Informed Consent Action Network

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

by Dorit Rubinstein Reiss
2022-06-20
Del Bigtree, MMR vaccine, Tdap/DTap vaccine, Vaccines

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.

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.

FDA rejects ICAN petition to revoke of EUAs issued for COVID vaccines

by Viridiana Ordonez
2021-11-03
COVID-19, Del Bigtree, JNJ, Moderna, Pfizer, Vaccines

This article about the FDA’s actions on a petition from ICAN to revoke EUAs for COVID-19 vaccines was written by Viridiana Ordonez. Ms. Ordonez has contributed other articles to this website and is a J.D. candidate at the University of California, Hastings College of Law.

Del Bigtree‘s Informed Consent Action Network (ICAN) submitted a Citizen Petition to the Food and Drug Administration (FDA) on September 27, 2021. In its petition, ICAN requested that the FDA revoke the Emergency Use Authorization (EUA) granted to ModernaTX, Inc. (Moderna) and JNJ Jansen Biotech, Inc. (Janssen) for their COVID-19 vaccines.

ICAN argued that because the FDA has now approved Comirnaty – the COVID-19 vaccine created by Pfizer-BioNTech – the requirements for issuance of the EUA for the other vaccines are no longer met.

The FDA replied to the petition on October 20, 2021, and rejected the request, explaining that ICAN’s petition did not contain facts demonstrating any reasonable grounds for its request. This post summarizes FDA’s response.

JNJ COVID-19 vaccine trial – FDA rejects another ICAN petition

by Viridiana Ordonez
2021-03-10
COVID-19, Del Bigtree, JNJ, Law, Vaccines

This article about the Informed Consent Action Network’s petition to halt the JNJ COVID-19 vaccine trial was written by Viridiana Ordonez, a J.D. candidate at the University of California, Hastings College of Law.

This is a summary of the FDA’s response to a citizen petition dated October 16, 2020, filed on behalf of the petitioner, Del Bigtree’s Informed Consent Action Network (ICAN), relating to the clinical trial of Ad26.COV2S, a Janssen Biotech, Inc. (a subsidiary of Johnson & Johnson, JNJ) COVID-19 vaccine.

Like a previous ICAN petition about COVID-19 vaccine trials, the FDA denied the petition in its entirety. FDA concluded that the vaccine trials were thorough, vaccine safety was carefully tested and monitored, and ICAN’s requests are not well-founded.

This summary is divided into three parts: (1) ICAN’s specific requests; (2) FDA’s description of the vaccine process and safety; and (3) FDA’s response to six specific requests.

COVID-19 vaccine trials – FDA rejects ICAN petition to stop the trials

by Viridiana Ordonez
2021-03-10
COVID-19, Del Bigtree, Law, Moderna, Vaccines

This article about the Informed Consent Action Network’s petition to halt COVID-19 vaccine trials was written by Viridiana Ordonez, a J.D. candidate at the University of California, Hastings College of Law.

This article summarizes the FDA’s response to Del Bigtree’s ICAN’s (petitioner) request regarding the Phase III trials for the COVID-19 vaccine. The summary is divided into three parts:

Petitioner’s Request;
FDA’s description of vaccine process; and
FDA’s response to the petition.

ICAN’s request for COVID-19 vaccine trials

Lipid nanoparticles in COVID-19 mRNA vaccines are safe – ICAN is wrong

This article about lipid nanoparticles in COVID-19 mRNA vaccines is by VaultDwellerSYR, a pseudonym used by a faculty member of a School of Pharmacy within a large medical school. They have significant research and publications on the effect of certain chemicals on the brain. Although we are opposed to all arguments from authority, the author has a substantial record of actual, published research in the fields of brain cell biology and biochemistry.

The anti-vaccine Del Bigtree‘s Informed Consent Action Network (ICAN), as expected, started to seed doubts and fallacious claims on COVID-19 mRNA vaccines, in an attempt to discredit and reduce the uptake of this vaccine by the population.

In their latest stunt, ICAN posted on January 17th on their Facebook page the following statement with a “legal update” pictogram:

ICAN INQUIRES WITH THE FDA ABOUT THE SAFETY OF LIPID NANOPARTICLES USED IN PFIZER’S AND MODERNA’S COVID-19 VACCINESICAN, through its attorneys, has once again written to Dr. Peter Marks, Director of the FDA’s Center for Biologics Evaluation and Research, to demand a response to the question of whether or not lipid nanoparticles used in both of the currently authorized COVID-19 vaccines are safe.  ICAN is aware that both Pfizer and Moderna have used lipid nanoparticles (“LNPs”) in their vaccines – LNPs are what the manufacturers use to surround the RNA so that it does not fall apart when injected and before reaching its target cells. Some have compared these LNPs to a fatty envelope or a delivery vehicle to get the mRNA into the human body in one piece.
A concern arose when ICAN was alerted to a study published in 2018 titled Lipid Nanoparticles: A Novel Approach for Brain Targeting. The study states: “…lipid nanoparticles are taken up readily by the brain because of their lipophilic nature. The bioacceptable and biodegradable nature of lipid nanoparticles makes them…suited for brain targeting.” The article also states, “these nanostructures need to be investigated intensively to successfully reach the clinical trials stage.” ICAN wants to fully understand whether the evidence that these LNPs are easily taken up and end up in the brain is a safety concern with these two particular vaccines. ICAN, through its attorneys, led by Aaron Siri, has therefore sent a letter to Dr. Peter Marks, the Director of the Food and Drug Administrations’ Center for Biologics Evaluation and Research. If you recall from previous legal updates, Dr. Marks has referred to himself as “the FDA point person on COVID-19 vaccines” and has assured Americans that the FDA “will make sure they’re safe and effective.”   ICAN also pointed out to Dr. Marks that there appears to be support for the proposition that the body may react strongly to a second dose of the LNPs. Stated differently, the body is primed to have an immune reaction to the LNPs with the first dose. As explained by Johns Hopkins, “Side effects were more frequent after the second dose in the vaccine trials.” Another article, titled Exogenous nanoparticles and endogenous crystalline molecules as danger signals for the NLRP3 inflammasomes, supports that the increasingly inflammatory side effects observed in those who received the vaccine in Pfizer’s and Moderna’s clinical trials are attributable to the LNPs and that these side effects get worse with repeated injection. We have seen this increased “reactogenicity” clearly in the data from both Pfizer’s and Moderna’s COVID-19 clinical trials.  ICAN continues to ask the hard questions of Dr. Marks and others: If LNPs from the vaccine, which contain mRNA, are entering brain tissue, and an immune reaction is occurring during the second dose to these LNPs, does this pose a safety concern for vaccine recipients? ICAN asked Dr. Marks to consider the question posed and provide support for the substance of any response he provides.
ICAN will closely review any response from Dr. Marks given his promise that he and the FDA “uphold globally respected standards for product quality, safety, and efficacy” and his statement that he would resign if “something that was unsafe or ineffective [] was being put through.” As always, ICAN offered to provide any additional information or to meet with Dr. Marks to discuss this issue.

As you can see, ICAN is on another one of their PR stunts in the attempt to “cease and desist”, as intimidation with little legal merit and certainly not based on an honest and critical review of the existing literature. Let’s critically examine ICAN’s claims about lipid nanoparticles.