Archive | MMR RSS feed for this section

Transcripts from the GMC hearings

2 Feb

With the defamation suit by Mr. Wakefield filed in Texas there is the strong possibility that the discussions will ensue again about what actually happened during Mr. Wakefield’s research at the Royal Free hospital. The one record of this is in the transcripts for the GMC hearings. These can be found online in a few places (casewatch and Sheldon 101’s blog Vaccines Work, for example). These are useful resources but somewhat cumbersome. Most people are not going to download a file to check a quote in context. And context can be very important, as we’ve seen here on Left Brain/ Right Brain where previous discussions by Mr. Wakefield’s supporters often involved pulling quotes out of context.

I don’t want to clutter this site with the transcripts, but I do want them in a place where internet search engines can find them and people can easily link and check quotes. So I am now uploading them to a new blog. It should take a few days to get the transcripts online in this format. About 30 days worth are up now.

In doing so I re-read some of the pages. One of the best examples of what happened is covered on Day 28. This is the day when the mother of Child 12 (last of the 12 children in the Lancet study) testified.

This one day’s testimony addresses many of the discussion topics which come up repeatedly in online discussions:

1) Parents of the Lancet Children were not prevented from testifying at the GMC.

2) She was the only one who did testify. She was the only one called by the GMC. The defense appears to have not called any of the parents.

3) Mr. Wakefield’s attorney declined the opportunity to even cross examine this parent.

4) The idea that Mr. Wakefield only reported what parents told him isn’t well supported by the evidence. Rather, there is a very circular route for the idea that the MMR causes autism. Mr. Wakefield and Mr. Barr (the attorney working on the litigation) were in contact with this parent multiple times before the child was seen at the Royal Free.

5) Some of the children in the Lancet study were registered with Legal Aid at the time of the study, and well before the Lancet paper was published.

6) The idea that the children were referred through normal channels is not accurate. While this child was referred through general practitioners, there was much contact between the mother, Mr. Wakefield and the attorney before that. One letter from the attorney makes it clear that they expressly told the parents to be sure to get the GP referral.

7) The idea that this work was not a research study isn’t really accurate. Mrs. 12 repeatedly gives her impression that they were involved in a research study.

Yes, this has all been covered before. Unfortunately, I fear this will all be covered repeatedly as this new case works its way through the court.

With that, here are some excerpts from the Day 28 testimony. Which you can check in context.

Q I think it is right that at around the same time, as well as that contact with Dr Wakefield, did you also have some contact with a firm of solicitors called Dawbarns?
A Yes, that is right.

Q Can you tell us how that came about. Why did you get in touch with them?
A The same mother told me about them as well.

Q What was your understanding of what they were doing?
A They were trying to really put a stop to the MMR vaccine being used and obviously to stop any damage that was being done to children.

Emphasis added. Mrs. 12 thought that Dawbarns “were trying to really put a stop to the MMR vaccine being used”.

After contacting the lawyers, she received a letter. This is dated 18 July 1996. Her son wasn’t seen at the Royal Free until 18 October, 1996, three months later:

“Dear [Mrs 12],

Thank you for contacting us regarding the MMR vaccination. We are investigating a number of vaccine damage cases and are also (with Messrs Freeth Cartwright Hunt Dickens of Nottingham) co-ordinating and managing the Mumps Measles and Rubella cases on behalf of the Legal Aid Board for the whole country. Recently the Legal Aid Board has also extended our contract to investigate claims following the Government’s measles/rubella vaccination campaign in the autumn of 1994.

To give you an idea of our work I enclose an information pack which consists of a copy of a fact sheet which we have produced on the MMR vaccine and a fact sheet on ourselves.

We have built up a considerable volume of evidence that vaccines can cause injury to children, and we are hoping to take compensation claims to court. See the fact sheets for more information. Legal Aid is now being granted in vaccine damage cases where we can show a close link up in time between the vaccine being administered and the onset of recognised side effects. In claims being brought on behalf of children the Legal Aid Office does not take into account the finances of the parents, but there are sometimes difficulties in obtaining legal aid …”

She was supplied with a “fact sheet” written by Mr. Wakefield. No contamination of the study there, right? In the Lancet he’s just reporting what the parents told him. No mention of the issue of the parents being supplied with a “fact sheet” to guide them.

Richard Barr (the attorney managing the litigation effort and teamed with Andrew Wakefield) wrote her on 14 August 1996

“We are also in touch with other experts and together they are hoping to establish a link between the vaccine, inflammatory bowel disease and autism. There is a clear cut biological mechanism for linking the two conditions. I suggest it might be worth your while to contact Dr Wakefield. If you would like me to do so I will be happy to make the introduction for you. May I have permission to send him a copy of the statement that I have prepared for [Child 12]?”

They are hoping to establish a link and “there is a clear cut biological mechanism for linking the two conditions [bowel disease and autism]”. Two months before being seen at the Royal Free she is informed about the effort to link MMR with autism and bowel disease and the idea that autism and bowel disease are linked.

Clearly any study reporting “what the parents told us” is contaminated at this point.

If you think the study could be salvaged, even with this level of contamination, here is a discussion of the fact sheet supplied to the parents as mentioned above:

Q The next document was a fact sheet, and that apparently comes from the Royal Free Hospital School of Medicine, as you will see at the top of the page. If I can just run through what some of that says, it is headed,

“Inflammatory Bowel Disease, measles virus and measles vaccination.

What is inflammatory Bowel Disease (IBD)?

IBD comprises 2 conditions that have many similarities. Crohn’s disease and ulcerative colitis. Crohn’s disease may affect any part of the bowel, from mouth to anus, whereas ulcerative colitis affects the large bowel only. Many people now believe that these two conditions are part of a single spectrum of intestinal disease. IBD is often difficult to diagnose in children, especially Crohn’s disease, and this may lead to a delay in diagnosis with frustration for parents, doctors and, in particular, the affected children.

What is the link with measles and measles vaccine?

Measles virus was put forward as a possible cause of Crohn’s disease in 1989. The dramatic rise in the incidence of inflammatory bowel disease in developed countries over the last 30 years, in the face of live measles vaccination, also suggested a link between the vaccine and the disease.

Several groups from around the world have now identified measles virus in tissues affected by Crohn’s disease and an immune response to measles virus in the blood of patients with Crohn’s disease and ulcerative colitis. Early exposure to measles virus appears to be a major risk factor for developing Crohn’s disease later in life, and one study recently linked live measles vaccine to both Crohn’s disease and ulcerative colitis. Several new studies are currently underway that are designed to clarify the association between measles vaccination and inflammatory bowel disease. Although no studies have formally examined the issue, we have been aware of a large number of new cases of childhood IBD following the MR revaccination campaign in November 1994”.

Then the fact sheet sets out what you would look for (and what you should do: contact Andrew Wakefield):

Q The next document was a fact sheet, and that apparently comes from the Royal Free Hospital School of Medicine, as you will see at the top of the page. If I can just run through what some of that says, it is headed,

“Crohn’s disease. The symptoms and signs of Crohn’s disease in childhood are often insidious and non-specific and may lead to a delay in diagnosis. Intestinal symptoms include mouth ulcers, cramping abdominal pains, loss of appetite, diarrhoea with or without blood and problems in the anal region, including skin tags, tears or abscess formation. However, children commonly present with weight loss and failure to thrive as the only indications that they may have Crohn’s disease. But be aware, unexplained joint paints, sore eyes and skin rashes can also be the presenting symptoms of Crohn’s disease.

Ulcerative colitis is often more clear-cut, with diarrhoea, urgency and blood and mucus mixed in with the stools. Again, growth failure and symptoms such as joint pain may precede the intestinal problems.

What should we do?

If you suspect that your child has inflammatory bowel disease, prompt referral to a specialist centre is essential. Either the diagnosis will be excluded and your mind put at rest, or it will be confirmed and the appropriate treatment instituted. As a first step you should contact Dr Andrew Wakefield at the Royal Free Hospital”,

A document by Wakefield, possibly from the Royal Free says that there is a link between Crohn’s disease and the measles vaccine. This given to prospective study subjects before being seen at the Royal Free. But no contamination of the study subjects again, right?

Child 12 was registered with Legal Aid before in August, two months before being seen by the Royal Free:

Q Also enclosed with that letter of 14 August 1996 were the legal aid forms. I think that is right. Did you fill in the legal aid forms in order for an application to be made for your child to be legally aided?
A Yes.

One issue that Mr. Wakefield has brought up in recent years is the concern over vaccines containing the Urabe strain of mumps. Mr. Wakefield has gone into detail about how he was informed by a “whistleblower” about how the government handled the licensure of those vaccines. Mr. Wakefield had those discussions with the whistleblower in 1999 but appears to have done little with the information until the past few years. Why? Perhaps this comment by his colleague Richard Barr will shed some light onto this: “Although Immravax and Pluservix were withdrawn on safety grounds, the particular problem they caused was fairly limited. ” It was the opinion of Mr. Barr at the time that the Urabe strain mumps concerns with some of the MMR vaccines was “fairly limited”. Mr. Barr and Mr. Wakefield, of course, had a different avenue to pursue: the measles/gut disease/autism hypothesis.

In Sept. 1996, Barr sent Mrs. 12 a newsletter:

Under the heading, “Pilot study”,

“If we can prove a clear link between the vaccines and autism/inflammatory bowel disease this will be exceedingly useful, not only for cases involving those conditions, but also for other types of damage such as epilepsy.

To obtain the evidence to do this, we will be running a pilot study. Around 10 children with symptoms which are closely linked to the vaccine will be extensively tested by a team of doctors headed by Dr Wakefield at the Royal Free Hospital in London. We will be selecting children to take part in the study from details and medical notes we already have. The investigations will involve a whole battery of tests to be carried out by a number of leading experts in their fields. We will of course be liaising closely with the families concerned and the doctors will be giving very full details of what will be involved”.

Need I point it out again? Before even arriving at the Royal Free, Mrs. 12 was informed about the need to provide a clear link between vaccines and autism/bowel disease.

Q We have heard from the Dawbarns newsletter that I read to you previously that as far as the solicitors were concerned there was a pilot study being arranged. Did you have any understanding or awareness whether your little boy was a part of that pilot study at all?
A He was referred to Dr Wakefield by my GP for investigations, which I understood to be research investigations, but that was the route he was referred.

She felt that her child was being referred for “research investigations”

Mr. Wakefield is keen to tell everyone that the referrals came through the GP’s. He doesn’t mention that he and Mr. Barr made sure ahead of time that they went through the GP’s:

“Dear Mrs [12]

Many thanks for your letter of 10 September 1996. I will contact some other parents in your area and if they agree then you can all swap names and addresses. It is interesting how isolated people feel (and sometimes are!).

I would like to see the records. These may well be helpful if we have any difficulties over legal aid. At the moment I am still waiting to hear from them.”

So that was the end of the correspondence, and I now want to ask you about the actual referral, which you have explained to us was through your GP to the Royal Free Hospital in respect of your boy. We have been through this already, but just to remind you, if you go back to the GP records, please, page 126, this is a letter that I asked you about when I first began to question you, Mrs 12, the letter from Dr Wakefield, and we see in that the suggestion that you in fact you should go to your GP for a referral. Did you do that?

Emphasis added.

On admission to the Royal Free:

Q “Soils – not had diarrhoea. Has variable abdominal pain”, and then I cannot read the rest of that sentence. Mr Miller is trying to assist me – “occurring every week”. Thank you. “Mother had not associated vaccination with his problems until met a parents support group”. Does that set out the problem as far as his gastrointestinal symptoms were concerned, I mean obviously in brief terms?
A Yes.

“Mother had not associated vaccination with his problems until met a parents support group”. Earlier in the transcript it is noted that this parent group included the mother of Child 6 and 7 and this is where Mrs. 12 was put in touch with Mr. Barr and Mr. Wakefield.

After her son was seen at the Royal Free, here’s the letter Mrs. 12 wrote. Note that she read the proposed “clinical and scientific study notes”. But this was just a routine referral, right?

“Dear Professor Walker-Smith,

I am writing following [Child 12’s] visit to the Royal Free Hospital last Friday 18 October 1996. My husband and I have thought long and hard about this situation since the appointment. We have also re-read Dr Wakefield’s proposed clinical and scientific study notes.

We do feel that [Child 12] does have a problem in that most children of his age do not soil themselves a number of times a day. As well as being pale in colour and foul smelling (as are his motions in general), this soiling is always very loose, which might explain why he is not always aware that he has done anything. Although I would not say it was diarrhoea exactly.

Obviously I do not wish to put my son through any procedures unnecessarily but there must be a reason why he has these problems. Also, as I mentioned to you at our meeting, [Child 12] is not growing or putting on weight like my other two children.

I keenly await the results of the blood tests and if you feel they warrant further investigations my husband and I are happy for him to be referred on to Dr Wakefield’s study project. As you pointed out, it might not help [Child 12] but if not hopefully it will be of benefit to others. There is also the chance that [Child 12] has a problem that can be detected and helped.

I do hope to hear from you in due course.”

In a letter to Mr. Wakefield she notes:

“Finally, I would like to say how nice it was to meet you at the JABS open meeting on 4 October in London. I found your short discourse both informative and interesting. I wish you all the best with your research.”

Yes, Wakefield was lecturing at JABS (an organization focused on vaccine injury) meetings. Mrs. 12 attended. This is Oct. 4, two weeks before her child was seen at the Royal Free.

Once again, we are in the merry-go-round. Mr. Wakefield only reported what the parents told him, except that here we have a clear example of a parent hearing from Mr. Wakefield on more than one occasion about what he was investigating.

The first visit to the Royal Free was not with Mr. Wakefield (Mr. Wakefield did not have clinical duties). Child 12 wasn’t even going to be referred to Mr. Wakefield at first:

Q So that was from your point of view, but you say in your letter to Dr Wakefield, Professor Walker-Smith’s main reasons for not referring [Child 12] on to Dr Wakefield was the absence of blood in the faeces and the lack of diarrhoea, you were saying that is what Professor Walker-Smith’s view was, is that correct?
A Yes.

But a blood test was “slightly abnormal” so they did make the referral.

“Dear [Mrs 12],

I do apologise for the delay in replying to your letter of 28 November. The slight abnormality that you referred to in your letter was that one of the markers of inflammation was just slightly above the normal range, it just means that we should go ahead. I understand that [Child 12] is coming in in the New Year to have a colonoscopy.”

A “slight abnormality” was enough to warrant a colonoscopy. Oddly enough, a later letter states that the blood tests were not abnormal.

The psychiatrist was not very clear on autism diagnosis:

Q If you to go page 18 in the medical records, we have a note dated 10 January, and in fact we have heard some evidence from Dr Berelowitz and he has given evidence in relation to all the children, including your son, and it was his evidence that this was his note, and we see at the bottom a diagnosis of “language delay ? [attention deficit disorder]” and then “? Asperger’s”: do you have any recollection of that?

The Royal Free didn’t think child 12 should have an MRI or a lumbar puncture.

Q If we go back to the Royal Free records – you can put FTP7 away, you will not need it again – at page 21 – it is on 6 January, so the day after the admission – at the bottom of the page it says, “[Ward round] Professor Walker-Smith” and it is a note signed by presumably a junior doctor, “colonoscopy” and then it gives, “prominent lymphoid follicles …” and “? some minor inflammatory changes” and then it says, “not to have MRI or L.P.” In other words, not to have an MRI scan and not to have a lumbar puncture. Then, Wednesday to have a barium meal. Were you aware at all of that note, Mrs 12? Were you aware at the time that that instruction had been given?
A No.

Emphasis added. But a colonoscopy and lumbar puncture were performed:

Q You say that you recall your son having a lumbar puncture and an MR scan; were you there for those?
A Yes.

Q You have obviously given consent for the MR but were you actually there when they were carried out?
A Yes.

Q Both of them?
A Yes.

Again, Mrs. 12 felt this was a research project:

Q You have told us that you thought that your son was part of a research investigation. Did you have any understanding as to which of those investigations, all of them or any of them, were part of the research investigations?
A As far as I understood, it was all part of the research into this possible link between the problems that [Child 12] had and the vaccine.

The tests apparently showed some immune activation

“Dear [Mr and Mrs 12],

I am writing to confirm the results from [Child 12]’s visit in the New Year. All were normal, including test for Fragile X, except the immune test. This shows evidence of persistent viral infection; i.e. [Child 12]’s immune system is activated in such a way that indicates it is trying to deal with some sort of ongoing viral infection. If you need to discuss these further please contact Dr Wakefield. I have passed on your query about gluten free diets to Dr Wakefield. I hope that [Child 12] is well and that his aching knees are settling”.

Then she gives some results at the bottom of the page. It shows,

“Full blood count and inflammatory markers – normal (i.e. no evidence of anaemia or inflammation”,

and various other negative tests.

Emphasis added. But above we read that the reason why Child 12 was referred for a colonoscopy was because a blood test indicated possible inflammation.

In June 1997, after the work at the Royal Free was finished, the attorney, Richard Barr, wrote to Mrs. 12:

“Thank you for your letters of 3 and 10 May 1997. I am sorry about the delay in coming back to you. I inevitably seem to be behind with my correspondence.

I haven’t heard anything more from the Vaccine damage Tribunal”.

Then he says,

“I haven’t had a copy of the Meridian TV item”,

so obviously you had made some reference to it, because he says,

“I would be very interested to see a copy if you can organise it some time.

We are all waiting for Andy Wakefield to deliver the goods and I really think that if he can provide the proof he thinks he can it is going to be much easier to win the cases.

I am interested in your comments about the rise in the incidence of mumps. What you say, of course, is absolutely correct.

I don’t think you have been updated on our fact sheet recently and in case it is of interest I enclose a further updated version. You will see that once again the section on autism has been extended. Don’t be deceived by the fact that it may not look quite as long as before. We have reduced the print size”.

Emphasis added.

After an extensive examination by the GMC’s attorneys, the defense was given an opportunity to cross exam:

THE CHAIRMAN: Mrs 12, as I indicated earlier, this is now the opportunity for representative counsel of the three doctors to cross-question you if they feel it appropriate. Are you happy to continue?
A Yes, that is fine.

THE CHAIRMAN: At any stage if you think that you need a little break, just give me a little hint and I am sure that the Panel will be quite sympathetic. Mr Coonan.

MR COONAN: Sir, I have no questions, thank you.

Mr. Coonan would be Mr. Wakefield’s attorney. He declined the opportunity to examine the one parent from the Lancet 12 who appeared at the GMC.

Mrs 12 was cross examined by Mr. Miller, attorney for Professor Walker-Smith.

Even as a summary this is long. But at least now people can easily check quotes in context.

Does MMR vaccine travel in time?

27 Jan

The news that the diagnosis of autism may be brought forward is primarily of importance because it may help identify children who will require specialised support. However, it is also interesting because it breaks the co-incidental temporal association that has been part of the reason the MMR vaccine-autism hypothesis gained traction. Since the behavioural cues for autism can’t be picked up well until after one year of age, parental concern about their child being different and autism diagnoses rose after administration of the MMR vaccine. This had unfortunate consequences for the perception of MMR vaccine’s safety.

Elsabbagh et al examined “brainwaves” (event-related potentials – ERPS) of babies with a familial risk of autism when presented with pictures of faces either gazing at the baby or away from the baby. Those children who went on to develop autism diagnoses had differing ERPs.

Although the evidence of fraud, failure to find epidemiological evidence to back-up Wakefield’s claims, and failure to find measles RNA that would have supported Wakefield’s work were enough to bury any scientific case for the MMR Vaccine-autism hypothesis, the fact that autism may now be diagnosed before the MMR vaccine lays a nice wreath on top.

Not all parents whose children developed autism blamed MMR vaccine, some parents were already aware of a “difference” about their child before MMR vaccine, but it is understandable how some parents would have made the connection with the vaccine. After all, it is a key part of how clinicians make connections between a drug and adverse event, and is a strong element of assessing causality (see Bradford-Hill criteria).

The causation in the MMR vaccine debacle was neatly illustrated in an article from Prescriber [Registration required] written by Paula McDonald (a former Consultant in Communicable Disease Control).

Some of these syllogisms may be plausible to some patients

Aristotle’s concept of syllogisms, says if certain prepositions are met, something distinct will arise from necessity. However, he also noted false syllogisms (In the UK we have an entire publication devoted to generating them, called the Daily Mail). McDonald’s figure illustrates the usual example of the horse being classified as a cat, along with the example of teddy bears and MMR vaccine causing autism.

You could replace the teddy bears with Peppa the Pig, or some other Greenfieldian scare. However, it sounds more convincing with vaccines, afterall you are introducing foreign material into a healthy child (and vaccines do cause adverse events sometimes).

Convincing people a false syllogism is wrong is a lot harder, than pointing out that A could not have caused B, because B arose months before A happened. Temporal associations are how we make sense of the everyday world. We don’t blame tripping up on a kerb on the beer we were going to have in the pub later that night.

Barring a Skynet conspiracy to send Terminators with MMR vaccine back in time to cause autism, this looks like a useful point to make to parents concerned about the risk of autism with MMR vaccine. Quite what the anti-vaccination groups will do, like the UK JABS cult, is interesting. Perhaps they will move to attack other vaccines given earlier, such as meningitis C or diptheria? Alternatively, they may look to the misapplication of physics, perhaps taking comfort in the news that neutrinos may have travelled faster than light, as their comrades-in-arms the homeopaths did.

Cross posted at Black Triangle.

The Omnibus Autism Proceeding: effectively over

21 Jan

The Omnibus Autism Proceeding (OAP) was held in the U.S. Court of Federal Claims to group the large number of claims filed involving autism and vaccines. The Docket was opened on July 3, 2002, nearly 10 years ago. The last entry was placed 1 year ago. Since then many cases have been dismissed. About half the cases are left to hear, but the fact that the two causation theories presented (that the MMR vaccine causes autism and that Thimerosal causes autism) were both found to have no merit (“not even close” one special master put it) and no new theory is proposed by the Petitioners’ Steering Committee (the attorneys who presented the case for the petitioners) makes it clear that the group claim, the omnibus, is effectively over.

That is not to say that other claims are not proceeding through the court, or that new cases will not be presented. There is at least one case pursuing the idea of mitochondrial dysfunction and autism, as with the Hannah Poling case. ([edit to add–the case ongoing, which was briefly closed, is not the Hannah Poling case. See the comments below). The case was actually dismissed for lack of action by the petitioners but the special master allowed it to continue again).

Looking back, the Omnibus peaked in 2003 when 2,437 cases were filed (close to 1/2 of the total that would eventually be filed).

Time Magazine: Great Science Frauds

14 Jan

Add Time magazine to the list of those calling out Andrew Wakefield a fraud. Not just any fraud, a “great science fraud”:

Great Science Frauds

Brian Deer responds to David Lewis’ complaint

10 Jan

Much attention has been focused on Andrew Wakefield again recently. This follows Mr. Wakefield’s lawsuit against Brian Deer, Fiona Godlee and the British Medical Journal (BMJ). Also, a lengthy complaint authored by David Lewis was made public, detailing his views about the allegations of fraud levied against Mr. Wakefield by the BMJ.

The two are not directly related as Mr. Lewis’ complaint fails to address many of the issues raised by the BMJ in their articles alleging fraud. That said, If one pokes around Mr. Deer’s website, one will eventually stumble upon this page: David L Lewis: indignant abuse as complaints turn to nothing. There is an introduction to the subject including Mr. Deer’s interactions with Mr. Lewis followed by a point by point response to Mr. Lewis’ complaint. For anyone who may be thinking that Mr. Deer is intimidated by the complaint I encourage you to read the response. It is very much in the style of Brian Deer. For example

DAVID L LEWIS: “My report, which I have submitted to UCL, UKRIO and HEFCE, includes 72 emails exchanged between me and the BMJ’s editors.”

DEER: I offer the recipients at UCL, UKRIO and HEFCE my sympathy.

Aside from such dismissive statements, Mr. Deer takes on the many (often repetitive) claims by Mr. Lewis directly. Mr. Lewis’ complaint and main thesis in his rapid response to the BMJ focus on non-specific colitis as used in the Lancet paper: the histology grading sheets of Dr. Dillhon somehow prove that there was no fraud. It is a confusing argument because it doesn’t address the many issues raised by Mr. Deer and the BMJ.

Per Mr. Deer in his introduction:

These biopsy assessments, however, weren’t the basis upon which, in January 2011, the BMJ concluded that Wakefield’s MMR work was “an elaborate fraud”. The evidence we presented rested firmly on the GMC panel’s findings of research dishonesty, and was overwhelmingly related to Wakefield’s activities with regard to the admission of patients to the study, as well as the purported clinical histories and findings which lay behind a claim by Wakefield of a 14-day temporal link between the administration of MMR and the first “behavioural symptoms” of autism. We say this purported link was fraudulent.

Later, in response to Mr. Lewis’ claim:

DAVID L LEWIS: “… alleged that Andrew Wakefield fabricated the diagnosis of colitis in a 1998 Lancet study involving 12 children with autistic spectrum disorder (ASD).”

Mr. Deer responds:

DEER: At the core of our problems in dealing with Lewis is that nowhere was such an allegation made in the BMJ. He repeatedly identifies my feature “Autistic enterocolitis under the microscope”, published in April 2010, but this simply doesn’t make such an allegation. Plain reading would make this clear.

Not only can I find no foundation for this fundamental of Lewis’s complaint (and I think I’d remember forming any view at that time that the histopathology reporting in the Lancet was fraudulent, as distinct from, say, wrong, misleading or incompetent), we consulted legal counsel, before and after publication, and expert peer-reviewers. We remain unable to identify any text inferring Wakefield’s intent with regard to histology reporting. I’ve similarly asked Nature to identify any such text, and they too have failed

Mr. Lewis has taken issue with the fact that the BMJ did not print his rapid response exactly as submitted:

DAVID L LEWIS: “To support their new fraud theory, Godlee rewrote my Rapid Response, removing any evidence that undermined their allegations against Wakefield and others.”

DEER: Lewis’s rapid response was extensively re-written because it was false and defamatory. Legal advice was taken. Two peer reviewers rejected the submitted text. No changes had any effect in supporting any “fraud theory”, whether new or otherwise. Lewis approved the published text.

In hosting the words of Mr. Lewis, the BMJ would itself be responsible in part for any defamatory language included. This is the way of the law in the U.K..

In my opinion, the Mr. Lewis’ arguments are a side show of the the Wakefield saga (Yes, in my view Mr. Wakefield is a major side show in itself). They don’t address the substance of the claims of fraud put forth by the BMJ.

BMJ instructs lawyers to “defend the claim vigorously” against Andrew Wakefield’s lawsuit

6 Jan

The British Medical Journal (BMJ) has issued a press release (below) about the lawsuit initiated by Andrew Wakefield claiming defamation arising from a series of articles published last year. The BMJ and Mr. Deer stand by their articles and statements and have instructed their attorneys to “defend the claim vigorously”.

Although not formally served with the legal papers, the BMJ is on notice that Andrew Wakefield has issued defamation proceedings, not in London as might be ordinarily expected as concerns a predominately English publication, but in Texas, USA, where he now lives. The proceedings primarily relate to an article written by Brian Deer and published a year ago on 5 January 2011, entitled Secrets of the MMR Scare: How the Case Against the MMR Vaccine was Fixed, and an accompanying editorial which related to Mr Wakefield’s now infamous Lancet Paper on MMR.

Of course, following the findings of the British General Medical Council’s Fitness to Practice Panel and Mr Wakefield’s history of pursuing unfounded litigation, any action brought against the BMJ and Mr Deer in London would have been immediately vulnerable to being struck out as an abuse of process.

Despite the findings of the GMC’s Fitness to Practice Panel and his co-authors having publicly retracted the causation interpretation put forward by the Lancet Paper, it would appear from the Claim filed at court that Mr Wakefield still stands by the accuracy of the Lancet paper and his conclusion therein, thereby compounding his previously found misconduct. While we await formal service, unsurprisingly the BMJ and Mr Deer standby the material published in the BMJ and their other statements and confirm that they have instructed lawyers to defend the claim vigorously.

NOTES TO EDITORS

1. The Lancet Paper was published on 23 February 1998 entitled “Ileal-lymphoid-nodular hyperplasia, non-specific colitis, and pervasive developmental disorder in children”. Its claims of a temporal association between MMR vaccine and autism were retracted by the authors (excluding Mr Wakefield) on 6 March 2004, following the first findings from Brian Deer’s investigation for The Sunday Times. The paper was retracted in its entirety by the Lancet on 2 February 2010, with the Lancet noting that elements of the paper “have been proven to be false” during hearings of a General Medical Council fitness to practise panel.

2. Following a 217-day investigation by the GMC’s panel, on 24 May 2010, the panel found Mr Wakefield guilty of serious professional misconduct. It found that Mr Wakefield “had a clear and compelling duty to ensure that the factual information contained in the [Lancet] paper was true and accurate and he failed in this duty”. The Panel also found that Mr Wakefield was intentionally dishonest and misleading in describing the patient population, and that he had been dishonest when questioned about it later. Similarly, the panel stated that “the description of the referral process was irresponsible, misleading, and in breach of [Mr] Wakefield s duty as a senior author”. The Determination also set out how Mr Wakefield compounded his misconduct by failing to correct the content of the paper.

3. As a result of Mr Wakefield’s “persistent lack of insight” into his behaviour, the GMC determined that his name should be erased from the medical register.

4. Mr Wakefield adduced no evidence in mitigation and made no arguments or pleas in mitigation in front of the Fitness to Practice panel. He did not appeal its decision and has not attempted to replicate the Lancet paper’s findings in order to attempt to vindicate his position.

5. At various times in the past, Mr Wakefield has brought claims and made complaints against Mr Deer, The Sunday Times, Channel Four and Twenty Twenty Productions in respect of allegations of dishonesty relating to his Lancet paper. In no case has he been successful. Indeed, in each instance the case has been dropped by Mr Wakefield. In Wakefield v Channel Four Television Corporation, Twenty Twenty Productions Ltd and Brian Deer [2005] EWHC 2410 (QB) Mr Justice Eady refused to grant a stay sought by Mr Wakefield, stating that the case would turn on fundamentally serious issues going to the heart of the Claimant s honesty and professional integrity.

In refusing the stay, Eady J considered Mr Wakefield’s conduct in relation to the various proceedings he had brought. He noted that Mr Wakefield had written to a number of other organisations including: the Cambridge Evening News; Evan Harris (an MP who criticised Mr Wakefield on a radio programme); and the Department of Health (which provided a link on its website to the Channel Four Dispatches website).

Mr Wakefield informed these entities in correspondence that he had issued proceedings against The Sunday Times, Mr Deer and/ or Channel Four, indicating that proceedings were ongoing. He made no mention of the stays which he had obtained, or was seeking. Eady J considered this misleading, and concluded that Mr Wakefield wished to use the existence of the libel proceedings for public relations purposes, and to deter critics, while at the same time isolating himself from the downside of such litigation, in having to answer a substantial defence of justification. The Judge believed that there was a pattern of using the existence of libel proceedings, albeit stayed, as a tool for stifling further criticism or debate.

6. On 2O December 2011, the BMJ’s solicitors, Farrer & Co, wrote to Mr Wakefield’s Texan lawyers setting out the matters referred to above, as well as other points. No response has been received.

7. Mr Wakefield’s allegations, that the MMR vaccines causes or contributes to autism, were investigated in three test cases in the United States Court of Federal Claims, heard from July 2007 and with judgments handed down on 12 February 2009. Although listed as a witness, Mr Wakefield was not called to give evidence, and his allegations were rejected. The judgments were upheld on appeal. In the lead case, Cedillo v Secretary for Health and Human Services, Special Master George Hastings said in his judgment with regard to evidence in the case: “Therefore, it is a noteworthy point that not only has that autistic enterocolitis theory not been accepted into gastroenterology textbooks, but that theory, and [Mr] Wakefield s role in its development, have been strongly criticized as constituting defective or fraudulent science.”

Andrew Wakefield takes to the courts again

5 Jan

Andrew Wakefield, one of the doctors who was stricken from the register by the U.K.’s General Medical Council, has filed a complaint in Texas claiming that Brian Deer (Journalist) and Fiona Godlee (Editor of the British Medical Journal). The complaint alleges that the articles, editorials and statements made later about those include “false and defamatory allegations” about Mr. Wakefield.

From the complaint filed:

This defamation lawsuit arises, in part, out of the publication on or about January 5, 2011 and thereafter, in the British Medical Journal, of an article authored for the BMJ by Brian Deer, titled Secrets of the MMR Scare (Exhibit A) and accompanying editorials by the BMJ’s editor, Fiona Godlee (Exhibit B 1-2). Defendants’ article and editorials, distributed to subscribers in Texas and which fonn the basis of Plaintiffs claims, contained unfair, incorrect, inaccurate and unjust criticisms of findings previously reported by Dr. Wakefield and 12 other co-authors. More significantly, Defendants accused Dr. Wakefield of fraud and of fraudulently and intentionally manipulating and falsifying data and diagnoses in connection with a clinical paper he co-authored called Ileal-lymphoid-nodular hyperplasia, non-specific colitis, and pervasive developmental disorder in children, originally published in the medical journal The Lancet in 1998 (the “Lance,t Paper”). Defendants’ false and defamatory allegations have been widely disseminated by Defendants through the BMJ and other sources since their original publication.

Mr. Wakefield sued Mr. Deer in the past, but dropped that suit.

Mr. Wakefield’s legal team consists of William M. Parrish, J.D. Ellwanger, John D. Saba Jr of DiNovo Price Ellwanger & Hardy LLP, a firm which primarily focused on intellectual property and commercial litigation.

Mr. Wakefield does not specify an amount for damages:

Dr. Wakefield hereby prays for a trial by jury as to all disputed issues of fact, and upon findings appropriate, further prays for judgment from this Court against the Defendants for: nominal damages, actual and compensatory damages, special damages, including injury to reputation and character, injury to feelings, humiliation, loss of earning capacity, exemplary damages pursuant to TEX. CIv. PRAC. & REM. CODE §41.001, et. seq., declaratory relief, costs and expenses, prejudgment and post-judgment interest as allowed by law, and for such other and further relief to which he may be justly entitled.

Should this go to court, Mr. Wakefield, In arguing a “injury to reputation and character, injury to feelings, humiliation, loss of earning capacity, will have to quantify the state of his reputation and character, feelings, humiliation and loss of earning capacity at the time. This will have to take into account the fact that he had already been struck off the medical register in the UK after being found to have committed “serious professional misconduct” and had lost his job at Thoughtful House. Were the donors to the “Strategic Autism Initiative” less likely to contribute after the BMJ articles?

Honestly, I thought the Andrew Wakefield saga was over and I was glad of it.

Mum’s plea: ‘Don’t miss MMR’ jab

17 Nov

The past couple of weeks has seen a lot of stories on vaccines again here at Left Brain/Right Brain. We’d all like to move along, but stories like “Mum’s plea: ‘Don’t miss MMR’ jab” just point out some of the real dangers involved, the real risks taken, when people don’t vaccinate.

Yes, there are people who can not vaccinate. Those of us who can vaccinate owe those people whatever protection we can offer.

She said confusion over the research by Dr Andrew Wakefield in the 1990s, which suggested the jabs could cause autism and bowel cancer, had convinced her not to allow her child to be inoculated.

However the 15-year-old was left in intensive care after being struck down with mumps.

His mother, who asked not to be named, said : “The doctor said to me it that if he didn’t have the MMR he would probably be okay because there would never be an epidemic.

There are a number of themes that come up repeatedly in discussions of vaccination online. Yes, Andrew Wakefield’s research has frightened (and continues to frighten) parents away from vaccination. Yes, there are doctors and parents counting on herd immunity to protect children (think Dr. Sears). Yes, these diseases are still dangerous, even in the developed world (for another example, read the story And another SSPE case: Angelina is dying and So predictable – so sad, Natalie dies of SSPE)

read the rest (it is relatively short) here.

The lack of substance in Andrew Wakefield’s supporters’ arguments

11 Nov

Andrew Wakefield, the man who brought us the MMR scare, is back in the news. In a relatively small way. Earlier this year, Mr. Wakefield was in the news in a big way when the BMJ called him out for research fraud. At the time, Mr. Wakefield was enjoying the hospitality of wealthy patrons in a Jamaican resort, under the auspices of a “vaccine safety conference“. Also attending the conference were a team from the National Whistleblowers Center (aside, I am getting more and more leery of groups that put “national” into their name). Why is this important? Because instead of responding to the BMJ article directly, Mr. Wakefield provided material to one of members of the Whistleblowers Center so he could reply. The letter, by David Lewis, attempts to address one of the many issues involved with Mr. Wakefield’s research. It does not do this well, to be frank.

One problem with discussing Andrew Wakefield’s work is that there is just so much wrong that one can easily lose the forest for the trees. The big picture gets lost going over count after count of dishonesty and unethical behavior.

When analyzing Mr. Lewis’ argument, there are again many problems to discuss. Once again, it is easy to lose the story for the details. Allow me to address a few.

First, the argument is a classic strawman. Mr. Lewis posits that it is reasonable for Mr. Wakefield to have reported nonspecific colitis in his 1998 Lancet article, therefore no intentional misinterpretation was committed. To bolster this argument, he provided the BMJ with the original scoring sheets used by the pathologist who reported on the samples. Writes Mr. Lewis:

As a research microbiologist involved with the collection and examination of colonic biopsy samples, I do not believe that Dr. Wakefield intentionally misinterpreted the grading sheets as evidence of “non-specific colitis.” Dhillon indicated “non-specific” in a box associated, in some cases, with other forms of colitis. In addition, if Anthony’s grading sheets are similar to ones he completed for the Lancet article, they suggest that he diagnosed “colitis” in a number of the children.

As though, even if accurate, this would exonerate Mr. Wakefield. As the BMJ point out, in not one, but two pieces by specialists (gastroenterologist and pathologist), these grading sheets do not support the claims made in the 1998 Lancet article.

If you don’t have time to read those short articles, here’s the title of one: “We came to an overwhelming and uniform opinion that these reports do not show colitis”. Pretty clear.

And, yet, one can already see the battle lines being drawn and the talking points distributed. Before, people ignored the facts and instead tried to frame this as a personal battle: “Brian Deer, journalist, vs. Andrew Wakefield, Doctor.” Just a quick tweak and we have “David Lewis, expert who knows colonic biopsy analysis vs. Brian Deer, mere journalist.” This is, of course, more convincing that “Opinion of soil scientist vs. a pathologist and a gastroenterologist.” And, of course, easier than tackling the facts.

Let’s consider some facts, then. The first sentence of the (now retracted) 1998 Lancet paper: “We investigated a consecutive series of children with chronic enterocolitis and regressive developmental disorder. ”

“Consecutive series” was, at best, misleading given the facts of how the children were referred to the Royal Free. A fact not addressed in any way by Mr. Lewis.

“Chronic enterocolitis”. Note, “enterocolitis”. Not “non-specific colitis”. Let’s break this down. “-itis” means inflammation. Colitis “refers to an inflammation of the colon and is often used to describe an inflammation of the large intestine (colon, caecum and rectum).”

All fine so far. But, “enterocolitis“? The word actually used in the first sentence of the Lancet? The word used in the condition Mr. Wakefield coined for the condition he proposed, “autistic enterocolitis“? Enterocolitis is “an inflammation of the colon and small intestine.” And small intestine.

You can check the scores on grading sheets in the table Mr. Deer provided on his website. These include links to the scanned sheets themselves. For example, the sheets for Child 1.

The sheets and the table are arranged in a specific order: top down. From the highest point reached in the colonoscopy on down to the rectum (the exit of the large intestine).

Why point this out? Because you will notice from the table that for two of the eleven children reported (child one and twelve), there are no data for the duodenum (start of the small intestine) or the ileum (as noted in the Lancet article). Those reports start at the Caecum (the start of the large intestine) or lower. For some of the other children (child four, seven and nine), there are data, and they are listed as “normal”. The Lancet reports them as having lymphoid nodular hyperplasia. Child two has some notation, but again is checked “normal” by Dr. Dhillon. Likewise child 5 and child 6.

Which begs the question: how can you diagnose “enterocolitis”, inflammation of the large and small intestine, without data from the small intestine, or when the data you do have is normal? For 8 out of the 11 children, by my count.

Answer: you can’t. Hence the switch from “enterocolitis” to “non-specific colitis” in Mr. Lewis’ letter to the BMJ. In that letter, the term “enterocolitis” only appears in his citation of a Brian Deer article.

So, back to the first sentence of the Lancet article and ask, what is accurate? Let’s include the points made by Mr. Deer that not all these children demonstrated regression, and there wasn’t a single developmental disorder. So, with thanks to a reader who pointed this out: “We investigated a consecutive series of children with chronic enterocolitis and regressive developmental disorder(s).

or,

“We investigated children with developmental disorder(s)”

Not really very exciting.

While I have fallen into the trap I described at the outset, losing the forest for the trees, allow me to discuss one last piece of the way people are attempting to frame the way Mr. Wakefield wrote his paper. Instead of being an active researcher, it seems he is considered to be merely the man who collected the data and typed the manuscript. Mr. Lewis wrote, “I do not believe that Dr. Wakefield intentionally misinterpreted the grading sheets as evidence of “non-specific colitis.” ”

As though the entire process of diagnosing children with enterocolitis involved looking at Mr. Dhillon’s grading sheets. Once again, what did the Lancet article say? Under “Histology”:

Formalin-fixed biopsy samples of ileum and colon were assessed and reported by a pathologist (SED). Five ileocolonic biopsy series from age-matched and site-matched controls whose reports showed histologically normal mucosa were obtained for comparison. All tissues were assessed by three other clinical and experimental pathologists (APD, AA, AJW).

AJW refers to Andrew J. Wakefield. So, did he just accept the diagnoses from others, as we are being asked to believe now, or did he assess tissues, as he wrote in the Lancet in 1998? Seems an important point to downplay, as Mr. Lewis is not attempting.

To bring this to a close, a press release has been issued in support of Andrew Wakefield. Mr. Lewis is quoted:

“There was no fraud committed by Dr. Wakefield. The crux of the matter in Wakefield’s case, so far as research fraud is concerned, is whether Wakefield fabricated the diagnosis of non-specific colitis for 11 of the 12 Lancet children as claimed in Table 1. Drs. Paul Dhillon’s and Andrew Anthony’s grading sheets clearly show that Wakefield did not fabricate the diagnoses of non-specific colitis reported in the Lancet article.”

Well, no. Nonspecific colitis is not the “crux of the matter” at all. Mr. Lewis is referred to Mr. Deer’s article, and the discussion of regressive autism and when symptoms appeared. Facts which were not reported accurately in the Lancet.

And there’s that whole first sentence not being accurate at all thing…let’s not even get started on the concluding sentence:

We have identified a chronic enterocolitis in children that may be related to neuropsychiatric dysfunction. In most cases, onset of symptoms was after measles, mumps, and rubella immunisation. Further investigations are needed to examine this syndrome and its possible relation to this vaccine.

Brian Deer on Andrew Wakefield: Pathology reports solve “new bowel disease” riddle

10 Nov

Today the British Medical Journal (BMJ) released a four articles on Andrew Wakefield and his research efforts at the Royal Free Hospital. To sum up the four articles in a single sentence (from Fiona Godlee of the BMJ): “Previously unpublished histopathology grading sheets apparently completed by Amar Dhillon, the senior pathologist on the paper, remove any remaining credibility from the claim that the Royal Free doctors had discovered a new inflammatory bowel disease associated with MMR”

For those who may wish a bit of background, earlier this year, the BMJ had a series of articles on Mr. Wakefield’s research:

Secrets of the MMR scare: how the case against the MMR vaccine was fixed (Feature by Brian Deer)

Secrets of the MMR scare How the vaccine crisis was meant to make money (Feature by Brian Deer)

The Lancet’s two days to bury bad news (Feature by Brian Deer)

and

Wakefield’s article linking MMR vaccine and autism was fraudulent (editorial by Fiona Godlee of the BMJ)

These articles came after Mr. Deer was able to review the transcripts of Mr. Wakefield’s “Fitness to Practice” hearings held before the General Medical Council (GMC).

Mr. Wakefield’s work focused on gastrointestinal disease. He went so far as to claim to have found a new syndrome, which he coined autistic enterocolitis. 13 years later, there is still no proof such a condition actually exists. When evidence came forward that the discussion of the children in the Lancet did not match the clinical records, Mr. Wakefield claimed that ““Dr Dhillon’s diagnosis formed the basis for what was reported in the Lancet,” and “I played no part in the diagnostic process at all.” Unfortunately it has been difficult to verify these statements. For one, the slides made from the samples taken from the children in the Lancet study are apparently missing, so direct comparison of what was reported in the paper to what was actually found in the children was difficult. Also, Dr. Dhillon’s analyses were not available. Until now. The scoresheets used by Amar Dhillon, the pathologist coauthor on the 1998 Lancet article, were recently made available to the BMJ. These form the basis for the articles published today.

In his new BMJ article, Pathology reports solve “new bowel disease” riddle, Mr. Deer discusses the pathology reports. He compiled a table based on these reports (for example, the report from Child 1). If I can summarize Mr. Deer’s discussion: what is striking about these reports is that they are not striking. Dr. Dhillon used his own score method to rank the disease found in the specimens. In most cases, these were “normal” or “mild”.

Mr. Deer shared the reports with a number of professionals for comment. Including Dr. Henry Appleman:

“Most of this stuff is so close to normal that you’ve really got to question whether there is really anything there,” said Henry Appelman, professor of surgical pathology at the University of Michigan and a specialist in gastrointestinal disease. “These are the kind of things that we in our practise here would ignore completely.”

And Ingvar Bjarnason:

“Everyone thinks I am crazy even asking them,” said King’s gastroenterologist Bjarnason, after discussing the scorings with other specialists. “All but one of the children is normal in their eyes. There is no enteritis and no colitis, simple as that.”

While the reports were not striking, there is indication of inflammation. Mr. Deer argues that a key point was left out of the Lancet article, the presence of constipation in many of the children, which would have put the inflammation signs into better perspective for the readers:

No less controversial, the authors omitted from the paper the children’s principal gastroenterological problem. “Almost all” had “severe” constipation.(30) The GMC panel heard, for example, that after bowel preparation by nasogastric tube, the first patient, who had mild caecal cryptitis, endured two attempted ileocolonoscopies that failed because of faeces in the caecum, with “scope trauma” noted on the second.

This omission of constipation was no small matter. It went to the heart of how the paper would be read. Specialists told me that both mild inflammation and prominent lymphoid follicles may be expected to be associated with this sign.

(30) Murch S, Thomson M, Walker-Smith JA. Authors’ reply. Lancet 1998;351:908.

Mr. Deer, of course, is not a medical professional. But, we do not have to rely solely on Mr. Deer’s report. The BMJ has two companion pieces by medical professionals.

In Commentary: I see no convincing evidence of “enterocolitis,” “colitis,” or a “unique disease process”, Karel Geboes, Professor Doctor, Department of Pathology Univ Hospital KUleuven reports:

In general, the data are rather similar to the reports of the Royal Free hospital pathology service, which I reviewed for the BMJ last year.(7) Although minor abnormalities are noted in a minority of patients, I see no convincing evidence of “enterocolitis,” “colitis,” or a “unique disease process” being present in all patients. The Wakefield et al paper is obviously problematic and its wording does not reflect the data shown in the grading sheets.

(7) Deer B. Wakefield’s “autistic enterocolitis” under the microscope. BMJ 2010;340:c1127.

In Commentary: We came to an overwhelming and uniform opinion that these reports do not show colitis, Dr. Ingvar Bjarnason, professor of digestive diseases, consultant physician and gastroenterologist at King’s College, London, writes:

The hospital pathology service found the histopathology to be normal,(3) and, except in the case of the child mentioned above, the grading sheets also note normal findings. The fact that these scores were interpreted as abnormal raises, in my opinion, questions for the authors of Wakefield et al to answer, and particularly for the consultant histopathologists.

From the histological and endoscopic reports, there are no grounds to believe that any new inflammatory bowel disease may have been discovered, or any possible “unique disease process” observed, as reported by Wakefield et al. Nothing can be said about the aetiology of any minor irritations noted, and nothing can be inferred regarding treatment.

(3) Deer B. Wakefield’s “autistic enterocolitis” under the microscope. BMJ 2010;340:c1127.

In Institutional research misconduct, Failings over the MMR scare may need parliamentary inquiry, BMJ editor Fiona Godlee discusses how there is no sign that the Royal Free Hospital (University College London) has begun the expected inquiry into the misconduct which occurred there in the 1990’s:

It is now more than 18 months since the UK’s General Medical Council found Andrew Wakefield guilty of dishonesty and other serious professional misconduct(1) ; and it is nearly a year since the BMJ concluded that his now retracted Lancet paper linking the measles, mumps, and rubella (MMR) vaccine with autism and bowel disease was an “elaborate fraud.”(2) (3) At that time, January 2011, we called on Wakefield’s former employer, University College London (UCL), to establish an inquiry into the scandal. Ten months on, no inquiry has been announced.

Ironically, these data were made available to the BMJ with the intent of exhonerating Mr. Wakefield.

In 1997, Dhillon was asked to reassess intestinal biopsy specimens taken from children enrolled in Wakefield’s research after the hospital’s histopathology service, under consultant and fellow coauthor Susan Davies, reported most of the children’s biopsies to be normal. His 62 A4 grading sheets were sent to the BMJ by c, a self employed environmental microbiologist. Lewis says he was given them by Wakefield after they met at a vaccine safety conference in January. In his accompanying letter, Lewis concludes that a non-expert pathologist such as Wakefield could have thought they showed that the children had non-specific colitis.

Ms. Godlee is being kind, in my opinion, using the title the self-styled “vaccine safety” conference chose. This was the same conference in Jamaica which was discussed here at Left Brain/Right Brain recently.

It strikes me as rather odd that Mr. Wakefield did not provide these documents to the BMJ directly. Perhaps in a response to the articles published earlier this year. What advantage he gained in providing them through a proxy is unclear.

When he was found guilty of misconduct by the GMC, Mr. Wakefield vowed that he would not go away. So far, this appears true. However, his arguments are getting weaker as time goes on. In this case, they seem to have outright backfired. Writes Ms. Godlee:

The grading sheets are certainly interesting, but not for the reasons Lewis (or, it may be assumed, Wakefield, in giving them to him) intended. We sent them to two independent reviewers and supplied the data for comment to two further senior gastroenterologists. We also showed them to Brian Deer, the investigative journalist who over the past eight years has uncovered the secrets behind the MMR scare and who arguably knows more about this case than anyone apart from Wakefield. Our expert reviewers are in no doubt that Dhillon’s findings—like Davies’s before him—are almost all normal, or as near to normal that the changes they reported were likely to be physiological.(6) (7) In an accompanying feature article, Deer explains what they add to our knowledge of the Wakefield saga.(8)

(6) Geboes K. Commentary: I see no convincing evidence of “enterocolitis,” “colitis,” or a “unique disease process.” BMJ 2011;343:d6985.
(7) Bjarnason I. Commentary: We came to an overwhelming and uniform opinion that these reports do not show colitis. BMJ 2011;343:d6979.
(8) Deer B. Pathology reports solve “new bowel disease” riddle. BMJ 2011;343:d6823.

← Older Entries
Newer Entries →