Archive | Vaccines RSS feed for this section

Jenny McCarthy angling for a spot on The View?

15 Jul

I don’t spend much time following celebrities. Jenny McCarthy was, for a time, an exception. She became the number one spokesperson for the idea that vaccines cause autism as well as for unproven and sometimes dangerous “therapies” for autism. She made a lot of money from autism, autism kept her name in the press and, as the money dried up, Ms. McCarthy quieted down on the topics that only a short time before she was so passionate about. Jenny McCarthy now makes news for topic like, “Jenny McCarthy ‘dating’ Donnie Wahlberg“.

New reports recently came out that Jenny McCarthy is being considered for a spot on the TV show “The View”. I saw a number of these sorts of news stories before I cancelled my news alerts. “Jenny McCarthy in talks with….for a job” They struck me as publicity and trial balloons. Attempts to get buzz going to help get the job.

If Jenny McCarthy’s publicity team are floating this as a trial balloon, they should have known the response they would get:

U.S. News and World Report: Jenny McCarthy’s Pseudoscience Has No Place on ‘The View

Slate: The View of Jenny McCarthy

Salon: Don’t put Jenny McCarthy on “The View” The “warrior mother” is dangerous for television

Atlantic: Destabilizing the Jenny McCarthy Public-Health Industrial Complex

Most discussions focus on Jenny McCarthy’s views on vaccines. She adheres to the idea that vaccines cause autism. It’s good to point out this stance but, as I’ll discuss below, I personally question why The View would be considering Jenny McCarthy given her unprofessional attitude and lack of integrity in regards to her visits on The View.

The vaccine stance has been a bit of a liability for Ms. McCarthy and her organization (Generation Rescue). They have toned down their message a great deal over recent years. Back at the time when Generation Rescue was founded, they were very upfront:

Generation Rescue believes that childhood neurological disorders such as autism, Asperger’s, ADHD/ADD, speech delay, and many other developmental delays are all misdiagnoses for mercury poisoning.

With the number 1 reason for “How was my child poisoned” being thimerosal in vaccines.

The founder of Jenny McCarthy’s autism charity famously wrote once:

With less than a half-dozen full-time activists, annual budgets of six figures or less, and umpteen thousand courageous, undaunted, and selfless volunteer parents, our community, held together with duct tape and bailing wire, is in the early to middle stages of bringing the U.S. vaccine program to its knees.

Generation Rescue both before and since Jenny McCarthy has had a focus on various “cures” for autism. They range from relatively harmless (homeopathy) to dangerous and clearly ill founded (Lupron), promoted at their parent conventions like AutismOne.

Jenny McCarthy not only promotes subjecting disabled children to dangerous therapies, she attacks those parents who don’t accept her advice in this regard.

What’s very interesting with the possible gig on The View is the fact that Jenny McCarthy has a very checkered past with that show. In her first autism book tour, the one person who had the guts to challenge Jenny McCarthy was Barbara Walters on The View. Jenny McCarthy was so angered by this that she reportedly told a rally of her supporters exactly where Barbara Walters could “stick her microphone”. (On a local autism news group, when some people proposed putting video of this event on YouTube they were discouraged from doing so. Even then people realized this was not a good move by Ms. McCarthy.)

In a later book, Jenny McCarthy told the story of her confrontation with Barbara Walters on The View, making herself into a brave “warrior” mom. Only, the story that she gave in the book was very different from the version she gave in a televised interview. In other words, at least one of the stories appears fabricated.

She also posited that Barbara Walters was jealous of Jenny McCarthy and that was the reason why Ms. Walters challenged her. Ms. McCarthy even “forgave” Ms. Walters for the incident. Barbara Walters acted like a journalist and asked Jenny McCarthy to back up her statements. Jenny McCarthy slammed Ms. Walters publicly and quite rudely. And Jenny McCarthy forgave Ms. Walters.

Seemed at the time, and still does, that Ms. McCarthy should have been apologizing, not forgiving.

In the time between the incident on The View and Ms. McCarthy offering “forgiveness”, Ms. Walters had published her biography. In it Ms. Walters disclosed that her sister was intellectually disabled. Jenny McCarthy then “understood” that Ms. Walters was jealous of the fact that she had recovered her son, while Ms. Walters’s sister did not have that opportunity. Forgiveness with a side order of condescension.

An interesting point in the “forgiveness” story. Jenny McCarthy didn’t offer forgiveness when Ms. Walters made the disclosure in her biography. No, Ms. McCarthy waited four months until her own book tour to make the statement. It doesn’t strike this observer as anything beyond a cheap publicity stunt by Ms. McCarthy.

Another interesting point is that it has since been reported that Jenny McCarthy’s “recovered” son needs a $100,000 per year school. So, tales of “forgiveness” because she had recovered her kid while Ms. Walters’s sister remained disabled her whole life fall rather flat.

I did find it interesting that when Jenny McCarthy returned years later to The View for another book tour, it was on a day when Barbara Walters was not present.

Barbara Walters is still active onscreen and behind the scenes at The View. Ms. Walters is a true pioneer of journalism. She didn’t last this long without a very thick skin, so I doubt any of the childish antics from Jenny McCarthy bother her personally. On the other hand, Ms. Walters has been able to see first hand how Jenny McCarthy puts integrity aside in favor of self promotion.

The View is not the sort of hard journalism that is the backbone of Ms. Walters’ legacy. But, one does wonder why Ms. Walters (co-producer and co-owner of The View) would take on Ms. McCarthy. Jenny McCarthy is not and never will be on par with Barbara Walters. Few of us are. But bringing Jenny McCarthy into The View would cheapen, just a bit, a lifetime of hard work and excellence by Ms. Walters.

—
By Matt Carey

A fishing expedition at Vaccine Court

14 Jul

The U.S. Court of Federal Claims has a section devoted to adjudicating claims of vaccine injury. This is often referred to as the “Vaccine Court”. Individuals or their families can file a claim (petition) the court for alleged vaccine injury.

Information on individuals who are vaccinated are kept by ten Managed Care Organizations (MCO’s) and the Centers for Disease Control as the Vaccine Safety Datalink (VSD) Project. Researchers working as expert witnesses for families in the Vaccine Court have accessed the VSD in the past, and in one case misused their access. Possibly as a result of this, the MCO’s stopped contributing their data to the CDC for a single VSD database. Hence the reason why there are now 11 separate databases, with each MCO retaining control over their data.

One can see how groups who want to argue vaccine injury in court might want access to the VSD. Mark and David Geier have in the past attempted to use the VSD and they were the ones caught misusing the database. They, together with Heather Young, used an older VSD dataset to produce a paper for the Petitioners Steering Committee (the attorneys arguing for the families in the Omnibus Autism Proceeding). A paper for which the PSC was charged $250,000. A paper which was of such poor quality that it was not used by the PSC in the Omnibus.

In a recent decision, the Court heard arguments that the information in the Vaccine Safety Datalink Project should be turned over to their expert, Theresa Deisher, for analysis:

Petitioners seek access to data from the Vaccine Safety Datalink Project (hereafter the VSD Project) to allow their expert, Theresa A. Deisher, Ph.D., to conduct an original study comparing the rate of autism disorder incidence among children who received a particular vaccine, with the rate among children who did not receive that vaccine. As discussed more fully below, petitioners’ expert does not seek to study the MMR vaccine at issue in this matter, but rather the varicella vaccine.

That last sentence is important. The Special Master points out the decision to research whether the varicella vaccine (chickenpox) is associated with autism for good reason. The petitioners are not arguing that the varicella vaccine caused their child’s autism. No, they argue that the child reacted to DNA in the MMR vaccine resulting in autism. So, how a study on the chickenpox vaccine would further their case is somewhat unclear. Why they are not asking for data on chickenpox is even less clear.

The petitioners asked for $260,000 up front to fund the study. To my knowledge, the Court does not fund expert witnesses for efforts not yet performed. Aside from that fact, the Special Master noted that Theresa Deisher’s studies on the subject done to date were already funded.

Dr. Deisher notes that this work was funded by the MJ Murdock Charitable Trust, Pet’rs’ Ex. 26 at 18, which according to information on Deisher’s CV, provided her with a $500,000 grant to study “Population, Bioinformatics and In Vitro Studies into the Relationship between Residual Human DNA Vaccine Contaminants and Autism.” Deisher’s CV at 3. Dr. Deisher’s inability to produce a paper of publishable quality, after receiving a substantial grant, does not lend support to petitioners’ claim that she is capable of competently leading a study.

Yes, half a million dollars so far with no papers published. A manuscript was submitted to Autism Research and rejected. My guess is that the manuscript will soon be submitted to a journal (there are those which will welcome this). Or, one of these journals will seek out Ms. Deisher for her work (I could easily see this being published in a certain Polish journal, for example).

One can apply to gain access to the VSD databases. However, Ms. Deisher has not attempted to access the data in this way, opting instead to gain access through a court order.

As discussed in more detail later in this Order, petitioners acknowledge that Dr. Deisher has not followed the CDC’s usual Data Sharing application process and that she has no intention of doing so.

She did, however, apply for an NIH grant to perform this research. The petitioners claim that the controversial nature of the study resulted in it not being funded. The referee reports, however, were clear that the planned study was weak and Ms. Deisher’s skills were not strong in epidemiology and statistics (among other weak points).

Although petitioners make assertions to the contrary, the evidentiary record before the undersigned contains a withering assessment of Dr. Deisher’s ability to competently lead the proposed study. Petitioners here seek extraordinary relief, and the undersigned is reluctant to substitute her scientific judgment for that of the NIH reviewers—a panel of Dr. Deisher’s peers—who have found her proposed study to be critically deficient. In the undersigned’s view, the NIH reviewers’ comments merit weighted consideration.

“Withering assessment”.

The special master also notes that the request for data from the VSD exceeds the data needed to do the proposed study.

The petitioners do not limit their data request to information that is needed for the study they propose:

Despite the stated limits of her study, petitioners’ request for production from respondent and the MCOs lacks correlative limits for patient age and injury. Instead: petitioners seek authority to issue subpoenae to compel [respondent and the MCOs] to grant the petitioners full and unrestricted access to all data collected by the respondent within the VSD related to the administration of vaccines, and the occurrence of neurodevelopment and other disorders from the inception of the VSD to date.

Which, in my opinion, points to this as a fishing expedition. An attempt to gather any and all data and test multiple questions later–with the probability of a chance “hit” going up with the number of questions tested.

Since the Special Master did not grant access to the VSD, the funding request was also denied.

The petitioners asked that the expert witness fees for Theresa Because petitioners’ discovery request is denied, petitioners’ motion for authorization of interim expert expenses is deemed moot.

The decision also includes much discussion of a large, broad request for information from the FDA on the vaccine approval process. Again, this appears as a “fishing expedition”

Petitioners’ motion does not appear to be a well-considered effort to meet their evidentiary burden under the Vaccine Program; but rather appears to be a brazen attempt to gain access to respondent’s comments on the various vaccine licensing applications in the hope that something therein might be of relevance. As presented, there is nothing in petitioners’ briefing or the record showing that the documents under FDA’s control are necessary to a determination of the issues in this matter

Ms. Deisher’s previous research has focused on “changepoint” analysis of autism prevalence data. She follows the method set forth by two people at the FDA who presented such a changepoint analysis previously. I found that analysis lacking and submitted a comment to the journal on it. I find Ms. Deisher’s analysis lacking as well.

In the end, the petitioners shot themselves in the foot, repeatedly. They made an overly broad request for data (essentially the entire VSD database). They requested the funding for the analysis in advance. Their expert witness’ track record was lacking. The proposed a search of FDA documents without providing a good reason why this was important for their case.

They went fishing and they got skunked.

—
By Matt Carey

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: https://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?’: https://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

IMFAR study: No Differences in Early Immunization Rates Among Children with Typical Development and Autism Spectrum Disorders

3 May

IMFAR, the International Meeting For Autism Research, is going on this week.  In preparation for the meeting, I posted the titles of a number of studies being presented.  The full abstracts are now available.  One might venture to guess that for a segment of the online parent community, this study (sadly) may get the most attention: No Differences in Early Immunization Rates Among Children with Typical Development and Autism Spectrum Disorders

It is not one of the very large population based epidemiological studies which have many thousands of participants.  But it is a good sized study with confirmed diagnoses.

As the abstract states, the difference immunization rates is not significant, with the autistic kids rate reported as slightly lower. One child was unimmunized, and that child is autistic.

One vaccine with significantly different uptake rates is the Hepatitis B vaccine, with autistic kids receiving this at a lower rate than the typically developing kids.  The HepB vaccine is one that gets a great deal of focus by those claiming vaccines causes an autism epidemic, with claims of much higher autism risk among those vaccinated with HepB. If this were true, one would expect the autistic group to show a higher uptake of this vaccine.

All in all, as the authors note, this is not a study about causation but the results do not lend support to the idea that vaccines are associated with higher autism risk. The study was undertaken by the MIND Institute, which is generally respected by the groups who promote the idea that vaccines are associated with autism.

K. Angkustsiri1,2, D. D. Li3 and R. Hansen2,4, (1)UC Davis MIND Institute, Sacramento, CA, (2)UC Davis Medical Center, Sacramento, CA, (3)M.I.N.D. Institute and Department of Psychiatry and Behavioral Sciences, University of California Davis Medical Center, Sacramento, CA, (4)The M.I.N.D. Institute, University of California, Davis, Sacramento, CA

Background: The relationship between vaccines and autism spectrum disorders (ASD) has been of great interest to families and health providers.

Objectives: This study compares the immunization practices of preschoolers with ASD and typical development (TD).

Methods: Immunization records were abstracted from 240 (161 ASD, 79 TD) children between the ages of 24.1-54.4 months participating in the Autism Phenome Project from April 2006 to August 2011. Seventy-eight percent were male. We compared immunization rates for the vaccines required by the State of California for children ages 18 months to 5 years (3 doses of Hep B, 4 DTAP, 4 Hib, 4 PCV, 3 IPV, and 1 MMR). Of note, there was a national HIB vaccine shortage from 2007-2009. Varicella was not included due to the possibility of naturally acquired immunity. 

Results: Immunization rates in ASD children were slightly lower than in TD (see Table 1), but this difference was not statistically significant, with the exception of Hep B, where 91.3% of children with ASD had received 3 doses compared to 98.7% of TD (p=0.024). These rates were at or above those reported in the 2011 National Immunization Survey (NIS). One (0.6%) ASD child had not received any immunizations. The national rate for children who received no immunizations was 0.8%. 

Conclusions: Despite the lack of evidence supporting any causal relation of vaccines to ASD (IOM, 2011) many parents remain concerned and some choose to delay or avoid vaccines. Immunization rates in preschoolers with ASD in our sample were generally lower than TD, although there were no statistically significant differences except for Hep B.  Our study, although not designed to specifically address a causal relationship, does not support an association between vaccines and ASD. In most cases, these immunization practices represent behavior during the first 18 months of life prior to receiving an ASD diagnosis. Further study looking at differences in vaccine acceptance during the 4-6 year booster period is warranted, as having an ASD diagnosis may affect parents’ attitudes towards future immunization.

ASD (n=161) TD (n=79) p-value 2011 NIS
Hep B 147 (91.3%) 78 (98.7%) 0.024 91.1%
DTAP 150 (93.2%) 78 (98.7%) 0.110 84.6%
Hib 107 (66.5%) 48 (60.8%) 0.386 shortage 2007-09
PCV 134 (83.2%) 66 (83.5%) 0.128 84.4%
IPV 149 (92.5%) 78 (98.7%) 0.066 93.9%
MMR 151 (93.8%) 75 (94.9%) 0.99 91.6%

—
By Matt Carey

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).

New Published Study Verifies Andrew Wakefield’s 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

← Older Entries
Newer Entries →