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December 05
Ensuring a coordinated response to Zika and other public health threats

When the first confirmed case of Zika transmission was reported in Puerto Rico on December 31, 2015, there were no vaccine candidates for Zika. Today there are at least a dozen approaches in the US alone that are being evaluated to someday be available for general use. Diagnostic assays to help patients make informed decisions about their health are also under development.

How have so many medical countermeasures advanced so quickly to fight a threat that few people were worried about just last year?

The partners in the Public Health Emergency Medical Enterprise (PHEMCE) are an important part of that answer. Working together PHEMCE partners are making smart investments and using a strategic approach to support the development of critical medical countermeasures for use in the fight against Zika.

The PHEMCE originally was created to speed development and licensure of products that address bioterrorism threats and other major public health impacts from chemical, nuclear and radiological events. It has evolved to also help our nation better respond to newly emerging infectious diseases.

Long before travel-associated Zika cases began to trickle into the U.S. states, officials from PHEMCE partner agencies worked together to assess what was known about this obscure and rapidly emerging threat. Recognizing that a range of federal departments and agencies possess knowledge, expertise and have stakes in protecting our national health security, the PHEMCE brings together the Departments of Homeland Security, Health and Human Services, Defense, Veterans Affairs and the U.S. Department of Agriculture. When ASPR was created in 2006, it was charged with leading the PHEMCE.

The PHEMCE partners worked together on a strategic approach. They started to evaluate the status of the development of vaccines, diagnostics and blood screening technologies and efficiently collaborate on ways to respond to the threat of Zika. The PHEMCE agencies could of course each independently respond to the various needs required for the Zika response, but it is the collaboration within this Enterprise that allows for better coordination of resources, funding, and decision making, to avoid duplication and quicken the response time.

The different agencies each also bring unique expertise to the table. For example, the experience of the National Institutes of Health’s National Institute of Allergy and Infectious Diseases and the Walter Reed Army Institute in basic and early clinical research was combined with additional expertise from ASPR’s BARDA for advanced development and industry partnerships to help determine which vaccine approaches to Zika could prove effective and were worth pursuing.

This level of coordination has been key to ensuring that the many vaccine candidates are evaluated against similar sets of criteria and take advantage of common overarching needs, like how and where to perform clinical trials to give us a more seamless transition of Zika medical countermeasures from the research and development stage to maturing into products. Several of these vaccine candidates have advanced into Phase I clinical trials, and the PHEMCE now is looking at setting up clinical trial sites for Phase II studies.

It also helped in the domain of developing commercial diagnostic assays. To date, the coordinated efforts of the PHEMCE partner agencies have resulted in six grants to commercial partners to develop diagnostic assays that can be used under of Emergency Use Authorization for patient identification and for blood screening.

The PHEMCE’s goal is to make sure the right medical products are available for the right patients at the right place and time. As simple as that goal may seem, it requires tremendous coordination among many federal partners.

In the 10 years since it was created, the PHEMCE has produced a greater national response capability, more medical countermeasures available to aid during a disaster, and a public health response structure that will help our nation deliver the materials needed during a public health emergency and boost capacity when new threats arise.

With these mechanisms in place, PHEMCE partners are better positioned to advance medical countermeasures for Zika and prepare for future threats to national health security.

December 05
Get Your Flu Shot for Yourself, Your Family and Your Community

This week is National Influenza Vaccination Week. You probably know that getting vaccinated is one great way to prevent getting the flu. Getting a flu vaccine also helps you keep your family and community healthy. It even helps you become a little more prepared for disasters.

Take care of yourself and your family

For everyone, getting the flu makes daily life harder. At a minimum, you’ll feel lousy and you’ll probably have to miss some time at school or work. But a lot of people have complications. People with the flu may also develop bacterial pneumonia, ear infections, sinus infections, and dehydration.

Of course, the flu is more likely to be a serious problem for some people. If you have an existing medical condition, like congestive heart failure, asthma, or diabetes, the flu can make your condition worse. If you are battling HIV or cancer, you are at risk. Even people who are pregnant or over 65 years old face special risks.

If you are a parent, make sure your children get their flu shots. The Centers for Disease Control and Prevention (CDC) recommends an annual flu vaccine for everyone six months of age and older. Children ages 5 and younger are at high risk of severe flu complications, especially those ages 2 and younger. It’s estimated that more than 20,000 children ages 5 and younger are hospitalized every year because of flu-related issues.

If your child is under 6 months old, he or she can’t get a flu shot, so parents need to take some extra steps to protect their children. Make sure that you and your child’s caregivers are vaccinated and take other steps to keep your child from getting the flu, like washing your hands and your child’s hands, washing toys, and taking other steps to keep them away from germs.

Help your community every day

You may not have any of these conditions – you might be totally healthy and you might not have any children. Now think about your the people that you see every day. Are any of them pregnant? Children? Elderly? Have a medical condition? What about people in your broader community?

By protecting yourself, you also help protect the people around you – from your family to your coworkers to your community. If you don’t have the flu, you probably won’t give it to other people. Most healthy people can infect others about a day before they start to feel sick. If you catch the flu, you could put others at risk without even knowing it.

Remember that it takes about two weeks for your flu vaccine to become effective. So if you are traveling for the holidays, you need to get one as soon as possible to protect the people you are planning to visit.

Getting vaccinated is one small way to help protect the people around you. Helping them to get vaccinated as well is even better. That could start with a quick conversation with your friends or neighbors reminding them to get their flu shot. You could also volunteer to help other people get vaccinated. Organizations like the Medical Reserve Corps run vaccination clinics and they rely on help from volunteers to make that happen.

Prepare for disasters

Being healthy and flu-free helps you face everyday challenges, but it is even more important if a disaster strikes in your community.

Think about a disaster that has happened in your area—a flood, a bad storm, or a wildfire. Now imagine all of the things you needed to do in the wake of that disaster—checking in with family, friends, and neighbors, cleaning-up your home, helping with relief actions or shelters. Now think about having to do all those things while you or your family are sick with influenza.

Everyday activities to stay healthy, like keeping up with influenza vaccinations, are a small way you can make sure that you’re ready and able to protect yourself and help others if and when the next disaster strikes.

Healthy People. Healthy Communities. A Healthy Nation.

The decisions we make for ourselves, within our families, and in our communities all add up.

Getting your flu shot is just one small way you can help national health security. In getting vaccinated, you and your family will be better protected against seasonal flu, and in having more people in your community vaccinated, the country is better protected overall against flu this year, creating a healthier, stronger, more resilient nation.

Where to get your flu shot

At your doctor’s office, your local pharmacy, schools, grocery stores, health clinics, private workplaces—there are many places where flu shots are made available each and every year. Ask your friends and family where they go for theirs.

Still not sure where to get your flu vaccination? Visit CDC.gov/flu to find a location near you!

November 18
Volunteer to make your community healthier, happier and more connected this holiday season

With holidays like Thanksgiving fast approaching, many people will have the opportunity to reconnect with loved ones and build new ties with other members of their community. Volunteering is a great way to make new friends and help your community become healthier.

Communities that are more connected – the ones where people know each other and care about them – are healthier. When people know each other, they are better able to look out for the people around them, to know who needs a little more help, and to care enough to provide that help. These connections help keep communities healthier during disasters and every day.

Volunteering is a great way to help you connect with your community and help the people who really need it. Remember, the holidays are really hard for some people, especially the elderly, disabled, or homeless. Many of these people can’t get out and join the community or they may not feel like they have much to celebrate. By volunteering with community organizations, you can bring some much needed cheer and help them become healthier. When the most vulnerable people in our communities become healthier, so does the community as a whole.

Volunteering is also a good way for you to celebrate the holidays. It is a great way to get to know new people and make lasting friendships. By getting out of your everyday routine and trying something new with people who care about others, you can make friends with some really great people – some whom you never would have met otherwise.

Did you know that volunteering and connecting with your community is good for you too? Research shows that people with more social ties within their communities often have lower blood pressure rates, better immune systems, and lower stress levels. Volunteering often gives people a sense of accomplishment and it can even lead to lower rates of depression. Volunteering can be an important part of a happier, healthier lifestyle.

So what can you do in your community to help your community become healthier?

Get together with your family, friends, or neighbors and use some of the following ideas to start strengthen your community:

  • Contact local hospitals and health clinics in your community to ask about what volunteer opportunities may be available, especially around the holidays. You can see firsthand what challenges members of your community may face and help address them.
  • Work with community- or faith-based organizations in your area that help isolated senior citizens or disabled residents so you can spend quality time getting to know others within your community.
  • Volunteer with nonprofit groups that work to deliver meals to residents in need or help serve Thanksgiving dinner at your local shelter or soup kitchen so you can get to know those members of your community who are more at-risk.
  • Contact local hospitals and health clinics in your community to ask about what volunteer opportunities may be available, especially around the holidays. You can see firsthand what challenges members of your community may face and help address them.

Through these actions, you can make your community more connected, and as a result, healthier and stronger. In addition to volunteer efforts, social activities like joining your children’s PTA, organizing a community block party or fall festival, or attending faith-based gatherings are all great ways to build connections in your community and help your community have a happier, healthier holiday season.

So get out there and meet one another! Your community—and your health—will thank you for it.

November 09
7 Ways You Can Help Your Community's Health Resilience

By working with friends and neighbors, community leaders and organizations across the country are keeping their residents safe and healthy every day and during disasters, building community health resilience in the process.

Communities can be as varied as the disasters they face. This means each community can create activities that work best for them and their unique needs.

Each community can make health resilience their own! To get you started, here are a few examples of activities that neighbors and community organizations can work on together to improve their community's health resilience, and in turn, our nation's health security.

Are you a community leader or neighborhood resident?

  • Get certified to be an active bystander during an emergency: First aid, family care, CPR, AED, emergency care, and bystander preparedness are examples of the many health arenas where you can get training and certifications. Red Cross offers classes throughout the country – so find a class and register today!

  • Volunteer in your community: There are many ways you can help your community every day! By volunteering in your city or town, you can help build your community's health resilience, especially by focusing on efforts that help your neighborhood's senior citizens, homeless, disabled, or children. Visit www.USA.gov/volunteer to find public service and volunteer opportunities.

  • Plan a block party: Just getting to know your neighbors is a step on the path towards community health resilience because it builds social support networks people can rely on during emergencies. Throw a block party where all the residents of your community can get out, meet one another, and socialize. Check out this example of a block party guide from the City of San Francisco's Neighborhood Empowerment Network!

  • Protect against the flu: Get your flu shot and encourage others to do the same! You could even work with a local clinic to see if you could offer flu shots at your community center and volunteer to help set up the event. There are probably many locations near you where you can get a flu shot. Check out the Flu Vaccine Finder to find a provider near you.

Are you a leader or member of a community organization?

  • Establish a health resilience council: Ask for volunteers who can find the best ways to help the community at large. These council members can serve as official liaisons to local health and emergency organizations, sharing information with and assisting police and fire departments, hospitals, and clinics.

  • Beautify a park or build a garden: The physical surroundings of a neighborhood are one of the many things that have an effect on the health of residents. Invite neighbors to clean up an existing park or build a community garden. You'll build new relationships in the process. Contact your local Parks & Recreation office to coordinate your project.

  • Plan an open house: Create an open house event for your organization where neighbors and residents can visit and get to know your organization, and each other, better. These connections and relationships are important, and can lead to new partnerships that strengthen your community's health resilience!

Whatever activities you think are best for your community, keep in mind that they should build new relationships and connections with those around you. The most likely person to provide immediate help in an emergency or disaster is a friend, neighbor, or bystander. Building stronger social connections among neighbors is a key way members of the community like you can help!

November 04
New Authority Gives State and Tribal Governments More Flexibility to Support a Better Disaster Health Response

When a disaster strikes, state, local, tribal and territorial governments may want all hands on deck to respond to the crisis.  Historically, that has been easier said than done.  Staff who are funded under the Public Health Service (PHS) Act were only allowed to work within the scope of the program they were funded to support, even if responding to a disaster would have enabled them to better protect the community’s health.

But now, a state governor, tribal leader, or their designees can ask the Secretary of Health and Human Services to authorize the temporary reassignment of state, tribal, and local personnel during a certain emergencies.

The ability to temporarily reassign these personnel during public health emergencies is an important flexibility for state, tribal, and local governments. Using this new authority, State and local health departments and tribal organizations are can increase the workforce available to respond to public health emergencies within the state or territory. 

Can this authority be used to respond to any disaster or emergency?

No.  This authority can only be used following the declaration of a Public Health Emergency by the Secretary of Health and Human Services.

What kinds of staff are typically funded by the PHS Act?  Who can be reassigned?

This grants HHS the authority to temporarily reassign state, tribal and local health department personnel, who are currently funded under PHS related programs, from their current positions to roles directly supporting the response to a public health emergency.

There are over a hundred programs eligible for temporary reassignment under this authority, including staff from ASPR’s Hospital Preparedness Program and CDC’s Public Health Emergency Preparedness program.  To learn more about your program’s options, talk to your program’s headquarters.

How can states and tribes request the temporary reassignment of personnel?

After the Secretary of the Department of Health and Human Services declares a public health emergency, a state governor, tribal leader, or designee can request the temporary reassignment of personnel by completing the Request for the Temporary Reassignment of State, Tribal, and Local Personnel During a Public Health Emergency Declared by the HHS Secretary and submitting it to TemporaryReassignment@hhs.gov.

As part of the request, you will need to include the location, contact information, the applicable program, number of personnel eligible to volunteer for reassignment, activities that will be conducted by reassigned personnel, and the impact the reassignment will have on both the emergency response and on the base program’s ability to meet the mission.

Does the Authority have any limitations?

Once approved, the reassignment will last no longer than 30 days or until the HHS Secretary determines that the public health emergency no longer exists, whichever comes first. States and tribes can apply for an extension if the emergency lasts longer than 30 days.  This authority is also only applicable to those states and tribes in the geographic area affected by the public health emergency. Additionally personnel have the opportunity to volunteer for temporary reassignment. They are not required to agree to be reassigned. 

Are States or Tribes expected to do anything after reassignment has ended?

Within 120 days of the end of the temporary reassignment, the state or tribe will submit a report to TemporaryReassignment@hhs.gov outlining the effect the reassignment had the program and the emergency response. This report will include: the number of personnel reassigned; the amount of funds used to support the reassigned personnel; impact the reassignment had on the program both positive and negative; and how it made the emergency response more efficient.

How will programs' steady-state work be handled during reassignment?

Reassignments are temporary and strictly voluntary. Thus, if staff have a critical deadline or project, they can opt out of the reassignment.

How can I learn more?

To learn more, check out the Guidance for Temporary Reassignment of State and Local Personnel during a Public Health Emergency.

October 21
Taking Stock of Cyber Threats During National Cybersecurity Awareness Month

October is National Cybersecurity Awareness Month, which provides us in the public health emergency management community a time to think about how we prepare for and respond to cybersecurity incidents within the context of all hazards. One thing has become increasingly clear over the past several years: cybersecurity is not just an IT problem. It also is a patient safety issue and it is increasingly an emergency management issue. This year healthcare organizations throughout the nation have been hit by an unprecedented round of ransomware attacks, which have temporarily incapacitated critical functions within hospital systems and led to disruptions in normal operations. These attacks have led facilities to implement emergency management plans, stop taking new patients, and cancel elective procedures. Responding to cybersecurity attacks has required close coordination among emergency managers, IT managers, healthcare staff, and law enforcement agencies to bring systems back on-line while mitigating the impacts of the attacks on patient care.

Two public events next week will showcase the work that ASPR and our HHS and other Federal Government, state, local, and private sector partners are undertaking to promote patient safety by promoting effective cybersecurity through two different bodies: the Healthcare and Public Health Sector Coordinating Council and the Health Care Industry Cybersecurity Task Force.

On October 24 and 25, the ASPR Critical Infrastructure Protection Program will host the annual partnership meeting of the Healthcare and Public Health Sector Government Coordinating Council and Sector Coordinating Council. This year’s meeting will focus on resilience, risk and reward within the critical infrastructure of the U.S. healthcare and public health sector, including a session-specific track focused on cybersecurity. The cybersecurity track will feature discussions on issues related to the management of cybersecurity threats, recent policy developments, information sharing coordination, and other topics that can help you prepare for, respond to and recover from a cybersecurity attack. The Healthcare and Public Health Sector Government Coordinating Council and Sector Coordinating Council represents private sector interests and perspectives in the public-private effort to protect the national healthcare infrastructure. Made up of representatives, organizations, trade associations, and professional societies who operate within the healthcare sector, the Council works to meet the specific needs of owners and operators and to inform and influence government policy and action with regard to infrastructure protection.

On October 26, 2016, Health Care Industry Cybersecurity Task Force will hold its third in-person meeting, which will focus on cybersecurity information sharing activities within the Federal Government and private sector. The meeting will include panel discussions on the Federal approach for healthcare industry cybersecurity and on commercial sector information sharing. HHS established the Health Care Industry Cybersecurity Task Force under the Cybersecurity Information Sharing Act of 2015 to bring together subject matter experts to provide recommendations for increasing healthcare industry cybersecurity in light of recent threats.

Registration is open for both events. See below for registration details:

We hope that you can join us to exchange ideas on improving cybersecurity and information sharing. By working together across industry, government and academia, we can find better solutions to cybersecurity challenges, improve information sharing, and decrease financial and health risks.

October 21
Acute Medical Care: Navigating a Complex System

Imagine you are on vacation. Your son slips, falls and is unable to walk on his injured leg. Should you go to the emergency department? Or would a retail clinic or urgent care center be better? And would that place have the X-ray machine or other capabilities necessary to care for your son?

Many factors influence when and why people choose to seek care. This is especially true for acute care – like your son’s injured leg – that is often time-sensitive and unscheduled. Some of these factors are personal, like the severity of an individual’s specific health condition; where they prefer to get care; how easy it is for them to get to the places where and when care is available; and what support they have from family and friends. Other factors are related to the communities where people live, like what options are available for care; the quality of that care; and how easy it is to get the other things people need to stay healthy, like housing, food, and support from their community.

Options for acute care in the U.S. are complex, even bewildering. For instance, acute care delivery occurs in many settings, including emergency departments, urgent care centers, retail clinics, doctors’ offices, and by telemedicine. The services and capabilities of these facilities may vary dramatically. People often need help navigating this complex system to choose the best place to go for the care they need and sometimes they need to do it quickly or in an unfamiliar location. Helping people navigate the increasingly complex system is critical.

So, how can we help your injured son get the care he needs after he has fallen on vacation?

The U.S. Department of Health and Human Services (HHS) has recognized that we need a more integrated and patient-centered way to deliver care during our most vulnerable of moments. HHS’s delivery system reform initiatives seek to ensure that the health care system delivers better care, spends health care dollars more wisely and results in healthier people. The Affordable Care Act created a number of new payment models that move the needle even further toward rewarding quality. Providers have a financial incentive to coordinate care for their patients and reduce duplicative or unnecessary x-rays, screenings and tests. This patient-centric approach can and should be extended to the acute care setting.

Accordingly, the ECCC contracted with the George Washington University to develop a Conceptual Model for Management of Acute Unscheduled Care in the U.S. The model helps to disentangle the complex acute care system by describing the options and factors that influence people’s decisions about where, when, and how to receive medical care during their time of need. The model begins with the social and individual determinants of health that influence the likelihood of acute illness and injury, then describes care-seeking decisions, care delivery settings, transitions in care, and how quality care leads to differences in health outcomes and costs.

This conceptual model is the first step in helping people navigate the increasingly complex acute care system. The model addresses the multitude of issues facing the day-to-day healthcare system, and has implications for disaster and public health emergencies that create increased demand.

The full report highlights that the management of acute illnesses, injuries, and exacerbations of chronic conditions is multifaceted and involves many stakeholders (e.g., patients, providers, payers, and policymakers) from across the healthcare system.

HHS will soon announce the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) final rule. Hundreds of thousands of Medicare providers across the country will be asked to choose their own path of participation in the Quality Payment Program – focused on moving the payment system to reward patient-centered care. As we shift to a system of care that rewards health care providers for providing quality care, it is critical to consider the acute care experience through similar lens and reward care coordination that result in better health.

October 13
Better preparing for future Ebola outbreaks globally

While the Ebola virus disease is not in the news as much now as it once was, we cannot afford to let down our guard. Ebola cases flared up again as recently as this March in West Africa, causing eight deaths in Guinea and one death in Liberia, and more than 30 other outbreaks of the disease have been recorded in the last 40 years.

The Ebola outbreak of 2014-2016 highlighted the urgent need for therapeutics that could increase the survival rate of infected patients and also aid response organizations in their efforts to limit the spread of this deadly virus. ZMapp, developed by Mapp Biopharmaceutical in San Diego with support from several components of the U.S. government, is a combination of three monoclonal antibodies that target the Ebola virus.

Based on a careful review of preclinical studies of various potential therapies, ZMapp was selected for field use and an evaluation of efficacy in the PREVAIL II study in Guinea, Liberia, Sierra Leone and the United States. However, with the decline in the outbreak’s severity came a slowing of the enrollment in the PREVAIL II clinical study, and that study was closed in January before sufficient patients could be enrolled to draw conclusive results about the efficacy of ZMapp, based on predetermined statistical thresholds. The data from this trial have now been published in the October 13 issue of The New England Journal of Medicine (2016;375:1448-56).

Although the trial did not conclusively prove that ZMapp works, the limited data gleaned from PREVAIL II are encouraging, suggesting there was a greater than 90 percent probability that the finding of increased survival amongst patients treated with ZMapp did not occur by chance alone. This trend toward efficacy means it is no longer ethical to continue a trial comparing ZMapp to standard of care; rather, efforts should shift to comparing ZMapp to other promising therapies. Meanwhile, given all of the work already done to study ZMapp, we anticipate that work will continue to seek FDA approval under the Animal Rule.

To better protect the health of their residents, the U.S. government and the governments of Guinea, Liberia and Sierra Leone want to ensure that ZMapp remains available in the event of new Ebola cases, future outbreaks and flare-ups.

On Aug. 5, these international partners announced that they are pursuing an effort to ensure ZMapp will continue to be a treatment option under an Expanded Access protocol for Ebola for the next three years.

ASPR’s Biomedical Advanced Research and Development Authority, or BARDA, is providing approximately $13.4 million over the next three years to implement and maintain the ZMapp Expanded Access Protocol. This will allow the continued use of ZMapp in the nations that participated in the PREVAIL II clinical study during the Ebola outbreak. The FDA approved the continued use of ZMapp under the Expanded Access Protocol earlier this year and continues to work with Mapp Biopharmaceutical to lay out a path that could lead to future approval.

The U.S. partners, including the National Institutes of Health, Centers for Disease Control and Prevention, BARDA, FDA, and Mapp Biopharmaceutical, will work with international partners, including the Ministries of Health in Guinea, Liberia and Sierra Leone, to ensure access.

Clinical sites are being set up in each of the three participating West African countries and will be staffed with experts with extensive expertise in those countries and professionals trained in administering ZMapp. The partnership also will operate one mobile Ebola treatment unit in each of these countries and provide air capability to reach remote areas.

Meanwhile, U.S. federal agencies will continue efforts to develop effective vaccines and therapies against Ebola. The response to Ebola underscored the importance of global health preparedness and, while the immediate threat Ebola poses has diminished since 2014, we must vigorously prepare against future emerging infectious disease outbreaks. Helping ensure the future availability of effective countermeasures to Ebola will help us better protect public health against this threat globally.

September 29
From the front lines of the anthrax investigation to pre-staging our future health response

Fifteen years ago this month, anthrax was used as a terrorist weapon against our nation. As a microbiologist with experience in dealing with Bacillus anthracis, the bacteria that causes anthrax illness, I was called in to be on the front lines of the investigation into the attack. Today, I help ensure our nation is best prepared for and can respond to a future one.

Soon after September 11, 2001, an attacker mailed letters laced with anthrax spores causing the deaths of five people and sickening 22 others. As part of the response, I donned a hazmat suit to investigate the possible extent of spread near one of these sites. When the FBI launched an investigation to determine who perpetrated this attack, the agency looked to the company I worked for at the time; with my background, I was to be part of the investigation to identify its source.

There were many challenges in the beginning. Decisively linking the anthrax spores collected from the attack site to the laboratory of a potential suspect would be necessary to prosecute and successfully charge the perpetrator. Therefore, every step including collection, analysis, and validation of samples; quality assurance and control; reporting out; and communication of complex molecular techniques needed to be resolved so that prosecutors and potential jurors would trust and understand for any potential litigation for attribution.

The first challenge was that different strains of Bacillus anthracis are very similar to each other at the genome sequence level, which presents challenges to differentiating strains. However, an astute scientist at United States Army Medical Research Institute of Infectious Diseases noticed unique differences in the appearance and growth characteristics of the anthrax spores used in these attacks. Therefore, we needed to be able to determine at the molecular level how these anthrax spores used in the attacks were different beyond a reasonable doubt.

The next challenge was that there were no established methods for differentiating anthrax spores at the molecular level. In order to determine definitively that the source of the anthrax used in the attacks, we had to create that method. We created one the first molecular forensics assays that identified unique fingerprints of the DNA of the anthrax spores used in the attacks, and then had to validate our assay and the technicians who would be testing any samples that were suspect.

We next had to determine optimal growth conditions to standardize the repository samples so they could be accurately compared using molecular testing. We also developed a method of isolating the DNA to be tested in our unique molecular assay.

Since Bacillus anthracis is a select agent, every researcher working with anthrax in their facility is required to register with the CDC and FBI, so researchers from all across the country were provided our standard growth conditions, and they prepared samples to be sent to my laboratory for comparison as part of the FBI’s investigation into the attacks. These became known as the repository samples.

Over the span of the next nine months, we examined over 1,000 repository samples using our standard methods for growth, DNA extraction, and molecular testing and found approximately 10 samples matched those used in the anthrax attacks in 2001. Those samples came from two laboratories, and one of those labs provided anthrax to the other. So, we were able to confirm the identity of the laboratory as the original source of the Bacillus anthracis used in the attacks.

Today, we have more tools at our disposal to respond to an attack. As the Director of the Medical Countermeasures Strategy and Requirements Division at ASPR, I have been able to play an important role in anthrax preparedness. My office has developed and updated anthrax requirements that determine how many medical countermeasures, such as treatments and vaccines, we need, how many can be used and what products would look like to preserve lives following a potential future anthrax attack. We work diligently within ASPR to prepare and respond against future attacks, to focus on preparedness; building federal emergency medical operational capabilities; countermeasures research, advance development, and procurement; and grants to strengthen the capabilities of hospitals and health care systems in public health emergencies and medical disasters.

Just as I was able to be a part of an innovative approach to identifying the source of the anthrax used in the attacks 15 years ago, I have seen the dedication and ingenuity within ASPR and am proud to be part of this vital mission.

September 15
Why some emerging infectious diseases cause epidemics

Forty years ago, a patient exhibiting symptoms believed to be from malaria sought treatment in a small village in the Republic of the Congo in Africa. Later, it was determined this patient didn’t suffer from malaria, but from a virus that would cause a major disease outbreak decades later and more than 1,000 miles away: Ebola.

When the Ebola epidemic struck in 2014, it claimed the lives of thousands. However, it also served as a reminder that nearly all emerging infectious diseases may not be altogether new to the medical community, but certain factors may have changed since they first emerged that allowed them to reach epidemic levels.

There are five major factors that allow viruses to cause epidemics:

Human population dynamics and behavior

As more people populate the planet, there is a greater possibility someone will encounter a virus that will spread to others. And, as we are traveling greater distances today than before, this allows viruses to spread more rapidly over greater distances more quickly. As was the case with the 2014-2015 outbreak, cultural norms also can cause an infectious diseases to propagate. For example, as families in West Africa cared for sick relatives they unknowingly exposed themselves to the Ebola virus through contact with contaminated body fluids. This practice initially resulted in further spread of the virus in families and in communities.


Changes in insect or reservoir populations

As a virus finds its way into new carriers, it can reach new ecosystems and populations. This was especially critical to the spread of the West Nile virus. This virus is believed to have been introduced into the Western Hemisphere by people or mosquitoes that originated in Eurasia, where it was a well-known viral disease involving animals, mosquitoes and people. We believe that once the virus established itself in a local site near urban New York City, it found a brand new environment to flourish within species of birds and mosquitoes in the United States. This eventually amplified the virus and allowed it to spread across the entire U.S. reaching a large number of people. From 1999 through 2015, more than 43,000 people contracted West Nile Virus disease in the U.S. Birds in the U.S. maintain the virus, and outbreaks could recur in the future.


Weather and climate changes

Changes in weather and the climate can drive some animals carrying viruses to different areas, where they could spread disease to people. A perfect example of this is the 1993 outbreak of Hantavirus in the Four Corners region of the U.S. An El Nino weather event in 1992 brought higher than average rainfall to the area. With more rainfall came more plants, and with more plant life came an increase in the local rodent population. As the weather returned to normal and that new habitat vanished, the enlarged rodent population suddenly needed to find additional sources of food and shelter, finding their ways into homes and spreading Hantavirus to nearby residents. Due in part to raising public awareness of the need to rodent-proof homes in the region, the outbreak ended.


Technology

Advances in technology have allowed us to identify outbreaks when before illnesses were believed to have a different origin. Consider an apparent increase in Leptospirosis that was observed in Baltimore in the mid-1990s. It was normally considered an uncommon infection and its prevalence largely went unrecognized because diagnosing it was challenging. When newer technologies and better diagnostic tools became available, the likely “true” prevalence of the disease became better understood, and, suddenly, the number of reported Leptospirosis cases appeared to jump.


Changes to the viruses themselves

Sometimes, a change in a virus itself allows it to become an epidemic. The flu virus is a great example of how mutations can allow viruses to spread widely among populations. The influenza virus changes on a regular basis as small mutational changes happen (called genetic drift). This is the basis for why we need to develop a new flu vaccine for general use each season. It is also the challenge that vaccine developers face in creating effective countermeasures to seasonal strains of flu. And, on occasion, the type of change seen in circulating strains of the virus come about from bigger shifts in the virus (called genetic shift) leading to some strains of flu that have the potential to cause pandemics.


Meeting the challenges of new epidemics

ASPR helps advance the development and procurement of critical countermeasures to protect people during public health emergencies whether they are caused by natural or manmade pathogens.

After the Ebola outbreak erupted in 2014, ASPR aggressively pursued the diagnostics, vaccines and treatments to address Ebola. We made meaningful strides toward developing the countermeasures we may need to combat this deadly disease if it re-emerges in the future.

We didn’t stop the recent Ebola outbreak with a vaccine or other countermeasure, but in large part by changing human behaviors that were allowing the virus to spread. After understanding how it spread between people, educating the public about steps they could take to avoid contracting Ebola helped turn the tide of the epidemic, and the outbreak halted. We were able to accomplish a lot in a short period of time because of partnerships with other federal agencies and with industry, as well as developing a better infrastructure for research and development. It is impossible to predict what the next emerging infectious disease will be, or which factors will make it re-emerge. When it does, ASPR and our global partners aggressively will pursue solutions to prevent its further spread.

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