concludes Just a "small subset" of studies that handle dangerous pathogens for their provide new capabilities pose potentially serious risk to the public, an advisory panel to the US government concluded in a new draft report released today. But the current patchwork of US policies to regulate such risky experiments "not enough," and "may require supplementation," concludes the report. He said there are a few so-called gain of function (GOF) of experiences that can never justify the risk.
Some outside scientists, however, say the apparent approval of the report for greater government oversight of these studies may not be sufficient to ensure public safety. "as usual, the devil is in the details," Harvard University epidemiologist Marc Lipsitch wrote in an email to Science Insider. "I'm glad to see some recognition experiences should not be doing, but I fear the exaggerated perception of the benefits and shortcomings in existing processes to weigh the risks and benefits, would thus neutralize this recognition anything de facto "will approach. "
The 70-page document, released today by a working group of the National Scientific Advisory Board for Biosecurity (NSABB), is the latest contribution to a long -Operation debate on how best to regulate potentially risky research with infectious agents. such studies are needed to develop treatments and vaccines, but the accidental or intentional release of pathogens changed is always a risk.
this debate gained prominence in 2011 when two groups of researchers announced that in experiments that seek to understand what makes influenza viruses spread, they had changed the deadly H5N1 bird flu for to transfer more easily between mammals. Some scholars have objected to the publication of results, fearing that they could help bioterrorism, while others fear the risks of a pandemic if the new virus escaped from a laboratory. The controversy eventually led researchers around the world to voluntarily declare a 1 year moratorium on these experiences GOF.
The work of GOF finally resumed, but the debate has taken a new turn in late 2014 when the US government made the unprecedented decision to end 18 GOF US studies funded involving making virus responsible for the flu and new diseases such as respiratory syndrome Middle East (MERS) or SARS pathogen or more likely to spread in mammals. The National Institutes of Health (NIH) later exempted some of the studies to the prohibition of funding, but government officials said it would remain in place while NSABB and the National Research Council (NRC) reviewed risks and rewards of GOF studies.
This discussion began with a meeting of the NRC in December 2014 where all sides have broadcast issues. And earlier this year the NIH has commissioned a private firm to conduct a risk analysis GOF-benefit studies; some documents of 1000 pages was published earlier this month and should be discussed at a meeting on 7-8 January NSABB in Bethesda, Maryland.
Risks and benefits
The draft report released today aims to inform and guide this discussion. He concluded that the benefit-risk, conducted by scientific Gryphon Takoma Park, Maryland, is "[o] ... GLOBAL complete, objective and reasonable and generally well documented." The Gryphon report includes a review of the probability both laboratory accidents and security breaches, the draft report notes. After examining a number of scenarios, it concluded that "[o] nly a small fraction of laboratory accidents would result in a loss of containment; of these, only a small fraction would result acquired laboratory infection, and of those, only a fraction would spread throughout the surrounding community (or of the world population) "
the. Gryphon report also suggests that certain types of GOF experiences are not likely to present significant risk to the public, the report notes NSABB. This includes experiments to improve the growth of influenza viruses for vaccines and efforts to adapt human stem in animal models.
Yet Gryphon analysis "has some weaknesses and limitations," the NSABB working group concludes. Data on GOF risks are often scarce, he notes, and some tests can "obscure material risks associated with GOF studies." For example, some scenarios have compared the risks of potential manipulations of certain strains of human influenza with influenza virus that caused a pandemic in 1918 and killed millions of people. But the use of the 1918 flu as a criterion could even relatively new deadly flu strains seem tame by comparison, the report notes.
The risk-benefit study also identified potential gaps in the current patchwork US regulatory systems that have evolved over the past decades to oversee risky research. Some pathogens are regulated as "agents selected" for example, with work restricted to laboratories with certain security and safety systems. But others are covered by less stringent systems and GOF studies involving a small number - , including the MERS virus and virus seasonal influenza - do not seem to fall easily into any single regulatory system. "Control Policies vary in scope and applicability, therefore, the current monitoring is not enough for all GOF studies of concern," the draft concludes NSABB.
Is it "of concern?"
to reduce risk, the draft report proposes a phased approach to the assessment of GOF studies before they are financed. in the first step, the evaluators will determine whether a study of GOF three criteria that would "concern" and in need of a special assessment. the pathogenic agent is to create researcher should be "highly communicable" and "significantly virulent" in a model mammal concerned, "probably resistant" to existing treatments, and more "able" to spread in human populations that existing strains.
GOF studies considered potentially problematic would be subject to a review that considers seven criteria. The reviewers would determine whether the study was "scientifically meritorious," for example, and if the benefits outweigh the risks. They also examine whether the sponsoring institution could achieve safely study, and if there are safer alternatives to achieve the same knowledge. "Proposals that do not meet these criteria will not be financed," the proposal of NSABB States. In a last step, the funded studies would be systematically reviewed and considered by the nominating institution and federal funding agencies.
This framework, and the many other issues raised in the draft report, are likely to attract many comments NSABB next meeting. Lipsitch, which helped catalyze the current moratorium on research funded by GOF US because of concerns about biosecurity, said he is still absorbing the document. But his first catch is that NSABB and Gryphon "agree very credulous statements not approved by those who make and fund GOF concern studies that these studies offer unique practical advantages ... [T] he NSABB draft report seems to show much more optimism than I think is justified that existing structures can take care of the matter. If that were the case, there would not have needed the funding break. "
With reporting by Jon Cohen. Reference materials from reports before by Jocelyn Kaiser.
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