Sep 29

On Sept 23, 2008 the National Biodefense Science Board (NBSB) held an afternoon meeting to review the report and recommendations for the National Disaster Medical System (NDMS) that had been prepared by the Disaster Medicine Working Group. The Working Group had assembled an assessment panel which evaluated previous reports done on the NDMS and put together their own report and specific recommendations which, with the approval of the NBSB, would be transmitted to the Assistant Secretary for Preparedness and Response.
Kevin Yeskey, Director of the Office of Preparedness and Response and Deputy Assistant Secretary for Preparedness and Response began the meeting by giving an overview of NDMS and its capabilities. He also highlighted the recent response to hurricanes Gustav and Ike and contrasted NDMS participation to what occurred in response to hurricane Katrina. For Gustav and Ike they had been able to mobilize fully equipped teams, totaling 1100 response personnel rather than the 37 in the wake of Katrina.
Next, Dr. Stephen Cantrill, the Chair of the Working Group presented the assessment panel’s key recommendations and the NBSB had the chance to go over each and comment. Below is an outline of the recommendations, as the panel chose to organize them.
Recommendation 1: Envisioning the Future
1.1 Develop a clear strategic plan for the NDMS and integration of all other disaster medicine response mechanisms.
1.2 Develop a civilian advisory group for NDMS.
Recommendation 2: Integrating the Past
2.1 Establish a formal mechanism to track the implementation of lessons learned and recommendations from after-action reports.
Recommendation 3: Strengthen the team
3.1 Ensure teams are fully staffed and well-equipped
3.2 Improve and streamline application process for all personnel - *This point was removed during the discussion because based on Director Yeskey’s opening presentation, the NBSB determined that this has been done. Yeskey reported that the application and hiring process has been reduced from 8-12 months to 42 days.
3.3 Implement a uniform training program across NDMS.
3.4 Put into place a system to register non-overlapping personnel so that response capability can be precisely accounted.
Recommendation 4: Serving the patient
4.1 Determine who the patient is, consider patients that have been displaced across state lines NDMS patients even if they were not receiving NDMS care.
4.2 Expand reimbursement so that it is not limited to NDMS hospitals. Ensure that it is timely.
4.3 Define a concept of operations for patient moving and tracking.
4.4 Expand Electronic Medical Records for field use.
4.5 Examine barriers to patient care in emergency response and define criteria for temporary suspension of HIPPA or other requirements during an emergency.
Recommendation 5: Engaging Partners
5.1 Partner with state and local organizations.
5.2 Seek out public/private sector partnerships for patient transport and care.
Recommendation 6: Secure Funding
6.1 Funding is inadequate for the program. Seek out new sources for sustained funding.
Recommendation 7: Future
7.1 Request feedback from ASPR for the NBSB Spring/Summer 2009 meeting on which of the recommendations are complete, in progress or will not be undertaken.
7.2 Recommend that a longer term follow-up study be conducted to focus on the NDMS and these recommendations - * This point was added by the NBSB during the discussion.

The next NBSB meeting will take place Nov 18-19, 2008 and the Board is expecting to hear a presentation from the Disaster Mental Health Subcommittee, a report from the Medical Countermeasure Processes Working Group, a report from the Personal Preparedness Working Group and receive a white paper from the Education and Training Working Group.

written by cvos

Aug 06

Documents related to the FBI’s investigation of the 2001 anthrax attacks have been released. The documents are available from the US Department of Justice website and include an outline of the case against Bruce E. Ivins as well as several search warrants.

written by cvos

Aug 01

It was reported today in the Los Angeles Times that Bruce E. Ivins, a bioweapons scientist at Ft. Detrick MD has died of an apparent suicide. Ivins died on Tuesday, July 29, 2008 according to an obituary published in the Frederick News-Post. According to the LA Times, Ivins was under investigation in connection with the 2001 anthrax mail attacks and “criminal charges were looming.”

According to the Associated Press, “a U.S. official says federal prosecutors investigating the 2001 anthrax attacks had planned to seek indictment and the death penalty” against Ivins.

Click here for a related story in the Washington Post.

written by cvos

Jun 26

On June 12, 2008 Senators Richard Burr (R- North Carolina) and Edward Kennedy (D- Massachusetts) introduced S.3127, a bill to reauthorize the Select Agent Program by amending the Public Health Service Act and the Agricultural Bioterrorism Protection Act of 2002 and to improve oversight of high containment laboratories. To provide a context for the content of the bill, the AAAS Center for Science, Technology and Security Policy hosted a briefing featuring Gigi Kwik Gronvall from the UPMC Center for Biosecurity, Nancy Connell from the University of Medicine and Dentistry of New Jersey and David Relman from Stanford University.

Gronvall gave a brief background of the Select Agent Program which is run jointly by the Center for Disease Control and Prevention and Animal and Plant Health Inspection Service at the US Department of Agriculture. She also made the point that the SA program is focused on security, but high containment laboratories and protocols are designed primarily to provide safety, not security.

Connell, a research scientist who works with select agents, contrasted the week or two it took to plan an experiment before the SA program was put in place to the 6-12 months it takes now. Experiments are also much more expensive, cumbersome, and according to Connell “what is missing now is an environment of transparency and collaboration.”

Relman, who is also a member of the National Science Advisory Board for Biosecurity (NSABB) underscored the fact that there are risks associated with expanding biotechnology, but there are also enormous benefits. For example, he highlighted the new NIH Human Microbiome Project “basically the human genome project on steroids”, an initiative to map the genomes of all the microorganisms that live on the human body - providing a tremendous amount of information. Relman also expressed concerns about overusing and over-relying on the SA program because regulates access to agents that are found naturally and provides a very specific list that could be circumvented with synthetic or engineered agents.

The bill has now been referred to the Committee on Health, Education, Labor, and Pensions.

written by cvos

Jun 19

On June 18, 2008 the National Biodefense Science Board held their second meeting. The NBSB was created under the 2006 Pandemic and All-Hazards Preparedness Act and was established to provide expert advice and guidance to the Secretary of the U.S. Department of Health and Human Services (HHS) on scientific, technical, and other matters of special interest to HHS regarding activities to prevent, prepare for, and respond to adverse health effects of public health emergencies resulting from chemical, biological, nuclear, and radiological (CBRN) events, whether naturally occurring, accidental, or deliberate. During the inaugural meeting of the NBSB on Dec 17-18, 2007 members were sworn in and working groups were formed to consider the issues members felt were important.

The meeting began with a presentation from Robin Robinson, the newly named the Director of the Biomedical Advanced Research and Development Authority (BARDA), on “Old & New Perspectives at BARDA”. Whereas in the past initiatives for CBRN threats and Pandemic Flu were independent projects within BARDA, and BioShield was used for high risk acquisition tasks, these have all been integrated under the new BARDA strategy. During both this and a later presentation, Robinson described BARDA’s interest in the possibilities of personal preparedness. He described the progress made on small medical kits (MedKits) containing doxycline to treat anthrax that could be stored by individuals in their homes in case of an emergency. He also discussed the plans for influenza-focused antiviral MedKits. On what became the hot topic of the day, Robinson solicited input from the board on the issues surrounding home stockpiling, whether it is safe, effective, and worthwhile. He also asked for input on what should be the  right balance of government and personal strategies for preparedness.

Later in the day Robinson continued the discussion of personal preparedness and invited comments from Richard Besser of the CDC and Boris Lushniak of the FDA. Besser and Lushniak discussed public safety issues with personal stockpiling as well as some of the underlying problems with antibiotic resistance, drug expiration, product labeling and other regulatory issues.

In their December meeting, the NBSB had expressed an interest in biosurveillance. To address this, Capt. Daniel Sosin of the CDC briefed the board on the draft National Biosurveillance Strategic Plan. The NBSB has also indicated a concern for vulnerable populations in the event of pandemic of other major public health emergency, and therefore invited Susan Cooper from the Tennessee Department of Health to come and talk about this issue. Cooper gave an overview of the Association of State and Territorial Health Officials (ASTHO) Guidance document on “At-Risk Populations and Pandemic Influenza: Planning Guidelines for State, Territorial, and Local Health Departments”.

The NBSB also heard from C. Norman Coleman from the Radiation Research Program at HHS and Richard J. Hatchett from the Radiation Countermeasures Research and Preparedness program at NIAID. Coleman presented some of the strategies within the Radiation Management System and Hatchett discussed providing support services for radiation countermeasures product development.

Amy Patterson, executive director of the National Science Advisory Board for Biosecurity (NSABB) provided an overview of NSABB efforts to the NBSB. The NSABB has a similar mandate as the NBSB, and has been working since 2005 on issues of dual-use research of concern. Patterson focused on the NSABB’s recent recommendations on synthetic genomics and their draft oversight framework for dual-use research.

Throughout the day the Chairs of the working groups which were formed in December (Pandemic Influenza, U.S. Government Medical Countermeasures Processes for CBRN Agents, Markets and Sustainability, and Disaster Medicine) gave progress reports. In addition, a new subcommittee on Disaster Mental Health was introduced.

Finally, the NBSB discussed their recommendations and future activities. The members expressed interest in looking more carefully at the issue of personal preparedness. To this end it was decided that a working group be formed to deal specifically with the issue. It was also decided that no formal recommendations be made to Secretary Leavitt at this time, however, they would ask the Secretary to review the comments made by individual members on the topics of personal preparedness and home stockpiling during the meeting.

The next NBSB meeting will be held in November 2008.

written by cvos

Jun 18

Yesterday the CUBRC Center for International Science and Technology Advancement held a symposium entitled “Promoting Mutual Security and Development through Bioscience Cooperation”. The meeting focused on ways to promote cooperation and networking across organizations to create a more prosperous and secure world.

Dr. Leonard Marcus of the Department of Health Policy and Management at Harvard University began the day by discussing the qualities of leaders that successfully link disparate groups and organizations. His remarks were especially relevant considering the diverse background and expertise of individuals and organizations involved in cooperative bioscience projects.

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written by nhafer

Jun 12

Today the American Association for Advancement in Science (AAAS) Center for Science, Technology and Security Policy sponsored a briefing on Capitol Hill entitled “Understanding President Bush’s FY2009 Biodefense Budget Request.” Dr. Alan Pearson of the Center for Arms Control and Nonproliferation was the featured speaker at the event and his presentation was followed up by comments from distinguished roundtable panelists.

Dr. Pearson has done an in-depth analysis of federal biodefense funding and his full report “Federal Funding for Biological Weapons and Defense, Fiscal Years 2001 to 2009″ is available online. Today Dr. Pearson presented data from this report and highlighted some trends. On the whole, since FY02, federal biodefense funding has remained relatively consistent between 5 and 7 billion dollars each year. In addition to this, Project BioShield received 3.3 billion dollars in FY04 and FY05 and is slated to receive an additional 2.175 billion in FY09 (which will bump total FY09 spending to nearly 9 billion). Overall, the bulk of funding is received by the Department of Defense, the National Institutes of Health, and the Center for Disease Control and Prevention. More than half of the funding goes towards research, development, testing and evaluation (RDT&E) as well as medical countermeasures procurement and stockpiling. In general, funding for these activities as well as surveillance and food and agriculture needs has been increasing since FY03, but money provided for state and local hospital preparedness is actually declining.

Dr. Pearson also pointed out that funding for prevention projects as compared to RDT&E projects decreased to about 3% of total biodefense spending immediately following September 11, 2001. For FY08 and FY09, funding has returned to 7%, which is approximately equal to the pre-9/11 levels. Other trends Pearson mentioned were the increased focus on global engagement as opposed to focusing on the former Soviet Union, and an increased emphasis on infectious disease surveillance, biosafety and biosecurity.

Immediately following Dr. Pearson’s presentation the roundtable panelists each added a few comments of their own. Dr. Brad Smith of the UPMC Center for Biosecurity said a few words about medical countermeasures. Specifically he noted that this really isn’t a large amount of money in defense terms, and likely isn’t adequate for the long term nature of drug development and testing to protect the entire nation.

Dr. Gerald Epstein from the Center for Strategic and International Studies continued by pointing out that this really isn’t a problem that can be addressed using an export control model as has been done in the past for nuclear material. In this case the spread of biotechnology is necessary to promote long-term capacity building worldwide, and the dual-use nature of it presents the security problem.

Dr. Eric Toner of the UPMC Center for Biosecurity briefly brought up the lessons learned from the 2001 anthrax attacks. He noted that hospitals are better prepared today to handle an event and have greatly improved the communications networks within their region and with first responders.

Dr. James Roth from Iowa State University discussed agriculture and food defense. He argued that this sector is underfunded because the U.S., since the end of World War II, has always had plenty of (cheap) food available. This has dramatically changed, and now the lack of agriculture and food security present huge vulnerabilities.

Finally, Dr. Georges Benjamin from the American Public Health Association talked about infectious disease surveillance and public health preparedness. He highlighted the fact that within the U.S. there is no culture of civilian preparedness; that most people have not recognized this issue as part of their daily lives and have not made family disaster plans.

written by cvos