The Biden administration's Food and Drug Administration marginalized a "safety data mining developer" whose updated methodology for COVID-19 vaccine safety surveillance found about 25 "statistically significant safety signals for adverse events" that the FDA's default methodology missed as early as March 2021, a congressional investigation says.

The Trump administration's FDA blocked peer-reviewed publication of two COVID vaccine studies that affirmed their safety because the agency staff and pharmaceutical consultants who jointly wrote them "drew broad conclusions that were not supported by the underlying data," the Department of Health and Human Services says.

Mainstream media showed no discernible interest in the former but great interest in the latter, omitting details about the papers' authorship and methodology that might lead the audience to give credence to National Institutes of Health Director Jay Bhattacharya's public concerns about weak methodology in FDA-sponsored research.

Wisconsin GOP Sen. Ron Johnson exclusively previewed his Permanent Subcommittee on Investigation's findings about the Biden FDA's attempts to hide the safety signals to Just the News, before an April 29 hearing and associated interim staff report based on documents provided by HHS.

Senior medical officer Ana Szarfman repeatedly showed top officials the proliferation of adverse events including death following COVID vaccination she "unmasked" in the FDA's system, using a new method she developed with the "inventor of the data mining algorithm" supporting the FDA's current system, the report said.

One senior official told colleagues they should avoid email to plan how they'll respond to Szarfman's entreaties, while Center for Biologics Evaluation and Research senior officials directed her to “hold off on creating and sending data mining reports and analyses."

Then-CBER Director Peter Marks told then-Center for Drug Evaluation and Research Patrizia Cavazzoni that Szarfman’s data mining could "create erroneous conflicts that feed in to anti-vaccination rhetoric," according to the report.

No mainstream media appear to have covered Johnson's report, but the industry swooned over a New York Times report Tuesday that FDA staff were told in October to withdraw the studies of 2023-2024 COVID vaccine safety from the peer-reviewed journals that accepted them.

The would-be Drug Safety study, available in full as a preprint since January 5, 2025, looked at Medicare beneficiaries 65 and older. 

The would-be Vaccine study, whose abstract alone is public but was presented at an August conference, looked at "commercial health plan enrollees" ages 6 months to 64 years. It includes every author from the 65-and-up study, including the ex-director and then-deputy director of the FDA Office of Biostatistics and Pharmacovigilance, plus 15 others.

STAT News first reported the latter's withdrawal in November in a feature on then-CBER Director Vinay Prasad, who returned to academia this month, and acting CDER Director Tracy Beth Hoeg and their allegedly hard-charging efforts to purge weak methodology from FDA research.

Biotech companies vented to Bloomberg this week about "what they describe as an inconsistent drug review process" under FDA Commissioner Marty Makary, especially the "toxic methodological purity" demanded by Prasad, in the words of the Alliance for Regenerative Medicine, which lobbies for cell and gene therapy makers.

'Blatant politics'

The Times and The Washington Post already pounced once recently on NIH's Bhattacharya, acting director of the Centers for Disease Control and Prevention, for supposedly suppressing research at odds with HHS Secretary Robert F. Kennedy Jr.'s agenda.

Bhattacharya axed a study in the CDC's in-house journal that found new COVID vaccines effective against serious outcomes for healthy adults, calling its "test-negative" design inherently unreliable to measure vaccine efficacy.

Morbidity and Mortality Weekly Report is not peer-reviewed and drew a reputation for publishing weak research that supported President Biden's COVID policies, details missing from legacy media reporting. It also published a methodologically challenged study on COVID vaccines and children under President Trump's CDC last year.

The Times reporter behind the "scoop" on the COVID studies' withdrawal, Christina Jewett, did not report on Johnson's Senate investigation despite officially covering the FDA for the newspaper.

"No such energy for Dr. Sztarfman's [sic] studies," former FDA regulatory review officer Jessica Adams wrote on X, sharing Jewett's reporting.

"Which is worse: FDA declining to publish two studies over methodological concerns and overstated conclusions, or senior officials directing their own data-mining expert to 'cease and desist' an alternative safety data-mining approach because it could 'create erroneous conflicts that could be used to feed into anti-vaccination rhetoric'?" Adams wondered.

Jewett's report did not elaborate on the methodology of the COVID vaccine studies except to note the 65-and-up study compared the 21 days immediately following vaccination with the 20 days subsequent to the 21, to discern whether "there were more health problems in the period right after vaccination."

She did not mention that an author on both papers, ex-OBP Director Steven Anderson, says he left the FDA in December 2024 and started his own pharma consultancy in March 2025. 

The 65-and-up preprint associates Anderson with the FDA, despite Anderson saying he left the FDA the month before, while a trade association's speaker bio for him says he directed OBP "until" January 2025. The under-65 abstract describes him as "formerly" FDA with no other affiliation. 

"Shouldn't the NY Times do a journalism and report the blatant politics, instead of pretending this is 'science'?" former Senate pharmaceutical payola investigator Paul Thacker, who flagged Anderson's role in both studies and alleged conflict of interest, wrote on X. 

Just the News could not find a way to reach Anderson to confirm when exactly he left the FDA. His consultancy is named on his LinkedIn profile but does not appear to have a website, email or phone number listed.

'Basically useless' study

Both studies relied on a "self-controlled case series," in which a patient acts as his or her own control group so that "only individuals who have experienced an event are included and all time invariant confounding is eliminated," as the British Medical Journal described the design in 2016, highlighting its use in vaccine adverse event research.

The problem with the methodology in this context is it ignores how people tend to time their immunizations, former Times drug industry reporter Alex Berenson wrote in his newsletter, dismissing the 65-and-up study as "junk" and exemplar of "The Science" rather than science. (Only that one can be read by the public in full as a preprint.)

"Under some circumstances, and particularly for longer periods when a facet of the variable one is attempting to measure does not confound the outcome, it can be reasonable," but in this case it "produces a bias hugely in favor of vaccine safety" because people are "unlikely to get vaccinated if they aren't feeling well" and will wait to feel better, Berenson wrote.

"Thus the days immediately following vaccination are likely to see a DROP in serious side effects" because jabs must come with "very serious problems to overcome that inherent bias in their favor," he said. "The people talking to Christina Jewett certainly know that inherent flaw makes the study basically useless. Does she?"

Jewett did not answer a query about her reporting's omissions and whether she has ever reported on vaccination risks sufficient to question any given jab in any given person.

Jeffrey Morris, director of the University of Pennsylvania biostatistics division, reviewed the study drafts at Jewett's request and told her, in Jewett's paraphrase, they were "generally well done."

But the Times left out his "methodological points" on the papers, Morris wrote on X. He believes they could have been published in full while satisfying the FDA's concerns, had officials simply asked the authors to remove an insufficiently substantiated claim that the research found vaccine "benefits outweighed the risk."

Such papers that track "events from millions of patients" are "the exact type of study we need more of from the FDA and CDC scientists to assess potential vaccine harms," he said.