Wakefield Drops a Bomb

Well, not really, merely an execrable bit of ordure (redundant, I know, but apropos) meant to titillate his adoring fans and distract from the larger issue of why he was erased from the GMC register. Andrew Wakefield appeared on the Today Show, Wednesday, 24 May 2010 and made some statements regarding the replication of his research and his accusation that the U.S. government has been settling vaccine-induced autism cases, some in secret, since 1991. Here is the clip from the Today Show:

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Here is the transcript of the interview that Leftbrain/Rightbrain has kindly put together (the times the relevant quotes appear in the video are marked in red):

INTRO

MATT LAUER: [But]...in the years following his publication in The Lancet.no large scale study could reproduce exactly what Dr. Wakefield’s small study found. Dr. Wakefield is here for an exclusive interview. Doctor, good morning.

WAKEFIELD: Good morning Matt.

MATT LAUER: It may sound like a strange way to start the interview but…do I still refer to you as Doctor?

WAKEFIELD: Yes, they can’t take away the fact that I have a medical degree.

MATT LAUER: You were not surprised by this action … the stripping of your medical license. Why?

WAKEFIELD: Not at all. It was determined from the very beginning I believe, the pressure the government brought on the GMC.. to find this ruling.

MATT LAUER: You don’t think this was an impartial panel?

WAKEFIELD: I think that the panel .. whether they believe they were influenced or not .. were certainly of this opinion .. when I read their decision which came out in February .. this decision had been made from the outset.

MATT LAUER: Doctor is this the final blow to your credibility? Doctor, I mean if you look at the studies that have been conducted since your research wved[sic] your theories. The fact that The Lancet has since said, “If we knew then what we know now, we wouldn’t have published the study in the first place”. You lost your job down in Texas and now your medical license. Is that it?

WAKEFIELD: The findings we made originally have been replicated in five different countries of the world. So, the bowel disease in these children exists. This is a little bump on the road .. and .. that’s how it should be perceived. It’s a bump on a very bumpy road .. but .. it’s a bump. What it does not detract from is the fact there are millions of children out there suffering .. and .. the fact that vaccines can cause autism. That’s a fact that’s accepted by the American government … because they have been settling cases of vaccine induced autism since 1991. [4:15]

MATT LAUER: You say to me the findings have been replicated. I have seen studies, several major studies. Your study involved twelve children … I’ve seen studies that involved hundreds of thousands of children that do not replicate your findings. And, so, today .. will you sit across from me and tell me you still believe there is a possible link between tha particular vaccine .. the MMR vaccine .. and .. autism in children?

WAKEFIELD: Not only do I think it .. but .. the American government has conceded that it exists. A causal relationship between vaccines and autism exists .. and .. they have actually been secretly settling cases as early as 1991. Out of court as well. [4:40]

MATT LAUER: As you know, we have talked to people since we had a chance to meet .. when you were kind enough to sit down for that exclusive interview with us .. and .. people in our government have said “NO! NO! We no longer believe this. We went out and checked out the possibilities and we no longer believe this to be true.” And .. every doctor I’ve spoken to says “It’s dangerous … it’s dangerous to even keep talking about it because .. every time you talk about it .. parents stop vaccinating their children .. and .. some children are dying from preventable diseases”.

WAKEFIELD: Matt, you are missing the point. The point is .. despite denying it .. in the public relations campaign they waged against me and against the parents .. they are conceding these cases in vaccine court. [5:15]

MATT LAUER: What’s your next step .. real quickly?

WAKEFIELD: My next step is to continue this work till it’s natural conclusion. These parents are no going away, the children aren’t going away ..and .. I most certainly am not going away.

MATT LAUER: Dr. Andrew Wakefield, thank you for joining us. I appreciate your time….

I'll take this statement first since Catherina already demolished that claim in a previous post

WAKEFIELD: The findings we made originally have been replicated in five different countries of the world. So, the bowel disease in these children exists. [4:15]

I will include reference #4, Balzola et al. (2005) since that wasn't discussed:

Autistic enterocolitis: confirmation of a new inflammatory bowel disease in an Italian cohort of patients.
Federico Balzola, Clauser Daniela*, Alessandro Repici, Valeria Barbon, Anna Sapino***, Cristiana Barbera**, Pier Luigi Calvo**, Marina Gandione*, Roberto Rigardetto*, Mario Rizzetto.

Dept of Gastroenterology. University of Turin. Molinette Hospital Turin, Italy

*Dept of Neuropsychiatry for Children. University of Turin Regina Margherita Pediatric Hospital, Turin, Italy ** Dept of Pediatric Gastroenterology. University of Turin Regina Margherita Pediatric Hospital, Turin, Italy *** Dept of Biomedical Science and Human Oncology University of Turin

Although the causes of autism are largely unknown, this long-life developmental disorder is now recognised to affect as many as 1 to 500 children. An upper and lower intestinal disease has been recently described in these patients (pts) in spite of gastrointestinal symptoms have been reported by the parents back more many years. This disorder comprising ileo-colonic lymphoid nodular hyperplasia (LNH) and chronic inflammatory colonic disease was called autistic enterocolitis: an association between autism and bowel disease was then proposed.

Nine consecutive male pts (mean age 18 years, range 7-30 years) with a diagnosis of autism according to ICD-10 criteria that showed chronic intestinal symptoms (abdominal pain, bloating, constipation and/or diarrhoea) were enrolled. After routinely blood and stool tests, gastroscopy and colonoscopy with multiple biopsies were performed under sedation. A wireless enteroscopy capsule was also performed in 3 adult pts.

Anemia and fecal blood positive test were found in 2 pts and 3 pts, respectively. Gastroscopy revealed mucosal gastritis in 4 pts, esophagitis in 1 and duodenitis in 1 pts. Histological findings showed a chronic inflammation of the stomach and duodenum in 6 pts (66%) but inconsistent with celiac disease. Macroscopic mucosal abnormalities (aphtoid ulcerations and loss of vascular pattern) were found in 1 pts (11%) at colonoscopy and a LNH in the terminal ileum in 4 pts. (44%) Microscopic colitis with intraepithelial lymphocytes and eosinophils infiltrations, mucosal atrophy and follicular hyperplasia was histologically present in all the pts (100%) whereas a chronic inflammation with iperemia and villous shortening of the terminal ileum was shown in 6 (66%) pts. The wireless capsule revealed areas of bleeding or patchy erythema, mucosal erosions and ulcers in both jejunum and ileum in 1 patients whereas a particular chronic jejunum and ileal erosive pattern was evident in the other two.

These preliminary data are strongly consistent with previous descriptions of autistic enterocolitis and supported a not-coincidental occurrence. Moreover, they showed for the first time a small intestinal involvement, suggesting a panenteric localisation of this new IBD. The treatment to gain clinical remission has still to be tried and it will be extremely important to ameliorate the quality of life of such pts who are likely to be overlooked because of their long-life problems in the communication of symptoms.

These findings do not support a distinct pathology unique to autism. Additionally, Wakefield's original claim was essentially, 'MMR vaccination, then appearance of gastrointestinal symptoms, then regression into autism'. So not only was Wakefield's original claim roundly disproven, but Balzola et al.'s findings do not indicate anything remotely descriptive of Wakefield's original claim. This abstract also remains just that, i.e. an abstract presented at a meeting 5 years ago and has not gone through any peer-review, nor publication.

None of these studies or conference presentation present any evidence of a novel, gastrointestinal disorder unique to autism. In fact, it doesn't appear as though those with autism spectrum disorders have prevalence of any gastrointestinal pathology above that of the general population aside from constipation or diarrhoea. In short, Wakefield's own work isn't what he claims, nor has anyone replicated his work, anywhere, because it is hard to replicate a fabrication.

The other claims that de-licensed physician Andrew Wakefield makes are:

WAKEFIELD: .. the fact that vaccines can cause autism. That’s a fact that’s accepted by the American government … because they have been settling cases of vaccine induced autism since 1991. [4:15]

WAKEFIELD: Not only do I think it .. but .. the American government has conceded that it exists. A causal relationship between vaccines and autism exists .. and .. they have actually been secretly settling cases as early as 1991. Out of court as well. [4:40]

WAKEFIELD: Matt, you are missing the point. The point is .. despite denying it .. in the public relations campaign they waged against me and against the parents .. they are conceding these cases in vaccine court. [5:15]

These hidden-out-in-the-open, not-so-secret vaccine injury cases were blogged about by Kathleen Seidel on Neurodiversity, over 2 years ago. And here are some key quotes from that:

In each of the above-listed cases, the autism diagnosis followed the development or aggravation of profoundly disabling physical conditions.

As established in Lassiter v. HHS, an autism diagnosis does not prevent compensation for individuals who can demonstrate to the satisfaction of the special master that they have experienced a vaccine injury. However, in no instance has the VICP awarded compensation to cognitively disabled individuals who were not also physically disabled.

Emphasis mine. None of these compensated cases even remotely resembles the six test cases that were chosen to represent the over 5000 Omnibus Autism Proceedings' petitioners. None of these cases were 'secretly settled' as Wakefield claimed. It appears as though nothing that falls from Wakefield's mouth is truthful, even now when he has nothing more to lose.

Just to add insult to injury, the much touted "American Rally for Personal Rights" held in Grant Park, Chicago, IL to converge with Autism One, ended up being quite the damp squid. Wakefield was a keynote speaker at the rally, attended by a whopping 100 or so of his adoring fans, falling well-short of the thousands anticipated. That's okay though; Andy only cares about the children.

Photo courtesy of Age of Autism. American Rally for Personal Choice, 26 May 2010.

KWombles on Countering Age of Autism is having a caption contest for all of you snarkmeisters.

Andrew Wakefield has written a book

Oh joy - Andrew Wakefield has written a book. In a brilliant display of his 'special kind of humour' (haha, two children fainted and one threw up over his mother, haha), he has called it "Callous Disregard". This comes from the ruling of UK's General Medical Council, which attested Wakefield "callous disregard for the distress and pain children might suffer". Good one, Andy, wink wink, nudge nudge.

Fiction is Andrew Wakefield's field and has been for over a decade, readers will remember his wonderful work of fiction about children with an autism specific gut inflammation caused by measles containing vaccines published in the Lancet in 1998. Certainly, we can expect the same kind of imagination from his new publication - cannot wait!

(sarcasm off)

You Spin Me Right Round, Blaxill Right Round

On 12 February of this year Neurotoxicology withdrew the article Delayed acquisition of neonatal reflexes in newborn primates receiving a thimerosal-containing Hepatitis B vaccine: Influence of gestational age and birth weight co-authored by none other than Andrew Wakefield. KWombles of Countering Age of Autism was the first to break this news and Just the Vax also blogged about it along with Respectful Insolence, A Photon in the Darkness and several others that day.

AoA's Mark Blaxill only just issued a predictably petulant diatribe regarding the withdrawn paper by Hewitson et al. It starts off with the bewildered meanderings of one that is clearly not familiar with scientific publications and editorial accountability.

How can a scientific study simply vanish? This paper had cleared every hurdle for entry into the public scientific record: it had passed peer review at a prestigious journal, received the editor’s approval for publication, been disseminated in electronic publication format (a common practice to ensure timely dissemination of new scientific information), and received the designation “in press” as it stood in line awaiting future publication in a print version of the journal. Now, and inexplicably, it has been erased from the official record. For practical scientific purposes it no longer exists.

The answer, of course, is that this is no ordinary scientific study. Age of Autism reported previously on its importance HERE , where we noted that “one likely tactic of critics of the study will include attempts to nullify the evidence based on the alleged bias of those involved.” The obvious risk, of course, was that a co-investigator on the paper, Dr. Andrew Wakefield, might make the study a target, especially in light of the hearings then underway at the U.K.’s General Medical Council (GMC).

First, let me point out that Neurotoxicology isn't a prestigious journal; it's an okay journal with an impact factor of 2.4. It may be nitpicking but it is disingenuous to attach exaggerated attributes such as 'prestigious' and 'world-renowned', especially when referring to cranks and their science. But Blaxill is right about two things; that was no ordinary scientific study and Wakefield's self-inflicted predicament was undoubtedly targeted, after the fact however. The monkey HepB study was not good, in fact, the study design, methods and results were quite poor. It never should have passed peer-review but somehow did; perhaps the editorial staff at Neurotoxicology were hedging their bets on a bombshell study and had enough reputable authors to withstand the blowback. That is evidenced by this response to Lynn Redwood's request for information by Elizabeth Perill:

Elizabeth Perill (Elsevier is a division of Reed Elsevier PLC, a large scientific publishing corporation and owner of Neurotoxicology). Perill wrote the following note to Ms. Redwood on February 4th.

Dear Dr. Redwood [sic],
Aside from any authorship concerns, on reflection the paper is not suitable for publication in this journal. The decision was based on the fact that the paper should not have been accepted in Neurotoxicology and the paper is not suitable for the audience of Neurotoxicology.
Kind regards,
Liz
Elizabeth Perill
Publisher, Toxicology,
Elsevier
360 Park Av. South, New York, NY 10010

So when more scrutiny was applied to the study itself, it didn't pass muster.

When Joan Cranmer accepted the primate paper in Neurotoxicology, her decision could not have been an easy one. The study subject and one of the study authors, Andrew Wakefield, were known to be highly controversial. All of the information about the GMC proceedings and the accusations against Wakefield were well known to the editors and peer reviewers. Despite that knowledge and the risks involved, Cranmer and her editorial team judged the science to be sound and decided to go ahead. We complimented them at the time, noting that “the journal editors at Neurotoxicology have taken a courageous stand in publishing what is sure to be unwelcome evidence in some circles.” It appears, however, that Cranmer’s superiors within Elsevier did not share those views.

Emphasis mine. That's bollocks Blaxill; let's review what the Conflict of interest statement in the study stated:

Prior to 2005, CS and AJW acted as paid experts in MMR-related litigation on behalf of the plaintiff. LH has a child who is a petitioner in the National Vaccine Injury Compensation Program. For this reason, LH was not involved in any data collection or statistical analyses to preclude the possibility of a perceived conflict of interest.

And let's review what the known conflicts of interest really are. Andrew Wakefield was well in the midst of GMC misconduct proceedings against him regarding the 1998 Lancet paper and the Neurotoxicology study was not submitted until 16 June 2009. Thoughtful House routinely treats autism as vaccine injury and promotes the use of chelation and Wakefield was firmly in place as the director then. Laura Hewitson is registered as a DAN! and also is employed at Thoughtful House as is her husband, Dan Hollenbeck. He is on the board of directors for SafeMinds, one of the funding sources for the monkey studies and a vitriolic supporter of the mercury-autism 'hypothesis'. Additionally, both openly support chelation. David Atwood from the University of Kentucky is the patent holder for N,N’-bis (2-mercaptoethyl)isophthalamide an industrial chelator designed for cleaning up mining sludge, or better known as OSR which is being marketed by Boyd Haley, also of the University of Kentucky as an autism cure for children.

As Orac pointed out, those of us involved in the topic of vaccines and the claims of 'damage' are an oddball bunch; it's a niche interest and it is audacious to assume that journal editors would have all of this information at their fingertips about any authors that makes submissions to their publications. That is what COI statements are for and probably a substantial reason why this study was withdrawn. Think about it; a group of authors don't declare their full COIs and then one is later shown in a formal proceeding to have acted with callous disregard for children that he was supposed to care for, unethically and dishonestly, not to mention the other glaring omissions. That cannot be simply ignored, at least in the real world. As Dr. Perill stipulated, "Aside from any authorship concerns, on reflection the paper is not suitable for publication in this journal.", can certainly be taken as the science was more closely scrutinised after the appalling COIs came to light. An update to AoA's post on this confirms this:

UPDATE: After publishing the article, Age of Autism received this statement from Joan Cranmer.

“Scientific integrity and good science are fundamental principles for publication of research articles in Neurotoxicology. Although rare, the journal withdraws papers whenever these essential principles are cast into doubt. The January 28, 2010 UK General Medical Council ruling of research dishonesty by Dr. Andrew Wakefield cast into doubt the scientific integrity of a new related paper co-authored by Wakefield*. However, it would be inappropriate for either me or the other editors to discuss the specific factors publicly.

Professor Joan M. Cranmer, Editor, Neurotoxicology

This shouldn't be so difficult for Blaxill and Co. to parse, but somehow it is. Scientific integrity and good science; principles that seem to allude the vaccine-autism pseudo-scientists. Blaxill also predictably pulls out the Galileo gambit and compares Wakefield to Herbert Needleman a physician who made the discovery that lead poisoning is responsible for developmental disorders and took on a powerful industry that tried to railroad him.

One of the reasons that Needleman is revered in the neurotoxicology community is because he had to surmount formidable obstacles and fight powerful opponents in order to protect children from dangerous exposures to heavy metals. Like Wakefield, Needleman once served as an expert witness in a legal proceeding, in this case on behalf of a child from Utah who had been injured by lead pollution. Also like Wakefield, Needleman found himself facing off against powerful industry forces, in this case the oil and gas industry and their suppliers of lead, companies such as Ethyl Corp and E.I. DuPont de Nemours. Most notably, in order to defend their profits, the lead industry mounted an aggressive effort to discredit Needleman. In 1991, he was called before the Office of Scientific Integrity at the National Institutes of Health (NIH) on charges of scientific misconduct.

The chasmic differences between Dr. Needleman and Wakefield are scientific integrity and unassailable science that prevailed even under intense scrutiny. It really is a grotesque affront to someone of Dr. Needleman's credentials and righteousness. Wakefield is no Galileo, no Needleman and no Marshall and Warren. Just because Wakefield is viewed by his supporters as David taking on the big bad Goliath of Pharma, that doesn't make him right. If he had the science to support his assertions, it would have been replicated and it would have withstood scrutiny.

Seen from this perspective, what if the next-generation incarnation of Herbert Needleman is Andrew Wakefield, but in today’s version of the story, the balance of power has shifted in critical ways? In Wakefield’s case the product is neither gasoline nor paint, but vaccines, one of the most privileged product categories ever invented, products that are produced and promoted by the medical industry with missionary zeal. In contrast to the limited scientific influence of the oil and gas industry, the medical industry Wakefield faces is far more powerful, pursues its interests with greater skill, controls the flow of scientific information and effectively dictates media coverage. It appears now that the medical industry is so powerful that it can rewrite scientific history when it wants and even erase important scientific publications in a reputable journal.

The oil and gas industry have limited influence? Are you kidding me? Sadly, that was a rhetorical question that I well know the answer to. If Pharma is so competent and omnipotent, how did they allow Wakefield to not only publish the 1998 Lancet case series, but leave it published for almost 12 years, not to mention all of his subsequent publications and the most recent Neurotoxicology study? And only just got around to getting the GMC to instigate proceedings against him? Scientific publications get retracted all the time, it's part of the process when scientific fraud is discovered, and Wakefield fits that bill.

Wakefield is in a league with the likes of Victor Ninov, Jan Hendrik Schön, Robert P. Liburdy and Hwang Woo-Suk, the latter also feigning ignorance of bioethics in his defence. But Wakefield is a rank amateur compared to the Piltdown Man hoax. Whoever that was, kept that going for more than 4 decades and the true identity of the perpetrator(s) remains unknown. Wakefield's fraud was discovered a mere 5 years after the 1998 (now retracted) Lancet paper by a journalist, no less. Even if one wishes to (erroneously) argue that Mr. Deer was aimed at Wakefield, if there was nothing there, then Wakefield wouldn't have been so thoroughly discredited and looking for his next gig right now.

AoA's call for Neurotoxicology's editor Joan Cranmer to resign in the name of 'think of the children' is preposterous and just isn't going to be considered, let alone done. It is a vapid attempt to rally the troops in the face of yet another failed attempt to get their pseudo-scientific tripe into a real peer-reviewed journal and game over for Wakefield. I think that even they can see the disgrace of having to publish in bottom-dwelling vanity press journals such as JAPandS, Medical Veritas (ooo, they say it's a 'pre-eminent' journal) and of course, Medical Hypotheses and even though that is an Elsevier journal, I think they would give the monkey study a go, given their standards.

If you are interested in reading more on this topic, please visit Countering Age of Autism and of course, Respectful Insolence.

And So the Spin Begins

Age of Autism has finally broken it's silence regarding the departure of Andrew Wakefield from Thoughtful House. Since Mark Blaxill and Carol Stott, the latter also quietly removed from Thoughtful House's research staff, couldn't procure the services of PR powerhouse Max Clifford, he had to settle for the bumbling, albeit puppy-dog loyal, Dan Olmstead. Here is Wakefield's 'exclusive' statement to AoA:

“There has been an extraordinary outpouring of support from the autism community in response to the events of the last two weeks”, Wakefield told Age of Autism in an exclusive interview. “The most exciting part of it has been the opening up of an entirely new sort of opportunity that will allow me to continue my work on behalf of autism families.” Wakefield said he would provide more specifics on the nature of that opportunity soon. “In addition, I will now speak publicly to refute the findings that have been made against me. I know my necessary silence on these issues has troubled many parents in both the U.K. and the U.S. But I’m ready now to get back on the front foot and publicly contest the false accusations that have been made against me, my colleagues, and indirectly The Lancet children. It’s been long overdue.”

I can only take that to mean that Wakefield will adopt the nom de plume of 'Dr. Andy' as notable celebretricians and all chiropractors do. And "The most exciting part of it has been the opening up of an entirely new sort of opportunity that will allow me to continue my work on behalf of autism families.” sounds like a segue to the announcement of, 'Dr. Andy is available for children's birthday parties; his specialities are magic tricks, balloon animals and venipuncture.'

Dan, you're a little late to the party as the news of Dr. Wakefield's departure from Thoughtful House was announced 18, February. You also forgot to mention the departure of Arthur Krigsman from Thoughtful House as well. I'm sure the spin which has been fed to you by Wakefield and, in turn passed on, serves as temporary morale boost for your readers. But make no mistake, Thoughtful House is cleaning house and Wakefield, Krigsman and Stott are liabilities. If they can't support them, notably Wakefield in light of the recent UK General Medical Council Ruling, the Lancet retraction of his 1998 paper and the subsequent withdrawn monkey study from Neurotoxicology, it certainly makes me wonder who could.

Wakefield is finished. There has been no conspiracy; his original publication was based upon atrocious ethics and conflicts of interest, highly-flawed science and fudged medical records. It doesn't get much worse than that. This man is no hero; he's nothing more than a predator.

Andrew Wakefield resigns from Thoughtful House!

Rumours had been going around since the early morning that Andrew Wakefield had resigned from his post as Director of Research at Thoughtful House. I have just had confirmation by email that he has indeed resigned. Note that this link www.thoughtfulhouse.org/staff/andrew-wakefield.php now leads to their home page and the statement of support recently posted after the GMC ruling has disappeared from their landing page. They issued the following statement today:

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

Call me Cassandra - I had indeed foreseen that this would happen on this blog.

Further commentary on Respectful Insolence here and here, and on LeftBrainRightBrain - this was Strike 4 (after the GMC ruling, the retraction by The Lancet, and the retraction of the NeuroToxicology paper). Can I predict there is more to come (this may cause some fallout for Wakefield for example)?

Monkey Business Indeed

The infamous monkey-hep B vaccine study, co-authored by none other than Andrew Wakefield, that was clearly part of a larger body of work has been withdrawn by the editors of Neurotoxicology after being accepted. First though, hat-tip to KWombles at Countering Age of Autism for the find. Last October, when the study was announced and e-published ahead of print, Just the Vax, Respectful Insolence and A Photon in the Darkness thoroughly debunked the methods and results but also highlighted the blatant conflicts of interest that remained undeclared in the study proof and corrected proof.

Elsevier's Policy on Article Withdrawl states:

An outcome of this principle is the importance of the scholarly archive as a permanent, historic record of the transactions of scholarship. Articles that have been published shall remain extant, exact and unaltered as far as is possible. However, very occasionally circumstances may arise where an article is published that must later be retracted or even removed. Such actions must not be undertaken lightly and can only occur under exceptional circumstances, such as:

Article Withdrawal: Only used for Articles in Press which represent early versions of articles and sometimes contain errors, or may have been accidentally submitted twice. Occasionally, but less frequently, the articles may represent infringements of professional ethical codes, such as multiple submission, bogus claims of authorship, plagiarism, fraudulent use of data or the like.

Article Withdrawal
Articles in Press (articles that have been accepted for publication but which have not been formally published and will not yet have the complete volume/issue/page information) that include errors, or are discovered to be accidental duplicates of other published article(s), or are determined to violate our journal publishing ethics guidelines in the view of the editors, may be “Withdrawn” from ScienceDirect. Withdrawn means that the article content (HTML and PDF) is removed and replaced with a HTML page and PDF simply stating that the article has been withdrawn according to the Elsevier Policy on Article in Press Withdrawal with a link to the current policy document.

At this juncture, it is purely speculation as to what led to the withdrawl of this study, however, it stands to reason that Andrew Wakefield's recent woes with the GMC rulings and the Lancet retraction of his 1998 study that implicated the MMR triple jab with his, entirely made-up, autistic enterocolitis diagnosis. In any event, it is safe to say that the withdrawl of this recent study by Neurotoxicology editors indicates something untoward.

There is no doubt that anti-vax sites like Age of Autism and Generation Rescue will use this opportunity to screed about 'persecution', 'suppression', 'censorship' and 'conspiracy' and keeping the 'Brave Maverick Doctors' down. But that is simply not the case. There is no doubt that that editors of reputable journals don't take such actions lightly and will have to answer for them. So whether this is a case of the science or ethics being more closely-scrutinised and/or the massive, undeclared conflicts of interest coming to light, that is more than enough to justify the withdrawl of this study.

In any event, we hope that the anti-vaxxers can at least get it straight that there were 20 monkeys used for this study. Twenty monkeys that were sacrificed (sorry Orac) to further a warped personal agenda and not to advance our scientific knowledge.

"Independent" the Wakefield way (really something for the fail blog)

One of the claims that keeps reappearing in the comments sections under articles covering the GMC ruling on Andrew Wakefield and colleagues is that

The key finding (chronic colitis found in ASD children) of Dr. Wakefield's early case report published in The Lancet in 1998 HAS been independently confirmed by medical researchers in five different countries.

That is a very significant claim. After all, independent confirmation of a recent finding, would make the validity of a finding more likely, and if 6 independent laboratories found the same gut changes in autistic children, then then likelihood that this was a) a fluke or b) made up by Andrew Wakefield would be drastically reduced.

Finally, one of those commenters has posted those ‘independent confirmations’ – so I thought it might be worth having a look at them.

Krigsman, A. (Assistant Professor of Pediatrics, New York University School of Medicine Director of Gastroenterology Services), et al.,Ileocolonoscopy in Children with Autistic spectrum Disorder and Chronic Gastrointestinal symptoms. Autism Insights 2010:2 1-11.

Gonzalez, L., et al., Endoscopic and Histological Characteristics of the Digestive Mucosa in Autistic Children with gastro-Intestinal Symptoms. Arch Venez Pueric Pediatr, 2005;69:19-25.

Balzola, F., et al., Panenteric IBD-like disease in a patient with regressive autism shown for the first time by wireless capsule enteroscopy: Another piece in the jig-saw of the gut-brain syndrome? American Journal of Gastroenterology, 2005. 100(4): p. 979-981.

Balzola, F., et al., Autistic enterocolitis: Confirmation of a new infammatory bowel disease in an Italian cohort of patients. Gastroenterology 2005;128(Suppl. 2);A-303.

Galiatsatos, P., et al., Autistic enterocolitis: Fact or fiction. Canadian Journal of Gastroenterology. 2009;23:95-98.

Let’s look at number 1, Krigsman et al. The name sounds vaguely familiar. In fact, anyone who has read a little about the MMR-autism affair will know Arthur Krigsman as the clinical director of Thoughtful House, which happens to be the same Texas Clinic out of which Andrew Wakefield practises. One editor of “Autism Insight”, the journal in which this “independent confirmation” was published, is Andrew Wakefield (another one the senior author of the study, Carol Stott). Gosh, I bet peer review was harsh for this one.

Gonzales et al, number 2, has been published in “Arch Venez Pueric Pediatr” which stands for Archivos Venezolanos de Puericultura y Pediatría. It was a bit tricky to get my hands on the paper, especially since the citation was not quite right, but I did manage and was not surprised to find that indeed the authors cannot replicate Wakefield’s 1998 “findings” of a distinct autistic enterocolitis, although they do report a higher incidence of gastrointestinal problems in their autistic group.

Balzola et al, number 3, is a case report of one adult autistic patient with inflammed bowel.

Similarly, Balzola et al, number 4, is a meeting abstract that never saw the light of day as a peer reviewed study.

Autistic enterocolitis: confirmation of a new inflammatory bowel disease in an Italian cohort of patients.
Federico Balzola, Clauser Daniela*, Alessandro Repici, Valeria Barbon, Anna Sapino***, Cristiana Barbera**, Pier Luigi Calvo**, Marina Gandione*, Roberto Rigardetto*, Mario Rizzetto.

Dept of Gastroenterology. University of Turin. Molinette Hospital Turin, Italy

*Dept of Neuropsychiatry for Children. University of Turin Regina Margherita Pediatric Hospital, Turin, Italy ** Dept of Pediatric Gastroenterology. University of Turin Regina Margherita Pediatric Hospital, Turin, Italy *** Dept of Biomedical Science and Human Oncology University of Turin

Although the causes of autism are largely unknown, this long-life developmental disorder is now recognised to affect as many as 1 to 500 children. An upper and lower intestinal disease has been recently described in these patients (pts) in spite of gastrointestinal symptoms have been reported by the parents back more many years. This disorder comprising ileo-colonic lymphoid nodular hyperplasia (LNH) and chronic inflammatory colonic disease was called autistic enterocolitis: an association between autism and bowel disease was then proposed.

Nine consecutive male pts (mean age 18 years, range 7-30 years) with a diagnosis of autism according to ICD-10 criteria that showed chronic intestinal symptoms (abdominal pain, bloating, constipation and/or diarrhoea) were enrolled. After routinely blood and stool tests, gastroscopy and colonoscopy with multiple biopsies were performed under sedation. A wireless enteroscopy capsule was also performed in 3 adult pts.

Anemia and fecal blood positive test were found in 2 pts and 3 pts, respectively. Gastroscopy revealed mucosal gastritis in 4 pts, esophagitis in 1 and duodenitis in 1 pts. Histological findings showed a chronic inflammation of the stomach and duodenum in 6 pts (66%) but inconsistent with celiac disease. Macroscopic mucosal abnormalities (aphtoid ulcerations and loss of vascular pattern) were found in 1 pts (11%) at colonoscopy and a LNH in the terminal ileum in 4 pts. (44%) Microscopic colitis with intraepithelial lymphocytes and eosinophils infiltrations, mucosal atrophy and follicular hyperplasia was histologically present in all the pts (100%) whereas a chronic inflammation with iperemia and villous shortening of the terminal ileum was shown in 6 (66%) pts. The wireless capsule revealed areas of bleeding or patchy erythema, mucosal erosions and ulcers in both jejunum and ileum in 1 patients whereas a particular chronic jejunum and ileal erosive pattern was evident in the other two.

These preliminary data are strongly consistent with previous descriptions of autistic enterocolitis and supported a not-coincidental occurrence. Moreover, they showed for the first time a small intestinal involvement, suggesting a panenteric localisation of this new IBD. The treatment to gain clinical remission has still to be tried and it will be extremely important to ameliorate the quality of life of such pts who are likely to be overlooked because of their long-life problems in the communication of symptoms.

These findings do not support a distinct pathology unique to autism. Additionally, Wakefield's original claim was essentially, 'MMR vaccination, then appearance of gastrointestinal symptoms, then regression into autism'. So not only was Wakefield's original claim roundly disproven, but Balzola et al.'s findings do not indicate anything remotely descriptive of Wakefield's original claim. This abstract also remains just that, i.e. an abstract presented at a meeting 5 years ago and has not gone through any peer-review, nor publication.

Finally, number 5, Galiatsatos et al., is a case report, featuring two adult patients with gastrointestinal problems and an ASD diagnosis. The authors call for “more investigations” in their discussion.

So what do we have here? Three (3) genuinely published cases of autistic adults who had consulted a doctor for gastrointestinal problems and were found to have gastrointestinal problems. One conference report from April 2005 that has not gone through peer review and has not appeared in a real journal in the 5 years since the conference. One real study looking at over 50 autistic children which does not confirm Wakefield’s findings. And finally, one study by Wakefield’s buddies in a freshly founded journal run by Andrew Wakefield and his buddies, to say that their buddy Andy was really right all along – how is that for "independent" confirmation?!

Edited on 19 January 2011 to add a find that Sullivan from LBRB led me to - it appears that the 2007 and 2008 tax forms (990) from Thoughtful House mention a "VENEZUELA COLLABORATION" under the projects they fund - a bit of thoughtful googling produced this gem

Gastrointestinal Pathology in Autism Spectrum Disorders: The Venezuelan Experience by Lenny G. Gonzalez, MD

Meet Lenny Gonzales, another Wakefield "buddy".