Lets make one thing clear, not a single politican gives a shit about your kids
Full scale political attack against kooky GOP. Ebola perhaps part of a 1-2 punch?
Geez. Maybe the whole Ebola crap was part of a 1-2 punch. Get people freaked about something that results in rectal bleeding, then crank up the MMR, which really is minor compared to 2012-2013. Them blammo, get all kinds of stupidity from prominent republicans. Pretty damned good.
Andy Wakefield exonerated because John Walker-Smith won his appeal? Not so fast there, pardner'... '' Respectful Insolence
Wed, 04 Feb 2015 23:56
I sense a disturbance in the antivaccine crankosphere.
Actually, maybe ''disturbance'' is the wrong word. Unabashed whooping it up is closer to correct. High-fiving is perhaps a better term. Or maybe partying like it's 2005. The question, of course, is what is the inciting event was that sparked such widespread rejoicing in the antivaccine world. I'll give you a hint. It has to do with the hero of the antivaccine movement, the man who arguably more than anyone else is responsible for the MMR scare that drove down MMR vaccine uptake in the UK to the point where measles, once vanquished, came roaring back. Yes, we're talking about Andrew Wakefield, whose incompetent and now retracted research launched a thousand biomedical quacks. (Actually, that's probably an underestimate.) However, we're not talking about Andrew Wakefield directly. Rather, we're talking about Professor John Walker-Smith, one of the co-authors of Andrew Wakefield's now rightly discredited 1998 Lancet paper. The anti-vaccine crank blog is going wild with the news that Professor Walker-Smith has succeeded in his appeal of the General Medical Council's decision that he should be struck off the medical record along with Andy Wakefield:
A High Court judge quashed the finding of professional misconduct against Professor Walker-Smith, who had carried out some of the tests for the controversial paper that suggested a link between the MMR vaccine and autism.
Mr Justice Mitting also called for the reform of the General Medical Council's disciplinary hearings after the lengthy battle by Professor Walker-Smith to clear his name.
The Wakefield paper prompted a nationwide scare over the safety of the jab after the study of 12 children was published in the medical journal The Lancet.
On AoA, we've been treated to some articles with titles like this:
The full ruling can be found here. Let's dig in, shall we? As usual, what the antivaccine movement is promoting and what is in the ruling are not necessarily the same thing. If there's one thing that's obvious from the outpouring of verbiage from various antivaccine blogs, Twitter feeds, and press releases, it's that the antivaccine movement somehow thinks that this decision exonerates Andrew Wakefield, too. Let's disabuse them of that delusion right now, shall we? According to Mr. Justice Mitting:
At a press conference, which Professor Walker-Smith did not attend, convened to accompany publication, Dr. Wakefield stated publicly the view which he had previously expressed privately to Professor Walker-Smith that he could no longer support the giving of MMR vaccine. The joint view of Professor Walker-Smith and Dr. Murch, stated in a letter to Dr. Wakefield on 21st January 1998, was that it was inappropriate to emphasize the role of MMR vaccine in publicity about the paper and that they supported government policy concerning MMR until more firm evidence was available for them to see for themselves. They published a press release to coincide with publication stating their support for ''present public health policy concerning MMR''. Dr. Wakefield's statement and subsequent publicity had a predictable adverse effect upon the take up of MMR vaccine of great concern to those responsible for public health. There is now no respectable body of opinion which supports his hypothesis, that MMR vaccine and autism/enterocolitis are causally linked.
Correct. There is no respectable body of opinion supporting Wakefield's hypothesis that the MMR is somehow linked to autism or the entity Wakefield made up called ''autistic enterocolitis.'' It's rather annoying that Mitting would refer to it as a ''body of opinion.'' One can only speculate that it's his legal background that leads him to use this particular phraseology. No scientist would. Scientists would (and do) point out that not only is there no good scientific evidence supporting Wakefield's hypothesis, but there is a lot of evidence that falsifies his hypothesis. There's a reason why Wakefield is viewed with such contempt in the scientific world. Actually, there are multiple reasons, not the least of which is that Wakefield is an incompetent scientist willing to commit research fraud to provide evidence for trial lawyers to use in lawsuits against vaccine manufacturers, a plot that Brian Deer uncovered and described in excruciating detail and with excruciatingly detailed documentation. This ruling says nothing about that; it's primarily about methodology and Mitting's legal ruling that the GMC didn't adequately explain the rationale behind its findings that Walker-Smith committed professional misconduct. Mitting's decision also relies a lot on his clearly poor understanding of medical research issues. (More on that below.)
It's a simple fact, though, that Mitting's decision regarding has nothing to do with whether Wakefield is a fraud or a pseudoscientist or not. Nor does it have anything to do with the question of whether vaccines, specifically the MMR vaccine, cause autism, as much as Wakefield's many apologists would like to convince people otherwise. In fact, as I've pointed out before, Wakefield's being struck off the British medical registry has nothing to do with the validity of the science. Even if Wakefield had prevailed and been allowed to keep his medical license, his claimed findings that vaccines cause autistic enterocolitis and/or autism would have been just as bogus. Legal rulings are not science. They can be based on science, but often they are not. It's nice when they don't go against science and nicer still when they resoundingly agree with science, but such is not always the case. To try to argue that a legal ruling such as the one regarding Professor Walker-Smith exonerates Wakefield is an even worse folly than arguing that his being struck off necessarily proves he is a quack. He's an antivaccine quack based on science; it matters not what the courts say.
Admittedly, I haven't paid much attention to Professor Walker-Smith. Back when I wrote about Andy Wakefield being struck off, I said very little, if anything about Walker-Smith. The reason, of course, is that I viewed the Walker-Smith decision as being at best peripheral. I didn't know enough about him to decide for myself whether the GMC decision was justified or not. Still, it's useful to look at the court's decision to see why it concluded that Walker-Smith didn't deserve to be struck off.
The first thing that needs to be considered is a dichotomy. John Walker-Smith appealed the GMC decision. Andrew Wakefield did not. Why not? It's hard to say. Was it because he was too busy being the medical director of the quack clinic Thoughtful House in Texas? After all, at the time he was already making plenty of cash without a medical license. There was no need for him to appeal, which would cost a lot of money and effort. He had already left England anyway, his reputation trashed long ago. In contrast, Professor Walker-Smith appears to have had more reason to fight. He had stayed behind and, unlike Wakefield, who had never been particularly respected, Walker-Smith had been highly respected in his field. There was a lot more motivation for him to try to salvage his reputation.
In any case, here is the conclusion of the appeal decision:
For the reasons given above, both on general issues and the Lancet paper and in relation to individual children, the panel's overall conclusion that Professor Walker-Smith was guilty of serious professional misconduct was flawed, in two respects: inadequate and superficial reasoning and, in a number of instances, a wrong conclusion. Miss Glynn submits that the materials which I have been invited to consider would support many of the panel's critical findings; and that I can safely infer that, without saying so, it preferred the evidence of the GMC's experts, principally Professor Booth, to that given by Professor Walker-Smith and Dr. Murch and by Dr. Miller and Dr. Thomas. Even if it were permissible to perform such an exercise, which I doubt, it would not permit me to rescue the panel's findings. As I have explained, the medical records provide an equivocal answer to most of the questions which the panel had to decide. The panel had no alternative but to decide whether Professor Walker-Smith had told the truth to it and to his colleagues, contemporaneously. The GMC's approach to the fundamental issues in the case led it to believe that that was not necessary '' an error from which many of the subsequent weaknesses in the panel's determination flowed. It had to decide what Professor Walker-Smith thought he was doing: if he believed he was undertaking research in the guise of clinical investigation and treatment, he deserved the finding that he had been guilty of serious professional misconduct and the sanction of erasure; if not, he did not, unless, perhaps, his actions fell outside the spectrum of that which would have been considered reasonable medical practice by an academic clinician. Its failure to address and decide that question is an error which goes to the root of its determination.
As you can see, the decision all boils down to the question of research and whether Walker-Smith thought he was doing research or actually treating autistic children using interventions that were clinically indicated. If the interventions were clinically indicated, then it could be argued that he did not commit professional misconduct. If the interventions were done with the knowledge that they were being done for research purposes rather than to treat the children, then Walker-Smith is guilty of misconduct. The reasons, of course, are the lack of ethical committee approval yet, as is discussed in the decision:
At the heart of the GMC's case against Professor Walker-Smith were two simple propositions: the investigations undertaken under his authority on eleven of the twelve Lancet children were done as part of a research project '' Project 172-96 '' which required, but did not have, Ethics Committee approval; and they were clinically inappropriate. Professor Walker-Smith's case was that the investigations were clinically appropriate attempts at diagnosis of bowel and behavioural disorders in children with broadly similar symptoms and, where possible, treatment of the bowel disorders or alleviation of their symptoms. The GMC's case was that he was conducting research which required Ethics Committee approval. His case was that he was conducting medical practice which did not. Accordingly, an unavoidable and fundamental question which the panel had to answer was: what is the distinction between medical practice and research?
In light of this introduction, what follows is profoundly contradictory in that the judge acknowledges that what Walker-Smith did could be reasonably viewed as research, but exonerates him because it could also be viewed as therapeutic:
The panel made no express finding on this issue and cannot have appreciated the need to do so. It was not helped by the premise upon which the GMC's case was founded. There was a good deal of evidence, to which I refer in greater detail below, that Professor Walker-Smith and his team were undertaking what any reasonable body of medical practitioners would categorize as research '' but also that he intended and genuinely believed that what he was doing was solely or primarily for the clinical benefit of the children. When such an issue arises, a panel will almost always have to determine the honesty or otherwise of the practitioner.
Justice Mitting then lists facts supporting and negating the proposition that what Walker-Smith was doing was research. I must admit, I find some of the ''facts negating' to be questionable. Particularly bizarre was Mitting's listing of a fact that no parent other than one was required to sign the consent form in the proposals submitted to the Ethics Committee or in the revised form approved by it. Well, duh! That was part of the problem, now, wasn't it? You know? Doing research without having obtained adequate informed consent from the parents?
Also rather odd was Mitting's other reasoning that ''none of the five clinicians involved in the investigation of the Lancet children who gave evidence to the panel considered that they were following Project 172-96.'' So what? The children's information and clinical histories ended up being used in Wakefield's Lancet paper. I suppose one could argue that Walker-Smith was an unwitting dupe of Andy Wakefield an therefore was not guilty of research professional misconduct, but, if that's the case, it's hardly flattering to Walker-Smith. it's also hard to imagine what clinical indications existed to subject these children to lumbar punctures. As a clinician, I always had a hard time figuring out how Wakefield, Walker-Smith, and the rest justified doing lumbar punctures on these children.
The implications of Mitting's ruling are frightening in their potential. Think about it. Basically, if his ruling stands, it's hard not to wonder whether it's open season on human research subjects in the UK. As long as the physician can construct a quasi-legitimate-sounding rationale that he can point to aside from a research protocol for doing research-related tests on human subjects, he apparently doesn't need to get ethical approval anymore. He can cite Mitting's ruling that, as long as he doesn't think he's doing research''even if that is incorrect''then he's not, and the GMC can't do anything about it. So much for the Helsinki declaration! Similarly, his ''any reasonable physician'' test fails spectacularly as well, at least in the way he applied it. ''Any reasonable physician'' would not subject autistic children to a battery of invasive tests including lumbar punctures for dubious clinical reasons. Those tests were quite correctly judged by the GMC to have been ordered for research purposes rather than for routine clinical care. Autism quacks in the UK have good reason to rejoice. As it stands, one has to wonder whether they can now get away with essentially anything.
Of course, none of this stops the antivaccine movement from lapsing into full mental jacket conspiracy mode. For instance, our old friend Ginger Taylor, speaking for the Canary Party, issued a press release:
''It is quite obvious to me that James Murdoch, Brian Deer and GlaxoSmithKline orchestrated the smear attack on Dr. Andrew Wakefield,'' said Ginger Taylor, executive director of the Canary Party. ''A judge has now ruled that the GMC hearings were a farce. Parents are waiting for journalists to find their spine and start some honest reporting on the character assassination of doctors that is blocking medical treatments for vaccine injured children, and the role that GSK and Merck may be playing to protect their profits on the MMR vaccine. The Canary Party honors and stands by doctors of integrity like Prof. Walker-Smith, who continue to fight and defend their hard-won reputations for going the extra mile to investigate and improve the chronic, difficult-to-treat cases that now permeate our society.''
I do love the conspiracy mongering, though. From my perspective, Judge Mitting's decision strongly implies that, rather than being involved in Wakefield's professional research misconduct, Walker-Smith was an unwitting dupe. Neither conclusion speaks particularly well of Walker-Smith, but I suppose it's better to be an honest dupe than a dishonest research cheat. Personally, I'd rather be neither. No matter how hard the antivaccine movement tries to spin this as some sort of exoneration of its hero Andy Wakefield, it's not.
Andrew Wakefield - Wikipedia, the free encyclopedia
Wed, 04 Feb 2015 23:50
Andrew Jeremy Wakefield (born c. 1957) is a British former surgeon and medical researcher, known for his fraudulent 1998 research paper in support of the now-discredited claim that there is a link between the administration of the measles, mumps and rubella (MMR) vaccine, and the appearance of autism and bowel disease.
After the publication of the paper, other researchers were unable to reproduce Wakefield's findings or confirm his hypothesis of an association between the MMR vaccine and autism or autism and gastrointestinal disease. A 2004 investigation by Sunday Times reporter Brian Deer identified undisclosed financial conflicts of interest on Wakefield's part, and most of his co-authors then withdrew their support for the study's interpretations. The British General Medical Council (GMC) conducted an inquiry into allegations of misconduct against Wakefield and two former colleagues. The investigation centred on Deer's numerous findings, including that children with autism were subjected to unnecessary invasive medical procedures, such as colonoscopy and lumbar puncture, and that Wakefield acted without the required ethical approval from an institutional review board.
On 28 January 2010, a five-member statutory tribunal of the GMC found three dozen charges proved, including four counts of dishonesty and 12 counts involving the abuse of developmentally challenged children. The panel ruled that Wakefield had "failed in his duties as a responsible consultant", acted both against the interests of his patients, and "dishonestly and irresponsibly" in his published research.The Lancet immediately and fully retracted his 1998 publication on the basis of the GMC's findings, noting that elements of the manuscript had been falsified.The Lancet's editor-in-chief Richard Horton said the paper was "utterly false" and that the journal had been "deceived". Three months later, Wakefield was struck off the Medical Register in May 2010, with a statement identifying deliberate falsification in The Lancet research, and is barred from practising medicine in the UK.
In January 2011, an editorial accompanying an article by Brian Deer in BMJ identified Wakefield's work as an "elaborate fraud". In a follow-up article, Deer said that Wakefield had planned to launch a venture on the back of an MMR vaccination scare that would profit from new medical tests and "litigation driven testing". In November 2011, yet another report in BMJ revealed original raw data indicating that, contrary to Wakefield's claims in The Lancet, children in his research did not have inflammatory bowel disease.
Wakefield's study and his claim that the MMR vaccine might cause autism led to a decline in vaccination rates in the United States, United Kingdom and Ireland and a corresponding rise in measles and mumps, resulting in serious illness and deaths, and his continued warnings against the vaccine have contributed to a climate of distrust of all vaccines and the reemergence of other previously controlled diseases. Wakefield has continued to defend his research and conclusions, saying there was no fraud, hoax or profit motive.
Early life and educationEditAt the University of Toronto from 1986 to 1989, he was part of a team that studied tissue rejection problems with small intestine transplantation, using animal models. He continued his studies of small intestine transplantation under a Wellcome Trust travelling fellowship at University of Toronto in Canada.
Claims of measles virus''Crohn's disease linkEditBack in the UK, he worked on the liver transplant programme at the Royal Free Hospital in London. In 1993, Wakefield attracted professional attention when he published reports in which he concluded that measles virus might cause Crohn's disease; and two years later he published a paper in The Lancet proposing a link between the measles vaccine and Crohn's disease. Subsequent research failed to confirm this hypothesis, with a group of experts in Britain reviewing a number of peer-reviewed studies in 1998 and concluding that the measles virus did not cause Crohn's disease, and that the MMR vaccine did not either.
Later, in 1995, while conducting research into Crohn's disease, he was approached by Rosemary Kessick, the parent of a child with autism, who was seeking help with her son's bowel problems and autism; Kessick ran a group called Allergy Induced Autism. In 1996, Wakefield turned his attention to researching possible connections between the MMR vaccine and autism.
At the time of his MMR research study, Wakefield was senior lecturer and honorary consultant in experimental gastroenterology at the Royal Free Hospital School of Medicine (from 2008, UCL Medical School). He resigned in 2001, by "mutual agreement and was made a fellow of the Royal College of Pathologists", and moved to the US in 2001 or 2004, both dates according to The Times. One report noted he was asked to leave Royal Free Hospital in 2001 after he did not fulfill a request to duplicate the findings in his controversial The Lancet paper.
Wakefield subsequently helped establish and served as the executive director of Thoughtful House Center for Children, which studies autism in Austin, Texas, where, according to The Times, he "continued to promote the theory of a link between the MMR vaccine and autism, despite admitting it was 'not proved'." He resigned from Thoughtful House in February 2010, after the British General Medical Council found that he had been "dishonest and irresponsible" in conducting his earlier autism research in England.The Times reported in May 2010 that he was a medical advisor for Visceral, a UK charity that "researches bowel disease and developmental disorders".
Wakefield is barred from practising as a physician in the UK, and is not licensed in the US. He lives in the US where he has a following, including celebrity Jenny McCarthy, who wrote the foreword for Wakefield's autobiography, Callous Disregard. She mistakenly believes her son has autism and that it is due to vaccines. According to Deer, as of 2011, he lives near Austin with his wife, Carmel, and four children.
Wakefield has set up the non-profit Strategic Autism Initiative to commission studies into the condition and is currently listed as a director of a company called Medical Interventions for Autism and another called the Autism Media Channel.
MMR controversyEditOn 28 February 1998, a paper written by Wakefield and twelve other authors about twelve autistic children was published in The Lancet. In it, the authors claimed to have identified a new syndrome they called autistic enterocolitis, raising the possibility of a link between a novel form of bowel disease, autism, and the MMR vaccine. The authors noted that the parents of eight of the twelve children linked what were described as "behavioural symptoms" with MMR, and reported that the onset of these symptoms began within two weeks of MMR vaccination. In the published The Lancet summary, known as the "interpretation", the authors wrote:
We identified associated gastrointestinal disease and developmental regression in a group of previously normal children, which was generally associated in time with possible environmental triggers.
These possible triggers were reported as MMR in eight cases, and measles infection in one. The paper was instantly controversial, leading to widespread publicity in the UK and the convening of a special panel of the UK's Medical Research Council the following month. One study done based in Japan found that there was no causal relationship between the MMR vaccine and autism in groups of children given the triple MMR vaccine and children who received individual measles, mumps and rubella vaccinations. The MMR was replaced with individual vaccinations in 1993.
Although the paper said that no causal connection had been proven, before it was published, Wakefield made statements at a press conference and in a video news release issued by the hospital, calling for suspension of the triple MMR vaccine until more research could be done. This was later criticized as 'science by press conference'. According to BBC News, it was this press conference, rather than the paper in The Lancet, that fuelled the MMR vaccination scare. According to the BBC, "He told journalists it was a 'moral issue' and he could no longer support the continued use of the three-in-one jab for measles, mumps and rubella. 'Urgent further research is needed to determine whether MMR may give rise to this complication in a small number of people,' Dr Wakefield said at the time." He said, "If you give three viruses together, three live viruses, then you potentially increase the risk of an adverse event occurring, particularly when one of those viruses influences the immune system in the way that measles does." He suggested parents should opt for single vaccinations against measles, mumps and rubella, separated by gaps of one year.
In December 2001, Wakefield resigned from the Royal Free Hospital, saying, "I have been asked to go because my research results are unpopular." The medical school said that he had left "by mutual agreement." In February 2002, Wakefield stated, "What precipitated this crisis was the removal of the single vaccine, the removal of choice, and that is what has caused the furore'--because the doctors, the gurus, are treating the public as though they are some kind of moronic mass who cannot make an informed decision for themselves."
Aftermath of initial controversyEditWakefield continued conducting clinical research in the United States after leaving the Royal Free Hospital in December 2001. He joined a controversial American researcher, Jeff Bradstreet, at the International Child Development Resource Center, to conduct further studies on the possible relationship between the MMR vaccine and autism.
In 2004, Wakefield started work at the Thoughtful House research center in Austin, Texas. Wakefield served as Executive Director of Thoughtful House until February 2010, when he resigned in the wake of findings against him by the British General Medical Council.
In February 2004, controversy resurfaced when Wakefield was accused of a conflict of interest. The Sunday Times reported that some of the parents of the 12 children in the study in The Lancet were recruited via a UK lawyer preparing a lawsuit against MMR manufacturers, and that the Royal Free Hospital had received £55,000 from the UK's Legal Aid Board (now the Legal Services Commission) to pay for the research. Previously, in October 2003, the board had cut off public funding for the litigation against MMR manufacturers. Following an investigation of The Sunday Times allegations by the UK General Medical Council, Wakefield was charged with serious professional misconduct, including dishonesty. In December 2006, the Sunday Times further reported that in addition to the money they gave the Royal Free Hospital, the lawyers responsible for the MMR lawsuit had paid Wakefield personally more than £400,000, which he had not previously disclosed.
Twenty-four hours before the 2004 Sunday Times report, The Lancet responded to the investigation in a public statement, describing Wakefield's research as "fatally flawed". The Lancet's editor said he believed the paper would have been rejected as biased if the peer reviewers had been aware of Wakefield's conflict of interest. Ten of Wakefield's twelve co-authors of the paper in The Lancet later published a retraction of an interpretation: The section of the paper retracted read as follows:
Interpretation. We identified associated gastrointestinal disease and developmental regression in a group of previously normal children, which was generally associated in time with possible environmental triggers.
The retraction stated:
We wish to make it clear that in this paper no causal link was established between (the) vaccine and autism, as the data were insufficient. However the possibility of such a link was raised, and consequent events have had major implications for public health. In view of this, we consider now is the appropriate time that we should together formally retract the interpretation placed upon these findings in the paper, according to precedent.
Wakefield v Channel 4 and othersEditIn November 2004, Channel 4 broadcast a one-hour Dispatches investigation by reporter Brian Deer; the Toronto Star said Deer had "produced documentary evidence that Wakefield applied for a patent on a single-jab measles vaccine before his campaign against the MMR vaccine, raising questions about his motives".
In addition to Wakefield's unpublished initial patent submission, Deer released a copy of the published patent application. At page 1, the first paragraph of this stated:
The present invention relates to a new vaccine/immunisation for the prevention and/or prophylaxis against measles virus infection and to a pharmaceutical or therapeutic composition for the treatment of IBD (Inflammatory Bowel Disease); particularly Crohn's Disease and Ulcerative Colitis and regressive behavioural disease (RBD) (also referred to as "Pervasive Developmental Disorder).
Before describing the research in Wakefield's 1998 paper in The Lancet, at the same page this patent explicitly states that the use of the MMR vaccine causes autism:
It has now also been shown that use of the MMR vaccine (which is taken to include live attenuated measles vaccine virus, measles virus, mumps vaccine virus and rubella vaccine virus, and wild strains of the aforementioned viruses) results in ileal lymphoid nodular hyperplasia, chronic colitis and pervasive developmental disorder including autism (RBD), in some infants.
According to Deer, a letter from Wakefield's lawyers to him dated 31 Jan 2005 said: "Dr Wakefield did not plan a rival vaccine."
In the Dispatches programme, Deer also revealed that Nicholas Chadwick, a researcher working under Wakefield's supervision in the Royal Free medical school, had failed to find measles virus in the children reported on in The Lancet.
In January 2005, Wakefield initiated libel proceedings against Channel 4, the independent production company Twenty Twenty and Brian Deer, The Sunday Times, and against Deer personally along with his website briandeer.com. Within weeks of issuing his claims, however, Wakefield sought to have the action frozen until after the conclusion of General Medical Council proceedings against him. Channel 4 and Deer sought a High Court order compelling Wakefield to continue with his action, or discontinue it. After a hearing on 27 and 28 October 2005, Mr Justice David Eady ruled against a stay of proceedings:
It thus appears that the Claimant wishes to use the existence of the libel proceedings for public relations purposes, and to deter other critics, while at the same time isolating himself from the "downside" of such litigation, in having to answer a substantial defence of justification ... I am quite satisfied, therefore, that the Claimant wished to extract whatever advantage he could from the existence of the proceedings while not wishing to progress them or to give the Defendants an opportunity of meeting the claims.
The judgment identified Channel 4's "very lengthy extracts" summarizing Deer's allegations against Wakefield:
i) [Wakefield] spread fear that the MMR vaccine might lead to autism, even though he knew that his own laboratory had carried out tests whose results dramatically contradicted his claims in that the measles virus had not been found in a single one of the children concerned in his study and he knew or ought to have known that there was absolutely no basis at all for his belief that the MMR should be broken up into single vaccines.(ii) In spreading such fear, acted dishonestly and for mercenary motives in that, although he improperly failed to disclose the fact, he planned a rival vaccine and products (such as a diagnostic kit based on his theory) that could have made his fortune(iii) Gravely abused the children under his care by unethically carrying out extensive invasive procedures (on occasions requiring three people to hold a child down), thereby driving nurses to leave and causing his medical colleagues serious concern and unhappiness(iv) Improperly and/or dishonestly failed to disclose to his colleagues and to the public that his research on autistic children had begun with a contract with solicitors who were trying to sue the manufacturers of the MMR vaccine(v) Improperly or dishonestly lent his reputation to the International Child Development Resource Centre, which promoted to very vulnerable parents expensive products for whose efficacy (as he knew or should have known) there was no scientific evidenceMr. Justice Eady's ruling states that, "The views or conclusions of the GMC disciplinary body would not, so far as I can tell, be relevant or admissible," that Channel 4's allegations "...go to undermine fundamentally the Claimant's professional integrity and honesty," and that, "It cannot seriously be suggested that priority should be given to GMC proceedings for the resolution of issues."
In December 2006, Deer released records obtained from the Legal Services Commission, showing that it had paid £435,643 in undisclosed fees to Wakefield for the purpose of building a case against the MMR vaccine. Those payments, The Sunday Times reported, had begun two years before publication of Wakefield's paper in The Lancet. Within days of Deer's report, Wakefield dropped all his libel actions and was ordered to pay all defendants' legal costs.
Other concernsEditOther concerns regarding Wakefield were that an extension of his project caused life-threatening complications in one child, who received substantial compensation in an out-of-court settlement. Wakefield's data were also questioned; a former graduate student, who appeared in Deer's programme, later testified that Wakefield ignored laboratory data that conflicted with his hypothesis. An independent investigation of a collaborating laboratory questioned the accuracy of the data underpinning Wakefield's claims.
In June 2005, the BBC programme Horizon reported on an unnamed and unpublished study of blood samples from a group of 100 autistic children and 200 children without autism. They reported finding 99% of the samples contained no trace of the measles virus, and the samples that did contain the virus were just as likely to be from non-autistic children, i.e., only three samples contained the measles virus, one from an autistic child and two from a normal child. The study's authors found no evidence of any link between MMR and autism.
The Institute of Medicine (IOM) of the United States National Academy of Sciences, along with the CDC and the UK National Health Service, have found no link between vaccines and autism. Reviews in the medical literature have also found no link between the MMR vaccine and autism or with bowel disease, which Wakefield called "autistic enterocolitis."
General Medical Council hearingsEditBetween July 2007 and May 2010, a 217-day "fitness to practise" hearing of the UK General Medical Council examined charges of professional misconduct against Wakefield and two colleagues involved in the paper in The Lancet. The charges included that he:
"Was being paid to conduct the study by solicitors representing parents who believed their children had been harmed by MMR".Ordered investigations "without the requisite paediatric qualifications" including colonoscopies, colon biopsies and lumbar punctures ("spinal taps") on his research subjects without the approval of his department's ethics board and contrary to the children's clinical interests, when these diagnostic tests were not indicated by the children's symptoms or medical history."Act[ed] 'dishonestly and irresponsibly' in failing to disclose ... how patients were recruited for the study"."Conduct[ed] the study on a basis not approved by the hospital's ethics committee."Purchased blood samples'--for £5 each'--from children present at his son's birthday party, which Wakefield joked about in a later presentation.Wakefield denied the charges; on 28 January 2010, the GMC ruled against Wakefield on all issues, stating that he had "failed in his duties as a responsible consultant", acted against the interests of his patients, and "dishonestly and irresponsibly" in his controversial research. On 24 May 2010 he was struck off the United Kingdom medical register. It was the harshest sanction that the GMC could impose, and effectively ended his career as a doctor. In announcing the ruling, the GMC said that Wakefield had "brought the medical profession into disrepute," and no sanction short of erasing his name from the register was appropriate for the "serious and wide-ranging findings" of misconduct. On the same day, Wakefield's autobiography, Callous Disregard was published. It argued that he had been unfairly treated by the medical and scientific establishment.
Fraud and conflict of interest allegationsEditIn February 2009, The Sunday Times reported that a further investigation by the newspaper had revealed that Wakefield "changed and misreported results in his research, creating the appearance of a possible link with autism", citing evidence obtained by the newspaper from medical records and interviews with witnesses, and supported by evidence presented to the GMC.
In April 2010, Deer expanded on laboratory aspects of his findings in a report in the BMJ, recounting how normal clinical histopathology results (obtained from the Royal Free hospital) had been subjected to wholesale changes, from normal to abnormal, in the medical school and published in The Lancet. On 2 January 2011, Deer provided two tables comparing the data on the twelve children, showing the original hospital data and the data with the wholesale changes as used in the 1998 The Lancet article.
On 5 January 2011, BMJ published an article by Brian Deer entitled "How the case against the MMR vaccine was fixed". Deer, funded by The Sunday Times of London and Channel 4 television network, said that, based on examination of the medical records of the 12 children in the original study, his research had found:
The paper in The Lancet was a case series of 12 child patients; it reported a proposed "new syndrome" of enterocolitis and regressive autism and associated this with MMR as an "apparent precipitating event." But in fact:
Three of nine children reported with regressive autism did not have autism diagnosed at all. Only one child clearly had regressive autism;Despite the paper claiming that all 12 children were "previously normal", five had documented pre-existing developmental concerns;Some children were reported to have experienced first behavioural symptoms within days of MMR, but the records documented these as starting some months after vaccination;In nine cases, unremarkable colonic histopathology results'--noting no or minimal fluctuations in inflammatory cell populations'--were changed after a medical school "research review" to "non-specific colitis";The parents of eight children were reported as blaming MMR, but 11 families made this allegation at the hospital. The exclusion of three allegations'--all giving times to onset of problems in months'--helped to create the appearance of a 14 day temporal link;Patients were recruited through anti-MMR campaigners, and the study was commissioned and funded for planned litigation.In an accompanying editorial, BMJ editors said:
Clear evidence of falsification of data should now close the door on this damaging vaccine scare ... Who perpetrated this fraud? There is no doubt that it was Wakefield. Is it possible that he was wrong, but not dishonest: that he was so incompetent that he was unable to fairly describe the project, or to report even one of the 12 children's cases accurately? No. A great deal of thought and effort must have gone into drafting the paper to achieve the results he wanted: the discrepancies all led in one direction; misreporting was gross. Moreover, although the scale of the GMC's 217 day hearing precluded additional charges focused directly on the fraud, the panel found him guilty of dishonesty concerning the study's admissions criteria, its funding by the Legal Aid Board, and his statements about it afterwards.
In a BMJ follow-up article on 11 January 2011, Deer said that based upon documents he obtained under Freedom of information legislation, Wakefield'--in partnership with the father of one of the boys in the study'--had planned to launch a venture on the back of an MMR vaccination scare that would profit from new medical tests and "litigation driven testing".The Washington Post reported that Deer said that Wakefield predicted he "could make more than $43 million a year from diagnostic kits" for the new condition, autistic enterocolitis. According to Deer's report in BMJ, the ventures, Immunospecifics Biotechnologies Ltd and Carmel Healthcare Ltd'--named after Wakefield's wife'--failed after Wakefield's superiors at University College London's medical school gave him a two-page letter that said:
We remain concerned about a possible serious conflict of interest between your academic employment by UCL, and your involvement with Carmel ... This concern arose originally because the company's business plan appears to depend on premature, scientifically unjustified publication of results, which do not conform to the rigorous academic and scientific standards that are generally expected.
WebMD reported on Deer's BMJ report, saying that the $43 million predicted yearly profits would come from marketing kits for "diagnosing patients with autism" and that "the initial market for the diagnostic will be litigation-driven testing of patients with AE [autistic enterocolitis, an unproven condition concocted by Wakefield] from both the UK and the US". According to WebMD, the BMJ article also claimed that Carmel Healthcare Ltd would succeed in marketing products and developing a replacement vaccine if "public confidence in the MMR vaccine was damaged".
In October 2012, research published in PNAS, the Proceedings of the National Academy of Sciences, identified Wakefield's 1998 paper as the most cited retracted scientific paper, with 758 citations, and gave the "reason for retraction" as "fraud".
Journal retractionsEditOn 2 February 2010, The Lancet formally retracted Wakefield's 1998 paper. The retraction states that, "The claims in the original paper that children were 'consecutively referred' and that investigations were 'approved' by the local ethics committee have been proven to be false."
The following day the editor of a specialist journal, Neurotoxicology, withdrew another Wakefield paper that was in press. The article, which concerned research on monkeys, had already been published online and sought to implicate vaccines in autism.
In May 2010, The American Journal of Gastroenterology retracted a paper of Wakefield's that used data from the 12 patients of the article in The Lancet.
On 5 January 2011, BMJ editors recommended that Wakefield's other publications should be scrutinized and retracted if need be.
Wakefield responseEditAs of January 2011, Wakefield continued to maintain his innocence. In a press release, he stated,
I want to make one thing crystal clear for the record'--my research and the serious medical problems found in those children were not a hoax and there was no fraud whatsoever. Nor did I seek to profit from our findings ... despite media reports to the contrary, the results of my research have been duplicated in five other countries ... I continue to fully support more independent research to determine if environmental triggers, including vaccines, are causing autism and other developmental problems ... Since the Lancet [sic] paper, I have lost my job, my career and my country. To claim that my motivation was profit is patently untrue. I will not be deterred'--this issue is far too important.
In an internet radio interview, Wakefield said the BMJ series "was utter nonsense" and denied "that he used the cases of the 12 children in his study to promote his business venture". Although Deer is funded by The Sunday Times and Channel 4, he has filed financial disclosure forms and denies receiving any funding from the pharmaceutical industry, which Wakefield says is paying him. According to CNN, Wakefield said the patent he held was for "an 'over-the-counter nutritional supplement' that boosts the immune system". WebMD reported that Wakefield said he was the victim of "a ruthless, pragmatic attempt to crush any attempt to investigate valid vaccine safety concerns".
Wakefield claims that Deer is a "hit man who was brought in to take [him] down" and that other scientists have simply taken Deer at his word. While on Anderson Cooper 360°, claiming he had not read the BMJ articles yet, he denied their validity and denied that Deer had interviewed the families of the children in the study. He also urged viewers to read his book, Callous Disregard, which he claimed would explain why he was being targeted, to which Anderson Cooper replied: "But, sir, if you're lying, then your book is also a lie. If your study is a lie, your book is a lie."
Wakefield later implied that there is a conspiracy by public health officials and pharmaceutical companies to discredit him, including suggesting they pay bloggers to post rumours about him on websites or that they artificially inflated reports of deaths from measles.
Deer counter-responseEditDeer responded to Wakefield's charge by challenging Wakefield to sue him:
If it is true that Andrew Wakefield is not guilty as charged, he has the remedy of bringing a libel action against myself, the Sunday Times of London, against the medical journal here, and he would be the richest man in America.
Deer noted that all of Wakefield's previous libel actions had been dismissed or withdrawn.
In January 2012 Wakefield filed a defamation lawsuit in Texas state court against Deer, Fiona Godlee, and the BMJ for false accusations of fraud, seeking a jury trial in Travis County. The filing identified Wakefield as a resident of Austin, and cited the "Texas Long-Arm Statute" as justification for initiating the proceeding in Texas. The journal responded that it stood by its reports and would "defend the claim vigorously". In August 2012 District Court Judge Amy Meachum dismissed Wakefield's suit. Her ruling was upheld on appeal in September 2014 and Wakefield was ordered to pay all parties' costs.
On 5 April 2011, Deer was named the UK's specialist journalist of the year in the British Press Awards, organised by the Society of Editors. The judges said that his investigation of Wakefield was a "tremendous righting of a wrong".
Epidemics, effects and receptionEditPhysicians, medical journals, and editors have made statements tying Wakefield's fraudulent actions to various epidemics and deaths. Michael J. Smith, a professor of pediatrics at the University of Louisville, an "infectious diseases expert who has studied the autism controversy's effect on immunization rates", said, "Clearly, the results of this [Wakefield] study have had repercussions."
The Associated Press said:
Immunization rates in Britain dropped from 92 percent to 73 percent, and were as low as 50 percent in some parts of London. The effect was not nearly as dramatic in the United States, but researchers have estimated that as many as 125,000 US children born in the late 1990s did not get the MMR vaccine because of the Wakefield splash.
ABC News Channel WWAY3 said:
Since Dr. Andrew Wakefield's study was released in 1998, many parents have been convinced the measles, mumps and rubella vaccine could lead to autism. But that study may have done more harm than good. According to the Centers for Disease Control and Prevention, in the United States, more cases of measles were reported in 2008 than any year since 1997. More than 90 percent of those infected had not been vaccinated, or their vaccination status was not known.
Paul H(C)bert, editor-in-chief of the Canadian Medical Association Journal (CMAJ) said:
There has been a huge impact from the Wakefield fiasco ... This spawned a whole anti-vaccine movement. Great Britain has seen measles outbreaks. It probably resulted in a lot of deaths.
A profile in a New York Times Magazine article noted:
Andrew Wakefield has become one of the most reviled doctors of his generation, blamed directly and indirectly, depending on the accuser, for irresponsibly starting a panic with tragic repercussions: vaccination rates so low that childhood diseases once all but eradicated here'--whooping cough and measles, among them'--have re-emerged, endangering young lives.
Journalist Brian Deer called for criminal charges against Wakefield.
J. B. Handley of the autism and anti-vaccine advocacy group Generation Rescue noted, "To our community, Andrew Wakefield is Nelson Mandela and Jesus Christ rolled up into one." Wakefield has a fundraising group dedicated to supporting his litigation.
On 1 April 2011, the James Randi Educational Foundation awarded Wakefield the Pigasus Award for "refusal to face reality".
A 2011 journal article described the vaccine-autism connection as "the most damaging medical hoax of the last 100 years".
In 2011, Wakefield was at the top of the list of the worst doctors of 2011 in Medscape's list of "Physicians of the Year: Best and Worst". In January 2012, Time Magazine named Wakefield in a list of "Great Science Frauds". In 2012 he was awarded the Lifetime Achievement in Quackery award by the Good Thinking Society.
Criticism of Wakefield can be risky. A writer from The New York Times, who was covering a 2011 event in Tomball, Texas where Wakefield spoke, was threatened by its organizer, Michelle Guppy: "Be nice to him, or we will hurt you." She is the coordinator of the Houston Autism Disability Network.
Selected publicationsEditBooksEditWakefield, Andrew J; McCarthy, Jenny, foreword (24 May 2010). Callous Disregard: Autism and Vaccines: The Truth Behind a Tragedy. Skyhorse Publishing. ISBN 1-61608-169-4. Journal articlesEditWithdrawn: Hewitson L, Houser LA, Stott C, Sackett G, Tomko JL, Atwood D, Blue L, White ER, Wakefield AJ (October 2009). "WITHDRAWN: Delayed acquisition of neonatal reflexes in newborn primates receiving a thimerosal-containing Hepatitis B vaccine: Influence of gestational age and birth weight". Neurotoxicology. doi:10.1016/j.neuro.2009.09.008. PMID 19800915. Retracted:Wakefield AJ, Anthony A, Murch SH, Thomson M, Montgomery SM, Davies S, O'Leary JJ, Berelowitz M, Walker-Smith JA (September 2000). "Enterocolitis in children with developmental disorders". Am. J. Gastroenterol.95 (9): 2285''95. doi:10.1111/j.1572-0241.2000.03248.x. PMID 11007230. (Retracted)Retracted:Wakefield AJ, Murch SH, Anthony A, Linnell J, Casson DM, Malik M, Berelowitz M, Dhillon AP, Thomson MA, Harvey P, Valentine A, Davies SE, Walker-Smith JA (1998). "Ileal-lymphoid-nodular hyperplasia, non-specific colitis, and pervasive developmental disorder in children". The Lancet351 (9103): 637''41. doi:10.1016/S0140-6736(97)11096-0. PMID 9500320. (Retracted)Wakefield AJ, Ekbom A, Dhillon AP, Pittilo RM, Pounder RE (March 1995). "Crohn's disease: pathogenesis and persistent measles virus infection". Gastroenterology108 (3): 911''6. doi:10.1016/0016-5085(95)90467-0. PMID 7875495. Wakefield AJ, Pittilo RM, Sim R, Cosby SL, Stephenson JR, Dhillon AP, Pounder RE (April 1993). "Evidence of persistent measles virus infection in Crohn's disease". J. Med. Virol.39 (4): 345''53. doi:10.1002/jmv.1890390415. PMID 8492105. Wakefield AJ, Sankey EA, Dhillon AP et al. (May 1991). "Granulomatous vasculitis in Crohn's disease". Gastroenterology100 (5 Pt 1): 1279''87. PMID 2013373. Wakefield AJ, Sawyerr AM, Dhillon AP, Pittilo RM, Rowles PM, Lewis AA, Pounder RE (November 1989). "Pathogenesis of Crohn's disease: multifocal gastrointestinal infarction". The Lancet2 (8671): 1057''62. PMID 2572794. ReferencesEdit^ abcGodlee F, Smith J, Marcovitch H (2011). "Wakefield's article linking MMR vaccine and autism was fraudulent". BMJ342: c7452. doi:10.1136/bmj.c7452. PMID 21209060. ^ abFang FC, Steen RG, Casadevall A (October 2012). "Misconduct accounts for the majority of retracted scientific publications". Proceedings of the National Academy of Sciences. doi:10.1073/pnas.1212247109. ^ ab"Great Science Frauds". Time Magazine, 13 January 2012^"GMC LRMP". Retrieved 2014-05-31. ^"briandeer.com" (pdf). Retrieved 2014-05-31. ^Madsen KM, Hviid A, Vestergaard M, et al. (November 2002). "A population-based study of measles, mumps, and rubella vaccination and autism". N. Engl. J. Med.347 (19): 1477''82. doi:10.1056/NEJMoa021134. 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Andrew Wakefield, discredited over autism-MMR vaccine link claims, is named Good Thinking Society's Golden Duck winner, The Guardian, retrieved 14 October 2014 External linksEditPersondataNameWakefield, AndrewAlternative namesShort descriptionsurgeon and medical researcherDate of birth1957Place of birthDate of deathPlace of death