Experts Pan RFK Jr.’s Inquiry Into Removal of Flawed Vaccine Study

Legal and public health experts expressed concern about HHS Secretary Robert F. Kennedy Jr.’s scrutiny of a medical journal’s decision to remove a study that purportedly suggested an increased incidence of sudden infant death syndrome (SIDS) within a few days after vaccination.

“Secretary Kennedy pretended in the past to support free speech,” Dorit Reiss, PhD, a law professor at the University of California San Francisco, said in a post on X on Monday. “Now he is using his position to bully a medical journal, in a way that’s reminiscent of the conduct the Supreme Court struck down here. He cites no regulatory authority, and has none.”

The study in question, entitled “Vaccines and sudden infant death: An analysis of the VAERS database 1990-2019 and review of the medical literature,” was published in 2021 in Toxicology Reports and was written by Neil Miller, a well-known vaccine skeptic. Readers who visit the study on the publisher’s site now see a removal notice.

“This article has been removed at the request of the Editor-in-Chief,” the notice says. “Following post-publication concerns raised by readers regarding potential research errors and methodological flaws in this article, the journal initiated an investigation and contacted the author for clarification. The Editor-in-Chief determined that the author’s response did not satisfactorily address the concerns raised about this article.”

The notice, which was posted on April 9, according to Retraction Watch, notes that “serious methodological flaws were identified in the use of VAERS data to infer a correlation between vaccination and sudden infant death syndrome.”

“Given the inherent limitations of passive reporting systems, including the expected temporal clustering of events independent of causality, the conclusions presented in the article are not supported by the methodology employed,” the notice continues. “In light of these concerns, and given the potential implications for medical practice, the Editor-in-Chief has decided that the article should be removed. The author disagrees with this decision and disputes the grounds for removal.”

VAERS is the FDA’s Vaccine Adverse Event Reporting System, which allows members of the public to post reports of possible adverse reactions to vaccines. However, the reports are unverified, and FDA regulators have said in the past that they consider them indicative of a possible “signal” to follow up on, rather than clinically verified information.

Kennedy, in a letter posted to X on Monday, said he wrote it because “Americans have a right to know why scientific papers are removed, who made those decisions, what evidence supported them, and whether the same standards are applied consistently. We will restore trust in public health by insisting on transparency, accountability, and open scientific inquiry — not by asking the public to accept decisions behind closed doors.”

In the letter, Kennedy noted that “retraction, and even removal, of seriously flawed publications is appropriate in certain cases. However, it should be accompanied by a transparent and full explanation of why such an action was carried out … The notice of removal you issued had only two sentences explaining the retraction. Given the high levels of public interest in vaccine safety and a history of both overt and obscure pressure against the study of some of these topics, such a brief notice of removal is woefully insufficient.”

The secretary requested that the journal’s editor-in-chief, Lawrence Lash, PhD, respond to Kennedy by June 26 and explain how the decision to remove the article was reached and who was involved in the decision. He also asked for more details about the implications for medical practices and why the study was removed instead of retracted. A spokesperson for Elsevier, the journal’s publisher, said that the letter had been received and that it was under review.

Paul Offit, MD, director of the Vaccine Education Center at Children’s Hospital of Philadelphia, said he agreed with the decision to remove the study.

“The paper’s title tells you that it shouldn’t be published,” he told MedPage Today. “The best thing you can say about VAERS reports is that they raise a question.” He noted that when the mRNA COVID vaccine first came out, VAERS “quickly reported some cases of myocarditis. So that raised a question,” which then compelled researchers to investigate the matter further. “We found that myocarditis is a rare but real side effect of that vaccine,” he added.

Kennedy’s efforts to get rid of studies he doesn’t like, or reinstate those he does, are a function of his belief system, Offit said. He “has these fixed and immutable beliefs — mostly anti-science beliefs — so he believes, for example, that aluminum adjuvants in vaccines cause harm.”

Offit pointed to a “paper published not too long ago out of Denmark in the Annals of Internal Medicine — it was an excellent study, a 23-year study involving more than 1 million children — showing children could receive anywhere from 0 mg to 4.5 mg of aluminum in vaccines, and it basically showed vaccines didn’t cause any harm.”

Kennedy then wrote a letter to that journal, “asking them to withdraw that paper because it went against his bias. That’s who he is,” Offit noted.