NVICP Tarsell decision not proof of HPV vaccine-related mortality – just legal errors

NVICP Tarsell decision

On September 25, 2017, Special Master Christian Moran from the National Vaccine Injury Compensation Program (NVICP), acting under a Court of Federal Claims decision that changed the legal standard for compensation, awarded compensation to Ms. Emily Tarsell for the tragic death of her daughter, Christina Tarsell. The family had blamed the tragedy on Gardasil. the HPV vaccine. Let’s review the facts and legal issues of the NVICP Tarsell decision.

A reading of the decision shows that the Special Master himself had serious doubts that the HPV vaccine had actually caused the death (and could probably have more strongly stated his doubts); however, he felt bound by a flawed decision of the Court of Federal Claims and compensated because of that guidance. The claimant’s theory that was used to claim that the vaccine caused the young woman’s death is also extremely far-fetched. It should not have fulfilled the plausible theory requirement even under the watered-down version ordered by the Federal Claims judge. The timing (i.e., cause and effect) was likely wrong – the Special Master thought the disease symptoms started before the administration of the vaccine – but for procedural reasons, he did not dwell on that issue.

While anti-vaccine websites present the Special Master’s award as proof that the death was caused by the administration of the vaccine, that is a serious misreading of the NVICP Tarsell decision. Ms. Christina Tarsell’s death is extremely tragic. But there is no good basis to claim that the HPV vaccine caused it.

There are three legal errors in the decision of the Court of Federal Claims judge, a decision that was then legally binding on the Special Master it was returned to for reconsideration:

  1. Reversing the burden of proof in relation to the timing of the alleged harm;
  2. relaxing the standard under which a medical theory is evaluated; and
  3. applying a de novo standard instead of an arbitrary and capricious standard to the Special Master’s findings of facts (which I’ll explain).

Continue reading “NVICP Tarsell decision not proof of HPV vaccine-related mortality – just legal errors”

Del Bigtree vaccine safety complaints – HHS Vaccine Program responds

Del Bigtree Andrew Wakefield

On January 18, 2018, Dr. Melinda Wharton, Acting Director of the National Vaccine Program Office in the Department of Health and Human Services, sent Mr. Del Bigtree, an anti-vaccine activist, and producer of the anti-vaccine film Vaxxed, a response to questions he raised about vaccine safety. The response is a very informative description of the substantial efforts regarding vaccine safety, and can and should reassure parents that there is abundant data – and many monitoring mechanisms in place – to examine and address vaccine safety, and that the expert consensus that vaccines are very safe is well grounded.

This post will shortly describe the background to the letter from Dr. Wharton, then provide some of the highlights. I do, however, encourage people to read the full letter, available here (pdf), for themselves, to understand many vaccine safety issues. Continue reading “Del Bigtree vaccine safety complaints – HHS Vaccine Program responds”

Vaccine injury payouts – another trope that abuses NVICP statistics

vaccine injury

Another day, another anti-vaccine trope finds it way out of the grave to enter the zombie apocalypse of anti-vaccine misinformation and lies. Today’s zombie trope is the one that the NVICP (National Vaccine Injury Compensation Plan, see Note 1) payouts are so huge that they the “prove” that vaccines are dangerous and should be kept it away from children.

My friend Liz Ditz wrote about this trope and gave it a solid debunking a couple of years ago. She is much nicer than yours truly, the cranky feathery dinosaur. We’re going to give it the full Skeptical Raptor treatment which means a lot of science, some snark, and a dollop of mockery. More seriously, I wanted to update her numbers and make a few more, possibly sarcastic, points. Continue reading “Vaccine injury payouts – another trope that abuses NVICP statistics”

NVICP Mini-Omnibus Autism decision – vaccines still do not cause autism

Mini-Omnibus Autism

On 7 February 2018, the National Vaccine Injury Compensation Program (NVICP) handed down a decision in a mini-omnibus autism proceeding asking whether petitioners established “by preponderant evidence, a medical theory connecting a vaccine and [the test case child]’s injury.”

The decision is important in two ways. First, it reminds us that NVICP has consistently and repeatedly rejected claims that vaccines cause autism. Second, it explains in detail why a theory (please see Note 1 at the end of the article) claiming human DNA fragments in vaccines cause autism – a claim whose main proponent is Dr. Theresa Deisher – is unconvincing and not supported by the evidence.

The detailed, thorough decision shows that the main study from Dr. Deisher to support the theory – a study attempting to draw a temporal connection between change points where vaccines containing such DNA were introduced and rise in rates of autism – is fundamentally flawed. It then also shows that the petitioners’ proposed mechanisms of causation – how the DNA fragments are supposed to cause autism – are untenable.

The Mini-Omnibus Autism decision is 94-pages, and this summary will just touch on the main points. I urge readers to wade into the full decision if they want to understand more.  Continue reading “NVICP Mini-Omnibus Autism decision – vaccines still do not cause autism”

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

vaccine-autism link

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. Continue reading “Using NVICP cases to prove vaccine-autism link – anti-vaxxers get it wrong”

Anti-vaccine doctor Mark Geier not exonerated – license still suspended

Mark Geier

Autism quack and anti-vaccine Mark Geier, a former physician stripped of his medical license by the State of Maryland, won a lawsuit against the Maryland Board of Physicians that awarded the Geier family $2.5 million in damages. Of course, the anti-vaccine and anti-autism world will claim that Mark Geier is an innocent man, and this ruling “proves” that.

Except it doesn’t. Geier is still not a doctor, being defrocked like his fellow fraud in the anti-vaccine world, Mr. Andrew Wakefield. Geier won a lawsuit that had everything to do with some serious breaches of privacy by the Maryland Board of Physicians, who had a vendetta against Mark Geier (and his son David) for their horrendous treatment protocol to “cure” autistic children. In fact, while the Board stripped Mark Geier of his medical license, they also charged David Geier, who is not a physician of any kind, of practicing medicine without a license.

I cannot repeat this enough – Mark Geier still won’t be practicing medicine, because his medical license is still suspended. This has not changed. And David Geier is still guilty of practicing medicine without a license.

Because this story is so important, we’re going to talk about Mark Geier, what he did, and what this case really means.  Continue reading “Anti-vaccine doctor Mark Geier not exonerated – license still suspended”

National Vaccine Injury Compensation Program facts

national vaccine injury compensation program

In this post I explain how one goes about proving a case in the  National Vaccine Injury Compensation Program (NVICP), and how that differs from proving a case in the civil courts, focusing on what it means to have a no-fault program and proving causation. I will use a case that started with the tragic death of a young child after a vaccine to illustrate the complexity and operation of the program, and also to address the idea of federal preemption, and how it limits the ability of those claiming vaccine injuries to use state courts for their claims.

Continue reading “National Vaccine Injury Compensation Program facts”

Ginger Taylor writes a letter about vaccines – this will be interesting.

ginger taylor

Recently, Ms. Ginger Taylor, a leader in a number of anti-vaccine organizations and a proponent of the belief that vaccines cause autism,  wrote a letter aimed at people participating in vaccine discussions online. In a video, Ms. Taylor said  it’s an expression of her belief she has a duty to warn against vaccines – but the message is directed at “trolls”. She defines trolls as people who contradict her claims about vaccines. Naturally, she hopes to reach anyone willing to consider her points in order to scare them away from immunizing.   Continue reading “Ginger Taylor writes a letter about vaccines – this will be interesting.”

Debunking myths about vaccine testing and safety

vaccine testing

The goal of this article is to respond to a number of recurring myths raised by anti-vaccine activists regarding vaccine testing and safety – a common trope used against vaccines.

The bottom line is that vaccines are extensively and carefully tested for safety, and that vaccine safety is shown by many, many studies from a variety of sources, reinforcing each other and all pointing to the same result – serious problems from vaccines are possible, but extremely rare. And those small, rare risks are far outweighed by the benefits vaccines provide by protecting us against much larger risks.

Continue reading “Debunking myths about vaccine testing and safety”

Physicians for Informed Consent – another radical anti-vaccine group

Physician for Informed Consent

There are a bunch of anti-vaccine groups out there who invent legitimate sounding names in an attempt to appear to be rational, positive organizations. They’re mostly neither rational nor positive. A new one (at least for me) is a group called the “Physicians for Informed Consent,” whose “vision is to live in a society free of mandatory vaccination laws.”

Although there are individuals who are pro-vaccine but are opposed to mandatory vaccination, mostly on a politically libertarian point of view, almost all of these groups, especially in California, are specifically anti-vaccine. In fact, “informed consent” is one of those veiled code-words used by the anti-vaccine world, especially in the fight against SB277, California’s recently enacted law that removes personal belief exemptions to vaccinations for school age children.

This article is going to examine some of the issues around “informed consent,” then look at a recent statement from the radical anti-vaccine gourd, Physicians for Informed Consent. Continue reading “Physicians for Informed Consent – another radical anti-vaccine group”