Fauci urges continuing pause on risky H5N1 studies

Jul 31, 2012 (CIDRAP News) – The head of the US agency that funds much influenza research today called on scientists to continue their voluntary moratorium on certain kinds of potentially hazardous H5N1 research, saying they need to better address public concerns about the studies, according to news reports from a flu meeting in New York City.

"I strongly recommend that you continue this voluntary moratorium until you can have this open and transparent process addressing the fundamental principles," said Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases (NIAID), as quoted in reports by Nature and National Public Radio (NPR).

Fauci said the NIAID and other federal agencies couldn't support lifting the moratorium now for government-funded studies and explained that plans for broader public discussion of the issue are in the works, according to the reports.

He spoke at the annual meeting of the NIAID's Centers of Excellence for Influenza Research and Surveillance (CEIRS), a network of five academic centers that conduct flu studies. (One of the CEIRS units is a component of the University of Minnesota's Center for Infectious Disease Research and Policy, which publishes CIDRAP News.)

Leading flu researchers announced their voluntary moratorium in January amid the debate over whether to publish the full details of two studies dealing with H5N1 viruses that were modified in the lab to give them airborne transmissibility in ferrets. The studies stirred concern about the potential for an accidental or deliberate release of an H5N1 virus that could trigger a deadly human flu pandemic.

The US National Science Advisory Board for Biosecurity (NSABB) recommended late last year that key details of the two studies be deleted before publication. But after learning more about the studies, the board reversed its decision on Mar 30, though a third of the panel still opposed full publication for one of the studies. The full studies were published in May and June, one in Nature and the other in Science.

The moratorium originally was supposed to last 60 days, but it has now been maintained for more than 6 months, and how or when it will end remains unclear.

According to the Nature story, Fauci spent a half hour at today's meeting explaining his reasoning and the process now under way to develop a government policy on "dual-use research of concern" (DURC), meaning studies that could be deliberately used to do harm. He said several federal agencies are involved in developing the policy, which would govern how researchers and institutions must report on DURC and address the risks involved.

This policy would include the formation of a "government-wide agency" assigned to develop and implement guidelines for federally funded researchers in a way that involves input from all interested parties, including the public, scientists in other fields, and the global community, Nature reported. Fauci said he hoped that the agency could be in place by the end of the summer, but he was careful not to promise, saying, "I don’t control it."

He said formation of this new agency may or may not be a precondition for ending the moratorium, according to the story.

Some researchers at the meeting supported continuing the moratorium, but others disagreed, the reports said.

Ron Fouchier, PhD, of Erasmus Medical Center in the Netherlands, lead author of the more contentious of the two H5N1 studies, called for ending the research pause, according to NPR. He argued that the original conditions for imposing the moratorium have now been met, including time for review of the biosafety requirements for such experiments.

Fouchier also observed that some scientists who joined the moratorium don't depend on US government funds and are working in countries that are not taking any new regulatory actions, so there is no reason to stop them from doing the work.

But Fauci insisted that flu researchers need to publicly address the concerns that have been raised, NPR reported. "You will unquestionably lose the battle for public opinion on this one if you ignore these concerns. You can't ignore them," Fauci said. "The flu scientific community can no longer be the only players in the discussion of whether the experiments should be done."

He also said there is a plan to call a public workshop with international participation to address the issues, according to the NPR story. A similar meeting being planned by the World Health Organization won't take place until next year, the story said.

Robert Webster, PhD, a well-known flu researcher at St. Jude Children's Research Hospital in Memphis, was among those who supported continuing the moratorium, according to the stories. He emphasized the need to communicate with the public.

See also:

Jul 31 Nature news blog

July 31 NPR report

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