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”

Maine anti-vaccine legislation appears again – flawed and misleading

On 4 January 2019, the Maine Coalition for Vaccine Choice – a Maine anti-vaccine organization – posted an article about a proposed bill that they called “The Maine Vaccine Consumer Protection Program.” As with the coalition’s previous attempt to pass such a bill, in 2015, the proposal is ill-founded. The premises it is based on are flawed, and the proposals themselves range from directly misleading to not very meaningful. Continue reading “Maine anti-vaccine legislation appears again – flawed and misleading”

Vaccines cause SIDS? Not supported by Boatmon vs HHS case

vaccines cause SIDS

This is about the case of little J. B. Boatman, who was born four weeks prematurely, at the 36th week.  However, he rebounded from his early start, and at his four-months, well baby pediatric visit, on September 2 was doing very well and found healthy.  At that visit, J.B. had the routine 4 months vaccines. Tragically, the next day (September 3) little J.B. was found lifeless in his crib. His death was ruled to be the result of Sudden Infant Death Syndrome (SIDS). But did vaccines cause SIDS in J.B.?

His parents filed suit under the National Vaccine Injury Compensation Program (NVICP). The case was decided on July 10, 2017. Special Master  Thomas L. Gowen with the National Vaccine Injury Compensation Program granted J.B’s parents compensation.

In August 2017 the Boatmon decision was shared on anti-vaccine sites as evidence that vaccines cause SIDS. The decision does not, however, support the claim because it is flawed internally in several ways. It misuses and discounts the epidemiological evidence, accepts a problematic theory over the objection of a more qualified expert, and ignores several of the important factors of the case. In addition to its internal flaws, the decision is in tension with many other decisions of NVICP – in fact, it seems an outlier – and it is interesting that the same sites that tout this problematic decision ignore other decisions that ruled otherwise. Continue reading “Vaccines cause SIDS? Not supported by Boatmon vs HHS case”

Plus ça change – anti-vaccine activists revive the Hannah Poling case

Hannah Poling

Following a pattern we have seen repeatedly, anti-vaccine activists have tried to claim a conspiracy to hide a link between vaccines and autism. The latest effort, reviving the Hannah Poling case, follows the pattern we have seen in previous cases – anti-vaccine activists claim that the government knew of evidence that vaccines cause autism (in this case, through mitochondrial disorders), that the government committed fraud to hide that information, and that the combination of fraud and evidence should be a game changer.

As with those past events, the claims cannot withstand scrutiny. In this case, another claim was added – a denial of due process for claimants in the Omnibus Autism Proceedings generally and in one family’s case specifically. This claim, too, does not hold. 

In contrast to the claims in the latest set of anti-vaccine articles, there was no fraud by the government, the behavior they complain about did not decide the fate of the Omnibus Autism Proceedings, they provide no new evidence that vaccines cause autism, the mitochondrial claim is neither new nor strong, and there was no denial of due process to the claimants in the Omnibus Autism Proceeding or in the specific case in question. Continue reading “Plus ça change – anti-vaccine activists revive the Hannah Poling case”

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”

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”

Vaccine court myths – instead, here are facts about the NVICP

vaccine court myths

The anti-vaccine world loves its myths, because, lacking any real scientific evidence supporting their outlandish claims, fairy tales are all they have. Not that I like picking and choosing the worst of the anti-vaccine urban legends, but the vaccine court myths are among the most egregious and ridiculous.

Although there are a lot of vaccine court myths, though this article will focus on just three:

  1. The vaccine court vs. civil courts.
  2. Vaccine manufacturers are immune to lawsuits.
  3. Billions of dollars have been paid out to “victims.”
  4. The vaccine court said that vaccines cause autism.

Let’s get to the article. Continue reading “Vaccine court myths – instead, here are facts about the NVICP”

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”

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”