A toxicology journal has retracted a 16-year-old study linking hepatitis B vaccines to autism in children following an independent statistical review that found a half-dozen concerns with the study’s methodology.
Using data from the National Health Interview Survey, the authors claimed boys vaccinated in their first month of life had “threefold greater odds for autism diagnosis” than those vaccinated later or not at all.
The study was included in a rapid systematic review of hep B vaccine studies presented by John Su, director of the Immunization Safety Office for the Centers for Disease Control and Prevention, at the Sept. 18 meeting of the Advisory Committee on Immunization Practices. It resurfaced in a presentation at the Dec. 4 ACIP meeting, just before the committee’s decision to no longer recommend that infants receive the hep B vaccine at birth if the mother tests negative for the virus.
Melody Goodman, the dean for the School of Global Public Health at New York University, is one of the study’s two authors. Lead author Carolyn Gallagher was a Ph.D. candidate at Stony Brook University at the time of the study and is now an instructor in the university’s Department of Family, Population and Preventive Medicine in New York.
According to the May 21 retraction notice in the Journal of Toxicology and Environmental Health, Part A, the paper was retracted due to “fundamental methodological flaws,” including a “critically small” number of autism cases — 31 — and an “overstated conclusion that inappropriately suggests causality.” The notice also states neither author agreed with the retraction, the first for both researchers.
Goodman told Retraction Watch she and Gallagher “stand behind the study’s methodology,” and said “many of the recent criticisms of the paper are consistent with what we recognized and noted at the time.”
“The paper was never meant to stand alone as the final word on this issue, which is precisely why we called for larger, stronger studies to evaluate this topic — and which other researchers have subsequently done,” she said.
The paper has been cited 50 times, according to Clarivate’s Web of Science, including in four papers by Mark and David Geier, the father-son duo known for promoting discredited claims that vaccines cause autism. David Geier was hired last year by U.S. Secretary of Health and Human Services Robert F. Kennedy Jr. (Mark Geier died last year.)
According to emails we have seen, the journal initiated an investigation into the study after a sleuth, cyber security expert Adam Capps, flagged several issues with the paper on PubPeer in June 2024, including those mentioned in the retraction notice. The same month, Capps also sent his concerns to the journal.
A spokesperson for Taylor & Francis, which publishes the journal, told us they are investigating a 2008 study in Toxicology and Environmental Chemistry by the same authors. The study found boys vaccinated with the triple series hep B vaccine “during the time period in which vaccines were manufactured with thimerosal [a preservative in some vaccines], were more susceptible to developmental disability than were unvaccinated boys.”
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