HHS Releases New Strategy for Emergency Medical Countermeasures Enterprise

In June 2012, the Department of Health and Human Services (HHS) released the 2012 Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) Strategy. ¹ The new document is meant to guide PHEMCE in its mission to advance national preparedness for natural, accidental, and intentional threats by coordinating medical countermeasure–related efforts in HHS and in cooperation with PHEMCE interagency partners.

Established by HHS in 2006, PHEMCE is the coordinating body for federal agencies, directed with protecting the civilian population from potential adverse health effects of chemical, biological, radiological, and nuclear (CBRN) agents and emerging infectious diseases through the use of medical countermeasures. PHEMCE is led by the Assistant Secretary for Preparedness and Response (ASPR), and its federal partners include the director of the Centers for Disease Control and Prevention (CDC), the director of the National Institute of Allergy and Infectious Diseases (NIAID) in the National Institutes of Health (NIH), the commissioner of the Food and Drug Administration (FDA), and senior leadership from the Departments of Veterans Affairs, Defense, Homeland Security, and Agriculture. There are 8 components of the PHEMCE mission, including establishing requirements for civilian medical countermeasures based on threat and risk assessments from the Department of Homeland Security (DHS); guiding early stage research to better understand threats concerning civilian public health; supporting advanced development and manufacturing capacity for medical countermeasures; and coordinating development of federal response plans, policy, guidance, and communication.

This document is the second PHEMCE strategy to be released by ASPR (the first was released in 2007), and it is the first since a comprehensive PHEMCE review was conducted in 2010. According to ASPR, much has been accomplished by PHEMCE since the 2007 strategy was released, including the development of 7 new medical countermeasures against anthrax, smallpox, botulism toxin, and radiological and nuclear agents.

The 2010 PHEMCE review concluded that lessons learned during the 2009 H1N1 pandemic should be incorporated into an updated strategy aimed at reducing or eliminating inefficiencies within PHEMCE and enabling PHEMCE to take a more active, capabilities-based approach to countermeasure development. ²

Building on the previous strategy and review documents, the 2012 PHEMCE Strategy establishes 4 updated goals, each with corresponding objectives, for PHEMCE over the next 5 years:

1. Identify, create, develop, manufacture, and procure critical medical countermeasures.

The strategy recognizes that resources are finite and thus encourages development of countermeasures for the most significant threats while prioritizing development of countermeasures that are both functional against multiple threats and can be effectively distributed and dispensed to the end-user. According to the strategy, high-priority threats include, among others, Bacillus anthracis, Clostridium botulinum toxin (botulism), pandemic influenza, smallpox, and radiological and nuclear agents.

An implementation plan corresponding to the new strategy is due to be released in late summer 2012. Together, the 2012 PHEMCE Strategy and the forthcoming 2012 PHEMCE Implementation Plan form a roadmap for the next 5 years of PHEMCE.

Ryan Morhard

Biological Weapons Convention Meeting of Experts Addresses Ways to Improve Treaty Compliance and Implementation

On July 16, 2012, the Biological Weapons Convention (BWC) Meeting of Experts convened for a 4-day closed meeting at the Palais des Nations in Geneva, Switzerland, to discuss compliance and implementation of the treaty. The BWC, which prohibits the development, production, and stockpiling of biological and toxin weapons, was drafted in 1972 and entered into force in 1975. Representatives of the 165 Member States convene every 4 to 6 years at a Review Conference to discuss issues surrounding the convention. ¹ In December 2011, the Seventh Review Conference of the BWC mandated a 4-year program to strengthen adherence to and implementation of the treaty, the first part of which was a July 2012 Meeting of Experts. ²

For the July Meeting of Experts, participants included intergovernmental organizations such as Interpol, the World Health Organization, and the Food and Agriculture Organization; expert bodies such as the International Union of Biochemistry and Molecular Biology; representatives from the private sector, including the International Gene Synthesis Consortium; and technical experts from academic and research institutions. ² In addition to the meeting, a separate event was convened on July 17 for participants to discuss their opinions on 2 controversial scientific papers on the mammalian transmission of H5N1 avian influenza virus.^3,4 At this event, participants specifically focused on implications of this research for scientific governance. ²

The July 2012 Meeting of Experts agenda focused on 3 areas: strengthening national implementation of the treaty, including increasing participation in Confidence-Building Measures (CBMs); reviewing developments in the field of science and technology, as relevant to the Convention; and strengthening cooperation and assistance, as relevant to Article X of the treaty. ⁵

Discussion around national implementation of the BWC focused on how states parties attempt to prevent biological pathogens from being used as weapons. Several states, including Malaysia and Morocco, highlighted efforts to assist in national implementation; both announced draft laws regarding the handling of biological agents and efforts aimed at strengthening national implementation. Some other states emphasized concern over low participation in CBMs and debated whether CBMs, which are actions taken to reduce the likelihood of deliberate biological release, are actually valuable in building confidence for the BWC. Participants discussed how states parties could improve transparency and information exchange surrounding the use of CBMs to build compliance, as only 62 CBMs have been received by the Implementation Support Unit (ISU) in 2012.^2,6

With regard to scientific and technological developments, participants addressed concerns over dual-use research and noted that advances in the life sciences have both benefits and drawbacks for international health and security. Some participants suggested that countries with sequencing capacity provide assistance to those lacking the capacity, in an effort to more fairly distribute and expand this capability. Many states supported policies for active risk monitoring to help mitigate negative effects of emerging technologies. ⁶

Participants highlighted the role of Article X of the BWC, which calls on states parties to promote information sharing and data exchange regarding the use of science and technology for peaceful purposes. The treaty encourages Member States with advanced scientific and technological capabilities to provide technical assistance to countries lacking such capabilities and to work collaboratively with international actors to promote further scientific and technical development. ¹ Several participants highlighted the need for enhanced assistance and cooperation, including in the area of biosafety practices. In response to requests for increased international assistance, the ISU, based in Geneva, announced the launch of an international assistance database. This system aims to connect Member States with requests for assistance with Member States that offer it. ⁶

The next BWC Meeting of states parties, to be held in Geneva from December 10-14, 2012, will review proposals and ideas from the Meeting of Experts and produce a report promoting strengthened adherence to and compliance with the BWC. ⁷

Nidhi Bouri

HHS Releases Retrospective and Improvement Plan for the 2009 H1N1 Pandemic Response

In May and June 2012, the Department of Health and Human Services (HHS) released its 2009 H1N1 Retrospective and Improvement Plan, examining successes and areas for improvement in the response to the 2009 H1N1 influenza pandemic and outlining priorities for future pandemic influenza preparedness. ¹ HHS released the plan in 2 documents: An HHS Retrospective on the 2009 H1N1 Influenza Pandemic to Advance All Hazards Preparedness ² and HHS 2009 H1N1 Influenza Improvement Plan. ³

The Retrospective is intended to stimulate discussion in HHS, among other federal departments, and across other relevant organizations—both government and nongovernment—about how to build on the successful elements of the 2009 response and how to concretely address areas that warrant improvement. ² The review organizes the results into 4 focus areas: surveillance, mitigation measures, vaccination, and communication education, as outlined in the National Framework for the 2009 H1N1 Influenza Preparedness and Response issued by the White House. ⁴ The retrospective identifies successes and opportunities for improvement in these areas:

• Surveillance: The Centers for Disease Control and Prevention (CDC) successfully identified and characterized the disease rapidly, and HHS approved and released diagnostic test kits, coordinated ongoing reporting of disease information, and identified H1N1 at-risk and non-risk groups early in the response. Because of the high volume and demand for surveillance data, clear and rapid communication remained a challenge. The pandemic highlighted the need for continued work to close gaps in the capability of the global surveillance network to detect emerging novel human pathogens.

The Improvement Plan builds on the suggestions in the Retrospective report, offering a refined blueprint that outlines new priorities for influenza-specific response and describes the ways in which next steps can be accomplished. ³ The Improvement Plan characterizes priorities under the 4 categories in the Retrospective, as well as additional categories. The important next steps going forward in pandemic influenza management include:

• strengthening influenza virus detection;

Moving forward, HHS will continue to address priorities presented in this review. In the coming months, HHS will release a companion implementation plan to guide specific planning efforts. ³

Kate Gilles

White House Unveils National Strategy for Biosurveillance

On July 31, 2012, the White House released the first-ever U.S. National Strategy for Biosurveillance. ¹ In the face of a dynamic and unpredictable set of natural and intentional threats to the nation's security and public health, the Strategy aims to strengthen and advance the nation's ability to rapidly detect and track incidents and inform decision making by local, state, federal, and tribal leaders. The stated goal of the Strategy is to “achieve a well-integrated national biosurveillance enterprise that saves lives by providing essential information for better decision making at all levels.” ¹ This Strategy is an extension of the White House National Security Strategy and the National Strategy for Countering Biological Threats, which emphasize the importance of biosurveillance and the need for improved sharing of relevant biosurveillance information among federal agencies.

To accomplish the goal of an integrated national biosurveillance enterprise, the Strategy offers 4 guiding principles:

• Leverage Existing Capabilities—The Strategy calls for taking full advantage of existing resources and extending electronic reporting of health information.

The Strategy identifies 4 core functions to be pursued simultaneously in order to improve incident understanding and inform decision making:

• Scan and Discern the Environment—The national biosurveillance enterprise should be able to rapidly detect incidents or epidemics from information being gathered from multiple health and security disciplines.

To support these core functions, the Strategy describes 4 enabling capabilities, which focus on harnessing the power of a distributed surveillance architecture and taking advantage of advances in science and technology.

• Integrate Capabilities—Examples include regional information sharing; combining animal, human, and plant health trends; and creative uses of social media.

The Strategy emphasizes 2 important themes in a national biosurveillance enterprise: the need to connect surveillance information to timely decision making, and the need for an integrated and interdisciplinary national approach. ² In particular, the Strategy seeks to better incorporate information from law enforcement, intelligence, agriculture, the private sector, and other non-health sectors into existing biosurveillance efforts. Furthermore, the Strategy addresses previous calls for increased oversight and coordination of federal biosurveillance efforts. ²

The Strategy requires that an implementation plan be completed within 120 days of July 31. The implementation plan will include specific actions, designated roles and responsibilities, and a mechanism for evaluating progress in biosurveillance.

Kunal J. Rambhia

CDC Releases Global Health Strategy for 2012-2015

On June 29, 2012, the U.S. Centers for Disease Control and Prevention (CDC) released its Global Health Strategy for 2012-2015. ¹ Through a series of workshops, interviews, and discussions, the CDC's Center for Global Health (established in 2010) worked closely with domestic and international partners to define and articulate its goals for the future of global health. The final report, which specifies 17 objectives in relation to 4 central goals, is an extension of CDC's mission “to protect and improve health globally through science, policy, partnership, and evidence-based public health action.” Following are the principal goals and objectives that CDC strives to accomplish by 2015: ¹

The Strategy goes on to highlight specific accomplishments, continuing efforts, and new initiatives, all aimed at facilitating the realization of these goals. The President's Emergency Plan for AIDS Relief (PEPFAR), for example, has made great progress since its enactment in 2003, increasing global antiretroviral therapy coverage to 47% in 2010 and significantly reducing vertical HIV transmission. As a PEPFAR partner, CDC continues to expand antiretroviral therapy coverage worldwide, promote HIV prevention efforts, and conduct research on new therapies and effective management strategies. CDC is pursuing similar endeavors in malaria and tuberculosis relief, including scientific research, educational programming, and surveillance.

Along with HIV/AIDS, malaria, and tuberculosis, CDC aims to alleviate the burden associated with select neglected tropical diseases: lymphatic filariasis, onchocerciasis, schistosomiasis, trachoma, and soil-transmitted helminths. In conjunction with the World Health Organization, CDC is evaluating the effectiveness of current relief initiatives and helping develop new diagnostic and epidemiologic tools with which to better inform eradication efforts.

Similar endeavors continue in the domain of vaccine-preventable illnesses. Measles and rubella, for instance, pose a significant threat to countries outside the western hemisphere. To prevent further entry of these diseases into the United States, CDC will focus its efforts on achieving major reductions in measles- and rubella-attributable morbidity and mortality. In light of the surge in polio cases in 2011, CDC is also allocating a considerable number of resources to eliminate the threat in Nigeria, Afghanistan, and Pakistan.

Noncommunicable diseases represent another major priority in CDC's overall strategy to improve global health. Over the next several years, CDC will improve surveillance, offer greater laboratory support, and help implement prevention programs to reduce the burden of chronic diseases, injuries, violence, and environmental hazards worldwide.

In addition to controlling the proliferation of the aforementioned diseases, CDC aspires to strengthen its efforts in public health emergency response. Specific objectives include conducting outbreak investigations, deploying response teams, and helping countries improve their response capabilities. CDC also seeks to fortify the existing health infrastructures of communities worldwide by increasing their surveillance abilities, expanding their research capacities, augmenting the public health workforce, and improving communications.

The integration of the Global Health Strategy into current planning efforts will enable CDC to better protect the global community from health threats while continuing to encourage collaboration with domestic and international partners. The goals articulated in the report promise to guide these efforts and facilitate progress toward CDC's ultimate goal of a safer and healthier world. ¹

Sanjana J. Ravi

FAO and OIE Continue Steps to Keep Rinderpest on the Eradicated Disease List

When the animal disease rinderpest was officially declared eradicated in 2011, the only remaining sources of the rinderpest virus were samples kept in labs. The declaration was accompanied by the passage of resolutions in which the World Organization for Animal Health (OIE) and U.N. Food and Agriculture Organization (FAO) member countries agreed to destroy remaining stocks of the virus or safely store them in a few high-containment laboratories approved by the FAO and OIE.^1,2 The approach to storing and destroying the virus is to be modeled on the process established after smallpox was eradicated in 1980, when the World Health Organization (WHO) supervised the destruction of all known Variola virus samples or their transfer to either the Centers for Disease Control and Prevention (CDC) in the US or the Institute of Virus Preparations in Russia.^3,4

Rinderpest is a highly contagious and deadly disease that affects cloven-hoofed animals. It is the only animal disease ever to be declared eradicated and only the second disease in history, after smallpox, to be eradicated. Although the disease is no longer present in nature, FAO and OIE member countries have committed to a post-eradication strategy that includes monitoring and surveillance for rinderpest outbreaks until 2020 to assure that rinderpest remains a disease of the past. ⁴

In July 2012, the FAO and the OIE called on countries to comply with a global moratorium on laboratory research using live rinderpest virus because the process of cataloguing existing virus-containing materials showed that biosecurity measures for these materials was sometimes insufficient. ⁴

More than 40 laboratories across the world currently store samples of the virus. The head of the OIE Scientific and Technical Department, Dr. Kazuaki Miyagishima, stated, “While rinderpest virus remains present in a large number of laboratories across the world, we cannot say that there is zero risk of a reoccurrence. Priority must be given to destroying remaining non-secured stocks of the virus and maintaining vigilance until this is accomplished.” ⁴

An external committee convened by the FAO and the OIE, called the Joint Advisory Committee (JAC) on rinderpest, will likely issue the first series of guidelines for an international oversight system in October and approve official repositories of the virus. The committee will also weigh the benefits and risks of all future research on live rinderpest virus. ⁵

Tara Kirk Sell

Polio Eradication Campaign Encounters Challenges in its Final Stages

For over 2 decades, the eradication of poliomyelitis (polio virus) has been the goal of one of the most ambitious global health efforts in history. Polio is primarily a disease of children, known for causing irreversible paralysis. According to the World Health Organization (WHO), 1 in 200 polio infections leads to irreversible paralysis, and of those paralyzed, 5% to 10% die from paralysis of the breathing muscles. ¹

Effective control and eventual eradication of polio hinges on high levels of vaccine coverage in pediatric populations in areas of the world where the virus is present. If the campaign is successful, polio would join smallpox and rinderpest as the only diseases to be eradicated from the world by human intervention.

The organization responsible for the execution of the eradication campaign is the Global Polio Eradication Initiative (GPEI), a partnership of WHO, the US Centers for Disease Control and Prevention (CDC), Rotary International, UNICEF, and the Bill and Melinda Gates Foundation. According to the GPEI, wild-type polio virus, a pathogen once responsible for 350,000 cases of pediatric acute flaccid paralysis per year, has caused only 111 cases of polio thus far in 2012, a 99% decrease in cases since 1998.^2,3 This impressive progress notwithstanding, the GPEI faces substantial challenges before eradication can be achieved.

On May 26, 2012, WHO's decision-making body, the World Health Assembly (WHA), declared a “programmatic emergency” in hopes of reenergizing the eradication effort, particularly in nations where polio virus transmission has not yet been interrupted. This renewed urgency was generated, in part, by an influential report issued in October by the GPEI's Independent Monitoring Board (IMB), which stated that “polio simply will not be eradicated unless it receives a higher priority … in many of the polio affected countries, and across the world.” ⁴

Polio is currently endemic to 3 nations: Nigeria, Pakistan, and Afghanistan. ³ Angola, the Democratic Republic of the Congo, and Chad have experienced low numbers of cases and are close to achieving certification as being polio-free. However, as long as polio virus remains active in a country, its neighbors, and ultimately the world, remain at risk. While the GPEI maintains active vaccination programs in countries surrounding endemic areas, many of these neighboring countries are also active conflict zones. Consequently, access to civilian populations is often limited or nonexistent for national or international health agencies. According to the IMB's July 2012 report, Every Missed Child, 2.7 million children in these at-risk nations remain unvaccinated. ⁵

In the remaining polio-endemic countries, parts of the majority Muslim populations have displayed resistance to polio vaccination on religious or political grounds. These objections have intensified because of the fallout from the US intelligence operation that led to the elimination of Al Qaeda leader Osama bin Laden. As part of last year's effort to locate bin Laden, the Central Intelligence Agency (CIA) worked with a Pakistani physician, Shakil Afridi, to develop a local hepatitis B vaccination program in and around Abbottabad, the Pakistani city where bin Laden was thought to be located. The program's apparent goal was to collect DNA samples from the residents of bin Laden's home, thereby verifying his presence, but it was conducted under the auspices of a vaccination effort. ⁶ While the resulting raid was successful in its goal, the resulting suspicion of vaccine workers has hindered the polio eradication effort at a critical juncture. Recently, a doctor affiliated with the UN's polio eradication team was shot and killed in Karachi, Pakistan. ⁷ The killing was apparently motivated by a ban on polio vaccination imposed by Taliban commanders in Pakistan's Federally Administered Tribal Area (FATA), which is home to roughly 300,000 children.

While the short-term impact of these events has been disruptive to eradication efforts, the GPEI remains committed to the goal of eradication and is close to achieving its goal. It remains to be seen if the world has the collective political will, including the necessary financial support, to finish the job.

Matthew Watson