Pandora Report 12.2.2016

Welcome to December! We hope you had a lovely Thanksgiving holiday. If you’re still craving poultry and happen to be in Sweden, you may want to keep in mind that the first H5N8 case was just detected. Want an overview on genome editing? Check out the Parliamentary Office of Science & Technology’s note on it here.

Army Reprimands General Over Anthrax Debacle
Biosafety failures have been an increasing concern over the last few years. Within the last few years, the Pentagon was involved in mistakenly shipping live anthrax to nine U.S. laboratories and an airbase in South Korea after failing to inactive the bacteria. The Army has now reprimanded Brig. Gen. William King, the highest-ranking officer implicated in the events. “A reprimand prevents an officer from receiving another assignment, effectively ending his career, according to a Defense official familiar with King’s case but not authorized to speak publicly about it. ‘Brig. Gen. King was reprimanded for failing to take appropriate action to respond to and mitigate lapses in safety and protocol while serving as commander of Dugway Proving Ground,’ Lt. Col. Jennifer Johnson, an Army spokeswoman, said in a statement.” Nine civilians were also demoted and another soldier was disciplined in this attempt to clean up the biosafety mess that has plagued military labs. Investigators at Dugway found several failures – a biosafety officer who lacked training and education needed for the job, failure to conduct routine environmental tests to ensure there was no breach in containment, and staff who “regularly manipulated data” certifying pathogens were safe to for use without PPE and shipment.

The Failure That Was the 8th RevCon epic-failure-thumbnail1-1
The 8th Review Conference of the BWC has closed and with it, the hope of reaching an agreement on a work plan for the next five years to strengthen the intersessional process. You can read the UN Office at Geneva statement here, in which they note that during the RevCon, a Final Document was adopted (including a Final Declaration on the articles of the Convention), renewal of the mandate of the Implementation Support Unit, and this RevCon had higher attendance than previous BWC meetings. If you’d like detailed overviews of each day’s proceedings, you can find them here – in the last day, you can see the frustrations and disappointment voiced by several countries.. The 8th RevCon did decide that States Parties will hold annual meetings in the process up to the next RevCon (2021), with hopes of reaching consensus regarding the intersessional process. You can also read the statement by U.S. State Department’s spokesperson, John Kirby, here, in which he points to the failures of the group to find consensus on a work plan (a plan that was highly supported by the U.S. and would involve much more intensive expert work to make decisions more frequently than every 5 years) to infuse decision-making and expert work into the intersessional process. Kirby’s statement notes that “While the United States does not support the need to negotiate a supplementary treaty, during the review conference, U.S. negotiators were supportive of creating a space in the post-RevCon work-plan for discussion of the full range of proposals to strengthen the Convention, which would have allowed proponents of a protocol to make their case. Although the United States is disappointed that negotiators did not take this opportunity to strengthen the intersessional process, the lack of consensus on a program of work does not damage the international nonproliferation regime.” While many of the official documents note “disappointment”, the realities of those in attendance were marked with frustration at the utter failure that was the 8th RevCon. Some of the noted frustrations including the halting of summer meeting of experts (MX), failure to increase ISU staff, and again, inability to agree on an intersessional process that would facilitate more real-time decision making with the necessary experts. “In their final declarations many countries, especially from the Non-Aligned Movement (NAM), put the blame squarely on Iran (without naming the country). This country’s obsession with returning to a negotiation format like the Ad Hoc Group to achieve the higher goal of a legally binding instrument—possibly with the sole goal of antagonising the USA—led it to exploit to the fullest to principle of consensus decision-making to torpedo any effort at compromise. Many NAM countries—often developing nations—lost out on concrete opportunities for international cooperation and assistance.” You can read the advanced version of the final report here. While this floundering don’t mean the end of the BWC, the lackluster outcome may indicate a gradual slip in overall confidence.

U.S. Military Preps for Gene Drive Woes genetic_manipulation
The new advances in genome editing and biotech point to a bright horizon for innovation, however the safety components to these advances are in need of response measures. DARPA is now working on a new program to respond to potentially harmful or devastating ecosystem outcomes that may come from engineered genes. Safe Genes will be a means of responding to a situation in which the gene-drive systems produce an outcome throughout generations that may be negatively impacting to the ecosystem. This may make genome editing systems, like CRISPR, sound nefarious, but there are growing hopes that this technology could alter insects or pests that carry diseases like malaria, dengue, etc. The gene-drive systems mean that within 20 generations, the newly altered genes could be passed through an entire population of insects (i.e. within 20 generations, a certain species of mosquito could be unable to carry malaria). The Bill and Melinda Gates Foundation has doubled its spending on gene drive tech and even DARPA has been one of the largest funders of synthetic biology research. While the the rewards may be high, so are the risks. “Kevin Esvelt, head of the Sculpting Evolution lab at MIT Media Lab, which is applying for Safe Genes funding in collaboration with eight other research groups, predicts that eventually, perhaps around 15 years from now, an accident will allow a drive with potential to spread globally to escape laboratory controls. ‘It’s not going to be bioterror,’ he says, ‘it’s going to be ‘bioerror.'” Several research teams, including those at the DARPA program, are looking to remove, replace, or inhibit the unwanted genetic changes that are made in order to best respond to a negative outcome. Getting rid of the engineered genes from a species or habitat is one focus area for DARPA’s new program – the second encourages teams (who received funding from Safe Genes) to create systems for controlling/reversing gene editing tools, and the last focal point is on developing small molecules or antibodies that allow organisms to fight off genome editors at the molecular level. “Evolutionary geneticist Austin Burt, who leads Target Malaria’s research at Imperial College London and has no affiliation with Safe Genes, concurs. The prospect of remediation, he says, ‘shouldn’t give us a cavalier attitude.’ Instead, the goal should be to do the incremental work to anticipate and prevent problems. ‘We have the precedent of biological control,” he says, “where if you have an invasive pest that is destroying your crop, you can release a parasitoid wasp,’ which kills its host. ‘They do a very careful assessment. They don’t have something in their back pocket,’ to delete errors.”

FBI Utilizes Student Bioengineers 
With the growing importance and challenges of biotechnology and genome editing, it’s not surprising the FBI is sponsoring the International Genetically Engineering Machine (iGEM) Competition. iGEM is a way for the FBI to collaborate with the biotech community to better understand the challenges, concerns, and help create a culture of trust and transparency. Stanford senior research scholar, Megan Palmer, highlights this growing relationship and its importance in bioterrorism prevention. Science plays a vital role and to better understand this, why not start with those looking to make a difference in the field? “Bioterror incidents are extremely difficult to predict. In the past governments have built the deadliest biological weapons programs, but one worry is that now small groups may also be able to do serious damage, Palmer says”. The biotech world is constantly evolving and it’s important that law enforcement understand the how’s and why’s of the field so that investigations can be more effective and efficient. In fact, GMU biodefense graduate program director and professor, Gregory Koblentz, is working with Dr. Palmer on a CRISPR project for this very reason. The Departments of Defense and State are even getting in on this approach – create transparency and trust with the biohacker community to better prevent and respond to future threats. Like FBI supervisory special agent, Edward You, Megan is looking to strengthen this relationship prior to “trigger events” (an event in which biologists are suspected to be behind it) to ensure the foundation of communication and trust can combat challenging situations. “But there’s a natural tension between biohackers embedded in fringe communities and government agencies that are traditionally secretive. To Palmer, the key to the collaboration is open communication. So far, it’s going well—Palmer says she has been asking the FBI questions about its involvement, what it sees in the field, and why the agency is spending so much time and effort to be involved, and so far she says they have ‘been willing to have more of those conversations.’”

The Diseases That Worry Public Health Officials 
CDC Director, Thomas Friden, and Susan Desmond-Hellman, Chief Executive of the Bill and Melinda Gates Foundation, sat down to discuss the infectious diseases outbreaks that keep them up at night. Frieden noted that every year we identify a new pathogen and every day the CDC starts a new investigation to find a new pathogen. Frieden admits that his biggest worry is pandemic influenza. “Even the 1957 influenza pandemic, which most people haven’t heard of, cost 3% of the world’s gross domestic product. Even SARS, a relatively small outbreak, cost about $30 billion. We don’t know when the next one will come, where it will come from or what it will be. But we’re certain there will be a next one.” Dr. Desmond-Hellmann noted that, “What we learned from Ebola is that there are a couple things that are underutilized and not ready. One is governance. Who makes the call when things happen? The second thing is having the right tools, which is why global health research-and-development is a big focus of our foundation.” Both emphasized the importance of faster and more effective prevention and the role of country accountability in global health security. Truly, Dr. Frieden notes, there is no way to know if a country is ready to handle a health emergency, which is where the GHSA’s Joint External Evaluation has come in as a means of objective, third party, accountability and readiness assessments.

Advances in Radiation Biodosimetry for Mass Casualty Events Involving Radiation Exposure 
GMU biodefense PhD student, Mary Sproull, is looking at the modeling and development of new medical countermeasures for CBRN events. “To respond to large-scale population exposures from a nuclear event or radiation dispersal device (RDD), new methods for determining received dose using biological modeling became necessary. The field of biodosimetry has advanced significantly beyond this original initiative, with expansion into the fields of genomics, proteomics, metabolomics and transcriptomics.” Cytogenetic assessment methods are also being utilized with ramping up laboratory surge capacity. In this assessment, Sproull looks to the progress being made regarding field-deployment readiness in the event of radiation exposure. She notes that the most promising and immediately useful mechanisms for biodosimetry are pointing towards cytogenetic assessment using surge capacity lab networks, proteomics, and genomics-based technologies. “Greater collaboration within each field of biodosimetry would benefit the development of a standardized panel of biological markers for dosimetry assessment. Assessing the application of radiation biodosimetry in special populations, and development of a rapid assay for assessment of partial-body exposures is needed. Critical organ-specific markers of radiation toxicity also need to be identified and validated.”

Zika News 
Shortly after the WHO declared that Zika is no longer a global health emergency, the first case of locally acquired Zika sprung up in Texas. While investigations are ongoing, the latest news points to the importance of maintaining vigilance towards vector control and continued education. The UK has reportedly found its first case of sexually transmitted Zika. You can find the latest updates from the Florida Department of Health here, which reveal two new travel-related cases and four new locally acquired cases on November 30th. A recent study found microcephaly in older babies who were exposed to Zika in the womb. “A study published in the U.S. journal Morbidity and Mortality Weekly Reportinvolved 13 babies in two Brazilian states born with small heads, but not small enough to be diagnosed with microcephaly. The babies tested positive for Zika. Imaging scans of the babies’ heads soon after birth showed brain abnormalities. Researchers then followed the infants. Around the time of their first birthday, 11 of the 13 babies were diagnosed with microcephaly. Their heads and brains had not developed in proportion to their growth and size.” Some are saying that the WHO’s move of declaring Zika no longer a public health emergency was a mistake. The CDC has reported 4,496 cases of Zika in the U.S. as of November 30th,

Stories You May Have Missed:

  • Trump Picks HHS Lead – President elect Trump, has selected Republican congressman, Dr. Tom Price, as the US Health Secretary to oversee CDC, NIH, etc. This selection has been met with a mixture of concern while many worry about the challenges to public health under the new administration.
  • New Viral Discoveries– a international research team has found the jackpot of viral discoveries – 1,500 new viruses! Looking for infection in invertebrates (think insects and spiders), the expansion of the catalogue of viruses will help us better understand viral diversity. Genetic sequencing helped these researcher delve deep into the world of viruses – the virosphere. “Next generation sequencing allows researchers to quickly determine the sequence of these letters. And if you work out the order of the letters on any chain of RNA, you can determine if it belongs to a virus and whether or not the virus is new. Its potential for virus discovery is huge.”
  • Traces of MDRO’s Found in Polluted City Air- recent research from Sweden’s University of Gothenburg looked at hundreds of environmental samples worldwide. The results revealed that the samples taken from Beijing, had high levels of antibiotic resistant genes. “‘We studied only a small number of air samples, so to generalize, we need to examine the air from more places,’ explains lead researcher Joakim Larsson. ‘But the air samples we did analyze showed a wide mix of different resistance genes.’ The research doesn’t show whether the bacteria in Beijing’s smog is actually alive – which would significantly increase the threat – but Larsson says it’s ‘reasonable to believe that there is a mixture of live and dead bacteria, based on experience from other studies of air’.”

 

Pandora Report 11.11.2016

The U.S. Election has concluded and whether your candidate is now our presidential elect or you’re just glad it’s all over, here’s something to celebrate – President Obama signed an executive order last week, cementing the GHSA as a national, presidential-level priority. Commitment to GHSA and fighting outbreaks on a global scale is a huge step forward to combating the health crises we’ve seen and will continue to battle in the future. Since researchers recently debunked the myth of Gaëtan Dugas as a primary source for HIV/AIDS in the U.S., check out more stories regarding the misunderstood “patient zero”.  World leaders are starting to realize that the antibiotic clock is ticking away.

Trump and the Issues Within Science
Donald Trump is the new president elect, but where does he stand on issues like Zika? Here’s a compilation of sources that cover his comments and plans for some of the top issues in science. NPR is looking at his comments on global health and humanitarian aid, while some are trying to figure out what Trump’s administration will mean for them and the need for a transition team tutorial. STAT is asking five questions regarding what the Trump administration will mean for science. Sources close to the Trump campaign have stated that two of the “best-known climate skeptics will lead his U.S. EPA transition team“.

It’s Time to Modernize the BWC 
GMU Biodefense graduate program director and professor, Gregory Koblentz teamed up with Filippa Lentzos to discuss why it’s so important for the BWC to modernize. They tackle the reality that while the convention isn’t failing, it’s definitely not flourishing. Despite its dedication to ban a whole class of weapons, the BWC is a somewhat toothless dog. “It lacks a dedicated forum to assess treaty implications of scientific advances, a robust institutional capacity, organized means of helping member nations meet their obligations, provisions for verifying compliance, and an operational role to respond in cases of a serious violations. The upcoming review conference provides a welcome opportunity to begin rectifying some of these shortcomings.” Koblentz and Lentzos point to the consistent challenges of science and technology reviews. Despite a rapidly evolving industry, the BWC hasn’t been able to keep up and maintain an international forum for the debates that are needed. Lagging behind the biotech times means the BWC is running the risk of irrelevance, not to mention the slow shift from the convention towards UNSCR 1540. In this climate, it doesn’t help that there is an even greater need for transparency. Biodefense programs have surged the last two decades, which means that transparency is increasingly important to ensure these programs aren’t biosecurity risks or being perceived as threats and becoming justifications for initiated offensive programs. The reform process is pivotal and this includes organizing a review of relevant S&T developments more systematically, renewing the mandate of an implementation unit, and setting up an Open-Ended Working Group on Providing Reassurance to encourage transparency and engagement in peer review exercises. “The Eighth Review Conference provides an opportunity to revitalize the bioweapons treaty by taking concrete actions to expand its relevance, enhance its capacity to review developments in science and technology, and strengthen the confidence of nations in the peaceful intentions of their fellow treaty members.”

RevCon began this week in Geneva and you can catch the U.S. opening statements by Thomas Countryman, Acting Under Secretary for Arms Control and International Security. You can also read Mr. Kim Won-soo’s remarks as High Representative for Disarmament Affairs. The International Committee of the Red Cross (ICRC) vice president, Christine Beerli, has also commented, noting that “States Parties should not become complacent; it remains their collective and individual responsibility to ensure that the treaty is implemented effectively. Over the past five years of annual meetings, a great deal of information has been shared and many proposals have been made on how to implement the treaty and improve its effectiveness. Disappointingly, however, there has been little collective agreement.” RevCon experts will also be focusing on new threats that may arise from technology. Guinea just became the 178th State Party to the BWC!

armas-biologicas-2NSABB Meeting on DURC and Other Hot Topics
On Friday, the National Science Advisory Board for Biosecurity (NSABB) hosted a call to review policy updates, new activities, updates from the working group on institutional oversight of the life sciences DURC policy stakeholder engagement, and updates from the Blue Ribbon panel that is currently reviewing the 2014 NIH variola incident. The conference call was fast-paced but covered substantial ground – most of it you can find on the Power Point slides. The policy updates focused on initiatives to strengthen biosafety/biosecurity stewardship. The 2016 NSABB report recommended additional, multidisciplinary evaluation prior to funding decisions and appropriate, ongoing oversight if funding were given to projects. It was noted that this is a particularly exciting time for science as we’re seeing so many advancements in human health, however the applications of these technologies are testing the oversight and policies we currently have in place to ensure science is performed safely (and securely). While they may or may not all be under the purview of the NSABB, the emergence of CRISPR and evolution of genomic sequences and gene drive techs, and abilities to create next gen of chimeras – are all examples of biotech that are evolving very rapidly and we may need to rethink how they fit our current policy and framework. NSAAB has been a part of the DURC conversation with policy focus on research responsibilities and institutional approaches. NSABB is also working on how to increase and approach stakeholder engagement in DURC polices. There were several listed strategies and topics, ranging from regional meetings at universities or panel sessions at conferences like ASM and ASV. The biggest focus was on getting dialogue and metrics across institutions, not to mention the need for feedback to evolve an objective oversight system. The Blue Ribbon panel is working on the review of the NIH variola incident but they did note that the event was handled very well and while there were obvious gaps, they were all addressed and that the interagency work between the FBI, NIH, and CDC went very smoothly.

Sverdlovsk, Three Mile Island, and Government Oversight of Biological Safety
Greg Witt is talking to us about government oversight of biological research and the lessons learned from the Three Mile Island nuclear accident (did I mention that Greg is a nuclear systems engineer?). Pointing to the biosafety failures that have happened recently (remember that time a Pasteur Institute employee improperly took MERS samples on a commercial airline???), Greg pulls together the pieces to paint a bigger mosaic of systemic failure to properly control biological agents. Pointing to similarities between these events (they even happened days apart) he notes that “both were caused, in large part, by errors in maintenance: at Sverdlovsk, technicians neglected to replace an exhaust system filter, while at TMI, staff had isolated an auxiliary feedwater pump during routine maintenance in violation of US Nuclear Regulatory Commission (NRC) rules.”

The Glamor of Bad Science02-ebola-w529-h352
Yours truly is talking about the disparaging addiction we have to dramatic science. I’m a fan of any movie that involves an outbreak, but the truth is that an overwhelming majority of these films depict infectious disease outbreaks so outrageously and dramatically, they have become anti-science. After watching the latest, Inferno, it became increasingly apparent that we’ve created a false threshold for science, specifically infectious diseases, in film. By painting the picture of diseases and outbreak response like that of Outbreak, I Am Legend, and more, we’re creating an increasingly de-sensitized culture. The result of this de-sensitization means that it takes a lot more for people to take infectious disease outbreaks seriously in real life. It’s not a genetically engineered airborne organism that will make flesh rot? Meh – not that big of a deal. Our love of bad infectious disease science in film and television could easily create a culture of poor public health support.

Ebola Was Just the Beginning…Are We Ready?
Peter Piot, Director of the London School of Hygiene and Tropical Medicine, is highlighting the realities that we simply aren’t ready for the next big virus epidemic. Piot discusses his work during the early days of Ebola in the 1970s, pointing to the challenges of attempting to figure out a novel virus while trying to put out the fires of an outbreak. Describing the 2014 outbreak as a perfect storm, he notes that the WHO response was too slow to act. The globalization of our interconnected world has made the capabilities of an outbreak much greater than 50 years ago. “Piot also believes there will be a ‘Big One’, a big influenza, similar to the likes of the Spanish Flu in World War One and we’re not quite ready for it. Yet. ‘Are we ready?’ Piot asked. ‘A little bit better than a few years ago but we’re not yet up to the job. We can’t afford to wait but we have a plan, and that’s the good news. The world has learnt from the problems of mobilisation around Ebola and we are now in a better situation; there is better technology to allow for more rapid diagnosis’.” Piot stresses the importance of investment in infrastructure, stronger global governance, and vaccine development incentives.

All Things Zika
The Florida Health Department has released their Zika updates here. PAHO has recommended that Bolivian women delay pregnancy to avoid Zika. “Fernando Leanes, PAHO representative in Bolivia, said at a press conference that it was one of several advised measures to avoid the proliferation of microcephaly cases. ‘The epidemic of Zika, from what we have seen in other countries, will have a rise and fall in Bolivia. Therefore, there are options such as delaying the decision to get pregnant in areas where Zika is spreading. This will avoid the dreaded microcephaly and the complications it represents,’ explained Leanes.” An $18 million plan was just announced to release Zika-resistant mosquitoes into urban areas of Colombia and Brazil.  “A swarm of Aedes Aegypti mosquitoes–the species that transmits dengue, yellow fever, chikungunya and Zika, have been modified to carry a bacterium called Wolbachia pipientis, which inhibits their ability to spread the viruses. Scientist released these ‘good mosquitoes’ in Brazil as part of a successful international program called ‘Eliminate Dengue’.” Many researchers are wondering why Colombia has had such few Zika-associated birth defects. They are the second largest outbreak in the world, yet have much fewer cases of microcephaly than Brazil. Researchers have noted that adult women in Puerto Rico were significantly more likely to develop Zika than men. The CDC has reported 4,175 cases of Zika in the U.S. as of November 9th, 2016.

Stories You May Have Missed:

  • How Trauma Explains Civil War– Don’t miss this event today at GMU’s Arlington campus, Founders Hall, Room 602. Eric Goepner will be discussing his research as to why “hurt people hurt people” and hypothesizing that a population’s prior traumatization predicts future civil war onset.
  • Searching for Ebola’s Hideout – The recent ebola outbreak is over, but this doesn’t mean the disease is gone. In fact, ebola is known for hiding out..so where has it gone? Leigh Cowart and other researchers are looking to stop future Ebola outbreaks by finding its hiding spot. “Such a long-term host, the quiet refuge of a pathogen, is known as a reservoir species. If a reservoir species is Ebola’s safe house, we are its luxury retirement property, a place for it to live out its last days with a bang. The trouble is that we aren’t sure where the safe house is. If we are going to be vigilant against Ebola’s re-emergence, we need to find it.”
  • The UK Forms Special Outbreak Response Team– with a five-year £20m funding, the UK is setting up a specialist team of health experts who will be able to respond to outbreaks around the world within 48 hours. “Public Health England will run the project with the London School of Hygiene and Tropical Medicine. Duncan Selbie, chief executive of Public Health England, said: ‘Speed is key in tackling infectious disease and with this new capability we can now deploy specialists anywhere in the world within 48 hours, saving and protecting lives where an outbreak starts and helping to keep the UK safe at home.'”

 

Pandora Report 11.4.2016

Happy Friday! We’ve got some great news – you can now watch our book launch and panel from the Biological Threats in the 21 Century event via YouTube here. Whether you missed out on attending or want a recap, you can get all the biodefense goodies there. UNMC was recently awarded $19.8 million to build an Ebola and advanced infectious disease training center. Their new center will include a training, simulation, and quarantine section, with the hope of training healthcare workers to treat patients with Ebola and other highly infectious diseases. A recent study found that limited access to Ebola diagnostic and supportive pathology assays facilitated the failure of initial 2014 outbreak control efforts, regardless if the setting was a resource-rich or resource-poor location.  Shocking news – hand hygiene is one of the biggest issues in norovirus infections.

3rd Annual Summit on Global Food Security and Health 
GMU’s Schar School of Policy and Government will be hosting this informational event on Wednesday, November 16th from 10:30am-5:30pm. Speakers include experts from organizations such as the Association of Public Land Grant UniversitiesBread for the World, the International Medical Corps and the US Agency for International Development: Academics will discuss their research on Food Security with an eye to improving access, addressing challenges and developing partnerships to improve global food security and related health outcomes. Organized with the support of the Center for Strategic and International StudiesThe Farm Journal FoundationThe Global Harvest Initiative, Policy Studies OrganizationWorld Medical & Health Policyjournal; Center for the Study of International Medical Policies and Practices (CSIMPP) in the Schar School of Policy and Government at George MasonUniversity; American Public University; and World Food Policy. The conference is free and open to the public, but registration is required. Contact Professor Bonnie Stabile bstabile@gmu.edu with any questions.

FDA Manipulation of Media
A new report from the Scientific American is drawing attention to the FDA’s arm-twisting of journalists “into relinquishing their reportorial independence”. Their investigators found that NPR and a series of other news outlets had a deal with the FDA-  get news announcements early but the FDA would dictate whom their reporters could and couldn’t interview. “This kind of deal offered by the FDA—known as a close-hold embargo—is an increasingly important tool used by scientific and government agencies to control the behavior of the science press. Or so it seems. It is impossible to tell for sure because it is happening almost entirely behind the scenes. We only know about the FDA deal because of a wayward sentence inserted by an editor at the New York Times.” The Scientific American was able to obtain supportive documents via the Freedom of Information Act, which revealed that despite their public demeanor, the FDA denies many reporters access and grows their own group of journalists that will follow their rules. Much of this is held together with the journalistic practice of embargo – a deal between source and journalist that the story won’t be published prior to a specific date/time. This is actually pretty common in the science world, but it can actually create an aura of favoritism and bias. The issue with the FDA situation is far deeper though – aside from getting early access to stories and agreeing not to publish before the agreed date/time (embargo), the other rules stated that journalists could not seek outside comment and in a nutshell, had to give up the ability to do independent reporting. In the end, this kind of control of the media and journalistic favoritism reveals things about both sides of the agreement, but also emphasizes the need for transparency and re-thinking of the embargo system.

BWC 8th Review Conference sheet-1
The eighth RevCon is fast approaching and if you’re behind as to what’s happened since the last RevCon, check out UNLOG’s (The United Nation’s Office at Geneva) Think Zone and the latest information. You’ll also find some great articles from GMU’s Biodefense faculty in there – like Dr. Koblentz’s article on dual-use and Dr. Sonia Ben Ouagrham-Gormley’s article on gene drive. Better yet, check out the BWC RevCon Series from the International Law and Policy Institute. These three papers discuss a series of issues related to the BWC and RevCon. The first, Divide and Delegate: the Future of the BWC, focuses on the pursuit of BWC aims outside RevCons and the normative strengths and operational weaknesses. LPI2, Keeping Up With the Science, looks to support enhanced science and technology review processes. LPI3, is a joint effort by GMU’s very own Biodefense Director, Gregory Koblentz, and the author of your favorite new book (Biological Threats in the 21st Century), Filippa Lentzos. The third paper, Risks, Trade-Offs & Responsible Science , looks at the security trade-off risks of the increasing volume of labs and scientists working on dangerous pathogens. They note that “the 2016 BWC Review Conference must encourage states to implement stringent national biosafety, biosecurity and dual-use research regulations; task the science advisory group to develop clear, internationally- recognized guidelines governing dual-use research of concern (DURC); establish a working group to revise the CBMs; and encourage states to participate in the CBM mechanism as well as more interactive information exchanges such as peer review and compliance assessment.”

RevCon will take place from November 7-25th in the Palais des Nations and a general agenda is available here. Gabrielle Tarini writes that this RevCon will be a “pivotal opportunity for countries to take action to ensure that the treaty remains a relevant and useful tool for preventing the development, spread, and use of biological weapons. A failure by member states to invest the necessary attention, time, and political capital in the conference could mean decreased interest and weakened multilateral engagement in a treaty that was the first to ban an entire category of weapons of mass destruction.” Moreover, the BWC should have a dedicated process, like that of the CWC, to inform and advise member states, pointing to the need for a great capacity to have expert-led meetings and continuous monitoring. Lastly, Tarini highlights that this RevCon will be an opportunity to strengthen and revise the intersessional process and framework. “The treaty should be restructured, with a stronger steering body and increased time for preparation and multilateral engagement. Adding more meetings, and limiting what gets discussed at each of those meetings, would allow the BWC to begin operating more like an international organization and would provide oversight equivalent to that for other nonproliferation treaties.” Can everyone help verify the BWC? Some are saying open source monitoring may just be that sweet spot.

Increasing Transparency in Biodefense: A 2016 Visit to a German Military Medical Biodefense Facility  screen-shot-2014-09-22-at-21-57-41
Filippa Lentzos is taking us on a journey through German biodefense practices and why transparency is so vital for these programs. Citing Germany as a prime example of countries going above and beyond their voluntary BWC efforts, she delves into the world of Germany’s biodefense activities. She notes the visitors were highly encouraged to review Germany’s most recent CBM submission and briefed on the Institute of Microbiology’s safety and health regulations. “Few restrictions were placed on us other than those related to safety and security. We were free to view rooms, lab equipment and installations. The type and scope of access was to be determined by Institute staff on a case-by-case basis. Any access denials could derive from national security, biosafety and health regulations, data privacy issues, unpublished scientific results or ongoing lab work. If access or certain information was refused, the Institute would explain the particular considerations and o er alternatives.” The Bundeswehr institute focuses on three main CBRN tasks – ensuring protection and an ability of the armed forces to act under CBRN threats, preventing vulnerability to potential CBRN threats and weapons via preventative measures, and limiting the consequences should a CBRN event ever occur. The medical biodefense responsibilities focus more on the ability to rapidly diagnose and identify pathogens, distinguishing natural outbreaks from intentional, and controlling outbreaks. The official noted on their visit that within the institute, there are 65 staff and 18 externally funded fixed-term positions over three departments (bacteria/toxins, viruses/intracellular pathogens, and medical biological reconnaissance and bioforensics). From genome sequencers to electron microscope rooms, check out Filippa’s report for a virtual tour of this amazing biodefense facility.

Assessing the Epidemic Potential of RNA and DNA Viruses  screen-shot-2016-11-02-at-7-19-56-am
Researchers from the University of Edinburgh are looking at zoonotic viruses and their transmissibility. The Ebola outbreak in 2014 highlighted the needed to better understand what kinds of pathogens, especially zoonotic, were likely to emerge as potential epidemics. Given the vast diversity and high rates of viral evolution, this was no easy task. “Of human transmissible virus, 37 species have so far been restricted to self-limiting outbreaks. These viruses are priorities for surveillance because relatively minor changes in their epidemiologies can potentially lead to major changes in the threat they pose to public health.” Researchers used the basic reproductive number, R0, as a means of answering this question. They looked at hundreds of viral species and then categorized them into 4 levels with epidemic potential in humans. They found that the taxonomic diversity is wide, but bounded and most human infective viruses are closely related to viruses of other mammals. Transmissibility within the human population is a key determinant, as well as the R0 threshold of>1. “We currently have few clues to help us predict which mammalian or avian viruses might pose a threat to humans and, especially, which might be transmissible between humans. One argument in favor of experimental studies of these traits, including controversial gain of function experiments, is that they could help guide molecular surveillance for high-risk virus lineages in nonhuman reservoirs.The first line of defense against emerging viruses is effective surveillance. A better understanding of which kinds of viruses in which circumstances pose the greatest risk to human health would enable evidence-based targeting of surveillance efforts, which would reduce costs and increase probable effectiveness of this endeavor.”

Spikes in C-diff and MDRO’s 
Halloween may be over but the rise of the resistant bugs is still going on. A recent study looked at the changing epidemiology of MDRO’s (multi-drug resistant organisms) within a specific healthcare network. While they were able to observe a significant reduction in MRSA, there was a sharp rise in other MDRO’s and C-diff (Clostridium difficile). Examining eight years of data from a Utah-based health network, researchers looked at 22 hospitals clinics to establish trends in C-diff and other MDRO’s. Of the 900,000 patient admissions, 1.4% tested positive for an MDRO and/or C-diff. MRSA was by far the most common MDRO (51% of MDRO infections) but they did see a 32% decrease in MRSA infections over the eight years. “Researchers, however, observed a 222% increase in C difficile and a 322% increase in ESBL-positive bacteria. The data also showed that 70% of all MDROs and C difficile cases originated from an ambulatory setting.” There has also been a significant rise in ESBL’s, which points to a need to refine and revise screening protocols. Overall, this points to the complexity and ever-changing habits of infection prevention and control.

Zika Updates
A recent study is showing that Zika infections have caused reduced fertility and low testosterone in male mice. The ECDC has updated their Zika epidemic rapid risk assessment, noting that “although continuing, vector-borne transmission seems to be slowing down in Central American countries and the Caribbean. The outbreak continues to evolve in Mexico and the southern part of the US, as weather conditions still favour seasonal vector activity. In addition to the Americas, cases have been reported in some Asian countries.” Researchers are working to use the Wolbachia bacteria (which naturally infect several mosquito species) against diseases like Zika and dengue. Overcoming the hurdle of infecting Aedes (a species not naturally infected with Wolbachia), they found that the bacteria was able to survive in the mosquito and then was a passed down through generations…but the best news is that those mosquitoes infected with Wolbachia weren’t able to pass dengue. When the Wolbachia-infected mosquitoes were infected with dengue, the virus couldn’t replicate and spread in the mosquito’s salivary glands (i.e. couldn’t be transmitted). This new technique shows some pretty remarkable abilities to reduce the capabilities of Aedes species to spread diseases like Zika, chikungunya, and yellow fever. The CDC has reported, as  of November 2nd, 4,128 cases in the U.S.  Interestingly 53 people in Minnesota have been found to be infected.

Stories You May Have Missed: 

  • Pandemic Simulations – The Ebola outbreak in 2014/2015 taught us a great many lessons regarding international preparedness and response to infectious disease outbreaks. As a result of this, the World Bank Group and the Bill and Melinda Gates Foundation is starting a new project to conduct the first set of pandemic simulation exercises. “President Jim Yong Kim, Bill Gates and Chancellor Angela Merkel of Germany will jointly host simulation exercises on pandemic preparedness for the Heads of State and private sector leaders during the next World Economic Forum in Davos in January 2017 and the G-20 Heads of State meeting in July 2017.  In preparation for the two major events, the World Bank will collaborate with the technical team from WHO, WEF and the German government to conduct similar exercises for G20 technical staff and and G20 Ministers of Health. Simulation exercises help make a theoretical possibility real, by allowing policymakers to role-play and map out gaps and concrete solutions to those gaps along with their peers.”
  • New Genetic Mutations in Antibiotic BW Agent– Researchers at Lawerence Livermore National Laboratory (LLNL) recently found a new genetic mutation in antibiotic-resistant tularemia (Francisella tularensis). Tularemia is a Category A Select Agent, which means it is a prime concern for bioterrorism and public safety. “This perspective allows you to see mutations that are new that we didn’t know about. If you don’t do this type of study, you’re going to miss other mechanisms that cause resistance in the bacteria. So by doing a genome-wide study, it gives you a much more complete picture about what’s going on,” said LLNL biologist and lead author Crystal Jaing. “The study found resistance-conferring mutations in a hypothetical protein, an asparagine synthase, and a sugar transamine/perosamine synthetase in addition to observing known variants.”