The role of NGOs in global health security: A conversation with Tausi Suedi

By Nick Alexopulos

Tausi Suedi, CEO and executive director of Childbirth Survival International (photo by Larry Canner)

Tausi Suedi, CEO and executive director of Childbirth Survival International (photo by Larry Canner)

On July 30, the Johns Hopkins Center for Health Security convened more than 60 experts to gather input and recommendations for the forthcoming U.S. Global Health Security Strategy, a document that will codify U.S. support for the Global Health Security Agenda. Among the many discussion topics—disease surveillance, laboratory diagnostics, workforce development, emergency management, antimicrobial resistance, and more—was the role nongovernmental organizations (NGOs) play in overall global health security, and how to ensure those organizations are meaningfully included in an interagency U.S. strategy.

Tausi Suedi, MPH, championed this cause in her questions and comments throughout the meeting. She is the CEO and executive director of Childbirth Survival International, a grassroots nonprofit advocating for maternal and newborn health in the Sub-Saharan African countries of Tanzania, Uganda, Nigeria, Ghana, and Somalia. Suedi is also an adjunct professor of global health at Towson University. 

After the Center’s event, the Bifurcated Needle spoke with Suedi about NGOs’ contributions to the GHSA: 

What major point did you communicate to the group, and what key message were you hoping to hear from your fellow experts and panelists?

The Global Health Security Agenda requires partnership and collaboration, especially with grassroots nonprofits that are actually implementing some of these packages. When you look at our nonprofit, Childbirth Survival International, we particularly focus on some of those action packages. For example, workforce development, immunizations, and making sure healthcare workers on the front lines are being trained to quickly recognize irregularities and act quickly if they identify a threat. 

What I was hoping to hear and what I think I did hear was the U.S. government’s commitment to continue engaging with [low resource] countries in order to strengthen their healthcare systems. As we all know, many systems are still inadequate, especially as you move from the urban to the rural areas—and so a lot more effort is needed. And that needs to be a concerted effort. Of course the U.S. government is a major player in this and very well recognized in its role, and what I heard from experts in the room is that the United States is on track to continue making those changes in the world.

How does the GHSA benefit from the work of NGOs?

We bring extraordinary value because we’re at the grassroots. If you look at the GHSA, how it’s structured, a vital component of its mission is to actually respond to a threat. It’s there, waiting; if something happens, let’s go. But the NGOs, we’re already on the ground working every single day, building the health systems, training the healthcare workers, educating the communities, getting families to immunize their kids, and working on other factors to prevent disease. We’re doing this work constantly, and like GHSA we’re responding to an emergency at the particular moment when it happens.

Your organization works in five Sub-Saharan African countries. What does the GHSA mean for them?

They will benefit tremendously from GHSA efforts to strengthen their healthcare systems, which still rely a lot on donor funding and international NGOs. With this collaboration of the U.S. government and international NGOs working together on this GHSA package, you’re bound to find countries improving with strengthened healthcare systems. 

Now, some countries are part of GHSA and others are not. Somalia, for instance, is one of those fragile countries, and one of the countries my organization serves. For it to be part of this GHSA consortium, a lot more work is needed to build its healthcare system and health infrastructure.

Final thought?

As an American, as an African, as a woman leader, I think we’re doing great work to improve health around the world. But I think we should not lose sight of what makes this happen: focusing at the grassroots level, the community level, where there is the most hurt.

***

A summary meeting report is forthcoming and will be available on the Center's website.

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.

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.

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.

Our Approach to Financing Epidemic Response is Broken

Earlier this week, the AP reported that the Obama administration has agreed to re-purpose roughly $589 million of the $5.5 billion that was originally appropriated to combat the Ebola virus epidemic for the response to Zika. The administration had proposed a Zika-specific appropriation of $1.9 billion in February, but encountered resistance from Congress, who were of the opinion that “left over” funds from Ebola could be applied to this most recent infectious disease emergency.

The bulk of the reprogrammed funds had been committed to supporting the Global Health Security Agenda (GHSA), whose reason for being is to help support international capacity to detect and respond to new epidemics before they cross borders, and threaten global health. Nearly all nations are obligated via the 2005 International Health Regulations to develop these programs, but by and large don’t have the necessary resources to meet those commitments. GSHA was established, in part, to mobilize support for establishing and maintaining those surveillance and response systems. We hope those programs will receive funding commensurate with their importance, as has been suggested by the White House and members of Congress.   

The referenced $589 million also appears to take funds out of domestic preparedness programs, as the New York Times noted:

In addition to funds moved from the Ebola budget, an additional $79 million would come from several other accounts, including money previously allotted to the national strategic stockpile of vaccines and other emergency supplies for epidemics, said Sylvia Mathews Burwell, the secretary of the Department of Health and Human Services.

So in effect, what we’ve done is take from prevention and preparedness to fund Zika response.

Now, I recognize that resource allocation decisions are inherently political. The two month-long back and forth between Congress and the White House represents a fundamental reordering of perceived threats and priorities, such that the present threat of Zika, particularly to expectant mothers in Puerto Rico and the Gulf Coast, now trumps the threat posed by the Ebola virus (put aside, for a moment, the fact that that disease has flared back up). Make no mistake - Zika represents a clear danger, and HHS and others are poised to respond. But to do the job right, funds over and above their routine operating budgets are needed. 

We have to face up to an uncomfortable reality: the way we finance responses to severe infectious diseases like Ebola and Zika is fundamentally flawed. This problem isn’t unique to the US government either. Governments around the world as well as international organizations have struggled to respond promptly in the face of new infectious disease threats. SARS, H1N1 influenza, MERS, Ebola, and now Zika have all emerged, and all caught us flat footed. In the global health arena, the WHO has recognized the importance of dedicated funding for epidemic response, and has included financing in their post-Ebola reform measures. If enacted, such a contingency fund would enable a more nimble organizational response to outbreaks and disasters.

In the federal budget, such rainy-day funds are a rarity, due in part to the practice of budgetary raiding and a desire on the part of appropriators to maintain control over the purse strings. Rare, but not non-existent. FEMA’s Disaster Relief Fund is one example of “no year” money. In general, this mechanism allows for FEMA to provide funding for emergencies without having to wait for an event-specific appropriation, and is replenished periodically by the Congress. No such mechanism exists for epidemic response. In my view, it may be time to consider establishing such a fund within the HHS budget, so that the business of epidemic response isn’t contingent on the waging and deciding of political battles going forward.  

Federal Health Security Funding: Doing More with (Much) Less

My colleagues and I have recently published our annual article that describes federal health security programs and their associated funding levels in the President’s annual budget request. The programs we include fall into several broad categories, including civilian biodefense; chemical, radiological/nuclear, and pandemic and emerging infectious disease preparedness and response; and multiple-hazard or general preparedness and response. This work is an expansion of an earlier series of articles that examined federal funding for biodefense programs alone. We’ve also published one article on funding and programs dedicated to nuclear consequence management.

Briefly, the President’s FY2016 budget proposed approximately $13.7 billion for health security programs across the US government, an increase of $1.2 billion from the FY2015 estimated total for health security programs. Much of this increase ($750 million) comes from the Multi-Hazard and Preparedness programs, including proposed additional investments at the Department of Health and Human Services (HHS) in the BioShield fund, the Biomedical Advanced Research and Development Authority (BARDA), and a new Public Health Emergency Response fund within the Public Health and Social Services Emergency Fund. Funding for health security is split in the following way:

  • Multiple Hazard and Preparedness Programs: $8.09 billion (59%)
  • Civilian Radiological/Nuclear Programs: $2.60 billion (19%)
  • Civilian Biodefense Programs: $1.38 billion (10%)
  • Civilian Pandemic/Emerging Infectious Disease Programs: $1.20 billion (9%)
  • Civilian Chemical Defense Programs: $423 million (3%)

In this year’s analysis, while proposed funding is set to increase for health security writ large, my coauthors and I were once again struck by how depleted the funding streams for state and local public health and healthcare preparedness have become. This declining support is particularly exemplified by the CDC’s State and Local Preparedness and Response program and the National Hospital Preparedness Program (HPP) in the Office of the Assistant Secretary for Preparedness and Response (ASPR) at HHS. Not only has funding for these programs not kept up with inflation, funding has been cut dramatically since they were established or expanded in the aftermath of September 11th, 2001.

Since that time, funding for State and Local Public Health Emergency Preparedness at CDC (which is comprised almost entirely of the Public Health Emergency Preparedness Cooperative Agreements (PHEP) that fund preparedness efforts at state and local health departments), has decreased from $940 million per year in FY2002 to a low of $619 million in FY2013, with a proposed budget of $643.6 in FY2016. For the coming year, this would mean that state and local public health departments would receive $300 million (32%) less than the funding level originally designed for this program.

The HPP program, which was funded fully in 2003 at $515 million per year has dropped to a low of $255 million proposed for FY2016. This means an overall reduction of $260 million (51%) per year to a program that is intended to support preparedness and response capabilities at the country’s more than 5,600 hospitals. These funds have been instrumental in the formation and operation of healthcare coalitions for emergency preparedness and response.

When adjusted for inflation by using 2002 dollars, the funding decline for these two programs is even more pronounced. Today’s funding simply has less buying power for health departments and hospitals and supports fewer people dedicated to preparedness than it did 15 years ago. The consequences of declining preparedness funding has been further described in the Trust for America’s Health’s annual “Ready or Not?” and “Outbreaks” reports.

Given recent global experiences with Ebola and MERS, which highlighted our reliance on prepared, resilient healthcare systems and illustrated the role that state and local health departments play during crisis response, it seems only prudent to devote adequate resources to public health and healthcare system readiness at all levels of government. Given recent challenges, we’re hopeful that Congress will see the wisdom in making long term investments to our nation’s health security going forward.  

Designer Babies “R” Us

Asilomar and Napa, separated by 150 miles, are now linked as meeting sites for scientists to discuss the self-regulation of biotechnology. In Asilomar in 1975, the topic was recombinant DNA technology, or the joining of DNAs from different organisms. After discussions on the safety and risks, scientists and physicians voluntarily produced governing principles for their work, including a list of prohibited high-risk experiments. In January 2015, scientists again gathered in California, this time to discuss CRISPR-Cas9 technology, concluding that there is an urgent need for continued open discussion on its use for human genome modification.

The CRISPR-Cas9 system is utilized by bacteria to protect themselves from infection by viruses. Upon detection of invading DNA, the bacterium produces two types of short RNA, one of which matches the viral sequence. This guide RNA forms a complex with Cas9, a nuclease that can cut DNA upon binding. The complex can then bind to the complementary virus DNA target site, leading to its excision and degradation, thereby disabling the virus. This bacterial system has been co-opted by scientists for use in genomic engineering to change exogenous DNA in a variety of cells and animals. Mutations can be introduced by targeting genes-of-interest for excision by the complex, simplifying the creation of gene-knockout models to examine gene function. However, the technique can also be used to repair mutations by adding DNA segments carrying the correct genetic sequence along with the CRISPR-Cas9 complex. After excision, the cell will use this DNA as a template for its repair machinery, thereby introducing the ‘healthy’ sequence into the genome. If this is done in reproductive cells, the CRISPR-Cas9 system has the ability to modify human embryos, an application that has enormous ethical implications.

By editing the DNA of the egg and sperm cells, called “germline engineering”, it could be possible to correct mutations that cause diseases. For example, a researcher described the potential to harvest the eggs from women carrying the BRCA1 mutation, a dominant mutation that predisposes women to breast and ovarian cancer. CRISPR-Cas9 would be used in these eggs to correct the mutated DNA and create a viable embryo with the ‘healthy’ BRCA1 gene. This genetic change would then be passed on through future generations. However, the technology is still in its infancy – scientists do not yet know the potential for off-target effects, or even on-target editing with possible side effects. Furthermore, the width of its potential application is troubling to bioethicists. With recent advances that further streamline the system, the possibility of designer babies that could alter the scope of human evolution is more reality than science fiction. In fact, rumors abound that scientists outside of the United States have already submitted papers for publication that detail their use of CRISPR in human embryos.

Given the lack of regulations on germline engineering in the United States, Jennifer Doudna, the molecular biologist who helped develop CRISPR, convened scientists, ethicists, and law experts to discuss the concerns. The group detailed a number of steps to be taken, including: discouraging attempts at genome modification, creating forums for continued discussion, encouraging transparency of research to evaluate the safety of the technology, and finally the convening of a global group to openly discuss the merits and risks and recommend policies.

The meeting at Napa was essential to begin the conversation on CRISPR-Cas9 technology and attract public attention to these issues. However, there are many additional measures that need to be addressed in further discussions. Notably, and in contrast to the original Asilomar, the researchers did not call for a moratorium on the controversial germline engineering, instead only “strongly discouraging” the work. Until the safety and efficacy of CRISPR in germline editing is determined, a self-imposed pause on altering human eggs, sperm, or embryos, should be in place. It is possible the recent government-imposed ban on funding for the gain-of-function (GOF) studies on influenza and SARS viruses led to the scientist’s reticence to impart additional restrictions on their community. In contrast though, GOF studies have broad biosecurity implications - the escape of a virulent strain has the potential to affect the general public, while germline engineering affects only the individual and his or her progeny. Therefore, it remains to be seen what regulatory approach the U.S. government will elect to take regarding genome editing using the CRISPR-Cas9 system.

However, this raises an additional point that was not defined in the Napa meeting: Who is responsible for leading the discussions on the technology moving forward? Should it be left exclusively to the research community, or done in conjunction with national and international regulatory bodies? An overhaul of the current laws and legal system may be necessary in light of the uncertainty of the role that the U.S. government should play in regulating biotechnology. A potential model is the United Kingdom and their response to the issue of mitochondrial DNA replacement therapy, which is another form of germline modification. The procedure was banned while the government sponsored numerous scientific and ethical studies. After these demonstrated the safety of the technique, the House of Commons and Lords voted to approve the technique, albeit under strict regulation. A similar protocol may be useful for the U.S. and abroad to evaluate CRISPR-Cas9, in order to ensure the technology is used safely for germline editing.

Frank Filches FEMA Funds

Spoiler Alert: This post goes into detail on one of the plotlines from the third season of House of Cards, which was released this past weekend on Netflix.

From: FEMA

From: FEMA

During the third season of Washington favorite House of Cards, President Frank Underwood finds himself in need of a quick $3 billion to fund America Works, his proposed federally subsidized jobs program. He reviews the federal budget and sets his sights on the Federal Emergency Management Agency’s (FEMA) Disaster Relief Fund (DRF). In true Underwoodian fashion, legality, propriety, and prudence be damned.

In a particularly wonk-tastic scene, President Underwood meets with the White House council to obtain their legal opinion on whether or not he’s got the authority to declare unemployment – with its attendant ill effects on health, income, and society as whole - a disaster under the Stafford Act. His lawyers agree that he probably does, as the law stipulates that the determination of what constitutes a disaster is left up to the president’s discretion. They note, however, that he’s bound to be challenged promptly through the courts. He predictably doesn't care.

Soon thereafter, the President pays a visit to his technically skilled but politically outmatched FEMA administrator to strong arm him into cooperation. After protesting in vain that a Category 3 hurricane can’t be compared to unemployment from a disaster standpoint, the administrator capitulates. The next task is to find a pliable chief executive of a state or local government, as Presidential disaster declarations are only granted subsequent to a governor’s request for federal assistance. Luckily for President Underwood, the mayor of Washington, DC proves more than willing to request assistance for the unemployment “disaster” plaguing his city. In the end, Frank gets his $$, and a pilot for America Works.

The Stafford Act in the Real World

The Robert T. Stafford Emergency Relief and Disaster Assistance Act is the primary legal mechanism by which the Federal government provides funds to local, state, and tribal governments to support disaster response and relief efforts. As noted in a 2014 Congressional Research Service report on the DRF: “The DRF functions as a reserve for potential, future incidents, as well as an account to pay for ongoing projects to recover from past disasters.” Sarah Kliff over at Vox has a great summary of how the Stafford Act fits into the plot of House of Cards. Briefly, the real-life DRF currently has a balance of roughly $11 billion. The majority of its biggest ticket expenditures have come in response to natural disasters, and specifically major hurricanes, which are unique in that they can rapidly devastate large swaths of the US. As frequently noted by preparedness researchers, the rate of Presidential disaster declarations has been increasing since the late 80’s.  

As Ms. Kliff notes, it’s highly unlikely that a President will ever attempt to “Underwood” the DRF. But the fictional President’s gambit does point to a real world concern, namely, keeping pots of emergency funds intact can be a difficult proposition. There is a temptation to borrow from, or “raid” these accounts for uses other than what congressional appropriators intended. For example, in 2010, legislators transferred $2 billion from the BioShield Special Reserve Fund (SRF) to fund advanced development of medical countermeasures. While this transfer was in no way as legally or operationally problematic as the Underwood raid of the DRF, it did arguably run counter to the spirit of the SRF, which was intended to provide a signal to industry that the public sector was committed to purchasing medicines and vaccines for which no other viable market exists.

The SRF and DRF are two examples of critical shock absorbers that enhance national preparedness and enable resilience from catastrophic events. So - to echo FEMA - hands off, President Underwood!

Health Security and the State of the Union

The annual State of the Union Address is a chance for the President to present his domestic and foreign policy priorities. Often, the President will reflect on the most difficult challenges facing the country. Last night was no different. In his speech, President Obama took a moment to acknowledge the Americans who are responding to Ebola in West Africa, an epidemic that appears to be moving from apocalyptic to “merely” severe.

Because the State of the Union reflects Presidential priorities, even a mention carries a lot of weight. Below are the best examples of where health security issues have been mentioned in the State of the Union during the Obama presidency.  

2015 - “In West Africa, our troops, our scientists, our doctors, our nurses and healthcare workers are rolling back Ebola — saving countless lives and stopping the spread of disease. I couldn’t be prouder of them, and I thank this Congress for your bipartisan support of their efforts. But the job is not yet done — and the world needs to use this lesson to build a more effective global effort to prevent the spread of future pandemics, invest in smart development, and eradicate extreme poverty.”

2014 – “American diplomacy, backed by the threat of force, is why Syria’s chemical weapons are being eliminated, and we will continue to work with the international community to usher in the future the Syrian people deserve – a future free of dictatorship, terror and fear.”

2013 –  “We can choose to believe that Superstorm Sandy, and the most severe drought in decades, and the worst wildfires some states have ever seen were all just a freak coincidence.  Or we can choose to believe in the overwhelming judgment of science -- and act before it’s too late.”

2010 – “…we are launching a new initiative that will give us the capacity to respond faster and more effectively to bioterrorism or an infectious disease -– a plan that will counter threats at home and strengthen public health abroad.”

These excerpts remind us that health security issues occur frequently, ranging from emerging infectious disease epidemics, natural disasters, and the use of WMD, and often necessitate a response by the President of the United States. That trend is not likely to change any time soon, which speaks to the need for continued awareness of the myriad threats and continued investment in America’s preparedness and response infrastructure.