ScienceInsider is reporting that the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) has suspended their research on biological select agents and toxins. Officials froze research last Friday when they realized that there were problems with the system of accounting for high risk microbes and biological materials in the laboratories at Fort Detrick, MD and have begun an inventory of select agents and toxins at the facility. Not coincidentally, this is the same facility that has been under intense scrutiny after the FBI named researcher Bruce Ivins as their main suspect in the 2001 anthrax letter attacks.

“The decision was announced by institute commander, Col. John Skvorak, in a 4 February memo to employees. The memo, which ScienceInsider has obtained, says the standard of accountability that USAMRIID had been applying to its select agents and toxins was not in line with the standard required by the Army and the Department of Defense. USAMRIID officials believed that a satisfactory accounting involved finding all the items listed on its database, the Army and DOD wanted the converse; that is, all select agents and toxins needed to be matched to the database.”

The Army is clearly clamping down on their select agent research programs with very strict accounting of biological agents and, personnel in direct response to the Ivins case. Of note, on October 28, 2008 Army Regulation 50-1 came into effect. AR50-1, outlines a strict Biological Personnel Reliability Program for all DoD employees with access to BSAT. In order to be cleared to work with or have access to BSAT everyone must go through intense screening. This includes an interview, personnel security investigation, personnel records review, medical evaluation (includes mental evaluation and any medications) and drug testing.

Today the National Academies of Sciences (NAS) and the American Association for the Advancement of Science (AAAS), released their survey of Attitudes and Actions on Dual Use Research in the Life Sciences. The survey was sent to AAAS members whose primary area of research was in the life sciences in order to assess their awareness of and attitudes toward “dual-use” research-studies undertaken for beneficial purposes that could also have harmful applications. The survey also explored actions the scientists might support to reduce the risk of misuse of research, as well as steps that scientists may already be taking in response to these concerns.

David Franz of the Midwest Research Institute and Ronald M. Atlas of the University of Louisville, two of the members of the committee which reviewed the survey results and wrote the final report presented the main findings. David Franz began by defining dual-use research and its importance within the life sciences community and Ronald Atlas discussed the primary findings of the survey. Atlas noted that a low response rate and uncertainty about whether the sample is representative of the broader life sciences community limits the ability to draw definitive conclusions. Nonetheless, the survey results are useful and informative and Atlas went on to explain that the results indicate that some respondents have already been so concerned about dual-use issues that they have altered their research or experiments. Even in the absence of guidelines or government restrictions some scientists have already taken action to try to avert misuse of biomedical research.

Copies of A Survey of Attitudes and Actions on Dual Use Research in the Life Sciences: A Collaborative Effort of the National Research Council and the American Association for the Advancement of Science are available from the National Academies Press.

Today’s presentation can be heard via podcast from the National Academies website.

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.

The Federation of American Scientists Biosecurity Project has the following position available:

Job Title: Project Manager for Biosecurity

Location: Washington, D.C.

Salary: Commensurate with experience, generous benefits

Education: Ph.D. or Masters degree considered.

Description: FAS is looking for a smart, energetic individual to help direct a major web-based project using innovative video, multimedia and social networking tools to revolutionize the way biosecurity issues are communicated. The initial work will focus on building and development of an interactive and easy to use web portal. Unique content will be created and updated daily. This project is part of an ambitious FAS program to use web 2.0 principles and new technologies to provide comprehensive information on biological and chemical weapons. It will expand on current FAS work to provide high-quality education material on dual-use awareness by providing a hub for biosecurity information and training.

The individual will help design and build the web portal, create new and unique content to feature, keep it up to date and current, oversee efforts to evaluate its impact, plan and execute future work that expands the scope and utility of the site. The person will also participate in broader FAS work and further existing research programs on biological and chemical weapons.

Candidates should have taken graduate-level courses in biology or chemistry and have knowledge of html, web design, and image/video editing. Familiarity with Flash, MySQL database management, and WordPress blog software is highly desirable but not essential.

FAS professionals are expected to be highly motivated and able to work independently.  They are expected to be able to analyze complex issues and summarize findings; communicate clearly, both orally and in writing; have strong organizational skills; be capable of prioritizing work assignments in a heavy workload environment; and possess superior research and information technology skills.

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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.

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.

On Tuesday, July 15, 2008 the National Science Advisory Board for Biosecurity (NSABB) hosted a meeting to solicit public comment on the June 2007 report, “Proposed Framework for the Oversight of Dual Use Life Sciences Research: Strategies for Minimizing the Potential Misuse of Research Information”.

The meeting was broken into three panels that examined different aspects of the framework document, and each panel included several members of the public who shared their perspective on these issues. (more…)

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.

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.

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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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.

The principle is simple. The products, information and techniques of some life sciences research could be misused for nefarious purposes, such as bioterrorism, and the scientific community should do everything it can to prevent such misuse without impeding research progress. What is unclear is what steps scientists should take when they have concerns about such “dual-use” research.

The problem is that we (myself included) have not taken the long-view on this issue.

Dual-use research has been the subject of much discussion in the biosecurity community since the 2003 release of the National Research Council report, Biotechnology Research in the Age of Terrorism, which suggested that, “Adequately addressing the potential risks that research in advanced biotechnology could be misused by hostile parties will require educating the community of life scientists, both about the nature of these risks and about the responsibilities of scientists to address and manage them.” But convincing scientists that they should add dual-use research awareness and evaluations to their already long list of idiosyncratic worries turned out to be far harder than anyone imagined.

Enter the National Science Advisory Board for Biosecurity. In June of last year, the NSABB released their Proposed Framework for the Oversight of Dual Use Life Sciences Research, in which the board recommend that life scientists receive “mandatory education about dual-use research issues and policies,” with the goal of “ensure(ing) that all individuals engaged in life sciences research are aware of the concerns and issues regarding dual use research and their roles and responsibilities in the oversight of such research.”

In addition to mandatory training, both the National Research Council and the NSABB have advocated for the creation of codes of conduct for life sciences researchers that includes dual-use awareness. Now, research societies are preparing and implementing their codes of conduct, infusing another layer of awareness into the research community.

Indeed, it will not be long before it is mandatory that all federal grantees in the life sciences receive such training, and that all biologists sign codes of conduct. Awareness will spread like happy little dandelions. That is until someone points out that they are weeds.

Don’t get me wrong. I am an advocate of mandatory training and think codes of conduct are a good tool for increasing awareness. Not least of the reasons for my support being that the Federation of American Scientists arguably has the most extensive dual-use training materials available to date in the form of our multimedia Case Studies in Dual-Use Research. Wide distribution of these case studies and materials created by other groups has been a goal of ours from the time we started the project.

The problem is that we (myself included) have not taken the long-view on this issue. If we dramatically increase awareness, then we also increase the chances that scientists will have concerns about dual-use research or worse—suspicions that a colleague is up to no good. What the NSABB, National Research Council and the biosecurity community on the whole have failed to fully address is how those researchers should attend to their concerns. Government-issued guidelines for researchers will only get them so far.

Since part of the duty of a responsible researcher will certainly be reporting unsafe experiments or suspicious behavior, instituting codes of conduct and training all scientists makes potential whistleblowers out of every working biologist. This creates an immediate need for protocols and methods for scientists to get advice and report their concerns.

There is currently no reliable independent system in place for these researchers to report or receive advice on how to handle their concerns.

It is well recognized that a major barrier to reporting such incidents to law enforcement, supervisors, biosafety officers, or institutional review boards, is the fear of reprisal. This might also be compounded by some members of the scientific community not trusting government officials and law enforcement in particular. This extends from laboratory technicians and support staff to primary investigators. Even if there is no indication of foul play, scientists may feel that there are experiments being conducted at their institution that have serious dual-use implications, or that are dangerous to those conducting them and their colleagues.

There is currently no reliable independent system in place for these researchers to report or receive advice on how to handle their concerns. Such a system would be a valuable contribution to strengthening biosecurity awareness and participation within the biological research community. It should be pointed out that such a system is a good way to get across the idea that official whistle-blowing is not the first and only resort.

I and others have suggested that we need to build a secure Internet-based system where scientists will be able to report their concerns and receive advice and recommendations on the steps that they should or should not take. Concerns will naturally run the range of how to fill out dual-use reporting forms on grants to reporting potentially illegal situations in the lab. It is important that the government not operate the system to ensure buy in. Rather, an ombudsman network should be run by a non-government organization that will allow partial anonymity.

In the event that a clear cause of action is required, such as when a law is being broken, a non-government organization would be well-placed to help facilitate conversations with law enforcement, make queries on the behalf of the scientist to government, or alleviate concerns without endangering their status at the institute.

The system will have to be backed by a large group of advisors, including experts from multiple science disciplines, ethicists, legal and law enforcement representatives to ensure that users are receiving timely and accurate advice. The system administrator will have to be available at all times and have constant access to advisors in the case of a serious problem.

One major concern of scientists will be the preservation of anonymity. This issue can be simply handled by having staff farm out the query to advisors without revealing the identity of the scientist. Total anonymity, however, cannot be completely preserved in such a system.

In principle, users will turn to this system when they feel uncomfortable reporting concerns within their institution or when they are unsure of who to turn to. Responses will either ask for further information, clarification, or report back advice on the appropriate course of action.

Users must also feel comfortable that the information they divulge will not be released to anyone unless they approve it. This can be accomplished by making users agree to simple terms before sending their query. Those terms will detail operation standards and will inform users under which conditions the managers have a legal responsibility to inform appropriate authorities, and that they may be contacted by such authorities directly in the event that a law has been or is about to be broken.

Detailed records of responses and customizable electronic form letters will allow us to provide useful assistance and inform users of their rights and the laws that might apply to them in a timely manner. It should be stressed that in the event a user reports an imminent threat, they will automatically receive instructions on who they should contact. There are several important issues that will have to be addressed while developing a biosecurity reporting system, among them:

Whistleblower Laws. The United States has a well-established set of “whistleblower” laws that protect people from reprisals for reporting. There are several excellent non-profit groups that specialize in this area and it will be important to bring them in for legal advice and possibly to present a series of Frequently Asked Questions on the site for scientists to learn about their options.

Legal Advice. We will need legal advice on a broad range of issues, including the liability associated with giving advice, maintaining anonymity, the situations under which those with knowledge of possible crimes are legally obligated to contact law enforcement, and applicable laws for users.

Advisory Boards. An advisory board consisting of scientists, ethicists, biosecurity experts, and legal advisors will have to be brought in for the design and implementation. A second advisory board will have to be available for advice on individual cases. It will be important to have a wide array of expertise and knowledge on hand to address any reports that come in.

Law Enforcement Guidelines. A clear relationship with law enforcement will need to be established so that in the event that there is a user who is uncomfortable going to law enforcement themselves, we would be able to report an incident on their behalf.

Testing. It will be necessary to test the system through a series of table-top scenarios that provide challenges to our response times and content.

It is a virtual certainty that this type of system would eventually be abused maliciously against other scientists trying to slow down a competitor, or exact revenge. In that sense, the system itself would have dual-use potential and like science, safeguards and awareness will reduce, but might not eliminate, unfortunate incidences.

It is also hard to predict how often such a system would be used and what percentage of the time it would receive cranks. But it is equally unclear to what degree dual-use research is a threat to national security. If we are going to require scientists to learn about the potential for misuse, then it is essential that they have a place to turn if they recognize potential misuse or have questions about complying with legal and ethical requirements.

Michael Stebbins is the Director of Biology Policy for the Federation of American Scientists, President of the SEA Action Fund and author of Sex, Drugs and DNA: Science’s Taboos Confronted.