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September 03
Expecting the Unexpected

Authors: Karen B. DeSalvo, M.D., M.P.H., M.Sc., National Coordinator for Health Information Technology, U.S. Department of Health and Human Services and Gregg S. Margolis, Ph.D., NRP, Director, Division of Health System Policy, U.S. Department of Health and Human Services

The question isn’t whether or not we will have another disaster – it is just a matter of when, where and how severe it will be. The recent earthquake in Northern California, centered near Napa, serves as a reminder that we must be prepared for the unexpected no matter where we live.

Northern California’s largest quake since 1989 happened in a large state where ONC has been working for the past year to ensure health data access every day and especially during disasters. In fact, in April of this year, we issued an assessment on available opportunities to address potential disasters in California and along the Gulf Coast.

Based on those assessments and our expectations of a catastrophic event in California, ONC started working with state emergency medical services officials last year to begin connecting the state’s 35 health information exchange organizations (HIEs) and EMS organizations. This effort was launched to help ensure health data access during emergencies.

The program currently focuses on a pilot project in Orange, San Diego and Riverside counties because of the robust HIE services that exist in these areas, coupled with the fact that tens of millions of people live in these parts of Southern California. However, the Northern California earthquake reminds us that there is much work to do, and it must happen faster statewide and nationwide. We simply cannot make assumptions about how best to prepare for emergencies. In recognition of the importance of this initiative, the HHS Idea Lab chose a joint ONC/ASPR proposal for the inaugural HHS Ventures Program. The team has been actively engaged on this project as well as other ways technology can improve the routine delivery of care as well as disaster response – all in an effort to create more resilient communities.

In late July this year, the White House hosted the Innovation for Disaster Response and Recovery Initiative Demo-Day, an event which brought together hundreds of technologists, entrepreneurs, and members of the disaster response community to showcase tools that will make a tangible impact on the lives of survivors in large-scale emergencies. The Demo-Day was part of a larger initiative, a public-private and government-wide effort to find the most effective ways technology can empower first responders and survivors.

At the Demo-Day, HHS announced two new initiatives:

  • is an ASPR-sponsored website that gathers data from Twitter to help provide insight to local and state health departments and public health emergency entities on emerging trends in health and disasters. The data presented on this site is used to indicate potential health issues emerging in a population; build a baseline of Twitter trend data; engage the public on trending health or disaster topics; or to cross-reference other data sources.
  • The HHS At-Risk Resiliency Interactive Map is an open data map that is being co-sponsored by ASPR and the Centers for Medicare and Medicaid Services (CMS) to show the number of electricity-dependent Medicare beneficiaries at the U.S. territory, state, county, and zip code level. The map also will use NOAA real-time weather-tracking capabilities to identify areas that may be impacted by severe weather and at risk for prolonged power outages. This interactive map is under development and anticipated to launch soon on

Technology and health information technology have the power to inform and help survivors, first responders, and local, state, tribal, territorial and federal governments with critical information and resources related to an emergency. The projects outlined above are just a few examples of the many ways we are working towards the goal of better preparing and supporting communities and survivors before, during and following a disaster.

August 11
Get Ready to Respond.  Get Vaccinated.
Capt. Tim Davis, M.D., Chief Medical Officer, National Disaster Medical System

I love vaccines. I’ll just admit that up front. As an emergency responder, a military member, a doctor, and a dad, I’ve seen the value of vaccines. There are plenty of things to worry about in a disaster, including any number of vaccine-preventable diseases disaster responders can be exposed to while doing our jobs. The same is true for doctors and other healthcare providers. And dads, too, for that matter! Getting sick doesn’t have to be one of them.

Staying up-to-date on vaccinations means we’re less likely to get sick and less likely to spread illness between our co-workers, patients, family, and members of the community. And it means we’ll be ready when our community and our families need us.

There are only a few immunizations most adults in the United States need: the tetanus/diphtheria/pertussis vaccination every 10 years and a seasonal flu vaccine every year. So staying current is pretty easy. Depending on your age and health, there may be other vaccinations that would be helpful in protecting your health. Check the CDC website for general recommendations and – most importantly – talk to your doctor.

OSHA, CDC and the National Advisory Committee on Immunization Practices also recommend a Hepatitis B vaccination for health care workers who could be exposed to body fluids but aren’t already immunized against Hepatitis B (either you’ve recovered from Hepatitis B or you’ve received the vaccination in the past).

In fact, employers are required by law to provide Hepatitis B vaccine (HBV) at no cost to their full or part-time if the employees plausibly could be exposed to body fluids and are not immunized to Hepatitis B.

Military members and other people who work overseas may need additional immunizations to protect their health. If, like me, you’re in this group, talk with your doctor about what’s appropriate for where you’ll be stationed.

Remember, vaccines drive your body to make antibodies to protect you against the virus or bacteria, and that can put a drag on your body’s energy. But feeling tired, sluggish or a little sore afterward is well worth the long-term benefits, especially for emergency responders and healthcare workers. (And parents, of course!)

Think about it like this: if your body hasn’t built up immunity (by already recovering from the virus or bacteria or by getting vaccinated), and you get exposed to a vaccine-preventable disease, the circumstances must be perfect to keep you from serious illness, death, or spreading the virus or bacteria to your family, co-workers and the people you’re responsible for protecting in your community. These circumstances aren’t always present after disasters.

Those perfect circumstances are:

  1. you must recognize that you’re sick;
  2. you must have access to competent medical care;
  3. that competent healthcare provider must recognize the disease, and sometime have access to diagnostic tests;
  4. that provider must have access to comprehensive treatments;
  5. those treatments must be genuine (not counterfeit), not expired, and maintained in an appropriate environment from manufacturer to the healthcare provider; and
  6. the treatments have to be dispensed or administered in a sterile and hygienic process.

You can risk getting sick and hope those six perfect circumstances happen to occur – or you can just get a shot in advance and live healthier. Plus you’ll have the peace of mind that in a disaster you can focus what you need to be focusing on – like recovering from the incident instead of recovering from illness.

August is National Immunization Month, so it’s a perfect time to check your online electronic health record or your doctor’s records to be sure you’re up to date on your vaccinations and ready to respond when disaster strikes.

August 01
Addressing access and functional needs can improve your whole community's resilience
Authors:  Cheryl A. Levine, Ph.D., Team Lead for At-Risk Individuals, Division for At-Risk Individuals, Behavioral Health, and Community Resilience (ABC) Office of the Assistant Secretary for Preparedness and Response (ASPR) and Tehmina Mall, Graduate Intern in the Division for At-Risk Individuals, Behavioral Health, and Community Resilience (ABC), MPH Candidate 2015, Columbia Mailman School of Public Health

To build resilient communities, we need to make sure that the entire community can withstand disaster and bounce back quickly. We can make a great stride toward resilience and health security by ensuring that emergency plans for hospitals, emergency responders, healthcare providers and government agencies meet the needs of the entire community, including people with access and functional needs, when disaster strikes.

About 20 percent of Americans live with some kind of disability. During disasters, many may require specialized care or different approaches to help them stay safe and healthy. Yet just because a person has a disability doesn't mean they automatically will need help from emergency responders. So in planning for emergencies, we need to consider access and functional needs.

So, what are access and functional needs how can we meet these needs?

Addressing access-based needs means community resources are easy to access by everyone in the community - all of the social services, accommodations, information, transportation, and disaster-related medications. Function-based needs are a person's basic needs - eating, dressing, mobility, and so on. To learn more, check ASPR’s Guidance on Integrating People with Access and Functional Needs into Disaster Preparedness Planning for States and Local Governments.

ASPR provides resources emphasizing the access and functional needs of children and older adults which, in collaboration with other relevant federal agencies, emphasize cross-cutting approaches to disaster preparedness planning for those with access and functional needs.

One of those tools is a cross-cutting framework called CMIST. CMIST highlights the specific areas of communication, maintaining health, independence, services, support, self-determination, and transportation to help communities plan for the needs of community members with access and functional needs.

This framework has been used successfully by communities across the country. State agencies in Kentucky and Massachusetts, for example, used the framework to integrate access to communication during disasters and emergencies. To learn how these states effectively used CMIST, check out the Emergency Management and Preparedness: Inclusion of Persons with Disabilities Webinar Series.

By using emergency planning frameworks and resources that integrate access and functional needs, we can build a social connectedness and bolster health security for everyone. Addressing access and functional needs may be hard to do during a disaster, so planning now is critical to protecting health and safety during an emergency.

July 14
A Pathway to Improving Community Resilience
Authors: CDR Jyl C. Woolfolk, MPH, CHES, Senior Policy Analyst, Office of Policy and Planning, HHS Office of the Assistant Secretary for Preparedness and Response and Darrin Donato, Senior Policy Analyst, Division for At-Risk Individuals, Behavioral Health, and Community Resilience, Office of Policy and Planning, HHS Office of the Assistant Secretary for Preparedness and Response

We all hope our communities will be resilient in the face of the many threats to health that strike during a disaster or emergency. But what exactly is resilience? Resilience is the ability to withstand and recover from adversity. Disaster resilience involves all the things that individuals can do to make themselves more prepared for disaster—like making a disaster kit and having a plan—and it also includes the things we can do together to make our communities stronger every day. This sense of individual and collective effort in service of the good of the community is a core principle of our nation. Our communities today are facing a number of threats. We know about the risks of natural disasters, and the damage that can be wrought by hurricanes, floods, and wildfires. But there are other threats to our communities’ health and well-being like chronic disease, poverty, and violence. A resilience approach helps us face the risks of major events like disasters, as well as the day-to-day challenges that are part of the life of any community.

Resilient communities take disaster preparedness seriously. As part of that approach, they strive to foster healthy individuals and families with access to health care, both physical and psychological. These communities work to equip people with the knowledge and resources to care for themselves and others in both routine and emergency situations. Resilient communities know the importance of social connectedness and they understand that that connected and engaged people and groups can work together to help their community resist disaster and recovery faster.

To affirm its commitment to community resilience and to improving the nation's ability to respond to and recover from major public health emergencies, the U.S. Department of Health and Human Services (HHS) asked the National Preparedness and Response Science Board (NPRSB) to examine the issue of resilience and offer recommendations. The NPRSB is an independent scientific body comprised of leading experts and stakeholders in disaster management, community health, and other related fields.

In its Community Health Resilience Report, the NPRSB provided recommendations to the HHS Secretary regarding Departmental actions that can build and sustain community health resilience and help communities better prepare, withstand, and recover from disasters and public health emergencies. These recommendations provide insight into the conceptual framework surrounding community resilience; outreach and communication; technical assistance; policy alignment; and the research agenda.

To learn about the NPRSB’s findings on actionable steps that can help improve our nation’s resilience, please read the Community Health Resilience Report. Please share your feedback on the board’s findings in a comment to this blog post.

July 09
Using innovative business models to enhance antibiotic development
Authors:  Joe Larsen, Acting Deputy Director, Division of CBRN Countermeasures, Biomedical Advanced Research and Development Authority (BARDA), Office of Assistant Secretary for Preparedness and Response (ASPR) and Tyler Merkeley, M.S. MBA, Broad Spectrum Antimicrobials (BSA) Program, Division of CBRN Countermeasures, Biomedical Advanced Research and Development Authority, Office of Assistant Secretary for Preparedness and Response

At BARDA, we want to revitalize the antibiotic pipeline. To do it, we’re pursuing an innovative business model and providing incentives for pharmaceutical and biotechnology companies to invest in antibiotic development.

BARDA has successfully established public-private partnerships with industry partners for the development of novel antibiotics and anticipates a long term commitment to this market.

BARDA has seen the companies we partner with raise additional funding in private markets, become more attractive assets for acquisition by larger pharmaceutical companies, enter into co-development agreements, and/or move forward with Initial Public Offerings (IPO). This additional funding can provide critical capital to support expensive Phase III clinical studies. While there are factors that impact each business decision our partners have made, it is clear that those that have partnered with BARDA have continued to accomplish important technical and business milestones. Securing technical guidance and financial resources through a BARDA partnership reduces the risk of drug development, freeing up additional resources to help companies grow and diversify.

We strive to be a collaborator and, as a result of our direct involvement, to mitigate regulatory uncertainty in developing antibiotics and other drugs, vaccines, and diagnostics.

In May 2013, BARDA entered into a unique strategic alliance with GlaxoSmithKline to launch a Portfolio Partnership. This Portfolio Partnership is a five-year, $200 million agreement formed under the Other Transactional Authority (OTA) granted to HHS by the Pandemic and All Hazards Preparedness Act of 2006. Partnerships formed using OTA aren’t traditional government contracts and allow for more flexible partnering arrangements.

In this case, instead of focusing the partnership on a single antibiotic candidate, this partnership supports an entire portfolio of candidate antibiotic therapies. The benefit of basing the partnership on a portfolio of candidates is that the partnership doesn’t end if a particular product fails in clinical trials. BARDA’s agreement with GSK possesses three central tenets: 1) flexibility in technical scope, 2) cost sharing, and 3) joint strategic oversight. This type of flexible, long-term partnership sends a strong signal of commitment to industry.

Currently under the Broad Spectrum Antimicrobial programs, our partners receive reimbursement for drug development activities in real time. This approach contrasts with that of models such as advanced market commitments, where reimbursement is provided only after the purchase of product, and milestone or prize payments, where awards are provided upon advancing a candidate antibiotic to predefined endpoints.

The near real-time direct reimbursement for drug development activities is a preferred structure for products in advanced development prior to approval. The “non-dilutive” funding provided by BARDA to support development activities does not need to be repaid and does not dilute shareholder’s equity. Further, the funding can favorably impact the net present value calculation of our partners when considering whether to undertake antibiotic development projects by reducing their upfront costs.

The rapid growth of the Broad Spectrum Antimicrobial program – from one partnership in August 2010 to six partnerships today, with three progressing in Phase III clinical development – speaks to the success of BARDA’s model.

This post is the fourth part in our series Combatting Antibiotic Resistance. Next week, our blog post wll be on the ways individuals, organizations and industry can do their part to responds to the threat of antibiotic resistance. To stay up to date as new blog posts are published, subscribe to the ASPR Blog on RSS, follow @PHEgov on Twitter or Like us on Facebook

June 24
BARDA Broad Spectrum Antimicrobials (BSA) program
Author: Tyler Merkeley, M.S. MBA, Broad Spectrum Antimicrobials (BSA) Program, Division of CBRN Countermeasures , Biomedical Advanced Research and Development Authority (BARDA), Office of Assistant Secretary for Preparedness and Response (ASPR)

Combating antibiotic resistance requires new, better antibacterial drugs. BARDA is taking a unique partnership approach to engage industry in antibiotic development in an effort to combat the rise in antibiotic resistance.

BARDA established a Broad Spectrum Antimicrobials (BSA) Program in April 2010 to develop novel antibacterial and antiviral drugs to treat or prevent diseases caused by biological threats. ASPR and BARDA leadership recognized that new antibiotics are needed immediately to address the increasingly prevalent public health threat of antibiotic resistance, as well as the likelihood that antibiotic resistance will complicate the response to a public health emergency.

The BSA program provides non-dilutive funding to support product development and augments our partners existing capital raised from their investors. For laypeople, this means that BARDA provides funding companies can count on and can add to their own funding to develop a drug. If the drug is approved by the FDA, the company can sell it on the commercial market to treat antibiotic resistant infections. The approved antibiotic would then also be available during a public health emergency, if needed.

BARDA continues to establish public-private partnerships with industry to develop novel antibiotics, and we anticipate a long-term commitment to this market. Through these partnerships, we support concurrent development of candidate products for biodefense and commercial indications based on strategic and funding priorities outlined in our Broad Agency Announcement (BAA).

This strategy helps ensure that novel antibiotics progress through the development pipeline to approval for public health and commercial indications. The approach also increases the likelihood that novel antibiotics will be added to the arsenal of possible treatments available to antibiotic resistant infections. Approval of a drug for a commercial indication also helps establish a human safety database and a warm-base manufacturing capability for the drug should it be needed in a biothreat emergency. 

By engaging with BARDA, our industry partners are able to receive funding and expert technical advice from BARDA for clinical studies (Phase 1-3), manufacturing, and regulatory activities. Industry partners are encouraged to visit the BARDA BAA and sign up for a TechWatch meeting with BARDA and other U.S. Government subject matter experts. 

Chart:  Product Pipeline Supported by the  BARDA Broad Spectrum Antimicrobials Program.  The chart shows the sponsor,   compound and phases of development.  Plazomicin TM  (ACHN-490) is sponsored by Achaogen.  It is a next-generation aminoglycoside to treat Broad Spectrum  Plague, Tularemia and carbapenem resistant Enterobacteriaceae (CRE) that is being sponsored through Phase 2.  Eravacycline TM  (TP-434) is sponsored by CUBRC/Tetraphase.  It is A novel fully synthetic tetracycline to treat Broad   Spectrum Plague, Tularemia  and Multi-drug resistant (MDR) infections (cIAI) that is being sponsored through Phase 2.  Solithromycin TM (CEM-101) is sponsored by Cempra.  It is a Next-generation fluoroketolide to treat Broad Spectrum threats (Anthrax, Tularemia  and community-acquired bacterial pneumonia (CABP)) that is being sponsored through Phase 2 BAL30072 is being sponsored by Basilea.  It is a A novel sulfactam to treat Broad Spectrum (MDR Gram negative infections)   that is being sponsoered through Phase 1.

In just four years our Broad Spectrum Antimicrobials program, has funded six partnerships through the BARDA BAA and we anticipate funding additional programs using this mechanism in the future.

  • In August 2010, BARDA entered into a public-private partnership with Achaogen, Inc. for the development of a drug called Plazomicin™. This novel, next-generation aminoglycoside antibiotic is being developed to treat plague and tularemia (known bioterrorism threats) as well as infections caused by carbapenem resistant Enterobacteriaceae (CRE) – which CDC Director Tom Frieden called a “nightmare bacteria”. We’re supporting a Phase 3 study of efficacy against blood stream and pneumonia caused by CRE.
  • In January 2012, BARDA entered into a public-private partnership with CUBRC, Inc. in partnership with Tetraphase Pharmaceuticals, Inc. for the development of eravacycline, a novel antibiotic of the tetracycline class. BARDA funding will support studies evaluating the effectiveness [efficacy] of eravacycline against biothreat pathogens as well as Phase I clinical trials to assess eravacycline safety, clinical pharmacology studies, and drug manufacturing. The BARDA contract supports development of oral and intravenous formulations of eravacycline.
  • In May 2013, BARDA entered into a public-private partnership with Cempra, Inc. for development of a novel fluoroketolide antibiotic, solithromycin for the treatment of anthrax and tularemia infections. BARDA is also supporting the development of a liquid version of the drug for children. Cempra also is developing solithromycin as a commercial indication for the treatment of community acquired bacterial pneumonia (CABP) and gonorrhea.
  • In May 2013, BARDA entered into an Other Transactional Agreement with GlaxoSmithKline (GSK) to support the advanced research and development of a portfolio of novel antibiotic candidates. The Pandemic and All Hazards Preparedness Act in 2006 gave HHS the authority to enter into Other Transactional Agreements and the one with GSK was the first ever awarded by HHS. The agreement is flexible, so that antibiotic candidates can move in or out of the portfolio based on their stage and feasibility. This approach balances risk for the federal government and GSK. At the same time, the approach supports development of multiple drugs simultaneously, increasing the likelihood that one or more will succeed in achieving approval by the U.S. Food and Drug Administration.
  • In June 2013, BARDA entered into a public-private partnership with Basilea Pharmaceutica Ltd for the development of BAL30072, a unique monosulfactam antibiotic that could treat a broad range of multidrug-resistant Gram-negative bacteria [including species of Pseudomonas, Acinetobacter, and Klebsiellathat are of great clinical concern]. The new antibiotic also looks promising as a treatment against biothreats like melioidosis and glanders for which there are no currently approved drugs. Under this project, Basilea will conduct clinical and non-clinical studies to evaluate the safety and efficacy of BAL30072. If approved, the new drug would provide doctors with new treatment options for severe and life threatening infections, including hospital-acquired pneumonia and complicated urinary tract infections, as well as for glanders and melioidosis.
  • In February 2014, BARDA entered into a public-private partnership with Rempex Pharmaceuticals, a wholly owned subsidiary of The Medicines Company, to support the advanced research and development of a novel drug called Carbavance™, a novel carbapenem/β-lactamase inhibitor combination. During this potential five-year partnership, Rempex will develop Carbavance™ for the treatment of complicated urinary tract infections, hospital-acquired and ventilator-associated pneumonia, and infections known or suspected to be caused by carbapenem-resistant Enterobacteriaceae (CRE). BARDA will provide funding for clinical, nonclinical, manufacturing and regulatory activities to support the commercial indications of the drug. In addition, BARDA will fund the assessment of Carbavance as a treatment for melioidosis and glanders.

This post is the third part in our series Combatting Antibiotic Resistance. Next week, our blog post will focus on the specific incentives BARDA is using under the BSA program to revitalize the antibiotic pipeline and engage industryTo stay up to date as new blog posts are published, subscribe to the ASPR Blog on RSS, follow @PHEgov on Twitter or Like us on Facebook

June 16
How is BARDA positioned to respond to the threat?
Author: Tyler Merkeley, M.S. MBA, Broad Spectrum Antimicrobials (BSA) Program, Division of CBRN Countermeasures , Biomedical Advanced Research and Development Authority (BARDA), Office of Assistant Secretary for Preparedness and Response (ASPR)

In drug development, there are many different kinds of market and business challenges. When those challenges place our nation’s health security at risk, the U.S. government must step up with critical leadership as well as financial and technical support to counter the forces that prevent the development of desired drugs such as antibiotics. Enter: BARDA.

At BARDA, we spur innovation, support development of medical countermeasures (which include drugs, vaccines, and diagnostics) to enhance national preparedness for chemical, biological, radiological, and nuclear (CBRN) threats, pandemic influenza, and emerging infectious diseases, and in some cases purchase such countermeasures for the Strategic National Stockpile. We have also partnered with industry to enhance our manufacturing infrastructure to produce needed medical countermeasures rapidly in the event of an emergency.

There is no market other than the government for medical countermeasures against threats such as anthrax and smallpox and the Pandemic and All Hazards Preparedness Act (PAHPA) of 2006 created BARDA to address the resulting gaps in medical countermeasure development. Drawing on authorities granted in PAHPA, the 2013 reauthorization of PAHPA (PAHPRA), and in the Project BioShield Act of 2004, BARDA addresses market and business challenges associated with the development of medical countermeasures for CBRN threats and pandemic influenza.

BARDA provides our industry collaborators with advanced research and development funding, a set of core services to facilitate development and manufacturing, and technical expertise to grow a portfolio of medical countermeasures. The government investment managed by BARDA has delivered significant results in recent years.

  • BARDA’s CBRN and pandemic influenza portfolio currently spans more than 150 medical countermeasures.
  • BARDA’s CBRN Division has added twelve new CBRN medical countermeasures to the Strategic National Stockpile to prepare our country to respond to a biological threat like smallpox or anthrax.
  • BARDA’s Influenza Division has supported the development of several first-in-class vaccines licensed in the U.S., established and maintains a stockpile of vaccines against influenza strains with pandemic potential, and supports the advanced development of novel influenza antiviral drugs, point of care diagnostics and next-generation ventilators.
  • Across the CBRN and pandemic influenza portfolio BARDA has provided funding to support the approval/licensure/clearance of 7 new products in the last two years.

BARDA has been successful to date in partnering with industry to address challenges in CBRN and influenza medical countermeasure development because we bring critical and unique resources to the partnership, such as congressional authorization and dedicated funding, flexible appropriations, innovative partnership mechanisms, and a clear mandate.

The progress achieved by our industry partnerships demonstrates that with the right leadership, strategies and appropriate targeted incentives the government can provide a successful response to challenges in the pharmaceutical market.

As described in CDC’s report Antibiotic Resistance Threats in the United States, 2013, our nation is challenged with the growing threat of antibiotic resistance while the antibiotic pipeline responsible for developing new antibiotics has been decreasing over the last 30 years.

Figure:  The Antibiotic Development Gap

Timeline showing antibiotics mapped across decades in the 20th century.  1930s:  Sulfonamides.  1940s:  Beta-lactams, aminoglycodides. 1950: Streptogramins, Quinolones, Lincosamides.  Box pointing to the 1950's section that says "No New Classes to Treat Gram Negative Bacilli for 4 decades".  1970s:  Trimethoprim.  2000:  Oxazolidinones, Lipopeptides.

There are many reasons we face this dire situation. Antibiotics are costly to develop, but provide a limited return on investment. Companies have shifted their focus to medicines that are used to treat chronic diseases (e.g. cardiovascular, diabetes, depression) over many years, since these medicines will bring larger and more reliable returns than antimicrobials, which are taken for much shorter periods and may lose their effectiveness as resistance rates increase. Simultaneously, as antibiotic resistance rates have risen, there has been greater pressure on healthcare providers to limit the use of new antibiotics and only prescribe/use these lifesaving drugs when truly needed. Antibiotic stewardship programs, while necessary to limit the emergence of resistance, further weaken the business case for continuing antibacterial development.

These negative market factors have been building and, today, the world is at a critical point. The number of new antibiotics coming to market has declined steadily for decades because of these technical and business challenges at the same time we are experiencing a surge in antibiotic resistance worldwide.

BARDA is working hard to reverse this decline. In 2010, BARDA established a Broad Spectrum Antimicrobials (BSA) Program to focus on developing novel antibiotics to address biological threats as well as the public health threat of antibiotic resistance. In four years, the BARDA program has grown from supporting one industry partnership with an antibiotic candidate in Phase 2 development to six partnerships with three of our industry partners in Phase 3 clinical development.

Reversing the decline in antibacterial drug development will require a response similar to the one BARDA and the rest of the U.S. government used to overcome the CBRN and influenza market failures. Dedicated funding for antibiotic development, flexible appropriations, continued ability to enter into innovative partnerships, and a clear mandate will ensure BARDA can help our nation combat these threats.

If we are to overcome the threat of antibiotic resistance, then the nation must respond with similar determination, conviction and resources as we have with other market challenges. At BARDA we are ready to respond to this evolving threat and we’ll need the assistance of individuals, organizations and industry.

This post is the second part in our series Combatting Antibiotic Resistance. To stay up to date as new blog posts are published, subscribe to the ASPR Blog on RSS, follow @PHEgov on Twitter or Like us on Facebook

June 10
What is Antibiotic Resistance and Why is it a Problem?
Author: Tyler Merkeley, M.S. MBA, Broad Spectrum Antimicrobials (BSA) Program, Division of CBRN Countermeasures , Biomedical Advanced Research and Development Authority (BARDA), Office of Assistant Secretary for Preparedness and Response (ASPR)

Antibiotics are drugs that are used to treat bacterial infections. They work by killing or slowing the growth of bacteria. (Antibiotics have no effect on viruses or fungi. Drugs used to treat viral and fungal infections are referred to as antiviral and antifungal medications, respectively.).

Antibiotics are frequently prescribed by health practitioners to treat common infections in both out-patient and hospital settings. Unfortunately, bacteria have the ability to change or evolve so that they no longer respond to the antibiotic (in other words become antibiotic resistant) and, as a result, the drug becomes useless in treating the infection.
Screenshot of video embed for PBS Hunting the Nightmare Bacteria
Antibiotic resistant bacteria have caused infections across the country and across the globe. The number of these infections is increasing and the number of antibiotics that some bacteria are resistant to is also increasing to the point where some infections have been caused by bacteria that are resistant to every available antibiotic.

Antibiotic resistance will have a profound impact on the standard practice of medicine. Imagine a day when a simple cut on your hand or a basic cough leads to a life-threatening infection and your doctors have few or no antibiotics to treat your infection. Effective antibiotics are crucial to the practice of modern medicine. Without effective antibiotics, minor operations, cancer treatment, and many other medical treatments would be associated with much greater risk of dying due to infections that can no longer be treated. In addition, antibiotic resistance has the potential to complicate the response to public health emergencies such as hurricanes, earthquakes or influenza pandemics. Unfortunately, because of economic factors, very few pharmaceutical companies have active antibiotic development programs and the number of drugs in the development pipeline has declined sharply in recent decades.

The Centers for Disease Control and Prevention (CDC) released a report last year entitled, Antimicrobial Resistance Threats in the United States 2013, which reported that antibiotic resistant infections infect 2 million patients per year in the United States and cause 23,000 deaths annually. The economic impact of these infections is currently estimated at $20-35 billion annually and may climb higher as rates of antibiotic resistant infections increase. The report ranks the public health threat that specific drug resistant pathogens pose and classifies these threats, from highest to lowest threat, as “Urgent”, “Serious”, or “Concerning”. 

Urgent Threats

Source: Ranking and estimates provided from the CDC Report: Antimicrobial Resistance Threats in the United States 2013

Clostridium difficile.  Image courtesy of CDC Public Health Image Library.
Clostridium difficile ​Infections: 250,000 per year
Deaths: 14,000
Excess Medical Costs: $1,000,000,000 per year
Carbapenem-resistant Enterobacteriaceae.  Image courtesy of CDC Public Health Image Library.
Carbapenem-resistant Enterobacteriaceae ​Infections: 9,000 per year
Deaths: 600
Drug-resistant Neisseria gonorrhoeae.  Image courtesy of CDC Public Health Image Library.
Drug-resistant Neisseria gonorrhoeae ​Infections: 246,000 per year

As part of the response to this threat, ASPR’s Biomedical Advanced Research and Development Authority (BARDA) is partnering with industry to develop new antibiotics that will enhance our nation’s arsenal against antibiotic resistant organisms.

We face a perfect storm: a growing number of increasingly fierce bacteria amidst a decrease in the number of pharmaceutical companies engaged in antibiotic development. The list of approved antibiotics and the current antibiotic pipeline of new antibacterial drugs to treat these infections is insufficient to fully respond to this threat.

To counter these concerning trends, BARDA has been supporting the development of novel antibacterial therapies to treat life threatening drug resistant infections by establishing public-private partnerships with pharmaceutical and biotechnology companies. BARDA initiated these efforts in 2010 and they are beginning to show real progress.

Over the next few months, we will continue our series on “Combatting Antibiotic Resistance,” with an overview of BARDA's Broad Spectrum Antimicrobials (BSA) program; the type of incentives BARDA is using to revitalize the pipeline; our vision for the future, and ways you or your organization can help enhance our nation’s preparedness and response to this threat. To stay up to date as new blog posts are published, subscribe to the ASPR Blog RSS feed, follow @PHEgov on Twitter or Like us on Facebook.

June 04
Create lifelong partners in health and community resilience

Author: Lt. Katie Hager, BSN, RN, Division of the Civilian Volunteer Medical Reserve Corps

Looking for great new partners for your emergency preparedness or health education programs? To bring energy, enthusiasm, a willingness to learn new things and a unique perspective to your mission and projects, tap into an often overlooked community resource: teens. Think about ways you can energize teens and encourage them to use their time, talents and skills to help their communities.

There are millions teens between 14 and 18 years old who are dedicated to making their dreams a reality, discovering new skills, and pursuing career and life goals. They’re driven to make a positive difference in the world. What they learn and practice now affects their behavior and habits as adults, including in health and emergency preparedness.

So by engaging them, you can help them achieve their goals while improving your community’s health and resilience for a lifetime. It’s a win-win. Engaging teens just takes a little creative thinking and a willingness to partner.

The first step is a broad search for youth organizations interested in partnering. Be sure to look beyond students interested in public health and emergency management, and don’t be afraid to start small; with successful first steps, a partnership grows stronger, bigger and better.

The most common place to start engaging teens is within the schools in your community. Many school districts now require community service credits in order to graduate and so by partnering with organizations, teens earn required credit and your community reaps immediate and long-term benefits of that engagement.

In addition, your community probably has a number of 4-H groups, faith-based youth organizations, national scouting programs, and career and technical student organizations. Learn about the options that exist in your community and find out if any of those groups would be interested in partnering with you on a few projects.

How could it work? Let’s say a shelter is opening in your community and toiletries kits are needed for the shelter. You could partner with a school or community organization so that young people can sort the supplies, assemble the kits, and provide the completed kits to the shelter. Or maybe you’re using school facilities for a health fair. Teens can serve as planners, educators, and marketing specialists who boost social media awareness of your event.

Maybe your public education and outreach material desperately needs an update. You could reach out to a local graphic design class or to DECA, an international association of high school and college students studying marketing, management, and entrepreneurship. Teens can help ensure that the program is effective with an often hard to reach demographic: other teens.

Teens are social networking nodes within the community, too, and their engagement and support on a specific topic or program can permeate through the layers of society to parents, guardians, adult mentors, teachers, younger siblings, fellow students, and teen organizations.

If you are worried about liability issues, remember that young people may be able to participate in health activities through a school, community organization, or place of worship and, therefore, could be covered under that organization’s liability protection. So to engage teens, consider partnering with local high schools, community organizations or places of worship.

The HHS Division of the Civilian Volunteer Medical Reserve Corps (MRC) has partnered with youth organizations since its inception in 2002. We know that engaging young people requires treating them as equals in decision-making and responsibility. They need to know that they are respected and that they are empowered to contribute as full team members.

Some MRC units allow teens to serve as MRC members; others partner with local organizations to encourage participation in health activities. Other units create Junior or Youth MRC units. All MRC units are encouraged to organize, identify needs and act to fulfill those needs within their community.

At the national level, DCVMRC partners with HOSA-Future Health Professionals to develop teens’ interest in public health, preparedness, and the MRC mission. HOSA-Future Health Professionals is organized into chapters throughout the country with a two-fold mission of promoting career opportunities for youth in the health care sector and enhancing the delivery of quality health care to all.

You can leverage this partnership. HOSA has nearly 165,000 members through 47 state associations with membership at the secondary, postsecondary, and collegiate levels, including students enrolled in health science and biomedical science programs or who have an interest in pursuing careers in the health professions.

Wondering what this engagement and HOSA look like in action? Take three minutes out of your day to check out the HOSA 37h Annual National Leadership Conference June 25-28.

Has your organization engaged teens or pre-teens in promoting health, emergency preparedness or community resilience? Share your experience by commenting on this blog.

May 30
More than just hurricanes:  Preparing healthcare facilities for extreme weather events

Author: Laura K. Wolf, Ph.D., Senior Program Analyst, Critical Infrastructure Protection Branch, Office of Emergency Management, HHS ASPR

It’s that time of year again—hurricane season is upon us! For most people who live in coastal areas, stockpiling food and water, battening down the hatches and checking on family and friends will get them through most storms. But for healthcare facilities, such as hospitals, ambulatory care centers, pharmacies, dialysis centers, and laboratories, shutting the doors isn’t an option. Often, the communities they serve rely on these facilities for continuous support before, during, and after the storm.

Hurricane Preparedness Week is a great time to remind those at healthcare facilities of the resources available to them to help plan for the worst.

The Critical Infrastructure Protection Program works with private sector partners to develop guides and checklists to prepare facilities to bounce back after a hurricane. Public utilities, including power, water, and communications systems are likely to fail, at least temporarily, during hurricanes. To make sure your facility is ready, check out:

Hurricanes aren’t the only reason to prepare for loss of these services. Facility managers across the country need to know the risks that severe weather can pose to infrastructure within their community. Every region in the U.S. is at risk for the similar destructive weather experienced during hurricanes: severe lightening, wind, tornadoes, and flooding are threats to many facilities. Even if you aren’t in a coastal region, your area is likely at risk for some other kind of damage this season.

While it’s important to understand your historical risks for such disasters, the changing climate may increase the impact of weather that you’re used to dealing with. Last summer, the President released the Climate Action Plan to help the country prepare for the impacts of climate change. The Federal government is currently analyzing its own resilience to weather and determining best practices for shoring up old structures and building new facilities with the latest flood risk reduction standards in mind. The Department of Health and Human Services is compiling resources for healthcare facilities to enhance their resilience to extreme weather events. Stay tuned for more information!

Take time to consider how you can best prepare your facility to meet the needs of those who need it most in the disaster. Some prevention now can help keep everybody safe when disaster strikes.

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