The Synthesis of Horsepox Virus and the Failure of Dual-Use Research Oversight

On January 19, 2018, the open access scientific journal PLOS One published an article that describes the de novo synthesis of horsepox virus, the first ever synthesis of a member of the orthopoxvirus family of viruses that includes the variola virus that causes smallpox. As I have written about before, this research crosses a red line in the field of biosecurity. Given the high degree of homology between orthopoxviruses, the techniques described in this article are directly applicable to the recreation of variola virus. The synthesis of horsepox virus takes the world one step closer to the reemergence of smallpox as a threat to global health security. That threat has been held at bay for the past 40 years by the extreme difficulty of obtaining variola virus which has been eradicated from nature and is only known to exist in two WHO-designated repositories.

The reemergence of smallpox would be a global health disaster.  Prior to its eradication, smallpox killed an estimated 300 million people, more people than all the wars of the 20th century combined. Most of the world’s population is susceptible to this lethal and contagious disease since routine immunization against smallpox was discontinued after the success of the WHO’s global eradication campaign.

Per its policy on dual-use research, PLOS convened its Dual-Use Research Committee, composed of PLOS editors and outside experts, to review the manuscript. According to a statement from PLOS,

“The Committee was asked to consider the potential risks of this research, notably the risk that the study might provide new information which could be misused to construct a smallpox virus. They concluded that the study did not provide new information specifically enabling the creation of a smallpox virus, but uses known methods, reagents and knowledge that have previously been used in the synthesis of other viruses (such as influenza and polio viruses). In consideration of the benefits of publication of the research, especially the potential for improvements in vaccine development, the Committee unanimously agreed that in this instance, the benefits of publication outweigh the risks. The Committee therefore supported publication of this manuscript.”

Given the serious potential risks that this research could be used to recreate variola virus, the blanket assertion by the PLOS Dual-Use Research Committee that the benefits of this research outweighs the risks is woefully insufficient. The committee dramatically understates the risks and overestimates the benefits this research presents. The U.S. government has outlined a number of factors to consider and questions to ask about dual-use research when weighing the risks and benefits of conducting and publishing such research. Although this research did not fall under current U.S. regulations on dual-use research of concern, the authors and publisher were well aware of the risks that I and others had raised and they had an ethical responsibility to carefully consider those risks before publishing the article. Based on the statement issued by PLOS One, it does not appear that this committee tried to answer these questions in a rigorous way. If the committee has more evidence to support their risk-benefit assessment, then they should present it for public scrutiny.

The committee’s central claim, “that the study did not provide new information specifically enabling the creation of a smallpox virus, but uses known methods, reagents and knowledge that have previously been used in the synthesis of other viruses (such as influenza and polio viruses),” is misleading. In fact, the article describes how the authors overcame several obstacles and challenges to synthesizing the horsepox virus, including design of the cloned synthetic DNA fragments, modification of the DNA fragments to aid genome assembly, design of synthetic hairpin telomeres based on vaccinia DNA, and the use of a “helper virus” to reactive infectious horsepox virus. Based on these original contributions to the science of orthopoxvirus synthesis, it is difficult to understand how the committee could claim that this article does not provide new knowledge about how to successfully synthesize other orthopoxviruses such as variola.

Furthermore, it is misleading for the committee to claim that this study uses only “methods, reagents and knowledge that have previously been used in the synthesis of other viruses (such as influenza and polio viruses).” This claim is an attempt to downplay the technical feat accomplished by this paper: the largest ever viral genome to be synthesized chemically. The horsepox virus genome (212,000 base pairs) is much larger than that of either polio virus (7,500 base pairs) or influenza (13,500 base pairs) which necessitated special steps to obtain and assemble the large DNA fragments required to create the complete genome of horsepox virus. In addition, unlike polio virus, the naked DNA of horsepox virus is not infectious and requires the assistance of a “helper virus” to recover infectious virus. While this reactivation technique has been used previously with vaccinia, it has never before been used to reactivate horsepox virus or a synthetic orthopoxvirus.

Given the high degree of homology between orthopoxviruses, it is also not accurate for the committee to claim this study does not pose any risk because it “did not provide new information specifically (emphasis added) enabling the creation of a smallpox virus.” Even the authors of the paper have publicly acknowledged that these methods are directly applicable to the synthesis of variola. Professor David Evans ,who led this research at the University of Alberta, told the World Health Organization that his synthesis of horsepox virus “was a stark demonstration that that this could also be done with variola virus.” We should not be comforted by the fact that the authors didn’t actually synthesize variola–the techniques described in this article are a blueprint for doing exactly that. Given the weak and patchy safeguards on ordering synthetic DNA, this research creates a new pathway for the acquisition of variola virus and a new vulnerability for global health.

Finally, the committee does not provide any evidence supporting its claim that the study’s “potential for improvements in vaccine development” provide tangible benefits sufficient to outweigh the very real risks that this research represents. The authors of this article justify their research based on the need for a safer smallpox vaccine. This justification is disingenuous. The safety issues that the authors refer to emerged during the 2002-2003 smallpox immunization campaign in the United States when the first-generation Dryvax smallpox vaccine caused an unexpected number of myopericarditis events. The United States now stockpiles a third-generation smallpox vaccine called IMVAMUNE that does not have the cardiotoxicity side effects of earlier smallpox vaccines. IMVAMUNE is even safe enough to give to people with compromised immune systems. Furthermore, the United States is prioritizing its limited biodefense dollars on improving the existing smallpox vaccines and has no interest in developing a brand new smallpox vaccine. Indeed, last year the Department of Health and Human Services signed a contract worth up to $532 million to procure up to 132 million more doses of a freeze-dried version of IMVAMUNE. Without U.S. government funding for research and development, there is no viable business model for getting a horsepox-based smallpox vaccine through the “valley of death” in the drug development process and turning this research project into a licensed medical countermeasure.

Based on these considerations, the horsepox synthesis research is all risk and no reward. Given the known risks of this research for pioneering a technique that can be used to recreate variola virus and its questionable benefits, the publication of this article represents a failure of PLOS One to exercise its responsibility to carefully consider the biosecurity implications of the research it publishes. Other journals had rejected this article, at least in part due to concerns about the biosecurity risks it posed. At the same time, as Tom Inglesby at the Center for Health Security has pointed out, this article was also made possible by fundamental flaws in the dual-use research oversight system in the United States. Unless those flaws are fixed, the dual-use oversight system will be relegated to monitoring a shrinking slice of the life sciences research enterprise which will decrease our ability to govern emerging technologies and increase our vulnerability to the misuse of biotechnology.

Pandora Report 1.19.2018

Happy Friday and welcome to your favorite source for all things biodefense! We hope you’re able to avoid the onslaught of respiratory viruses that are circulating right now, but on the off chance that you’re battling a bug, here’s some infectious disease new that won’t get you sick.

Fighting Influenza
Whether you’re fighting the flu or watching the mayhem unfold in the news, you can’t escape influenza right now. We’re getting hit hard with flu season in the United States and the CDC has reported that activity is still rising and we’re not out of the woods yet. You can find the latest flu data here, but what is worrying so many is the hit that hospitals are taking across the country. It’s not just that we’re facing an IV bag shortage due to the devastation Hurricane Maria wreaked upon Puerto Rico, but that hospitals are being overrun with an onslaught of ILI (influenza like illness) patients. Wait times are through the roof, staff are stretched thin, patients are being admitted into overflow areas, hospitals are having to divert patients because they’re so full, triage areas have been set up in parking lots and emergency areas, and hospitals are even struggling to ensure they have enough PPE and influenza tests. This year marks the centennial of the 1918/1919 influenza pandemic, and it seems like what’s going on is out of a history book instead of down the street. As an infection preventionist and infectious disease epidemiologist, it is not surprising or unexpected that we’re running into these issues. It’s easy for people to point to the current situation and use it as an example of why we’re not ready for a flu pandemic – and they’re right, but it shouldn’t take what’s going on to see that. These are not new issues. Infection control and hospital preparedness has been struggling for a long time and it doesn’t take a pandemic to prove it. Even after the surge of funding and focus on hospital preparedness post-Ebola, we still struggle with these issues, but throw in budget cuts and an administration that is set to pull funding away from public health…well, the outlook is dismal.

With so much attention on influenza, pandemic preparedness, and how we’re just not ready for the next great flu pandemic, what kind of household interventions can we apply in our own little ecosystems? Researchers looked at a HPAI H5N1 outbreak and estimated the reduction in primary attack rates for household-based interventions. “We show that, for lower transmissibility strains, the combination of household-based quarantine, isolation of cases outside the household, and targeted prophylactic use of anti-virals will be highly effective and likely feasible across a range of plausible transmission scenarios. For example, for a basic reproductive number (the average number of people infected by a typically infectious individual in an otherwise susceptible population) of 1.8, assuming only 50% compliance, this combination could reduce the infection (symptomatic) attack rate from 74% (49%) to 40% (27%), requiring peak quarantine and isolation levels of 6.2% and 0.8% of the population, respectively, and an overall anti-viral stockpile of 3.9 doses per member of the population.” While we all may not access to anti-virals, the use of quarantine and isolation are all effective strategies. From an infection control standpoint, it can be tough to maintain such efforts in a household where one or two people are sick. When in doubt, wash your hands, cover your cough, and clean those high-touch surfaces/objects!

GMU Biodefense MS Open House
Mark your calendars for the February 21st Master’s Open House at GMU’s Arlington campus! If you’ve been thinking about getting a MS in biodefense (who wouldn’t want to take classes on biosurveillance, historical bioweapons programs, and more?!), this is a great chance to talk to faculty and learn about the admissions process. GMU has biodefense MS programs in person and online, so even if you’re not in the DC-area, you can get your biodefense on.

Smallpox, Horsepox, And The Trouble With Poxviruses
It seems only a few months ago that news broke of a Canadian research team’s de novo synthesis of horsepox. Since then, there has been considerable discussion surrounding not only the biosafety and biosecurity behind research involving an orthopoxvirus, but also the implications of normalizing orthopoxvirus synthesis, and again, if the remaining smallpox stockpiles should be destroyed. The latest report from researchers at the University of Alberta points to the potential smallpox vaccine developments that synthetic viruses could bring. “Virologist David Evans and his research associate Ryan Noyce produced an infectious horsepox virus, which they synthetically reconstructed using a published genome sequence and DNA fragments manufactured entirely by chemical methods. The team went on to show that the synthetic horsepox virus could provide vaccine protection in a mouse model of poxvirus infection.” Unfortunately, the implications of synthesizing an orthopoxvirus aren’t so simple. GMU biodefense professor and program director Dr. Gregory Koblentz evaluated the implications of such synthesis for biosecurity and what would be needed to prevent a reemergence of smallpox. “The synthesis of horsepox virus takes the world one step closer to the reemergence of smallpox as a threat to global health security. That threat has been held at bay for the past 40 years by the extreme difficulty of obtaining variola virus and the availability of effective medical countermeasures. The techniques demonstrated by the synthesis of horsepox have the potential to erase both of these barriers. The primary risk posed by this research is that it will open the door to the routine and widespread synthesis of other orthopoxviruses, such as vaccinia, for use in research, public health, and medicine.” Koblentz notes that while there are potentially legitimate uses for synthesizing orthopoxviruses (safer smallpox vaccine development), it also means that such labs have the potential to produce smallpox from synthetic DNA and emphasized that action is needed now to avoid the misuse of synthetic biology by nefarious actors. “Unfortunately, the current legal and technical safeguards against the synthesis of smallpox virus are weak and fragmented. There is no clear international legal or regulatory framework to prevent the synthesis of smallpox virus. The WHO has a policy banning the synthesis of the smallpox and regulating who can produce and possess large fragments of smallpox DNA, but it hasn’t been widely adopted by states. Furthermore, there is no mechanism—at either the national or international level—for detecting or punishing violations of this policy.” GMU biodefense PhD student Saskia Popescu cited the importance of medical providers understanding the dual-use research of concern debate and that ultimately, biosecurity impacts us all. “From the healthcare perspective, it may not seem like something we should worry about, but the direction of gene editing and dual-use research of concern is something that is intrinsically linked to public health. Nefarious outcomes of such experiments, regardless of the origin or intent, will inevitably make their way into an emergency department, urgent care, or worse, the community. Although we may not be seeing the implications today, as medical providers and healthcare workers, we must keep our ears to the ground, listening for these biotech advancements, and then thinking through what they mean for us tomorrow.”

Blue Ribbon SLTT Ability to Respond to Large Scale Biological Events: Challenges and Solutions
If you missed the Wednesday meeting, here’s a recording to catch up on all things biodefense. “State, Local, Tribal, and Territorial Ability to Respond to Large-Scale Biological Events: Challenges and Solutions government officials, federal and academic representatives, and subject matter experts will discuss their perspectives, experiences, challenges, and recommended solutions with regard to SLTT response to large-scale biological events.”

Gene Therapy Hits a Wall With Microbial Resistance
Can gene editing trigger an immune reaction in humans? A new study is suggesting that it may be a risk. “The CRISPR-Cas9 system, which functions as a genetic scissors and tape for editing DNA, is generally derived from either Staphyloccoccus aureus or Streptococcus pyogenes bacteria.” Most of us though, have been exposed to these organisms throughout our lives. “This prior exposure could potentially render the gene editing ineffective, with the body quickly eliminating all the CRISPR–Cas9 proteins. Or worse, it could trigger the kind of immune storm that killed a young gene therapy patient named Jesse Gelsinger in 1999, derailing the field for more than a decade. ‘We share everyone’s excitement about doing Cas9 genome editing, but we want to make sure we have learned from what happened in the gene therapy world and not ignore the possibility that this could become a problem,’ Porteus says. ‘As we’re all thinking about developing Cas9-based therapeutics, we should think carefully about this potential problem’.”

Pediatric Rabies Death
A 6-year-old boy in Florida has died from rabies he contracted after being scratched by an infected bat. The boy’s father reports that he found the sick bat, put it in a bucket, and told him not to touch it however, he did and was scratched. In response, the father had the boy wash his hands thoroughly based off what he read online and opted not to take him to the hospital because the boy didn’t want to get shots. Unfortunately, within a week, the boy became ill and even after attempts at treatment, passed away. Rabies is almost always fatal once symptoms appear, which highlights the importance of seeking care immediately after exposure.

Stories You May Have Missed:

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

Pandora Report 1.12.2018

 The Bright Side of Synthetic Biology and Crispr
GMU biodefense professor Sonia Ben Ouagrham-Gormley and Phd alum Shannon Fye-Marnien are looking at the realities of synthetic biology and fears of bioterrorism. Biological advances have inspired questions regarding the safety and potential for nefarious use, but are such technologies guilty until proven innocent or innocent until proven guilty? “As with previous advances in biology, Crispr is sometimes characterized as a blueprint for bioweapons development or bioterrorism, and it has elicited calls for increased control and regulation of science. But while it is important to examine the potential dangers of emerging technologies, reaching a balanced assessment of risks and benefits requires that technologies’ potential to improve human life be appreciated as well. Synthetic biology and Crispr offer a potentially enormous package of benefits, spanning from medicine to energy to agriculture and beyond. Discussions about the security and safety of synthetic biology and Crispr should not obscure these technologies’ potential to address a wide variety of complex and pressing problems.”

The United States Battles Influenza
Flu season is hitting hard in the United States as 46 states report widespread activity. 80% of cases are of the H3N2 strain, which is associated with severe symptoms and hospitalizations. “The flu is now widespread across the country and the peak of transmission probably occurred during the Christmas-New Year’s holiday week, just as many people were crowded into planes, buses and cars or in large family gatherings, said Dr. Daniel B. Jernigan, director of the influenza division of the Centers for Disease Control and Prevention. ‘H3N2 is a bad virus,’ Dr. Jernigan said. ‘We hate H3N2’.” 26 states (and New York City) are reporting high influenza-like illness (ILI) activity. The CDC has reported that “Influenza-like illness (ILI) went from 4.9% to 5.8%. ‎These indicators are similar to what was seen at the peak of the 2014-2015 season, which was the most severe season in recent years.” This tough influenza season is a helpful reminder that it could always get worse, especially in the context of the 1918/1919 influenza pandemic, which marks its centennial this year. Michael T. Osterholm and Mark Olshaker recently wrote an OpEd regarding the dismal truth – we’re not ready for a flu pandemic. Pointing to not only massive growth in population, but also challenges of supply shortages, and an outdated approach to vaccine research, they highlight the need to find a universal vaccine that can do battle against all influenza A strains with a longer immunity. “But there is no apparent effort to make these vaccines a priority in the current administration. Its national security strategy published last month cites Ebola and SARS as potential bioterrorism and pandemic threats, yet makes no mention of the risk of pandemic influenza nor any aspect of critical vaccine research and development. The next few weeks will highlight how ill prepared we are for even ‘ordinary’ flu. A worldwide influenza pandemic is literally the worst-case scenario in public health — yet far from an unthinkable occurrence. Unless we make changes, the question is not if but when it will come.”

GMU Biodefense Professor – Robert House
We’d like to welcome back professor Dr. Robert House to GMU biodefense, who will be teaching BioD766: Development of Vaccines and Therapeutics. Dr. House holds a PhD in medical parasitology and is a senior VP for government contracts at Ology Bioservices (previously Nanotherapeutics). The world faces a growing threat from microbiological agents in the form of terrorist weapons, pandemics (particularly influenza) and emerging/re-emerging diseases. Characteristics such as high pathogenicity/toxicity and lack of appropriate animal models, as well as lack of a viable commercial market, make it difficult to develop effective medical countermeasures for these agents. In his course, students will explore how the US Government is developing medical countermeasures (MCM) against these threats and will explore the various threat agents, the context of regulatory considerations, and the specifics of how MCMs are developed.

Infectious Disease Mapping Challenge Launched!
Do you love infectious diseases and maps? The goal of the challenge is to promote the use of geospatial mapping to address the objectives of the GHSA. The NextGen Network has partnered with the U.S. Department of State’s Virtual Student Foreign Service program to launch the 2018 challenge. You can find out more information from this engaging and informative webinar or at the page here. The deadline for signing up for the challenge is January 19, 2018. This is a great way to contribute to the GHSA goal of creating a world safe and secure from the threat of infectious diseases.

Biodefense Alum – Stay Connected! 
Are you a GMU Biodefense alum? If so, please make sure to keep your information updated in our Schar Stay Connected site. We have a strong alum community and would love to keep you up to date on future events and give shout outs for the amazing work our biodefense students accomplish.

Biopreparedness Needs to Start At the Frontlines of Disease Control
GMU biodefense PhD student and infection preventionist Saskia Popescu evaluates the attention to biopreparedness and how our focus on bioterrorism fails to address the major gaps within disease control in the United States. “The Blue Ribbon Panel report and the CNN article both highlight the bureaucratic challenges with coordination at a national level across many agencies and sectors. The crux of it all is that from a grass-roots level, we’re struggling to better prepare and respond for a host of reasons. Public health funding is always in a chronic state of too little too late and often, we don’t push out resources until we’re already in the throes of a major incident (Ebola, Zika, etc.). Preparing for biothreats, regardless of origin, requires that we strengthen the most basic surveillance and response systems within public health and health care. During the 2014–2015 Ebola outbreak, for example, there was a lot of attention on enhanced precautions. Although this was beneficial and brought attention to several gaps infection control and prevention measures, I found myself reminding staff that we can’t truly prepare and respond to rare events if we can’t get our daily practices down. The shear challenges of ensuring staff practice appropriate hand hygiene and isolation precautions in health care are indicators that we are struggling on the frontlines of disease preparedness.”

Lessons from A 2016 CRE Outbreak in A Kentucky Hospital
Hospital outbreaks are tough. The shear volume of people that go into a single patient’s room is considerable (healthcare workers, visitors, ancillary staff, etc.) and enough to spread germs throughout an entire hospital. Now imagine that the organism is a highly resistant one, such as carbapenemase-producing carbapenem-resistant Enterobacteriaceae (CP-CRE). A hospital in Kentucky experienced this very thing in 2016 and a recent CDC MMWR revealed just how difficult it can be to conquer an outbreak involving one of the worst resistant organisms you can imagine. “Over the next 4 months, scientists identified an additional 21 CRE isolates from patients at the hospital via screening and clinical cultures. The investigators believe organisms were imported into the facility and then spread among patients.” Epidemiological investigation found that five of the thirteen interviewed patients had received healthcare outside the local area and that three of the patients may have brought CP-CRE into the facility. “The authors of the report say their investigation highlights the potential role of cleaning equipment, which frequently moves between patient rooms, in CP-CRE spread. In addition, they note that although there is a low prevalence of CP-CRE in rural areas, rural hospitals should be aware that patients who’ve also accessed healthcare in areas with higher CP-CRE prevalence—primarily urban areas—can introduce these organisms into their facilities.”

Stories You May Have Missed:

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

Pandora Report 1.5.2018

Welcome to our first Pandora Report of 2018! While things may have been relatively quiet over the holidays, we still have some health security gems for you to start the new year right.

 An Infection Preventionist’s Take on the 2017 Biological Weapons Convention
GMU Biodefense Phd student and infection preventionist Saskia Popescu recently attended the BWC Meeting of States Parties and is discussing the importance of civil society and why even the most unlikely participants are important for the future of the BWC. “It seems an unlikely story that an infection prevention (IP) epidemiologist would attend a Meeting of the States Parties (MSP) at the United Nations (UN), but here’s why civil society has an important role in the work that IPs do.” Highlighting the Confidence Building Measures (CBMs) and the role of NGOs, she uses communicable disease reporting as an example of how so many of us play an unsuspecting role. “In fact, I feel that there are 2 things that should underline the importance of NGOs and civil society being involved in international treaties such as the BWC: 1.) Inherently, our work plays into the CBMs. Who does communicable disease reporting at a county level? Yours truly, and that feeds into the state health departments and then up through the Centers for Disease Control and Prevention (CDC), which goes into the CBM. 2.) With the rapid pace of advancements in the life sciences—such as gain-of-function research or genome editing like CRISPR—it is critical that treaties like the BWC be modernized to maintain relevancy. This requires experts from civil society who can work across international borders.”

Enhancing BioWatch Capabilities Through Technology and Collaboration
The latest proceedings of a workshop report from the National Academies are now available online. “The Department of Homeland Security’s (DHS’s) BioWatch program aims to provide an early indication of an aerosolized biological weapon attack. The first generation of BioWatch air samplers were deployed in 2003. The current version of this technology, referred to as Generation 2 (Gen-2), uses daily manual collection and testing of air filters from each monitor, a process that can take 12 to 36 hours to detect the presence of biological pathogens. Until April 2014, DHS pursued a next-generation autonomous detection technology that aimed to shorten the time from sample collection to detection to less than 6 hours, reduce the cost of analysis, and increase the number of detectable biological pathogens. Because of concerns about the cost and effectiveness of the proposed Generation 3 system (Gen-3), DHS cancelled its acquisition plans for the next-generation surveillance system.” Within the report, you can find an overview of BioWatch priorities, collaborative planning, recommendations from the GAO and DHS responses, and future opportunities at the state and local level. Some of the GAO’s findings included failure by DHS to develop performance requirements that would allow for conclusions about Gen-2’s ability to detect attacks, and that the modeling and simulation studies that DHS commissioned had not directly and comprehensively assessed Gen-2’s capabilities.

 GMU Biodefense MS Open House
Mark your calendars for the February 21st Master’s Open House at GMU’s Arlington campus! The session will provide an overview of our master’s degree programs, an introduction to our world-class faculty and research, and highlights of the many ways we position our students for success in the classroom and beyond. Our admissions and student services staff will be on hand to answer your questions. This is a great chance to speak with biodefense faculty, learn about some of the awesome classes our students get to take, and find out why we study health security threats from anthrax to Zika.

Winter 2018 Mid-Atlantic Microbiome Meetup Biodefense and Pathogen Detection
Don’t miss out on this January 10th event at the University of Maryland College Park. The University of Maryland Institute for Advanced Computer Studies (UMIACS) is hosting this regional conference next week, the Winter 2018 Mid-Atlantic Microbiome Meetup, with a focus on biodefense and pathogen detection. The workshop is a great way to learn about the latest in synthetic biology, biodefense, and pathogen detection. Several federal agencies are sending experts, and the conference will include a keynote talk from Tara O’Toole, executive vice president of In-Q-Tel.

Three Global Health Issues To Watch in 2018
What are the biggest stories health reporters are looking to follow this year? STAT polled their reporters and predicted that the three big stories in public health would be the final push to end polio, how the WHO will do with a new Director General amidst shaken confidence, and vulnerability to pandemics as we march into the centennial of the 1918 Pandemic. “This year marks the centenary of the Spanish Flu, the influenza pandemic of 1918, which killed somewhere between 50 million and 100 million people as the H1N1 flu virus swept the globe. Many of the people who died were in the prime of life. There are unsettling reports of people who were well at breakfast and dead by dinner. This uniquely fatal outbreak haunts influenza scientists and emergency response planners to this day. The latter know health systems don’t have the capacity to cope with the huge upsurges in illness that would accompany a major disease outbreak. A regular old bad flu season can severely tax hospitals. Those who worry about these issues will use the anniversary to focus attention on the risk of ‘the next Big One’.” What do you think the big pubic health topics will be this year? Tweet us @PandoraReport and we’ll report back on what the biodefense community is saying!

Three Children Hospitalized With Dengue Following Vaccination
Three Filipino children have been hospitalized with suspected dengue infections following their immunization with Dengvaxia, the latest Sanofi Pasteur dengue vaccine. “The hospitalizations come 1 month after Sanofi recommended Dengvaxia not be used in anyone who is dengue-naive. In recipients without previous dengue infections, the vaccine can lead to more severe illness.”

Stories You May Have Missed:

  • Raw Water” Trend Sparks Public Health Concern – This is both hysterical and deadly – a new Silicon Valley obsession with untreated and unfiltered “raw” water. “When food-safety expert Bill Marler saw The New York Times’ trend piece on Silicon Valley’s recent obsession with raw water, he thought he was reading a headline from The Onion. According to The Times, demand for unfiltered water is skyrocketing as tech-industry insiders develop a taste for water that hasn’t been treated, to prevent the spread of bacteria or other contaminants.”

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

Pandora Report 12.29.2017

This will be our last Pandora Report of 2017 and we’d like to take a moment and thank our wonderful readers for a great year of biodefense news! We hope you have a marvelous and safe New Years celebration. We’re starting the festivities early with some memories of infectious disease research from 2017.

Agroterrorism – A Threat To America’s Food Supply
Food vulnerability is not something people tend to think about very often and even less in the context of terrorism. There have been many experts noting that food safety is America’s soft underbelly for years, but just how vulnerable are we? “Agroterrorists have access to animal based bio-agents, which are easy to transport and simple to conceal. Just as ramming a speeding truck into a crowd is low-tech, an attack via the food chain has a low barrier to entry and little skill needed to execute. Weaponizing livestock is as simple as tending the flock or feeding the cattle. There is little expertise or special equipment required and given most animal borne pathogens are not communicable to humans, the logistics are easy. It really is farm to table pathogen delivery.” Increasing automation within food processing and rapid delivery from farm to table has the potential to be used as a weakness. Not only are these systems inherently weak against terrorist attacks, but one would severely damage the U.S. economy. A 2013 study found that outbreaks in FMD-free countries/zones could cause losses of more than $1.5 billion a year.

Biological Weapons Threat In The Spotlight – UN News
Check out this great podcast of UN news in which Dr. Tom Inglesby from the Johns Hopkins Center for Health Security discusses the BWC Meeting of States Parties and the importance of global cooperation to address biothreats. “He told Daniel Johnson that because most biological research now takes place ‘far outside the control of government’, a key objective should be to ensure that an information-sharing mechanism exists between industry and Member States.

Meeting of the Blue Ribbon Study Panel on Biodefense: SLTT Ability to Respond to Large-Scale Biological Events: Challenges and Solutions
Don’t miss this event on January 17th, 2018 in Miami, Florida! “The Nation continues to confront infectious disease events and the threat of biological terrorism. This meeting of the Study Panel, chaired by former Secretary of Health and Human Services Donna Shalala and former Representative James Greenwood, will provide the Study Panel with a better understanding of the ability of state, local, tribal, and territorial (SLTT) governments to: respond to large-scale biological events, identify and utilize SLTT assets and resources for immediate response (prior to a declaration of a SLTT biological emergency or disaster), operate before federal assistance arrives and after federal resources are exhausted, and shift to population management when a biological event overcomes pre-hospital and hospital response protocols.”

Analyzing the Detection and Response Aspects of Global Health Security
GMU biodefense PhD student Saskia Popescu is taking a trip down the detection and response rabbit hole of health security. Evaluating research on laboratory response networks, public health coordination, frontline epidemiology training, and more, she highlights the vulnerability we all share if even one country has a weak public health and healthcare infrastructure. “Response efforts often point to gaps within our plans, like the need to train staff on enhanced use of personal protective equipment during the Ebola outbreak, or cultural dynamics that challenge public health education efforts. Public health response is an evolving process and with each new challenge, lessons are learned and we hope that we can appropriately apply them in the future. The most important lesson is the global aspect of health security—an outbreak anywhere is an outbreak anywhere. Strengthening national prevention, detection, and response efforts will only serve to protect us all.”

WHO Priority List of Antibiotic-resistant Bacteria and Tuberculosis
The WHO has released a list of priority pathogens to help encourage the development of new antibiotics. “Detailing its findings in The Lancet Infectious Diseases yesterday, the WHO Pathogens Priority List Working Group used a multicriteria decision analysis method to select 20 antimicrobial-resistant bacteria. The experts then applied 10 criteria to assess priority: mortality, healthcare burden, community burden, prevalence of resistance, 10-year resistance trends, transmissibility, preventability in the community, preventability in healthcare settings, treatability, and drug pipeline.” The list of 20 bacterial species highlights three categories (critical, high, and medium priority), which includes “carbapenem-resistant Acinetobacter baumannii andPseudomonas aeruginosa, and carbapenem-resistant and third-generation cephalosporin-resistant Enterobacteriaceae. The highest ranked Gram-positive bacteria (high priority) were vancomycin-resistantEnterococcus faecium and meticillin-resistant Staphylococcus aureus. Of the bacteria typically responsible for community-acquired infections, clarithromycin-resistant Helicobacter pylori, and fluoroquinolone-resistantCampylobacter spp, Neisseria gonorrhoeae, and Salmonella typhi were included in the high-priority tier.”

 Drug Discovery, Development and Deployment
Speaking of the importance of drug R&D…the NIH has released their Drug Discovery, Development and Deployment Maps (4DM) to help engage and support this complicated process. There are two maps – one for small molecules and one for biologics, using monoclonal antibodies as the representative therapeutic. “The maps provide a common framework for discussing the therapeutic development process and serve as an education tool for those who are new to it. A common language and collective knowledge base for therapeutic development is essential to enable systemwide improvements that will benefit patients. The 4DM can help facilitate dialogue among those interested or participating in drug development to explore innovative solutions to existing bottlenecks and potential collaborative action to overcome those barriers and accelerate new medicine discovery.”

Bird Flu in South Korea
Avian influenza is wreaking havoc in South Korea. Officials have reported the culling of 201,000 birds in efforts to prevent the spread of H5N6 after it was found in four duck farms. “Last year, South Korea slaughtered more than 30 million birds to contain the worst outbreak of bird flu in the country‘s history.” Such efforts are especially important as the country prepares to host the Winter Olympics, which begin on February 9, 2018.

ASM Supports NIH Decision To Lift Funding Pause on GoF Research
Last week saw a surge of news regarding the official lift on the funding moratorium on GoF research. The news released an onslaught of over-the-top headlines and debates, but nonetheless the existence of GoF research will likely remain one that sparks concerns on both ends of the spectrum. The American Society for Microbiology (ASM) has come out in support of the lift on the funding pause though, noting that they are “in complete support of the National Institutes of Health lifting the funding pause on gain-of-function (GoF) experiments involving influenza, SARS, and MERS viruses. GoF research studies ways nature might make some viruses more virulent or transmissible. This is important in helping identify and develop strategies and effective countermeasures against rapidly evolving pathogens that pose a threat to public health, as well as to prepare for pandemics. ASM also applauds the review framework released by the Department of Health and Human Services. This process will ensure that any proposal that passes scientific peer review and fits the Potential Pandemic Pathogen (PPP) definition will undergo a multidisciplinary review process before funding is received. The review panel will provide oversight and facilitate safe and responsible conduct of this type of research.”

Stories You May Have Missed:

  • United States Flu Season Update– This flu season is already shaping up to be rough, so where are we? “Influenza A viruses have been most commonly identified, with influenza A(H3N2) viruses predominating. Several influenza activity indicators were higher than is typically seen for this time of year. The majority of influenza viruses characterized during this period were genetically or antigenically similar to the 2017–18 Northern Hemisphere cell-grown vaccine reference viruses. These data indicate that currently circulating viruses have not undergone significant antigenic drift; however, circulating A(H3N2) viruses are antigenically less similar to egg-grown A(H3N2) viruses used for producing the majority of influenza vaccines in the United States.” Outpatient visits have spiked with patients seeking care for influenza-like illness (ILI) across the U.S. The national average is 2.2% and last week saw 2.7% however, this week is now 3.5%, which points to a growing influenza season.

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

Pandora Report 12.22.2017

Happy Holidays from your friends at the Pandora Report! We hope you have a lovely holiday weekend and enjoy this warm cup o’biodefense. If you’re still looking for the perfect gift for a microbe-loving person in your life, check out the latest holiday pack here.

International Criminal Court Adds Use of Biological Weapons to Rome Statute
Last week, during the Assembly of States Parties to the ICC, it was decided that three new crimes would be now be classified as war crimes within the Rome Statute. “The new war crimes added to the Rome Statute are, respectively, the use of biological and toxin weapons, the use of weapons causing injuries by fragments which in the human body escape detection by X-rays and the use of laser weapons causing permanent blindness. These weapons kill without discrimination or inflict very severe suffering. Their elevation to the rank of war crimes strengthens international law. The use of these weapons during armed conflicts will become even more difficult. The inscription of these new crimes in the Statute of Rome ensures also legal certainty to the victims and gives a specific recognition to their pain.” The Belgium Ministry of Foreign Affairs has come forward noting that “It was Belgium that had proposed these amendments to the Statute, the founding treaty of the ICC, as early as 2009. Belgium has tirelessly mobilized, through its diplomatic network and the voices of its foreign ministers, its ministers of justice and even its prime ministers to promote the adoption of these amendments.”

2017 National Security Strategy – Biodefense
Just in the nick of time, the National Security Strategy was released – and with a biodefense gem hidden on page 9! Pillar 1 (of 4) within the NSS includes a section on securing U.S. borders and territories, in which the “combat biothreats and pandemics” section is buried. Citing biological threats, whether it be natural outbreaks like Ebola, bioterrorism, or advancements in life sciences that have the potential to be mis-used, the NSS includes several priority actions. The three priority actions to combat biological threats are: “detect and contain biothreats at their source, support biomedical innovation, and improve emergency response. ”

Trump’s Biodefense Strategy – Naught, Nice, or MIA?
GMU biodefense MS student Janet Marroquin is taking a look at the Trump administration’s biodefense strategy and what the past year has shown us in terms of what we can expect. With the release of the NSS this past week, some direction is being given, but just how far have we come in terms of a true strategy? Marroquin delves into the nitty gritty and also gives us a holiday wish list for what we’d like to see on a biodefense strategy. She notes that “An important reform present in the proposed FY 2018 Federal budget is the call to dismantle the Academic Centers for Public Health Preparedness under the CDC and the distribution of its funds among state governments to support state-led public health preparedness.  Interestingly, this action seems to contradict expert recommendations to the federal government for the development of a centralized approach to health security.” In response to the release of the NSS, the Blue Ribbon Study Panel has released a statement and highlights, like Marroquin, the importance of a comprehensive approach.

Congrats to GMU’s Biodefense December Graduates!
We’re excited to announce the graduation of several GMU Biodefense students this winter. Congrats to our students graduating with a MS: Zamawang Almemar, Alexander Rowe, and Stephanie Smith – and congrats to those graduating with a Certificate in Biodefense: Mi Chung and Mary Oberlies. We can’t wait to see where the future takes you and the amazing biodefense adventures you’ll have!

Federal Funding Resumes for Gain-of-Function Research
On Tuesday, it was announced that DHHS has ended the funding pause on GoF research. Suspended since the 2014 moratorium, guidance was released in January of this year by the White House Office of Science and Technology Policy (OSTP) for individual agencies reviewing research. While the OSTP P3C0 recommendations provided guidance for agencies looking to conduct, support, or planning to conduct such research, its sole purpose was “to recommend consistent and appropriate Federal agency review and reporting processes for the enhanced oversight of Federally funded research that is anticipated to create, transfer, or use enhanced pathogens with pandemic potential.” In fact, once agencies adopted a review process and satisfied such requirements, they could lift their moratorium on GoF research. It is this week’s NIH announcement however, that fully lifted the moratorium and provided framework for guiding funding decisions about such research (FYI – you won’t find many differences between the framework and the OSTP P3C0).  “The framework, condensed into a 6-page document, spells out a multidisciplinary review process that involved the funding agency and a department-level review group that considers the merits and possible research benefits and the potential to create, transfer, or use an enhanced potential pandemic pathogen (PPP).” Funding for GoF research on potential pandemic pathogens, like SARS, MERS, and avian influenza, was resumed jointly with the DHHS framework that seeks to guide funding of proposed research that would involve enhancing such pathogens. “The HHS P3CO Framework is responsive to and in accordance with the ‘Recommended Policy Guidance for Departmental Development of Review Mechanisms for Potential Pandemic Pathogen Care and Oversight’ issued on January 9, 2017  and supersedes the previous ‘Framework for Guiding U.S. Department of Health and Human Services Funding Decisions about Research Proposals with the Potential for Generating Highly Pathogenic Avian Influenza H5N1 Viruses that are Transmissible among Mammals by Respiratory Droplets’.” The new framework includes 8 criteria for department-level review, which includes “An assessment of the overall potential risks and benefits associated with the research determines that the potential risks as compared to the potential benefits to society are justified” and “The research will be supported through funding mechanisms that allow for appropriate management of risks and ongoing Federal and institutional oversight of all aspects of the research throughout the course of the research”.

GMU Biodefense Student Tackles USPS Safety
Speaking of awesome things GMU biodefense graduates are doing…Stephanie Smith is using her forensic chemistry background and new biodefense degree to tackle safety in the USPS. “I’m a forensic chemist by training, that’s what I’ve done my entire career,” she said. “I came to Mason to study the ‘bio-side’ of this complex advisor position, but I realized I was also expanding my knowledge beyond science and into the policy side.” Having studied a range of different topics like agroterrorism and biosurveillance during her time at GMU, Smith’s capstone project “was based on her idea that the method of detecting bioagents in the mail could be improved.” While she was working on her studies at GMU, she was also working at the USPS within the Security and Crime Prevention Group and was tasked with writing the job description for a new permanent scientific advisor position. “Once Smith wrote the job description for the new position of ‘Scientific and Technical Advisor, Dangerous Mail Investigations’ for the Postal Inspection Service, it was determined there was only one person qualified to fill a job that required knowledge of chemistry, biodefense, security and public policy. That would be Stephanie Smith. She got the job.”

2017-2018 PHEMCE Strategy and Implementation Plan
The latest Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) SIP has been released, which highlights some of the priorities that the Department of Health and Human Services will focus on over the next five years. Within the SIP, you can find a summary of the major accomplishments, new activities, updates to the 2016 SIP activities, and specific information required annually under the Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA). The latest SIP includes accomplishments from 2016 that include regulatory science management, Zika and Ebola response, international collaboration on MCMs, etc. Some of the new projects include Ebola response, bacterial threat projects like CARB-X, etc. You can also read the PHEMCE multi-year budget for fiscal years 2016-2020 here.

GMU Biodefense Students Visit DARPA
If you’ve ever wondered what it’s like to go inside the walls of the Defense Advanced Research Projects Agency (DARPA), this article is just for you! GMU biodefense professor Andrew Kilianski took students from one of his classes to visit DARPA and gain a better understanding of their biodefense efforts. Dr. Kilianski is currently a biological scientist at the DoD and his work focuses on combating current and future threats from weapons of mass destruction in addition to teaching classes on biosurveillance and virology in the GMU Biodefense graduate program. In this segment, biodefense MS student Janet Marroquin takes us on a tour of DARPA and some of the fascinating projects they work on. “These projects range from surveillance tools to diagnostics and therapeutics, using futuristic mechanisms such as a dialysis-like purification of pathogen-infected blood or unobtrusive nanoplatforms that continuously monitor the physiological state of the patient for the detection of infectious disease. ”

Preventing An “Outbreak Anywhere” From Becoming An “Outbreak Everywhere”
GMU Biodefense PhD student Saskia Popescu is addressing the trifecta of efforts within global health security – prevention, detection, and response. Drawing on the special edition Emerging Infectious Disease journal, she highlights the importance of prevention and the obstacles that are often met. “Prevention is the first component to health security, but in many ways, it is also the most difficult. Biological threats can come from anywhere: a naturally occurring outbreak, a laboratory accident, or even an act of biological terrorism. How do we prevent biothreats when they come from so many directions? Zoonotic diseases are one place to start as more than 60% of known diseases spread from animals and roughly 75% of new or emerging diseases in humans spread from animals.”

Is Captain America A Biological Weapon?
Attending the Biological Weapons Convention will make you ponder such things and Matt Shearer from the Johns Hopkins Center for Health Security is venturing down that rabbit hole. Article I of the BWC states that each state party will not develop, produce, stockpile, or otherwise acquire or retain “microbial or other biological agents, or toxins whatever their origin or method of production, of types and in quantities that have no justification for prophylactic, protective or other peaceful purposes;” and “weapons, equipment or means of delivery designed to use such agents or toxins for hostile purposes or in armed conflict.” Shearer poses a unique question about what constitutes a biological agent – what if there is no infection but rather a human who has been enhanced? “But normal humans, animals, and plants do not seem to count as “other biological agents” in the context of the BWC, but what about enhanced or modified versions like Captain America or, perish the thought, the accidentally enhanced Teenage Mutant Ninja Turtles? Have we been unwittingly cheering for bioweapons this whole time?”

Stories You May Have Missed: 

  • Cadavers in the Ballroom – Shockingly, this not the title of a zombie wedding movie, but rather a reality of medical conferences. This recent article found that some medical conferences, operating in grand ballrooms, utilize cadavers and body parts for teaching at their lectures. “When the deceased are cut open, there’s an increased risk of a disease being transmitted to others, said Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota. ‘I will be the first to acknowledge there have been no big outbreaks or situations that have occurred yet from a dead body,’ Osterholm said. ‘But I am absolutely convinced it’s just a matter of time’.”
  • Building A National Capability to Monitor and Assess Medical Countermeasures Use During A Public Health Emergency – Don’t miss the latest NAS report on MCM use. “During public health emergencies (PHEs) involving chemical, biological, radiological, or nuclear threats or emerging infectious diseases, medical countermeasures (MCMs) (e.g., drugs, vaccines, devices) may need to be dispensed or administered to affected populations to help mitigate the human health impact of the threat. The optimal MCMs determined for use during an emergency might be U.S. Food and Drug Administration (FDA) approved but used in unapproved ways (e.g., in a new age group or against a new agent); FDA approved using animal models because human efficacy testing is not ethical or feasible; or not yet FDA approved for any indication.”

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

GMU Biodefense Visits DARPA

By Janet Marroquin

One of the many advantages of being a student in the Schar School of Policy and Government at GMU is having the unique opportunity to go on a field trip to the Biological Technologies Office (BTO) of the Defense Advanced Research Projects Agency (DARPA)!  Dr. Andrew Kilianski graciously arranged a visit to the facility, located less than a mile away from Founder’s Hall, for a portfolio briefing to provide insight to real-world application of the themes explored in his Biosurveillance class (BIOD 751 for those of you interested).

Team members supporting Col. Matthew Hepburn, one of the nine program managers at the BTO, briefed in great detail about the mission at DARPA, project selection and development, and the role that Scientific, Engineering, and Technical Assistance (SETA) team members play in the day-to-day operations of the Col. Hepburn’s BTO portfolio..

The mission at DARPA is consequential to its name: “creating breakthrough technologies and capabilities for national security.”  Within the BTO, Program Managers strive to develop cutting-edge biotechonologies that are 10-15 years into the future and can provide innovative support to the military and civilians alike. These projects range from surveillance tools to diagnostics and therapeutics, using futuristic mechanisms such as a dialysis-like purification of pathogen-infected blood or unobtrusive nanoplatforms that continuously monitor the physiological state of the patient for the detection of infectious disease. For the Program Managers, the challenge is not envisioning the innovative biotechnology but rather the pre-emptively assessment of risk for these projects, which is particularly a problem for biologics.  With increased innovation may come increased risk, hence the highly selective process in hiring each Program Manager and the assembly of their skilled teams.

Another challenge that comes to mind in thinking about cutting-edge biotechnology is addressing the dual-use dilemma. While BTO projects do not involve working with select agents or particular pathogens, the security implications of manipulating in vivo nanoplatforms or other platform technologies for nefarious purposes should be considered.  Rapidly advancing technology demands a strong security policy that is prepared to address dual-use research intentionally being developed ahead of its time.  Just as health risks are effectively evaluated by a highly skilled team of scientists, so should security risks be managed by a skilled team of biodefense experts.

As a biodefense student, it was exciting to witness the wonders at the BTO and to get a glimpse of the future in biotechnology.  For those unable to visit DARPA in the near future, all of Col. Hepburn’s projects are open-source and descriptions are available on the BTO website.  As I previously stated, the Schar School is full of unique opportunities to GMU students and to faculty alike, so as such, we should take full advantage!

Trump’s Biodefense Strategy: Naughty? Nice? M.I.A?

By Janet Marroquin

At the Aspen Security Forum this past July, homeland security adviser Thomas Bossert reassured the country that the White House would fill the void of a comprehensive biodefense strategy “as soon as we can.”

Under the Biodefense Strategy Act signed into law in December 2016, the Trump administration is required to produce a new strategy for biodefense as a joint endeavor by the secretaries of Defense, Health and Human Services, Homeland Security, and Agriculture.  This congressional requirement solicited an initial briefing on the strategy no later than March 1, 2017 and a formal strategy due to Congress no later than 275 days after December 23, 2016.  More than nine months past due, we may finally have been given a small sneak preview of biodefense policy within the US National Security Strategy.  Unfortunately, as the year comes to a close, there is still no mention of an anticipated release date and biodefense experts are left wondering about the future contours of biodefense strategy.

Upon examination of the proposed FY 2018 federal budget, the initial outlook for biodefense did not look very good.  The significant decrease in federal spending on public health agencies suggested a decrease in priority for public health and thus a decrease in health security.  According to the Congressional Review Service, the proposed budget for the CDC in FY 2018 represents a decline of 17% from the estimated FY 2017 budget.  Biodefense-related programs within the CDC all saw a negative trend in spending compared to the estimated budget allocated this year, regardless of previously rising or declining trends.

Program 2016 Budget

(in Million Dollars)

2017 Estimated Budget (in million dollars) 2018 Proposed Budget (in million dollars)
Emerging & Zoonotic Diseases 582 585 514
Public Health Scientific Services 491 489 460
Global Health 427 435 350
Public Health Preparedness & Response 1413 1405 1266
CDC-wide Activities 411 274 105

Similarly, NIH saw a decline of 21.5% in federal spending for FY 2018, with the National Institute of Allergy & Infectious Diseases (NIAID) also experiencing a steep decline in funding despite a previously positive trend.

Program 2016 Budget (in million dollars) 2017 Estimated Budget (in million dollars) 2018 Proposed Budget (in million dollars)
NIAID 4750 4907 3783

An important reform present in the proposed FY 2018 Federal budget is the call to dismantle the Academic Centers for Public Health Preparedness under the CDC and the distribution of its funds among state governments to support state-led public health preparedness.  Interestingly, this action seems to contradict expert recommendations to the federal government for the development of a centralized approach to health security.

The initial budget proposal also called for closing the National Biodefense Analysis and Countermeasures Center (NBACC).  Fortunately, it is Congress that controls the purse strings and has the last say in the finalized federal budget.  Heavy lobbying by scientists and law-enforcement resulted in amendment of the proposal to reverse the September 2018 closure of NBACC, thus exhibiting the powers at play and illustrating the influence that various stakeholders have in biodefense policy.[1]

Furthermore, there is still some good news for the biodefense budget.  In spite of the proposed cuts to NIH and the CDC funding, there is no proposed change in federal spending for BARDA and there is even an increase of about 3% on pandemic influenza programs, underscoring a support for public health emergency funds and DoD measures against biological threats.[2]  It is also imperative to keep in mind that the proposed federal budget is only representative of priorities for the fiscal year 2018 and is not necessarily indicative of an overarching biodefense strategy.  As such, non-fiscal factors must also be considered.

Recent  U.S. participation in the Global Health Security Agenda confirms support for global health security, contrary to the proposed decrease in global health spending under the CDC for FY 2018.  At the United Nations General Assembly, President Trump expressed approval of the GHSA in his remarks to African leaders, “we cannot have prosperity if we’re not healthy.  We will continue our partnership on critical health initiatives.”  On that note, Secretary of State, Rex Tillerson, praised the Agenda and extended support a few weeks prior to the GHSA Summit in Kampala, “while we’ve made tremendous progress since GHSA was launched in 2014, considerable work remains.  That is why the United States advocates extending the Global Health Security Agenda until the year 2024.”

Biodefense scholars have expressed concern about the Trump Administration’s ability to develop an effective, coherent strategy in light of political division between and within parties, budget cuts to biodefense-related agencies, and the administration’s general anti-science attitude.[3]  Though it remains unclear of what the Trump Administration will include in the new biodefense policy, recommendations from various advisory councils such as the President’s Council of Advisors on Science and Technology, the National Security Council, the Blue Ribbon Study Panel on Biodefense and the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria, all seem to have the following items on their holiday wish list for biodefense strategy:

  • A single, centralized approach to biodefense (i.e. a federal council dedicated to coordinating efforts against biological threats)
  • A comprehensive strategy that encompasses human and animal health (i.e. One Health)
  • An interdisciplinary approach to health security, inclusive of all stakeholders (i.e. policy makers, scientists, health experts, etc.)
  • Defense against both global and domestic biological threats
  • A proactive policy preventing the misuse/abuse of advancing biotechnology

The new National Security Strategy supports an international, One Health approach to biosurveillance, biomedical innovation, and improved emergency response in “protecting the homeland and the American people”.  Accordingly, the administration must now produce a biodefense strategy that effectively protects the American people from biological threats.  May the force be with the secretaries of Defense, Health and Human Services, Homeland Security, and Agriculture in granting us a unified and comprehensive biodefense strategy!

REFERENCES

[1] Kirby, “The Trump’s administration’s misaligned approach to national biodefense,” 386.

[2] U.S. Department of Health and Human Services. Office of the Assistant Secretary for Preparedness and Response, “Fiscal Year 2018 Budget-in-Brief: Public Health and Social Services Emergency Fund,” Accessed December 17, 2017, https://www.phe.gov/about/ofpa/Documents/bib-2018.pdf

[3] Kirby, Reid, “The Trump’s administration’s misaligned approach to national biodefense,” Bulletin of the Atomic Scientists 73, no. 6 (November 2017), 382-383.

Blue Ribbon Study Panel on Biodefense. A National Blueprint for Biodefense: Leadership and Major Reform Needed to Optimize Efforts – Bipartisan Report of the Blue Ribbon Study Panel on Biodefense. Hudson Institute: Washington, DC, October 2015.

Hourihan, Matt and David Parkes. “Deep Cuts for NIH, Other Life Sciences in FY 2018 Budget Plan.” June 15, 2017. https://www.aaas.org/news/deep-cuts-nih-other-life-sciences-fy-2018-budget-plan

National biodefense strategy, U.S. Code 6 (2016), §104.

Watson, Crystal, Matthew Watson, Tara Kirk Sell. “Federal Funding for Health Security in FY2018.” Health Security 15, no. 4 (August 2017): 351-372. https://doi.org/0.1089/hs.2017.0047

U.S. Congress. Senate. Committee on Homeland Security and Governmental Affairs. Biodefense Strategy Act of 2016 (to Accompany S. 2967). 114th Cong., 2d sess., 2016. S. Rep. 114-306. I-12. https://www.congress.gov/114/crpt/srpt306/CRPT-114srpt306.pdf

U.S. Library of Congress. Congressional Research Service. Public Health Service Agencies: Overview and Funding (FY2016-2018), by C. Stephen Redhead, Agata Dabrowska, Erin Bagalman, Elayne J. Heisler, Judith A. Johnson, Sarah A. Lister, and Amanda K. Sarata. R44916. 2017.

U.S. Department of Health and Human Services. Office of the Assistant Secretary for Preparedness and Response. “Fiscal Year 2018 Budget-in-Brief: Public Health and Social Services Emergency Fund.” Accessed December 17, 2017. https://www.phe.gov/about/ofpa/Documents/bib-2018.pdf

Pandora Report 12.15.2017

Welcome back to your weekly dose of all things biodefense! We’ve got a packed newsletter for you, so buckle up. Curious about CRISPR and how it works? Check out the best and worst analogies here.

Read Out On The GHSA Ministerial Meeting in Kampala
If you missed our Read-Out on the GHSA meeting in Kampala, we’ve got a great overview with attachments. The NextGen Global Health Security Network Reflections can be found here and Coordinator Jamechia Hoyle was kind enough to provide her powerpoint from the Read-Out, which you can access here. The Read-Out involved presentations and discussions from not only NextGen GHSA Coordinator Hoyle, but also Jennifer Nuzzo from the Center from Health Security, and two GMU Biodefense MS students – Anthony Falzarano and Stephen Taylor. In fact, Anthony and Stephen provided several great photos from the Kampala summit, which you can see here. “While they discussed that the dialogue was driven by high level members of government. The overall consensus was the need to bring in non-governmental and academic voices. The panel members emphasized this by showcasing the work with Next Generation Global Health Security Leaders and the continued efforts to bring young professionals and students into these working groups. From the discussion, it is evident that GHSA’s efforts are being felt in many nations. The Response Center in Uganda, while small, had the hallmarks of the CDC and other organizational support.” Dr. Nuzzo brought her talk to a close with a poignant quote from the summit – “it is much cheaper to spend on preparedness than it is to spend on response.” Attendee and biodefense MS student Janet Marroquin noted that “the containment of the Marburg virus in Uganda during the conference perfectly illustrated the benefits of improved health security measures, but it is easy to overlook this success when good health is expected as a guarantee. In addition to bringing attention to current deficiencies in global health security, the GHSA is needed to look to the future and anticipate and prevent roadblocks in implementation.”

Biological Weapons Convention Meeting of States Parties – Recap
Last week, GMU biodefense PhD student Saskia Popescu attended the Biological Weapons Convention Meeting of States Parties (MSP) with the Johns Hopkins Center for Health Security ELBI program. This MSP started on somewhat of a bated breath as last year’s Review Conference was, as described by many, an epic failure. Having endorsed the Joint NGO Statement, Popescu noted that “the role of the NGOs felt even more important in such a disjointed climate where the future of the BWC was in many ways, up in the air. The importance of support and pushing for future cohesion regarding not only the intersessional process (ISP), but also S&T developments, was a significant point within the NGO statement.” As you can find in many of the live-tweeting that was occurring (#MSP2017), the MSP started off with a bang as Iran noted that they were not convinced further ISP work would be productive and if the BWC isn’t legally binding, it can’t truly be universal. Chairman Gill started the MSP with a quote from Rumi and worked tirelessly to maintain focus and forward momentum. Thankfully, despite several days of closed-door discussion, consensus was reached and the ISP was established to include 4 days of meetings of the MSP and 5 meetings of experts, which would focus on cooperation and assistance, development S&T, strengthening national implementation, assistance for preparedness and response, and the institutional strength of the BWC.  You can also find detailed overviews of each day here. A few of Popescu’s favorite moments from attending: “Sweden’s inclusion of antimicrobial resistance in their opening statement, Australia’s comments on the need for a more diverse attendance in the future and the growing presence of women within the BWC. It was also surprising how shockingly low the states costs for BWC inclusion are…and how some are delinquent by a few hundred dollars. Lastly and perhaps the most important part of the trip was getting to attend a pivotal event in biodefense history with such an amazing group of people who were all as excited and enthusiastic as I was. As we took a break to visit the WHO and peered upon the famous smallpox statue, I think it all hit us how vital this work is on a global level.”

Jurassic Ticks?
Paleontologists have recently announced the finding of a 99-million-year-old tick that not only was holding on for dear life within the feathers of a dinosaur, but provides evidence that these blood-suckers fed on dinosaurs. While this tick came from the Cretaceous period, it feels eerily similar to how Jurassic Park began. “This study provides the most compelling evidence to date for ticks feeding on feathered animals in the Cretaceous,” said Ryan C. McKellar, a paleontologist at the Royal Saskatchewan Museum in Canada who was not involved in the study. “It demonstrates just how much detail can be obtained from a few pieces of amber in the hands of the right researchers.” Imagine the kind of dino-arboviruses we might come across with this finding! It’s hard not to chuckle at the timing of the announcement since the latest Jurassic World movie trailer was released just last week.

Podcast “Syria(s) Problem: Chemical Weapons & International Norms from Power Problems
Don’t miss this episode of the bi-weekly podcast Power Problems from the Cato Institute hosted by Emma Ashford and GMU biodefense professor Trevor Thrall. In this episode on the use of chemical weapons in Syria, GMU biodefense professor and graduate program director Gregory Koblentz discusses how the use of such weapons calls into question the utility of international norms. Some of the show notes also include the discussion of taboos against chemical weapons, and antibiotic resistance as a biological threat.

Is North Korea’s Bioweapons Threat Growing With Increasing Biotech Expertise?
Are the technical hurdles to biological weapons eroding in North Korea? Advances in the life sciences have brought forth a wealth of new capabilities, like manipulating DNA, but are we also lowering the bar for bioweapons development? There’s been increasing talk regarding the potential for North Korea to develop and deploy biological weapons. While there certainly has been a lowering of technical hurdles in some aspects of bioweapons development, has North Korea truly developed a functioning program? “The gains have alarmed U.S. analysts, who say North Korea — which has doggedly pursued weapons of mass destruction of every other variety — could quickly surge into industrial-scale production of biological pathogens if it chooses to do so. Such a move could give the regime yet another fearsome weapon with which to threaten neighbors or U.S. troops in a future conflict, officials and analysts say. Current and former U.S. officials with access to classified files say they have seen no hard evidence so far that Kim has ordered production of actual weapons, beyond samples and prototypes. And they can only speculate about the reasons.” Many note that their possession of biological agents is known but that the unknown is just how far along a bioweapons program might be. The development of a high-functioning and successful bioweapons program requires significant funding, human resources, and tacit knowledge. Dr. Sonia Ben Ouagrham-Gormley recently broke down just how realistic these concerns are (hint: she’s a GMU biodefense professor and guru on tacit knowledge). In response to this week’s increased attention on a potential program in North Korea, Dr. Ben Ouagrham-Gormley was also interviewed regarding the cost of a biological weapons program and just how much it would take to truly develop and maintain one. “The cost of maintaining an active biological weapons program is high, according to Sonia Ben Ouagrham-Gormley, associate professor in the Schar School of Policy and Government at George Mason University. She said the Soviet Union spent ‘several billion dollars’ on its program, while terrorist group Aum Shinrikyo spent about $10 million, though the latter ‘failed at every step.’ The United States spent about $700 million on its program, which was active over the course of roughly 27 years. ‘The challenge is in acquiring the expertise to handle and manipulate living organisms that are fragile and unpredictable: that requires time and a work organization that ensure continuity and stability of work,’ Ben Ouagrham-Gormley said. ‘These are conditions that are difficult to maintain in a covert program. That’s why most covert bioweapons programs have failed thus far’.”

Global Health Security and the US Export Economy
It’s easy for many to think that outbreaks only impacts public health, but the truth is that the effects of health security threats are felt across many sectors and industries. The export economy is not immune to disruption should there be a public health emergency. A recent study reviewed economic vulnerability to the US export economy that would be impacted by disruptions in 49 countries. These 49 countries are currently being targeted by the CDC and partners to improve capabilities to prevent/respond to public health infectious disease threats throughout laboratories, workforce, surveillance, and response systems. Enhancing global health security by strengthening the country capacity is the goal for these 49 countries. “US exports to the 49 countries exceeded $308 billion and supported more than 1.6 million jobs across all US states in agriculture, manufacturing, mining, oil and gas, services, and other sectors. These exports represented 13.7% of all US export revenue worldwide and 14.3% of all US jobs supported by all US exports. The economic linkages between the United States and these global health security priority countries illustrate the importance of ensuring that countries have the public health capacities needed to control outbreaks at their source before they become pandemics.” The numbers are startling, especially if you consider that the 2002-2003 SARS epidemic was estimated to have a global economic impact of almost $40 billion USD. The total value of US material goods/services exported to all countries was estimated to be $2.3 trillion in 2015. The findings of this study point to the significant economic disruption that would occur if a health security event occurred in one of these 49 countries. Global health security is truly an investment that provides a return, as we know that an outbreak anywhere is an outbreak everywhere.

CyberbiosecurityDNA Has Gone Digital – What Could Possibly Go Wrong?
As biotechnology and biology go full-steam ahead, there is increasing use of technology and informatics databases to support such innovation. Where does that leave us in terms of cybersecurity? Coined as “cyberbiosecurity”, many in the field, like Colorado State University’s Jean Peccoud, are drawing attention to the risk this new frontier has for researchers, industry, and the government. Peccoud and his colleagues point to the potential for accidental or intentional breaches, noting that “In the past, most biosecurity and biosafety policies were based on sample containment,” Peccoud says. “Now, it’s so easy to read DNA sequences, for example, or to make DNA molecules out of sequences publicly available from bioinformatics databases. Most projects have a cyber dimension, and that introduces a new category of risk.” Traditional biosecurity efforts focus on containment of the organism from accidental or nefarious use, but that doesn’t really focus on the computational aspect of new biotech, like synthetic biology. “The authors recommend employee training, systematic analyses to examine potential exposure to cyberbiosecurity risks, and the development of new policies for preventing and detecting security incidents. ‘Once individuals in a community are aware of cyberbiosecurity risks, they can begin to implement safeguards within their own work environments, and work with regulators to develop policies to prevent cyberbiosecurity breaches,’ they write.” Peccoud also pointed to the potential for computer viruses to impact the physical world. Citing the 2010 computer virus that caused equipment failure at an Iranian nuclear plant, such malware could result in biological outcomes that could be dangerous. It doesn’t take much of a venture down the rabbit hole to think about the automated processes that are used in laboratories, especially high-containment labs, and how they could be damaging if commandeered for nefarious purposes. So what can be done? The first step is truly recognizing the threat – “The threats are bidirectional. And not all cyberbiosecurity threats are premeditated or criminal. Unintentional errors that occur while translating between a physical DNA molecule and its digital reference are common. These errors might not compromise national security, but they could cause costly delays or product recalls.” Synthetic biology and biotech have taken us to places we would’ve never dreamed of, but it’s critical that the ability to manipulate DNA be protected through proper measures and we protect the digital components as well. The growing attention to cyberbiosecurity also comes at a time when the FDA has issued a warning on DIY gene therapy, noting that “the sale of these products is against the law. FDA is concnered about the safety risks involved.” “Last month, Josiah Zayner, CEO of The Odin, which sells DIY biology kits and supplies through its website, posted a video in which he injected himself with the gene-editing tool CRISPR during a biohacker conference in California. That video has been viewed more than 58,000 times on YouTube. In its statement, which FDA Commissioner Scott Gottlieb tweeted on November 21, the same day it was posted to the agency’s website, the regulator took aim directly at companies selling CRISPR supplies intended for self-administration.”

Biodosimetry: A Future Tool for Medical Management of Radiological Emergencies                                                                                                                          How can we better manage patients in radiological emergencies? GMU biodefense PhD student Mary Sproull and professor/graduate program director Gregory Koblentz are looking at biodosimetry as a medical management tool for this very predicament. “The field of radiation biodosimetry has advanced far beyond its original objectives to identify new methodologies to quantitate unknown levels of radiation exposure that may be applied in a mass screening setting. New research in the areas of genomics, proteomics, metabolomics, transcriptomics, and electron paramagnetic resonance (EPR) applications have identified novel biological indicators of radiation injury from a diverse array of biological sample materials, and studies continue to develop more advanced models of radiation exposure and injury. In this article, we identify the urgent need for new biodosimetry assessment technologies, describe how biodosimetry diagnostics work in the context of a broad range of radiation exposure types and scenarios, review the current state of the science, and assess how well integrated biodosimetry resources are in the national radiological emergency response framework.”

Fellowship in Grand Strategy, Security, and Statecraft
The International Security Program of Harvard Kennedy School’s Belfer Center for Science and International Affairs and the MIT Security Studies Program at the Center for International Studies in the School of Humanities, Arts, and Social Sciences are launching a collaborative program to mentor the next generation of foreign policy scholars. The Project on Grand Strategy, Security, and Statecraft is made possible with support from the Charles Koch Foundation: a $1,846,200 grant to MIT and one for $1,853,900 to Harvard Kennedy School (HKS). Those interested in this fellowship should apply to the International Security Program Fellowship when the Belfer Center’s online application system becomes available on December 15, 2017.  Those desiring to apply before then may apply through MIT’s application system. For more information, click here.

National Academies Publication – Combating Antibiotic Resistance
The National Academies has released their latest report on a one health approach to the global threat that is antimicrobial resistance. “As of 2017, the emergence and spread of antimicrobial resistance continues unabated around the world, leaving devastating health and economic outcomes in its wake. Those consequences will multiply if collaborative global action is not taken to address the spread of resistance. Major drivers of antimicrobial resistance in humans have been accelerated by inappropriate antimicrobial prescribing in health care practices; the inappropriate use of antimicrobials in livestock; and the promulgation of antibiotic resistance genes in the environment.” The report focuses on the global momentum to counter AMR, microbial movements across the one health domain, utilization of social and behavioral sciences to combat AMR, R&D, and strengthening partnerships and international cooperation. AMR is a multi-sectoral, international problem that requires a One Health approach to combat it – reports like these are a critical step towards combatting AMR

Boston University’s Needle Gets the Greenlight
After years of controversy and $200 million in federal funds spent on a BSL 4 high-containment lab, the Boston University Lab “The Needle” is finally opening. Located in the heart of the city, local citizens raised substantial opposition over biosafety concerns for the neighboring areas. It’s taken nearly a decade to get to this point, but the Boston Public Health Commission gave the official greenlight for the lab to open. “The commission’s OK was the final step allowing the study of Biosafety Level 4 pathogens — those that have no treatment or vaccine, such as Ebola. Level 4 research could begin in a month or two at the facility, called the National Emerging Infectious Disease Laboratories. Facing fierce opposition from neighbors and others concerned that dangerous germs would escape, the biolab underwent more than a dozen years of risk assessments, public hearings, and failed lawsuits. It received more than 50 permits and approvals from federal, state, and city agencies, most recently passing muster a year ago with the US Centers for Disease Control and Prevention.”

Doreen and Jim McElvany Nonproliferation Challenge
To advance this goal, the Doreen and Jim McElvany Nonproliferation Challenge will recognize the most outstanding new ideas and policy proposals published in Volume 25 (2018) of the Nonproliferation Review. The Challenge will award a grand prize of $5,000, a $3,000 runner’s-up prize, and a $1,000 honorable mention prize. The deadline to submit is 11:59 pm/EST, July 6, 2018. However, due to the limited number of pages that we can publish in a single volume, eligible articles will be accepted for publication on a rolling basis. We therefore encourage interested authors to submit early. Decisions on the winners of the scholarly award will be announced in early 2019

Stories You May Have Missed:

  • Most Americans Think A Zombie Pandemic Is Likely – We recently stumbled across this survey and were surprised to find that while a surprisingly high number of Americans think a zombie plague is going to happen, few are prepared for it. “Only 9% of respondents considered it likely that undead zombies might ever walk the earth. Nearly three times that many respondents (28%) consider it likely that a worldwide epidemic of a neurological disease that makes people more aggressive and likely to lose control of their thoughts and motor functions.”

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

Pandora Report 12.1.2017

Are you registered for the Read-Out on the GHSA Summit in Kampala? Just a friendly reminder – we’ll be on hiatus next week as we attend the Biological Weapons Convention Meeting of States Parties. Make sure to look out for a packed newsletter on 12.15 as we’ll be covering both the Read-Out on the GHSA Summit and the BWC meeting! If you’d like real-time updates, check out our Twitter account @PandoraReport.

 Read-Out on the GHSA Summit in Kampala
Global health security on your lunch break? Only at the Read-Out on the GHSA Summit will you get lunch and an in-depth recap of this international health security event. Don’t miss this exciting opportunity to hear from global health practioners and young professionals who attended the 4th annual Global Health Security Agenda (GHSA) Ministerial Meeting in Kampala, Uganda in October. You’ll want to register ASAP for this exciting opportunity on December 4th, from 12-1:30pm at the George Mason University Founders Halls in Arlington. The GHSA meeting, Health Security for All: Engaging Communities, Non-governmental Organizations, and the Private Sector, was a multi-sectoral collaboration between governments, civil society, and industry dedicated to the strengthening of globaly capacity to prevent, detect, and respond to infectious disease threats. Attended by the ministers of health, finance, and agriculture and other senior officialfs from more than 50 nations, this was the first Ministerial GHSA Meeting held on the African continent. The meeting was held in late October at the same time as an unprecedented outbreak of pneumonnic plague in Madagascar and a rare outbreak of Marburg in Uganda itself. These outbreaks were timely, but unfortunate reminders, that global health security is still very much a work in progress. Our panel will include four participants who were on the ground in Kampala and actively engaged in this historical step forward for global health security. Attendees will have the opportunity to engage and hear the perspectives of esteemed public health practitioners and rising health security professionals. Lunch will also be provided. This event is free and open to the public.

Mason, Stanford Researchers Join Forces To Study The Science, Benefits And Dangers Of Genome Editing
GMU Biodefense researchers are teaming up with Stanford University to better address the complexities of genome editing and what it means for science, security, and governance. “The study is the only unclassified, independent academic project of its kind, said Gregory Koblentz, director of George Mason’s Schar School of Policy and Government biodefense graduate program and co-principal investigator. The Mason and Stanford researchers will examine scientific advances in the field of genome editing that can have benefits for human health and the bioeconomy, as well as the security aspects of preventing the misuse of this technology. They expect to deliver a suite of policy recommendations based on their research in summer 2018.” Genome editing has not been without controversy, as the technology allows the deletion and replacement of DNA within living organisms and many are concerned about the dual-use nature of such work. While there is potential to eradicate disease and strengthen agriculture, there is also worry that such technology will be misused for nefarious purposes or even poorly handled and result in negative outcomes. This collaborative effort is a huge step to ensuring we’re aware of the risks, benefits, and oversight needed for this exciting new technology.

Maintaining U.S. Investment in Global Health Security
Progress must continue on the global health security front and industrialized countries like the United States have a critical role in sustaining forward movement. “However, the work of the GHSA, including motivating and assisting countries to improve their capacities to prevent epidemics like Ebola from reoccurring, is now at a crossroad. Even though senior officials in the Trump administration have voiced support for the GHSA, and at a recent GHSA ministerial meeting in Uganda signed onto the Kampala Declaration to extend the GHSA for at least another 5 years, US funding for the initiative is ending and no commitment for future financial support has been made. Without additional funding, prospects for the next phase of the GHSA will be endangered. It is important for the United States to commit to support the GHSA to help protect the nation and the rest of the world from epidemic disease.” U.S. financial support encourages other countries to pledge funds but if our efforts waver, it may cause a domino effect. Not only does U.S. engagement encourage others to support the GHSA, but it also supports our own national security. “If vulnerable countries do not have the capacity to quickly cope with disease outbreaks, those outbreaks are more likely to spread internationally, including to the United States.” You can hear more about the importance of the GHSA from Jennifer Nuzzo (one of the authors of this paper) at the Read-Out on the GHSA Summit in Kampala event on December 4th!

Failure to Diagnose Monkeypox Highlights Nigeria’s Poor Health Infrastructure
Like most outbreaks, Nigeria’s monkeypox cases have exposed weaknesses in the country’s ability to rapidly identify and test potential patients. These inadequacies highlight gaps within their International Health Regulations compliance as there were no national labs that could test patients for the disease. “Consequently, for more than two weeks after the outbreak (from the September 22 to October 13), there was no conclusive confirmation that the suspected case was actually that of monkeypox. According to experts, the implication of this is that the country may be dealing with a dangerous outbreak, but unsure of what it is dealing with on time, thereby giving room for a lot of things to go wrong during the waiting period. For instance, during the waiting period for the monkeypox confirmation, different statistics on the actual number of cases were being bandied, even as the large number of suspected cases (94 cases) and the manifestation of the disease had already caused fright and panic.” Laboratory delays can be devastating to outbreak control as it can delay treatment, isolation, quarantine, and data collection. Public health laboratories are the early warning system in many ways. Many are drawing attention to these gaps as a way to reinforce the need to strengthen country-level laboratory infrastructure and capacity. The National Centre for Disease Control (NCDC) was established in 2011, but still is struggling to find the capacity to respond to health threats due to funding and personnel issues. As 14 more cases of monkeypox were reported in Nigeria, this services as a reminder of  why the GHSA is so vital!

The WHO Reports on Fake Drugs
This week the WHO released a report on medical products  that shed light upon the startling realities of patient safety and public health in low and middle income countries. The report, “Global Surveillance and Monitoring System for Substandard and Falsified Medical Products”, found that 1 in 10 products circulating in such countries are either substandard or fake. The findings of this report are extremely worrying as it means that people are taking medications intended to treat life-threatening ailments and they are either fake or not effective. In many cases, the individual is paying a considerable amount of money for such medications and can have severe medical complications from contaminated or expired products. “Substandard and falsified medicines particularly affect the most vulnerable communities,” says Dr Tedros Adhanom Ghebreyesus, WHO Director-General. “Imagine a mother who gives up food or other basic needs to pay for her child’s treatment, unaware that the medicines are substandard or falsified, and then that treatment causes her child to die. This is unacceptable. Countries have agreed on measures at the global level – it is time to translate them into tangible action.” You can read the report here. The report also cites some of the work being done around this endemic issue – 17 WHO training workshops, 126 Member States and more than 400 regulatory personnel trained, 1500 product reports, etc.

How Will We Handle Contamination On An Airplane?
What would happen if you were on a plane with a patient who had a highly infectious disease like SARS or Ebola? What’s our national plan to deal with such issues? Hint: we don’t have a plan. How do flight attendants or pilots relay to ground control that a patient or entire plane needs to be quarantined? These are all the sorts of questions that need to be considered when planning and responding to such events. How would we quarantine an entire plane? On February 7, 2011, such an event occurred – a pilot issued a public health emergency to the air traffic control tower in Milwaukee, WI, for 3 (of 115) passengers with flu-like symptoms. “Airport officials soon learned something interesting about Flight 703 that could point to the presence of a communicable disease. The plane included at least 12 people who had returned from Cozumel, Mexico, on a cruise in which many of the passengers had fallen ill with flu-like symptoms. The incident revealed gaps in America’s emergency planning for communicable diseases aboard planes — gaps that were still present four years later when the U.S. Government Accountability Office investigated. ‘The United States lacks a comprehensive national aviation-preparedness plan aimed at preventing and containing the spread of diseases through air travel,’ the GAO found.” Sadly, it seems as if there’s still no plan. The creation of such a plan would require collaboration between the CDC and U.S. Department of Transportation, and while meetings have occurred, it is reported that no one has taken the lead. So, how are airports currently handling infectious disease incidents? “The lack of uniformity in dealing with communicable diseases during air travel was evident when the National Academy of Sciences asked 50 different airports in the U.S. and Canada how they expect to learn of an incident aboard a plane. They found 15 different notification procedures.” Report after report has found a gap within these response efforts and with the holiday season upon us and airline travel to be busy, it seems that should a public health emergency arise, we may be flying by the seat of our pants.

 Flu Season is Upon Us!
Flu season is starting to hit the United States as the CDC reports an up-tick is influenza positive tests. A majority of the positive specimens have been Influenza A (78% are H3, 13% have been H1N1). “Three southeastern states are reporting high or widespread flu activity, and the CDC said it received reports of five more pediatric flu deaths. In its report, which covers the week ending Nov 18, the CDC also reported one more novel flu infection, an H1N1 variant (H1N1v).Globally, flu activity in the Northern Hemisphere is rising, with H3N2 and influenza B the most frequently detected strains, the World Health Organization (WHO) said yesterday in an update.” Flu season and vaccination compliance is increasingly becoming an issue even in healthcare – in fact, many hospitals are terminating employees who don’t get their flu shot. Remember – get your flu vaccine, stay home when sick, wash your hands, and cover your cough!

Stories You May Have Missed:

  • Exclusive Interviews: Tackling Regulatory and Economic Challenges of Antimicrobial Resistance – “It is imperative for medical experts and drug discovery specialists to stay on top of the latest clinical advancements, developments and industry initiatives related to antimicrobial resistance. SMi Group will gather industry experts and government bodies to share their insights at the 20th annual conference on Superbugs and Superdrugs taking place on 19-20 March 2018 in London, UK. SMi Group recently had the opportunity to sit down with three of the event’s featured speakers to discuss some of the challenges they face in the industry and their strategies for overcoming them.”
  • Raw Flour and E. coli – this whole time we thought it was the eggs in the cookie dough that were doing it, but it seems that flour may also be a culprit for foodborne illness! “Research published today in the New England Journal of Medicine describes how raw flour, an unlikely suspect, caused an Escherichia coli outbreak in 2016. Because of its low-moisture properties, flour was not thought to be a conduit of E coli bacteria, but a multistate team of investigators discovered that flour processed in one facility was linked to the outbreak.”

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