Michael O. Leavitt
U.S. Department of Health and Human Services
Committee on Appropriations
Subcommittee on Labor, Health and Human Services, Education and Related Agencies
Wednesday May 2, 2007
Good afternoon Mr. Chairman, Senator Specter, and members of the Subcommittee.
I am honored to be here today to talk with you about important challenges and opportunities in global health.
For the past six years, this Administration has worked hard to make our country— and our world— a healthier, safer and more compassionate place. We thank you,
Mr. Chairman, and your colleagues for your solid financial support for our global efforts.
I thank the Congress and the President for their vision and the American people for their generosity that always seeks to help others. I am proud to be part of our Nation’s efforts to make for a healthier and more secure world.
HHS’ Mission and Mandate
The U.S. Department of Health and Human Services (HHS) recognizes that our job does not end at the shoreline. This is true for a number of reasons. First, pathogens and other threats to human health have become as mobile as we are, and have, in some cases, become increasingly deadly through mutations and resistance to drugs: as more people move and diseases change, our own health is intertwined with that of people in other nations.
Second, the health of other nations is important, and affects global productivity, stability, security, and good governance. It is clearly in our nation’s interest to address global health concerns. This includes not only obvious threats, such as infectious diseases, but also health issues that do not pose such an immediate risk to the American people.
But there is a third crucial role: to demonstrate the generosity and heart of the American people, a fact made clear in my travels, including recently to Central America. Health holds a special place as a foreign-policy tool. It is a universal and fundamental desire of all people, and is a common concern among almost every electorate in the world.
We know that because health programs address these fundamental human interests, they also enjoy a level of acceptance and gratitude far beyond other types of assistance programs. Health programs are uniquely situated to be both an act of benevolence and a clear and powerful tool for advancing American diplomatic interests. Its importance as a diplomatic tool will only increase as we move forward to face the challenges and opportunities of the future.
In short, a healthy world is good for America.
How HHS Meets Its Mandate
HHS works to fulfill its mandate to improve global health through direct assistance, technical and program support, training and capacity-building, and research. We partner with many other Departments, including the U.S. Departments of State, Defense, Agriculture, Homeland Security, and Commerce. We also collaborate closely with the U.S. Agency for International Development (USAID) and with the Environmental Protection Agency. We enjoy excellent bilateral partnerships with other Governments, multilateral organizations, non-governmental and faith-based organizations, and with the private sector.
Within HHS, Centers for Disease Control and Prevention (CDC) work to detect, verify, and quickly respond to infectious disease outbreaks around the globe, to address major causes of global morbidity and mortality, to build sustainable public-health systems and to control other health threats at their origin to prevent international spread. To maintain the safety of the American people, the Food and Drug Administration (FDA) regulates millions of products grown and manufactured abroad. The National Institutes of Health (NIH) address global health challenges through innovative, collaborative biomedical and behavioral research and training programs, and through basic clinical research to discover new medical interventions and evaluate their effectiveness. The Health Resources and Services Administration (HRSA) brings critical expertise in community health, the training of health-care workers, and “twinning” relationships that link U.S. institutions to our international work. And the Substance Abuse and Mental Health Services Administration (SAMHSA) is providing advice on mental health and drug and alcohol rehabilitation to several strategic global programs.
Over the last six years, we have doubled our international presence. We have almost 270 HHS staff— both civil servants and U.S. Public Health Service Commissioned Corps officers— in over 31 countries around the globe. These dedicated professionals work to improve the health of people throughout the world—through work on President Bush’s Malaria Initiative, the President’s Emergency Plan for AIDS Relief, the Global Polio Eradication Initiative, the Global Measles Partnership, and through work to encourage innovative, cooperative biomedical research. We also regularly send HHS staff to work as Health Attachés in U.S. Embassies and Missions abroad who represent the U.S. Government to host-country Ministries of Health and to international organizations, such as the World Health Organization.
Looking to the Future: Health Diplomacy
Last year, fifteen U.S. Government Departments and Agencies, including HHS, cooperated on Project Horizon, an innovative, ground-breaking, long-term planning project that looked at the role of the U.S. Government in global affairs in the long-term future. The project was innovative because it examined, not just one possible or probable future, but at a range of possible futures. Through three workshops, U.S. Government senior executives, leaders from civil society, and private-sector executives considered how the world might look in 20 years, and what the U.S. Government should be doing today to be prepared to operate in those future scenarios.
Out of these high-level workshops came a set of ten capabilities that project participants recommended, across a wide range of possible futures, the U.S. Government develop to continue its global affairs leadership in the future. One of those was the capability to mobilize health resources across the Federal Government to advance U.S. global leadership. No matter what the future looks like, we will need hands-on, high-visibility methods for engaging the world-- to help prevent disease, to mitigate global health risks and to strengthen perceptions of the U.S. abroad.
Global Health Challenges
Members of this committee know well the current landscape in international health.
I would like to highlight for you five challenges we are working to address at HHS: HIV/AIDS, tuberculosis, malaria, polio, and pandemic influenza.
President Bush’s Emergency Plan for AIDS Relief is the largest commitment ever by any nation for an international health initiative dedicated to a single disease—a five-year,
$15 billion, comprehensive approach to combating the disease around the world. We are proud to work with USAID, the Peace Corps, and the Departments of State, Defense, Commerce, and Labor in this effort.
Thanks to the commitment of President Bush, Congress and the American people, the U.S. Government is indeed the global leader in this fight. Based on estimates by the United Nations Joint Programme on HIV/AIDS, in 2005 our Government contributed more than all other Governments combined to HIV/AIDS control in foreign countries. That contribution has risen substantially in 2006 and 2007.
With the overall U.S. contribution of approximately $4.6 billion for the Emergency Plan in the current Fiscal Year (FY), and the President’s unprecedented $5.4 billion request for FY 2008, there can be no doubt the United States will continue to lead the world in responding to the AIDS crisis. The Emergency Plan has financed care for almost four and a half million people, including two million orphans and vulnerable children. We have supported counseling and testing for 18.6 million– 69 percent of whom are female.
To meet our treatment goals, the Emergency Plan has supported treatment for over 822,000 individuals in 15 countries – 61 percent of whom are women, and nine percent of whom are children. We have also supported anti-retroviral treatment for HIV-positive women during more than 530,000 pregnancies, and experts estimate these treatments have averted more than 100,000 infant HIV infections.
CDC provides expert field presence and support from headquarters for surveillance, laboratory support and the delivery of care to those infected or affected by AIDS. HRSA is also building on its management of the domestic HIV/AIDS efforts to provide training and quality-improvement interventions in the Emergency Plan focus countries, and runs a Twinning Center to match volunteers and health-care institutions in the United States with counterparts in the focus countries to share expertise and best practices. NIH is helping to further strengthen evaluations of Emergency Plan outcomes, and linking its network of clinical trial sites to Emergency Plan care and treatment programs. SAMHSA is providing expert direction for programs in Viet Nam and Southern Africa to address the important intersection of HIV/AIDS and substance abuse, including alcohol.
The FDA has reviewed and approved 44 generic anti-retroviral (ARV) drug formulations, including combination drug formulations and formulations appropriate for children. We estimate that when our host-country colleagues in Africa, the Caribbean and Asia take full advantage of these generic ARVs, the Emergency Plan will realize a cost savings of $23 million. The safety and quality of these generic ARVs matches that of drugs marketed for HIV/AIDS in the United States. This process is also providing savings and greater choices for our HIV-positive patients here at home as well: seven of these generic ARVs approved through this process are already on the market here in the United States. We expect more to appear in U.S. pharmacies in the years to come as other patents or exclusivities on the underlying branded drugs expire.
In addition to our bilateral assistance to 15 focus countries and numerous additional countries for HIV/AIDS control and the integration of tuberculosis control activities into those HIV/AIDS interventions, we also contribute to the Global Fund to Fight AIDS, Tuberculosis and Malaria. Our contributions as a Government to the Global Fund constitute our principal multilateral contributions to the global efforts to control these diseases, and are a significant part of the President’s Emergency Plan. The United States is a founding member of the Global Fund, was the Fund’s first donor and remains its largest contributor, and continues to play a leadership role in ensuring the success of this important international effort. My predecessor, former Secretary Tommy Thompson served as the Chair of the Global Fund Board from 2003 to 2005. HHS is at the heart of our Government’s relationship with the Global Fund: my Special Assistant for International Affairs, Dr. Bill Steiger, serves as the U.S. representative to the Global Fund Board. The U.S. Government’s Global Fund activities extend to the country level. As U.S. Government personnel, many of them from HHS, they sit on 57 of the 97 Country Coordinating Mechanisms that submitted proposals to the Fund in 2006.
The United States has given the Global Fund close to $1.9 billion, or 27 percent of total funding from all donors ($7.1 billion). As of April 19, 2007, the Global Fund had committed to funding a total of $7 billion in 136 countries, and disbursed nearly $3.6 billion to grant recipients in 130 countries. Fifty-eight percent of proposals the Fund Board approved during the first six rounds of funding were dedicated to HIV/AIDS, 24 percent to malaria, and 17 percent to tuberculosis.
The overlapping epidemics of tuberculosis and HIV require expanded screening and treatment for Tuberculosis (TB) among HIV/AIDS patients, and better screening and treatment for HIV/AIDS in TB patients. These complementary responses are a key part of treatment and care programs under the Emergency Plan as well. This year, the U.S. Global AIDS Coordinator allocated an additional $50 million for work on this dual threat, over and above the baseline work in this area already underway in the Emergency Plan. This plus-up will support enhanced case detection, laboratory capacity, infection-control activities, and clinical care.
Our strategy to control TB and drug-resistant TB includes the following: expanding and strengthening TB-control programs; better integrating TB screening and treatment into HIV/AIDS programs, and HIV screening and treatment into TB programs; systematically improving laboratory networks, disease surveillance, and monitoring; developing reliable drug-supply mechanisms; enhancing the development and production of the next generation of anti-TB drugs; and, helping local partners in all countries in which we work to fully implement the World Health Organization’s Stop TB Strategy.
We must be especially vigilant about the alarming increase in drug-resistant tuberculosis, including multi-drug-resistant (MDR-TB) and extensively drug-resistant TB (XDR-TB). XDR-TB is fatal in a significant percentage of those with this infection, including people whose immune systems HIV/AIDS has compromised. Experts are identifying XDR-TB in an increasing number of countries throughout Asia and Africa. In one documented outbreak of XDR-TB in South Africa among 53 individuals, most of whom were co-infected with HIV, 52 died within 25 days. CDC and NIH are working domestically and internationally to understand the extent of the XDR-TB situation, to build clinical and laboratory capacity to detect, control and treat this disease, and to address research needs to better understand the disease, its transmission, diagnosis, prevention and treatment. A Federal TB Task Force is examining activities across Federal agencies, including CDC, NIH, FDA, USAID, immigration services, health care institutions managed by the Federal bureau of Prisons health care systems, the Veterans Administration, the Indian Health Service, and others, and is preparing recommendations to address this threat. The National Security and Homeland Security Councils have also convened an interagency working group to put together an international strategy on MDR and XDR-TB.
Each year, over one million people die from malaria, and an estimated 300 to 500 million become ill and debilitated. Of these deaths, 85 percent or more occur in sub-Saharan Africa, the vast majority among children under five years of age. In many countries, malaria is the leading cause of mortality for both children and adults. Malaria has significant economic and social burdens: it accounts for more than 40 percent of public-health expenditures in Africa, and causes an estimated annual loss of $12 billion from the continent’s gross domestic product.
In spite of these grim statistics, malaria is a preventable and treatable disease. In June 2005, President Bush issued a global call to action on malaria, and announced
$1.2 billion in additional funding the U.S. Government will invest over five years to fight the disease in 15 sub-Saharan African countries.
The President’s Malaria Initiative (PMI) represents a historic five-year expansion of the U.S. Government’s efforts to fight malaria in the region most affected by the disease. The President set two ambitious goals for PMI focus countries: first, to reduce the estimated deaths from malaria by 50 percent by 2010; and second, to reach 85 percent of those most vulnerable to malaria— children under five years of age and pregnant women— with a package of four proven and highly-effective prevention and treatment measures. In each country, PMI works closely with national malaria-control programs to strengthen their efforts, complement ongoing activities, and meet the PMI targets of
85 percent coverage with proven interventions, including indoor spraying of homes with insecticides, the distribution of insecticide-treated mosquito nets, the use of lifesaving anti-malarial drugs, and expanding access to treatment to prevent malaria in pregnant women. PMI also works with civic leaders, non-governmental organizations, faith-based and service organizations, as well as corporations and foundations, in their commitments to defeat malaria as a public-health problem.
I am proud HHS/CDC is partnering with USAID as the implementing agencies for the PMI, and that we are already seeing results in the early stages of the initiative. Aid from the American people has already reached about six million Africans in the first three focus countries. A U.S. Government spraying program in Zanzibar last August treated 200,000 households, which protected more than one million people from malaria. In camps throughout northern Uganda, a PMI-supported campaign distributed more than 200,000 nets, targeted at children under five years old. In Tanzania, PMI has delivered 380,000 treatments of drug therapy. This year, an additional 30 million people should benefit from life-saving treatment and prevention measures as PMI expands to four additional countries. Complementing PMI’s ongoing efforts, NIH continues to support clinical researchers in the quest to understand or intervene against malaria.
The PMI has provided critical global leadership has rejuvenated interest and action on malaria prevention and treatment worldwide, and has saved children’s lives in Africa.
At the launch of the Global Polio Eradication Initiative (GPEI) in 1988, polio was endemic in more than 125 countries, and paralyzed 350,000 children each year. In 2006, polio paralyzed 1,985 people, and now there are only four endemic countries— Afghanistan, India, Nigeria, and Pakistan. We can attribute this tremendous progress to the commitments and monumental work of national, Provincial, and local Governments and communities worldwide to vaccinate all children against polio. The battle to wipe out polio truly is being fought on a grassroots, house-to-house level.
HHS, through CDC, has been honored to work closely with the World Health Organization (WHO), the United Nations Children’s Fund, and Rotary International as founding co-partners of the polio-eradication campaign. The U.S. Government is historically the largest financial donor to the effort, and has provided over $1.2 billion since 1988. U.S. Government contributions to polio eradication represent nearly 30 percent of all global contributions. In addition, HHS/CDC continues to provide significant technical expertise and support to Governments and international organizations as we work to eradicate polio.
We have never been closer to the goal of eradicating polio, but we also now face what might be the final and most difficult mile. We will continue to need your generous support and political commitment. Recent setbacks include the exportation of polio virus from endemic areas to regions and countries that had been polio-free. The populations polio affects in the four remaining endemic countries are among the poorest and most difficult for health workers to reach, whether through vaccine drives or communication campaigns. Conflict, poverty, inaccessibly, and religious and social tensions compound the difficulties. Nevertheless, we at HHS are convinced polio eradication is still possible.
A little over a year ago, the President mobilized our Nation to prepare for an influenza pandemic. I traveled to almost every U.S. State and territory to hold planning summits. The appropriation this subcommittee made played a significant role as well. Every level of Government in the United States has developed plans and allocated resources, so that, today, we are better prepared than we were a year ago — but there is still much for us to do.
There is also the danger that, as influenza slips from the headlines; people will believe the threat is no longer real. While the media buzz might have died down, the H5N1 strain of highly pathogenic avian influenza has not. As of April 11, 2007, the WHO has reported 28 new cases of avian influenza in humans since the beginning of the year in six countries, and 14 of these people died.
To date, 291 people have contracted the H5N1 strain around the world. Dozens of countries— across three continents— have seen H5N1 claim poultry and wild birds. While we cannot be certain H5N1 will be the spark of the next pandemic, we can be sure pandemics happen. They have happened in the past, and they will happen in the future.
That is why we continue to take this threat so seriously.
At the national level, we have made significant investments in critical areas of research, including the development of vaccines, antiviral medications, and diagnostic tools. This research will benefit not only the citizens of the United States, but individuals throughout the world.
In addition, NIH and CDC are supporting the development of new vaccines against H5N1 influenza and other virus strains. Our goal is to support and clinically test a library of live vaccine against all foreign influenza strains with pandemic potential, which could allow us to have a faster head start as any pandemic strain emerges.
We are also working on adjuvants and other dose-optimizing strategies for vaccine administration that could enable the United States to immunize more people. In January 2007, HHS awarded contracts that totaled $132.5 million to three vaccine makers for the advanced development of H5N1 influenza vaccines that will use an adjuvant. We are developing rapid diagnostic tests that could shorten the testing time for H5 strains, from what has been in the past two or three days, to just a matter of four hours. In my judgment, that is still too slow, and we continue to work hard in that area, making substantial research investments targeting rapid diagnostics.
We are also looking at mitigation strategies should a pandemic occur. Some recent pandemic modeling suggests there are partially effective interventions, such as school closings and social distancing, and we are working to use them in a layered manner that can be highly effective, we believe, in controlling influenza in a community. In February 2007, CDC released new guidance on community planning strategies that State and local community decision-makers, as well as individuals, need to consider based on the severity of an influenza pandemic. These strategies are important because the best protection against pandemic influenza – a vaccine – is not likely to be available in sufficient quantities for the entire population at the outset of a pandemic. Community strategies that delay or reduce the impact of a pandemic could help reduce the spread of disease until a vaccine that is well-matched to the virus is available.
Internationally, we have also made significant contributions in preparing our world for an influenza pandemic.
Partially through the appropriations this Committee made, the United States pledged $334 million last January to help nations prepare for, and respond to, outbreaks of avian influenza. You added to this total in the FY 2007 Joint Resolution, which provided us at HHS with $24 million additional dollars for international work. This funding has made a significant difference in improving our preparedness and response, and I wish to thank you for your commitment to this important effort.
With the funding you have given us, we at HHS have entered into cooperative agreements for influenza-control work in approximately 35 countries, and have also awarded over $20 million to the WHO Secretariat and its Regional and Country Offices for influenza surveillance and capacity-building. We have stationed influenza experts in newly created positions overseas in the countries of greatest concern, like Indonesia, and at WHO Headquarters and Regional Offices around the world. For the first time, we will also have a liaison person focused on influenza inside the European Centers for Disease Control in Stockholm. In addition, around the world through CDC, we have established five Global Disease Detection and Response Centers to build regional capacity to respond to the emergence of pandemic influenza or any other infectious-disease threat.
We have added value to the larger Departmental and U.S. Government activities by establishing and funding projects with the Institut Pasteur Network (in Viet Nam, Cambodia, Laos, Francophone North Africa and key Francophone West African countries at risk), the International Center for Diarrheal Disease Research in Bangladesh and the Gorgas Memorial Institute in Panamá to make the collective global disease-epidemiologic surveillance/laboratory diagnostic network more robust.
The United States also supports efforts by the international community and multilateral organizations to meet the global need for an appropriate and efficacious influenza vaccine. The Office of the Assistant Secretary for Preparedness and Response (ASPR) in HHS provided $10 million last Fiscal Year to the WHO Secretariat to help developing countries produce safe and effective vaccine against influenza. The WHO Secretariat just announced the first five beneficiaries of this program on April 25 (Brazil, Mexico, Thailand, Viet Nam and Indonesia). We have also invested heavily in vaccine research, and in expanding our own production capacity.
President Bush has made clear his commitment to a forward-leaning position on the development of antiviral stockpiles. In May of 2006, the U.S. Government deployed treatment courses of Tamiflu to a secure location in Asia to aid an international rapid-response and containment effort if a potential pandemic breaks out overseas.
As requested by the Homeland Security Council, HHS also leads an interagency effort to implement the International Health Regulations (IHRs) for the U.S. Government, linked across Federal Departments and agencies. The IHRs, an international legal instrument that comes into force in June 2007, will govern the roles and responsibilities of the WHO Secretariat and its Member States in identifying, responding to and sharing information about public-health emergencies of international concern (including a pandemic influenza).
We have done significant work to prepare for the possibility of a pandemic influenza, but many challenges remain. Responding to a pandemic will require the cooperation of the entire global community, as no nation can go it alone. If a country is to protect its own people, it must work together with other nations to protect the people of the world.
It is my belief we are better prepared for an influenza pandemic today than we were a year ago. And we are working to assure we are better prepared a year from now than we are today. Thank you for your continued interest and support. It will be crucial as we move forward.
Health Diplomacy Today: Central America
I spoke in my introductory comments about Project Horizon and health diplomacy in the future. Under the President’s leadership, I have already begun to implement the kind of health-diplomacy capability Project Horizon identified as a critical need.
As you know, in March 2007, President Bush shared with the people of the Americas his commitment to advancing social justice in the Western Hemisphere. That commitment includes helping democracies in the region to build Governments that are fair, effective, and free from corruption; to maintain economies that make it possible for people to provide for their families; and to meet basic needs for education, housing, and health care.
My part in this effort is helping to improve the region’s health care, especially in rural or areas that lack sufficient health-care personnel, in ways that are complementary to what other Federal Departments and agencies are already doing. The U.S. Government invests millions of dollars each year in health programs in Latin America; since 2001, the United States has spent almost $1 billion on health programs in the region.
Our new effort at HHS will focus on three main objectives:
- Increasing direct patient care provided by U.S. Government personnel;
- Improving the training of local health workers; and
- Forging partnerships of public and private groups to provide more and better health care.
Toward the first objective, people from my Department and the U.S. Department of Defense will work with our Central American partners to provide health care to those most in need. The President is sending the USNS Comfort — a Navy medical ship — to Latin America and the Caribbean. The Comfort will make port calls in 12 countries. Between June and September of this year, its doctors, nurses, and technicians expect to treat 85,000 patients — and conduct up to 1,500 surgeries.
Dental care among the poor is an area of special concern. So, this summer, dentists and dental hygienists from the U.S. Public Health Service Commissioned Corps will join military dentists from the U.S. Southern Command on humanitarian missions to the region. They will perform basic treatments like filling cavities, treating infections and pulling teeth. They will apply sealants to children’s teeth to protect them from cavities for many years to come. They will also offer preventive education on oral health and hygiene to children and their parents.
Our second objective is improving training of local health workers in the region. To do that, my Department is working with the Governments of Central America to start a Regional Training Center in Panamá. This training center will train a range of health-care workers — community health workers, physicians assistants, nurses assistants, technicians, and dental hygienists, among other disciplines – according to the particular needs in each country, because needs vary significantly across the region.
To make the school a success, we are working together as partners with our Central American hosts —
- To forge agreements between our countries and the school to supply and fund its students;
- To develop a governing structure and curricula for the school; and
- To engage universities, professional associations, and non-government health workers to build school faculty, resources, distance-learning capabilities, and other needs.
Our third objective is working more closely with American non-governmental health-care providers in the region. By partnering with these providers, we can have a greater impact on health care delivery in the region.
Now, let me tell you about our recent activities in Central America.
In June 2006, I visited Panamá to build the groundwork for the training facility, in the former Canal Zone, which I hope Panamanian Minister of Health Alleyne and I can inaugurate in June 2007. In September 2006, I discussed the idea of a training partnership with Health Ministers from Central America at the annual Directing Council of the Pan American Health Organization in Washington. In January 2007, I discussed the partnership with Central American Heads of State while in Nicaragua for President Ortega’s inauguration. In March 2007, I visited Guatemala, Honduras, El Salvador, Costa Rica, and Nicaragua to discuss this initiative with heads of state, ministers of health, medical and dental professionals, and grass-roots health-care providers.
We formalized our planning by signing Letters of Intent between HHS and each Central American Minister of Health to establish the Regional Training Center. The first training module at the training center took place in April 2007, and went very well. Fifty health-care workers from six Central American countries received training on pandemic-flu preparedness and response. At every step, we have worked with local health-care providers, who are the real experts in the needs of their countries and their communities.
No matter what the future looks like, the U.S. Government will have to be engaged in a serious and direct way in global health. On my trip to Central America, I not only experienced the very real needs of the present; I glimpsed the future of that kind of cooperation. Given the many challenges we face— HIV/AIDS, tuberculosis, malaria, polio, pandemic influenza— I can tell you that we need today, and will increasingly need tomorrow, to strategically wield all the global health assets we have as a Government. HHS counts it a privilege to be one partner in the larger fight for a healthier, safer, more compassionate world.
Last revised: April 19, 2011