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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.

The Wakefield Rehabilitation? Not really.

18 Oct

Reading about Andrew Wakefield gets old and tiring. I’m sure that isn’t news to readers here. Writing about Andew Wakefield gets very tiring. Who wants to keep reminding him/her self about a man who has caused so much harm to both the autism communities and public health in general? Who wants to read about dishonesty and unethical behavior?

I can only imagine that Brian Deer must want to put his award on a shelf and move on.

Which all begs the question: why do I think people reading Left Brain/Right Brain might want to read about him again? Because in this case it isn’t about Mr. Wakefield. Rather it is about his supporters. People who put aside the proved charges of dishonesty and unethical behavior. People such as Kent Heckenlively of the Age of Autism blog who are looking for The Wakefield Rehabilitation. It’s about how and why authors cite previous literature, and not reading too much into citations.

Beyond the hopes of those supporting Andrew Wakefield, there is some good research here and a bit of information about how and why people cite certain papers in the scientific literature.

First, how is Mr. Wakefield being “rehabilitated”? Answer: his papers were recently cited in a recent study. Seriously, something that small. That’s how hard people have to look for validation for Mr. Wakefield. A few citations and he’s on the road to rehabilitation.

The new paper isn’t by just any team, though. The study, recently out in PLoS One is Impaired Carbohydrate Digestion and Transport and Mucosal Dysbiosis in the Intestines of Children with Autism and Gastrointestinal Disturbances. The study is a follow-on to the PLoS One paper by Hornig et al., Lack of association between measles virus vaccine and autism with enteropathy: a case-control study.

Why is that important? “Lack of association…” is the paper which definitively put an end to the Wakefield MMR hypothesis. The team tried, with meticulous attention to detail, to replicate the most important factors of various Wakefield MMR-autism papers. They studied children with autism and gastro-intestinal complaints. They restricted their study to children who had demonstrated clear need for endoscopy (one major difference from the Wakefield studies). They were very careful about correctly reporting the patient histories (another major difference). They tested intestinal biopsy samples for measles virus (similar to as study by the Wakefield team), but were very careful to avoid contamination (unlike the Wakefield studies). The recent study used multiple laboratories to test for measles virus (Wakefield used two: his own and the O’Leary laboratory). Unlike Mr. Wakefield, the recent study reported on results from all the laboratories (Mr. Wakefield neglected to mention the results from his own laboratory which were contradictory to his theory).

Hornig et al. wrote:

The work reported here eliminates the remaining support for the hypothesis that ASD with GI complaints is related to MMR exposure. We found no relationship between the timing of MMR and the onset of either GI complaints or autism. We also could not confirm previous work linking the presence of MV RNA in GI tract to ASD with GI complaints.

About as clear a conclusion as I’ve ever seen. “The work reported here eliminates the remaining support for the hypothesis that ASD with GI complaints is related to MMR exposure.”

So, what about the new paper and the citations? Well, members of the team that produced the Hornig et al. study did further research on the tissue samples taken. Brent L. Williams heads up the author list on the new study.

Here is the (highly technical) abstract from the new study by Williams et al.:

Gastrointestinal disturbances are commonly reported in children with autism, complicate clinical management, and may contribute to behavioral impairment. Reports of deficiencies in disaccharidase enzymatic activity and of beneficial responses to probiotic and dietary therapies led us to survey gene expression and the mucoepithelial microbiota in intestinal biopsies from children with autism and gastrointestinal disease and children with gastrointestinal disease alone. Ileal transcripts encoding disaccharidases and hexose transporters were deficient in children with autism, indicating impairment of the primary pathway for carbohydrate digestion and transport in enterocytes. Deficient expression of these enzymes and transporters was associated with expression of the intestinal transcription factor, CDX2. Metagenomic analysis of intestinal bacteria revealed compositional dysbiosis manifest as decreases in Bacteroidetes, increases in the ratio of Firmicutes to Bacteroidetes, and increases in Betaproteobacteria. Expression levels of disaccharidases and transporters were associated with the abundance of affected bacterial phylotypes. These results indicate a relationship between human intestinal gene expression and bacterial community structure and may provide insights into the pathophysiology of gastrointestinal disturbances in children with autism.

If this were really about the autistics and not about Andrew Wakefield, those claiming that there is something different about the GI disturbances in autistics should be extatic. Here is a top notch team pointing to a possible real difference. In the kids tested, the genes were expressing enzymes and transporters–i.e. the genes are performing differently–for autistic kids. Also, they are seeing differences in the bacteria in the autistic kids.

Not only that, but these kids benefited from dietary intervention, although it isn’t specific to the autistic kids: “Beneficial effects of dietary intervention on GI disturbances were reported for all AUT-GI and Control-GI subjects with FA.”

But, it apparently isn’t about the autistics or the research when it comes to the Age of Autism. It’s about rehabilitating Andrew Wakefield’s reputation. (With apologies in advance–the image that comes to mind is a team that has been performing CPR on his reputation for years now. It’s time to move on.)

The important piece of this study, according to Mr. Heckenlively, is that they cite some of Andrew Wakefield’s papers. In particular:

Wakefield AJ, Anthony A, Murch SH, Thomson M, Montgomery SM, et al. (2000) Enterocolitis in children with developmental disorders. Am J Gastroenterol 95: 2285–2295.

Wakefield AJ, Ashwood P, Limb K, Anthony A (2005) The significance of ileo-colonic lymphoid nodular hyperplasia in children with autistic spectrum disorder. Eur J Gastroenterol Hepatol 17: 827–836

Ashwood P, Anthony A, Torrente F, Wakefield AJ (2004) Spontaneous mucosal lymphocyte cytokine profiles in children with autism and gastrointestinal symptoms: mucosal immune activation and reduced counter regulatory interleukin-10. J Clin Immunol 24: 664–673.

Mr. Heckenlively appears to have built a nice straw man argument in which every thing Mr. Wakefield has done is now discredited. Somehow citing a paper by Mr. Wakefield then becomes some sort of a statement that everything he did was actually right. Both sides of that argument are false. The authors should cite what is in the literature. By citing, say, the Ashwood (2004) paper, they aren’t saying that, say, the 1998 Wakefield Lancet paper is now “rehabilitated’.

Notice that the authors didn’t cite the 1998 Lancet paper. One big reason: it’s been retracted. Which begs the question, why are the authors citing Wakefield et al. (2000)? The paper in the American Journal of Gastroenterology has also been been retracted:

On 28 January 2010, the UK General Medical Council’s Fitness to Practice Panel raised concerns about a paper published in the Lancet by Dr Wakefi eld et al. (1). The main issues were that the patient sample collected was likely to be biased and that the statement in the paper, that the study had local ethics committee approval, was false. Th ere was also the possibility of a serious conflict of interest in the interpretation of the data. Th e Lancet has now retracted this paper (1). Th is paper in the American Journal of Gastroenterology (AJG) (2) also includes the 12 patients in the original Lancet article and therefore we retract this AJG paper from the public record.

One really shouldn’t cite things that have been retracted from the public record. So, is there some message that Williams et al. are trying to send us? Are they saying that Andrew Wakefield was correct all along? Hardly. That paper was retracted in May of 2011, the same time that Impaired Carbohydrate Digestion and Transport and Mucosal Dysbiosis in the Intestines of Children with Autism and Gastrointestinal Disturbances was submitted to PLoS One. The authors weren’t aware of the retraction. Says a lot about how closely they follow Andrew Wakefield, don’t it?

Apparently, the authors have contacted PLoS about the citation, and it will be corrected to notify readers of the retraction. That is the right thing to do. It isn’t a statement about Mr. Wakefield’s research, other than this paper was retracted.

Authors can’t control the message bloggers may try to create from their research (heck, one of the authors, Ian Lipkin, consulted on the recent movie “Contagion”, a main character is a blogger whose message is unscientific and irresponsible). From what I’ve heard, the authors are still very clear on the message of their first PLoS paper: “The work reported here eliminates the remaining support for the hypothesis that ASD with GI complaints is related to MMR exposure. ”

I think the point was made pretty clearly. Mr. Heckenlively in his excitement read way too much into this new paper. Not surprisingly, he just goes on and on making more mistakes. Consider this paragraph:

Isn’t Dr. Wakefield supposed to be some super-villain, leading all of us gullible parents to believe that vaccines aren’t quite as safe as sugar water? Didn’t he make up fake diseases? So, after being stripped of his license to practice medicine in the U. K., it turns out there really is something called autistic entercolitis and ileo-colonic lymphoid nodular hyperplasia in children with autism. At least Dr. W. Ian Lipkin seems to think so.

Wow. All this is extrapolated from a single sentence in the introduction of the paper: “Macroscopic and histological observations in ASD include findings of ileo-colonic lymphoid nodular hyperplasia, enterocolitis, gastritis, and esophagitis [2], [3], [4], [5], [6], [7].”

What does that sentence mean? Simple interpretation: others have reported these findings. Not “we confirm that these findings are real”. Given that reference [3] (a retracted Wakefield paper) may be removed or noted to be retracted, the only support for “enterocolitis” will be gone from the paper.

Mr. Heckenlively wrote “Although this study used a relatively small sample of gut biopsies from children with autism (Hey, isn’t that what Wakefield got in trouble for? Or is my memory failing me?),”

Mr. Heckenlively, your memory is failing you. The findings of the General Medical Council are easily found online.

Let me remind you of some of that document:

The Panel concluded that Dr Wakefield’s shortcomings and the aggravating factors in this case including in broad terms the wide-ranging transgressions relating to every aspect of his research; his disregard for the clinical interests of vulnerable patients; his failure to heed the warnings he received in relation to the potential conflicts of interest associated with his Legal Aid Board funding; his failure to disclose the patent; his dishonesty and the compounding of that dishonesty in relation to the drafting of the Lancet paper; and his subsequent representations about it, all played out against a background of research involving such major public health implications, could not be addressed by any conditions on his registration. In addition, the Panel considered that his actions relating to the taking of blood at the party exemplifies a fundamental failure in the ethical standards expected of a medical practitioner. It concluded that conditional registration would not mark the seriousness of such fundamental failings in his duty as a doctor

and

The Panel made findings of transgressions in many aspects of Dr Wakefield’s research. It made findings of dishonesty in regard to his writing of a scientific paper that had major implications for public health, and with regard to his subsequent representations to a scientific body and to colleagues. He was dishonest in respect of the LAB funds secured for research as well as being misleading. Furthermore he was in breach of his duty to manage finances as well as to account for funds that he did not need to the donor of those funds. In causing blood samples to be taken from children at a birthday party, he callously disregarded the pain and distress young children might suffer and behaved in a way which brought the profession into disrepute.

Mr. Heckelively also poses the question: “Didn’t he [Andrew Wakefield] make up fake diseases?”

That would be “autistic enterocolitis”, a term Andrew Wakefield coined and a condition which still, 13 years later, doesn’t have support. Autistic enterocolitis is not just any and all GI disturbances in autistics. Enterocolitis is “…an inflammation of the colon and small intestine”. Note the “and”, there. Even more important, the PLoSOne paper is not about inflammation at all.

Mr. Heckenlively finishes with the rather hopeful, wishful thinking statement: “But if a big shot scientist like Dr. W. Ian Lipkin is quoting Dr. Andrew Wakefield as a reliable source, maybe the rest of the world will soon be doing the same thing.”

Again, wow. Here we have Ian Lipkin, one of the team that just put an end to the Wakefield-MMR hypothesis. Again, let’s remind ourselves, Ian Lipkin is part of the team which wrote: “The work reported here eliminates the remaining support for the hypothesis that ASD with GI complaints is related to MMR exposure.” There is such a major disconnect between that statement (which, yes, Dr. Lipkin stands by) and what Mr. Heckenlively wrote that I am just left in amazement.

This isn’t a story about rehabilitation. This is a story about diversion. Diversion of attention away from important subjects in autism. These include the medical treatment of major health problems. How does one treat something like bowel problems in individuals with communication and/or sensory difficulties? That’s a big question that gets lost in this whole “Andrew Wakefield” discussion. Research like this new paper is important in that respect: is there something specific to kids with autism, regression and GI disease? Leave aside any discussion about GI being linked to the regression, how do you treat it? I, for one, am glad to see something come out of this research project than just the “MMR doesn’t cause autism and GI disease” conclusion. Instead of trying to read the tea leaves of this paper and try to recoup the damage Andrew Wakefield did to his reputation, why don’t we just read the paper in the context of what this might tell us about the health problems of autistics?

The 2011 “Vaccine Safety Conference” in Jamaica

6 Oct

Earlier this year, a conference was held in Jamaica. The declared subject: vaccine safety. Even from the beginning, it was clear that this was no ordinary scientific conference. It had all the signs of a junket. A meet-and-greet for vaccine “skeptics” and wealthy patrons. Precisely the sort of junket that people complain about “Big Pharma” hosting. Well, not precisely. I suspect even Big Pharma doesn’t put on such a lavish event.

The number of speakers was small (only 19), and didn’t include anyone who is a vaccine researcher. 21 presentations were made in the course of a week, leaving a lot of time for people to enjoy the resort and to network.

Talks included “Rethinking the germ theory”, “Vaccination Programs: Prevention or Corruption?” and “Gardasil: Prophylaxis or Medical Misconduct?”.

Getting a picture of the conference agenda? And by “agenda”, I do not mean the schedule.

The conference received some brief public attention when Anderson Cooper interviewed Andrew Wakefield. Mr. Wakefield (who refused to be on the segment if Seth Mnookin were included) appeared via Skype from that conference in Jamaica. Mr. Wakefield’s talk at the conference: “Autism & Vaccines: a Research Strategy Focused on Cause”.

The event was titled: Vaccine Safety|Evaluating the Science Conference. A nearly one week event (January 3-8) in the Tryall Club in Jamaica.

I’ve been to a lot of scientific conferences. I’ve even helped organize scientific conferences. None of them were ever held in a place remotely similar to the Tryall Club. Heck, when I think of “big pharma” hosting junkets for doctors, it’s in places not nearly as nice as the Tryall Club.

In case you didn’t get a chance to see the website, here’s a picture of the Tryall Club:

Nice, isn’t it? The Tryall Club isn’t a hotel. It is a collection of 86 Villas (including 73 privately owned estate villas) plus 13 “great house” suites.

The property’s 86 villas offer visitors a dazzling array of options, from beachfront bungalows to elegant hillside chalets. Each carefully situated villa offers distinctive architectural elements, a singular style and a unique floor plan. A couple may choose a cozy one-bedroom retreat, while an extended family of several generations may opt for a 7- or 8-bedroom manor.

Consider as an example, the six bedroom “Twin Palms” Villa. Cost for 1 week: $30,000, or $5,000 per bedroom. (Cost is $40K/week if you include the master suite). The Villa comes complete with a staff of 9 and “Dining areas are designed to seat 20 guests or more. Formal dining is in the 80’ dining room under Italian chandeliers at place settings of Lalique crystal, Tiffany china and silver from France.”

As I said, not like any conference I’ve ever attended.

So, who put this conference on? Aside from a stay in Jamaica, were the attendees compensated? I wondered these questions so I emailed the contact address on the website. Here’s the response:

The conference was co-sponsored by the National Vaccine Information Center and private individuals and family foundations who are concerned about the safety of vaccine ingredients, preparations, combinations and schedules. Speakers volunteered to speak as is customary for scientific conferences, and accommodations were provided in private homes donated by or as guests of individuals who are concerned about vaccine safety. No funds exchanged hands except to reimburse for travel expenses, which were funded by donations to the National Vaccine Information Center.

The Vaccine Safety Conference

“No funds exchanged hands except to reimburse for travel expenses, which were funded by donations to the National Vaccine Information Center.” Nice. Reimbursing the speakers directly probably isn’t tax deductible. Donating to NVIC is. And it lets NVIC look like they are pulling more money.

Who put this on? The sponsors are listed clearly on the conference website:

Albert J. and Lisa Claire Dwoskin Family Foundation

Cmdr. Richard and Joan Curtis

Mark and Candace Hart

Daisy and Paul Soros

Danny and Stency Wegman

One name jumps out (to me at least): Soros. Sponsors Paul and Daisy Soros. Paul Soros is the brother of George Soros, but is quite well off in his own right.

We are talking some serious money was backing this conference.

Case in point. First in that list is the Dwoskin family. Claire Dwoskin has worked as a board member of the National Vaccine Information Center.

The Dwoskins have hosted fundraisers for political candidates at their home and been guests at White House dinners.

Apparently, they also set up the “vaccine safety” conference website. Mrs. Dwoskin is listed as the contact for the website:

Administrative Contact:
Dwoskin, Claire novaccine4me@XXXXX.com
Vaccine Safety Conference

No, I did not make that email address up. It really is listed as “novaccine4me”. Pause a moment to consider that choice.

The physical address given for the website contact is that of the McLean, Virginia home of the Dwoskins. It is sizable and valuable. As the domain registration reports, this is also the address for “Vaccine Safety Conference”. It seems reasonable to assume that the Dwoskins are the primary organizers of the conference. The Dwoskins also appear to own other valuable property. Mr. Dwoskin is a real estate developer, so this is no great surprise. But, one property which they (or their business) are associated with: Twin Palms. Yes. the 7 bedroom Villa in Jamaica described above. What leads me to believe this? The website twinpalmsjamaica.com is registered to A.J. Dwoskin & Associates.

Seems reasonable to think that the first tier of presenters at the conference were hosted in Twin Palms.

In case you are curious as to the Dwoskins’ position on vaccines, Mrs. Dwoskin wrote in an email to John Stossel of Fox: “Vaccines are a holocaust of poison on our children’s brains and immune systems.”

Seriously. A holocaust of poison.

There is nothing wrong with wealthy people hosting gatherings of people on a subject they feel strongly about. Anyone who chooses an email address “novaccines4me” and considers vaccines “a holocaust of poison” certainly has strong feelings.

Wealthy people have a right to offer their hospitality to people who may promote their views. People with less means have the right to accept the largess of the wealthy.

I have the right to voice my opinion. This was a junket. Seriously. 6 days to have 19 speakers present? Rooms costing $5,000 a week? I wonder how much time at the “vaccine safety” conference was spent talking about safety and how much was spent talking about the “holocaust of poison” view of vaccines.

Next time I hear or read about Big Pharma buying off doctors with exotic junkets I’ll be thinking of Andrew Wakefield, talking via Skype from the Tryall Club in Jamaica.

Law Firm Faces Legal Action Over Handling Of MMR Vaccine Case

21 Sep

This story is in the U.K. version of the Huffington Post. The article, Law Firm Faces Legal Action Over Handling Of MMR Vaccine Case, brings the question of MMR litigation back up, but in a different way. First, the families are claiming that encephalitis, not autism, was the claimed injury. Second, they are suing the law firm that handled the case, not the vaccine manufacturers.

Three families who claim their children suffered a potentially fatal illness from the mumps, measles and rubella (MMR) vaccine are suing a law firm they say grouped them with a now discredited case over a link between the jab and autism.

A case was brought against the manufacturers of the MMR jab – Smithkline Beecham, Smith Kline & French Laboratories and Sanofi Pasteur MDF – in 2007, over claims that the jab caused autism in children. However three families who say the vaccine caused encephalitis in their children, not autism, believe they were unable to claim compensation because of the way the case was dealt with.

Note that the Huffington Post has the dates wrong in the section quoted above. The case was brought in the late 1990’s and abandoned in 2003 when lack of evidence resulted in a loss of public funds to support the investigation further.

The BMJ also covers the story, noting that in 2002 the then chairman of the UK’s Committee on Safety of Medicines, Alasdair Breckenridge, said: “There is sound evidence that mumps vaccine containing the Urabe stran of virus is associated with a risk of meningitis and [has} no proven additional benefits. The risk to children of a potentially serious neurological complication makes its use unacceptable.”

Since the focus here at Left Brain/Right Brain is primarily autism, and the Wakefield case has been discussed (and discussed, and discussed), I expect that most readers know the basic story. But, indulge me for a moment while I give a short history.

Back in the mid-1990’s, some families believed that MMR caused their child’s autism. They sought both legal and medical expertise to pursue their case. The legal end was led by Richard Barr of the firm Alexander Harris. For medical expertise, they (parents and leagal team) approached Andrew Wakefield, a research gastroenterologist who had just recently implicated the measles vaccine in Crohn’s disease.

After Mr. Wakefield and his team published their first paper in The Lancet in 1998 (a paper since retracted), he became even better known for his views on MMR. Sometime after this, attorney Richard Barr was contacted by a public health insider with concerns about the MMR. Mr. Barr and Mr. Wakefield met with this “whistleblower” in secret.

The thing is, the concern was about encephalitis from the mumps component. Not autism from the measles component, as was Mr. Wakefield’s hypothesis.

The meeting between Mr. Wakefield and this gentleman became known only recently, 1998, while Mr. Wakefield faced charges before the General Medical Council. Mr. Wakefield released details of his story and threatened to disclose the name of the “whistleblower”. Mr. Wakefield later followed through on this threat.

This raises very important questions. Most notably, why didn’t the legal and scientific team working on MMR litigation follow up on the mumps/encephalitis question? The idea was known to Mr. Wakefield and Mr. Barr. The MMR litigation went forward with the theory that the measles component was causing autism, and failed.

And now some parents consider these events to be a strong enough case to sue a law firm handling their case: Alexander Harris.

The families claim the MMR vaccine brought neurological injury and are suing the law firm that brought the original litigation against the vaccine’s manufacturer.

As part of the group autism case, the families claim they were deprived of the compensation likely to come from bringing individual actions.

Mr. Wakefield’s discussion of his meeting with the “whistleblower”, together with commentary from Brian Deer, is in the video below:

While Mr. Deer focuses on how Mr. Wakefield is treating the “whistleblower”, another big question is left open by this discussion: did Mr. Wakefield act on the information he was given? Did the attorneys? The secret meeting in the train station makes a rather dramatic story, but it doesn’t really reflect well on Mr. Wakefield.

Lessons from the MMR scare

13 Sep

Fiona Godlee, editor of the British Medical Journal (BMJ), recently presented to the National Institutes of Health on the “Lessons from the MMR scare”.

The talk is now online at the NIH site (no embed link is obvious to me at present).

The talk gives a nice hour long discussion of the issues surrounding Andrew Wakefield’s research efforts in autism and the MMR vaccine.

One of the points Ms. Godlee goes into is a good example of the sort of falsification that is prevalent in the Lancet paper. She discusses the fact that 11 of the 12 families thought that the MMR vaccine was linked to developmental regression. The paper reported that only 8 families felt there was a link. Earlier drafts of that more families thought there was a link, but those families reporting long times to onset after MMR were removed.

Another discrepancy to emerge during the GMC hearing concerned the number of families who blamed MMR. The paper said that eight (1, 2, 3, 4, 6, 7, 8, and 11) linked developmental issues with the vaccine. But the total in the records was actually 11. The parents of child 5, 9, and 12 were also noted at the hospital as blaming the vaccine, but their stated beliefs were omitted from the journal.

It is one of those very simple arguments that shows misrepresentation of the facts.

How did the misconduct become exposed? She discusses how 4 factors played into why this case of fraud was exposed:

1) A skilled investigative reporter was put on the case (Brian Deer)
2) the freedom of information act was enacted in 2000 (allowed access to information)
3) Mr. Wakefield’s decision to sue Brian Deer. (This forced Brian Deer to do further digging to defend himself.)
4) The GMC’s decision to take up the case. (This placed much data in the public domain)

It has been discussed a number of times previously that Mr. Deer gained access to the medical records after the lawsuit was started, and that the lawsuit was withdrawn literally as he was reviewing the documents.

She discusses the backlash that the BMJ has received with negative comments. Also some very strange misrepresentations. For example, an article in “Natural News” is incorrect (not surprising to those familiar with the site) in stating “BMJ admits that fraud claim against Dr. Andrew Wakefield has no basis in fact”.

She discusses the claim that Andrew Wakefield’s work has been replicated. It is a common argument that comes up. And, it isn’t true. There are attempts to replicate which his work which failed to do so.

No legal challenge from Mr. Wakefield and no complaints to the press complaints commission. Interestingly (to me at least) is that he declined an offer from the BMJ to write a reply.

I find it intersting that she couldn’t even recall Jim Carrey’s name (and had even less recall of Jenny McCarthy’s name).

She points out that the GMC was not really the proper forum to investigate the research fraud. But, at present the UK has no office of research integrity.

She poses the question of what could have been done to prevent this. She suggests that greater oversight needs to be in place. She also points out that co-authors need to take a more active role in oversight of data reporting. Better peer review is needed. But when an author lies, it is difficult for an editor to discover it. There should be some level of penalty for research fraud–as in, why isn’t this a criminal act?

She calls for better research on vaccine safety research. Also for better autism research.

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