DAY TWENTY OF THE AUTISM OMNIBUS PROCEEDING

The Assault on Dr. O’Leary – Day Twenty of the Autism Omnibus Proceeding – Snyder v. the Secretary of Health and Human Services

By Kent Heckenlively, Esq.

On this last day of testimony the government needed to attack the petitioner’s most compelling piece of evidence; the measles virus RNA found in the cerebral spinal fluid of Colten Snyder and Michelle Cedillo by the Unigenetics Lab of Dr. John O’Leary.

If the questions from Special Master Denise Vowell are any indication, the government is failing in that task.

Direct Examination of Dr. Bertus Rima by Ms. Alexis Babcock – Attorney for the Government

Dr. Rima teaches at the undergraduate and post-graduate level at the Queens University of Belfast and is head of the School of Biomedical Sciences.  The primary focus of his research has been paramyxoviruses and the neurovirology of measles. 

He’s been in measles research for about 33 years and has published more than 100 articles on measles, as well as on canine distemper and mumps.  Rima sits on the editorial board of the “Archives of Virology” and the “Journal of General Virology, where he has been the editor for the past 5 years.  He was an expert witness in the MMR litigation in the United Kingdom, for which he was paid approximately $160,000.

Dr. Rima has read all the relevant documents in this case and stated he has never seen any clinically relevant immunosuppression after a vaccination.

According to Dr. Rima, the measles virus is passed through monkey kidney cells, then through chicken embryo fibrolasts, and finally grown in order to make it less virulent.  It’s known that a large number of mutations take place during this process, but they’re not sure which mutation is most important it making it less virulent.

The Edmonton strain of the measles virus which was used in the late 1960s and early 1970s had some negative reactions including thrombocytopenia (low platelet count in the blood, fever in a certain percentage of children, and Koplick’s spots.  The explanation is that the Edmonton strain wasn’t well-attenuated (made less virulent).

The MMR vaccine has not been associated with SSPE (sub-acute sclerosing pan-encephalitis), but there have been two reports of MIBE (measles induced brain encephalopathy).

Dr. Rima disagrees with Dr. Kennedy’s assertion that the measles virus produces an “R” protein  from ribosome shifting during the course of viral assembly.  He also disagrees with Dr. Kennedy that CD-46 is the primary receptor for the vaccine-type measles, claiming instead it’s either CD-150 or SLAM.

In an individual afflicted with SSPE their measles antibody levels are extremely high and infection appears to be diffuse throughout the brain.  Curiously, there is not any good evidence that it alters cytokine expression (a marker of inflammation).

Dr. Rima has worked with Dr. Andrew Wakefield in the past, but became disillusioned because Dr. Wakefield didn’t seem to follow up criticisms of his work.  He has concerns with the Uhlman paper which claimed to have duplicated Dr. Wakefield’s findings.

He reviewed the record of the Unigenetics lab of Dr. O’Leary, but has difficulty discussing the information because those records have been sealed by the English court.  He visited the lab twice, and based on his review doesn’t believe they were able to reliably differentiate between the vaccine strain of the measles and the wild variety.

One of his concerns about the Unigenetics lab is the way in which they reported their numbers.  For example, one test might show a value of 2,400 for a sample, while the next reported a value of 0.  They would report the value as 2,400.  He also believes there were contamination problems.

Dr. Rima also questioned the use of the GAPDH gene as a “housekeeping” gene because he thought those values were low, which would give the viruses a higher value.  In summation, he felt the Unigenetics lab made structural mistakes in how they calculated their values.

In Colten Snyder’s case, it didn’t make sense for his cerebral spinal fluid levels of measles virus RNA to be strongly positive, while his blood was entirely negative.  He acknowledges Colten’s numbers for measles virus RNA were high, but not beyond the maximum he has seen.  Similarly, the numbers from Dr. Bradstreet’s article also seemed implausible.

In discussing his work on the United Kingdom MMR litigation he said that he had talked with Professor Carter in England at the behest of the government lawyers about doing some tests of the children at issue in that case, but decided against it because the tests were too invasive.

He conceded that there were problems with the sensitivity of the testing, but it didn’t change his opinion that there was no linkage between MMR vaccination and autism.

Cross-Examination of Dr. Rima by Mr. Timothy Powers – Attorney for the Family

Mr. Powers first took issue with the graph Dr. Rima had shown to the court.  The standard curve lines used were actually based on marketing materials from the company which sells the PCR equipment.

In addition, the comparison of positive controls from O’Leary’s lab that came up negative and vice-versa was based on information from the U.K. MMR litigation and was not available to the court.

Dr. Rima was unable to answer the question of whether the presence of measles virus after exposure to the virus represented continued replication of the virus.  In SSPE it must continue to replicate in order for it to appear years later, but there is no evidence to support this belief.

Dr. Rima agreed that the Uhlmann paper did say they used immunochemistry to confirm the PCR test results.

Next, Powers asked in further detail about the U.K. MMR litigation and with whom exactly he discussed the idea that further testing should be done of the children in that case.  Dr. Rima said the question came from the legal team representing the pharmaceutical companies.

The discussion about obtaining materials from the U.K. MMR litigation were brought up again and each side asserted they were doing their best to obtain the materials, but were having trouble with the foreign tribunal.

Questions for Dr. Rima from Special Master Denise Vowell

Special Master Vowell began by reciting what she knew of Dr. O’Leary’s reputation; specifically his recent receipt of the St. Luke’s Medal by the Royal Academy of Medicine and St. Luke’s Hospital, his well-respected publications, and his current position as Chair of Pathology at Trinity College.

I almost got the impression the Special Master was angry at Dr. Rima for his testimony regarding Dr. O’Leary.

After stating what she knew of Dr. O’Leary, this is exactly how she framed her question to Dr. Rima.  “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?”

Dr. Rima had no observations to make.

Next, she asked whether at the time that Colten Snyder and Michelle Cedillo’s samples were sent to the O’Leary lab other labs were also doing the same type of testing.

Dr. Rima answered that the Unigenetics lab was the only lab in the world doing that type of testing at the time.  He went onto give his opinion that the technology had not been validated which is why it had not been adopted.

Finally, Dr. Rima restated his opinion that the levels of measles virus RNA from Colten
Snyder were too high to be believed.

Redirect Examination of Dr. Rima by Ms. Babcock – Attorney for the Government

Ms. Babcock began by asking if Dr. O’Leary’s recent publications dealt with measles virus PCR research.  According to Dr. Rima, those publications hadn’t dealt with the subject.

Dr. Rima reaffirmed his opinion that the MMR vaccine had no connection to autism.

Direct Examination of Dr. Brian Ward by Ms. Alexis Babcock – Attorney for the Government

Dr. Ward works at McGill University in the Division of Infectious Diseases and Microbiology.  He has published articles and studied the measles virus in addition to seeing thousands of patients with measles.

Dr. Ward noted SSPE (sub-actuce sclerosing panencephalitis) shows surprisingly little inflammation in the brain and that ADEM (acute disseminated encephalomyelitis) and PIEM (post-infection encephalomyelitis) are also associated with the measles virus.  However, none of Colten’s symptoms were consistent with these conditions.

He believes that the editorial by Dr. Dykken in which he equated the autistic symptoms alleged by measles infection (MINE, or measles-induced neuro-encephalitis) was a fanciful hypothesis without scientific support.

According to Dr. Ward, IVIG (intravenous gamma-globulin) treatments are used in rare situations for newborns when the mother has contracted measles in the last few days of pregnancy, or in the weeks after delivery.  IVIG treatments are also used sporadically for patients suffering from MIBE as a way to temporize their immune system for a while, in the hope that their own natural immune system will come back.  However, most patients with MIBE will die, even with this type of treatment.

Curiously, infection by the measles virus has been observed to cure some auto-immune disorders.

The examination then turned to an account of the interaction between Dr. Michael Oldstone and Dr. O’Leary.  Dr. Ward was familiar with Dr. Oldstone’s reputation for taking people’s heads off, having once observed him laying into a graduate student for making a mistake.  Given his reputation Dr. Ward was nervous about approaching him, but wanted to more fully understand his experience with Dr. O’Leary.

Dr. Ward found Dr. Oldstone to be more welcoming than expected.  According to Dr. Ward’s account, Dr. Oldstone was approached by Rick Rollens of the MIND Institute at UC Davis about working with Dr. Wakefield to confirm what O’Leary’s lab was finding.

The O’Leary lab was about 80% accurate in their sample identification of measles virus, with about 10% being false positives, and 10% being false negatives.  A retest of the same materials showed a similar rate of error.  After that, Dr. Oldstone declined to continue working with Dr. O’Leary.  The court has a copy of the letter Dr. Oldstone wrote to Dr. Ward detailing this relationship.

Dr. Ward took issue with the assertion by Drs. Kennedy and Hepner that SYBR green was an inadequate tool for comparing the results of the Taqman PCR testing done by Unigenetics.  In his opinion, the use of SYBR green was entirely appropriate.

Dr. Ward doesn’t believe that the high copy numbers of measles virus RNA found in Colten Snyder’s cerebral spinal fluid eliminates concerns about contamination and inefficiency in the threshold cycle.  He went on further to say that many of Colten’s results, when looked at in isolation, don’t mean anything.  As a comparison, said Dr. Ward, everybody in the courtroom could be given a variety of tests, and some of them would come out abnormal, even though the people are healthy.

The direct testimony was finished up by Dr. Ward’s statement that the MMR vaccine is not know to cause clinically relevant immune compromise and that he has no confidence in the Unigenetics results for Colten Snyder.

He conceded that sometimes weird theories are true, such as Dr. Stanley Pruisner’s work on prions, but that the theory that the MMR vaccine causes autism is no longer biologically plausible.

Cross-Examination of Dr. Ward by Mr. Timothy Powers – Attorney for the Family

The examination began with Dr. Ward agreeing that the whole idea of attenuating a virus is to make it less virulent, but still provoke an immune response.  In the attenuation process a series of mutations take place, but the scientists are unsure which mutation caused the virus to be less virulent.  Dr. Ward referred to the process as creating a “black box virus” with unknown characteristics.

However, after 40 years of its use, we know a great deal about the attenuated measles virus.  Dr. Ward could not answer the question of whether a mutation in the measles virus could cause the symptoms observed here, saying it’s difficult to prove a negative.

On the issue of how the measles virus was noted in certain cases to cure some auto-immune disorders like low platelet counts, or juvenile rheumatoid arthritis, he agreed that when the theory was first proposed it was new and novel.

Dr. Ward agreed that his recollection of conversations with Dr. Oldstone and the accompanying letter are all the information we have about the O’Leary/Oldstone relationship.  Dr. Ward also agreed the letter doesn’t give us any supporting data on which he relied in forming his opinion.

Rebuttal Testimony of Dr. Ronald Kennedy by Mr. Timothy Powers – Attorney for the
Family

In his direct testimony Dr. Rima stated the Schwarz and Moraten strain of the measles virus were genetically identical.  The standard manual on viruses by Dr. Dianne Griffin says they’re closely related.

Dr. Kennedy also pointed out that the Physican’s Desk reference cites immuno-suppression as a contraindication for the MMR vaccine.  This also includes children with low CD-4 T-cells counts.  Dr. Rima said immuno-suppression was not a contraindication.

Dr. Kennedy admitted that in his report he’d made a mistake in saying the measles virus uses the CD-46 receptor.  He’d meant to also include that the measles virus also uses the CD-150 receptor as well as SLAM.  In his single publication on the measles virus he’d included the information, stressing he’d made an oversight.  The measles strain used in the MMR vaccine seems to use the CD-46 receptor.

Dr. Rima’s direct testimony had stated that the “R” protein was not part of measles virus assembly.  However, Dr. Griffin’s work on viruses mentions it, as well as stating it’s caused by ribosomal frameshifting.

Cross-Examination of Dr. Kennedy by Ms. Alexis Babcock – Attorney for the Government

Ms. Babcock elicited from Dr. Kennedy that according to the Physician’s Desk Reference, the MMR vaccine is contraindicated for those children with “clear manifestations of immune compromise.”

Rebuttal Testimony of Dr. Rima by Ms. Babcock – Attorney for the Government

Dr. Rima conceded that the information on “R” proteins is in the standard textbook, but claimed it was based on a single publication, and was not generally accepted by experts in the field.

Thoughts on this Day of Testimony

The government set out to destroy Dr. O’Leary’s reputation.  From my read of the testimony they failed.  I reproduce again the question of the Special Master, Denise Vowell in regards to Dr. O’Leary.

“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?”

She asked no questions of Dr. Ward.  Was it because a clear picture was emerging in her mind as the case neared its conclusion?  Assuming for a moment that it was, what might she have taken away from Dr. Ward’s testimony to support her opinion?

Well, in this case Colten Snyder was diagnosed with autism, then treated with IVIG, and recovered.  Petitioners claim it was because the IVIG treatments brought under control the measles infection raging in his central nervous system.  Dr. Ward admitted that IVIG treatments are used for newborns when the mother has contracted measles in the last few days of her pregnancy or the few weeks after delivery.

Colten was identified as having a certain disease (measles, which had invaded his brain and caused his autism), it was treated with an appropriate intervention (IVIG), and he recovered.

Any questions?

Kent Heckenlively is Legal Editor for Age of Autism.

Comments

[Richard]

Merck Says 44K Sign for Vioxx Settlement
Amazing that our mercury damaged kids have to jump through hurdles for years to get considered for compensation if they are lucky enough to get that chance. In the real world those normal people outside can go after pharma directly.and get fast large settlements.
I cannot help but wonder if pharma did not have the VICP protecting them and could have been sued civilly from the get go would they would have allowed dirty vaccines to have hurt so many kids? I think they may have been more careful if for no other reason than to limit their liability.
It seems so unfair that the damage done to our children is so much more severe in most cases compared to vioxx,zypexia etc yet our kids will at the most get a comparatively small settlement that is spread out over their lifetime.

[Sandy Gottstein]

As for MMR vaccine-associated SSPE, go to this link to see what the IOM reported: http://books.nap.edu/openbook.php?record_id=2138&page=136

[Sandy Gottstein]

I also wonder how Dr. Rimas could make this claim when even the IOM reported on considerably more cases in the book "Adverse Events Associated With Childhood Vaccines": http://books.nap.edu/openbook.php?record_id=2138&page=124

Here's the first two paragraphs alone: 'Measles Vaccine The first published case of encephalopathy (acute cerebellar ataxia) attributed to measles vaccine was discussed above (Trump and White, 1967). Retrospective analyses of populations who have received measles vaccine have been reported from many countries, including the United States. These uncontrolled observational studies provide no information on the concurrent background rates of encephalopathy. Table 6-2 summarizes case series and uncontrolled observational studies in which the incidence rates of encephalopathy or encephalitis following administration of measles vaccine were calculated by the authors.

Two case series addressed early concerns in the United States that measles vaccine might cause encephalitis. The first was a report of 23 cases of neurologic disease following measles vaccination in the United States from January 1965 to February 1967 (Nader and Warren, 1968). The authors characterized 18 of the 23 cases as "encephalitis" (described as including disturbances of sensorium, seizure, major loss of motor function, and cerebral edema; no data are provided regarding pleocytosis in the CSF). The interval from vaccination to the onset of symptoms ranged between 3 and 24 days. Postmortem findings in one case revealed herpes simplex virus in brain tissue. There were two cases of aseptic meningitis, two cases of cerebellar ataxia, and one case of extraocular muscle paralysis. The authors estimated a rate of 1.5 reported cases of "encephalitis" within a 4-week period of vaccination per 1 million doses of vaccine distributed. They compared this with a background rate of 2.8 cases of encephalitis (unrelated to vaccination or known parainfectious causes) per 1 million children for any 4-week period. The authors concluded, ''No single clinical or epidemiologic characteristic appears consistently in the reports of cases of possible neurologic sequelae of measles vaccination" (p. 998).'

In fact on page 125 of the book they document 112 cases that had been reported. (http://books.nap.edu/openbook.php?record_id=2138&page=125 )

[Sandy Gottstein]

Dr. Rimas claims that "The MMR vaccine has not been associated with SSPE (sub-acute sclerosing pan-encephalitis), but there have been two reports of MIBE (measles induced brain encephalopathy)."

I wonder then, why I was able to find two VAERS reports of encephathy associated with MMR vaccine in just 1990 alone?

See cases number 419 and 1375 at http://vaers.hhs.gov/scripts/dnloadStaticVAERS.cfm?filename=1990VAERSDATA%2Ecsv

[Ginger Taylor]

"He also believes there were contamination problems."

This charge has been thrown around in articles before, but I have never seen examples given. Did he say what the contamination problems were or how they knew that there were problems?

Were their kids with measles in the lab sneezing on the tables? Were the lab techs spilling their beer on the slides?

[Jill]

"Finally, Dr. Rima restated his opinion that the levels of measles virus RNA from Colten
Snyder were too high to be believed."

It would seem that no matter what evidence you proffer, they *always* have an argument to the contrary. At least in that there is a clear pattern of expected behavior. We in the bio-medical community have a name for this sullen-headed, panned, non-obfuscated response, its called "banging your head against a brick-wall."