More than seven million turkeys were culled during a bird flu outbreak this year, and you might be wondering about the one that’s going to serve as the centerpiece for your Thanksgiving dinner.
The good news is the bird you’re eating on Thanksgiving didn’t get the flu, but what about the people you’re gathering around the table with?
Influenza affects humans and many other animals. Birds, pigs, ferrets, horses and even ocean mammals can get the flu, but not all of these strains can be transmitted to humans.
To help make sure these strains don’t cross over to people, federal agencies are focused not only on preventing humans from getting flu, but also on controlling disease in animals when they are experiencing an outbreak of a strain that has the potential to make us ill.
After the highly pathogenic H5N2 avian influenza broke out earlier this year, the U.S. Department of Agriculture culled millions of infected and exposed birds, primarily chickens and turkeys, to help prevent the spread of the flu and prevent it from entering the food supply. Last summer ASPR’s Biomedical Advanced Research and Development Authority (BARDA) along with the Centers for Disease Control and Prevention began development of new H5 vaccines that may protect humans and birds.
According to the USDA’s Animal and Plant Health Inspection Service (APHIS), more than 32 million egg-laying chickens – almost 10 percent of the total U.S. flock – were culled during the outbreak, which started in January 2015 and wasn’t brought under control until June. By September the average price of eggs nationally had climbed by more than 50 percent compared to the price a year before.
At present, most flu vaccines for humans use are grown in eggs, so you might think the egg shortage could lead to shortages and/or higher prices for flu vaccines. Fortunately, this is not the case. To prevent such outbreaks from threatening the vaccine supply, hens providing eggs for flu vaccines are kept separate from those producing eggs for food. The heightened sanitary and biosafety precautions used to protect these hens worked to keep our seasonal influenza vaccine supply secure.
It was with just such a scenario in mind that more than 10 years ago, HHS’ Office of Research and Development Coordination (the predecessor office to today’s BARDA) established a program to ensure a secure, year-round supply of embryonated eggs for manufacturing influenza vaccines. In subsequent years, ASPR/BARDA also supported the development of new egg-free influenza vaccines. Two of the egg-free vaccines that BARDA has supported, one grown in a cell culture system, the other produced using recombinant technology, have now been licensed by the U.S. Food and Drug Administration (FDA).
To help further protect our nation against a potential pandemic flu outbreak, BARDA announced in September that it is supporting the development of the first monoclonal antibody treatment for flu. It is helpful to know the shape of influenza viruses to better understand how drugs target them.
Influenza viruses are roughly spherical and their outer coats are studded with proteins called the hemagglutinin (the H in a virus’s name) and neuraminidase (the N). Think of the hemagglutinin as one of the pieces of broccoli on your Thanksgiving table. Flu vaccines elicit an immune response that targets the flower heads at the tip of the broccoli and these frequently change, which is why public health officials have to try and predict which flu strains vaccines should target each year. The monoclonal antibody BARDA is supporting targets a conserved region on the stem of the broccoli, which changes much more slowly than the flower heads and could allow the drug to be effective against a broader range of flu viruses. If this drug’s efficacy is proven, it will give us another weapon against seasonal and pandemic flu. At the same time, BARDA is also seeking to develop improved influenza vaccines that more effectively target the conserved region of the hemagglutinin stem. The ultimate goal is to develop a vaccine that protects against all or nearly all subtypes of influenza A – a so-called “universal vaccine” that would protect against both seasonal and pandemic influenza.
Even though we aren’t facing a pandemic right now, seasonal flu can be a real threat to you and your family. If the flu strikes in your home this holiday season, it could ruin your family’s gathering or worse. The consequences of the flu can be very serious, even life-threatening, especially for children, pregnant women, the elderly and people with compromised immune systems. If you are getting together with anybody in one of those groups this holiday season, it is especially important to get your flu vaccine.
It takes about two weeks for a flu vaccine to take effect, so get your vaccine today. Not sure where to go? The Flu Vaccine Finder can help you find a pharmacy in your area where you can get the vaccine.
We hope that you have a safe, happy holiday season full of great memories. You can help make that happen by taking a few minutes to get your flu shot.
Like so many people around the world, I have family, friends, and colleagues in Paris, and like others around the world, my first thought when I heard of the terrorist attack last Friday was whether the people I knew were safe. While I was relieved that they were, my heart went out to the hundreds of people who lost loved ones. As Paris and the world mourn the senseless loss of life in the attack, Parisians and visitors to the great city are moving to recover quickly and, in doing so, are showcasing for the world what it means to be resilient.
As I learned about the attack and its aftermath, I was inspired by the textbook medical response and the resilience of Parisian health care system. They had been drilling intensively for just such a situation, and it paid off. In the minutes after the attacks, Paris health officials activated a coordinated emergency response, even before the full extent of medical needs became clear. They were ready for the surge of patients. The Paris health care community maintains an emergency response protocol that requires all emergency medical personnel to be on call and ready for work. Even non-emergency health care workers who were not on duty at the time reportedly raced to the attack sites and to emergency rooms to help. The city had hospital beds ready, ambulances on the road, and medical professionals to work so that waves of patients did not overwhelm the system. The response was a powerful reminder for those of us in health care that every health care worker needs to be aware of disaster procedures and ready to implement them.
Yet what struck me most was the community response. People reached out to help each other, driven by the desire to do something, anything, to help the community. They flooded blood banks. They took in survivors. Instinctively in disasters people want to band together, to feel connected. We see, time and time again, that people fare better after disasters when they have strong social connections in their community.
Of course, people around the world used social media to reconnect with loved ones in Paris. Several years ago ASPR sponsored a contest to inspire the development of apps to could help people check on each other through Facebook and other social media. In the process, we had numerous discussions with staff at Facebook, so I was encouraged when the company announced their tool, Safety Check, and activated it for this man-made disaster. Reportedly 360 million people received notifications that their Facebook friends were safe after Friday night’s attacks.
People also are relying on social networks, whether interpersonal or social media, to work through the psychological impact. Almost immediately after the attack, people began sharing expressions of resilience and hope, from simple messages to songs and art. The importance of that social connectedness and of having a network of friends, family and neighbors to count on should not be underestimated, especially for first responders, the families of victims and others for whom recovery may take years.
The attack is a traumatic reminder that to be resilient our nation, our community, our family and each of us must be ready continually for whatever may come our way. If you don’t already have one, please make a plan today to communicate with your family, friends, and neighbors. Make emergency information and emergency contacts easy for first responders to find. Think about our responsibilities as citizens and what you may be called to do if in the path of a disaster. Look for opportunities to learn how to “stop the bleed” and other aspects of first aid, CPR, and psychological first aid so you can be a bystander who doesn’t just stand by. Being ready and able to help the people around us can fill that innate desire to take action and to connect with the community. As we’re seeing in Paris, such readiness is the foundation of resilience.
Clinicians have relied on antibiotics to treat bacterial infections ever since they were discovered in the early 20th century. As a result, mortality and hospitalization rates that resulted from common infections went down. So did the Western world’s urgency to pursue alternative methods of fighting bacteria.
Since the discovery of antibiotics, western researchers have instead focused on developing drugs that block an essential enzyme or process that bacteria require to survive or replicate. At first, this approach was successful. Several new classes of antibiotics were discovered and brought to market. However, the antibiotics developed in recent years have been second, third, fourth or even fifth generation versions of the products discovered decades earlier. Researchers have tried exhaustively to find new drugs or drug targets through genomic approaches, bioinformatics, and high throughput screening with little success.
Unfortunately, this approach has created a situation where the last novel class of antibiotics to be approved was discovered in 1987. Moreover, the last novel class of antibiotic capable of treating Gram negative infections was introduced in the 1960s. Gram-negative bacteria have a more complex cell wall, containing two cellular membranes, which provides protection to the bacteria and makes it difficult for some antibiotics to access and interrupt their intracellular machinery. In the meantime, bacteria rapidly developed resistance to the antibiotics in use while the novelty of the drugs used to fight them stagnated. Today, the Centers for Disease Control and Prevention estimates that drug-resistant infections kill approximately 23,000 people per year in the U.S. at a cost of more than $20 billion to our healthcare system.
To address this public health crisis, innovative methods must be explored to treat and prevent infection. The White House stressed the importance of novel thinking in this area by including in the National Strategy for Combating Antibiotic-Resistant Bacteria (CARB) the goal of developing “non-traditional therapeutics and innovative strategies to minimize outbreaks caused by resistant bacteria in human and animal populations.”
Some therapeutics that were no longer pursued after antibiotics became widely used might prove worthy of additional research. Take bacteriophage therapy, for example. Bacteriophages are viruses that specifically infect bacteria. Discovered in 1915, bacteriophage research and clinical trials spread quickly throughout Europe and the United States in the 1920s and 30s. By the 1940s, companies such as Eli Lilly had begun to commercialize bacteriophage treatments, and World War II Russian soldiers carried bacteriophage treatment doses for dysentery. However, starting in the 1950s, interest in bacteriophage therapies within the United States and the western nations waned as multiple antibiotics were discovered and commercialized. Drug manufacturers saw the promise of small molecule antibiotics, which could act in a broad spectrum manner against a range of bacteria, as a potent and efficient means treating diseases.
Other examples of nontraditional therapeutics being researched include, but are not limited to, antibody therapies, altering or supplementing the bacteria that naturally populate the human intestine, or harnessing the power of the human immune system to fight infection.
BARDA is not yet funding any nontraditional therapies in the antibacterials portfolio, but is considering future investments in this area.
In September 2015, BARDA entered into a cooperative agreement with the UPMC Center for Health Security Inc. The first objective of this program is to gain a better understanding of the scientific, regulatory, clinical, and commercial challenges that must be overcome in order to advance nontraditional antimicrobial therapy development. UPMC will conduct literature searches, interviews, and a workshop of invited attendees before delivering a final detailed report. This assessment will help inform BARDA’s strategic direction as the organization considers future investments in these types of therapies for resistant bacterial infections as well as emerging infectious diseases.
As researchers pursue new and more effective antibiotic therapies, it is up to all of us to protect the antibiotics that we have by ensuring that we use them appropriately. The use of antibiotics is the single most important factor leading to antibiotic resistance around the world. Whether you are a potential patient, medical professional, or an agricultural professional, you have an important role to play in protecting existing antibiotics. Take some time during Get Smart about Antibiotics Week to learn about actions that you can take to help protect the antibiotics that we all rely on to stay healthy.
No one wants to guess how a disaster will impact their community. To respond well and recovery quickly when a disaster strikes, health and emergency management professionals need to know quickly how the emergency will impact their community. There is only a brief period after a disaster when researchers can gather to aid community members in making decisions about responding and recovery. Without a solid research base, community members are left relying on their best guesses or past experience to make critical decisions on disaster health.
In the wake of Hurricane Sandy, ASPR, CDC, and NIEHS were awarded a series of grants to study aspects of disaster recovery, and the conclusions of those studies are starting to be published.
Social Connections Reduce Depressive Symptoms
Amid busy lives, does taking time to get to know your neighbors matter, especially your elderly neighbors? A study from Rowan University indicates that, yes, having strong social connections can help make people, especially elderly people, be more resilient. The researchers found that some aspects of neighborhood social connectedness (social capital) promoted resilience of older adults exposed to Hurricane Sandy. The study also found that people who developed PTSD after Hurricane Sandy had fewer social connections before the hurricane. Older adults who reported stronger neighborhood connections reported fewer depressive symptoms after the storm.
Although neighbors helped to mitigate feelings of physical danger during the hurricane, they played a less central role when homes were damaged. The findings show that coming together as a community before a disaster strikes makes the community more resilient in the face of a disaster. Promoting social connectedness could enhance quality of life for older people; reduce health care costs; and minimize the damage caused by natural disasters. That’s a lot of reasons to try to increase connectedness in your community.
Another behavioral health study sought to identify the groups most vulnerable to mental health impacts from the hurricane. Researchers from Project LIGHT (Leaders In Gathering Hope Together) investigated various mental health symptoms and diagnoses in people who lived through Hurricane Sandy. They found that individuals with greater exposure to Hurricane Sandy had greater symptoms of PTSD, anxiety, depression and generalized stress. The study showed the greatest mental health impacts among people with a history of mental health difficulties, people with lower educational levels, and people of Hispanic ethnicity. The study’s results can help community organizations target their behavioral health intervention strategies and help emergency planners prioritize behavioral health activities in future disasters.
Do workers face new and different risks following a disaster? Turns out, following Hurricane Sandy, many immigrant laborers who engaged in clean-up and reconstruction work did not have prior access to health and safety training, and there was a lack of OSHA-approved trainers in the New York area who could conduct health and safety trainings in Spanish. With HHS grant funding, the United Steelworkers Tony Mazzocchi Center partnered with Make the Road New York and the National Day Labor Organizing Network to develop 40 immigrant worker-trainers who are now qualified to conduct “OSHA 10 construction worker” courses in Spanish. Since March 2014, this partnership has trained more than 3,600 Spanish-speaking workers with almost 58,000 contact hours of “OSHA 10 construction” training.
Recommendations to Improve Coordination and Resilience
Researchers at the New York State Department of Health collected feedback from local health departments, emergency management, and a variety of public health service providers. Among the notable findings: local drinking water providers did not have identification that allowed them to pass roadblocks, and clinics that serve women, infants and children (WIC clinics) experienced severe service delays. Based on the findings, the researchers developed recommendations for improving disaster response, such as improving shared emergency reporting between health departments and emergency management agencies and exploring options for alternate/mobile WIC sites.
The way in which resources are allocated after a disaster can impact the community’s ability to withstand disasters in the future. A group of researchers from the University of Delaware developed a conceptual and corresponding computational model to help New York City policymakers decide how to allocate resources to make the city more resilient in the face of a disaster. The model is based on a theory of community functioning, and what characteristics of a community – social, physical, economic, political, etc. – may predict a community’s experience with a disaster. The researchers use this model to explore how much loss of function the community experiences and how long it might take the community to recover.
These are just a few of the studies that our grantees conducted. Other researchers looked at issues related to modeling community resilience;
recovery worker safety; working with city and local health departments; health system response and health care access; mental health outcomes; recovery work and resilience in volunteers and citizens; reducing morbidity and mortality; training in mold mitigation and other health impacts of flooding; and vulnerable populations impacted by Hurricane Sandy. Check out these findings to see how they can be used to help you plan more effectively.
When the Pope came to Philadelphia earlier this year, I got to be part of the action. But I wasn’t a spectator and I didn’t go to mass. Instead, I got to be a part of the Medical Reserve Corps (MRC) response. MRC staff and volunteers from throughout the Pennsylvania and neighboring states came together to make sure that people could get urgent medical care if something happened while people were gathered to see the Pope.
The crowds were huge. Hundreds of thousands of people gathered in the city of brotherly love to welcome the Pope. When you have that many people in one place, there needs to be a plan to help people who need urgent medical care. What if someone has a heart attack? Or goes into labor? What if a bomb goes off? Thankfully, there were no bombs or other serious threats. But MRC volunteers did help handle the needs for urgent care that arose and stood by ready to help in case of an emergency.
So what is the Medical Reserve Corps? The Medical Reserve Corps (MRC) is a national network of volunteers, organized locally to improve the health and safety of their communities. MRC volunteers can be medical and public health professionals, but they don’t have to be. Many community members join the MRC to provide other forms of support that helps make their communities healthier. When there are major events, like an emergency or a big event, MRC volunteers may go to help other communities as well.
Being ready to help other communities starts with a plan and some great partnerships. MRC planners worked for a year to get ready for this event. The planners knew that they would need a lot of volunteers – more than they could get locally. So they reached out to other MRC units throughout the state. A total of 176 MRC volunteers stepped forward to help – at least one volunteer from every MRC unit in Pennsylvania was part of this response.
Even though volunteers came from all over the state and most of them had never met each other before, they came together as a team. Just to get into the city, some people traveled on an eight hour bus ride and met an additional one hour delay when they got into town. They then worked 12 hour shifts and bunked at a local community college. And despite all that hard work, travel and delays, MRC volunteers told me that they were excited. They wanted to serve and they pretty psyched to be part of something bigger.
Despite the people coming from so far away and so many different places, the coordination worked. People had their assignments before they even got to town, so with a few instructions they were ready to get started. They worked together to set up medical tents and get ready to help the people who needed them.
Over the course of the Pope’s visit to Philadelphia, MRC volunteers saw 166 patients. The time that they dedicated helped keep those people healthy and gave their families peace of mind. MRC units also served during Pope’s visit to New York and Washington, DC.
Medical Reserve Corps volunteers come together to make a difference every day. Sometimes, they get people urgently needed medical attention at a major event like the Pope’s visit or they come together to help respond to a disaster. More often, they support everyday health in their communities by staffing vaccination clinics, blood drives and other health events. But their contributions matter to their communities and there is a very good reason that so many MRC volunteers say that they are proud of the ways that they serve their communities.
If you would like to find out more about ways that you can serve as part of the Medical Reserve Corps, find a unit in your area and talk to other volunteers about ways that you can help your community.
To view more images from the Papal Visit to Philadelphia, please visit the MRC facebook page. You can also watch MRC voluteers tell their stories and a Red Cross volunteer talk about their partnership with the MRC during the Papal visit.
A culture of responsibility is fundamental to good stewardship in the life sciences. Without it, we can’t safely study the pathogens that threaten health and develop new or better ways to diagnose, treat or prevent disease. However, research that benefits public health and agriculture may also involve risk. A culture of responsibility and effective oversight for research in the life sciences is important for the protection of health.
This is especially important when dealing with select agents and toxins, agents that have the potential to pose a severe threat to both human and animal health, to plant health, or to animal and plant products. Mishandling select agents and toxins, like the agents that cause anthrax and plague, botulinum neurotoxins, or ricin, pose serious risks to biosafety and biosecurity. Biosafety risks refer to accidental exposure to a pathogen or toxin that could adversely affect lab workers, the general public, plants, animals and/or the environment. Biosecurity risks come from the deliberate use of a pathogen or toxin to cause harm to humans, plants, animals, or the environment. We need to minimize these risks so that we can conduct research safely and securely.
Effective oversight promotes biosafety and biosecurity. A successful biosafety and biosecurity oversight framework should evolve to address new challenges, scientific advances, and social changes. The federal government is working on a number of ongoing initiatives to refine and enhance this oversight framework.
For example, experts from across the federal government recently developed and released two key reports. The first of these is the Recommendations of the Federal Experts Security Advisory Panel (FESAP) and the second is the Fast Track Action Committee Report: Recommendations on Select Agent Regulations Based on Broad Stakeholder Engagement (FTAC-SAR). These reports offer recommendations to enhance biosafety and biosecurity and the government recently developed a plan to implement these recommendations.
The recommendations from both reports cover a variety of topics that aim to support life sciences research and improve biosafety and biosecurity while minimizing the risk involved. Implementation of the FESAP and FTAC-SAR recommendations is expected to
- enhance the culture of responsibility;
- improve oversight;
- enhance outreach and education;
- allow for the support of an applied biosafety research agenda and development of an incident reporting system;
- address material accountability;
- improve inspection processes; and
- support the development of regulatory changes and guidance to improve biosafety and biosecurity.
The FESAP also identified an approach to determine the appropriate number of high-containment U.S. laboratories required to possess, use, or transfer biological select agents and toxins.
By embracing a culture of responsibility and taking actions that enhance biosafety and biosecurity, scientists can more safely conduct critical, lifesaving research and ultimately enhance national health security.
To find out more about the recommendations of these committees and plans for their implementation, check out the Recommendations of the Federal Experts Security Advisory Panel (FESAP) and the Fast Track Action Committee: Recommendations on Select Agent Regulations Based on Broad Stakeholder Engagement (FTAC-SAR). To learn more about biosafety stewardship, check out the S3 website.
Earlier this month I wrote about National Cybersecurity Awareness month and HHS agencies’ collaborative efforts with industry partners to improve the cybersecurity of the Healthcare and Public Health Sector. One of the greatest challenges we face is always chasing a moving target of advancing technology. In order to protect our systems, we have to be able to predict where technology will drive tomorrow’s security concerns. But as the recently departed Yogi Berra would remind us, “It’s tough to make predictions, especially about the future.” With technology changing so fast, how does the federal government keep up?
Across HHS, organizations working to address cybersecurity in healthcare and public health settings are finding that by working closely with the many diverse stakeholders, they can stay on top of emerging trends.
At the Food and Drug Administration, for example, all medical devices are regulated based on risk. Moderate- and high-risk devices are generally evaluated for their safety and effectiveness before they are allowed to be sold to the public. Increasingly, these devices are designed to be wireless, Internet- and network connected, which enables remarkable advances that have the potential to transform patient care. At the same time, this interconnectivity means cybersecurity risks need to be addressed.
The FDA recognizes that collaboration with the private sector is essential to enhancing medical device cybersecurity. Engaging with all of the stakeholders in the medical device ecosystem including security researchers, is an important step toward strengthening medical device cybersecurity. Security or vulnerability researchers are sometimes referred to as “white hat” hackers, a reference to the cliché headgear of “good guy” cowboys in old Western films. They study medical devices and systems, looking for flaws, weaknesses, or vulnerabilities that, if exploited, could cause harm. White hats work with manufacturers, regulators, and other stakeholders to safeguard patient care and privacy without putting patients at risk – by revealing flaws in a controlled setting and reporting them so they can be proactively addressed in both current and future designs. While skilled and persistent adversaries seek to harm, skilled and persistent “white hat” protectors seek to safeguard. Distinguishing between malicious attack by adversaries and good faith effort by security researchers allows medical device manufacturers to discourage the former and derive value from the latter.
For example, when security researcher Billy Rios discovered potential vulnerabilities in a line of infusion pumps, he alerted the manufacturer, the Department of Homeland Security’s cybersecurity response team known as ICS-CERT and the FDA prior to making any public announcement. This allowed FDA experts to analyze the issue and, based on their findings, issue a safety communication to healthcare facilities earlier this year with mitigation strategies and a recommendation that they transition away from using this line of pumps.
According to Dr. Suzanne Schwartz, Associate Director of Science and Strategic Partnerships and Acting Director of Emergency Preparedness and Medical Countermeasures in the FDA’s Center for Devices and Radiological Health, the best outcomes happen when security researchers work with medical device manufacturers and federal partners in a coordinated manner to identify and help address medical device cybersecurity concerns together. The FDA highly values the researchers’ technical expertise and regards their contributions as essential to identifying medical device cybersecurity vulnerabilities, which if exploited, may result in patient harm.
Then there is the HHS Office for Civil Rights (OCR) which enforces the privacy, security, and breach notification provisions of the Health Insurance Portability and Accountability Act (HIPAA). Electronic health records and other forms of health data management systems have been in use by healthcare facilities for a long time, but the landscape is changing. Increasingly providers and patients alike are looking for easy ways to access information on the go through the use of mobile devices. Mobile device technology changes rapidly, so developers face the complex challenge of developing new systems while maintaining strong privacy and security safeguards of patient data.
To help keep these mobile applications secure, OCR launched a new platform this month to assist mobile health developers and others interested in the intersection of health information technology and HIPAA. The new portal allows stakeholders to submit questions about HIPAA, present a use case, or see what their peers are discussing. Users can comment on the discussions and vote on which topics or use cases would be most helpful or important.
OCR staff, in turn, will consider the input provided in the portal as they develop guidance and technical assistance related to the HIPAA Rules. Deven McGraw, Deputy Director of OCR’s Health Information Privacy Division, says that the new portal helps innovators address privacy and security at the best point possible: while applications are being developed. It's always easier to build safeguards in from the beginning than to try to add it to a finished product. Through the portal, OCR wants to demonstrate to developers that we are there to support them in developing products that provide assurance to customers that their information is safe and secure, and will be used and disclosed only as approved or expected.
Working together, HHS and our private sector partners in the Healthcare and Public Health Sector can continue to increase the security of the systems the public depends on to protect their lives, health, and privacy.
Seemingly never ending storms brought historic flooding to South Carolina over the past few weeks, making the Palmetto state the latest one impacted by flooding this year. How quickly and completely such communities across the country recover may depend, at least in part, on how inclusive they are in recovery decision-making and how mindful they are of cultural differences among disaster survivors and impacted groups.
Cultural competency can help emergency managers be as inclusive as possible. Cultural competency is the ability to respond respectfully and effectively to people of all cultures, classes, races, ethnic backgrounds, sexual orientations, and faiths or religions in a manner that recognizes, affirms, and values the worth of individuals, families, tribes, and communities, and protects and preserves the dignity of each.
A key component of cultural competence is being self-aware of potential biases. Some biases are easy to see in yourself, while other biases may be more subtle. If you establish recovery task forces or long-term recovery committees, take a hard look at the structure. Does everyone in the community have a representative involved and does that representative have an active voice in recovery decision-making and planning? Are you drawing them into the discussions? Do task force or committee structures quietly reinforce traditional gender roles or place more weight on representatives of one group more than another (men’s opinions more than women’s, for example)?
Include individuals with access and functional needs, such as people with limited English proficiency, in recovery decision-making. Plan with them instead of planning for them!
Watch for cultural differences and consider how different points of view can be an asset to your planning and the community’s acceptance of that plan. For example, in South Carolina, the Catawba Indian Nation was impacted by flooding. People of this federally recognized tribe have lived along the banks of the Catawba River for generations. Tribal communities may have social norms and communication styles distinct from the sometimes rushed culture of emergency management.
To manage the dynamics of cultural differences better, build rapport with disaster survivors and encourage health and social services providers with established community relationships to be proactive in seeking disaster assistance.
How much do you really know the community? The more you know, the more you can help with recovery. Did you know that many Hindus call South Carolina home? Did you know that South Carolina is home to Gullah (Sea Island Creole English) speakers, a language spoken by descendants of enslaved Africans who have preserved much of their linguistic and cultural heritage? Every state has unique cultural facets and traditions that should be respected in disaster recovery operations.
To be truly successful, recovery planning and activities should be adapted to fit the culture of the whole community. Emergency managers should avoid forcing a one-sized fits all recovery approach across the state. South Carolina, for example, has 46 home rule counties with established systems and networks to consider in recovery.
Like many states, South Carolina is home to urban, rural, and agricultural communities. Richland County, South Carolina, is home to approximately 400 farms and more than 60,000 acres of farmland used to produce grain, oilseeds, dry beans, dry peas, cotton and cottonseed, vegetables, other crops and hay.
The diverse needs of urban and rural communities will be need to be included for the state to fully recover.
Not sure where to start? The HHS Office of Minority Health’s Think Cultural Health initiative provides resources pertinent to emergency management and the provision of culturally and linguistically appropriate services.
What is your community doing to incorporate cultural differences into health emergency planning and recovery decisions?
The Internet touches almost all aspects of everyone’s daily life, whether we realize it or not. With a world that’s more connected than ever, cybersecurity matters whether you’re with a government agency or a private company.
Alarmingly, criminal cyberattacks against healthcare organizations are up 125 percent compared to five years ago, replacing lost laptops as the top cause of breaches, according to the Ponemon Institute’s Fifth Annual Benchmark Study on Privacy and Security of Healthcare Data. The survey also showed that the average consolidated total cost of a data breach was $3.8 million, a 23 percent increase from 2013.
What can we do about it? Some very basic best practices can make a significant difference in protecting businesses and government agencies (and your home computer system). These basic best practices – like keeping software patches and antivirus definitions up-to-date, training users to spot e-mail phishing attempts, and making use of a variety of strong passwords for on-line accounts – can be done by the smallest organizations and even at home so you can stay protected and connected. For more tips, check out this helpful list from www.healthit.gov, as well as these cybersecurity games.
To combat cyberattacks at a healthcare system level, public and private organizations have to work together and share information about cyber threats and best practices in cybersecurity. In a study this year by the Healthcare Information Management Systems Society, a majority of respondents said that information sharing was beneficial to their organizations, and 60 percent cited peers as sources of cyber threat information.
To identify the cybersecurity information needs and gaps of hospitals and other healthcare organizations across the country, ASPR has engaged one of the most wired health care systems in the country, the Harris Health System in and around Houston, Texas.
Over the next year, Harris Health experts not only will identify needs and gaps but also will propose a strategy for enhancing the sharing of cybersecurity information among the federal government and private sector partners to better protect the critical cyber infrastructure of the nation’s health care system. This activity is aligned with HHS’s commitment to support, promote, and enhance the information sharing capability of the healthcare and public health sector, as called for in the Nationwide Interoperability Roadmap recently released by HHS’s Office of the National Coordinator for Health Information Technology.
HHS currently shares information on cyber security threats with state and local agencies and private industry through the Homeland Security Information Network. Health sector CIOs and CISOs with a need to know cybersecurity information, can contact email@example.com to learn more.
HHS has also formed a cybersecurity working group for companies and agencies in health care and public health. Chief Information Officers and Chief Information Security Officers in the healthcare and public health sector – government agencies, hospitals, healthcare organizations, nursing homes, dialysis providers, insurers, biopharmaceutical companies, medical device manufacturers, health IT developers, and more – are welcome to join the working group.
Participants will discuss how the sector can enhance cybersecurity information sharing, manage cyber risks, and apply the Cybersecurity Framework (the national standard for cybersecurity across all economic sectors) to the diverse organizations that make up the healthcare and public health sector . Encourage your CIO or CISO to contact firstname.lastname@example.org to learn more. ASPR and other HHS agencies are conducting internal planning, too, on how to respond best to cyber incidents and are developing resources to help private sector partners to protect their systems. Check out phe.gov/cip for the latest guidance, guides and checklists.
Can a federal agency engage in long-term strategic partnerships with business? Yes.
ASPR’s Biomedical Advanced Research and Development Authority (BARDA), for instance, is pioneering an innovative approach to collaboration that uses Other Transaction Authority (OTA for short) to create flexible business partnerships between government and industry. Partnerships formed under OTA allow both parties to invest in the development of a portfolio of products for biodefense and to combat the growing public health threat of antibiotic resistance. This approach allows the partners to operate strategically and to proceed even in cases where antibacterial drug candidates fall out during the development process.
The ability of government to enter into such relationships with industry comes at a critical time in the practice of medicine. With the incidence of antibiotic resistance rising, once treatable infections are becoming untreatable and threatening routine medical procedures which depend on available and effective antibiotics.
The CDC estimated that in the U.S alone, antibiotic resistant bacteria are responsible for two million infections and 23,000 deaths annually with an estimated annual economic burden of $35 billion on the healthcare system.
At the same time, the pace of new antibiotic drug development has slowed. Many pharmaceutical companies have been withdrawing from antibacterial R&D due to the significant scientific and commercial market challenges leading to a lower return on investment than in many other therapeutic areas.
With the recent focus on antimicrobial resistance, we’re seeing increased interest from industry in partnering with the government to develop new medical countermeasures – vaccines, drugs, diagnostics and other medical products for emergencies. HHS’ Other Transaction Authority allows for the creation of a strategic alliance between government and industry in which the cost and risk are shared between the two.
For companies large enough to have drug portfolios, this kind of alliance with BARDA could offer:
- Flexible portfolio-based funding: The successful development of new antibacterials is a significant business risk; some estimates are that 16 promising antibiotic drug candidates enter clinical development for every drug product that gets approved. With agreements under OTA, the partners share the cost of developing a portfolio of products and jointly decide to move candidates into and out of the portfolio based on product performance, technical risk, and programmatic need. This approach increases the probability of bringing urgently needed new antibacterials to market.
In contrast, asset-specific funding – for example a traditional government contract to develop a single drug – lacks the flexibility needed to reposition funds when a drug candidate fails or when public health priorities change.
Both of BARDA’s OTA partners, GlaxoSmithKline and AstraZeneca, have portfolios of potential candidates under development that meet the dual needs of biodefense and antimicrobial resistance. The portfolio approach is a fundamental difference between an agreement and a traditional government contract – and an advantage.
- Consortia: Agreements under OTA allow the company and the government to enter into consortia with multiple industry partners. Through consortia, the companies can identify antibacterial candidates in development by other companies that could be brought in to the portfolio through in-licensing, co-development or alliances with other companies. The probability is high that antibacterial candidates would enter the portfolio this way.
- Time & cost savings: Agreements under OTA also allow the government and its industry partner to decide jointly to replace an underperforming candidate in the portfolio with a promising new candidate. This flexibility results in a significant time, effort and cost savings to both partners.
In contrast, a traditional federal contract often requires significant costs and time to modify or close-out if the government terminates a contract (for example, due to product failure) and then award a new contract to develop a new promising drug candidate.
- Cost Sharing: The industry cost to bring a single medical product to the market can exceed hundreds of millions dollars. With agreements under OTA, BARDA can provide steady, non-dilutive funding over multiple years. For example in this week’s agreement with AstraZeneca, BARDA could provide up to $170 million over five years and the company agrees to cover the remaining costs to develop the drugs in the portfolio.
When licensed, the new antibiotics will become available on the commercial market which means not only a return on investment for the company but also a lower long-term cost for taxpayers since less or none of the product would need to be stockpiled by the government.
- True collaboration: With agreements under OTA, both partners are represented on joint scientific or technical oversight committees. BARDA brings insight about the nation’s biodefense and public health needs and ensures that there is a sound public health rationale for portfolio decisions. The joint oversight committee meets regularly to monitor the progress of each product in the portfolio. The committee endorses potential new projects, agrees on how funding should be allocated, and evaluates overall performance.
There’s quite a bit of support behind this approach. The 2015 President’s National Action Plan for Combating Antibiotic-Resistant Bacteria called for forming public-private partnerships with pharmaceutical and biotechnology companies to advance the development of antibiotics through a portfolio approach. This plan specifically called on BARDA to create at least one additional portfolio partnership with a pharmaceutical or biotechnology company by March 2016.
Although we’ve met the 2015 President’s National Action Plan for Combating Antibiotic-Resistant Bacteria goal of forming public-private partnerships with industry with the new AstraZeneca agreement, we’re always looking for solid partners.
Other federal plans call for innovative approaches for partnering with industry, too, including the strategic plan from the Public Health Emergency Medical Countermeasure Enterprise (a coordinating body with members from BARDA, NIH, DoD, VA, FDA, and CDC), the National Health Security Strategy and the BARDA Strategic Plan.
That’s because partnerships – whether they’re under OTA or other cost-sharing agreements – reduce the risk and burden for everyone in developing the broad spectrum antimicrobials urgently needed to counter antibiotic resistance.
Forming public-private partnerships under OTA is a unique way to ensure that the public has, and will continue to have, treatment options for biodefense and to combat the growing threat of multi-drug resistant bacterial infections.