“The U.S. government [on Thursday] released a new policy [.pdf] that will require federal agencies to systematically review the potential risks associated with federally funded studies involving 15 ‘high consequence’ pathogens and toxins, including the H5N1 avian influenza virus,” Science Insider reports. “The reviews are designed to reduce the risks associated with ‘dual use research of concern’ (DURC) that could be used for good or evil,” the news service writes (Malakoff, 3/29).
Pneumonia & Flu
The debate about two studies showing that, with few genetic mutations, H5N1 bird flu strains could become more easily transmissible among ferrets, a laboratory model for humans, “has become a debate about the role of science in society. Two questions should be addressed here: should this type of research be conducted at all; and if so, should all data generated by this research be published?” Ab Osterhaus, head of the Institute of Virology, at Erasmus Medical Centre in Rotterdam, writes in a Guardian opinion piece. A team from Erasmus conducted one of the two studies, he notes.
“As researchers from both sides of the debate over two controversial H5N1 studies weighed in [Tuesday] on full publication versus a more cautionary approach, two U.S. journals” — the Journal of Infectious Diseases (JID) and its sister publication, Clinical Infectious Diseases — “said they are developing policies to address any future such instances,” CIDRAP News writes. “We are developing policies that address these issues on a case-by-case basis, so that freedom of scientific expression can be maintained without sacrificing individual safety or national security,” JID Editor Martin Hirsch wrote in an editorial, the news service notes, adding, “He also introduced three new JID perspective pieces that discuss the difficult issues” (Schnirring, 3/28).
The National Science Advisory Board for Biosecurity (NSABB) is scheduled this week to hold “a closed-door meeting to once again look at unpublished manuscripts describing” two studies that showed how H5N1 bird flu virus could be manipulated to become transmissible among ferrets, a model for humans, NPR’s health blog “Shots” reports, noting that the meeting “will include a classified briefing from the intelligence community.” The article examines the “dual use” nature of the studies, meaning “legitimate scientific work that’s intended to advance science or medicine, but that also might be misused with the intent to do harm.” Though the “concept of dual use got a lot of attention even before this bird flu controversy,” scientists, institutions and funding agencies do not always have policies in place to review the potential consequences of research, the blog notes (Greenfieldboyce, 3/26).
Keiji Fukuda, WHO assistant director-general for health security and environment, “is hoping bird flu studies currently in publishing limbo will be released by the time the agency hosts a second meeting on the controversy this summer,” the Canadian Press/Winnipeg Free Press reports. “A major break in the impasse would be needed for that to happen,” the Canadian Press writes, adding, “As things currently stand, revised versions of the two studies are due to be presented late this month to the U.S. biosecurity panel that earlier recommended against their full publication.”
Rep. Sensenbrenner Sends ‘Fact-Finding Letter’ To White House Science Adviser About Bird Flu Studies
“Representative Jim Sensenbrenner (R-Wis.), a former head of the House committees on science and the judiciary, and currently vice chair of the House Committee on Science, Space, and Technology, last week sent a ‘fact-finding letter’ to White House science adviser John Holdren, asking pointed questions about how the U.S. government has handled the controversy” surrounding two studies that showed how H5N1 bird flu virus could be manipulated to become transmissible among ferrets, a model for humans, “and questioning whether it should have funded the two flu studies,” ScienceInsider reports. “The [Obama] Administration’s response has appeared ad hoc, delayed, and inadequate,” Sensenbrenner writes, adding, “An ad hoc approach is inadequate to balance the priorities of public health and the free flow of academic ideas,” according to the article, which includes the full text of the letter.
U.S. Panel May Re-Evaluate Bird Flu Research After Scientists Present New Data About Risks To Humans
Speaking at the American Society for Microbiology’s (ASM) Biodefense and Emerging Diseases Research meeting in Washington, D.C. on Wednesday, Ron Fouchier, the leader of the team at Erasmus Medical Center in the Netherlands that genetically altered the bird flu virus, making it transmissible between ferrets and “touching off public fears of a pandemic, said … that the virus he created was neither as contagious nor as dangerous as people had been led to believe …, prompt[ing] the United States government to ask that the experiments be re-evaluated by a government advisory panel that recommended in December that certain details of the work be kept secret and not published,” the New York Times reports (Grady, 2/29).
In an analysis (.pdf) published Thursday in the online edition of the journal Science, a team led by virologist Peter Palese of Mount Sinai School of Medicine in New York raises questions about the WHO’s estimated fatality rate from H5N1 bird flu, saying the rate of 59 percent is based on “an estimate of human bird flu cases that is simply too low,” Reuters reports. The WHO has recorded 586 cases of people infected by bird flu, and of those, 346 have died, the news agency notes (Begley, 2/23). Palese and colleagues say “it is not possible to determine an accurate fatality rate for H5N1 infections based on” available data, but “if one assumes a one to two percent infection rate in exposed populations, this would likely translate into millions of people who have been infected, worldwide” (Wang et al., 2/24). And in a paper published Friday in mBio, the journal of the American Society for Microbiology, Michael Osterholm of the University of Minnesota and a member of the U.S. National Science Advisory Board for Biosecurity (NSABB) and a colleague conclude that “[t]he available seroepidemiologic data for human H5N1 infection support the current WHO-reported case-fatality rates of 30% to 80%” (Osterholm/Kelley, 2/24).
Attendees of a recent WHO meeting that discussed the possible publication in the journals Nature and Science of two studies that modified H5N1 bird flu strains to show the virus could be more easily transmissible among humans decided publication of redacted versions would be ineffective and that “a system for distributing the full paper only to selected individuals would be impossible to set up on any relevant timescale,” a Nature editorial states. Participants also learned “not only does the mammalian transmissibility threat seem greater than previously thought, but also that current avian viruses have some of the mutations identified in the new work,” according to the editorial.
WHO Meeting Decides To Extend Moratorium On Bird Flu Research, Delay Full Publication Of Two Studies Detailing Lab-Modified Strains
A group of 22 public health and influenza experts reached a consensus on Friday at a WHO-convened meeting regarding the work of two research teams that created genetically altered strains of the H5N1 bird flu virus that are easily transmissible among ferrets, a laboratory model for humans, a WHO press release reports (2/17). “In December, the [U.S. National Science Advisory Board for Biosecurity] asked two leading scientific journals, Nature and Science, to withhold details of the research for fear it could be used by bioterrorists,” Reuters writes, adding that on January 20, flu researchers also imposed a 60-day moratorium on continuing research using highly pathogenic strains (Nebehay/Kelland, 2/17). At the meeting, the group agreed to “extending the temporary moratorium on research with new laboratory-modified H5N1 viruses and recogni[zed] that research on naturally occurring H5N1 influenza virus must continue in order to protect public health,” the press release states, adding that they “also came to a consensus that delayed publication of the entire manuscripts would have more public health benefit than urgently partially publishing” (2/17).