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Wakefield, O’Leary and Bustin

4 Feb

Below is an old post from 2007 when the Omnibus hearings were in full swing. It goes through the testimony of Professor Stephen Bustin and why it was so deadly to the MMR hypothesis. I thought now might be an ideal time to republish it.

On Day 8 of the Autism Omnibus proceedings, the MMR section of the hypothesis under examination (that thiomersal and MMR together cause autism) was examined. Just to briefly generalise about the MMR hypothesis –

It was hypothesised that measles virus (MV) from the MMR was travelling from the injection site, to the gut and then to the brain where it either a) causes autism or b) in conjunction with thiomersal causes autism. Wakefield claims to have found MV in the gut of several kids. Krigsman claimed to have replicated this work. They both used the lab of one Professor John O’Leary (Unigenetics IIRC) in Ireland.

So, on Day 8 of these proceedings Stephen Bustin came to the stand. Bustin is possibly _the_ world expert on the techniques used in the O’Leary lab that he claimed led to identifying MV in autistic kids gut and brain. The technique is called PCR. Not only does Bustin use PCR every day, he has 14 papers in the peer reviewed literature on PCR, over 8 book chapters and is personally the author of the _A to Z of Quantitative PCR._ which is considered ‘the bible’ of PCR. One of his papers has been cited over 1,000 times. Another has been cited over 500 times. He both organises and speaks at international PCR conferences (1934 – 37).

Basically, when it comes to PCR – this is the guy.

The first part of Bustin’s testimony concentrated on an explanation of PCR techniques and how these techniques were employed in a key study relied upon the week previous to make the MMR/Cedillo case: Uhlmann 2002. This paper describes the _exact process that Unigentics lab used to carry out their PCR work_ .

This is a mind bogglingly techie area so I’m going to try and stick to laypersons terms. Basically, the Uhlmann study is badly flawed. The key issues related to controls. Uhlmann (and a subsequent, as yet unpublished Walker poster presentation) didn’t use any.

a positive control is an essential control that tells you whether your assay is working, so what you would do is you would take the target that you’re interested in detecting and put it into a test tube and use your assay to detect it. If you don’t detect it, you know there’s a problem with your assay because it’s a positive control. If you do detect it, you know your assay is working. If you do this consistently each time, you know how efficient your assay is from day to day.

The positive control is simply something that tells you that your assay is okay.

Q And a negative control?
A A negative control is something very crucial. There you leave out your target, so if you don’t detect it then that means that there’s no amplification, which is what you want. If you do detect a positive in a negative control then you know there’s a problem with your assay because it should not be there, and you always get suspicious of any assay that gives you a positive result in a negative control.

So, back to Uhlmann:

Q And did Uhlmann provide the information necessary to establish whether these controls were working as expected?
A No. One of the surprising aspects of this paper is they give you very little information about how the assay was performed, about what the results actually were, and it really does not let you evaluate at all how reliable and consistent the results are.

Q Is there any discussion in Uhlmann about contamination?
A No.

Q Is this important?
A It is essential because obviously if you are trying to detect a very low copy number target and there is contamination around, and if you do not know whether there’s contamination around, then you can’t rely on your assay.

……

Q Now, did Uhlmann discuss how the RNA was handled?
A No. As I think I said one of the things about this paper is that it’s fairly unique in my experience, and it’s given no information at all about what actually was done. It actually tells you in outline what they did, where they got their samples from and that they prepared RNA, but it gives you no information whatsoever about, for example, the quality of the RNA the quantity of the RNA and how the different RNAs were extracted from different samples which they refer to.

Without being sure of how RNA is handled, it is impossible to rule out contaminants. i.e. that the samples are contaminated. And there’s more:

Q Did you also identify a mismatch between the measles virus sequences listed in the paper and the probes?
A Yes. This is, again, well, it suggests that there’s a problem with the probe design.

Q Now, regarding consistency and reproducibility did Uhlmann provide any data regarding amplification sensitivity or efficiency?
A No. I need to come back to what I’ve been saying several times now. There’s this lack of information that doesn’t allow you to evaluate this paper properly in terms of its validity.

And specifically regarding the Walker poster presentation:

….Now, as I tried to point out today I think virtually every expert in this case has referred to controls are essential. You always want controls of your samples. There’s no controls on this. So even though this is a poster presentation at the very least there should be a negative control on there to show that the PCR in the negative control hasn’t worked.

We don’t have that information. So this immediately invalidates these results because we can’t now say whether these are genuine or not because there’s no negative control there. So that’s a real problem….

Q Unless these issues are resolved would you have confidence at least in what’s been presented from the Walker lab?
A I can’t have any confidence because there’s actually no results I can evaluate without referring to a negative or a positive control, and these don’t give them to me.

So basically, Mr PCR – the guy who literally wrote the book on PCR – thinks these two things – the Uhlmann paper and the Walker poster presentation – are essentially useless.

Lets also not forget that these two items describe the exact methodology that Unigentics – O’Leary’s lab – used to state that Wakefields/Krigsmans and a multitude of private cases had MV in their samples.

Oh yeah – and as for the old crapola about the two clinical studies done thus far not repudiating Wakefield et al because the look at blood, not gut, Bustin states emphatically:

this is not an assay that is at its limits so this should be easily detectible, and it also means that if you’ve got that much measles virus in a gut sample it probably is in other cells as well and you should be able to detect it, for example, in blood.

In blood.

Turning to Unigenetics itself, as part of the failed UK litigation against MMR, Bustin was asked to look at the lab and samples that the Unigentics team had worked on. For this work he put in an astonishing 1,500 hours of work.

Now, Professor O’Leary’s own controls tell us that this should have been shifted upwards because this is much poorer quality RNA. The evidence from his own data is completely clear. There’s no such shift. This must mean that whatever this is is a contaminant that has been introduced after the sample has been formalin-fixed.

So by definition this cannot be part of the original biopsy because if it had been it will have shifted upwards.

Ouch. But the next one is a body blow to the entire MMR hypothesis.

…if you have a reference gene in that sample that is a cellular reference gene you should detect it if the RNA is of good quality.

If you don’t detect it there’s something wrong with the RNA. As Professor O’Leary’s SOP states, if we can’t detect the GAPDH we shouldn’t use the sample for analysis, which makes perfect sense.

Now, it happens that Professor O’Leary did use those samples for his analysis, and that’s why I was able to then hopefully identify what the contaminant is.

To summarise: O’Leary’s RNA was poor quality. There is no reference gene. There is something wrong with the RNA. O’Learys lab SOP (Standard Operating Procedure) states that in the events of this happening, they shouldn’t use the sample for analysis. But they did use it. They used contaminated RNA for their analysis. And Bustin has identified exactly what the contaminant was.

But first, what is _definitely not_ ?

If you detect a target that is apparently measles virus in the absence of an RT [like this one] step by definition it can’t be measles virus because it has to be DNA [measles virus does not exist as a DNA molecule]. It’s a very simple concept. At least it is to me. It’s not to everyone else.

Whatever it is that O’Learys lab is picking up in their lab tests, it cannot possibly be Measles virus. No RT step was taken:

What I immediately observed was that they had forgotten to do the RT step

No RT step means it’s DNA. Measles virus does not exist as a DNA molecule. That’s simple medical fact. Bustin later summed up:

So all of this evidence suggests very, very strongly that what they are detecting is DNA and not RNA. Because measles virus doesn’t exist as a DNA molecule in nature, they cannot be detecting measles virus RNA. They are detecting a contaminant. All of the additional evidence, from the nonreproducibility by Professor Cotter of the same samples that Unigenetics analyzed to the analysis of the data where there are discordant positives, where the negatives came up positive, suggests very, very strongly to me that there is a lot of contamination in the laboratory, which is not unusual, but they have not handled it very well in how they have troubleshot their problems.

So I have very little doubt that what they are detecting is a DNA contaminant and not measles virus, and I do not believe there is any measles virus in any of the cases they have looked at.

And just as an added kick in the teeth:

Q Now, we know that cerebral spinal fluid samples were sent from Dr. Bradstreet to Unigenetics for testing. Do the same concerns you’ve outlined here apply to that testing?
A Yes. Exactly the same concerns would apply to that.

This testimony exposes the MMR hypothesis as totally dead in the water. What a waste of time, money and health.

Elsewhere

Arthur Allen in the Huffington Post
Autism Diva

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.

Did Andrew Wakefield plan to develop “vaccine alternatives”?

29 Jan

One question that has been actively discussed here on LeftBrainRightBrain is whether Dr. Wakefield’s patent covered the use of his “transfer factor” as a preventive vaccine against measles. This is important because it would indicate an undisclosed conflict of interest.

One of the charges the General Medical Council investigated had to do with a proposed company to work on the “transfer factor” that Dr. Wakefield was a co-inventor on (i.e. Dr. Wakefield was one of the inventors on the patent). A proposal was submitted to the Royal Free Hospital (Dr. Wakefield’s employer) about the possible company. The proposal was drafted by “Mr 10”, the father of child 10 in the Lancet study.

That Lancet paper was published on February 28th, 1998. The proposal was submitted to the Royal Free on March 4th, 1998.

The “transfer factor” is discussed in charge #40. Subsection f of charge 40 discusses the company. I quote the GMC charge sheet as it stood last week, before the decisions were handed down.

f. A proposal, dated 4 March 1998 and drafted by Mr 10, was submitted to the Royal Free Hospital School of Medicine in relation to the proposed company,
Admitted and found proved

i. seeking funding for a clinical trial of Transfer Factor in the treatment of Inflammatory Bowel Disease, and Pervasive Developmental Disorder, and for research into using Transfer Factor as an alternative measles specific vaccine,
Admitted and found proved with the exception of the words ‘an alternative’

So, you can see that a company proposal was submitted (admitted and found proved). Further, in sub-subsection “i” of subsection “f” (complicated, isn’t it?), you see that there was a charge that the “Transfer Factor” could be used as “an alternative measles vaccine”. Dr. Wakefield admitted to this with the exception of the words ‘an alternative’. This is consistent with his public statements (e.g. on Dateline) that the vaccine was a treatment only.

Here is how that section reads today, in the GMC ruling. Note the final paragraph which was added for the ruling.

f. A proposal, dated 4 March 1998 and drafted by Mr 10, was submitted to the Royal Free Hospital School of Medicine in relation to the proposed company,

Admitted and found proved

i. seeking funding for a clinical trial of Transfer Factor in the treatment of Inflammatory Bowel Disease, and Pervasive Developmental Disorder, and for research into using Transfer Factor as an alternative measles specific vaccine,

Admitted and found proved with the exception of the words‘an alternative’

Found proved in respect of the words “an alternative” on the basis of the proposal referred to above in 40.f. where it states, “The company will also investigate the potential of Transfer Factors as vaccine alternatives.”

Yes, the GMC ruled that the company proposal showed that the intent was to “…for research into using Transfer Factor as an alternative measles specific vaccine”.

In other words, the GMC appears to accept that, in addition to the use of the transfer factor as a “theraputic agent”, there was an intent to investigate the potential for the transfer factor as “vaccine alternatives”. I hope the full document is made public so we can see this sentence in full context.

As recent as last year, on Dateline, Dr. Wakefield steadfastly denied that his patent and plans had anything to do with a measles vaccine. Below is that clip.

Here is Brian Deer discussing the patent activities with Matt Lauer:

I wonder if Mr. Lauer’s reporting would differ, now that the existence of the company proposal is made public. It appears clear from this proposal demonstrate that Dr. Wakefield and his colleagues (Mr. 10 and whoever else was going to be in the company) had the intent to investigate the “transfer factor” as a vaccine alternative. This proposal was submitted a few days after the Lancet article was published, and after the news conference. I don’t see that excusing not informing the public of the potential commercial interests.

The GMC ruling states:

At or around the same time as the events set out at paragraphs 40.a. and 40.b., you were involved in a proposal to set up a company called Immunospecifics Biotechnologies Ltd to specialise in the production, formulation and sale of Transfer Factor,
(amended) Admitted and found proved with the exception of ‘40.a.’

Note that paragraph 40b describes events of February 2, well before the publication of the Lancet Article and the press conference. I.e. the intent to form a company dates from before the study became public.

I am left wondering how “The company will also investigate the potential of Transfer Factors as vaccine alternatives” can be interpreted differently than how the GMC has read it.

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 release “Offit’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.

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