The Omnibus Autism Proceeding (OAP) was held in the U.S. Court of Federal Claims to group the large number of claims filed involving autism and vaccines. The Docket was opened on July 3, 2002, nearly 10 years ago. The last entry was placed 1 year ago. Since then many cases have been dismissed. About half the cases are left to hear, but the fact that the two causation theories presented (that the MMR vaccine causes autism and that Thimerosal causes autism) were both found to have no merit (“not even close” one special master put it) and no new theory is proposed by the Petitioners’ Steering Committee (the attorneys who presented the case for the petitioners) makes it clear that the group claim, the omnibus, is effectively over.

That is not to say that other claims are not proceeding through the court, or that new cases will not be presented. There is at least one case pursuing the idea of mitochondrial dysfunction and autism, as with the Hannah Poling case. ([edit to add—the case ongoing, which was briefly closed, is not the Hannah Poling case. See the comments below). The case was actually dismissed for lack of action by the petitioners but the special master allowed it to continue again).

Looking back, the Omnibus peaked in 2003 when 2,437cases were filed (close to 1/2 of the total that would eventually be filed).

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Dr. Mark Geier is a name which has come up frequently in the autism/vaccine discussion, and in alternative medical therapies (such as Lupron) of autism. Dr. Geier has been an expert witness for petitioners in the vaccine court for about two decades. He has been criticized by the court for almost as long. Dr. Geier has recently had his medical license suspended.

Mark Geier and his son David have worked for the Petitioners Steering Committee (the lawyers handling the plaintiffs’ cases in the Autism Omnibus). But their relationship seems a bit strained. They filed suit asking for $600,000 in payment. The Geiers have had previous requests for fees drastically reduced or denied, including one where they expected the Court to cover $20,000 as their costs (and hourly rate, including while sitting on planes) to attend conferences in Italy and France. The court called this “a complete abdication of billing judgment.”

In a recent court decision, Dr. Geier has been criticized again. Thoroughly. But this very strong statement from the special master makes it clear that Dr. Geier’s future as an expert witness or consultant will be very restricted:

I will not likely be inclined to compensate attorneys in any future opinions for consultant work performed by Mark Geier after the publication date of this opinion.

The decision focused on expenses the Petitioner’s Steering Committee (PSC) charged in the Omnibus Autism Proceeding for Mark Geier, his son David Geier and their colleagues. Much of these charges resulted from a study they published, Thimerosal exposure in infants and neurodevelopmental disorders: An assessment of computerized medical records in the Vaccine Safety Datalink. Epiwonk (a former professional epidemiologist for the CDC) discussed the paper in New Study on Thimerosal and Neurodevelopmental Disorders: I. Scientific Fraud or Just Playing with Data?

The study noted in the acknowledgements that the study was funded by the PSC:

This study received funding from the Autism Petitioners’ Steering Committee of the no-fault National Vaccine Injury Compensation Program (NVICP).

The Geier/Young team billed the PSC, and the PSC billed the vaccine injury trust fund vaccine court. As you can read, they just weren’t successful.

The Geiers tried some fancy footwork to get the Young-Geier study paid for by our tax dollars.  Including an apparent attempt to get the non-doctor David Geier compensated by charging work at their company, “medcon”, rather than naming David Geier as the recipient.

Bottom line—the PSC asked for $440k to compensate the people who worked on the Young-Geier study.  They got $33k, and a strong statement that Geier will be unlikely to be compensated by the program in the future.

If you are curious about the value of the study itself, there is a whole section of the decision titled “The Young-Geier article itself did not add any value to the petitioners’ causation case.”

In their application, the PSC sought a total of $7,202,653 for interim fees and costs. with $1.35M for costs, primarily expert witness costs (note that the Geiers did not actually serve as witnesses, so they are part of the “costs”)

Out of $1,350,000 in costs one might ask how much of this was for the Young-Geier study?

As noted above, this Decision on Remand concerns the PSC’s claim for compensation for amounts paid, or to be paid, to four experts/consultants: Dr. Mark Geier, David Geier, Dr. Heather Young and Dr. Robert Hirsch. Conceptually, this claim can be broken into two parts. First, petitioners seek $447,004.02 to compensate all four of those individuals for work on an original medical article that was published in 2008. Second, petitioners seek $197,823.94 more for miscellaneous additional services provided by Mark Geier and David Geier between 2003 and 2008.

$447K. One third of the total. A large number of expert witnesses actually produced reports and testified, but the Geier team was to receive 1/3 of the total. If you take a high rate of $500/hour, this works out to 22 full time man weeks. For a study where they didn’t have to collect data, just analyze it. I find it difficult to believe this study took 22 weeks (or more, as the $500/hour is a very high estimate).

The Geiers were not slated to get the majority of the money. Heather Young, an associate professor at George Washington University, was to get the lion’s share. About a quarter of a million dollars:

Petitioners would receive $248,636.91 to compensate Dr. Young, $157,407.11 for the two Geiers, and $41,000 for Dr. Hirsch

Unless GWU pays their associate professors much more than is common, this represents well over one year’s pay for Prof. Young.

Thankfully HHS (respondent) argued against this request:

Respondent argues strenuously, in response, that it would be wholly unreasonable for the Program to provide compensation to these individuals for their efforts concerning the article.

Is it reasonable to charge for studies created for litigation? Are they of high value to the case?

I note that the Supreme Court has expressed the view that medical studies produced expressly for litigation purposes should be viewed with skepticism.

and

The views of these courts, then, reinforce the concern that if a lawyer involved in a Vaccine Act case chooses specific experts and pays them to carry out a study, the potential is great for bias in the study, toward the outcome that would assist the clients of the lawyer paying for the study. Thus, it is arguable that, as the respondent contends, it would be poor public policy, in general, for special masters to award public funds for such original studies.

and

Rather, I conclude that under all the specific circumstances of this case, it would not be reasonable for me to compensate the named individuals for the production of this particular article.

The PSC argued that the paper was not “litigation driven”.  The SM didn’t accept the argument:

As to the former point, I am simply not persuaded by the suggestion that the article was not litigation-driven….The mere fact that the PSC lawyers contributed or promised monetary support for another article co-authored by the Geiers, concerning the topic of whether thimerosal-containing vaccines can cause autism, is itself strong evidence that the article was litigation-driven.

Further, the very fact that the petitioners are now seeking Vaccine Act funds for the cost of producing the article is a very strong indication that the article was litigation-driven.

If that wasn’t enough, the PSC argument backfired in another way:

If the article was produced “completely apart from [Dr. Geier’s] involvement in this [Vaccine Act] litigation,” and would have been produced even absent that litigation, that would seem to contradict the petitioners’ claim that paying the cost of producing the article was a necessary and reasonable cost of the Vaccine Act litigation.

How was the Young-Geier study used in the Omnibus? Was it persuasive? Answer: it wasn’t really used and it wasn’t persuasive.

The HHS/DOJ’s experts were critical of the Young-Geier study:

Perhaps the strongest factor leading to my result here is my conclusion that the Young-Geier article itself did not add any value to the petitioners’ causation presentation in this case. Two epidemiologic experts, both of them testifying for respondent, testified at the trial in this case concerning the merits of the Young-Geier article, and both testified that the article was deeply flawed.

Even the PSC’s own experts were not impressed by the Geiers in general:

And, very significantly, none of the petitioners’ five medical experts who testified at the trial offered any testimony in support of the validity of the Young-Geier article. It is especially striking that among petitioners’ experts was an expert who has excellent credentials in epidemiology, Dr. Sander Greenland. Dr. Greenland in fact testified negatively about the Geiers’ prior epidemiologic articles concerning the vaccine-autism controversy, describing those studies as“deficient in methodology.”

Prof. Greenland didn’t speak to the Young-Geier article directly, just their methods in other studies.  But the special master points out that this appears to be a trick on the part of the PSC to avoid having to defend the Young-Geier study on cross examination:

Yet they [the PSC] put Dr. Greenland on the witness stand in this King case on May 12, 2008 (Tr. 69-135), did not ask him about the article, and did not reveal the existence of the article to the special masters and respondent until May 16 (see fn. 6 above), thus ensuring that no one could ask Dr. Greenland about the Young-Geier article. From these circumstances, the most reasonable inference is that petitioners’ counsel deliberately intended to avoid any questioning of Dr. Greenland, their epidemiologic expert, about the Young-Geier article.

The special master concludes that the study did not add any value to the PSC’s case and “no rational hypothetical paying client” would have agreed to pay for the production of such a “flawed study”:

In short, the Young-Geier study itself was severely criticized by respondent’s experts, who articulated persuasive reasons for that criticism. In my own analysis, the Young-Geier study also appears flawed. And the other special masters who reviewed that article reached the same conclusion. Clearly, no rational “hypothetical paying client” of the PSC would have agreed to pay for the production of such a flawed study. Thus, the fact that the Young-Geier article did not add any value to the petitioners’ causation presentation in this case is a very strong reason why I should decline to compensate the PSC for the cost of producing the article.

The Special Master notes that given the long history of the Geiers in the vaccine program, it would be unreasonable to expect the program to pay for the cost of the study:

A review of prior legal opinions discussing the Geiers casts strong doubt on the reasonableness of compensating the cost of an article co-authored by them.

The Special Master then goes into detail of those decisions , with an entire section  of the decision dedicated to “Vaccine Act opinions concerning the general credibility of Dr. Geier as an expert witness” including subsections “Criticisms of Dr. Geier for offering testimony outside his area of medical specialty” and “Opinions questioning Dr. Geier’s honesty, candor, or veracity” and “Opinions declining compensation or substantially reducing compensation for Dr. Geier’s services”

If you get the time, read through those. They are highly critical. A condensed version of 20 years of highly critical comments about the actions of the Geiers in the vaccine program (mostly Mark Geier):

Criticism of the Geiers is not limited to their activities in the Vaccine Court. In “Judicial opinions outside of the Vaccine Act” they quote decisions stating “federal appellate court concluded that Dr. Geier gave erroneous testimony” and “state court found Dr. Geier’s testimony to be “unsubstantiated” and unpersuasive” and “federal court was “unimpressed with the qualifications, veracity, and bonafides” and, lastly, “federal judge stated that he was “unconvinced” that Dr. Geier was qualified to offer testimony concerning certain vaccine safety issues.”

The Special Master went into detail about previous flawed studies by the Geiers on vaccines and autism.  He also notes that the assertion that Dr. Geier is qualified as an epidemiologist is not supported:

Thus, Dr. Geier does not appear to have had any formal academic training or degrees or medical faculty experience in epidemiology, and his medical experience has been chiefly in genetics rather than epidemiology. Thus, it is unclear why he was named a “Fellow” of the American College of Epidemiology, and it is doubtful whether he should be considered an expert in epidemiology. I conclude that the petitioners have failed to shoulder their burden of demonstrating that Dr. Geier should be considered an expert in epidemiology.

and

Further, a number of judges and special masters have also examined Dr. Geier’s credentials, and have specifically concluded that Dr. Geier should not be considered an expert in epidemiology.

He awards fees, as a consultant not expert, for Mark Geier’s other efforts on the Omnibus:

Accordingly, I awarded $33,130.35 (147.246 hours times $225 per hour) for the services of Dr. Geier.

No mention of payment for David Geier or Heather Young.

The Special Master makes it clear that even this amount was grudgingly awarded. Given that in the past it was reasonable to hire Mark Geier as a consultant:

I note that it is not an easy judgment whether to award any funds for the services of Dr. Mark Geier in this case. On balance, I conclude that, in light of the cases awarding funds to Dr. Geier as a consultant (see p. 33 above), it was not unreasonable in this instance (several years ago) for the PSC to employ Dr. Geier for consultant services.

But, after 20 years, the vaccine program may have had enough of Mark Geier:

I will not likely be inclined to compensate attorneys in any future opinions for consultant work performed by Mark Geier after the publication date of this opinion.

(emphasis added)

If the court won’t pay his fees, the career of Mark Geier as an expert for vaccine injury cases is over. His son David is not likely to be taking his place, as he has not been considered even viable as a consultant by the special masters. As noted above, Mark Geier’s license to practice medicine has been suspended (in multiple states). David Geier was charged with practicing medicine without a license. One has to wonder if or how the Geiers will re-emerge on the autism/vaccine scene.

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A news conference today will confirm that autism/anti-vaccine groups have lost the scientific battle for the idea that vaccines cause autism as they turn to the legal battle instead.

...a new report in a New York law school journal, the Pace Environmental Law Review, could reignite the often-inflammatory debate over the issue. Based on a sampling of cases in which plaintiffs won settlements or awards in vaccine court, the authors found that many of the victims demonstrated evidence of autism – even though, perhaps as a legal tactic, their lawsuits emphasized other injuries.

Readers of this site might be forgiven for looking and yawning – here we go again. This is nothing but re-hash of already discussed material. But lets look at the main claim of this issue:

Of the 170 cases the report’s authors examined, 32, or 19 percent, provided documented evidence of autism or autism-like symptoms. The evidence in some cases included findings by the court that the children had autism, “autism-like symptoms” or “symptoms and behavior consistent with autism.” In other situations, third-party medical, educational or other court records confirmed an autistic disorder.

The report – at least in this news story – doesn’t seem to mention how many children were compensated for having autism. As we all kow ‘autism like symptoms’ or ‘symptoms and behavior consistent with autism.’ might be just that – but they are not autism. If they were I’m sure the court would’ve reported it.

And thats not all. Nobody seems to be giving an estimate for how many of these kids actual autism (not autism-like symptoms etc) was actually caused by an actual vaccine.

And thats still not all. One of the most problematic issues for this new ‘line of attack’ is this.

Daubert. This is the standard of science that should be used in legal cases. When Daubert is applied, the bottom line is that the best science must be applied. In none of these cases was Daubert applied. In fact, in only one instance was Daubert applied – the Autism Omnibus hearings. And as we all know, they failed.

So here we have a fairly desperate roll of the dice. Eschewing science completely, the autism/anti-vaxxers have decided to turn their attention to the law. By muddying the legal waters, they are attempting to make it appear as if autism by any other name has been compensated in at least 19% of the cases they looked at.

The truth is, it hasn’t. The truth is that in no cases I can see has a case been established scientifically to show vaccines cause autism.

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A study is in review looking at the records of the vaccine court and, purportedly, showing that a large number of the cases compensated involve autistics. Robert Kennedy Jr. was prepared to give a press conference on the paper, but this got called off. There has been chatter about a study like this for a few years now and I’ve been curious about what the results would be. I was then curious why the chatter basically died down.

The big question I would have for the author of this study and for Mr. Kennedy should he get his press conference is: how many of these children were compensated for a residual seizure disorder following DPT vaccination?

Why ask that question? The “table” is a list of reactions which the Court will assume are vaccine-caused if they happen within the prescribed time after vaccination. The table is created with the best knowledge available at the time. What happens when the best knowledge available changes? After much deliberation, the table changes. That’s what happened to residual seizure disorders as an injury for DPT vaccines. It was part of the original table, but as new research came out showing that residual seizure disorders were not a risk from DPT vaccines, it was removed from the table.

This isn’t a small issue. The idea that residual seizure disorders could be caused following DPT vaccination are basically what created the Vaccine Act, the special Court and the rest of the program as we know it today.

As of today, there have been 2,699 cases compensated within the program. Of those, by far the largest share is due to the DPT vaccine, with 1,267 compensated claims. That’s 47%. Pretty high percentage especially when you consider the DPT (the whole cell vaccine) was discontinued 15 years ago.

Let’s say that there are a lot of cases in the court where autistics have been compensated for injury. How many of these people were compensate for what was an incorrect assumption of fault? Epilepsy is common in autistics. It is certainly reasonable to think that a number of autistics were compensated for residual seizure disorders.

It will be interesting to see how they address this question in the paper, if they address it at all. It will be interesting to see how Mr. Kennedy addresses this problem, if he addresses it at all.

If you want more details on the history, here is some of it, with some links.

Take a look at the original vaccine injury table (from the mid-late 1980’s) for the DPT vaccine:

DTP; P; DTP/Polio Combination; or Any Other Vaccine Containing Whole Cell Pertussis Bacteria, Extracted or Partial Cell Bacteria, or Specific Pertussis Antigen(s).
Illness, disability, injury, or condition covered:Time period for first symptom or manifestation of onset or of significant aggravation after vaccine administration:
A. Anaphylaxis or anaphylactic shock24 hours
B. Encephalopathy (or encephalitis) 3 days
C. Shock-collapse or hypotonic-hyporesponsive collapse3 days
D. Residual seizure disorder in accordance with subsection (b)(2)3 days
E. Any acute complication or sequela (including death) of an illness, disability, injury, or condition referred to above which illness, disability, injury, or condition arose within the time period prescribed

Take a look at the table now for pertussis containing vaccines:

I. Tetanus toxoid-containing vaccines (e.g., DTaP, Tdap, DTP-Hib, DT, Td, TT)
A. Anaphylaxis or anaphylactic shock 1 0-4 hours
B. Brachial neuritis 6 2-28 days
C. Any acute complication or sequela (including death) of above events 4 Not applicable

It’s a lot shorter. Note specifically that “Residual seizure disorder” is now gone. Here is how residual seizure disorderwas defined:

(B) in the case of any other vaccine, the first seizure or convulsion occurred within 3 days after administration of the vaccine and 2 or more seizures or convulsions occurred within 1 year after the administration of the vaccine which were unaccompanied by fever or accompanied by a fever of less than 102 degrees Fahrenheit.

The change came in 1995. The reasons were not arbitrary, as noted here in the announcement in the Federal Register. They were working from recently published and studies:

During the process of analyzing the comments received in response to the NPRM, the Agency became aware of the imminent publication of a 10-year follow-up study to the National Childhood Encephalopathy Study (NCES) (Madge N., Diamond J., Miller D., Ross E., McManus C., Wadsworth J., Yule W. The National Childhood Encephalopathy Study: A 10-year follow-up. A report of the medical, social, behavioural and educational outcomes after serious, acute, neurologic illness in early childhood. Developmental Medicine and Child Neurology 1993; Supplement No. 68;35(7):1–118; Miller D.L., Madge N., Diamond J., Wadsworth J., Ross E. Pertussis immunization and serious acute neurological illness in children. British Medical Journal 1993; 307:1171– 1176, hereinafter ‘‘Miller study.’’).

Because the Miller study looked specifically at the relationship between vaccine administration and subsequent neurological damage, the Department determined that it should not proceed with publication of the final rule until there had been a sufficient opportunity to consider the conclusions of the new Miller study. Accordingly, the Department asked the IOM to convene a Committee for purposes of evaluating the Miller study in light of the conclusions of its initial report. On March 2, 1994, the Institute of Medicine issued a report entitled ‘‘DPT Vaccine and Chronic Nervous System Dysfunction: A New Analysis.’’

The pubmed link to the NCES study (Madge et al) is here. The Miller study is available in full here. The IOM report is here.

To pull one short quote out as to why the table changed:

The consensus of the Commission was that the original table in the statute requires modification to make it consistent with current medical and scientific knowledge regarding adverse events associated with certain vaccines.

Basically, they found that the research which had been used for the first Vaccine Injury Table was wrong to assume cause for residual seizure disorders following DPT vaccines. Again, I await the chance to see if the upcoming paper addresses this important issue. If a large number of the autistics were compensated for an injury which modern science says isn’t really an injury, the readers of the study need to know this.

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Autism and mitochondrial medicine have become a very hot topic in recent years. What the connections are between autism and mitochondrial disorders has yet to be clarified. Mitochondria are little structures within cells that produce much of the energy required. Mitochondria have their own DNA (mtDNA) in addition to the nuclear DNA (nDNA) of the cell. nDNA is what most people think of when we hear “genes” or DNA. Given the focus on mitochondrial dysfunction and autism, it is natural to consider the question: are there mutations in the mtDNA which increase the risk of autism?

A new paper takes a look at the question. They studied 148 patients with ASD and found, well, no support for a link to mtDNA mutations. Here is the abstract:

BMC Med Genet. 2011 Apr 6;12(1):50. [Epub ahead of print]
Reassessing the role of mitochondrial DNA mutations in autism spectrum disorder.
Alvarez-Iglesias V, Mosquera-Miguel A, Cusco I, Carracedo A, Perez-Jurado LA, Salas A.
Abstract
ABSTRACT:
BACKGROUND: There is increasing evidence that impairment of mitochondrial energy metabolism plays an important role in the pathophysiology of autism spectrum disorders (ASD; OMIM number: 209850). A significant proportion of ASD cases display biochemical alterations suggestive of mitochondrial dysfunction and several studies have reported that mutations in the mitochondrial DNA (mtDNA) molecule could be involved in the disease phenotype.

METHODS: We analysed a cohort of 148 patients with idiopathic ASD for a number of mutations proposed in the literature as pathogenic in ASD. We also carried out a case control association study for the most common European haplogroups (hgs) and their diagnostic single nucleotide polymorphisms (SNPs) by comparing cases with 753 healthy and ethnically matched controls.

RESULTS: We did not find statistical support for an association between mtDNA mutations or polymorphisms and ASD.

CONCLUSIONS: Our results are compatible with the idea that mtDNA mutations are not a relevant cause of ASD and the frequent observation of concomitant mitochondrial dysfunction and ASD could be due to nuclear factors influencing mitochondrion functions or to a more complex interplay between the nucleus and the mitochondrion/mtDNA.

PMID: 21470425 [PubMed – as supplied by publisher]Free Article

This is consistent with previous studies, as noted in a recent review article which was itself summarized at The Thinking Person’s Guide to Autism by Emily Willingham as Mitochondrial Disease and Autism: Linked?

Ms. Willingham noted there:

Thus, tracking down mitochondrial dysfunction in the context of ASD to a specific mutation has remained an elusive goal. Two scenarios are likely for this lack of mutational findings: (1) there are mutations, but we just haven’t found them yet; or (2) the environment is largely responsible for any mitochondrial dysfunction that abnormal marker levels might indicate.

This paper is available as a free manuscript online. Here is the

Although it is widely accepted that some forms of ASD appear concomitantly with the impairment of mitochondrial energy metabolism, there are reasons to believe that the cause of these mitochondrial disorders does not systematically rest on mutations or variants in the mtDNA molecule. Pathogenic mtDNA mutations have been reported in ASD patients, but this seems to be the exception rather than the rule. It is more likely that the real causes of mitochondrial deficiencies in some ASD cases are due to the intervention of several nuclear factors acting alone (additively or epistatically) or through a complex interplay with mtDNA variants. For the time being, while the cause for mitochondrion dysfunction in ASD remains unclear, there is no reason to indicate systematic screening for mtDNA mutations in ASD patients unless a mitochondrion disorder is suggested by a clear phenotype.

What is also interesting to me is the table of characteristics of the study subjects. In particular, there is a big difference in the percentage with epilepsy and dimorphism between adults and children:

Mitochondrial dysfunction is listed as mild and somewhat infrequent (about 10%). Not the very high prevalences of mitochondrial dysfunction that some have suggested are present in autitics. This does beg the question: should this genetic study be performed on those with some measure of mitochondrial dysfunction?

This doesn’t mean that mitochondrial dysfunction isn’t an important area for autism research, or that a genetic study such as this shouldn’t be done on a larger group with some measure of mitochondrial dysfunction.

Of course it would be great to hear that there is something definitive in this study. As in, “this is it!” rather than “this probably isn’t it”. Mitochondrial DNA mutations “probably isn’t it” when it comes to the etiology of ASD in most people.

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My guess is that you are reading this thinking: this is news? Doesn’t pretty much every day go by without Robert F. Kennedy holding a press conference? Well, yes. But there was a press conference planned for Monday. Yes, the man who brought you “Deadly Immunity” (an article promoting the mercury/autism link that was so flawed that it was retracted by Salon.com and quietly removed from the Rolling Stone website) has something so new and important that he wants to tell the world about it from in front of the White House.

The subject? A study purportedly showing that many autistic kids have been compensated over the years by the National Vaccine Injury Compensation Program (a fact that has been public knowledge for 9 years or more). The article, under review by his University’s law journal, appears to be the one which was touted as ongoing a few years ago (I recall this being on a piece by David Kirby on the Huffington Post before he focused on his new project of food safety).

That press conference, from what I’ve heard, has been put off until after the paper is actually accepted and published.

Here’s the background history:

1) The US adopts a National Vaccine Injury Compensation Program in the mid-late 1980’s.

2) Autistic kids are amongst those compensated.

3) The concept of a vaccine-induced autism epidemic gains momentum in the late 1990’s.

4) Enough cases are submitted to the Program that an Omnibus proceeding is started to cover all the cases.

5) The first item added to the docket, Autism General Order #1, tells attorneys to be aware that autistics with table injuries should be handled outside the Omnibus for faster processing. (year 2002)

One important caveat, however, is drawn to the attention of all petitioners and their counsel! There may be cases involving autistic-like disorders which manifested following an injury defined in the Vaccine Injury Table. That is, a vaccine may have suffered an episode involving a severe acute encephalopathy within 72 hours after a pertussis vaccination (DTP or DTaP), or 5 to 15 days after an MMR vaccination. If so, such an acute encephalopathy and any residual effects thereof would be presumed to be vaccine-caused pursuant to the Vaccine Injury Table.

and

Autism cases involving Table Injuries have been compensated under the Program. If in a particular case there exist medical records demonstrating that such a qualifying “acute encephalopathy” occurred within the appropriate time frame, petitioner or counsel should bring that to the assigned special master’s attention so that, if appropriate, the case can be processed without delay as a Table Injury.

6) The government concedes Hannah Poling’s case as a table injury (late 2007) and the Hannah Poling concession was leaked while still in process. (Feb. 2008).

7) Given the news focus generated, then Chief Special Master Gary Golkiewicz was quoted:

“Years ago, actually, I had a case, before we understood or knew the implications of autism, that the vaccine injured the child’s brain caused an encephalopathy,” he said. And the symptoms that come with that “fall within the broad rubric of autism.”

And there are other somewhat similar cases, Golkiewicz says, that were decided before autism and its symptoms were more clearly defined.

8) Kathleen Siedel found a number of cases which were in the public record involving vaccine injury cases compensated. This list then appeared in many places, including a journal paper.

9) it was signaled that a new study was in the works where the prevalence of autism was notably higher amongst people compensated in the vaccine-injury program.

10) The autism prevalence estimate in the US was increased to 1 in 100, up from 1 in 150. Whether this had an impact on the apparent delay of (9) I can’t say.

Short form: we’ve been waiting for years for the study which will show us that the fraction of kids compensated by the Court is higher than expected. Now it appears that the study is in process and in a law journal. And that Robert F. Kennedy wanted to tell us all about it on Monday. But that won’t happen now, apparently. Apparently even law journals have embargoes.

Even though the press conference seems to be canceled for now, I guess that sometime in the near future Robert F. Kennedy will confirm what is and has been public knowledge. This will be followed by a blog storm acting as though this is news. Perhaps I’ll be surprised and something new will be in the announcement.

So far, the fraction of children with ASD diagnoses who have been compensated by the Autism Omnibus Proceeding is 1 in 838. This isn’t a fair estimate of what the final fraction will be, as many of those cases dismissed are for procedural issues like failure to prosecute and timeliness of filing. For that one compensated case, there is the note:

*May include case(s) that were originally filed and processed as an OAP cases but in which the final adjudication does not include a finding of vaccine-related autism.

**HHS has never concluded in any case that autism was caused by vaccination.

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A study published today looks for mitochondrial dysfunction in autistic children. In specific, the researchers are looking directly at the brains of autistic children. The team, from the University of Washington, used both MRI (Magnetic Resonance Imaging) and proton magnetic resonance spectroscropic imaging (HRMS). MRI gives structural information on soft tissues. HMRS is a “spectroscopic” techinque: it gives chemical information on
Here’s a good reference with a discussion of HMRS on brain tissue (as a spectroscopy, not an imaging technique): Quantitative neuropathology by high resolution magic angle spinning proton magnetic resonance spectroscopy

With that background in hand, here is the abstract from the recent study on autism:

Proton Magnetic Resonance Spectroscopy and MRI Reveal No Evidence for Brain Mitochondrial Dysfunction in Children with Autism Spectrum Disorder.

Corrigan NM, Shaw DW, Richards TL, Estes AM, Friedman SD, Petropoulos H, Artru AA, Dager SR.

Department of Radiology, University of Washington, Seattle, WA, USA.
Abstract

Brain mitochondrial dysfunction has been proposed as an etiologic factor in autism spectrum disorder (ASD). Proton magnetic resonance spectroscopic imaging ((1)HMRS) and MRI were used to assess for evidence of brain mitochondrial dysfunction in longitudinal samples of children with ASD or developmental delay (DD), and cross-sectionally in typically developing (TD) children at 3-4, 6-7 and 9-10 years-of-age. A total of 239 studies from 130 unique participants (54ASD, 22DD, 54TD) were acquired. (1)HMRS and MRI revealed no evidence for brain mitochondrial dysfunction in the children with ASD. Findings do not support a substantive role for brain mitochondrial abnormalities in the etiology or symptom expression of ASD, nor the widespread use of hyperbaric oxygen treatment that has been advocated on the basis of this proposed relationship.

Does this mean that mitochondrial dysfunction never occurs in autistics? No. But it makes it very unlikely that more than a fraction of autistics have mitochondrial dysfunction in their brains.

Beyond that, the use of spectroscopic imaging is very impressive to me. MRI structural data is quite valuable on its own, but adding chemical information is very powerful.

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Mitochondrial disease and autism. I don’t read about it as much as during the peak of the Hannah Poling story, but it is a big topic. Emily Willingham at
Thinking Person’s Guide to Autism has put together an excellent post on the subject. Here’s the first paragraph:

Hannah Poling’s family entered the national spotlight when they revealed that Hannah’s autism-like symptoms may have been linked to a reaction to several childhood vaccines at once in combination with her mitochondrial dysfunction. Her case was not the first revelation of a possible mitochondrial disorder (MD)-autism spectrum disorder (ASD) link, but because of her ultimately successful vaccine injury suit, she became the avatar of the vaccines-cause-harm movement—which almost eclipsed the real scientific and therapeutic feature of her case: the mitochondria.

I’d love to do a wholesale copy of the post, but that’s hardly fair now, is it? So, I’ll send you all to the Thinking Person’s Guide to Autism and Mitochondrial Disease and Autism: Linked?

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Families who have filed claims as part of the Omnibus Autism Proceeding, OAP, should read the latest update from the Court.

Many families who filed can’t be found, by the court or by their attorneys. They need to contact the court if they wish to keep their cases going. Otherwise they risk the cases being dismissed.

I find this an interesting point. People have moved on, literally. They filed and they haven’t kept in contact to continue their cases.

Also, the Petitioner’s Steering Committee (the group of attorneys working together on the Omnibus) has dissolved.

The Omnibus is over. Petitioners can either exit the vaccine program, go ahead with the theories the petitioners steering committee proposed and tried (and lost), or come up with new theories.

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A recent paper from the MIND Institute, published in the Journal of the American Medical Association (JAMA) entitled Mitochondrial Dysfunction in Autism caused a bit of a stir. One which is far beyond what is supported by the paper’s conclusions or data, I will add.

The study is very small: 10 autistic children and 10 controls. The authors used a very nonstandard methodology. Perhaps the best summary of this study so far can be found on the Simons Foundation blog SFARI (Defects in mitochondria linked to autism). Deborah Rudacille discusses the methodology and brings in quotes from the study’s lead author (Cecilia Giulivi) as well as established experts in the field of mitochondrial disease and autism such as Jay Gargas.

Before I get too far ahead of myself, here is the abstract:

Context Impaired mitochondrial function may influence processes highly dependent on energy, such as neurodevelopment, and contribute to autism. No studies have evaluated mitochondrial dysfunction and mitochondrial DNA (mtDNA) abnormalities in a well-defined population of children with autism.

Objective To evaluate mitochondrial defects in children with autism.

Design, Setting, and Patients Observational study using data collected from patients aged 2 to 5 years who were a subset of children participating in the Childhood Autism Risk From Genes and Environment study in California, which is a population-based, case-control investigation with confirmed autism cases and age-matched, genetically unrelated, typically developing controls, that was launched in 2003 and is still ongoing. Mitochondrial dysfunction and mtDNA abnormalities were evaluated in lymphocytes from 10 children with autism and 10 controls.

Main Outcome Measures Oxidative phosphorylation capacity, mtDNA copy number and deletions, mitochondrial rate of hydrogen peroxide production, and plasma lactate and pyruvate.

Results The reduced nicotinamide adenine dinucleotide (NADH) oxidase activity (normalized to citrate synthase activity) in lymphocytic mitochondria from children with autism was significantly lower compared with controls (mean, 4.4 [95% confidence interval {CI}, 2.8-6.0] vs 12 [95% CI, 8-16], respectively; P = .001). The majority of children with autism (6 of 10) had complex I activity below control range values. Higher plasma pyruvate levels were found in children with autism compared with controls (0.23 mM [95% CI, 0.15-0.31 mM] vs 0.08 mM [95% CI, 0.04-0.12 mM], respectively; P = .02). Eight of 10 cases had higher pyruvate levels but only 2 cases had higher lactate levels compared with controls. These results were consistent with the lower pyruvate dehydrogenase activity observed in children with autism compared with controls (1.0 [95% CI, 0.6-1.4] nmol × [min × mg protein]?1 vs 2.3 [95% CI, 1.7-2.9] nmol × [min × mg protein]?1, respectively; P = .01). Children with autism had higher mitochondrial rates of hydrogen peroxide production compared with controls (0.34 [95% CI, 0.26-0.42] nmol × [min × mg of protein]?1 vs 0.16 [95% CI, 0.12-0.20] nmol × [min × mg protein]?1 by complex III; P = .02). Mitochondrial DNA overreplication was found in 5 cases (mean ratio of mtDNA to nuclear DNA: 239 [95% CI, 217-239] vs 179 [95% CI, 165-193] in controls; P = 10?4). Deletions at the segment of cytochrome b were observed in 2 cases (ratio of cytochrome b to ND1: 0.80 [95% CI, 0.68-0.92] vs 0.99 [95% CI, 0.93-1.05] for controls; P = .01).

Conclusion In this exploratory study, children with autism were more likely to have mitochondrial dysfunction, mtDNA overreplication, and mtDNA deletions than typically developing children.

As the abstract states, the MIND Institute study methodology involved: “Mitochondrial dysfunction and mtDNA abnormalities were evaluated in lymphocytes from 10 children with autism and 10 controls”. Lymphocytes (a type of white blood cell). Children were concecutively recruited and genetically unrelated. Mitochondrial function was tested first, and given the results seen, children were brought back for a second blood draw where mitochondrial DNA (mDNA) and nuclear DNA (nDNA) were examined.

As shown in the figure below, they found that the autistic children had different mitochondrial activity levels than their controls. Note that “low” activity is not referenced to any standardized norms, but to the 10 control children.

They also performed genetic testing. Table 3 from the paper is reproduced below:

They show that, by their methodology, 7 of their 10 autistic kids have some form of genetic signature for mitochondrial dysfunction. 2 of 10 of their controls meet their criteria as well.

The Simons blog quotes the study author, Prof. Giulivi on this choice:

“Lymphocytes do not rely as heavily on mitochondria as the brain does,” she says, “so if this is happening in cells that don’t use mitochondria as much, it’s likely to be happening in cells that rely more heavily on mitochondria, like neurons.”

They also quote Dr. Fernando Scaglia, of the Baylor Clinic:

However, the unconventional decision to use lymphocytes should have been validated, says Fernando Scaglia, associate professor of molecular and human genetics at Baylor College of Medicine in Houston. “I’m not saying that studies done in lymphocytes are useless,” says Scaglia, an expert in inherited metabolic disease. “But they should be validated in other tissue.”

and Prof. Gargas of the University of California at Irvine:

“Lymphocytes are fine to study chromosomal DNA, but they are a horrible source for studying mitochondrial DNA,” he says.

Cells have hundreds of mitochondria, each with multiple copies of the DNA. In people with mitochondrial disease, some cells have healthy DNA and others have the mutated copies, he notes. In a blood sample, defective lymphoctyes tend to get lost among rapidly proliferating healthy cells.

“The best source for studying mitochondria are post-mitotic cells such as muscle,” he says. “That way you are sampling the set of cells the child was born with.”

In the end, if we stick to the idea that this is a very preliminary report and relies on a new unproven methodology at that, we can consider the study as posing interesting questions. Is mitochondrial dysfunction more prevalent in autistics than the general population? Are there ways to test this in a faster, less intrusive manner than is often used? If we take this study in context, there may be some value. Unfortunately as Seth Mnookin has already pointed out, this study has already been used to promote ideas that are clearly outside of the study and conclusions. This is the unfortunate world of autism research: it is hard for people to push the boundaries and risk being wrong. Not because it may cause the researchers some embarrassment, but because there are a multitude of people waiting to misuse information and mislead.

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