Holland on the Omnibus Autism Hearings: 7/21-22

By Mary Holland, Esq.

Omnibus Autism Hearings,
July 21-22, 2008
Thimerosal-Autism General Causation Theory
Test Case 3:  Dwyer v. HHS
Monday, July 21

Petitioners’ Opening Remarks [Mr. Powers]
Colin Dwyer had developed normally until 20 months.  Then, the thimerosal in Colin’s vaccines led to a neuroinflammatory process causing autism.  Dr. Mumper will connect the general causation evidence to Colin’s case, showing the logical sequence of cause and effect leading to Colin’s injury.

Respondent’s Opening Remarks [Ms. Ricciardella]
This hearing is about specific causation only; general causation evidence is closed.    I want to express my respect and admiration on behalf of the government for the Dwyer family.  (Mr. and Mrs. Dwyer are present at Petitioners’ table.)  But, this case must be based on science, and good science, “reliable, credible science is the bedrock of the vaccine program.”  Daubert [Supreme Court case on scientific evidence] and its progeny should carry weight and be the paradigm for science here.   “Unproven hypotheses based on unproven data” should have no place.  Dr. Mumper will discuss oxidative stress, mercury efflux disorder, neuroinflammation, methylation abnormalities and a “plethora of hypotheses;” “you’ve heard information that disproves these.”  Dr. Bennett Leventhal, an autism expert of 30 years, will testify for the government and show that there’s “nothing unusual” about Colin’s case.

Petitioners’ First Witness:  Direct Examination of Maria Dwyer

[Mr. Farrell leads direct examination]  Mrs. Dwyer:  I live in Queens, New York.  I have a bachelor’s degree from St. John’s College; I worked in media at NBC radio and then MTV; I married in 1995.  In June, 1997, my first son Shane was born; he’s now 11 and in the fifth grade.  He has no developmental issues at all.  Shane was 17 months when Colin was born.  Mrs. Dwyer had an uncomplicated pregnancy with Colin; his birth was induced at 38 weeks; I was given Pitocin to induce labor.  There is no family history of autism or PDD on either side of the family.

There were no issues in Colin’s early development.  At 9 months he was starting to walk; at 12 months he was walking well.  He loved to be held; he babbled; he watched TV; he liked to build blocks; he played with stuffed animals; he loved to play the drum; and he was always with his older brother.  At Colin’s second Christmas, when he was 13 months old, he was “all over the place, into everything.”  From 13-20 months, he started to form words, and could say “mamma,” “dada,” bye-bye,” “baby,” “up,” “cookie.”  He could wave, point and gesture.  He continued to flourish up to 20 months; he had normal development.  He was very consolable.  In Colin’s first 20 months, I was working 9:00 – 6:00 during the week, so my husband, Timothy Dwyer, was the main caregiver during the week, and I cared for Colin in the evenings and on weekends.

In fall 2000, Colin was not using as much language, and his behavior started to change.  He would become extremely upset about going out; he would scream and cry; it was difficult to pick him up.  He had loved baths, but now he refused to take a bath.  At Colin’s third Christmas, there were lots of people over because they couldn’t take Colin to any other family members’ homes.  Colin was sick, sad and unhappy.  He never opened a present and didn’t acknowledge people.

By spring of 2001, Colin wasn’t using any words; he would scream if people got near him; he stopped eating; he didn’t want to wear any clothes; he had diarrhea; he would sit alone in a corner.

On March 1, 2001, we took Colin to the pediatrician.  The doctor referred him for speech and language and hearing evaluations.  They did an Early Intervention evaluation.  On May 1, 2001, we were told that Colin was profoundly delayed.  We then took Colin to see NYU neurologist Dr. Irving Fish who diagnosed Colin’s autism as moderate to severe.  Dr. Fish said he was not optimistic about the outcome.  In June, 2001, Colin started speech therapy.  At this point, Colin had no speech.  He disliked being around people.  He obsessively lined things up; he was very sensitive to clothes and hated shoes.  He would strip at home and liked to be naked. 

Later in 2001, Colin developed self-injurious behaviors.  He banged his head on the wall and punched his head.  We went to see Dr. Cece McCarton, a specialist for children with autism.  She recommended a 40 hour per week home ABA program.  We did this in 2001 and supplemented with speech and language services at the McCarton Center; those services cost $100/hour.  We were concerned that Colin was not making adequate progress; we had Dr. McCarton do a home visit.  She advised then that we have Colin come to her Center to do intensive ABA work there.  In January, 2002, Colin started there.  It cost $4,000 per week; he was there for 12 weeks.  Then in March, 2003, a place opened in the McCarton School.  The School had a 1-to-1 ratio and an individualized curriculum.  Colin stayed there from March 2003 to August 2006.  We saw improvement and Colin benefited from speech therapy.  The School cost $90,000/year.  We refinanced our home and liquidated our savings.  100% of my salary goes to Colin’s education.

Q:  What medical interventions have you done for Colin?
A:  We saw Dr. Kenneth Bock, a DAN doctor.  He started biomedical interventions right away.  The first interventions were to address Colin’s weight loss and chronic diarrhea.  Dr. Bock thought Colin was highly allergic to a number of things.  We started him on the casein-free gluten-free diet and supplements; we saw dramatic improvements.  His stomach became less distended and we saw improvement in bowel function.  Colin’s physical appearance improved. Dr. Bock then did chelation therapy with Colin using DMSA and ALA to rid Colin of heavy metals.  While Colin’s unprovoked urine in April 2002 at 2 years old was in the reference range, after provocation, his urine level of mercury was off the charts. 

We also did glutathione infusions; we did 30 IV infusions, but these didn’t help.  We also did 15 B-12 shots – they provided minimal improvement. 

Then we started seeing Dr. Russell in New York to follow the NIDS protocol for viral and fungal issues.  Colin’s condition improved.  We recently put Colin on an SSRI medication; we didn’t want to do this, but it has helped.

Q:  Has there ever been any suggestion that Colin is mentally retarded?
A:  No.  Everyone says he learns quickly and that he has a lot of intelligence.  He is using the PECS (Picture Exchange System) system successfully. 

Q:  What’s Colin’s functioning today?
A:  We have to deal with difficult behaviors on a daily basis; rigidity and compulsive behavior.  It’s not possible to go to a restaurant because Colin will scream or run out of the restaurant.  He may hit himself or be very difficult to manage and control. 

But, I can compare Colin to other families with similarly affected children who didn’t pursue biomedical intervention.  Colin is higher functioning that those other 3 kids with whom he started many years ago. 

I left my work in 2001 and my husband decided to retire.  We parents are left to our own devices.  It takes an extraordinary amount of time to deal with doctors, evaluations, therapies; it requires a full-time commitment.  When my husband was eligible for retirement, we decided he would take over and I would return to work.

Cross-examination:

[Mr. Johnson] Q:  Why do you think that thimerosal-containing vaccines caused Colin’s autism?
A:  His regression started right after his vaccines in July 2000; it’s the timing.

Special Master Vowell:
Q:  Colin received 4 Hepatitis B vaccines rather than the usual 3?  At birth, two weeks, and then twice more before 2 months?
A:  Yes.

Q:  You started the casein-free gluten-free diet and then shifted to just the casein-free; why?
A:  Colin’s bowels were better.  Other kids in his class were eating gluten, and we let him try and didn’t see a downside.

Petitioners’ Second Witness:  Direct Examination of Timothy Dwyer

[Mr. Farrell]  I worked with the New York City police force for 4 years and then in the fire department for 16 years.  My father was a fire fighter for 30 years.  I was involved in 9/11.  I went there in the second wave, just after a 24-hour shift.  I got there as the towers were coming down; I lost friends. 

In Colin’s first year of life, there was no problem for him with fire department sirens.  He had no sensitivity to sound.  He and his brother loved the fire department; I would take them there.  At 13 months, as my wife said, Colin was “into everything.”  When Colin was 17-18 months, I took care of him during the work week.  We were “road warriors;” we would be out in the neighborhood and at the beach all the time.  After 20 months, Colin would have a complete meltdown at the beach.  He wouldn’t get out of the car.  Therapists said keep trying it and he’ll get over his anxiety.  Now he loves the beach again. 

Q:  Prior to 20 months, did Colin have any self-injurious behaviors?
A:  No.

Q:  Any obsessive-compulsive behaviors?
A:  No.  That all started in early 2001.  Hand flapping; sensory issues.  It was a very tough winter.  In early spring, he started the head banging on the floor.  Before that, Colin and his brother were “Irish twins” and “we were 3 happy guys hanging out in Bayside.”

Q:  What about Colin today?
A:  In the afternoons, I take him for community-based therapy.  He still can’t sit in a restaurant, but I’m working on McDonalds and French fries.  He’s now better in stores.  We went to a water park and he could wait on lines. 

Q:  What concerns do you have about Colin’s future?
A:  I can’t sleep at nights; I am worried his brother won’t be able to take care of him.  I don’t want him to be in a group home or be lonely.  [Mr. Dwyer can’t speak further.]

No cross examination.

Tuesday, July 22

Petitioners’ Third Witness:  Direct Examination of Dr. Elizabeth Mumper

[Mr. Powers]  Please include Dr. Mumper’s non-specific testimony in the King and Mead cases with her testimony in this case.  We will just cover that here in five minutes.

Q:  Tell us your background.
A:  I am a pediatrician since 1983.  I now have a private practice and am the medical director of the Autism Research Institute and Defeat Autism Now!  I am also the director of the Rimland Center.

Q:  What did you rely on for your report in the Colin Dwyer case?
A:  Colin’s medical records; laboratory information; the mother’s affidavit; my previous reports in the King and Mead cases.

Q:  Have you received additional information since then?
A:  Yes.  I received some additional pages from Dr. Bock; I listened to the parents’ testimony on audio; and I met Maria Dwyer last night. 

Q:  How many kids do you see each year in your pediatric practice?
A:  About 1,700.

Q:  What percentage of the kids have ASD?
A:  I spend about half my time on kids with ASD; it’s a significant focus of my practice.

Q:  Please tell us your impression of Colin Dwyer’s records from birth to 12 months.
A:  Colin was a healthy baby.  He had an uncomplicated birth.  He had only a few problems in the first year – pink eye, but nothing you would characterize as chronic illness.  His “well baby check ups” show that he met his gross and fine motor milestones and that he was developing language skills.  He was doing all these things on schedule.  3-5 words at 12 months was very good.  This was typical or normal. 

Q:  Do you see any indication of delays or problems in the notes from the 12-month visit to the pediatrician?
A:  No.  The doctor says she heard babbling and occasional words, as is consistent with the parents’ testimony.

Q:  What’s significant about the 15 month well-baby check up?
A:  The pediatric record show that he was running and climbing and “talking some.”  It notes he has sleep problems “like brother.”

Q:  Does this show any evidence of delay?
A:  No.

Q:  Do you think the parents’ testimony is inconsistent with this record?
A:  No.

Q:  Before 20 months, do you see anything to indicate developmental problems?
A:  No.

Q:  At what point do you see evidence of problems?
A:  At the 20 month visit I see the first evidence of developmental delay.  The pediatrician notes, “he says a few words (3-5).”  This is what would be expected at the 12-14 month visit.  The record says to check speech at 2 years.  This note suggests that the pediatrician is concerned but not panicked.

Q:  Is there anything in the birth record to indicate problems?
A:  No, but he did receive the Hepatitis B vaccine at birth, and that was not reflected in the initial report I received.  He got the thimerosal-containing Hep B vaccine at birth, 13 days, 7 weeks and then at 6 months.  Typically there are only 3 Hep B vaccines, not 4.  This is a time of particular vulnerability.  This record of 3 shots makes me more concerned.  This changes Colin’s total exposure to mercury from 237 mg to 250 mg.

Q:  Was there anything during Maria’s pregnancy that’s notable?
A:  No, I didn’t perceive anything.

Q:  Were there any known risk factors for autism during Maria’s pregnancy – viral flu, rubella, valproic acid, terbutalene, thalidomide?
A:  There’s no history of any of these things.  Her husband referred to her as a “healthy girl” during her pregnancy.

Q: Evidence of alcohol or cigarettes?
A:  No.

Q:  Were there indications of delay after 20 months?
A:  Yes.  The 2-year check-up was not routine.  The parents brought up their concerns.  The pediatrician wrote that she “stresses the importance of the Early Intervention evaluation” and wrote “speech and language delay!”  This implies the doctor’s concern.  The parents described loss of language; this is a very big red flag; regressive autism would be a possible concern.

Q:  Do you believe that Colin regressed into autism?
A:  Yes.  I base that belief on the medical records and the parents’ reports.  There is a clearly documented loss of language milestones and changes in behavior.  Based on the parents’ dramatic testimony, we hear that Colin changed from a kid in the stroller, playing with his brother and engaging in social interaction, to a withdrawn child who couldn’t tolerate the stroller, who had tantrums and rigid play.  This is a vivid clinical picture of regressive autism.  I’ve seen this pattern often in regressive autism.

Q:  When did Colin get the ASD diagnosis?
A:  He received it from Dr. Fish when Colin was 2 years and 7 months; he received a diagnosis of Pervasive Developmental Disorder with autistic features.  It’s first documented at 31 months.  Colin went to Dr. Bock.  I know him well.

Q:  Let’s review the lab reports from Dr. Bock and Dr. Russell.
A:  [They review various documents that are shown on the screen to the Special Master and lawyers.]  This blood test reflects neuroinflammation; it ties to Dr. Kinsbourne’s theory of neuroinflammation.  These antibodies are suggestive of neuroinflammation.

This next blood test shows antibodies against myelin basic proteins.  It suggests an elevation in these levels.  The test also indicates oxidative stress.  When under oxidative stress, the body would be less able to detoxify heavy metals.  Colin’s glutathione level is very low.  The test also indicates Colin’s cysteine level, showing problems with methylation and an inability to deal with heavy metals.  The test for plasma sulfate is below the normal range, showing that he is detoxifying suboptimally.

Here’s a urine test, pre-provoked and post-provoked.  The baseline is normal, with no detectible mercury.  The post-provocative urine shows 17 mg of mercury per gram creatinine; this is 3 times the normal range.

Q:  Could this reflect an ongoing exposure?
A:  Well, this subsequent test of red blood cells shows no evidence of ongoing mercury exposure.  This would only be an accurate measure for the last 120 days; it shows no evidence of an acute exposure. 

Q:  Could Colin have been exposed to mercury through breast milk?
A:  I learned that Maria Dwyer did not breast feed.

Q:  Were there other potential sources of mercury?
A:  I didn’t see other exposures.

[a couple other urine tests reviewed]

Q:  In sum, what do you see?
A:  We see a kid “tipped” towards neuroinflammation or neurotoxicity.  We’ve shown that Colin’s glutathione is low; his cysteine is low; and multiple lab tests show a pattern consistent with mercury toxicity. 

Colin had normal development; then a regression.  Colin’s parents “moved heaven and earth,” went into debt; changed their career paths; and sought out the best resources.  They traveled to doctors to address Colin’s medical problems.  He has made progress and is better.  At this time, Colin is much better than when he was 2.  He is able to socially engage, but it’s still not possible to take him to a restaurant.  I feel bad about that.  I am very impressed with the dedication of Colin’s parents.  But he is likely to have residual problems in his future, as his father articulated so well.

Q:  Did you reach a medical opinion on Colin’s autism?
A:  Yes.  I came to the opinion that thimerosal-containing vaccines must be on the list of those factors that could have caused his autism.  I couldn’t find any other source of mercury.  Colin’s lab data and his clinical course suggest that in my best professional judgment, thimerosal-containing vaccines substantially contributed to Colin’s medical problems and autism.

Q:  Do you see any evidence of mental retardation in Colin?
A:  No.

Q:  Anything in your conversations with the parents to indicate that he’s mentally retarded?
A:  No.  His mother shared her story that teachers, including experienced teachers at the McCarton Center, think that Colin is intelligent and progressing well.  His receptive language has improved and his expressive language has lagged.  I have not personally examined him, though.

Q:  Would you look for genetic causes for Colin’s autism?
A:  There are genetic precursors; there can be dismorphic features in the face and hands.  There are no notations for dismorphologies.  I didn’t see that a genetic exam was done, but I didn’t see evidence of genetic abnormality.  I must think that the doctors who examined Colin thought that such testing would be low yield.  They all would have had these possibilities in their minds.  It suggests to me that Drs. Bock, McCarton and Fish did not suspect any genetic abnormality.

Q:  Have you reached your opinion to a reasonable degree of medical certainty?
A:  Yes.

Cross Examination of Dr. Mumper

[Mr. Johnson]

Q:  Is it correct that you have not done an evaluation of Colin?
A:  Correct.

Q:  Did you spend time with Colin’s parents after your report?
A:  Yes.

Q:  You said you spoke with Dr. Bock after you submitted the report.  Why?
A:   The September 17 and September 20, 2002 urine tests were both labeled post-provocation, and I suspected this was an administrative error; that the first was pre-provocation.  I wanted to clarify this.

Q:  Did you discuss anything else about Colin?
A:  No.  I only asked about that lab report.

Q:  You mentioned the lab test showing myelin basic protein (MBP) antibodies.  Do you use this test in your practice?
A:  Yes; sometimes.  These tests are expensive, but I have ordered them.  This panel costs $600, but it can be expanded and will cost $1,200.

Q:  Can you diagnose autism with these lab tests?
A:  No.   I agree that you can’t diagnose autism with these diagnostic tests.

Q:  You said that these results were consistent with Dr. Kinsbourne’s theory, but he didn’t discuss MBP antibodies?
A: Correct.

Q:  Are you aware that these markers are present in Alzheimer’s and ALS?
A:  Yes.

Q:  Isn’t it equally likely that these antibodies are secondary to the problems and not primary?
A:  I looked at these results as confirmation of the inflammatory process.

Q:  Isn’t it true that Dr. Kinsbourne is not proposing demyelination as part of his theory?
A:  Correct.

Q:  Can’t these markers be elevated in normal people?
A:  Yes.  The better measure would be in the central nervous system fluid, but we are prohibited from getting that because of standards of care.  We have to rely on other markers.  These are not direct assessments, but we can’t do direct assessments of neuroinflammation.

Q:  Do you know what the lab protocols are for this Immunosciences lab?
A:  No, but I have visited this lab twice.

Q:  Do you know how they establish reference ranges?
A:  No.

Q:  Do you know if these ranges are accurate for children?
A:  I don’t think so; I think they are adult ranges, but if anything the numbers for kids would be less.

Q:  Is this lab accredited by the College of American Pathologists?
A:  I don’t know; the reports come with disclaimers.

Q:  [Mr. Johnson shows Dr. Mumper several letters and documents from the Immunosciences website and from Center for Medicare and Medicaid Services (CMS) finding problems with the lab’s testing.  Mr. Johnson shows Dr. Mumper a settlement agreement between the lab and CMS saying that the lab must be certified by the American College of Pathologists or must withdraw from a group of laboratories authorized by CLIA (a federal law related to laboratories).  It didn’t get certification so either the lab likely didn’t get certification or elected not to be certified.]

Q:  Do you have concerns about the lab’s reliability?
A:  Yes.  I was not aware of these concerns.  If this was the only lab report I was relying on, I would be concerned.  But I am relying on many other lab results as well.

Q:  You show abnormal glutathione levels from tests done in 2001 and 2002.  But these don’t tell us whether there was oxidative stress at the time of immunization, correct?
A:  Yes.

Q:  And other factors can cause oxidative stress?
A:  Yes.

Q:  Would you agree with the mercury efflux disorder hypothesis?
A:  Yes.

Q:  I’d like to review with you all the mercury testing data in the record.  [He reviews a 4/19/02 normal pre-provoked test; a 9/20/02 post-provocative test with no elevation; a 9/22/02 test showing 17 mg/g creatinine excreted; and 3 later post-provocation tests showing no elevation.]

Q:  So Doctor’s Data, the lab, has a disclaimer that there are no reference ranges for post-provocation urine, and we have only one positive test, is that correct?
A:  Yes.  Mercury excretion is variable and dependent on a number of factors.

Q:  Is this 2002 post-provocation test the only one indicating excreted mercury?
A:  Yes.

Q:  If that piece of data were unreliable, would that be a problem?
A:  Yes.

Q:  Is it true that that test is not specific as to the species of mercury?
A:  Yes.

Q:  Is it true that none of the other tests are diagnostic of mercury?
A:  Yes.

Q:  Could Colin’s medical condition be explained by other factors?
A:  Yes, but we would need to correlate them with the child’s medical record, which here includes oxidative stress, glutathione depletion, acidosis and low amino acids.

Q:  Couldn’t poor nutrition explain some of these factors?
A:  Yes.

Q:  Is it true that no tests were done to diagnose neuroinflammation?
A:  Correct, but I’m not aware of anything short of biopsy that would diagnose neuroinflammation definitively.

Q:  You’re not aware of any good clinical markers?
A:  Central nervous system fluid would be a good marker, but I’m not aware of how you would get it in a situation like this.

Q:  Is it true that the parents said that they went to Dr. Russell because the DAN protocol didn’t work?
A:  It’s difficult to isolate efficacies.  We don’t know whether the treatments worked.

Redirect Examination of Dr. Mumper

Q:  Is any medication associated with antibodies to MBP?
A:  Not that I’m aware of.

Q:  You said that MBP is associated with Alzheimer’s and ALS.  Is there any suggestion that those diseases are present, or any other neurological disorders, besides autism?
A:  No.

Q:  Who reached the autism diagnosis?
A:  A pediatric neurologist based on a case history and symptoms.

[questions on some specific lab reports]

Q:  Are you aware of science that supports the mercury efflux disorder hypothesis?
A:  Yes.  The substance of Dr. Aposhian’s testimony supports it.

Q:  Are you relying on his testimony for that?
A:  Yes.  He has vast experience with heavy metals; I rely on his knowledge for that.

Q:  Are there normal ranges for post-provocation chelation tests?
A:  It’s true that we don’t know normal post-provocation ranges, but if a sample is 5 times the reference range for a non-provoked sample, it’s not normal under any circumstances.

Q:  Would you consider Colin’s vaccines to be evidence of exposure to mercury?
A:  Yes.

Q:  Does the lack of evidence of acute mercury intoxication change your opinion?
A:  No.  Our concern is that low amounts of mercury go to the brain, and the body has great difficulty getting them out.  This is my concern with chronic exposure at this critical developmental window.  Colin got a large load of mercury in his first two months of life when his brain was doing a lot of work.

Q:  What is your opinion as to what contributed to Colin’s injury?
A:  Colin received a series of thimerosal-containing vaccines.  He was subject to accumulation in his brain.  He had a chronic exposure and his symptoms manifested later. 

Q:  Do his lab reports indicate autism or a mercury body burden?
A:  Yes.

Q:  Are you relying on one test?
A:  No.  The most important evidence is his history and a constellation of tests.  There are no clear biomarkers for autism.  But this collection of results shows a pattern that’s striking – the number of different lab results show that Colin had mercury exposure; excretion of mercury with provocation; and multiple tests showing evidence of metabolic dysfunction.

Recross Examination of Dr. Mumper

Q:  You point to the post-provocative urine test as abnormal.  But there’s no data to support that, correct?
A:  To my knowledge that is true.

Special Master Vowell

Q:  So if we took 100 3-year olds today, there is no reference range for post-provoked chelation?
A:  It has not been done.  “It desperately needs to be done.  We’re trying to do these comparisons with porphyrin data.”

Q:  There is no reference data for pre- and post-chelation tests?
A:  There’s evidence of excretion, but the quantification has not been determined.

Q:  When we chelate and measure – it’s a measure of body burden?
A:  I don’t have the data to tell you that a normal kid would excrete 17 mg/g creatinine if he had a body burden of X.

Q:  How can you say that 17 mg/g creatinine is extremely high?
A:  [no audible response]

Respondent’s First Witness:  Dr. Bennett Leventhal

[Ms. Ricciardella reviews Dr. Leventhal’s qualifications.]  He is a professor of child psychiatry at University of Illinois in Chicago.  He is board certified; the member of lots of professional associations; has honors for his work in autism; has taught for 30 years; has a clinical practice with children with developmental problems.  He diagnoses about 50-200 news cases of autism per year.  The age range of his autism patients is 1 ½ to 50 or 60 because “they never go away, which is great.”

Q:  Do you work with parents?
A:  Yes; all the time.  They are in charge; they make the decisions.  They know the child and they bear the burden.  The stress on the family is gigantic.  There are high divorce rates; it’s an inherent part of the practice to work with families.

Q:  Do you have a research practice?
A:  Yes.  I’m part of an NIH designated “Center of Excellence” for autism – it’s one of 5 or 6 centers.  I run the clinical care for the patients in the Center.  We do MRIs, pharmacokinetic studies, genotype work, pre-clinical work with animals.

Q:  Are you one of the authors of the ADOS?
A:  Yes. 

Q:  Have you published articles?
A:  Yes.  120 peer-reviewed articles, some on autism; 20 book chapters with some on autism. 

Q:  Are you an advisor to any autism groups?
A:  Yes.  I’m on the professional advisory board for the Autism Society of America; I’m also on boards for a number of professional journals.

Q:  Have you testified before?
A: Yes, 15-20 times.  In child abuse and neglect cases; divorce cases and other “odds and ends,” but never before in vaccine court.

Q:  Have you consulted with pharmaceutical companies?
A:  Yes.  I helped Johnson & Johnson bring Risperadone to market so that it’s now on label for autism.

Q:  Why did you agree to testify here for the government?
A:  A number of my colleagues asked me to, and I’m concerned about the families.  “We work too hard to let families go down wrong paths.”

Q:  Did you listen to the testimony of the parents and Dr. Mumper?
A:  Yes.

Q:  Do you think Colin’s thimerosal-containing vaccines contributed to his autism?
A:  No.

Q:  Do you agree with the autism diagnosis?
A:  Yes, but it’s likely not definitive.

Q:  Has proper testing been done in this case?
A:  No.  The “gold standard” is the ADI/ADOS, and proper cognitive function tests have not been done.  Colin’s course is like most of those I see.  We started to see “regressive autism” in the late 1990’s, when Andy Wakefield was trying to make his case, but the term never really entered the scientific community.  We tried hard to find it, but we can’t support it.

Q:  Do you use the term “regressive autism”?
A:  No.

Q:  Would you say that Colin suffered a regression?
A:  He has a progressive illness.

Q:  How would you describe it?
A:  He had a normal birth and was progressing.  There were hints, though, that things were not right.  His growth curve starts to slip at 6 months.  He started to lose weight by 6 months.  We see finicky eating at 4 months in kids with autism; this was part of the “progress of his illness.”  Colin has yet to receive appropriate cognitive assessment.  To work on intervention, you need to break down cognitive abilities.  You need to know what someone’s cognitive level is.  Otherwise, you may set unreasonable demands.  You have to get a whole clinical picture.  Colin’s autism is “likely co-morbid with moderate mental retardation.”  Because appropriate testing hasn’t been done, I can’t say for sure.  Mental retardation is co-morbid with autism 70-80% of the time. 

Q:  Were any cognitive tests done?
A:  Two tests were done – the Bailey and the Stanford-Bennett tests.  These tests and the Vineland tests repeatedly and consistently show mild to moderate mental retardation levels.  Those indicators are consistent.

Q:  His mother testified that Colin is very responsive to PECS; does that show brightness?
A:  PECS is not an indicator of intelligence; it’s used for kids with autism and mental retardation.  Appropriate genetic testing was not done.  The basic view is that autism is genetic.  We’d want to know if this is Fragile X or tuberous sclerosis, or if he had gene 15Q, a marker. 

Q:  The fact that no tests were recommended – does that mean they weren’t necessary?
A:  No.  My test is, would I do it for my kid?  I would.  It’s not that expensive.

Q:  Dr. Mumper relied on lab tests to support her hypothesis.  A constellation of tests.  If this were your patient, would you do these tests?
A:  I would not have ordered most of them.  The so-called abnormal results are at the margin.  Clinical practice has to be correlated with the patient.  “I didn’t find any of these tests particularly relevant.”  I use the term “children with autism” rather than “autistic children.”  They are people first.  I wouldn’t have ordered most of the tests here.

Q:  What would you do if you thought a child had neuroinflammation?
A:  I’d consult a neurologist.  I’d do a lumbar puncture and look at the CSF.  I’d do a brain scan with an MRI.  You could see gliosis or inflammation.

Q:  In your report, you said that the dismorphology exam wasn’t sufficient.
A:  We have to look carefully for abnormalities.  Even in the quick look at the pictures that Mrs. Dwyer identified at the beginning, I thought Colin’s ears look low; his eyes might be wide set; he could have certain pigmentations that reflect neuropathology.  You have to look.

Q:  You’re not making a diagnosis, are you?
A:  Not at all, but I am concerned that it wasn’t done.

Q:  Is there any clinical evidence that autism is caused by thimerosal-containing vaccines?
A:  I don’t see any.

Q:  Is this thesis generally accepted in the autism community?
A:  No, it is not.

Cross Examination of Dr. Leventhal [Mr. Powers]

Q:  What have you relied on for this testimony?  Did you read the testimony in the King and Mead cases?
A:  No.

Q:  Did you read the expert reports in the King and Mead cases?
A:  No.  I relied entirely on the medical records for Colin Dwyer, Dr. Mumper’s report and the testimony of the Dwyers and Dr. Mumper.

Q:  Anything else?
A:  No.

Q:  How long have you practiced as a psychiatrist?
A:  30 years.

[colloquy about history of psychiatry seeing autism as caused by “refrigerator mothers”]

Q:  Do you believe that autism is entirely genetic?
A:  No.

Q:  Is there room for an environmental contribution?
A:  Yes.  We know that ABA, speech and language instruction make a difference.

Q:  As a scientist, do you recognize a causal relationship between thalidomide and autism?
A:  It hasn’t been demonstrated.

Q:  Terbutalene?
A:  I’m not aware that it’s causal.

Q:  Maternal rubella exposure?
A:  There are data on association.

Q:  Are they suggestive of a causal link?
A:  Not until it’s demonstrated.

Q:  Do you think there are causal links between prenatal exposures and autism?
A:  I have no knowledge of a causal link between prenatal rubella and autism.

Q:  You’ve diagnosed thousands of children with autism.  What percentage have known genetic causes?
A:  10%.

Q:  You mentioned the cases you’ve testified in; have you appeared in civil suits about autism?
A:  I testified in a Rett’s case on behalf of the parents in a case with the School Board.

Q:  Have you been a witness in pharmaceutical cases?
A:  No.

Q:  Have you consulted to pharmaceutical companies?
A:  Not much. 

Q:  Are you in pharmaceutical company speakers’ bureaus?
A:  Not that I’m aware of. 

Q:  [shows him an article where in the disclosure section, it says Dr. Leventhal gets money from Lily, Glaxo, Pfizer and several other drug companies]

Q:  Is this information you provided to the journal in 2004 correct?
A:  Yes.

Q:  Which are you working for now?
A:  Grants go to the university, not to me.  I gave talks for Lily and Bristol Myers.

Q:  On regression.  You said you don’t believe there’s a regressive phenotype.
A:  Right.  We’ve looked, but the data don’t support it.

Q:  The articles in evidence – Pardo, Vargas, Zimmerman; do you know them?
A:  No. 

Q:  Do you believe that some kids develop normally and then regress?
A:  Yes.  There’s childhood disintegrative disorder.

Q:  Would you concede that even when you’re looking vigorously, there are cases of normal development followed by regression into autism?
A:  That picture is exceedingly rare.  It reflects our inability to measure and diagnose earlier.

Q:  Do you know Dr. Rust who testified for the government previously?
A:  No.  I know nothing about those cases or Dr. Rust.

Q:  Dr. Rust identified that about 20% of the kids in his practice have no early problems.  Would you dispute that 20%?
A:  We used to think that 30% were regressive; we now know that 90% of children have problems earlier.  Where we don’t have early evidence, it’s our failure.

Q:  What do you see in this record to evidence abnormality in early development?
A:  Weight fall off over time; the pediatrician’s notation that Colin has “some words;” I read that as doubt.  The mom listed 7-9 words at 20 months; that is way behind.  Before 12 months, he was falling off the growth curve. 

Q:  Couldn’t weight loss be related to lots of things unrelated to autism?
A:  That’s right.

Q:  Isn’t it true that there’s nothing in the record before 12 months to demonstrate abnormal development?  He was interactive, playing with toys.  The only thing not typical is the growth rate from 6 months to 12 months.  Was there anything in the parents’ testimony to raise issues before 12 months?
A:  Not in the testimony.

Q:  You heard them testify that Colin was playing with his sibling; had a normal Christmas at 13 months.  He was a healthy baby boy; nothing suggests otherwise, does it?
A:  Yes, but that doesn’t mean it was all OK.

Q:  Can you direct us to something in the record that’s not normal before 20 months?
A:  These are terrific parents, but they’re not experts.  ADIR/ADOS helps parents find out what happened.  They might not have been asked the right questions.

Q:  There’s nothing you see in the record that you can point to of abnormality?
A:  There was a failure to find that information – the tests weren’t done.  I can’t agree with you.

Q:  You talk about the signs being subtle.  But isn’t it true that there’s the lack of an affirmative record of abnormal development?
A:  Yes.

Q:  On mental retardation, you agree there’s no diagnosis.  There’s nothing any autism specialist said to indicate mental retardation.
A:  His learning was very variable.  It was uneven.

Q:  And you acknowledge the limitations of the Bailey, Stanford-Bennett tests; they depend on a child’s verbal functioning and compliance?
A:  Yes, they depend on verbal functioning, and that’s why it’s essential to test cognitive skills.

Q:  You said you might do a lumbar puncture for a child with autism?
A:  I said I’d do 3 things:  (1) consult a neurologist; (2) a lumbar puncture; and (3) an MRI.

Q:  Isn’t it true that a lumbar puncture is pretty invasive?
A:  No more so than the IV chelation or glutathione Colin received.

Q:  How many times have you done a lumbar puncture?
A:  I’ve never seen a child with an allegation of neuroinflammation.

Q:  [questions about genetic forms of autism – Fragile X, tuberous sclerosis – and that there were no indications that these are present.]

Q:  Do you think there are genetic preconditions that can be triggered by the environment?
A:  Possibly.

Q:  Have you come across ideas of glutamate in the brain in autism?
A:  Yes.  Glutamate is the most pervasive neurotransmitter.  It’s a matter of interest. 

Q:  In this paper where you are an author, do you say “aberrant glutamate function is often cited as a risk for ASD”?
A:  Yes, but it may be a glutamate receptor, not the glutamate itself.

Q:  Do you agree that at the least, glutamate is of continuing interest?
A:  Sure.

Redirect Examination of Dr. Leventhal

Q:  What did you review and rely on?  In addition to records and testimony, did you rely on your 30 years of experience?
A:  Yes.

Q:  Do you think thimerosal-containing vaccines are an environmental contributor to autism?
A:  We see no evidence to support that.

Q:  You’ve not said that lumbar punctures should be done for most autism patients?
A:  Correct.

Special Master Vowell

Q:  Let me restate your position and please correct me if I am wrong.  You do not have confidence in this record that this child developed normally and then regressed.
A:  Right.  This record is inadequate.  Pediatricians at that time were not adequately trained.  In 2000-01, autism was on the rise; I was involved in training efforts in Illinois.

Q:  [Mr. Powers] You just said prevalence went up in 2000-01.  What about incidence? 
A:  Prevalence has risen.  I haven’t seen whether incidence is rising.  I’m working on it.  There aren’t strong indicators of an increase in incidence.  We have to nail this down.  It will take us 5-6 years and it will be big and expensive.   

Closing Remarks
July 22, 2008

Petitioners
General Causation:  Mr. Williams [using a PowerPoint presentation]

The thimerosal-autism theory is a biologically plausible mechanism.  Neuroinflammation can lead to regressive autism.  Mercury can cause neuroinflammation; this is known from the adult monkey studies.  Thimerosal-containing vaccines deliver mercury to infant brains; we know this from the Burbacher infant monkey studies.  While there is a wide variability in blood and brain levels of mercury after exposure, some infants at the far end of the bell curve will get very high exposures. 

Respondents’ mercury experts Magos and Clarkson are not testifying this week, but this is what they would have confirmed.  [Mr. Matanoski:  Objection; not appropriate to speculate.  Special Master Vowell:  Inference permitted; this information is in evidence.]  Mercury is toxic to brain cells.  Dr. Clarkson is a co-author with Dr. Burbacher of the infant monkey study.  The human brain to blood ratio is 6.0; the macaque brain to blood ratio is only 2.6.  The infant macaques had the blood levels comparable to human infants in the Pichichero and Stajich studies.  It is therefore reasonable to conclude that brain levels of mercury in some human infants are in the same range that ignited neuroinflammation in adult macaques.

Thimerosal-containing vaccines (TCVs) belong on the list of potential environmental triggers of autism spectrum disorders, and especially of regressive autism.  There are several well-recognized environmental agents that can trigger autism:  thalidomide; valproic acid; terbutaline; viruses; and mercury belong on this list.  TCVs deliver mercury to the brain.

Existing epidemiological studies on autism are uninformative.  None of them have isolated regressive autism.  None has ruled out an association between TCVs and regressive autism.  Respondent’s epidemiologist Dr. Goodman agrees with Petitioners’ epidemiologist Dr. Greenland on these points.

Respondent’s expert epidemiologist Dr. Fombonne’s testimony should be ignored.  He contradicted himself, and he can’t have it both ways.  On the one hand, he says that the studies that purport to show an increasing rate of autism are unreliable because they grossly underestimate the true rate of autism over the past years.  On the other hand, he says that epidemiological studies that purport to show an increasing rate of autism after the discontinuation of TCVs are unreliable.  We showed these contradictions on cross examination.

Respondent has not refuted the Young study using the Vaccine Safety Datalink showing that epidemiology favors causation.  Special Master Vowell, you may distrust the Geiers, who are co-authors on the paper, but Dr. Young did the work; the Geiers just provided access.  This study can be duplicated.  If Dr. Young’s analysis is wrong, we would have heard that.  Only Dr. Fombonne critiqued this study, and he did not understand it.  He claimed the study was linear when it was non-linear.  HHS can rerun the data and critique it; it didn’t do that.

The standard of proof in this vaccine program does not require Petitioners to have epidemiology to support causation.  If the Special Masters decide that the Petitioners need epidemiology, then the Special Masters must presume the Vaccine Safety Datalink studies that the NIEHS recommended would have been found in Petitioners’ favor, or the Special Masters should issue an order to Respondent permitting Petitioners to do these studies. 

Alternatively, if Petitioners must have epidemiology evidence, then the Special Masters may wait for results from Respondent’s two pending TCV-autism studies:  a CDC case control study and the CDC Italian DTaP randomized trial study specifically on autism and TCVs.  CDC Director Dr. Julie Gerberding said in a 2008 report to Congress that both studies would be finished by September 2008.  It is undesirable for the Special Masters to decide causation without the benefit of these two expensive studies.

If the Petitioners must have primate brain studies to show that TCVs ignite neuroinflammation, then the Special Masters should delay their decision until Burbacher and Clarkson finish their infant monkey study which was funded by Respondent or the Special Masters should presume that the study will show neuroinflammation.

In summary, the link between TCVs and regressive autism is plausible and coherent.  TCVs deliver mercury to the brain.  There is wide individual variability in blood and brain levels of mercury.  Mercury persists in the brain for years.  Mercury at doses only five times higher in adult primates ignited the kind of neuroinflammation found in autopsies of brains from autistic individuals.  Neuroinflammation has been found in almost all brains of people with autism.  Persistent neuroinflammation can explain the symptoms of autism.

Thank you for your attention.  This is the most important case that any of us has probably ever worked on; millions of kids were getting thimerosal.  Your decision will be very important in this country and elsewhere. 

Specific Causation:  Mr. Powers

First, I want to thank the Special Masters, Respondent and all the families; it’s been a privilege to be here.  I will talk about individual causation.  If this were a civil case, we’d be entitled to a directed verdict.  Dr. Leventhal gave wildly unsupported testimony about Colin Dwyer.  He says Colin’s autism is related to a mix of genetic factors, even though no tests show that.  Even though genetic factors are associated with autism in only 10-12% of cases, he thinks doing genetic tests would have shown the cause.  There is no evidence in the record to show any signs of genetic abnormality.  Dr. Leventhal says the signs are subtle; well, sometimes they are so subtle they are not there.  He has engaged in wild speculation, contradicted by the parents’ testimony.  There is NOTHING related to autism in this early record.  There can be some debate about the 15 month chart record note “talks some,” but before 20 months, this is the ONLY evidence; everything else is speculation, explicitly contradicted by the record and testimony.

Dr. Leventhal also testified that there is no regressive phenotype of regressive autism.  Dr. Rust said that at least 20% of his autistic patients had “perfectly normal progress” before regression.  Dr. Leventhal’s testimony is a classic example of Tyco Brahe’s telescope, just like Dr. Rust’s testimony.  He has interpreted the data with such a strong bias that the data always give the answers you want.  Dr. Leventhal’s testimony is like Dr. Rust’s, arguing that autism is like Rett’s disease, and Rett’s disease is genetic, so therefore autism is genetic. 

The evidence shows that there are environmental causes of autism, but Dr. Leventhal stubbornly refuses to entertain that environmental exposures can result in regressive autism.  He is yet another example of Respondent’s rigid idea that all autism is genetic.  The field has been looking for genetic abnormalities for ten years.  It’s supported by the literature that there’s something else out there, and Respondent should be open to this.  Dr. Leventhal’s testimony should be given very, very little weight. 

You should decide that Colin deserves compensation.  There are three different models that you could adopt for Colin Dwyer’s autism.  First, you could decide that nothing caused it, but science won’t accept this.  Second, you could decide that TCVs contribute to regressive autism spectrum disorders.  Third, you could follow Dr. Leventhal’s testimony and decide that Colin’s autism was caused by something, but we don’t know what that something is – but that something could only be genetic.  At present, only 10-12% of autism cases have genetically identifiable causes; so 88-90% of the time, his argument would be untrue.  The evidence supports the general causation theory that TCVs cause autism; the specific history in this case supports an award of compensation.

Respondent’s Closing Remarks:  Mr. Matanoski   

Thank you to Mrs. Dwyer. 

I want to address the issue of specific causation.  Mr. Powers’ remarks made me think for a split second that Respondent has the burden of proof.  But in fact it’s the Petitioners who must show that TCVs cause autism.  We don’t have to show that the cause is genetic.  Dr. Leventhal was saying that most people believe autism is largely genetic.  That’s been a fruitful perspective; everything “points to genetics as strongly associated with autism.”  Everything shows that there’s a prenatal course.

I think there’s some misconception about Dr. Leventhal’s testimony.  He said that Colin Dwyer’s case is like many of the cases he sees; it’s a gradually emerging picture.  When you go back in time, you see earlier signs.  Dr. Lord made this point clear – the concept has become more encompassing. They start seeing differences earlier on.

Dr. Mumper’s testimony was not the subject of Mr. Power’s closing.  She seems to be relying on isolated lab results to show that TCVs cause autism.  There doesn’t seem to be a particular pattern.  In the King case, she looks at some results; in the Mead case, other results; and in Colin’s case, we see something different.  There is no pattern.  How can one say there is anything to rely on?  We believe she moved away from each specific test as being definitive.  The only tests that show mercury are the post-provocation tests, but she says she doesn’t know what the normal range of post-provocation excretion of mercury is.  Dr. Mumper holds a DAN! view that toxins and heavy metals lead to autism; she is looking through the Tyco Brahe telescope.

The scenario that we see with Colin is played out too often – here and around the globe.  It’s a gradually emerging picture of a kind of slipping into autism, emerging with trouble speaking.  This doesn’t seem to be implicated by vaccinations.  Whether thimerosal is in the vaccines or not does not seem to have an impact.  It doesn’t change the clinical presentation; thimerosal is not having an impact at all.

Now, on general causation.  The Petitioners’ glutathione theory seems to have dropped out.  The theory is now thimerosal and neuroinflammation alone.  Dr. Kinsbourne’s theory of neuroinflammation was presented only a few weeks before the first hearings in May, six years after the start of this proceeding.  This theory came up at the end.  The Petitioners say that they meet the burden of proof tests set by Althen and Grant of the Federal Circuit.  But before you reach the burden of proof, you must make sure that your evidence meets the standard of Daubert; you must be sure that your evidence meets the standards of good science.  If you don’t have good scientific evidence, you don’t have anything to test.

Petitioners’ evidence fails to meet the standard of reliable science.  Daubert says there’s one kind of science used by scientists and judges – this Court must reject testimony that doesn’t meet scientific evidence.  Their testimony does not meet the Daubert standard.  They’ve had six years; they have a large group of attorneys; they have the resources of hundreds of other attorneys; they’ve had discovery.  This Court has given the Petitioners ample opportunity to develop a case.  This last-minute theory of neuroinflammation is speculation. 

Mr. Williams talked about the Burbacher and Clarkson studies.  I want to distill them to a kernel.  The adult monkey studies show that when given huge dose amounts, inorganic mercury was left in the monkey brains, causing glial inflammation but causing no symptoms.  The Burbacher study showed that ethylmercury leaves the brain more quickly, and causes glial activation similar to the adult monkey study.  What should we expect?  They also rely on the Pardo and Lopez-Hurtado studies.  These are non-specific findings; they are not specific to regressive autism.  Dr. Pardo sent a letter that he was ready to testify. 

Mr. Williams talked about epidemiology and said that the studies to date should be dismissed.  They say that the neuroinflammation mechanism is not limited to regressive autism, but they say there should be epidemiology just for regressive autism.

Mr. Williams mentioned Petitioners’ letter from Dr. Young about her study with Geier and Geier.  That study was sponsored by the Petitioners’ Steering Committee, done for litigation purposes.  There is criticism of this study out there.  Dr. Greenland, their expert, criticized it.  It is not true that the government has conceded this simply because it hasn’t criticized it.

Good scientific evidence is not a hypothesis strung together by a couple of studies; it’s not litigation driven.  Good science should come from people in the field who make their professional lives in the field.  Daubert is about scientific methods and processes.  After six years and countless opportunities, it’s the same thing; Petitioners seem to think that it’s different here from outside.

The main proponent of Petitioners’ theory, Dr. Kinsbourne, just a few months before this hearing, told you that he couldn’t conclude that TCVs cause autism.  And that witness doesn’t treat children at all.  Petitioners have failed to meet their burden.  They can’t meet their burden under Althen and Grant.

Rebuttal:  Mr. Williams

Respondent makes the allegation that this theory is a recent invention.  If we had had this hearing in 2004, we would not have had the Burbacher infant monkey study and new information on neuroinflammation.  We’ve resisted an effort to rush.  We don’t think there’s a need to decide this case in a hurry.  But we think we’ve proven our case.  There is a regressive phenotype; the Charge study from California proves this.  They find that in 15% of children with autism, there is true regression.  Neuroinflammation may explain all cases of autism, and it explains this one.  Colin Dwyer had early insults. 

Dr. Aposhian cited all these articles on neuroinflammation last August.  We wanted Dr. Pardo to come testify.  This Court could call witnesses at its own discretion; it could call Dr. Pardo.

Special Master Vowell

This concludes the case of Colin Dwyer.  Thank you to Mrs. Dwyer.  It is hard to listen to the proceedings about your own child.  It takes courage. 

First we will issue decisions on the first theory of the Omnibus Proceeding; then we will issue decisions on this second theory related to thimerosal. 

Any procedural issues from the Parties?

Petitioners

We anticipate that before completing the briefing schedule, we will submit a couple of motions on evidence.  We want to submit a brief to draw the inferences Petitioners are entitled to about Respondents’ withdrawal of witnesses.  We also anticipate making a motion on additional evidence about toxicology because we expected to submit evidence in rebuttal.  We also want to be able to submit new and relevant evidence, such as the second phase of Dr. Burbacher’s work, or new population studies; we want leave to introduce new, relevant evidence.

Respondent

We will need to decide on new evidence on a case-by-case basis.

Closing Remarks
May 30, 2008 (not previously posted)
Petitioners

[Mr. Powers]  I really have no intention to summarize the evidence or argue the evidence because that happens later on motions and pleadings.  But we do want to take the opportunity to comment on the proceedings over the last three weeks and about the Omnibus Autism Proceeding in general.

One idea I want to address is the notion that Petitioners somehow want to spring surprises on the Court or on Respondent’s counsel.  I want to make it clear, especially to the Special Masters, that that this is absolutely not Petitioners’ intent.  We are responding to a dynamic scientific environment, and we’re doing our best to stay on top of it.  We’re monitoring the literature and when we find something new, we want to bring it to your attention to inform your decisions in these important cases.  We’re working hard to do that.  If we found something helpful, we would want to talk about it early and talk about it often.  There’s no intent here to slip something in or hide the ball.  We want our best and our strongest case in front of you and in front of the Respondent as early and often as we can.  But as I said, we are in a dynamic scientific environment.  During this proceeding, there have been international conferences, new peer reviewed articles, new abstracts, some papers only became available in our language during this proceeding. 

It’s also important to understand, I believe, that there’s an interesting dynamic at work in the vaccine program that one does not encounter in traditional civil litigation.  I believe it’s intentional, and Congress set it up this way.  It’s important to remember that the Respondent here is the United States Department of Health and Human Services and its related agencies.  They have a public obligation and public mission and public duty to stay abreast of the science, to follow the science,  and, in a sense, to not be surprised by the science.  It’s important that in these proceedings, the litigation goal of prevailing not be confused with the client’s overarching public policy goal of staying abreast of the science,  interpreting the science, and getting the word about the science out to folks, whether it’s to the attorneys here in the proceedings, to the families of the children here, to the Special Masters or to the scientific community at large.   

One of the reasons that discovery is not available as a matter of right in this program is to help address the tension that you see in civil litigation about the interests of the parties.  In civil litigation, each party in the adversarial system has only its self-interest in mind.  That is, the only interest they have is to prevail in that litigation and to win in that litigation.  But here, the Respondent, the U.S. Department of Health and Human Services, has that larger obligation, to be doing the scientific research, to fund research, to make data and research available to the public.  So by taking away the contentious, adversarial rules of discovery, it seems that it helps alleviate that tension and doesn’t create a conflict between the litigation defense goals and the public policy goals of not being surprised by the science. 

We’ve heard testimony that a lot of the work that the Petitioners have introduced in this case has been funded by the NIH, the CDC and other entities involved with Respondent HHS.  To the extent that Respondent is involved in the science, whether it’s doing the science itself, funding the science or monitoring the science,  they ought not to be claiming complete surprise when new science does come out.  Again, we cannot confuse the litigation goal with the public policy goal and the institutional goal that HHS has.  And I believe that is one of the reasons that Congress wanted this to be a non-adversarial system and to not have those rules of discovery in civil litigation then really turn it into a fight, sometimes, about every scrap of paper you’re trying to pull from the other side.  So the program should be less adversarial in that way.

It’s also important to remember that the program is designed to be less adversarial in order to provide an environment for families who believe that they have legitimate claims to appear and present their case.  And that also includes having experts who are willing to come in and testify for them.  The experts in this process are obviously critically important because all of the issues that you all have to decide are issues of fact that require technical explanation, interpretation and presentation.  And I just think it’s a
shame that in these Omnibus Autism Proceedings we have seen from the Respondent a regrettable inclination to launch attacks, often unsubstantiated smear attacks, on some of the witnesses involved in these cases.  We saw it with Dr. Kinsbourne in this proceeding.

Again, if the Federal Civil Rules of Procedure were at play, none of the issues that Respondent’s counsel tried to use to impeach the credibility of Dr. Kinsbourne would have been allowed in.  This is a 31-year old employment dispute that was resolved in his favor.  But they brought it in, and I argue, and Petitioners believe, that the lack of the Federal Rules of Civil Procedure applying here explicitly was done by Congress to make it less adversarial and to remove some of those adversarial qualities that one sees in the civil litigation system.  And in that system, you commonly do see these kinds of attacks constrained by the Rules, but here the absence of the Rules shouldn’t allow people to engage in conduct that would be barred by the Rules in a civil proceeding.  It’s regrettable. 

Dr. Kinsbourne obviously was perfectly capable of defending himself, and he did, and he made that record.  But it’s just regrettable that at every one of these hearings, whether it’s Dr. Bradstreet being accused of being an exorcist, to Dr. Kinsbourne being attacked for the issues that he was attacked for here, it is regrettable, and we ought to be able to avoid that in this Congressionally mandated non-adversarial process.

One of the last things I wanted to conclude on is addressing a thematic argument that I have heard, and the Petitioners have heard, from all of Respondent’s experts, that somehow all of Petitioners’ witnesses are so fixed on a conclusion that they’ve leapt to, that they’re willing to ignore contrary evidence, that they’re staring through Tycho Brahe’s telescope, insisting that the earth is the center of the universe.  I think the testimony that you have heard shows that that absolutely is not the case. 

I want to use the example of Dr. Mumper.  Dr. Mumper is a clinician; not a bench scientist, not someone who does original research, but a clinician who has responded to the needs of a significant patient population who weren’t being addressed by other doctors, including Dr. Rust.  Even if Respondent’s experts disagree with her conclusions, what you heard from Dr. Mumper is a doctor who is doing her absolute best to follow good science, to stay on top of the science.  Here is a pediatrician in Lynchburg, Virginia, spending her resources to prepare bibliographies of science and to disseminate that information to other physicians, to validate that work as scientifically as she can, to bring in the resources to increase the scientific rigor and integrity of the work she is doing. 

She is doing that while, on the other hand, Dr. Rust is so fixed in his “telescope,” in the Tycho Brahe telescope, or the idée fixe, that he testified for at least an hour on Rett’s syndrome.  And it seemed to be his argument that Rett’s, because it’s congenital and genetic, is a model for autism, because if Rett’s is genetic, and autism shares some of the symptoms of Rett’s, then autism itself must be genetic.  That is a faulty syllogism.  It’s another example of the classic false syllogism that all men are mortal, Aristotle is a man, therefore, all men are Aristotle.  It’s a flawed logic.  It just represents how fixed he is on the idea that this is an inevitable, at conception, predetermined outcome.  He is not willing to entertain the idea that environmental factors might be at play, that care and treatment might alleviate the symptoms, that an investigation into etiologies that are not presumed to be genetic are worthwhile.  His mind is closed to that.   

And those are just two very contrasting and telling examples describing expert advocacy in these cases.  That is an example of the Respondent’s experts who are so focused on what they think the outcome is that they are willing to spend 114 pages and a Powerpoint really just arguing a false syllogism that all autism is like Rett’s, so all autism is congenital.  That is not supported by the science. 

So these are just some observations about this proceeding as we move forward.  Again, this ought to be a science-based inquiry; this ought to be a non-adversarial setting; this ought to be the type of setting where families and their experts can come and air their meritorious claims.  And whether one disagrees with the conclusions that any particular witness reaches, the idea that at every single one of these test cases, there is going to be some one of Petitioners’ experts who is going to be targeted as they have been in these earlier proceedings is something that we should avoid. 

We should focus on the science, understand that the science is changing, understand that there will be a convergence in the science over time and that when we do close the evidence in these cases, there probably will be more information out there.  The science will need to speak for itself at some point, and when we converge on some of these key issues, the Petitioners will do everything that we can to bring that information to the Special Masters, to share it with the Respondent, but ultimately with the idea that litigation strategy in this program is really not what should be driving the consideration of the science.  Considering the unique position of Respondent as a party here, [it should be] responsible to fulfill the mission to keep up to date with the science, to protect public health, consider the science and apply it in a way to provide the best information to the three of you ultimately deciding the general issues and the specific issues in all of these cases.

Respondent

[Mr. Matanoski]  In putting together my closing remarks, even though our time is brief, it would be an error on my part not to acknowledge the families that were involved here, the King and the Mead families.  Probably the most poignant moments in this proceeding were hearing their testimony, that of Mylinda King and George Mead, discussing William and Jordan.  We thank them for their participation.  Our hearts go out to them and to all the families who have autistic children.  We may be litigating one side of this issue, but we certainly have tremendous respect and admiration for all of them.   

The threshold matter before you is a scientific matter, however.  And a scientific question necessarily turns on scientific evidence.  And there are certain legal standards that must be applied in this courtroom, and every courtroom, as to how you handle the scientific evidence.  What can even be considered reliable scientific evidence.  The Supreme Court has spoken and said that it is evidence that must be tested; it must be published and subject to peer review; and it must have general acceptance in the scientific community.  You have not heard that scientific evidence yet from Petitioners; you’ve heard speculation, pure and simple.  What you’ve heard from Mr. Powers suggests that that evidence, as far as the Petitioners are concerned, is still not available.  He talks about the dynamics of science, ongoing studies, which in some ways may imply a lack of scientific evidence that is available to the PSC [Petitioners’ Steering Committee] at this point to prevail. 

Now  the PSC’s case started with a curious approach.  Rather than putting on evidence in support of their claim, they put on testimony designed to undermine evidence against their claim.  That was the testimony of Dr. Greenland.  His testimony and whole postulate
depended on a supposition that Petitioners would prove to you that their mechanism applied to clearly regressive cases only.  You’ve heard Dr. Deth’s hypothesis, and he says it does not apply only to clearly regressive cases. You heard this morning from Dr. Kinsbourne, who said he hasn’t even looked at whether his mechanism would apply to cases other than regressive autism. 

All of the abundant epidemiological evidence that has addressed the precise issue that you have in front of you, whether TCVs can cause autism or are associated with autism, are back on the table.  They never were off.  Dr. Greenland’s supposition is in error. 

If you follow the mechanisms proposed here by the PSC to their logical conclusion, they fail to show that thimerosal is the cause.  They propose that inorganic mercury is the causative agent.  Inorganic mercury is not specific to childhood vaccines.  It’s in what we eat, it’s in the air we breathe, it may be in the fillings in our mouth.  They fail to specify how much inorganic mercury is necessary to cause autism.  Their experts consistently refuse to say.  In fact, when forced, they say, any amount.  They’ve pushed the threshold down, so that any exposure to mercury could be a potential cause of autism.

They have described a causal mechanism that is so general it applies to virtually every disease and to every case of autism.  Oxidative stress is present in every disease.  Even after jogging or banging a hand with a nail.  Neuroinflammation is seen in other neurological diseases, including Alzheimer’s and Parkinson’s diseases.  In the Vargas study, every single patient in that study had neuroinflammation – regressive, non-regressive, young and old alike.  These are non-specific causal mechanisms that are proposed to you.  In the end, you could just as easily conclude that a tuna sandwich or a dental filling could cause autism as a vaccine.  And to flip it around, you could just as easily consider that an 80-year old man who receives the flu vaccine could get Alzheimer’s from it. 

Mr. Powers described what he considered “smear campaigns” or heavy handed treatment of Petitioners’ experts.  We take the witnesses as they come.  Perhaps there was an explanation, and you’ve heard it, for the events that transpired with Dr. Kinsbourne’s departure from the University of Toronto. 

Again, you take the witnesses as they come.  When Dr. Deth took the witness stand and said that he’s willing to come before you, and say that you should accept his hypothesis and make a decision of this import based on it, even though he is not willing to go to the scientific community and say that it’s acceptable without further testing, I think that bears consideration. 

When Dr. Kinsbourne came before you, he put his credibility on the line.  He’s saying rely on me, believe me, trust me, as an impartial scientist.  That’s how he’s coming to you.  You deserve to know whether he gets that kind of trust.  He’s known to you.  He’s appeared here many times.  If you look at the records, Dr. Kinsbourne has testified in over thirty cases that vaccines have done harm.  In the last year, he’s authored only one article in a medical journal.  I think that tells you whether he’s coming to you as a witness who spends his time in the courtroom or as an impartial scientific expert witness who is adding some value to what your deliberations are from the point of view of reliable science.

Good science and reliable science come from testing, publication, critical review, validation and verification of results.  It’s performed by those working in the field using scientific methods for research.  The Supreme Court tells us it can’t be an untested hypothesis, as Dr. Deth has essentially described his causal mechanism.  Good science won’t be first revealed in the courtroom, as Dr. Kinsbourne’s hypothesis is.  It’s going to see the light of day through critical discussion of the research among scientists themselves.  It’s not any kind of science to sit at your computer and run “find and replace” on a report you used for the last litigation, replacing “measles vaccine” with “thimerosal-containing vaccines.”  A litigation contrivance like that has no place in this courtroom; the Supreme Court has mandated that.

When the trial began, Mr. Powers described TCVs as a relic of history.  Perhaps that was a reference to provide some leeway in what your evidentiary standards would be to drive some grading on the curve of the science you would accept.  In fact, they have done everything they could to make this anything but a relic of history.  That day they held a press conference to discuss the case.  Their experts are here telling you that trace amounts in vaccines, the flu vaccine, could be enough to cause autism.   

Whether we like it or not, this issue has great importance and attention drawn to it.  It’s on the cover of Time magazine last week.  Many eyes are going to be turned to this court to see how you handle the scientific evidence before you.  What you make of that evidence.  And it’s not just for parents who are before you with their claims, it’s for parents of autistic children who haven’t brought claims and who are wondering if, by getting them vaccinated, they are somehow responsible for that condition.  It’s from scientists who work in these relevant fields, it’s from those who treat autism, and it’s going to be viewed by parents of children who’re wondering if they should vaccinate their children or not. 

I’m going to be blunt at this very late hour.  Are you going to decide that question on the say-so of Dr. Deth and Dr. Kinsbourne?  Or are you going to decide that question on the evidence given to you by witnesses like Dr. Catherine Lord, Dr. Eric Fombonne and Professor Sir Michael Rutter.  Are you going to look at and consider the fact that every reputable, independent medical organization that has considered this issue – the IOM, the AAP, the European Medicine Association, the WHO – have all come to the conclusion that thimerosal containing vaccines do not cause autism?  Or are you going to also consider that every court that has considered the issue before it has concluded that the claim is so lacking in scientific merit that it even should not be presented to a jury? 

Reliable scientific evidence is all on one side of the ledger: vaccines don’t cause autism. 

Special Masters

At this time, we have reached the conclusion of this portion of the evidentiary hearing in the Omnibus Autism Proceeding. 

We thank members of the King and Mead families who came to Washington and were with us for part of this.  We thank the counsel for both sides who have presented the evidence so well during the hearing. We appreciate their hard work.  We thank the expert witnesses.  We thank the U.S. Court of Claims for the Federal Circuit for use of the court room.  We thank court personnel. 

We want to acknowledge certain other people: families of all other 5,000 vaccine claimants who have been diagnosed with autism.  To all such family members, all we three Special Masters pledge to you again that we will consider very carefully the evidence put forth at this hearing and give that evidence our careful consideration.  We realize the great importance of the task assigned to us and we will give our greatest effort in carrying out this heavy responsibility. 

Finally, now that this hearing is finished, what will happen next?  First in July we will hear from two more expert witnesses for Respondent.  At the same time, we will hear any rebuttal to those two witnesses.  We will hear case-specific testimony in a third, yet to be identified test case.  After the July hearings, parties will file written briefs summarizing the testimony.  That process will likely take several months.  I will issue the ruling in the William Mead case, Special Master Hastings will issue the ruling in the Jordan King case, and Special Master Vowell will issue the ruling in the third case.

Finally, for updates, please do check the Omnibus Proceeding page on the court website. 

* * *
Mary Holland teaches at New York University Law School and may be contacted HERE  Thank you to A-CHAMP for providing this important service. A-CHAMP, Advocates for Children’s Health Affected by Mercury Poisoning, is a national, non-partisan political action organization formed by parents in support of children with neurodevelopmental and communication disorders.

Comments

[Teresa]

Mary,

This is just fabulous! Your focus on details is great. I just wanted to mention that again, Levethal's comments here do not seem honest--he is not upfront about ALL of his consulting and/or-how much money he is paid to keep saying "genetic".

Q: Have you consulted with pharmaceutical companies?
A: Yes. I helped Johnson & Johnson bring Risperadone to market so that it’s now on label for autism.

but no mention of his other affiliations-
Dr. Leventhal receives research support from Abbott, Eli Lilly, GlaxoSmithKline, Shire, Pfizer, and Forrest Laboratories; he is on the speaker bureaus of Eli Lilly, GlaxoSmithKline, Pfizer, and Bristol-Meyers Squibb/Otsuka; and he has consulting relationships with Abbott, Eli Lilly, Janssen, McNeil, Pfizer, and GlaxoSmithKline, as reported in the Journal of the American Academy of Child and Adolescent Psychiatry, Volume 44- Number 4- April 2005
http://www.bcc-asa.org/Lexapro-Cook.pdf

This line was on target:
"Dr. Leventhal’s testimony should be given very, very little weight."