Some scientists are criticizing the federal government for implementing stricter guidelines for research into pathogens.
The government’s policy is based on the Potential Pandemic Pathogen Care and Oversight, or P3CO framework, created in 2017. The framework states that it is “intended to guide HHS funding decisions on individual proposed research that is reasonably anticipated to create, transfer, or use enhanced PPPs.”
The framework distinguishes between potential pandemic pathogens, which are highly transmissible, highly virulent and likely to cause significant morbidity and/or mortality in humans, and enhanced PPPs, which result from the enhancement of the transmissibility and/or virulence of pathogens.
Department-level review of proposed research is based on various factors, including whether the research is scientifically sound; whether the pathogen to be created, transferred, or used by the research could be a credible source of a potential future human pandemic, and whether there are any other feasible, equally efficacious alternative methods to address the same question in a manner that poses less risk.
But as Angela Rasmussen, a virologist at the Vaccine and Infectious Disease Organization at the University of Saskatchewan in Canada, told The New York Times, the “P3CO framework needs to be overhauled pretty dramatically. The whole process is kind of a black box that makes it really difficult for researchers.”
The N.I.H.’s advisory board released a draft in which it urged a larger net of pathogens that could prompt a review beyond those with a high fatality rate. “The definitions of PPP and ePPP should be modified to include potentially highly transmissible pathogens having low or moderate virulence or case-fatality rates as well as pathogens that are less transmissible but that have higher virulence or case-fatality rates,” the draft stated.
“Unlike smallpox or Ebola, Covid has a low fatality rate but is so contagious that it still wreaked global devastation,” the Times noted.
Dr. Tom Inglesby, the director of the Johns Hopkins Center for Health Security at the Bloomberg School of Public Health, told the Times bluntly, “If it’s research that could be anticipated to possibly result in the enhancement of a potential pandemic pathogen — a more transmissible and/or virulent strain than exists in nature — it needs to be reviewed. Period.”
“There is really no one in charge of scanning the medical literature, and it can be random events that bring these particular experiments to public attention,” he added. “And it shouldn’t be that way.”
“I think that ultimately we would all agree that publishing a policy that would be broadly applicable would be ideal,” said Karmella Haynes, a biomedical engineer at Emory University.
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