OMNIBUS AUTISM PROCEEDING: Monday, May 12, 2008

Summary of Monday, May 12, 2008 proceeding.

By Mary Holland, Esq.

Test Cases of Jordan King and William Mead for Petitioners’ Second Theory that Thimerosal Alone Causes Autism

Opening Statements:

Special Master Hastings:

Special Master Hastings opened the evidentiary hearing by introducing himself and Special Masters Vowell and Campbell-Smith.  He said that the proceeding has two purposes:  to hear the claims of Jordan King and William Mead about autism and other medical issues and to hear testimony that this autism is vaccine-related on the theory that thimerosal alone can cause autism.  All three Special Masters will evaluate general causation evidence; individual cases will be decided by one Special Master using evidence from the general causation hearing.

Special Master Hastings acknowledged the claimants’ families and extended sympathy, admiration and thanks for their willingness to have their cases be test cases; he also thanked counsel, the Court of Claims, the marshals and listeners.  He said that the hearing would generally start at 9:00 a.m. with a break for lunch around 1:00 p.m. and adjournment around 5:00 – 6:00.

Petitioners:

Mr. Powers:
He is the attorney of record for Jordan King and William Mead and also represents the Petitioners’ Steering Committee.  He said that the hearing is about these two boys who filed claims seven years ago for regressive autism, but it’s also about the other 4,800 claims filed in this proceeding.  Third, it’s about public policy and science.  In addition to advocates, there are scientific experts here.  The case is about the mercury-based preservative thimerosal; it’s about an uncontrolled experiment over a huge population of children that’s now largely a relic of history.  But this is not an anti-vaccine case.  It’s about this preservative that’s still used in flu vaccines but that should be in the dustbin of history.  It’s not about the government’s rhetoric that this case endangers the vaccine program. 

Mr. Powers argued that the Department of Justice’s “rigid pro-vaccine” position co-mingles the interests of HHS, HMOs and vaccine manufacturers.  The effect of this co-mingling has been to cut off scientific inquiry and prevent the development of science so that vaccines are as effective and safe as possible.  He argued that this cut-off of science is apparent in the blocked access to the Vaccine Safety Datalink that’s been privatized.  Although the Institute of Medicine in 2005 urged better public access to the Datalink, that has not happened.  For years there has been discussion of a study in Italy about children vaccinated with thimerosal and without thimerosal; that study has never emerged.  About a year ago the National Institute of Environmental Health Sciences recommended that VSD data be extended forward; that hasn’t been done.  And lack of availability of information has been an issue in this proceeding; DOJ and HHS had wanted to keep these proceedings secret.  Transparency is important to good science, safe vaccines and public confidence.

The Petitioners’ basic roadmap is this:  (1) neuroinflammation is a hallmark of autism; neuroinflammation leads to the “overactivated brain.”  We know that inorganic mercury can trigger neuroinflammation and that it accumulates in the brain.  Gene-environment interaction is the “likely culprit” in the 88-90% of the cases of autism where there is no significant identifiable cause.  Thimerosal-containing vaccines (TCVs) should be on the list in evaluating the cause of regressive autism.

In the two test cases of Jordan King and William Mead, both boys developed typically until after the first year of life and then both were diagnosed with regressive autism.  Each boy had a period of normal development of at least a year and then began to lose skills of social interaction and speech and they acquired new symptoms, including self-stimulatory behavior, odd vocalizations and tics that they didn’t have before. 

Using vaccine court’s standard of causation, Petitioners must show (1) a reasonable theory of causation; (2) a logical sequence of cause and effect confirming the theory and (3) a temporal relationship between the TCVs and appearance of symptoms.  Under this standard, both boys should be awarded compensation. 

We can show circumstantial, indirect evidence that they were unable to rid their bodies of mercury effectively.  They show indirect evidence of oxidative stress; direct evidence is only available at autopsy.

Mr. Powers also addressed the “tone” of some of the submissions of HHS.  Mr. Powers conceded that some of the Petitioners’ doctors “pushed the envelope” because the medical establishment has been so been unhelpful and has basically told parents “deal with it.”  These doctors have been willing to challenge the establishment on behalf of their patients.  Mr. Powers remembered asking Dr. Wiznitzer in the Cedillo hearing if any children recovered from autism.  Dr. Wiznitzer said that some “just grow out of it.”  Mr. Powers said children don’t “grow out of it,” but that some, with allies such as Dr. Mumper, fight their way back.  He said that it’s a shame that some of Respondents’ comments are at the line of offensive and are disdainful, characterizing children’s progress as “anecdotal.”  These hearings are about science and about a safe immunization schedule for all children.

Mr. Williams:
Mr. Williams said that he would review the three or four most important studies that would be discussed over the next three weeks.  Mr. Williams briefly described articles on autopsies of autistic children’s brains, showing neuroinflammation and uneven development of brain cells.  Neuroinflammation can be triggered by various causes, including viruses and chemicals.  We know that inorganic mercury can cause neuroinflammation.  Here he pointed to the Burbacher monkey studies; five separate papers focusing on changes in glial cells in adult monkeys.  The inorganic mercury does not leave the brain.  He noted that one of the authors, Mr. Thomas Clarkson, would be testifying for Respondent. 

He said that the defense had lots of citations to epidemiological studies in Europe, but none of those studies look specifically at regressive autism.  He said there is a consensus that 15% or less are clear cases of regressive autism.  He said that environmental studies show that tributalene, a drug given to pregnant women during their third trimesters, made those infants far more likely to become autistic due to neuroinflammation.

He outlined the schedule of Petitioners’ expert witnesses:  Dr. Greenland on epidemiology; Dr. Aposhian on toxicology; Dr. Deeth on thimerosal research; Dr. Kinsbourne, a pediatric neurologist; and Dr. Mumper, the treating physician for the two boys and for hundreds of autistic kids.  He reviewed the experts’ credentials. 

He said that there’s a debate about whether autism is wholly genetic and whether there’s been a real increase in incidence.  He will persuade us that there is a real epidemic and that there’s no such thing as a genetic epidemic.  Only gene-environment interaction explains regressive autism.  There is a genetic susceptibility and wide variation in infants’ ability to detoxify heavy metals.  He said Petitioners will show a medically plausible theory; a logical sequence of cause and effect; and a temporal relationship between the injections and injury.

Respondent:

Ms. Riciardella:  She has been working on these cases for four years and she has seen how dedicated and loving these parents are.  She said she has tremendous respect for the families that take care of autistic children and she echoes Special Master Hastings’ appreciation of the families willing to be test cases. 

She said the issue of whether vaccines and autism are linked has received lots of public attention.  She said the government will litigate this issue with “good, solid, reliable evidence” that applies to this case and to most, if not all, of the other cases.  She said that the Supreme Court set the standard for such evidence in its Daubert decision.  Scientific evidence should be based on research, not speculation; it should be reduced to writing; it should be peer-reviewed and replicated; and it should be testified to by experts.  She said that the government’s experts had done decades of research and that petitioners’ novel hypotheses were not accepted and validated.  She said that autism’s pathogenesis is in utero.  She said that Petitioners introduced no expertise in regressive autism and no evidence of differences between regressive and non-regressive autism.  Petitioners have not shown an association between TCVs and autism.

She pointed out that much of Petitioners’ evidence is about methyl mercury, not the ethyl mercury that is contained in vaccines.  She said that Petitioners’ evidence is about high dose exposure to mercury, not the small doses in vaccines.  She criticized much of Petitioners’ evidence as based on animals, not humans.  She argued that over the six years since the Omnibus Autism Proceeding has existed, Petitioners’ hypothesis hasn’t moved.  She said that in science, “the debate is over;” the only controversy is the media controversy.  To appreciate how “radical” Petitioners’ theory is, she asked that the listeners consider the origins of the hypothesis.  It was put forward by a marketing consultant and parent of an autistic child in a journal that for a fee publishes “radical, unsubstantiated and probably untrue” articles. 

Ms. Ricciardella reviewed the 2001 and 2004 IOM studies on potential vaccine-autism links and while the first study was non-commital, the 2004 study “favors rejection” of any link.  That study discouraged further research into any link.  She pointed out that other organizations have rejected a potential link, including the WHO, AAP, CDC, FDA and other organizations.  How do Petitioners look at these rejections?  They say that the studies didn’t look at the right evidence and didn’t focus on regressive autism. 

The first pronouncement of a link between autism and vaccines shouldn’t come from a courtroom, it should come from science.  The scientific community has considered and rejected these allegations and so too should this courtroom.

Petitioners’ Rebuttal:

Mr. Powers pointed out that many of the studies that are central here were not considered by the IOM when it was meeting in 2004.  There are approximately 275 articles on Petitioners’ list that were published after the IOM’s 2004 report.  He noted that their theories are testable, but that defendant has put more money into fighting claims than into science.  He said that the 2004 IOM study stopped vaccine-autism study before it got started; it “cut science off at the knees.”  He said that Petitioners can show a mechanism of injury that meets the standards of this proceeding and that the two claimants are entitled to compensation.

Petitioners’ Witnesses:

Direct Examination of Dr. Greenland:
After being sworn in, Dr. Greenland reviewed his qualifications as an epidemiologist.  He said that although autism’s causation is unknown, there are distinctive subtypes of autism and that a possible association between TCVs and regressive autism would have been “diluted” by large epidemiological studies.  Because regressive autism is a small minority of all cases, failure to separate it could make an association undetectable; epidemiology is “too crude a tool.”  He noted that failure to demonstrate an association is not the same as “no association.”  He pointed out that the government has not introduced any studies on regressive autism; he pointed out problems with data the government relies on from other countries where the thimerosal usage in vaccines was about a half that of the U.S.

In particular, Dr. Greenland addressed the studies of Dr. Fombonne, the government’s epidemiologist witness.  He said that the study looks at Pervasive Development Disorder, a much broader category than autism.  He said that Dr. Fombonne’s evidence could not rule out an association between TCVs and “clearly regressive autism.” 

Dr. Greenland criticized Dr. Goodman’s article related to autism subtypes as “rhetorical” and “ridiculous.” 

He repeated his main point that the epidemiological literature has not ruled out a TCV-autism link. 

Cross examination of Dr. Greenland:
Dr. Greenland clarifies that it is theoretically possible that “clearly regressive autism” has links with TCVs.  He reiterates that none of the existing epidemiological studies disproves the hypothesis of a link between regressive autism and TCVs.  Dr. Greenland could not opine as to whether it was more likely than not that there is a link between regressive autism and TCVs.  He would not express a belief about whether “clearly regressive autism” is caused by TCVs.  He did opine that the subset of regressive autism cases is probably small to have remained hidden for this long.

Direct Examination of Dr. Aposhian:
After being sworn, Dr. Aposhian reviewed his toxicology qualifications.  He then explained that the purpose of his testimony is to show that thimerosal is involved in the causes of autism.  He said that “dose determines the poison” is outdated, and that other factors affect toxicity, including interaction with other agents, such as metals; immune status; and age and stage of development of the host.  He briefly reviewed the role of oxidative stress in autism.  He reviewed the Pichichero 2002 and 2008 studies on thimerosal in infants; he focused on evidence in the studies that it takes 30 days for infants’ mercury levels to return to pre-vaccine levels after injection. 

Dr. Aposhian briefly discussed the De Soto study.  He also showed a slide comparing the toxicity of ethyl and methyl mercury.  He said that while their pharmokinetics are different, their toxicity is not that different, and that both can cause neuronal necrosis and both convert to mercuric mercury that is stored in the brain.  He outlined the plausible causation pathway as injection of ethyl mercury, its conversion into mercuric mercury in the brain, leading to neuroinflammation and autistic symptoms.  He pointed to the Vargas autopsy studies as confirmation of these theories.  He referred to this as a “mercury efflux disorder” and said that it is comparable to Wilson’s disease, a well-recognized copper efflux disorder where copper accumulates in individuals’ cells.  He then referenced studies related to mercury efflux disorder, including hair studies, Jill James’ glutathione studies, Bradstreet’s DMSA chelation studies and Adams’ tooth study.  He mentioned a mercury excretion study he is currently working on; he said all these studies were consistent with the theory of a mercury efflux disorder.  Dr. Aposhian also pointed to the case of tributalene, a teratogen that causes autism through neuroinflammation. 

Special Master Hastings (after break): 
He noted that Petitioners had introduced 250 new articles last week in connection with Dr. Aposhian’s testimony and that the government was considering motions to deal with this situation. 

Cross examination of Dr. Aposhian:
Ms. Renzi reviewed Dr. Aposhian’s credentials; she emphasized that he is not a medical toxicologist, neurologist, immunologist or doctor at all.  She also clarified that he is not an autism expert.  She questioned whether Dr. Aposhian’s comparison of data on methyl mercury at high doses was comparable to very small doses of ethyl mercury.  She asked questions about dose – response and threshold levels for detection of effects. 

CROSS EXAMINATION TO BE CONTINUED ON MAY 13.

Mary Holland teaches at New York University Law School and may be contacted HERE. Thank you to A-CHAMP for providing this important service.

Comments

[Pamela Felice]

What is this about tributalene? I was given tributalene for my ASD recovered daughter.

I googled but found no information regarding tributalene and autism. Does anyone know where I can get info regarding the link that Dr. Aposhian is referring to?

[Theresa Cedillo]

Thank you Mary and Kent - great job as always. I likely will not have time to listen in - but will definitely be sure to check here for my daily update from you both!

Theresa

[Craig Willoughby]

I want to thank Mary for this article and giving me an excuse to use unauthorized internet time at work :P

Jack, the statement you mentioned looks very weak now. I know she's a lawyer and just doing her job, but I want to slap her and say "LOOK!"

[Kelli Ann Davis]

A busy day in DC yesterday for sure! Both the IACC meeting and the Vaccine Court were in session and I was definitely in the "mad dash" mode all day running between the two!

I missed the opening statements for Court (heard Sallie was given a "memorable mention" by the government) but I did get to see Dr. Aposhian on the stand and he had me laughing at several points during cross-examination by the government. He *definitely* was not going to being painted into the corner by the government attorney even though she tried her best to do so!

Anyways, running out the door to catch the afternoon session.

[Jack]

"Ms. Ricciardella reviewed the 2001 and 2004 IOM studies on potential vaccine-autism links and while the first study was non-commital, the 2004 study “favors rejection” of any link. That study discouraged further research into any link. "

In light of Dr. Healy's comments yesterday, how weak does that last sentance now look.