Autism omnibus trial

On June 11, 2007, the US Court of Federal Claims opened hearings on what has been dubbed the autism omnibus trial. This trial stems from over 4,800 lawsuits filed by families claiming that thiomersal contained in earlier vaccinations and the measles in the mumps-measles-rubella (MMR) vaccine played a causal role in the development of autism in their children.

Build-up to trial
On October 1, 1988, the National Childhood Vaccine Injury Act of 1986 created the National Vaccine Injury Compensation Program (VICP). During the 1980s, there was rising concern over the potential liability of vaccine producers. To "streamline" any such issues, the US Congress established a fund that would be created by charging an extra $0.75 tax on each vaccine. This fund could be used to pay out any claims from anyone who could prove they had been injured due to a vaccine. It was established that the US Court of Federal Claims would hear the case and make a ruling to assess the claimants' causal link of injury to the vaccine.

In 2001, Dr. Thomas Verstraeten published preliminary results that showed a potential link between autism and thiomersal (later, larger studies conducted by Verstraeten in 2003 would show that this effect was not replicable, and he would conclude there is no link). The first finding served as the motivating force for almost 5,000 families (and is still touted as undeniable proof), led by various anti-vaccination advocacy groups, to file claims against the VICP on the grounds of a thiomersal-autism link.

All 5,000 cases were lumped into an "omnibus" trial set. Since all the cases revolve around the same findings, a series of "test cases" were scheduled to be heard. Between 2001 and 2007, a significant number of delays occurred, mainly because all the scientific evidence the claimants relied on turned out to be wrong, and they were searching for new evidence. Finally, in June 2007, the first test case was heard over three weeks. This case is that of Theresa Cedillo, who claimed that her 12-year-old daughter Michelle's autism was caused by vaccination. The trial ended on June 26, 2007.

Plaintiffs have claimed that this is the first time the connection between autism and vaccinations has had a hearing in a court of law. This is not the case, as the autism and vaccination link had been brought up in several courts over the last 20 years but has always been thrown out at the early stages.

Special masters and the US Court of Federal Claims
The VICP is a "no-fault" administrative procedure, which means that any claims deemed valid do not assign fault to the vaccination company or the product, nor is there any criminal liability imposed. Since it is an "administrative" claim against a funding source that the US Congress put into place, the cases are not heard in a "court of law". The US Court of Federal Claims is ordered by the VICP to hear the cases, but they are not heard by judges. Rather, three "special masters" were appointed to hear the case:


 * Denise Vowell, a former US Army chief trial judge
 * Patricia Campbell-Smith, a former environmental lawyer and clerk at the Federal Claims Court
 * George Hastings, a former tax claims expert

The "no-fault" aspect cut both ways: if the special masters deem no connection exists, it does not invalidate any potential legal action in another court. Likewise, attorneys for the plaintiffs had promised civil and criminal action against the vaccination companies after the omnibus hearings were all concluded.

Plaintiff's "experts" present their case
At 8:58 a.m. this morning, Teresa and Michael Cedillo of Yuma, Arizona pushed their 12-year-old, wheelchair-bound daughter Michelle to the front of a gleaming federal claims courtroom. While the court officers listened in silence, Michelle, a pudgy girl with short hair, yelled and groaned and punched herself in the face for a few minutes, before her guardians wheeled her back out of the room. No one was to misunderstand what this proceeding was about.

It's a little bizarre that way, because the lawyers for the claimants — so normally when you go into a court where a judge is making the decision … there's a podium right in front of the judges and the lawyers stand in front of the judges... in this case the claimants' attorney turned the podium around and spoke to the audience instead of to the special masters who will actually make the decision and I think it tells a lot about this case.

This was not a trial, it was a circus, and the pseudoscience pushers were out in full force. Williams, Love, O'Leary, Craine, and Powers represented the plaintiffs in this case. This law firm has made its mark by representing the "thousands of children" who have "suffered severe neurological damage, including autism, as a result of their exposure to a toxic preservative added to many of the most common childhood vaccines." This firm represented many of these families and was probably hoping to get some of that $2.5 billion stashed away by the government.

The plaintiffs rolled out some "serious" experts and theories in their sideshow of a case, such as:
 * Dr. Vasken Aposhian, a toxicologist with a wide range of crazy ideas about mercury (an atom in the thiomersal molecule). He claimed that Michelle's autism was caused by "mercury efflux disorder" and was pushing a bizarre idea that the thiomersal in one vaccine damaged Michelle's immune system to the point that the MMR vaccine penetrated the GI tract and attacked the brain. This idea is so… novel… that Aposhian testified on the stand that "he had elaborated it 'about three or four weeks ago' based on journal articles from other scientists." Aposhian was slaughtered on cross-examination when he was forced to admit there was no record of any child becoming autistic due to mercury exposure.
 * Five additional witnesses were called to support Dr. Aposhian's claim: gastroenterologist Arthur Krigsman, molecular biologist Karin Hepner, immunologist Vera Byers, virus immunologist Ronald C. Kennedy, and pediatric neurologist Marcel Kinsbourne (a "regular" for autism/vaccine trials). The main point of these witnesses was to describe the purported sequence of events where the thiomersal in previous vaccines degraded the immune system, which allowed the measles in the MMR vaccine to infect the girl's gut and eventually her brain. In addition to her autism, the claimants stated that all of Michelle's illnesses were caused by the MMR, including inflammatory bowel disease, a seizure disorder, arthritis, and chronic eye inflammations.
 * The only non-anecdotal evidence presented by these witnesses was that a tissue sample of Michelle's gut that was analyzed by Dr. John O’Leary showed measles RNA. O'Leary and his lab had previously published that they had made this discovery in several autistic children and had been making the rounds offering to do this lab work for others. The whole case seems to rest on this evidence. Unfortunately, the O'Leary results failed repeated attempts at replication and have been criticized for methodological problems.
 * Childhood videos were shown of Michelle between 6 and 8 months to demonstrate that she was a "normal" baby before suddenly and inexplicably developing autism after the MMR shot. This video would soon become important evidence against the Cedillo case, where an expert on autism diagnosis would find plenty of evidence even at 8 months of Michelle's neurodevelopmental problems.

Several interesting things emerged from this part of the case. First, the plaintiffs had originally slated many more witnesses than ultimately called, including such notables as Mark Geier and Andrew Wakefield. These "regulars" of autism trials suddenly disappeared come the start of the trial. Another interesting point is that none of the plaintiffs' experts were stationed out of hospitals, and many had turned testifying in court into a career. The state witnesses were established experts at respectable research labs and hospitals.

Science responds
The Cedillo case can be broken down into the following claims:
 * Michelle was normal before receiving the MMR vaccine, evidenced only by a series of home videos between 6 and 8 months.
 * The thiomersal in early vaccines degraded Michelle's immune system, although the only evidence presented to support this was that a couple of plaintiff experts thought this might be possible.
 * The degraded immune system allowed the measles to infect Michelle and cause autism and other health problems. Again, the only evidence offered for this was the O'Leary lab claiming to find measles RNA in Michelle's gut.

The Cedillo claim falls apart if any one of these claims or their evidence is shown to be faulty. In the end, the state witnesses showed that all three of these and the evidence for them were bogus:

Michelle was a normal baby who got sick suddenly
Dr. Eric Fombonne, a professor and Head of the Division of Child Psychiatry at McGill University, Montreal Children's Hospital, dissected the first point. Fombonne broke down the videos the plaintiffs had earlier presented to show that even as early as 6–8 months (well before she received her vaccine), Michelle was showing stereotypical autistic patterns. In the videos, Fombonne testified that Michelle failed to follow hand and eye indications from her mother, exhibited repetitive arm flapping, and showed a single-purpose obsession with a Sesame Street video. All of these are classic indications of a neurodevelopmental disorder such as autism. Fombonne also points out that these are sometimes hard for parents, particularly new parents, to spot as abnormal. However, he also says that any expert in diagnosis would immediately see these behaviors as indicative of autism.

Thiomersal damaged the immune system
The State presented Dr. Jeffrey Brent, a pediatrician and medical toxicologist at the University of Colorado, countered the nonsensical theory about thiomersal. Brent re-iterated that every large-scale study that has ever been done on thiomersal-containing vaccines has shown no ill effects. The evidence presented by the experts for the plaintiffs for immune system damage by thiomersal was based on in-vitro exposure of immune cells to several hundred to a thousand times the dosage present in vaccines. Based on extensive evidence to the contrary, Brent summed up the plaintiff's theory that thiomersal caused Michelle to be sensitive to a measles infection as, "That couldn't possibly be the case".

Measles detected in the GI tract
Kinsbourne, one of the plaintiff's experts, said quite plainly that the detection of the measles RNA in the GI tract was the key to the whole case. Kinsbourne said the whole hypothesis would fall apart if that was not the case. The O'Leary lab used a technique to identify the measles RNA called PCR, or polymerase chain reaction (which basically consists of putting genetic material in a soup of enzymes and nucleotides, putting it through repeated heating/cooling cycles, and thereby obtaining vast numbers of copies of the original DNA/RNA in a relatively short time). The state's expert to dissect O'Leary's claim was Dr. Stephen A. Bustin. Bustin is a renowned expert in PCR techniques and impeccably credentialed.

Bustin laid out a trail of incompetencies — and perhaps out-and-out fraud — by O'Leary. This is nothing new since the British government conducted a detailed investigation of O'Leary's lab and decided to pull all funding from it and shut it down in 2002. What O'Leary detected could not have been measles: the detected sample the lab put forth as measles turned out to be DNA, not RNA, and measles does not contain any DNA. Every attempt to replicate the O'Leary results in other studies ultimately failed. There's no way to emphasize enough that this part of the case is absolutely wrong, and there's no doubt that it was contamination that O'Leary was picking up. Perhaps Bustin himself said it best: So all of this evidence suggests very, very strongly that what they are detecting is DNA and not RNA. Because measles virus doesn’t exist as a DNA molecule in nature, they cannot be detecting measles virus RNA. They are detecting a contaminant. All of the additional evidence, from the nonreproducibility by Professor Cotter of the same samples that Unigenetics analyzed to the analysis of the data where there are discordant positives, where the negatives came up positive, suggests very, very strongly to me that there is a lot of contamination in the laboratory, which is not unusual, but they have not handled it very well in how they have troubleshot their problems.

So I have very little doubt that what they are detecting is a DNA contaminant and not measles virus, and I do not believe there is any measles virus in any of the cases they have looked at.

Analysis
The scientific testimony has been devastating to the plaintiffs because the recognized experts on autism, vaccines, and immunology do not support even one of these premises, let alone a linkage between any of them. The only thing the government and Cedillos agree on is that Michelle Cedillo has autism.

The government position is backed by the overwhelming weight of scientific evidence, which has repeatedly found the vaccines safe. But what the Cedillos and other parents lack in hard data, they have made up for with a stubborn passion and sorrow that science cannot dispute. "It is parents versus science," said Kevin Conway, one of the attorneys for the Cedillos.

The question about whether vaccines play a role in the development of autism was answered well before this trial began. Extensive studies of the evidence in the field and lab have put it to bed. The problem is that parents are looking for someone to blame, and there are far too many quacks in the world willing to provide them a scapegoat for profit. The plaintiff's experts were ill-prepared and unprofessional, and the case presented was extremely weak. The true scientists professionally and convincingly destroyed the tattered linkages that make up the hypothesis that (thiomersal-preserved) vaccines cause autism. One interesting point about this is that this case was chosen from over 5,000 pending cases to represent the plaintiffs' best shot at getting a favorable verdict. If this is the best they have, they are in real trouble. However, as seen by the above quote, science doesn't matter to the lawyers or the parents; this is about faith to them, and no amount of science or evidence seems to shake that faith.

As a final note, this case is also about Michelle Cedillo and her family. This article and all of our work on the pseudoscience surrounding autism is not about cheapening their plight. Rather, for people like this, we show how vacuous and unscientific the claims are of those that prey upon the desperate. Those who peddle hope for profit are our targets. We truly hope that Michelle Cedillo and her parents, and those in similar plights, find better and better alternatives and solutions to their difficulties every year&nbsp— due to good, clear, scientific research.

Decision
On February 12, 2009, the special court rendered its decision. The ruling states that the plaintiffs are not entitled to compensation. There were three sets of litigants participating in the trial:
 * 1) Claims that MMR vaccines and other thiomersal-containing vaccines can combine to cause autism.
 * 2) Claims that center on vaccines containing thiomersal causing autism.
 * 3) Claims that MMR vaccines alone (with no mention of thiomersal) can cause autism.

This decision affected only the first set.