Testimony

Tuesday, January 31, 2006

Introduction
Mr. Chairman and members of the Subcommittee, I am honored to be here today to describe for you how the Department of Health and Human Services is working to improve preparedness for a potential human influenza pandemic. Thank you for the invitation to testify on this topic which Secretary Mike Leavitt has made a top priority. As you know, the President requested $7.1 billion in emergency funding for the National Strategy for Pandemic Influenza (PDF), of which $6.7 billion was requested for HHS. Congress appropriated $3.8 billion as the first installment of the President’s request to begin these priority activities, and of this amount, $3.3 billion was provided to HHS. We appreciate the action of Congress on this appropriation as it takes us an essential step forward to become the first generation in history to be prepared for a possible pandemic.

As you are aware, the potential for a human influenza pandemic is a current public health concern with an immense potential impact. Pandemics are not new. There were three in the 20th century, the worst of which was the Spanish flu epidemic in 1918-1919 that is estimated to have killed over one half million people in the U.S. and 50 million worldwide. While we are focusing today on the impact of a possible pandemic of avian flu, many of the policy issues and preparedness measures that arise for avian flu apply as well to pandemics of other types of influenza, other infectious disease outbreaks and public health emergencies. To put the impact of a pandemic in context, the seasonal influenza that we have today causes an average of 36,000 deaths each year in the United States, mostly among the elderly, and adds more than 200,000 hospitalizations.

Scientists cannot accurately predict the severity and impact of an influenza pandemic, whether from the H5N1 virus currently circulating in birds in Asia and Europe, or the emergence of another influenza virus of pandemic potential. However, it is still useful to model possible scenarios based on analysis of past pandemics. In a report released in December 2005, the Congressional Budget Office presents the results of modeling a severe pandemic scenario similar to the 1918 Spanish flu outbreak and a more moderate outbreak resembling the flu pandemics of 1957 and 1968. In the severe scenario, roughly 90 million people become ill and 2 million die in the United States and the impact on the real Gross Domestic Product [GDP] is about a 5 percent reduction in the year following the outbreak. In the “mild” pandemic scenario, about 75 million people are infected in the U.S. and about 100,000 of them die. The impact on the GDP is approximately a 1.5 percent decline. While there is substantial uncertainty associated with these estimates, they illustrate the enormous public health threat of an influenza pandemic and the need for effective access to vaccines, treatments, and a robust public health infrastructure to meet the challenge.

There are several important points to note about an influenza pandemic:

• A pandemic could occur anytime during the year and could last longer than typical seasonal influenza, with possible repeated waves of infection.
• The capacity to prevent or control transmission of the virus once it gains the ability to be efficiently transmitted from person to person will be limited.
• Right now, the H5N1 avian influenza strain that is circulating in Asia and Europe among birds is considered the leading candidate to cause the next pandemic. However, it is possible that another influenza virus, which could originate anywhere in the world, could cause the next pandemic. This uncertainty is one of the reasons why we need to maintain year-round laboratory surveillance of influenza viruses. As is the case with the avian virus H5N1, pandemic influenza viruses often emerge in animals. As they are transmitted among animals the viruses can potentially mutate to a form that can be transmitted to humans. Thus, it is critical to maintain constant surveillance of viruses worldwide affecting animal populations and that can potentially be transmitted to humans.
• We often look to history in an effort to understand the impact that a new pandemic might have, and how to intervene most effectively. However, there have been many changes since the last pandemic in 1968, including changes in population and social structures, medical and technological advances, and a significant increase in international travel. Some of these changes have increased our ability to plan for and respond to pandemics, but other changes have made us more vulnerable.

The Current Status of H5N1 Virus in Asia
Beginning in January 2004, the World Health Organization (WHO) confirmed reports of new outbreaks of HPAI H5N1 infection among poultry and waterfowl in several Asian countries. In 2005, outbreaks of H5N1 disease have also been reported among poultry in Russia, Ukraine, Kazakhstan, Turkey, and Romania. Mongolia has reported outbreaks of the H5N1 virus in wild, migratory birds. In October 2005, outbreaks of the H5N1 virus were reported among migrating swans in Croatia. In 2004, sporadic human cases of avian influenza A (H5N1) were reported in Vietnam and Thailand. In 2005 additional human cases have been reported in Cambodia, China, Indonesia, Thailand, Vietnam, and most recently Turkey. Turkey first reported confirmed H5N1 cases on January 5, with 3 cases (2 fatal) in eastern Turkey. On January 9, Turkey reported 10 H5 cases, and an additional 2 cases from Agri province on January 16. To date, Turkey has reported a total of 21 H5N1 human cases, 4 of them fatal, confirmed by a national laboratory in Ankara. Four cases (2 fatal) have been verified by a WHO lab in the United Kingdom. Of the 21 cases, 19 have been children aged 4-18 years. All cases seen in Turkey so far developed illness following direct exposure to diseased poultry. Cumulatively, as of January 30, 2006, 160 human cases have been reported and laboratory confirmed by WHO. These cases have resulted in 85 deaths, a fatality rate of approximately 53 percent among reported cases. Almost all cases of H5N1 human infection appear to have resulted from some form of direct or close contact with infected poultry, primarily chickens. In addition, a few persons may have been infected through very close contact with another infected person, but this type of transmission has not led to sustained transmission.

For an influenza virus to cause a pandemic, it must: (1) be a virus to which there is little or no pre-existing immunity in the human population; (2) be able to cause illness in humans; and, (3) have the ability for sustained transmission from person to person. So far, the HPAI H5N1 virus circulating in Asia and Europe meets the first two criteria but has not yet shown the capability for sustained transmission from person to person.

The highly pathogenic avian influenza A (H5N1) epizootic (or animal) outbreak in Asia that is now beginning to spread into Europe is not expected to diminish significantly in the short term. It is likely that H5N1 infection among birds has become endemic in certain countries in Asia and that human infections resulting from direct contact with infected poultry will continue to occur. So far, scientists have found no evidence to indicate that the virus has changed to make it easier to transmit from person to person. However, the animal outbreak continues to pose an important public health threat, because there is little preexisting natural immunity to H5N1 infection in the human population. It is quite certain that a threat anywhere in the world is a threat everywhere.

Working to Meet the Existing Threat
On November 1, 2005, President Bush released the National Strategy for Pandemic Influenza, which outlines the roles of the Federal government, State and local governments, private and international partners, and individual citizens in preparing for and responding to an influenza pandemic. The following day, Secretary Leavitt announced the HHS Pandemic Influenza Plan—a blueprint for all HHS pandemic influenza preparedness and response planning. The HHS Plan provides guidance to national, State, and local policy makers and health departments with the goal of achieving national readiness and the ability to respond quickly and effectively to a pandemic. The HHS plan also includes an outline of key roles and responsibilities during a pandemic. In the event of a pandemic and the activation of the National Response Plan, HHS has a critical lead role to manage the public health and medical response and support the Department of Homeland Security in their role of overall domestic incident management and Federal coordination.

On November 1, 2005, the President requested an additional $7.1 billion in emergency appropriations for FY 2006, including appropriations for HHS totaling $6.7 billion to support implementation of the National Strategy for Pandemic Influenza (PDF).

In seeking this funding, the goals were to:

1. Produce a course of pandemic influenza vaccine for every American within six months of an outbreak;
2. Provide enough antiviral drugs and other medical supplies to treat over 25 percent of the U.S. population; and
3. Ensure a domestic and international public health capacity to detect and respond to a potential pandemic influenza outbreak.

On December 30, 2005, President Bush signed into law the Department of Defense Appropriations Act of 2006 (Public Law No: 109-148) providing approximately $3.8 billion for pandemic influenza preparedness activities for FY2006, of which $3.3 billion was appropriated to HHS. The majority of the HHS appropriation will be spent in two major areas: the production of countermeasures (vaccines and antiviral drugs) and enhanced domestic preparedness. I would like to talk in depth about these areas, as well as describe other ongoing activities.

Vaccines
The optimal way to control the spread of a pandemic and reduce its associated morbidity and mortality is through the use of vaccines. Broadly speaking, vaccines may be divided into those that are developed against strains of animal influenza viruses that have caused isolated infections in human, which may be regarded as “pre-pandemic” vaccines, and those that are developed against strains that have evolved the capacity for sustained and efficient human-to-human transmission (“pandemic” vaccines). Because emergence in human populations necessarily reflects genetic changes within the pandemic virus, pre-pandemic vaccines may be a good or poor match for – and offer greater or lesser protection against – the pandemic strain that ultimately emerges. Thus, our strategy is to simultaneously stockpile a limited amount of pre-pandemic vaccine and also build vaccine manufacturing capacity so that we can quickly produce pandemic vaccine when and if a pandemic occurs.

Roughly $1.76 billion of the HHS allocation will be spent on increasing vaccine production capacity. A portion of this funding will go to accelerate cell-based manufacturing technology. Because the surge capacity needed for a pandemic cannot be met by egg-based production alone, cell-based technology, which is insensitive to seasons and can be adjusted to vaccine demand, is a critical supplement to our nation’s surge capacity.

At the same time, HHS believes that it is vital that investments continue to be made to increase egg-based vaccine production capacity, given the years of experience and proven success with this technology. Therefore, HHS will fund projects to increase egg-based capacity, including buying pre-pandemic vaccine from existing egg-based manufacturers. In addition, HHS will retrofit existing non-flu manufacturing facilities for emergency production of influenza vaccine. In addition, HHS will support advanced development contracts for antigen sparing techniques. Antigen-sparing strategies, if successful, could extend the vaccine supply by decreasing the amount of vaccine needed to protect each individual. Finally, HHS intends to develop a vaccine registry to monitor vaccine use (safety/efficacy) and distribution.

Antiviral Drugs
In the event of a pandemic, antiviral drugs will be the first line of defense before a vaccine is available and could delay the spread of the pandemic, particularly if the strain is not efficiently transmitted between humans. Their effectiveness will be limited to the accuracy of detecting pandemic influenza and whether the pandemic strain is sensitive to current antiviral drugs.

HHS funding will also be allocated to acquire antiviral drugs. Currently two drugs, Oseltamivir (Tamiflu) and Zanamivir (Relenza) provide clinical benefit against all of the H5N1 virus strains currently circulating in Asia. HHS intends to complete the “20/20 plan” of achieving 20 million courses in FY 2006, with the goal of achieving 44 million courses by FY 2008, subject to the availability of funds. HHS also intends to purchase 6 million courses of antiviral for purposes of containment, if feasible, in the event of 1-2 isolated, domestic outbreaks. The plan calls for states to purchase the remaining 31 million treatment courses, for which the Federal government would subsidize 25 percent of the cost. Finally, HHS intends to fund the advanced development work on promising new antiviral drugs.

Domestic Preparedness
HHS will allocate $350 million directly to states to enhance their state and local preparedness. This money will be divided into two pieces, with the first piece totaling $100 million to be divided amongst the states on a population basis. Secretary Leavitt announced this $100 million in funding for state and local preparedness on January 12th. CDC is currently finalizing a self assessment tool for states to evaluate their readiness. This self-assessment tool will be sent to states, and as soon as the assessment is completed and sent back to CDC, each state will receive its portion of these funds. The second piece, the remaining $250 million, will be used to enhance state preparedness and will be allocated in the near future contingent on each state meeting specific preparedness goals, timelines, and targets as agreed to by HHS, CDC, and the state. These stipulations will be contained in an Agreement that each state governor will sign with Secretary Leavitt at the ongoing state summits.

Other FY2006 funds will be used to enhance the Strategic National Stockpile by increasing the quantities of personal protective equipment (PPE), ventilators, and other medical supplies needed in a pandemic outbreak. Approximately $50 million will be spent on establishing and increasing laboratory surge capacity. Funding has also been designated for the advanced development of rapid detection tests for human avian influenza. With regard to domestic surveillance, HHS plans to accelerate CDC’s BioSense real-time surveillance system to enhance our ability to detect an outbreak early.

HHS will also direct funding to enhance international surveillance, expanding clinical trials in Southeast Asia, and implementing rapid outbreak response in currently affected countries. HHS plans to allocate funds for risk communications strategies and overall pandemic preparedness and planning within the Office of the Secretary.

State and Local Preparedness
In addition, at the direction of President Bush, Secretary Leavitt convened senior state and local officials from across the country on December 5, 2005 to establish an integrated Federal-State influenza-pandemic planning process. The White House Homeland Security Council, the U.S. Department of Homeland Security, and the U.S. Department of Agriculture also participated in the meeting. Secretary Leavitt asked participants to begin preparing for a series of in-state pandemic-planning summits to be held in each State over the next several months. The summits are intended to inform and involve public health, emergency response, political, economic and community leadership in the planning process.

Secretary Leavitt has since embarked on a nation-wide tour to support state and local pandemic preparedness and planning efforts. His tour has the ambitious goal of visiting 50 states and 10 U.S. territories within 120 days. Thus far, the Secretary has completed summits in Minnesota, Arizona, Rhode Island, Vermont, Georgia, West Virginia, and Kentucky. These summits have been attended by hundreds of people at each venue and have brought together physicians, hospital executives, transportation workers, business owners, town officials, police officers, rescue squad volunteers, members of the agriculture sector and many other community leaders. In some states, the summit was broadcast to audiences in remote locations across the state as well. The central goal of the Secretary’s visits is to raise awareness of pandemic preparedness in sectors which may have not been previously briefed on the current pandemic threat. The Secretary feels that it is essential that schools, universities, businesses, faith-based organizations, and various other community groups and organizations realize the impact that a pandemic may have on them.

In this regard, to assist in state and local preparedness, the Centers for Disease Control and Prevention has released a series of checklists to aid states in their preparation for a pandemic in a coordinated and consistent manner across all segments of society. At this time, a state and local government checklist, a business checklist, an individual & families checklist, and a checklist for community organizations have been released. The state and local government checklist, of note, is specifically aligned with the CDC Preparedness Goals and the HHS Pandemic Influenza Plan, Public Health Guidance for State and Local Partners. It delineates action items over a comprehensive range of issues, including community preparedness leadership and networking, surveillance, public health and clinical laboratories, healthcare and public health partners, infection control and clinical guidelines, vaccine distribution and use, antiviral drug distribution and use, community disease control and prevention, public health communications, and workforce support. In addition, there are a number of checklists pertaining to the education and healthcare communities that are in the clearance process and scheduled to be released in the coming weeks. CDC has also prepared a Pandemic Influenza Toolkit for health care providers which provides a compilation of resources and information to clinicians for their use in discussing pandemic influenza with patients and providing care in case of a flu pandemic in the United States. Finally, www.pandemicflu.gov, the U.S. government’s official Web site for information on pandemic flu and avian influenza, contains updated information on international developments, the status of state summits, and on activities that can be initiated by various sectors of government and community to prepare now for a pandemic.

Finally, at each State summit, the Secretary and the Governor will be signing an Agreement laying the foundation for the financial assistance to be provided to States and also clearly delineating areas for mutual cooperation between the federal government and States as we jointly prepare for a potential future pandemic. For example, HHS will be providing substantial technical assistance to States in the areas of pandemic planning and logistical support and assistance to state and local health departments, health care agencies, and hospitals. The CDC will be particularly involved in support for epidemiological and diagnostic services, and distribution and storage of vaccines and antiviral drugs.

Conclusion
I hope my testimony today has provided you a summary of the current threat of pandemic influenza, the plans for which the Department of Health & Human Services intend to spend appropriated money to enhance domestic and international readiness, and the on-going activities and relationships being forged with states to enhance their overall preparedness for a potential pandemic. Although much has been accomplished, continued vigilance and preparation are needed for us to be ready for a pandemic.

Thank you for the opportunity to share this information with you. I am happy to answer any questions.

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Last Revised: February 2, 2006

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