Saturday, October 17, 2009

Heckenlively's Fallacious Analysis of the Cedillo Appeal Decision Rebutted

Kent Heckenlively, Esq., a regular contributer to the AoA Collective posted his analysis of the Cedillo Appeal, and, as usual, got it completely wrong. How did he manage to be so wrong, considering that he is so educated?

A guest Blogger, PeterP, will explain:

Heckenlively claims to be a lawyer, like most lawyers his skill is therefore to cherry-pick the bits of evidence that suits him rather than looking at it all. This suits an adversarial court system but does not lend itself to finding the truth in science.

>Reading the decision in the Cedillo appeal gives me a greater appreciation
>of that story. It doesn't seem to matter what's presented, the Special
>Masters are still going to deny any connection between vaccines and autism.

Probably because no one has managed to show there is one. The Cedillo case certainly didn't.

>The Cedillo case depended a great deal of the identification of the measles
>virus discovered in an intestinal biopsy taken from Michelle Cedillo and
>analyzed by the Unigenetics Laboratory of Dr. John O'Leary. The court
>agreed that "the general reputations of Unigenetics and Dr. O'Leary are
>good." (P. 11) It also agreed that the reliability of the Unigenetics
>Laboratory was "the single-most critical issue in the case." (P. 10)

Having considered both the general reputation and specific work on measles it concluded :

"However, I conclude that the overall evidence weighs strongly in favor of a conclusion that, whatever the general caliber of the work of the O'Leary laboratory group, the group's measles virus detection work, done largely under the Unigenetics Ltd. name, simply is not reliable. The overall evidence specific to that measles virus detection issue is simply too strong to be outweighed by mere evidence of a good general reputation concerning other work.

In this regard, two further observations are relevant. First, as noted above, the measles virus detection work was done, at least for the most part, under the Unigenetics Ltd. name. Dr. Bustin testified that Unigenetics Ltd. was not accredited, and that Unigenetics Ltd. declined to participate in a quality control program, so that there was never any independent quality assessment made of any of the work that was carried out by Unigenetics. (Tr. 2034, 2057A.)

Significantly, petitioners never attempted to rebut that aspect of Dr. Bustin's testimony.

Second, the record also indicates that Unigenetics Ltd. is no longer in business, and there is no evidence that the O'Leary laboratory has ever published any work defending the reliability of the Uhlmann study, despite the criticism of that study. Thus, it seems that the O'Leary laboratory has not publicly defended the reliability of its efforts at measles virus detection during the early 2000s.

Accordingly, considering all of the evidence of record, I conclude that, regardless of whether the O'Leary laboratory might have a solid reputation with respect to its other work, nevertheless that laboratory's efforts to detect measles virus in the early 2000s were flawed and unreliable."

>There was discussion of other studies, namely the Uhlmann study which
>supported the finding of a measles infection in the guts of children with

Using the same Unigenetics Lab as Wakefield. Remember also that Unigenetics was not a university laboratory but a private "for profit" company specifically established to test for an MMR/measles link on behalf of the UK MMR litigants. It was closed in 2005.

>On the issue of DNA contamination, though, the testimony was pretty clear
>that DNA contamination is an issue only if there are relatively low numbers
>of the virus detected. Michelle Cedillo's test results showed high levels
>of the measles virus, and thus even from the testimony, should not be
>something cited by the Special Masters in their review.

The testing was by PCR, I assume Heckenlively knows little about this procedure and how sensitive it is to contamination. To say that "DNA contamination is an issue only if there are relatively low numbers of the virus detected" shows remarkable ignorance.

One of the telling points against Unigenetics was that they produced positive results when it was simply impossible. They omitted the Reverse Transcriptase step in their tests. Measles virus exists as an RNA molecule. The polymerase chain reaction (PCR) assay amplifies DNA. Thus to detect an RNA molecule in a PCR assay, the RNA must first be copied (by the reverse transcriptase enzyme) into DNA, which can then be amplified. Bustin showed that the O'Leary lab reported positive results even when they could not possibly have detected an RNA molecule because they had left out the step to copy that RNA into DNA. Thus the positive results reported for such test were, without any doubt at all, false positives.

>On the issue of reliability, it's curious that while the court admits that the general
>reputation of the lab and Dr. O'Leary are good, they unaccountably failed in
>this instance.

See above. That they failed, and failed abysmally, is beyond question. Why they failed may have something to do with their sole source of funding. They were for example using older instruments, and on some of these faults were discovered by Bustin. For example there was a huge variation in the heating and cooling characteristics across the sample block producing variable results depending on where sample tubes were placed on the instrument.

>(Author's note - The U.S. government later hired Dr. John
>O'Leary to set up two labs for the Hornig/Lipkin study on the prevalence of
>the measles virus in the guts of children with autism. Amazing how one day
>the government is trying to destroy your reputation and soliciting your help
>on another.)

The US government did not "hire" O'leary, and by the time of Hornig/Lipkin Unigenetics had been closed. Three laboratories were utilised by Hornig/Lipkin, O'Learys Trinity College laboratory at Coombe Women's Hospital,. The Center for Infection and Immunity, New York; and the Measles, Mumps,Rubella, and Herpes virus Laboratory Branch, CDC, Atlanta.

>And this is where the independent judgment of the court is supposed to come
>in. One side says you didn't perform the tests the way you should. That's
>fair game and deserves to be explored. The other side says, you can't find
>the measles virus in the red blood cells of affected children, only in the
>gut which you can biopsy, or the brain, which short of an autopsy, is
>exceedingly difficult. You should consider that claim as well.

The fact was that no measles virus was detected in the gut. This was the conclusion reached by Chadwick, working with Wakefield, before Unigenetics came into being. As it wasn't the answer which was wanted the work was taken away from a University laboratory and given to a commercial one set up for the purpose.

As a matter of interest the vast majority of samples from autistic tested for MV by O'Leary in the Unigenetics lab in Dublin were from blood, not gut tissue.

>But that didn't happen in the Cedillo case. The Special Masters accepted
>one side, and paid no attention to the other. I acknowledge these are
>confusing issues, but where's the evidence disputing the claim that measles
>virus is not present in red blood cells, but only affected organs?

There is nothing confusing about there being no credible evidence that measles was in the gut. This is the simple fact that the author seems to ignore.

The Unigenetics findings were false. Unigenetics claimed to have found measles virus in _both_ blood and gut samples. Bustin's lengthy report clearly showed their results were as a result of poor laboratory practice. As Bustin, far more of an expert in PCR than O'Leary ever will be, aid :-

"My clear conclusion then was that O'Leary's results were caused by
defective experimental technique and inappropriate interpretation of
results, since he was detecting DNA, and measles virus does not exist
as DNA. "
> The
>Court acted as if these issues weren't even worthy of consideration. And if
>Dr. O'Leary's lab was so incompetent in detecting the measles virus, why did
>our own government later hire him to set up two such labs?

It didn't. He collaborated as a professor at the Department of Histopathology, Trinity College Dublin, Dublin, not as Managing Director of the closed Unigenetics Laboratory Ltd. Unigenetics had some specific problems associated with trying to do things cheaply. Many of the "staff" were undergraduates. Unigenetics was also not an accredited laboratory and Unigenetics had no external quality controls.

>A similar narrowness of vision was present in other parts of the decision.
>The third criterion to be satisfied to obtain recovery is a "proximate
>temporal relationship between vaccination and injury." The medical records
>for Michelle Cedillo are actually quite compelling in establishing a short
>time period between her vaccinations and the development of her problems.

Actually, together with recordings of her made beforehand, they were very compelling in showing symptoms of ASD long before she received MMR.

>"A May 2, 1997 letter from an Arizona neurologist, Dr. William Masland,
>deserves particular mention. After examining Michelle Cedillo on May 2,
>1997, Dr. Masland noted that Michelle lost her speaking ability after her
>post-MMR fever episodes. He further stated 'it would appear that there was
>some neurological harm done at the time of the fevers.' He added, 'whether
>this was a post-immunization phenomenon or a separate occurrence, would be
>very difficult to say.' The Special Master concluded that Dr. Masland's
>letter, at most, speculated as to whether the MMR vaccine was causing
>Michelle's neurologic abnormality and did not constitute an opinion that the
>MMR vaccine caused Michelle's autism." (P. 20-21)

That's correct, it was an opinion of an observer. It could equally well have been made about the temporal association between visiting McDonalds and losing her speaking ability.

>I know this will be disputed by some, but the fault in Cedillo wasn't with
>the evidence, or the way the attorneys presented the case. The fault was
>with the Special Masters and may lie in a prejudice that even they don't
>fully appreciate.

However you try to spin it the evidence was overwhelmingly against the claimant. Look at the authors of the Hornig/Lipkin study :- Lack of Association between Measles Virus Vaccine and Autism with Enteropathy: A Case-Control Study Mady Hornig, Thomas Briese, Timothy Buie, MargaretL.Bauman, Gregory Lauwers, Ulrike Siemetzki, Kimberly Hummel, Paul A. Rota, William J. Bellini, ,John J. O'Leary, Orla Sheils, Errol Alden, Larry Pickering, W.Ian Lipkin O'Leary and Sheils are co-authors. If they were that convinced that their Unigenetics work was right why did they support this later studies conclusion which was :-

"This study provides strong evidence against association of autism
with persistent MV RNA in the GI tract or MMR exposure. "
Was it simply because they realised they had been wrong with
Unigenetics and this later, properly conducted, properly documented
and properly supervised work, clearly showed that?