HOLLAND ON THE OMNIBUS AUTISM PROCEEDING: 5/16

By Mary Holland, Esq.

Friday, May 16, 2008

Continued Cross Examination of Dr. Mumper

Mr. Johnson, Respondent’s lawyer, asked questions about Dr. Mumper’s testimony in a previous civil case in Baltimore in 2007, the Blackwell case.  Dr. Mumper submitted a deposition and testified at an evidentiary hearing.  She did not specifically mention neuroinflammation in that case, although it was also related to TCVs.  She did cite to Dr. Zimmerman’s work, although it is Dr. Mumper’s impression that Dr. Zimmerman does not share her view that TCVs are linked with autism. 

Have you been in touch with Dr. Zimmerman? I spoke with him a few weeks ago in connection with a patient who died.  I had a patient who developed normally until 18 months when he got his vaccinations, at which point the child had a cardiac arrest and seizure that day.  He was airlifted to a hospital where the parents were told that the problems could not be related to vaccines.  He was seen at the University of Virginia and eventually came to me for management.  He died three weeks ago at age 18 in his sleep of a seizure that I could not control.  We had put a device in his brain to reduce the seizures from 100 per day to 10-25 seizures per day.  I encouraged the parents to donate the brain to the Autism Tissue Bank in Baltimore, and Dr. Zimmerman and his colleagues would be glad to work on the brain.  I did not discuss Dr. Zimmerman’s views on TCVs at that time.

You presented a slide in 2007 about the Vargas work, that Dr. Zimmerman participated in; you don’t mention neuroinflammation.  Have you changed your hypothesis?  I have expanded my knowledge since 2007.

Do you agree with Dr. Kinsbourne’s model?  Yes.  Were you aware of it before this proceeding?  Not in precisely the way he’s articulated it.  Is this theory different than previous theories you’ve held?  There is a tendency to oversimplify here; neuroinflammation is a common pathway that can result from various mechanisms.  I want to “follow the science wherever it goes.”  Has Dr. Kinsbourne’s theory been published?  No.  Peer-reviewed?  No.

What’s your training?  As a general pediatrician.  How did you learn to diagnose autism?  As part of my general training and in writing a book chapter on developmental pediatrics.  What methods do you use to diagnose autism?  I do not do the diagnosis; I take patients who have already been diagnosed.  But I recommend that the ADOS and ADIR tests be used, and that the evaluations include speech, motor and intelligence testing. 

How do you define regressive autism?  It’s normal development followed by the loss of developmental milestones and the development of autistic symptoms.

Mr. Johnson asked whether in evaluating regression in language skills, does it matter how a child uses words?  Yes.  Do you use the term “clearly regressive autism” in your practice?  Yes.  Did you personally evaluate the two boys in these cases today?  No. 

Didn’t you say in the Blackwell lawsuit in which you testified that you would need to evaluate the autistic subjects in order to make an opinion?  How are these cases different from the Blackwell case?  What’s different is that I know Dr. John Green, the treating physician well; I know how careful he is; I’m better able to make a judgment about his treating.  But furthermore, it’s my understanding that in this case, I am here as an expert clinician, not as a treating physician.  I thought there is a distinction in role. 

Do you think these proceedings are at a lower standard than you’d apply in your clinical practice?  My understanding of vaccine court is that it’s meant to be a non-adversarial, family-friendly forum for providing compensation to children injured by vaccines and that it’s based on a model of plausibility that certain vaccine components might have contributed to the injury. 

Do you think this is a lower standard of evidence than was used in the Blackwell case where you testified before?  I think this is a different standard, not a lower standard.  But I agree that vaccine cases should be based on reliable science. 

When did William Mead’s regression occur?  Between 15 and 18 months.  When did Jordan King’s regression start?  15-20 months.  What did you rely on?  Medical charts; parental descriptions.  Does it matter when the regression occurred?  Yes.  It can occur at different points, but the classic case is a regression in the second year of life.  If regression occurs after age 3, however, it is not considered autism under the formal diagnostic criteria.

Do you know how much thimerosal William Mead received?  I think he received 187.5 mg by 7 months, assuming that his vaccines were from multivial injections rather than single vials; it’s possible the amount was lower if single vials were used.  Is 187.5 mg sufficient to cause autistic regression?  It depends, but to the best of my knowledge, that amount would be sufficient.  We have no known safe levels of mercury.  Could one vaccine cause regression?  It is theoretically possible, depending on the situation of the child at the moment.  If a child had birth trauma or oxidative stress, it might be particularly vulnerable.

In the Blackwell case, you testified that even “trace amounts” of thimerosal are suspect.  Are you aware of any studies showing that trace amounts cause problems?  No.  Is it your opinion that TCVs lead to autism?  Yes.  Is that opinion limited to regressive autism?  I don’t know the answer to that yet.  We are now seeing children whose mothers received thimerosal in pregnancy; we may see a shift in the pattern.  This science is in its infancy; we can’t be sure.

Let’s talk about proximate relationship between the vaccines and autism.  This is different from the classic vaccine model where you’d expect to see an acute reaction shortly after the injection, such as in the pertussis case.  With mercury and autism, it’s a chronic reaction, not an acute reaction; the mercury leads to neuroinflammation.

Does every kind of ASD include susceptibility to mercury?  I don’t know.  What markers do you look for susceptibility to mercury?  Indirect markers.  We look at markers for methylation and transulfuration; we use Jill James work on methylation levels.  We will be better aware of numbers after NIH studies.  Would you agree that there are general biomarkers for mercury susceptibility?  We have to use indirect measures, but porphyrin tests and provoked urine samples are good.  Is it true that you think that blood, unprovoked urine and hair testing are not reliable markers for mercury and metal toxicity in autism?  Yes; blood tests are only for acute exposures.

In the tests for Jordan King, why didn’t Dr. Green do a pre-provoked urine test for a particular sampling?  Probably because he had other pre-provoked measurements and to reduce costs for the family.  Doesn’t the DAN! Protocol recommend pre-provoked measurements be taken?  We suggest it; that was particularly when there were concerns about the way creatanine was measured in various tests.  After saying she would prefer not to speak on the record about a particular laboratory, Dr. Mumper said that in her best medical judgment its results were unreliable. 

Mr. Johnson reviewed tests for William Mead.  What numbers would we expect to see from non-autistic patients?  We don’t really know; it would be a good study.  Dr. Mumper pointed out that she has been careful not to say that “thimerosal causes autism.”  She has said that thimerosal “exacerbates” or “substantially contributed to” autism; there are other exposures and we can’t rule them out entirely.  Mr. Johnson asked several times what is your strongest piece of evidence for thimerosal playing a causative role?  Dr. Mumper said the excretions of large amounts of mercury after known exposures is very important.  We know that injected mercury bypasses the normal protections of the gut; goes across the blood-brain barrier; is broken down to inorganic mercury; and causes neuroinflammation.  This is the best evidence, but of course I look at the bigger picture, utilizing indirect evidence from post-provocation urine tests; lab reports showing oxidosis; history and examination of utilized nutrients; and a clinical picture.  The post-provocation tests are only a part of a bigger picture analysis.
In my clinical practice, in 80% of regressive autism cases, when I look for methylation markers, I find them.  I acknowledge that we don’t have good enough biomarkers for non-autistic patients; this is one area where we hope to do more research.

In William Mead, we saw dramatically low digestive enzymes.  Mercury inhibits DTP4 enzyme; the body uses DTP4 to break down gluten and casein.  So a gluten-free and casein-free diet gives a diet that doesn’t require the subject to break down foods they can’t digest.  Both boys in these test cases benefited from the diet.  There is significant relevance of digestive enzymes as biomarkers.

Is secretin used to address digestive enzymes?  Isn’t it true that in the controlled study of secretin, the kids who received placebo did better than those getting secretin?  That’s not my understanding.  I believe that there were 1-2 dramatic responders in the study, and that many did not improve, diluting the effect on the responders.  This study gives us impetus to better identify sub-populations. 

Is intestinal disbiosis compatible with mercury toxicity?  Yes.  In kids with early antibiotic use, this can cause a killing off of the gut’s “good flora,” and mercury’s role with enzyme production can exacerbate this disbiosis. 

Do you think that the MMR vaccine was a contributing factor to William Mead’s autism?  I don’t know; I’m concerned about that.  I’m concerned about triple vaccines combined with antibiotic use; we don’t know with certainty.  In this case, my task is to evaluate the contribution of TCVs.  I did not rule out the role of the MMR in differential diagnosis.

Do kids ever recover from autism without biomedical intervention?  Yes. 

Did you play a role in choosing these test cases?  Yes.  Why did you choose these cases?  It was a complex decision, but I looked at evidence of mercury excretion.  I wanted to provide different models, so I wanted different cases.  I wanted evidence of clear regression.  I didn’t want cases with “million dollar work-ups;” I wanted cases where we were forced to rely on things like clinical histories and parental reports. 

Why did you reject other cases?  Many didn’t have enough data; I do want this to be driven by the science.  We needed biomarkers to present the footprint of mercury. 

Are you a member of AAP?  Yes.  Have you ever served on a committee?  Yes.  And I met with the President President-elect this spring to plan a meeting with DAN! senior clinicians to discuss how to make vaccines safer.  Are you on any NIH committees? No.  What is your position with the Autism Research Institute?  I am the medical director; I plan the program for two DAN! conferences each year and am gone from my practice for 8 days.  I am paid $16-18,000 per year. 

Did you teach at Univ. of Virginia?  Yes; I taught in a residency program.  Were you terminated by the University because you were no longer teaching residents?  My appointment was not renewed because I was no longer teaching; I was not terminated. 

How many autistic patients do you have?  400-500. For how many have you concluded that TCVs contributed to their autism?  Well, I just analyzed my last 156 autistic patients, and 50% were clearly regressive, so I’d say that 100-200 cases of regressive autism involved TCVs. 

Do you believe there is an epidemic of autism?  I believe there is an epidemic of neurodevelopmental disorders.  The AAP says that 1 in 6 children have a neurodevelopmental disorder and the CDC says that 1 in 150 has autism.  In Virginia, there has been an 11-fold increase in autism since 1988; this is a Department of Education figure.  While there is some ascertainment bias, there is a real rise; I saw it in my practice before I saw the DOE numbers.  What percentage of autism cases would you say are related to TCVs?  I don’t know; it’s not well studied.

Is it true that thimerosal was taken out of vaccines in 2001?  I take issue with that.  In 1999, there was a decision to phase it out.  It was never taken off the shelf.  We had at least one patient in my clinic who received shots with TCVs in 2003.  Also, at the same time thimerosal was being phased out, a recommendation was made to give flu shots to pregnant women, and 98% of flu vaccines contain thimerosal.  Kids were then recommended to get flu vaccines at 6 months, 12 months and every year thereafter.  So the thimerosal load can still be half that of what it was in the 1990’s. 

But has the number of autism cases increased since 2001?  Yes.  There are many, many factors we need to look at. 

Do you know about the IOM, AAP, WHO, CDC and Canadian and European studies that have rejected a link between thimerosal and autism? Yes.  I think that the regressive autism group does not show up in epidemiological studies.  I perceive flaws in these studies. 

Are you aware that the AAP recently reaffirmed that “there is no mercury in routine vaccines”?  I am very concerned that the AAP is misleading families with that statement, because of the thimerosal in flu vaccines; I would like the AAP to be more careful. 

Is your opinion on the link between autism and thimerosal generally accepted in the medical community?  No.  Isn’t it true that for most of the medical community, the “case is closed.”  “Sadly, that is the case.”

Redirect Examination of Dr. Mumper 

First Mr. Powers returned to the Burbacher monkey studies.  Dr. Mumper pointed to the language in the 2005 Burbacher study that says that it is hard to understand how the IOM could have concluded that no further research on the link between autism and thimerosal was necessary when the pharmacokinetics in their study suggest that ethyl mercury is even more toxic to the brain than methyl mercury. 

Mr. Powers reviewed loss of skills in developmental regression.  Dr. Mumper stressed that loss of skills is across domains of social interaction and language.  She looks for a qualitative change in demeanor. 

Then Dr. Mumper returned to the question of other environmental exposures.  She said she was very concerned about synergistic toxicities.  It is well understood that if you take two toxins and combine them, the combined toxicity may not be double the strength of each; it may be orders of magnitude more toxic.  Mercury in vaccines may make children vulnerable to synergistic toxicities. 

Do you think that Dr. Kinsbourne’s theory of general causation is consistent with what happened in these two cases?  Yes, and it’s consistent in what I see in my patients.  The little boy I mentioned earlier today who died at 18 of seizures – he had precisely what you’d expect from Dr. Kinsbourne’s testimony.  He was constantly in anxiety; he could not stop stimming; we had to implant a device in his head to prevent him from having more than 100 seizures per day. 

I review everything I learn in terms of my clinical experience.  I embrace these scientific findings and can tie them back to what I see as a clinician.  If you saw evidence that changed your opinion of the science, would you say that?  Yes; I’ve vowed to tell the truth and nothing but the truth.

Of course I’ve wondered why I’m here when the AAP, CDC, WHO and other organizations have found no link.  I may be wrong and time will tell, but I think the science is accumulating that there is a link.

You were asked many questions about what is the “key evidence.”  Dr. Mumper reviewed that she thinks it’s critical that the two boys received the full TCV schedule; there is no family history of autism; neither sibling has any developmental delays; there are no genetic markers of autism; and no signs of other known causes of autism, such as tributalene.

Re-Cross Examination of Dr. Mumper

Do you feel implicated in the autism epidemic as a pediatrician?  Yes.  Do you feel you have a debt to repay?  Yes. 
* * *

The Petitioner rests its case in chief on general causation.  There was some
argument between Petitioner and Respondent about when Petitioner would have rebuttal to Respondent’s case.  Respondent will have doctors Clarkson and Magos testify in July; Mr. Powers would like to have all rebuttal then, rather than only rebuttal as to Clarkson and Magos then.  The Special Masters did not rule on the matter.  The hearing will resume on Monday at 9:00 a.m. with Respondent’s case in opposition.

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

[Elizabeth Mumper, MD]

I have spent the last several days Monday morning quarterbacking my testimony and thinking of things I coulda/shoulda/wouda said had I thought of them at the time. Therefore, it is gratifying to read Heckenlively's impressions of my testimony.

I would like to clarify several points of fact that I may have not made clear in my testimony. The Blackwell 2007 civil case and the patient who died last month were two different cases. The parents of the boy who died last month did not file a civil lawsuit or a case in Vaccine Court. The mother is now a nurse, who understands that all medical interventions carry some risk. They knew that no amount of compensation would make up for the son's lost future.

At the time I told his story in court, I had not reviewed his history in several years. I did so this weekend. Recorded in the chart is a respiratory arrest, not cardiac. Status epilepticus after one set of shots and autistic regression after shots around two years were what the parents reported in association with vaccines.

The thing that is extraordinary to me about his story is that, after he developed gastrointestinal symptoms, status epilepticus, worsening of his seizure disorder, and autistic regression associated with immunizations, the parents report being told by many physicians who evaluated him (they went to 20-30 specialists) that those events were not related to his vaccines. One wonders if checking his immunization titers would have shown he did not need boosters. There are many possible reasons for the course of his seizure disorder and autism, but I think receiving a thimerosal containing vaccine should be on the differential diagnosis list. There were many days he suffered hundreds of seizures per day. He died at the age of 19, after many years of devoted care and extraordinary expressions of love from his family and many friends.

The way I was able to tell his story in court was in response to the question about whether I had talked to Dr. Zimmermann since I heard public comments from him at the Autism Treatment Network several years ago. At that time I got the impression, perhaps erroneously, that he was quite skeptical of the Defeat Autism Now! emphasis on treating methylation and transulfuration abnormalities. Since then, I have had the opportunity to read many more of his papers and realize that we have arrived at many areas of common ground from different paths. I was very impressed with his contributions to the Poling case. I was honoring his expertise by asking for his involvement in the analysis of a very precious gift, the brain of a young boy whose life was changed forever and ultimately cut short: a gift given by the parents who loved him, in order to prevent what happened to their son from continuing to happen to other children.

Elizabeth Mumper, MD
Medical Director, Autism Research Institute
CEO, Advocates for Children
Founder, RIMLAND Center
2919 Confederate Avenue
Lynchburg, VA 24501
Phone 434-528-9075
Fax 434-528-9078

[Nothing but the truth]

Dr. Mumper speaks and practices with integrity. In comparison, the pediatric community at large, and especially organized and academic pediatrics, simply cannot respond meaningfully, and cannot justify its actions (and inaction). Autism parents owe her an fathomable debt of gratitude.

[Richard F]

Thanks Mary,it was great being able to see the case from your perspective and compare your observations with Kents'.

[nhokkanen]

Thank you, Mary, for your articulately detailed report. I wonder why the delay for Clarkson and Magos to testify.