Cultures: Volume 1, Issue 4

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HAPPENING NOW Jimmy Kolker / P. 08

ACROSS THE DIVIDE Michael Callahan / P. 16

NATIONAL & GLOBAL HEALTH LAW The O’Neill Institute / P. 70










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From Mother Nature’s emerging infectious diseases, to Statesponsored biological weapons programs and intentional misuse of a dangerous pathogen, there is a spectrum of biological threats that we collectively face. Truly global challenges, with those living in resource-constrained settings far less capable of meeting them. Even the most developed nations have been put on their heels with the recent unprecedented Ebola outbreak, revealing the weaknesses in our public health systems, our communications, and our desperate need for more basic research and fundamental clinical capacity. It has challenged our domestic policies, put our global relationships to the test, and forced microbiology and its practitioners into the spot light. It has tested our assumptions, and reinforced the need for not only the basics, but also the next generation: from diagnostics to vaccines to personal protective equipment, and a renewed culture of safety. Like most catastrophic events, an outbreak of this scale is a reminder that preparedness (of every type) is as urgent a need as the response that follows. And yet, Ebola is just one example, among that broad spectrum of biological threats we face; from chronic disease, to biosafety or “bioerror,” to intentional misuse, or bioterror. SNAPSHOT OF CULTURES

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All have grave potential, with the ability to destabilize civil society as we know it. In this issue, we take a closer look at how we can collectively address this spectrum of threats, not only to protect ourselves, but also to protect and advance science itself. Resiliency comes from a coordinated “whole of society” approach, inside and outside the government, involving scientists, “AN OUTBREAK OF educators, advocates, policy makers, THIS SCALE IS A the media, and more.


Long before the Ebola outbreak, this issue was slated to be on PREPAREDNESS “biothreats,” with an all-star cast of contributors lined up – each of (OF EVERY TYPE) IS whom was immediately swept up in AS URGENT A NEED the unprecedented outbreak, and each of whom still found time to AS THE RESPONSE contribute to and shape this edition of Cultures. From Ambassador THAT FOLLOWS.” Jimmy Kolker, Assistant Secretary for Global Affairs at the U.S. Department Health and Human Services, to Dr. Michael Callahan, a world-class infectious disease physician on the front lines in Liberia as well as in the laboratory developing the next generation of vaccines, we are grateful for their precious time. Collectively, these contributors advance Culture’s mission to raise awareness on the most important issues we face, by hearing from those closest to them. “Evidence-based advocacy” is a term we use among the editorial staff, and this issue captures that intent. Our own Katy Stewart provides a fascinating update on the growing DIYbio movement in “On the Ground,” before we head back to the era of State-sponsored biological weapons programs in our “A Historical Lens” story, featuring one scientist’s race to develop weapons to defend the U.S.S.R., Gennadiy Lepeshkin. We “Share the Vision” in this issue with the O’Neill Institute, a unique and impressive group housed in Georgetown University’s Law Center, with the worthiest of missions: bringing innovative solutions to the most pressing national and international health concerns. CULTURES Vol 1, Issue 4 » Page 5


BIOLOGICAL T H R E AT S 63% of deaths are caused by chronic disease each year 1

75% of global GDP is estimated to be lost over the next 20 years because of chronic disease 2

100% of low-income countries are affected by at least five neglected tropical diseases simultaneously 3


of deaths are caused by infectious diseases each year 4

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C H R O N I C D I S E A S E : While you might think diseases like cardiovascular disease, diabetes, and cancer mostly affect high-income countries while infectious disease affect low-income countries, nearly 80% of chronic disease deaths occur in low- and middle-income countries.5

I N F E C T I O U S D I S E A S E : According to a report from Reuters, research funding levels for a particular disease often have little correlation with the burden of that disease. Neglected diseases, such as diarrhoeal illnesses, which kill 1.8 million people yearly, collectively receive less than 6% of total funding while 80% of disease spending in developing countries goes towards HIV/AIDs, TB, and Malaria.6

B I O L O G I C A L W E A P O N S : While biological weapons account for a very small percentage of global annual deaths, the potential for impact is enormous. Only one gram of botulinum toxin (anthrax) evenly released and inhaled could kill one million people. Similarly, f​ ootand-mouth disease, which affects cattle, if intentionally or unintentionally released could devastate the global agricultural industry.7


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Ambassador Jimmy Kolker is the Assistant Secretary for Global Affairs at the U.S. Department of Health and Human Services. He had a 30year diplomatic career with the U.S. State Department where he served as Deputy Global AIDS Coordinator in the Office of the U.S. Global AIDS Coordinator (2005–2007) and U.S. Ambassador to Uganda (2002–2005) and to Burkina Faso (1999–2002).

JASON: Thanks for taking the time to talk with Cultures. In this issue, we focus on the spectrum of global biological threats; our readers may not know that well before coming to HHS, you were the U.S. Ambassador to Burkina Faso and Uganda as well as the Chief of the HIV/AIDS section at UNICEF. You’ve been a tireless advocate for bettering global strategies and partnerships for improved public health. Indeed, in all of your professional roles, you’ve made progress to that end.

KOLKER: Thank you. The issues are important ones. If diplomats are good at their job, their role is to put their country’s priorities onto someone else’s agenda. That is an essential skill these days for global public health, and it is not just advocacy. There is a lot of evidence, but we need people who can put the science and data and evidence into context for implementers and policy makers to promote best practices and make health a political priority.

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JASON: The average American may not think of HHS as a global organization. Can you give us a sense of how your mission is inherently tied to international partners?

security of countries. HHS has also been a major supporter of domestic and international influenza programs. As the largest funder of global health, we can take some credit that rates of infectious disease and resultant mortality are declining impressively nearly everywhere.

KOLKER: Now, more than ever, HHS has to have a global Furthermore, our role. HHS is charged with PRIORITY efforts in global protecting the health of health represent what the American people, but, America ought to stand in order to accomplish this, for in the world – sharing we must work to ensure what we have and creating the health of others. lasting partnerships between Ebola is a vivid example nations with direct benefits of the fact that threats to the populations. This is one reason or diseases in other countries that global health – GHS to combat impact the lives of Americans. So emerging disease, HIV, malaria, we have to work with international and influenza – continues to have partners, which means we share broad bipartisan support. Diplomacy technical expertise, collaborate on and coordination with multilateral science and public health norms, partners – such as WHO – to ensure and exchange best practices. The that the lives of Americans are questions of health access, quality, kept safe requires HHS technical and cost are challenges in nearly leadership and presence. every country. We are working on these here in America, but so are JASON: From your perch at partner countries, large and small. HHS, you’ve been central to the new Global Health Security Agenda HHS has such a long history of (GHSA), which seeks to accelerate working on global health issues progress toward a world safe and broadly, including considerable secure from infectious disease. From work on global health security (GHS) your vantage point, how important is issues. HHS investments in GHS the GHSA when addressing the recognize that emerging infectious ongoing Ebola outbreak? What diseases are a threat to national changes can we expect to see in security, whether naturally occurring, health policy strategies as a accidental, or deliberate acts of result of the GHSA? bioterrorism. More than a decade ago, the United States declared HIV/ KOLKER: To begin, I think it is AIDS a threat not only to health, but important to take a step back also to the economic and national CULTURES Vol 1, Issue 4 » Page 9

and note that GHSA started as a way to accelerate progress toward full implementation of the International Health Regulations (IHR). When we realized that less than 20% of countries had met their IHR obligations to detect, report, and respond to public health emergencies, the White House, agencies across the U.S. Government, and international partners launched the GHSA in an effort to make sure that all nations around the world are better able to prevent disease outbreaks, rapidly detect them when they do occur, and respond effectively. I think the importance CONTRIBUTOR, of the GHSA ROGER I. GLASS OF must be NIH’S THE FOGARTY looked at from INTERNATIONAL CENTER, two different ELABORATES ON THE perspectives. IMPORTANCE OF In the short INVESTING IN HUMAN term, GHSA is a CAPACITY IN DEVELOPING mechanism that COUNTRIES. READ HIS can mobilize PIECE ON PAGE 30. support among traditional donor nations and links them with nations that are in need of assistance. We have seen this as countries – including the United States – have started to partner with Ebola-affected countries, working to establish a capacity to prevent, detect, and respond to threats and outbreaks. If you don’t have this capacity, you are at risk for potentially devastating outbreaks of disease. But I believe that the true strength and importance of the GHSA is its ability CULTURES

to encourage long-term, international collaborations, with nations focused on building and enhancing capacity through their own efforts and through cooperation with their neighbors and partners. Global health security really is a problem of collective security – anyone’s vulnerability could be everyone’s vulnerability. The GHSA comes at a very opportune time, because it gives us a high-profile political platform to draw attention to this vulnerability and the need to address the weakest links. JASON: With emerging infectious diseases, particularly Ebola, now in the headlines like never before, the world is anxiously awaiting new treatments and better health infrastructure to handle these outbreaks, something we know you care deeply about and have experience with as the Deputy Global AIDS Coordinator back in 2005. What is HHS doing to support new solutions to the Ebola outbreak? KOLKER: With GHSA, we have seen cooperation among the health, agriculture, security, foreign affairs, and development assistance sectors in many countries. This includes the increased support for public health capacity building by the security sector – but with health system strengthening as the goal, not a siloed approach. Within HHS, the Centers for Disease Control and Prevention is guiding

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Ambassador Jimmy Kolker greets Speaker Rebecca Kadaga at a breakfast discussion on the last day of the Learning Tour to Uganda.

the public health response. CDC has been a powerful force on the ground, sending, as of this writing, more than 200 disease detectives to the affected area, as well as working tirelessly on the domestic response. Additionally, the U.S. Public Health Service has deployed medical providers to West Africa to staff an Ebola Treatment Facility for the health workers who may become ill with Ebola. This will help medical responders to contain the spread of the virus at its source in West Africa. But I think one of the most important pieces of interest to your readers is the way HHS has responded to the crisis by investing in research and accelerating its application. It is absolutely fundamental that we are able to do research during public health crises. That is why the National Institutes of Health and the Biomedical Advanced Research and Development Authority (BARDA) under the HHS Assistant

Secretary for Preparedness and Response (ASPR) have been working to speed up vaccine trials and the development of new countermeasures for fighting this outbreak. The Food and Drug Administration is providing unprecedented support to this effort, demonstrating tremendous regulatory flexibility to expedite and facilitate the rapid development of safe and effective countermeasures. JASON: As the death toll from Ebola rises, we’ve also seen a rise in fear from Americans and others. Misinformation is always a challenge. How are you getting the word out, and how can our members help? KOLKER: This is an example of the need for “health diplomacy” skills I mentioned earlier. How can we

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Hardly anyone predicted an Ebola best use science and evidence to outbreak in West Africa. Nor did we encourage good policy and good expect the first U.S. case to be in behavior? We’re communicating Dallas. Heightened awareness every day with our scientific and capacity at every level and experts and international location are our best defense. partners, such as the WHO, ASM and its members to make sure all are the “boots on the the information ground” in doing that. we communicate is as accurate and “HARDLY ANYONE JASON: You’ve timely as possible. PREDICTED AN made enormous In addition to strides as a global stakeholder calls EBOLA OUTBREAK health advocate and and meetings, Many of HHS has a number IN WEST AFRICA.” diplomat. our readers are earlyof ways to get career scientists, information out, interested in contributing outside such as the CDC web page on Ebola the lab. Any advice for them? and the various social media channels on which the Department regularly KOLKER: Global health careers take shares information and updates. many different shapes and paths In addition HHS is making itself as and will be markedly different a available as possible to the media generation from now from what to keep the public abreast of what is they are today. For example, the going on. As new information comes ability to rapidly sequence and in, we review messages to make understand emerging diseases – sure they are still accurate and are such as severe acute respiratory communicating what we want to say syndrome (SARS) and Middle East – and also that they are addressing respiratory syndrome (MERS) – is a the attitudes and misconceptions that powerful tool in combatting global cause counterproductive practices or health security threats. Just a few policy proposals. years ago, this wouldn’t have been a possibility, but it is now a significant ASM is a force multiplier in this part of global health work. process. The membership of ASM is a resource of expertise as well as I have no academic qualification for leadership at regional, national, and what I do. My degrees are in political international levels. One concrete science and public administration. way in which all ASM members But when I was getting those could help is to get involved with degrees, no one had even heard of preparing for health security threats AIDS. Talking to young people now, I at whatever level in the public health urge them to ask the question, “how infrastructure they are most active. Page 12 » Happening Now

will I prepare myself for the job that doesn’t yet exist?” The experiences gained in the lab now could very well impact global health practice in years to come, especially if you think outside the lab. Publishing in a peer-reviewed journal is an important step, but not an end in itself. How can the solutions and data presented be packaged and discussed to make them useful to practitioners and policy makers? Scientists who have that focus will be promising health diplomats. And, of course, living overseas, if the chance presents itself is valuable both for self-awareness and professional development. JASON: You have no shortage of things on your to-do list, but what are some of the things you hope to realize during your tenure at HHS? KOLKER: Secretary Burwell asked me the same question when she came to HHS in June. The Global Health Security Agenda brings together a lot of “ideas whose time has come” – preparedness and response to emerging threats, fighting antimicrobial resistance, encouraging research on problems of poor people and poor countries, trying to bring a health systems and public health approach to countries where those are weak. These relate closely to the Department’s Global Health Strategy. This strategy has three goals: protect and promote the health and well-being of Americans; provide leadership and technical expertise; and

advance U.S. interests in diplomacy, development, and security. But a particular goal of mine and the Office of Global Affairs is to strengthen our department’s global health workforce and create a more logical global health career track. HHS faces challenges in recruitment, training, and personnel deployment, both overseas and on completion of overseas tours of duty. We have only a small number of Health Attaches, who combine detailed knowledge of the health issues with diplomatic and interagency skills. Expanding programs like these will allow us to find common solutions with partner nations and contribute to the health and well-being of all of us. JASON: Any hobbies outside of work that you can tell us about? Our readers love that stuff… KOLKER: I find the distinction between “work” and “outside of work” a hard one to make. For nearly 30 years, the U.S. government paid me as a diplomat to live in interesting places, talk politics, and write about it. If I had all the time and money in the world, that’s probably how I would have spent it on my own. Now I’m reborn in the fascinating world of multilateral negotiations and global health. Travel and the epiphanies of new knowledge give me energy and delight. That I can jog and swim and read in new environments isn’t so much a hobby as a coherent part of the whole experience.

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, M.D.


The defining characteristics of this outbreak are a long list of what was referred to by Dr. Marcelle Dado, a colleague I worked with on two prior Ebola outbreaks, as the “Horrible List of Firsts.” This list of unprecedented characteristics unique to this epidemic include the massive scale of the outbreak in both number of patients infected and geographic land area involved, the dramatic expansion rate, the high rate of transmission in urban communities, the rapid destruction of the public health infrastructure, and the high number of fatalities among health care workers infected during patient care or clinical laboratory activities. This outbreak, caused by the most pathogenic strain of Ebola, EBOV (formerly known as Ebola Zaire), which untreated can kill over 70% of those infected, had previously never been seen in West Africa. This Ebola outbreak is the first to disrupt the continuity of governments and national commerce and to impact cities with airports offering direct international flights to Europe and other African nations. Of this list of horrible firsts, the most important feature of this outbreak is the mismatch between the number of medical care providers and the sheer number of Ebola patients, each of whom require isolation, supportive care, and compassion, all delivered in austere and improvised medical settings. In previous Ebola outbreaks our Ebola Treatment Units (ETUs) would be staffed with a nurse-to-patient ratio of 1 to 4.

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In the summer of this year, our nurses were often managing over 24 patients at one time. In every category, this outbreak has presented challenges to outbreak response that have surpassed all prior Ebola and Marburg outbreaks. Since April 1, when the medical charity Medicines San Frontieres (MSF) first sounded the alarm that this Ebola outbreak was unprecedented in size, the virus has spread from the epicenter of Guinea, Sierra Leone, and Liberia to Nigeria, with “OF THIS LIST 20 cases arising from a single patient, to OF HORRIBLE Senegal, and, as of late October, to Mali, F IRSTS, THE which has had two separate incidents MOST IMPORTANT of cross-border infection. More F E ATURE OF THIS cases in Mali are expected and more OUTBRE AK IS THE exportation of cases to other regions are likely. On the ground in West MISMATCH BE TWE E N Africa, our clinical experiences with this THE NUMBE R OF outbreak are equally unprecedented. ME D ICAL CARE With over 14,300 cases to date and over PROVID E RS AND THE 5,100 fatalities, this outbreak serves as SHE E R NUMBE R OF a live fire test for mass-casualty disease E BOL A PATIE NTS.” outbreak response, as well as a test of the U.S. biological threat detection and response capabilities. In no prior Ebola or Marburg outbreak have our previously proven strategies of contact tracing of exposed patients, early identification and isolation of symptomatic patients, and rigorous supportive care of critically ill patients been so ineffective. Although nongovernmental organizations, the WHO, the CDC, and European and U.S. military resources have been increasing arithmetically in the affected areas, the virus has been increasing exponentially. Against these grim observations, however, there are some positive developments. In recent weeks, there have been encouraging decreases in the number of new cases, predominantly in areas that are receiving the most support. Not all the credit, however, should be directed at the international relief efforts. It should be emphasized that the people in these areas have participated directly and

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undeniably in the reduction of Ebola transmission in their homes, neighborhoods, and communities. The result is that the rate of new cases admitted to ETUs in several regions of Liberia are decreasing. Also, for the first time, there are several ETUs that have no lines of patients waiting to be admitted, and, as early as November 1, several ETUs are reporting unoccupied beds. With this positive information comes an opportunity to reflect on how we can retune our medical care and laboratory support strategy in a way that saves more lives, accelerates the control of the epidemic, and establishes a new play book for countering future outbreaks of Ebola. This report from the field was written for the American Society of Microbiology community to highlight the unique, critical contribution of the laboratory in the diagnosis, care, and cure of Ebola patients in West Africa and in other resource-constrained settings. To understand the contribution of the laboratory to mass casualty disease outbreak response operations, it is helpful to review some of the features of this virus, and what is now known about the disease in humans. Following the identification of the first cases in rural Guinea in March 2014, the global community learned that the West African outbreak was caused by the most pathogenic strain of Ebola virus, EBOV, formerly known as Ebola Zaire. The epicenter of the outbreak has been based in three West African countries, Guinea, Sierra Leone, and Liberia, which have one of the weakest public health infrastructures in the world. This health care infrastructure possessed virtually no biohazard laboratories suitable for BL4 viral diagnosis and testing. Still, the clinical and laboratory support capabilities in these nations, while ill prepared for addressing the challenges of Ebola, were critical for the diagnosis and medical management of nonEbola viral disease. The loss of this infrastructure will have a persistent impact on the diagnosis, management, and cure of routine diseases that will persist for years after this epidemic. Summarized below is the list of major laboratory support challenges that are impacting our ability to care for Ebola and non-Ebola patients in the current outbreak.

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1. LOSS OF TRAINED LABORATORY WORKERS The international community was slow to recognize the risk that Ebola posed to health care professionals such as laboratory professionals that were distant from the ETU. The systematic failure to notify clinical laboratories of possible infected specimens resulted in the “precision targeting and elimination” of clinical laboratory capacity through Ebola infection delivered as clinical samples. The reasons that this occurred resulted from the local health care community’s slow response to recognize Ebola in their wards and clinics. This resulted in clinical samples being sent to the laboratory without proper labeling and containment precautions, resulting in infections and fatalities among clinical laboratory workers. A second factor contributing to the high infection rate of clinical laboratory personnel was the lack of the uniform use of personal protective equipment when working with infectious blood, stool, and other body fluid from Ebola patients. These missteps resulted in infection and fatalities among staff at the central laboratories serving the hospitals during the early weeks of the epidemic. By the end of June, five of seven laboratory workers that I worked with at JFK hospital in Monrovia had died of Ebola. By the end of July, it was impossible to get a blood chemistry panel from any of the preexisting government or private laboratories in Monrovia. The implications for the loss of basic laboratory studies caused a dramatic reduction in the ability to “BY THE E ND diagnose and care for common medical OF JUNE, 5 OF 7 conditions in the region. This point was emphasized in our teaching mantra recounted to all new Ebola health care workers who arrived in Monrovia: “Ebola does not protect you from malaria, typhoid, flu or diabetes.” This point underscores that, while the World’s attention is understandably directed at Ebola, multiple other treatable diseases are killing our patients in West Africa.

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2. INADEQUATE PATHOGEN DIAGNOSTIC CAPABILITY The burden of infectious disease in West Africa is among the highest in the world. A review of major infectious disease morbidity and mortality in the region shows that malaria, severe acute respiratory illness (SARI), viral and bacterial enteritis, typhoid and paratyphoid fever, HIV and associated coinfection, and multiple zoonotic diseases account for the majority of fatalities. Over the past decade, the laboratories of West Africa have worked successfully with the international community to improve quality, diversity of tests and bioassays, and time to diagnosis. Where laboratory capacity has been weak, as demonstrated in the current outbreak, is the timely diagnosis of unexpected and emerging infectious diseases. In the present situation, Ebola would kill twice: first, through the direct death of patients including health care workers and laboratory workers, and second, by eliminating critical laboratory capacity throughout West Africa resulting in additional deaths owing to an inability to diagnose and manage other local and usually treatable diseases. Through infection and death of laboratory workers and the disruption of sample transportation networks, the ability to maintain integrated diagnosis, laboratory testing, and clinical support of any patient who needed laboratory testing disappeared in West Africa. The loss of skilled laboratory personnel above also denied Ebola response organizations the opportunity to leverage local laboratory capacity to help deliver better care for our patients. These skilled personnel were needed to support the clinical diagnosis of coinfection with malaria, typhoid, rickettsia, coxiella, meningococcus, and multiple other routine and treatable infections. Without this diagnostic capability, our team was compelled to either treat empirically, thus increasing adverse drug reactions, squandering critical therapies on patients that did not need them, and increasing selection pressure for drug-resistant Gram-negative organisms, malaria and other pathogens. A list of endemic pathogens, including those implicated in increasing the case fatality rate in Ebola infection, is listed in Table 1.

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TABLE 1: Endemic Infections mimicking acute Ebola infection in Liberia (EBOV; n=491) and Democratic Republic of Congo (BEBOV; n=44) High frequency: Plasmodium falciparum 1, Plasmodium vivax, Salmonella typhi 2, S. paratyphi, Shigella spp, HIV and HIVassociated GI infections (MAC, CMV colitis) 3 Low frequency: rickettsia spp; meningococcus; dengue 4, leptospirosis, Lassa Fever 5


P. falciparum positive rapid antigen tests were positive in 6% of EVD patients admitted in Monrovia and 1% of all admissions had a + malaria smear


S. typhi closely resembles the early presentation of EVD, with chief completes of fever, nausea, vomiting and abdominal complaint


Approximately 3% of EVD patients in Monrovia had a positive HIV ELISA (courtesy, Institute Pasteur, publication in preparation)


Dengue, both uncomplicated primary infection and dengue shock syndrome were uncommon in this series. The symptoms of dengue are perhaps the most consistently similar to those of early EVD. In regions where EVD and dengue are present, accurate diagnosis will require that dengue be ruled out by NS1 assay or PCR


Lassa Fever (LF) is a common seasonal viral zoonosis in many parts of West Africa, in particular, Sierra Leone and Nigeria. In these areas, differentiation of LF which can be partially treated with ribavirin, from Ebola is a diagnostic priority

3. DELAYED EBOLA PCR TESTING The backbone of Ebola and Marburg viral disease outbreak management is the rapid detection of virus in symptomatic patients. The absence of this capability endangers the lives of uninfected patients and health care workers and hinders efforts to prevent the spread of Ebola to uninfected areas. To understand the critical role of PCR and other definitive tests for Ebola (e.g., ELISAs), one has to understand the protocol with which clinicians evaluate patients suspected of having Ebola viral disease (EVD). In filovirus outbreaks caused by any of the 5 Ebola and 2 Marburg strains, the priority is for the rapid identification, focused diagnosis, and isolation of infectious patients from the community. At the beginning of an outbreak, the majority of patients presenting with early symptoms of Ebola, typically high fever, retro-orbital headache, nausea, vomiting, and diarrhea, may have Ebola, or coendemic infections such as malaria, typhoid, or a wide array of unspecified viral or bacterial gastrointestinal illness. PCR, when immediately available, allows the clinician to quickly identify true positive EVD patients from among patients isolated in the Suspect Case Ward, and separate them from those infected by other treatable infections. When PCR is not available, the physician is compelled to keep these undiagnosed patients in the ETU, where the risk of nosocomial transmission of EVD from infected to uninfected patients is increased. In several unfortunate cases in Kenema and Monrovia, patients who had to wait in the ETU for days for PCR test results, which eventually came back negative, became infected with Ebola from other patients. A second way in which PCR provides support for outbreak control is the correlation of quantitative viral load (VL) with disease severity. In this capacity, quantitative VL is used to monitor a decrease in VL and the likely onset of convalescence. The final method in which PCR testing helps in the control of Ebola outbreaks is ensuring that convalescent patients are free of virus and able to return to the community. Once viral load is undetectable, convalescent patients can be moved to a lower-risk ward where the focus is on feeding; treatment of post-Ebola sequelae such as arthralgia, muscle wasting, and

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malabsorption; and patients can be educated about personal health and their return to the community. It should be noted here that PCR has also generated critical information regarding possible Ebola risk factors such as the documentation of Ebola virus in the semen and breast milk of Ebola survivors weeks after the resolution of symptoms. Under ideal circumstances, expanded PCR testing can be extremely helpful in identifying coinfection that exacerbates Ebola mortality. For example, PCR testing for HIV, viral hepatitis, malaria, and other infections allows the clinician to improve survival by treating coinfections concurrent with supportive care for Ebola. In our anecdotal experience in Democratic Republic of Congo and in Liberia, the treatment of malaria coinfection (both Plasmodium falciparum and Plasmodium vivax), helminth infection (primarily ascariasis, hookworm, and strongyloides), and salmonellosis all contributed to reducing the mortality for Ebola. These patient outcome results are now undergoing intensive review and will be published in the near future. 4. LABORATORY GUIDANCE OF MAXIMUM USE OF SUPPORTIVE CARE (MUST) There is no vaccine or drug for treating Ebola or Marburg infection. At this time, we believe that patient survival relies heavily on basic medical support. The priority focus areas of this support are the replacement of fluids lost from diarrhea, which can exceed 10 liters per day, from vomiting, and from insensible losses resulting from increased metabolic state. Fluid replacement is accomplished through oral rehydration therapy or, more effectively, through intravenous or interosseous access that allows for more rapid correction of shock. The diarrhea and vomiting that are increased in patients infected with the current strain of EBOV in West Africa cause profound electrolyte abnormalities, in particular, hypokalemia and loss of bicarbonate, which, if not recognized and corrected, contribute to mortality. Restated, survival from Ebola depends on correction of life-threatening abnormalities while the patient mounts an effective immune response. Death occurs when this race between the virus and acquired

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immunity is lost. What is tragic is that a number of Ebola patients succumb late in the disease course when the VL is decreasing and, in some cases, undetectable. In our bedside experience, we have had Ebola patients die as late as ETU day 13, a time when most patients are well into convalescence. In two occasions, these patients had a undetectable VL. These cases suggest a cause of death that is initiated by the virus but which progresses independent of the patient’s immune response to Ebola. For this reason, the U.S. government medical research agencies, the WHO, major Ebola response nongovernmental organizations, such as MSF and the International Medical Corps, and rapid-response Ebola teams, such as Rescue Medicine, have all shared clinical laboratory data from Ebola patients. These data have guided the development of a unified patient care strategy to maximize the impact of basic medical care on the survival of Ebola. The current system, referred to as Maximal Use of Supportive Care (MUST), employs basic medical care principals applied early, rigorously, and under the guidance of laboratory testing. Without routine laboratory testing, the clinician in the ETU can only make crude estimations as to whether a patient’s serum potassium is high, normal, low, or life threatening. Other critical laboratory assays that support MUST are listed in Table 2.

TABLE 2: Laboratory studies that support MUST management of Ebola High priority: serum potassium*, bicarbonate*, lactate* calcium, magnesium, phosphate, glucose, AST, ALT, creatinine and BUN, platelets* , lactate*, malaria antigen test of smear showing high parasitemia Moderate priority: amylase, hematologic profiles, including CBC with WBC differential Lower priority: amylase, lipase, bilirubin, CPK, LDH * Indicates predictor of patient survival in Ebola Viral Disease

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LOOKING AHEAD There is a general acceptance within the WHO and the Ebola outbreak response community that future “SURVIVAL F ROM Ebola and Marburg outbreaks will EB OL A D E PE ND S be more frequent, and more likely UP ON CORRE CTION to involve cross-border and even O F LIF E THRE ATE NING intercontinental transmission. The A B NORMALITIE S WHILE continued development of Africa, T H E PATIE NT MOUNTS explosive expansion of trade with India, China, and other Asian A N E F F E CTIVE IMMUNE countries, and the proven capacity R ESPONSE. D E ATH for Ebola to be transmitted within O CCURS WHE N THIS RACE urban communities dramatically B ETWE E N THE VIRUS AND increases the probability that future ACQUIRE D IMMUNIT Y IS outbreaks may produce clusters of LO ST. WHAT IS TRAGIC disease in densely populated cities of Asia, Europe, and the Americas. The IS THAT A NUMBE R OF magnitude of the current outbreak EB OL A PATIE NTS SUCCUMB has demonstrated in dramatic L ATE IN THE D ISE ASE fashion the shortcomings of our mass CO URSE WHE N THE VL IS casualty disease response capabilities DECRE ASING AND IN SOME and the limitations of our current CA SE S, UND E TE CTABLE.” laboratory capacity for supporting outbreak prevention and control. There are several areas of laboratory technology and assay development that can be strengthened to support future mass casualty viral hemorrhagic fever (VHF) outbreaks. These areas include: 1. The efficient integration of high-throughput diagnostics with the mass casualty treatment operations 2. Development of new handheld point-of-care technologies that allow the physician wearing

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personal protective equipment inside a hot ETU to quickly rule in VHF patients and quickly separate out patients infected with non-VHF, treatable diseases before they become infected 3. Development of a platform that wirelessly communicates patient clinical laboratory information and laboratory diagnostic information to the bedside for rapid clinical decision making by the physician 4. Use of social media and other unbound data sources to analyze syndromic trends in the community and to trigger more intensive investigation by regional laboratories 5. Development of high-quality, robust mobile laboratories that can bring the laboratory to the rural ETU to reduce the time to results and provide a more agile laboratory capacity for developing nations 6. Use of simulations and biosecurity audits where our hospital, state, and federal reference laboratories, both domestic and foreign, are tested to ensure these facilities are capable of detecting index cases, and, later, capable of meeting the surge demands of mass casualty infections and poisonings 7. Ensure that the diagnostic and clinical laboratories of our partner nations receive adequate training and resources to ensure protection from highly dangerous pathogens, and that this capacity does not degrade the ability of the laboratory professional to work quickly, efficiently, and accurately on the pathogen or patient samples sent for investigation

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In summary, our ground experiences in West Africa show that the clinical laboratories remain vulnerable to the dangerous of large-scale disease outbreaks, and second, the loss of laboratory support directly degrades our ability to diagnose and to treat our patients. One can speculate that large-scale outbreaks caused by a true airborne pathogen would have an even more devastating effect on regional laboratory capacity. As we continue to move forward to control the current West African outbreak, we should regularly revisit our assumptions regarding the protection of our laboratories, and consider new strategies that will help them adapt to meet the challenges of emerging, reemerging, and drug-resistant disease outbreaks.

MICHAEL CALL AHAN, M.D. Michael Callahan, M.D. is board-certified in infectious diseases, internal medicine, and tropical medicine, and carries a Command Physician rating for disaster medicine. He has responded to five Ebola and Marburg outbreaks. Dr. Callahan previously led the Defense Advanced Research Projects Agency (DARPA) biodefense research portfolio that developed biodefense countermeasures and detection systems for the U.S. government. Dr. Callahan’s academic appointment is at the Division of Infectious Diseases at Massachusetts General Hospital/Harvard Medical School. He is guest clinical faculty at the WHO Center for Emerging Diseases at Chulalongkorn University Hospital in Bangkok and at the University of Panama Medical Center. In 2011, he became the President and Chief Medical Officer of Unither Virology, a biotechnology company that has developed broad-spectrum host-based antiviral agents against dengue and influenza that are currently in clinical trials. When not repairing his backhoe, he is advising the World Health Organization, the U.S. Department of Defense, and the World Bank on health security issues in Asia and Africa. He lives with his wife Shannon and boys Quinn and Cash in the mountains above Boulder, Colorado.

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B Y: R O G E R I. G L A S S , M .D. , P H.D.

It has been heartbreaking to see the images and learn of the horrific details emerging from the Ebola outbreak in West Africa, where the health systems are fragile and medical research capacity is lacking. With health care workers on the front lines, many have become infected themselves. Liberia has lost 96 already, according to a recent Washington Post op-ed by President Ellen Johnson Sirleaf. “This is a huge hit for a country that had barely 50 doctors to care for a population of 4.4 million at the start of this outbreak,” she observed. “THIS IS A HUGE HIT FOR A COUNTRY THAT HAD BARELY 50 DOCTORS TO CARE FOR A POPULATION OF 4.4 MILLION

In the 24 previous outbreaks of Ebola, the virus was controlled early by rapid response, active surveillance, and quarantine. This time, the outbreak is occurring in countries recovering from conflict, without the health infrastructure or quantity of trained personnel to effectively deal with the problem.


With health officials and care providers overwhelmed by the sheer numbers of THIS OUTBREAK.” people stricken by this terrible virus, it’s no LIBERIAN PRESIDENT, wonder that little attention is being given to ELLEN JOHNSON SIRLEAF studying the outbreak in any detail. There is barely time to count the dead. Without trained epidemiologists tracking the outbreak, studying its transmission, noting what care is provided, how many recover, and how many succumb – we are losing the opportunity to learn vital information that could help us discover new and better ways to contain this or future outbreaks. It is imperative that the international community provide Liberia, Sierra Leone, and Guinea not only with the immediate assistance they so desperately need, but also with an investment in longterm capacity building to improve medical education, increase the quantity and quality of doctors and health care workers, and develop scientific expertise and disease surveillance skills.

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West Africa lacks the trained personnel required to conduct surveillance and an adequate response to stop outbreaks of diseases such as Ebola. Through the U.S. Medical Education Partnership Initiative, a dozen African countries are strengthening their training and research programs.

As none other than smallpox veteran Dr. D. A. Henderson recently noted, it is distressing that there is still such an utter lack of epidemiological data – months after the alarm was sounded and the world began taking notice. As he pointed out, there is so much that can be learned from age distribution curves, intervals between dates of onset of patients in households, viral load, and other information from laboratory tests and more. It’s just this kind of scientific capacity the NIH’s Fogarty International Center has been working to develop in low- and middle-income countries for more than a quarter century. Four years ago, we began a partnership aimed at revitalizing African medical education. Known as the Medical Education Partnership Initiative (MEPI), the program is funded by the President’s Emergency Plan for AIDS Relief (PEPFAR) and NIH, and is administered jointly by Fogarty and our sister agency, the Health Resources and Services Administration. With MEPI support, African medical schools are dramatically increasing enrollment, broadening curricula, upgrading Internet access, and providing cuttingedge skills laboratories and other technologies. Where students used

If the international community provided resources to train more healthcare workers, epidemiologists and other experts in African countries where they are lacking, the continent would be better prepared to respond to future disease outbreaks, preventing the need for largescale emergency efforts.

to fight to use shared text books, they are now each provided with notebook computers loaded with the latest instructional materials and equipped to access current journal articles. The pace of change is astonishing, and we hope it will result in sustainable health improvements across the continent. Sadly, the countries hardest hit by Ebola did not submit successful proposals to receive MEPI awards. And yet we must join together to share information and resources to help them recover and move forward. MEPI was envisioned by the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) to address the terribly inadequate supply of health and medical personnel required to support health programs in sub-Saharan Africa, particularly around HIV/AIDS but extending to other medical needs as well. By investing in education in medicine and the allied health sciences, MEPI is building human capacity for health in Africa by strengthening the medical education system in an environment that values and nurtures research. Why do we see research as integral to this endeavor?





In the 1980s, the world was challenged by the emergence of a new virus – HIV – that was uniformly fatal and was to become most problematic in Africa. Since then, research discoveries have informed care and treatment so that a diagnosis of HIV/AIDS has been transformed from a death sentence to a manageable chronic illness. Much of this research has been conducted by African investigators working in African academic institutions at African field sites with African populations, often but not always in collaboration with academic colleagues in the United States. This research has been truly game changing and could not have been conducted as quickly, carefully, or effectively without outstanding local scientific leadership and implementation of solutions. The results have included the development of rapid diagnostics for detecting and monitoring HIV infections, new drugs for treatment, and new strategies for prevention, such as avoiding mother-to-child transmission, voluntary medical male circumcision, and treatment as prevention. MEPI has been built on the idea that outstanding academic institutions in the health sciences must be excellent in education, service, and research. Research can play a key role in producing effective and sustainable leadership in health, in developing knowledge and practice for the delivery of care, and for

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building academic centers in sub-Saharan Africa. The research perspective provided to students and faculty, the ability to raise and answer questions, and the idea that medical knowledge and practice are continually changing are being supported by MEPI sites and will hopefully endure long after the program ends. Finally, as bandwidth expands across Africa, it is vital that we take advantage of the opportunities for online research collaborations, distance learning, mobile apps for data collection and analysis, telemedicine, and other approaches that have the potential to revolutionize how we conduct research and training in low-resource settings. Some of these technologies are being deployed in the Ebola fight, which has been an encouraging sign, but much study is needed to find out how to effectively adapt these tools for the local environment and circumstances – and that will take resources. A modest investment in health infrastructure – including training health care workers, doctors, and researchers – could provide the tools countries like Liberia need to halt disease outbreaks in their tracks and prevent the need for large-scale emergency efforts like the one we’re assembling to fight Ebola. The United Nations is calling on the international community to provide $1 billion to stop this outbreak. I join Liberia’s president in encouraging that some funds be directed to strengthen medical education and research training in Western Africa to prevent a future disaster on this scale. In her words, “We owe it to the thousands of citizens and health workers who have so far lost their lives to be prepared.”

ROGER I. GL ASS, M.D., PH.D. Roger I. Glass, M.D., Ph.D., is Associate Director of Global Health Research at the U.S. National Institutes of Health (NIH) and Director of the NIH’s Fogarty International Center.

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B Y: S E A N G . K A U F M A N , M . P. H . , C H E S

I have had the honor of training over 3,000 scientists working in or supporting high-containment laboratories around the world. During the training programs I provide, I ask the scientists to report incidents and accidents immediately after they occur. Reporting incidents provides the organization with the opportunity to learn and become better by changing what caused the incident to occur in the first place. I have taught these scientists the difference between punishment and reinforcement, a simple concept that has a profound impact on behavioral practices. A scientist is a human being and, until that changes, mistakes even among the most competent, will occur. If scientists fear punitive actions for reporting these errors, the likelihood of doing so is greatly reduced. In July 2014, I testified during a congressional hearing about the CDC Anthrax Incident – claiming the error was one of organizational culture rather than staff competency. I had trained the scientists involved in this incident and know for a fact it was not a competency issue. The facts about what happened are clear – a verified procedure was used, a sterility test was done too early, the plate had no growth after 24 hours, the sample was inactivated (because it had sat for 24 hours), the sample was transferred, the plate showed growth (3 days later), and the incident was immediately reported. Unfortunately, the blame of this bioerror fell solely on the scientists, leading to the resignation of the laboratory leader, and with the organization taking little to no responsibility for the failures in organizational safety. Bioerror begins within the first step of the biological risk mitigation process. A process that consists of identifying risk, assessing the risk from multiple perspectives (scientific and perception), managing the risk with standardized policies, and integrating the risk management strategies into the workforce. Bioerror is the failure of the biological risk mitigation CULTURES Vol 1, Issue 4  Page 39

process, impacting an organization’s ability to conduct safe science. The first step of biological risk mitigation is the most critical step in preventing bioerror. Most leaders within organizations believe the greatest risk they face in science is the agent itself. The dangers of working with Tier 1 Select Agents or any infectious substance poses significant risks to the organization’s workforce, reputation, and the overall scientific agenda. However, the agent itself is the lowest risk when you consider several critical factors. The agent is stable, it does not change, it is understood, it is not moody, does not have personal problems, nor does it have expectations. The agent just is and in that it remains until the workforce interacts with it. At one time, I believed the workforce was the greatest predictor of bioerror. The people working with the agent had to be well trained and extremely competent. In the years I have been serving science, I have seen incompetent individuals, not well trained, have access to pathogens, which has made me quite nervous. Bruce Ivins, who has been accused of facilitating the 2001 Anthrax Attacks, was a well-trained scientist who was extremely competent. The most recent CDC Anthrax Event, an incident that was caused by a sterility test being facilitated too early was not a failure in the inactivation protocol nor was it an indicator of scientific incompetence. Although the workforce can contribute significantly to bioerror, I am convinced it is the safety culture of the organization – where the workforce interacts with the agent – which poses the greatest risk of bioerror. Leadership within organizations must establish a set of beliefs that promotes a culture of safety. These beliefs should focus on core concepts that include preparing, protecting, and promoting scientists.


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Preparing scientists means leadership never uses the word “trained” because training never ends. Leadership must protect their scientists, because incompetence is not the issue – human risk factors are – and until robots replace human scientists – mistakes will happen. Leadership must promote the benefits of science, encouraging a balance between safety policies and scientific innovation. If scientists have an organization that prepares, protects, and promotes them – half of the safety culture has been developed.


Scientists must conduct themselves according to a set of rules that promotes a culture of safety. The difference between a lesson learned and a lesson ignored is change. Unfortunately, there have been many circumstances of bioerror, leading to incidents, accidents, laboratory-acquired illnesses, and even death. Establishing behavioral expectations based on previous lessons and ensuring those expectations are met is a critical step in establishing an effective safety culture. All scientists should be expected to do the following: 1. I will follow all standard operating procedures (SOPs) to the best of my ability. 2. I will ensure others follow all SOPs to the best of their ability. 3. I will report all laboratory incidents and accidents. 4. I will report any signs or symptoms that match the clinical presentation of the biological agents I am working with. 5. I will report any new medical conditions (including but not limited to diabetes, heart disease, pregnancy, medications that may cause seizures/compromised immune functions, and chronic asthmatic conditions).

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It is at the intersection of organizational beliefs and behaviors – where safety culture exists (or ceases to exist) – and where the risk of bioerror is at its greatest. What happens when an SOP is not followed? What does someone say when they see an SOP not being followed? If someone reports an accident – what are the consequences? What happens if signs and symptoms are reported? If a medical condition is reported, will it put a scientific career at risk? If scientists believe the organization is committed to the preparation, protection, and promotion of its workforce – the behavioral responses to these questions could be quite amazing. It is the culture of an organization that influences how the workforce interacts with the agent. Organizations that tolerate insubordination (individuals who deliberately choose to violate SOPs), do not hold everyone accountable to every rule, and inadvertently punish the workforce for reporting incidents and accidents with administrative tasks (reports, interviews, unintentional professional scrutiny) suppress actions and information that would make their organization stronger and safer. The workforce must believe they are prepared, protected, and promoted to FO L LOW T H E PR O C EDURES behave appropriately within AS C LO S E LY A S PO SSIB LE. organizations. The complete burden of safety culture does not fall solely on leadership beliefs. The workforce must behave as one, requiring the suppression of egos and the commitment to the organization over oneself. Commitment to the organization does not mean the suppression of individuality, innovation, or creativity. Commitment to the organization over oneself means operating within the organization with the understanding that individual behavior affects more than the individual – it affects all other individuals in the organization as well. The mistake of one individual could affect the scientific agenda

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of an entire organization or place the lives of others at risk. There may be several projects, with different goals – but all projects are committed to the same behavioral expectations under the beliefs of preparation, protection, and promotion of scientists. Biological risk mitigation includes the process of identifying risks associated with working with biological agents. Most of time, the focus of risk identification is solely on the agent. There has been some progress, and the preparedness of the workforce is now being discussed as a contributing factor of bioerror. However, the focus on cultural issues where the beliefs of the leadership intersect with behaviors of the workforce must be explored. It is at this intersection where scientists and biological agents interact and where the real threat of bioerror exists.

SEAN G. KAUFMAN, M.P.H., CHES Sean G. Kaufman, M.P.H., CHES is an internationally renowned biosafety expert who developed and delivered the BSL3/BSL4 Science and Safety Training Program at Emory University. His expertise has allowed for him to serve in many infection control capacities, most recently serving in the isolation unit during the first clinical treatment of Ebola in the United States at Emory University and in Liberia preparing doctors and nurses to work with patients infected with Ebola. Sean’s focus is on the behavioral practices and beliefs of leadership and workforce within laboratory environments – practices and beliefs that create a safety culture. He is the CEO and President of Behavioral-Based Improvement Solutions, a company that specializes in biological safety training, infection control, and workforce development.

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Check out our video interviews with these ASM Young Ambassadors of Science and more:















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5 6 7 2 3

1 2


3 4 5

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E A R L Y- C A R E E R S C I E N T I S T S T H I N K A N T I B I O T I C

R E S I S T A N C E P O S E S T H E G R E A T E S T T H R E A T T O H U M A N I T Y.







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The loosely formed biohacking movement was popularized in 2008 when two friends founded DIYbio, a group of amateur biologists with a “strong sciencepower-to-the-people” ethos.1 Since then, small groups around the world have embraced the ideology behind the “do it yourself” biology movement and are actively trying to make science more accessible for everyone. Despite the fact that there is an ever-growing number of selfproclaimed hacker groups around the world, 92% of the American public have not heard of DIYbio. For those who have, perception is often shrouded in skepticism about the intention of “biohackers” and the safety behind the movement. Headlines like “Biohacking: Exciting Science or Terrifying Threat”2 and “Hacking the President’s DNA”3 imply that there is something to fear about the largely unregulated “at home” biology movement. Yet Ellen Jorgensen, founder of the DIYbio group Genspace, says: “fears about the technology used in these labs is misplaced. While [the technology] is incredibly powerful, it’s not inherently good or evil – it’s what you use it for.”

And, as the next few pages exemplify, the technology is being used for educational, innovative, and decidedly original purposes around the world. Aside from a set of ethics agreed upon in 2012, there is no central organization behind the movement; each community space or DIYbio group has had an organic genesis and is invested in unique projects. There are a wide spectrum of practices from creating art with live tissue, bacteria, and living organisms to at-home gene sequencing to making vegan cheese. To temper concerns and promote a culture of responsibility among the budding amateur scientists, the Federal Bureau of Investigation and the American Association for the Advancement of Science have established trusting partnerships with DIYbio groups across the United States, which helps to balance scientific promise and risk. The DIYbio community even got a recent nod of recognition from the White House when two community leaders, Ellen Jorgensen and Patrick D’Hasaeleer, were invited to Washington, D.C. to participate in a collaborative meeting with the U.S. Agency for International Development (USAID), the White House Office of Science and Technology, the CDC, and the Department of Defense. More than 100 experts convened to explore ways to improve the personal protective equipment (PPE) currently being used by health care workers battling Ebola in West Africa. Around the world, not only biologists, but also geologists, chemists, philosophers, engineers, poets, artists, anthropologists, and others are joining DIYbio groups to collaborate and learn. Impassioned biologists and eager students embrace the DIYbio movement as a way make science more accessible and to collaboratively find innovative solutions to global problems. Ellen Jorgensen and Patrick D’Hasaeleer left Washington D.C. and returned home to ask their DIYbio groups – composed of artists, designers, and amateur scientists – to help them brainstorm solutions to the overheating problem in PPE suits. It is increasingly a “do it together” mentality that has made these biohacker groups focal points for innovation and science creativity across the globe.

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Demonstration during a bio display workshop.

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C U R R E N T P R OJ E C T S :


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C U R R E N T P R OJ E C T S :



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C U R R E N T P R OJ E C T S :

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Here’s a video that highlights a recently completed project known as Glowria: a person monitor for your carbon footprint.



C U R R E N T P R OJ E C T S :

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C U R R E N T P R OJ E C T S :



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C U R R E N T P R OJ E C T S :

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C U R R E N T P R OJ E C T S :

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With a Ph.D. in molecular biology, Ellen spent many years in the biotech industry before focusing her attention on the open science movement. As a trained scientist in the United States, she quickly became disheartened by the widespread public distrust and negative attitudes toward science. So, in 2008, as critics increasingly lobbied against the validity of climate change, Ellen left the biotech industry for a movement few had heard of. She saw the budding DIYbio movement as a key way to bridge the communication gap between scientists and the general public. Ellen strongly believes that science information is too often delivered in a “top down” manner that invokes mistrust in the public. Take, for example, Ebola. Scientists, policy makers, and top U.S. health officials have repeatedly told the American public that they are largely safe from the disease. Yet despite headlines like “We do not need to worry so much about Ebola in the US”4 and “Don’t worry about Ebola, get a flu shot”5, public fear is still high6. However, several DIYbio groups are currently working together to explore ways to help the effort to redesign the Ebola personal protective equipment, and are helping to allay misconceptions along the way.


Ellen shared her excitement about the inclusion of DIYbio groups in the International Genetically Engineered Machine competition (iGEM) earlier this year. For the first time ever, five groups, LA Biohackers, London Hackspace, Genspace, Counterculture labs, and Biocurious, were allowed to work on projects for the premiere Synthetic Biology competition. Competitions like these not only increase public awareness about DIYbio groups, but also encourage groups to come together to share tips and ideas. Many groups are constantly look for way to collaborate with one another, pushing the limits of what they’re capable of independently. As collaborations grow, and DIYbio groups gain further recognition, the movement is likely to continue advancing science communication and advocacy. And, as Ellen sees it, the movement has already begun to embody the “out of the box” thinking that is needed to not only improve general science education, but to help find solutions to current and future global security concerns. CULTURES Vol 1, Issue 4 » Page 69




ABOUT O’NEILL INSTITUTE: The O’Neill Institute for National and Global Health Law at Georgetown University was established to respond to the need for innovative solutions to the most pressing national and international health concerns. The O’Neill Institute reflects the importance of public and private law in health policy analysis. As health lawyers, one of the first questions we are invariably asked by our nonlegal peers is, “what does the law have to do with anything?” Our response is, “everything.” Typically we’re met with a mixture of surprise, hostility, and bemusement – but as the conversation progresses, incredulity gives way to understanding as it becomes evident that law does play a central role in shaping health outcomes. While the law cannot provide the technical medical expertise

to prevent and treat diseases, it can provide the conditions necessary for innovation, regulation, and implementation to occur. It does so by creating a foundation for governance, supporting growth in all sectors, and ensuring sustainability. Effective laws are invisible – when they work well, most people aren’t even aware that they are at work. But when there is a breakdown somewhere in the legal chain, the ensuring health consequences can be catastrophic.

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Take the current Ebola crisis. Primarily concentrated in West Africa, the disease is wreaking havoc in three of the poorest countries in the world – Guinea, Liberia, and Sierra Leone. At the date of this writing, the World Health Organization (WHO) estimates over 4,500 have died of the disease, with around 9,200 reported cases. While there is neither cure nor vaccine for Ebola, the root cause of this current outbreak is not a failure of science, but one of governance – first, the failure of governance at both the national and global levels to build sufficient legal frameworks and institutions to prevent such outbreaks, and second, the failure of governance to detect and respond to them when they do occur. And, at the heart of governance is law. In the midst of a disease outbreak, law provides guidance on roles and responsibilities. It may afford local, state, and federal authorities extraordinary powers. It can make clear the role of international organizations, like WHO. It provides a framework for testing and rolling out experimental drug therapies. It also may afford extra protections to affected individuals and communities to shield them from undue discrimination and stigma. On the whole, effective law is the equivalent of an effective map – but you don’t attempt to draw a map after you’re already lost. The O’Neill Institute for National and Global Health Law at Georgetown University seeks to help draw this map. Our vision is that that law has been, and will remain, a fundamental tool for solving critical health problems. Our primary goal is to work on impactful projects while building legal capacity in health throughout the world to more effectively respond to today’s health priorities. THE O’NEILL INSTITUTE FOR NATIONAL AND GLOBAL HEALTH LAW The O’Neill Institute was formally established in 2007 to respond to the need for comprehensive solutions to the most pressing national and international health concerns. Housed at Georgetown University

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Law Center in Washington, D.C., the institute addresses urgent health problems through world-class research and scholarship by using a comprehensive, interdisciplinary, and transnational approach that extends beyond a narrow vision of health law that focuses solely on health care as an industry or scientific endeavor. While we pride ourselves on developing thoughtful and innovative analysis, a core tenet of our mission is also to have a measurable impact on the health of individuals in the United States and around the world. Consequently, we employ an integrated approach to our work, combining elements of research projects, capacity building, and scholarship. Our work is organized around seven thematic areas: food and drug law, global health governance, health and human rights, health care, infectious diseases, noncommunicable diseases, and trade, investment, and health. These areas are intentionally broad and were selected as those in which the institute felt law could have the most impact on health outcomes. RESEARCH PROJECTS We engage in research projects across our thematic areas with external partners. We have worked with the Robert Wood Johnson Foundation, the Bill & Melinda Gates Foundation, the U.S. Centers for Disease Control and Prevention, the World Health Organization, policy makers on Capitol Hill, legal scholars, and health practitioners from around the world, as well as many other international organizations and nongovernmental organizations. As each project is unique, so too is the expertise required. We seek out the right experts to ensure we are providing the best potential solutions to the given challenges. Case in Point: Global Tobacco Control Tobacco use is one of the greatest public health and human rights threats facing the world today. Engineered to addict and ultimately kill Page 72 Âť Sharing the Vision

its user, tobacco products are peddled by an industry that specifically targets the most vulnerable – in particular, women, children, and the poor. If left unchecked, it will kill 1 billion people this century. While the public health community has made significant strides in curtailing global tobacco use, consumption is increasingly concentrated in marginalized populations. Moreover, while the majority of tobacco-related morbidity and mortality will occur in developing countries, rates of tobacco use in vulnerable populations in developed countries have remained static or are on the rise. Our work in this area has been supported in part by the Campaign for Tobacco-Free Kids as part of the Bloomberg Initiative to Reduce Tobacco Use. We examine emerging trends in tobacco control policies, legislation, and litigation, and link research with policy discussions around the world. For example, litigation is a key tool in tobacco control. Our activities include advising health advocates, public agencies, and governments in their response to industry challenges, creating and supporting litigation strategies, and translating research into potential policies for leaders around the world. We also engage with courts through the development of amicus briefs – tools that offer courts additional information to assist in deciding a pending matter. Amicus briefs can be very effective in supporting tobacco control efforts at the national and regional levels. For example, Peru’s Constitutional Tribunal upheld the constitutionality of the country’s reformed smoke-free law based on the O’Neill Institute’s recommendations. CULTURES Vol 1, Issue 4 » Page 73


HARVARD UNIVERSITY PRESS 2014 No single person has had a greater influence on the O’Neill Institute than faculty director, Lawrence O. Gostin. An internationally acclaimed scholar, Professor Gostin has spent his academic career shaping the fields of both public health law and global health law. His most recent, and potentially most ambitious, scholarly work, Global Health Law, brings coherence to a nascent field. The treatise drives home the need for effective global governance for health and offers a blueprint for reform, based on the principle that the opportunity to live a healthy life is a basic human right.



STUDENT PROFILE: BELÉN RIOS Three years ago, a fledgling tobacco control advocate, Belén Rios, attended our summer program on Non-Communicable Diseases and the Law with the certainty that she wanted to return. She subsequently applied to our Global Health Law LL.M. program to gain a deeper understanding of the field. During the course of her LL.M. program, Belén concurrently worked as a research assistant for the O’Neill Institute, working with our team on projects in health and human rights and global tobacco control. Upon graduation in 2013, she returned to her native country of Argentina, where she currently directs the Legal Area at Fundación Interamericana del Corazón - Argentina (FIC Argentina), a local nongovernmental organization whose mission is to promote public policies and social changes that guarantee the protection of the right to health, through the reduction of chronic noncommunicable diseases, particularly cardiovascular and cerebrovascular diseases. Belén is part of the growing cadre of new health lawyers throughout the world trained by the O’Neill Institute. To date, the Global Health Law LL.M. program boasts approximately 70 graduates. Many have matriculated to positions in national governments, civil society, academia, the private sector, and normative agencies. In its short life, the O’Neill Institute has gained a reputation as a place that can develop solutions and cultivate new talent to respond to real-world health challenges. Whether building a database, as we did for human rights and health law, developing strategies for tobacco control, structuring arguments to help with the passing of U.S. health care reform, exploring ways forward with universal health coverage, or assessing the shortcomings of global health governance as it pertains to the current Ebola outbreak, the institute tackles issues large and small that will help develop new health laws, sets precedents for litigating health cases, and develops innovative policies for solving critical health issues. Page 74 » Sharing the Vision

THE FIRST OF ITS KIND A significant portion of what we do is to administer and teach the Global Health Law LL.M. programs at Georgetown Law. We share the wisdom we have gained and the strategies we have developed with current practitioners around the world. We offer a summer program and conduct symposia and workshops internationally to offer lawyers, advocates, policy makers, and other academics the opportunity to explore leading health issues and to gain expertise in specific health law areas. The Global Health Law program, the first and currently the only one of its kind, offers lawyers working nationally and internationally the opportunity to advance their knowledge and skills through focused studies in core legal and policy courses on global health, individual and public health, human rights, bioethics, economics, biotechnology, and science. Visit our website ( academic-programs/graduate-programs/degree-programs/ global-health/) to learn more about the Global Health Law LL.M. and the Global Health Law and Institutional Institutions LL.M. CULTURES Vol 1, Issue 4 Âť Page 75

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His nickname among friends was Guenna---he was a respected microbiologist who loved to go fishing, play guitar and volleyball, and sing songs with his dog Chase. Guenna grew up in a military family and went into the military himself; he was a true patriot. He loved his work and found microbiology exciting because, “in any kind of research involving microorganisms, you’re discovering something new every day.” Guenna loved adventure, he worked hard, and he partied hard, but he was a dedicated family man whose children were proud that he was a military doctor. Guenna also produced biological weapons that were aimed at killing thousands of Americans.

This is the story of Gennadiy (Guenna) Lepeshkin, a former Soviet bioweapons scientist. The Soviet bioweapons program is considered to be the largest and longest-running bioweapons program.1 Having operated between the late 1920s and the early 1990s, the Soviets achieved a level of sophistication and technological advancement in bioweapons development that surpassed that of the American program. Soviet scientists researched, developed, and weaponized a large number


For extensive details of this program, see: Milton Leitenberg and Raymond Zilinskas, The Soviet Biological Weapons Program: A History (Cambridge: Harvard University Press, 2012).

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of biological agents that cause anthrax, smallpox, pneumonic plague, and other diseases. They also designed novel, genetically engineered bioweapons. Part of our team (Ben Ouagrham-Gormley and Vogel) first came to know Gennadiy about fifteen years ago. Ben Ouagrham-Gormley first met Gennadiy in the late 1990s, during a visit at the Stepnogorsk anthrax production plant in Kazakhstan that Gennadiy managed for many years. Vogel met Gennadiy in 2000 when she, along with a group of Americans and other international participants, attended a conference at the Stepnogorsk plant. The conference focused on the current status of U.S.-funded dismantlement of the bioweapons facility and on the conversion of its personnel and equipment to peaceful uses.2 Paperno and Grunberg met Gennadiy during one of his U.S. visits in 2010. Since then, we have had other opportunities to meet and talk with Gennadiy. As he has opened up over the years about his past work, we have been intrigued to explore how a respected microbiologist came to work on weapons that would kill indiscriminately. For the past four years we have been working on an oral history research and education project, called The Anthrax Diaries, that has involved interviewing men and women like Gennadiy who were directly involved in bioweapons work to try and understand how and why they came to produce such terrible weapons. Although it is easy to merely rationalize their work as a by-product of Cold War hostilities, interviews with Gennadiy and others reveal a more complex set of ethics that structured their career choice to use microbiology for harm. As we have embarked on this oral history project, we see that a sociological and psychological study of the Soviet bioweapons program offers new contributions to the understanding of Cold War defense logics and the personal and ethical responsibilities of those who worked in such programs. Interviews with Gennadiy and other former bioweapons scientists reveal how secrecy, patriotism, propaganda, scientific priorities, technical interests, different national and laboratory cultures, politics, and scientific practices all shaped scientist participation in weapons development. When asked how he felt about working on biological weapons, Gennadiy is very matter-of-fact, “I was offered a job, and I accepted it and went there to work.” When probed further about how he felt at the 2

Michael Dobbs, “Soviet-Era Work On Bioweapons Still Worrisome,” Washington Post, 12 September 2000, p A1.

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time about working with biological weapons, Gennadiy replies, “My feelings about working with biological weapons were positive… I liked the work, I felt that it was very important and promising. And, very necessary… You’re learning new things, studying the work of other research scientists, analyzing, getting various types of new findings, getting results…” Gennadiy goes on to say, “I chose the life of a military man, military doctor, microbiologist, a professional military man in the biotechnology field, so the work gratified me and I lived out my life… lived a life that pleased me.” Some of the other Soviet scientists interviewed, however, found the work profoundly depressing and felt trapped. To date, our interviews reveal interesting ethical variability within these weapons programs that show individuals and cultures within and across institutions embodying and justifying different norms and value systems. They illustrate how the social context and technical practices within particular work environments can create circumstances through which scientists can ignore, as well as rationalize, the risks associated with their work. In examining these kinds of issues, the interviews will illuminate the local, national, and international challenges regarding the ethics of scientific and technological work for students in the physical and natural sciences, social sciences, and engineering. There has been long-standing debate and interest among the public and scholarly community about whether or not scientists are responsible for the technologies they create, but what is less visible is that this discussion also takes place between and within communities of scientists and engineers. This kind of discussion is important for our students and the policy community to see and hear. Furthermore, the frequent conception of biological agents as “dual use,” i.e., having both military and civilian applications, complicates efforts to put scientific work in the life sciences into neat ethical categories; this historical project and its insights are particularly salient with respect to recent discussions on how advances in the life sciences are creating more dual-use challenges.3


For an example, see Gigi Kwik Gronvall, H5N1: A Case Study for Dual-Use Research, Council on Foreign Relations. Working Paper. July 2013, accessible at: http://www.upmchealthsecurity. org/our-work/pubs_archive/pubs-pdfs/2013/2013-07-15-h5n1_dual-use_research.pdf

Page 80 » A Historical Lens



In our video-taped interviews, we have seen fascinating dimensions of how the particular U.S. and Soviet contexts have shaped how these former bioweapons scientists have viewed the ethical dimensions of their work. One point that came up in interviews with Gennadiy and other former Soviet scientists was the international Biological and Toxin Weapons Convention, which banned the research, development, and production of biological weapons. This treaty was ratified by the Soviet government in 1975 and was consistently violated for the next fifteen years, in secret, at dozens of bioweapons facilities around the Soviet Union. Gennadiy admitted that he knew about the Convention from the moment it came into force and that he discussed it with his colleagues at Stepnogorsk. When asked what he and his colleagues did after that discussion, Gennadiy notes, “nothing much. People just did their work. We’re military folks, you see, in the military, you receive your orders, and you do your work.” In interviews we have conducted with other former Soviet bioweapons scientists, we have recorded a variety of explanations from Soviet scientists about why they violated the treaty, from “I was just following orders” to “We had to protect our country” to “We believed that the U.S. was also continuing their bioweapons work.” Perhaps the most striking aspect of this is the ease with which these explanations are offered. Recording such discussions on video (as opposed to text or sound alone) has the advantage of capturing the body language and facial expressions that accompany the statements. It is quite obvious in our interviews that violating an international treaty

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did not bother some of the scientists then and does not make them uncomfortable now. Gennadiy, however, felt clearly uncomfortable when asked why he had not told his family the truth about his weapons work – even now, when he is no longer bound to keep that secret. His grown children still think that he was “a military doctor.” This comment reveals how he is still trying to partition his former work, life, identity, and representation of self. To inform our work, we are drawing on literature from the history and anthropology of science and technology to illustrate the social and psychological processes through which particular ethical arguments acquire compelling force for Soviet biological weapons scientists.4 We can also record the boundaries that these scientists construct regarding what counts as ethics to them, and document the “central axioms” and “different ethics” that govern how these scientists considered their work. For example, Gennadiy repeatedly mentioned that, although his life’s work during the Soviet era was to develop a potent biological weapons capability to use against Americans, he never believed they would be used, “I don’t think that biological weapons could have been used offensively… because it’s a type of weapon that can always have an impact on both sides.” He also argued that, “if any sort of conflict did occur, it would be small in scale, not global, because nuclear weapons were the primary focus.” Anthropologist Hugh Gusterson has revealed a similar boundarysetting rationale among U.S. nuclear weapons scientists, who by believing that nuclear weapons would never be used, rationalized their work and created ethical partitions to their daily work life. When asked if he felt that all work in biological weapons was to be considered a crime, Gennadiy constructs additional justifications, “Well, people who think that weapons designers are criminals… it’s just not true. Because the people who did that work, on top of everything else, were doing work that was primarily to develop defenses against weapons of mass destruction.”


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Here, Gennadiy is trying to point out the alternative, beneficial civilian work that the scientists were also involved in, instead of focusing all attention on the darker side of their microbiological work. “THE PEOPLE WHO DID In 1991, a new set of U.S. government THAT WORK, ON TOP initiatives, called the Nunn-Lugar OF EVERYTHING ELSE, Cooperative Threat Reduction Programs, WERE DOING WORK were launched to mitigate the proliferation THAT WAS PRIMARILY of threats from the former Soviet Union – to TO DEVELOP include the Soviet bioweapons program.5 DEFENSES AGAINST In the mid-1990s, Gennadiy and his colleagues were funded to dismantle his WEAPONS OF MASS former bioweapons facility at Stepnogorsk, DESTRUCTION.” and to work on peaceful scientific research - GENNADIY LEPESHKIN projects. In reflecting on that moment Gennadiy shares, “I felt very bad! I felt bad about all the effort that had gone into this. We were all upset, of course. It was sad that such a big plant had to be destroyed.” In looking at old photos of the ten twenty-thousand-liter fermenters before their dismantlement, Gennadiy longingly comments that the fermenters were “beautiful.” We have been surprised how forthcoming Gennadiy has been in answering our questions to him about his past. When asked generally what he would like people to know about the Soviet bioweapons history, Gennadiy replies, “I don’t have a special noble mission of any kind, but I feel that it would be valuable for people to know how things went as far as that work was concerned, how people lived back then, what they were doing, and what was on their minds. Because that field is one of the most classified the world has ever known, and few people know who the scientists were who were involved in that situation and those things.” To date, we have received some interesting responses from students watching some of the interviews with Gennadiy. One student wrote that she expected Lepeshkin to be a repentant old man and was surprised to see “a kind and grandfatherly kind of person, at peace with his past.”


See: Hugh Gusterson, Nuclear Rites: A Weapons Laboratory at the End of the Cold War (Berkeley, CA: University of California Press, 1996); Brian Balmer, “Killing Without the Distressing Preliminaries’: Scientists’ Defence of the British Biological Warfare Programme,” Minerva 40/1 (Spring 2002): 57-75.


Amy F. Woolf, Nonproliferation and Threat Reduction Assistance: U.S. Programs in the Former Soviet Union, Congressional Research Service, March 6, 2012, available at: crs/nuke/RL31957.pdf CULTURES Vol 1, Issue 4 » Page 83

R U S S I A N . C O R N E L L . E D U / B W/ C F M / F I L M . C F M Another student recounted a telephone conversation about Lepeshkin with her grandmother: she was trying to explain to the old woman that doing research into biological weapons must be really exciting and that she would have enjoyed doing that kind of work. Another student who was taking courses in history and biology found the videos especially fascinating: she made connections between the two disciplines and said, to our considerable satisfaction, that history presented by its participants offers much better lessons than the “anonymous history of big events and places.” She wrote that Gennadiy did not appear to be an evil person, even though he dealt with evil forces all his life: “how strange that they seem so normal.” Another student, however, was more bothered by the interviews: “Overall, I was really disturbed by the interviews with Soviet bioweapons scientists. While it seems that the Soviet scientists are able to identify what drove them to continue with the development of weapons of mass destruction in hindsight, they simultaneously reveal that they did in fact feel their work was justified and necessary.” In working with these oral history materials, we desire for our students to experience and wrestle with the complicated social and ethical aspects of science in a security context. The project also aims to help life scientists and policy makers in understanding the various motives that might push future life scientists in crossing wittingly or unwittingly to the darker side of science, and develop policies to identify and prevent such behaviors. Pending further funding, we plan to release a documentary film and interactive multimedia website to the public that reveals more in-depth inquiry of ethical lives of Soviet bioweapons scientists. Page 84 » A Historical Lens

KATHLEEN M. VOGEL, PH.D. Kathleen M. Vogel is an associate professor at North Carolina State University (NCSU) in the Department of Political Science. She also serves as Director of the Science, Technology, and Society Program. Vogel holds a Ph.D. in biological chemistry from Princeton University. Previously, she has been appointed as a William C. Foster Fellow in the U.S. Department of State’s Office of Proliferation Threat Reduction in the Bureau of Nonproliferation. Vogel has also spent time as a visiting scholar at the Cooperative Monitoring Center, Sandia National Laboratories and the Center for Nonprolif¬eration Studies, Monterey Institute of International Studies.

SONIA BEN OUAGRHAM-GORMLEY, PH.D. Sonia Ben Ouagrham-Gormley is an associate professor at the George Mason University (GMU) Biodefense Program. Prior to joining the GMU faculty in 2008, Ben Ouagrham-Gormley spent ten years working as a senior research associate at the Monterey Institute Center for Nonproliferation Studies (CNS). In 1999-2001, Ben Ouagrham-Gormley was based in the CNS Almaty office in Kazakhstan where she conducted studies on the conversion of bioweapons facilities in the former Soviet Union. In 2002-2005, she conducted a study of the Anti-Plague System of Central Asia and the Caucasus and participated in the Biological Weapon Proliferation Prevention program, under the Cooperative Threat Reduction Program funded by the Department of Defense.

SLAWOMIR GRUNBERG Slawomir Grunberg has directed and produced over 45 television documentaries. He is a winner of the National Emmy Award as well as numerous other awards at the International film festivals including awards for documentaries filmed in Russia. Slawomir’s work has appeared on PBS stations and on many television stations around the world. He has received multiple grants from the NEA, NEH, and the New York Council on the Arts. Slawomir speaks English, Polish, and Russian and has worked in Europe, Asia, and the Middle East. He owns and operates LOGTV, Ltd., a film production studio. His complete portfolio can be found at

SLAVA PAPERNO Slava Paperno is an expert on Russian language and culture; over the past 25 years he has produced cutting-edge multimedia tools for teaching. He is leading a very successful Russian language program at Cornell University that he designed around his own innovative ideas, with intensive use of online technologies. His work has been used at schools all over the world. He has written books for learners of Russian, produced numerous multimedia titles, and designed an ethnographic virtual museum Communal Living in Russia, kommunalka. Working with Slawomir Grunberg, Slava has co-produced several documentaries that explore social issues in post-Soviet Russia. For his numerous projects, he has received major grants from the National Security Agency and the U.S. Department of Education, amoung many others. His documentaries earned him an award from the American Association of Teachers of Slavic and East European Languages.

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asmicrobiology FOLLOW


Submitted by: Penard Thanks to the author: Eckhard Voelcker, Private Researcher

Submitted by: Sturm Thanks to the author: Tasha Sturm, Cabrillo College Submitted by: Josiah Padget

Photo Credit: NIAID

CULTURES Vol 1, Issue 4 Âť Page 87


S, S, & ONS On page 72 in the Summer 2014 issue, Dr. Errol Fields is



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incorrectly quoted as saying “guided”. His quote should be corrected to “The opportunity to have a mentor guide me through each step, question, process, method, analysis, and even writeup and presentation was amazing to have as a high school student.”

The views and opinions expressed in this publication are those of the individual authors and do not necessarily represent or reflect the views of the American Society for Microbiology.

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9. Federal agency biodefense funding, FY2013-FY2014 (Sell & Watson, 2013) http://

1. The Global Economic Burden of Non-

communicable Diseases (World Economic Forum and the Harvard School of Public


Health, 2011)

1. 2014 Ebola Outbreak in West Africa (CDC)

2. The Global Economic Burden of Noncommunicable Diseases (World Economic

2. Infographic: The Deadliest Disease

Forum and the Harvard School of Public

Outbreaks in History (Column Five)

Health, 2011) infographic-the-deadliest-disease-out-

3. Neglected Tropical Diseases Fast Facts


(CDC) fastfacts.html

ON THE GROUND 4. Top Causes of Death Due to Infectious

1. FBI, AAAS Collaborate on Ambitious

Disease Worldwide (Clinispace Worldwide)

Outreach to Biotech Researchers and

DIY Biologists (AAAS, 2011)

death-due-to-infectious-disease-worldwide 5. Ten facts about chronic disease (WHO, 2005)

2. Biohacking: Exciting Science or Terrifying Threat? (Liberty Voice, 2014) chp/01_en.html

3. Hacking the President’s DNA (The Atlantic, 2012)

6. Morning Briefing: HIV/AIDS, TB, Malaria Account for 80% of Disease Funding in Developing Countries, Report Says

4. Fears of U.S. Ebola Unwarranted, Experts Say (U.S. News, 2014)

(Kaiser Health News) 7. Botulinum Toxin—Biological Weapon

5. Forget Ebola And Get A Free Flu Shot (Kaiser Health News, 2014)

(NYU Lagone Medical Center); Potential revenue impact of an outbreak of foot-and-mouth disease in the United

6. The Ebola Hysteria (Charles M. Blow, New York Times, 2014)

States (Paarlberg et al, 2002) 8. World Health and Bioterrorism (J Vincent, 2009) v85/n6/full/clpt200973a.html

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