
OSR: Off The Market
• OSR: The Littlest Consumers
• OSR: A Bevy Of Adverse Events
• OSR: Fuel For Thought
• FDA To Haley: OSR#1 A Misbranded, Mislabeled, Unsafe Drug
• On Autism: A Word Of Caution
• Participate in a New Gateway Study
• Study: Gender Identity In Individuals With Autism
• Improbable Causes & Extravagant Claims (Excerpts from Dwyer v. HHS)
• Thimerosal-Autism Test Cases Dismissed
• U.K. General Medical Council Rules Wakefield & Co. "Dishonest," "Irresponsible"
• Waist Deep In The Autism Fundraising Hole
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In a decision issued on July 24, 2009, Judge John P. Wiese of the United States Court of Federal Claims upheld the Vaccine Injury Compensation Program’s February 2009 dismissal of Hazlehurst v. HHS (Case 03-654V) — one of the three Omnibus Autism Proceeding test cases intended to establish that autism can be induced by the MMR vaccine, both on its own and in combination with vaccines containing the mercury-based antifungal thimerosal.
In so doing, the court affirmed VICP Special Master Patricia Campbell Smith’s evaluation of evidence purporting to detect the presence of measles virus in the gut tissue of autistic children as “critically flawed,” “scientifically untenable” and “glaringly unreliable,” and her assessment of the petitioners’ medical theory as “premised upon a series of biological implausibilities.”
In their appeal, the petitioners argued that it was “fundamentally unfair” for the special master to have considered evidence discrediting the work of Unigenetics, the now-defunct laboratory that produced positive test results for measles virus in their child’s intestinal tissue, and that admission of this evidence transformed the proceeding into “full blown tort litigation.” The court, however, concluded that “fundamental fairness” did not require the special master to disregard crucial evidence and effectively deny the U.S. Department of Health & Human Services the right to rebut the petitioners’ claims. The court observed that the special master had afforded the test case petitioners the opportunity to seek relevant reports from the UK MMR litigation and to recall microbiologist Dr. Stephen Bustin for further questioning for many months after the conclusion of the test case hearings, but that they had failed to do so, and concluded that the special master would have reached the same conclusion regarding the reliability of Unigenetics’ findings even in the absence of Dr. Bustin’s analysis.
The petitioners faulted the special master for discounting the significance of evidence produced by Dr. Stephen Walker and his colleagues at Wake Forest University School of Medicine, who also claimed to have found measles virus in autistic children. Calling attention to the testimony of petitioners’ expert Dr. Karin Hepner, who herself acknowledged that the Walker group’s preliminary, unpublished and unconfirmed findings findings were “not useful at this time,” the court concluded that those findings were not entitled to substantial weight.
Lastly, the petitioners contended that the special master had erred by failing to decide whether “regressive” autism is a distinct phenotype from “classic” autism. The court found, however, that the petitioners had failed to offer persuasive evidence that the MMR vaccine causes any type of autism, and that the scientific community does not distinguish between classic and regressive autism; therefore, it was “entirely proper” for the special master to refrain from devoting judicial attention to the matter.
In conclusion, the court expressed its sympathy for the petitioners and for other families dealing with autism spectrum conditions, and simultaneously affirmed its obligation to dispassionately evaluate the evidence presented to support their autism causation claims.
[T]his court, like the special master, acknowledges both the burdens many of these families have faced and the tremendous love and support they have shown their children. The facts, however, do not support petitioners’ appeal and we have no choice but to deny their motion. Accordingly, for the reasons set forth above, the special master’s decision of February 12, 2009, is affirmed.
Should the petitioners in Hazlehurst v. HHS choose to appeal Judge Wiese’s decision, that appeal will be heard by the U.S. Court of Appeals for the Federal Circuit.
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I listened to the first part of the audio from this appeal. It was interesting. Much less formal than the proceedings for the test case hearings. The judge was very involved in asking questions and taking part in discussion (and judge in the appeal vs. Special Master in the test cases).
The petitioners spent a great deal of time trying to get the Bustin testimony thrown out. They did this under the “fairness doctrine”, not based on any suggestion that Dr. Bustin was wrong. The judge noted that the fairness doctrine would also eliminate the Walker study. The Walker study has never been published, so it has not been exposed to peer review. I doubt the Walker study would pass the Althen standard used by the “vaccine court”, much less the Daubert standard in use in civil courts.
It would seem a very safe bet that this case will be appealed to the U.S. Court of Appeals. If they fail there, it will likely be the end of the appeals as the Supreme Court is unlikely to pick this case up. The Autism Omnibus cases do not touch on constitutional matters.
— Sullivan 2009-08-02 22:06 #Great blog posts….I will be adding you to my blogroll!
— Sharon daVanport 2009-08-18 12:45 #