False Claims in the California Medical Misinformation Bill

Numerous people have spoken out against California’s recently passed medical misinformation bill, AB 2098, which threatens a doctor’s medical license if they “disseminate misinformation” about COVID, about treatment for COVID or about COVID vaccines. The bill will go into effect in January, 2023. A common refrain from critics is that what counts as “misinformation” today, can become commonly accepted knowledge, tomorrow. Even vax zealots like Leana Wen have spoken out against the bill, pointing out that official guidance from the CDC and other agencies often lags behind actual medical practice.

What many critics have overlooked, however, is that the bill itself is based on basic misinformation. Section 1(c) states:

(c) The safety and efficacy of COVID-19 vaccines have been confirmed through evaluation by the federal Food and Drug Administration (FDA) and the vaccines continue to undergo intensive safety monitoring by the CDC.

Never mind that both the FDA and CDC are responsible for continued safety monitoring of the vaccines (not just the CDC), but the claim that the vaccines are subject to “intensive safety monitoring” is unsupported by facts on the ground. Indeed, recent FOIA requests and reporting by the Epoch Times have shown that the CDC has failed to conduct even the minimal safety monitoring outlined in the agency’s own documents.

As outlined in two CDC briefing documents, Vaccine Adverse Event Reporting System (VAERS) Standard Operating Procedures for COVID-19 (as of 29 January 2021) and Vaccine Adverse Event Reporting System (VAERS) Standard Operating Procedures for COVID-19 (as of Febrary 2, 2022), the “CDC will perform PRR data mining on a weekly basis or as needed” and the “FDA will perform data mining at least biweekly (with stratified data mining monthly) using empirical Bayesian data mining.”

Excerpt from CDC document - Vaccine Adverse Event Reporting System (VAERS) Standard Operating Procedures for COVID-19 - describing CDC safety signal analysis of VAERS.

Excerpt from CDC document - Vaccine Adverse Event Reporting System (VAERS) Standard Operating Procedures for COVID-19 - describing FDA data mining of VAERS.

However, a FOIA request for these analyses filed by Josh Guetzkow and the Children’s Health Defense shows that the CDC never conducted the safety monitoring they promised. In response to the FOIA request, Roger Andoh, the CDC’s FOIA officer, asserts that no PRRs were ever calculated:

[P]rogram staff  within the Immunization and Safety Office inform me that no PRRs were conducted by CDC. Furthermore, data mining is outside of th[e] agency’s purview; staff suggest you inquire with FDA.

To recap, the CDC’s own briefing documents outline the process by which “safety signals” are assessed from reports to VAERS, and yet the CDC itself asserts that the agency has not calculated a single PRR (proportional reporting ratio) for any of the adverse events associated with the COVID vaccines.

But there is simply no good reason for why PRRs have not been calculated. As Guetzkow points out,

PRRs are one of the oldest, most basic and most well-established tools of pharmacovigilance. The calculations are so straightforward that the CDC automated it several years ago, so it could have been done at the press of a button.

It simply beggars belief that the CDC failed to do this simple calculation. Even now, a paper published by CDC staff in March on the safety of the mRNA COVID-19 vaccines remains purely descriptive with no PRR calculation.

Indeed, using publicly available data from VAERS, Guetzkow, et al. used the CDC’s own methodology to calculate PRRs for a number of adverse events associated with the COVID vaccines and submitted these calculations into the public record during ACIP and VRBPAC meetings in August and September 2021. (ACIP and VRBPAC are the CDC and FDA advisory committees.) These calculations showed clear and substantial safety signals for such adverse events as death, Guillain-Barré Syndrome, coagulopathy, myocardial infarction, and myocarditis.

Safety Signal (PRR) calculations for adverse events associated with the COVID vaccines.

Indeed, while myocarditis was eventually acknowledged as a vaccine side effect, the signal for coagulopathy was twice that for myocarditis. In other words, not only did CDC fail to perform the safety signal analyses laid out in their own policy documents, but they have ignored the alarming safety signal analyses performed by private citizens and entered into the public record.

New FOIA Release Shows CDC Lied About Its VAERS Safety Monitoring Efforts

So the California legislature’s assertion that the COVID vaccines “continue to undergo intensive safety monitoring by the CDC” is demonstrably false. The legislators may in fact believe that the CDC is closely monitoring safety signals related to the vaccines, but the CDC itself asserts that this is not the case. What else can we call this claim, if not “misinformation”?

Even so, here’s where the story of CDC safety monitoring goes completely off the rails and enters a bizarre alternate reality.  The Epoch Times reported July 23 that Dr. John Su, head of CDC’s VAERS team at the CDC’s Immunization Safety Office, told the Times via email that “CDC has been performing PRRs since Feb 2021, and continues to do so to date.” And yet, according to the CDC’s letter in response to the FOIA request from Guetzkow and Children’s Health Defense, the CDC’s Immunization Safety Office (where John Su hangs his hat) insists that no PRRs were ever calculated.

John R. Su, MD, PhD, MPH, head of CDC Vaccine Safety Team

But the story doesn’t end there! After following up on the question of whether CDC calculated PRRs or didn’t calculate PRRs, the Epoch Times reported on August 13 that in fact the CDC only began calculating safety signals (PRRs) on March 25, 2022 and stopped calculating safety signals on July 31, 2022. CDC also now claims that they were simply “confused” by the FOIA request, even though the request straightforwardly asks for records of PRR calculations. At this stage, it’s impossible to know whether CDC did or didn’t calculate safety signals for the COVID vaccines and it is impossible to say when they started (if they did) and when they stopped. One could speculate that the safety signals were so clearly alarming that CDC would rather claim that no such analysis was ever performed than to have them published and discussed publicly.

The CDC Gave Me Whiplash

Even so, the California legislature asserts in Assembly Bill 2098 – a bill that is ostensibly concerned with the scourge of COVID misinformation – that the COVID-19 vaccines continue to undergo “intensive safety monitoring” by the CDC. The California medical misinformation bill relies on assurances from the CDC, and yet the CDC has itself been the source of multiple, conflicting pieces of misinformation – and not about just any old thing, but specifically about the safety of the COVID-19 vaccines and whether any safety monitoring was or wasn’t conducted.