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ICAN V-Safe

ICAN misuses v-safe data to mislead about COVID-19 vaccines

This article, about how ICAN misuses v-safe data, 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.

The Informed Consent Action Network (ICAN), an anti-vaccine organization, has claimed that V-Safe data that it obtained access to shows COVID-19 vaccines are unsafe. ICAN misrepresented CDC’s obligations about v-safe data and its treatment of it and is making claims that, at best, overstate what v-safe shows – while ignoring the extensive evidence from all around the world on COVID-19 vaccines.

This post may come across as a bit cranky, and it likely is. This is Yom Kippur, I am fasting, and this is not how I wanted to spend my fast evening. But countering anti-vaccine misinformation that can harm and kill people is important, I already did the groundwork – I was thinking of writing about the earlier press release from ICAN – so here goes.

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vaccines autism

ICAN lawsuit against CDC statement that vaccines do not cause autism

This article about another ICAN lawsuit disputing the CDC statement that vaccines do not cause autism 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 March 31, 2022, a federal district judge dismissed the Informed Consent Action Network‘s (ICAN) lawsuit demanding that CDC remove the statement that vaccines do not cause autism. The judge dismissed the lawsuit because ICAN failed to show that the alleged harms it claimed were caused by anything CDC did, or that removing the statement would fix the problem that they claim they identified. 

The claim never got to be examined on the merits, and for the purpose of dismissal at this early stage, the judge is required to treat ICAN’s claims as true. But it’s worth reminding readers that extensive data shows that vaccines do not cause autism.

Read More »ICAN lawsuit against CDC statement that vaccines do not cause autism
FDA FOIA

FDA responses to FOIA requests on COVID vaccines – not a conspiracy

This article about FDA responses to Freedom of Information Act (FOIA) requests by anti-vaccine activists 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.

In contrast to anti-vaccine claims (and the headline that echoed them), the FDA responses to a broad Freedom of Information Act (FOIA) requests are not evidence of a conspiracy or some kind of unusual problem (though it may reflect some of the general issues with our FOIA system).

In a recent set of posts by anti-vaccine activists, they criticized FDA for, allegedly, wanting 55 years to process a FOIA request for vaccine data. Unfortunately, some media sources repeated the claim uncritically. 

The reality, unsurprisingly, is different. A group that includes several anti-vaccine activists and people who have had anti-vaccine support in the past submitted a very broad request for documents related to the Pfizer-BioNTech vaccine trial.

These documents need to be redacted before being released, to protect interests like patient privacy and trade secrets. The parties are wrangling about the rate at which FDA should process those documents, and the anti-vaccine talking point is basically a misrepresentation of the FDA’s position about the schedule. Here is the report of both parties’ positions to the courts.

FDA explained that this is a very large request, it is one of several hundred they are dealing with, and their FOIA office is small. It wants to provide it at a rate of 500 pages a month, a rate that, from cases cited by FDA, has been repeatedly accepted by courts as reasonable (reflecting standard practice) and has already started providing some of the data. The group is demanding all the information in the next four months. The court will have to decide what is the appropriate rate of release. 

To emphasize — at no point did FDA ask the plaintiffs to wait 55 years for documents. The FDA offered to start releasing documents immediately, and work at a rate of 500 pages a month after December 1, releasing 500 pages to the plaintiffs each month – in order of priorities set by the plaintiffs.

This post will examine numerous issues surrounding FOIA requests to the FDA, and whether the responses by the FDA are reasonable or not.

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Anti-vaccine Informed Consent Action Network requests emails

On January 7, 2020, my school informed me that it received a new Public Records Act request for my emails, this time from the Informed Consent Action Network (ICAN), a well-funded anti-vaccine organization headed by Mr. Del Bigtree. The request was submitted via the law firm of Siri and Glimstad in New York, though it was not signed by Aaron Siri, a lawyer who represented groups fighting vaccines in the past.

They were also involved in an aggressive 9-hour deposition against a vaccine expert who agreed to support, pro-bono, a father seeking to vaccinate his young daughter (the father recently won his appeal). The request was signed by Attorney Allison Lucas; but since one of the requests was for emails with the word “Siri”, it is fair to see Attorney Siri as relevant, whether or not he was directly involved.Read More »Anti-vaccine Informed Consent Action Network requests emails

HPV vaccine consent case

HPV vaccine consent case in New York – a review

On March 3, 2017, a complaint was filed with a federal court in New York attacking a rule that allows children to consent to HPV vaccines if they were exposed to a sexually transmitted disease. The complaint is competently written, but its arguments are unconvincing legally and deeply flawed factually. It may proceed past summary judgment, since the court is required to assume the factual premises in it are correct; but it should ultimately fail. This article will review the HPV vaccine consent case, as it stands.Read More »HPV vaccine consent case in New York – a review