ICAN Presses FDA and CDC on Drug Ad Disclosures, Vaccine Contraindications
Updated
The Informed Consent Action Network (ICAN) has had a busy month that has included legal requests to the CDC and FDA, recommendations to the Agency for Toxic Substances and Disease Registry (ATSDR) about hazardous substance evaluations, and a fulfilled FOIA request that provides a 2019 presentation to the National Vaccine Advisory Committee suggesting vaccination rates could be increased through coercion, social pressure, and public shaming.
2019 Presentation About Shaming “Anti-Vaxxers” to Change Behavior
The 2019 presentation from Arthur Caplan started with his financial disclosures, including payments he received from Janssen, Sanofi, Novartis, GlaxoSmithKline, Otsuka, CS, and others. Page 5 of his slideshow says “facts alone are not enough to increase vax rates” because “anti-vaxxers lie, social media propagates lies and misinformation,” and “facts sometimes look weaker than they should. Caplan’s conclusion on that page is that “facts are ‘is’ and behavior change is ‘ought.’”
At the end of his presentation, Caplan concludes that ethical arguments should be used to reframe the conversation and to influence “guilt hesitators” in order to change their behavior. “Anti-vaxxers” should be called “selfish, bad neighbors, [and] indifferent to the vulnerable.” Caplan also argues for government control over the vaccination of children, because the state has “broad authority to regulate the actions and the treatment of children.” Caplan compares the action of not vaccinating children to the action of beating children, for which the state has enacted laws for the protection of children.
Caplan also clearly states that “preventable harm to others allows restriction of liberty.” He supports efforts by states to restrict nonmedical exemptions and says, “Do not allow bogus values to override protection of children.”
CDC Contraindications Recommendations Letter
ICAN Attorney Aaron Siri sent a letter to Secretary Kennedy and CDC Acting Director Jay Bhattacharya asking them to consider revisions to the CDC’s “Contraindications and Precautions” website. The letter includes additions and strikethroughs on the page that doctors and clinicians use to determine when to provide medical exemptions for vaccines.
The recommended updates include strikethrough of a section stating that clinicians may “misperceive” contraindications and that doing so results in “missed opportunities to administer recommendations.” The strike-through section also says routine physical exams are not a prerequisite to vaccination for patients who “appear to be healthy.”
Additions to that section recommend that all patients should be screened before each vaccine dose for “all absolute and relative contraindications, including clinically significant warnings and precautions to the vaccine before each dose of vaccine is administered as they appear below” and “all contraindications, warnings, and precautions listed in Section 6 of the package insert or vaccine information statement for each relevant vaccine.”
FDA Direct to Consumer Letter
ICAN Attorney Aaron Siri sent a letter to the FDA requesting that the agency take action on direct-to-consumer pharmaceutical ads by requiring companies to disclose all known risks associated with each product in each advertisement. The Trump administration and HHS Secretary Robert F. Kennedy Jr. have taken steps to initiate stricter guidelines on pharmaceutical advertising, but they are seeking a return to pre-1997 standards. ICAN is asking for all known risks to be listed, not just the major ones.
Only two countries in the world allow pharmaceutical companies to advertise directly to consumers – the US and New Zealand. Secretary Kennedy advocated for a complete ban while campaigning with President Trump in 2024, but later learned that such a ban would likely fail First Amendment challenges in court. Kennedy and others have also criticized the model of pharmaceutical advertising for its influence on the news media, which receives large amounts of ad dollars from these companies but is also expected to report on the companies and their products from a neutral perspective.
“At the least, FDA should require that DTC advertising for all drugs, biologics, and medical devices fairly and equally disclose all risks along with any benefits related to the product,” Siri wrote. “The FDA can effect this change within its existing regulatory authority by amending 21 CFR § 202.1, titled “Prescription-drug advertisements,” and clarifying the types of products and platforms it applies to.”
Hazardous Substance Evaluations
In response to a public notice from ATSDR, ICAN submitted a comment nominating four substances commonly used as vaccine ingredients for evaluation in the registry. Aluminum is an adjuvant used to stimulate an immune response and is an ingredient in DTaP, Tdap, hepatitis A, hepatitis B, Haemophilus influenzae type B (Hib), human papillomavirus (HPV), pneumococcal, and meningococcal vaccines.
Mercury is found in some multi-dose influenza vaccines as a preservative, thimerosal. Phenol is used as an inactivating agent or preservative in certain vaccines, such as pneumococcal disease and Hib. Formaldehyde is used as an inactivating ingredient and is present as a residual in several vaccines, including DTaP, hepatitis A, hepatitis B, influenza, and meningococcal disease.
ICAN submitted a comment suggesting these four ingredients be evaluated under the toxicology registry since they are “injected directly into the bloodstream of millions of healthy children every year.” The ATSDR typically evaluates substances based on environmental exposure routes, such as inhalation, ingestion, or skin contact.