Study Finds Supplements Contain Contaminants

27 May

A story in the New York Times by Gardiner Harris discusses the results of a Congressional investigation on dietary supplements. Many were found to be contaminated with heavy metals and/or pesticides:

Nearly all of the herbal dietary supplements tested in a Congressional investigation contained trace amounts of lead and other contaminants, and some supplement sellers made illegal claims that their products can cure cancer and other diseases, investigators found.

The levels of heavy metals — including mercury, cadmium and arsenic — did not exceed thresholds considered dangerous, the investigators found. However, 16 of the 40 supplements tested contained pesticide residues that appeared to exceed legal limits, the investigators found. In some cases, the government has not set allowable levels of these pesticides because of a paucity of scientific research.

You can read the actual report in summary, highlights and full report.

The report focused on herbal supplements like Ginko and St. John’s Wort. The levels were low as noted:

GAO also found trace amounts of at least one potentially hazardous contaminant in 37 of the 40 herbal dietary supplement products tested, though none in amounts considered to pose an acute toxicity hazard. All 37 supplements tested positive for trace amounts of lead; of those, 32 also contained mercury, 28 cadmium, 21 arsenic, and 18 residues from at least one pesticide. The levels of heavy metals found do not exceed any FDA or Environmental Protection Agency (EPA) regulations governing dietary supplements or their raw ingredients, and FDA and EPA officials did not express concern regarding any immediate negative health consequences from consuming these 40 supplements.

Earlier this year, Kirkman Labs (who markets their supplements towards the autism parent community) was found to have a number of supplements contaminated with antimony.

A representative for the Council for Responsible Nurtirion downplayed the contamination issues:

Steve Mister, president of the Council for Responsible Nutrition, a trade association representing the dietary supplement industry, said it was not surprising that herbal supplements contained trace amounts of heavy metals, because these are routinely found in soil and plants. “I don’t think this should be of concern to consumers,” Mr. Mister said.

Andrew Wakefield sets out his talking points in a new book

27 May

Only a few years ago it seemed you couldn’t go into an online discussion without hearing David Kirby’s talking points from his book Evidence of Harm. I recall hearing over and over about pink’s disease, Minimata disease and many more “facts” that had really nothing to do with autism.

Now it seems to be Dr. Wakefield’s chance to shape (again) the discussion. His book “Callous Disregard” is sort of published (published but not generally available from what I can see). Luckily, a blogger for Examiner.com seems to have a copy and he lays out Mr. Wakefield’s responses to the ethics lapses which cost him his license in the UK. The talking points seem mostly to be about Mr. Wakefield, rather than about autism, but let’s go through them and see how they stand up to scrutiny, shall we?

Keep one thing in mind, Mr. Wakefield’s arguments seem to this observer to be of the type to mire people in details and confuse the issues with sidetracks.

Regarding financial conflicts of interest, Wakefield says that the funds for the Lancet 12 study came from the National Health Service. According to Wakefield, the money he received from lawyer Richard Barr was for a separate study looking for measles in the intestine of affected children. Wakefield states that the parents of the 12 children in the Lancet study came to him before he was hired as an expert on MMR litigation.

Wakefield writes that he was not required in 1997 to publish in the Lancet article his role of being an expert on MMR litigation but he did notify appropriate officials: “Long before publication ? details of my involvement as an expert in the litigation had been provided to my senior coauthors, the dean of the medical school, and the editor of The Lancet.”

As with much of Mr. Wakefield’s explanation, Brian Deer has responded to this one. But, let’s take a different look:

Andrew Wakefield was the key person in the Royal Free Hospital’s press conference on his paper in the Lancet. At that time, Mr. Wakefield was in the employ of lawyers seeking to litigate MMR injury cases. At that time he called into question the safety of the MMR vaccine.

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.

What do you think? Should a person working as a paid expert in MMR litigation announce this in a press conference where he calls for the suspension of the MMR vaccine? I would suggest that pretty much anyone who looked at this would say, “Yes, he should have made his conflict of interest public”.

Mr. Frandsen continues:

In a letter to pediatric gastroenterologist John Walker-Smith in February 1997, Wakefield explained his reasons for acting as an expert:

“Vaccination is designed to protect the majority, and it does so at the expense of a minority of individuals who suffer adverse consequenses…If this disease is caused by the MMR vaccination, then these childen (sic) are the few unfortunates that have been sacrificed to protect the majority of the children in this country. If that is the case, our society has an absolute obligation to compensate and care for those who have been damaged by the vaccine for the greater good.”

Which is irrelevant to the question of whether Mr. Wakefield’s actions were ethical. Really, how does the above apply to, say, whether Mr Wakefield had a conflict of interest or performed procedures without ethical approval? It doesn’t.

Wakefield was accused of conducting unnecessary and invasive medical procedures such as lumbar puncture on children with autism. Wakefield states that the history of developmental regression justified lumbar punctures. Later it would be discovered that neuro-inflammation in children in autism showed abnormal cytokine levels in cerebral spinal fluid. In addition, Swedish autism expert Christopher Gillberg advocates lumbar punctures to exclude encephalitis, and the procedure is conducted on children with autism in the U.S.

First, many lumbar punctures were performed before ethical approval was granted. Second, and more importantly, many of the lumbar punctures were found to be unnecessary. Here is but one comment from the GMC finding on Mr. Wakefield:

The Panel has taken into account that there is no evidence in Child 3’s clinical notes to indicate that a lumbar puncture was required. Professor Rutter and Dr Thomas, experts on both sides, considered that such a test was not clinically indicated.

Note–experts from both sides considered that the test was not clinically indicated. So, even Mr. Wakefield’s expert agreed that there was no reason to do a lumbar puncture on this child.

Anecdote here–I don’t think I have ever run into a parent who had their autistic child undergo a lumbar puncture. Autism is not a general indication for lumbar puncture. How many times have you read in the comments on, say, the Age of Autism blog, “When we got our lumbar puncture…”

Mr. Frandsen continues:

Regarding “data fixing” alleged by a British journalist, Wakefield said there were no allegations by the GMC that he manipulated data: “In the hands of someone determined to discredit the work, discrepancies between the routine clinical report (which may have come, for example, from a pathologist with an interest in brain disease or gynecological pathology) and the standardized expert analysis were falsely reported in the national media as ‘fixing’ of the data.”

One good reason why “data fixing” was not a charge by the GMC is very simple–the information on “data fixing” came out from the GMC hearings. The charges were, not surprisingly, made before the hearings.

I would like to see what an investigation into the question of data fixing would conclude.

On the decision by the Lancet’s editors to retract the article because the 12 patients in the study were not “consecutively referred,” Wakefield responds, “This is bizarre, since it is factually entirely correct – these were the first 12 children to be referred to the care of Walker-Smith with a regressive developmental disorder and intestinal symptoms.” Wakefield writes in the book that he indeed did have ethics committee approval to conduct the research elements of the Lancet study.

Let’s look at this in pieces–Mr. Wakefield is redefining “consecutively referred” to suit his needs. How did the GMC interpret “consecutively referred”?

The Panel is satisfied that a general reader would interpret the wording in 30a to mean that children were referred to the gastroenterology department with gastrointestinal symptoms and that the investigators had played no active part in that referral.

But, Mr. Wakefield’s team did play an active part in the recruitment of at least some of the children involved in the study. Not all of the children were referred for GI complaints.

Or, to put it quite simply: the statement “consecutively referred” was supposed to tell us all that there was no bias in how the patients came to be in the care of the Royal Free. But the truth was that there were huge biases involved.

Here is what the GMC had to say on this question:

Having regard to its findings in relation to Child 1, 9, 5 and 10, namely that these children were admitted to undergo a programme of investigations for research purposes, and that they all lacked a history of gastrointestinal symptoms, the Panel is satisfied that these referrals did not constitute routine referrals to the gastroenterology department.

Now let’s address the last sentence in that section above “Wakefield writes in the book that he indeed did have ethics committee approval to conduct the research elements of the Lancet study.”

This is one of those things where Mr. Wakefield and his supporters try to bury people in the details to create doubt. He claims that there was an approval in place, for project 162-95. The GMC rejected that idea:

The Panel has heard that ethical approval had been sought and granted for other trials and it has been specifically suggested that Project 172-96 was never undertaken and that in fact, the Lancet 12 children’s investigations were clinically indicated and the research parts of those clinically justified investigations were covered by Project 162-95. In the light of all the available evidence, the Panel rejected this proposition.

Why would they reject the idea? Project 162-95 allowed Prof. Walker-Smith to take two extra biopsies for research purposes when he did colonoscopies on patients.

Rather than get mired in the details ask a simple question: How does that allow the team to, say, perform lumbar punctures? Simple answer, it doesn’t.

Wakefield also cites conflict of interest among his critics. Professor Michael Rutter of the Institute of Psychiatry, a witness for the prosecution in the GMC case, had been a paid expert by vaccine manufacturers and the U.S. government. Dean Arie Zuckerman of the Royal Free Hospital wrote to the British Medical Association in October 1996 worried that Wakefield’s study could lead to a case against the government.

Assume it is all true. Does it change anything about Mr. Wakefield’s ethical lapses? It is the researcher version of “But mom, the other kids shoplift too”.

Wakefield answers the charges that it was unethical to take blood samples from children at his own child’s birthday party in 1999 to compare with samples of children with autism. “The blood was taken by a suitably qualified medical practitioner with standard aseptic precautions. Children were rewarded with the equivalent of just over $7. The entire procedure passed off without mishap or complaint. This process did not have the approval of an EC (Ethics Committee), which I now accept was naïve, but it was most certainly not unethical,” Wakefield writes.

Let’s boil this down to the basics: Mr. Wakefield made children into study subjects without first obtaining ethics approval.

That is unethical. By definition. Mr. Wakefield is not in a position to say “it wasn’t that bad an ethical breach” or “it happened safely”. What he really can’t say is “well, it would have been approved if I had asked”. None of those excuses work at all. His actions were unethical.

As if to make that point, the article goes on:

Wakefield compares that to a measles and rubella (MR) campaign the UK administered to approximately 8 million school children in November 1994: “In contrast, the MR campaign had multiple ethical failings on many levels, but the most staggering omission of all seems to me to have been the failure to alert parents to the known threat of severe adverse reactions – to deny them the fundamental right of informed consent in making a decision about their child. It puts the birthday party into the shade and rather makes a mockery of the post-GMC headlines about my callous disregard.”

Basically, Mr. Wakefield is saying, “other people were more unethical, so you should ignore my small ethical breaches”.

The birthday party story just fills in the narrative that Mr. Wakefield had a “callous disregard” for obtaining ethics approvals. Whether it was for very serious procedures on disabled children (lumbar punctures) or smaller actions like blood draws from non-autistic young children, he exhibited a pattern of unethical behavior.

“My experience serves as a cynical example to discourage others,” writes Wakefield. “As a consequence, many physicians in the United Kingdom and United States will not risk providing the care that is due to these children.”

This is a diversionary tactic. He’s using disabled children as a shield. Doctors in the US and the UK–and the world over–should not provide “care” that is not clinically required and potentially risky in order to obtain research results to support litigation. And that is where Mr. Wakefield failed.

In his piece, Mike Frandsen goes on with another talking point by Dr. Wakefield: that the US Government has acknowledged that vaccines cause autism. He cites the Hannah Poling case, the Bailey Banks case and the Hiatt case.

Again, let’s avoid getting bogged down in the details of those case and ask the simple question: did any of them involve Mr. Wakefield’s hypothesis of persistent measles in the gut? Answer, no.

This is another diversion.

Mr. Frandsen goes on to state:

Injury claims filed with the National Vaccine Injury Compensation Program since 1989 total 12,356. Claims involving deaths from vaccines number 1,035 in the same time period. According the VICP website, 52 cases have been filed for deaths since 1989 involving MMR and 19 cases filed for deaths involving the measles vaccine. Of those cases alleging injury or death due to vaccines, the U.S. government has compensated 2,440 awards totaling more than 1.8 billion dollars, though none of the awards have been compensated specifically for autism, according to the government’s statistics.

Again, what does any of this have to do with Mr. Wakefield’s research? Nothing. If they had a single case that was on point, they’d use it.

More to the point, what does this have to do with whether Mr. Wakefield’s research was performed *ethically*? Answer: nothing.

That’s always a good question to ask as Mr. Wakefield attempts to reinvent his image: does his excuse really address the issues? Mostly, do they address the issues of whether he acted ethically in his research activities? The answer is a very clear “no”.

Addendum:

The WakefieldWatch blog has also discussed the book “Callous Disregard” in “Who’s Callous Disregard”

Do you think vaccines are related to autism?

24 May

Do you think vaccines are related to autism? That is the question that the Today Show has posed in an online poll.

The Age of Autism has called for a Poll Mob via Twitter:

http://bit.ly/a69a4X Take NBC poll, do you think there is autism vaccine link. So far 54% yes.

Well, in the two hours since they posted that, the “yes” answer has gone from 54% to 44%.

If you have the time and the inclination, let them know what you think. Do you think vaccines are related to autism.

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.

New study: many vaccines at once OK for kids

24 May

A new study from Pediatrics has come to the conclusion that:

Timely vaccination during infancy has no adverse effect on neuropsychological outcomes 7 to 10 years later. These data may reassure parents who are concerned that children receive too many vaccines too soon

Lead researcher Michael J. Smith said:

Our study shows that there is only a downside to delaying vaccines, and that is an increased susceptibility to potentially deadly infectious diseases,

…

We hope these findings will encourage more parents to vaccinate according to the American Academy of Pediatrics schedule, and reassure them that they’re making a safe choice when they do so.

Lets hope so. Today is a great day in the forward momentum of the confidence in vaccines now that Andrew Wakefield has been struck off and this latest study can only add yet more weight that no vaccine, no vaccine ingredient and no vaccine schedule has _ever_ been shown to cause autism either directly or indirectly.

This is the first time that a study such as this has been carried out:

…nobody had studied whether getting several vaccinations in a short time could have negative consequences, for instance by overloading the immune system, as many parents believe, according to Smith. He found that receiving as many as 10 different shots — including flu and whooping cough — had no impact.

And a CDC spokesman said:

Parents that are considering delaying vaccination should realize that there aren’t any specific benefits, and that they are putting their child at risk, and not only their child but also the community,

An excellent point. The benefits of vaccination are not just personal but societal. Those who refuse to vaccinate not only risk the personal well being of their children but the society they choose to live in.

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.

Blogging IMFAR: Wrap-Up Notes

23 May

One of the things I wanted to do in blogging about IMFAR, was try to provide a bit of a wrap-up of my experience there in Philadelphia this year. Since it was my first time attending an IMFAR, and I really had no idea what to expect ahead of time, I figured it might be useful to jot down some overall notes retrospectively.

First and foremost, IMAR is a scientific meeting. There is no shortage of introduction to what is out there in current autism research. This began with Wednesday’s pre-meeting press conference. It was there, that the press would learn about several selected abstracts (apparently thought to be worthy of media attention): the University of Rochester’s (Dr. Susan Hyman) negative GFCF study results, the Kennedy Krieger Institute’s (Dr. Brian Freedman) debunking of the 80% divorce rate claim, and others such as, landmark genetic studies, infant sleep fMRI as potential early diagnostic tool in the future, and social/educational intervention strategies that demonstrate the importance of peer involvement. Each of the study authors presenting their work to the press, spent about 5-10 minutes giving the highlights and taking a few questions, but in reality, each presentation was barely a thumbnail sketch of what the research was about and perhaps a minute of discussion about potential real world significance of the findings. You can read more about the items that caught my attention in the press conference at Blogging IMFAR: Opening Press Conference and GFCF Diet Trial Results and Blogging IMFAR: Autism And Divorce Debunked, Among Others.

Following the day of the press conference, IMFAR was off and running, with full daily schedules of presentation sessions, and poster sessions running the majority of the day (one floor below where the presentation sessions were taking place). On one hand, I suppose the science presentations could seem fairly frustrating to many. Like the press conference, the oral sessions presentations are given on a fairly tight schedule, and often contain little more than an introduction, a few minutes of methodology discussion, a quick look at statistical results, and time for one or two questions – then it’s on to the next, which might even be something only very loosely related at times.

For a typical parent, I think it’s quite possible they’d find the whole format approaching “tedious-to-learning” much of the time, with only an occasionally very interesting or very well-presented piece of research. Don’t get me wrong, I wouldn’t want detract from the likely importance of researchers having an open venue to share ideas with each other, but for me, there are only so many shotgun presentations you can listen to, or posters you can look at in one day.

On the other hand, IMFAR is a place where it seems ridiculously easy to get the big picture quickly, and even talk with expert researchers in the field of autism science if you are so inclined. It’s hard not to catch the what of what’s currently taking place in autism research world, as it’s everywhere – in the program, in the posters, and in the discussions. As an example, if one wanted to learn what’s taking place in autism research that’s using brain imaging, whether looking at language response and differences in infant siblings of autistic children, or looking at the potential impact of some specific intervention on brain funtion, researchers studying just those kinds of things are at IMFAR presenting and discussing their research. From what I saw, one can attend the relevant presentations, and then visit with researchers later on – I saw this occur on several occasions, with researchers like Eric Courchesne (University of California, San Diego). “Accessibile” is word that is probably a pretty good way to sum up my general thoughts on the science at IMFAR. while the format can seem very dry, especially to someone like myself (who didn’t arrive with a specific scientific field of interest that I was dying to scout out), the science and the researchers do seem really accessible.

Which brings me to what I thought was an important impression of IMFAR. The scientists really do seem accessible – willing to spend time for those with quesitons, and willing to provide explanation and lay translation where appropriate. On the first full day at IMFAR, I have to admit that I really didn’t know where to start. How was I ever going to explore all the science, and then distill that down to something digestible in size, yet explanatory of the trends in autism science? I was so fortunate to have the opportunity to meet with Dr. David Mandell. Besides being a local Philadelphia researcher, he was the Scientific Program Chair for IMFAR this year. And I could not be more appreciative of the time he gave to me (and LBRB readers), in sitting down to explain the trends in autism research at IMFAR – and he’s probably one of the best possible people to see and understand those trends, as he read every one of nearly a thousand abstracts accepted at IMFAR this year. If you want the inside scoop on the science at IMFAR, as well as an opportunity to simply get to know the thoughtful Dr. Mandell a little better, it can be found at Blogging IMFAR: Excerpts Of An Interview With David Mandell, ScD.

Speaking of thoughtful autism researchers, while at IMFAR, I literally ran into (interrupting his cell phone conversation while on an escalator) Dr. Roy Richard Grinker, professor of anthropology and human sciences, autism epdemiologist, author of the book “Unstrange Minds”, and wouldn’t you know it, a jazz pianist and marathoner too! Dr. Grinker was gracious enough to sit down with me for coffee, and share a little more about why he was at IMFAR with LBRB readers. You can read the interview at Blogging IMFAR: Meet Roy Richard Grinker.

At this point in my notes, we’ve arrived at midday Friday. And it as midday Friday when I see what I consider the most interesting science. As a recipient of a travel/attendance grant (that partially funded my trip to IMFAR) from the Autism Science Foundation, I was also invited to attend their “Science and Sandwiches” luncheon. It might be tempting to think I was attracted simply for the free food, but the sad truth was, that I had eaten a very late breakfast and wasn’t even hungry at the time of the luncheon. During the “Science and Sandwiches” lunch, each of 6 pre-doctoral students presented an overview of their research plans. These are pre-doctoral students who applied, and in turn, the Autism Science Foundation selected, to fund their research directly. They all seemed fairly interesting and unique, ranging from researching social conversation rules among ASD kids and infant emotions measurement, to very specific mouse model genetics/pharmacological experiments, to epidemiology. Yes, epidemiology. It might seem surprising that a young autism science advocacy org like ASF, or anyone for that matter, would fund epidemiology. I can’t help but think that field is already maturing to some degree in the U.S. I thought to myself, other than potential minority underrepresenation, what kind of breakthroughs in scientific understanding could we really get from epidemiology in the U.S.? I mean, we already know that we’re probably finally very close to what is a pretty stable 1 in 100. What else is there?

That’s when we were introduced to Matthew Maenner. Maenner is a pre-doctoral student of the University of Wisconsin, Madison (working under the mentorship of Dr. Maureen Durkin), who proposed, what to me, looks like a very interesting take on autism epidemiology with his research titled, “Phenotypic Heterogeneity and Early Identification of ASD in the United States”. He asked the luncheon group (of what looked like about 60 attendees), about how many possible combinations of the individual DSM diagnostic criterion can result in an ASD diagnosis. You know, if one looks at all the possible permutations of: “(I) A total of six (or more) items from (A), (B), and (C ), with at least two from (A), and one each from (B) and (C )” and the criteria for Asperger’s and PDD-NOS from the DSM IV-R, how many many combinations are there? It turns out there are 616 (I think I wrote that down correctly). He had a fascinating cloud-graph-type illustration of this (there’s probably a good technical term for this), that looked like a spiral galaxy – the point being that diagnostic criteria steer categorization to a shared core, but at the same time, there are numerous arms extending in several directions. He explained how he intended to look at the CDC’s ADDM data to begin to answer questions about the basis for the landscape of real world diagnoses compared to the actual possibilities described within the diagnostic criteria. Like a fool, I assumed that the ADDM data, like much of published autism epidemiology, tended to be focused on fairly simple prevalence, even dichotomous in nature (Autistic – yes/no, Asperger’s – yes/no, PDD-NOS – yes/no, X percent of all ASD’s = Autistic Disorder, etc.). Also, like a fool, I asked about him about this with something to the effect of, “In assuming the CDC’s ADDM data doesn’t have the resolution to go beyond diagnosis results, and into the individual combinations of criteria that result in those diagnoses, how are you going to even look at answering that question your research is about?”. He politely responds, explaining that, in fact, the CDC’s ADDM data does have this resolution. My assumption is way wrong, and this is an “Aha!” moment for me. We have tons of what is probably pretty good data available from the CDC, and it seems, to me, that no one has looked at it in quite this way before now.

So here’s my take on this ASF-funded doctoral student’s proposed research – he may be digging into something much more descriptive and potentially useful to the biological and educational sciences with respect to autism spectrum disorders, than has been done so previously (that I am aware of). If there’s epidemiology that can quantitatively describe the distribution of characteristics that result in ASD diagnoses, biological, and even educational research may have a leg up on being meaningful. As an example, suppose that this epidemiology determines that a certain percentage of ASD diagnoses include selection of the C – 4. “persistent preoccupation with parts of objects”. With real numbers, biological research may have a starting point to evaluate associations of differences in brain structure or function with respect to this characteristic. With real numbers, perhaps the success of specific educational strategies (that take advantage of this specific knowledge) can be meaningfully evaluated with more individualized approaches. Here’s the bottom line as I see it: Matthew Maenner is taking a solid step towards building understanding of the variation that occurs in autism spectrum disorders. It’s possible, if not likely, that his work could contribute to entirely new and much more individualized directions in other autism research. The days of any notion of singularity in etiologic origin of autism are long gone (in favor of complex combinations of numerous factors). Here’s a researcher who, in my opinion, understands that and will take steps towards building real understanding by looking at that distribution of variation. It wouldn’t surprise me in the least if “Matthew Maenner” is a name associated with the more interesting and useful autism epidemiology in the future.

So there you have it. That was my couple of days at IMFAR: an early look at some of the “newsworthy” science, an opportunity to learn much more about current trends in autism research from a hard-working scientist (the IMFAR Scientific Program Chair, Dr. David Mandell), a chance to sit down and chat with a very thoughtful researcher and author (Dr. Roy Richard Grinker), as well as first-hand look at some new research direction in graduate programs. All in all, it was a pretty interesting couple of days.

I’d also like to take just a minute and thank the Autism Science Foundation for partially, yet generously funding my travel (as a parent who blogs) to IMFAR. I had complete freedom to check out and write about whatever I wanted to, and it wouldn’t have been possible without their financial assistance.

(Disclosure: my attendance at IMFAR was funded in part, by a travel grant from the Autism Science Foundation.)

Blogging IMFAR: Meet Roy Richard Grinker

22 May

I had a neat opportunity here at IMFAR. Last night, as I was standing on the long escalator that traverses 3 floors from the IMFAR convention area to the lobby below, I glanced backwards to peek at the person behind me who was having a pretty animated conversation on a cell phone. His name tag read, “Roy Grinker”.

He noticed the glance (which was probably more like a bit of a stare, not too inconspicuous I suppose), and politely paused his conversation long enough for me to interrupt, introduce myself, and invite him to coffee this morning. He accepted.

Most LBRB readers will know Dr. Grinker as the author of “Unstrange Minds” and as a professor of anthropology and human sciences at The George Washington University. He continues to conduct autism research, and he has a role (that we’ll learn a little more about in a minute) at IMFAR too.

He arrives to coffee right on time, and is every bit as friendly as he appears in the pictures that often accompany articles about him online. He sits down to chat with me, and LBRB readers, so…

Meet Roy Richard Grinker, PhD

LBRB: Is it correct to say that your interest in autism research is with epidemiology?

RRG: Yes, my focus has been on epidemiology, but also on doing qualitative research on how culture influences the prevalence and recognition and management of developmental disabilities.

LBRB: Tell us a little more about what you mean by how culture influences those things. Is that willingness to diagnose, etc.?

RRG: Well, we don’t know very much, right now, about autism in other places in the world. It’s, at this point, an assumption that the onset, the core symptoms, and the course is universal. We don’t know, because we don’t have data from other cultures. For example, let alone phenotypes, we don’t have prevalence data for any country in the entire continent of Africa, any country in South America, any country in Asia other than Japan (that includes south Asia), and basically, in the international realm of autism research, it’s wide open.

LBRB: So what specifically brings you to IMFAR?

RGG: I came to the meeting this time primarily to meet and talk with people from other countries, where we don’t know much autism. And we have people here from all over the world. The reason that I’m wearing this button…

[He’s wearing a button with the IMFAR name and logo that reads, “DIVERSITY AMBASSADOR”]

…is to be part of IMFAR diversity.

LBRB: International reach?

RRG: International reach. It’s not so much like the American “diversity”, it is international diversity. We reach out to all the different countries, and as an example, there’s one autism researcher here from Nigeria. With this, he knows that I’m interested in meeting him. He can feel comfortable to just walk up and talk to me, or have coffee. There are a lot of people here from other countries who may not know anyone here.

LBRB: So you’re here for that purpose?

RRG: Yes, and to talk with other people at the meeting.

LBRB: Let’s switch gears a little. What about “American diversity”? What’s your take on the science about that, at a meeting like this?

RRG: In terms of diversity, I’m really inspired, inspired because, when a diversity committee meeting was held, there were about sixty people there. Most them are actually in the U.S., working in the U.S., and are interested in the barriers to care, and the obstacles to services within minority communities.

LBRB: That sounds like it could be interesting in and of itself.

RRG: We know that the age of diagnosis for minorities in the United States is significantly higher than the average age of diagnosis for non-minorities, and that means that they’re getting services later.

LBRB: What does the research science say about this?

RRG: Research supports the premise, one, that outcomes are better if interventions are earlier, and two, epidemiologic data supports the findings that African-American and Latino children are diagnosed later, and receive fewer services. There are data (but not published data) that I’m aware of, that show that even Latino children who are insured, don’t always get services as frequently as others. It could be that they were referred, but don’t take advantage of them, or perhaps there are other structural barricades; like they have insurance, but they also have three jobs, or they live far away from the services. We really don’t understand what all the barriers to uptake of care are, in minority populations. One of the projects I’m working on now is an NIMH-funded project to look at early identification of autism in two communities where there are virtually no autism services delivered.

[Dr. Grinker did provide a little more detail about one research project in southwest Florida, among migrant worker families, as well as a project in South Africa, from where he’d recently returned].

LBRB: So these are your real research interests?

RRG: There are three strands to my research. One strand is this work I’m doing in southwest Florida and South Africa. The second strand is the continued work on the prevalence of autism in South Korea, and we hope to report the results soon there, it’s been a long study – nearly thirty thousand children (the denominator in the sample). The third strand is my book writing – I love to write books.

LBRB: Tell us more about “Unstrange Minds”.

RRG: It just came out this week in Portuguese (so it’s available in Portugal and Brazil), and it really means a lot to me to be able to provide a message that people find uplifting. The thing is, that sometimes when people talk about my book, they focus on the argument about epidemic. And I think that’s important, and I spent a lot of time in my book going through the various reasons why autism diagnoses have increased. But, for me the most important part of the book is that it doesn’t present having a child with autism (or relative with autism) as a tragedy, or something that’s horrible and devastating. Rather, it’s a life experience which is distinctive, and can be incredibly rewarding. I take that positive perspective. I’m invited to give talks, occasionally. Sometimes I’ll give a talk somewhere, and I’ll ask why they invited me. Frequently the answer is, “because you’re not angry”. There are plenty of people out there who give public presentations that have to do with their anger – the anger that the community is not answering their questions, the anger that the services aren’t there, anger that their theory of causation isn’t taken seriously. I guess some people just want to hear somebody who’s got a more positive perspective, without being a Pollyanna, and I think that’s what I offered in the book.  To me, that’s the most rewarding thing.

LBRB: Can you give a personal scoop to Left Brain/Right Brain Readers? What do you like to do in your free time? Do you have any hobbies?

RRG: I have two hobbies. Jazz piano – and I’ve played jazz piano since I was very young. I played throughout college and graduate school. I played alumni parties, that sort of stuff. And I actually still work with a really talented guy in Washington, I’m still, you know, “taking lessons”. I started when I was four, I didn’t start jazz at four, but I probably started jazz when I was about 9 or 10. My parents’ apartment building was down the street from a jazz club.

[Grinker went on to explain that he was able to spend a little time at that jazz club (back in that day), and although I didn’t take down all of the names, he quickly rattled through a list of jazz greats (such as Dizzy Gillespie) he was able to meet in his youth].

What about hobby number two? He just finished (and finished well in) the Boston Marathon.

(Disclosure: my attendance at IMFAR was funded in part, by a travel grant from the Autism Science Foundation.)

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