
FDA Discovers Publishing Research May Actually Require Researching What Gets Published
Agency officials express surprise that oversight responsibilities may involve overseeing things.
By Theo Pappas
Science & Society Desk
A landmark study of regulatory protocols has revealed that the Food and Drug Administration may have been accidentally approving the publication of research without first determining what constitutes research worth publishing. The finding, which examined 847 vaccine studies over a period of eighteen months, appears to suggest that federal oversight may actually require federal officials to engage in oversight activities.
"What makes this finding particularly striking is the implication that regulatory agencies may need to regulate things," said Dr. Melissa Thornfield, Chair of Bureaucratic Epidemiology at Johns Hopkins. "We always assumed that publication oversight was more of a conceptual framework than an actual process that required specific actions."
The study, which is already drawing attention from researchers not involved in the original research, found that halting publication may actually require agencies to examine what they are halting and why they are halting it. Dr. Raj Patel, Associate Professor of Administrative Virology at UC San Francisco and not involved in the study, told reporters that the implications could extend far beyond vaccine research. "This suggests that every regulatory decision may actually require some form of decision-making process," Patel said. "The implications are staggering."
FDA officials could not immediately be reached for comment, though a spokesperson who asked to remain anonymous confirmed that the agency is currently reviewing its review process to determine whether reviews actually require reviewing anything. "The real question," Thornfield told me, "is whether we've been publishing studies or just publishing things that look like studies." The study's findings remain under review.
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Theo Pappas
Science & Society Desk, The Daily Fab
Theo Pappas covers science, technology, and society for The Daily Fab. He has a graduate degree in something adjacent to this and is not shy about it. He dislikes writing about geology.
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