’98 study theorized that the measles vaccine causes autism. Soon vaccine critics began questioning other additives in vaccines.

5. What epidemiological studies reveal. No link is found between autism and the MMR shot or thimerosal. And the British doctor’s ’98 study is discredited, but critics demand more studies.

6. Vaccines, what’s at stake. The debate goes beyond the medical risks-benefits: it involves parents’ rights to make choices v. the needs of the community.

In the first segment, they interview a pro-vaccine mother in Ashland. She notes that if there is an outbreak, the response may get contentious. It may get ugly.

Beyond the direct human cost, one of my worries: how much blowback will there be to the autism communities? How much blame will be applied and what will it cost?

As part of the introduction, The Vaccine War discusses the story of Desiree Jennings. She was a Washington Redskins cheerleader who claimed dystonia as an adverse reaction to her vaccine. Her story broke out not through the TV news show that covered her story, but through YouTube. Jenny McCarthy is quoted about how Generation Rescue took Ms. Jennings to see Dr. Rashid Buttar and how chelation and HBOT cured her.

What makes the Desiree Jennings story even more interesting is the possibility that the vaccine-injury/dystonia story may not be real. As noted on LeftBrainRightBrain, Ms. Jennings was later followed by cameras from a TV program and shown to be driving and walking normally.

The possibility that Generation Rescue is using the story even though it may not be true was probed by Frontline. Here is a part of an interview from Frontline with one of Generation Rescue’s founders:

[Frontline]Talk about the viral spread of an image over the Internet, like [Redskins cheerleader] Desiree Jennings’ flu shot story, for example.

It’s remarkably powerful what an image or an idea can do in today’s day and age, and for a group of parents who feel completely outmatched — because think for a moment about who our enemy is; our enemies are the largest pharmaceutical companies on the planet, making billions of dollars in net profit a year — you’d think that we could never compete with that. But an idea can transmit itself powerfully and very cheaply for millions to see.

So in the case of Desiree, here you have an image of this beautiful woman who’s been severely disabled that literally tens of millions of people view overnight, and imagine the chilling effect that has on a flu vaccine that she attributes as the cause of her condition. It’s remarkably powerful.

[Frontline] Does it matter whether it’s true or not?

Truth always bears out in the end, so I’m a firm believer in that. Are there moments in time where truth is exaggerated or expanded? Absolutely. But truth bears out in the end. …

Perhaps I missed it, but it appears to this reader that Frontline’s question was completely dodged. Does it matter whether the Desiree Jennings story is true or not? I think so. But what seems important to Generation Rescue is not the truth of the story, but the fact that it is a gripping narrative that sells their message.

The Vaccine War has a rather large cast, if I may call them that. Parents both pro and anti vaccine, a writer from Ashland who is anti-vaccine, Paul Offit, bioethicist (and polio survivor) Arthur Caplan, Jenny McCarthy, Anthony S. Fauci (immunologist from NIAID), Cynthia Cristofani (pediatric intensivist), Alvaro and Myrian Fontan (a family who almost lost their daughter to whooping cough) and J.B. Handley, Barbara Loe Fisher–plus more.

In some ways, “The Vaccine War” takes the same approach that Dr. Offit uses in books like “Autism’s False Prophets”. Let the skeptics make their points, ask their questions, then respond. Sometimes this is quite jarring.It is tough to sit back and listen to someone spread information and wait for the response.

The Vaccine War is well researched. Even though people like Jenny McCarthy got some air time for their ideas, they are quite upset about the Frontline episode.

Perhaps I am the only one who will find this ironic. In response to this episode, one which discusses how groups like Generation Rescue use social networking on the internet to get their message out, they are taking to social networking. Twitter, blogging…

As noted above Jenny McCarthy and Dr. Jay Gordon have taken to the Huffington Post to respond to the show. the Age of Autism is being very critical. They are attempting to “poll mob” the Frontline website. (humorous aside–they haven’t figured out that the survey doesn’t record their answers. It only shows you how your responses compare to the actual survey.)

If you have friends, family who are wondering about the vaccine/autism “controversy”, this is a good show to refer them to. It gives both sides. It allows people like Jenny McCarthy to give her viewpoint–and it gives the response.

Does autistic enterocolitis exist?

20 Apr

The piece below is from the blog justthevax, where it ran as “Independent” the Wakefield way (really something for the fail blog). I like this piece because, frankly, I wish I had done it. Catherina takes a look at the exact claims made by Dr. Wakefield’s supporters and shows that they are clearly false.

“Independent” the Wakefield way (really something for the fail blog).

One of the claims that keeps reappearing in the comments sections under articles covering the GMC ruling on Andrew Wakefield and colleagues is that

The key finding (chronic colitis found in ASD children) of Dr. Wakefield’s early case report published in The Lancet in 1998 HAS been independently confirmed by medical researchers in five different countries.

That is a very significant claim. After all, independent confirmation of a recent finding, would make the validity of a finding more likely, and if 6 independent laboratories found the same gut changes in autistic children, then then likelihood that this was a) a fluke or b) made up by Andrew Wakefield would be drastically reduced.

Finally, one of those commenters has posted those ‘independent confirmations’ – so I thought it might be worth having a look at them.

Krigsman, A. (Assistant Professor of Pediatrics, New York University School of Medicine Director of Gastroenterology Services), et al.,Ileocolonoscopy in Children with Autistic spectrum Disorder and Chronic Gastrointestinal symptoms. Autism Insights 2010:2 1-11.

Gonzalez, L., et al., Endoscopic and Histological Characteristics of the Digestive Mucosa in Autistic Children with gastro-Intestinal Symptoms. Arch Venez Pueric Pediatr, 2005;69:19-25.

Balzola, F., et al., Panenteric IBD-like disease in a patient with regressive autism shown for the first time by wireless capsule enteroscopy: Another piece in the jig-saw of the gut-brain syndrome? American Journal of Gastroenterology, 2005. 100(4): p. 979-981.

Balzola, F., et al., Autistic enterocolitis: Confirmation of a new infammatory bowel disease in an Italian cohort of patients. Gastroenterology 2005;128(Suppl. 2);A-303.

Galiatsatos, P., et al., Autistic enterocolitis: Fact or fiction. Canadian Journal of Gastroenterology. 2009;23:95-98.

Let’s look at number 1, Krigsman et al. The name sounds vaguely familiar. In fact, anyone who has read a little about the MMR-autism affair will know Arthur Krigsman as the clinical director of Thoughtful House, which happens to be the same Texas Clinic out of which Andrew Wakefield practises. One editor of “Autism Insight”, the journal in which this “independent confirmation” was published, is Andrew Wakefield (another one the senior author of the study, Carol Stott). Gosh, I bet peer review was harsh for this one.

Gonzales et al, number 2, has been published in “Arch Venez Pueric Pediatr” which stands for Archivos Venezolanos de Puericultura y Pediatría. It was a bit tricky to get my hands on the paper, especially since the citation was not quite right, but I did manage and was not surprised to find that indeed the authors cannot replicate Wakefield’s 1998 “findings” of a distinct autistic enterocolitis, although they do report a higher incidence of gastrointestinal problems in their autistic group.

Balzola et al, number 3, is a case report of one adult autistic patient with inflammed bowel.

Similarly, Balzola et al, number 4, is a meeting abstract (if anyone has access, could they email me that abstract, please) that never saw the light of day as a peer reviewed study.

Finally, number 5, Galiatsatos et al., is a case report, featuring two adult patients with gastrointestinal problems and an ASD diagnosis. The authors call for “more investigations” in their discussion.

So what do we have here? Three (3) genuinely published cases of autistic adults who had consulted a doctor for gastrointestinal problems and were found to have gastrointestinal problems. One conference report from April 2005 that has not gone through peer review and has not appeared in a real journal in the 5 years since the conference. One real study looking at over 50 autistic children which does not confirm Wakefield’s findings. And finally, one study by Wakefield’s buddies in a freshly founded journal run by Andrew Wakefield and his buddies, to say that their buddy Andy was really right all along – how is that for “independent” confirmation?!

Brian Deer discusses Andrew Wakefield’s “autistic enterocolitis” in the BMJ

15 Apr

Before the General Medical Council reached a verdict on Dr. Wakefield, Brian Deer was promising that he was going to report on the data Dr. Wakefield used for his now retracted Lancet paper. We were told that he would give a first time ever view of a journalist allowed to check the facts on a scientific research paper.

After the GMC verdict was handed down, I watched the Sunday Times for such an article. I waited. Well, the wait is over. And it isn’t in the Times. Mr. Deer reports his findings in the British Medical Journal (BMJ).

Although much of the attention on Dr. Wakefield’s work has centered on the possible MMR connection, the topic of a “new syndrome” called “autistic enterocolitis” was proposed in that paper. In Wakefield’s “autistic enterocolitis” under the microscope, Mr. Deer takes a closer look at that claim. He does what is very rarely done: he obtained original data used for the study and obtains expert opinions on that data.

In his introduction, he notes the “new syndrome” and the MMR angles of the Lancet paper. Citing the press release from the Lancet paper:

“Researchers at the Royal Free Hospital School of Medicine may have discovered a new syndrome in children involving a new inflammatory bowel disease and autism,” the institution announced in a press release in February 1998. “Their paper . . . also suggests that in a number of cases the onset of behavioural symptoms was associated with MMR vaccination.”

Mr. Deer notes that before any patients were investigated, Dr. Wakefield was already proposing in a submission to the Legal Aid Board that such a new syndrome exists and it is linked to regression in children.

“In contrast to the IBD cases, which have a prima face [sic] gastrointestinal pathology, children with enteritis/disintegrative disorder form part of a new syndrome,” said Wakefield and the lawyer in a confidential submission for legal aid funding for the project in June 1996, before any of the 12 children in the paper had been investigated. “Nonetheless, the evidence is undeniably in favour of a specific vaccine induced pathology.”

For emphasis:

The evidence was “undeniably in favour of a specific vaccine induced pathology”.

Before children were investigated.

That on its own is huge. And, from what I can tell, not consistent with the image Dr. Wakefield is portraying in the alternative media.

That said, was there evidence of this “new syndrome”?

But when the children were brought in to the Royal Free for ileocolonoscopy, between July 1996 and February 1997, a snag in Wakefield’s project emerged. The hospital’s pathology service repeatedly judged colonic biopsy samples to be unexceptional, and thought bowel disease was a possibility in only one child.

The Royal Free’s own pathology service thought that the biopsy samples were unexceptional.

How can Mr. Deer make such a claim? He obtained data from the children’s records from their investigations at the Royal Free. Unfortunately, the actual samples are no longer available, but the reports are, and Mr. Deer submitted these to experts to review:

The biopsy slides are no longer available, according to one of the paper’s authors, Professor Amar Dhillon, but the GMC obtained all but one of the hospital pathology reports, and for the missing case I obtained the discharge summary. I passed the summary and reports to specialists for their reaction. They concluded that most of the 11 children reported as having non-specific colitis in the Lancet paper had been reported by the Royal Free as having normal pathology.

One expert reviewer stated:

“In the present reports and patients, overall, it is my impression that 8 of the 11 [for whom pathology reports were available] were normal,” Karel Geboes, a professor in the gastrointestinal pathology unit of the Catholic University of Leuven, Belgium, told me.

How does this compare to what was reported in the Lancet?

Eleven of the 12 children were said to have “non-specific colitis”: a clinically significant inflammation of the large bowel. In all 11, it was said to be “chronic,” while in four it was reported as both “acute and chronic.”

In other words, the report in the Lancet is not consistent with how experts interpret the pathology reports.

Mr. Deer further notes:

In fact the [Royal Free’s pathology] service identified findings suggestive of possible inflammatory bowel disease in only one of the 12 children. “The mild patchy generalised increase in inflammatory cells with lymphoid aggregates and follicles is not very specific but could be in keeping with low grade quiescent inflammatory bowel disease,” it reported for child 2. But this inflammation resolved after two months’ enteral feeding with a product now marketed as Modulen. A repeat ileocolonoscopy found no abnormality, and a food intolerance was diagnosed.

Yes, it appears that the pathology service, at Dr. Wakefield’s own hospital, at the time of the investigation, didn’t find evidence of abnormalities reported by Dr. Wakefied’s team.

In the GMC hearing, one of the co-authors on the Lancet paper, Dr. Susan Davies, discussed her concerns about the changes in the findings from normal to abnormal at the time of the investigation.

These changes—from normal to abnormal, or from healthy to diseased—had also raised concern in the mind of at least one of the paper’s authors. In September 2007, Davies, the lead histopathologist for the Wakefield project, was examined at length before the panel. “When you were given a draft of the Lancet paper, did you read it?” she was asked by Sally Smith QC, for the doctors’ regulator.
“Yes,” Davies replied.
“What was your overall view of the terminology used in relation to the histology findings in the Lancet paper, just when you read the paper?”
“I was somewhat concerned with the use of the word colitis.”
“First of all, what did you understand that word to mean?”
“I personally use that terminology, ‘colitis,’ when I see active inflammation, or a pattern of changes which suggest a specific diagnosis, and it was not my impression that the children coming through in the spasmodic way that they had, I [sic] had formulated some distinct pattern warranting that terminology.”

If even a co-author was concerned, and the hospital’s pathology reports don’t support the diagnosis of colitis, the obvious question would be: how did the paper reach it’s conclusions?

The answer appears to be that the results underwent a second review. This second review is discussed in the Lancet paper, but there is no mention of the review changing the interpretation of the data,

Mr. Deer poses an important question:

[H]ow many peer reviewers would have felt comfortable approving the paper if they had known that the hospital pathology service reported biopsy specimens as largely normal, but they were then subjected to an unplanned second look and reinterpreted?

Which we are fortunate enough to have answered. Mr. Deer was able to obtain an answer from one of the peer reviewers:

“I’m surprised the GMC didn’t make more of this,” said David Candy, paediatric gastroenterologist at St Richard’s Hospital, Chichester, who reviewed the paper in 1997. “That’s an example of really naughty doing—to exclude the original pathology findings.”

“Really naughty doing”. Not very clinical but I think it tells the story well.

Is it possible that the hospital’s pathology service missed the condition? Apparently at least one author (Dr. Walker-Smith, a co-defendant with Dr. Wakefield in the GMC hearings) noted this in his GMC testimony:

And how bad was this “colitis,” such that the hospital’s pathology service didn’t spot it as the children came through? Walker-Smith told the GMC panel that he had “concerns” about the service and its ability to detect inflammation.

In his report, Mr. Deer counters with:

Yet inflammatory indices that were not reported in the Lancet paper, including serum C reactive protein concentrations and other blood tests, were almost all within normal ranges for the 12 children.6 And as an alternative explanation for any inflammation that was present, nearly all of the children had constipation with megarectum16 (unreported in the paper), which specialists say can cause cellular changes.

Mr. Deer attempted to speak with Dr. Dillhon, a co-author on the Lancet paper. Dr. Dillhon viewed the slides made from the samples taken from the children, and he graded them with Roman numerals to rank the degree of inflammation. At some point, those Roman numerals were translated into “non-specific colitis”.

So who translated these scores on the grading sheet into findings of “non-specific colitis” in the paper? Dhillon says it wasn’t him. He says he would like to see the slides again, but they are missing from the Royal Free laboratory. “He [Dhillon], Andrew Anthony, and Wakefield all looked at them,” I was told, on Dhillon’s behalf, by a senior member of staff at the Royal Free. “Andy [Wakefield] then synthesised their results into what appeared in the paper.”

But still, according to Mr. Deer, “…how the Roman numerical scores, histopathological gradings for a variety of sites in the colon, became the “colitis” findings might, under such circumstances, be anybody’s guess.”

Mr. Deer posits a possible scenario, based on Dr. Wakefield’s complaint to the press complaints commission:

Wakefield wrote: “When the biopsies were reviewed and scored by experts in bowel pathology—namely, Drs Dhillon and Anthony—these doctors determined that there was mild inflammation in the caecum, ascending colon, and rectum,” he said. “This was correctly reported as non-specific colitis in the Lancet.” In other words, it looks like it was Wakefield who translated the scores.

A companion editorial was published in the BMJ by Prof. Sir Nicholas Wright, warden, of Barts and the London School of Medicine and Dentistry, Queen Mary University of London. He lists in his conflict of interest statement: “He has provided expert opinion in the case of Wakefield v GMC and acted as a character witness for Professor John Walker-Smith.”

His editorial:

Does autistic enterocolitis exist?
Despite the retracted Wakefield study, questions remain

His conclusion:

Is autistic enterocolitis a histopathological entity or even an entity at all? In view of the lack of data and the entrenched position of many of the protagonists and antagonists, any firm conclusion would be inadvisable. The expert review, referenced by Deer, concludes that key areas such as the prevalence and best treatment of gastrointestinal disorders in people with autistic spectrum disorders are incompletely understood, and that evidence based recommendations are not yet available. We should remember, as recent experience in several fields has shown, that although science has its defects, it is a self correcting process. Time is, perhaps, the wisest counsellor of all. In the meantime, this case offers a salutary reminder for researchers and journal editors alike that coauthorship means bearing responsibility for what is written.

First, I would submit that Dr. Wright is not being clear on the subject. It is not whether autistics have a greater prevalence of GI issues, or whether there is a difference in the treatment for autistics. The question is whether there is a specific entity which is unique to autistics: autistic enterocolitis. Further, it is also a primary question whether “autistic enterocolitis” is causal in autism. While one can hide behind the “you can’t prove a negative” shield, the answers at present appear to be no to both questions.

Second, the idea that science is a self correcting process is often times true. In this case, it clearly is not. The science, the Lancet paper, was not corrected through science but through investigative journalism. Without the stories in The Sunday Times, Dr. Wakefield’s “science” would likely still be in the official record of The Lancet. Much more, the Lancet study and the presumed expertise of Dr. Wakefield would have likely been key in litigation in the UK and the US. Without Mr. Deer’s continued scrutiny, the facts behind the research into the Lancet paper, specifically that the pathology reports on those children were not consistent with the findings of the paper, would almost certainly not have come to light.

Returning to Mr. Deer’s article, he concludes:

So what should we make of all this? Now the Lancet paper is retracted, its findings don’t officially exist. And, if Dhillon is right in saying the slides can’t be found, the ultimate proof is missing. All we have are the pathology reports, which independent specialists seem to agree are largely unremarkable. “They wanted this bad,” commented Tom MacDonald, dean of research at Barts and the London School of Medicine and coauthor of Immunology and Diseases of the Gut. “If I was the referee and the routine pathologists reported that 8/11 were within normal limits, or had trivial changes, but this was then revised by other people to 11/12 having non-specific colitis, then I would just tell the editor to reject the paper.”

Clearly the Lancet paper should have been rejected. But this isn’t just a scientific paper that made a bad conclusion. This paper impacted multiple families inside the autism communities to believe that their child’s autism was caused by MMR. This paper led many families in the autism communities to apply poorly researched “therapies” to their disabled children. This paper led many families to stop vaccinating their children, leading to outbreaks of measles in the UK and elsewhere.

It is easy to go through Mr. Deer’s paper in the BMJ point by point in a clinical fashion, noting how the research went awry, showing that “autistic enterocolitis” has what appears to be no founding in science. But how does one express the reaction to so much damage caused by Dr. Wakefield’s investigation?

Of course, a further question I have and I bet I share with Dr. Wakefield’s supporters is this: is Brian Deer finished or is there even more yet to be unearthed in this sad tale of research gone awry?

Brian Deer challenges Andrew Wakefields words

5 Apr

Andrew Wakefield has recently published a series of videos on YouTube (the only media outlet still left interested in his ramblings). Fascinating in largely no aspect, they do however remain riddled with innaccuracies which Brian Deer has challenged in his own response video which is below.

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