Pandora Report 7.14.2017

Welcome to your weekly dose of all things biodefense! We’ve got a lot of global health security goodies for you this week, so grab a coffee and let’s get our biodefense on!

Canadian Researchers Reconstitute Horsepox With Online DNA Order
Friday was an exciting day in the world of dual-use research of concern (DURC) and biosecurity efforts. News of a Canadian research team and their successful experiment in reconstituting horsepox, brought to light several concerns and gaps within DURC oversight. Led by virologist David Evans, the team was able to synthesize horsepox, a relative of smallpox, which is no longer found in nature. What is really concerning so many about this experiment is that Evans and his team were able to do this with little specialized knowledge, $100,000, and using mail-order DNA fragments. While the study hasn’t been published, it is drawing a lot of attention, not only for the potential that such a process could be applied to smallpox, but also that it failed to trigger more reviews at an institutional level for DURC risks. While the U.S. DURC oversight only applies to federally funded research with fifteen select agents, the Canadian processes cover such research that could disseminate knowledge, regardless of what organism is being used. GMU’s Dr. Gregory Koblentz spoke to Science and discussed DURC oversight, noting, “That should have captured the horsepox synthesis,”. “But as far as I understand, they did not engage in a systematic review of the broader dual-use implications of synthesizing an orthopox virus,” says Koblentz. “I don’t think this experiment should have been done.” Researchers and biosecurity experts around the world are weighing in on this study, especially since its publication is immiment. Tom Inglesby of the Center for Health Security pointed to three serious questions and concerns that this work raises – whether experimental work should be performed for the purpose of demonstrating that a dangerous or destructive  outcome could be created by using biology, how much new detail will be provided in the forthcoming publication regarding the processes for constructing an orthopox virus, and the international biosecurity and biosafety implications regarding the approval process for such experimental work. Perhaps one of the most startling aspects of all the commentary and reports on the horsepox experiment has been Evans own opinion on it all – “Have I increased the risk by showing how to do this? I don’t know,” he says. “Maybe yes. But the reality is that the risk was always there.” Where ever you might stand on the topic of dual-use research, bioethicist Nicholas Evans of the University of Massachusetts (of no relation to David Evans), said it best regarding this debated experiment – “an important milestone, a proof of concept of what can be done with viral synthesis. Aside from the oversight and life science research questions that this experiment brings to light, it also stirs the embers of the fiery debate regarding the destruction of the remaining smallpox stockpiles. The most recent blue ribbon panel review regarding the 2014 NIH variola incident sheds some light on the biosecurity and biosafety challenges of maintaining the stockpiles. You can check out the report of the Blue Ribbon Panel to Review the 2014 Smallpox Virus Incident on the NIH Campus  here. The report goes through the event itself, as well as their findings on the incident, response to the incident, and policy changes. Some of the contributing factors they identified included lack of responsibility for infectious materials in shared space, failure to find all variola samples in the 1980s, lack of complete and regular inventory of potentially hazardous biological materials, lack of policy for abandoned materials, history of NIH lapses following implementation of the Select Agent Regulations, etc.

Summer Workshop – Last Chance to Register!
Our Summer Workshop on Pandemics, Bioterrorism, and Global Health Security starts on Monday, July 17th, which means you still have time to register! Don’t miss out on this wonderful opportunity to discuss everything from Ebola to the concerns surrounding the horsepox dual-use dilemma. This three-day workshop will feature experts across the field of biodefense and will provide participants with a wonderful opportunity for networking and brainstorming!

The Pentagon Weighs the Threat of Synthetic Bioweapons 
While the topic of synbio and DURC is still fresh in our minds, how is the Pentagon considering gene-editing as a potential threat? Sure, we prepare for natural outbreaks and acts of bioterrorism, but how does CRISPR come into the mix? “Pentagon planners are starting to wonder what happens if the next deadly flu bug or hemorrhagic fever doesn’t come from a mosquito-infested jungle or bat-crowded cave. With new gene editing tools like Crispr-Cas9, state enemies could, theoretically, create unique organisms by mixing-and-matching bits of genetic information.” In response to these questions and potential scenarios, deputy assistant secretary of defense for chemical and biological defense, Christian Hassell, is working to get some answers. Hassell and other Pentagon colleages funded a year-long review by the National Academies of Sciences to evaluate the health security threats of synbio. While the review is still going on, a preliminary report is undergoing “classified review” before it can be publicly released. This review will be vital to consider the future of gain-of-function research and other dual-use research of concern in the context of biodefense. “Scientists at the meeting expressed a range of ideas about how the military could best defend against biological threats. Sriram Kosuri runs a synthetic biology lab at UCLA that has developed libraries of DNA sequences that can be developed into new kinds of organisms. While he understands the possibility of a lab-engineered threat, he believes the Pentagon and federal health officials should focus on responding to emerging public health menaces rather than monitoring academic labs that use genetic manipulation tools. ‘There’s a legitimate threat of emerging viruses and we need to be prepared for those things,’ Kosuri said during a break in the meeting. ‘The tiny threat of engineered viruses is miniscule compared to that’.” The challenging part in all of this is that there’s no precedent – this is a new field of threat and risk analysis where historical examples are lacking. Hypothetical situations and response scenarios are the best we can offer, but some of the most valuable tools are the ones we already have, like surveillance or early-stage review processes.

Trump Appoints A Key Bioterrorism Position But Still Leaves Dozens Open
Biological threats aren’t just acts of bioterrorism, but also natural outbreaks or laboratory accidents. If the latest horsepox experiment hasn’t convinced you already, we live in a time of quite unique and diverse biothreats. The spectrum of threats requires an array of agencies and personnel with the skills and resources to prevent and respond to such an event. Unfortunately, we’re currently at a national disadvantage in terms of biodefense. If we look at just one small facet of biothreats (bioterrorism), the U.S. has twenty-six (now twenty-five with the nomination of Kadlec) major and vital roles that are vacant and have not been filled by the Trump administration. While some are awaiting confirmation, there are vacancies without even a nominee like the White House position of Director, Office of Science and Technology Policy. The Department of Health and Human Services is missing a surgeon general and assistant secretary for health (awaiting confirmation), while the U.S. Agency For International Development lacks a nominee for the assistant administrator for global health. There are just a few of the vital positions we rely upon for preventing and responding to acts of bioterrorism. In the wider context of all biological threats, it may not seem like much, but the truth is that these vacancies leave the U.S. in a dangerously vulnerable position. Fortunately, President Trump announced on Monday his plans to nominate Robert P. Kadlec of New York to be the Assistant Secretary of Health and Human Services for Preparedness and Response. “Currently, Dr. Kadlec is the Deputy Staff Director for the Senate Select Committee on Intelligence. Previously, he served as a Special Assistant to the President for Biodefense Policy for President George W. Bush. Dr. Kadlec holds a B.S. from the U.S. Air Force Academy; a M.D. from the Uniformed Services University of the Health Sciences, and a M.A. in National Security Studies, Georgetown University.” He was also the Director for the Biodefense Preparedness on the Homeland Security Council and aided in drafting the Pandemic and All-Hazard Preparedness Act, as well as conducting the biodefense end-to-end assessment (culminating in the National Biodefense Policy for the 21st Century). You can even watch Dr. Kadlec speak on C-SPAN at the Bipartisan Policy Center & Kansas State University forum on biodefense in October of 2016. Dr. Kadlec also directed the Blue Ribbon Study Panel on Biodefense during their efforts to establish guidance during critical biothreats.

Public Health Preparedness and Response National Snapshot 2017
The CDC just released their 2017 snapshot regarding U.S. public health preparedness and response, noting that “this year has shown us, once again, that we can’t predict the next disaster. But it has also shown us clearly how being prepared protects health and saves lives. Emergencies can devastate a single area, as we saw with Hurricane Matthew, or span the globe, like Zika virus. Disasters from 9/11 to Ebola have demonstrated that we absolutely must have people, strategies, and resources in place before an emergency happens.” Within the snapshot, there are four main sections- Prepare, Respond, Connect, and Looking Forward. Within these sections, you can look at Zika, laboratories as the front lines of America’s health, global training programs, delivering results through partnership, etc. I found the section on Health Security: How Is The U.S. Doing, quite interesting. They note that “as part of the Global Health Security Agenda, teams of international experts travel to countries to report on how well public health systems are working to prevent, detect, and respond to outbreaks. This process is known as the Joint External Evaluation.” The CDC and Office of the Assistant Secretary for Preparedness and Response (ASPR) work together to establish evaluators , etc. Thankfully, this position is in the process of being filled so that these efforts can move forward. While this snapshot captures the range of issues that must be covered in public health preparedness, it also draws attention to how vital the roles in each agency are, which makes the vacancies that much more impacting.

Summary of Key Recommendations – Meeting to Solicit Stakeholder Input on Forthcoming 2017 National Biodefense Strategy
The Johns Hopkins Center for Health Security, supported by the Open Philanthropy Project, recently held a meeting to discuss and consider the landscape of biological threats to the United States and what response measures, programs, and policies are in place, etc. Featuring members from across academia, industry, and government, these subject matter experts weighed in on this honest and frank discussion about U.S. biodefense strengths and weaknesses. There were several recommendations and topics that were discussed but some of the highlights include improving biosurveillance capabilities and laboratory network, performing risk assessments and characterizing threats, strengthening emergency response capabilities including decontamination efforts, prevention-related efforts, building global capacities for bio-threat preparedness and response, etc. They noted several components to improving U.S. biodefense – “internationally, laboratory and surveillance systems for early detection of new outbreaks will be most effective when they serve the needs of countries where they are housed. It will not work for the US to create systems to gather and export data that the US needs from countries if those countries do not get the information themselves and find it to be valuable.” In regards to healthcare system response and strengthening the workforce, the group pointed out that “national and international preparedness for biological threats requires a strong workforce, including public health experts and animal and plant disease scientists. To some degree, success at controlling infectious diseases in the US may have inadvertently resulted in workforce attrition in these fields. Federal support for developing the workforce in these fields is important”.

Strategies for Effective Biological Detection Systems: A Workshop
Don’t miss this workshop put on by the National Academies of Sciences on Monday, September 18th – Tuesday, September 19th. “The National Academies of Sciences, Engineering, and Medicine will host a two-day public workshop on strategies for effectively updating biological detection systems. The workshop will explore alternative effective systems that would meet requirements for the Department of Homeland Security’s BioWatch Program as a biological detection system for aerosolized agents. There will be a focus on systems or strategies that could be deployed by 2027, and enable indoor surveillance and dual-use with day-to-day environmental surveillance that would be of value to the public health and medical communities. There will also be a focus on the integration of improvements and new technologies into the existing biological detection architecture.”

MRSA Screening – Healthcare Prevention Methods for Resistant Germs & Swabbing Our Way To A Solution for Antibiotic Resistance
Antibiotic resistance is a growing global issue and one of the hotspots for transmission of resistant germs is in hospitals. Given that MRSA (Methicillin-resistant Staphylococcus aureus) is now a common bacteria in the community and healthcare world, hospitals are working to screen patients to ensure those with MRSA are isolated appropriately and they can stop the spread of infection. GMU biodefense PhD student and infection preventionist Saskia Popescu looks at MRSA screening practices within hospital intensive care units (ICUs) and the cost analysis that can make or break a program. Most hospitals utilize one of two approaches – preemptive universal precautions (isolate all ICU patients until microbiology labs can prove they are negative for MRSA) or targeted isolation (wait until labs come back and then isolate). Each tactic has benefits and weaknesses. Delays in isolation can translate to further spread of MRSA, while longer periods in isolation mean additional costs associated with isolation. A recent study evaluated these very two strategies and the “researchers found that the total cost of preemptive isolation ‘was minimized when a PCR screen was used ($82.51 per patient). Costs were $207.60 more per patient when a conventional culture was used due to the longer turnaround time.’ For ICUs that used targeted isolation, the researchers found that costs would be lowest when chromogenic agar 24-testing was used and not PCR.” What this study highlights is that there is inherently no best practice and that depending on laboratory capability, hospitals may have to plan their MRSA screening and isolation protocols off their microbiology department and cost centers. While hospitals are working to screen patients as a means of responding to microbial resistance, researchers are working against the clock to find solutions. Dr. Adam Roberts is one such innovative microbiologist in the UK who is using an old-school approach to respond to a new problem. Popescu was able to interview him regarding his Swab and Send program, which utilizes citizen scientists from around the world to collect samples that may help produce new antimicrobials from the environment. Roberts is working to utilize environmental samples that hold microorganisms which produce compounds that can help build new antibiotics. “The initiative also helps create a microbial database. For £30, Dr. Roberts’ team will send anyone a handful of sample tubes, a mailing envelope, and directions for what to swab (for example: a nutritious area bacteria would likely grow, likely something unsanitary). After you send back your swabs, you can check out Swab and Send’s Facebook page and see what microbes grew from the samples.” Check out Dr. Roberts’ comments on trends he’s seeing and how even GMU biodefense students are getting in on the swabbing!

Naval Research Lab Find High Prevalence of Antibiotic Resistance in Kenya
Microbial resistance has a way of popping up in even the most unexpected places and projects. The U.S. Navy Research Laboratory (NRL), U.S. Army Medical Research Directorate-Kenya (USAMRD-K), Kenya Medical Research Institute (KEMRI), and University of Washington, led a joint effort to evaluate intestinal tract bacteria and its resistance in patients across Kenya. The NRL-developed microarray they used is capable of detecting over 200 difference antimicrobial resistant genes. “These results suggest that there is selective pressure for the establishment and maintenance of resistant strains,” said Dr. Chris Taitt, research biologist, NRL Center for Bio/Molecular Science and Engineering. “This is potentially due to agriculture and prophylactic use of antibiotics and further suggests the need for more effective public health policies and infection control measures than those currently implemented.” “Specific to Kenya, widespread use of tetracycline in livestock production, use of trimethoprim/sulfamethoxazole (SXT) and chloramphenicol as first line therapeutics for typhoid, and prophylactic use of SXT in persons exposed to or infected with human immunodeficiency virus (HIV) might have contributed to the high prevalence of resistance.” Surveillance of antimicrobial resistance has been a struggle on an international level however, joint efforts like this are vital to not only establishing global standards and processes, but also highlighting the importance it has for military personnel abroad.

Stories You May Have Missed:

  • Agroterrorism Bill – a new bill was recently introduced by U.S. Rep. David Young (R-IA) and Sen. Pat Roberts (R-KS) regarding the preparedness of the U.S. agriculture, food, and veterinary systems. “The Securing Our Agriculture and Food Act requires the DHS Secretary, through the Assistant Secretary for Health Affairs, to ensure food, agriculture, animal, and human health sectors receive appropriate attention and are also integrated into the DHS’s domestic preparedness policy initiatives. The legislation specifically addresses issues seen after the 2015 avian influenza outbreak, which killed millions of turkeys, backyard flocks, and layer hens. It was the deadliest outbreak of avian influenza in Iowa’s history.”
  • What The G-20 Needs To Do To Fight The Next Ebola– The G-20 summit occurred last week in Hamburg and many were hoping for a renewed passion surrounding biological threats. While much attention was focused on climate change, there is also a call for efforts to prevent the next outbreak that will produce a pandemic. “Ultimately, strong health systems depend on communities, health workers, managers, researchers and other local stakeholders being empowered to respond to the inevitable, future waves of change we all face. At Health Systems Global, our members represent these multiple groups. Strengthening everyday resilience demands that we all — governments, donors, researchers, communities, health professionals — work with the resources that health systems already have — their people and relationships. This must be done as we take wider action to confront inequality at all levels. If we do not do that, then efforts to safeguard disease outbreaks will be meaningless.”

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