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Posted by on Aug 29, 2010 in Infectious diseases, Legal, Pediatrics

Decision Upheld: Vaccines Did Not Cause Autism

Decision Upheld: Vaccines Did Not Cause Autism

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At the heart of Cedillo v. US DHHS was the claim that thimerosal-containing vaccines damaged Michelle Cedillo’s immune system, which then allowed attenuated measles virus in the MMR vaccine to injure her brain, thereby causing autism. It’s a convoluted (and medically illogical) argument, but one that was ostensibly supported, at least in part, by data from a questionable Dublin-based laboratory, Unigenetics.

In the original 2009 decision against the petitioner in the Omnibus Autism Proceeding,* Special Master George Hastings found the detection of vaccine-derived measles virus by Unigenetics in an intestinal sample from Cedillo “not reliable.” The decision was based partly on expert testimony from Stephen Bustin, PhD, a UK-based molecular biologist who, as part of UK vaccine litigation, had obtained access to the Unigenetics laboratory and some of its relevant data. On the basis of a number of procedural flaws at Unigenetics, Bustin testified both in the UK and US courts that the company’s work was plagued with potentially contaminating errors. Bustin also suggested that results from Unigenetics might even be fraudulent, after reviewing some of the laboratory’s altered notebooks.

Access to documents from Unigenetics, on which Bustin based his expert opinion, was the crux of a recent appeal by Cedillo’s parents to the US Court of Appeals for the Federal Circuit. This appeal was denied Friday, August 27th. And while the appeal court ruled that Special Master Hastings “erred in permitting the government to introduce the expert reports and testimony of Dr. Bustin because the government did not make available the underlying Unigenetics documents upon which Dr. Bustin relied,” the court also noted that Hastings had given the petitioners virtually every opportunity to obtain this information from the UK court themselves, which they apparently did not try to do. (It should be noted that the government argued against the reliability of Unigenetics with other expert testimony. It is presumed on this basis that the Special Master’s error was not a reversible one.)

In 2007, the government, in its case preparation, successfully petitioned the UK court to release the Bustin reports, but it did not request the laboratory notebooks or other data on which Bustin relied. The appellate decision further describes the background facts, 

The government explained at oral argument that UK counsel informed them that an application to the UK court requesting “everything” from the UK litigation would be denied as overbroad, and as a result, they needed to narrow their request to the most essential items. The government therefore subsequently “honed down” their request to cover solely the three reports, two of which were filed by Dr. Bustin, that they eventually obtained.

The upshot: Cedillo v. US DHHS has been put to bed.

In a coda to this case, it can be said that life, outside the courtroom, moves relatively quickly and in curious directions. Unigenetics dissolved as a company 5 years ago, although its former director, pathologist John O’Leary, is evidently still working in Dublin at Trinity College. In 2008, O’Leary, in an apparent effort to regain academic credibility, was coauthor of a multi-institutional study (“Lack of association between measles virus vaccine and autism with enteropathy: a case-control study” in PLoS One) that essentially negated the results produced by his own company for Cedillo.

DHHS = Department of Health and Human Services; MMR = measles-mumps-rubella.

* Which was affirmed by Judge Thomas Wheeler in the US Court of Federal Claims.

bmartin (1127 Posts)

A native East Tennessean, Barbara Martin is a formerly practicing, board-certified neurologist who received her BS (psychology, summa cum laude) and MD from Duke University before completing her postgraduate training (internship, residency, fellowship) at the Hospital of the University of Pennsylvania in Philadelphia. She has worked in academia, private practice, medical publishing, drug market research, and continuing medical education (CME). For the last 3 years, she has worked in a freelance capacity as a medical writer, analyst, and consultant. Follow Dr. Barbara Martin on and Twitter.