The Anti Vax Epidemic - Good Parents Getting Gamed. Episode 6: Vaccine Injuries Part II: Vaccine Court Adjudication of Autism Cases

Welcome to Episode 6 in my series on vaccines. Throughout this series I use the term anti-vax as a concise way to type the anti-vaccine movement. I use it to refer to those people who speak out against vaccines, not parents who are hesitant. Wherever you fall, I welcome you here. Thank you for taking the time to come here and discuss this with me. I hope I can dispel some misconceptions and ease your mind about vaccines.

Now that we know the real reason behind establishment of VICAP, let's look at the cases that have been adjudicated. More specifically, let's look at autism cases. (links are to court documents (& scientific articles where appropriate))

Omnibus Autism Proceeding: The Special Masters created the Omnibus Autism Proceeding (“OAP”) to determine the relationship, if any, between vaccines and autistic spectrum disorders. They chose six test cases, that, in the petitioners’ judgment, presented the clearest and strongest arguments for the proposition that vaccines had caused autism, representing two separate theories of causation (1: that measles, mumps, and rubella (MMR) vaccines and thimerosal containing vaccines can combine to cause autism; 2: that thimerosal-containing vaccines, by themselves, can cause autism; A third theory - that MMR vaccine, by itself, can cause autism was later abandoned due to extensive evidence to the contrary, and so was not adjudicated in test cases by OAP. Note: Given the depth of discussion deserved by The Hannah Poling case, also part of the OAP, that case will be presented in an independent post (coming soon).

In 2007, three Special Masters heard three test cases to represent the first theory of causation:

Cedillo v. SHHS Case No. 2010-5004

Snyder v. SHHS Case No. 01-162V; and

Hazlehurst v. SHHS Case No. 2009-5128

The Special Masters’ decisions in the three test cases, issued on February 12, 2009, rejected the petitioners’ causation theories. All three of the Theory 1 test cases were appealed (to court of Federal Claims & U.S. Court of Appeals for the Federal Circuit). The Special Masters’ decisions were upheld each time.

From George L. Hastings, Jr., Special Master, in the case of Michelle Cedillo, No. 98-916V:
"I concluded that the evidence was overwhelmingly contrary to the petitioners’ contentions.... Considering all of the evidence, I found that the petitioners have failed to demonstrate that thimerosal-containing vaccines can contribute to causing immune dysfunction, or that the MMR vaccine can contribute to causing either autism or gastrointestinal dysfunction. I further conclude that while Michelle Cedillo has tragically suffered from autism and other severe conditions, the petitioners have also failed to demonstrate that her vaccinations played any role at all in causing those problems."

From Denise K.  Vowell, Special Master, in the case of Colten Snyder, No. 01-162V:
"After careful consideration of all of the evidence, it was abundantly clear that petitioners’ theories of causation were speculative and unpersuasive. Respondent’s experts were far more qualified, better supported by the weight of scientific research and authority, and simply more persuasive on nearly every point in contention."

From Patricia E. Campbell-Smith, Special Master, in the case of  William  Yates Hazlehurst, No. 03-654V:
“[P]etitioners’ experts tended to assign greater weight to speculative conclusions offered by the investigators involved in the studies than did the investigators themselves. Petitioners’ experts also urged reliance on a few carefully selected sentences from particular articles which, when considered in the proper context of the referenced articles, did not support the propositions advanced by the witnesses. Moreover, because petitioners’ experts relied on a number of scientifically flawed or unreliable articles for several important aspects of their causation theory, their testimony on those aspects of their offered theory could not be credited as sound or reliable. Finally, petitioners’ experts made several key acknowledgments during testimony that rendered their proposed theory of vaccine causation much less than likely.”

The full OAP record encompasses tens of thousands of pages of medical literature, more than four thousand pages of hearing testimony, and fifty expert reports. The committee ultimately concluded that a causal relationship between MMR vaccinations and autism did not exist. The committee based its conclusion on four factors:

1) A consistent body of epidemiological evidence shows no association, at a population level, between MMR vaccine and autism spectrum disorder.

2) The original case series of children with autism spectrum disorder and bowel symptoms and other available case reports are uninformative with respect to causality. In addition, they were ALL linked to Andrew Wakefield's fraudulent Unigenetics data and none of the studies indicating the presence of measles virus in autistic children had been successfully replicated by an accredited laboratory independent of Dr. Wakefield or Unigenetics.

3) Biologic models linking MMR vaccine and ASD are fragmentary.

4) There is no relevant animal model linking MMR vaccine and autism spectrum disorder.

In 2007, three Special Masters heard three test cases to represent the Second  theory of causation - that thimerosal-containing vaccines, by themselves, can cause autism. The three cases were:
Mead v. SHHS Case No. 03-215V
King v. SHHS Case No. 03-584V
Dwyer v. SHHS Case No. 03-1202V

From Patricia Campbell-Smith, Special Master, in the case of  William P. Mead, No. 03-215V

“The underpinnings for the opinions of petitioners’ experts   are scientifically flawed, and in the absence of a sound basis for the offered opinions of causation, those opinions cannot be credited....Based on the developed record in this proceeding, the undersigned is unpersuaded that the thimerosal content of the prescribed childhood vaccines contributes to the development of autism as petitioners have proposed under this theory of general causation.”

From George L. Hastings, Jr., Special Master, in the case of Jordan King, No. 03-584V

“...I conclude that the evidence is overwhelmingly contrary   to the petitioners’ contentions.  The expert witnesses presented   by the respondent were far better qualified, far more experienced, and far more persuasive than the petitioners’ experts, concerning the key points.  The numerous medical studies concerning the issue of whether thimerosal causes autism, performed by medical scientists worldwide, have come down strongly against the petitioners’ contentions. Considering   all of the evidence, I find that the petitioners have  failed  to demonstrate that thimerosal-containing vaccines can contribute to the causation of autism. I further conclude that while Jordan King has tragically suffered from autism, the petitioners have also failed to demonstrate that his vaccinations played any role at all in causing that condition.”

From Denise K.  Vowell, Special Master, in the case of Colin R. Dwyer, No. 03-1202V:

"To prevail, they must show that the exquisitely small amounts of mercury in  TCVs that reach the brain can produce devastating effects that far larger amounts experienced prenatally or postnatally from other sources do not. In order   to account for this dichotomy, they posit a group of children hypersensitive to mercury’s effects, but the only evidence  that these children are unusually sensitive is the fact of their   ASD [autism spectrum disorder] itself. In an effort to render irrelevant the numerous epidemiological studies of  ASD and TCVs that show no connection between the two, they contend that their children have a form of  ASD involving regression   that differs from all other forms biologically and behaviorally. World-class experts in the field testified that the distinctions they drew between forms of  ASD were artificial, and that they had never heard of the ‘clearly regressive’ form of autism   about which the petitioners’ epidemiologist testified. Finally, the causal mechanism petitioners proposed would produce, not  ASD, but neuronal death, and eventually patient death as well. The witnesses setting forth this improbable sequence of cause and effect were outclassed in every respect by the impressive assembly of true experts in their respective fields who testified on behalf of respondent."

When parents are bombarded with propaganda, it's easy for us to forget a critical truth about medicine: there are risks. There always will be. But we can't lose sight of the greater risks of infectious diseases. Diseases that can sicken and kill millions of children worldwide. Diseases we haven't had to suffer through because of vaccines. Vaccines offer powerful protection from some truly horrific diseases. Is that protection perfect? No. But neither is any other tool used in medicine. We have a mechanism to help anyone who is injured by a vaccine, VICP. Let's allow vaccines help the rest of us.

Cheers,

Heather

Citations:
This post provides in-text links to all relevant court documents and an article that summarizes this nicely. If you have questions, please feel free to ask. I am here to help.

The Anti Vax Epidemic - Good Parents Getting Gamed. Episode 5: Vaccine Injuries Part I: Creation of the Vaccine Court

Welcome to Episode 5 in my series on vaccines. Throughout this series I use the term anti-vax as a concise way to type the anti-vaccine movement. I use it to refer to those people who speak out against vaccines, not parents who are hesitant. Wherever you fall, I welcome you here. Thank you for taking the time to come here and discuss this with me. I hope I can dispel some misconceptions and ease your mind about vaccines.

VACCINE COURT

Parents who are just trying to do the best they can for their kids, are bombarded with anti-vax messages daily. Anti-vaxxers argue that vaccines cause autism (despite the many studies that prove they do not, including the most recent study See my post dedicated to vaccines and autism). Anti-vaxxers claim that scientists and physicians cover up these vaccine side effects so Big Pharma can profit (not true at all - post forthcoming). And their coup de grâce? The very existence of the National Vaccine Injury Compensation Program. The fact that this program exists is their evidence that vaccine injuries are so common and so severe, that there must be an independent court to process the cases. Is that true? No. Emphatically, no. How can we tell? We can determine the truth about that argument by understanding why VICP was created and the results of the claims brought to them over the last 30 years.

The National Vaccine Injury Compensation Program (VICP)

In the 1980s there was a big scare over side effects of the DPT vaccine and a ton of parents sued vaccine makers (Post on DPT coming soon). Public health officials were confident that the claims were baseless, but juries awarded compensation to plaintiffs. DPT vaccine makers couldn't afford this, and why should they when vaccines were not their bread and butter, so they stopped production. This put all vaccines at risk. But we need vaccines. 

SIDEBAR [When anti-vaxxers tell parents we don't need vaccines, when they tell parents vaccines are dangerous, they can do so because they (& we) haven't experienced the horror of a community decimated by disease. Make no mistake, the fact that we have not experienced that horror, is because of vaccines. To trash-talk vaccines is a luxury only possible because we've been protected by vaccines and so no longer take the threat of infectious diseases seriously. The anti-vax movement is a luxury given to anti-vaxxers, by vaccines. Put that in your pipe and smoke it.]

Back to VICP: Due to the DPT scare, and to keep manufacturers from abandoning vaccine production, VICP was established by Congress' 1986 National Childhood Vaccine Injury Act (NCVIA). Within VICP resides the “vaccine injury court” - AKA the Office of Special Masters - which is a division of the United States Court of Special Claims. If someone thought their child was harmed by a vaccine they could present their case to this court.  

Compensation awarded by VICP:

Another component of VICP is a trust fund to pay for compensation awards. An excise tax of 75 cents per administered vaccine, was implemented to finance the trust fund. To settle cases quickly and fairly, through VICP, cases are argued before a Special Master and adjudicated on a no-fault basis. In 80% of all cases brought since 2006, the parties settled. According to HHS, “Settlements are not an admission by the United States or the Secretary of Health and Human Services[…]that the vaccine caused the petitioner’s alleged injuries,” Let's reiterate. In these cases, after extensive review of the evidence, the HHS had not concluded that the vaccine caused the injury. So why settle? Many reasons, such as “a desire by both parties to minimize the time and expense associated with litigating a case to conclusion and a desire by both parties to resolve a case quickly and efficiently." If the petitioner disagrees with the court's ruling, they can appeal their case in civil court.

Anti-vax message: The Government hides the vaccine court!

One website, typical of the anti-vax movement, reads, “It is obvious that the government does not want to publicize the existence of the [court], because the more Americans learn that there are vaccine injuries and deaths … the more they may start to question the safety of vaccines.”

TRUTH: Okay. The above anti-vax message is completely false. The law was well-publicized when it passed. There is a very public website for it that explains the Court, and provides the names and contact information of lawyers in all 50 states. It also helps you file a claim. No one is hiding the existence of the court. But that is not what anti-vaxxers want you to think. The anti-vax agenda is to convince you that the government is hiding this information.

Anti-vax message: Existence of VICP is proof that vaccine injuries are so common & severe, that we need an independent court to process the cases.

Since 1988, more than 16,000 claims have resulted in $3.18 billion awarded to families alleging vaccine injury. Anti-vaxxers point this out and say, see? We are right, vaccines need to go, and the existence of the court itself is proof that we are right and everyone else is lying on behalf of big pharma. 

TRUTH: Anti-vax interpretation of the numbers is completely incorrect. In reality, the numbers prove that vaccines are safe. Let's examine the facts so we can understand why that is.

Vaccines Administered Vs Claims Adjudicated by VICP:

From 2006 to 2017 over 3.4 billion doses of covered vaccines were distributed in the U.S. During that time, 6,571 petitions were adjudicated by the Court, with compensation awarded to 4,525 of those. Thus: One individual was compensated for every one million doses of vaccine administered. One individual was compensated for every one million doses of vaccine administered. This means vaccines are incredibly safe. 

[SIDEBAR: One in a million. To be clear, that is not the risk of vaccine injury, that is how often vaccine claims are settled without establishing that a vaccine caused an injury. So the risk of proven vaccine injury is even lower. But we'll use 1 in a million here just to make it easy. Now, let's look at how that risk compares to the risk of a significant injury from other drugs that parents give their kids with confidence. Let's take Acetaminophen (e.g, Tylenol) for example. A 2013 review reads:

"Acetaminophen is the over-the-counter (OTC) antipyretic and analgesic medication most commonly used in children." They go on to say:
"Acetaminophen monographs might surprise clinicians and parents alike, as many consider the drug safe to use and provide parents with the “feeling of mastery.” Numerous potential adverse effects are mentioned in guidelines for its labeling. However, most severe adverse effects are generally rare. In one large study from Boston, Mass, children younger than 2 years of age with fever were randomized to receive acetaminophen (12 mg/kg) or ibuprofen (E.g Advil) and were found to have a low rate of adverse effects. Among the more than 9000 children who received acetaminophen, the absolute risk of hospitalization for asthma or bronchiolitis was 260 children per 100,000, and the risk of hospitalization for vomiting or gastritis was 24 children per 100,000."

So for acetaminophen, the risk is 260 per 100,00 and 24 per 100,000 and we consider that level of risk to be RARE. That means the 1 in a million risk for vaccines is LESS THAN 10X the risk of acetaminophen. But you don't see parents marching in the streets to get Tylenol banned or filing lawsuits against the manufacturer. Why? Because there is no anti-acetaminophen movement using propaganda to scare parents into not using it. The risks ARE RARE for acetaminophen. And we need it! It helps our children. It prevents febrile seizures and other risks that illness and fevers bring. Not to mention it makes kids feel better and let's parents and kids get some rest.
Pro tip: Vaccinated children need drugs like acetaminophen less often. Bonus!]
BOTTOM LINE - The Vaccine Court Decisions demonstrate that vaccines are incredibly safe. 

So What Are the Real Side Effect Risks of Vaccines?

The truth is, that most vaccines side-effects are those we've all heard of. They are all listed on the flyer the doctor gives you before your child is vaccinated and they give you a copy to take home when you leave the doctor's office. So they are not being covered up. No one is hiding this. Just like the possible adverse reactions to Tylenol are right there on the package. If you check the CDCs website - which provides info on all ingredients in the vaccine etc, right there for us to see - I investigated it all when I was pregnant and here is the package insert for the only MMR vaccine approved in the US. So, the common side effects of that vaccine are:

• Sore arm from the shot (Ouch. This one hurts cuz it goes into back of the upper arm. I did not get the full series as a child because I am older than...ahem...well anyway, so I got the full series last year after vaccine rates in my community had decreased enough to cause me concern (You should do the same if you're...like me). And yes, it hurt my arm, but the pain didn't last. And I had no other side effects. My son has also had all his vaccines on schedule and has had no adverse reactions.)
• Fever
• Mild rash
• Temporary pain and stiffness in the joints, mostly in teenage or adult women who did not already have immunity to the rubella component of the vaccine

That's a common list for the currently required vaccines.

How about rare and serious side effects?

There are about three claims per year (out of millions of vaccines given) to the vaccine court in which petitioners allege lifetime injury. These account for ~half of the total dollars spent on VICP awards. And most of these are settled without any determination of causation.  

Because parents hear so much about possible vaccine injuries, I am in the process of writing posts on all severe adverse outcomes that parents might be concerned over. I have a post specifically for VICP autism cases, and others in the works on the 1980s DPT scare; Guillain-Barré Syndrome (really, the only one that is a concern in the US -and is it really a concern? We'll find out when I finish the post); and on severe vaccine injuries caused by vaccines not approved in the US and that have been withdrawn from the international market like Pandemrix and Dengvaxia. I am also writing a post on the Hannah Poling case as that also deserves in-depth discussion. I will add links here when those posts are live.

I hope this post gives parents better context for understanding the Vaccine Court and why, in reality, it actually demonstrates the safety of vaccines. When parents are bombarded with propaganda, it's easy for us to forget a critical truth about medicine: there are risks. There always will be. Even with things like acetaminophen. But we can't lose sight of the greater risks of infectious diseases. Diseases that can sicken and kill millions of children worldwide. Diseases we haven't had to suffer through because of vaccines. Vaccines offer powerful protection from some truly horrific diseases. Is that protection perfect? No. But neither is any other tool used in medicine. We have a mechanism to help anyone who is injured by a vaccine, VICP. Let's allow vaccines help the rest of us.

Cheers,

Heather

Citations:
This post provides in-text links to all relevant court documents and articles. If you have questions, please feel free to ask. I am here to help.