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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 His initial paper suggesting this link has been retracted by The Lancet, and the General Medical Council ruled that he was dishonest in his research efforts and showed a callous disregard for his subjects.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.

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?

It’s official, Dr. Krigsman to leave Thoughtful House

20 Feb

Thoughtful House, the clinic and research center founded by Dr. Andrew Wakefield, is losing both Dr. Wakefield and, now, Gastroenterologist Dr. Arthur Krigsman.

From a Yahoo group (as posted by Mike Stanton in the comments on LeftBrainRightBrain):

Re: Dr. Krigsman

Dr. Krigsman’s decision to relocate his clinical practice to a facility outside Thought House reflects his belief that the complexities inherent in a referral-based practice can be best addressed by his working independently. We will continue to refer patients for GI evaluations when appropriate, and we look forward to continuing to work with Dr. Krigsman on research projects. We are grateful to Dr. Krigsman for his dedication to Thoughtful House and for the work he does on behalf of the children we serve.

Just to be clear, this is official.

Jane

Was Dr. Wakefield the complainant in his own GMC case?

19 Feb

Pop quiz: of these two people, who was the first to request that the General Medical Council (GMC) investigate Dr. Andrew Wakefield

a) Brian Deer
b) Dr. Andrew Wakefield?

Ah–trick question! Brian Deer didn’t ask the GMC to investigate Dr. Wakefield. Mr. Deer offered and gave information to the GMC, but, it turns out, only after Dr. Wakefield called for an investigation.

Let me start by saying I hesitated to publish this post as it will be just make it seem like there is a real controversy here. There isn’t. But after noting that the addendum to the Press Complaints Commission (PCC) complaint filed against Brian Deer included citations to LeftBrainRightBrain I decided to check into the “complainant” question.

Here’s the PCC complaint. Here’s the addendum.

There is a long “forensic analysis” argument to make the case that supposedly Brian Deer was the complainant. This struck me odd. Why do a “forensic” argument, unless you don’t have substantial proof.

In the matter of Dr Wakefield and the GMC, and based upon forensic analysis of all the available documentary evidence, one is entitled to believe that Mr. Deer was the original and only substantive complainant to the GMC, whether or not he was the ‘Complainant’ who instructed the legal prosecution of the case (which was the GMC through its lawyers Field Fisher Waterhouse).

OK, Brian Deer was the complainant, whether or not he was the ‘Complainant’. Everyone got that? Clear as mud?

It wasn’t to me, so I contacted the General Medical Council to ask a simple question:

I am sorry to bother you, but I was hoping you could help with a question. Is it public knowledge whether Mr. Brian Deer was a “complainant” for the Wakefield case? Was there any “complainant” or was this case brought forward by the GMC itself?

I received a very simple answer:

Dear Sir/Madam

The General Medical Council can act in response to complaints about doctors but we do not require someone to make a formal complaint to us before we can act. We can in fact initiate action against doctors of our own volition. This enables us to launch an investigation in response to publicly expressed concerns about the conduct of doctors, whether or not those concerns have been directly and formally referred to us.

The case against Dr Wakefield, Professor Walker-Smith and Professor Murch was brought by the GMC there was no complainant in this case.

I hope you find this information helpful and if you have any further queries relating to this case please do not hesitate to contact me.

When I asked if I could make this public, I was informed that this information is already public. Yes, I forgot the fact that Brian Deer had a letter from the GMC’s attorneys already. That is from May, 2005. I guess this whole, “he’s a complainant even if he isn’t a Complainant” thing has been going on for some time.

The “forensic analysis” seems to rest on the fact that Brian Deer has communicated with the GMC. There doesn’t seem to be any actual complaint filed, but, as we are told:

But what Deer does not reveal is that on February 25, 2004, three days after his article attacking Wakefield had been published in the Sunday Times, he had written to the GMC…

Yes, according to this timeline, Brian Deer published his article and then contacted the GMC 3 days later. It is characterized as a “spontaneous” communication in the complaint. As in, Brian Deer just out of the blue decided he needed to contact the GMC.

Dr. Wakefield left out an important part of the timeline. Namely, his own call for a GMC investigation. Here is a timeline:

February 22, 2004, Brian Deer’s article, Revealed: MMR research scandal is published.

February 23, 2004: Dr Wakefield states, “I’d welcome inquiry

“Serious allegations have been made against me in relation to the provision of clinical care for children with autism and bowel disease, and the reporting of their disease. It has been proposed that my role in this matter should be investigated by the GMC. I not only welcome this, I insist on it and I will be making contact with the GMC personally.”

Two days later, on February 25, 2004: Brian Deer emails the GMC. This appears to be the first contact between Mr. Deer and the GMC. According to the excerpt in the PCC complaint filed by Dr. Wakefield:

email from Brian Deer to Tim Cox-Brown, Caseworker GMC, 12.16 pm 2.25.04. This is a sixpage letter concluding with the statement “As a matter of public duty, I write to offer this outline of my main findings, and to offer the GMC my fullest cooperation in getting to the bottom of these matters”.

Which, according to Dr. Wakefield, makes Brian Deer the “complainant” in the GMC hearing:

This reads as a spontaneous and intentional contact with the GMC for the purpose of requesting to put before them the substance of his complaint and in fact, doing so i.e. making a complaint.

Spontaneous? I guess if you leave out critical details like Dr. Wakefield’s own call for investigation. As I titled the post, couldn’t one say that Dr. Wakefield is the complainant? After all, it is Dr. Wakefield who appears to have called for the investigation.

Dr. Krigsman “steps down” from position at Thoughtful House?

18 Feb

In an article in the Times Online, the departure of Dr. Wakefield from Thoughtful House is confirmed, but also a statement is made:

It has also emerged that Arthur Krigsman, director of the gastroenterology clinic at Thoughtful House, has stepped down in recent weeks. The departure is not thought to be directly related to Dr Wakefield’s situation

Dr. Krigsman is still listed on the Thoughtful House website, where he is still listed as director of the gastroenterology clinic.

Dr. Krigsman is the director of the gastroenterology clinic at Thoughtful House Center for Children in Austin, Texas.

I am unclear on whether “stepping down” means he is still with Thoughtful House but not as director, or whether he has left Thoughtful House altogether.

Dr. Krigsman is the lead author on a paper which came out recently purporting to support Dr. Wakefield’s research.

Andrew Wakefield Resigns from Thoughtful House?

18 Feb

According to several anti-vax Yahoo news groups, Andrew Wakefield has resigned from Thoughtful House.

This is apparently the Thoughtful House statement:

The needs of the children we serve must always come first. All of us at Thoughtful House are grateful to Dr. Wakefield for the valuable work he has done here. We fully support his decision to leave Thoughtful House in order to make sure that the controversy surrounding the recent findings of the General Medical Council does not interfere with the important work that our dedicated team of clinicians and researchers is doing on behalf of children with autism and their families. All of us at Thoughtful House continue to fight every day for the recovery of children with developmental disorders. We will continue to do our very best to accomplish our mission by combining the most up-to-date treatments and important clinical research that will help to shape the understanding of these conditions that are affecting an ever-increasing number of children worldwide.

I’ve left a question mark ove this as there’s no official word of this on the Thoughtful House website and Andrew Wakefield is still listed amongst its staff.

Jim Carrey Jenny McCarthy Definitely not anti-vaccine

6 Feb

In the recent statement released by Jim Carrey and Jenny McCarthy regarding Andrew Wakefield, the twosome made a number of references that clear up once and for all how they feel about vaccines. Because as we all know they’re not anti-vaccine.

Dr. Andrew Wakefield is being discredited to prevent an historic study from being published that for the first time looks at vaccinated versus unvaccinated primates and compares health outcomes, with potentially devastating consequences for vaccine makers…

Dr. Wakefield and parents of children with autism around the world are being subjected to a remarkable media campaign engineered by vaccine manufacturers…

The retraction from The Lancet was a response to a ruling from England’s General Medical Council, a kangaroo court where public health officials in the pocket of vaccine makers…

The fallout from the study for vaccine makers and public health officials could be severe. Having denied the
possibility of the vaccine-autism connection for so long while profiting immensely from a recent boom in vaccine sales around the world, it’s no surprise that they would seek to repress this important work.

No, definitely not anti-vaccine.

Is Wakefield being shut up, or are Jenny and Jim trying to get publicity for his research?

5 Feb

In a public statement, Jenny McCarthy and Jim Carrey claim that “Dr. Andrew Wakefield is being discredited to prevent an historic study from being published”. Readers of LeftBrainRightBrain are already well aware that Dr. Andrew Wakefield was recently found to be “dishonest” and to have acted in a manner against the clinical interests of the children who were his research subjects. This recent statement is in support of the now discredited doctor.

Or, is it? A cynical mind might consider that this is a public relations ploy to get Dr. Wakefield’s current research in front of the media. His last paper was much hyped by Jenny McCarthy’s organization, but got little if any actual press coverage. But now, with the media focused on Dr. Wakefield, what better time to promote his research in hopes of getting some play in the media?

Ms. McCarthy and Mr. Carrey are prominent members of Generation Rescue (“Jenny McCarthy and Jim Carrey’s Autism Organization”) and have posted their statement on the Generation Rescue website with the full version on the blog sponsored by Generation Rescue, the Age of Autism.

This reader is somewhat amazed at the language used and the ignorance of the history of the General Medical Counsel proceeding that Ms. McCarthy and Mr. Carrey have shown.

The language puts the team well into the world conspiracy-theory:

It is our most sincere belief that Dr. Wakefield and parents of children with autism around the world are being subjected to a remarkable media campaign engineered by vaccine manufacturers reporting on the retraction of a paper published in The Lancet in 1998 by Dr. Wakefield and his colleagues

We are to believe that the news reporting on the retraction of the paper in The Lancet is orchestrated by vaccine manufacturers. That’s worth considering a moment–two actors, people who depend on their public image for their livelihood–are claiming that the reporting on a major news event is “engineered by vaccine manufacturers”.

The fact is that Dr. Wakefield thrust himself into the limelight with a press conference to publicize the paper. This and the fact that he has kept himself in the public’s eye for 12 years appears to have been lost on the McCarthy/Carrey team. After over a decade of promoting his research well beyond its importance or scientific merit, of course the media would take to the story that Dr. Wakefield had been found guilty of misconduct and that his paper had been retracted.

If there is any doubt as the conspiracy-theory theme of the statement, phrases like “Kangaroo court” and “in the pocket of vaccine makers” should put that to rest:

The retraction from The Lancet was a response to a ruling from England’s General Medical Council, a kangaroo court where public health officials in the pocket of vaccine makers served as judge and jury.

The article goes on:

Despite rampant misreporting, Dr. Wakefield’s original paper regarding 12 children with severe bowel disease and autism never rendered any judgment whatsoever on whether or not vaccines cause autism, and The Lancet’s retraction gets us no closer to understanding this complex issue.

This is a very strange statement to have made by representatives of Generation Rescue. Generation Rescue states on their own website, in reference to Dr. Wakefield’s paper in The Lancet, “”This study demonstrates that the MMR vaccine triggered autistic behaviors and inflammatory bowel disease in autistic children”.

Much more to the point, the press release for Dr. Wakefield’s press conference on the release of his study in The Lancet states that “Their [Wakefield et. al] paper, to be published in The Lancet 28 February, suggests that the onset of behavioural symptoms was associated with MMR vaccination”

If the defense now is that there is a difference between “proven” and “associated with” in the minds of the public, the importance of that is lost on me. Dr. Wakefield himself put the idea in the public’s mind that the MMR was causing autism.

In a video interview about his 1998 study, Dr. Wakefield stated that the link was not proven. However, he went on to claim that the “risk of this particular syndrome developing is related to the combine vaccine”:

Again, this was very contentious and you would not get consensus from all members of the group on this, but that is my feeling, that the, the risk of this particular syndrome developing is related to the combined vaccine, the MMR, rather than the single vaccines.

If there is rampant misreporting of the notion that Dr. Wakefield’s study in The Lancet promoted the idea that vaccines cause autism, then it is the fault of Jenny and Jim’s own organization, together with Dr. Wakefield himself.

Much of the trouble resulting from Dr. Wakefield’s work (and by that I mean trouble caused to the world and the autism communities in particular, not trouble to Dr. Wakefield), stems from Dr. Wakefield overplaying the importance or the quality of his research. Even had the study been done as claimed in the publication, it was not a very strong study. It has been reported that four referees recommended rejecting the paper before publication. I don’t know the policy at The Lancet, but often 2 or 3 referees total are used to screen a paper for a journal.

Those who forget history are doomed to repeat it. In this case, overplaying the importance of research well beyond its scientific merit. In their statement, Jenny McCarthy and Jim Carrey promote Dr. Wakefield’s ongoing research as though it is so earth shattering that it must be stopped at all costs. They discuss a series of studies Dr. Wakefield’s new group is undertaking. This research has been discussed by Medical Researcher David Gorski in an article Monkey business in autism research.

We are to believe that there is a media campaign afoot to keep Dr. Wakefield from making his new research public. In the internet age, there is no way to keep information from the public. Dr. Wakefield and his colleagues are even editors of a new pseudo-journal for autism research.

At no point to Ms. McCarthy and Mr. Carrey address the ethical violations that Dr. Wakefield was found guilty of. No mention of whether it is appropriate for medical researchers to perform invasive procedures on disabled children when there is no clinical reason to do so.

In other words, Ms. McCarthy and Mr. Carrey never actually defend Dr. Wakefield for his actions. They never address the serious ethical lapses found proved by the General Medical Counsel.

I am left thinking that this is in reality a pre-release promotional event to get press coverage for Dr. Wakefield’s upcoming paper. The study is “on the brink” of being published. In other words, it is likely already in-press. The faux outrage that his work is being suppressed in light of this is painful to read.

With the facts against them Dr. Wakefield’s supporters appeal to emotion

3 Feb

I should stop being shocked and amazed at how little groups like the Age of Autism blog think of their readership. Sorry to put it so bluntly, but it is pretty clear that they expect us all to just read what they have to say and never go to the original sources and think for ourselves.

Case in point, the GMC hearing on Dr. Andrew Wakefield. Dr. Wakefield was guilty of ethical violations in the treatment of his disabled patients. Not once, not twice but many many times. But you wouldn’t know that to read some of the reports on the blogs and even a couple in newspapers.

We have the NAA SafeMinds and TACA telling us all about how bad this ruling is. We have been told that there was “false testimony”.

OK, take a look at the actual charges. Just for a moment. Here are a few examples

1) Dr. Wakefield took money from the Legal Aid Board (LAB) for procedures paid by the NHS. He then diverted some of the LAB money to other projects.

2) Dr. Wakefield got ethical permission to do his study in December 1996, only on patients enrolled after that date. However, he had already started research on children. Here are two examples:

Child 2 had an MRI, colonoscopy and lumbar puncture in September of 1996.

Child 1 was also a research subject without ethical approval. Tests were performed which were not in the clinical interests of the child.

3) For people who promote the myth that “the only thing he did was start early”, note that Dr. Wakefield’s team did invasive tests that were not called for. For example:

Child 3 was also a research subject without ethical approval, having started before the approval. He underwent a lumbar puncture even though: “The Panel has taken into account the fact that there is no evidence in Child 3’s clinical notes to indicate that a lumbar puncture was required.”

Was this the result of some “false testimony? According to the GMC ruling, experts on both sides stated that the lumbar puncture was not clinically indicated.

Experts on both sides, Professor Rutter and Dr Thomas both considered that such a test was not clinically indicated.

Dr. Thomas is not accused by the defenders of Wakefield as “giving false testimony”.

The above are only a few of the examples of clear misconduct on the part of Dr. Wakefield.

How many times must a man be found guilty of not doing what was in his patients’ clinical interests before we are allowed to consider him as, well, someone who doesn’t always put his patient’s clinical interests first?

Kim Stagliano has taken to the Huffington Post with “The Censorship of Autism Treatment“. No mention of the actual charges. No mention of the fact that Andrew Wakefield was guilty. No mention of the fact that Andrew Wakefield’s research efforts for the past 12 years have centered on repairing his own damaged reputation, not on autism treatment.

Can you find a single mention of the word “ethics” in her post? How about any comment about the actual charges levied against Dr. Wakefield?

You know you are in trouble just with the title from this story: MMR doc’s just guilty of caring . At least that article makes one clear statement:

It [the GMC ruling] focused on the methods of research used, some of which were undoubtedly questionable, but which were performed in the name of finding solace for desperate parents convinced their children had changed for ever following their one-size-fits-all MMR injection.

Yes, you can be unethical if you are “finding solace for desperate parents”.

A blog post by the National Autism Association stated:

“Many parents of children with autism view the GMC investigation as little more than character assassination of a physician brave enough to investigate controversial issues”

Well, not this parent. Anyone who paints the GMC investigation as “character assassination” didn’t read the ruling. Seriously, trying to dismiss this fact-filled ruling as “character assassination” is just plain bizarre.

another post comments, discussing the work Dr. Wakefield’s team performed on his study subjects:

the procedures involved were routine

and

No children were harmed and no parent or guardian has complained about the care these three men provided.

Lumbar punctures are hardly “routine”. Further, there is no reason to do them if not clinically indicated. Colonoscopies are not routine, especially in patients whose symptoms don’t warrant them. Say, as in Child 1.

One child suffered a perforated bowel (in 12 places!). His family won a lawsuit against the Royal Free hospital.

High Court papers alleged that the colonoscopy procedure performed on Jack in 1998 was ‘not clinically indicated or justified’. They also claimed the ‘principal reason’ for the surgery was to further research into links between autism and bowel conditions rather than Jack’s clinical needs.

How does that not count as not “harmed”? Is it because he wasn’t one of the original 12 from the study in The Lancet?

The behavior of the Wakefield supporters is totally predictable. They have no science. They have no first (or second) tier researchers. They rely heavily on Dr. Wakefield. Who else has the perceived stature of Dr. Wakefield for them? When Brian Deer broke the story that Dr. Wakefield may have “fixed” data in his study last year, there was an immediate reaction from the Wakefield supporters: give him faux awards! Make him the keynote speaker at their conventions!

For the past year the message has been “Dr. Wakefield has not been discredited”. They’ve lost that now.

We’ve been warned that they are bringing out their big guns. Yes, David Kirby will blog about this on the Huffington Post. With apologies to Mr. Kirby, but when he’s their “ace in the hole”, you know they don’t have much.

As I finished this, David Kirby came up with his post: “The Lancet Retraction Changes Nothing”. Joining in the style of the times, Mr. Kirby also ignores the actual GMC ruling. Nothing that actually defends Dr. Wakefield against the real charges.

Seriously, go read for yourself. It’s David Kirby with his usual talking points and straw men.

I hope David Kirby is wrong. I hope that things have changed. I hope that the future is a world where the loudest voices in the autism communities fight for a better life for autistics, rather than for a political goal of recognition for bad science, badly done.

I hope.

Wakefield’s Inquisition: Abuse of the legal system and media by anti-vaccine doctor

29 Jan

As the GMC approaches a verdict on the misconduct of Andrew Wakefield, anti-vaccine sources are engaged in a concerted effort to make the “doctor” into a martyr rather than a failed researcher. It is vital to ensure that the general public is not in any way lulled into sympathy for the “doctor”.  In my judgment, the most important point to drive home is that, while Wakefield and associates play up the image of the “doctor” being persecuted for his ideas, he is the one who has persistently acted to suppress any discussion not entirely in his favor.  To that end, I have compiled the following list, complete to the best of my ability, of recorded frivolous lawsuits, libels, complaints and harassment by Wakefield and his immediate associates against his numerous critics.

3 October 1996: Wakefield files a complaint with the Broadcasting Standards Commission over a broadcast critical of his claims that MMR was associated with Crohn’s disease.

1998-2003: Nick Chadwick withholds negative results suppressed by Wakefield from the public, apparently as required while litigation was ongoing.

February 2002: Wakefield files or threatens to file complaints to  the GMC against critical colleagues. One formal complaint involved a statement made in 1997. He reportedly told government chief medical health officer Sir Liam Donaldson: “It has come to my attention that you have sought details of our studies from the ethical practices committee of the Royal Free NHS trust. I infer from this that faced with an increasingly compelling scientific case against the MMR vaccine you are seeking to discredit the scientists involved. Your attempts to interfere in the scientific process are unacceptable. Not only do you have no right whatsoever to this information without permission, but also your action has had an indirect but nonetheless profound effect upon our ability to help these desperately ill children. I am seeking advice prior to taking this issue up with the General Medical Council.

27 February 2004: The Sunday Times and the Lancet a letter from Wakefield’s attorneys denying Feb. 20 reports that Wakefield failed to disclose conflicts of interest related to the 1998 paper, with the stated purpose “to invite you to agree promptly to publish a full apology to our client”.

November 2004: Wakefield files a lawsuit against Brian Deer and Channel 4 for libel. At around the same time, his attorneys send a letter falsely alleging that Deer “has made a formal statutory complaint to the General Medical Council against Mr Wakefield and others concerning these matters.” The letter also refers prominently to “a current Press Complaints Commission” of Brian Deer, though no such complaint is on record. The claim of a complaint by Deer is taken up by Carol Stott, and continues to circulate to the present despite repeated denials by Deer and the GMC. Curiously, a February 27, 2004 BBC article stated, “The General Medical Council is now carrying out an investigation into Dr Andrew Wakefield, the doctor who led the 1998 study.” This statement, coming only five days after Deer’s first report was published, not only weakens any suggestion that Deer directly initiated the investigation, but raises the possibility that some form of GMC inquiry on Wakefield (conceivably rising from his own past complaints against others) was under way even before Deer’s allegations were made public.

March-October 2005: Wakefield’s attorneys seek to freeze further action in the libel suit against Deer. Justice Eady “The claim form was issued on 31st March but only served on 22nd June 2005. Thereafter, it seems, the particulars of claim were served with some reluctance following prompting by the Defendants and an order of Master Rose on 27th July of this year. They eventually appeared on 10th August. There has thus apparently been a rather relaxed and dilatory approach towards litigation of a kind which is supposed to achieve vindication of reputation.” He further questions Wakefield’s motives in the lawsuit as a whole: “Claimant wished to extract whatever advantage he could from the existence of the proceedings while not wishing to progress them or to give the Defendants an opportunity of meeting the claims.”

31 January 2005: Wakefield files a second lawsuit against Deer, over content of briandeer.com, and a third against the Sunday Times and Channel 4.

29  June 2005: Cambridge Evening News receives a letter from Wakefield’s attorneys over a citation of a Brian Deer report (worded as “the article alleged…”), calling on the paper to “publish an apology”.

July 2007: Martin J. Walker initiates smears against Brian Deer.  Claims include allegation that Deer initiated GMC hearings against Wakefield.  Though Wakefield condemns Walker on 3 November 2008, Deer reports a December 2009 newsletter for Wakefield’s “network” requesting donations to pay an additional 5,500 pounds to Walker.

6 February 2009: A letter sent to Brian Deer requests that an article (published 2 days later) presenting evidence that Wakefield case histories in 1998 paper not be published: “(Y)ou appear to be considering publishing an account which covers much of the same material as is being considered by the Panel. Publication of your allegations and account at this time will give rise to serious risk that the GMC process will be prejudiced and the faimess of the hearing compromised. You also know that, at this juncture in the GMC process it would be inappropriate for Dr Wakefield to give a detailed response to you. He has denied t he allegations and gave a detailed response  over many days to the GMC Panel.”

13 March 2009: Andrew Wakefield files complaint with Press Complaint Commission, over Feb. 8 story. The key allegations are that Deer “knew that these allegations were either false or misleading, based on incomplete records – or, at the very least, open to question” and that “it was he who brought the original complaint. He therefore has an undeclared interest in its conclusions.

20 March 2009: Andrew Wakefield files addendum to complaint over Brian Deer’s statement, “I did not lay the initial complaint against Wakefield. This allegation is a fabrication, albeit rather a small one in the MMR issue.”  Bizarrely, Wakefield presents truth of his own allegation as immaterial: “(W)hether or not Mr. Deer initiated the GMC investigation as ‘complainant’ in his letter dated Feb. 25, 2004, or acted as an ‘informant’ in an investigation already begun by the GMC, he did not disclose his own direct participation in the GMC investigation in his most recent accounts in the Sunday Times, intending to give the public the misimpression that he was acting as a neutral and disinterested reporter.“

3 July 2009: Thoughtful House release, Press Complaints Commission Orders Sunday Times to Remove MMR journalist’s Stories on Dr. Wakefield from Paper’s Web Site”, alleges, The PCC decision today appears to indicate there are questions about the accuracy of the Deer stories,”  despite implicit admission in Feb. 6 that Deer reported only what had been alleged by others.

9 July 2009: Second press release, “Sunday Times Defies Press Complaints Commission”, alleges that the Sunday Times has now defied the PCC by putting the stories back online after complaining Dr. Wakefield publicly announced the PCC’s directive.”

8 September 2009: NAA press releaseOffit’s Failure to Disclose Jeopardizes Swine Flu Vaccine Program” is carried by Reuters.  The stated location of “Austin, Texas”, in contrast to NAA headquarters location of Nixa, Missouri, strongly suggests that Wakefield and/or Thoughtful House are the creators of the release. The release defends Wakefield, attacks Paul Offit, and by extension attacks Dateline broadcast in which Wakefield was portrayed critically.  It includes the claim, first made in a hoax published by Age of Autism, that Offit’s share of a royalty sale for the Rotateq vaccine to Merck is a minimum of $29 million and may approach $50 million.” Wakefield’s use of a third party to promote the hoax in September raises the possibility that he significantly contributed to the hoax itself, in which figures were inflated through an inapplicable 2007 CHOP policy and documents from a patent which preceded the one which was sold.

27 January 2009: On the day before the GMC released its first findings against Wakefield, a 104-page complaint is filed with the GMC by multiple or.  The most straightforward and prominently publicized claim is that Drs. Horton, Salisbury, Zuckerman, Pegg, and Rutter “gave false statements”. Obviously prepared long in advance, this complaint can be presumed without merit, and could easily be used as a basis for countersuits. Its greatest significance will almost certainly be as yet another obstacle to timely disclosures of findings and to further legal actions, of which US disciplinary proceedings against Wakefield and litigation against him and Thoughtful House are the most threatening to the “doctor’s” interests.

In hindsight, there are many things that were “off” about Wakefield. He relied (perhaps not wholly by his own choice) on an image of a “young maverick”, though he was in fact a well-established but not distinguished researcher with dozens of previous publications (none of which is listed in a Thoughtful House bibliography!). He earned his doctorate in 1981, at the strikingly early age of 25, yet PubMed records only 3 papers of his published before 1991. He held several formal titles at Royal Free, yet his contract stipulated that he have “no involvement in the clinical management of patients.” His previous efforts to link MMR with Crohn’s disease came very close to drawing charges of fraud (see review )  His publications in the affair show a shifting roster of coauthors and repeated changes in publishing journals. I find the path of his career (particularly his early display of apparent talent followed by surprising early difficulties) strikingly like that of artists who go on to commit forgery.

The bottom line is that the only thing necessary to stop Wakefield was for those who knew the most about his conduct to speak up before his spurious claims became cultural currency.  The best way to ensure that similar (or even worse) offenders are exposed before they do harm is to reform the courts, so that litigation is NEVER allowed to trump timely criticism among scientific professionals.