The Autism Omnibus held hearings into three tests cases that were intended to establish a principle of general causation that links vaccinations with developmental conditions or neurological damage and would therefore qualify for compensation from the Vaccine Injury Compensation Program. Three families agreed to be the test cases presented in court – the Cedillos, the Hazelhursts and the Snyders – on behalf of the Petitioners’ Steering Committee (PSC). However, the panel of Special Masters has ruled that the PSC did not presented sufficient plausible or adequante evidence to demonstrate that vaccines are causally linked to autism in these children, even using the comparatively light standard of the ‘preponderance of evidence’. Brief ruling note.
Thousands of parents who claimed that childhood vaccines had caused their children to develop autism are wrong and not entitled to federal compensation, a special court ruled today in three decisions with far-reaching implications for a bitterly fought medical controversy…
The decision by three independent special masters is especially telling because the special court’s rules did not require plaintiffs to prove their cases with scientific certainty — all the parents needed to show was that a preponderance of the evidence, or “50 percent and a hair,” supported their claims. The vaccine court effectively said today that the thousands of pending claims represented by the three test cases are on extremely shaky ground.
In his ruling on one case, special master George Hastings said the parents of Michelle Cedillo — who had charged that a measles, mumps and rubella (MMR) vaccine caused their child to develop autism — had “been misled by physicians who are guilty, in my view, of gross medical misjudgment.”
There is some additional information on US Court of Federal Claims and the detailed rulings behind the decisions are available.
The three tests cases are known as Cedillo, Hazlehurst and Snyder.
Dr Michael Fitzpatrick gave an excellent account of why Professor Stephen Bustin’s testimony was so devastating to the petitioners’ case and the petitioners’ efforts to stop him presenting it: ‘The MMR-autism theory? There’s nothing in it’.
Testimony in a US court last week by London-based molecular biologist Stephen Bustin comprehensively exposed the unreliability of O’Leary’s findings, based on an investigation of his laboratory carried out in early 2004. ‘It has been incredibly frustrating’, Professor Bustin told me on his return from the USA. ‘For three years we have been unable [for legal reasons] to reveal our findings. Now, based on the publicly available information, I want to get the message out about the O’Leary/Wakefield research: there’s nothing in it.’
Bustin’s revelations follow a series of studies, using the most rigorous analysis techniques, which have failed to replicate O’Leary’s results…
We learn some of the details behind the petition to strike Professor Stephen Bustin’s authoritative and damning testimony about the flawed laboratory techniques (ftp and pdf) that underpinned Dr Andrew Wakefield’s research from consideration by the Autism Omnibus hearings.
Moreover, petitioners assert that “[m]ost of Dr.
Bustin’s testimony at the Cedillo hearing and all but 4 (of 25) slides in Dr. Bustin’s Power-Point[sic] presentation were also based on Dr. Bustin’s work for Mer[c]k, Aventis, and GSK.” Id. (citations omitted). Noting that the “claimants in the U.K. litigation relied on PCR testing from Unigenetics laboratory for both claimant specific evidence and in support of the general proposition that some children with regressive autism might have persistent measles infections,” petitioners contend that Dr. Bustin “was hired by Merck, Aventis and GSK to discredit the PCR results from Unigenetics laboratory.” [pg. 7] [Emphasis added.]
“The reliability of Dr. Bustin’s testimony may be evaluated, in part, by considering the testimony offered by other witnesses in this litigation either with knowledge of the laboratory testing technique of PCR or with personal knowledge about the laboratory testing methods employed by the Unigenetics laboratory. Both parties have presented witnesses with knowledge about PCR techniques in general or the laboratory practices of Unigenetics in particular that inform the undersigned’s consideration of the reliability of Dr. Bustin’s testimony, and the undersigned’s determination that Dr. Bustin’s testimony is more likely than not reliable. Additionally, having had an opportunity to observe Dr. Bustin during his testimony in the Cedillo hearing, the undersigned found Dr. Bustin to be a credible and very knowledgeable witness, who demonstrated a learned facility with the subject matter of his testimony….[pg. 11] [Emphasis added.]
As discussed in this ruling, Dr. Bustin’s testimony regarding the reliability of the test results obtained by the Unigenetics laboratory are particularly relevant in this case. The testimony of other witnesses in this case together with Dr. Bustin’s own presentation as a witness militates in favor of a finding that his testimony is scientifically reliable. Finally, the opportunity afforded to petitioners to make application to the court in the United Kingdom for the release of additional documents from the MMR/autism litigation that would rebut Dr. Bustin’s testimony satisfies the requirement of procedural fairness that inheres in Vaccine 8(c). Having considered petitioners’ requesti [sic] in the light of Vaccine Rule 8(c), the undersigned DENIES petitioners’ motion to strike.” [pp. 12-13.] [Emphasis added.]
One of the recurring elements in the three reports concerning the cases of the children is that all of the Special Masters express their sympathy for their families and their respect for them: they acknowledge that they found the parents’ accounts to be very moving. All of them paid tribute to the loving families that they saw and the sincerity of the parents: they reserved harsh criticism for the physicians they felt had mislead the families so egregiously.
In the case of Cedillo v. Secretary of Health and Human Services (ftp and pdf).
Special Master George L. Hastings, Jr.
Ronald Homer and Sylvia Chin-Caplan, Boston, Massachusetts, for petitioners
Vincent Matanoski and Lynn Ricciardella, U.S. Department of Justice, Washington, D.C., for respondent
The petitioners in this case have advanced a causation theory that has several parts, including contentions (1) that thimerosal-containing vaccines can cause immune dysfunction, (2) that the MMR vaccine can cause autism, and (3) that the MMR vaccine can cause chronic gastrointestinal dysfunction. However, as to each of those issues, I concluded that the evidence was overwhelmingly contrary to the petitioners’ contentions. The expert witnesses presented by the respondent were far better qualified, far more experienced, and far more persuasive than the petitioners’ experts, concerning most of the key points. The numerous medical studies concerning these issues, performed by medical scientists worldwide, have come down strongly against the petitioners’ contentions. Considering all of the evidence, I found that the petitioners have failed to demonstrate that thimerosal-containing vaccines can contribute to causing immune dysfunction, or that the MMR vaccine can contribute to causing either autism or gastrointestinal dysfunction. I further conclude that while Michelle Cedillo has tragically suffered from autism and other severe conditions, the petitioners have also failed to demonstrate that her vaccinations played any role at all in causing those problems. [pg. 2] [Emphasis added.]
Nor do I doubt that Michelle’s parents and relatives are sincere in their belief that the MMR vaccine played a role in causing Michelle’s devastating disorders. Certainly, the mere fact that Michelle’s autistic symptoms first became evident to her family during the months after her MMR vaccination might make them wonder about a possible causal connection…After studying the extensive evidence in this case for many months, I am convinced that the reports and advice given to the Cedillos by Dr. Krigsman and some other physicians, advising the Cedillos that there is a causal connection between Michelle’s MMR vaccination and her chronic conditions, have been very wrong. Unfortunately, the Cedillos have been misled by physicians who are guilty, in my view, of gross medical misjudgment. Nevertheless, I can understand why the Cedillos found such reports and advice to be believable under the circumstances. I conclude that the Cedillos filed this Program claim in good faith.
Thus, I feel deep sympathy and admiration for the Cedillo family. And I have no doubt that the families of countless other autistic children, families that cope every day with the tremendous challenges of caring for autistic children, are similarly deserving of sympathy and admiration. However, I must decide this case not on sentiment, but by analyzing the evidence. Congress designed the Program to compensate only the families of those individuals whose injuries or deaths can be linked causally, either by a Table Injury presumption or by a preponderance of causation-infact evidence, to a listed vaccination. In this case the evidence advanced by the petitioners has fallen far short of demonstrating such a link. Accordingly, I conclude that the petitioners in this case are not entitled to a Program award on Michelle’s behalf. [pg. 173-4] [Bold emphasis added.]
In the case of Hazlehurst v. Secretary of Health and Human Services (ftp and pdf).
The Hazlehursts’ experience as parents of an autistic child, as described during the evidentiary hearing in this case, has been a very difficult one. The undersigned is moved as a person and as a parent by the Hazlehursts’ account and again extends to the Hazlehursts very sincere sympathy for the challenges they face with Yates. The undersigned’s charge, however, does not permit decision making on the basis of sentiment but rather requires a careful legal analysis of the evidence.
The parties have submitted a wealth of evidence and have presented the testimony of a number of experts who have extensive clinical and research experience in the particular areas of interest in this case. Having carefully and fully considered the evidence, the undersigned concludes that the combination of the thimerosal-containing vaccines and the MMR vaccine are not causal factors in the development of autism and therefore, could not have contributed to the development of Yates’ autism. The weight of the presented evidence that is scientifically reliable and methodologically sound does not support petitioners’ claim. Petitioners have failed to establish entitlement to compensation under the Vaccine Act. Absent the filing of a timely motion for review, the Clerk of the Court shall enter judgment accordingly. [Emphasis added.] [pp. 199-200.]
Snyder v. Secretary of Health and Human Services (ftp and pdf).
After considering the record as a whole, I hold that petitioners have failed to establish by preponderant evidence that Colten’s condition was caused or significantly aggravated by a vaccine or any component thereof. The evidence presented was both voluminous and extraordinarily complex. After careful consideration of all of the evidence, it was abundantly clear that petitioners’ theories of causation were speculative and unpersuasive. Respondent’s experts were far more qualified, better supported by the weight of scientific research and authority, and simply more persuasive on nearly every point in contention. Because of pervasive quality control problems at a now-defunct laboratory that tested a key piece of evidence, petitioners could not reliably demonstrate the presence of a persistent measles virus in Colten’s central nervous system. Petitioners failed to establish that measles virus can cause autism or that it did so in Colten. They failed to demonstrate that amount of ethylmercury in TCVs causes immune system suppression or dysregulation. They failed to show that Colten’s immune system was dysregulated. Although Colten’s condition markedly improved between his diagnosis and the hearing, the experimental treatments he received cannot be logically or scientifically linked to the theories of causation. Given the advice that petitioners received from a treating physician, Colten’s parents brought this action in good faith and upon a reasonable basis. However, they have failed to demonstrate vaccine causation of Colten’s condition by a preponderance of the evidence. Therefore, I deny their petition for compensation. [pp. 2-3] [Emphasis added.]
To conclude that Colten’s condition was the result of his MMR vaccine, an objective observer would have to emulate Lewis Carroll’s White Queen and be able to believe six impossible (or, at least, highly improbable) things before breakfast. The families of children with ASD and the court have waited in vain for adequate evidence to support the autism-MMR hypothesis. Although I have the deepest sympathy for families like Colten’s, struggling emotionally and financially to find answers about ASD’s causes, and reliable therapies to treat ASD’s symptoms, I must decide Colten’s case based on the evidence before me. That evidence does not establish an adequate factual basis from which to conclude that Colten’s condition was caused by his vaccines.…
Petitioners have not demonstrated by a preponderance of the evidence that Colten’s condition was either caused or significantly aggravated by his vaccinations[.] Thus, they have failed to establish entitlement to compensation and the petition for compensation is therefore DENIED. [pg. 278] [Emphasis added.]
Snyder v. Secretary of Health and Human Services (ftp and pdf) also contains some commentary from Dr Rima about Unigenetics, the lab that was the subject of extensive and detailed criticism by Stephen Bustin who revealed that it was contaminated and ran poor procedures.
For a period of about five years, Dr. Rima was one of the defense experts in the U.K. MMR litigation. His report was filed in two parts, with the first a general description of measles virus and virology, and the second an evaluation of the claims for the presence of measles virus in the tissue of various claimants in the litigation. His work also involved explaining measles virology to the legal teams. His appearance in the Snyder hearing was the first time he had testified in court. Snyder Tr. at 828A-830A.
Doctor Rima was a superb expert witness. He was well-qualified in the subject matter of his testimony, testified directly and forthrightly, and made extremely difficult topics understandable. He made his disapproval of certain laboratory practices perfectly plain, without engaging in ad hominem attacks… [pg. 17]
Irreconcilable Conflicts in Unigenetics’ Test Results
Even if all three test results are accepted as probative and reliable evidence, there is a serious conflict among them. There is no biologically plausible explanation for Colten’s blood to test negative, the gut biopsy to test positive at a very low copy number (or, as Dr. Kennedy called it, “indeterminate” (Snyder Tr. at 380A)),526 and his CSF to test positive for a very high level of the virus.
Doctor Rima explained that because measles is an entirely cell-associated virus, the F gene reported as present in Colten’s CSF must have come from cells in the CSF. Snyder Tr. at 881A. Doctor Ward concurred, noting that measles virus has not been isolated from plasma, only from cells. The only cells in the CSF are lymphoid (white blood) cells, the same white blood cells circulating in the blood. Snyder Tr. at 950-51A.
Assuming a long-term, persistent measles infection, measles-infected cells in the CSF are inconsistent with the PBMCs having no detectible virus. Snyder Tr. at 881A-82A. If there were high levels of infection in the white blood cells of the brain, it is logically inconsistent that the virus would be absent from the white blood cells in the peripheral circulatory system. Snyder Tr. at 950-51A. [pg. 266] [Emphasis added.]
Test results from hospital or independent laboratories are generally reported in a “headline” form, and are accepted in that form. That is, the laboratory report reflects the test performed and the results therefrom, compared to established normal values, without reference to any underlying data concerning the manner in which the testing was performed.
Doctor Rima raised concerns about Unigenetics “headline” report for measles virus in Colten’s case based on the specific amount reported for Colten being biologically implausible…He explained that the CSF results reported by Unigenetics for the three children in Dr. Bradstreet’s 2004 paper were all scientifically implausible because the amounts of F gene reported were simply too high to be believed….
A test that produces impossible results should not be relied upon, and certainly should not be
accepted at face value. Even if test results are, in the normal course of business, presumed to be valid, Dr. Rima’s testimony shifted the burden of establishing the validity of Unigenetics’ results back to petitioners. They failed to convince me that Unigenetics’ test results were reliable… [pg 269] [Emphasis added.]
In the U.K. litigation, Dr. Rima had access to both the headline reports and the underlying data for those reports. The underlying data included the CT number, RNA extraction data, the CT for the GAPDH in the same run, the results for the known positive and negative standards, the actual copy number535 and information concerning other samples in the same run. Snyder Tr. at 850A. In Colten’s case, Dr. Rima had none of that background data to examine.
There were several discrepancies in the way Unigenetics reported their copy numbers. The most disturbing one was the way Unigenetics handled discordant results. If one run showed a result of zero and the next run of the same sample showed a result of 2,400, Unigenetics would report the sample as positive at 2,400 copies. This happened frequently. Doctor Rima called this reporting method bad science. [pg. 269-70] [Emphasis added.]
Same Snyder case also has a seemingly harsh yet fair discussion of the expert witnesses that the petitioners chose to field: Snyder v. Secretary of Health and Human Services.
Doctor Kinsbourne was the pivotal petitioners’ witness on causation in both Cedillo and Snyder, providing the theories upon which the causation cases were based. In some measure, his testimony that measles virus caused some cases of autism reflected one of the concerns about expert testimony reliability discussed in Kumho Tire. In what has become known as “the same intellectual rigor” test, the Supreme Court stated that a judge is obligated to ensure that the testimony of experts reflects “the same level of intellectual rigor that characterizes the practice of an expert in the relevant field.” Kumho Tire, 526 U.S. at 152. In a book chapter he authored, filed as Cedillo Pet. Ex. 61, Tab PP,42 Dr. Kinsbourne included a chart on the causes of autism. In his testimony in Cedillo, he used the same chart, but with one addition; he included measles as a cause. Cedillo Tr. at 1169-70. A fair assessment of this change is that Dr. Kinsbourne was unwilling to say measles was a cause of autism in a publication for his peers, but was willing to do so in a Vaccine Act proceeding.
Another concern is that Dr. Kinsbourne suffers from the stigma attached to a professional witness–one who derives considerable income from testifying in Vaccine Act cases. In the 20 years of the Vaccine Program’s existence, Dr. Kinsbourne has appeared as an expert witness in at least 185 decisions. 43 This figure does not include his opinions in the many unpublished cases adopting stipulations of settlement, nor does it reflect pending cases in which he has filed an expert opinion. Payment for expert testimony is expected, and the mere receipt of payment does not, of itself, cast doubt upon an expert’s qualifications or opinions. See Daubert, 43 F.3d at 1317 (noting, however, that an expert’s normal workplace should be “the lab or the field, not the courtroom or lawyer’s office”). I emphasize that I gave Dr. Kinsbourne’s opinions full and fair consideration, and that the frequency in which he appears as a petitioners’ witness was but one small factor in the myriad of reasons I found them to be unpersuasive. [pp. 18-19] [Emphasis added.]
[Details of qualifications, experience and credentials.] Doctor Wiznitzer was an excellent expert witness, and well-qualified one to offer opinions on autism’s diagnosis, cause, and treatment. He was the witness primarily, although not exclusively, involved with rebutting Dr. Kinsbourne’s opinions on the biological mechanisms by which vaccine strain measles virus could cause autism. Doctor Wiznitzer’s greater qualifications contributed to the greater credibility of his opinions on this topic. His opinions were buttressed by the scientific journals he discussed and cited. I found him forthright and credible. [pg. 22] [Emphasis added.]
NB – if any of the following criticism of Dr Byers seems harsh, we have to say that the Special Master expresses the matter with great discretion and comparative delicacy, as did Dr Michael Fitzpatrick in his account. Dr Byers demeanour and the errors in her testimony beggared belief as you might discern from Ms Clark’s account at Autism Diva. It was so bad that leading anti-vax figure, Sherri Tenpenny was forced to spin a remarkable theory.
Ya have to wonder if someone got to her or threatened her kids by her response. Absolutely unbelievable and I would suspect was really unexpected by the Chin-Conway team or they wouldn’t have put her on the stand. pNB Chin-Conway were the legal team for the petitioners.]
Still from Snyder v. Secretary of Health and Human Services.
Doctor Byers’ credibility was not enhanced by several instances of apparent “resume padding.” Her CV indicated that she was still on the faculty at the University of Nottingham, although her work there ended in 2000. Doctor Byers explained that it was “an old CV.” Cedillo Tr. at 960A. Her CV described that she was “Medical director on the team responsible for filing the BLA [Biologics License Application] for Embrel,” that secured approval for Embrel as a treatment for rheumatoid arthritis. She acknowledged on cross-examination that this statement was “not exactly correct” and that she was “a consultant medical director.” Cedillo Tr. at 958-60A. When informed that there was no record at the FDA of Dr. Byers playing any role in the Embrel licensing application, she stated that the information did not make any difference because she was a member of the team that secured Embrel’s approval. Cedillo Tr. at 959-60A. Her testimony on cross-examination regarding her faculty status at UCSF was somewhat confusing. She stated that she was an adjunct faculty member and participated in rounds with the doctors there from 1974-1981and in 1984, and “was there episodically probably through about two years ago.” In preparation for her evaluation of the U.K. litigants, she spent three or four months in the immunodeficiency clinic to “find out what was new.” Cedillo Tr. at 960A-64A. Her other involvement with the UCSF medical school was using the library, attending social functions, and taking a class in biostatistics. Cedillo Tr. at 964A. According to the university (Cedillo Res. Tr. Ex. 5), she taught an occasional class, but had “no significant activity in the last decade.” Doctor Byers’ CV described her as a “medical toxicologist” with “hands-on experience in assessing medical damage to over 3000 patients in the past 15 years.” Cedillo Pet. Ex. 58 at 1. Her testimony indicated that these were patients seen to determine if litigation concerning toxic exposures was warranted. She had not seen patients, other than in a litigation context, for the prior seven years. Cedillo Tr. at 964A-966.
Even without considering Dr. Byers’ apparent misstatements on her CV, I find that she was not a particularly good expert witness. Her testimony was disjointed and often unclear. It was apparent, particularly when she testified about the purported effects of mercury on the immune system, that she did not have a solid understanding of the toxicokinetics of mercury, and she strayed into matters beyond her expertise. Doctor Byers’ insistence that it was acceptable to use adult norms to measure the immune function of infants and young children (Cedillo Tr. at 994) was, frankly, incredible, particularly when she was provided with documents reflecting the relevant pediatric norms. [pg 24] [Emphasis added.]
As an indication of how poor the case was, Special Master Hastings wrote this in the Cedillo case.
I have not required a level of proof greater than “more probable than not,” which has also been described as “50 percent plus a feather.” I understand fully that petitioners are not alleging that the MMR vaccine was the sole cause of Michelle’s disorders, but are alleging only that the vaccine contributed to the causation of her disorders, possibly in concert with an underlying genetic vulnerability. I have looked beyond the epidemiologic evidence to determine whether the overall evidence–i.e., medical opinion and circumstantial evidence and other evidence considered as a whole–tips the balance even slightly in favor of a causation showing as to any of Michelle’s conditions.
This case, however, is not a close case. The overall weight of the evidence is overwhelmingly contrary to the petitioners’ causation theories. The result of this case would be the same even if I totally ignored the epidemiologic evidence, declined to consider the video evidence, and/or excluded the testimony of Dr. Bustin. The result would be the same if I restricted my consideration to the evidence originally filed into the record of this Cedillo case, disregarding the general causation evidence from the Hazlehurst and Snyder cases. The petitioners’ evidence has been unpersuasive on many different points, concerning virtually all aspects of their causation theories, each such deficiency having been discussed in detail above. The petitioners have failed to persuade me that there is validity to any of their general causation arguments, and have also failed to persuade me that there is any substantial likelihood that Michelle’s MMR vaccination contributed in any way to the causation of any of Michelle’s own disorders. To the contrary, based upon all the evidence that I have reviewed, I find that it is extremely unlikely that any of Michelle’s disorders were in any way causally connected to her MMR vaccination, or any other vaccination.
In short, this is a case in which the evidence is so one-sided that any nuances in the interpretation of the causation case law would make no difference to the outcome of the case. [pg. 172-3] [Bold emphasis added.]
Special Master Hastings in Cedillo v. Secretary of Health and Human Services (ftp and pdf) found a poverty of evidence for petitioners’ claims for toxic levels of mercury from cumulative vaccines in combination with ‘mercury efflux disorder’.
I have examined all of the items of medical literature cited by petitioners, and those items do contain some evidence indicating that mercury in some forms and dosages can be toxic. However, a thorough examination of the record makes it clear that there is no evidence, beyond Dr. Aposhian’s own assertion, that ethylmercury, in the very small amounts contained in thimerosal-containing vaccines, can damage infant immune systems, or otherwise contribute to autism in any way. For example, none of the medical articles, cited by petitioners at the pages of their brief set forth above, conclude or even suggest that thimerosal or ethylmercury, in the amounts contained in infant vaccines, can damage immune systems or cause other harm. Accordingly, I conclude that those general citations of petitioners to medical literature do not offer any substantial support to their theory that thimerosal-containing vaccines can damage the infant immune system…[pp. 31-32] [Emphasis added.]
Two additional experts also gave brief testimony on behalf of petitioners concerning this general issue. Dr. Vera Byers, M.D., Ph.D., an immunologist…offered testimony that seemed to generally support Dr. Aposhian’s theory that the thimerosal in thimerosal-containing vaccines can cause immune system damage…The testimony of Dr. Byers, however, was quite vague. She repeatedly emphasized that concerning this issue of the possible effects of mercury on the immune system, it was her intent to “defer” to Dr. Aposhian, or that she was “relying” on Dr. Aposhian…indicating that she was merely adopting Dr. Aposhian’s conclusion on this issue, not developing her own opinion. Beyond relying on Dr. Aposhian, she did not offer any analysis concerning how she reached her opinion on this point, except to indicate that she was relying on the Goth and Agrawal studies, which I have found to be of dubious value for reasons discussed above…
The main point of Dr. Byers’ testimony seemed to be her conclusion that Michelle Cedillo had a malfunctioning immune system, thereby allowing the vaccine-strain measles virus to persist in her system. To be sure, Dr. Byers generally indicated the conclusion that this malfunction of Michelle’s own immune system was at least in part the result of her thimerosal-containing vaccines…[O]ther than her brief discussion of the Goth and Agrawal articles, Dr. Byers did not provide any support for her apparent conclusion that thimerosal-containing vaccines can damage immune systems, saying only that she was relying on Dr. Aposhian for that point.
I conclude that Dr. Byers’ testimony, concerning this general issue of whether thimerosal containing vaccines can damage the immune system, was not persuasive. Dr. Byers’ testimony in this regard was far outweighed by the testimony of Dr. Brent and respondent’s other witnesses, discussed above.
Additionally, petitioners pointed to the opinion of another of their experts, Dr. Marcel Kinsbourne, asserting that he listed “mercury” as a “possible cause of immune dysregulation.” A close reading of the section of the transcript cited by petitioners, however, indicates that Dr. Kinsbourne was careful to offer no opinion of his own concerning this topic. He stated only that mercury was “one of the possibilities” as a cause for the alleged immune dysregulation of Colten Snyder, and he also noted that even in going that far, he was not stating his own opinion, but was “relying on another expert’s independent opinion on that”. Dr. Kinsbourne also made it quite clear, during his testimony in this Cedillo case, that he does not have an opinion of his ownas to whether thimerosal-containing vaccines can cause immune dysfunction…
Accordingly, I find that the testimony of Dr. Kinsbourne, like that of Dr. Byers, offered no support to the petitioners’ assertion that thimerosal-containing vaccines can damage human immune systems. [pp. 32-3] [Bold emphasis added.]
Likewise, in this case, Special Master Hastings found no reason to repose confidence in any results that relied upon testing at Unigenetics.
[A] number of factors have contributed to my conclusion that the Unigenetics testing for measles virus cannot be considered reliable. As explained, the most important factors in my rejection of the Unigenetics testing are that the laboratory failed to publish any sequencing data to confirm the validity of its testing, the failure of the efforts by other laboratories to replicate the Unigenetics testing, and the demonstration by the D’Souza group that the Uhlmann primers were “nonspecific.”
In addition, the testimony of Drs. Bustin, Rima, and MacDonald convinced me that severe problems existed with the procedures, facilities, and equipment of the Unigenetics laboratory, adding a secondary, additional reason to doubt the reliability of the Unigenetics testing. Other important factors are the failure of the petitioners to supply any persuasive evidence that any purportedly detected measles virus material was vaccine-strain measles virus material, the dramatic contrast between the credentials of the expert witnesses for the two sides, and the lack of persuasiveness of the petitioners’ main arguments.
For all of those reasons, I conclude that the Unigenetics testing for measles virus was not reliable. I conclude that the Unigenetics laboratory never reliably detected the presence of measles virus, in the Uhlmann study or in the testing of individual samples of persons such as Michelle Cedillo and Colten Snyder. And, in particular, I conclude that the purported detection by Unigenetics of measles virus in the tissue of Michelle Cedillo was not reliable and cannot be considered valid. [pp. 77-78.] [Bold emphasis added.]
Special Master Hastings then addressed the specific issue of the theory that the MMR vaccine is causative for autism in some individuals.
After a complete analysis of the record, I conclude that I must reject both petitioners’ general theory concerning the causation of autism, and their contention that the measles virus substantially contributed to Michelle’s own autism. Petitioners have failed to demonstrate that it is “more probable than not” either that the MMR vaccine can cause or contribute to autism in general, or that a MMR vaccination did cause or contribute to Michelle’s autism…
I will divide my discussion, concerning petitioners’ general theory that the measles virus can contribute to the causation of autism, into nine parts below. Those points may be summarized as follows:
First, Dr. Kinsbourne’s general causation theory depends, in any individual case, upon the existence of a reliable laboratory test that finds persisting measles virus in the autistic child’s body. Such a reliable test, however, likely does not exist.
Second, even if in some case a reliable test could demonstrate the existence of persisting vaccine-strain measles virus in an autistic person’s body, the available evidence still does not demonstrate that measles virus persistence in the brain would result in autism.
Third, the fact that the wild measles virus has never been shown to cause autism makes it quite unlikely that the vaccine-strain form of the measles virus can cause autism.
Fourth, Dr. Kinsbourne’s causation theory seems unlikely in light of several accepted understandings concerning the causation of autism. The theory seems doubtful in light of the accepted points that there is a strong genetic component to autism, and that the only non-genetic factors that have ever been conclusively found to contribute to autism are factors that influence development during the early prenatal period. The petitioners’ theory is also directly contradicted by autopsy studies demonstrating that the brains of autistic individuals show abnormal features that, of necessity, would have occurred during specific parts of the prenatal period.
Fifth, there are other difficulties with Dr. Kinsbourne’s theory, especially the contradictions and inconsistencies in Dr. Kinsbourne’s testimony concerning the appropriate time period between MMR vaccination and onset of autism symptoms, under his causation theory.
Sixth, the testimony of Dr. Corbier, Dr. Hepner, and Dr. Kennedy fails to provide any substantial support to Dr. Kinsbourne’s causation theory.
Seventh, the qualifications of the respondent’s experts concerning this issue substantially exceed the qualifications of the petitioners’ expert witnesses.
Eighth, the epidemiologic evidence, consisting of numerous studies by qualified medical researchers around the world, adds another reason to reject the petitioners’ theory that the MMR vaccine can contribute to the causation of autism.
Ninth, two well-qualified committees of medical experts, selected by the Institute of Medicine, have extensively studied the general MMR/autism causation issue, and have concluded that the evidence favors rejection of the proposition that the MMR vaccine can cause autism. [pp. 87-88] [Bold emphasis added.]
Special Master Hastings then detailed his reasoning for each of the 9 points. He followed this with his detailed reasoning for finding that “accepted scientific understandings make petitioners’ theory seem unlikely”.
I want to be clear that, in including this point concerning “accepted” scientific understandings, I do not mean to suggest that a petitioner’s causation theory must automatically be rejected simply because it differs from “generally accepted” medical thinking, or because it goesbeyond “generally accepted” medical principles. To the contrary, under the applicable case law, a petitioner certainly may advance a new and unproven medical theory, and may prevail on a causation issue via such a theory, if the petitioner can supply adequate evidentiary support for that theory…My point here, rather, is simply that because of the way in which the petitioners’ general causation theory diverges from scientifically accepted points, there is reason to be cautious in evaluating that theory…
I note that it is certainly not necessary to resolve, in this case, the general question of whether any postnatal environmental factors, other than the MMR vaccine, can contribute to the causation of autism. That is, even if the evidence showed clearly that some postnatal factors can contribute to the causation of autism, that by tself would still do very little to advance the petitioners’ general causation case here. The petitioners would still need to demonstrate that a particular postnatal factor, the MMR vaccine, can contribute to the causation of autism. And that they have failed to do. [pg. 100] [Bold emphasis added.[
Special Master Hasting’s then discussed several additional problems with the testimony of the petitioners’ key witness, Dr Kinsbourne. One of the most interesting details is that Kinsbourne had argued that Michelle Cedillo had been developing normally until her MMR vaccine with a sudden onset of autism afterwards. However, the respondents’ expert witnesses had convincingly demonstrated otherwise.
particular case, her first signs of autism actually preceded her MMR vaccination.
Moreover, respondent’s experts testified that even when signs of autism are first recognized during a child’s second year of life, that does not provide significant evidence that some environmental factor played any type of causal role in the autism. In this regard, those experts noted that, as explained above (pp. 93-94), there is a strong genetic component to autism, and that a number of disorders that are undisputedly genetic in origin, such as Huntington’s disease and Rett’s syndrome, do not manifest themselves until long after birth. [pg. 102] [Bold emphasis added.]
It seems that Kinsbourne’s testimony relied heavily upon the research and publications of Dr Andrew Wakefield.
Accordingly, it is relevant to note that Dr. Wakefield’s causation theory has not only failed to gain acceptance in the medical community, but instead has been strongly criticized. I will discuss those criticisms below, in my discussion of the petitioners’ gastrointestinal claims, since petitioners’ gastrointestinal expert, Dr. Krigsman seemed even more strongly influenced by Dr. Wakefield’s theory…
To be sure, this is a minor point, since Dr. Kinsbourne’s causation theory does differ, in the
proposed mechanism, from Dr. Wakefield’s original theory. I have evaluated Dr. Kinsbourne’s theory on its own merits, and simply found that theory to be unpersuasive. However, the fact that Dr. Kinsbourne’s theory was influenced by Dr. Wakefield’s theory is at least worthy of note. [pg. 103] [Bold emphasis added.]
I also note that in listing and discussing the epidemiologic studies relevant to the MMR/autism causation issue, the IOM committee also mentioned the above-described original article published by Wakefield and colleagues in 1998. The authors of that article examined the medical records of 12 children who each had a history of loss of developmental skills, and also had intestinal symptoms. Ten of the 12 seemed to have a disorder falling within the autism spectrum, and in most of those individuals the initial autistic symptoms were first noticed within two months after MMR vaccination. The authors concluded from these findings that they had possibly discovered a “unique disease process” or “syndrome” in which children had both developmental disorders and intestinal disorders, both potentially linked causally to the MMR vaccine.
That Wakefield article, however, cannot be considered to offer significant evidence concerning the MMR/autism causation issue. The article was intended to raise a question about a possible causal association—a question that would then be addressed in the future by large epidemiologic studies. (Such studies have in fact taken place, and have failed to find any evidence of association—see discussion […] above). The study examined only 12 individuals, far too few to yield any strong evidence concerning causation. The 2004 IOM Report pointed out that “because of the overlap in timing between the typical age at which ASD symptoms are initially suspected and the [typical] schedule for MMR * * * vaccinations,” it was hardly surprising that the Wakefield authors could find some children whose autistic symptoms were first noted within two months after MMR vaccination. The IOM report concluded that the Wakefield article was simply “uninformative” concerning the MMR/autism causation issue. Dr. Fombonne also pointed out deficiencies in the Wakefield article.
I agree with the 2004 IOM Report that the 1998 Wakefield article is simply uninformative concerning the MMR/autism causation issue. I also note that, after Wakefield himself came under considerable professional criticism, ten of Wakefield’s twelve co-authors on the 1998 article published a letter in which they clarified that a causal link between MMR vaccine and autism had not been established by their study. Furthermore, they formally “retract[ed]” the causation interpretation suggested in the original article. (pp. 117-118)