Happy Friday! We’re glad to start the weekend with a healthy dose of all things biodefense. Before we get too far down the nCoV-2019 rabbit hole…Senator Dianne Feinstein recently wrote a letter to DHHS regarding steps the department is taking to protect the U.S. against pandemics.
It’s almost that time of year and if you can’t make the January 28-30 ASM Biothreats conference, don’t worry – we’ll have great coverage. GMU Schar School Biodefense is sending graduate students to the conference to report out on these three days of all things biothreats. Check out previous years of our coverage here, where we provide detailed overviews of the talks and events. “ASM Biothreats is a one-of-a-kind meeting offering professionals in biodefense, biosecurity and biological threats the opportunity to exchange knowledge and ideas that will shape the future of this emerging field. ASM Biothreats offers a unique program that explores the latest developments and emerging technologies in the industry.”
The end of 2019 and the start of 2020 sees an uptick in discussion regarding artificial intelligence-driven weapons. Three of the world’s biggest plays – the United States, Russia, and China – are all strongly indicating that artificial intelligence (AI), considered a transformative technology, will be dominant in their respective national security strategies. Recent headlines on the topic include terms like “killer robots” and “Terminator-style war.” Indubitably, we are in an era of rapid and momentous technological advancement and discovery; however, the true application of these technologies is fairly narrow and now necessarily nefarious. Larry Lewis, a senior advisor for the State Department in the Obama administration and a member of the US delegation in the UN deliberations on lethal autonomous weapons systems, recently published an article in the Bulletin of the Atomic Scientists about the utility of AI in reducing the collateral damage of war. Lewis spent the last decade working to reduce the civilian casualties in war, and he found that such casualties were largely the result of inaccurate indicators regarding civilian presence or the misclassification of civilians as combatants. Though military applications of AI include autonomous weapons, this technology can also be employed to optimize automated processing to detection and as a decision aid to helping personnel interpret complex or vast sets of data. Though discussion tends toward the risks of AI technology, especially its military applications, Lewis endorses adding a new facet to the discussion that focuses on the benefits of AI technology in minimizing civilian casualties in warfare.
nCOV-2019 and the Wuhan Outbreak
The past few weeks have been busy with the news of this novel coronavirus cluster in Wuhan, China. Following the identification of it as a novel strain and the temporary name of nCoV-2019, public health authorities have been working to better understand the epidemiological aspects of the virus and how we can prevent further transmission. News of a case in Thailand, following travel to the affected region in China, quickly spread as it meant that cases were no longer contained in China. Interestingly, the Chinese woman whose infection was detected after her arrival in Thailand, had no exposure to the market that is considered to be the epicenter of the outbreak. “A new statement from the World Health Organization (WHO) today had several new details, including that the woman had not visited the Wuhan seafood market, which also sold live animals such as chickens, bats, and marmots, where most patients are thought to have been exposed. However, she reported regularly visiting a local fresh market before her symptoms began on Jan 5. That illness onset is later than that of the others infected in the outbreak, which ranged from Dec 8 to Jan 2, according to a Jan 12 update from the WHO. The incubation period for nCoV-2019 isn’t known, and authorities closed the seafood market on Jan 1.” 182 contacts are being monitored related to this case and eight febrile travelers at the Suvarnabhumi Airport have been isolated and tested (all were negative). Japan also confirmed their first case in a 30-year-old man who tested positive following a visit to Wuhan. On Thursday, officials released more information regarding a second family cluster in Wuhan (likely exposed via the same source), as well as findings from environmental testing at the market in Wuhan.
Antibiotic Tolerance Can Affect Combo Treatments, Study Finds
A team of scientists in Israel found evidence that antibiotic resistance in microbes may render combination therapies ineffective, a long-held fear that may now be reality. Combination drug therapy is a commonly used clinical method for treating infections caused by resistant microbes and to prevent the progression of resistance. This team monitored the evolution of Staphylococcus aureus strains in patients undergoing combination treatment and exposed the swift emergence of tolerance mutations trailed by the emergence of resistance. Tolerance mutation in antibiotics is a general term “used to describe the ability, whether inherited or not, of microorganisms to survive transient exposure to high concentrations of an antibiotic without a change in the MIC, which is often achieved by slowing down an essential bacterial process,” whereas antibiotic resistance is “the inherited ability of microorganisms to grow at high concentrations of an antibiotic, irrespective of the duration of treatment, and is quantified by the minimum inhibitory concentration (MIC).” After the discovery of tolerance to combination treatments in the S. aureus case, the scientists were able to expand the finding by measuring bacterial growth in Escherichia coli after drug combinations from four different antibiotic classes. Isolates with tolerance to norfloxacin and ampicillin promoted resistance in some of the combinations for treating E. coli. Therefore, the authors conclude that “rescue of resistance mutations by tolerance is a general phenomenon that may have crucial implications for the evolution of resistance in patients treated with combinations of antimicrobials.” A short article summarizing the study can be found here and the original publication can be found here.
WHO- Urgent Health Challenges for the Next Decade
The World Health Organization has released their list for the new decade – which was “developed with input from our experts around the world, reflects a deep concern that leaders are failing to invest enough resources in core health priorities and systems.” The list does not place challenges by priority, as they are all urgent and includes elevating health in the climate debate, delivering health in conflict and crisis, making healthcare fairer, expanding access to medicines, stopping infectious diseases, and more. Within each challenge, the WHO discusses what it is and what they are doing to help correct it.
While much attention has been to the novel coronavirus outbreak, more Ebola cases have been identified in the DRC. The latest situation report from The Who reports 8 new cases, including 3 in Beni.
Welcome to 2020! We’re excited to start the new year with a short newsletter to keep you up to date on all things biodefense.
Alcatraz of Viruses
The Island of Riems in the Baltic Sea, once inhabited by the Nazis for biological weapon research, is now a heavily restricted site for German scientists to develop vaccines against viruses. The island hosts the Friedrich Loeffler Institute, Germany’s National Institute for Animal Health, which is a hub for the study of pathogens like rabies, African swine fever, and Ebola, and maintains the primary objective of preparing for future infectious disease outbreaks. The deputy head of the Friedrich Loeffler Institute, Franz Conraths, dubbed the island to be the “Alcatraz of Viruses.” Given its nickname-sake, the island is subject to stringent security protocols in order to safely contain all pathogenic samples and protect researchers and visitors. Since 2008, the German government has invested over $300 million in the Institute for infrastructural upgrades; there are now 89 laboratories and 163 stables for the research animals within the facility. Animal welfare is an important pillar for the Institute, hence their efforts to minimize animal research and minimizing the suffering of any tested animal. That said, the potential for their vaccine research to save millions of human and animal lives, protect the livelihoods of farmers, and alleviate global hunger, according to the head of the diagnostics department, outweighs the desire to eliminate animal testing.
NAS Workshop Proceedings: Improving International Resilience and Response to Chemical, Biological, Radiological, and Nuclear Events
In October 2017, the National Academies of Sciences, Engineering, and Medicine (NAS) coordinated an international, science-based workshop in Tokyo regarding resilience to Chemical, Biological, Radiological, and Nuclear (CBRN) events. The CBRN resilience workshop, in collaboration with Niigata University and the Japan National Research Institute for Earth Sciences and Disaster Resilience (NIED), aimed to “increase understanding of the communication, interoperability, and coordination issues that arise among various international stakeholders who are responsible for responding to CBRN event.” Partakers included experts and representatives from the government/public sector, private sector and industry, international organizations, academia, and NGOs. The event included a simulation as well as various plenaries covering topics such as lessons from past CBRN events and strengthening collaborative capacity. The workshop included a Resilience Exercise that used an explosion created by the collision of a large Liquid Natural Gas Tanker into a chemical depot on the shore near the Tokyo Motor Show as its base scenario. The explosion was compounded when the adjacent industrial complex ignited and debris oil was launched into Tokyo Bay. The flames and smoke of the chemical fire travelled inland toward Tokyo, home to about 14 million people, and smoke is further spreading toward the Tokyo Big Sight complex. Additional simulation components include the challenges of responding to a cascading CBRN event and the difficulty stimulating multi-party discussion for rapid response and international cooperation. Examples of some of the issues recognized during the workshop include delayed information sharing, incongruent definitions and terminologies across organizations, and the lack of defined roles and responsibilities for response.
Antimicrobial Resistance – A New Plan For A New Year?
Since the CDC announced their latest report and findings that each year 2.8 million Americans are infected with a drug-resistant organism, 35,000 of whom later die, we can safely say we’ve got a big problem. Antimicrobial resistance (AMR) isn’t new though and the problem has been boiling up for decades however it seems that we’re starting to truly take it seriously. From rivers to traveling patients, it’s hard to escape resistant microbes. New efforts to invigorate surveillance/reporting, as well as stewardship initiatives and even addressing the drying pipeline of antibiotics, are all tactics that have been employed. In fact, this latest piece is the one that is perhaps the most damning – big pharma has all but fled the antibiotic R&D field and those start-ups courageous enough to try, are increasingly falling upon financial ruin. “Antibiotic start-ups like Achaogen and Aradigm have gone belly up in recent months, pharmaceutical behemoths like Novartis and Allergan have abandoned the sector and many of the remaining American antibiotic companies are teetering toward insolvency.” Sadly, this is only adding to the issue as it paints a grim image for those considering any investment in antibiotic R&D. Many are calling for government intervention to help address the push-pull dynamics of antibiotic development – noting that “If this doesn’t get fixed in the next six to 12 months, the last of the Mohicans will go broke and investors won’t return to the market for another decade or two,” said Chen Yu, a health care venture capitalist who has invested in the field. Another component though is the heavy push on stewardship and prescribing practices, which often makes hospitals and providers weary against using new antimicrobials. Adding to this sentiment, Dr. Rick Bright, BARDA Director and Deputy Assistant Secretary for Preparedness and Response, wrote on the need for better diagnostics for resistant infections. Dr. Bright shares his own experiences with a simple-turned-complex infection that required several antibiotics. From delays in diagnostics/treatment, to being on six antibiotics, this is a great personal account of what it’s like to have a resistant infection and the inherent limits of existing diagnostics. “The gardening incident gave me personal insight into the many challenges that confront medical professionals and every patient fighting a resistant infection. I am more committed than ever to overcoming this challenge, to identifying solutions, and to partnering with private sector to get ahead of antimicrobial resistant infections and protect our nation’s health security. I hope more potential industry partners will look closely at the problem and join me by partnering through programs like CARB-X, BARDA DRIVe and other BARDA-supported initiatives.”
Happy Friday fellow health security friends! We will be on holiday next week, but rest assured, your favorite source for all things biodefense will be back right after the New Year. We hope you have a lovely holiday – remember, wash your hands!
Speeding Ahead- the Pace of Biotech Democratization
Gryphon Scientific researchers recent discussed in Nature the fast pace of biotech development and the challenges of establishing regulatory oversight and policies. They underscored that to set about such a course would require considerable dedication and resources – both in terms of financial and personnel. But what really does the investment into democratizing biotech look like? In this novel approach, researchers analyzed the exact pace of biotech and what those timeframes for democratization of novel techs look like. “Our assessment provides evidence that novel technologies currently can complete this transition in less than 4.5 years from their discovery and may do so in less than 3.5 years by the end of the next decade.” Investigating 22 biotechnologies, they highlighted milestones that point to the spread of such tech from lab to easily accessible. This is a highly enlightening article and includes data on reproduction of biotechnology trends and regression analysis that helps predict current and future trends in both the development and spread of these biotechnologies. “These results underpin the necessity for constant review of the security implications of the democratization of powerful biotechnologies, and the proactive development of policies, oversight and guidance systems, to ensure that they are leveraged responsibly by those outside the established scientific community.” You can find the article here.
GMU Class on Medical Countermeasures
Spring semester is fast approaching and if you’re a GMU biodefense student, don’t miss out on the chance to take BIOD766: Development of Vaccines and Therapeutics with Dr. Robert House. The course analyzes the process of developing new medical countermeasures against biological weapons and emerging infectious diseases such as SARS and pandemic influenza. Special attention is paid to the scientific, technical, political, regulatory, and economic obstacles to developing new vaccines and therapeutics. Examines the causes and potential solutions of public and private sector failures. Dr. House is an expert in the field of MCMs and worked for more than 11 years at DynPort Vaccine Company in Frederick, Md., where he held the positions of VP of Science and Technology, Chief Scientific Officer and President. During this time he developed extensive experience in winning and managing large USG-funded programs for developing medical countermeasures. He previously worked at Covance Laboratories in Madison, Wis. and IIT Research Institute in Chicago, Ill., where he managed highly successful programs in immunotoxicology assessment. Don’t miss out on your chance to take this engaging class with one of the top minds in the field.
Smallpox Virus Stocks
9 December 1979 was the historic day on which smallpox was confirmed as eradicated. A few months later, the World Health Assembly (WHA) officially declared that “the world and all its peoples have won freedom from smallpox.” Yet, four decades later, two nations maintain a stockpile of the variola virus that causes smallpox: The United States and the Russian Federation. Smallpox is an infectious and disfiguring viral disease that plagued humans for thousands of years, so its eradication is, arguably, one of the greatest achievements of our species and the greatest achievement of modern medicine. These specimens are stored under high-security conditions at the US Centers for Disease Control and Prevention (CDC) laboratory in Atlanta and at Russia’s State Research Centre of Virology and Biotechnology (Vector) in Novosibirsk, a town in Siberian. The decision to maintain a store of the virus is based on the completion of five fundamental goals goals: (1) further research in case of disease reemerge, (2) vaccine improvement, (3)creation of new treatments, (4) development of antivirals, and (5) improvements in diagnostics methods. According to guidance by the WHO, the stocks will be maintained until those goals are realized; however, disagreement exists on the status of their completion. Last year, the US Food and Drug Administration (FDA) approved a new drug for smallpox treatment; however, the WHO’s Advisory Committee on Variola Virus Research concluded that another antiviral treatment is needed. Arguments against keeping these stockpiles include the risk of variola being used as a weapon of bioterrorism and the risk that an accident could spur an accidental release of the pathogen. Additionally, there exist fears of undeclared stocks and the intentions with those potential samples. David Relman, professor of microbiology and immunology at Stanford University, asserts that the arguments in favor of maintaining the stockpiles outweighs those of destroying them. Another expert, Grant McFadden, director of the Biodesign Center for Immunotherapy, Vaccines, and Virotherapy at Arizona State University, who remains on the fence about retaining or destroying stockpiles, states “A great deal has been achieved on the original research goals, but the argument that more remains to be done is hard to refute…It is important to have these debates about whether mankind should deliberately eliminate feared pathogens, or study them.” As the debate continues, the future of the US and Russian variola virus stockpiles remains to be seen.
Tis the season of giving and here are some great books to buy as a gift for others or keep for yourself. Mark Kortepeter’s Inside the Hot Zone: A Soldier on the Front Lines of Biological Warfare is being released soon – “During Kortepeter’s seven and a half years in leadership at USAMRIID, the United States experienced some of the most serious threats in modern germ warfare, including the specter of biological weapons during the Iraq War, the anthrax letters sent after 9/11, and a little-known crisis involving a presumed botulism attack on the president of the United States. Inside the Hot Zone is a shocking, frightening eye-opener as Kortepeter describes in gripping detail how he and his USAMRIID colleagues navigated threats related to anthrax, botulism, smallpox, Lassa, and Ebola.” Nathan Myers’ Pandemics and Polarization – Implications of Partisan Budgeting for Responding to Public Health Emergencies is also out, “Partisan divisions over policy in the U.S. Congress and rising disease threats put millions of Americans at risk. The Zika public health emergency is used to illustrate the key functions of coordination, providing countermeasures, and engaging in disease surveillance which the government must engage in during such an emergency. The author looks at how the standoff over Zika funding negatively affected the government’s response within federal agencies, as well as at the state and local level. Also examined in the book are serious threats still on the horizon that are expected to require strong government action in the future. Possible policies to avoid future gridlock are considered.”
GMU Biodefense December Graduates
We’re so excited to celebrate the graduation of several students from the Schar School biodefense graduate and certificate programs. PhD graduates include Margaret D.M. Barber (Dissertation Title: Call of Duty? How Insurgent Organizations Choose to Provide Social Services) and Katherine V. Paris (Dissertation Title: An Assessment of the Risk of Misuse of Genome Editing Technologies). Congrats to Rubi Izquierdo on graduating with a MS in biodefense. We’re also happy to announce several students who completed their graduate certificates in Biodefense: Global Health Security and Terrorism and Homeland Security – Kelly Choic, Dianna Del Valle, Hiwot Yohannes, Joe Bob Merriman, and Gula Tang. Congrats! Read more about our biodefense graduate programs here.
Chinese Gangs Spreading African Swine Fever
African Swine Fever (ASF) is a viral infectious disease that is fatal for pigs, domestic and wild, and it is obliterating the Chinese pork industry, which is the largest in the world. To put the severity into perspective, certain estimates indicate that the number of pigs in China that have died from ASF exceeds the number of pigs in the entire US pork industry. Recent reports by PRC state media claim that Chinese criminals are intentionally propagating the ASF outbreak in an effort to drive down domestic pork prices so that these criminals can smuggle the meat and sell it as safe product. These criminal efforts range from spreading rumors about ASF to using drones that drop fomites into healthy farms. ASF-related losses plummeted China’s herd stock by over 40% to date, both as a result of infections and mass culling to contain the disease. Shortages in pork products, a cultural and nutritional protein staple in China, surged prices to over double the pre-outbreak prices. The price drops provided opportunities for the criminals to exploit the situation. Gang members traffic pigs or meat, regardless of its health and safety, to regions with especially high prices and sell it. The profit margin can reach 1,000 yuan (US$143) per pig for smugglers, and estimates fear a further rise of ¥65-75 per kilogram in the near future. Further price surges are expected as the Lunar New Year approaches, further incentivizing criminal meddling in China’s already suffering pork industry.
Investigations into Chinese Lab Outbreaks
A painful truth: biosafety failures do occur…it’s the name of the game when working with dangerous pathogens. While we have the proper practices and safety processes to avoid exposures, human mistakes do happen. Currently, two Chinese agriculture research facilities are assessing how over 100 staff and students were not only exposed, but ultimately infected with Brucella. One institute, the Lanzhou Veterinary Research Institute reported 96 asymptomatic infections. Despite their forthcomings about the numbers, the institute has not released where the source of the exposure occurred. In the Harbin Veterinary Research Institute, it was reported last week that 13 students were infected with the zoonotic disease. “The outbreak at the Lanzhou Veterinary Research Institute was first uncovered in November when some students in the institute‘s foot and mouth disease research unit noticed that large numbers of their lab mice were infertile, according to The Beijing News. The mice tested positive for Brucella, as did four students. The institute then tested 317 people, and found that 96 had been infected.” Lab-associated infections with Brucella do occur frequently, as it is the most commonly reported bacterial infection in labs and the ease of aerosol transmission facilitates such cases. Sadly, this is not the first exposure and it will likely not be last, but it does give insight into the risks of such work and a clear need for heightened biosafety measures. You can read more here.
Mobile Lab Created Out of Ebola Frustrations
Often the greatest developments are created out of sheer frustration during situations – vaccines, biocontainment units, etc. In this case, a lab-on-wheels was developed to help combat outbreaks in countries that have limited laboratory resources. “A prototype was recently displayed at the annual American Society of Tropical Medicine and Hygiene (ASTMH) conference. The company that developed it, Greensboro, North Carolina–based Integrum Scientific, says the first vehicle may soon be tested in Uganda. Integrum Scientific’s lab units can be configured to provide on-site diagnostic capabilities for known pathogens or experimental diagnostics. This configuration also supports standard care during an outbreak or attack, providing routine chemistry, hematology, and blood products.” Check out the mobile lab here.
A Deep-Dive Into Samoa’s Measles Outbreak
Recent estimates put the outbreak on the small island at over 5267 cases with 73 associated deaths. Vaccination rates had dropped dramatically over the years, and were recently estimated at 31% prior to response efforts. The herd immunity threshold for measles is 93-95%, which means that the low rates of vaccination in Samoa were essentially a ticking time bomb. Thankfully, response efforts have gotten the islands vaccination rate up to 93%, which will hopefully slow the deadly outbreak. Currently, the island continues to be in a state of emergency, which was first declared in mid-November. The government has barred children 0-14 years of age from attending public gatherings and requires children of that age to also show proof of immunization prior to boarding inter-island ferries. “The government has also closed its offices (with the exception of public utilities) so that civil servants can aid in the response efforts. Response efforts have continued to pour in to help halt this devastating outbreak. The population of Samoa is just over 196,000 individuals and when there are more than 5000 cases, more than 2.6% of the population have been infected.” Read more here.
When A Lab Explosion Ruins Your Day – Stories of Vector
A few months back, an explosion at the Russian laboratory complex known as the State Research Centre of Virology and Biotechnology (Vector), raised a red flag regarding the stockpiling of smallpox and realistically, biosafety/biosecurity. Not surprisingly, stories about where the explosion occurred, what was kept in that area, and all manner of horror movie-esque plots began to swirl. Gwyn Winfield though, has broken down the rumors, the realities, and the challenges of understanding what exactly happened when well, there’s not a lot of trust in Russian explanations. Gwyn takes care to highlight how fast speculation occurred though, and that while it may not have been easy to get answers right away, the theatrics of lab-to-bioweapon speculation does little good. Noting that the blast occurred on the 5th floor of building one – “The floor had been under repair since July, and since there was no research in progress there, and the area was not secure, there were no pathogens on that floor to be released.” As Winfield notes, the lack of information makes things challenging and while experts might make guesses, “the individuals that need to take the most lessons from this are exercise planners, globally but especially in Russia”. You can read the full article here.
The Microbiome and AMR
Microbiota bear effects on a variety of chronic diseases such as gastrointestinal, autoimmune, respiratory, neurological, and cardiovascular conditions; however, the microbiome also plays a role with infectious diseases. The growing body of research on the importance of the microbiome to human health links natural flora and the immune system, which are in a largely symbiotic relationship. More specifically, a healthy microbiome aids in the induction, training, and function of the immune system and, in return, the immune system maintains a happy balance between natural flora and the host human. Unfortunately, that relationship is under great threat as the persistent overuse of antibiotics destroys not only the invasive bacteria but also the healthy bacteria that help maintain immune function. Antimicrobial resistance (AMR) is ability of microbes – bacteria, viruses, fungi – to circumvent the mediating effects of antibiotic, antiviral, and antifungal therapeutics. The overuse of antibiotics enables strong, resistant bacteria to survive in the host, so your gut ultimately populates with mostly resistant bacteria, even bacteria resistant to multiple drugs. Disruptions to the microbiome by antibiotic use adds to the spread and strength of antimicrobial resistance in harmful microbes. Our overreliance on the prescription of antibiotics to alleviate bacterial infections, even minor ones that the immune system may be able to overcome, and a lack of medication compliance resulting in misuse are chipping away at the clinical efficacy of these drugs. This is of considerable concern as microbes become cleverer and less susceptible to multiple medications, resulting in infections that are less and less treatable. According to the CDC, there are over 2.8 million antibiotic-resistant infections in the US each year and more than 35,000 people die from those infections. The critical task at hand is to develop alternative therapeutics that can treat infections while, at least, not contributing to further microbial resistance. As a mediator for colonization resistance and a symbiote of the immune system, the microbiome possesses potential as a therapeutic gateway to subvert resistance.
Biodosimetry Biomarkers and Serum Proteomic Signatures – GMU Biodefense Alum Tackles It All
GMU Biodefense doctoral student Mary Sproull is our resident guru on radiation – she’s a biologist in the Radiation Oncology Branch of the National Cancer Institute at NIH. Here are just two more reasons why Sproull is the go-to person for things like biodosimetry: she has two new publications that you’ll want to check out. The first, Comparisons of Proteomic Biodosimetry Biomarkets Across Five Different Murine Strains (try saying that five times fast) “seeks to compare the expression levels of five previously established proteomic biodosimetry biomarkers of radiation exposure, i.e., Flt3 ligand (FL), matrix metalloproteinase 9 (MMP9), serum amyloid A (SAA), pentraxin 3 (PTX3) and fibrinogen (FGB), across multiple murine strains and to test a multivariate dose prediction model based on a single C57BL6 strain against other murine strains.” Make sure to read this study as it discusses why these strain specific differences exist between expression levels. In the second article A Serum Proteomic Signature Predicting Survival in Patients with Glioblastoma, Sproull and the research team discuss this common brain tumor and how developing adequate biomarkers can help drive stronger patient outcomes. “Analysis of potentially relevant gene targets using The Cancer Genome Atlas database was done using the Glioblastoma Bio Discovery Portal (GBM-BioDP). A ten-biomarker subgroup of clinically relevant molecules was selected using a functional grouping analysis of the 40 plex genes with two genes selected from each group on the basis of degree of variance, lack of co-linearity with other biomarkers and clinical interest. A Multivariate Cox proportional hazard approach was used to analyze the relationship between overall survival (OS), gene expression, and resection status as covariates.”
Advancements in biotechnology pose potentials and perils as such technology becomes easier to access and use by a wide array of bio-users, not just formally trained scientists at professional laboratories. Gene editing, the alteration of an organism’s DNA, is one such biotechnology. A number of research and government entities are working diligently to maximize the potential benefits of gene editing while simultaneously minimizing its perils. Two such entities are the National Academies of Sciences, Engineering, and Medicine and the Defense Advanced Research Projects Agency (DARPA). The former is concerned with perils of synthetic biology while the latter is trying to unlock its potential. The National Academies of Sciences, Engineering, and Medicine just released Strategies for Identifying and Addressing Vulnerabilities Posed by Synthetic Biology: Proceedings of a Workshop in Brief, which summarizes the key discussions in an October 2018 meeting of experts and policymakers following a report for the DOD, Biodefense in the Age of Synthetic Biology. The meeting’s purpose was to assemble federal personnel and the committee for the DOD report to consider the implications for actions DOD might take to quell potential misuse of synthetic biology capabilities. The committee evaluated 12 capabilities associated with (1) the synthesis and modification of pathogens; (2) production of chemicals, biochemicals, and toxins; and (3) modulation of human physiology. Each of the three capability areas were assigned relative levels of concern in terms of the usability of a technology, its usability as a weapon, its requirements of actors, and the potential for its mitigation. Additional workshop discussions included the potential of delivery mechanisms to serve as a barrier to the misuse of synthetic biology to produce weapons, the possibility to use synthetic biology to modify human physiology in new ways, and opportunities in computational biology to alleviate fears about synthetic biology capabilities through the prevention, detection, and attribution of its misuse. DARPA’s latest biotechnology project is the “Detect It with Gene Editing Technologies” program, more lovingly called DIGET. The primary objective of DIGET is “to provide comprehensive, specific, and trusted information about health threats to medical decision-makers within minutes, even in far-flung regions of the globe, to prevent the spread of disease, enable timely deployment of countermeasures, and improve the standard of care after diagnosis.” The DIGET dream deliverables are two devices: (1) a handheld and disposable point-of-need tool that simultaneously screens 10 or more pathogens or host biomarkers and (2) a multiplexed detection platform that simultaneously screens at least 1,000 clinical and environmental samples. DIGET seeks to incorporate gene editors and detectors biosurveillance as well as swift point-of-need diagnostics for endemic, emerging, and engineered pathogens. DARPA is hosting a Proposer’s Day meeting about the DIGET program on 11 December 2019.
Biological Threats to U.S. National Security – Subcommittee on Emerging Threats and Capabilities
On Wednesday, Dr. Thomas V. Inglesby, Dr. Tara J. O’Toole, and Dr. Julie Gerberding gave testimony to this subcommittee within the U.S. Senate Committee on Armed Services. During the testimony, Dr. Inglesby “noted the growing threat of biological events that can emerge from nature, deliberate attack, or accidental release and reviewed current US government efforts in this arena. He presented recommendations to improve the government’s response to and preparedness for a major biological event.” You can read his full testimony here.
Revisiting the Biological Weapons Convention Protocol Lynn Klotz recently wrote on the gaps within the BWC in relation to compliance monitoring. Despite efforts to change this in the past, those pushing for a protocol to randomly select site visits as means to do quality checks, have been disappointed over the years as administrations cite that such additions would not truly verify or provide greater security. As Klotz underscores – this sentiment fundamentally misses the goal of the protocol…which is transparency. “But recent events serve to underscore that a protocol to the convention to address the treaty’s shortcomings is an idea that should be revisited. Unfounded Russian allegations about biological weapons development in former Soviet countries are threatening the effectiveness of the convention. This concern along with strong arguments for the high importance of transparency in international treaties calls for revisiting the protocol, which had provisions for both transparency and for dealing with allegations like Russia’s.” Citing the 2019 meeting in which Russia alleged that several former Soviet states had active bioweapons programs, distrust soon grew and disruption rippled throughout the BWC. Klotz emphasizes that this exact situation is a prime reason why a protocol should be revisited – to help build confidence through increasing transparency. Not a free-for-all, but rather through managed-access rules, such as random visits by inspection teams would help verify the absence of bioweapons. Klotz takes care to discuss why protocol efforts were abandoned in 2001 and the role of transparency in multilateral arms control regimes, which you can read more about here.
GMU Hosts Health Security Career Panel
Last week, adjunct professor Ashley Grant, a lead biotechnologist at the MITRE Corporation, held a career panel at the Schar School of Policy and Government at George Mason University as part of her course on Global Health Security Policy. To highlight the different paths that graduate students in the Biodefense program can take in the health security field, Professor Grant convened a diverse panel of health security practitioners to discuss their jobs and the skills they have needed to succeed. The panel included professionals from a variety of different backgrounds ranging from local health providers to Federal employees. Students in the Schar School’s Biodefense Graduate Program were able to ask the panelists about the challenges of moving from a technical career path into science policy and opportunities for internships. The panel included Stuart Evenhaugen of the Assistant Secretary for Preparedness and Response (ASPR)’s Strategy Division in the Department of Health and Human Services (HHS); Syra Madad, the Senior Director of System-Wide Special Pathogens Program at NYC Health + Hospitals; Halley Smith, a program lead with the U.S. Department of State Cooperative Threat Reduction Program, on detail from Sandia National Laboratories Global Chemical and Biological Security Program; Sapana Vora, the Deputy Team Chief for the U.S. Department of State’s Biosecurity Engagement Program (BEP) and Iraq Program in the Office of Cooperative Threat Reduction (CTR); and Malaya Fletcher, a Lead Scientist at Booz Allen Hamilton in Washington, DC. The panel also included LTC Justin Hurt a CBRN/WMD Organizational Integration Officer in the Army G-3/5/7 Office who is currently enrolled in the Biodefense PhD program. As biodefense graduate student Michael Krug noted, “The panel was immensely valuable in providing detailed insights and experiences into each of the panelist’s unique career paths. Emphasizing the demand for multi-disciplined approaches, as well as active communication to answer the many health security questions facing the world.”
A Little Bit of Plague and A Whole Lot of Panic
Plague – a word that still sparks fear after hundreds of years. Two cases were recently reported in China’s Inner Mongolia and of course, it involved a hunter and butchering/eating a wild animal. Diagnosed on November 5th, there were two additional cases reported in Beijing but from the Inner Mongolia area. “In both cases, the two patients from Inner Mongolia were quarantined at a facility in the capital after being diagnosed with pneumonic plague, health authorities said at the time. The Inner Mongolia health commission said it found no evidence so far to link the most recent case to the earlier two cases in Beijing.” As many have pointed out, the fear around this news has been more damaging to response efforts. Pneumonic plague is not as highly contagious as many news outlets have let on – only requiring Droplet + Standard isolation precautions and plague is easily treatable with antibiotics or prophylaxis.
Should We Be Celebrating CRISPR’s Anniversary?
It’s not many times an expert and innovator writes an article entitled “CRISPR’s unwanted anniversary” about a tech they were instrumental in developing. Dr. Jennifer Doudna recently wrote on those moments that can make or break a disruptive technology and in the case of CRISPR, it was last year, when Hong Kong-based scientist He Jiankui started the CRISPR baby drama. This was a pivotal moment in not only biotech, but also genome editing and its future. As Doudna notes, it’s comforting that scientists around the world reacted with conversations about the need for safeguards and transparency as CRISPR technology grows. In the face of this anniversary though, what has been done? Are there consequences for going against widely accepted norms? Doudna leaves us with the notion that “The ‘CRISPR babies’ saga should motivate active discussion and debate about human germline editing. With a new such study under consideration in Russia, appropriate regulation is urgently needed. Consequences for defying established restrictions should include, at a minimum, loss of funding and publication privileges. Ensuring responsible use of genome editing will enable CRISPR technology to improve the well-being of millions of people and fulfill its revolutionary potential.”
Hot Spots and Inadequate Monitoring for Bioterrorism – An American Story
Law professor Ana Santos Rutschman of Saint Louis University recently wrote on the usual and unusual biological suspects and how organisms like Salmonella can easily be overlooked as cases of bioterrorism (case in point the 1984 Oregon attack). Rutschman delves into preparedness efforts, like BioWatch, and how “there is a profound lack of coordination between federal agencies and local communities. When asked about what happens after notifications of a possible bioterrorism attack, Dr. Asha George, executive director of the Bipartisan Commission on Biodefense, answered: “They go off but nobody knows what to do.”
Stories You May Have Missed:
Ongoing Outbreaks Trigger Laws to Limit Vaccine Exemptions – in the middle of measles outbreaks and pertussis cases occurring frequently, there is a desperate need for reducing vaccine exemptions that protect the anti-vaccine instead of the public’s health. “In 2018, the same research group published a study showing that, despite rising numbers of proposed antivaccine laws, pro-vaccine bills were more likely to become law. For the current study, the team looked at how health data might affect laws. The new findings come following a surge of measles activity in the United States this year, mostly fueled by a few large outbreaks that nearly cost the nation the measles elimination status that it achieved in 2000.”
Acinetobacter Baumannii Risk Factors– “After assessing 290 isolates, they found that 169 were endemic (96 of REP-1) and the most common site for isolation was the respiratory tract. In total, 109 patients (37%) had only Acinetobacter baumannii isolated, while some had up to 5 other organisms also identified. In those colonized, 69 were REP-1, and 64 with REP-2-5, the research team found that for those patients with REP-1, there was a 70% increase in carriage per increase in Schmid score (statistically significant), and a 50% increase in REP-2-5. Interestingly, prior colonization, longer lengths of stay, and immunosuppression did now have a statistically significant relationship with Acinetobacter baumannii colonization. “
Stevie is a part-time PhD student in the GMU Biodefense program, and a full-time transportation security analyst. Her area of study is extreme right wing terrorism and WMD.
In June 2019, FBI leadership testified to the House Oversight and Reform Committee that “individuals adhering to racially motivated violent extremism ideology have been responsible for the most lethal incidents among domestic terrorists in recent years, and the FBI assesses the threat of violence and lethality posed by racially motivated violent extremists will continue.” In September 2019, the Department of Homeland Security published a Strategic Framework for Combating Terrorism and Targeted Violence, which acknowledges that “white supremacist violent extremism…is one of the most potent forces driving domestic terrorism” and “another significant motivating force behind domestic terrorism has been anti-government/anti-authority violent extremism.” A few weeks later, William Braniff, director of START at the University of Maryland, testified to the Senate Homeland Security and Governmental Affairs Committee that “among domestic terrorists, violent far-right terrorists…are responsible for more…pursuits of chemical or biological weapons…than international terrorists.” Just as policymakers have been slow to acknowledge and act upon the threat of domestic CBRN terrorism, timely extant research on the issue is scarce as well. In this article, I focus on ricin as an agent of domestic terror. As government agencies acknowledge the threat domestic terrorism poses, policymakers and law enforcement should take ricin seriously as a potential weapon.
To understand the plausibility of ricin’s use as a weapon, I reviewed a number of journal articles, news articles, and court records from 1978 through 2019 and compiled data on 46 incidents of ricin acquisition and/or use. Of these 46 incidents, 19 could be credibly tied to terrorism, 19 were not related to terrorism, and 8 were unclear. The most common motivation after terrorism was murder (10 instances). Of the 19 terrorist incidents, 58% were committed by extreme right-wing terrorists, a term that here encompasses the following ideologies: neo-Nazi/neo-fascist, white nationalist/supremacist/separatist, religious nationalist, anti-abortion, anti-taxation, anti-government, and sovereign citizen. The remaining incidents were committed by Islamist terrorists (16%), Chechen nationalists (10%), or their exact ideology was unclear (16%). Continue reading “What Can We Glean from a Bean: Ricin’s Appeal to Domestic Terrorists”→
Russian Virology Research Center Hit By Blast/Fire
In perhaps not the best of places to have a gas-cylinder explosion, the Russian Virology Center, Vektor, is causing a bit of concern around the world. Cue the conversations regarding the destruction of smallpox stockpiles…”Russia’s consumer-safety watchdog Rospotrebnadzor said on September 16 that one worker was sent to hospital for third-degree burns suffered in the incident at the State Research Center of Virology and Biotechnology (Vector) near the Russian city of Novosibirsk. It added that no biohazardous substances were present in the sanitary inspection room at the time of the fire. The city’s mayor, Nikolai Krasnikov, said the laboratory, on the fifth floor of a six-story building in the city of Koltsovo, was undergoing renovation and repair work at the time of the incident. All glass in the building was said to have been broken in the blast. A fire covering about 30 square meters was extinguished after the explosion. In the 1970-1980s, the research center developed biological and bacteriological weapons, as well as means of protection against them.”
Preparedness for a High-Impact Respiratory Pathogen Pandemic
The Johns Hopkins Center for Health Security has just released their report, which “examines the current state of preparedness for pandemics caused by ‘high-impact respiratory pathogens’—that is, pathogens with the potential for wide- spread transmission and high observed mortality. Were a high-impact respiratory pathogen to emerge, either naturally or as the result of accidental or deliberate release, it would likely have significant public health, economic, social, and political consequences. Novel high-impact respiratory pathogens have a combination of qualities that contribute to their potential to initiate a pandemic. The combined possibilities of short incubation periods and asymptomatic spread can result in very small windows for interrupting transmission, making such an outbreak difficult to contain. The potential for high-impact respiratory pathogens to affect many countries at once will likely require international approaches different from those that have typically occurred in geographically limited events, such as the ongoing Ebola crisis in Democratic Republic of the Congo (DRC).”
UK Vaccine Network – Mapping Pathogens of Pandemic Potential
Do you know what the United Kingdom is doing to develop vaccines against pandemic pathogens? “During the 2013–2016 Ebola outbreak in West Africa an expert panel was established on the instructions of the UK Prime Minister to identify priority pathogens for outbreak diseases that had the potential to cause future epidemics. A total of 13 priority pathogens were identified, which led to the prioritisation of spending in emerging diseases vaccine research and development from the UK. This meeting report summarises the process used to develop the UK pathogen priority list, compares it to lists generated by other organisations (World Health Organisation, National Institutes of Allergy and Infectious Diseases) and summarises clinical progress towards the development of vaccines against priority diseases. There is clear technical progress towards the development of vaccines. However, the availability of these vaccines will be dependent on sustained funding for clinical trials and the preparation of clinically acceptable manufactured material during inter-epidemic periods.”
Global Preparedness Monitoring Board
In their very first report, the GPMB “reviewed recommendations from previous high-level panels and commissions following the 2009 H1N1 influenza pandemic and the 2014-2016 Ebola outbreak, along with its own commissioned reports and other data. The result is a snapshot of where the world stands in its ability to prevent and contain a global health threat.” The report includes actions for leaders to take, like commitment and investment from heads of government, building strong systems, and preparing for the worst. For example, they note that “Donors, international financing institutions, global funds and philanthropies must increase funding for the poorest and most vulnerable countries through development assistance for health and greater/earlier access to the United Nations Central Emergency Response Fund to close financing gaps for their national actions plans for health security as a joint responsibility and a global public good. Member states need to agree to an increase in WHO contributions for the financing of preparedness and response activities and must sustainably fund the WHO Contingency Fund for Emergencies, including the establishment of a replenishment scheme using funding from the revised World Bank Pandemic Emergency Financing Facility.”
Blue Ribbon Study Panel Becomes Bipartisan Commission on Biodefense
At their latest event, the Blue Ribbon Study Panel announced it would be “taking on a new name to more accurately reflect its work and the urgency of its mission. Effective immediately, the organization now will be known as the Bipartisan Commission on Biodefense. ‘We do not simply study the problem,’ said Executive Director Dr. Asha M. George. ‘We conduct our activities with a self-imposed mandate and the same sort of urgency that congressional commissions demonstrate. Moving forward, we will be the Bipartisan Commission on Biodefense. Our leadership team and unyielding focus remain unchanged.’ The organization was established in 2014 to comprehensively assess the state of U.S. biodefense, and to issue recommendations to foster change. The Commission will continue to be co-chaired by former Senator Joe Lieberman and former Governor Tom Ridge, the first Secretary of Homeland Security.”
NAS Workshop – Public-Private Partnerships for Global Health at the National, Municipal, and Community Levels
Don’t miss this National Academies event on October 23rd and 24th in Washington, D.C. “The National Academies’ Forum on Public-Private Partnerships for Global Health and Safety is convening a 1.5 day workshop to examine the enabling environments for public-private partnerships (PPP’s) at the national, municipal, and community levels. Panelists will provide case studies that focus on the mechanics of building a partnership in a region, the conditions the private sector needs to establish itself in a region, and how a country becomes PPP-ready to accept private partners. The panelists will include: the private sector actors who established a business in a region; the government representative who worked with the private sector actors to create the conditions for private sector involvement; and the intermediary who helped to facilitate the partnership. Additionally, local business owners who distribute the products from larger businesses, or that develop their own businesses within a region, will be brought in to discuss the conditions they need at the local level to form sustainable business models. Intermediaries that work to facilitate global partnerships will also give a broader view of how partnerships are enabled.”
Efforts to Reduce Nosocomial Ebola Transmission
Today there were 15 new cases of Ebola virus reported in the DRC, bringing the case counts to 3,145. Ongoing violence has been a concern, but the growing number of nosocomial infections is also worrisome. “In the wake of this outbreak, the threat of health care-associated infections has grown and thus far 18% of the outbreak cases are nosocomial. The ability for hospitals and treatment centers to act as amplifiers in the middle of an outbreak is not a novel concept. Unfortunately, this number is deeply concerning and represents critical breakdowns in infection control measures. In addition to the avoidable cases, the high number of nosocomial cases is also a driving factor for many to avoid care within the treatment centers. Consider an already skeptical community, and now include the fact that nearly 1 out of 5 cases occur as a result of exposure within a medical setting. Not only can this fuel fear and apprehension to seek care within the community, but it also can put health care workers in danger. In response to this trend, the WHO is partnering up with agencies like the United Nations Children’s Fund, and the US Centers for Disease Control and Prevention (CDC) to help boost health care response and infection prevention in the 3000 nurses, physicians, and health care workers responding to the outbreak.”
Big Pharma Drops New Drugs Despite Drying Antibiotic Pipeline
Despite the continued warnings of the drying antibiotic pipeline and the growing threat of antimicrobial resistance, the pharmaceutical world has shown little interest in investing in the production of new antimicrobials. These costly efforts are a considerable hurdle for companies as a new class of antibiotics is desperately in need. “According to an in-depth report from German public broadcaster NDR this week, the reason for this lack of preparation for the impending crisis is simple: Antibiotics simply aren’t profitable. Antibiotics are only used for a few days once in a while, and are being prescribed less as doctors become more aware of the dangers of overprescription. Instead, drug companies are focusing on lucrative medications for chronic conditions such as high cholesterol, arthritis, epilepsy and cancer. Johnson & Johnson, Sanofi, Pfizer, AstraZeneca, Novartis, Otsuka and many others have all gutted their antibiotic development teams and moved those budgets elsewhere. This is despite a 2016 pledge signed by over 100 companies, including Johnson & Johnson and Novartis, saying they would help prevent the next epidemic by investing in ways to combat the rise of antibiotic-resistant superbugs.”
Stories You May Have Missed:
Rising Cases of EEE in Massachusetts – “Eastern equine encephalitis (EEE) virus—a rare but often fatal mosquito-borne virus—has been found in Massachusetts for the first time since 2013. Since the beginning of August, seven people in the state have tested positive for the virus, and one woman from Bristol County has died from the illness. State officials have additionally found the virus in 400 mosquito samples.”
The Future of Duodenoscopes – “Over the years, these scopes have shown a propensity for making the transmission of multidrug-resistant organisms easier than we anticipated. There continues to be a strong infection control and regulatory focus on reprocessing to ensure patient safety. The flexible medical devices are used to help visualize and assess not only the small intestine, but also the pancreas and bile ducts. Since they products are reusable, the complex, error-prone process of reprocessing becomes critical to avoid disease transmission between patients. Unsurprisingly, there has been increased pressure to move to avenues that reduce the risk for patient exposure and promote safety during these procedures. On August 29, 2019, the US Food and Drug Administration (FDA) put forth a recommendation that both duodenoscope manufacturers and health care facilities alike, should move towards those scopes with disposable components, specifically the endcaps.”
Alumna Spotlight: Biodefense Grad Tam Dang, Dallas County Epidemiologist
“Tam Dang started in the biology world, earning her Bachelor’s of Science degree from George Mason University in 2008. But it was her course of study in the Master’s in Biodefense program at the Schar School that put her on her present career path. The degree, she said, ‘introduced me to the public health field, and offered a unique perspective from a biosecurity and bioterrorism standpoint.’ Today, Dang is an epidemiologist for the Dallas County Department of Health and Human Services in Dallas, Texas. She works in the Acute Communicable Disease Epidemiology Division, helping to lead epidemiological investigations for infectious disease outbreaks or potential bioterrorism events. She monitors local, regional, and state data sources related to infectious diseases, and helps develop outbreak and bioterrorism plans to help support public health preparedness. Her work is at the intersection of public health and health security, an important field in the modern era.”
BioWatch Data Stored on Vulnerable Contractor Website for Years
Well that’s a big oops… “For more than a decade, the Department of Homeland Security failed to properly secure sensitive information on the primary BioWatch information portal, which contained bioterrorism surveillance testing information and response plans that would be put in place in the event of an attack. In August 2016, Harry Jackson, who worked for a branch of Homeland Security that deals with information security, was assigned to the BioWatch program. Three months later, he learned about biowatchportal.organd demanded the agency stop using it, arguing that it housed classified information and that the portal’s security measures were inadequate. A security audit completed in January 2017 found ‘critical’ and ‘high risk’ vulnerabilities, including weak encryption that made the website ‘extremely prone’ to online attacks. Internal Homeland Security emails and other documents reviewed by the Los Angeles Times show the security issue set off a bitter clash within the department over whether keeping the information on the dot-org website run by Logistics Management Institute posed a threat to national security.”
Oversight of Lab-Created Potential Pandemic Pathogens and the BWC
Lynn C. Klotz discusses accidental releases and research with pathogens of pandemic potential in relation to the Biological Weapons Convention. “Seeding a pandemic is not a problem for future consideration; the possibility is upon us now. There is an urgent need for international oversight and regulation of this research. The countries that are party to the Biological Weapons Convention (BWC) may not believe it to be within the BWC mandate to oversee academic research whose goal is public health. But if the parties decide this kind of oversight is within the BWC mandate (under Article XII), guidelines and regulations could be enacted fairly quickly. At the very least, the parties could act as a catalyst, launching discussions toward a new international treaty on oversight and regulation of this dangerous research. In the meantime, since enacting new treaties is an uncertain and long process, the BWC parties should work to pass legislation in their nations.” Klotz breaks down if such a release could result in a pandemic and if those pathogens could be classified as a biological weapon. “For lab-created potentially pandemic pathogens, any quantity, however small, could seed an outbreak or pandemic. In this circumstance, development also implies production and stockpiling, since a single vial of infectious agent and one to a few infected individuals are all that is necessary to launch an attack. From a military tactical point of view, however, lab-created pandemic pathogens would not be good biological weapons; they would boomerang back on the attackers since they are highly transmissible. Nonetheless, a suicidal terrorist group or a desperate country might employ them as a last resort, or threaten to employ them as a means of extortion.” Klotz ultimately notes that there is a need for action from the parties of the BWC – “Hopefully, the states that are party to the BWC will set in motion a process for overseeing relevant new research and technologies. If they decide that lab-created potentially pandemic pathogens are within the BWC mandate under Article XII, they could speed up the enactment of guidelines and regulations.”
Data Collection Gaps Are Damning the Ebola Outbreak
The outbreak in the DRC is continuing to spread as 14 new cases were reported on Wednesday and the South Kivu cluster has grown by 5, bringing the outbreak closer to 3,000. GMU Biodefense PhD alum Saskia Popescu discusses the implications of the data gaps within the current Ebola outbreak in the DRC. “Late last week 2 Ebola virus disease (EVD) cases were confirmed in the South Kivu region of the Democratic Republic of the Congo (DRC), some 400 miles away from where the outbreak first began. The cases were reported in a woman, who had been vaccinated, and her child who had traveled from Beni. The government is currently working to vaccinate and monitor 120 contacts of these 2 individuals. In the face of this expanding outbreak that has surpassed 2700 confirmed cases, there has been much attention on the drug and vaccine trials that are ongoing. Unfortunately, in the fervor of excitement surrounding the promise of treatment, few have paid attention to the quality of data that is made available. Pierre Rollin, MD, a veteran Ebola fighter, recently drew attention to some deeply concerning issues in the outbreak response in an article in TheLancet Infectious Diseases. Rollin underscored that although there was initial confidence in the response to the outbreak, mostly due to therapeutics and experienced personnel, leadership and coordination failures amid a conflict zone and community mistrust all helped the outbreak spiral. One component of Rollin’s review is deeply concerning—the ‘ineffectiveness of the collection, analysis, and diffusion of epidemiological data, the centerpiece of any response, is predictive of the situation worsening.’ Similar to what was felt by many on the ground during the 2014-2016 West African Ebola outbreak, the various databases between agencies, groups, etc., all made situational awareness and response that much more challenging.”
How Does USAMRIID’s Shutdown Impact US Biodefense and Bioterrorism Laboratory Response Network?
“The Laboratory Response Network (LRN) is a collaborative federal effort run by the U.S. Centers for Disease Control and Prevention in cooperation with other federal agency and public health partners. Most state public health laboratories participate as reference laboratories of the LRN. These facilities support hundreds of sentinel laboratories in local communities throughout the U.S. and its territories, providing confirmatory diagnosis and typing of biological threats used in a bioterrorist attack or causing a public health emergency. The U.S. Army Research Institute of Infectious Diseases (USAMRIID) Special Pathogens Laboratory at Fort Detrick is one of only three National Laboratories at the top of the protective umbrella of the LRN structure, along with those operated by the CDC and the Naval Medical Research Center (NMRC), responsible for specialized characterization of organisms, bioforensics, select agent activity, and handling highly infectious biological agents. It begs the question then, what happens when an important component of the nation’s biopreparedness infrastructure fails to meet CDC biosafety requirements and has its Federal Select Agent certification pulled? Global Biodefense submitted requests to USAMRIID and the CDC on Aug. 6 for information on the status of the Institute in the LRN structure and whether another Biosafety Level-4 laboratory will be designated as an interim substitute National Laboratory.”
Identifying and Responding to Newly Resistant Infections
“In the world of growing antimicrobial resistance, the identification of patients with highly resistant (or newly resistant) infections is critical. Because this is an emerging challenge, national and international surveillance efforts are still being strengthened to tackle all the avenues that contribute to antimicrobial resistance. The frontline identification of these newly resistant infections is critical though and surveillance is not only the first step in identifying and understanding the problem, but it also allows us to properly isolate the patient to avoid further transmission. Bacteria like Klebsiella pneumoniaeare increasingly developing resistance to antimicrobials and can easily be spread through health care facilities. Klebsiella bacteria are also showing a relatively new resistance to the carbapenem class of antibiotics. Typically, these bacteria cause infections like pneumonia, bloodstream infections, wound or surgical site infections, and even urinary tract. A recent publication in the US Centers for Disease Control and Prevention’s (CDC) Morbidity and Mortality Weekly Report (MMWR) described experiences surrounding the identification of a Klebsiella pneumoniae isolate that had 3 carbapenem-resistant genes (CR-Kp) and was related to urinary procedures.”
NTI’s Educational Resources
Whether you’re a student or an educator, you’ll love these resources from NTI’s Education Center. “You’ll find teaching tools, such as the new Building Security Through Cooperation report about working with North Korea on denuclearization and Middle East Missile Mania, our new comprehensive interactive map and analysis detailing the history of missile programs in 12 countries across the Middle East. Do you want to know more about what’s making headlines but only have a few minutes to catch up? We have a new U.S.-Russian arms control infographic and a one-page fact sheet on the INF Treaty. You may also want to watch our 3-minute video about the importance of the New START treaty. Those wanting a deeper dive for their advanced classes might want to check out our updated Global Incidents and Trafficking database, which tracks global incidents involving nuclear or other radioactive material, or the North Korea Missile Test Database.”
Stories You May Have Missed:
Outbreak of Resistant Salmonella Newport Tied to Soft Cheese-“The Centers for Disease Control and Prevention (CDC) today detailed an unusual 255-case outbreak of Salmonella Newport infections in 32 states tied to both beef and soft cheese and showing resistance to multiple antibiotics. ‘Infections were linked to beef obtained in the United States and soft cheese obtained in Mexico, suggesting that this strain could be present in cattle in both countries,’ the CDC said in an overview emailed to physicians as part of its Clinician Outreach and Communication Activity (COCA) efforts.
Welcome to your favorite source for biodefense nerdom! We hope your week was wonderful and you’re ready for a dose of health security news…
STEM: An Open Source Tool for Disease Modeling Have you been looking for a good epidemiological modeling software? Lucky for you, there’s STEM (Spatiotemporal Epidemiologic Modeler) and one of GMU’s very own biodefense doctoral alums, Nereyda Sevilla, was part of a team who published on how great this software is. “The Spatiotemporal Epidemiologic Modeler (STEM) is an open source software project supported by the Eclipse Foundation and used by a global community of researchers and public health officials working to track and, when possible, control outbreaks of infectious disease in human and animal populations. STEM is not a model or a tool designed for a specific disease; it is a flexible, modular framework supporting exchange and integration of community models, reusable plug-in components, and denominator data, available to researchers worldwide at www.eclipse.org/stem. A review of multiple projects illustrates its capabilities. STEM has been used to study variations in transmission of seasonal influenza in Israel by strains; evaluate social distancing measures taken to curb the H1N1 epidemic in Mexico City; study measles outbreaks in part of London and inform local policy on immunization; and gain insights into H7N9 avian influenza transmission in China. A multistrain dengue fever model explored the roles of the mosquito vector, cross-strain immunity, and antibody response in the frequency of dengue outbreaks. STEM has also been used to study the impact of variations in climate on malaria incidence. During the Ebola epidemic, a weekly conference call supported the global modeling community; subsequent work modeled the impact of behavioral change and tested disease reintroduction via animal reservoirs. Work in Germany tracked salmonella in pork from farm to fork; and a recent doctoral dissertation used the air travel feature to compare the potential threats posed by weaponizing infectious diseases. Current projects include work in Great Britain to evaluate control strategies for parasitic disease in sheep, and in Germany and Hungary, to validate the model and inform policy decisions for African swine fever. STEM Version 4.0.0, released in early 2019, includes tools used in these projects and updates technical aspects of the framework to ease its use and re-use.”
GMU Biodefense Fall Courses – Are You Registered?
The start of the Fall semester is just around the corner and if you’re a GMU biodefense graduate student, you’ve got a great menu of courses this term. There are still open spots in three courses – Global Health Security Policy taught by Ashley Grant (lead biotechnologist at the MITRE Corporation and previously the Senior Biological Scientist at the Government Accountability Office where she led government-wide technical performance audits focused on biosafety and biosecurity issues), Nonproliferation and Arms Control with Richard Cupitt (Senior Associate and Director of the Partnerships in Proliferation Prevention program at Stimson and prior to joining Stimson, he served as the Special Coordinator for U.N. Security Council resolution 1540 in the Office of Counterproliferation Initiatives at the U.S. State Department from 2012 through 2016.), and Biosurveillance with Andrew Kilianski (GMU professor and CINO for the Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense JPEO-CBRND). These are just a handful of the classes but since there are a few spots left in each, now is your change to grab a seat!
GMU Biodefense MS and PhD Open Houses
Have you been considering investing in your education and career through a graduate degree in biodefense? Check out one of our Schar School Open Houses to get a feel for what the MS and PhD programs are like – you can chat with faculty, students, and learn more about the coursework and application process. The Master’s Open House will be at 6:30pm on Thursday, September 12th, and the PhD Open House will be at 7pm on Thursday, September 19th – both will be held at our Arlington campus in Van Metre Hall.
Ebola Outbreak – New Cases in Remote Areas
Late last week two remote regions in the DRC reported cases of Ebola virus disease – North and South Kivu, of which there hadn’t been cases for several incubation periods. Moreover, there were 27 cases reported over 3 days, bringing the outbreak closer to 2,900. “According to Reuters, DRC officials today confirmed a new case of Ebola in the remote, militia-controlled territory of Walikale, which is 95 miles northwest of Goma. Goma recorded four cases of Ebola in the last 6 weeks, and it is unclear if the case in Walikale had any contact with other Ebola patients. Reuters also reported the DRC confirmed a third case in South Kivu region, which reported its first case late last week. South Kivu is more than 430 miles from the outbreak’s epicenter. The first cases in South Kivu were a mother and child who were likely exposed in Beni. For almost a year, the DRC’s Ebola outbreak—the second largest in history—was contained to North Kivu and Ituri provinces along the country’s eastern border.” Unfortunately, there has also been transmission within healthcare facilities where patients are being treated, as infection control is increasingly a challenge. “The World Health Organization (WHO) said today the third case of Ebola identified in South Kivu province was in a patient who contracted the virus at a health center where other Ebola patients had been treated. The details on the nosocomial transmission emerged in the WHO’s latest situation report on the ongoing Ebola outbreak in the Democratic Republic of the Congo (DRC). In the past week, two more DRC regions far from outbreak hot spots have reported cases: South Kivu province and Pinga health zone, which is in North Kivu province. The WHO is still investigating how the case-patient in Pinga contracted the virus, but investigations have shown a mother and child in Mwenga, South Kivu, became infected after contact with a patient from Beni, the city most hard hit by the outbreak this summer. The two towns are about 473 miles apart, and South Kivu province shares a border with Rwanda and Burundi.” The Department of Health and Human Services (HHS) is helping via $23 million funding towards Merck’s Ebola vaccine production. The WHO also just released their list of eight lessons being applied to the DRC outbreak in a “Ebola then and now” segment. This list includes things like putting research at the heart of response and supporting survivors.
Syria: Anniversary of the Ghouta Chemical Weapons Attack
The U.S. State Department recently released a statement on the attack that occurred six years ago. “On August 21, 2013, the Assad regime launched a horrific chemical attack with the nerve agent sarin on the Ghouta district in Damascus – killing more than 1,400 Syrians, many of them children. On this solemn anniversary we remember the numerous lives lost to the Assad regime’s use of chemical weapons. We reiterate our resolve to prevent further use of these deadly weapons and to hold the Assad regime accountable for these heinous crimes. The regime’s barbaric history of using chemical weapons against its own people cannot and will not be forgotten or tolerated. Assad and others in his regime who believe they can continue using chemical weapons with impunity are mistaken. The United States remains determined to hold the Assad regime accountable for these heinous acts and will continue to pursue all efforts alongside partner countries to ensure that those involved in chemical attacks face serious consequences. We will continue to leverage all of the tools available to us to prevent any future use. We condemn in the strongest possible terms the use of chemical weapons anywhere, by anyone, under any circumstances.”
Stories You May Have Missed:
Packed Dorms Help MERS Transmission – Crowded living spaces and a high stress environment encouraged the transmission of a respiratory virus? Shocker… “New findings from an investigation into a large MERS-CoV cluster in a women’s dormitory revealed that crowded living conditions can lead to higher attack rates and hints that even healthcare workers who don’t directly care for patients can play a role in disease spread. In other developments, Saudi Arabia reported one new MERS-CoV (Middle East respiratory syndrome coronavirus) case.”
NIH Study to Offer Genetic Counseling – “A US government study that aims to sequence the genomes of one million volunteers will partner with a genetic-counselling company to help participants understand their results. It will be the largest US government study to provide such a service. The National Institutes of Health (NIH) is leading the project, called All of Us. And on 21 August, the agency announced the award of a US$4.6-million, 5-year grant to Color. The firm, in Burlingame, California, will counsel every study participant with a genetic variant that could have serious health implications — such as BRCA mutations associated with breast cancer — when they receive their results. Color will also develop educational materials for all study participants, and will offer telephone consultations to anyone who wishes to discuss their results with a counsellor.”
Pandemic Bonds – Designed to Fail Ebola
Is the World Bank’s funding approach to outbreak response hurting the DRC during their fight against Ebola? Olga Jones discusses how the Pandemic Emergency Financing Facility (PEF) works and how it is ultimately helping investors but not health security. “The World Bank has said that the PEF is working as intended by offering the potential of ‘surge’ financing. Tragically, current triggers guarantee that payouts will be too little because they kick in only after outbreaks grow large. What’s more, fanfare around the PEF might have encouraged complacency that actually increased pandemic risk. Following false assurance that the World Bank had a solution, resources and attention could shift elsewhere. Rather than a lack of funds, vigilance and public-health capacity have been the main deficiencies. When governments and the World Bank are prepared to respond to infectious-disease threats, money flows within days. In the 2009 H1N1 influenza outbreak in Mexico, clinics could diagnose and report cases of disease to a central authority that both recognized the threat and reacted rapidly. The Mexican government requested $25.6 million from an existing World Bank-financed project for influenza response and received the funds the next day.” Jones notes that “the best investment of funds and attention is in ensuring adequate and stable financing for core public-health capacities. The PEF has failed. It should end early — and IDA funds should go to poor countries, not investors.”
Maximizing Opportunities for US Bioeconomy Growth and National Security with Biology
“Recently, the Johns Hopkins Center for Health Security and Gingko Bioworks convened key science, technical, academic, and industry experts for a meeting to solicit stakeholder input on specific ways that national policy can strengthen the US bioeconomy. Their recommendations are synthesized in a summary report, released today. Participants considered the benefits to the US if its bioeconomy were to be expanded; examined the current health of the US bioeconomy; discussed existing US government programs, policies, and initiatives related to the bioeconomy; and identified priorities for strengthening the US bioeconomy.”
DRC Ebola Outbreak Updates Beni and Madnima continue to be hotspots for the disease as they have accounted for 60% of recent cases, not to mention ongoing violence and unrest. “The security situation increased in volatility as a result of a surge in attacks from suspected ADF elements in Beni Health Zone and successive demonstrations,” the WHO said. “A recent attack in Mbau on the Beni/Oicha axis led to the deaths of six civilians, including a prominent civil society leader. EVD operations in the area were temporarily suspended with resumption pending improvement in the security situation.” On a more positive note, two outbreak treatment trials are showing promise. “An independent monitoring board meets periodically to review safety and efficacy data, and at their Aug 9 review recommended that the study be stopped and all future patients be randomized to receive either Regeneron, an antibody cocktail, or mAB 114, an antibody treatment developed from a human survivor of the virus. The other two drugs involved in the original trial were zMapp, which in an earlier trial didn’t show statistically significant efficacy but performed better than standard care alone, and Remdesivir, an antiviral drug. Earlier in the outbreak, an ethics committee in the DRC approved the four experimental treatments for compassionate use, and patients at all of the country’s Ebola treatment centers have had access to them, along with safety monitoring. However, the formal clinical trial has been under way since November at four treatment centers with the help of the Alliance for International Medical Action (ALIMA), the International Medical Corps (IMC), and Doctors Without Borders (MSF). At a media telebriefing today, Anthony Fauci, MD, director of the National institute of Allergy and Infectious Diseases (NIAID), said Regeneron was the drug that crossed the efficacy threshold, triggering a pause in the study. And he said the group recommended proceeding with mAb 114, because there were only small differences in the data between the two drugs.”
Combatting Legionella and Carbon Footprints
Can we reduce the burden of Legionnaire’s disease while reducing our carbon footprint? GMU Biodefense PhD student and infection preventionist Saskia Popescu discusses a new strategy to preventing this water-based bug. “Typical health care control methods range from routine sampling to temperature control measures, like keeping cold water below 20°C and hot water at a minimum of 60°C. This has been the tried and true approach to Legionella control since there will always be some small level of the bacteria in water and the ultimate goal is to avoid growth that can cause human disease. Investigators in the United Kingdom recently published a study assessing a large health care facility’s approach to reducing Legionella risk through use of copper and silver ionization at hot water temperatures that were deliberately reduced to 43°C within a new water system. The research team collected 1589 water samples between September 2011 and June 2017, looking for not only Legionella bacteria, but also copper and silver ion levels, and total viable counts. To also assess the internal costs and function of this system, investigators collected data on energy consumption and water usage.”
2015 HPAI Outbreaks in the US – Insight Into Airborne Transmission
“The unprecedented 2015 outbreaks of highly pathogenic avian influenza (HPAI) H5N2 in the U.S. devastated its poultry industry and resulted in over $3 billion economic impacts. Today HPAI continues eroding poultry operations and disrupting animal protein supply chains around the world. Anecdotal evidence in 2015 suggested that in some cases the AI virus was aerially introduced into poultry houses, as abnormal bird mortality started near air inlets of the infected houses. This study modeled air movement trajectories and virus concentrations that were used to assess the probability or risk of airborne transmission for the 77 HPAI cases in Iowa. The results show that majority of the positive cases in Iowa might have received airborne virus, carried by fine particulate matter, from infected farms within the state (i.e., intrastate) and infected farms from the neighboring states (i.e., interstate). The modeled airborne virus concentrations at the Iowa recipient sites never exceeded the minimal infective doses for poultry; however, the continuous exposure might have increased airborne infection risks. In the worst-case scenario (i.e., maximum virus shedding rate, highest emission rate, and longest half-life), 33 Iowa cases had > 10% (three cases > 50%) infection probability, indicating a medium to high risk of airborne transmission for these cases. Probability of airborne HPAI infection could be affected by farm type, flock size, and distance to previously infected farms; and more importantly, it can be markedly reduced by swift depopulation and inlet air filtration.”
Serbia Suspects African Swine Fever – Implications for Imports
One Health in a nutshell – the economic implications of zoonotic diseases like African swine fever (ASF). “Serbia has reported four suspected outbreaks of African swine fever among backyard pigs, the Paris-based World Organisation for Animal Health (OIE) said on Monday, prompting neighbouring countries to ban imports of the animals. Three of the cases were detected in the Belgrade area and one in the district of Podunavski, the OIE said, citing a report from Serbia’s Agriculture Ministry. The suspected cases of the disease killed seven pigs while another 114 were slaughtered, the report showed. Bosnia, Montenegro and North Macedonia banned imports of pigs, wild boar and related products from Serbia to prevent the spread of the outbreak, the countries’ veterinary authorities said.”
A New Drug to Tackle Extensively Drug-Resistant TB
XDR-TB is a disease that causes significant health issues on a global scale and the effort to try and treat can be costly. A “new drug, pretomanid, has been approved by the US Food and Drug Administration (FDA) for use in a treatment for XDR-TB. Amazingly, it’s the first time that a treatment for XDR-TB infections has been recognized for actually working—no other treatment has demonstrated any consistent effectiveness. Up until now, people with XDR-TB had to suffer through up to two years or more of toxic treatment that worked only one third of the time. Today’s news means that treatment time is drastically reduced—to six months—while the effectiveness of treatment is significantly improved. We welcome this approval as it shows the real-world impact of US government investment in finding new cures and vaccines for the world’s deadliest diseases. The developer of pretomanid, the nonprofit organization TB Alliance, could not have succeeded in advancing this breakthrough without support from the American people, through the US Agency for International Development (USAID) and National Institutes of Health (NIH).”
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Mega Malaria Vaccine Test Postponed in Kenya – “Kenya has postponed a large-scale pilot test for a malaria vaccine that could reduce the burden of the disease. The World Health Organisation (WHO) chose Malawi, Ghana and Kenya to vaccinate 360,000 children per year; and while the two nations began the rollout in April, Kenya is yet to start. The introduction in Kenya, planned for this Thursday, was postponed by the Ministry of Health. ‘I regret to inform you that the stakeholders breakfast meeting planned for this Tuesday, August 13, and the launch planned for Thursday, August 15, have been postponed to a later date to be communicated to you shortly. This is due to the upcoming Health Summit scheduled on August 14 and 15,’ head of the National Vaccines and Immunisation Programme, Dr Collins Tabu, said.”
Launch of the 2019 Next Generation Biosecurity Competition
Are you a global health security and biosecurity student or professional? “NTI | bio is partnering with the Next Generation Global Health Security (GHS) Network to advance the biosecurity and biosafety-related targets of the Global Health Security Agenda (GHSA). Together, we are launching the third annual joint competition to foster a biosecurity professional track within the Next Generation GHS Network. The 2019 competition will spur next generation experts in health security to discuss catalytic actions that can be taken to reduce biological risks associated with advances in technology and promote biosecurity norms. For the 2019 Next Generation for Biosecurity Competition, we will publish creative and innovative papers that promote regional, multi-sectoral, and global collaboration. Each team can include up to three people and should: 1) explore concrete collaborative actions that can be taken to build national, regional, and global norms for preventing deliberate and/or accidental biological events; and 2) promote cross-sectoral and cross-regional partnerships to advance biosecurity and biosafety. Papers should directly address the biosecurity targets included within the World Health Organization Joint External Evaluation and the GHSA Action Package on Biosecurity and Biosafety (APP3).” If you’re a GMU biodefense student or alum – you’re in luck as we’ve got a Next Generation Global Health Security Network chapter (membership is a requirement for the competition).
CSIS- Federal Funding for Biosafety Research is Critically Needed
The Center for Strategic & International Studies (CSIS) has just released their report on why we desperately need to provide funding for biosafety research in the face of new biotech and emerging infectious disease threats. “Currently, we lack the evidence basis to take new, needed measures to prevent accidents in biological laboratories, which, as mankind continues to expand its capabilities to manipulate life (including the viruses and bacteria that cause disease), leaves us more vulnerable to the accidental initiation of disease outbreaks with potentially dangerous consequences locally, regionally, and beyond. New biotechnologies are enabling scientists to design or modify life in ways not previously possible. These biotechnologies enable professional and amateur researchers to use simple life forms (e.g., bacteria and yeast) to create simple sensors and produce industrial chemicals, materials, and pharmaceuticals cheaply and from commonplace reagents. The manipulation of pathogens (the microbes that cause disease) fosters a better understanding of how these agents evolve and interact with the body, enabling the development of next generation cures. Despite the significant U.S. and global investment in biotechnology, concern has been voiced by scientists, policy experts, and members of the community that scientists may be ill-equipped to handle novel, manipulated microbes safely, potentially resulting in accidental infection of themselves or their local communities, accidental release into the environment, or even the initiation of a global pandemic.”
Biological Weapons Convention Meeting of Experts – Updates and Deciding on Emergency Assistance in Cases of Bioweapons Use
If you’ve been missing the MXs, Richard Guthrie has you covered with his daily accounts of these meetings and events. Thursday was the closing day of MX4 and focused on the financial situation. “The Chair of the 2019 Meeting of States Parties (MSP), Ambassador Yann Hwang (France), held informal consultations with delegates from states parties to discuss the financial situation for the BWC which remains difficult. Non- payments of agreed assessments by a number of states parties continue to cause problems. While some of these eventually appear as late payments, the ongoing deficit is sufficiently large to put the MSP at risk. As the financial accounting period is the calendar year, the MSP at the end of the year is always going to be the most vulnerable activity if there is a financial shortfall. In 2018, some economies were made on the MSP by having one informal day of activities without interpretation, putting a number of delegates at a disadvantage. The government of France has a clearly stated position on multilingualism within multilateralism and so the MSP Chair would be extremely reluctant to implement a similar route to financial savings. The Working Capital Fund established by the 2018 MSP is specifically designed not to subsidise non-payment, but to smooth out cash flow during the year. Depleting the fund — which is not even close to its target value – in its first year to cover the costs of the MSP would render it useless for purposes of supporting core activities such as the ISU. There are also financial implications of decisions that will need to be taken in relation to the Ninth Review Conference to be held in 2021.” Dr. Jean Pascal Zanders was also in attendance and has reported out on discussions surrounding Article VII – “Being one of the more obscure provisions in the BTWC, Article VII only attracted state party attention over the past ten years or so. In follow-up to the decision of the 7th Review Conference (2011), parties to the convention looked for the first time more closely at the provision during the August 2014 Meeting of Experts (MX). As it happened, the gathering coincided with the expanding Ebola crisis in West Africa. The epidemic gave urgency to the concrete implementation of Article VII. The daily images of victims and fully protected medical staff broadcast around the world left lasting impressions of how a biological attack from another state or terrorist entity might affect societies anywhere. Operationalising Article VII has proven more complex than anticipated. The provision comprises several clauses that fit ill together upon closer inspection and hence obscure its originally intended goals. In addition, it contains no instructions about how a state party should trigger it or the global community respond after its invocation.”
CSIS Commission on Strengthening America’s Health Security Meeting
“On June 26, 2019, the CSIS Commission on Strengthening America’s Health Security convened for the third time since its launch in April 2018. The Commission’s core aim is to chart a dynamic and concrete vision for the future of U.S. leadership in global health security—at home and abroad.” “On June 26, Commission members—a diverse group of high-level opinion leaders who bridge security and health and the public and private sectors, including six members of Congress—met to discuss a proposed U.S. doctrine for global health security. Commission members deliberated and reached a broad consensus endorsing a doctrine of continuous prevention, protection, and resilience, which would protect the American people from the most pressing global health security threats we face today. The measures outlined in the paper are affordable, proven, and draw support from across the political spectrum. The time to act is now.” Participants called for Congress and the administration to take action across seven areas, including ensuring full and sustained, multi-year funding for the GHSA, ensuring ample and quick-disbursing finances, establishing a global health crises response corps, etc.
Combatting AMR Through Payment Shifts
In the battle against the resistant bug, sometimes you have to change tactics and bring in the big guns – like the Centers for Medicare and Medicaid Services (CMS). Developing antimicrobials has been a particular challenge, despite efforts to push and pull research and development. BARDA Director Rick A. Bright recently discussed this problem, but now a new CMS rule could help guide change. “Without payment reform, the antimicrobials marketplace will not survive. CMS Administrator Seema Verma understands this reality and the necessity for a strong marketplace for both public health and national security purposes. On Friday, August 2, CMS issued its fiscal year (FY) 2020 Hospital Inpatient Prospective Payment System (IPPS) Final Rule. Among other changes to the way CMS pays for Medicare services, CMS recognized the need for greater payment of newer, potentially safer and more effective antimicrobial drugs. The new rule will (1) change the severity level designation for multiple ICD-10 codes for antimicrobial drug resistance from ‘non-CC’ to ‘CC’ (which stands for complications or comorbidities) to increase payments to hospitals due to the added clinical complexity of treating patients with drug-resistant infections, (2) create an alternative pathway for the new technology add-on payment (NTAP) for qualified infectious disease products (QIDPs), under which these drugs would not have to meet the substantial clinical improvement criterion, and (3) increase the NTAP for QIDPs from 50 percent to 75 percent. This final rule lessens economic incentives to utilize older antimicrobial drugs such as colistin, and shift medical practice to employ more appropriate, newer generation antimicrobials. Payment more closely aligned with the value of these lifesaving medicines will shift the current market realities of these drugs for companies, investors, and patients. No single action will solve the antimicrobial resistance problem; however CMS’ efforts undoubtedly can improve the marketplace and re-catalyze innovation in basic science discovery, and research and development efforts. We appreciate and congratulate Administrator Verma for taking such bold leadership in this fight. ”
Ebola in the DRC
The latest WHO dashboard is showing that the outbreak has reached 2,787 cases. Seven cases were reported from the DRC ministry of health earlier this week and there is growing concern about the impact the outbreak is having on children in the area. “Last December UNICEF sounded the alarm about the high number of children infected in the outbreak, noting that one of every third people confirmed infected in the DRC’s outbreak was a child, unusual for Ebola epidemics. The agency noted that 1 in 10 children were under age 5 and that kids were more likely to die from the disease than adults. Save the Children said in its statement yesterday that around 737 children have been infected with Ebola in the DRC’s outbreak. And based on the latest numbers, the impact on kids has increased. In the first 6 months of the outbreak, which was declared on Aug 1, 2018, just under 100 deaths in children had been reported. However, in the 6 months that followed, over four times as many have died. Heather Kerr, Save the Children’s country director in the DRC, said, ‘This is another grim milestone in a crisis that is devastating children in its path, especially the youngest. Some 40% of children who have contracted the disease are under the age of five, and many of them have died.’ She also said the outbreak has had a wider impact on children because of the high overall fatality rate from the virus, with thousands losing at least one of their parents or separated from their families.”
SWP Comment- Why the Containment of Infectious Diseases Alone Is Not Enough
You can now access this commentary by Daniel Gulati and Maike Voss here, which discusses the current DRC Ebola outbreak and that in “crisis situations like these, the interdependencies between health and security are highly complex. Which population groups and which diseases are perceived as suspected health risks, and why, is a normative question for donor countries. It has political consequences above all for affected developing countries. Where health and security are common goals, it is not enough to contain infectious diseases in developing countries. Instead, resilient, well-functioning, and accessible health systems must be established. This fosters the implementation of the human right to health, creates trust in state structures, and takes into account the security interests of other states. In the United Nations (UN) Security Council, the German government could advocate for policies based on the narrative ‘stability through health’.”
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MERS and Healthcare Transmission– “Since its last update in June 2018, 219 cases were reported in four countries: Saudi Arabia (204), Oman (13), South Korea (1), and the United Kingdom (1). However, of the 97 secondary cases reported to the WHO, 52 were linked to transmission in hospitals, including 23 infections in healthcare workers. Since the virus was first detected in humans in 2012, 2,449 cases have been reported through Jun 30, 84% of them in Saudi Arabia. The virus is known to spread more easily in healthcare settings, and research is under way to better understand the factors that drive transmission. The WHO said awareness of the disease is still low, and the nonspecific early symptoms can make it difficult to identify cases. Gaps in infection prevention and control measures also contribute to disease spread. ‘Much more emphasis on improving standard IPC [infection prevention and control] practices in all health care facilities is required,’ the WHO said.”
Managing Measles: A Guide to Preventing Transmission in Health Care Setting– “Perhaps one of the most challenging aspects of this outbreak from a health care perspective is preparation. Although some may not consider this to be a concern, between 2001-2014, 6% of US measles cases (that were not imported) were transmitted within a health care setting. Sadly, I experienced this firsthand during a 2015 exposure at the health care facility I worked at, in which a health care worker was exposed to the virus while treating a patient and subsequently became infected. As a result of the health care worker’s infection, 380 individuals were exposed and the response efforts were extensive and significantly disruptive to the daily infection prevention duties. Due to the fact that hospitals can easily act as amplifiers for airborne diseases like measles, the CDC has provided interim infection prevention and control recommendations for measles in health care settings. At its core, this guidance focuses on health aspects of both the employee and the patient. For health workers, it is critical to ensure presumptive evidence of immunity to measles and manage exposed/ill health care workers properly. On the patient side, rapid identification and isolation of known or suspected cases and proper isolation maintenance is critical. “