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BIODEFENSE BRIEFING: NRC Report Calls for New Review System For Biothreat Applications of Research; UT Southwestern Gets Tularemia Research Grant amid Slew of New Funding

NEW YORK, Oct. 9 (GenomeWeb News) - In addition to a slew of new grants to academic and government institutions, the biodefense sector saw this week the release of a mammoth report recommending a new system to deal with the potential bioterrorism-related applications of biotechnological advances.


The report, issued by a committee of the National Research Council in Washington, deals with such issues as what should be done when a scientist wants to publish a paper on genetic elements that make a strain of pathogen-say, Anthrax--resistant to known antibiotics.


Right now, the only gatekeeper preventing this research from becoming available to anybody online is the scientific community itself.


But the committee, comprised largely of academic researchers and bioethicists, recommended in the 110-page report that a new system with several stages of scientific review be established in order to "provide reassurance the advances in biotechnology with potential applications for bioterrorism or biological weapons development receive responsible oversight," --and ultimately, prevent potentially dangerous research from being published or otherwise disseminated.


This report, entitled "Biotechnology Research in an Age of Terrorism: Confronting the dual use dilemma," contains seven recommendations.


First, they recommended that the scientific community be educated on the potential risks involved in certain research. Included in this recommendation is the proposal for "a regular series of meetings and symposia in the US and overseas" on this subject, possibly hosted by a major profession society or science organization, or an industry group.  But the committee emphasized that awareness and discussion of the issue is not enough. "The committee believes that biological scientists have an affirmative moral duty to avoid contributing to the advancement of biowarfare and bioterrorism, the report states. Not only do scientists have to "take reasonable steps" to avoid aiding in the advancement of biowarfare or bioterrorism, they have to define what these steps are, and the scientific community has to educate itself about these steps, the committee said.


Secondly, the committee recommended that the Department of Health and Human Services add new criteria for NIH's already-existing system for review of experiments that involve recombinant DNA. These criteria include seven groups of "experiments of concern": those that "would demonstrate how to render a vaccine ineffective," "would confer resistance to therapeutically useful antibiotics or antiviral agents," "would enhance the virulence of a pathogen or render a non-pathogen virulent" " would increase transmissibility of a pathogen," "would alter the host range of a pathogen," "would enable the evasion of diagnostic/detection modalities" or "would enable the weaponization of a biological agent or toxin."


Third, the report recommended that scientists and scientific journals enact a system of "voluntary self-governance" to review publications for national security risks-building on the statement from a group of editors at major life science journals in February 2003.


Fourthly, they recommended that DHHS create a National Science Advisory Board for Biodefense within the department, which would facilitate dialogue between the scientific and national security communities and would review the list of "experiments of concern," and other aspects of the system being proposed.


Fifth, they recommended that the government "rely on the implementation of current legislation and regulation" to safeguard biological materials and personnel; and said they believed efforts to identify or control the personnel that work with pathogenic microorganisms in the US "are impractical." 


The last two recommendations included a proviso "that the national security and law enforcement communities develop new channels of sustained communication with the life sciences community about how to mitigate the risks of bioterrorism," and "that the international policymaking and scientific communities create an International Forum on Biosecurity to develop and promote harmonized national, regional, and international measures" as a counterpart to the US system."


In general, the committee said it tried to balance the need to counter biowarfare and bioterrorism with the need for the life sciences community to freely operate without chilling research. "The system proposed in this report is intended as a first step in what will be a long and continuously evolving process to maintain an optimal balance of risks and rewards."



In other news, the University of Texas Southwestern Medical Center at Dallas received $15.1 million in NIH grants to study four biological agents; the US Centers for Disease Control and Prevention awarded about $27 million in grants for biodefense and emerging infectious disease research; and Ft. Detrick in Maryland, the home of the US Army Medical Research Institute for Infectious Diseases, received $88 million for a new biodefense center.


The UT Southwestern grants cover numerous projects to study the Category A pathogens anthrax, plague, tularaemia, and Lassa fever, and the Category B pathogen ricin.


The largest of these, an $8.7 million, four-and-a-half year award, covers tularemia, which is caused by Francisella tularensis. Under the grant, Michael Norgard, chairman of microbiology at UT Southwestern, will lead six researchers in five projects to study the bacterium and its host cell response.


"The former Soviet Union spent a lot of time and money working on this organism to weaponize it as an offensive weapon and subsequently, probably has given it out to a number of renegade countries who are not our friends and therefore, next to Anthrax, this is probably the next ... major bacterial threat," said Norgard.


However, since the US abandoned its own offensive weapons programs over 30 years ago and until recently, has not been focused on study of organisms such as Francisella tularensis, Norgard said, "it's amazing how little is known about the organism."


Norgard's team plans to change this, by applying what he calls "a multifactorial, multipronged approach" to study the outer surface of the organism and characterize the host-pathogen relationship. This approach, while still in the early stages, is likely to involve, in addition to other traditional technologies, a combination of genomics and proteomics, although there are currently limitations in these areas. For one, the full genome has not yet become available, and additionally, the organism can only be handled at a high-level biocontainment facility, Norgard said.


Different researchers will look at secreted products of the organisms for potential toxic products that aid in colonization; lipoproteins and other aspects of membrane biology; mechanisms of iron acquisition from the host; the organism's machinery for invading the host's target cells; and developing genetic systems such as gene knockouts.


"The ultimate goal is really to understand the infection process and try to figure out new ways to block that," Norgard said.


The other grants this week include nine CDC grants to Purdue, Duke University, St. Louis University, Scripps Research Institute, University of Minnesota, the University of Massachusetts, Johns Hopkins University, SRI International, and Ibis Therapeutics.


The grant to Ft. Detrick, from the Department of Homeland Security, is for a 160-acre campus that will include a National Biodefense Analysis and Countermeasures Center, according to an October 8 Associated Press Report.

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