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Another appeal heard in the Autism Omnibus

Posted Jun 14 2010 2:53pm

Part of the United States Court of Federal Claims includes the “vaccine court”, where claims against the government are heard regarding vaccine injuries. Probably the most well known activity of the vaccine court, especially to readers of LeftBrainRightBrain, is the “ Omnibus Autism Proceeding “. The Omnibus comprises over 5,000 families claiming vaccine injury resulted in autism. Rather than hear all these cases individually, both sides agreed to first hear “test cases” where the stories of six children were heard to answer the question of whether vaccines induced autism in those children and to decide whether the general question of whether vaccines cause autism could be addressed. The first three test cases presented the argument that the MMR vaccine, either alone or with thimerosal from other vaccines, could cause autism. The next three cases presented the argument that thimerosal alone could cause autism.

The Omnibus is back in the news, in a small way, after another appeal for the Cedillo test case was heard last week. The attorneys and the bloggers are concentrating on whether the testimony and expert reports of Prof. Stephen Bustin should have been allowed. I’ll go into the detail about this argument below. It is worth saying at the outset that this argument is likely to accomplish nothing, whether they win or lose. The Special Master who decided the Cedillo case and the judge who heard the first appeal both stated, clearly, that the decision to deny the Cedillo claim would be the same without Prof. Bustin’s testimony and report.

That is worth repeating: win or lose on this point in the appeal, the Cedillo’s still do not have a compelling case that the MMR vaccine causes autism.

Before going any further, it is worth stopping and recognizing the human side of this proceeding. The “test cases” are six children whose families agreed to let their stories be heard and analyzed in public. They went into this with faith in their positions, but without the knowledge of the legal outcome. When the decisions were handed down against them (yes, they lost), they didn’t have the opportunity to change their arguments. They were committed. So, in two big ways, these are brave families. Agree or disagree with the science they depend upon, they had some guts to step forward as they did.

It is also worth noting that no one gets wealthy from successful claims in the Court. Settlements are typically around US$1 million. While this sounds like a lot, the purpose is to pay for the needs of the injured and to set up an annuity which will supplement the government support already in existence for the disabled. Most readers to this blog will have an idea to how far that support goes.

The Omnibus hearing and the appeals

The first of the test cases heard was that of Michelle Cedillo. Miss Cedillo is a severely handicapped girl with multiple disabilities. Her case was heard in June 2007 . The decision, by Special Master Hastings, was handed down in February 2009 . The Cedillo family appealed and the case was heard by a Judge in the U.S. Court of Federal Claims, Judge Wheeler, whose decision in August 2009 went against the Cedillo family. The Cedillo family appealed again, this time to the U.S. Court of Appeals for the Federal Circuit . Their appeal was heard on June 10 before judges Newman, Linn and Dyk.

The Court of Appeals for the Federal Circuit is probably the last appeal for the Cedillo family. Should this go against them, they have the right to appeal to U.S. Supreme Court. But the Supreme Court is not required to hear their case. In fact, the Supreme Court usually chooses cases which decide points of law. The arguments by the Cedillo family are more questions of procedure and, as such, I would expect the Supreme Court would refuse to hear any appeal. But, that is getting ahead of ourselves. Right now, we still haven’t heard the decision from the Appeals Court.

Public Responses to the Recent Appeal

I haven’t heard the arguments made in court. I wish I had because in my experience there is a fairly large gap between what I’ve heard in past proceedings and how they are portrayed on the net. A fairly egregious example was in the portrayal of an expert witness for the Cedillos, Dr. Vera Byers. When she testified in 2007, someone was portraying her as coming across with the gravity of Dame Judi Dench (who plays “M” in the James Bond movies, amongst other roles). During the hearing, Dr. Byers was found to have seriously padded her resume, claiming she worked at the prestigious University of California San Fransisco when, in fact, she only used their libraries and attended their parties. She also accused the Department of Justice lawyer of “making faces” at her. I did not think of Dame Judi Dench when I heard her testimony.

Following the original hearings for the Cedillo case, many bloggers in the vaccines-cause-autism groups were optimistic. They felt that they had made a strong case and they would prevail, complete with imagery of “Dark Towers” being brought down by bolts of lightening . From my perspective, such cheer-leading seemed to border on cruel given the very weak case made to support the general question of MMR causing autism.

Given this background you would probably not be surprised that I look at the optimistic reports coming out of last week’s appeal with a somewhat skeptical eye. Which begs the question, “what was said” by these bloggers? From Mr. Olmsted’s piece, here are two quotes.

The first is from one of the attorneys working with the Cedillo family:

“I have a very positive feeling about the federal judges,” said Sylvia Chin-Caplan, who argued the appeal.

The second quote comes from an attorney who blogs for the Age of Autism blog and who, I believe, has a child who is a claimant in the Omnibus:

“I leave with the sense that the judges were very troubled that the government had not acted in good faith,” said Mary Holland. “Those judges were very troubled by what the government’s done – very troubled.”

The argument for the appeal: Prof. Bustin’s testimony

So, what are the judges supposedly “troubled” by? Well, this has to do with part of the appeals argument by the attorneys for the Cedillo family: the testimony of Prof. Stephen Bustin .

Professor Bustin is a world expert on a technique called polymerase chain reaction (PCR) which he describes as

Real-Time PCR is a variation of the polymerase chain reaction (PCR) that allows simultaneous (i.e. in real-time) amplification and detection of DNA templates. Because it is used to quantitate DNA, it is often abbreviated to qPCR, although that abbreviation is not universally accepted.

PCR played an important rule in the Omnibus. PCR was used in attempts to identify measles in tissue samples taken from autistic children’s bowels. One of the key papers for the families in the Omnibus was written by Uhlman et al. Potential viral pathogenic mechanism for new variant inflammatory bowel disease . The Uhlman paper concluded “The data confirm an association between the presence of measles virus and gut pathology in children with developmental disorder. ” One of the co-authors on that paper is Professor J J O’Leary, whose laboratory, Unigenetics, performed the tests on samples sent from the group headed by Andrew Wakefield in London. The same laboratory was used to test samples taken from Michelle Cedillo.

The presence of measles virus in the tissues is key to the theory argued in the Omnibus. This was made very clear when the expert reports were filed, in February of 2007. At that time, the Department of Justice attorneys sought information to rebut the “persistent measles in the gut” argument. One source they sought was information filed in the United Kingdom for the MMR litigation that was held there. In specific, they sought the report by Prof. Bustin, who had testified in that litigation. Those reports are sealed and require special permission to obtain. The DoJ attorneys received the first of those reports on May 31, 2007, 1 hour after receiving it, but only 12 days before the start of the Cedillo hearing. One week later, the DoJ filed two more reports by Prof. Bustin.

The attorney’s for the Cedillo family argued that they didn’t have time to assimilate such technical information and prepare a good response. Further, they argued that the reports were submitted after a deadline imposed by the Special Master. The Special Master allowed Prof. Bustin to testify and to submit his expert reports. The Special Master argued that the admissibility of the testimony and reports could be decided after the hearings.

This history and greater detail are summarized in the Wheeler decision denying the first Cedillo appeal .

Was Prof. Bustin’s Testimony Damning to the Case?

Professory Bustin is possibly the word’s number one expert on PCR. Not only that, he was given access to the Unigenetics laboratory and the notebooks they kept. He found that the Unigenetics laboratory was missing a key step in the process. PCR tests DNA. Measles is an RNA virus. So, there must be a step to turn the RNA into DNA or PCR won’t work.

At the time Unigenetics were testing samples for the Uhlmann paper and the sample from Michelle Cedillo, they weren’t using RNA>DNA step. Whatever they were detecting, it wasn’t an RNA virus and, hence, it wasn’t measles.

Prof. Bustin also testified that at that time Unigenetics was not using “controls” correctly, making interpretation of their results problematic at best.

Prof. Bustin also testified that the laboratory notebooks had been altered after the fact.

Prof. Bustin also testified that Unigenetics found the same results from two different types of samples (fresh-frozen and formalyn fixed). That could only happen if they were detecting contaminants.

And the list of errors at Unigenetics goes on. (There is an extensive summary in the Hastings decision for the Cedillo case)

These are only parts of the testimony. But, yes, it is safe to say that Prof. Bustin’s testimony hurt the case the attorneys for the Cedillos were trying to make.

Would the case have been decided for the Cedillos had Prof. Bustin’s testimony been excluded?

As noted at the outset of this piece, Prof. Bustin’s testimony is not key to the decision to deny the claim of the Cedillo family. It also isn’t key to denying the question of general causation (does MMR, in general, cause autism).

Special Master Hastings has a section of his decision entitled, “Even if I were to disregard Dr. Bustin’s expert reports and hearing testimony, all my conclusions in this case would remain the same.” I quote that section in its entirety below:

Finally, even if I were to completely exclude and disregard all of Dr. Bustin’s reports and all of his hearing testimony, nevertheless all of my conclusions in this case would remain exactly the same.

First, the testimony and reports of Dr. Bustin were relevant chiefly in establishing my conclusion discussed at pp. 58-60 above, i.e., that there were severe problems with the facilities and procedures of the Unigenetics laboratory. But even concerning this narrow point, Dr. Bustin’s testimony was not the only evidence. Dr. Rima provided extensive, convincing evidence to the same effect, and Dr. MacDonald provided some corroboration as well. (See discussion at pp. 52-54, 58-59 above.) I would have reached the same conclusion, that there were severe problems with the Unigenetics facilities and procedures, based just on the evidence supplied by Dr. Rima and Dr. MacDonald, even without any information from Dr. Bustin.

Second, even if there had been no testimony from Dr. Bustin, Dr. Rima, Dr. MacDonald, or any other expert who participated in the British litigation, concerning the problems with the Unigenetics procedures and facilities, nevertheless I still would have concluded that the Unigenetics testing was not reliable. That is, as explained above (p. 77), the most important points in my rejection of the Unigenetics testing were (1) the fact that the laboratory failed to publish any sequencing data to confirm the validity of its testing, (2) the failure of other laboratories to replicate the Unigenetics testing, and (3) the demonstration by the D’Souza group that the Uhlmann primers were “nonspecific.” The testimony by Drs. Bustin, Rima, and MacDonald, about the many problems with the Unigenetics laboratory and procedures, was merely a secondary, additional reason to doubt the reliability of the Unigenetics testing. Accordingly, I would still have found the Unigenetics testing to be unreliable even if there had been no reports or testimony at all from Drs. Bustin, Rima, or MacDonald.

Accordingly, for all the reasons set forth above, I conclude (1) that there is no valid reason for me to disregard the evidence supplied by Dr. Bustin, and (2) that even if I did disregard that evidence, my conclusions concerning all of the issues in this case would remain the same.

Testimony of Nicholas Chadwick

One reason that the Special Master could be so decisive on the unreliability of the Unigenetics laboratory was the fact that other groups were unable to replicate those findings. One of those researchers was Nicholas Chadwick, a post doctoral researcher in Wakefield’s own group. Dr. Chadwick used PCR to test biopsy samples from autistic childrenmany of whom were a part of the now-retracted Lancet paper by Wakefield’s teamand found that they were negative for measles virus.

Dr. Chadwick’s Ph.D. thesis includes results from “Autistic enteropathy samples. Biopsies, PBMCs and Vero/PBMC cocultures were analysed from 22 patients with autistic enteropathy and 6 controls.”

He found

Results. Hybrid capture and RT-PCR could detect 104 molecules of a measles RNA transcript added to control tissue homogenates. The fidelity of NASBA, in terms of its nucleic acid error rates, was found to be comparable with that of RT-PCR. All samples were found to be positive for a housekeeping RNA species and internal modified positive control RNA. None of the samples tested positive for measles, mumps or rubella RNA, although viral RNA was successfully amplified in positive control samples.

Conclusion. The results do not support previous data implicating persistent measles virus infection with the aetiology of IBD or autistic enteropathy.

He studied gut biopsy samples, cerebral spinal fluid samples and blood samples .

This isn’t a separate group and different children. This is Mr. Wakefield’s own hospital, someone he was in contact with. It is likely that some of these children’s samples were also tested by Unigenetics and with false positive results.

Dr. Chadwick’s expert report and testimony are online.

Should Prof. Bustin’s Testimony have been Allowed?

Prof. Bustin’s report was submitted very close to the start of the Cedillo hearing. In fact, it was past a deadline imposed by the Special Master. The attorneys for the Cedillos have argued that they were unable to prepare a response to such a technical report and that they didn’t have access to the lab notebooks which Prof. Bustin relied upon.

Let’s take this in stages.

First, yes the report was submitted past the deadline. So were reports submitted by the attorneys for the Cedillos. The vaccine court is supposed to be flexible in allowing evidence in.

So, the attorneys for the Cedillos not only had an expert on their team to discuss PCR, but their expert was familiar with the Unigenetics laboratory. Their report was filed four months before Stephen Bustin’s reports and, presumably, their team had access to information from well before that.

How about the idea that the attorneys for the Cedillos didn’t have access to the lab notebooks which Prof. Bustin reported upon? First, it is clear that Prof. Bustin’s analyses did not rely solely on the lab notebooks. Some of the problematic results were public (from the paper) and other information he obtained in his 1,500 hours spent analyzing the Uhlmann work. Yes, 1500 hours.

The whole argument begs the question: how are the Cedillo’s attorneys and their expert (Prof. Kennedy) so confident of the Uhlmann results if they haven’t seen the notebooks?

One of those attorney’s is quoted:

Chin-Caplan told Examiner.com, “Two reports that he submitted on behalf of the government were of such technical matter and so incomprehensible that at the very least a motion to continue the hearing should have been entertained and it wasn’t.”

I am again at a bit of a loss. Why were Ms. Chin-Caplan and her team unprepared to respond to Prof. Bustin’s reports? She and her team were the ones who were admitting PCR testing as evidence.

Ms. Chin-Caplan is also quoted:

“The fact that they went over there (to the U.K.) secretly four months before the hearing to try and get these documents without giving me notice that they were going to do this leads me to think that they wanted to examine those documents without me being present,” Chin-Caplan told Examiner.com. “And that violates the concept of fundamental due process as far as I’m concerned.”

The idea of obtaining information from the U.K. litigation was not a surprise to the Cedillo’s attorneys. They had attempted as early as 2004 three years before the hearingto obtain reports from the U.K. The idea that the DoJ attorney’s “wanted to examine those documents wihout me being present” is totally at odds with the fact that the DoJ submitted the first report 1 hour after receiving it. One hour.

One might ask why Ms. Chin-Caplan didn’t call upon, say, Andrew Wakefield or others to write reports or to serve as an expert witness. Mr. Wakefield is on the list of potential experts. Mr. Wakefield is one of the authors of the Uhlmann paper. Of course, the answer is that Mr. Wakefield, father of the MMR causes autism hypothesis, is not a very credible witness.

Friend of the Court Brief

That brief concentrates much space to the reliability of the O’Leary lab results. It introduces new “data”

Michelle submitted further compelling evidence of the reliability of the O’Leary lab results in her motion for reconsideration. She submitted a new study on the recovery of measles RNA from the gut tissue of autistic children. The multi-center Hornig study,57 relying on laboratories at HHS’s own Centers for Disease Control, Columbia University and Dr. O’Leary’s laboratory at Trinity College were all concordant in finding measles RNA in one clinical subject and one control, again showing the O’Leary laboratory’s reliability.

The Hornig study was an attempt to recreate some of the Wakefield group’s studies. The study was much more careful than Wakefield’s team’s efforts. It was discussed on this blog at that time .

I am always amazed when people try to use the Hornig study to support the MMR-causes-autism hypothesis. The paper concluded:

This study provides strong evidence against association of autism with persistent MV RNA in the GI tract or MMR exposure

As far as supporting the idea that the O’Leary laboratory was reliable, it is far from convincing. There is a vast difference between how a laboratory performs in, say, the late 1990’s and ten years later after facing much criticism and while under intense scrutiny for accuracy. In other words, it is very possible that the O’Leary laboratory’s methods were different for the Hornig study than used for the Wakefield/Uhlmann studies.

Summary

It seems unlikely to this observer that the Cedillos will win this appeal. They rely on discounting the testimony of Stephen Bustin. The arguments to throw out his testimony have not proven persuasive in a previous appeal. More importantly, the Court made it extremely clear that the decision would be the same whether or not Prof. Bustin’s testimony was allowed. The public statements being made about this appear to be coloring the facts somewhat to create an image of impropriety by the government. Also, those making public statements appear to ignore the fact that even without Prof. Bustin’s testimony, the case was not close.

At every step along the process of the Omnibus Proceedings, public statements have been heard suggesting the families had a strong case. In my opinion, this has been a disservice to those families. I worry that this is yet another instance of building up false hope for the families in the Omnibus.

If you want to reference this post in your site, use the code below to link to me from your website.

<a href="http://leftbrainrightbrain.co.uk/2010/06/another-appeal-heard-in-the-autism-omnibus/">Another appeal heard in the Autism Omnibus</a>

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