Pandora Report 9.22.2017

Happy Friday! Are you a fan of antibiotics and their ability to fight off microbial threats? So are we, which makes the recent WHO report that much scarier. Since this latest report points to the dire situation of antibiotic development, we’re super-sizing the focus on the antimicrobial resistance and super bugs this week.

Fifteen Years of Public Health Emergency Preparedness  & AJPH Special Edition
Make sure not to miss the special edition of the American Journal of Public Health (AJPH), focusing on public health emergency preparedness. Within this edition there are great articles on science in emergency response at the CDC, children’s health in emergency preparedness, evolution of the field, funding, etc. One of the best parts was the Editor’s Choice – From Anthrax to Zika: Fifteen Years of Public Health Emergency Preparedness. This article discusses public health threats, regardless of origin, and how they can lead to national emergencies. “Our current frame of reference is shaped by the events of September 11, 2001. In response to the terrorist attack, the US Congress set up appropriations to support state, local, tribal, and territorial public health departments nationwide; these funds are administered through a cooperative agreement from the Centers for Disease Control and Prevention (CDC) to fortify national security. The Public Health Emergency Preparedness (PHEP) cooperative agreement helps health departments strengthen their abilities to effectively respond to a range of public health threats, including infectious diseases; natural disasters; and biological, chemical, nuclear, and radiological events. As a result, the CDC and the PHEP community have played critical roles over the past 15 years in preventing, responding to, and rapidly recovering from public health threats ranging from anthrax (2001) to Zika (ongoing currently as of publication). Responses to these public health threats highlight the need for preparedness efforts to protect people and support communities when disaster strikes.” The authors discuss the impact of the 2001 Amerithrax attacks on public health countermeasures and response, and then the 2009 pandemic of H1N1 during the school year. They also touch on food safety and biosurveillance, which caught the 2015 E. coli and meningitis B outbreaks in Oregon, not to mention the recent impact of Zika and Ebola. “These are just a few examples of public health preparedness capabilities that the CDC identified in its 2011 guidance document issued to aid in the development of successful public health preparedness programs. The articles in this issue of AJPH provide detailed accounts of preparedness in action, showcasing competencies in biosurveillance, incident management, community resilience, information management, countermeasures and mitigation, and surge management. These articles demonstrate how and why public health agencies, health care systems, and communities play a vital role in protecting and securing the nation’s public health.”

CARB-X: Fighting AMR through Public-Private Partnerships
GMU biodefense MS alum Nick Guerin is taking us through the journey of fighting resistant organisms and the importance of antimicrobial stewardship partnerships. Guerin looks to the new CARB-X strategy at curbing the impending threat of antimicrobial resistance (AMR). “One possible protection against AMR is the development of new medical countermeasures (MCMs). The strategies to find the best MCMs crisscross multiple organizations and functions, namely through either public or private initiatives. However, such divided efforts create limitations that might best be overcome through comprehensive public-private collaborative efforts.” Not only does Guerin highlight the details of CARB-X and other partnerships, but he also addresses past approaches and failures in fighting AMR. “AMR’s threat demands expedient solutions; the decade’s long wait for new antibiotics cannot continue. AMR poses one of the most difficult development requirements for these new MCMs, one that public and private sectors haven’t overcome on their own.”  

Global Health 2030 Symposium  
The second annual Global Health 2030 Symposium will be held on October 4th at the United Institute of Peace in Washington, D.C. “Experts, academics, and practitioners will be exploring the Science of Health: Bridging Epidemics and Technology. Join us as we convene the community to prepare for the growing health challenges at home and abroad. Learn about the latest technology and global health innovations combating widespread epidemics and improving disaster response. The keynote address, ‘The Persistence of Epidemics and Our Response’ will be given by Dr. Michael Cowan, Executive Director, Association of Military Surgeons of the United States.”

Space – The Next Microbial Frontier?
How do bacteria act in space? Sure, we know the microgravity can permanently alter bacteria and make them even better at reproducing, but we need to really understand why this happens and how it might impact our health during space exploration. “In an experiment planned by researchers at the University of Colorado at Boulder and carried out on the ISS, cultures of Escherichia coli bacteria were doused with the antibiotic gentamicin sulphate, which usually kills off E. coli quite easily. Out in space, it was a totally different story. ‘We knew bacteria behave differently in space and that it takes higher concentrations of antibiotics to kill them,’ says one of the researchers, Luis Zea. ‘What’s new is that we conducted a systematic analysis of the changing physical appearance of the bacteria during the experiments’.” Their experiment found that E. coli reacted with a 13-fold increase in cell numbers and reduced their cell volume by almost 75%. This reduction in size can make treatment with antimicrobials tricky as there is a smaller surface area for them to interact with. Researchers also found that the bacteria increased cell envelope thickness and outer membrane vesicles. “The bacteria threw up extra shields by thickening their cell walls and outer membranes, and growing in clumps so a shell of outer cells could protect the inner ones from getting exposed. ‘Both the increase in cell envelope thickness and in the outer membrane vesicles may be indicative of drug resistance mechanisms being activated in the spaceflight samples,’ says Zea. ‘And this experiment and others like it give us the opportunity to better understand how bacteria become resistant to antibiotics here on Earth’.” While more research is needed, perhaps this environment will be the new proving ground for novel antimicrobials and tougher processes. If nothing else, this just gives me a lot of appreciation for how tough space disinfection is.

How China’s AMR Outbreak Revealed the Changing Landscape of Infection Control                                       The news that a Chinese hospital lost five patients to a severe strain of drug-resistant Klebsiella pneumoniae left many concerned about the growing threat of antibiotic resistance. The strain of K. pneumoniae was not only highly resistant, but also hypervirulent and highly transmissible, which is just about everyone’s worst nightmare when it comes to antimicrobial resistance. GMU biodefense PhD student and infection preventionist Saskia Popescu takes a look at this outbreak and how it reveals the changing landscape of infection control. “The recent report from the Chinese ICU outbreak points to the increasing threat of microbial resistance and the desperate need to address prevention efforts in terms of both stewardship and infection control. As the landscape changes for both medical care and biothreats, it is important that infection prevention and control efforts be a part of this evolution. We must consider these practices and hospital programs when modernizing healthcare and public health. These infectious disease events can, and should, teach us about the diverse range of issues hospitals face and how we can better prevent the spread of infection through active, instead of passive, efforts. “

Attribution of Biological Crime, Terrorism, and Warfare: Challenges and Solutions                                                                                                                                         The latest Blue Ribbon Study Panel on Biodefense event, highlighting biocrimes and biowarfare, will be on October 3rd from 10am-1pm. “Effective prosecution and decisions regarding U.S. response depend on accurate attribution of biological attacks. Despite ongoing biological crimes and suspected development of biological weapons for the purpose of attacking the Nation, the United States has yet to establish this capability fully. The Study Panel will host a special focus meeting entitled Attribution of Biological Crime, Terrorism, and Warfare: Challenges and Solutions. This meeting of the Study Panel, chaired by former Homeland Security Advisor Ken Wainstein and former Senate Majority Leader Tom Daschle, will address the current states of science, investigations, and intelligence for biological attribution and the extent to which they inform strategic, operational, and tactical decisions; and provide a better understanding of the ability of the United States to identify pathogens and their sources correctly, attribute biological crimes, terrorism, proliferation, and warfare to their perpetrators, using scientific and other forms of evidence and information, and explore the processes used for investigative, legal, policy, and political decisions involving biological attribution.”

Cryptology History Symposium
GMU biodefense PhD alum Craig Wiener will be presenting his dissertation research at the October Center for Cryptology History Symposium. His research, “Penetrate, Exploit, Disrupt, Destroy: The Rise of Computer Network Operations as a Major Military Innovation”. Don’t miss out on this opportunity to listen to Craig discuss his research “determining the origins of computer network exploitation and computer network attacks in the U.S. intelligence community.”

Health Security Call for Papers – Extended Deadline
The call for papers on communication and health security deadline has been extended to December 31st, 2017. “A special feature in Health Security will be devoted to analysis of the current communication environment and efforts to effectively communicate during outbreaks of infectious diseases and other health threats. The journal seeks papers that address the wide range of policy, practice, and research issues relevant to communication in large-scale health events. The special Journal section devoted to communication and health security will be published in the March/April 2018 issue of Health Security. Scholarly and review articles, descriptions of practice, and opinion and commentary pieces are welcome. Manuscripts can be up to 5,000 words exclusive of the abstract, tables, figures, and references. Please consult the journal website for specific submission instructions.”

Stories You May Have Missed:

  • Biosecurity Luncheon – NAS– Don’t miss the September 27th luncheon and “informal discussion on Global Catastrophic Biological Risks (GCBRs), led by the Director of the Johns Hopkins Center for Health Security, Dr. Thomas Inglesby. Dr. Inglesby will review the Center’s recent attention on GCBRs, and how the synthesis of horsepox by a Canadian researcher has moved the needle on the necessity of discussing these potential future events. This meeting is the second in a series of biological, chemical, and health security discussions to address compelling topics and to provide a forum for engagement among the DC-based community interested in biosecurity issues. The lunch will take place at the Keck Center of the National Academies of Sciences, Engineering, and Medicine (located at 500 Fifth Street NW, Washington, DC). The event is free and lunch will be provided, but space is limited, so you must register to attend this event.” Make sure to register here!
  • CDC & Its Partners’ Contributions to Global Health Security– A new report from Emerging Infectious Diseases is highlighting the challenges many countries face when attempting to comply with the WHO’s IHR. “The US Centers for Disease Control and Prevention (CDC) works with countries and partners to build and strengthen global health security preparedness so they can quickly respond to public health crises. This report highlights selected CDC global health protection platform accomplishments that help mitigate global health threats and build core, cross-cutting capacity to identify and contain disease outbreaks at their source. CDC contributions support country efforts to achieve IHR 2005 compliance, contribute to the international framework for countering infectious disease crises, and enhance health security for Americans and populations around the world.”
  • San Diego Battles Hepatitis A – San Diego is battling a deadly hepatitis A outbreak, in which sixteen people have died. Shortly after announcing it had become a public health emergency in San Diego, Los Angeles reported cases and has declared an outbreak. Sanitary conditions, especially in public bathrooms, have been considered one source of transmission and many cases have been within the homeless population. The outbreak has “infected 421 since November, ravaging San Diego’s large homeless and illicit drug-using population. It could eventually cost the county health department up to a million dollars, a local health official estimated.” While there hasn’t been a point source identified, efforts are being taken within homeless shelters and even bleaching of streets are underway. Many are pointing to the lack of affordable housing in San Diego as a catalyst for homelessness and the certain laws and practices that push homeless people into smaller areas, which can facilitate the spread of disease. “It was a wake-up call that this is killing people,” Norris said. “It’s killing people we know. It’s killing our neighbors.” “We’re not a third world country,” added McConnell, the community advocate. “We should quit acting like we are.”

Thank You For Reading the Pandora Report. If you would like to share any biodefense news, events, or stories, please contact our Editor Saskia Popescu (biodefense@gmu.edu) or via Twitter: @PandoraReport

CARB-X: Fighting AMR through Public-Private Partnerships

By Nick Guerin

The world is fast approaching a day when our fundamental medicines are rendered ineffective by antimicrobial resistance (AMR). AMR kills hundreds of thousands every year with a potential for millions more in the coming decades if nothing is done. One possible protection against AMR is the development of new medical countermeasures (MCMs). The strategies to find the best MCMs crisscross multiple organizations and functions, namely through either public or private initiatives. However, such divided efforts create limitations that might best be overcome through comprehensive public-private collaborative efforts.

What is AMR?
The Centers for Disease Control and Prevention (CDC) defines antimicrobial resistance as “the ability of microbes to resist the effects of drugs – that is, the germs are not killed, and their growth is not stopped.”[1]  Antibiotic use creates the inevitable spread of AMR; inadequate prescriptions, misuse, overuse, and other factors enable microbes that survive antibiotic use to spread their genetic traits (drug resistance) to later generations. In the United States, AMR causes 2 million infections and 23,000 deaths annually,[2] while globally AMR death rates surpass 700,000 deaths each year. By 2050, the global rate could climb to 10 million annually if no MCMs (countermeasures) are successful in stemming the threat.[3]

Past Approaches & Failures
The perils of AMR are well documented and understood, so what development and response capability should we expect to see? Governments and private organizations invest hundreds of millions of dollars and decades of man hours searching for the latest breakthrough against AMR. However, each has encountered limitations to their functional capabilities.

Private
Private medical enterprises often find themselves at the forefront of medical innovation. The financial characteristics of antibiotic research motivate private sector AMR research and development. The current antibiotic market remains stocked with decades old drug developments or minute variations to existing antibiotics (see Figure 1).[i][4]

Despite the financial incentive, ambiguity over profit hinders antibiotic research in large pharmaceutical companies. For example, GlaxoSmithKline is closing in on producing one of the first new antibiotics in over thirty years. However, the company remains immensely uncertain over its ability to turn a profit due to repeated changes in AMR research demands, including greater requirements for broad-spectrum antibiotics. The economic uncertainty associated with developing new MCMs to combat AMR drove another major pharmaceutical company, AstraZeneca, out of the antibiotic market all together in 2016.[5]

Further financial disincentives impact MCM efforts against Gram-negative bacteria such as carbapenem-resistant Enterobacteriaceae (CRE), an AMR type public health officials label an issue of immediate concern. Only half of the roughly three dozen antibiotics in development by private initiatives are capable of fighting Gram-negative bacteria. Moreover, whereas the financial burden often hinders the largest of pharmaceutical companies, it outright prevents small biotech businesses from accumulating the necessary capabilities to confront these new biothreats.[6]

Public
The government prepares for the defense of the nation’s health from bioterrorism and natural outbreak events through the acquisition and stockpiling of MCMs. Unlike the private sector that acts based on profit seeking, the government can absorb the financial liabilities of broad funding approaches. The federal government coordinates MCM development and strategy through the interdepartmental Public Health Emergency Medical Countermeasures Enterprise (PHEMCE).

The PHEMCE primarily induces private MCM research through Project BioShield and the Biomedical Advanced Research and Development Authority (BARDA). Created in 2004, Project Bioshield sought to address the needs and concerns of the private sector for a stable and guaranteed market by creating artificial markets for MCM development.[7]  However, after BioShield failed to achieve success, the government organized the PHEMCE in 2006 with BARDA specifically founded to address BioShield’s limitations. A primary goal of BARDA is to bridge the “Valley of Death” (See Figure 2),[ii] the gap between pre-clinical development in NIH and the final procurement funding from BioShield. Specifically related to the realm of antibiotics, BARDA removed restrictions that prevented research and development into broad-spectrum antimicrobial solutions. Despite being a successful program overall, BARDA still has room for improvement. Small businesses are awarded most BARDA contracts yet they often lack the capabilities necessary for AMR development.[8] As a result, BARDA is forced to implement repeated course corrections to sway large pharmaceutical companies into the high-risk world of AMR development.

Collaborative Partnerships
Active collaboration portends the best solution to gaps in private and public forms of AMR MCM research. Possibly the most complete and far reaching public-private collaboration in the field of AMR research is the Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator(CARB-X), a large-scale cooperative program between multiple government agencies and leading private national and international biotech, pharmaceutical, and advanced research enterprises. Specifically designed to counter the gaps of individualized private and government efforts to combat AMR, CARB-X focuses on preclinical discovery development of AMR MCMs by using government and private biopharmaceutical research partners to identify and accelerate key antimicrobial products through the risk-sodden safety and efficacy testing phases that traditional market incentives obstruct[9] (See Figure 3 for CARB-X’s Process Snapshot).[iii]

BARDA’s partnership has already funded $30 million out of a possible 5-year, $250 million dollar contract, with accelerator partners like the AMR Centre funding $14 million out of a possible $100 million.  In less than a year, CARB-X’s portfolio of nearly one dozen development partners created a pipeline of 11 products, four of which are already in the pre-clinical stage.[10] One of those, Tetraphase Pharmaceuticals’ TP-6076 novel antibiotic, has already moved to Phase 1 studies (See Figure 4 for the CARB-X Pipeline).[iv]  While much remains to be done, the success of a truly start to finish private-public collaborative effort demonstrates the progress such programs are cable of in the highly stagnant field of antibiotic development.

We only need to look to our European allies to see how comprehensive models of collaborative agreements create turnarounds in AMR pharmaceutical production. The European Union sponsors its own large-scale public-private AMR partnership, the New Drugs for Bad Bugs program.  A €650 million investment has nearly tripled the number of large European pharmaceutical companies engaged in AMR research (from 4 to 11). Concrete results of the public-private collaborations include the first ever AMR phage therapy trials and the operation of AMR detection networks similar to those in the U.S.[11]

AMR’s threat demands expedient solutions; the decade’s long wait for new antibiotics cannot continue. AMR poses one of the most difficult development requirements for these new MCMs, one that public and private sectors haven’t overcome on their own. Early progress in collaborative AMR solutions, both home and abroad, reveal that such efforts are the best way to fight the AMR threat.

References

[1] Centers for Disease Control and Prevention, “About Antimicrobial Resistance” https://www.cdc.gov/drugresistance/about.html

[2] CDC, “About Antimicrobial Resistance”

[3] Line Matthiessen, Richard Bergström, Shiva Dustdar, Pierre Meulien, and Ruxandra Draghia-Akli, “Increased Momentum in Antimicrobial Resistance Research,” The Lancet (British edition), (August 2016), pp. 865.

[4] Carolyn K. Shore and Allan Coukell, “Roadmap for Antibiotic Discovery,” Nature Microbiology, (May 2016), np. https://www-nature-com.mutex.gmu.edu/articles/nmicrobiol201683

[5] Stephanie Baker, “Why Superbugs Are Beating Big Pharma,” Bloomberg, (September 2016). https://www.bloomberg.com/news/articles/2016-09-21/inside-the-10-year-1-billion-battle-for-the-next-critical-antibiotic

[6] Natalie McGill, “As Antibiotic Resistance Rises, so do Research, Development.” The Nation’s Health, Vol. 46, Iss. 8 (October 2016), pp. 14.

[7] Robert Kadlec, “Renewing the Project BioShield Act What Has It Bought and Wrought?,” Center for New American Security, (January 2013), pp. 1-16. https://www.bio.org/articles/renewing-project-bioshield-act

[8] Jonathan Tucker, “Developing Medical Countermeasures: From BioShield to BARDA,” Drug Development Research, Vol. 70, Iss. 4 (June 2009), pp. 224–233.

[9] HHS Forges Unprecedented Partnership to Combat Antimicrobial Resistance,” Targeted News Service (July 2016)

[10] “HHS Forges Unprecedented Partnership”

[11] Matthiessen, Bergström, Dustdar, Meulien, & Draghia-Akli, “Increased Momentum,” pp. 865

[i] Figure 1: Timeline of Novel Antibiotic Discoveries

https://www-nature-com.mutex.gmu.edu/articles/nmicrobiol201683

 

 

 

 

 

[ii] Figure 2: Valley of Death https://sigs.nih.gov/RACD/Lists/Calendar/Attachments/8/NIH_CC_19Nov2013.pptx

 

 

 

 

 

[iii] Figure 3: CARB-X Process http://www.carb-x.org/portfolio

 

 

 

 

 

 

[iv] Figure 4: CARB-X Product Pipeline http://www.carb-x.org/portfolio

Pandora Report 9.15.2017

Global Health and the Future Role of the United States
The latest report from the National Academies of Science Engineering, and Medicine, is now available! “Growing forces for globalization have increased the interconnectedness of the world and our interdependency on other countries, economies, and cultures. Monumental growth in international travel and trade have brought improved access to goods and services for many, but also carry ongoing and ever-present threats of zoonotic spillover and infectious disease outbreaks that threaten all.” The report includes chapters on investing in global health for America and how such investments protect U.S. interests, the effects of globalization, and looking into the future. There are individual chapters on infectious diseases like pandemic influenza and global health security as national security, TB, and how we can enhance productivity and economic growth. “By investing in global health over the next 20 years, there is a chance to save the lives of millions of children and adults. Beyond these health benefits to individuals, global health is directly linked to economic productivity and growth worldwide. According to the Lancet  Commission on Investing in Health, the return on investments in global health can be substantial—as the benefits can exceed the costs by a factor between 9 and 20, for low-income and lower middle-income countries, respectively. Worldwide, investing in core capacities to prevent, detect, and respond to infectious disease outbreaks through the development of multidisciplinary ‘One Health’ systems focused on the interface of human and animal health can result in an estimated savings of $15 billion annually from the prevention of outbreaks alone.” The report emphasizes the importance of continued commitment to global health and that ultimately, aid is truly an investment in global health, which benefits us all. Disease knows no borders and an outbreak anywhere is an outbreak everywhere. Melinda Gates also recently discussed the importance of foreign aid, noting that “If we don’t make these investments in global health, my argument to people is, you’re going to see a lot more things like Ebola in our own country, and we’ll be dealing with them in our own health clinics because borders are porous,”.

GMU Biodefense Graduate Program Information Sessions 
Don’t miss out on the chance to learn about our PhD program on September 21st! You can join the info session at 7pm at the GMU Arlington Campus. The GMU Schar School PhD info session will also include a panel of current PhD students to discuss their experiences and answer questions. This is also a great chance to chat with faculty and learn about admissions. Where else can you study a range of topics that include biosurveillance, select agents, global health security, and policy with such an engaged group of faculty and students?

Tom Frieden Launches New Global Health Initiative
Former CDC director Dr. Tom Frieden is launching a new program to combat not only global cardiovascular disease, but also infectious diseases. The new initiative Resolve to Save Lives, will be located in New York City, and “will prevent heart attacks, strokes, and epidemics with the goal of saving 100 million lives and making the world safer from epidemics.” The initiative has $225 million in backing over the next five years by major funders including the Chan Zuckerberg Initiative, Bloomberg Philanthropies, and the Bill and Melinda Gates Foundations. Frieden hopes to work with major players like the WHO and CDC “to persuade more countries to ban trans fats and lower the salt content in foods and shore up defenses against disease outbreaks”.

Johns Hopkins Center for Health Security ELBI Workshop
The Johns Hopkins Center for Health Security Emerging Leaders in Biosecurity Initiative (ELBI) recently hosted their last event for the 2017 class. The 2017 group capped off their fellowships with a day of engaging lectures and discussions including talks from FBI SSA Ed You, STAT reporter Helen Branswell, MIT’s Peter Carr, and more. The group was able to tour the Ginkgo Bioworks and George Church labs while chatting with Andy Weber, George Church, Patrick Boyle, Tom Knight, and Devin Leake about the future of synbio and biotechnology. Last but not least, the fellows participated in a viral storm exercise, which challenged them through a real-world scenario that required policy, security, public health, and science responses on a global scale. GMU biodefense PhD student Saskia Popescu attended as a member of the class, noting that “one of my favorite parts from this workshop was getting to hear from Tom Inglesby and several analysts from the CHS regarding their research and initiatives they’ve worked on. Learning about projects like Outbreak Observatory, data-driven outbreak response (outbreak science), and healthcare capacities during natural disasters, was fascinating and really opened my eyes to the range of topics the CHS is involved in.”

Biological Engagement Programs: Reducing Threats and Strengthening Global Health Security Through Scientific Collaboration
Don’t miss out on this latest eBook addressing biological engagement programs and the health security perspective. “Biological engagement programs are a set of projects or activities between partner countries that strengthen global health security to achieve mutually beneficial outcomes. Engagement programs are an effective way to work collaboratively towards a common threat reduction goal, usually with a strong focus on strengthening health systems and making the world a safer place. Cooperative programs are built upon trust and sharing of information and resources to increase the capacity and capabilities of partner countries.” You can download the PDF here – make sure not to miss the chapter “Strengthening Biosecurity in Iraq: Development of a National Biorisk Management System”, co-authored by GMU biodefense professor and graduate program director, Dr. Gregory Koblentz.

NAS Symposium on Cooperative Threat Reduction (CTR) for the Next Ten Years and Beyond
The National Academy of Science will be hosting this symposium on September 18-19 at the Keck Center in Washington, D.C. “In 2009 the National Academy of Sciences (NAS) report Global Security Engagement: A New Model for Cooperative Threat Reduction concluded that expanding and updating U.S. Government Cooperative Threat Reduction (CTR) programs in both form and function would enhance U.S. national security and global stability. The NAS Committee on International Security and Arms Control (CISAC) is convening a symposium to examine how CTR has evolved since that time and to consider new approaches for CTR programs and related WMD elimination efforts to increase their ability to enhance U.S. security. The symposium is sponsored by the Project on Advanced Systems and Concepts for Countering Weapons of Mass Destruction (PASCC) in the Naval Postgraduate School and will be open to the public. A ‘meeting in brief’ document will be issued by NAS after the symposium. For detailed information on this event and a draft agenda please visit:  www.nas.edu/cisac.”

Stories You May Have Missed:

  • GAO Report on Medical Devices for Infectious Disease Rapid Diagnosis – The latest GAO report is looking to the capabilities and challenges of technologies that allow for the rapid diagnosis of infectious diseases. Diagnosis of bio-threats is a crucial component to prevention and control, which makes the efficacy of these technologies critical. “Some stakeholders GAO spoke to identified the need for more clinical studies to establish the benefits of these technologies. Implementation challenges included reluctance by medical users to adopt these technologies, due to factors such as (1) lack of familiarity with such technologies, (2) costs and resources to use them, and (3) reluctance to order, and pay for, all of the tests for a given multiplex assay. Further, in some situations, positive test results for rare diseases are more likely to be false positives; thus systematic testing for such diseases may result in wasted resources to address all patients who test positive.”
  • CSIS Event: The New Barbarianism- don’t miss out on this event organized by the CSIS Global Health Policy Center on Monday, September 18th, from 6:30-9pm at the Newseum. “This hour-long film explores the recent surge of violence we’ve witnessed against the health sector across multiple wars, both new and old, and the accompanying shredding of international humanitarian norms”. Make sure to register here.

Pandora Report 9.8.2017

Happy Friday and welcome to your weekly source for all things biodefense. Got plague? Good news – if you have some live chickens hanging around, you can try this medieval treatment.

Defense Against Biological Attacks
Biological threats come in all shapes and sizes – whether it’s an outbreak of Ebola, a biological weapon, a laboratory mishap, or even the potential for biosafety breaches following  a hurricane. Preparedness and response efforts need to be just as diverse. As Texas begins the process of rebuilding and the threat of nuclear weapons has been fresh in everyone’s mind, it is crucial we don’t forget about the importance of health security. Disease knows no borders and it’s easy to diminish the threat of it however, Laura Holgate and Elizabeth Cameron are drawing attention to the need for President Trump to prevent the next biological attack before it happens. “As Congress and the Trump administration mull a new biodefense strategy, we urge them to use this time — the time in between biological crises — to get ahead of the curve before the next major biological event inevitably comes our way.” They point to several different strategies that should to be followed – watch out for emerging threats in unstable regions, fund and renew the Global Health Security Agenda, replenish the budget to maintain global biosecurity, keep laboratory assets for attributing biological attacks, and use biosurveillance to stop outbreaks before they start. We need to take the National Bioforensics Analysis Center off the chopping block, stop slashing the biosecurity budget as programs like the Cooperative Biological Engagement Program are vital, and truly, the GHSA renewal is a no-brainer. These efforts not only defend against current threats, but work to address the next generation of bioweapons and biothreats.  Holgate and Cameron note that “We know that biological threats must remain at the top of the national security agenda, and leaders must recognize that stopping outbreaks at the source requires strong global and domestic capacity to prevent, detect and rapidly respond to naturally occurring outbreaks and biological attacks”

Health Security – Call for Papers
The Health Security journal is currently looking for papers on communication and health security: improving public health communication in response to large-scale health threats. Manuscript deadlines are October 20, 2017. “Effective communication is an essential tool in establishing an appropriate response to any large-scale health threat or disaster, such as a newly emerging infectious disease, terrorism, environmental catastrophe, or accident. Yet, public health communication is occurring in an increasingly complex world with competing messages, new platforms, and limited trust.A special feature in Health Security will be devoted to analysis of the current communication environment and efforts to effectively communicate during outbreaks of infectious diseases and other health threats. The journal seeks papers that address the wide range of policy, practice, and research issues relevant to communication in large-scale health events.” Topics might include exploration of the communication environment during recent infectious disease events or public health disasters, investigation of the role of social media and other emerging or recently emerging communication platforms, etc. Submission information can be found here.

GMU Biodefense MS – Open House on September 14th
Don’t miss out on the Master’s Open House next week for the GMU Biodefense MS program!  From 6:30-8:30pm next Thursday, September 14th, at the GMU Arlington campus, you can speak to faculty, learn about admissions, and why biodefense students have a blast while getting their graduate degrees. This is a great chance to learn about the MS program (for both online or in-person) and chat with faculty about the exciting classes and activities GMU biodefense students get to enjoy.

The Biological Weapons Convention At A Crossroad
As Robert Frost once said, “Two roads diverged in a wood, and I- I took the one less traveled by, and that has made all the difference.” Which direction will the BWC take? Bonnie Jenkins investigates the uncertain future of the BWC, its current challenges, which direction it might take, and the direction it should take. Despite its relevance and capacity to endure decades of challenges, the latest RevCon was considered a monumental disappointment and left many in a state of disagreement. “Some of the major issues that were discussed at previous meetings—but at this point have no platform for discussion at the BWC—include advances in science and technology, disease outbreak preparedness and response, and national BWC implementation. Previously-held mid-year experts’ meetings have also been dropped, so there is now no chance for the exchanges with experts from relevant international organizations, including input from the World Health Organization that has been so useful in the past. These are all steps backward.” Despite a lack of Meeting of States Parties in August, there is hope that the December meeting with work towards developing an inter-sessional work program. On top of these barriers, the BWC has funding challenges, which severely impacts the Implementation Support Unit (ISU). Against these odds, the BWC ISU continues to promote universal membership and treaty implementation. Global initiatives are also beneficial to promotion of health security and prevention of biological weapons. “When global initiatives interconnect like this, it reinforces all of the initiatives. The Global Health Security Agenda, for instance, brings over 55 countries together to strengthen countries’ capacities to prevent, detect, and respond to infectious disease threats, whether natural, deliberate, or accidental.” These efforts seek to strengthen the BWC through global health security, but there is still work to be done. Jenkins suggests three tasks are crucial to maintain BWC relevancy and sustainability: “1) Sufficient and sustained funding by states parties, to include payments now in arrears; 2) Strong leadership and a successful December MSP that reaffirms the importance of the treaty to the international community and that also develops an inter-sessional work program; and 3) A vision for developing the role of the BWC as part of a larger interconnected global security architecture.”

Using Ebola Data to Fight Future Outbreaks
Learning from past outbreaks to avoid future failures is always a tough aspect of public health however, a new strategy is using data to help stop the next outbreak of Ebola. Researchers have developed a new platform to help organize and share Ebola data that was previously scattered and unable to be utilized. This was a significant issue on the ground during the 2014/2015 outbreak, which makes this project all the more important. “The information system is coordinated by the Infectious Diseases Data Observatory (IDDO), an international research network based at the University of Oxford, UK, and is expected to launch by the end of the year. At a meeting to discuss Ebola on 7–9 September in Conakry, Guinea, the team heading the platform will seek input from West African scientists, health officials and advocacy groups.” One of the most vital components to the system is the emphasis of partnership and involvement of African collaborators. Not only will this focus encourage the use of historical data, but will also allow utilization during future outbreaks. Control of the data has also been a challenging hurdle to overcome, as there are many cooks in the kitchen. “Amuasi says that he would have liked the database to be hosted and curated in Africa, rather than in Oxford, because training and paying African researchers to manage the platform would teach them how to use the information and improve their ability to respond to future outbreaks in the region. But he adds that this seems unlikely, because it would raise the cost of the project, and the infrastructure already exists at Oxford. Merson says that a copy of the database will be maintained in West Africa, although its exact location has yet to be determined. She adds that an African committee may be in charge of deciding who gets access to the data. And she says that fellowships are likely to be made available for West African students who want to work on the database.”

The Global Health Security Agenda: Public & Private Partnerships
The Global Health Security Agenda Consortium and EcoHealth Alliance will be hosting this meeting on Thursday, September 14th at 12pm. Held at the ONE UN New York Hotel in NYC, you can catch this event with speakers like Dr. Beth Cameron from the Nuclear Threat Initiative and Admiral Tim Ziemer from the US National Security Council. Make sure to RSVP here.

Launch of International Health Regulations Costing Tool
Georgetown University Center for Global Health Science & Security is launching their new open-access IHR costing tool. “In 2016, the World Health Organization adopted the Joint External Evaluation tool (JEE) to measure country-specific progress in developing the capacities needed to prevent, detect, and respond to public health threats, as mandated under the 2007 International Health Regulations (IHR). However, national governments and development partners have struggled to accurately define the costs of strengthening and maintaining critical health security systems that often depend on multi-sectoral coordination. This poses a serious dilemma for global health security and presents a compelling opportunity to improve the drafting and implementation of practical health security policies.” A joint effort with Talus Analytics, this new tool was developed to help estimate the cost to build capacity under the IHR. You can access the tool here (you may want to use Google Chrome).

IDSA Slams Budget Cuts to AMR
Biodefense budgets aren’t the only ones to be taking a beating… The president’s FY2018 budget released in May would cut the CDC’s Antibiotic Resistance Solutions Initiate (ARSI) by 14%, as well as 23% from the NIH and NIAID, which funds research on AMR. Leaders from Infectious Disease Society of America (IDSA) are rallying to oppose such efforts. “In a letter published yesterday in Annals of Internal Medicine, IDSA treasurer Helen Boucher, MD, past president Barbara Murray, MD, and current president William Powderly, MD, argue that the budget cuts for public health and research proposed by the Trump administration will not only diminish the nation’s surveillance capacity and its efforts to reduce infections and promote appropriate antibiotic use, but also undercut US leadership in global efforts to tackle the AMR threat, which is responsible for more than 700,000 deaths each year globally.” The letter emphasizes that such cut would severely impact AMR efforts, which is highly worrisome and dangerous given the severity of the global AMR threat. You can read the letter here.

An Integrated Approach to Forensic Investigation of Threat Agents
In the wake of a chemical or biological event, threat analysis is a high-stakes operation that has little room for error. Determining the substance, origin, and components all make for a stressful situation that requires effective analytical methods. “Traditional analytical methods are good at confirming the presence or absence of a particular agent or substance. If a sample is believed to contain Bacillus anthracis, standard biological analysis will quickly determine whether or not this is the case. But it will not provide insight into its virulence, origin or how it might have been manipulated. And if the sample turns out to be something other than B. anthracis, it will not tell you what it actually is. An integrated approach to CB forensics provides investigators with richer information. Integrated forensics combines advanced forensic science technologies to provide more comprehensive and timely technical intelligence.” Some of these strategies include advanced genomic analysis like massively parallel sequencing and advanced chemical analysis like gas chromatography and high resolution mass spectrometry. Currently, the extraction methods for biological analysis can render the sample unusable for chemical analysis, which make analysis problematic. A new strategy from Battelle is looking to combat these discrepancies, which involves a new process to “systematically triage samples and integrate biological and chemical forensics, as well as developing and testing new technologies to help investigators more quickly identify and characterize biological agents, including new, emerging and synthetic agents, to glean more forensic information from the samples.”

Stories You May Have Missed:

  • Zika Vaccine Efforts Slow– Sanofi recently announced they are halting work on a candidate Zika vaccine. The vaccine was a joint effort with Walter Reed Army Institute of Research however, budgetary cuts and federal efforts to scale back put the project in jeopardy. “In its Sep 1 statement, Sanofi said BARDA informed the company on Aug 17 that the agency reassessed its Zika-related projects and have decided to focus on a more limited set of goals and deliverable, and that BARDA has decided to “de-scope” its contract with Sanofi for the manufacture and clinical development of an inactivated Zika vaccine. BARDA said it would limit its funding to a case definition and surveillance study, as well as any activities needed to pause work on the vaccine until an epidemic re-emerges. As a result, Sanofi said it doesn’t intend to continue developing or seek a license from WRAIR for the Zika vaccine candidate.”
  • Australia Battles Influenza – As Australia experiences a particularly harsh flu season, many are wondering what this will mean for Europe and North America.”In general, we get in our season what the Southern Hemisphere got in the season immediately preceding us,” Fauci said. An “intelligent guess,” therefore, is that the north will probably have a bad flu season. “With influenza, it is never 100%,” he said. “So when you talk about influenza, almost nothing is absolutely precision,” Fauci said. “In general, one can say we usually see here what they see there in their season.” Schaffner agrees: “There’s not a one-to-one correlation.” Still, hearing about Australia’s high number of flu cases, he said, “I started to tighten my belt.”

Pandora Report 9.1.2017

Craving some satyrical genome editing? Check out the Onion’s pros and cons list on this biotechnology.

The De Novo Synthesis of Horsepox Virus: Implications for Biosecurity and Recommendations for Preventing the Reemergence of Smallpox 

The recent de novo synthesis of horsepox by Canadian researchers has raised concern and spurred serious conversations about the future of orthopoxviruses, like smallpox, and the dual-use research that could bring them back. GMU biodefense associate professor and graduate program director Dr. Gregory Koblentz evaluates this horsepox experiment and what it means for biosecurity and efforts to prevent the reemergence of smallpox. Koblentz notes that this experiment represents a significant crossroads within the field of biosecurity and that the techniques for synthesis of such viruses are increasingly reducing barriers to potential misuse. Unleashing smallpox back into the world would be a global disaster as most of the world is no longer immune. Koblentz points out that “The threat of smallpox has been held at bay for the past 40 years by 2 conditions: the extreme difficulty of acquiring the virus and the availability of effective medical countermeasures. Synthetic biology is on the brink of erasing both of these formidable barriers to the reemergence of smallpox as a global health threat.” He highlights the limited and rather lackluster legal and technical safeguards against smallpox synthesis and that the increasing normalization and globalization of it will likely create a boom of researchers performing such experiments. Think of the gold rush, but rather the orthopoxvirus syntehesis rush. As orthopoxviruses, are being used to develop new vaccines and oncolytic medical treatments, its popularity and wider range of applications carries with it inherent risks that should be considered. “The combination of rising demand and increasing supply could lead to the global diffusion of the capability and expertise to create orthopoxviruses de novo as well as modify these synthetic viruses. With this diffusion will come an increased risk that scientists, acting on their own volition or on behalf of a terrorist group, might misuse their know-how to create variola virus, or that governments could use civilian biomedical research with synthetic orthopoxviruses as a cover for offensive applications. The release of the smallpox virus— whether due to a biosafety failure, a breach in biosecurity, or an act of biological warfare—would be a global health disaster.” Koblentz draws attention to the challenges that the normalization and globalization of orthopoxvirus synthesis poses to national and international systems working to ensure life sciences research is safely conducted. He points out that there is no clear international legal framework to prevent the synthesis of the variola virus, few comphresensive legal safeguards, and that the private DNA industry (the main supplier of large synthetic DNA fragments) has inconsistent regulatory interventions. With these concerns, Koblentz suggests several recommendations to prevent the return of smallpox, ranging from the WHO’s World Health Assembly (WHA) passing a resolution to enshrine the WHO’s Advisory Committee on Variola Research (ACVVR) recommendations on the handling and synthesis of variola virus DNA into international law, to efforts within the DNA synthesis industry to declare a temporary moratorium on the synthesis of orthopoxvirus DNA fragments until effective WHO oversight can be established. Overall, Koblentz points to the importance of this experiment in terms of how such work is performed and the lack of informed debate surrounding the dual-use nature prior to the start of research. He emphasizes  “the risks posed by the routine and widespread synthesis of orthopoxviruses that could lead to the creation of a widely distributed network of laboratories and scientists capable of producing infectious variola virus from synthetic DNA.”

GMU Biodefense Master’s Open House – September 14th
We’re two weeks away from the first Master’s Open House and you won’t want to miss the chance to learn about GMU’s biodefense MS program. From 6:30-8:30pm on Thursday, September 14th, at the GMU Arlington campus, you can speak to faculty, learn about admissions, and why biodefense students have a blast while getting their graduate degrees. From Anthrax to Zika, we’ve got the place for all things biodefense.

Stanford’s New Biosecurity Initiative  

Stanford University’s Freeman Spogli Institute for International Studies (FSI) just announced their new biosecurity initiative, the Stanford Biosecurity Initiative, which will be led by David Relman and Megan Palmer. “Relman said the biosecurity initiative will seek to advance the beneficial applications of the life sciences while reducing the risks of misuse by promoting research, education and policy outreach in biological security. His CISAC leadership gives him the know-how to lead such a wide-ranging effort across diverse disciplines and communities,”. Palmer is a senior research scholar at Center for International Security and Cooperation (CISAC) and leads research on risk governance in emerging technology development and is an all around biotechnology guru. The biosecurity initiative also includes key Stanford partnerships and expertise within the fields of life sciences, engineering, law, and policy. Palmer noted that, “Stanford has an opportunity and imperative to advance security strategies for biological science and technology in a global age. Our faculty bring together expertise in areas including technology, policy, and ethics, and are deeply engaged in shaping future of biotechnology policy and practices.” We look forward to seeing the amazing work this new initiative will accomplish!                                                                                         

NAS Symposium on Cooperative Threat Reduction (CTR) for the Next Ten Years and Beyond
Don’t miss out on this September 18-19 event at the Keck Center. “In 2009 the National Academy of Sciences (NAS) report Global Security Engagement: A New Model for Cooperative Threat Reduction concluded that expanding and updating U.S. Government Cooperative Threat Reduction (CTR) programs in both form and function would enhance U.S. national security and global stability. The NAS Committee on International Security and Arms Control (CISAC) is convening a symposium to examine how CTR has evolved since that time and to consider new approaches for CTR programs and related WMD elimination efforts to increase their ability to enhance U.S. security. Speakers will include Amb. Laura Holgate, former U.S. Representative to the Vienna Office of the UN and IAEA, Amb. Ronald Lehman, Counselor to the Director of LLNL, William Tobey, former Deputy Administrator for Defense Nuclear Nonproliferation at NNSA, Andrew Weber, former Assistant Secretary of Defense for Nuclear, Chemical, and Biological Defense Programs, and other key thinkers and practitioners from CTR programs as well as experts from outside of CTR implementing agencies who have experience addressing complex international security problems. The symposium is sponsored by the Project on Advanced Systems and Concepts for Countering Weapons of Mass Destruction (PASCC) in the Naval Postgraduate School and will be open to the public. A ‘meeting in brief’ document will be issued by NAS after the symposium.”

International Biosecurity Fellows Reflect on SB7.0
The Johns Hopkins Center for Health Security recently partnered with Stanford’s Drew Endy to bring 32 emerging biosecurity leaders together for a fellowship program to attend the 7th International Meeting on Synthetic Biology (SB7.0) in Singapore. “In addition to attending the conference, fellows had the opportunity to engage with practicing experts and to discuss—with peers and senior scientists and government officials—biosecurity as it relates to synthetic biology. The fellows represented 19 countries on 6 continents and professions in the public and private sectors, the nonprofit space, and academia. The fellowship program was sponsored by the Open Philanthropy Project, hosted by Endy, and coordinated by the Center, BioBricks Foundation, and SynBioBeta. Center staffers Crystal Watson, DrPH, MPH, senior associate, and Matt Watson, senior analyst, organized the fellowship discussions and events and joined the fellows in Singapore for the 4-day experience. Gigi Kwik Gronvall, PhD, a senior associate at the Center and author of Synthetic Biology: Safety, Security, and Promise, spoke at SB7.0 and helped lead the fellowship’s panel discussions along with Watson and Watson.” Don’t miss out on GMU Biodefense PhD student Yong-Bee Lim’s reflection on page 39. Lim comments on the unique insight that comes from researchers with a non-technical background who still focus on the biosecurity, biosafety, and governance of emerging biotechnologies. “However, the enthusiasm of the technical conference attendees and fellows that I met about the advancements in synthetic biology was infectious. Whether Christina Smolke was talking about leveraging yeast to produce opioids to address medical access inequities, Kate Adamala was discussing synthetic cells as an alternative for research purposes, or Dorothee Krafft explained how her lab was seeking to synthesize a simple cell with alternate building blocks, their passion for their work came through. This allowed me the rare opportunity to enjoy the possibilities of these new avenues of innovation.” Don’t miss out on his tales of confiscated beef jerky and how there’s often a disparage between the science and security communities.

Building Airborne Isolation Units During Emergent Times  & Why the CDC Quarantined Potentially Defective Equipment
GMU biodefense PhD student Saskia Popescu is taking a deep-dive into faulty PPE and hospital preparedness efforts that might just save us during an airborne outbreak. Popescu first looks at the recent CDC actions to pull defective PPE from the SNS. “The special focused on personal protective equipment (PPE) that was being stockpiled by the CDC for use against future outbreaks or public health emergencies, such as treating an influx of Ebola patients during an outbreak. The 60 Minutes investigative team filed a Freedom of Information Act request to obtain documents regarding MicroCool gowns that are part of the US Strategic National Stockpile (SNS). The filing of the Freedom of Information Act request is especially prudent as a group of hospitals were recently awarded $454 million in damages from PPE manufacturers Kimberly-Clark and Halyard Health (formerly a division of Kimberly-Clark) after a jury found they were liable for fraud and defects within the MicroCool gowns.” While these gowns were advertised as meeting standards for the highest level of impermeability, their efficacy is clearly in question. Many are concerned about the existing stockpiles hospitals have been holding onto since the Ebola outbreak in 2014 and if such PPE is still effective. Popescu also takes a look into a recent study that evaluated the potential for hospitals to readily and cheaply convert entire wings into negative-pressure, airborne isolation units. Such a measure would be necessary if there was an influx of infectious patients with SARS, MERS, or another disease that requires airborne isolation, as most hospitals have limited amounts of negative-pressure rooms. “Following their analysis, the team found that they were able to maintain negative pressure that was actually higher than the CDC recommendations for airborne isolation and there was no pressure reversal during the entering and exiting of the ward by medical staff. They did find that ‘pressures within the ward changed, with some rooms becoming neutrally or slightly positively pressured’, which means that healthcare staff would need to wear proper personal protective equipment (PPE) at all times in the unit and not just while in the patient rooms.” While this isn’t a permanent response measure, it does show proof of concept that would allow safer hospitalization for infectious patients during an airborne outbreak.

Stem Cells, Smallpox Vaccines, and FDA Crackdowns 
Earlier this week, the FDA announced it was taking action to shut down clinics that were advertising and performing unproven stem cell therapies. Clinics in California and Florida have received warning letters and the StemImmune Inc, clinic in San Diego, CA, received a visit from U.S. Marshals, who seized five vials of smallpox vaccine. “The FDA says it learned that StemImmune was using the vaccines as well as stem cells from body fat to create an unapproved stem cell therapy. On its website, StemImmune says ‘The patient’s own (autologous, adult) stem cells, armed with potent anti-cancer payloads, function like a ‘Trojan Horse,’ homing to tumors and cancer cells, undetected by the immune system’.” These clinics have been using stem cell treatments for patients suffering from Parkinson’s, ALS, COPD, heart disease, and pulmonary fibrosis. “Action by the FDA on clinics promoting unproven stem cell therapies is ‘a long time coming,’ says Sean Morrison, former president of the International Society for Stem Cell Research (ISSCR) and d irector of the Children’s Research Institute at UT Southwestern.”

Hurricane Harvey – Harbinger of Infectious Disease?
As hospitals are forced to evacuate patients and medical centers become overwhelmed, the George R. Brown Convention Center has become the city’s largest emergency shelter. It’s always challenging though, meeting the medical demands of so many people in an emergent environment. As providers work to meet basic medical needs there is another concern that bubbles up with an influx of people into a small environment…disease. Floodwater injuries are of course a concern, but we also worry about infectious diseases associated with overrun sewage systems, lack of potable water and safe food, and the existence of mega-shelters that are ripe for transmission of respiratory and diarrheal illness. That’s not even considering the potential for nasty resistant infections like MRSA, VRE, etc. Did I mention mosquitoes? “Based on experience following Hurricane Katrina, there will be several competing effects on the population of mosquitoes and the prevalence of arboviruses, such as Zika, dengue and West Nile, that they transmit. Mosquitoes need stagnant water to lay eggs. Winds and floods will wash away containers that would have been breeding pools, said Hayden, who studies weather and vector-borne disease. In the immediate future, both Hayden and Hotez anticipate that local mosquito populations will decline. But once the floodwaters recede, mosquitoes will recover. In 2006, a year after Katrina, Tulane University public-health experts reported that cases of West Nile infection increased more than twofold in communities that had been in that hurricane’s path. The study authors suggested that increased exposure was the culprit. Fleeing partially submerged buildings, people spent days outside waiting for rescue.” Sadly, it will take years to recover and rebuilding Houston after Harvey, and there are lessons we can apply from not only Harvey, but also Hurricane Sandy, towards future preparedness and response efforts. Matt Watson and Eric Toner from the Center for Health Security are drawing attention to the need for Congress to start gearing up for the health impacts following Harvey.  “Stepping back from the operational response, it’s important to recognize that Congress has a vital role to play in both preparing for and enabling recovery following large scale disasters. On the recovery front, it will be important for lawmakers to pass an emergency appropriation that provides emergency funding. It is critical that Congress reverse that trend and continue to support annual appropriations for hospital and public health preparedness so that the nation is able to respond to increasingly frequent natural disasters and other large-scale emergencies.”

Stories You May Have Missed:

  • Distinguishing Virulent from Harmless Bacteria to Improve Biosurveillance- “Researchers at Los Alamos National Laboratory are working to eliminate false positives in detection of Francisella bacteria, a few species of which include highly virulent human and animal pathogens. The effort contributes to more efficient and effective biological surveillance, such as that conducted by the US Department of Homeland Security and the Department of Defense, which provides early warning of infectious disease outbreaks, hazardous environmental exposures, or possible bioterrorist attacks by spotting trends of public health importance.”
  • Deadly Strain of Klebsiella pneumoniae Found In China– Chinese researchers are reporting a highly virulent, resistant, and deadly strain of the bacteria in five patients at a hospital in Hangzhou, China. “All five patients—who were admitted to the ICU between late February and April of 2016—had undergone surgery for multiple trauma followed by ventilation and subsequently developed carbapenem-resistant K pneumoniae infections and severe pneumonia that responded poorly to all available antibiotics. All five patients died of severe lung infection, multi-organ failure, or septic shock.”

 

Pandora Report 8.25.2017

Happy Friday and welcome to your weekly dose of all things biodefense. Have you ever wanted to take a tour of Dugway Proving Ground? Here’s your chance at a virtual tour through some amazing photography.

GMU Biodefense Graduate Programs & Information Sessions
Classes are just starting up and if you’ve ever wanted to take classes on synthetic biology and biosecurity, global health security policy, nonproliferation and arms control, biosurveillance, or emerging infectious diseases, we’ve got just the program for you! GMU offers both Masters and PhD programs in biodefense and has several informational sessions coming soon. Our program provides the perfect intersection of policy and science with courses taught by a range experts. If your time is limited or distance is a problem, we also offer an online MS program, which means you can study biodefense from anywhere!

Revisiting NIH Biosafety Guidelines
It’s been forty years since NIH established the Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules to assess the risks of genome editing. Now more than ever, with the speed of biotech development, it is relevant to take a moment and look back at the significance of such guidelines. “Responsibilities include setting up Institutional Biosafety Committees (IBCs) to assess risks and potential hazards through standards for containment and laboratory practices. Noncompliance on any project, whatever the funding source, can result in loss of all such NIH funding. In his address to the workshop.” Since its inception, there have been several advances in the field, like DIY gene editing and CRISPR, which may require changes to the existing guidelines. “And conventional risk management practices that focus on listed pathogens may underestimate risks of new, unlisted organisms. The informality of voluntary guidelines has enabled prompt responses by funders and researchers to emerging evidence on benefits and risks of technologies. But what has worked with those receiving NIH funding with IBCs may not work with the wider range of actors who now have access to these technologies.” How can the NIH meet these challenges with a forty-year-old set of rules? A few things might help it maintain relevancy- participation in international forums, facilitating researchers/publishers/insurers to set common benchmarks on researcher conduct, engage more with institutional biosafety officials, and working to ensure there are more IBCs. Overall, there is a need to modernize the guidelines to better meet and serve the expanding plain of the life sciences.

Revisiting Compliance in the Biological Weapons Convention                                                                       Have you noticed a trend this week? Revisiting is the name of the game and that’s just what the latest occasional paper from the Middlebury Institute of International Studies at Monterey is doing. The latest RevCon was a dud and the future of the BWC and its relevance is being tested. James Revill is looking at compliance and an incremental approach within the BWC. Revill notes that “compliance with the BWC is more than a simple binary choice to sign a commitment not to develop or produce biological weapons. It requires the adherence to all the obligations, both negative and positive, undertaken by BWC states parties in signing and ratifying the convention. In the BWC context, this is complicated by the ambiguity surrounding certain obligations, changes in science and security, and the limited resource capacity of some states to fulfill their obligations. Under such circumstances, without episodically revisiting compliance, there remains the risk that BWC will become ever more fragmented, outmoded and poorly implemented.” He emphasizes that despite many pushing for multilaterally negotiated, legally binding verification protocols, this is an unlikely outcome. An incremental approach to revisiting compliance, Revill suggests, could incorporate several activities – review relevant science and technology, enhance the collection and analysis of compliance indicators, develop the consultative mechanism, building the provision of assistance in the event of a violation of the BWC, explore voluntary visits, enhance the United Nations Secretary-General’s Mechanism, and remedy the institutional deficient. Overall, he points to the wavering nature of norms against bioweapons and that “without revisiting compliance and tending the convention, there is a risk that the regime will be left to fester and fragment, in time potentially diminishing the norms against biological weapons.”

Meeting on the Attribution of Biological Crime, Terrorism, and Warfare
The Blue Ribbon Study Panel on Biodefense will be hosting this October 3rd meeting in Washington D.C. “Effective prosecution and decisions regarding U.S. response depend on accurate attribution of biological attacks. Despite ongoing biological crimes and suspected development of biological weapons for the purpose of attacking the Nation, the United States has yet to establish this capability fully. The Study Panel will host a special focus meeting entitled Biological Attribution: Challenges and Solutions. This meeting of the Study Panel, chaired by former Homeland Security Advisor Ken Wainstein and former Senate Majority Leader Tom Daschle, will provide federal government, industry, and academic representatives with the opportunity to discuss their perspectives, experiences, challenges, and recommended solutions with regard to biological attribution.” Stay tuned for more details!

SynBio Salmagundi: Proposed Framework for Identifying Potential Biodefense Vulnerabilities Posed by Synthetic Biology – Report, SB7.0 & Options for Synthetic DNA Screening 
It’s a good day to get your synbio nerdom on with this potpourri of news! If you missed the webinar on Tuesday, you can now access the latest NAS interim report regarding the biodefense implications of synthetic biology. “Synthetic biology and related biotechnologies hold great promise for addressing challenges in human health, agriculture, and other realms. At the same time, synthetic biology raises concerns about possible malicious uses that might threaten human health or national security. This interim report is the first phase of a study by the National Academies of Sciences Engineering and Medicine to assess potential vulnerabilities. The report proposes a strategic framework that can be used to identify and prioritize potential areas of concern.” Within the report you can find definitions and study scope regarding synthetic biology in the context of biodefense, factors to assess capability for malicious use, technologies and applications to assess, and framework approach (parameters to consider, use and limitations, etc.). Check out this latest article regarding the screening processes of for synthetic DNA ordering. Sure, there are current screening processes (providers affiliated with the International Gene Synthesis Consortium voluntarily screen double-stranded DNA synthesis orders over 200bp to check for regulated pathogens and additional customer screening), but truly, the processes isn’t that easy…or cheap. Researchers, like Gigi Kwik Gronvall, pointed out actions that could help “preserve the effectiveness of DNA order screening as a security tool and develop additional mechanisms to increase the safety and security of DNA synthesis technologies.” Highlighting the DHHS screening guidance as quickly becoming obsolete, they emphasized options like including direct financial support to companies for screening, especially as we look to the future costs and responsibilities of the U.S. government. “The screening of dsDNA orders is not a panacea for biosecurity concerns: it is possible for nefarious actors to work around the screening. However, we believe that screening dsDNA orders still raises barriers to the development of biological weapons and may offer some protection against biosafety concerns.” The future of synthetic DNA ordering will surely be debated as experiments, like the recent horsepox reconstitution, bring to light new gaps. One such focus onto the realm of biosecurity and synthetic biology comes from Dr. Eric van der Helm, who participated at the latest SB7.0 synthetic biology conference. Van der Helm attended as part of the SB7.0 biosecurity fellowship and has highlighted some of the biorisks we worry about. He also points to the latest horsepox experiment which brought about so much attention to the biosecurity implications of reconstituting an extinct virus. “Synthetic biology has only been recently recognized as a mature subject in the context of biological risk assessment — and the core focus has been infectious diseases. The main idea, to build resilience and a readiness to respond, was reiterated by several speakers at the SB7.0 conference.  In the case of biosecurity, we’re already dependent on biology [with respect to food, health etc.] but we still have an opportunity to develop biosecurity strategies before synthetic biology is ubiquitous.  There is still an opportunity to act now and put norms and practices in place because the community is still relatively small.” Van der Helm emphasizes the need to have these conversations regarding biosecurity measures and synbio, like those at SB7.0, more frequently and openly.

North Korea’s Bioweapon Program: What do we actually know?
If you haven’t gotten enough on discussions regarding North Korea’s bioweapons program, check out GMU biodefense professor Sonia Ben Ouagrham-Gormley‘s latest interview in which she discusses what we know and what we might be missing. What a perfect way to enjoy the morning commute or a lunch break!

Post-Ebola Recovery – An Upside to an Epidemic
A recent mudslide in Sierra Leone is revealing a positive outcome from the 2014/2015 Ebola outbreak – sustained disaster response. Shortly after the mudslide, emergency response crews were already working alongside volunteers to help rescue victims. Sidi Tunis chatted with Buzzfeed, noting that “During Ebola we had a lot of community engagement, so they knew how to be first responders. They knew how to do search and rescues, they knew how to convey corpses safely to the morgue.” Many of the young men digging through rubble were already experienced, having helped with Ebola burial teams and the ambulance system was better equipped and supported as a result of the outbreak. “There was a lesson learnt from Ebola that instead of creating parallel system of NGOs, let’s take leadership from the start,” she said. “So this time it’s been led by the government from the onset, and having them take that ownership is more of a sustainable system.” “Still, NGOs playing a critical role are in a better position than they might typically have been. Three days after the mudslide, unclaimed bodies piling up in Freetown’s main mortuary posed another health risk. There were so many that they began to decompose in the tropical heat, prompting the government to order mass burials over the following two days. Workers from UNICEF were among those who helped scrub out the morgue during a massive clean-up operation that followed. ‘That needed a lot of infection prevention equipment – gloves, boots, aprons,’ James said. ‘UNICEF had emergency stock ready to go from Ebola’.”

Meeting of the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria
Don’t miss out on this September 13th and 14th meeting in which the “Advisory Council will provide advice, information, and recommendations to the Secretary regarding programs and policies intended to preserve the effectiveness of antibiotics by optimizing their use; advance research to develop improved methods for combating antibiotic resistance and conducting antibiotic stewardship; strengthen surveillance of antibiotic-resistant bacterial infections; prevent the transmission of antibiotic-resistant bacterial infections; advance the development of rapid point-of-care and agricultural diagnostics; further research Start Printed Page 38913on new treatments for bacterial infections; develop alternatives to antibiotics for agricultural purposes; maximize the dissemination of up-to-date information on the appropriate and proper use of antibiotics to the general public and human and animal healthcare providers; and improve international coordination of efforts to combat antibiotic resistance.” The meeting will be held at the DHHS Hubert Humphrey Building or you can attend online here.

Pandemic Readiness (Hint: We’re Not There Yet)
Despite funding for the Hospital Preparedness Program (HPP) and an increase in funding to the Public Health Emergency Preparedness Program (PHEP), many are pointing out that these programs are chronically underfunded to begin with. “This House bill also does little to create a realistic public health emergency response fund, a standing pot of money to meet the immediate needs of a public health crisis. We saw how long it took to get emergency funds to respond to Zika, Ebola and Hurricane Sandy, with each event taking longer and longer to help these communities respond to devastating disasters.” You can also check out this latest meeting with Judy Woodruff and Liberian-born Dr. Raj Panjabi at Spotlight Health. Dr. Panjabi discusses the seriousness of infectious disease threats and the challenges of pandemic prevention.

Forecasting Outbreaks One Image at a Time
Tracking infectious diseases is a tough job and requires a lot of boots on the ground (shout out to gumshoe epidemiologists who go door to door doing contact tracing). Researchers at Los Alamos National Laboratory have been using computer modeling for a while to track disease movement, but a new partnership with Descartes Labs, is bringing high-resolution satellite imagery into the arsenal. “By mapping where high-moisture areas intersect with those social media signals and clinical surveillance data, we can help identify areas at risk for disease emergence and subsequently predict its potential path. Descartes Labs collects data daily from public and commercial imagery providers, aggregating the images into a single database. Our team at Los Alamos will use the Descartes Labs Platform to correlate satellite imagery with multiyear clinical surveillance data from approximately 5,500 Brazilian municipalities for mosquito-borne diseases such as dengue, chikungunya, and Zika in order to better understand how they spread.” This new imagery will allow Los Alamos Lab researchers to focus on specific neighborhoods and other small geographical areas. By using retrospective analysis via historical data, they’ll make sure the mathematical models are accurate and ensure that future models are truly capable of prediction.

Stories You May Have Missed:

  • Munich Re Signs Strategic Agreement With Metabiota to Enhance Insurability Against Epidemic Losses – The risk analytics firm Metabiota has announced a strategic agreement with Munich Re, one of the world’s leading reinsurers, to better establish insurability “by protecting companies and local economies from the financial loss related to epidemics. This really is the next frontier for the insurance industry – given the high risk of infectious disease outbreaks, it is imperative that we find new ways to manage and finance these risks for our customers.” Metabiota’s newest platform is a modeling method for estimating epidemic preparedness and risk, as well as the cost and severity of outbreaks by using historical data and disease scenarios and analytics.
  • Ebola Survivors Plagued With Long-term Disabilities – Imagine becoming infected with one of the most deadly viruses on the planet. Now, imagine by some stroke of luck and medical marvel, you’re able to survive. After the long, miserable road that is Ebola infection, survivors have been finding themselves with chronic conditions and high rates of disabilities. A new study found that Ebola survivors have seven times the disability rate compared to their close contacts. “In the first study, researchers followed 27 Ebola survivors in Sierra Leone for 1 year after diagnosis and found they were seven times more likely than their close contacts to report a disability. Almost 80% of the survivors (77.8%) reported a disability 1 year post-infection, compared with 11.1% of their close contacts. Disabilities included major limitations in vision, mobility, and cognition. ‘This study has demonstrated that a year following acute disease, survivors of the recent EVD outbreak have higher odds of persisting disability in mobility, vision, and cognition,’ the authors concluded. ‘Mental health issues such as anxiety and depression persist in EVD survivors and must not be neglected’.”
  • Minnesota Measles Woes & Anti-vaxxers– The benefits of vaccines have been under fire from anti-vaccine activists, despite the overwhelming good they’ve done for the world. While Minnesota continues to battle their worst outbreak of measles in decades, the antivaxxers are becoming energized in their efforts. “In Facebook group discussions, local activists have asked about holding ‘measles parties’ to expose unvaccinated children to others infected with the virus so they can contract the disease and acquire immunity.” The initial cases of this outbreak were in the Somali American community, which are believed to be the result of anti-vaccine activists speaking to community members and instilling fears and concerns. “Despite the anti-vaccine drumbeat, Minnesota’s Somali American community has begun to push back, according to some health-care providers. As part of an unprecedented collaboration clinicians and public health officials launched this summer, ­Somali American imams are urging families to protect their children by getting the measles-mumps-rubella (MMR) vaccine.”

Pandora Report 8.18.2017

ECDC Tool for Prioritizing Biothreats
The European Centre for Disease Prevention and Control has released their tool for the prioritization of infectious disease threats. “This qualitative tool, implemented as an Excel workbook, is based on multi-criteria decision analysis. It ranks infectious disease threats in a transparent, comparable and methodologically reproducible manner. The tool enables the relative ranking of different infectious disease threats. It is intended as a supplement to other methods that also support decision-making in preparedness planning.” Part of the tool involves a scoring of diseases, in which it suggests that a multidisciplinary expert group works to establish reliable information and adequate scoring. The ECDC tool also includes a handbook and manual for users to get the most out of it.

 Long Ignored: The Use of CBW Against Insurgents
GMU Biodefense PhD alum Glenn Cross investigates the use of chemical and biological weapons in counterinsurgency campagins like that of Rhodesia, South Africa, and Syria. Cross notes that history has shown the efficacy of CBW against ill-equipped and often poorly trained insurgents. He points to the debate regarding application of use – some say that these weapons are used when conventional forces are ineffective and often a last resort, while others note that the lack of an international and effective response have given insurgents incentive. “The conclusion from these examples is that regimes in extremis — when the battle is for their very survival — seem to have little compunction about resorting to chemical and biological weapons use. The much-heralded international norms and conventions prohibiting and condemning chemical and biological development and use go out the window when a regime’s survival is at stake. The examples of Rhodesia and Syria show that the international community must be united and demonstrate the requisite political will to enforce norms if the use of chemical and biological weapons is to be prevented.” Cross highlights two case studies, Rhodesia and Syria, pointing to the use of biological weapons by Rhodesian forces as being the only example of a nation using bioweapons since the end of WWII. While the regime was aware of treaty obligations, it had no bearing on their decision to use such weapons. So what are effective constrains on the use of CBW? The case studies reveal that regimes care little about their efficacy, international norms, or international agreements, but it is really deterrence that likely prevents the use of such weapons. The credible threat of military action is the strongest deterrent and realistically, until international norms include uniform enforcement amongst nations, they won’t be as effective. “As we’ve seen in Syria, such consensus is elusive, and the international community has failed to act. As a consequence, the world faces a sad, but inevitable conclusion. The Syrian regime is unlikely to ever face justice for its use of chemical weapons.”

A View from the CT Foxhole: Edward You, FBI Weapons of Mass Destruction Directorate, Biological Countermeasures Unit
As if we need any more reasons to think Edward You is a biosecurity action hero! The Combating Terrorism Center recently sat down with Supervisory Special Agent in the FBI’s WMD Directorate, Biological Countermeasures Unit, and discussed not only his role within the FBI but also their work and coordination with partners. You notes that hisprimary mission is to support outreach and engagement, but probably most importantly it is to backstop the WMD Coordinators who are positioned in the field. They have to cover the whole broad range of modalities—chem, bio, nuke, explosives. They do the initial engagements, the partnerships, the initial response, but they can always call back to headquarters where we leverage all of our expertise as subject matter experts. We can bring in the laboratory division; we can bring in Centers for Disease Control and Prevention (CDC), if necessary, the Department of Homeland Security to support them when they run into an incident out in the field.” He emphasizes the importance of the relationship the FBI has with the private sector, not only in terms of shared interests, but also communicating security problems to help get more buy-in and coordination. When asked about the DIY biohacker, You notes that “We look at these community labs as a big positive force in the economy and engines of innovation. That has helped us overcome the natural tendency for such outfits to be a little bit anti-establishment. By engaging with them, we’re helping them to raise their level of awareness that they could potentially be targeted by malicious actors seeking to subvert their work, steal their technology, or recruit insiders on their staff. By helping them establish a form of ‘neighborhood watch,’ they will be best positioned to identify and report on instances of suspicious activity both internal and external to their community. Who better to identify threats than the community members themselves?” While the partnerships with DIY labs haven’t garnered any leads to potential threats, they help the FBI understand the direction biotech is heading, which allows them to flag areas of concern faster than if they used a top-down approach. You also addresses the 2016 Europol warning of potential ISIS experimentation with bioweapons, commenting that “With ISIS, al-Qa`ida, or any other threat actor for that matter, we are faced with two significant challenges. The first is ideology. What happens if that lone individual that becomes persuaded by their ideology happens to be a microbiologist or a biochemist? The counter WMD mission has always proceeded by identifying the actors expressing the intent to acquire, develop, or use WMDs (e.g., counterproliferation efforts). And historically, significant effort and investments have been made to counter the biological weapon threat ranging from state/non-state actors to individual level biological crimes (e.g., attempted ricin poisonings). But this introduces the second challenge. Unlike the chemical and radiological/nuclear realms where materials of concern are highly regulated and the expertise is almost arcane, biology could be classified as dual use or multi-use. The strength of the field is based on the fact that it is inherently open in nature (e.g., peer-reviewed scientific journals), which has led to significant advances in areas such as healthcare.” Lastly, You points to what he considers the greatest biosecurity threat facing the U.S. – the concerns of non-state actors, but also the role of data in terms of gene editing and other biotech, noting that “we may have have been short-sighted. Most of our legal frameworks have been focused on privacy and not on security.” “Because there’s a lack of understanding about where bio is going, we’re in danger of falling behind, and my biggest concern is that for lack of our foresight and being strategic in this space, I think China is going to become a potential biological superpower.” Did I mention that Edward You is frequently a speaker at our summer workshops?

North Korea’s Chemical Arsenal Complicates U.S. Options 
As concerns over North Korea’s nuclear weapons program grows, the threat of chemical weapons has seemingly been downplayed. Tackling nuclear threats through preemptive strikes could push North Korea to utilize their chemical weapons program and sizable stockpile, which is considered to be one of the largest. “Experts are also disturbed by Kim Jong-un’s brazen public assassination of his half-brother using the nerve agent VX, saying it demonstrates the regime’s willingness to use deadly toxins. ‘I think if people paid more attention to the chemical side, they’d be less inclined to talk about preemption and going first against North Korea,’ said Greg Koblentz, a researcher of weapons of mass destruction at George Mason University.” In the event that chemical weapons are deployed, the South Korean capitol of Seoul would surely take a hit, which is home to 25 million people. While details of North Korea’s biological weapons program have given little insight into what is actually going on, there is considerably more knowledge regarding their chemical weapons initiatives. “The exact composition and size of North Korea’s chemical arsenal is unclear, but it’s believed to include everything from antiquated chlorine gas all the way up to sarin, VX, and other highly lethal nerve agents. These weapons are distributed at facilities across the country, often tucked away in underground bunkers or other sites unknown to U.S. and allied intelligence. The weapons are also deployed along the armistice line, which sits just 35 miles north of Seoul.” While there are limits to their chemical weapons capabilities, they surely provide little comfort to South Korean citizens and those living in Seoul.

 Chatting With the WHO
New WHO Director-General Tedros Adhanom Ghebreyesus spoke with Foreign Affairs’ regarding his plans for the future of the WHO and efforts to combat global disease. Tedros notes that epidemics or pandemics keep him up at night, especially something like the 1918 pandemic and the “serious gaps we have”. He comments that “I think the world should unite and focus on strong health systems to prepare the whole world to prevent epidemics—or if there is an outbreak, to manage it quickly—because viruses don’t respect borders, and they don’t need visas.” In regards to irrational beliefs as a public health threat, Tedros highlights the role of governments (and the WHO in supporting them) to communicate with communities and use media as a tool for teaching. Tedros discussed the WHO’s response to Ebola and when asked about hesitancy governments may experience regarding raising the alarm for an outbreak, he noted that “it’s not an issue between the WHO and the member state in question; it’s about the overall implementation of the International Health Regulations [the rules that govern how states respond to outbreaks]. That involves not only the country in question but other countries, as well. For instance, a country may fear the impact on the economy if it reports a certain disease. And if the other countries, instead of banning travel or other measures, could be supportive and implement the IHR, then the country could be encouraged to report immediately.”

Book Review – Barriers to Bioweapons
As the summer winds down, you may find yourself needing a new book to delve into. GMU biodefense professor Sonia Ben Ougrham-Gormley‘s book, Barriers to Bioweapons, is a great addition to any lover of health security and the realities of biological experiments. This latest book review gives a witty and entertaining overview of her work, noting that “Barriers to Bioweapons argues that actually, we’re not all living on borrowed time – that there are real organizational and expertise challenges to successfully creating bioweapons. She then discusses specific historical programs, and their implications for biosecurity in the future.”

Pandemic Preparedness & A Global Catastrophic Biological Risk By Any Other Name Would Smell As Sweet

GMU biodefense PhD student Saskia Popescu tackles the importance of pandemic preparedness and the latest publication from the Center for Health Security regarding global catastrophic biological risks. “We may think written plans and the occasional table-top exercise are making us more prepared to handle a pandemic, but true preparation goes far beyond that. The ability to prevent, detect, respond, and control outbreaks is a hefty investment that countries are still struggling to make, and as a new report recently revealed, a paltry amount of countries may be ready for a pandemic.” She highlights the latest World Bank report that only six countries have truly taken efforts to evaluate their readiness to handle a pandemic. Like many things, the devil is in the details, and often that is as simple as a real name for a problem. A recent publication from the Johns Hopkins Center for Health Security sought to fix this by establishing a working definition for global catastrophic biological risks (GCBR). “What makes this definition unique, aside from it being the first working definition for GCBRs, is that it highlights several components, such as sustained catastrophic damage, and instead of highlighting a specific number of deaths, it looks to a range of negative outcomes, such as infertility. The challenging task of defining such a globally feared, but poorly understood risk was daunting; however, the Center for Health Security has provided us with a working tool that can now be applied to policy, and future preparedness and response efforts.”

H5 Hits the Philippines and Plague in Arizona
The Philippines is reporting its first highly pathogenic H5 avian influenza outbreak. Hitting a commercial poultry farm in Luzon, the outbreak began in July and killed 36,485 of the 190,000 birds. “A report today in the Manila Times, based on a media briefing with Emmanuel Pinol, the country’s agriculture secretary, said the outbreak was confirmed in the city of San Luis and that six poultry farms were affected. Most of the poultry deaths were in layer chickens. Pinol told reporters that the outbreak may have begun as early as April when deaths were reported in quail housed above ducks. He said ducks are the likely source of the outbreak, since they had contact with migratory birds. The Manila Times report said the outbreak site is 37 miles north of Manila and is close to swamps that are stopovers for migratory birds from the Asian mainland.” Public health officials in Arizona have announced that fleas in two counties have tested positive for plague (Yersinia pestis). While plague is endemic in the southwest, public health officials still work to ensure residents are aware that there is an increased risk. Officials are warning residents to be mindful of the potential for exposure via pets. “Fleas can bite rabbits, prairie dogs and other rodents — and anything that may eat them — and transfer the disease to pets, who in turn can infect humans. Cats who get plague transmit it through their cough. Dogs typically carry the fleas on their fur. Health officials cautioned county residents and visitors to keep their pets leashed and to avoid touching dead animals. Evidence of a large die-off could indicate plague is present, they say.”

Strategies for Identifying and Addressing Biodefense Vulnerabilities Posed by Synthetic Biology
Don’t miss out on these events by the National Academies Committee on Strategies for Identifying and Addressing Biodefense Vulnerabilities Posed by Synthetic Biology:

  • August 21 – the committee’s interim report and proposed framework will be released at 11am EDT here
  • August 22 – a public release webinar and report briefing will be held from 11am-12pm EDT. Committee Chair Michael Imperiale and committee members Patrick Boyle and Andrew Ellington will be reviewing the interim report and the proposed framework. This webinar is free to attend and open to the public, but you must register to attend. You can register at the following link:  https://nasevents.webex.com/nasevents/onstage/g.php?MTID=e39277a767b1f0190db4f7ee491c01271  You will be able to submit questions and comments during this webinar through a text-based feature but will not be able to speak directly with the presenters.
  • August 23-24: The meeting will be held at the National Academies of Sciences, Engineering, and Medicine’s Keck Center at 500 5th Street NW, Washington, DC Room 208. You must register to attend the meeting in person; the Keck Center is a secure building and we will need to have your name on the guard’s list to enter the building. You can register by emailing synbiodefense@nas.edu. If you would like to attend via teleconference, you can access the conference by dialing the following: to listen, please dial 1-(866) 668-0721 and use conference code 380 454 1676.

The committee is also soliciting feedback from the public on the interim report and the associated framework. You can submit questions or comments through September 5, 2017 at the following link:  http://www.surveygizmo.com/s3/3758337/A-Proposed-Framework-For-Identifying-Potential-Biodefense-Vulnerabilities-Posed-By-Synthetic-Biology  Due to the anticipated volume of questions, the committee may not explicitly address every comment received but all comments will be considered and reviewed. PLEASE NOTE: if you submit a question, your question and any associated identifying information you provide will be added to the study’s public access file as per the National Academies’ requirements to comply with FACA.

Stories You May Have Missed:

  • Uganda Ebola-like Illness Demystified- Public health officials in Uganda are sighing with relief as results from the Uganda Virus Research Institute (UVRI) have reported the death of a 20-year-old woman in Luweero was due to carbon monoxide poisoning and not the suspected Ebola virus. “There are currently 3 female cases admitted at Bishop Asili hospital, Luweero. However, results from UVRI indicate that all cases were negative for Ebola, Marburg, Crimean-Congo hemorrhagic fever, Rift Valley fever, and Sosuga viruses. ‘The ministry of health team is working closely with the District Health Team to monitor, review, and manage these cases as well as orienting health workers on management and referral protocols of suspected cases,’ reads the statement.”

Pandora Report 8.11.2017

Norovirus may be plaguing athletes in London for the World Championships, but we’re making sure to deliver the latest biodefense news to you (germ free)! Check out these WHO courses for managing public health emergencies.

CDC Invests $200 Million For Infectious Disease Preparedness
Last week the CDC announced that it awarded more than $200 million to help prevent, detect, respond to, and control biothreats posed by emerging and re-emerging infectious diseases. The funds will go through the Epidemiology and Laboratory Capacity for Infectious Diseases (ELC) cooperative agreement and reach all fifty state health departments and several local health agencies in large metropolitan areas. The CDC announcement noted that the “CDC and states work together to improve local surveillance, laboratory diagnostic capabilities, and outbreak response. The CDC has awarded more than $200 million through the Epidemiology and ELC cooperative agreement to help states, cities, counties, and territories prevent, detect, respond to, and control the growing threats posed by emerging and re-emerging infectious diseases. State programs are the foundation of the U.S. public health system and are integral to the nation’s efforts to combat infectious disease threats. CDC and states work together to improve local surveillance, laboratory diagnostic capabilities, and outbreak response.” This also includes $77 million to help state health departments combat antibiotic resistance in their areas. The 2017 funding enhances current Antibiotic Resistance Laboratory Network (AR Lab Network) activities by increasing testing nationwide for Candida fungal threats, strengthening national TB surveillance and infrastructure, and enhancing detection of drug-resistant gonorrhea. This surge of funds, mixed with a new strategy that combines market entry rewards with population-based payments from insurers, could help bring us ahead in the battle against the resistant bug. “The proposal, dubbed the Priority Antimicrobial Value and Entry (PAVE) award, would use limited public funds to cover the majority of revenue for the first 1 to 2 years a new antibiotic is on the market, but that revenue would be phased out over 5 years and replaced by revenue from population-based contracts with health insurers. The purpose of the PAVE award, the authors said in their recent Journal of the American Medical Association paper, is to guarantee a return-on-investment for antibiotic developers by ‘de-linking’ the revenue of new antibiotics from the volume used and to promote stewardship of those drugs, so that thy remain effective and available.”

A Short History of Biological Warfare: From Pre-History to 21st Century
Don’t miss out on the latest bioweapon gem from W. Seth Carus – a history on biological warfare! “It covers what we know about the practice of BW and briefly describes the programs that developed BW weapons based on the best available research. To the extent possible, it primarily draws on the work of historians who used primary sources, relying where possible on studies specifically focused on BW. By broadening our knowledge of BW, such studies have enabled us to write about the topic with more accuracy and detail than could have been done even a few years ago.” Carus breaks BW history into three sections – prehistory to 1900, 1900-1945, and then 1945-modern day. He focuses on the agents covered by the BWC and looks at the history of state-sponsored programs, the role of scientific advances in understanding microorganisms, use of BW in warfare, and more.

What It Means To Militarize Biotechnology
Biotechnology is a fickle beast and a frequently debated topic. While many focus on the security implications of gene-editing and other biotechnologies in the hands of nefarious actors, there has been an increasing militarization of the field. Military research and investment in biotechnology can be a bag of mixed outcomes and there has been little discussion regarding the growing military interest in it. “One such issue is the risk that military investment in biotechnology will adversely affect research priorities. Another is the possibility that military investment into defensive or public health projects by one state might be misinterpreted by other states as having offensive potential. In the same vein, the scarcity of publicly available information about military research into biotechnology might fuel public distrust of valuable and well-intended work. It is clear, for example, that research into preventing, identifying, and treating infectious diseases by various militaries around the world will continue to provide broader spin-off benefits—but publics in some states might be unsure why military rather than public health institutions lead such work.” Progress in fields like synthetic biology has brought forth almost a renaissance of research and also engagement in security discussions. Brett Edwards highlights the role of the Amerithrax attacks in bringing biology into the forefront of American terrorism worries. He notes that the synbio community has been heavily engaged in the debate of misuse and its implications for innovation and regulation. Working in the synbio field inherently carries with it a forced sensitization to these issues. Edwards emphasizes that the future should include international dialogue with researchers regarding biotechnology militarization. “This sort of dialogue might allow shared principles regarding state investment in biotechnology to be identified and articulated—principles that would both guide research priorities and establish hard limits about what is permissible. Such discussions could draw upon relevant principles in international human rights, humanitarian, and arms control law—including, but not limited to, treaties specifically dealing with biological, chemical, and environmental warfare.”

Air Travel or Bug Travel?
We’ve all been on that flight with one (or more) people who are visibly and audibly ill…and there’s nothing like that ominous feeling of “I’m definitely getting sick after this flight.” A new study investigated disease transmission on airplanes and found that things like plane size and boarding method can have some pretty profound implications for disease transmission. Sure, jamming ourselves into a metal box where it’s cold and we’re in close quarters should already be a redflag for disease transmission, but there are many more variables that impact airborne disease spread. Researchers started first with how Ebola might be transmitted on a plane. “Unfortunately for current fliers, the commonly used three-section boarding technique, where passengers board by first class, middle zone and back section, is actually the worst strategy for reducing the number of infected. The reason this works so poorly is that it forces passengers to stand together in the aisle while they all wait to get to their seats, which means more time for a tightly packed group to be exposed to the contagious passenger”. They found that changing the boarding method to a two-section, random method is much more protective. Also, the speed at which we all race off the airplane once we’re landed appears to have little impact. “For plane size, you might think the bigger the plane, the smaller your odds, right? Not quite. In fact, the study found that planes with less than 150 seats are better at reducing new infections; there are fewer susceptible people present overall, fewer people within a given person’s contact radius and less time spent moving through the plane to reach assigned seats. ‘Using smaller airplanes during an outbreak, instead of completely banning flights to a specific destination, can drastically reduce the probability of introduction of infection,’ Mubayi said.” The investigative team found that if airlines stuck to their existing boarding strategies during an ebola outbreak, there would be a 67% chance of infection rates reaching 20 air-travel-related cases per month. Regardless of plane size, if airlines modified their boarding strategies, the change for infection drops to 40%. Such work gives us great insight into strategies to help slow the rate of transmission during outbreaks through the powerful vector that is international air travel.

Computer Security and DNA Sequencing
A recent article on the implications of DNA sequencing and big data highlights investigations into the “robustness of such tools if (or when) adversarial attacks manifest”. Researchers noted that DNA synthesis can provide attackers with arbitrary remote code execution and highlight the need to look at the feasibility of such attacks. Performing their own attacks on a modified down-stream sequencing utility, they found data leakage and used such lessons to evaluate security hygiene of the more common DNA processing programs. Such work is especially prudent given that biohackers recently encoded malware in a DNA strand. University of Washington researchers revealed at the USENIX Security conference this week that it’s actually possible to encode malware into DNA strands, “so that when a gene sequencer analyzes it the resulting data becomes a program that corrupts gene-sequencing software and takes control of the underlying computer. While that attack is far from practical for any real spy or criminal, it’s one the researchers argue could become more likely over time, as DNA sequencing becomes more commonplace, powerful, and performed by third-party services on sensitive computer systems.” The researchers are calling it the “the first ‘DNA-based exploit of a computer system‘.” This new finding sounds like something out of a science fiction film, but points to the unexpected threats within DNA sequencing and data processing. Thankfully, the process was pretty unreliable and the researchers had to take some significant shortcuts, which means attacks like this may be not be in the immediate future. Nonetheless, it brings forth the need to consider the security implications of information stored within DNA.

Next Generation Global Health Security Network & the Nuclear Threat Initiative Webinar 
Don’t miss out on this webinar today, at 2pm EST regarding the Next Generation for Biosecurity in GHSA Competition! This webinar will provide an overview of eligibility and submission requirements for the NTI-sponsored biosecurity competition to develop regional and global partnerships among next generation professionals. Participants will also have an opportunity ask questions about the competition. Click here to add the event to your calendar.

Bio-Labs of the Future – The Promises & Perils of the Fourth Industrial Revolution
The Wilson Center’s Science and Technology Innovation Program takes a deep-dive into the bio-labs of the future . The rise of the biotech revolution and advances in gene-editing DNA synthesis, AI, etc. are all helping laboratories grow in connectivity and intelligence. “While this may be a boon for the development of novel vaccines and therapeutics by parties that have traditionally not had access to the necessary tools, it also opens the risk of nefarious use to engineer or edit biological agents or toxins. While there have been attempts at governance to limit the avenues by which a bad actor may gain access to the pathogens or tools to create biological weapons, the ever-increasing pace of innovation has left gaps that may be exploited.” Many are calling this time a Fourth Industrial Revolution, and with technologies like portable genomics sequencers, there is a need to examine the vulnerabilities, which includes things like growing accessibility. The Wilson Center paper highlights the need to evaluate threat, potential for exploitation of gaps, and provides policy recommendations.

Combating Biological Terrorism Roundtable Discussion
Don’t miss out on this event put on by the Inter-University Center for Terrorism Studies on Thursday, August 24th, noon-2pm at the Potomac Institute for Policy Studies (901 N Stuart Street, Suit 200, Arlington, VA 22203). Roundtable speakers include Professors Rita Colwell, S. Gerald Sandler, Rashid Chotani, and Normal Kahn. “Biological security concerns are a permanent fixture of history, ranging from Mother Nature’s infectious diseases to man-made threats. Recent epidemics, such as Ebola and Zika, and the potential dangers of biological terrorism urgently need to be addressed through international partnerships to reduce the gravest health risks at home and abroad. Experts with governmental, inter-governmental, and non-governmental experience will provide an assessment of future challenges and offer recommendations for an international comprehensive biosecurity strategies.” RSVP is required (please email icts@potomacinstitute.org).

The Future of the GHSA Matters for US Clinicians
GMU Biodefense PhD student Saskia Popescu discusses the importance of the GHSA and why it should matter to U.S. clinicians. “Fundamentally, the GHSA is a crucial component to ensuring a solid and reliable global foundation exists for responding to, detecting, and preventing public health crises. Whether you are a physician in an urgent care, a nurse in a major hospital, a public health epidemiologist, or working in national policy, the importance of the GHSA and its work is apparent and a future without it will only serve to weaken US and global health security.”

CBRN Insurance Approaches
GMU biodefense MS alum Zamawang F Almemar is looking at a new actuarial approach to a CBRN insurance policy. A WMD attack against a major city would have devastating consequences but countries often struggle with the realities of costly prevention efforts. It’s important to truly analyze the threats of national security and develop countermeasure infrastructure accordingly. Drawing parallels to homeowners insurance, “investing national resources to prevent and recover from the effects of a nuclear attack is an appropriate choice for national policymakers, but what level of protection is warranted to guard against non-state actor developed and employed chemical or biological weapons, or against a radioactive attack.” The authors looked to factors that may help determine how much should be spent on WMD “insurance” and a method for evaluation. While calculating some factors, like societal fears, are challenging, there are things to consider, like economic cost of property cost damage and recovery costs, economic and societal costs of injuries, deaths, disruption, and changes to society, etc. “Factors affecting the cost of implementing a protection action include the difficulty of taking the action, the equipment needed, and the extent of the measure being taken”. Regarding policy recommendations, the authors focus on the imminent threat from terrorist organisations, noting that “it is now of utmost importance for the new administration to prioritize cWMD efforts within the national defense strategy and to ensure there is a balance in appropriations investing in these cWMD efforts.”

A Shadow Network of Science Experts
At first glance, this sounds like an elusive club of James Bond-esque scientists. In reality, the truth gives a startling look into the White House. In effort to combat several science gaps within the new administration, there are reports that an unofficial network of Obama loyalists is working to continue the Obama science agenda. “Participants have provided counsel to Democratic lawmakers and their staffs on Capitol Hill, and they have held group-wide strategy sessions much in the same fashion as they did when they worked out of a fourth-floor wing in the Eisenhower Executive Office Building, adjacent to the White House.” “In interviews, members of the new Obama group — which numbers in the dozens — said they have remained more engaged than they expected to before Trump’s victory in November. Beyond fielding policy questions from congressional offices, they have consulted with scientific societies, and advised organizers of the March for Science, among other activists — a few have even made those organizations their new professional homes. They have also assisted in analyzing the impact of White House budget proposals — which have outlined deep cuts to federal research agencies — and the impact of policies including Trump’s decision to withdraw the United States from the Paris climate accords.”

Using Vaccines to Fight Antimicrobial Resistance
While we’re working to find new antimicrobials, reducing antibiotic use, and stopping the spread of AMR, there may be another strategy – vaccines. Many are pointing to the prevention of disease via vaccines as a means of countering infections in the first place, which are frequently misdiagnosed and treated with unnecessary antibiotics. Consider pneumococcal conjugate or influenza vaccines. “A study published in the Lancet led by Ramanan Laxminarayan of the Center for Disease Dynamics, Economics, and Policy found that if every child under 5 years old in the 75 countries studied received pneumococcal conjugate vaccines, the resulting reduction of pneumonia would avert 11.4 million days of antibiotic use each year.” Vaccines can be an effective tool in reducing illness and these infections often lead to not only the missuse of antibiotics, but also hospitalizations that often result in exposure to resistant organisms. We know the benefits of vaccines against specific viral infections however, perhaps it’s time we start adding them to the arsenal against antibiotic resistance? Overcoming AMR will not be a result of a singular effort, but rather a mosaic of combined practices and changes as diverse as the reasons resistance occurred in the first place.

A Silent Anthrax Outbreak Within The Chimpanzee Population
Researchers in the Tai forest within the Ivory Coast are working to find out why chimpanzees are dying from anthrax. The anthrax strain, a new form of Bacillus cereus, known as Bcbva, has been responsible for 38% of local wildlife deaths in the forest. Anthrax in the rainforest environment is unique and this outbreak is challenging the ways we traditionally think about such infections. “In the savannah, anthrax almost always infects hoofed grazing mammals, which ingest soil laced with bacterial spores. Although it can spill over into humans, until 2001, there was no record of it afflicting wild primates. Now, we know that the Taï strain hits chimpanzees, as well as other unusual hosts like mongooses and porcupines. It even affects monkeys that spend all their time in the treetops, far away from contaminated soil. ‘We don’t know how they get infected,’ says researcher Fabian Leendertz. ‘How do the spores make it up in the trees?’” Fortunately, Bcbva isn’t active in other parts of Africa. Chimpanzees, like many great apes in this region are already fighting off disease like Ebola, so this new surge of an unsual disease is worrying researchers.

Stories You May Have Missed:

  • Hot Topics In Biodefense –  What would you consider the hottest topics? GMU’s Biodefense program has students just as diverse as the topics we face in global health security, which makes the classroom discussions pretty fantastic. One of our PhD students recently sat down and wrote about the biggest issues we face in biodefense and why this field is so crucial – check it out here.
  • Graphic Design – A New Public Health Tool?– A new exhibit at London’s Welcome Collection is drawing attention to the role of graphic design during outbreaks and epidemics. The designs range from ambulances, hospital interiors, posters, cigarette packaging, and street art. “Rebecca Wright, who has co-organised the show with graphic designer Lucienne Roberts, says that exhibits in a section about contagion are especially dramatic. An Italian ‘plague notice’ from 1681 ‘uses bold typography to give authority in time of panic,’ she says, adding that it is a beautiful object. Graphic design responding to the early spread of HIV/Aids is included, such the historic and controversial, ‘Don’t Die of Ignorance’ campaign launched by the British government in 1986. ‘It was the first time every household in the UK received a health leaflet, Wright says.”
  • China & the U.S. Battle for Biotech – Check out this latest article on FBI Supervisory Special Agent, biosecurity guru, and GMU summer workshop instructor, Ed You on the U.S.-China dispute over genetic data and its implications for biotechnology. FYI – You’ll need access to the Financial Times.

Pandora Report 8.4.2017

We all know that kitchen sponges are like little densely populated germ cities, but did you know that cleaning them could make it worse?

Only Six Nations Have Evaluated Pandemic Readiness
A new report from the World Bank is calling out how little work has been done to evaluate and prepare for pandemic readiness. The report notes that only six countries have evaluated their capacity and capabilities for responding to a pandemic. Of these countries, three are wealthy (Finland, Saudi Arabia, and the U.S.) and are were poor (Eritrea, Pakistan, and Tanzania). All six countries had gone under external evaluations and developed funding plans to rectify their inadequacies. “The annual number of disease outbreaks around the globe has more than tripled since 1980, and air travel spreads contagions across oceans far more often. To convince countries that preparedness pays, the report included estimates of the economic damage various epidemics had done. For example, the viral pneumonia SARS — which ultimately killed only 774 people — shrank China’s gross domestic product by 0.5 percent in 2003.” We’re seeing an increasing emphasis on the financial aspect of pandemics and as this report points out, knowledge is power. The report includes an entire section on incentivizing countries to prioritize allocation of funds to preparedness, assessment of economic vulnerability, sovereign credit rating, etc. It was interesting to see that antimicrobial resistance was not considered a pandemic. What would happen if a fully resistant bacteria swept the world?

We Don’t Need Another Biodefense Strategy
Al Mauroni is taking a deep dive into the history of American biodefense strategies and why Thomas Bossert’s recent comments about a new one aren’t exactly promising. White House homeland security advisor Bossert announced this during a security forum in Aspen, noting that until the development of a new plan, the U.S. lacked a comprehensive biodefense strategy. When this was announced there was a collective “um….about that..” from many within the biodefense community. Mauroni points to the three recent biodefense strategies within the last fifteen years, highlighting what we’re all thinking – this won’t be the first comprehensive strategy. First, there was the Homeland Security Presidential Directive 10 in 2005, then the National Strategy for Countering Biological Threats (Presidential Policy Directive 2) in 2009, and most recently, the National Strategy for Biosurveillance in 2012. So, if we’ve had strategies for the better part of two decades, why is there a demand for a new one? Increased outbreaks and concern for biothreats have many calling for further funding of biodefense efforts, like that of the Blue Ribbon Study Panel on Biodefense. Funding is one thing though, but a whole new strategy? “A recent article on the ‘proliferation’ of national strategies suggests that strategic guidance only adds to the confusion, allowing executive agencies to pick and choose what they want to implement.” Mauroni notes that “Going back to Bossert’s statement at the Aspen Security Forum, he referenced the 2001 anthrax-filled letters, pandemic influenza outbreaks, genetic engineering research, and the Global Health Security Agenda. He didn’t reference the protection of US military forces against adversarial use of biological warfare agents. All of these fall under the area of ‘biodefense,’ and there is no one agency that comprehensively addresses all of these threats. Because US government funding, authorities, and capabilities for biodefense reside in different agencies, it is very difficult to articulate objectives and responsibilities in one single strategy. There is no single point of authority to execute the strategy, and very often, no incentive to change given an inability to redirect resources or authorities”. Biodefense is a unique term though as it is often considered in a singular context and while the DoD plays a significant role in countering biological threats, there are other players. Biosafety and biosecurity is a large component, which rests heavily on both the private and public sectors. The DHHS leads in times of public health concerns (even if some of these efforts are duplicated by the DoD) and we can’t forget the role of public health surveillance and health security efforts like that of the GHSA. Mauroni leaves us with several points – “there cannot be one national biodefense strategy because there are at least three distinct policy areas that, while overlapping, are significantly different in execution of their policy objectives.” He notes that “I am not optimistic that the US government will consider a more diverse and complex policy process that articulates these differences. Having one national biodefense strategy offers a façade of simplicity and organization that three separate strategies will not.”

Opening Statements for ASPR Nominee
The nomination hearing for Dr. Robert Kadlec as Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services began on August 1st. You can check out the transcript here, in which Kadlec highlights five priority issues he wishes to pursue if confirmed. His priorities include providing stable leadership and clear policy direction, creating a “national contingency health care” system, supporting the sustainment of robust and reliable public health security capabilities, re-invorgorating and advancing an innovative MCM enterprise, and working to reauthorize the Pandemic and All-Hazards Preparedness Act in 2018. You can watch the nomination hearings here. Reports are pointing to his likely confirmation as his nomination “lacks controversy“.

European Report on Drug Resistance
Is the food we eat helping antimicrobial resistance take over? A new joint report from several European public health agencies notes that “To contain antibiotic resistance we need to fight on three fronts at the same time: human, animal and the environment. This is exactly what we are trying to achieve in the EU and globally with our recently launched EU Action Plan on antimicrobial resistance. This new report confirms the link between antibiotic consumption and antibiotic resistance in both humans and food-producing animals.” The impact of consuming antimicrobial agents is increasingly becoming an area of concern. While there are many factors that contribute to the rise of antimicrobial resistance, it’s not surprising that antibiotic use in food-producing animals would become a topic of interest. “Although consumption is defined differently in humans and animals, to make the comparison as consistent as possible, the report expresses consumption in milligrams of active substance per kilogram of estimated biomass (mg/kg). Human antimicrobial consumption is typically reported as defined daily doses per 1,000 inhabitants. Overall, the report found that average antimicrobial consumption was higher in food-producing animals than in humans, although the difference was largely influenced by a handful of countries with significant animal populations.” Analysis points to a relationship between consumption and antimicrobial resistance (seen in isolates in certain species of bacteria). This latest report underscores the complexity of antimicrobial resistance and the challenges in truly addressing this hydra-like problem. Perhaps we are what we eat?

Australian Raid Finds Chemical Weapon Attempts
The Sydney police raids across four properties, which resulted in four arrests, found components for improvised explosive devices (IEDs) and construction on an “improvised chemical dispersion device”. Two men were ultimately charged with building the military-grade device and were reportedly supported by ISIS operatives but their attack plans were foiled. “Police will allege that components for an improvised explosive device (IED) were sent to Australia in air cargo from Turkey via Isis operatives in Syria. Two men, who remained in custody after facing court on Friday, then allegedly assembled the devices with instruction from ‘a senior Isis operative’, according to the Australian federal police deputy commissioner Mike Phelan.” In response to the attempt, intelligence and law enforcement agencies are working to improve screening. Fortunately, the chemical weapon was in the early stages of development.

Biothreat Worries Over Cancer Research
At last week’s DEF CON hacking conference in Las Vegas, Intel’s chief medical officer John Sotos brought forth a somewhat surprising topic – bioweapons. Building on his discussion of the cancer moonshot, Sotos discussed the same technology (DNA manipulation) having the potential for misuse and development into biological weapons. “’The reason you haven’t heard much about bioweapons is that they’ve been held back by a pretty severe limitation, which is the potential for blowback’,” Sotos said. It is hard for any attacker to use weaponised diseases because they spread beyond their initial distribution range: destroy your neighbouring nation and you destroy your own as well. Sotos noted, ‘the cancer moonshot is going to really drive new technologies to manipulate DNA because cancer is a disease of DNA. [And] the same exquisite targeting that allows it to attack only your cancer cells also overcomes the blowback potential for bioweapons’.” While this level of precision medicine isn’t available yet, it draws parallels to gene-editing tools like CRISPR, in which targeted application is becoming more real. Soto hones in on the fear that such genetic engineering capabilities will not only be possible, but used for nefarious purposes like stealing genetic codes or rewriting DNA to tamper with fertility. Soto’s points are valid and it is important to consider the full spectrum of use for biotech developments in the future however, we must not lose sight of the consistent and growing threat that is natural disease.

Stories You May Have Missed:

  • Saliva Secretions & Zika Transmission – A recent study found that rhesus monkeys, when infected with high levels of the virus, could theoretically transmit via saliva. When compared to rhesus monkeys with more common viral loads, it was possible, although extremely unlikely, that the highly infected monkey could spread via saliva “All three monkeys who were exposed to high doses of Zika virus (20-fold higher than that typically found in saliva) applied directly on their tonsils developed the disease. Another group of 7 monkeys were exposed to the virus via the saliva of monkeys who had received subcutaneous infections, representing a typical virus count. None of the monkeys exposed to doses typically found in saliva contracted the disease when their tonsils (5 animals), conjunctivae (1), or nasal passages (1) were exposed. ‘We tried to simulate sneezing, sharing utensils, and other mucosal exposures,’ said Friedrich. ‘But the amount of virus typically founding saliva was not enough to infect a monkey or suggest any seroconversion [development of detectable antibodies]’.”
  • Biodefense World Summit Coverage – Get the latest overview of the Biodefense World Summit here, with a focus on biosurveillance! Topics range from DHS work to enhancing situational awareness for global disease surveillance.

Pandora Report 7.28.2017

Happy Friday! As we close out the month of July, Texas has reported its first local case of Zika in 2017. If you’re not convinced about the threat of antimicrobial resistance, check out this video on the ability for bacteria to resist even new antibiotics.

The Reality of Trump’s R&D Cuts 
There’s been a steady stream of reports regarding the hits to global health spending that the new administration is making. The proposed 2018 “A New Foundation for American Greatness” budget hits financing of global health security, which is already poorly funded. While Bill Gates met with president Trump several times in efforts to persuade him of the importance of investing in global health and the R&D that goes into it, it seems that the continued assaults to funding aren’t going anywhere. A recent report by the Global Health Technologies Coalition and the Policy Cures Research of Australia took a different approach to swaying the president – money and fear. “The report explains that between 2007 and 2015 an investment of $14 billion (£10.7bn) in global health R&D resulted in a $33 billion injection back into the economy and the creation of 200,000 jobs. Spending since 2000 resulted in 42 successful products, including 11 for malaria and ten for TB. Want to ‘Make America Safe Again?’ Start by investing in R&D.” Just like the Nuclear Threat Initiative highlighted last week in their focus on the GHSA and importance of investment in global health, this report drives home the economics of global health security. We know that an outbreak anywhere is an outbreak everywhere, but for many, it can be difficult to see that when we’re not experiencing a major outbreak on American soil. Despite the impact of Ebola cases in the U.S. in 2014, the rise of antimicrobial resistance, and growing concerns regarding dual-use research and biosafety, there is a consistent struggle to truly get support for not only global public health, but also the R&D that supports biodefense efforts. The report notes that “Between 2007 and 2015, the US government invested nearly US$14 billion dollars in R&D for global health. In comparison, in 2015 alone, the US government spent $1.05 trillion on Medicare and health, $609 billion on the military, and $102 billion on education. Despite relatively limited investment, US government support was essential in helping advance 42 new technologies approved since 2000 – including 11 new products for malaria, 10 for tuberculosis (TB), and 1 for HIV/AIDS.” The U.S. is not an island – we rely on global cooperation and R&D alliances to help fight off current and future microbial threats. Global health security means that we must invest in efforts at home and abroad and to decimate an already limited budget for such efforts would have worldwide ramifications. FYI – the DoD released their guidance on global health engagement  (hint: global health cooperation and engagement is important).

Worry About Water Bugs, Not Sharks
While everyone is up in arms about Michael Phelps not really racing a great white shark, some are saying, “hey…there’s actually a lot of microscopic water germs that are way scarier!” “You’re 75 times more likely to be killed by lightning than by a shark. On average, one person dies of a shark attack every other year in the United States.” The real danger rests in our love of water activities during the summer, whether it be a public pool, water park, private pool, or lake. FYI, I’ve seen one too many presentations on outbreaks associated with splash pads…they are diarrheal disease hotspots.  Here are some of the bugs you should actually be worried about in water – crypto, pseudomonas, shigella, legionella, norovirus, cyanobacteria, and the brain-eating amoeba Naegleria fowleri. How can we dodge these party-crashers? Avoid swallowing the water…don’t go swimming if you’ve had diarrhea recently, check those chlorine and pH levels, and make sure to rinse off from time to time.

Emergent Biosolutions Goes On A Spending Spree
While the future of global health R&D is a little bleak, Emergent Biosolutions is sprinkling some funding around to expand its drug portfolio. “Five days after the company agreed to pay $97.5 million to acquire the smallpox vaccine assets of pharmaceutical giant Sanofi it handed another $96 million to GlaxoSmithKline, one of biggest healthcare providers in the world, to acquire raxibacumab, an antibody that treats a form of anthrax that can be inhaled. Both deals are part of a broader expansion plan that Emergent’s executives hope will turn it into a $1 billion-a-year company by 2020.” These investments are more in the direction of defense against high-consequence biothreats, and their Chief Executive, Daniel Abdun-Nabi, is pointing to not just nefarious biological events, but also those related to climate change. Abdun-Nabi notes that “There’s a real worry starting to grow across the globe about the re-emergence of pathogens that we might not have seen for a number of years,”.

Infection Control vs. MERS
Not surprisingly, infection control failures are a big source for MERS-CoV transmission. Despite ongoing outbreaks and training on PPE and isolation precautions, there’s a pretty significant trend in healthcare – poor infection control practices. A recent WHO report revealed the findings of a risk assessment regarding 199 MERS cases in four countries. Since December, 1/3 of MERS cases have been linked to healthcare facilities and while initial signs and symptoms are non-specific, they found that simply improving standard precautions (also known as universal precautions) could make a difference. Using basic infection control practices, like putting a mask on a patient with a cough, or utilizing isolation precautions when caring for a febrile patient, are all easy and critical components to preventing the spread of disease. “How MERS-CoV spreads in hospitals still isn’t clear and is the topic of scientific studies. The WHO, however, said observations suggests transmission occurs before infection prevention and control steps are applied and patients are isolated. The agency added that hospital outbreak investigations suggest that aerosolizing procedures done in crowded emergency department or medical wards without adequate control measures may have led to human-to-human spread and environmental contamination.” This is an interesting finding for several reasons. Firstly, infection control steps should be applied the second a patient walks into a healthcare facility. During measles outbreaks (and influenza season), many hospitals put kiosks in the hospital entrance that contain alcohol-based hand sanitizer and masks, with signs highlighting the importance of such practices and to wear one if you have a cough. Secondly, utilize your triage staff. Either isolate or ask patients to wear masks during their triage process to prevent the spread of infection. We often wait until patients are in rooms to use PPE but the truth is that it can start a lot earlier. Also, emphasizing hand hygiene from the beginning can be monumentally helpful for everyone involved in patient care. Yes, healthcare workers are a significant part of the transmission chain, but visitors and the patients themselves play a big role. Overall, this study draws attention to infection control failures however, these aren’t new for those of us working in healthcare, and MERS is just a good example of how we can improve them. Preemptively isolating a patient won’t hurt, but delayed isolation can kill.

First Human Embryos Edited in U.S. 
Researchers in Oregon are now the first team to attempt creating a genetically modified human embryo in the U.S. “The effort, led by Shoukhrat Mitalipov of Oregon Health and Science University, involved changing the DNA of a large number of one-cell embryos with the gene-editing technique CRISPR, according to people familiar with the scientific results.” Such work has not been previously done in the U.S. and Mitalipov’s team has shown it can be successful. While the embryos weren’t allowed to develop past a few days and there were never intentions of implantation, the altering of DNA codes within human embryos is a significant leap for biotechnologies like CRISPR. While many highlight concerns with the future of such work and the risk of “designer babies”, the NAS report in February has been seen as a green light to test germline modification. “The advisory committee drew a red line at genetic enhancements—like higher intelligence. ‘Genome editing to enhance traits or abilities beyond ordinary health raises concerns about whether the benefits can outweigh the risks, and about fairness if available only to some people,’ said Alta Charo, co-chair of the NAS’s study committee and professor of law and bioethics at the University of Wisconsin–Madison. In the U.S., any effort to turn an edited IVF embryo into a baby has been blocked by Congress, which added language to the Department of Health and Human Services funding bill forbidding it from approving clinical trials of the concept.”

MSF Lessons Learned During the DRC’s Recent Ebola Outbreak
There have been dozens of analyses since Ebola burned through West Africa in 2014/2015 however, a latest report from Médecins Sans Frontières/Doctors Without Borders (MSF) is providing insight regarding the 2017 outbreak in the Democratic Republic of Congo. The small outbreak (which seems odd to say about a disease like Ebola, but that was until 2014) resulted in the deaths of four people in a remote part of the DRC. When news first sprung up that cases were identified, the world waited with bated breath as the memories of the the last horrible outbreak were all too fresh. Fortunately, rapid field team and resource deployments aided in the quick response that halted the disease in its tracks. MSF was a part of such efforts and since the outbreak was declared over, they have identified five major lessons. Firstly, train frontline health workers. This one is music to my ears, especially in terms of the poor infection control practices among healthcare workers that made them 21-32 times more likely to acquire the diseases. “Healthcare workers play a crucial role not only for the health of the people they serve directly, but also for general epidemiological surveillance for outbreaks like Ebola, but also for more common deadly infectious diseases such as measles and cholera. A health system cannot rely on just one person to play the crucial role of on-the-ground surveillance. What is needed are proper surveillance systems in resource-poor countries, which were clearly lacking in West Africa at the beginning of the epidemic.” Secondly, a forgotten disease finally taken seriously – this is all too true in that many did not know of Ebola until it sent shockwaves through West Africa. Now, the disease is top of the agenda and rapid mobilization is triggered. Third, back to basics, which means that while we can focus on vaccines and new drugs, we can’t forget the basic pillars of outbreak control, like surveillance, isolating and treating the sick, looking for new cases, contact tracing, burying the dead safely, and engaging and mobilizing the local community. Fourth, location matters. The recent outbreak occurred in a very remote and forested area, which impacts movement of contacts, as well as acquisition of supplies. “As in all previous outbreaks before West Africa isolation played a key factor for the containment of the virus.” Lastly, medical interventions are not the magic bullet. “MSF was willing and actively preparing to use the Ebola treatments that are still in development. However the outbreak was over before the process to allow the use of experimental products was complete, so none could be used this time. This outbreak however acted as a booster to speed up the process of preparing medical protocols so that new drugs, still in the experimental phase, can be used in a way that is as safe and ethical as possible.” In the end, the rapid control and early response measures, coupled with the limited size of the outbreak, helped prevent its spread before the vaccine could even really make a difference.

Global Catastrophic Biological Risks Definition – Center for Health Security
The Johns Hopkins Center for Health Security released their working definition for global catastrophic biological risks (GCBR) in efforts to draw attention to this special category of global threats and focus future efforts to combat them. The definition is: “Those events in which biological agents—whether naturally emerging or reemerging, deliberately created and released, or laboratory engineered and escaped—could lead to sudden, extraordinary, widespread disaster beyond the collective capability of national and international governments and the private sector to control. If unchecked, GCBRs would lead to great suffering, loss of life, and sustained damage to national governments, international relationships, economies, societal stability, or global security.” You can read the article and ten commentary pieces written by a variety of leading scientists and public health experts here.

How Infectious Diseases Shape Culture
When we think of infectious diseases, we tend to imagine morbidity and mortality. While this is accurate, there’s a lot more that these microbes impact, like language, culture, etc. We know that during the European bubonic plague in the 14th century, urbanization and economic development were slowed, but those skilled laborers who survived were highly valued. Consider even the food we eat, which has several cultural dynamics within it. We avoid raw meat, raw milk, and even stopped eating raw cookie dough or cake batter (ok, let’s be honest, we still lick the bowl, right?). “Many words and expressions commonly used in English have origins linked to an infectious disease. One such common phrase, used for a person who may not have symptoms of an infectious disease but can transmit it, is to call them a Typhoid Mary. In 1906 Mary Mallon, a cook, was the first healthy person identified in the USA as a carrier of the typhoid bacilli that causes typhoid fever, a serious disease for the Western world in the 19th century (but which globally exists and has often existed in poor communities).” Consider even the term, “feeling lousy”, which originated in conjunction to those with lice who became anemic and experienced general malaise. “In the late 1880s Tunisia experienced severe infectious disease epidemics of cholera and typhoid, and famines, which so badly depleted its economy that it was unable to pay off its debts. This made it vulnerable to French occupation and then colonisation.” There’s been a substantial body of literature that looks to the security implications of disease and how it may leave countries open to political and military disputes (check out Andrew Price-Smith’s Contagions and Chaos). The recent outbreak of Ebola has even changed the way American healthcare handles preparedness. Long thought a rare disease that we would never see, hospitals around the country now have Ebola Response plans and work to train front-line staff in case an outbreak occurs again.

Reports of Pediatric Deaths Following UN Sanctions Is Untrue 
A recently article in BMJ Global Health is highlighting the fictitious statements made by Saddam Hussein’s government during the UN sanctions in 1990. “The United Nations Security Council imposed the sanctions in 1990 following Iraq’s invasion of Kuwait. The sanctions remained in place after the Iraqi army was expelled, on the grounds that Iraq’s weapons of mass destruction would need to be destroyed before they could be lifted. The sanctions greatly restricted Iraq’s ability to export oil and therefore to import supplies of food and medicines, prompting international concerns that the country’s children were being particularly hard hit.” Following these sanctions, a 1999 national survey was conducted by UNICEF and the Iraqi government, which reportedly found that “children in the centre and south of the country were dying at over twice the rate of 10 years earlier”. These results were used by several outlets for either support or refusal to invade Iraq. The researchers in BMJ Global Health have found that the results were “a deception” and studies done since 2003 have found no evidence of such high rates. The researchers concluded that “The rigging of the 1999 Unicef survey was an especially masterful fraud. That it was a deception is beyond doubt, although it is still not generally known.”

Stories You May Gave Missed:

  • CARB-X Awards $17.6M To Fight Global Antimicrobial Resistance – the private initiative, CARB-X, was established with the purpose of facilitating global efforts to combat antimicrobial resistance. This week they announced $17.6 million will fund research efforts by scientists in India, Ireland, France, Switzerland, the U.S., and the U.K. “The seven supported projects include five potential antibiotics targeting Gram-negative bacteria, a new treatment for drug-resistant gonorrhea, a new drug molecule that targets resistance in cystic fibrosis infections, and Phase I development of an oral, broad-spectrum antibiotic. The latest round of awards is part of a $455 million commitment by the U.S. Government and the Wellcome Trust over five years. The first 11 projects to receive funding were confirmed in March, and additional funding announcements are expected later this year.”
  • Biodefense World Summit – If you missed this event in June, check out some of these highlights that include talks on pathogen detection, food safety, and the importance of biodefense in the U.S.!
  • Papaya-linked Salmonella Outbreak – Just went you thought it was safe to go back to the summer fruit salad…. Sadly, salmonella is a current risk for papaya-lovers across the U.S. as an outbreak of Salmonella Kiambu has sickened 47 people across 12 states. “Most of the cases were reported in five eastern states: New York (13), New Jersey (12), Virginia (6), Maryland (5), and Pennsylvania (4).  Seven states across a wide swath of the country, however, have each reported 1 case: Iowa, Kentucky, Louisiana, Massachusetts, Minnesota, Texas, and Utah. So far, 12 people have been hospitalized. The death involved a person from New York City. Illness onsets began May 17, with the most recent on Jun 28.Patient ages range from less than 1 year to 95 years, with a median age of 27. About two-thirds are female, and, of 31 patients with available information, 18 (58%) are Hispanic. The epidemiologic and lab investigations both point to tainted papayas as the source of the outbreak. Interviews with 25 sick patients found that 11 (44%) had eaten papayas, a significantly higher proportion of papaya consumption than in healthy Hispanic people (16%) interviewed around the same time.”