Wakefield Leaves Thoughtful House

For parents like me, dealing with the severe part of the Autism spectrum, Dr. Wakefield’s findings gave us hope and a reason for the chaos that no one else could explain. I have never meet him and probably never will, but nevertheless I will be forever in his debt. This witch hunt against a good doctor is disheartening and unfair. I am so very sad to hear he has resign from Thoughtful House Center for Children.

By Mary Ann Roser, statesman.com is.gd/8KsJK

Council, which regulates doctors in the U.K., found that Wakefield was dishonest and irresponsible in conducting research on children in England a dozen years ago. The panel also said Wakefield showed a “callous disregard” for children at his child’s birthday party in 1999 when he had blood taken from them and paid them about $10 each. He later joked at a conference about the children being “paid for their discomfort.”
Wakefield’s 1998 work, published in The Lancet, a prestigious British medical journal, fueled a worldwide scare over vaccines and autism. The Lancet retracted the study earlier this month.
Thoughtful House would not answer questions about Wakefield’s departure. By Thursday morning, he was removed from the center’s staff list, and the center issued a statement when asked whether Wakefield had resigned.
“The needs of the children we serve must always come first,” it said. “All of us at Thoughtful House are grateful to Dr. Wakefield for the valuable work he has done here. We fully support his decision to leave Thoughtful House in order to make sure that the controversy surrounding the recent findings of the General Medical Council does not interfere with the important work that our dedicated team of clinicians and researchers is doing on behalf of children with autism and their families. All of us at Thoughtful House continue to fight every day for the recovery of children with developmental disorders.”
Wakefield, who is in his early 50s, helped draw musicians and other celebrities to the Thoughtful House, where he was said to be in charge of research.
Parents who brought their children to the clinic said they saw him as a persecuted hero whose staff helped their children improve. The parents said they believe in the theory he advanced in the Lancet paper — that some children might develop a form of autism and gastrointestinal disease from exposure to the combined measles-mumps-rubella vaccine.
Other researchers have widely disputed the theory. Mainstream practitioners also oppose many of the alternative treatments at Thoughtful House, including chelation — the use of chemicals to remove metals from the body.
Starting April 7 in England, Wakefield will go to the next level of hearings before the General Medical Council, which will decide whether he is guilty of serious professional misconduct and whether he should be sanctioned, which could include losing his medical license.
Wakefield does not have a U.S. medical license.
Last month, he told reporters outside the medical council’s office in London, “The allegations against me and against my colleagues are both unfounded and unjust. I repeat, unfounded and unjust, and I invite anyone to examine the contents of these proceedings and come to their own conclusion.”

A Petition to help Dr. Andrew Wakefield

“The Nigel Thomas Petition”
http://www.ipetitions.com/petition/gmc/

Mark Blaxill promotes bad science

[wags finger]…and don’t you ever forget it

Basically, the story is that The Blax wrote a blog post in which he said:

Despite the relentless drumbeat of propaganda from the CDC, public health authorities and the thuggish on-line goons of the medical industry, there’s a funny thing going on. The evidence of a connection between mercury exposure and autism keeps growing.

It does? Really? Such as what science exactly?

Well The Blax has the answer to that in that he quotes from a study which according to The Blax:

They found that thimerosal at the same concentrations received in human infants had clearly measurable effects on opioid receptor development in the infant rats.

Huh. Well imagine my surprise when I read two blog posts, one from Emily in which she says:

Their starting dose is at least 3.2 times the relevant exposure of Hg. But they’re not finished. They don’t use that dose once. They use it four times, injecting the newborn rats on days 7, 9, 11, and 15 of life, each time with 3.2 times the actual relevant exposure of Hg, for a total of 48 mcg of Hg/kg in a little over a week. Indeed, even if 12 mcg were the relevant exposure, they’re dosing their animals with it four times within a week, give or take, giving us ~13 fold the relevant exposure.

and another from Orac in which he says:

…the minimum dose received was 48 ?g Hg/kg, and the maximum dose received was a whopping 12,000 ?g Hg/kg, or 12 mg Hg/kg!

So when The Blax states that this paper is a like for like comparison between infant vaccines and their dosage, I think its clear to see that this is incorrect. What these researchers have in fact done, is massively overdose their test subjects.

And thats not the only problem with this paper that The Blax is so in love with. Geier, Haley, Bernard…recognise these names? Of course you do! They’re the names that this paper relies on to support its underlying ‘science’.

I think the only real question that needs answering here is – how in heck did this paper get past peer review??

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Age of Autism – Amazon file wisely

We all know the new Age of Autism book is coming soon. Its stocked at Amazon for example where pre-orders for the book have placed the books ranking at the heady heights of the top 100,000.

However, whats most interesting is the cover art that Messers Blaxill and Olmsted have chosen for the Kindle edition of the book. In a refreshing turn of honesty, they selected the below (click for bigger) as the cover art.

You can also see it in situ at Amazon US store.

A brave and refreshingly intellectually honest move by Blaxill and Olmsted, I think you’ll agree.

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Autism Science Foundation anounces pre and post doctoral training awards in autism research

The Autism Science Foundation has announced a new round of fellowships for grad students, medical students and post-doctoral fellows who will pursue autism research.

(September 7, 2010—New York, NY) The Autism Science Foundation invites applications for its Pre and Post Doctoral Training Awards from graduate students, medical students and post-doctoral fellows interested in pursuing careers in basic and clinical research relevant to autism spectrum disorders.

The proposed training must be scientifically linked to autism. ASF will consider for training purposes all areas of related basic and clinical research including but not limited to: human behavior across the lifespan (language, learning, communication, social function, epilepsy, sleep, repetitive disorders), neurobiology (anatomy, development, neuro-imaging), pharmacology, neuropathology, human genetics/genomics, immunology, molecular and cellular mechanisms, studies employing model organisms and systems, and studies of treatment and service delivery.

Applicants for the pre-doctoral awards must be students enrolled in a program in the United States leading to a research doctorate such as a Ph.D. or Sc.D., a combined degree such as an M.D./Ph.D., in an academic department at an accredited university or health/medical institution, or an M.D. at an accredited university medical school. Applicants for the post-doctoral awards must have completed their doctoral degree and have been accepted as a post doctoral fellow in good standing in a program in the United States. The selected awardee must spend 80% of his/her professional time engaged exclusively in autism research activities stipulated in the application for the duration of the award, and cannot simultaneously hold another named fellowship award during the support period.

Each applicant must apply with a mentor, who must hold a tenured or tenure-track faculty appointment (or equivalent) at an accredited institution of higher education or health/medical/research institution in the United States, and must be an established and active investigator in some aspect of autism research.
Each mentor may sponsor one pre-doctoral candidate and one post-doctoral candidate per year.

Learn more at www.autismsciencefoundation.org/ApplyForaGrant.html

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Amy Wallace gives “lessons from the field” to health journalists

In a recent article on the University of Southern California’s site Reporting on Health, Amy Wallace gives lessons learned in her activities covering the vaccine/autism discussion. The site, part of the Annenberg School for Communication, hosts her piece, Covering Vaccines.

Amy Wallace wrote a piece for Wired Magazine last year, An Epidemic of Fear: How Panicked Parents Skipping Shots Endangers Us All. As you might imagine, this piece was not well accepted by parts of the autism, nor the self-styled “vaccine safety” communities. Ms. Wallace first had to endure the negative responses of those communities online, with emails such as an essay Paul Offit Rapes (intellectually) Amy Wallace and Wired Magazine as well as blog posts depicting her sitting down to a thanksgiving feast consisting of roast human baby.

She, her publisher and Dr. Paul Offit were also subjected to a lawsuit by Barbara Fisher of the self-named “National Vaccine Informational Center” over a statement by Dr. Offit quoted in the piece:

Paul Offit has a slightly nasal voice and a forceful delivery that conspire to make him sound remarkably like Hawkeye Pierce, the cantankerous doctor played by Alan Alda on the TV series M*A*S*H. As a young man, Offit was a big fan of the show (though he felt then, and does now, that Hawkeye was “much cooler than me”). Offit is quick-witted, funny, and — despite a generally mild-mannered mien — sometimes so assertive as to seem brash. “Scientists, bound only by reason, are society’s true anarchists,” he has written — and he clearly sees himself as one. “Kaflooey theories” make him crazy, especially if they catch on. Fisher, who has long been the media’s go-to interview for what some in the autism arena call “parents’ rights,” makes him particularly nuts, as in “You just want to scream.” The reason? “She lies,” he says flatly.

“Barbara Loe Fisher inflames people against me. And wrongly. I’m in this for the same reason she is. I care about kids. Does she think Merck is paying me to speak about vaccines? Is that the logic?” he asks, exasperated. (Merck is doing no such thing). But when it comes to mandating vaccinations, Offit says, Fisher is right about him: He is an adamant supporter.

The phrase “she lies” was singled out in the lawsuit, which was dismissed on its merits.

The article brings the story to health journalists, who are being educated in the manner in which some groups use in response to articles with which they disagree. Such responses as those levied against Ms. Wallace do not further the needs of disabled children or adults, in this readers opinion.

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A busy week in vaccine-injury news: the Cedillo appeal

The past week has had three somewhat major news events in the world of vaccine injury: the denial of the Cedillo appeal, the award of damages in the UK for an MMR case and the damages award in the Hannah Poling case. I thought I would write about them all, but the Cedillo appeal part is already long so I will leave the other subjects for another time.

The Cedillo Appeal

Kev blogged the denial as Cedillo appeal denied. I had blogged the hearing in June as Another appeal heard in the Autism Omnibus, then blogged the actual audio from the hearing as Audio of the Cedillo appeal part 1 and Audio of the Cedillo appeal part 2.

The arugument used in the Omnibus Autism Proceeding for MMR causing autism is basically the model that grew out of the work of Andrew Wakefield: that measles virus (MV) from vaccines persisted in the body, particularly in the digestive tract. Wakefield’s theory involved the MV infection causing intestinal permeability which allowed substances to “leak” out into the system (the “leaky gut” hypothesis). The Cedllio’s attorneys argued that the measles virus itself traveled to the brain, causing inflammation and autism.

This is not the first appeal for the Cedillo family, or for the test cases in the Omnibus. It is likely the last, however. The next step would be the U.S. Supreme Court. The Supreme Court would be unlikely to hear an appeal. The Supreme Court does not hear all the cases submitted, instead choosing to hear mostly cases which clarify points of law. The Cedillo appeal so far has not been about the laws for the most part but about the procedure of the case. One exception is the question of whether the correct standard was applied to reviewing the admissibility of the evidence. The Court used the Daubert standard, which the Cedillo’s attorneys argued was incorrect. This is not the first time the Court used Daubert, and it is not the first time the appeals court upheld it.

The other arguments made include whether the testimony and reports of Dr. Stephen Bustin should have been allowed. Dr. Bustin’s reports were obtained very shortly before the hearing and were based on closed documents from a U.K. proceeding on MMR and autism. The Cedillo’s attorneys argued that they were unable to prepare a counter argument to Dr. Bustin on short notice and that since they did not have access to the underlying data and documents. In a civil court, these arguments would have carried much weight. However, in the vaccine court, much flexibility is allowed. In this case, the Special Master allowed the evidence to be heard, and gave the Cedillo’s attorneys over a year to obtain the background data from the UK and mount a counter argument.

The Cedillo’s attorneys did not attempt to obtain the background data for the Bustin testimony in year that followed the hearing. Yes, it isn’t that they were unsuccessful, they didn’t try to obtain it. They stated that their consultants in the UK advised them that it was unlikely that they would be able to obtain the documents without the permission of the experts. However, Dr. Bustin gave his permission.

From the appeals court decision:

Petitioners considered making such a re-quest from the UK court, but never did so. They contend that British counsel informed them that it was unlikely that the UK court would permit disclosure of the expert reports without the consent of the experts, which peti-tioners stated that they could not obtain. But Dr. Bustin did consent to the release of his reports. Once his consent for the release of his reports had been obtained by the government, there is no reason why the data underlying his reports could not also have been requested

Dr. Bustin’s testimony focused on a critical part of the argument used to claim that MMR causes autism: the claimed presence of measles virus in the bodies of autistics like Miss Cedillo. Dr. Bustin is arguably the worlds top expert on PCR, the method used by the Unigenetics Laboratory to test tissue samples for measles virus. Dr. Bustin discussed at length multiple reasons why the Unigenetics Laboratory results were not reliable.

A few points to be made here.

(1) The Cedillo’s attorneys presented an expert (Dr. Kennedy) to claim that the Unigenetics laboratory was reliable. Dr. Kennedy also had worked on the UK litigation and Dr. Kennedy’s underlying data were also under seal in that litigation. In other words, the Cedillo’s attorney’s were asking that the Special Master apply one standard to the government’s witness (rejecting his report without the underlying data) while applying the exact opposite standard to their own witness (Dr. Kennedy, who also didn’t have the underlying data).

(2) Michelle Cedillo was one of three “test cases” used to test the question of “general causation”. The other two children used as test cases did not have evidence of persistent measles virus in their bodies.

There is only one paper with reliable data showing the presence of measles virus in the tissues of an autistic child. This paper came out after the Cedillo hearing. The paper: Lack of Association between Measles Virus Vaccine and Autism with Enteropathy: A Case-Control Study. In that study they found measles virus in one autistic child, and in one non-autistic “control”. The Cedillo’s attorney’s argued that this was “significant new evidence” that showed the reliability of the Unigenetics laboratory.

I found it very odd that a paper titled “Lack of association between Mealses Virus Vaccine and Autism with Enteropathy” would be used as evidence for an association between measles virus vaccine and autism. But the argument is that this paper validates the Unigenetics laboratory as being able to produce reliable results. The argument is not valid, and the court did not agree with it. The work done by Unigenetics on Miss Cedillo was performed in 2002. The research on the paper was performed much later, after significant criticism was already levied against Unigenetics. Quite simply put, it is possible that Unigenetics “cleaned up its act” by the time of the recent paper.

(3) It was noted that the arguments about Dr. Bustin’s testimony were essentially moot, as the Special Master would have come to the same decision without his testimony.

(4) It was also noted that the appeals court had already decided on Dr. Bustin’s testimony in an appeal mounted by the attorneys for the Hazelhurst family (another of the Omnibus test cases).

The Cedillo’s attorneys further argued that it was unfair that evidence was brought in from the other “test case” hearings (Hazelhurst and Snyder). The appeals ruling noted that the Cedillo hearing was not a stand-alone proceeding. As a test case in an Omnibus Proceeding, evidence from all the test cases would be used to answer the question of general causation. I was surprised at the time of the appeal that the Cedillo’s attorneys were arguing that they were not actively monitoring the other test case hearings. What, in the end, is the point of an Omnibus Proceeding or a “petitioners steering committee” of the petitioners are not acting in some way as a group?

The Cedillo’s attorneys argued that the Special Master did not give enough weight to Miss Cedillo’s doctor, Dr. Krigsman, who stated that her condition was caused by MMR. The fact is that the Special Master rejected Dr. Krigsman’s argument with good cause:

He [the special master] also concluded that Dr. Krigsman’s opinion should be rejected because 1) he relied on the discredited Unigenetics testing in forming his opinion, 2) he misunderstood Michelle’s medical history and his testimony was inconsistent with her medical records, and 3) his conclusion that Michelle suffered from chronic gastrointestinal inflammation was substantially out-weighed by Michelle’s medical records and the testimony of the government’s experts.

The Cedillo’s attorneys argued that sufficient weight was not given to Miss Cedillo’s other physicians whom, they assert, associated her condition with the MMR vaccine:

Petitioners cited nine notations in Michelle’s records from eight individuals, including four physicians who treated Michelle and four non-physicians who exam-ined Michelle, in which the treating physicians mentioned her vaccinations, as support for the proposition that these individuals concluded that her autism was caused by her MMR vaccine.

The appeals court disagreed:

The Special Master did not err in failing to afford sig-nificant weight to the opinions of Michelle’s treating physicians. As the Special Master observed in his deci-sion, in seven of the nine notations, the physician was simply indicating an awareness of a temporal, not causal, relationship between the fever Michelle experienced after her MMR vaccine and the emergence of her autistic symptoms sometime thereafter. Initial Decision, slip op. at 100. In one of the other notations, the physician sim-ply noted that an exemption for Michelle from vaccination requirements could be arranged. In the other notation, the physician speculated that Michelle’s fevers might have caused her neurological abnormalities. However, he expressly stated that it would be “difficult to say” whether this was “a post-immunization phenomenon, or a separate occurrence.” Id. at 100. Thus, “none of the treating physicians concluded that the MMR vaccine caused Michelle’s autism.” Final Decision, 89 Fed. Cl. at 176. The Special Master

In the end, the appeals court decision takes on the arguments by the Cedillo’s attorneys point by point and refutes them. The closest the Cedillo’s attorneys got to making a point stick was in the case of Dr. Bustin’s testimony, which the appeals court stated:

We agree with petitioners that the government’s fail-ure to produce or even to request the documentation underlying Dr. Bustin’s reports is troubling, but we think that in the circumstances of this case, that failure does not justify reversal.

The fact of the matter is, the petitioners in general, and the Cedillo’s in specific, did not have a good case for MMR causing autism. The mechanism they proposed was not sound, the data they had was poor and incomplete and the experts speaking for the government were excellent and refuted the petitioner’s arguments. The Omnibus cases were, as the Special Masters noted, not close.

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Damages awarded in the Poling case?

A document has recently been posted the Court of Federal Claims website, describing an award in a vaccine injury case. The document is redacted, but the following paragraph indicates to me that this involves the case of Hannah Poling:

Respondent has conceded that petitioners are entitled to compensation due to the significant aggravation of Child’s pre-existing mitochondrial disorder based on an MMR vaccine Table presumptive injury of encephalopathy, which eventually manifested as a chronic encephalopathy with features of autism spectrum disorder and a complex partial seizure disorder as a sequela.

The amount involves 4 parts: (1) a payment of about US$1.5M for life care, future earnings and pain-and-suffering, (2) a lump sum payment of about US$140,000 for past unreimbursable expenses, (3) a lump sum payment of about $7,800 to cover a medicaid lien and (4) an undisclosed amount to purchase an annuity to cover items in the life care plan.

The award amount seems larger than typical to me. I don’t put this out as a criticism. Rather the opposite. If we as a people are going to compensate those injured by vaccines, as we should, we should compensate highly. We can not fully compensate a person or a family for injury. For example, the cap on pain and suffering damages has not been increased in the roughly 25 years that the vaccine program has been in place.

It is not easy to write this piece, and I hesitate to publish it. Assuming this document refers to the Poling family, they chose to redact information.

I will end with this statement from the Special Master who wrote the decision:

Based on the persuasive factors supporting petitioner’s vaccine claim and respondent’s election not to challenge petitioner’s claim, the undersigned finds that petitioner is entitled to compensation under the Vaccine Program. Accordingly, a determination of damages is appropriate.

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A reminder for neurodiversity

Its been awhile since I blogged about neurodiversity and why it matters to me as a concept. Two recent events in my own life has made me more aware of that than usual.

In the first event, which concerns me directly, I have had to have a change in the medication I take that helps me regulate the manic depression (bipolar) I am diagnosed with. Nobody knows why I need to adjust my medication, only that it needs adjusting and so I shall shortly have Lamotrigine added to the medication regime I have to take.

How does that remind me about neurodiversity? It reminds me that the basic tenets of neurodiversity – respect for the individual differences those with different neurological makeups have – are my best way of being able to move forward in this world. More on this later.

In the second event, which occurred to some of my new family two days ago, myself, my partner and her two daughters – of whom the eldest (she is 4) is autistic – were shopping. Lily began to have a meltdown, a not unknown event in supermarkets for her and one for which we have a carefully worked out strategy. However, this time our strategy was rudely interrupted when a young woman began to shake her head, gawp openly at Lily and make tutting noises. She obviously felt Lily was a naughty child, rather than an autie child.

My partner and I decided that we had had enough of people judging Lily and so remonstrated with this woman. We both explained that Lily was autistic and unable at the age of four to regulate herself in high impact environments but we had to eat and anyway why should we exclude Lily from coming out with us as a family?

The woman waved her hand at us both in a casual dismissal and said we weren’t ‘controlling’ her properly. I smiled through gritted teeth and asked her what she knew about autism. She refused to answer. I asked her again and she walked off with another casual wave of dismissal. My partner’s by now angry shout of ‘shes autistic and a little girl, she can’t help herself’ following her down the aisle.

Of course, this isn’t the first time either one of us have been exposed to such ignorance and I doubt it will be the last. I’m also sure that many parents and autistic people reading this will be familiar with ‘the look’ that can come from such ignorant people who believe they have a divine right to judge others. But it again reminded me of neurodiversity and why I believe in its most basic tenet.

My partner said to me later that what had upset her so much was that Lily (and you can substitute her name for your own or your child’s) would be – to a certain degree either a lot or some – be dependant on the good will of society as she grew up.

People like the woman in Sainsburys are the ‘anti-neurodiversity’. They believe we can and should judge immediately, based on no other evidence than what we see and hear right in front of us. To me, neurodiversity should sit and think, consider the possibilities and act accordingly, based on a desire to help society in the belief that society should do the same for us.

By specifying a desire to include those with differing neurological disorders/disabilities/differences, neurodiversity helps me to feel secure in the world. It also means that I can feel secure in the world my children will inherit.

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MMR vaccine damaged man

Jackie Fletcher is well known to many – she routinely insists the MMR jab is dangerous despite reams of evidence to the contrary. However, a panel in the UK has found that her son, Robert, was damaged by the MMR vaccine he was administered.

I nearly didn’t blog about this. Why? Well, this blogs predominant focus is autism and Robert did not and does not have autism. The panel in this case found that the MMR caused seizures and mental retardation. Its difficult therefore to get a ‘hook’ into this story. As Mike Fitzpatrick is quoted as saying in the Daily Mail:

It is a very important principle that parents should be compensated in cases of this kind…

and he’s absolutely right. Thats why the Vaccine Damage Payment Unit exists in the UK.

Like any other form of medical procedure, vaccines are not 100% safe. I can’t recall anyone anywhere ever making that claim. What they are however, is very safe indeed. Robert Fletcher was injured and has been compensated. I might even agree with his mum that the amount is ‘derisory’. Robert will need full time care all of his life and £90,000 ($140,000) is nowhere near enough. However, campaigners uninterested in Robert’s day to day needs say that:

Campaigner Polly Tommey, who edits the magazine The Autism File and believes her son Billy is autistic because of MMR, says: ‘This is fantastic news. Now doctors can’t tell me that the MMR is safe.

‘This payout is evidence that it is not safe. It’s interesting that they will look at epilepsy and not autism, and you have to ask why.

‘Is it because the compensation would be billions?’

I very much doubt that any doctor, anywhere has ever told any recipient anywhere that any vaccine is 100% safe. If they did, they were liars.

However, this payment, far from being ‘evidence that it is not safe’ (a bizarre claim) is more like a recognition that the Vaccine Damage Payment system is working as it should. A man was vaccine damaged and was compensated as a result.

As for the claim that ‘they’ will not look at autism, this is simply incorrect. Robert, does not have autism and therefore it would be impossible in this case to look at autism. I would imagine if someone with autism was adjudged to be damaged by their MMR vaccine, Ms Tommey might have a point. As that has not happened, she does not. This kind of fear-mongering by the likes of Tommey is no doubt why the panel made the clear point:

We would stress that this decision is fact-specific and it should not be seen as a precedent for any other case.

In particular, it has no relevance to the issue… as to whether there is a link between the MMR vaccine and autism.

And Fletcher goes on to claim:

Claims for autism are not considered. There are 120 MMR cases waiting to be heard, but none is for autism…

So why should that be? Why is autism apparently ‘excluded’?

Its because the science – both epidemiological and clinical clearly shows that MMR does not cause autism. And that is not the odd paper here and there. We are talking about overwhelming science that shows that the whole autism/MMR connection is simply false and was built up by one man too stupid to admit his clear errors and a mass media keen to build sensation out of this same man’s ego.

Tommey, Fletcher and all others who believe that there’s some kind of conspiracy afoot to block autism from MMR causation cases need to understand the science involved and that unless some new science is forthcoming that establishes MMR as a causative agent in regards to autism then the simple fact of applying for compensation listing the MMR as a cause of their child’s autism is always going to be an immediate strikeout.

Campaigners need to start seeing this event for what it really is – compensation for a vaccine damaged man – and not as what it isn’t – evidence that MMR is inherently unsafe or that theres some mysterious conspiracy to prevent autism from being linked to MMR.

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Cedillo appeal denied

In conclusion, we have carefully reviewed the decision of the Special Master and we find that it is rationally supported by the evidence, well-articulated, and reason-able. We therefore affirm the denial of the Cedillos’ petition for compensation.

Nobody should take any pleasure from this decision. If the Cedillo’s happen to read this I would urge them to step away from the quackery. It is doing nobody any good.

More details here.

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