Pandora Report: 9.21.2018

U.S. National Biodefense Strategy
On Tuesday, President Trump released the National Biodefense Strategy, which “sets the course for the United States to combat the serious biothreats our country faces, whether they arise from natural outbreaks of disease, accidents involving high consequence pathogens, or the actions of terrorists or state actors. The strategy enables risk awareness to inform decision-making across the biodefense enterprise; ensures biodefense enterprise capabilities to prevent bio-incidents; strives for biodefense enterprise preparedness to reduce the impacts of bio-incidents; enables rapid response to limit the impacts of bio-incidents; and facilitates recovery to restore the community, the economy, and the environment after a bio-incident.” The strategy is implemented through a National Security Presidential Memorandum (NSPM), “Support for National Biodefense“. A Biodefense Steering Committee is to be established, which will be chaired by the Secretary of Health and Human Services. Robert Kadlec, HHS Assistant Secretary for Preparedness and Response, released a statement here, noting that “Coordination of such complex actions requires a sound strategy, commitment, and governance structure. As an initial step in implementing the strategy, leaders from every federal department involved in biodefense formed a steering committee, led by Secretary Azar, that provides strategic guidance in preparing for, countering, and responding to biological threats. I am honored that Secretary Azar asked me to lead the day-to-day coordination team that supports this committee in improving biodefense readiness.” The new strategy includes goals related to enabling risk awareness to inform decision-making, ensuring biodefense enterprise capabilities to prevent or reduce the impact of bioincidents, rapidly respond to limit the impacts of bioincidents, etc. Each goal has a series of measures regarding implementation and strategies. A personal favorite is Goal 2 (Ensuring Biodefense Enterprise Capabilities to Prevent Bioincidents) 1.1 and 1.2 – strengthening infection prevention measures domestically and internationally, and reducing the spread of antimicrobial-resistant pathogens domestically and internationally. Ultimately, the new strategy will “better coordinate the often overlapping efforts of 15 departments and agencies and 16 branches of the intelligence community.” Biodefense Twitter is also a great source for feedback on this – Check out Greg Koblentz here or simply search #biodefense.

 Passing of Raymond Zilinskas
The biodefense world is mourning the loss of Dr. Raymond Zilinskas this week – a man whose work helped to lay the foundation for the field. “Zilinskas was one of the world’s foremost experts on chemical and biological weapons. He directed the Chemical and Biological Weapons Program at the James Martin Center for Nonproliferation Studies (CNS) and taught courses on the subject since joining the Institute in 1998. Working as a clinical microbiologist, Zilinskas became interested in ‘the area where microbiological science meets policy and ethics,’ as he recounted in a 2016 interview in Communiqué. Much of what is now known about the Soviet biological weapons program from its inception in the 1920s comes from the 11 years of research Zilinskas and Milton Leitenberg conducted for their book The Soviet Biological Weapons Program: A History.” The Middlebury Institute of International Studies at Monterey also released this statement regarding Zilinskas – “As my CNS colleague Sandy Spector recalls, Ray was always ready to take his research into the field, even if that meant plucking fleas from a captured rodent in search of bubonic plague or inspecting the dilapidated storage facility of a post-Soviet Anti-Plague Institute. He also had a knack for writing about overlooked dimensions of the BW problem, including agro-terrorism, synthetic biology, and a major article in Scientific American on counterfeit Botox.”

Emerging Infectious Disease Issue – Influenza – The Mother of All Pandemics 
The latest CDC publication brings forth images of the 1918/1919 influenza pandemic with a colorful cover – a painting by John Singer Sargent of the interior of a hospital tent during the pandemic. The issue contains a wide variety of articles from Candida auris in healthcare facilities, to influenza epidemic predicting in Sweden, and more. City Lab‘s Linda Poon underscores 1918/1919 flu as the mother of all pandemics, noting that “When the first wave crept up in New York City during the spring, residents and officials alike saw it as just another round of the seasonal flu. By mid-summer, the number of related deaths waned, and that first wave barely received a mention in the health department’s weekly bulletins. A century later, though, historians remember the 1918 Spanish flu as the ‘mother of all pandemics‘.”

FDA Plan – Antibiotic Development & Stewardship
The FDA has released their goals for supporting antimicrobial stewardship in veterinary settings for FY2019-2023. “‘We can’t count on outracing drug resistance,’ FDA Commissioner Scott Gottlieb, MD, said in announcing the strategy. ‘But we can use stewardship and science to slow its pace and reduce its impact on human and animal health.’ Noting the agency’s role in overseeing and regulating drug development, safety, and use, Gottlieb said the strategy aims to combat AMR by addressing the ‘full continuum’ of antibiotic development and use in both humans and animals. ‘Because of the FDA’s statutory responsibility for assuring safe and effective products that promote and protect both human and animal health, we have a unique vantage point for coordinating all of these aspects of a product’s development and application to health,’ Gottlieb said.” The FDA release includes several goals – align antimicrobial drug product use with the principles of antimicrobial stewardship, foster antimicrobial stewardship in veterinary settings, enhance monitoring of antimicrobial resistance and antimicrobial drug use in animals, etc. Pew Charitable Trusts also released updated information regarding the pipeline of antibiotic development – “Of the 42 antibiotics in development, 15 were in Phase 1 clinical trials, 12 in Phase 2, 11 in Phase 3, and four have had new drug applications submitted. Two drugs had been approved by the FDA since Pew’s last analysis. Historically, about 60 percent of drugs that enter Phase 3 will be approved. (See the glossary of terms for descriptions of each phase.)” You can also read some of the live Tweeting from the FDA/Pew event that discussed this report here (or by searching #FDAatPew).

DARPA- Defense Advanced Research Projects Agency 1958-2018
Check out where we’ve been and where we’re going with this overview of DARPA’s history and innovative future plans. The online magazine includes a reflection from former directors, a mosaic of warfare, inventions of new materials for national security, future plans, and the tactical edge. Don’t miss the section on page 102 regarding security and surprise at biological scales, which focuses on biotechnologies and the threat of outbreaks. Goals of halting a pandemic within 60 days are discussed within this section, as are the medical countermeasures and diagnostics of responding to biological threats.

 Blue Ribbon Study Panel Meeting – Fits and Starts: Reactionary Biodefense
The next Blue Ribbon Study Panel On Biodefense meeting is on October 9th at 10am. “The Panel will examine our national experience with the anthrax events of 2001, Hurricane Katrina, Ebola, a primate research laboratory, and the H1N1 pandemic, to answer the question – are we better positioned today to defend the nation against today’s biological threats?” The panel meeting will include a section on dealing with anthrax, preparedness for the future, dealign with dangerous diseases, etc. Make sure to RSVP before October 2nd here, or watch via the live webcast!

The Rise of Resistant Staphylococcus Epidermis 
GMU Biodefense doctoral student Saskia Popescu discusses why the increasing resistance of a common skin bug is raising concern. “Staphylococcus epidermidis is a skin bacteria that is so prevalent, the US Centers for Disease Control and Prevention (CDC) classifies it as a common commensal for certain health care-associated infections. Its presence can cause infections, especially in patients with invasive procedures and compromised immune systems; however, the bacteria often fail to get the kind of attention that would make headlines. The results of a new study may soon change the wallflower status of S epidermidis. The results of this study reveal not only the genomic mutations and different lineages that result in resistant S epidermidis, but also the global spread. Given that resistance to rifampicin encourages resistance to other antibiotics, these findings should be weighed seriously as we consider what bacteria are considered normal and often ignored.”

Stories You May Have Missed:

• UK Monkeypox Healthcare Worker Exposure – A friendly reminder of why infection control is so important – “Because monkeypox was not immediately suspected in the most recent UK monkeypox case, healthcare workers (HCWs) were not wearing adequate personal protective equipment (PPE) and may have been exposed to the virus, UK officials reported today in Eurosurveillance. They also noted that the patient—the second recently reported by Public Health England (PHE), on Sep 11—had two potential exposures. The patient had contact with a person who had a “monkeypox-like rash,” and he also ate bush meat while visiting Nigeria. Nigeria has had 262 suspected and 113 confirmed monkeypox cases since September 2017.”
• Navy Researchers Work to Reduce Risk of Melioidosis Among Deployed Military – “Dr. Kevin Schully, contractor and chief science officer with Naval Medical Research Center’s (NMRC) Austere environments Consortium for Enhanced Sepsis Outcomes Department (ACESO) recently returned stateside after screening Sailors and Marines deployed to Darwin, Australia, who are at risk of developing melioidosis. While in Darwin, Schully used a tool he developed with colleagues to continuously screen U.S. forces serving in B. pseudomallei endemic areas. He asked volunteers to fill out a brief questionnaire and give blood samples at the beginning of their deployment, mid-deployment, and again post-deployment. Each time, samples were screened for serological evidence of infection and then compared to the questionnaire responses to identify potential risk factors.”
• Cyclospora Surges Linked to Tainted Produce – “The US Centers for Disease Control and Prevention (CDC) said yesterday that 2,173 lab-confirmed domestically acquired Cyclospora cases in 33 states were reported from May through August, markedly higher than the past 2 years, and that some of the illnesses reflect several restaurant clusters linked to contaminated basil and cilantro.”