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Comment on: Wrong About Vaccine Safety: A Review of Andrew Wakefield’s “Callous Disregard”

23 Jan

Andrew Wakefield has been discussed here and elsewhere a great deal. Thankfully his presence in the autism communities seems to have retreated to a small core of supporters and the occasional parent convention where he can, yet again, defend himself. Yes, his supporters are vocal. And, yes, he continues to cause harm. But his heyday is long past.

Mr. Wakfield was stripped of his medical license after an extremely lengthy hearing. Mr. Wakefield chose to not present evidence at the hearing, chose not to appeal the decision and has, instead, offered up his defense in a book: “Callous Disregard”. Callous Disregard has been discussed online multiple times.

Mr. Wakefield and his supporters tend to make sciency appearing defenses of him. For example, there are claims that his work has multiple independent replications in various countries. If one checks the references used to make that claim, one finds the claim is, well, false. Citations in “Callous Disregard” often do not support the arguments Mr. Wakefield is making. But few people have the time to go through his prose, much less his references.

One gentleman has taken on that task. Joel A. Harrison, PhD, MPH, has published a paper: Wrong About Vaccine Safety: A Review of Andrew Wakefield’s “Callous Disregard” in which he debunks the main claims in “Callous Disregard”. Here is the abstract:

Abstract: On February 28, 1998, Dr. Andrew Wakefield published an article in the Lancet on 12 children “with a history of pervasive developmental disorder and intestinal symptoms. Onset of behavioral symptoms was associated, by the parents, with measles, mumps, and rubella vaccination in eight of the 12 children.” Though not claiming the MMR vaccine caused the symptoms, adding what parents thought certainly raised the possibility. Statements and articles by Wakefield suggested he believed such a link probable. Vaccination rates plummeted in the UK and outbreaks of vaccine preventable diseases followed. Investigative journalist Brian Deer uncovered dishonest and unethical medical practices by Wakefield, resulting in Wakefield losing his medical license. Rather than appeal the decision, Wakefield wrote a book, “Callous Disregard: Autism and Vaccines – The Truth Behind a Tragedy,” wherein he claims loss of his license was a political attempt to silence his criticism of vaccine safety. This paper examines the validity of Wakefield’s claims. A careful review of publicly available information makes it clear that Wakefield’s claims regarding vaccine safety are wrong. It is hoped that this review will be used by doctors and public health personnel to encourage parents hesitating to have their children vaccinated to question anti-vaccination claims in general, given that many proponents often refer to Wakefield as an authority and display in their own writings and pronouncements similar erroneous claims.

The paper is 17 pages as published and includes 142 references. His conclusion is quite strong, and includes this paragraph:

I have shown that every major claim Wakefield makes in his book concerning vaccine safety is wrong. I have given accurate quotes from both Wakefield’s book and sources that contradict his claims, including those he misquotes. Based on the old adage, “trust but verify,” where possible I have given the URLs to many of the documents and articles referred to in this paper. My hope is that those who take the time to check will realize that Wakefield’s claims regarding vaccine safety are not only wrong but also harmful, and that once this is realized, people will read Deer’s articles [3] and the British Medical Council’s findings [1,2] with an open mind.

How does he back up such a strong conclusion? Consider this point he makes in his summary (which is discussed at length in the paper)

Wakefield claims that a leading Swedish vaccine researcher, Dr. Christenson, told him that vaccine safety studies had not been carried out in Sweden; yet, gives references to two Swedish papers that extensively report on vaccine safety studies in Sweden, one of them coauthored by Dr. Christenson.

Yes, once again, we see Mr. Wakefield claiming something which the very references he uses show the opposite.

Consider Mr. Wakefield’s stance on the Urabe-strain containing mumps vaccine (a component of the MMR used for some time in the UK). Mr. Wakefield ignored the Urabe vaccine during his time as an expert for the MMR litigation in the UK but has more recently taken the story up as some sort of defense of himself. If that sounds confusing, it really isn’t. Mr. Wakefield thinks we all will just forget that he pushed his own pet theory 15 years ago and just listen to the fearful message he gives now.

Dr. Harrison states:

“Wakefield claims that the Urabe mumps strain contained in the MMR vaccine used in the UK starting in 1988 had been approved after the Canadians withdrew it. Not True.”

Yes, the UK didn’t approve the Urabe Strain vaccine after Canada withdrew it.

Canada licensed Trivirix in May 1986 [57]. The starting date for the UK for MMR vaccinations was October 1, 1988 [58,59]. The license for Trivirix was withdrawn in Canada in May 1990 stating: “Recent laboratory findings from the United Kingdom, Canada and Japan have provided sound evidence. . . In addition, the report states: “The infection follows the course of benign aseptic meningitis” [60]. The UK withdrew the Urabe-containing vaccine on September 14, 1992 [61].

Dr. Harrison also goes to great length to discuss how Mr. Wakefield’s characterization of the Urabe strain vaccine is inaccurate–painting a story of a dangerous vaccine where the evidence does not support this argument.

So Wakefield carried out an incorrect statistical analysis, claimed the authors combined the data when they did not, and incorrectly gave a shorter follow-up time. All of these inaccuracies move evidence from showing safety to showing possible harm.

Dr. Harrison concludes the paper with:

The only conclusion that can be reached from this review is that the title of Wakefield’s book is incomplete. It should read: “Andrew Wakefield’s Callous Disregard for the Facts.”

A rather bold statement given Mr. Wakefield’s litigious nature, having brought suit against the BMJ and Brian Deer and threatening an autism charity with legal action.

Mr. Wakefield’s supporters will likely ignore this lengthy takedown. Mr. Wakefield is dishonest. He lies. And the sad thing is that people believe him.


By Matt Carey

note: minor edits were made after this article was published

Wakefield dodges debate – again

9 Jun

The following comment was submitted to the Age of Autism blog but not approved:

Dr Wakefield is being disingenuous. In an earlier video posted on Age of Autism, he offered to debate the MMR-autism link ‘with any serious contender’. In an article published in the online magazine Spiked on 16 April, readily accessible through a link on AoA, I indicated that, as both the parent of an autistic son and as a doctor who has been engaged in this controversy for 15 years, I was prepared to engage in such a debate:

http://www.spiked-online.com/site/article/13532/

On 17 April Matt Carey published an article on the Left Brain, Right Brain blog, entitled ‘Mike Fitzpatrick calls Andrew Wakefield’s Bluff. Wakefield moves the goalposts’, drawing attention to Dr Wakefield’s apparent switch from being ready to debate ‘any serious contender’ to proposing that he was only prepared to debate with British immunisation chief, Dr David Salisbury: http://leftbrainrightbrain.co.uk/2013/04/

As Dr Wakefield is well aware, this is a very safe offer because Dr Salisbury has publicly indicated that he will not engage in any debate with Dr Wakefield.

Still receiving no response from Dr Wakefield, I publicly repeated this challenge in a posting on the Left Brain, Right Brain blog on 30 April, under the title ‘Andrew Wakefield: Now What About That Debate?’: http://leftbrainrightbrain.co.uk/2013/04/

Given the findings of the General Medical Council inquiry that removed Dr Wakefield’s name from the medical register on the grounds of ‘dishonesty’ and ‘irresponsibility’ in the conduct of his research, doctors and scientists are reluctant to engage in any public discussion with him. Many have advised me against accepting his challenge on these grounds. Yet I recognise that he continues to exert some influence among parents of autistic children. Hence I am prepared to engage in a debate that can only expose his failure, after 15 years, to produce any evidence in support of a link between the MMR vaccine and autism.

Michael Fitzpatrick 6 June 2013

Studies ‘supporting’ Andrew Wakefield

7 May

It is 15 years since Andrew Wakefield first hypothesised a link between the MMR vaccine and autism in children, mediated by an inflammatory bowel condition (subsequently labelled ‘autistic entercolitis’). Over this period Dr Wakefield and his supporters have cited a range of studies which are claimed to ‘verify’, ‘replicate’ or ‘support’ his MMR-autism theory. Here is the most recent list:

‘Here is a list of 28 studies from around the world that support Dr. Wakefield’s research:
1.The Journal of Pediatrics November 1999; 135(5):559-63
2.The Journal of Pediatrics 2000; 138(3): 366-372
3.Journal of Clinical Immunology November 2003; 23(6): 504-517
4.Journal of Neuroimmunology 2005
5.Brain, Behavior and Immunity 1993; 7: 97-103
6.Pediatric Neurology 2003; 28(4): 1-3
7.Neuropsychobiology 2005; 51:77-85
8.The Journal of Pediatrics May 2005;146(5):605-10
9.Autism Insights 2009; 1: 1-11
10.Canadian Journal of Gastroenterology February 2009; 23(2): 95-98
11.Annals of Clinical Psychiatry 2009:21(3): 148-161
12.Journal of Child Neurology June 29, 2009; 000:1-6
13.Journal of Autism and Developmental Disorders March 2009;39(3):405-13
14.Medical Hypotheses August 1998;51:133-144.
15.Journal of Child Neurology July 2000; ;15(7):429-35
16.Lancet. 1972;2:883–884.
17.Journal of Autism and Childhood Schizophrenia January-March 1971;1:48-62
18.Journal of Pediatrics March 2001;138:366-372.
19.Molecular Psychiatry 2002;7:375-382.
20.American Journal of Gastroenterolgy April 2004;598-605.
21.Journal of Clinical Immunology November 2003;23:504-517.
22.Neuroimmunology April 2006;173(1-2):126-34.
23.Prog. Neuropsychopharmacol Biol. Psychiatry December 30 2006;30:1472-1477.
24.Clinical Infectious Diseases September 1 2002;35(Suppl 1):S6-S16
25.Applied and Environmental Microbiology, 2004;70(11):6459-6465
26.Journal of Medical Microbiology October 2005;54:987-991
27.Archivosvenezolanos de puericultura y pediatría 2006; Vol 69 (1): 19-25.
28.Gastroenterology. 2005:128 (Suppl 2);Abstract-303

http://healthimpactnews.com/2013/new-published-study-verifies-andrew-wakefields-research-on-autism-again/

Which of these studies supports a link between MMR and autism? None of them. Which studies support a link between MMR and inflammatory bowel disease? None. In fact, none of these studies focuses on MMR: the term ‘MMR’ is not included in any of the titles.

One study (no 6) by Vijendra Singh, published in 2003, claims a link between measles virus and autism. According to virologists in London, Singh’s methodology was suspect and the evidence for the specific ‘anti-MMR’ antibody he identified was ‘not credible’(see Michael Fitzpatrick, MMR and Autism: What Parents Need To Know, p90).

Several studies claim to show an association between ‘autistic enterocolitis’ and autism. Of these (nos2, 3, 4, 9, 18, 19, 28) all but two feature Dr Wakefield as a co-author. Study no 9 is the work of Wakefield collaborators Arthur Krigsman and Carol Stott, published in a journal whose editors include Wakefield and Stott. Study no 28 is the work of Wakefield’s former Royal Free colleague Federico Balzola. The study by Dr Lenny Gonzalez, (no 27) a former collaborator with Wakefield at his Thoughtful House clinic in Texas, published in Venezuela, reports the extraordinary findings of autistic enterocolitis in 100% of 45 children with autism, and in 66.66% of 57 ‘developmentally normal’ controls. Apart from Wakefield and his former or current colleagues, no other researchers in the world have confirmed the existence of ‘autistic enterocolitis’ in children with autism.

Some studies suggest the presence of gastrointestinal disorders other than ‘enterocolitis’ in association with autism. These include upper gastrointestinal conditions, such as gastritis and oesophagitis (no 1, Horvath;no 10, Galiatsatos; no 20, Torrente); coeliac disease or malabsorption (no 12, Genuis;no 16, Walker-Smith;no 17, Goodwin); microbial factors other than measles (nos14, 15, 24, 25 – the Finegold, Bolte, Sandler team; and no 26 –Parracho and colleagues at Reading). Most of these studies feature small numbers of cases and two (nos 16,17) were published more than 40 years ago.In study no 10, Polymnia Galiatsatos and colleagues in Montreal, Canada report the cases of two young adults, one with colonic inflammation, the other with gastritis. Nikolov and colleagues at Yale(no 13) simply report on ‘gastrointestinal symptoms’ in association with autism.

Other studies suggest immune or autoimmune dysfunction in association with autism: Jyonuchi (nos7,8) and Singh (nos5,11). One study (no 23, Shinohe) focuses on abnormal glutamate metabolism in adults with autistic spectrum disorders. These studies do nothing to advance the vaccine-autism hypothesis.

Given that supporters of Dr Wakefield often claim that his work has been ‘independently’ replicated, it is worth pointing out that Wakefield himself is a co-author on a quarter of the studies listed here (2,3,4, 18,19, 21,22). Others (9, 20, 27,28) feature former Royal Free team members(Ashwood, Torrente, Furlano, Balzola), or subsequent collaborators (Krigsman, Stott, Gonzalez).
Those who, like me, have been following this sad story over the past 15 years, will have noticed that several authorities formerly cited in support of Wakefield’s theory seem to have fallen by the wayside.

In the early days of the MMR controversy, Wakefield often cited the studies of Rosemary Waring and Patricia D’Eufemia in support of his notion of a ‘leaky bowel’. His colleague John Walker-Smith claimed that a letter from Aderbal Sabra published in the Lancet in 1998 (about children with food allergies and ADHD) provided a ‘great public vindication’ of the work of the Royal Free team (see MMR and Autism, p143-4). Tokyo physician Hishashi Kawashima’s claims to have identified measles virus in children with autism were widely promoted – but soon discredited. In Sunderland, retired pharmacy lecturer Paul Shattock, an ardent Wakefield supporter, attracted widespread publicity for his claims to have identified distinctive urinary peptides linking MMR and autism, but his research was never published.

The most widely cited research supposedly supporting Wakefield came from his Dublin collaborator John O’Leary (published in 2002 in separate papers with Uhlmann and Shiels). This was discredited by the evidence of Stephen Bustin in the Omnibus Autism Proceedings in the USA in 2009 (see Stephen A Bustin, Why There Is no Link Between Measles Virus and Autism, DOI: 10.5772/52844).
Another study by Balzola, based on the use of the technique of ‘capsule endoscopy’ in a single (adult) case has also been dropped. It was rapidly followed by a report from another member of his team of ‘acute small bowel perforation secondary to capsule endoscopy’.

Other forgotten Wakefield supporters are the South Carolina immunologist Hugh Fudenberg, and the Florida preacher and vitamin salesman Jeffrey Bradstreet, whose dubious practices were exposed in Brian Deer’s Channel Four documentary in 2004. The father and son team of Mark and David Geier, notorious for their promotion of the ‘Lupron protocol’ of chemical castration and heavy metal chelation as a treatment for autism as well as for their shoddy researches, have also been dropped from the list of supportive researchers.

Another widely quoted ‘study’ supposedly supporting Wakefield was a poster presentation by Stephen Walker (working in collaboration with long-standing Wakefield ally Arthur Krigsman) at the IMFAR meeting in Montreal in 2006.These preliminary, provisional, unconfirmed, non-peer-reviewed findings – of measles virus in bowel biopsy specimens – in an uncontrolled study (which does not mention MMR) were widely reported – and enthusiastically acclaimed by Dr Wakefield. Walker himself disclaimed the interpretation that his work supported any link between measles and autism. This study has never been published.

In conclusion, after 15 years, we are offered 28 studies, none of which supports the MMR-enterocolitis-autism hypothesis. It is not surprising that over this period Wakefield has failed to win the support of a single paediatrician, paediatric gastroenterologist, child psychiatrist or autism specialist in England. Surely it is time to call a halt?


By Michael Fitzpatrick

Andrew Wakefield and Vaccine Safety

30 Apr

All about Andy

Even if everything Andrew Wakefield says about the safety of MMR were true it would still not advance the claim that it causes autism.

Having failed, over the past 15 years, to come up with evidence for his theory of a link between the MMR vaccine and autism (or even for his original claim of a link between measles virus and inflammatory bowel disease), Andrew Wakefield has resorted to making wider (and wilder) claims about the safety of MMR. Moving away from his former field of academic gastroenterology, Wakefield has embarked upon studies in paediatrics, vaccinology and public health. These are spheres in which he has neither expertise nor experience – and it shows. He has alleged that surveys associated with the introduction of MMR in Britain 25 years ago were methodologically inadequate, too small in scale, too short in duration or otherwise unsatisfactory. He claims that evidence of adverse reactions was suppressed, conflicts of interests among public health authorities were undisclosed and whistleblowers were silenced. Critics of the programme are alleged to have had their phones tapped, their homes burgled and to have been persecuted by the medical/political/pharmaceutical establishment. Most recently Wakefield has claimed that procedures for dealing with potential anaphylactic reactions within the MMR programme were inadequate.

I do not intend to revisit here the case against Wakefield’s claims about the safety of MMR which is presented in my book MMR and Autism: What Parents Need To Know. (1)On the red-herring of anaphylaxis, including a report of a curiously high incidence in association with separate measles vaccine in a private clinic, see these studies. (2,3,4) Here I would like to pose three questions that arise for anybody who accepts his allegations about the introduction of MMR in Britain after 1988.

1. What about the other countries in which MMR has been introduced?

Surely, if there are significant dangers associated with MMR – which were supposedly ignored in Britain – these would have been noticed in the 60 countries in which the vaccine has been introduced (both before and after 1988)? In fact, the excellent safety record of MMR – 500 million doses and counting – is a major reason for its successful worldwide use. Several countries in Europe and the Americas have been able to declare measles eradicated, apparently without experiencing the sort of adverse effects Wakefield and anti-vaccine campaigners have attributed to MMR in Britain. Indeed, even if public health authorities had succeeded in suppressing reports of adverse reactions to MMR 20 or 25 years ago, these must surely have become apparent by now?

2. Did MMR not dramatically reduce the incidence of mumps meningitis (even if one strain of the vaccine caused a small number of cases)?\

One of the recurring complaints of Wakefield and his supporters is that in the early years of the programme, British vaccine authorities used a brand of MMR including a strain of the mumps virus (Urabe), which was associated with a small number of cases of meningitis, a recognised complication of mumps. In 1992 this was replaced by another strain (Jeryl Lynn) which does not cause this problem. However, if the Jeryl Lynn strain had not been available, it would still have been preferable to carry on with the MMR including Urabe because the benefit of dramatically reducing the incidence of mumps (in the 1980s the commonest cause of viral meningitis) far exceeded the risk of vaccine-related meningitis. A judgement of this sort was made for many years in relation to the use of the oral polio vaccine which caused a handful of cases of polio every year (until it was finally replaced by the currently used injected polio vaccine, which does not carry this risk).

3. Even if MMR is shown to be unsafe in general, how does this support the specific claim that it causes autism?

Wakefield’s strategy appears to be that, if the safety of MMR in general can be put in doubt, the credibility of any particular risk attributed to the vaccine is raised. In reality, this strategy merely draws attention to his failure – over 15 years – to produce any evidence in support of the MMR-autism theory.

Given his failure to substantiate the MMR-autism hypothesis, Wakefield’s persistence in his campaign against MMR has acquired an increasingly irrational character, confirmed by his bizarre video diatribes against leading figures associated with the MMR programme. He is still bitterly aggrieved that British authorities did not accede to his preposterous demand (issued at the notorious 1998 press conference to launch his now retracted Lancet paper) for the replacement of MMR with separate vaccines given 12 months apart. Not a single member of his own team supported this proposal, which was not included in the paper and was in no way supported by it. Such a scheme has never been implemented in any country. Wakefield is further incensed that vaccine authorities insisted on upholding the integrity of the MMR programme in face of his proposal.

If Wakefield had any experience of child health he might have a better understanding of the importance of the organisation of a vaccine programme. Before the introduction of MMR, a measles vaccine had been available in Britain for 20 years, but its administration was unsystematic, uptake remained unsatisfactory and outbreaks continued to occur. In a similar way, rubella vaccine had been given to schoolgirls with considerable success, but occasional cases of congenital rubella were still reported. Mumps vaccine had never been made widely available and cases were seen commonly in surgeries and hospitals. The introduction of the new combined MMR vaccine – within a comprehensive administrative framework, inviting parents into clinics when their children’s jabs were due, properly recording them – brought within a few years a dramatic improvement in children’s health.

If Wakefield had seen, as I have, children suffering from measles, or if he had admitted children to hospital, as I have, with mumps meningitis, or if he had cared for adults with the multiple handicaps of the congenital rubella syndrome, as I have, he might not be so casually disparaging of the MMR programme. But, unfortunately, for Wakefield it is all about Andy and his petty personal grudges against the vaccine authorities who have quite properly put children’s health before his combination of bad science and egotism.

Now, what about that debate?

REFERENCES
1. Michael Fitzpatrick, MMR and Autism: What Parents Need To Know, Routledge 2004; p 128-133.
2. Lakshman R, Finn A (2000). MMR vaccine and allergy, Arch Dis Child 2000;82:93-95 doi:10.1136/adc.82.2.93.
3. Erlewyn-Lajeunesse M, Manek R, Lingam R, Finn A, Emond A (2008). Anaphylaxis following single component measles and rubella immunization, Arch Dis Child 2008; 93:974-975. doi:10.1136/adc.2008.138289;
4. Erlewyn-Lajeunesse M, Hunt LP, Heath PT, FinnA (2011). Anaphylaxis as an adverse event following immunisation in the UK and Ireland, Arch Dis Child 2011; doi:10.1136/archdischild-2011-301163.


By Michael Fitzpatrick

A few points about Steve Walker’s measles/autism study

30 Apr

Michael Fitzpatrick is a general practitioner and autism parent in the U.K. who has been countering misinformation for over a decade. His books include Defeating Autism: A Damaging Delusion and MMR and Autism: What Parents Need to Know. Dr. Fitzpatrick offered to take Andrew Wakefield’s recent challenge for a public debate. Mr. Wakefield has not responded.

One report of a replication of key finding by Andrew Wakefield’s team was presented at an IMFAR conference in 2006but never published. Even though it has not been published, and has in fact failed to replicate, that work by Steve Walker is often cited by Mr. Wakefield’s supporters.

Below are a series of points Dr. Fitzpatrick has collected in regards to the Walker study.


Matt Carey
———-

‘It [the Children’s Immunisation Centre – offering single measles vaccines] argues that the MMR vaccine can cause autism, saying: ‘In 2009 a Dr Walker in the USA studied 275 autistic children and found in a large percentage of cases that these children had the live measles virus in their gut after vaccination with the triple MMR’.Sunday Times, 21 April 2013.

1. In 2006 Dr Stephen Walker presented a poster at the Montreal IMFAR meeting claiming to have identified measles virus in intestinal biopsies of children with autism. These preliminary, provisional, unconfirmed, non-peer-reviewed findings in an uncontrolled study (which does not mention MMR) were widely reported – and enthusiastically acclaimed by Dr Andrew Wakefield.
http://www.autism-insar.org/index.php?option=com_content&task=view&id=19&Itemid=82

2. In a subsequent statement issued by Wake Forest University Baptist Medical Center in North Carolina, Walker denied that he had shown any link between measles virus and autism.http://www.wakehealth.edu/News-Releases/2006/Wake_Forest_Researcher_Warns_Against_Making_Connection_Between_Presence_of_Measles_Virus_and_Autism.htm

3. The Walker study has never been published.

4. The Walker study was dismissed as evidence in the 2009 Omnibus Autism Proceedings in the USA after a detailed critique by expert witnesses.http://lizditz.typepad.com/i_speak_of_dreams/2011/01/the-daily-mail-uk-continuing-sorry-contribution-to-fear-uncertainty-and-doubt-vaccine-fears.html

5. The Walker study is not included in a recent list of ‘28 studies from around the world that support Dr Wakefield’s work’ (though none of these validate his claim of a link between MMR and autism).

http://healthimpactnews.com/2013/new-published-study-verifies-andrew-wakefields-research-on-autism-again/

6. Though reports claimed that the Walker study had ‘replicated’ the work of Wakefield’s Dublin collaborator John O’Leary published in 2002, this work has been thoroughly discredited, most comprehensively by Professor Stephen Bustin (and is no longer even claimed by Wakefield in his support).
(Stephen A Bustin, Why There Is No Link Between Measles Virus and Autism, DOI: 10.5772/52844)

7. A co-author on the 2006 Walker study (and on his recent, unrelated, 2013 publication) is Dr Arthur Krigsman, a long-standing colleague and supporter of Dr Wakefield (and collaborator in his current Autism Media Channel initiative). http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0058058

Observations on Dr Krigsman by the ‘Special Masters’ in the Omnibus Autism Proceedings 2009:

‘After studying the extensive evidence in this case for many months, I am convinced that the reports and advice given to the Cedillos by Dr Krigsman and some other physicians, advising the Cedillos that there is a causal connection between Michelle’s MMR vaccination and her chronic conditions have been very wrong. Unfortunately, the Cedillos have been misled by physicians who are guilty, in my view, of gross medical misjudgment.’

Dr Krigsman appeared as both expert witness and as ‘treating physician’ to Michelle Cedillo and Colten Snyder. The special masters found that his credentials were ‘scant’ and noted that though he claimed to be ‘assistant clinical professor’ at New York University he had never taught there. His four publications were reduced on inquiry to one. It emerged that he left New York following disciplinary action at his former hospital and was fined $5,000 on arrival in Texas for misrepresenting his registration status.
The special masters were not impressed by Dr Krigsman’s performance as an expert witness. Hastings commented that in the Cedillo case he ‘did not find Dr Krigsman to be an expert upon whom I could reasonably rely for sound opinion and judgment’.

It was in relation to his personal testimony as Michelle’s doctor that Hastings found Dr Krigsman to be most ‘unpersuasive’ and of ‘doubtful credibility’. He was shocked to discover that he had ‘presented an opinion concerning Michelle’s case either without examining Michelle’s medical records at all, or after badly misreading these records’. He noted that Dr Krigsman had ‘diagnosed Michelle with “inflammatory bowel disease” in July of 2003, before he had even met and examined her’. Hastings further noted that ‘Dr Krigsman seems highly inclined to diagnose the presence of gastrointestinal inflammation on the basis of almost any chronic gastrointestinal symptoms’. He concluded that Dr Krigsman had advanced a ‘grossly mistaken understanding of Michelle’s gastrointestinal symptoms’ and that ‘a simple reading of Michelle’s medical records demonstrates that Dr Krigsman’s understanding was clearly wrong’. Michelle endured five upper gastrointestinal endoscopies and three lower gastrointestinal endoscopies, none of which in the opinion of the respondent’s experts, revealed inflammatory bowel disease.

http://www.spiked-online.com/site/article/6283/


Michael Fitzpatrick 23 April 2013

Mike Fitzpatrick calls Andrew Wakefield’s bluff. Wakefield moves goalposts

17 Apr

As recently noted here at Left Brain/Right Brain, Andrew Wakefield asked to debate someone about the MMR vaccine. In specific, he wrote:

The more light that shone on this subject by way of informed, balanced debate, the better. I am offering to debate any serious challenger on MMR vaccine safety and the role of MMR in autism, live, in public, and televised.

Dr Michael Fitzpatrick wrote in Andrew Wakefield: return of the wicked witch, Wakefield’s MMR-autism nonsense had a baleful influence on public health, but he doesn’t bear sole responsibility for recent measles outbreaks. that he would take Mr. Wakefield’s challenge.

As both a GP and a parent of an autistic son who had followed the destructive consequences of Wakefield’s campaign over the past 15 years, I for one would welcome the opportunity to challenge his baleful influence. Are you ready for a debate now, Andrew Wakefield?

As you might surmise from the wording above, Dr. Fitzpatrick has previously attempted to debate Mr. Wakefield and offered to engage in a full debate:

Wakefield has subsequently restricted his public appearances to conferences of sympathetic parents, anti-vaccination activists and promoters of quack autism therapies. When I asked him a question from the floor at one such conference in Bournemouth in February 2007, he simply refused to answer, deferring to another platform speaker. When I offered to debate with him at a follow-up conference in March 2009, the organisers refused.

How has Mr. Wakefield responded?

What I’m suggesting is a formal scientific debate in public in front of an audience that is televised. And specifically Dr David Salisbury I would like to debate you because I believe you are at the heart of this matter. I believe the decisions taken by you and by your committee, the Joint Committee on Vaccination and Immunisation, lie at the heart of this matter.

Yes, having had his bluff called, Andrew Wakefield moves the goalposts. He won’t take on Mike Fitzpatrick. He won’t take on “any serious challenger”. Only Dr. David Salisbury.

In addition to lacking integrity, Mr. Wakefield now shows that he lacks courage.

Mike Fitzpatrick is a physician. He is an autism parent. He has written two books on autism: MMR and Autism: What Parents Need to Know and Defeating Autism: A Damaging Delusion. Hard to find a more “serious challenger”.

Hundreds of children are suffering from measles in the U.K.. This isn’t the time for empty offers of debate. This isn’t the time for publicity stunts. It’s time to own your mistakes and do what you can to fix the problems you helped create. Do you have that courage, Andrew Wakefield?


By Matt Carey

Andrew Wakefield: Don’t try to blame me for the results of what I said and did

17 Apr

Andrew Wakefield is back in the news. Sadly this is because the predicted outbreaks of measles are again occurring in the U.K.. As Dr. Michael Fitzpatrick points out, Andrew Wakefield is not the only one who helped spread unfounded fear of the MMR, but he is the man most responsible for promoting the idea that the MMR vaccine causes autism. Without Mr. Wakefield, the scare would not have happened.

Now, 15 years after Mr. Wakefield’s heyday, an outbreak of measles has hit south Wales. And the press are reminding us all that Mr. Wakefield’s research reports were wrong and that he acted unethically in the process of creating those reports. And Mr. Wakefield is responding with the blame shifting and goalpost moving that has become his standard. To their shame, a UK newspaper hosted Mr. Wakefield’s response. And he has gone direct to YouTube with a video where he lays out his explanation. And calls for a debate. Yes, a debate. Televised. Because that’s how science is decided, right? TV debates? If there weren’t children suffering and in danger, this would be a bad joke.

Dr. Fitzpatrick also points out that he has offered to debate Mr. Wakefield in the past and Mr. Wakefield refused. Dr. Fitzpatrick has offered to take Mr. Wakefield up on his debate request. So far I don’t see any signs from Mr. Wakefield that he’s going to take Dr. Fitzpatrick up on his offer. Mike Fitzpatrick has been countering Andrew Wakefield’s misinformation since the early days of the MMR scare.

Let’s step back a moment and ask how did we get to this situation where low vaccine uptake has resulted in a major outbreak? Well, 15 years ago Mr. Wakefield’s team at the Royal Free Hospital released a paper which suggested a link between autism and the MMR vaccine. Mr. Wakefield did much more than suggest a link. At the press conference for the paper’s release (note that very few papers have press conferences) Mr. Wakefield called for the suspension of the MMR vaccine in favor of single measles, mumps and rubella vaccines. He didn’t really explain why the single vaccine would be more safe in his mind, making it very difficult for parents to accept how the single vaccines were, in his faulty opinion, safe.

Mr. Wakefield’s current logic has it that it is the government’s fault for not allowing the importation of single vaccines. Ignore the unfounded fear that Mr. Wakefield created about measles vaccines, he asks. Blame the government. Sure the government can take some blame (anyone recall when the prime minister refused to answer whether his family used the MMR?). As does the press. But without Andrew Wakefield and his faulty assertions, there would have been no scare.

Mr. Wakefield repeats his claim that his opinions on the MMR were based on a 200 page report on measles vaccines. He didn’t even mention his 200 page report at the time of the Lancet paper and press release. Ignore the research he did (we should have. It was faulty and unethically performed). Instead, let’s look to his report. A report which only now he will release to the public, according to his YouTube video. Yes, no one has seen his report. We were all supposed to take his opinion for the past decade and a half. He didn’t even tell us about his report. We were just supposed to have such confidence in him that we were supposed to have assumed he had some reason.

Now he will finally release his report, he says. That is, if his attorneys give him permission. Yes, he will spend the money to have attorneys read his 200 pages and only then, possibly, make some edits and then let us see how he came to this faulty conclusion.

Keep in mind, in 1998 Andrew Wakefield’s statements were made in the context of an active researcher who claimed he had evidence to support a reason to instill fear about the MMR vaccine (and, let’s face it, fear of the single vaccine. One of the lancet 12 got the single vaccine.) What did he say at the time?

In a video released with the press conference, he is shown stating:

I think if you asked members of the team that have investigated this they would give you different answers. And I have to say that there is sufficient anxiety in my own mind of the safety, the long term safety of the polyvalent, that is the MMR vaccination in combination, that I think that it should be suspended in favour of the single vaccines, that is continued use of the individual measles, mumps and rubella components.

No mention of his report. He gave this in the context of a man who led the team that had just released the 1998 Lancet study.

He further asks us to accept a new revised history, and this is the statement that forced me to write again about this man. In his video he claims, “all I could do as a parent is state what would I do for my child.” He didn’t present his views as “what would I do as a parent”. He presented his mistaken views as a researcher who was actively exploring the question. Don’t take my word for it. Take his. From his testimony before the GMC:

At that stage, having done a good deal of research, I wanted to make it clear to my colleagues, including Professor Zuckerman, that since a press briefing had been recommended and was being organised, that if I were asked, if the question were put to me, then I would have to act in due conscience based upon my researches and I would not be able to continue to recommend the combined measles/mumps/rubella vaccine.

emphasis added. Not his position as a parent. As a researcher.

Many of the children in Wales who are at risk for measles infection are older than those who typically get the MMR. Their parents decided years ago, during the height of the scare, to forgo the MMR vaccine. Even if Mr. Wakefield’s ideas were correct (and multiple studies have shown they are not), these children are not at risk of developing autism by his mechanism. And yet he doesn’t call for parents to vaccinate their children. Instead, he spends his time telling us all about how it isn’t his fault that children are getting infected.

It’s not about the children or their safety. It’s about him.

The idea that Mr. Wakefield’s claims could cause a scare and lead to outbreaks of measles is not new. His own research colleagues warned him of the possibility before their press conference. They asked that they show a public face that was “agnostic” towards the safety of the MMR. Mr. Wakefield refused. And now he asks us to ignore that it was his own actions that have put children at risk.

Mr. Wakefield’s colleague and co-author on the Lancet paper, Dr. Simon Murch, made this statement long ago:

This link is unproven and measles is a killing infection. If this precipitates a scare and immunisation rates go down, as sure as night follows day, measles will return and children will die

Night has followed day. Measles has returned. And we now wait and pray that none die.


By Matt Carey

Stephen Bustin: Why There Is no Link Between Measles Virus and Autism

9 Apr

Andrew Wakefield promoted the idea that the MMR vaccine caused autism. While his now-retracted 1997 Lancet paper is most often discussed, the strongest evidence he had actually came in later work where his team reported that they found evidence of the vaccine strain of the measles virus in the intestinal tissues of autistic children. The team used a methodology called Polymerase chain reaction (PCR). PCR amplifies a specific fragment of DNA, allowing one to identify if small amounts of that gene are present in larger samples. PCR tests were performed by John O’Leary in Dublin. As revealed later, Andrew Wakefield had a business stake in this laboratory.

As part of the MMR litigation in the UK, the vaccine manufacturers hired Stephen Bustin to review the methods and results of the O’Leary laboratory. Those results were not made public, but Prof. Bustin later was called in to testify in the U.S. Autism Omnibus Proceeding (the vaccine court). That testimony was discussed here at LeftBrain/RightBrain and elsewhere. Prof. Bustin is one of the world’s experts on PCR.

Prof. Bustin has now written his own account of the history of the measles-virus/autism work by Mr. Wakefield’s team in Why There Is no Link Between Measles Virus and Autism. The full report is free, open access. The report discusses what he already disclosed in his testimony: the multiple failures which resulted in the reporting of a false association of measles virus and autism.

Some of those failures include:

Absence of transparency: the key publication shows no data; hence an expert reader cannot evaluate the reliability of its conclusions

Unreliable techniques and protocols: analysis of the qPCR data was incorrect

Disregard for controls: obvious evidence of extensive contamination was disregarded

Lack of reproducibility: the data could not be duplicated by several independent investigators

One key failure involved skipping key steps in using PCR on measles virus. The measles virus is an RNA virus. PCR is very inefficient at detecting RNA, so a step called reverse transcriptase is used to convert the RNA to DNA before PCR (RT-PCR). The O’Leary lab did not perform this step. This result, and others, show that the samples used by Mr. Wakefield’s team were contaminated. Prof. Bustin goes into detail and covers more important topics, and as the paper is relatively short, it is worth a read for those interested in the science.

Prof. Bustin concludes:

As a result, the conclusions put forward by this [the Wakefield/O'Leary] paper are entirely incorrect and there is no evidence whatever for the presence either of MeV genomic RNA or mRNA in the GI tracts of any of the patients investigated during the course of the studies reported by O’Leary et al. Instead, it is clear that the data support the opposite conclusion: there is no evidence for any MeV being present in the majority of patients’ analysed. Unfortunately, the authors do not report whether any the patients had received the MMR vaccination. However, assuming that a significant proportion had done so, it is also clear that there is no link between the MMR vaccine and the presence of MeV in the intestine of autistic children.

The Wakefield MMR hypothesis is already failed, so this does not really change the conversation. What this report by Prof. Bustin does is document his own observations, measurements and analyses for the historical record so we can see just how bad the science was that promoted the Wakefield hypothesis.


By Matt Carey

An autism reality show…run by Andrew Wakefield?

15 Feb

There is a TV reality show being shopped around right now focused on autism. The team behind this project includes Andrew Wakefield and Polly Tommey. They have an enterprise called the “autism media channel” which has been making YouTube videos for some time. But they have a promo for their “Autism Team” program which appears to be the basis for their reality show.

Where Mr. Wakefield failed to accomplish with science, where he failed to accomplish with books, he is now attempting to accomplish with TV: create the image that his ideas of autistic enterocolitis is a real entity and that he and his friends (such as Arthur Krigsman) are the source of hope for the autism community. Like many reality shows, it appears to be a commercial.

There is a blog post on the Autism Media Channel website, Guest Post by Autism Mother Diane-Cecilia Graham, which begins:

Did you know someone stole my children? He took them away from me and never intended to give them back but I am fighting him. I used all my skills and abilities to learn what I could about him. In battles knowing your enemy is your best defence. He is a mystery, his place of birth is unknown, his future is unpredictable, no one knows how far he can go and he snatches every child in a unique way and holds them captive for an indeterminable amount of time. He comes when you do not see him coming.

Very reminiscent of the “I am autism” video that Autism Speaks put out a few years back, to much criticism. Take autism and personify it as a monster, stealing children.

The framing is all too familiar: create an atmosphere of doom and gloom, plus fear, then bring in the heroes to save the day. The nice thing about TV is that there is no peer review. Editing for effect is expected. Facts are supposed to take backseat to a good story.

I didn’t consider this a viable project. But, Andrew Wakefield has been spotted at a convention for reality TV people recently. And he has the support of a husband/wife film maker/producer team who have a studio in Austin, his home town.

We are a community with great needs. There is no denying that the needs of autistics are often times very great. But I don’t see how a failed researcher, failed author turned TV reality show producer is on the path to a better future for this community. Especially when the failed researcher is one whose lost his medical license for multiple counts of unethical behavior.

Andrew Wakefield may have hit on something: being a business guy for TV or movies. He could probably sell a studio on the sequel to Plan 9 from Outer Space. But the thought of him creating a reality TV show in his image is frankly frightening.


By Matt Carey

Note:edited to correct spelling of Ms. Tommey’s name

A look at the financials for Generation Rescue and the Strategic Autism Initiative

15 Feb

Generation Rescue is a well known charity with a focus on alternative therapies for autism and promoting the idea that vaccines cause autism. The Strategic Autism Initiative was formed by Andrew Wakefield after he left Thoughtful House (now the Johnson Center). Many of these organizations have close ties and, in fact, GR helped SAI get started with a $100k grant its first year.

The most recent tax forms are from 2011 and are below:

Generation Rescue IRS form 990Strategic Autism Initiative IRS form 990

Generation Rescue pulls in a great deal of money, nearly $1.2M. Of which about $240k goes to the “rescue grant” program. About $125k goes to running their website. Another $125k to pay their executive director.

Under grants, Generation Rescue (GR) has two:

$25,000 to the Strategic Autism Initiative
$20,000 to Jackson State University

Both “for researching causes of autism”. We see again the link between GR and SAI. Jackson State is the institution engaged by Generation Rescue and the SAI to perform a vaccinated/unvaccinated study using homeschooled kids. I’ll point out that when I reviewed the GR and SAI tax forms last year, I speculated that they were starting to fund the vax/unvaxed study.

Now consider the SAI’s form 990. SAI pulled in $284k. They paid out $250k in salaries and other compensations. Yep, 88% of intake went to salaries. Luckily they had a bit of a war chest from the year before to draw on. But let’s look at those salaries. Andrew Wakefield is compensated $200k/year for a reported 30hours/week. That’s $270k/year (his salary at Thoughtful House). Terri Arranga ( of AutismOne) was paid $28.8k for reported 15hours/week.

But, as I said, they had a war chest from 2010 (due in big part to a $100k donation from GR). How did they spend that? Well, they appear to have a grant of $25k to Generation Rescue for “research related to the vax/unvax study”. Which strikes me odd as GR gave SAI $25k, so it looks like the money went in a circle.

That said, what expenses did SAI report?

$158k to Dr. “Lenys G. Gonzalez” to work with Arthur Krigsman and Stephen Walker on “molecular and clinical signatures of inflammatory bowel disease and adverse vaccine reactions in autistic children.”

Lenny Gonzalez is a researcher in Venezuela who was funded by Wakefield at Thoughtful House in one of the supposed “independent” replications of Wakefield’s findings. Arthur Krigsman is a former colleague at Thoughful House, with a colorful history. Stephen Walker’s name comes up periodically in regards to a study he presented at IMFAR but never published which supposedly confirmed Andrew Wakefield’s finding of measles virus in intestinal tissues of autistics.

$43k for a study on “vaccination status and health outcomes among homeschool children in the United States”, with Anthony Mawson of Jackson State. Mr. Mawson was named as the lead researcher for this project back when GR was seeking funding from money left over from a class action lawsuit to fund it.

$86k for an “IRB approved” (are the others not?) investigation using the Florida Medicaid database. And, no surprise, this is to look at vaccines. (1) acute adverse reactions to vaccines as predictors of neurodevelopmental disorders and (2) age of vaccination and risk of adverse outcome.

I am curious if the Florida project is the same one the Geiers were attempting to get pushed through approval a few years ago. A t that time a vaccine-causation focused chiropractor and heavy political donor was pushing both access to the Florida medical records and for things like changing a bill to improve access to services for families with autistic children into a vaccine bill.

Many people might be wondering how Andrew Wakefield managed to gather half a million dollars in under two years. I can’t say for sure but I can put out some information for speculation.

One of his board members is Elizabeth Avellan. She also serves on the board for Mr. Wakefield’s “Autism Trust”, which lists her accomplishments as including ” highly successful film producer and co owner of Trouble Maker studios “. Troublemaker Studios has the “Spy Kids” franchise.

Another board member is Phil Rawlins. There was a Phil Rawlins in Austin who owned a soccer team. He has since moved to Florida.

So whatever skills he had, Mr. Wakefield is basically now a fundraiser. He’s good at it, you gotta hand it to him. I can think of a lot of ways that money could be better spent, though.


By Matt Carey

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