Autism Omnibus: Hazelhurst appeal denied

29 Jul

The Autism Omnibus Proceedings is, for better or worse, one of the big stories in the world of autism news. Hearings have been held, using the best science and arguments that could be brought to bear. The two theories were (1) does MMR cause autism and (2) does thimerosal cause autism.

Each theory was tested using three “test cases”. Essentially, three trials for each theory, each discussing an individual child plus arguments on “general causation”.

So far, the decisions are only in on the MMR question
. The answers were clear and decisive: “this is not a close case”.

The Omnibus decisions are not the end of the vaccine/autism lawsuits. Not by a longshot. The first step was an appeal, and the first appeal has been decided.

Here is the conclusion of the Judge who heard the appeal for the Hazelhurst case:

In hearing this appeal, the court is not without sympathy for Yates, the Hazlehursts, and the other children and families dealing with autism and autism spectrum disorders. And this court, like the special master, acknowledges both the burdens many of these families have faced and the tremendous love and support they have shown their children. The facts, however, do not support petitioners’ appeal and we have no choice but to deny their motion. Accordingly, for the reasons set forth above, the special master’s decision of February 12, 2009, is AFFIRMED.

I.e. the appeal failed. The decision stands. The Court holds that MMR does not cause autism.

The judge’s decision in the appeal gives a good summary of the original case. If you want to read about the Hazelhurst case, it would be the first place I would send you.

From the appeals judge’s ruling, here are the two “cardinal” flaws in the petitioner’s case:

1) First, the special master explained that petitioners’ experts based their opinions on the characteristics of the “wild-type” measles virus rather than on the characteristics of vaccine-strain measles, despite the fact that the measles vaccine is distinguishable from the wild-type measles virus in several key respects.

2) Second, the special master observed that petitioners’ experts further based their opinions on studies (detecting the presence of the measles virus in the gut tissue of autistic children) that the special master found to be unreliable.

The special master considered the presence of the measles virus in the gut to be the “linchpin” of the petitioner’s case. In other words, they needed to show reliable data or studies demonstrating that the virus was still in the tissues of the children long after the vaccination.
The two studies they had to rely on were (a) that by Dr. Wakefield’s team and (b) an unpublished study by Dr. Stephen Walker, presented as a poster at the 2006 IMFAR conference. Well, the Wakefield study was pretty well discredited, and the Walker study was never published.

In the appeal, the Hazelhurst’s lawyer argued that the testimony of Dr. Stephen Bustin should not have been considered. Amongst the arguments were that some of the information was submitted at the last minute.

No arguments were made that Dr. Bustin was wrong in his analysis of the O’Leary laboratory. That was one of those strange moments in law–no one challenged Dr. Bustin on being right. The judge hearing the appeal noted that the rules for the Vaccine Court are different from a typical court of law. Specifially, the rules are designed specifically to allow more information in to inform the Special Master. The judge further noted that under the typical rules of evidence, the Walker study would never be admitted anyway.

If you haven’t read about Dr. Bustin’s testimony, you should consider it now. Dr. Bustin basically discredited the entire “persistent measles in the gut” idea by showing that the O’Leary laboratory that made tests had serious methodological flaws and, basically, couldn’t make the tests at all.

The Hazelhurst’s lawyer then argued that the Special Master failed to include all the relevant evidence., In specific, that the Walker study wasn’t given due weight.

Again, one of those strange moments in law. The laywers moved directly from trying to get the Special Master to exclude evidence that was clearly relevant, to claiming that the Special Master had to include all relevant evidence. I guess that’s why I am not a lawyer. I couldn’t pull that off with a straight face.

As it turns out, even the witness for the Hazelhurts’ side stated that the Walker study wasn’t reliable:

Respondent additionally notes that Dr. Hepner herself acknowledged that the preliminary data from the study was “not useful at this time” (Cedillo Tr. at 682), declined to draw any conclusions about the biological significance of the Walker group’s findings (Cedillo Tr. at 682), and identified what respondent describes as several significant drawbacks to the study, including that the experiments had not been “blinded”28 and had lacked negative controls.

So, it is rather moot as to whether the Walker study was considered, since it doesn’t really provide substantial evidence to support the MMR theory.

The third main argument used in the appeal was that the Special Master failed to decide on a “critical issue”. Namely, whether regressive autism exists as a separate phenotype.

The Special Master wrote in his decision, and the appeals judge agreed: since the decision held that MMR doesn’t cause autism, there was no point in deciding on the question of regressive autism as a separate phenotype.

Given that the expert testimony was against this idea, it is probably better for the petetioners that this question was left unanswered.

The main result is, of course, the original decision was upheld. Looking forward, it doesn’t look good for the MMR theory to win in civil litigation from my perspective. The Bustin testimony is very damning to the little evidence there is, and that will be allowed in a civil case. The Walker study, however, will almost certainly not be allowed as it is unpublished and has severe limitation

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8 Responses to “Autism Omnibus: Hazelhurst appeal denied”

  1. passionlessDrone July 29, 2009 at 22:58 #

    Hi Sullivan –

    FYIW – I have been told (i.e., saw a video of a presentation, but I don’t think it was IMFAR) that what is holding the Walker study up as far as publishing is the fact that they are having problems collecting sufficient tissue samples from control children to form a control group; despite having hundreds of samples from children with autism (vaccinated and unvaccinated) with triple confirmed measles in the gut. [i.e., same samples confirmed by three different labs as measles positive]. Because of the sensitivity of the issue, the author is exercsing what he believes to be requisite caution in releasing any paper without an adequate number of control children; he seemed genuinely concerned that he could insure the question as to specificity to autism was addressed.

    Of course, even if they did publish tomorrow, it wouldn’t prove the MMR caused autism in this case, or any other, IMO. But it would be a significant finding. It is also possible that the presenter / supposed author was full of rocks.

    – pD

    • Sullivan July 29, 2009 at 23:38 #

      pD-

      interesting information. It would be very interesting to hear if the paper is still in progress. The lack of negative controls was a big issue. If they wanted to go add negative controls, wouldn’t they have to do the samples from autistic kids at the same time? I.e. redo the measurements? Only then would they show that the procedures used for the autistic kids and the controls would be the same.

      I’d have to agree that the presence of measles virus wouldn’t prove the case. In fact, Dr. Walker himself made that statement:

      Even if we showed association (between measles virus and bowel disease) and we published it in a peer-reviewed journal, the conclusion will be simply that there is measles virus in the gut of a large number of children who have regressive autism and bowel disease. End of story.

  2. Ringside Seat July 30, 2009 at 10:00 #

    With Walker being a front for Wakefield (and paid through Wakefield’s organizations), and Hepner having ties to Krigsman, I would expect any peer reviewers would look at the work with extra care.

    They also have the problem that, as soon as they try to introduce any data in litigation (which is, of course, the whole point of the Wakefield-Walker-Krigsman-Hepner operation), the drug companies will do what they did to O’Leary: they will demand every decimal point of the data and rip it to shreds.

    This is not independent work, and these are not smart people.

  3. brian July 30, 2009 at 11:24 #

    Sullivan wrote: “It would be very interesting to hear if the [Walker] paper is still in progress.”

    FWIW, Walker and others (including Wakefield) presented a PCR-related poster at IMFAR 2004 claiming to have found measles virus in cerebral spinal fluid from MMR-vaccinated children with regressive autism (19 of 28 CSF samples; also 10 of 10 gut biopsy samples and 16 of 28 blood samples were reported as positive) but rarely in vaccinated controls (1 of 37 CSF samples). Also FWIW, it seems that this remains unpublished over 5 years after its presentation.

  4. DT35 July 30, 2009 at 16:32 #

    I understood from Kathleen’s site that a motion for judicial review in the Snyder case was to argued (decided?) yesterday. Any word on that?

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