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The Autism Omnibus: When you don’t have scientific evidence, tug on the heartstrings!

The Autism Omnibus is now officially under way, having begun with the first test case, that of Cedillo v. Secretary of Health and Human Services. The Omnibus proceeding is the culmination of the legal cases brought to the Vaccine Injury Compensation Program by nearly 5,000 families who “feel” that their children’s autism was in fact caused by vaccines. Most, but not all, of the plaintiffs blame the mercury in the thimerosal in childhood vaccines, despite there being no good evidence to support such a link, so much so that both David Kirby, whose book Evidence of Harm: Mercury in Vaccines and The Autism Epidemic: A Medical Controversy popularized the bogus “science” of the alleged mercury-autism connection is backpedaling furiously, to the point of ploys as ridiculous as blaming mercury from crematoria in California, forest fires, and pollution from China. Meanwhile, even the most diehard of the mercury militia, a man who used to say routinely that autism is a “misdiagnosis” for mercury poisoning, our old “friend” J. B. Handley, is racing Kirby away from the thimerosal hypothesis, now obfuscating his former clarity of vision with fuzzy combinations of heavy metals, live viruses, antibiotics, and “toxic loads” as “causes” of autism. In essence, the mercury militia, realizing that it’s backed a scientific loser, is quickly shifting the goalposts in order to make their ideas about the environmental “causes” of autism into conveniently unfalsifiable hypotheses.

Unfortunately, thanks to the low bar of evidence required in the Autism Omnibus hearings, the mercury hypothesis may not be a legal loser. I don’t plan on blogging the trial every day, but I do think it’s worth discussing the first day’s festivities, because I think they give a crucial indication of what the tactics of the plaintiffs will be. Not surprisingly, when the science supporting their case is weak to nonexistent, the plaintiffs’ attorneys have decided to go for the heartstrings:

Theresa Cedillo said her daughter suffered five days of fever, her temperature often spiking to 105 degrees, after receiving a measles, mumps and rubella vaccination at age 15 months. Michelle was a happy, robust, responsive and loving child — in short, normal — but hasn’t been the same since, her mother told the court.

Wearing noise-canceling headphones, Michelle was brought into the courtroom in a wheelchair at the start of the proceedings. She stayed only a short time, moaning audibly several times. Besides autism, Michelle suffers from inflammatory bowel disease, glaucoma and epilepsy. In addition, her bones, weakened by years of malnourishment, are prone to breaks, Theresa Cedillo said. Everything she eats is pumped in through a feeding tube, except for crackers and water.

Only the most cold-hearted would fail to agree with Special Master George Hastings, Jr., one of the three Special Masters who will preside over the hearings, when he characterized Michelle’s case as “tragic.” Certainly, the Cedillos have a challenge far greater than that of the vast majority of parents face when raising a child. However, just because they have come to believe that vaccines are somehow responsible for their child’s plight and just because we feel sorry for them do not constitute a reason to conclude that vaccines did, in fact, cause Michelle’s plight. We can feel sympathy for Michelle and admiration for their determination to take care of her, but that does not mean that we have to accept their pseudoscientific explanation for how their daughter got the way she is. In my mind, perhaps the most sadly ironic thing about the whole vaccine/autism hysteria is that it’s a huge distraction away from real research elucidating the pathophysiology of autism that might be of value in helping children like Michelle. It’s also an enormous distraction away from putting effort and resources into services that might assist families like the Cedillos deal with the day-to-day struggles of taking care of their daughter.

What caught my interest most about this first test case, though, was that the Cedillos seem to be using an argument that I’ve never heard before, in essence, combining the two most common rationales that antivaxers use to try to blame vaccines for autism:

Theresa Cedillo and husband Michael allege thimerosal-containing vaccines weakened their daughter’s immune system and prevented her body from clearing the measles virus after she was immunized. That theory is one of three alleged by the thousands of plaintiffs. The others claim either thimerosal or the measles vaccine alone caused their children’s autism.

Traditionally, there have been two main schools of antivax thought in blaming vaccines for autism. The first was “pioneered” (if you can call it that) by Andrew Wakefield, who in 1998 published a paper in The Lancet claiming that the MMR vaccine, which contains live attenuated measles virus, somehow caused a form of inflammatory bowel disease as well as regressive autism. Unfortunately for this concept, no other researcher has been able to confirm such a link, and in fact, when the distortions, inconsistencies, and omissions in the paper were pointed out, the majority of the authors of Wakefield’s article later disavowed it. More recently, Wakefield was found to have been paid by lawyers seeking to sue for “injury” due to the MMR vaccine and has been charged with unprofessional conduct in the matter. As a result, vaccination rates in the U.K. plummeted, and measles made a frightening return, with the decline in vaccination rates caused by the furor only recently starting to recover.

It should be noted that the MMR vaccine does not contain, nor has it ever contained, thimerosal. However, the idea that mercury in vaccines due to the thimerosal preservative started to become a concern in the late 1990s and early 2000s, as the number of vaccines in the childhood vaccine schedule increased. Confusing correlation with causation, some noted the increase in autism diagnoses that occurred during the 1990s, correlated it to the increase in the number of childhood vaccines, specifically the thimerosal in the vaccines, and–voilà!–a myth was born, complete with a myth of a cabal of scientists, big pharma, and the CDC meeting in an “isolated” complex to “suppress” this link, a myth stoked by David Kirby’s book and Robert F. Kennedy, Jr.’s scaremongering and dishonest article in and Rolling Stone two years ago. It’s a movement complete with its own talking points about an “autism epidemic,” such as asking, “Where are all the autistic adults, if autism has been around so long?” Never mind that they are among us and always have been. Although not totally implausible based on the evidence several years ago, the hypothesis was never particularly plausible scientifically. Despite its relative implausibility, however, investigators have done several studies looking for a link between thimerosal in vaccines and autism, and In the interim time and science have not been at all kind to the hypothesis. Indeed, as of today, several large epidemiological studies have failed to find a link between thimerosal-containing vaccines and autism, the most recent being a large Canadian study. Despite thimerosal having been removed from vaccines in the U.S. in 2002, autism diagnoses continue to increase. As Dr. Paul Offit put it:

Certainly there is plenty of evidence to refute the notion that vaccines cause autism. Fourteen epidemiological studies have shown that the risk of autism is the same whether children received the MMR vaccine or not, and five have shown that thimerosal-containing vaccines also do not cause autism. Further, although large quantities of mercury are clearly toxic to the brain, autism isn’t a consequence of mercury poisoning; large, single-source mercury exposures in Minamata Bay and Iraq have caused seizures, mental retardation, and speech delay, but not autism.

Finally, vaccine makers removed thimerosal from vaccines routinely given to young infants about six years ago; if thimerosal were a cause, the incidence of autism should have declined. Instead, the numbers have continued to increase. All of this evidence should have caused a quick dismissal of these cases. But it didn’t, and now the court has turned into a circus. The federal and civil litigation will likely take years to sort out.

A “circus” is an apt description of the Autism Omnibus proceedings. Even so, it is necessary to ask: Is there any evidence to support the Cedillo’s contention? To hear Arthur Allen report on the trial, this is the best that the Cedillo’s attorneys can apparently come up with so far:

This is a novel, untested theory–the Cedillos’ first expert witness, Dr. H. Vasken Aposhian, said on the stand that he had elaborated it “about three or four weeks ago based on journal articles from other scientists.

Aposhian, an elderly, hard-of-hearing toxicologist with a halo of white hair surrounding his large bald pate, testified that the form of autism Michelle is suffering from is a “mercury efflux disorder.” She has a genetic susceptibility that makes her unable to get rid of toxic metals from her system. Their damage results in autism and all the other symptoms of illness she’s suffering, he said.

On cross examination, Aposhian acknowledged there was no record of any child becoming autistic as a result of mercury exposures prior to the thimerosal theory–despite the millions of tons of the stuff that we supposedly breath in from dental amalgams and factory fumes and consume in contaminated fish.

Aposhian also disputed the timeless toxicological truism that the dose is the poison. The poison, he testified, is based on the dose but also on the genetic susceptibility of the patient and the age in their development–in the case of a fetus or child. So, although all documented cases of mercury poisoning involve doses hundreds or thousands of times larger than the thimerosal given to children in vaccines, Aposhian argued, you couldn’t say that the dose in vaccines was harmless.

Quite frankly, I can’t say anything other than that this is about as lame as it gets when it comes to “expert” testimony, the frantic attempts of advocates to spin it as anything other than disastrous notwithstanding. There’s no biological or epidemiological evidence presented to support Dr. Aposhian’s “ideas”; they seem like something that he just pulled out of his–well, you know what I think he pulled them out of. Indeed, after only one day, this trial is starting to remind me of the Kitzmiller Trial, where the luminaries of the “intelligent design” creationism movement, one after the other, embarrassed themselves on the stand, most amusingly during the infamous exchange in which Michael Behe was forced by the defense attorneys to admit that his overbroad definition of a scientific theory would encompass astrology.

The problem is that scientific and epidemiological evidence ultimately may not matter in this case. As Steve Novella points out, there is history to support a pessimistic viewpoint regarding the ultimate outcome of the Autism Omnibus, specifically the case of silicone breast implants and their alleged link to autoimmune disorders and cancer. Based on poor quality studies purporting to show a correlation between these implants and a wide variety of autoimmune diseases, hordes of activists waged legal war against Dow Corning, in essence suing it into bankruptcy. More recent studies fail to find a link between silicone implants and autoimmune disease. Certainly, there are risks of local complications, such as implant rupture and capsular contracture, but the risk of connective tissue disorders and autoimmune disease is not elevated in women with silicone implants.

If you think the same thing that happened with silicone breast implants can’t happen with vaccines, think again. If women who got silicone implants and happened to develop connective tissue disorders evoked a lot of sympathy from juries, imagine how parents of children like Michelle Cedillo will appear. As we can see just from day one of the trial, even the Special Masters aren’t immune to the “heartstring” ploy, and we can expect considerably more tugging of the heartstrings as the test cases are presented. The difference is that, unlike the case of silicone implants, where pseudoscience merely had the effect of eliminating a medical device used mainly for cosmetic purposes (although, as a breast cancer surgeon, I have to point out that the loss of these implants eliminated a reconstruction option for patients with breast cancer), if the plaintiffs in the Autism Omnibus succeed, the results will be far more grave than just one large company going bankrupt and the banning of a breast implant.

If the plaintiffs prevail in the test cases of the Autism Omnibus, it will open the floodgates to a tsunami (yes, I chose that word intentionally) of lawsuits against the VICP that will bankrupt the system. Moreover, from what I understand, the courts are still available to litigants if the VICP rules against them; the system merely requires that litigants go through the VICP first. Over the last few decades, thanks to liability concerns and declining profitability of their vaccine business, more and more pharmaceutical companies have stopped manufacturing vaccines. Should the Autism Omnibus result in a ruling against vaccines, not only would it give the whole “mercury-causes-autism” fearmongering an undeserved patina of legal respectability, but the few companies who continue to manufacture vaccines would likely come under serious pressure on strictly business grounds to remove a major source of potential liability and simply drop out of the vaccine business. This would be a result that would make the consequences of the victory of pseudoscience in the 1990s on the silicone implant issue pale in comparison. If pseudoscience triumphs over science with regard to vaccines, the single public health intervention that has saved more lives than any other medical intervention will be in danger in this, allegedly the most scientifically advanced nation on earth.

More on the Omnibus:

By Orac

Orac is the nom de blog of a humble surgeon/scientist who has an ego just big enough to delude himself that someone, somewhere might actually give a rodent's posterior about his copious verbal meanderings, but just barely small enough to admit to himself that few probably will. That surgeon is otherwise known as David Gorski.

That this particular surgeon has chosen his nom de blog based on a rather cranky and arrogant computer shaped like a clear box of blinking lights that he originally encountered when he became a fan of a 35 year old British SF television show whose special effects were renowned for their BBC/Doctor Who-style low budget look, but whose stories nonetheless resulted in some of the best, most innovative science fiction ever televised, should tell you nearly all that you need to know about Orac. (That, and the length of the preceding sentence.)

DISCLAIMER:: The various written meanderings here are the opinions of Orac and Orac alone, written on his own time. They should never be construed as representing the opinions of any other person or entity, especially Orac's cancer center, department of surgery, medical school, or university. Also note that Orac is nonpartisan; he is more than willing to criticize the statements of anyone, regardless of of political leanings, if that anyone advocates pseudoscience or quackery. Finally, medical commentary is not to be construed in any way as medical advice.

To contact Orac: [email protected]

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