Everything You Wanted to Know about the Autism Omnibus Proceeding, but Didn’t Know How to Ask
By Kent Heckenlively, Esq.
As the first three of nine planned test cases have finished and lurch toward a conclusion, I think it’s a good idea to provide the community with an overview of what’s happened, some relevant questions, and what’s planned for the upcoming months.
What’s the structure of the Autism Omnibus Proceeding and how is it different from a traditional trial?
The Autism Omnibus Proceeding is asking three distinct questions about vaccines and autism, which in the normal world might seem overbroad, but will hopefully establish precedents under which the families can recover compensation. Each question, or argument, expresses a different theory of how vaccines might cause a child’s autism.
Each of the three theories espoused by the lawyers for the autistic children will hear testimony from three “test cases”, making a total of nine test cases.
The first theory is that thimerosal and the MMR vaccine can combine to cause a child’s autism. The three test cases; Cedillo, Hazlehurst, and Snyder, heard testimony in June, October, and November of 2007. Issues in those three cases are still being heard by the Special Masters. There has been discussion of having a decision in at least one of these cases before May of 2008. However, a decision in one case or in all three might not happen until mid-to-late summer of 2008.
The second theory is that thimerosal by itself can cause autism. The three test cases will be William Meade, a child from the Portland, Oregon area, Jordan King, another boy from the Portland area, and Alexander Krakow, a child from New York, whose father, Bob Krakow, has been a long-time autism advocate. These three cases are scheduled to be heard in Washington D. C. from May 12 – May 30, 2008.
The third theory is that the MMR vaccine by itself can cause autism. The three test cases will be heard in September of 2008, but the individuals have not been identified.
The hearing itself is different from a traditional civil trial in many important ways. First, in place of a jury trial, these cases are presided over by a Special Master, an administrative judge who guides the cases, listens to testimony, and at the end of a witness’s testimony can ask questions. Unlike a juror however, the Special Master does not need to keep him/herself ignorant of related matters. So, while it’s grounds for a mistrial for a juror to read a newspaper about a case in which he’s a juror, the Special Master can cruise the internet looking for information about vaccines and autism, read David Kirby’s “Evidence of Harm”, or call up Jenny McCarthy to talk for hours about her son, Evan.
Another way the Autism Omnibus Hearing differs from a traditional trial is that the parties cannot compel the production of witnesses or relevant documents. It is up to the Special Master to approve the documents the parties can see, and it’s up to any individual witness to decide whether they want to appear.
In a conversation I had with attorney Thomas Powers, head of the Petitioner’s Steering Committee, he remarked this was one of the most difficult obstacles in bringing his case. Information such as that contained in the Vaccine Safety Databank would normally be discoverable in a typical civil trial, but this request was refused by the Special Master.
One of the problems Mr. Powers had with the testimony of Drs. Rima and Bustin were that they relied upon evidence which was not available to the petitioners. This NEVER happens in a civil trial. In Mr. Powers opinion, it allowed Drs. Rima and Bustin to “cherry-pick” evidence which supported their opinion, while ignoring other evidence which contradicted it. In a typical civil trial the plaintiffs would be able to review all of the data upon which an expert was rendering his opinion.
How will the Government Concession in the Hannah Poling Case affect the Remaining Cases?
The Poling case was scheduled to be one of the second group of three cases, looking specifically at the question of whether thimerosal by itself could cause autism. One of the points Mr. Powers felt was often inaccurately reported in the media was who decided to make the concession to the Polings. It was not the court, or the Special Master, or even the government attorneys.
Instead, the concession was recommended by a group of medical experts at the Department of Health and Human Services who reviewed the medical evidence as well as the current scientific research. It wasn’t a case of government attorneys “throwing in the towel,” said Mr. Powers, “but the government’s own medical experts coming to the conclusion that the Polings proved their case.”
Even though the recent government concession of February 22, 2008 which also linked Hannah Poling’s seizure disorder to her vaccinations downgraded Hannah’s “mitochondrial disorder” to a “mitochondrial dysfunction”, it was unclear how much this will help the remaining cases. The critical question is how prevalent this mitochondrial dysfunction is in autistic children. Is it one in five thousand among children with autism, or is it one in five?
Mr. Powers believes that in some of the remaining cases there may be evidence of “metabolic disorders” which are linked to mitochondrial dysfunction. I have also heard an unconfirmed report that some compelling medical research linking thimerosal to mitochondrial dysfunction is coming close to publication. In the event of such a publication the attorneys would be able to submit this new research to the court.
Opinion on the Strengths and Weaknesses of the Three Cases Presented
In reviewing the three cases so far; Michelle Cedillo, Yates Hazlehurst, and Colten Snyder, several interesting questions were raised and must be dealt with in any judgment.
Although the Special Masters will each render a verdict on their own case, they were usually present during testimony on the other two cases and it’s reasonable to conclude that common questions will guide their deliberations.
1. Do some people have difficulty ridding their body of mercury?
Both sides agreed that there was once a condition called acrodynia which persisted from the 1890s into the 1950s and was caused by mercury in baby teething powders. The disease caused painful neuropathy and discoloration of the extremities. Only about 1 in 500 children who used the teething powders were affected, but the two sides parted ways on why only some were afflicted.
Attorneys for the families argued it suggested a difficulty in some children of ridding the body of mercury. The government attorneys suggested it was simply a question of dosage. Those children who suffered from acrodynia were simply taking more than all of the other children.
In the cross-examination of government witness Dr. Michael McCabe, Jr. in the “Snyder” case however, agreed that the Urinary Porphyrins Test developed by Dr. Woods effectively measured a person’s body mercury level. However, Dr. McCabe expressed no opinion on the work of the same Dr. Woods, showing approximately 13% of dentists who work with mercury amalgam fillings showed signs of mercury retention.
Dr. McCabe was also unable to express an opinion on further research by Dr. Woods showing that the dentists with elevated porphyrin levels had a CPOX-4 polymorphism.
The argument put forth by the attorneys for the families that some individuals have a “mercury efflux disorder” which prevents them from fully excreting mercury went unanswered by the government’s own witnesses.
2. Where does the mercury go and what does it do once it’s retained?
The attorneys for the families relied a great deal on the research by Dr. Thomas Burbacher of the University of Washington which showed that at least in primates, ethyl mercury (which thimerosal breaks down into once in the body) deposits twice as much mercury into the brain as does methyl mercury (supposedly the more toxic kind of mercury). Once in the brain this ethyl mercury further breaks down into mercury plus 2, the most toxic form of mercury at a rate. The rate of breakdown into mercury plus 2 is seven times higher for ethyl mercury than methyl mercury, overturning previous assumptions that ethyl mercury was a relatively benign form of mercury.
Even the government’s own witness, Dr. McCabe, agreed that once in the brain it would be difficult to detect the mercury.
The family attorneys relied on the work of Dr. Isaac Pessah of the University of California, Davis, which showed that thimerosal could provoke changes in intracellular calcium. Government attorneys however parted ways on the further assertion by Dr. Pessah which linked these changes in intracellular calcium to changes in signal transduction in dendritic cells. (In plain language, thimerosal prevents the cells from being able to talk to each other. You’ve got the cell-phone, but no reception!)
Dr. McCabe was further unable to determine the level at which mercury exposure can cause immune dysregulation.
All in all, I thought the government performed poorly on the mercury question.
3. Is the measles virus persisting in the brain of some children with autism?
The government went to great lengths to discredit the work of Dr. John O’Leary’s Unigenetics Lab. The testimony of Dr. Rima and Dr. Bustin were undercut by the fact that the documents they relied upon in forming their opinion were not available to the family attorneys, a practice which would not be allowed in a traditional civil trial.
Perhaps even more troubling to the government’s case is the apparently strong professional reputation of Dr. O’Leary. Dr. O’Leary is Chair of Pathology at Trinity College in Ireland, the recent recipient of the St. Luke’s Medal by the Royal Academy of Medicine and St. Luke’s Hospital, as well as publishing frequently in well-respected, peer-reviewed medical journals.
After Dr. Rima had spent much of his testimony attacking Dr. O’Leary’s lab, Special Master Vowell asked him quite pointedly, “Publications, awards, university chairs don’t seem to square to me with the picture you’ve painted of what happened in the Unigenetics O’Leary lab. Can you shed any light for me on this?” In a legal proceeding it really doesn’t get much nastier than that.
From my read of the testimony it appears that the results from the Unigenetics lab emerge as credible.
4. What is the measles virus doing in the brain to cause autism?
For me this was the most challenging question of the entire trial. I understand the comparison made by the family attorneys and it sounds plausible.
Everybody agrees the measles virus can hide in the brain after a measles infection for years without being detected. After hiding in the brain for as long as seven years, the virus reactivates as causes diseases such as sub-acute sclerosing pan-encephalitis (SSPE) and measles-induced brain encephalopathy (MIBE), usually resulting in neurological complications before bringing about death.
The claim is that the attenuated, or weakened measles virus used in the vaccine has somehow been shorn of its lethal properties, but maintains its ability to hide in the brain, and cause inflammation and encephalopathy. In other words, this virus has had it’s ability to kill taken away by the attenuation process, but it can still cause a lot of trouble.
The government’s experts weren’t able to help their case a great deal by their explanation of the attenuation process as being akin to a “black box” in which they put a lethal virus in, and draw out a non-lethal virus.
5. Does autism involve inflammation of the brain and gut?
If there was any argument which it seemed as if the government went to great lengths to avoid it was this one. While Dr. Wakefield’s work was roundly criticized by the government, it seemed that many others noted signs of inflammation in the gut, and even somebody like Harvard neurologist Dr. Martha Herbert in her review of autism research noted clear signs of inflammation in children with autism.
The government could’ve agreed with findings of inflammation, but then argued that the source was unclear. Inflammation is supposed to be present in many conditions, but the mechanism has not been found. Why should autism be any different?
I suspect the government declined this approach because it came perilously close to supporting the claim of the family attorneys about autism.
6. How does the government explain the recovery of Colten Snyder?
The government attorneys can complain all they like about the gaps in knowledge about how the mercury and live viruses used in vaccines may cause autism, but how do you explain the recovery of a child from a condition which supposedly has no cure?
The government conceded that Colten had mild to moderate autism. When he was 27 months old he had the communication and verbal skills of a 9-10 month old. After a few years of treatment with Dr. Bradstreet Colten was re-evaluated. At the age of 6 years old his expressive and receptive language skills were actually slightly above normal development.
In explaining Colten’s return to normal development the government could only credit the two sessions a week he spent with his speech therapist, not the intravenous gamma-globulin treatments and other supplements provided by Dr. Bradstreet.
The speech therapist, Katherine Timlin, saw clear benefits from the IVIG treatments Colten received and said that the type of progress made by Colten was extremely rare. She had only seen similar results in one other case, when a child with autism was started on a gluten/casein free diet.
It’s been said that nothing succeeds like success, and there’s no doubt that Colten’s story will weigh heavily in the deliberations of the Special Masters. If you get cancer, go for chemotherapy, and the cancer goes away, everybody believes it must have been the chemotherapy.
However, there’s a chance it might have been something else. But the more reasonable explanation is that the treatment was based on sound medical principles and it worked. I think the same common-sense approach will be used by the Special Masters.
I have personally been impressed with the attention and thoroughness with which the Special Masters have approached these cases. I have heard some commentators wondering if they’re secretly in the pay of pharmaceutical companies or medical agencies intent on the truth not being exposed, but I have not detected any hint of undue influence.
Even Thomas Powers, head of the Petitioners Steering Committee has been impressed with the dedication of the Special Masters and echoed my impressions that we’re likely to get an unbiased opinion. Mr. Powers has seen no sign of undue influence on the Special Masters.
When people stop and listen to the stories we tell with an open mind, the medical research we cite, they are often persuaded we’re onto something. People as diverse as Joe Lieberman, John McCain, and Don Imus, have all rallied to our cause. Our ranks will only continue to grow.
I believe the decisions which will come down from the Special Masters will not only answer questions of what happened in the past, but will hopefully create a brighter future by pushing the medical community in new directions of research to help our kids.
Kent Heckenlively is Legal Editor for Age of Autism.