Friday, January 24, 2020

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.

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' 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.



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.

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