The life sciences have many examples of where research results and technologies can be used for good, but also for bad purposes. Because such scenarios are so common, it is critical to identify that research which is particularly bad and would be classified as dual use research of concern (DURC). Attributes that might result in a DURC designation include how immediate a threat it represents, the magnitude of the threat, the availability of safeguards to defend against its nefarious use and its relative risk to benefits ratio. Several policy forums have studied this problem and the National Science Advisory Board for Biosecurity (NSABB) is currently the official U.S. government advisory group for DURC policy. Recently, NSABB was asked to review two manuscripts that reported adaptation of the high-path avian influenza virus H5N1 to transmission in a mammalian model. This virus rarely infects humans but when it does, it has catastrophic consequences with ~60% mortality. The board weighed the risks and the benefits of the work and recommended that the papers not be published as written, but only in a highly redacted form that would prevent the rapid and direct replication of the work. NSABB also argued for a communication pause so that the consequences of these papers and this research focus be evaluated by a broad cross section of science, public health and society. The US government accepted these recommendations and the two journals (Science and Nature) have thus far not published the papers. Multiple additional forums are planned to discuss the issues and recommendations. The future for policy development in the area of pathogen research and DURC will be shaped by these recommendations and subsequent activities.

About the speakers:

Dr. Paul Keim holds the E. Raymond and Ruth Cowden Endowed Chair in Microbiology at Northern Arizona University (NAU), where he is also a Regents Professor of Biology. In addition, he directs the Pathogen Genomics Division at The Translational Genomics Research Institute (TGen). Both institutions are based in Flagstaff, Arizona. His biological interests span many types of organisms and microbes, but revolve around genetic diversity and its organization in populations and species. This necessarily has involved systematic and phylogenetic analyses to understand how observable genetic diversity is based upon past evolutionary processes. Biodefense programs have capitalized upon his approach of using genomic analysis to understand bacterial pathogen populations for microbial forensics and molecular epidemiological analyses. His laboratory was heavily involved in analysis of evidentiary material from the 2001 anthrax-letter attacks. He has published extensively on the evolution and population genetics of Bacillus anthracis, Yersinia pestis, Francisella tularensis, Burkholderia pseudomallei, Burkholderia mallei, Brucella spp., and Coxiella burnetii. Recently, these same principles have been applied to other public health-related and clinically important pathogens such as S. aureus and E. coli. In all, he has published over 230 scientific or policy papers. Dr. Keim received his B.S. in Biology and Chemistry from Northern Arizona University in 1977 and his Ph.D. in Botany in 1981 from the University of Kansas. Dr. Keim has previously served on the editorial boards of Crop Science and Molecular Breeding; he currently serves on the editorial boards of Infection Genetics and Evolution, Investigative Genetics, and Biotechniques.

Dr. David Relman is a professor of medicine – infectious diseases, and of microbiology and immunology at Stanford. He joined CISAC as an affiliated faculty member in November 2011. He is also chief, Infectious Diseases Section, at the VA Palo Alto Health Care System. Among his other activities, Dr. Relman currently serves as Vice-President of the Infectious Diseases Society of America, Chair of the U.S. National Academies of Science Institute of Medicine's Forum on Microbial Threats, and member of the National Science Advisory Board for Biosecurity. He received a S.B. in biology from the Massachusetts Institute of Technology (1977) and an M.D. from Harvard Medical School Medicine (1982).

Recent events in the U.S. have raised concerns about the safety and security of research with hazardous microbial agents, particularly with regard to the insider threat. The anthrax letters of 2001 and several technical surprises in legitimate infectious disease research, led to a series of high-level committee recommendations on safety and security of the ongoing work. When a scientist from a U.S. military high-containment laboratory was implicated in the anthrax letters case, the president and congress called for more regulation. Subsequently, a series of steps to reduce the risk have been proposed: from armed guards, pathogen accountability and medical and psychological exams for scientists to training, ethical frameworks, codes of conduct and standards of quality research. Franz will discuss the implications of these events on both security and productive research in support of public health and the life-sciences enterprise, and the important role of leadership and culture in enhancing both safety and security.

About the speaker: Dave Franz is a Vice President and Chief Biological Scientist at MRIGlobal. He served in the U.S. Army Medical Research and Materiel Command for 23 of 27 years on active duty and retired as Colonel. He served as Commander of the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) and as Deputy Commander of the Medical Research and Materiel Command. Prior to joining the Command, he served as Group Veterinarian for the 10th Special Forces Group (Airborne). Dr. Franz was Technical Editor for the Textbook of Military Medicine on Medical Aspects of Chemical and Biological Warfare released in 1997. He serves on numerous national committees and boards. Dr. Franz holds an adjunct appointment as Professor for the Department of Diagnostic Medicine and Pathobiology at the College of Veterinary Medicine, Kansas State University. The current focus of his activities relates to the role of international engagement in the life sciences as a component of national security policy.

Infectious diseases, especially those transmitted from person to person through the respiratory route, continue to pose a threat to the global community. Public health surveillance systems and the International Health Regulations are intended to facilitate the recognition of and rapid response to infectious diseases that pose the risk of developing into a pandemic, but the response to the 2009 H1N1 influenza pandemic illustrates the continuing challenges to implementing appropriate prevention and control measures. The response to the 2009 H1N1 influenza pandemic will be discussed and its implications examined.

Speaker biography:

The production and distribution of counterfeit medications has become a significant global public health issue. Though not as rampant in the United States, the Food and Drug Administration (FDA) has seen a 10 fold increase in the number of cases investigated, particularly a rise in illegally imported and diverted medications entering our legitimate drug supply. In order to curb these illegal activities, California and the federal government have introduced various pieces of legislation to address this. In addition, international entities, State Boards of Pharmacy and the FDA have begun promoting utilization of radio frequency identification technology and other technology to effectively track the medication supply. In a recent California survey, pharmacists felt strongly that the presence of counterfeit medications poses a problem in their pharmacy practice, but they still face several challenges in identifying counterfeit medications, counseling their patients, and forging their role in implementing legislative requirements.

This presentation will aim to provide an introduction to the international and domestic counterfeit drugs situation, discuss possible factors facilitating patient exposure to counterfeit medications, examine potential sources for counterfeit medications in the United States, identifiy federal legislation issues, discuss various forms of technology being used to combat counterfeit medications, and recognize the role of pharmacists and the challenges they face in dealing with counterfeit medications.

Speaker Biography:

Dr. Elaine Law is currently a Clinical Pharmacist specializing in Adult General Surgery at UCSF Medical Center and an Assistant Clinical Professor in the UCSF School of Pharmacy. She received a B.S. in Molecular, Cell and Developmental Biology from UCLA, earned a Doctor in Pharmacy from UCSF School of Pharmacy and completed a General Practice Pharmacy Residency at UCSF Medical Center. She holds a Board Certification in Pharmacotherapy and her research interests include roles pharmacists can play in public health issues including counterfeit medications and pharmacist-based immunization programs. She is an advocate of patient care in underserved areas and reaches out regularly to the Tenderloin communities and elderly populations of San Francisco through pharmacy health outreach programs.

The large-scale industrial accident at the Fukushima-Daiichi Nuclear Power Plant was the culmination of three inter-related factors: external natural hazard assessment and site preparation, the utility’s approach to risk management, and the fundamental reactor design.

The reactor accident was initiated by a magnitude 9 earthquake followed by an even more damaging tsunami. However, it was the inability to remove the decay heat in the reactor core that led to core meltdown and radioactive release.

A review of the timeline of the major Fukushima accident sequences: The plant first experienced a station blackout (i.e. loss of all offsite and onsite power) due to flooding of backup critical emergency cooling equipment. The lack of an ultimate heat sink led to the fuel overheating. Subsequently, the generation of hydrogen through steam oxidation of of the fuel cladding led to chemical explosions causing significant structural damage.

The focus of this talk (presentation slides below) is on the engineering aspects of the reactor accident and the prospects for local environmental recovery. Radionuclide measurements in space and time provide important evidence for the exact evolution of fuel damage leading to partial core melting in multiple units. A review of the spent nuclear fuel pools is given where isotopic water composition and visual inspection images provide important evidence for the condition of the spent nuclear fuel.

While it will be several months to a year before we will be in a position to learn most of the lessons from this tragdy, several conclusions about defensive design, mitigation actions, and emergency response have been drawn by international organizations.

While the public health impact appears to have been low, the economic and nearby environmental consequences are severe, There is no doubt that land restoration will take over a decade and perhaps much longer. A review is given of actions taken by the Japanese government for land recovery in areas such as decontaminating top soil and local farmland as well as highly radioactive water used during ‘feed and bleed’ cooling of the core.