Using NVICP cases to prove vaccine-autism link – anti-vaxxers get it wrong

In general, the anti-vaccine religion lacks any scientific evidence supporting their beliefs about vaccine safety and effectiveness. So, they have to default to using memes and tropes based on anecdotes, fake science, or decisions made by the National Vaccine Injury Compensation Plan (NVICP). A recent paper, written by Dorit Rubinstein Reiss and Rachel Heap, reviewed how NVICP cases are being used and misused by anti-vaccine forces to prove an autism-vaccine link.

Mostly, the anti-vaccine zealots use NVICP cases to attempt to convince the world that there is actual “evidence” that vaccines cause autism spectrum disorders. Of course, we know that the vast body of scientific research tells us that there is no vaccine-autism link. Professor Reiss’ article examines key NVICP cases and shows how they are being used and misused by anti-vaccine forces.

This post is going to review some of the key points presented by Professor Reiss and Ms. Heap in their published article. Of course, their article is over 70 pages long (with extensive footnoting), so I’m just going to hit the key points. However, the full article (pdf) is an important and detailed discussion of the misuse and abuse of NVICP cases in an attempt to claim that there is a vaccine-autism link.

National Vaccine Injury Compensation Program primer

Before we talk about NVICP cases, we should give a quick background on the National Vaccine Injury Compensation Program. The NVICP, sometimes called the Vaccine Court, was established by the 1986 National Childhood Vaccine Injury Act (NCVIA). The law was signed into law in response to threats to the vaccine supply caused by unfounded scares regarding the DPT vaccine (for diphtheria, pertussis, and tetanus).

Despite the scientific evidence that the claims of side effects from the vaccine were groundless, large jury awards had been given to some plaintiffs. As a result, many DPT vaccine manufacturers exited the US market, and many public health officials were concerned about the unavailability of vaccines.

A major component of the NCVIA was the creation of the NVICP, which had two goals – first, to replace the flawed tort system for vaccine injuries with a no-fault system designed to resolve claims “quickly, easily, with certainty and generosity,” and to maintain a healthy vaccine supply while keeping prices affordable by protecting manufacturers from unpredictable liability.

The NVICP compensates successful plaintiffs for medical and legal expenses, loss of future earning capacity, and up to US$250,000 for pain and suffering. Also, a death benefit of up to US$250,000 is available. The NVICP may even compensate individuals for legal expenses in unsuccessful claims, as long as minimum requirements are met. To cover this compensation, the NVICP is funded by an excise tax of US$0.75 on every purchased dose of vaccines covered by the program.

Each case is heard and adjudicated by a Special Master of the United States Court of Federal Claims. Decisions by the Special Master can be appealed to judges of the Court of Federal Claims, then to the Court of Appeals, and ultimately to the Supreme Court. Appeals are generally rare.

A successful NVICP case requires that the claimant must have experienced a vaccine-related injury that is covered in an “injury table” published by the NVICP. A successful claimant must show this injury within the required time period or show a causal link. The burden of proof follows the civil law “preponderance of the evidence standard,” which means that the claimant can establish that causation from vaccines was more likely than not. As opposed to what is pushed by the anti-vaccine world, denied claims can be pursued in civil courts, although it is rare because the standards of showing causality can be much higher and more difficult to substantiate in most civil courts.

To win a claim, a petitioner does not have to establish a product defect. But they still have to establish at least minimal level of causality to table (or non-table) injuries. As Professor Reiss wrote in an article on this website,

The program still requires that the petitioner meet the causation requirements it set. This is a separate requirement; in cases in the regular courts plaintiffs would usually have to show both fault and causation. In NVICP cases, they do not have to show fault. But NVICP is a compensation program, not a welfare benefit one. It’s designed to compensate for injuries that at least potentially were caused by vaccines. So it is very, very reasonable for the program to require showing some level of causal connection to the vaccine – and the program’s requirements are substantially less demanding than those of the civil courts.

I have tried to cover the whole NVICP process in a few paragraphs. Although Professor Reiss covers the process in much more detail in her recent article, she has also laid out the process for adjudicating NVICP cases in her article on the NVICP published on this website.

NVICP cases and the vaccine-autism link

Most of the article by Reiss and Heap focuses on the claims made by the anti-vaccine community about how NVICP cases “prove” a vaccine-autism link. Again, despite the mountain of scientific evidence that refutes that belief, the anti-vaccine world looks to where it can to find anything that promotes its belief.

I’m going to digest Reiss and Heap’s logic into a few key points, but again, I recommend reading the full article so you have all the information you need to know.

Courts and science

Courts are not constructed to decide on scientific matters. I’ve written about this before, specifically regarding an Italian court ignoring all science, which claimed that there was, indeed, a vaccine-autism link. Of course, Italian appeals courts overturned the decision, so that whole manufactroversy is irrelevant to the world.

It is important to understand why courts are not able to provide a judgement on scientific matters. As Paul Offit wrote in “The Cutter Incident,”

Judges, with little training in science or the scientific method, are often poor arbiters of the truth. . . . Jurors are also not usually well suited to decide complicated issues of medicine, science, and technology.

A scientific consensus is developed by a wealth of evidence, with more weight given to the quantity and quality of evidence. The scientific consensus that vaccines are not related to autism is not based on legal arguments or emotional pleas, it’s based on evidence published in peer-reviewed journals.

A court often uses one or two “expert” witnesses on each side of an argument – but that’s a version of false balance, where a court tries to present scientific principles based on a debate between two people. In reality, and it would be procedurally impossible, we would need to have all the researchers that show there is no link between autism and vaccines testify – that would be hundreds of scientists. And on the other side of the question, that there is a link, there would be no scientists with evidence published in real scientific journals.

Thus, as Reiss and Heap write, “NVICP claims – however, they may turn – cannot overcome the abundant evidence refuting any such causal link.” Using courts to determine the viability of any scientific principle is simply not a viable process. So if NVICP decisions did claim that there was a vaccine-autism link, and as you will see they generally don’t, it wouldn’t qualify as evidence.

The Omnibus Autism Proceeding

Because there were so many NVICP cases that involved a claim that vaccines caused autism, over 5000 of them in fact, the attorneys for the plaintiffs and the Special Masters agreed to examine six test cases to determine if there was sufficient evidence to support a vaccine-autism link. They directly confronted the claim of whether there is evidence of causality between vaccines and autism. Despite what is said by the anti-vaccine flock, the NVICP rejected those claims.

In 2002, the NVICP in consultation with a Petitioners Steering Committee whose members were chosen by plaintiffs who were claiming the autism-vaccine link, set up the Omnibus Autism Proceeding to aggregate these cases.  They decided to examine six test cases that  made one or more of the following claims about the vaccines-autism link:

  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.

Three Special Masters examined the evidence for each of those claims. In 2009, they handed down their decisions. For each claim, the three Special Masters concluded that there was no evidence to support a vaccine-autism link.

Two of the decisions were appealed to the United States Court of Federal Claims and then to the Circuit of Appeals. In Cedillo vs the Secretary of Health and Human Services, the Court of Appeals for the Federal Circuit stated (pdf) that:

…we have carefully reviewed the decision of the Special Master and we find that it is rationally supported by the evidence, well-articulated, and reasonable. We therefore affirm the denial of the Cedillos’ petition for compensation.

Reiss and Heap comment on this Appeals Court decision in no uncertain terms:

This is not a lukewarm or hesitant endorsement. The court is making is very clear that the Special Master’s decision deserves to be upheld. …it went through the Special Master’s decisions on the issues appealed and clearly endorsed the Special Master’s decision on each.

The OAP made a critical decision for thousands of cases involving the claim of a vaccine-autism link – they clearly stated that there was no link. But, I’m not giving the OAP decision any special weight. In fact, they followed the scientific consensus and agreed that vaccines have nothing to do with autism. So,  if you’re going to make any assertion that the NVICP has found in favor of a link between vaccines and autism, you’d be wrong.

The Hannah Poling case

If you follow any of the anti-vaccine arguments in favor of a vaccine-autism link, you are certain to have heard of Hannah Poling, who may be one of the more famous NVICP cases. It is often used as proof that the NVICP agreed that vaccines caused Poling’s autism, because the case comes closest to the ideal one that the anti-vaccine front wants.

Despite that “proof,” it is fairly clear that the NVICP Special Masters made no such decision support a link between vaccines and autism. But let’s go back to the beginning.

Poling was born in 1999 and received five vaccines in one day in 2000 at the age of 19 months. This happened because she needed to catch up with the vaccine schedule – she had fallen behind on vaccinations as a result of a series of ear infections.

Dr. Paul Offit, in an article published in the New England Journal of Medicine,  then explains what happened next:

At the time, Hannah was interactive, playful, and communicative. Two days later, she was lethargic, irritable, and febrile. Ten days after vaccination, she developed a rash consistent with vaccine-induced varicella. Months later, with delays in neurologic and psychological development, Hannah was diagnosed with encephalopathy caused by a mitochondrial enzyme deficit. Hannah’s signs included problems with language, communication, and behavior — all features of autism spectrum disorder.

In 2002, the Poling family filed a case with the NVICP claiming a link between the five vaccines given in 2000 and Hannah’s development of autism. Hannah’s case was originally included with the nearly 5,000 NVICP cases included in the Omnibus Autism Proceedings but was pulled out for unknown reasons In 2008, the government conceded Hannah Poling’s vaccine injury case.

The decision explains that:

Respondent has conceded that petitioners are entitled to compensation due to the significant aggravation of Child Doc/77’s (Hannah Poling) pre-existing mitochondrial disorder based on an MMR vaccine Table presumptive injury of encephalopathy.

At this point, the anti-vaccine forces got ahold of the decision, and have waved it in the air for the past few years as evidence that the NVICP had, in fact, decided there actually was a vaccine-autism link.

Except, that’s not what happened.

Numerous scientists stepped into the fray and said that the Hannah Poling case does not show that vaccines cause autism. In fact, the evidence points to a preexisting condition – the informative Orac wrote that he saw evidence that she had a mitochondrial disorder caused by a gene mutation.

Dr. Paul Offit, again from the New England Journal of Medicine article,  points out,

…although experts testifying on behalf of the Polings could reasonably argue that development of fever and a varicella-vaccine rash after the administration of nine vaccines was enough to stress a child with mitochondrial enzyme deficiency, Hannah had other immunologic challenges that were not related to vaccines. She had frequent episodes of fever and otitis media, eventually necessitating placement of bilateral polyethylene tubes.

On 21 July 2008, Steven Novella posted an article in Neurologica, in which he discussed Poling case. He stated that “the case was settled (not judged in Poling’s favor, but settled) because both sides realized it was a special case that could not be extrapolated to other vaccine-autism cases.” And in another article, posted on Neurologica in response to a letter in the Age of Autism by Jon Polling, a neurologist and father of Hannah, Dr. Novella said “Hannah Poling’s history has many features that are not typical of autism – like a history of otitis media with frequent fevers, seizures, and what sounds like a rare encephalitis that probably did result from vaccines. Even if we put her mitochondrial mutation aside – this is not a typical case of autism.”

In other words, “it is not at all clear whether there is a causal connection between mitochondrial disorders and ASD or if similar initial problems cause both.”

But there’s more. Reiss and Heap also argue that the Hannah Poling case does not show a vaccine-autism link from a legal perspective. They write,

The government decided to concede that there was enough evidence that the vaccines aggravated an encephalopathy, a Table Injury, in the time required. To reiterate, the problem was already there, and the child was predisposed to regress, but because it was a Table Injury and it was possible that it was the vaccines that caused the aggravation, the presumption of causation came into play. The government was not willing to try to prove it was not the vaccines. The legal standard for compensation was met. This was an appropriate case to compensate a vaccine injury, but not strong proof of causation.

…the most recent word from NVICP is that the evidence does not support a causal connection between mitochondrial disease and vaccine injuries, and more particularly, does not support the claim that mitochondrial disorders make it more likely that vaccines will cause ASD in a child.

In other words, despite the claims of the anti-vaccine world that the Hannah Poling case confirms that the NVICP paid a claim that proves a link between vaccines and autism, the scientific evidence, and the legal decision both reject a vaccine-autism link in this case.

Summarizing the NVICP and a vaccine-autism link

I thought about writing a conclusion, but Reiss and Heap do it so much better than I ever could:

The question whether vaccines cause autism is first and foremost a scientific one. The scientific consensus on this question, backed by abundant data—dozens of largescale studies from all around the world—is clear: vaccines do not cause autism. There is no real scientific support to the opposing view.

Despite this, a dedicated minority—parents, alternative practitioners, doctors rejecting the evidence and others—clings to a belief that vaccines cause autism. Unable to support it using traditional scientific tools, they seek alternatives.

NVICP cases are one tempting alternative. But it is a broken reed. It is almost inevitable that some children compensated by NVICP would also have autism. Rates of autism in the population are high. Autism is not a barrier against a vaccine injury. And parents of children with autism who believe vaccines cause autism—a claim prevalent in the popular press for several years, and still heard in the public sphere and social media—may be more likely to sue (and if they join the VCAC, they will likely be directed to do so). But in its years of existence, NVICP has never compensated a child on the theory that vaccines caused that child’s autism. It rejected such claims in detailed, well-reasoned decisions in the Omnibus Autism Proceeding. The only way to use NVICP cases to support the claim that vaccines cause autism is to take them out of context, ignore their actual content, and occasionally directly misrepresent them—in other words, to misuse them.

When your best evidence for a claim is misusing cases by an adjudicative forum that, when addressing your claim, ruled against you, it’s time to reconsider. Vaccines do not cause autism, say both science and law.

Citations

 

The Original Skeptical Raptor
Chief Executive Officer at SkepticalRaptor
Lifetime lover of science, especially biomedical research. Spent years in academics, business development, research, and traveling the world shilling for Big Pharma. I love sports, mostly college basketball and football, hockey, and baseball. I enjoy great food and intelligent conversation. And a delicious morning coffee!