Mass Casualty Incidents and the Overlap Between Trauma Systems and Hospital Disaster Preparedness

The horrific mass shooting in Las Vegas on October 1, 2017 has resulted in nearly 60 deaths and more than 500 injuries at the time of this writing. The injured have been transported to a number of hospitals around Las Vegas and have overwhelmed some of the hospitals closest to the scene. A number of the injured are in critical condition and hence the death toll is likely to rise. Among other issues, this tragedy illustrates the overlap between trauma systems and hospital disaster preparedness.

A single patient with a gunshot wound (GSW) to a vital body part (e.g., head, chest, abdomen, or major artery) will stress a typical community hospital. Most community hospitals do not routinely treat these kinds of patients because trauma systems have been organized across the country over the last 50-60 years. Trauma systems consist of hospitals that have been certified as having varying levels of expertise and resources for treating trauma victims. Level I trauma centers are held to the highest standard, Level III to the lowest. University Medical Center is the only Level I trauma center in Nevada, and reports indicate that at least 30 critical patients were treated in its trauma center and more than 100 non-critical patients in the emergency department. Sunrise Hospital, a Level II trauma center and the closest trauma center to the shooting, reports having treated 180 patients and operated on approximately 30.

Today, Emergency Medical Services (EMS) ambulances will usually transport severely injured patients to accredited trauma centers, which are typically part of large academic medical centers. As a result, community hospitals rarely treat gunshot wounds anymore except for the occasional “walk-in” minor gunshot victim. Before the creation of trauma centers in the 1960s and 70s the situation was different: patients with severe traumatic injuries, including GSWs, would be taken to the closest hospital where general surgeons with varying degrees of trauma training and experience would treat them. The patient outcomes were often less than optimal.

Level 1 trauma centers have round-the-clock in-house coverage by specially trained trauma surgeons, surgical subspecialists (e.g., thoracic, cardiovascular, neuro), and anesthesiologists. In addition, they have specialized equipment—such as cardiac bypass—not often found in community hospitals. With the advent of the specialized trauma centers, patient outcomes have greatly improved but this progress has come at a price: community hospitals’ trauma capabilities have atrophied because they no longer routinely see severe trauma patients. A severe trauma patient who does somehow present to a community hospital emergency department these days is typically stabilized and transferred to a trauma center as quickly as possible. On a routine day-to-day basis, this benefits the patients, but in a large-scale trauma disaster like a mass shooting this centralization of trauma care limits a community’s surge capacity for trauma in a disaster.

While all hospitals must have disaster plans and practice them twice a year, no hospital can handle a large-scale disaster on its own—especially a complex mass casualty event. Because of this challenge, hospital disaster preparedness and response is increasingly organized around collaboration among different hospitals and between hospital and EMS, emergency management, and public health agencies. This has given rise to healthcare coalitions across the country.

Complex mass casually events of all types (e.g., chemical, biological, radiological) require highly specialized care that is only found in large academic medical centers—the same hospitals that are the Level 1 trauma centers. For the most part, community hospitals do not have the resources, depth of staff, or expertise needed for these types of events. But even the largest trauma centers can be overwhelmed by a very large-scale mass disaster. It is therefore important that trauma centers be integrated with the other hospitals in the community in a well-coordinated system that delivers the right care to the right patient in the right place—the more severe injuries to the trauma centers and the less severe to other facilities. For this to work well, it must be planned and practiced. In my view, this is best done through the emerging healthcare coalitions. As the disaster preparedness and response system continues to develop in the United States, it should be integrated with the existing trauma system with large academic medical centers being at the hub of both systems.  

A New Framework for Considering Security Risks Posed by Synthetic Biology

The ongoing biotechnology revolution – particularly in the fields of genome sequencing, editing, and synthesis – has led to advancements and applications in the fields of medicine, agriculture, and environmental science. Naturally, the potential use of these technologies by those with malicious intent has brought up many questions and concerns. To begin to provide some answers and clarity, the US Department of Defense (DoD) asked the National Academies of Science, Engineering, and Medicine (NAS) to conduct a study regarding the potential concerns related to advances in synthetic biology. On Aug. 25, 2017, they published their initial report, “A Proposed Framework for Identifying Potential Biodefense Vulnerabilities Posed by Synthetic Biology.”

Synthetic biology is the use of biotechnology to predictably modify or create organisms or biological components. Synthetic biology is being used to design microbes that will seek and destroy tumors, build organisms to consume toxic chemicals in water or soil, and synthesize biofuels that would reduce our dependency on fossil fuels. However, in this golden age of biotechnology, the dual-use threat of synthetic biology has raised questions such as: what are the synthetic biology threats, their time frames, and options for mitigation? Some of these issues have been explored by our colleague Dr. Gigi Gronvall in her recent book, Synthetic Biology: Safety, Security, and Promise. Dr. Gronvall is also a contributor to the NAS report under consideration.

The NAS committee created a framework that seeks to answer these questions. It is important to note that the authors limited their analysis to threats that could potentially be used to directly target either human health or prevent military personnel from executing their missions. Modification of plants, animals, their associated pathogens, and organisms with an environmental effect (e.g., undermine agricultural productivity) were beyond the scope of their report. It would be interesting to see a future study that applies the guidelines in this report to synthetic biology threats that target the biosphere at large such as engineered insects, modification of bacterial and fungal species to produce chemicals on demand, and gene drives.

Proposed Framework

The framework breaks down synthetic biology technologies and applications into several broad categories. Within these categories various questions will be asked regarding specific technologies, potential actors who may use them, the feasibility of creating biological weapons, and options for mitigation.

Each synthetic biology technology and application was categorized in terms of the ways in which they enable the Design-Build-Test (DBT) cycle – which is an iterative design strategy that demonstrates the cyclical nature of practical synthetic biology from the designing of a prototype, to the building of said prototype, and finally testing to evaluate and improve its design.

Approaching synthetic biology in this manner allows the guiding principles of the framework to be applicable to not only the technology of today but of those in the future. However, some technologies may enable multiple aspects of the DBT cycle, and those will be of particular interest to the NAS committee during the second phase of this project. Additionally, the committee will examine the complex interplay that advancement in other fields may have on increased use or ease of access to synthetic biology technology.

The committee’s final report will further refine their initial framework with the input of those in the synthetic biology research community and provide insight as to what biosecurity concerns are most warranted and what the DoD can do to address the areas of greatest concern.

Important questions global health and science leaders should be asking in the wake of horsepox synthesis

The publication of the experimental work that synthesized horsepox is imminent, according to multiple reports. Horsepox no longer exists in nature, so this was the creation of an extinct virus in the same genus as smallpox. It doesn’t infect people, but causes pox disease in horses. Researchers have cited several objectives for the work, including the intention to develop it as a smallpox vaccine, the intention to develop it as a virus-based cancer treatment, and the intention to show that synthesizing smallpox de novo is possible.

The work raises a number of serious questions and concerns, partly about the specifics of the work and partly about what this says about biosecurity and biosafety considerations related to a circumscribed set of experiments.

The first question is whether experimental work should be performed for the purpose of demonstrating something potentially dangerous and destructive could be made using biology. In this case, horsepox was created in the laboratory, at least in part to show that synthesis de novo of smallpox virus is feasible. In this specific case, leading virologists have agreed for many years that de novo smallpox synthesis was scientifically feasible, and there has been no serious counterargument that it was not feasible. But the important decision going forward is whether research with high biosafety or biosecurity risks should be pursued with a justification of demonstrating that something dangerous is now possible. I don’t think it should. Creating new risks to show that these risks are real is the wrong path. At the very least, it’s a serious issue needing serious discussion.  

A second question that is more relevant to this experiment is how much new detail will be provided in the forthcoming publication regarding how to construct an orthopox virus. It is one thing to create the virus; it’s another thing altogether to publish prescriptive information that would substantially lower the bar for creating smallpox by others. The University of Alberta lab where the horsepox construction took place is one of the leading orthopox laboratories in the world. They were technically able to navigate challenges and inherent safety risks during synthesis. Will labs that were not previously capable of this technical challenge find it easier to make smallpox after the experiment methodology is published? 

A third question relates to the approval process for experimental work with implications for international biosecurity or international biosafety. The researchers who did this work are reported to have gone through all appropriate national regulatory authorities. Researchers who created horsepox have said that the regulatory authorities “may not have fully appreciated the significance of, or potential need for, regulation or approval of” this work. So while work like this has potential international implications – it would be a bad development for all global citizens if smallpox synthesis becomes easier because of what is learned in this publication – the work is reviewed by national regulatory authorities without international norms or guidelines that direct them. This means that work considered very high risk and therefore rejected by one country may be approved by others. 

In the case of the horsepox experiment in Canada, the Advisory Committee on Variola Virus Research at WHO was briefed on the work after it was completed. Moreover, the primary charge of that committee is actual smallpox research itself (as opposed to horsepox). Beyond that, this WHO committee is unique. WHO does not have special disease by disease committees that review work on a case by case basis for other pathogens.

I think the new P3CO policy published by the White House in January 2017 could be a good step forward in the US regarding future policy development for experiments involving potential pandemic pathogens. Whether and how that policy will be implemented remains to be seen since it is guidance for federal agencies but does not require their action. Importantly in this case, even if this policy had been implemented in the US, it doesn’t seem that the policy would have had bearing on the horsepox research had that been proposed in the US. So even as the US has spent a substantial amount of time considering these kinds of issues, it still doesn’t have policy (or high-level review committees) that directly considers experiments like this. Beyond that, there is no international component to P3CO. There clearly needs to be an international component to these policies. We need agreed upon norms that will help guide countries and their scientists regarding work that falls into this category, and high-level dialogue regarding the necessary role of scientific review, guidance, and regulation for work that falls into special categories of highest concern. It is not clear that these considerations are now even being discussed internationally.   

The rapid advance of biology in the world overall will continue to have enormous health and economic benefits for society. The entrepreneurial and unpredictable nature of biological research, now coupled with powerful global markets, is overwhelmingly positive for the world. But this case of horsepox synthesis shows us that there are also specific and serious challenges that require special attention now.  

Tom Inglesby, MD, is the director of the Johns Hopkins Center for Health Security

What’s needed to improve health sector resilience to serious infectious diseases? We asked people who responded to Ebola in four U.S. cities

In December 2013, what would become the largest Ebola epidemic ever recorded began in Guinea. The virus was transmitted from village to village and across country borders within West Africa, eventually reaching the United States in August 2014 in a limited fashion when two American health workers who had contracted the disease in Liberia were brought back to the U.S. for treatment.

Over the course of the domestic Ebola response, 11 people—including those two health workers—were treated for Ebola at five different health facilities across the country. Four of these facilities—the Nebraska Biocontainment Unit (NBU) at the University of Nebraska Medical Center (UNMC) in Omaha, the Serious Communicable Diseases Unit (SCDU) at Emory University in Atlanta, the Special Clinical Studies Unit at the National Institute for Health (NIH) in Bethesda, and the Special Pathogens Unit at NYC Health + Hospitals/Bellevue—had designated units for treating patients with high-consequence pathogens, as well as staff trained in the use of specialized personnel protective equipment (PPE). The fifth facility—Texas Health Presbyterian Hospital Dallas—treated the first domestically identified case of Ebola, a traveler from Liberia, and was the only facility that did not have an advanced treatment unit.

Additionally, numerous other healthcare facilities in the U.S. encountered individuals who had been in close proximity to someone with Ebola, or who had recently traveled to areas where it was being actively transmitted, illustrating the need for the entire health sector – hospitals, private practices, public health clinics and others - to be prepared to manage a high consequence infectious disease (HCID) event.

Everyone involved in the domestic Ebola response—including physicians, nurses, public health personnel, emergency medical services, emergency management, academics, media personnel, state and local government, and law enforcement—faced unique challenges and circumstances. Our Center, with support from the CDC, set out to gather lessons learned from this event, and help inform future responses to HCIDs such as Ebola.

After soliciting feedback and recommendations from 73 key informants who were intimately involved in the domestic Ebola response, we published “Health Sector Resilience Checklist for High-Consequence Infectious Diseases.” This checklist provides actionable recommendations and highlights topics that may need to be addressed during the response to a future HCID event. It is our hope that, by using this tool, state and local health sector leadership can help “improve the overall resiliency of their health sector and community to HCID events.”

Much of the research completed at the Center entails conducting semi-structured interviews—like was done for this research project—to gather lessons learned and important anecdotes that may benefit future public health endeavors. Our Center has a history of conducting this kind of work. Past examples include:

Our methodology typically involves identifying and interviewing those involved in public health  response efforts, documenting their experiences, and soliciting feedback/recommendations on a range of given topics that the Center regards as integral to health security and public health preparedness. These interviews are then analyzed qualitatively, focusing on common themes and recommendations conveyed by study participants. We find this methodological approach to be extremely important (and surprisingly under-utilized), as it helps improve preparedness and response efforts by providing insight and recommendations on how to overcome challenges that are all but guaranteed to arise during future responses.

For example, in the course of conducting research for our project on health sector resilience to HCIDs, participants revealed challenges that had likely not been considered by state and local health sector leadership. One common theme that arose at health facilities treating Ebola-infected individuals and persons under investigation was the resource-intensive nature of caring for these patients, particularly in terms of nursing coverage, which led to staff shortages throughout the facility. While facilities had anticipated that additional personnel would be needed, the requisite 21-day monitoring period for those who had taken care of infected patients led to protracted staff shortages, with those involved in the response not able to return to their home units even after patient care had ended. Additionally, hospitals that treated PUIs noted that these patients required nearly identical isolation and infection control precautions as confirmed Ebola patients, as the uncertainty about their infection status raised concerns about the risk they posed to clinicians and other patients.

Our hope is that this checklist will familiarize health sector leadership and personnel with the challenges experienced during the domestic Ebola response and improve future epidemic and pandemic response, thereby enhancing the resiliency of communities across the US to these types of events.

Bioviolence: A Very Brief History

This past week, two of my colleagues—Crystal Watson and Gigi Kwik Gronvall—and I were honored to participate in SB7.0, the preeminent international meeting of the synthetic biology community. Synthetic biology seeks to apply engineering principles to the squishy, often chaotic world of biology (read Gigi’s book for a deeper dive). Our role at SB7.0 was to convene an international group of graduate students and early career scientists from the ‘synbio’ and biosecurity communities to jointly consider how to ensure that advanced biotechnologies are applied solely for the benefit of mankind.

As part of the program, this group of fellows attended a series of panel discussions and presentations on the past, present, and future of biosecurity. At one of those discussions I gave the following remarks on the history of bioviolence—a term I prefer to the more common and specific “bioterrorism” and “biowarfare”.

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This morning, it’s my job to convince you of the immediacy of biological threats, particularly those of an intentional nature. It is after all the case that the life sciences—and the biotechnologies that spring from them—are no different than most other technologies, in that they have the potential to amplify humanity’s worst impulses, as well as our best.

I’m acutely aware that this word of caution and line of thinking may sound tonally somewhat out of place, being that we’re all at a conference intended to highlight the exciting and universally constructive applications of synthetic biology. Even still, I would suggest that it’s essential for you to be aware of the history of bioviolence in order to be responsible stewards and creators of our shared future.

Of all the scourges of mankind, plagues and warfare are almost certainly the most dreaded and dangerous. Several times throughout history—and more frequently than most people are aware of—there have been attempts by individuals, organizations, and nation-states to harness the former in service of the latter.

So, if I was to attempt to be comprehensive, there is easily a 2-3 hour version of this talk that would probably start in 1346 at the Black Sea port of Caffa; take us through to British held Fort Pitt in 1763; and possibly leave off with the events of October 2001, when an already shaken U.S. population suddenly became acutely concerned about the contents of our mail. At all of these times and places, there is evidence to suggest that weaponized pathogens were utilized during conflict. But sadly, I will have to be considerably more brief. What I’d like to do is to quickly touch on a few episodes in the history of bioviolence that I hope you’ll keep in mind as we go through this week together.

No discussion of the history of biological weapons would be complete without understanding something about the Soviet biological weapons (BW) program during the Cold War period, so that’s where we’ll start. Most people are at least peripherally aware of the nuclear arms race that characterized the Cold War. What far fewer people—even those with a background in the life sciences—are aware of is the extent to which that same mindset carried over into the biological realm.

During the Cold War, the U.S. and USSR both ran offensive BW programs, and both were successful in developed deployable BW for use against personnel and agricultural targets. In the course of developing these weapons, sophisticated open air testing was conducted that conclusively demonstrated the terrible effectiveness of these weapons. As our colleague, Randy Larsen (our Center's National Security Advisor) likes to say in reference to the biological threat, “we’ve had Trinity, but thankfully not Hiroshima and Nagasaki “.

However, in 1970, President Nixon renounced and abandoned America’s offensive BW program, limited research to biodefense aims, and signed the Biological Weapons and Toxins Convention (BWC), which would enter into force in 1975, and was the first arms control agreement to ban an entire class of weapons.

The Soviet Union, however, chose another path.

Right around the time the BWC was signed, the USSR established a covert and nominally civilian offensive BW program under an organization called Biopreparat. This was a massive undertaking. At its height, it involved between 16-20 research and production facilities, thousands of scientists, and high-level political support. Biopreparat was capable of producing tons of B. anthracis, variola virus, Y. pestis, F. tularensis, and others.

Very little was definitively known about the scale and scope of the Soviet program until the early 90s, when a series of disclosures were made by the Yeltsin government, and several of their weaponeers defected. Western intelligence agencies certainly had their suspicions, however. The most compelling evidence was provided when an unusual epidemic of anthrax occurred in the city of Sverdlovsk in 1979. Local and military authorities responded with urgency, and quickly propagated the fiction that the epidemic had been caused by the ingestion of tainted meat. After the demise of the Soviet Union, it was revealed that a technician working in Sverdlovsk’s production facility had not replaced a filter, causing an environmental release that killed roughly 100 people via inhalation anthrax.

For those interested in learning more, I would recommend Leitenberg and Zilinkas’s “The Soviet Biological Weapons Program: A History”.

Another program I’d like to touch on briefly is South Africa’s Project Coast. This was a smaller scale offensive chemical and biological program run by South Africa’s apartheid government from 1981 to 1992. Project Coast and its director, Dr. Wooter Basson, focused on developing unconventional weapons systems primarily for use in assassination and sabotage operations. Officials from the U.S. State Department have publically stated that, should a state-run BW program be uncovered in the near future, that they would expect it to more closely resemble Project Coast than Biopreparat.

Distinct from but related to threats posed by state-run offensive biological weapons programs is the acquisition and use of these weapons by terrorist organizations. Notable examples include:

  • The 1984 contamination of a salad bar in Oregon with Salmonella by a religious commune known as the Rajneeshees that caused over 700 cases of gastroenteritis;
  • The research, development, and deployment of multiple chemical and biological weapons by a Japanese cult called Aum Shinrikyo in the 1990s;
  • The 2001 anthrax letters;
  • The repeated mailing of letters containing crude preparations of ricin;  
  • ISIS’s infamous “Laptop of Doom” which apparently contained information on BW; and
  • The foiled 2016 plot that allegedly involved a small network of Kenyan medical students who planned to use anthrax during an attack.

I would also point to the recent use of chemical weapons on the battlefields of Syria and Iraq as well as an audacious assassination carried out by agents of the North Korean government in Malaysia as having a potentially degradative effect on norms relating to BW non-proliferation and use.

In closing, my challenge to you as biosecurity fellows would be to keep this history in mind, learn more about it if I’ve been successful in piquing your interest, and some of you should consider going into government to work on these issues. I’ve long thought that one reason we as a species survived the Cold War was that nuclear scientists—on both sides of the Iron Curtain—went into government and advised policymakers about the nature of the threat they faced. It’s imperative for our collective security that biologists do the same.

Hearing Notes: U.S. Public Health Response to the Zika Virus - Continuing Challenges

On May 23, the U.S. House Committee on Energy and Commerce held a hearing to explore continuing challenges in the U.S. public health response to the Zika virus. Drs. Luciana Borio (Acting Chief Scientist, FDA), Rick A. Bright (Director, BARDA, HHS), Anthony Fauci (Director, NIAID), Timothy Persons (Chief Scientist, GAO), and Lyle Peterson (Director, Division of Vector-Borne Diseases, NCEZID, CDC) testified.

Common themes that emerged were the uncertainty of long-term impacts of Zika infection; the importance of steady, predictable funding for public health response, including mosquito control and diagnostic and vaccine development; and the need to conduct effective risk communication to at-risk populations.

Some highlights:

Zika epidemiology

  • Every state besides Alaska has reported a Zika case
  • 84 countries have evidence of vector-borne Zika cases

We still don’t know …

  • Actual number of infections
  • Enough about the long-term health impacts of Zika infection in men and children who are born to infected mothers
  • No good model for how virus will spread this year

Public health needs

  • A case definition and understanding of how the virus spreads
  • Development and use of diagnostic tools and new vaccines
  • Mosquito control 
  • Effective communication on all levels

Witnesses

Dr. Persons

  • Stressed need to figure out biological mechanisms and risk factors, and short-and  long-term outcomes
  • Identified two key epidemiological research challenges: insufficiency of data and lack of computer models to predict spread, and a lack of time and funding to conduct research 
  • Identified a key diagnostic manufacturer challenge: lack of samples and FDA communication
    • He noted that HHS has led the way in progress but many challenges still remain
    • He said officials must determine which tests are most effective

Dr. Petersen

  • Noted that it will be important to follow the development of microcephalic babies to understand long-term effects

Dr. Borio

  • Said that FDA’s central role in response to public health emergencies is to support the development and availability of diagnostic tests, vaccines, and therapeutics 
  • Added that FDA also helps to ensure a safe blood supply (preventing 400 infected donations to date), advance strategies for vector control, and protect the nation from fraudulent products
  • Noted that vaccine candidates progressing at rapidly expedited pace

Dr. Fauci

  • Said that NIAID is conducting research to develop countermeasures, including rapid, specific, low cost diagnostic tools
  • molecular, serological (detect immune response of someone already infected)
  • Referenced a study in Brazil on 10,000 pregnant women  
  • Reported that NIAID is currently investigating five candidate Zika vaccines, including (from Dr. Fauci’s written testimony):
    • A DNA vaccine developed by the NIAID Vaccine Research Center – phase 2a/2b trial began in March, 2017
    • A live-attenuated Zika vaccine – will enter Phase 1 trials in late 2017
    • A Zika purified inactivated vaccine (ZPIV), codeveloped by NIAID, BARDA and WRAIR – phase 1 trials began in November, 2016
    • A mRNA vaccine - will enter Phase 1 trials in late 2017
    • A Zika vaccine developed on the rVSV platform – in preclinical development

Dr. Bright

  • Reported that BARDA is currently supporting the development of four candidate Zika vaccines (from Dr. Bright’s written testimony):
    • Moderna’s mRNA-based Zika vaccine
    • Sanofi Pasteur - an extension of the BARDA/NIH/WRAIR collaboration described above
    • Takeda Pharmaceuticals
    • Instituto Butantan

How does this vaccine response compare to other infectious diseases?

  • Dr. Fauci: Zika is the fastest vaccine development we’ve ever had 
    • Three months between time we uncovered sequence to putting it in an animal

 Should we have an emergency fund for issues like this?

  • Dr. Fauci: Yes, because money is being moved from other areas like Ebola in order to work on other urgent issues like Zika
    • “This whole thing is a marathon. We have to have consistent support to be prepared for consecutive years.”  
  • Best possible scenario for vaccine: efficacy signal by mid-2018 for FDA evaluation
    • “While we have begun clinical testing of several Zika vaccine candidates, a safe, effective, and fully licensed Zika vaccine likely will not be available for several years."

Why does CDC think pace for emerging infectious diseases is accelerating?

  • Dr. Petersen: Growth of world population and mega cities, increases in travel and trade that bring viruses to every corner or earth very quickly, climate change 
  • He added that we need to increase efforts toward innovation and discovery: surveillance, mosquito control (sustained effort to rebuild infrastructure), and develop a more national and sustained approach toward vector-control

What are the roles contraceptives and preventive care measures play in combating Zika?

  • Dr. Petersen: Half of the pregnancies in the United States are unplanned, two-thirds in Puerto Rico are unplanned. Our job is to provide women with most accurate info possible so they can make their individual decisions alongside physicians
  • Dr. Fauci: lifetime care of microcephalic baby that survives costs millions of dollars

Why is strong public health infrastructure key to avoiding epidemics we see play out in other parts of the world?

  • Dr. Fauci: You can’t prevent an outbreak of a new infection. The trick is to prevent it from becoming an epidemic or pandemic
  • We have systems in place and the best public health agency in the world to track and control all threatening outbreaks  

How do we make predictive modeling to forecast future cases given that 80 percent of those infected do not have symptoms?

  • Dr. Persons: We have to take current models on sexually transmitted infections and vector-borne diseases. They’ve never been conjoined until now, so we have to come up with a new model that uses both. Consistent research is the only way to do this
  • Dr. Bright: BARDA’s scope does not currently include vector control. However, if enough data is collected to prove vector control significantly reduces infection, then there would a significant role of federal government in implementing vector control measures
  • Dr. Fauci: Work is being done to try to develop a universal flaviviruses vaccine using a common part of all flaviviruses  

$300 million has already been spent to develop vaccine. The Army is not guaranteeing a fair price. What if the vaccine is priced out of reach of many? 

  • Dr. Fauci: It’s important for it to be available to as many people as possible, but I am not sure we have the measures in place to make that happen  

More information on the hearing and witnesses is available at energycommerce.house.gov.

Johns Hopkins Center for Health Security Teams with NTI and the Economist Intelligence Unit to Develop a Global Health Security Index

We are very excited to announce that thanks to generous support from the Open Philanthropy Project and the Robertson Foundation, our Center is working with the Nuclear Threat Initiative (NTI) and the Economist Intelligence Unit (EIU) to develop a Global Health Security Index.

The mission of the index is to encourage progress towards a world that is capable of preventing epidemics of international impact (either natural, accidental or deliberate) from arising, or, should, prevention fail, respond quickly to contain them.

In the first phase of this project, our team is focusing on developing a framework (i.e., the value, principles, attributes, and major components) to assess and compare countries’ levels of health security. To help inform the development our framework, we are convening next month an international expert advisory group. Once we’ve developed our framework, we will begin the process of assessing, collecting, and analyzing data on a country-by-country-basis. 

Below we explain in more detail why we’ve embarked on this important project.

Why try to measure global health security?

Recent infectious disease outbreaks, such as the ongoing Zika virus outbreak, the Ebola outbreak in West Africa, and the spread of MERS-CoV in the Middle East, continue to show us that when individual countries experience difficulties detecting and effectively containing the spread of infectious disease outbreaks, they can quickly threaten the health, security, and economies of countries across the globe. The increasing frequency of events that threaten global health security illustrates how now, more than ever, there is a strong global need for collective action to bolster all countries’ health security capabilities.

Some measures have been taken by the World Health Organization (WHO) and more recently through the Global Health Security Agenda (GHSA). Although these are worthwhile, important initiatives, they have some limitations that an index could address.  

In 2005, updates were made to the International Health Regulations (IHRs) to improve countries’ abilities to detect, assess, notify, and report public health emergencies of international concern (PHEICs). Among the modifications, the revised IHRs created a set of 8 core public health capacities that countries must develop. To help countries assess their progress, the World Health Organization created a list of indicators for development of the IHR core capacities. But lack of funding, lack of political will, and a myriad of other factors have slowed implementation of the revised IHRs.  By its implementation deadline in mid-2012, approximately 80% of the 194 WHO member states had not reported implementation of the core competencies required under the IHRs. The results of those countries that do report are publicly available.

Recognizing the lack of progress toward implementation of the IHRs, the Obama Administration in early 2014 announced the launch of the Global Health Security Agenda. The initiative, which has since attracted the participation of more than 50 countries, attempts to establish common goals and methods to reduce the spread and impact of infectious disease by strengthening countries’ abilities to prevent, rapidly detect, and effectively respond to disease outbreaks. Participating countries have developed commitment packages and related targets under the GHSA.

The WHO recently launched an effort that is complementary to the goals of the GHSA. In developing the WHO IHR Joint External Evaluation (JEE) tool, the WHO has created a framework and process by which countries can measure their capacities to implement the IHRs. The JEE tool provides a standard metric by which countries can, on a voluntary-basis, assess their current baseline capacities and measure future progress toward full development of IHR capabilities to prevent, detect, and respond to public health threats, whether they are naturally occurring, deliberate, or accidental. Though the passage of the IHRs required countries to conduct self-assessments of their IHR capacities, the JEE enables countries to sign up for external evaluations by their peers. It is this peer-to-peer aspect that seems to be attractive for countries. Those involved in the JEE process have reported that countries that have volunteered to undergo a JEE have found the exercise to be helpful to their own planning effort. The positive reviews of the JEE process have spread, and countries continue to volunteer to undergo a JEE.

The GHSA and the JEE are important steps toward increasing accountability and transparency for countries’ efforts to improve their current global health security capacities. As we have written before, the international community—including the current US Administration--should continue to do all it can to support these efforts.

But the GHSA and JEE process alone will likely not fully address the need to motivate improvements in global health security. More work is needed to encourage those countries who have not yet signed up for the GHSA to participate. And work will be needed to ensure that all countries agree to undergo a JEE and—most importantly—take meaningful action to improve their scores in the areas that the JEE identifies as needing improvement.

Finally, the determinants of a country’s global health security are not entirely in the hands of the health sector. Larger political factors—such as land use policies and the presence of terrorist groups--can influence a country’s risk of experiencing an outbreak or bioattack. Societal factors, such as government corruption, social stability, and basic infrastructure, can be important determinants of how ably that country can contain the event before it spills across its borders.  These factors, while important determinants of global health security, are not incorporated into existing frameworks like the GHSA or JEE.

Why an index?

For the reasons articulated above, we think more work is needed to identify trends promoting global health security and to examine underlying conditions that contribute to or detract from favorable health security conditions. Metrics also are needed to identify areas in greatest need of improvement and to create political incentives for health security investments. A global health security index that is informed by international expert judgment, measured by a nongovernmental entity, and made publicly available could highlight current needs and add momentum to existing global health security efforts.

In preparation for this work, we have spent almost two years researching this topic and have learned that indices can be important tools in measuring and motivating progress. There is much evidence in the literature that national and international indices are influential in affecting government decision making. Policymakers tend to rely on these tools because decision-making processes that rely on indices can be presented as efficient, consistent, legitimate, transparent, scientific, and impartial. They also are relatively easy for the public to interpret.

Social science researchers have determined that indices tend to motivate policymakers to respond via three complementary mechanisms. First, indices can influence governments through the creation of international pressures (e.g., credit-rating agencies may respond to a country’s ranking in an international corruption index). Second, they can influence domestic political pressures (e.g., via mobilization of advocacy groups). Even the anticipation of negative publicity can prompt governments to review and modify domestic policies. Third, indices can have reputational effects on individuals or groups of policymakers and can motivate change through peer pressure.

We also have direct, favorable experiences in creating an index related to this topic. For several years our center director, Tom Inglesby, has been involved in the creation of the National Health Security Preparedness Index, which measures US states’ progress in preparing for, preventing, and responding to potential health incidents. Tom will bring to our team his experiences in developing and refining the NHSPI, which is now in its fourth iteration.

Why this team?

This effort will be jointly led by our Center and NTI, and developed with help from EIU.

NTI works to protect our lives, environment, and quality of life now and for future generations. They work to prevent catastrophic attacks with weapons of mass destruction and disruption (WMDD)—nuclear, biological, radiological, chemical, and cyber. Founded in 2001 by former U.S. Senator Sam Nunn and philanthropist Ted Turner, NTI is guided by a prestigious, international board of directors. Sam Nunn serves as chief executive officer; Des Browne is vice chairman; and Joan Rohlfing serves as president.

Economist Intelligence Unit (EIU) is the research arm of The Economist Group, publisher of The Economist. As the world’s leading provider of country intelligence, it helps governments, institutions, and businesses by providing timely, reliable, and impartial analysis of economic and development strategies. Through its public policy practice, the EIU provides evidence-based research for policymakers and stakeholders who are seeking measureable outcomes, in fields ranging from gender and finance to energy and technology. It conducts research through interviews, regulatory analysis, quantitative modeling, and forecasting, and it displays the results using interactive data visualization tools. Through a global network of more than 350 analysts and contributors, the EIU continuously assesses and forecasts political, economic, and business conditions in more than 200 countries.

NTI and EIU make for expert partners on this project, as we intend to build on their experience and success in developing the NTI Nuclear Security Index.  Created in 2012, this first-of-its-kind resource is designed to encourage governments to take actions and build confidence in the security of their nuclear materials. Now in its third edition, the NTI Index is recognized as the premiere resource and tool for tracking progress on nuclear security and identifying priorities.  

Not If, but When: A Warning

Last month, my colleagues and I released a series of memos addressed to the Trump Administration and Congress describing the state of national and global health security and our recommendations on how to strengthen it. This is the second set of health security memos to an incoming administration that we’ve written. We write these transition memos to help new staffers navigate the complex biological threat environment, and to understand the programs and concepts that have been developed to address those challenges. As a result, the memos cover a wide range of topics, including public health and healthcare preparedness, the organization and funding of the federal health security enterprise, biosurveillance, community engagement, the security implications of synthetic biology, and others.

I’d like to focus here on a prediction that can be found in our memos, and has also been recently articulated by other subject matter experts. That is the judgment that this administration can expect to face a severe infectious disease emergency at some point during its tenure.

To wit (emphasis mine):

“If history has taught us anything, it is that the new administration is likely to experience at least one infectious disease crisis of significance. We have learned from the past decades that it is important to have strong global surveillance systems; transparency and honest communication with the public; strong public health and health care infrastructure, or capacity building efforts where needed; coordinated and collaborative basic and clinical research; and the development of universal platform technologies to enable the rapid development of vaccines, diagnostics, and therapeutics. We also have learned that it is essential to have a stable and pre-established funding mechanism to utilize during public health emergencies similar to a FEMA-like emergency disaster fund. What we know for certain is that emerging infections will continue to be a perpetual challenge, requiring the attention of all Presidents to come.”

Dr. Anthony Fauci, Director, National Institute for Allergy and Infectious Diseases

“Finally, the near and long term challenge most in need of a global response is that of emerging infectious disease. Terrorism and cyber threats have featured prominently in all three of the transitions on which I worked.  Most recently, in my transition meetings with my successor, I urged that the new administration will need to maintain a third focus when it comes to transregional threats that will keep people up at night: infectious disease.

It is a virtual certainty that the new administration will be challenged by some new pathogen, one that no wall will keep out. Ebola and Zika showed us pandemics need not have a malicious origin to take lives, cause panic, and drain resources. This will take focus, resources and precisely the sort of global cooperation that is difficult when countries feel alienated from American leadership. The Global Health Security Agenda, championed by the Obama Administration and now 50 countries strong, must be sustained. It requires United States investment and leadership to ensure that countries continue transparent, independent health assessments and are accountable for progress.”

Lisa Monaco, Former Assistant to President for Homeland Security and Counterterrorism and Deputy National Security Advisor

“It's not if, but when these events are going to occur again…We need to ramp up our preparedness.”

Dr. Peter Salama, Executive Director, Health Emergencies Programme, World Health Organization

“Each POTUS has faced outbreak crises: AIDS, SARS, Bird flu, swine flu, Ebola. Just a matter of time.”

Jeremy Konyndyk, Former Director, Office of US Foreign Disaster Assistance, USAID

“…it is safe to assume that one or more events that require a national-level response will occur in the near term. As a result, ensuring a high degree of public health preparedness should be a national priority.”

Matthew Watson, Dr. Jennifer Nuzzo, Matthew Shearer, Diane Meyer, JHSPH Center for Health Security

While I’ve highlighted just handful of examples above, I don’t think this is a particularly controversial position. Anyone with a passing familiarity with microbiology or epidemiology would probably agree.

A couple of things strike me as notable. First, the consistency and near-certainty of the message. While the occurrence of infectious disease outbreaks is highly stochastic, the sheer volume of recent, off-normal biological events - to include the 2001 anthrax attacks, biosafety lapses, and major epidemics or pandemics like SARS, H1N1 influenza, MERS, Ebola, Zika, and others - strongly suggests more to come.

Just why these events have been coming at such a rapid clip, and why we should expect more, can be explained by several different factors including environmental degradation, a changing climate, available and affordable international air travel, changes in human behavior and consumption patterns, the mutation rate of pathogens, and the occurrence of spillover events. In some cases, human failings such as malevolence or carelessness have come into play. For me, though, the most important contributing factor is that humanity is getting really good at recognizing cases and clusters of viral, bacterial, and fungal infections. We can now watch epidemics develop in real time, and we are increasingly on the lookout for emerging and re-emerging infectious diseases. The increasing speed and accuracy of surveillance and diagnostic systems makes it critical that we develop a more nuanced appreciation of the risks posed by a given outbreak or pathogen, both in public and in the halls of power.  Some rational setting between indifference and panic would be optimal. 

Second, this warning of outbreaks to come is being sounded by a diverse group of scholars and practitioners from both poles of the health security spectrum. Now, it’s important to remember that individual judgements are just that, and it’s understood that expert judgment is not infallible. But taken in aggregate, I would suggest that these statements can best be understood as a warning that should be taken seriously at the highest levels of our government.

That’s what we know. What we don’t know, and what is probably unknowable, is the source, scale, severity, and nature of the next infectious disease emergency. The past 16 years have seen naturally occurring outbreaks, intentional events that can rightly be characterized as attacks, and accidents.

To ensure that we’re able to meet the next threat when it inevitably arrives, strengthening our national and global health security posture should be a high priority for this administration.

 

My thanks to research assistant Ashley Geleta (@ashley_geleta) for her help in preparing this post.

2016 Gets its Very Own Bio-lapse

In mid-December, USA Today published an article by Alison Young entitled Emergency trainees mistakenly exposed to deadly ricin. In it, she reports that more than 9,600 trainees at the Federal Emergency Management Agency’s (FEMA) Center for Domestic Preparedness (CDP) located in Anniston, Alabama had been unintentionally exposed to a lethal form of ricin during a series of training exercises spanning a five year period. In response to this revelation, FEMA administrator Craig Fugate has already called for an investigation by DHS’s inspector general, and CDP has suspended all trainings involving toxic exposures.

Most importantly, there is no indication that anyone became ill following exposure to the ricin used during training, and students wearing proper personal protective equipment while working with the toxin. That’s the good news. It would have been a cruel irony for anyone to be harmed simply while honing their skills for this rewarding but uniquely dangerous calling. What follows are some initial reactions to this story.

Some background is in order. CDP is where the nation’s police officers, firefighters, emergency medical services providers, emergency managers, and healthcare workers gain the particular knowledge and experience needed to respond to a range of crises, including those of a CBRN nature. State and local responding agencies can send staff to Anniston for highly specialized training courses, such as the infection control and clinical course offered to US-based healthcare providers who deployed to West Africa to contribute to the Ebola response effort in 2014-15.

Second, a few observations about ricin. From the Center’s fact sheet:

Ricin toxin or ricin, as it is more commonly known, is a protein that consists of A and B subunits that can be extracted from the beans of the castor plant, Ricinus communis…The toxic effects of ricin are caused by its ability to inhibit protein synthesis. Ricin can be introduced to the body through inhalation of an aerosol, or through ingestion, injection, or infusion.

The mosaic nature of ricin’s composition is important to understanding what had apparently been going on at Anniston for the past 5 years. Per FEMA’s statements in the USA Today article, they thought their students were working with a powdered preparation of ricin’s A chain protein, which would have been much safer to work with while still generating positive results by environmental detection assays. Here is where things get (semi) interesting.

There are actually two chemically distinct lectins produced in castor beans, ricin and Ricinus communis Agglutinin (abbreviated “RCA”), which is significantly less toxic than ricin. To add to the confusion, at least one naming convention designates the whole ricin toxin “RCA60”. One might wonder whether CDP staff saw that they were receiving a product labeled “RCA” and interpreted that to mean “Ricin Chain A.”

Needless to say, there should be a thorough investigation in this case, as the question of responsibility appears to have devolved into a finger pointing exercise between FEMA and the contractors responsible for providing the agency with the product they ordered.

Regardless of confusion over names, labels, purchase orders, and intentions, many people may quite reasonably be wondering why first responders should have anything to do with ricin toxin in the first place. The answer relates to a worrisome but under-appreciated trend in the post 9/11 era: the skyrocketing occurrence of white powder incidents. First responders are called to thousands of these events per year, the vast majority of which events turn out to be hoaxes. But, every once in a while, a bored college student, romantic rival, or would-be assassin figures out how to formulate and use at least a crude preparation of the real thing. As a result, every suspect powder has to be treated as potentially harmful until field-based detectors, confirmed by laboratory diagnostic tests, indicate otherwise.  Make no mistake, the high frequency of these white powder incidence makes bio-detection as vital for some local first responders as CPR.

In order to be sure that responders can handle these white powder incidents safely, there is no substitute for rigorous training. To protect themselves and the public, local first responders have to be able to discriminate fake threats from real ones. The myriad detection technologies available to first responders vary significantly in their ease of use, sensitivity, specificity and turn-around-time. In other words, they can be difficult to use properly, and thus the need for training with live agents – to ensure that equipment works properly and first responders can accurately run them and interpret the results.

Unavoidably, there is the issue of optics. Ms. Young understandably links the Anniston incident with prior examples of biosafety lapses by federal biodefense programs. Let’s review. Last year it was live samples of anthrax inadvertently mailed by a Department of Defense lab (a story that may actually say as much about the incredibly hardy biology of B. anthracis as it does the sufficiency of inactivation protocols). The year before that, it was the unexpected discovery of viable variola virus in an FDA freezer on NIH’s campus in Bethesda, MD. In that same year, CDC made headlines with an unexpected exposure of staff to B. anthracis. So… not great. And now, 2016 has a bio-lapse of its very own.

Once you get past the headlines though, it’s less clear what should be done about that less-than-stellar track record. In each instance, the value of the underlying program to national and global health security is beyond question. What’s more, each of those incidents took place in very different operational and organizational contexts, so a one-size-fits-all policy fix isn’t likely to materialize. Finally, because of the amount of agent CDP was working with (reportedly less than 70mg), they were not recognized as a regulated entity under the CDC’s Select Agent Program, this instance should not be interpreted as a regulatory failure.

That said, it is not my intention to downplay the significance of this unusually long running event. Had a health impact occurred resulting from exposure to a pathogen or toxin, the results could have been tragic. Additionally, should the public or their legislative representatives begin to perceive more risk than benefit from federal biodefense programs, their continued existence could be called into question, to the detriment of our national health security.

What this series of unfortunate events underlines is the need for continued, systemic commitment to - and flawless execution of - biosafety and biosecurity practice at every governmental agency engaged in these efforts. In addition, the field could probably benefit from an increased level of scientific inquiry into how to enhance biosafety at the institutional and national levels. Whether or not those steps are taken before the next lapse takes place is an open question. 

Tonight’s Top Story: Ebola and the News Media

When the first few cases of Ebola came to the US in 2014, it seemed as though it was impossible to watch or read the news and not hear about the disease.  At first, news coverage of Ebola rose in response to the return of media personnel diagnosed overseas.  Then news coverage increased greatly after the diagnosis of the first case on American soil in late September, 2014.

Most of us can agree that the intense public and media reaction to the limited number of cases in the US was unwarranted when considering the actual risks involved in the situation.   In fact, many actions were put forth, out of an abundance of caution, which were unnecessary and counter-productive, such as border closures and excessive quarantines. But what was the source of this reaction? Was the news media responsible for stoking people’s fears? What messages were people receiving about the risks of and policy responses to the occurrence of Ebola in the United States? 

To investigate this, colleagues and I set out on a news media content analysis, reading over 1,200 news articles from 12 news sources spanning the time frame from the beginning of July through the end of November 2014. Each time we read an article, we searched for a set of messages relating to risk and policy using a coding instrument that had been piloted on a separate set of articles. We used Paul Slovic’s risk perception framework to determine if some messages would likely have increased perception of risk or decreased perception of risk. Our methods and findings can be found here and here.

We found that nearly every article in our sample (96%) had at least one risk-elevating message while approximately half (55%) had at least one risk-minimizing message. However, although skewed towards risk elevating messages, news coverage from the main stream news sources we analyzed did not seem to report on Ebola in a hyperbolic or overly irresponsible manner – for instance, we found relatively few mentions of use of Ebola as a bioterror weapon or the suggestion that, once introduced, the disease could not be stopped in the US.  In fact, messages about the ability to interrupt transmission in the US were more frequent, when directly compared to messages about an inability to interrupt transmission. It may have been that the news media played a smaller role in hyping the Ebola outbreak than expected, and the nature of the disease itself played a stronger role than was originally recognized in increasing public concerns.

Perhaps most importantly from a risk communication perspective, it was clear that public health policy messages were frequently eclipsed by more controversial messages.  The most frequent policy messages we found were focused on isolation (47%) and quarantine (40%), which were often confused with each other (isolation is the separation of someone who is ill from those who are not sick while quarantine is the separation of someone who may have been exposed to a disease from those who have not been exposed). In contrast, one of the more central public health response policies – assigning different levels of risk and associated movement restrictions for potentially exposed individuals – was rarely found (5%). This difference could be due to the newsworthiness of controversial issues – quarantine was controversial while a measured public health approach was not.  As a result, Americans may have gained a skewed or incomplete understanding of the response activities that public health agencies were putting into place in the midst of the crisis.

At the end of the day, the news media played an important role in delivering messages about Ebola to the public and will no doubt perform a similar role in future outbreaks.  Although our study methodology prevents us from drawing conclusions about the public’s understanding of the risks posed by Ebola and associated response activities, it allows us to gain a more granular understand about the messages the public may have been exposed to via the news media. Although the news media frequently mentioned risk-increasing messages, some of the most inflammatory messages were not found as frequently as expected (though they may have been present in more “fringe” news sources that were not included in our analysis). However, we did find that communication of important scientific principles and policies can struggle to gain traction in the face of controversial issues. In the future, public health communicators should keep these factors in mind when communicating via the news media and emphasize the scientific underpinning of our understanding of the disease and appropriate responses.