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National Biodefense Science Board Meeting: Day 2

To begin the day the NBSB listened to presentations from each of the members of the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE). The Enterprise is coordinated within HHS by the Assistant Secretary for Preparedness and Response and includes the NIH, CDC, FDA and BARDA. PHEMCE’s role in HHS is to coordinate the research, development, acquisition and deployment of medical countermeasures to chemical, biological, radiological or nuclear (CBRN) threats. Many of the topics the NBSB will consider and provide recommendations on will fall within the PHEMC Enterprise, so the board heard a representative from each of the agencies describe their efforts and role in PHEMCE. The morning session ended with presentations from Bruce Gellin giving an overview of the HHS pandemic flu program and Robin Robinson detailing BARDA’s pandemic preparedness and response activities.

During the afternoon session the board got down to business. After being presented with information on the possible topics that they were considering, the NBSB voted for 4 specific topics and formed subcommittees for each.

First the NBSB wanted to address the issue of pandemic influenza preparedness. The subcommittee will evaluate current research, identify the gaps, and then report to the whole board to begin making recommendations.

The second subcommittee will review the US government research portfolio to determine whether efforts are as integrated as they could be. They too will return their findings to the whole board with the goal of making recommendations to increase collaboration and avoid duplication of efforts.

The third subcommittee was commissioned to look at disaster medicine. They will take HSPD-21 as a framework for evaluation and further development of a national disaster medicine plan. It will include the possibility of promoting ‘disaster medicine’ as a new discipline and setting up dedicated training courses and programs.

Finally, it was agreed that a subcommittee be set up to look at the gaps in the medical countermeasures marketplace. This subcommittee will focus on the private sector and look at ways to engage their involvement in countermeasures development.

It was also agreed that the issue of special and at-risk populations and the issue of communications and data interoperability not be stand alone topics. They will be integrated into each of the four subcommittees and a decision to exclude them would need to be explicitly justified.

Finally the members of the NBSB volunteered their placement on subcommittees within their areas of expertise and subcommittee chairs were appointed. Andrew Pavia will chair the pandemic influenza subcommittee, Patrick Scannon; the government research evaluation subcommittee, Jim James; the disaster medicine subcommittee and John Parker; the gaps in countermeasure marketplace subcommittee. The NBSB will meet again in 6 months to hear reports from the subcommittees and make recommendations.

Written with Cheryl Vos

National Biodefense Science Board Meeting: Day 1

The National Biodefense Science Board (NBSB) began their inaugural meeting yesterday in Washington DC. The board, made up of 13 voting members and 21 non-voting ex officio representatives, was created as part of the 2006 Pandemic and All-Hazards Preparedness Act. The NBSB was chartered with the task of providing expert advice to the Department of Health and Human Services (HHS) Secretary on science, technology, and other matters of special interest on chemical, biological, radiological, and nuclear issues, including both naturally occurring and deliberate events.

The members include Patricia Quinlisk (Iowa Dept. of Public Health, chair), James J. James (American Medical Association), Steve Cantrell (Denver Health Medical Center), Eric Rose (SIGA Technologies), Albert Di Rienzo (Welch Allyn), Ken Dretchen (Georgetown University Biosecurity Institute), John Grabenstein (Merck Vaccine Division), Ruth Berkelman (Emory University , Thomas MacVittie (University of Maryland School of Medicine), John Parker (SAIC), Andrew Pavia (University of Utah Medical Center) Roberta Carlin (American Association on Health and Disability), and Patrick Scannon (XOMA).

After the morning introductory session, the group listened to several talks presented by executive branch officials that discussed current US Government policies on preparedness and response. After this, the group heard another series of talks that outlined possible topics and issues that the NBSB could focus on initially. The broadly defined proposed topics, developed by officials at HHS, are as follows- an evaluation of research and development components of the HHS influenza preparedness strategy, innovation and medical countermeasure development, how to address gaps in the medical countermeasures marketplace, modeling and metrics to inform medical consequence assessment, and considerations for special and at-risk populations.

Today the group will make decisions about how to go forward as a board. The group will try to prioritize topics and determine how to fulfill their charge. Since the mandate to the NBSB is so broad, many members agreed that it is important to determine the group’s focus in a way that considers issues based on their timeliness and achievability.

The agenda for the meeting is here
NBSB main page
Members list

Written by Nate Hafer

National Research Council Report slams NIH findings on Boston U containment lab

The National Research Council (NRC) just released a report that finds that “a National Institutes of Health draft assessment of the risks associated with a proposed biocontainment laboratory at Boston University is “not sound and credible.””

The NRC report came in response to a request by the Commonwealth of Massachusetts for technical input into the scientific adequacy of the NIH study. The NIH study, known as the Draft Supplemental Environmental Report (DSER), was to perform additional risk assessments and site analyses in response to environmental safety concerns raised in an earlier Federal court ruling.

From the NRC report cover letter:

The NRC committee was asked to address three specific questions:

1. Are the scientific analyses in the DSER sound and credible?
Overall, the Committee believes that the DSER as drafted is not sound and credible.

2. Has the NIH identified representative worst case scenarios?
The DSER as drafted has not adequately identified and thoroughly developed worst case scenarios.

3. Based on the comparison of risk associated with alternative locations, is there a greater risk to public health and safety from the location of the facility in one or another proposed location?
The DSER does not contain the appropriate level of information to compare the risks associated with alternative locations.

This latest report is unfortunate, but not unexpected in this case. The handling of the new BU lab has been mishandled on just about every conceivable level and has led to community distrust and has unfairly marked other biocontainment facilities with a scarlet letter. That the report was simply a draft is a poor excuse in this case because everyone involved was aware of the controversy surrounding the BU facility. This case is certainly cause for a serious re-evaluation of practices associated with the expansion of US biodefense capabilities and, at the very least, a system of checks and balances that prevent this brand of folly from ever happening again.

For the full NRC report click here.

To see the draft NIH study in question click here.

For a copy of the news release from the NRC, visit here.

Written with Nate Hafer.

Another Foot and Mouth Disease case in the UK

The the Institute for Animal Health has confirmed a positive test for foot-and-mouth in Surrey, just outside London. The latest report that I could find indicated that they had ordered the slaughter of 300 animals in the area of the outbreak and that all cattle movement and exports had been halted. The site of the infection is very close to the location of an August outbreak. British authorities are apparently also investigating a possible case in Norfolk. If positive, that would be even more devastating than the reemergence of the disease in Surrey because it is over 100 miles away.

What I find remarkable is the British response to the reports, which are rapid collection, identification and diagnosis immediately followed by the establishment of a 6 mile control region and, perhaps most unusual, clear communication with the public. We do not have as sophisticated a system in the US right now, mainly due to the size and nature of our cattle industry, which dwarfs the UKs. While 80 to 90 percent of U.S. cattle production is concentrated in less than 5 percent of the nation’s feedlots, it is unclear that we could respond this quickly. Also, our herds are vastly larger than those kept in the UK and an outbreak in even a moderately sized herd of cattle could be devastating to our beef industry.

Senator Burr (R-NC) introduced the National Agriculture and Food Defense Act in July. The bill takes Homeland Security Presidential Directive 9 (HSPD-9) and turns it into law, expanding and detailing how the 28 sections of the Presidential directive will be implemented. The overall goal of HSPD-9 and the bill are simply to establish a national policy to defend our agriculture and food system against terrorist attacks, major disasters, and other emergencies. The bill has not been marked up in committee yet, and there are some contentious issues surrounding some of its provisions, but on the whole it is sorely needed so we can move forward with the Herculean task of establishing a system as advanced as the UK system, here. The thought of an FMV outbreak in any major US herd in the feed-belt makes me shutter.

Iraqi Chemical Weapons Found…at the UN? Don’t Panic!

Hey, we found the Iraqi WMD’s. They were being stored at the UN! I am sure it will be all over the news by tonight, but it is astonishing how fast the press was all over what really amounts to an act of stupidity, and most certainly not a large public hazard. Sure, one can’t even begin to fathom how disorganized the UN must be to actually lose track of vials that contain chemical weapons (even small amounts), but do a few handful of containers with dangerous chemicals that have been stored in a cabinet for over a decade deserve to be a headline story?

The details are not completely clear yet, but it appears as if there were only a few containers of which, at least one contained liquid phosgene. The UN staff learned of the vials on Friday while they were cleaning out storage cabinets, but it took them until Wednesday to figure out what they were, report them and get them out of the building. These containers have been around since 1996 and are not an imminent threat to public safety because of the small amount of agent reported to be in question.

So we are left with the bizarre fact that someone thought it would be OK to store them in a cabinet at the UN and then somehow they lost track of them. It’s embarrassing to the UN, for sure. Fodder for the Tonight Show monologue? Absolutely. The point should be made that chemicals far more dangerous than a few vials of phosgene (or whatever other chemical weapon they contained) are trucked in and out of cities and stored in large quantities every day. It is the aura of their previous purpose that the press finds sexy, not the true threat. Perhaps it is the culture of fear and panic that we have cultivated in the US that I abhor, but I would much rather spend my time avoiding stories about Lindsey and Paris than another over-hyped story about terrorism or media-perceived danger to the citizenry.

National Bio-Surveillance Integration System Program has been mismanaged

Department of Homeland Security’s Inspector General released a stinging new report that details serious issues facing the National Bio-Surveillance Integration System (NBIS). NBIS was launched in 2004 with the goal of integrating all of the biosurveillance programs across the US into a single system to enhance our capability to detect agents and disease trends and respond rapidly. For example, the Centers for Disease Control and Prevention operates their BioSense program, to collect data on human health, but the data from that system is not integrated with data from the Department of Homeland Security’s BioWatch program, which is designed to detect the release of airborne biological agents. There are other surveillance systems in place and in development as well, and although you would be hard pressed to find anyone that thinks any of the systems are working optimally it is still important to try to integrate the programs into a single system (in case they ever do become robust and efficient).

The US has spent an estimated $32 billion on electronic surveillance systems and various other IT initiatives to address biodefense since 2001.

The report tells of inconsistent leadership and staffing, which has hampered NBIS delivery. In some cases many months were wasted with unnecessary administrative hurdles delaying the program. The few contracts that have been awarded under the program seem of questionable value, sometimes because the contractor was not given sufficient guidance to complete the work.

Most shocking to me was the fact that they have yet to finish a plan for implementation. The report stated plainly that, “As a result of the repeated transitions and staffing shortfalls, planning documents needed to guide information technology (IT) development have yet to be finalized. Program management has not effectively communicated and coordinated with stakeholders to secure the data, personnel, and information sharing agreements needed to support system development. Additionally, program management did not provide the contractor with adequate guidance, requirements input, or data sources to deliver a fully functional system. As such, the contractor may not fulfill NBIS capability and schedule requirements, which potentially could result in cost increases to the program.”

Assistant Secretary for Health Affairs and Chief Medical Officer, Jeffrey Runge MD, agreed with all of the findings and recommendations in the report and provided very constructive comments that indicate a sincere willingness to improve the program and stated that many of the IG’s recommendations were already being addressed. That is the nugget of good news here.

Update on UK Foot and Mouth Disease Outbreak

Most Strategic Security Blog readers are probably already aware of the recent outbreak of Foot and Mouth Disease (FMD) in the UK, but I thought it might be useful to post summary information on what we know to date. In short, it appears as if the virus was found on two farms, that the likely source of the virus was a research and vaccine production facility located nearby, and that there will be hell to pay if it is determined that someone at that facility is responsible for the outbreak and subsequent shut down of beef exports from the UK. The good news is that the response to this outbreak was vastly improved from a 2001 outbreak, which resulted in close to 7 million animals being destroyed. The bad news is that it was probably released from a laboratory and will no doubt spark new concerns about animal disease research.

Details:
An out break of FMD was confirmed on August 3rd on a farm in Surrey, according to the British Department for Environment Food and Rural Affairs (DEFRA). A second case was found at a nearby farm, but tests at two other farms were negative. The owner of the Woolford Farm, where the first disease outbreak was found, reported symptoms to his veterinarian and then DEFRA on the 2nd. DEFRA said in a statement that the strain is a 01 BFS67-like virus, isolated in the 1967 FMD outbreak in the UK. That strain was being used this past July for vaccine production at a nearby facility run by Merial Animal Health, which is jointly owned by Merck and French pharmaceutical company Sanofi-Aventis.
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New Antibiotic Resistance Case Study for Dual-Use Education

The Federation of American Scientists has added a fifth Case Study to our Dual-Use Research education series. This new case study focuses on the work of Dr. Stuart Levy of Tufts University School of Medicine in antibiotic resistance. Dr. Levy is also a member of the National Science Advisory Board for Biosecurity (NSABB).

Dr. Levy’s lab identified a gene in Yersinia pestis, the causative agent of plague, that was similar to an E. coli multiple antibiotic resistance gene. A non-virulent strain of Y. pestis overexpressing the gene was resistant to several common antibiotics, including those typically used to treat plague infection. The case study includes a history of antibiotics and resistance, a description of the experiments as well as an in-depth interview with Dr. Levy discussing the work, its implications, and his perspectives on dual-use research. Dr. Levy is also one of the members of the NSABB, which is involved in developing strategies for oversight of dual-use research.

FAS is has also launched a survey for the case studies. To thank participants for completing the survey, we will enter them into a drawing for an 8GB iPod nano. Click here to go to the case studies or here to go directly to the survey. The survey is open through May 31, 2007.

The first four case studies include an introduction to biosecurity, the poliovirus synthesis experiments conducted in Eckard Wimmer’s laboratory at the State University of New York at Stony Brook; the porous particle development work of David Edwards at Harvard University; and the mousepox experiments conducted by two Australian researchers, Ron Jackson and Ian Ramshaw.

Complete a biosecurity education survey and enter to win an iPod nano!!!

The Federation of American Scientists Biosecurity Project has prepared a brief online survey to collect feedback on our “Case Studies in Dual-use Biological Research.” To thank participants for completing the survey, we will enter them into a drawing for an 8GB iPod nano. Click here to go to the case studies or here to go directly to the survey. The survey is open now through May 31, 2007.

If you have any colleagues, students or friends involved in biological research or biosecurity, please let them know about the Case Studies and the survey. Thank you for your feedback!

The first four case studies include an introduction to biosecurity, the poliovirus synthesis experiments conducted in Eckard Wimmer’s laboratory at the State University of New York at Stony Brook; the porous particle development work of David Edwards at Harvard University; and the mousepox experiments conducted by two Australian researchers, Ron Jackson and Ian Ramshaw.

We include in-depth interviews with the researchers to document their personal experiences and present the details of their experiments, the implications for biosecurity, and the aftermath of publication. We also include commentary and analysis, accounts of the public reaction, and a discussion of scientist’s roles and responsibilities. The ultimate purpose of the case studies is to vividly illustrate the challenge and ethical complexities of conducting biology research in “an era of bioterrorism,” and to illustrate how government, the public, the scientific community, and law enforcement have interacted in the past and need to cooperate in the future.

Testimony on Homeland Security Biodefense budget

Last month, there were three significant congressional committee hearings dealing with the Department of Homeland Security biodefense budget for FY’08. The Science and Technology Directorate’s budget request reached $799.1 million including $142.6 million for Administration and $656.5 million for research, development, testing and evaluation. A big chunk of that budget, $228.9 million was requested for Chemical and Biological security. The Department as well as the directorate has been significantly restructured in the past year after a, shall we say, rocky couple of years. It will be interesting to see what happens with the budget and how the reorganization of the biosecurity programs will play out. On the whole, they appear to be taking steps in the right direction to clean up their act.

Jerry Epstein from the Center for Strategic and International Studies testified before the Committee on Science and Technology regarding the FY’08 Biodefense budget at the Department of Homeland Security. Notably, Epstein comments on the transfer of the Biowatch program to the Office of Health Affairs, the creation of the Biomedical Advanced Research and Development Authority within the Department of Health and Human Services, and comments on classified biodefense research.

Undersecretary for Science and Technology Hon. Jay Cohen testified before the House Appropriations Committee, Subcommittee on Homeland Security. Admiral Cohen discussed the restructuring of the S+T directorate, fiscal responsibility within the agency, and their focus on etting products out of their research and development programs.

Dr. Jeffrey Runge, Chief Medical Officer for the Departments Office of Health Affairs also testified before the House appropriations Committee Subcommittee on Homeland Security where he discussed the new role of the Office of Health Affairs in BioWatch and how they will be cooperating with the S+T directorate. Dr. Runge was the Chief Medical Officer for the Department and in January of this year, the CMO office was renamed the Office of Health Affairs and given a larger role in directing the Departments Biosecurity Programs.