Tuesday, July 31, 2012

Flu researchers bristle under federal policy

31 Jul 2012

Adolfo Garcia-Sastre

It has been four months since the US government issued a hastily released policy for monitoring what is called dual-use research of concern (DURC), research that could pose significant risks to the public if misapplied. At a meeting in New York on Monday, representatives of leading institutions that perform such research discussed their experiences fitting the new policy into their current procedures for managing research projects. Some were frustrated at the lack of definition in the policy and some expressed concern about what would be contained in an expansion of the policy that is soon to be released for public comment.

“We are trying to comply with as rational an approach as possible,” said Adolfo Garcia-Sastre, who runs one of the Centers of Excellence for Influenza Research and Surveillance (CEIRS) at Mount Sinai School of Medicine in New York, which hosted the meeting for other CEIRS researchers.

On 29 March, as US government advisers were considering as whether or not to publish two controversial papers describing a lab-created, mammalian-transmissible avian H5N1 strains of influenza, the government released a new DURC policy. It required federally funded institutions to take stock of any projects engaging in such research and develop plans for mitigating potential consequences. The policy was meant to shore up what some saw as a hole in the government’s approach to DURC, and government advisers said its existence was integral in persuading them to ultimately recommend publication of the two papers.

The researchers on the panel Monday morning included Yoshihiro Kawaoka of the University of Wisconsin–Madison and Ron Fouchier of Erasmus Medical Center in Rotterdam, the Netherlands, who finally published papers in May and June. Kawaoka described an approach to assessing the safety and appropriateness of laboratory protocols that is relatively unchanged since the adoption of the policy, except, he says, for the fact that it is put more specifically into the context of DURC. It means specific research protocols are assessed against a list of seven experimental approaches that should raise eyebrows.

Fouchier, with more than a bit of exasperation in his voice, described procedures for biosafety and security reviews that he says his group and institution have been in compliance with for years owing to existing laws. He urged fellow flu researchers to push back against what he feared would be further bureaucratic measures to come. Particularly worrying, he said, was that regulators are now taking issue with experiments — like the ones described in his recent paper — that result in a gain of function to existing pathogens. Fouchier said that these studies have to be done to fully understand how influenza works.

Michael Osterholm, a CEIRS leader at the University of Minnesota in Minneapolis and one of the government advisers to oppose full publication of Fouchier’s paper, said that he did not want to see extra layers of draconian regulation applied to his colleagues. But he says that the research can not proceed with a business-as-usual ethos. “If you want to see life sciences punished,” he warned, an accidental or intentional release of a deadly human pathogen will ensure it. The public’s reaction, he said, “will make anything we’re talking about here sound modest.” The goal, he said was not to limit research, but to communicate it responsibly. That may mean redacting certain elements, a stipulation that many academics won’t agree to.

Carole Heilman, director of the microbiology and infectious disease division at the National Institutes of Allergy and Infectious Disease in Bethesda, Maryland, cheekily advised the audience that “if you think there’s one point of view on this, I want to dissuade you from that.” Nevertheless, she said, “as a group we’re going to have to come to a position.”

This CEIRS meeting, the sixth annual but the first since the mutant H5N1 kerfuffle, may be a good place for researchers to start talking about consensus. Many expected that the meeting would be where flu researchers would finally agree to lift a moratorium on certain H5N1 research. It has been in place since January. And although it seemed that this meeting would be closed to the public, organizers decided at the last minute to open it up to reporters.

Robert Webster, a flu researcher at St Jude Children’s Research Hospital in Memphis, Tennessee, says: “This is a delicate time… . The public seems to think we have something to hide. We don’t have anything to hide and we’ve got to make sure that that’s made clear.”

Photo courtesy Mount Sinai School of Medicine

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