Study Linking Vaccines to Autism Retracted

A 2010 paper that linked hepatitis B vaccines in infant boys to an increased risk of autism diagnosis was retracted and another study by the same authors is under investigation.

The study, published in the Journal of Toxicology and Environmental Health, Part A, claimed that boys vaccinated as neonates had a three times higher odds of an autism diagnosis compared with boys vaccinated after their first month of life or not at all.

The paper was included in a safety review of hepatitis B birth vaccination alongside work from David Geier and presented to the CDC’s Advisory Committee on Immunization Practices at their meeting on December 4, the day before the committee voted to drop the agency’s long-standing recommendation that every newborn receive a hepatitis B vaccine at birth.

A 2008 paper in Toxicology and Environmental Chemistry from the same authors — Carolyn Gallagher, PhD, of Stony Brook University in New York, and Melody Goodman, PhD, currently the dean for the School of Global Public Health at New York University — is also under investigation, according to Taylor & Francis, the British company that publishes both journals.

“I can confirm that there is also an investigation being led by our Publishing Ethics & Integrity team into concerns about ‘Hepatitis B triple series vaccine and developmental disability in U.S children aged 1-9 years.’ We will not be able to comment further while this investigation is underway,” a Taylor & Francis spokesperson stated in an email to MedPage Today.

The neonate paper was retracted because “concerns were raised regarding the methodology of the study and the reported conclusions,” according to a notice from the journal’s editor and publisher.

The journal contacted Gallagher and Goodman for an explanation and engaged an independent reviewer for a post-publication statistical review. The reviewer concluded that the study’s conclusions were unsound “due to fundamental methodological flaws,” leading the journal to retract the article. Gallagher and Goodman did not agree with the retraction.

The study had multiple flaws, noted David Mandell, ScD, of the University of Pennsylvania Perelman School of Medicine in Philadelphia, who was not involved in either the research or the journal’s retraction decision.

These shortcomings led to “spurious findings based on a tiny group of children,” said Mandell, a member of the Coalition of Autism Scientists, a group of autism researchers. “They speak to the need to radically reform the peer review process so that all science is reviewed with a keener eye.”

The study used weighted probability samples from the National Health Interview Survey 1997-2002 datasets.

“Only 45 autistic children had a vaccination record. The authors ignore this fact, and provide no information comparing those with and without a vaccination record,” Mandell told MedPage Today.

“Of this group, nine autistic children received the hepatitis B vaccine in the first month of life,” he observed. “All of the associations the authors present are based on these nine children.”

The journal’s independent reviewer also pointed out that the study’s number of autism cases — 31 — was “critically small” within a highly selective sample and the researchers did not fully adjust for confounders, “resulting in likely biased effect size.” The confounded association was not statistically significant, the reviewer said.

The paper is not the only autism study to be retracted in recent months. In January, the European Journal of Pediatrics withdrew the largest clinical trial that tested leucovorin (Wellcovorin) in children with autism. The Trump administration promoted leucovorin as an autism treatment last year and subsequently reversed its stance, approving it not for autism but for rare hereditary cerebral folate deficiency.