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Court Clarifies: Hannah Poling case “does not afford any support to the notion that vaccinations can contribute to the causation of autism”

8 Jul

One of the most common arguments in the “vaccines-cause-autism” discussion involves the case of Hannah Poling. Miss Poling is autistic and was compensated by the government through the vaccine-court system. Online discussions usually end up going around in circles with people explaining why the concession doesn’t mean the government has stated that vaccines cause autism, and the other side saying “but it does”.

Well, the Court has clarified the situation. Here is a footnote from the decision in Brian Hooker’s case.

I am well aware, of course, that during the years since the “test cases” were decided, in two cases involving vaccinees suffering from ASDs, Vaccine Act compensation was granted.
But in neither of those cases did the Respondent concede, nor did a special master find, that there was any “causation-in-fact” connection between a vaccination and the vaccinee’s ASD. Instead, in both cases it was conceded or found that the vaccinee displayed the symptoms of a Table Injury within the Table time frame after vaccination. (See Section I above).

In Poling v. HHS, the presiding special master clarified that the family was compensated because the Respondent conceded that the Poling child had suffered a Table Injury–not because the Respondent or the special master had concluded that any vaccination had contributed to causing or aggravating the child’s ASD. See Poling v. HHS, No. 02-1466V, 2011 WL 678559, at *1 (Fed. Cir Spec. Mstr. Jan. 28, 2011) (a fees decision, but noting specifically that the case was compensated as a Table Injury).

Second, in Wright v. HHS, No. 12-423, 2015 WL 6665600 (Fed. Cl. Spec. Mstr. Sept. 21, 2015), Special Master Vowell concluded that a child, later diagnosed with ASD, suffered a
“Table Injury” after a vaccination. However, she stressed that she was not finding that the vaccinee’s ASD in that case was “caused-in-fact” by the vaccination–to the contrary, she
specifically found that the evidence in that case did not support a “causation-in-fact” claim, going so far as to remark that the petitioners’ “causation-in-fact” theory in that case was “absurd.” Wright v. HHS, No. 12-423, 2015 WL 6665600, at *2 (Fed. Cl. Spec. Mstr. Sept. 21, 2015).

The compensation of these two cases, thus does not afford any support to the notion that vaccinations can contribute to the causation of autism. In setting up the Vaccine Act
compensation system, Congress forthrightly acknowledged that the Table Injury presumptions would result in compensation for some injuries that were not, in fact, truly vaccine-caused. H.R. Rept. No. 99-908, 18, 1986 U.S.C.C.A.N. 6344, 6359. (“The Committee recognizes that there is public debate over the incidence of illnesses that coincidentally occur within a short time of
vaccination. The Committee further recognizes that the deeming of a vaccine-relatedness adopted here may provide compensation to some children whose illness is not, in fact, vaccine related.”

While the arguments may still not convince those who wish to believe, the conclusion is clear: The compensation of these two cases, thus does not afford any support to the notion that vaccinations can contribute to the causation of autism.

The Special Masters (basically the judges in this special court) are not only the experts in the decisions (they work every day in the court and write the decisions), they are legally bound by the decisions. If a case sets a precedent, they must follow it. Or they will be overturned by higher courts.

I agree that following the logic takes time and effort, but, again, if you don’t have the time to go through that, the conclusion is very clear. And repeated again for emphasis

The compensation of these two cases, thus does not afford any support to the notion that vaccinations can contribute to the causation of autism.


By Matt Carey

The next Hannah Poling. Not vaccine injured. No mitochondrial disease.

27 Jun

One of the main talking points for the idea that autism is a “vaccine induced epidemic” is the case of Hannah Poling. Hannah Poling was chosen as one of the test cases for the Omnibus Autism Proceeding (OAP). But before the case went to hearing, the Department of Health and Human Services conceded her case on the grounds that she met the criteria for a table injury. If you want more details there are a lot of discussions online, including a lot of misinformation. But basically a table injury means that Miss Poling met certain criteria in a prescribed time frame after receiving vaccines, so she is presumed vaccine injured. One can go into length about how this isn’t “the vaccine court decided vaccines caused her autism”, but that’s another story (if you are interested, Prof. Dorit Reiss discusses it in Vaccine Injury Compensation and Mitochondrial Disorders).

At the time, the Poling concession was big news, on CNN and elsewhere. The story broke when David Kirby released some of the details of the concession (the Rule 4c report, a report written by Department of Justice attorneys on behalf of HHS describing the concession.) Kirby was journalist/PR man working with groups promoting the idea that vaccines cause autism. Much of his writing was problematic at best, much more PR than journalism. Kirby stayed with the Poling story for some time, pushing the idea that mitochondrial disorders are highly prevalent in the autistic population and suggesting that these disorders were caused by vaccines. As part of that PR effort, he wrote this article:

The Next Vaccine-Autism Newsmaker: Not Isolated, Not Unusual

Which begins:

In February, I leaked news of the Federal government’s admission that vaccines had triggered autism in a little girl named Hannah Poling. The stunning revelation, though still reverberating around the world, was roundly downplayed by US officials, who insisted that Hannah had an extremely rare, genetic case of “aggravated” mitochondrial disorder, with zero bearing on other autism cases.

Dr. Julie Gerberding, Director of the US Centers for Disease Control and Prevention (CDC), rushed to the airwaves, exhorting parents to adhere to the nation’s intensive and virtually mandatory immunization schedule, and brushing off their legitimate anxieties by saying: “We’ve got to set aside this very isolated, unusual situation.”

Well, the days of setting aside are over: Hannah Poling is neither isolated nor unusual.

In fact, the boy who was selected to replace Hannah Poling as the first-ever thimerosal “test case” in so-called Vaccine Court, has just been found with many of the same unusual metabolic markers as… you guessed it, Hannah Poling.

You see, Hannah Poling was supposed to be a test case for the OAP. One of the arguments the families and attorneys were going to argue in the OAP was that autism is a form of mercury poisoning caused by thimerosal (which used to be in infant vaccines as a preservative.) That idea (and the Wakefield inspired MMR causes autism and bowel disease) failed to even come close to the rather lenient standard of proof of the vaccine court. No one knew for sure before the OAP hearings that the thimerosal argument would fail so completely. Those involved actually had a great deal of confidence. But even with this confidence, some families decided to leave the OAP when the Poling concession was made public.  Most notably Robert Krakow (an attorney and activist in the autism-is-vaccine-injury community) pulled his son’s case from the OAP. His son was to be one of the three thimerosal test cases and is the one Mr. Kirby was discussing in his “Not Isolated, Not Rare” article quoted above.

In many ways it was a strange decision on the part of Mr. Krakow. The expert report on the Krakow boy (made public as part of the OAP and since pulled) made no mention of mitochondrial dysfunction. Also, the court hadn’t decided that the idea that vaccines aggravate mitochondrial disorders causes autism. While many deny this, as an attorney Mr. Krakow must have known this point. Miss Poling was compensated because she showed signs of an encephalopathy soon after vaccination, so it was presumed that encephalopathy was caused by the vaccines. The Krakow boy’s history did not show this.

In another recent case, a vaccine court Special Master noted,

In Poling v. HHS, the presiding special master clarified that the family was compensated because the Respondent conceded that the Poling child had suffered a Table Injury–not because the Respondent or the special master had concluded that any vaccination had contributed to causing or aggravating the child’s ASD.

So the situation for the Krakow boy (and Hannah Poling)  was very, very different than David Kirby painted (as was often true). This wasn’t another Poling case. Mr. Krakow and his attorneys and experts would have to show that (a) his son had real signs of mitochondrial dysfunction, (b) the hypothesis that vaccines vaccines contribute to causing autism was valid (recall, it hadn’t been decided by hearing), (c) this hypothesis applied to his son even though his son didn’t show signs of encephalopathy following vaccination.

As you will see, none of these points were valid.

Mr. Krakow pulled his son’s case  in 2008. The case dragged on for 7 years as the Krakows tried to put together their argument. And it appears that they did not win. Based on the facts presented, these documents appear to be the final decision and a ruling on motions in the Krakow case. These have been anonymized so it is possible that these are not a discussion of the Krakow case, but since the facts so closely match, I will write as though it is the Krakow case for brevity and clarity.

The decisions are lengthy. This case is as involved–if not more–than those in the OAP itself. It’s as if this is the test case for a third OAP argument.

Here is a key paragraph from the documents:

“Petitioners have failed to show that A.K. had an underlying mitochondrial disorder. They have also failed to show that the onset of A.K.’s ASD was in any way related to his influenza vaccinations. Indeed, respondent persuasively presented significant evidence indicating that A.K.’s ASD onset predated his vaccinations. Nor did petitioners establish by preponderant evidence that A.K. experienced any regression of skills related to his ASD or his vaccinations””

The Krakow boy’s history is in no way similar to that of Hannah Poling. Since her case was conceded, we don’t know if she showed signs of autism before vaccination. We do know now that the Krakow boy did show signs of autism. Poling regressed. Krakow didn’t. Poling has evidence of mitochondrial disease. Krakow doesn’t.

There are other interesting statements in these documents. Here are a few. First:

“The measles, mumps, and rubella [“MMR’] vaccines are ordinarily administered in a combined MMR vaccination, but A.K. received his in three separate vaccinations administered on December 1, 2000 (mumps); December 19, 2000 (measles), and January 2, 2001 (rubella), when he was between 13-14 months of age”

Yes. The Krakow family was following the Wakefield-recommended “separate the MMR into single vaccines” schedule. Didn’t prevent autism. This seems like valuable information for the autism community, but Mr. Krakow chose to hold this information back.

The Special Master took on the general idea that vaccines trigger regression in people with mitochondrial disorders. The evidence is very much lacking and “remain speculative”.

Here, petitioners’ experts strained to stretch the idea of mitochondrial regression to encompass vaccines as triggers of such regression. As described above, that extension is completely unsupported by any scientific literature; it was presented in this case almost entirely through the opinion of Dr. Kendall, supported by one case report (Poling, Res. Ex. MM, Tab 14). Doctor Kendall’s and Dr. Shafrir’s further reliance on the Shoffner and Weissman papers was misplaced and their opinions that vaccines can act as triggers of mitochondrial regression were unpersuasive. Evidence that regression in ASD, a well-described phenomenon involving the loss social communication and behavior, “looks like” mitochondrial regression was also nearly non-existent. “Mitochondrial autism” may someday be accepted as a descriptor for co-morbid autism and mitochondrial disorder diagnoses, but there is little evidence that autism itself is caused by such disorder, and no evidence that autism causes mitochondrial disorders. While Dr. Kendall is one of the few mitochondrial disorder specialists in the U.S., her opinion that vaccines can trigger either onset of a mitochondrial disorder with symptoms looking like ASD, or ASD via a mitochondrial regression are insufficiently supported and remain speculative.

We parents are often hit with testimonials about how alternative medicine works wonders on autistic kids. With the OAP cases we heard about a child who had adverse reactions to chelation. In this case we hear that these alternative therapies just didn’t work:

Doctor Boris recommended a gluten-free, casein-free diet for A.K. and began therapies such as chelation, supplements to counteract the effects of his MTHFR gene defect, and autoimmune medications. Tr. at 168-69. He testified that A.K. “did not respond very well to most of the treatments [he] administered.”

In an interesting twist, The Krakow boy’s geneticist  recommended he get vaccinations:

I [the special master] noted that the geneticist who had been seeing A.K. had specifically recommended that he continue to receive vaccinations and indicated that he was a “good candidate” to receive seasonal vaccinations, such as influenza.

Many people have been trying to characterize the “vaccine court” (the Court of Federal Claims) as highly adversarial. But Mr. Krakow writes that “The tenor of VICP proceedings is exceptionally hostile and adversarial”. The record show the Court was far from hostile and adversarial.

Consider this. The record shows that Robert Krakow (an attorney who appears in the vaccine court) and the attorney he chose to take over his son’s case were not proactive in prosecuting their case:

Other than the filing of medical records, petitioners did little to advance their claim during the period in which [A.K.’s father] was attorney of record.

and

However, the glacial pace of progress toward a causation hearing continued for many months thereafter. Mr. McHugh’s representation has been marked with missed deadlines, repeated requests for delays, late filings, and difficulties in properly designating and filing exhibits. His failure to meet deadlines nearly cost petitioners the opportunity to fully litigate their son’s claim.

That last sentence refers to the fact that after years of delays and missed deadlines, the court was finally forced to dismiss the case for inaction:

Accordingly, after petitioners missed the deadlines set forth in my August 18, 2010 order, I ordered them to show cause why their case should not be dismissed for failure to prosecute and comply with court orders. See Order to Show Cause, issued Sept. 3, 2010 (ECF No. 98). After petitioners ignored the deadline in the show cause order, I dismissed their petition on October 13, 2010.

The Court allowed the family to petition and re-enter the vaccine program. Not only that, but the Court granted the motion to redact parts of the dismissal. The dismissal was available on the vaccine court website (where I found and read it) but was pulled.

Many in the “autism is a vaccine epidemic” community call for a repeal of the vaccine act and a return to the time when vaccine manufacturers could sued directly.  How many cases in regular court are dismissed and allowed back in?

We could go on as the decisions are lengthy but instead let’s get back to the key points above.  When David Kirby wrote his article he concluded “And there are many more Hannah’s out there, waiting to be counted.”  Just not so.  First off, the real Hannah Poling case isn’t what Kirby claimed. The Court has stated that neither they nor the government  “…concluded that any vaccination had contributed to causing or aggravating the child’s ASD.”  More importantly, this new  case isn’t about a child with mitochondrial disorder, or even regression. It is a case of a child who showed signs of autism before the vaccines the parents claim caused autism.

This is a case of one of the most vocal proponents of the idea that vaccines cause autism misleading the public.  Mr. Krakow probably believes the story he tells of his child’s development.  He probably believes the story about how contentious the vaccine court is. But the facts tell a very different story.

I am often asked why I can not support the idea that vaccines cause autism.  Thousands of parents tell the same story, I’m told.  The problem is that the parents stories don’t match the facts. We saw this with Jenny McCarthy. We saw this with the Omnibus Autism Proceeding test cases.  We’ve seen this with more vaccine court cases.  We’ve seen this with parent stories shifting in online discussions. And now we’ve seen this with “the next Hannah Poling”.

By Matt Carey

Stephen Bustin: Why There Is no Link Between Measles Virus and Autism

9 Apr

Andrew Wakefield promoted the idea that the MMR vaccine caused autism. While his now-retracted 1997 Lancet paper is most often discussed, the strongest evidence he had actually came in later work where his team reported that they found evidence of the vaccine strain of the measles virus in the intestinal tissues of autistic children. The team used a methodology called Polymerase chain reaction (PCR). PCR amplifies a specific fragment of DNA, allowing one to identify if small amounts of that gene are present in larger samples. PCR tests were performed by John O’Leary in Dublin. As revealed later, Andrew Wakefield had a business stake in this laboratory.

As part of the MMR litigation in the UK, the vaccine manufacturers hired Stephen Bustin to review the methods and results of the O’Leary laboratory. Those results were not made public, but Prof. Bustin later was called in to testify in the U.S. Autism Omnibus Proceeding (the vaccine court). That testimony was discussed here at LeftBrain/RightBrain and elsewhere. Prof. Bustin is one of the world’s experts on PCR.

Prof. Bustin has now written his own account of the history of the measles-virus/autism work by Mr. Wakefield’s team in Why There Is no Link Between Measles Virus and Autism. The full report is free, open access. The report discusses what he already disclosed in his testimony: the multiple failures which resulted in the reporting of a false association of measles virus and autism.

Some of those failures include:

Absence of transparency: the key publication shows no data; hence an expert reader cannot evaluate the reliability of its conclusions

Unreliable techniques and protocols: analysis of the qPCR data was incorrect

Disregard for controls: obvious evidence of extensive contamination was disregarded

Lack of reproducibility: the data could not be duplicated by several independent investigators

One key failure involved skipping key steps in using PCR on measles virus. The measles virus is an RNA virus. PCR is very inefficient at detecting RNA, so a step called reverse transcriptase is used to convert the RNA to DNA before PCR (RT-PCR). The O’Leary lab did not perform this step. This result, and others, show that the samples used by Mr. Wakefield’s team were contaminated. Prof. Bustin goes into detail and covers more important topics, and as the paper is relatively short, it is worth a read for those interested in the science.

Prof. Bustin concludes:

As a result, the conclusions put forward by this [the Wakefield/O’Leary] paper are entirely incorrect and there is no evidence whatever for the presence either of MeV genomic RNA or mRNA in the GI tracts of any of the patients investigated during the course of the studies reported by O’Leary et al. Instead, it is clear that the data support the opposite conclusion: there is no evidence for any MeV being present in the majority of patients’ analysed. Unfortunately, the authors do not report whether any the patients had received the MMR vaccination. However, assuming that a significant proportion had done so, it is also clear that there is no link between the MMR vaccine and the presence of MeV in the intestine of autistic children.

The Wakefield MMR hypothesis is already failed, so this does not really change the conversation. What this report by Prof. Bustin does is document his own observations, measurements and analyses for the historical record so we can see just how bad the science was that promoted the Wakefield hypothesis.


By Matt Carey

The Next Vaccine-Autism Newsmaker…5 years later

6 Feb

Years back, much focus in online autism parent community discussions focused on the Omnibus Autism Proceeding (OAP). This was the large “vaccine court” proceeding to explore if people could be compensated for autism as a vaccine injury. Those hearings were held in 2008, and the decisions went against the families.

A year ago I wrote (The Omnibus Autism Proceeding: effectively over), and while, yes, as an “Omnibus” it is effectively over, there is still activity for those who filed claims and were included in the Omnibus Autism Proceeding. Statistics as of today show there were 5,635 claims included in the Omnibus, and 4,564 have been dismissed. 2 claimants have been compensated, with the caveat given that “**HHS has never concluded in any case that autism was caused by vaccination.” This leaves 1,069 cases still pending. A relatively small fraction of the original Omnibus, but a large number nonetheless.

Another way to look at this is the Omnibus proceedings are over, the docket hasn’t been updated for quite some time but there are still individual cases to be decided. Including one case that was rather prominent in the Omnibus: that of A. Krakow. He was intended to be one of the test cases for the thimerosal but was pulled out to pursue another argument: that metabolic dysfunction is involved. David Kirby referred to him as “The Next Vaccine-Autism Newsmaker”, following the supposed game-changer of Hannah Poling.

That was in 2008. As it’s been nearly 5 years, I checked the status of the case. It turns out the first hearing was held in December (a hearing on fact) and a second hearing is set for expert witnesses to testify in April of this year. One way to explore the arguments the family may be taking is to review the experts that are testifying. For example, the family has chosen Richard Deth as an expert. His work has not focused on mitochondria. On the other hand, Yuval Shafir is also listed as an expert and has listed many articles on mitochondria with his report. Richard Frye’s CV was submitted (he also has some work on mitochondria and autism), but I don’t see that an expert report from him has been submitted.

Other experts date from 2008 (from when he was going to be an Omnibus test case) include: Elizabeth A. Mumper, Robert S. Rust, Richard Deth and Sander Greenland.

(edit to add, I see a report in the docket from Marcel Kinsbourne in 2010).

So, is this going ahead as a “mitochondrial autism” case? The “Next Hannah Poling” as David Kirby claimed in Spectrum Magazine? Well, even Hannah Poling wasn’t the game-changer some people predicted. Probably the most we can say is that is 10 years old, with a docket 16 pages long, will finally be heard.

edit to add: For the curious, here is the docket.

By Matt Carey

The Omnibus Autism Proceeding: effectively over

21 Jan

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 2,437 cases were filed (close to 1/2 of the total that would eventually be filed).

Is Mark Geier finished as an expert witness in the vaccine court?

10 Dec

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.

When the science fails you, turn to the legal option

10 May

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.

Questions in advance of study analyzing vaccine court cases for autism

20 Apr

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 shock 24 hours
B. Encephalopathy (or encephalitis) 3 days
C. Shock-collapse or hypotonic-hyporesponsive collapse 3 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.

Reassessing the role of mitochondrial DNA mutations in autism spectrum disorder.

12 Apr

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.

Robert F. Kennedy Jr. not holding a press conference on Monday

9 Apr

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.