Congenital Rubella Syndrome: a Novel Form of Mercury Poisoning?

13 Sep

I considered titling this: A peak into the upcoming book “Age of Autism?” as this seems to show us the sorts of arguments that will be made in that book.

One of the known environmental causes of autism is Congenital Rubella Syndrome, or CRS. This was discussed as part of a presentation to the IACC, What Causes Autism? The Case for an Environmental Contribution, by Dr. Philip Landrigan. (video is here, starting at about minute 79. Sorry it doesn’t embed).

In the question/answer session for that presentation on at about 114 minutes into the IACC meeting) Lyn Redwood of SafeMinds brought up a new argument–that CRS induced autism may be due to mercury. It turns out that in the 1950’s gamma globulin therapy was started as a means of preventing CRS. Gamma Globulin was injected into pregnant mothers who to prevent or reduce the rubella infections. This exposed the mother and fetus to mercury and should be considered the cause of the autism according to Ms. Redwood.

I must admit that when I heard this question I thought: “Well, here is one of the talking points we will hear from the upcoming book, ‘Age of Autism’, by Mark Blaxill and Dan Olmsted”. Their book appears to be an attempt to tie all of autism (and many other conditions) to mercury, including, I suspect now, CRS. There are other loose ends they will undoubtedly bring up and tie into the mercury hypothesis (like the existence of autistics who were born before thimerosal was invented. That will be interesting to read).

There is at least one big reason why CRS was possibly not linked to autism before Stella Chase’s work in the 1970’s. Congenital Rubella Syndrome causes major disability. Severe to profound mental retardation. There are big spikes in the California Department of Developmental Services data for severe and profound mental retardation corresponding to the CRS outbreaks of the 1960s. Why bring this up? Because for the first two decades after Kanner’s original paper, many people considered intellectual disability (mental retardation) and autism to be completely separate.

From Infantile autism reviewed: a decade of research, a review article written in 1981:

One of the chief problems has been how to handle the questions of mental retardation and organic brain disease, issues especially troublesome with regard to infantile autism. When Kanner (1943) first described the diagnostic features, he also remarked that the condition bore no resemblance to any known neurological condition and implied that autistic children had a basically normal intelligence. For over two decades afterwards, diagnosticians generally believed that the presence of mental retardation or neurologic signs ruled out the diagnosis of infantile autism in the Kannerian sense, even if the child met all behavioral criteria (Eisenberg 1966). Thus diagnosis was frequently one dimensional; a child was labeled as afflicted with either infantile autism or mental retardation, not both.

Or, to put it another way, what many people today call “Kanner’s Autism”, with intellectual disability and/or apraxia, is not what Kanner and most of the people of his time thought of as autism.

But, data, as they say, there’s a funny thing about evidence. Real data is worth more than all these blogger discussions. The paper out today from Pediatrics included immune globulins in their analysis and showed that mercury exposure prenatally and in infancy and found that these exposures did not increase the risk of autism.

Then again, the funny thing about evidence is that it is repeatable. Two previous papers showed no link between immune globulins and autism:

Maternal Rh D status, anti-D immune globulin exposure during pregnancy, and risk of autism spectrum disorders


Lack of association between Rh status, Rh immune globulin in pregnancy and autism.

So, if I am correct and “Age of Autism” the book claims immune globulins *are* a cause of autism, what can we say? We can say that the funny thing about evidence is that some people are not swayed by it. Some people will continue to push the mercury hypothesis forever.

Thimerosal in vaccines did not cause an autism epidemic

13 Sep

There have been two main theories linking vaccines to an “epidemic” of autism. Both theories have been studied. Both have been heard in the courts. Neither theory had a sound scientific basis and epidemiological data has shown that neither theories explained the increase in autism prevalence in the last 20 years.

First it was proposed that the MMR vaccine resulted in persistent measles infections that lodged in the intestines of children leading to “leaky guts” and that harmful substances were leaked into the blood, traveled to the brain and resulted in autism symptoms. This was proposed by Dr. Andrew Wakefield and has since been shown in epidemiological and other studies to be unsound. (This theory morphed for the Omnibus Autism Proceeding, the vaccine court. The argument there was that the measles virus itself traveled to the brain. Again, it is not supported by epidemiological data and is not scientifically sound).

The second theory was that mercury in vaccines from a compound called thimerosal caused autism. In that theory, it was proposed that autism symptoms were similar to mercury poisoning (autism was a “novel” form of mercury poisoning). This theory was not scientifically sound as autism symptoms are not like mercury poisoning. Previous epidemiological studies have also shown thimerosal was not behind the rising numbers of people diagnosed with autism.

In 2007 there was a study which looked at 1,000 kids aged 7-10 to see if various neurological symptoms were more prevalent in those who received higher exposures to thimerosal. Orac at Respectful Insolence blogged it and Kev posted that piece here on LeftBrainRightBrain as well. That study showed indications that in some measures children may perform more poorly with thimerosal exposure. It also showed that in some measures children may perform better with thimerosal exposure. This mixed result is (a) not very strong in either direction and (b) not very surprising when you look at a lot of different measures at the same time. Chance will result in some measures positive, some negative.

The 2007 study was published in the New England Journal of Medicine as Early Thimerosal Exposure and Neuropsychological Outcomes at 7 to 10 Years, by Thompson, et al.. (Thompson (2007))

What was missing in that report was a direct study of autism. Given the numbers of children (1,047) selected, there would only be about 10 kids with ASD expected in the group. This is too few for a strong conclusion on autism. At the time of that study it was noted that another study would follow concentrating on autism alone.

That study has just been published in the journal Pediatrics as Prenatal and Infant Exposure to Thimerosal From Vaccines and Immunoglobulins and Risk of Autism. They studied “256 children with ASD and 752 controls matched by birth year, gender, and [managed care organizations]”. I will give some details here. I expect the treatment on the Science Based Medicine and Steven Novela’s Neurologica blogs to cover the science thoroughly should you wish more detail.

Short answer: thimerosal exposure doesn’t cause an increased risk of autism. Neither thimerosal from vaccines given to the children nor thimerosal from products like Rhogam are behind the increase in autism prevalence we have seen.

It is worth noting that the authors looked at autism with and without regression.

Here is the abstract:

OBJECTIVE: Exposure to thimerosal, a mercury-containing preservative that is used in vaccines and immunoglobulin preparations, has been hypothesized to be associated with increased risk of autism spectrum disorder (ASD). This study was designed to examine relationships between prenatal and infant ethylmercury exposure from thimerosal containing vaccines and/or immunoglobulin preparations and ASD and 2 ASD subcategories: autistic disorder (AD) and ASD with regression.

METHODS: A case-control study was conducted in 3 managed care organizations (MCOs) of 256 children with ASD and 752 controls matched by birth year, gender, and MCO. ASD diagnoses were validated through standardized in-person evaluations. Exposure to thimerosal in vaccines and immunoglobulin preparations was determined from electronic immunization registries, medical charts, and parent interviews. Information on potential confounding factors was obtained from the interviews and medical charts. We used conditional logistic regression to assess associations between ASD, AD, and ASD with regression and exposure to ethylmercury during prenatal, birth-to-1 month, birthto-7-month, and birth-to-20-month periods.

RESULTS: There were no findings of increased risk for any of the 3 ASD outcomes. The adjusted odds ratios (95% confidence intervals) for ASD associated with a 2-SD increase in ethylmercury exposure were 1.12 (0.83–1.51) for prenatal exposure, 0.88 (0.62–1.26) for exposure from birth to 1 month, 0.60 (0.36–0.99) for exposure from birth to 7 months, and 0.60 (0.32– 0.97) for exposure from birth to 20 months.

CONCLUSIONS: In our study of MCO members, prenatal and early-life exposure to ethylmercury from thimerosal-containing vaccines and immunoglobulin preparations was not related to increased risk ASDs. Pediatrics 2010;126:656–664

My guess is that there will be much discussion of the methods on many websites. For now, here are the data from Table 2 and Table 3.

Table 2 (click to enlarge)

Table 3 (click to enlarge)

As with Thompson (2007) the authors will make longer reports available on their website and will allow access to the data.

This study is not the first of its kind. Here are a few of the large studies which have shown a lack of association between thimerosal exposure and autism in the past.

Thimerosal and the Occurrence of Autism: Negative Ecological Evidence From Danish Population-Based Data

Safety of Thimerosal-Containing Vaccines: A Two-Phased Study of Computerized Health Maintenance Organization Database

Thimerosal Exposure in Infants and Developmental Disorders: A Prospective Cohort Study in the United Kingdom Does Not Support a Causal Association

Autism and Thimerosal-Containing Vaccines Lack of Consistent Evidence for an Association

There are more.

One question is whether this will finally quiet those claiming an autism epidemic caused by mercury in vaccines. Unfortunately, I sincerely doubt it. This study included Sallie Bernard of SafeMinds in the acknowledgments. Ms. Bernard was also involved in the Thompson study of 2007. At that time she was listed as a “dissenting” member of the team. She submitted a letter to the NEJM discussing the reasons for her dissention, Perhaps the lack of the word “dissenting” this time is a good sign. I’ll wait and see.

The main question is how much impact this will have on the next generation of families with autistic children. I can’t but wonder that the age of the mercury hypothesis has seen its peak. Not only in research but in general acceptance.

Sharyl Attkisson blogs the Hannah Poling settlement

10 Sep

I had forgotten Sharyl Attkisson. She is a reporter for CBS news who has covered vaccines in the past, but has been silent on the issue for the past year or more.

Her recent piece shows exactly the sort of reporting that frustrated me in the past: Family to Receive $1.5M in First-Ever Vaccine-Autism Court Award

In that piece she links to her piece from 2008 on the Hannah Poling case: Vaccine Case: An Exception Or A Precedent?

Here’s a quote from that earlier piece:

While the Poling case is the first of its kind to become public, a CBS News investigation uncovered at least nine other cases as far back as 1990, where records show the court ordered the government compensated families whose children developed autism or autistic-like symptoms in children including toddlers who had been called “very smart” and “impressed” doctors with their “intelligence and curiosity” … until their vaccinations.

They were children just like Hannah Poling.

What’s still being debated is whether the Poling case is an exception … or a precedent.

So, which is it? Were there children “just like Hannah Poling” or is this the “First-Ever Vaccine-Autism Court Award”?

Actually, it is neither. This isn’t the first vaccine court award involving autism, and the other cases are not “just like Hannah Poling”.

For real information on the other nine cases, read Kathleen Seidel’s piece on Neurodiversity.com. Few, professional or amateur, can compare the the thoroughness of Kathleen Seidel. For example, one case (the first I read involving autism from the vaccine court) is Suel v. HHS. Young David Suel had tuberous sclerosis, a condition known to be associated with autism and epilepsy. Epilepsy occurs in about 60 to 90% of individuals with TS. Autism occurs in about 25-50%. David Suel’s case was declared to be a “table injury” wherein the seizures began within a set period after his DPT vaccination. What is notable about that is the table for DPT was later changed–when it was shown that DPT was not responsible for inducing seizure disorders. In other words, had David Suel been vaccinated, or just filed, after the change in the table, he likely would not have been awarded damages.

“They were children just like Hannah Poling”? Is tuberous sclerosis just like mitochondrial disease? (answer: not even close).

Shall we go on? In her recent piece, Ms. Attkisson states:

In 2002, Hannah’s parents filed an autism claim in federal vaccine court. Five years later, the government settled the case before trial and had it sealed

Not accurate. The court did not “settle” the case in 2007. They conceded the case, and they were in the process of completing the settlement when someone leaked the information to the press. The government did not “seal” the case–it is standard procedure to keep this information confidential until the settlement is completed.

But that doesn’t make a good story, does it?

Ms. Attkisson goes on:

In acknowledging Hannah’s injuries, the government said vaccines aggravated an unknown mitochondrial disorder Hannah had which didn’t “cause” her autism, but “resulted” in it. It’s unknown how many other children have similar undiagnosed mitochondrial disorder. All other autism “test cases” have been defeated at trial. Approximately 4,800 are awaiting disposition in federal vaccine court.

Mito-autism was a big thing for a while there. David Kirby took the story and ran with it–making a lot of mistakes along the way and propagating a lot of misinformation. It is unknown how many other children have similar disorders–but the researchers who studied cases like Hannah Poling have stated that cases such as hers are “rare”.

“All other autism “test cases” have been defeated at trial”.

What is conspicuous about the other “test cases” is that in none of them was it argued that the children were like Hannah Poling–i.e. the attorneys did not argue that a mechanism of autism through mitochondrial dysfunction aggravated by vaccines existed. In fact, one child named as a test case was pulled from that slot in order to argue that mitochondrial based case. The expert report filed for that child (since pulled from the Omnibus website) did not argue mitochondrial disorder or dysfunction at that time. In other words, the idea of a mitochondrial disorder being linked to autism was so alien from the cases being made by the attorneys for the families in the Omnibus that this child had to argue the case separately.

It is often pointed out that many autistics may have mitochondrial dysfunction. This is based largely on studies out of Portugal. It is left implied, and it is often believed that mitochondrial dysfunction means vaccine injury in these cases. This was the impression that David Kirby put forth and it was clearly wrong. First, mitochondrial disorders are a very broad spectrum. The type that Hannah Poling has is not the same as those detected in most autistics. Second, most reports of mitochondrial disorders and autism, including the Portugal studies, do not involve regression. Third, even amongst those children reported by the groups that identified Hannah Poling, regression was often idiopathic or followed fever clearly independent of vaccination.

I do not expect Ms. Attkisson to present the following (quality) information, so I will repeat it here:

Here are the answers to some questions posted to mitochondrial medicine experts and their answers:

When asked, to respond to the position: ‘‘I view the risk of vaccination in known metabolic disease patients to generally be outweighed by the risk of the infectious diseases being vaccinated against”

63.2% strongly agreed
31.1% agreed
0.9% disagreed
and 0.9% strongly disagreed.

Asked about the opinion that the risk of vaccination in metabolic disease was ‘‘greater than the risk of the infectious diseases being vaccinated against”

52.9% strongly disagreed
40% disagreed
3.5% agreed
and none strongly agreed

Mark Blaxill promotes bad science

8 Sep

[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??

Age of Autism – Amazon file wisely

8 Sep

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.

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

7 Sep

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

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

7 Sep

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.

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

4 Sep

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.

Damages awarded in the Poling case?

3 Sep

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.

A reminder for neurodiversity

2 Sep

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.

← Older Entries
Newer Entries →