WHO to convene additional meeting to discuss next steps
F6 .. just a bit more detail re the WHO meeting .. it's the 2nd link in your article, and feels worth outing ..
Public health, influenza experts agree H5N1 research critical, but extend delay
News release
17 February 2012 | Geneva - A small group of global public health and influenza experts at a WHO-convened meeting reached consensus on two urgent issues related to the newly created H5N1 influenza viruses: extending the temporary moratorium on research with new laboratory-modified H5N1 viruses and recognition that research on naturally-occurring H5N1 influenza virus must continue in order to protect public health.
“Given the high death rate associated with this virus -- 60% of all humans who have been infected have died -- all participants at the meeting emphasized the high level of concern with this flu virus in the scientific community and the need to understand it better with additional research," says Dr Keiji Fukuda, Assistant Director-General of Health Security and Environment for the World Health Organization. “The results of this new research have made it clear that H5N1 viruses have the potential to transmit more easily between people underscoring the critical importance for continued surveillance and research with this virus.”
WHO convened the meeting as a first step to facilitate the discussion of differing opinions that have arisen in recent months after two research groups, one in the Netherlands and the other based in the United States, have created versions of the H5N1 influenza virus which are more transmissible in mammals than the H5N1 virus that occurs naturally.
The experts at the meeting included lead researchers of the two studies, scientific journals interested in publishing the research, funders of the research, countries who provided the viruses, bioethicists and directors from several WHO collaborating-center laboratories specializing in influenza.
Consensus to delay publications
The group also came to a consensus that delayed publication of the entire manuscripts would have more public health benefit than urgently partially publishing.
“There is a preference from a public health perspective for full disclosure of the information in these two studies. However there are significant public concern surrounding this research that should first be addressed,” says Fukuda.
Two critical issues are to increase public awareness and understanding of this research through communications and the review of biosafety and biosecurity aspects raised by the new laboratory-modified H5N1 influenza virus. WHO will continue discussion with relevant experts to move this forward.
Broad issues raised, but not limited to, these research studies will be discussed at future meetings convened by WHO soon with participation by a broader range of experts and interested parties relevant to these issues.
For more information, please contact:
Gregory Härtl WHO Media coordinator Telephone: +41 22 791 4458 Mobile: +41 79 203 6715 E-mail: hartlg@who.int
Christy Feig WHO Director of Communications Mobile: +41 79 251 70 55 E-mail: feigc@who.int
John Kraemer, Georgetown University Law Center, and Lawrence O. Gostin, Georgetown University Law Center, O'Neill Institute for National and Global Health Law, have published The Limits of Government Regulation of Science, .. http://papers.ssrn.com/sol3/papers.cfm?abstract_id=2012429 .. at Science 1047 (March 2012). Here is the abstract.
Science and Nature redact key parts of two papers on transmissible avian (H5N1) influenza reveal a troubled relationship between science and security. While NSABB’s request does not violate the First Amendment, efforts to censor the scientific press by force of law would usually be an unconstitutional prior restraint of the press absent a compelling state interest. The constitutional validity of conditions on grant funding to require pre-publication review of unclassified research is unclear but also arguably unconstitutional.
The clearest case where government may restrict publication is when research has been properly classified as a security risk. It is less clear whether government may suppress the publication of “controlled unclassified information” (CUI). The key inquiry is whether the information poses a genuine security risk and the restraint is the least restrictive alternative.
At the same time, the federal government has fairly broad latitude to protect sensitive data in its sole possession from disclosure under FOIA.
We propose that future decisions on dual-use research should be taken through a fair and transparent institutional review process, likely best modeled on the institutional biosafety committees required for recombinant DNA research.
Press Statement on the NSABB Review of H5N1 Research
For Immediate Release Tuesday, December 20, 2011 Contact: News Media Branch 301-496-5787
The U.S. government remains concerned about the threat of influenza, for the risks it poses seasonally, as well as its potential to cause a pandemic. Our domestic and global influenza surveillance efforts have become increasingly capable, along with expanded vaccine manufacturing capacity and assistance to other countries in their efforts to detect and respond to a pandemic. To enhance the detection of and response to influenza outbreaks, the U.S. government supports a broad range of domestic and global preparedness and response efforts that include research on better diagnostics, vaccines, and therapeutics.
Currently, H5N1 avian influenza virus — the strain commonly referred to as "bird flu" — rarely infects humans and does not spread easily from person to person. However, many scientists and public health officials are concerned that the virus could evolve in nature into a form that is transmissible among humans — an event that could potentially make this deadly virus an extremely serious global public health threat. Thus research on factors that can affect the transmissibility of the H5N1 virus is critically important to international efforts to prepare and prevent threats to public health.
While the public health benefits of such research can be important, certain information obtained through such studies has the potential to be misused for harmful purposes. The National Science Advisory Board for Biosecurity (NSABB) — an independent expert committee that advises the Department of Health and Human Services (HHS) and other Federal departments and agencies on matters of biosecurity — completed a review of two unpublished manuscripts describing NIH-funded research on the transmissibility of H5N1. These manuscripts — which describe laboratory experiments that resulted in viruses with enhanced transmissibility in mammals – concluded that the H5N1 virus has greater potential than previously believed to gain a dangerous capacity to be transmitted among mammals, including perhaps humans, and describe some of the genetic changes that appear to correlate with this potential.
Following its review, the NSABB decided to recommend that HHS ask the authors of the reports and the editors of the journals that were considering publishing the reports to make changes in the manuscripts. Due to the importance of the findings to the public health and research communities, the NSABB recommended that the general conclusions highlighting the novel outcome be published, but that the manuscripts not include the methodological and other details that could enable replication of the experiments by those who would seek to do harm.
The NSABB also recommended that language be added to the manuscripts to explain better the goals and potential public health benefits of the research, and to detail the extensive safety and security measures taken to protect laboratory workers and the public.
HHS agreed with this assessment and provided these non-binding recommendations to the authors and journal editors.
Recognizing the significant potential benefit of the information about the experimental details to the global influenza surveillance and research communities, the U.S. government is working to establish a mechanism to allow secure access to the information to those with a legitimate need in order to achieve important public health goals. The U.S. government is also developing a proposed oversight policy that would augment existing approaches to evaluating research that has the potential to be misused for harmful purposes.
The NSABB supports the overall goals of the National Institutes of Health, in conducting safe, ethical and informative research to enhance health, lengthen life, and reduce the burdens of illness and disability. To learn more about the NSABB, visit www.biosecurityboard.gov.
About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.
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