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Wakefield’s research: from The Lancet to Medical Veritas?

9 Feb

The Lancet is one of the medical community’s premier journals. As such, tetting a paper into such a journal is a big accomplishment for any medical researcher. When Dr. Andrew Wakefield chose to submit his 1998 study to The Lancet, it is likely he wanted to put it in as high a profile journal as possible. One can speculate how the Andrew Wakefield of 1998 would have viewed publishing his work in Medical Veritas, a newer journal which, well, is not generally highly regarded. Somehow, this observer thinks Dr. Wakefield would not have welcomed a suggestion to submit to Medical Veritas had it existed at the time.

Frequent readers to LeftBrainRightBrain, or most places autism is discussed for that matter, will know that Dr. Wakefield’s study has been retracted by the editors at The Lancet.

Frequent readers here may be also familiar with the magazine, Medical Veritas as it has been the home for a number of questionable autism/vaccine articles. If you aren’t familiar with Medical Veritas, let’s just say that Medical Veritas is not in the same league as the Lancet, to put it mildly.

Why bring these two very disparate journals into this blog post? Well, Medical Veritas has offered to republish Dr. Wakefield’s study:

So with zero confidence in The Lancet, Dr. Horton, those paying his salary, and those criticizing him for his actions, Medical Veritas editors are inviting Dr. Wakefield to re-publish his controversial paper in their next issue.

Wow. What a strange move, and on so many fronts. The most obvious being–what sort of standards does Medical Veritas show when it is willing to publish a paper that has been found to be so fatally flawed? It is really hard to consider that this offer was serious. The Royal Free Hospital, Dr. Wakefield’s employer, assigned the copyright to his paper to The Lancet. The study, even retracted, likely remains the property of The Lancet. Also, it isn’t Dr. Wakefield’s right to decide for his coauthors whether to submit to another journal.

The strangeness goes on and on. Let me just pick out one more oddity of this offer by “the editors” of Medical Veritas. Dr. Wakefield is one of the editors. Yes, one read is that Dr. Wakefield has basically invited himself to reprint “his” paper in Medical Veritas.

Just when you thought the story of the Wakefied/Lancet paper couldn’t get stranger.

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.

RETRACTED

4 Feb

We’ve had a lot of discussion on Dr. Wakefield and his retracted paper. But seeing the actual paper with big red letters saying “RETRACTED” was something I was waiting for. I thought others might like to see it as well.

So, here is the first page of Dr. Wakefield’s article as it appears now.

Retracted

This paper has caused so much harm in the autism communities. Too bad it won’t go to rest quietly.

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.

Lancet retracts Wakefield paper

2 Feb

Following the judgment of the UK General Medical Council’s Fitness to Practise Panel on Jan 28, 2010, it has become clear that several elements of the 1998 paper by Wakefield et al1 are incorrect, contrary to the findings of an earlier investigation.2 In particular, the claims in the original paper that children were “consecutively referred” and that investigations were “approved” by the local ethics committee have been proven to be false. Therefore we fully retract this paper from the published record.

Source.

Andrew Wakefield – What happens next?

31 Jan

So Andrew Wakefield has been found proved guilty of the vast majority of the accusations against him and been found dishonest and acting irresponsibly with both the children under his ‘care’ and the not inconsiderable sums of public money he had occassion to recieve and ‘manage’.

None of this would have come as a surprise to anyone who had taken the time to carefully read Brian Deer’s thorough works on the subject. That it was a major shock to the John Stone’s and Martin Walker’s of this world tells you more about their capacity for self delusion than how shocking the findings regarding Wakefield were.

So whats next for Andrew Wakefield? Now that the official findings have been made public, the GMC must consider:

…whether those facts found proved or admitted, were insufficient to amount to a finding of serious professional misconduct. The Panel concluded that these findings, which include those of dishonesty and misleading conduct, would not be insufficient to support a finding of serious professional misconduct.

Yeah, pointless double speak aside (would not be insufficient??) the panel are basically saying that Andrew Wakefield’s behaviour could easily constitute serious professional misconduct.

So what can result from that? Brian Deer, writing in the Times Online provides a possible answer:

Lawyers have told me that any one of the more than 30 charges that were proved against Wakefield would typically lead to his being struck off. His days as a medical practitioner will soon be history…

And so what is the next step?

In the next session, commencing 7 April 2010, the Panel, under Rule 28, will hear evidence to be adduced and submissions from prosecution counsel then Dr Wakefield’s own counsel as to whether the facts as found proved do amount to
serious professional misconduct, and if so, what sanction, if any, should be imposed on his registration.

From April 7th then Andrew Wakefield will be fighting for the right to refer to himself and be referred to by others as ‘Doctor’. That will be a victory for anyone concerned with patient care in the UK.

Oh Deer…

31 Jan

Apart from people who have boosted Andrew Wakefield’s discredited and dishonest wild theories about MMR vaccine over the years (Lucy Johnston, Melanie Phillips, Fiona Phillips et al), one journalist will forever be associated with Wakefield: Brian Deer.

Brian Deer is no shill for the pharmaceutical industry. Back in the 90s he tackled the harms of Septrin (a widely prescribed antibiotic), and later went on to tackle Merck over Vioxx. Brian has pursued Wakefield in the same way as he carried out his investigations of “big pharma”. Not that this has protected him from allegations about his motivations, his detractors being unable to accept that a journalist might investigate the Wakefield hoax without help from “big pharma” or a conspiring UK government. Melanie Phillips alleged he was part of a witch hunt, although she was incorrect. Last year, the increasing lunatic fringe of the UK’s anti-vaccine movement alleged Brian’s sexuality was the reason for his investigative reporting:

By all accounts a gay man and therefore unlikely ever to have to face the multiple vaccine risk agonised over by parents from around the world in relation to their children, Brian Deer has made it his business to portray the parents of these autistic vaccine damaged children as deluded mendacious chancers.

We now know that the man with callous disregard for children’s welfare was the man they have supported; Andrew Wakefield. He had a financial conflict of interest. He treated children unethically. He exposed children to “high-risk” procedures without ethical approval and against their best clinical interests [Here’s an example of what can happen].

Brian was also subjected to a libel action brought against him by Wakefield, the current toy of the rich (Wakefield leads a comfortable life in Texas now, working at a quack treatment centre for £170,000 a year). In an article at the Sunday Times today, Deer talks of the benefits of exposing Wakefield.

Wakefield will probably never admit to his errors. But exposing his methods has been worthwhile, according to medical sources.

“People can’t understand whether a scientific study is valid or invalid,” said a senior doctor who had watched vaccination rates slump, even in the face of endless research on MMR safety. “But they can understand ‘right’ and ‘wrong’, and they can understand ‘honest’ and ‘dishonest’.”

Lawyers have told me that any one of the more than 30 charges that were proved against Wakefield would typically lead to his being struck off. His days as a medical practitioner will soon be history. A further hearing will determine whether “serious professional misconduct” was committed.

Yet more troubling for Wakefield’s future are his prospects for research, or at least of getting it published.

“Any journal to which a researcher shown to be dishonest submitted a paper would reject it,” said Richard Smith, former editor of the British Medical Journal, this weekend. “They would say, ‘This man can’t be trusted’. His career as a researcher is effectively over.”

On the latter point, I’m not so sure. His days as a real researcher are over, but he and his friends already have a plan to tackle that obstacle.

Brian Deer in the Sunday Times on the GMC decisions

31 Jan

I had a strong feeling that an article by Brian Deer would appear in today’s Sunday Times. Brian Deer has followed the story of Dr. Andrew Wakefield closer than anyone, uncovering much of what has now brought the doctor one step away from being struck off the register in the U.K.. So, I was not surprised when I found ‘Callous, unethical and dishonest’: Dr Andrew Wakefield on the Sunday Times’ website.

The article describes the events as the GMC decision was read out. Brian Deer was there, Andrew Wakefield was not.

Dr. Wakefield was found guilty on multiple counts, but the most important from my perspective:

Other proven charges included nine of mistreating developmentally challenged children: causing invasive “high-risk” research to be carried out without ethical approval and against their best clinical interests.

Mr. Deer points out that this ls likely the end of Dr. Wakefield’s career as a researcher. Well, yes and no. I think his career as a mainstream researcher was over years ago. But, as a contributor (and editor) to the world of third-tier research, he appears to be moving ahead.

Based on previous public statements by Mr. Deer, I am hopeful that more articles delving into the details of the research Dr. Wakefield performed at the Royal Free Hospital are forthcoming.

Autism Insights, another journal for questionable autism research?

30 Jan

The double standards applied by the autism alternative medicine community never cease to amaze me. Typically they do a game of “six degrees of separation” with any one they disagree with. Do you have ties to anyone who has worked on vaccines? Do you have ties to anyone who knows anyone who might have worked with a governmental agency? Well, if so, anything you say is ignored as biased.

Funny that no one took a good look at the Journal that the recent “confirmation” of Dr. Wakefield’s research was published in. The alt-med community doesn’t question research they like.

Confused? Here’s the back story. A recent article was published Clinical presentation and Histologic Findings at Ileocolonoscopy in Children with Autistic spectrum Disorder and Chronic Gastrointestinal symptoms in a journal called “Autism Insights”. The paper came out the day before the decision from the GMC on Dr. Wakefield. The paper was touted as “Wakefield’s Science Proven Valid Again In New Study That Replicates Findings” in a blog post (guess where?)

Have you ever heard of “Autism Insights“? Neither had I. Don’t feel bad. Unless you read one of the two other articles published in that “journal”, you couldn’t have heard of it.

Yes, two other articles. One is an editorial.

This new article brings the total published in “Autism Insights” to 3.

The first:

Trends in Developmental, Behavioral and Somatic Factors by Diagnostic Sub-group in Pervasive Developmental Disorders: A Follow-up Analysis
Authors: Paul Whiteley, Lynda Todd, Kalliopi Dodou and Paul Shattock

Then an editorial:

Autism Etiology: Genes and the Environment
Authors: A.J. Russo

and now

Clinical Presentation and Histologic Findings at Ileocolonoscopy in Children with Autistic Spectrum Disorder and Chronic Gastrointestinal Symptoms
Authors: Arthur Krigsman, Marvin Boris, Alan Goldblatt and Carol Stott

Yep, that’s it. The entire production of “Autism Insights” is two papers and one editorial.

So far, every paper has had an author on the journal’s editorial board.

Take a look at the Editorial Board. This paper, timed to come out exactly when Dr. Wakefield needed good press has no fewer than four people from Dr. Wakefield’s own clinic, ThoughtfulHouse.

Bryan Jepson, MD
Director of Medical Services, Medical Center at Thoughtful House Center for Children, Austin, TX, USA

Arthur Krigsman, MD
Director of Gastrointestinal Services, Pediatric Gastroenterology, Thoughtful House Cener for Children, Austin, TX, USA

Carol Mary Stott, PhD
Senior Research Associate, Research Department, Thoughtful House, Austin, TX, USA

Andrew Wakefield, MBBS, FRCS, FRCPath
Research Director, THoughtful House Centre for Children, Austin, TX, USA

There are prominent DAN doctors, Richard Deth, and others from the alt-med community on the editorial board as well.

Come on guys. Is this really the standard of science that is acceptable to support Dr. Wakefield?

As an aside, a year or so back I emailed some friends with a speculation that the alt-med community would create their own journal. As far as predictions go, this wasn’t really a longshot. Still, it is interesting to see the prediction come true.

As to the paper itself? I’ll only say a few brief words as it really isn’t worth the time.

1) I recall in the Omnibus hearings that many of the GI “findings” claimed by the petitioners were found to be misinterpretations by the experts who reviewed them

2) No one has ever said that autistic kids are somehow immune from GI complaints, including inflammation.

3) There are multiple details where, even if correct, this research is very dissimilar from that of Dr. Wakefield’s original Lancet paper and later work.

It is too bad that these researchers chose to make clinical findings into what amounts to a political statement of support for Dr. Wakefield. If there is any valuable information gained from these children, I don’t see how this paper respects their contribution.

edit to add: I forgot to acknowledge that this post came from a tip from Prometheus at the Photon in the Darkness blog.

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