The misleading claims of anti-vaccine Steve Kirsch — a review

Steve Kirsch

This article about misleading claims from anti-vaccine activist Steve Kirsch was written by Dorit Rubinstein Reiss, Professor of Law at the University of California Hastings College of the Law (San Francisco, CA), who is a frequent contributor to this and many other blogs, providing in-depth, and intellectually stimulating, articles about vaccines, medical issues, social policy, and the law.

Professor Reiss writes extensively in law journals about vaccination’s social and legal policies. Additionally, Reiss is also a member of the Parent Advisory Board of Voices for Vaccines, a parent-led organization that supports and advocates for on-time vaccination and the reduction of vaccine-preventable diseases. She is also a member of the Vaccines Working Group on Ethics and Policy.

I have not previously discussed posts by Mr. Steve Kirsch, of the new generation of antivaccine activists, because they are not generally related to law or regulation, and they have been well debunked by those that are in the field, such are Dr. Jeffrey Morris, Dr. David Gorski, and others more suited to address his statistical errors. 

But his recent post, “Silenced healthcare workers speak out publicly for the first time,” is sufficiently jarring that I would like to address it. Mr. Kirsch’s claims have been getting increasingly more extreme, and this post is a good example of some of the problems with his views that you do not need an extensive background in statistics to address. (I do not link to anti-vaccine posts, but with the title and author they should be easy to find, should anyone wish to). 

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VAERS facts — contradicting anti-vaccine claims and beliefs

VAERS facts

This article about VAERS facts, literally a FAQ, was written by Dorit Rubinstein Reiss, Professor of Law at the University of California Hastings College of the Law (San Francisco, CA), who is a frequent contributor to this and many other blogs, providing in-depth, and intellectually stimulating, articles about vaccines, medical issues, social policy, and the law.

Professor Reiss writes extensively in law journals about vaccination’s social and legal policies. Additionally, Reiss is also a member of the Parent Advisory Board of Voices for Vaccines, a parent-led organization that supports and advocates for on-time vaccination and the reduction of vaccine-preventable diseases. She is also a member of the Vaccines Working Group on Ethics and Policy.

Some of the new generation of anti-vaccine activists appear to have built their careers on misrepresentation of VAERS. One example is Dr. Jessica Rose, who apparently started her career as a legitimate young scientist, but at some point became a devoted anti-vaccine activist. Dr. Rose’s background is described by Orac thus:

Her background is more in the sort of computational biology that looks at protein structures and bioinformatics related to DNA sequences than it is to the sort of mathematical and statistical skill set necessary to delve into VAERS with any credibility. A perusal of her curriculum vitae, which is included on the profile, confirms my assessment, particularly her publication record, which includes a lot of molecular biology and virology, but nothing in the way of epidemiology.

In 2021, Dr. Rose joined the anti-vaccine organization IPAK as a research fellow, and she has published several papers in IPAK’s own publication, named Science, Public Health Policy, and the Law, whose editorial board is comprised of leading anti-vaccine activists.

Dr. Rose’s specialty appears to be doing bad analyses of VAERS and claiming, based on them, that COVID-19 vaccines are dangerous.

On August 9, 2022, Dr. Rose published a “Question and Answer” “facts” about VAERS, titled “A question and answer document on the subject of VAERS as a pharmacovigilance tool”. It is highly misleading. But it gave me an opportunity to provide information based on actual facts about VAERS.

If you want to see how it’s misleading, jump ahead to question 3 (and I hope you then go back and read the long discussion in questions 1 and 2).

I will repeat each question, answer it, shortly summarize Dr. Rose’s claims, and explain why they are misleading. Note that this discussion is limited to the mRNA vaccines and the J&J vaccine, which are the ones used in the United States and subject to reporting to VAERS – Novavax is newer and is not the subject of most of the misinformation from the anti-vaccine activists misleading people about VAERS. 

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Settlement of lawsuit about COVID vaccine religious exemptions

COVID-19 vaccine religious exemption

This article about the settlement of a lawsuit and COVID-19 vaccine religious exemptions was written by Dorit Rubinstein Reiss, Professor of Law at the University of California Hastings College of the Law (San Francisco, CA), who is a frequent contributor to this and many other blogs, providing in-depth, and intellectually stimulating, articles about vaccines, medical issues, social policy, and the law.

Professor Reiss writes extensively in law journals about vaccination’s social and legal policies. Additionally, Reiss is also a member of the Parent Advisory Board of Voices for Vaccines, a parent-led organization that supports and advocates for on-time vaccination and the reduction of vaccine-preventable diseases. She is also a member of the Vaccines Working Group on Ethics and Policy.

Headlines about a settlement between healthcare workers and their employer related to COVID-19 vaccine religious exemptions led people to ask what is the relevance of that settlement. This post explains this settlement and puts the issue in context.

Three points need to be made:

  • First, this is not the first time an employer settled a claim for denial of religious exemption.
  • Second, sometimes the settlement is the result of an employer making mistakes in handling religious exemptions and having a really bad case, and settling is the right thing.
  • Third, in legal terms, the settlement has no relevance to any other case. In practical terms, though, it can be used to put pressure on other employers, even when those employers are on legally solid ground.
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Brook Jackson False Claims lawsuit against Ventavia COVID-19 vaccine clinical trial

pexels-photo-5878514.jpeg

This article about the Brook Jackson lawsuit claiming false payment claims for the Pfizer COVID-19 vaccine was written by Dorit Rubinstein Reiss, Professor of Law at the University of California Hastings College of the Law (San Francisco, CA), who is a frequent contributor to this and many other blogs, providing in-depth, and intellectually stimulating, articles about vaccines, medical issues, social policy, and the law.

Professor Reiss writes extensively in law journals about vaccination’s social and legal policies. Additionally, Reiss is also a member of the Parent Advisory Board of Voices for Vaccines, a parent-led organization that supports and advocates for on-time vaccination and the reduction of vaccine-preventable diseases. She is also a member of the Vaccines Working Group on Ethics and Policy.

Brook Jackson worked as an operator of three of Pfizer’s COVID-19 vaccine clinical trials sites for 18 days. Based on what she saw, she brought suit against the operator – Ventavia, the company that hired clinical trials site operators, ICON PLC., and Pfizer in the name of the United States under the False Claims Act. Jackson’s lawsuit claims, if true, may show that Ventavia had many issues in running the trial.

But they do not show fraud in relation to claims of payment from the federal government, which is the heart of a False Claims claim, and that alone should probably lead to her lawsuit being dismissed. The False Claims Act is not a catch-all tool for violation of FDA regulations. 

Again, even if true, they do not show a problem with Pfizer’s vaccine, a vaccine for which there is now extensive independent data on safety and effectiveness. 

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Brook Jackson False Claims lawsuit against Ventavia COVID-19 vaccine clinical trial

close up view of a vaccine vial

This article about the Brook Jackson lawsuit claiming false payment claims for the Pfizer COVID-19 vaccine was written by Dorit Rubinstein Reiss, Professor of Law at the University of California Hastings College of the Law (San Francisco, CA), who is a frequent contributor to this and many other blogs, providing in-depth, and intellectually stimulating, articles about vaccines, medical issues, social policy, and the law.

Professor Reiss writes extensively in law journals about vaccination’s social and legal policies. Additionally, Reiss is also a member of the Parent Advisory Board of Voices for Vaccines, a parent-led organization that supports and advocates for on-time vaccination and the reduction of vaccine-preventable diseases. She is also a member of the Vaccines Working Group on Ethics and Policy.

Brook Jackson worked as an operator of three of Pfizer’s COVID-19 vaccine clinical trials sites for 18 days. Based on what she saw, she brought suit against the operator – Ventavia, the company that hired clinical trials site operators, ICON PLC., and Pfizer in the name of the United States under the False Claims Act. Jackson’s lawsuit claims, if true, may show that Ventavia had many issues in running the trial.

But they do not show fraud in relation to claims of payment from the federal government, which is the heart of a False Claims claim, and that alone should probably lead to her lawsuit being dismissed. The False Claims Act is not a catch-all tool for violation of FDA regulations. 

Again, even if true, they do not show a problem with Pfizer’s vaccine, a vaccine for which there is now extensive independent data on safety and effectiveness. 

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ICAN anti-vaccine rhetoric — getting it wrong about informed consent

This article about ICAN and its anti-vaccine rhetoric about informed consent was written by Dorit Rubinstein Reiss, Professor of Law at the University of California Hastings College of the Law (San Francisco, CA), who is a frequent contributor to this and many other blogs, providing in-depth, and intellectually stimulating, articles about vaccines, medical issues, social policy, and the law.

Professor Reiss writes extensively in law journals about vaccination’s social and legal policies. Additionally, Reiss is also a member of the Parent Advisory Board of Voices for Vaccines, a parent-led organization that supports and advocates for on-time vaccination and the reduction of vaccine-preventable diseases. She is also a member of the Vaccines Working Group on Ethics and Policy.

In a misleading “White Paper,” the anti-vaccine organization, Del Bigtree‘s Informed Consent Action Network (ICAN) argued that “eliminating vaccine exemptions and curtailing criticism is unethical and un-American” because, they argue, it invalidates vaccination informed consent. The initial statement is wrong, and the arguments brought to support it are wrong. This article corrects the record.

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FDA, CDC, and COVID-19 vaccines — who does what?

FDA CDC COVID-19 vaccines

This article about the role of the CDC and FDA concerning COVID-19 vaccines was written by Dorit Rubinstein Reiss, Professor of Law at the University of California Hastings College of the Law (San Francisco, CA), who is a frequent contributor to this and many other blogs, providing in-depth, and intellectually stimulating, articles about vaccines, medical issues, social policy, and the law.

Professor Reiss writes extensively in law journals about the social and legal policies of vaccination. Additionally, Reiss is also a member of the Parent Advisory Board of Voices for Vaccines, a parent-led organization that supports and advocates for on-time vaccination and the reduction of vaccine-preventable diseases. She is also a member of the Vaccines Working Group on Ethics and Policy.

I write this right after the FDA expert advisory committee, Vaccines and Related Biological Products Advisory Committee (VRBPAC), voted unanimously that the benefits of both Moderna and Pfizer-BioNTech’s COVID-19 vaccines for children 6 months to 5 years of age outweigh their risks, clearing a smooth path for FDA to grant emergency use authorization (EUA) to these vaccines. I was asked about the division of labor between CDC and FDA on COVID-19 vaccines, and it seems like something worth setting out.

So this is a short post about the relative roles of the FDA and CDC in getting COVID-19 vaccines to people in the USA. It is not a full picture of how vaccines get to us; there is a lot more to that. I am not even going into the full requirement for approving or authorizing a vaccine; just who does what. But this piece of the puzzle can be useful by itself.

For those looking for a full description of the vaccine approval process, I recommend either the Skeptical Raptor’s post on that topic or the description by the Vaccine Education Center of the Children’s Hospital of Philadelphia.  

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Hospital COVID vaccine mandate – Texas Federal District court rejects challenge

Hospital COVID vaccine mandate

This article about a Texas Federal District Court that rejected a challenge to a hospital COVID vaccine mandate was written by Dorit Rubinstein Reiss, Professor of Law at the University of California Hastings College of the Law (San Francisco, CA), who is a frequent contributor to this and many other blogs, providing in-depth, and intellectually stimulating, articles about vaccines, medical issues, social policy, and the law.

Professor Reiss writes extensively in law journals about the social and legal policies of vaccination. Additionally, Reiss is also a member of the Parent Advisory Board of Voices for Vaccines, a parent-led organization that supports and advocates for on-time vaccination and the reduction of vaccine-preventable diseases. She is also a member of the Vaccines Working Group on Ethics and Policy.

On June 12, 2021 (yes, a Saturday), a Texas federal district judge dismissed a lawsuit brought by employees of the Houston Methodist Hospital against the hospital’s COVID vaccine mandate which required employees to be vaccinated unless they qualify for a medical or religious exemption.

I wrote about the lawsuit here. It is a badly argued lawsuit, with multiple extreme claims, and it does a bad job in setting out the one somewhat plausible argument it has, the argument that you cannot mandate a vaccine under an Emergency Use Authorization (EUA). 

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The ICAN Freedom of Information Act (FOIA) gambit, why it’s dishonest

FOIA ICAN

This article, about the ICAN FOIA gambit, was written by Dorit Rubinstein Reiss, Professor of Law at the University of California Hastings College of the Law (San Francisco, CA), who is a frequent contributor to this and many other blogs, providing in-depth, and intellectually stimulating, articles about vaccines, medical issues, social policy, and the law.

Professor Reiss writes extensively in law journals about the social and legal policies of vaccination. Additionally, Reiss is also a member of the Parent Advisory Board of Voices for Vaccines, a parent-led organization that supports and advocates for on-time vaccination and the reduction of vaccine-preventable diseases. She is also a member of the Vaccines Working Group on Ethics and Policy.

Repeatedly, Del Bigtree’s anti-vaccine organization Informed Consent Action Network (ICAN) and others engage in a “FOIA (Freedom of Information Act) gambit” to mislead their followers. Essentially, the FOIA gambit involves asking an agency for something that is not likely to be an agency record, and when the agency said it was not found, claiming that the fact, or point, or something is unproven.

This is misleading because FOIA is only designed to get agency records, not as a tool to ask agencies questions or examine scientific issues. ICAN’s lawyers, at least, should know this, and should so advise their clients. Its repeated use suggests that this is not just ignorance, but dishonesty, and it can work – which is why I am writing this debunking post. 

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Legal challenges to remove religious exemptions to school vaccine mandates rejected by Courts

architecture art clouds landmark

This article challenges to stricter school vaccine mandates was written by Dorit Rubinstein Reiss, Professor of Law at the University of California Hastings College of the Law (San Francisco, CA), who is a frequent contributor to this and many other blogs, providing in-depth, and intellectually stimulating, articles about vaccines, medical issues, social policy, and the law.

Professor Reiss writes extensively in law journals about the social and legal policies of vaccination. Additionally, Reiss is also a member of the Parent Advisory Board of Voices for Vaccines, a parent-led organization that supports and advocates for on-time vaccination and the reduction of vaccine-preventable disease. She is also a member of the Vaccines Working Group on Ethics and Policy.

On December 3, 2019, Judge Denise Hartman, from the New York Supreme Court in Albany (see Note 1), rejected a claim challenging the removal of the religious exemption from school vaccine mandates.

Judge Hartman has previously, in a careful decision upheld on appeal, rejected plaintiffs’ request for a preliminary injunction on stricter school vaccine mandates. In this decision, she provided a well-reasoned, thoughtful analysis of the constitutional issues.

Judge Hartman found that the change in the law in New York was based on public health, not hostility to religion, and fits well within the extensive precedent upholding mandates without requiring a religious exemption.

This lawsuit was the strongest, best-argued challenge to the New York law on religious freedom grounds. Unless plaintiffs appeal, this is likely the end for any serious chance opponents had at overturning the law, and even on appeal, their chances are likely low.

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