May 7, 2003
Mr. Chairman and Members of the Committee, I am Tommy G. Thompson, Secretary of the U. S. Department of Health and Human Services. I am pleased to be here today to provide an overview of the Administration's activities to combat the global spread of HIV/AIDS, Tuberculosis (TB), and Malaria.
At the outset, I would like to acknowledge that we, at HHS, are in your debt, Mr. Chairman, and in the debt of your colleagues on this Committee, and others in this Chamber, for your support of prevention, and treatment measures for HIV/AIDS. The leadership of this Committee has been crucial to the U.S. Government's response to these devastating diseases, and will continue to be, as Congress and the Administration work together to support the Global Fund for AIDS, TB and Malaria, and implement the President's Emergency Plan for AIDS Relief, including the President's international Mother and Child HIV Prevention Initiative. The broad bipartisan support these initiatives enjoy — as well as the strong public support — speaks to their vital importance. I look forward to continuing to work with each of you to move them forward.
The United States has a long history of assisting other countries in need. And I am pleased to report that the Department of Health and Human Services, in conjunction with the U.S. Agency for International Development, the Department of State and other partners, is continuing that humanitarian tradition in a variety of ways, but most particularly in helping countries in need address the devastation caused by AIDS, TB and malaria.
From Tanzania to Vietnam to Haiti, HHS employees are on the ground, working with Ministries of Health, non-governmental organizations (NGO), faith-based groups, and — equally important — with other U.S. government entities, such as the Department of State and USAID, to develop country-specific solutions to the ravages of AIDS. Together with USAID, we are working with 16 countries and with international organizations such as the World Health Organization (WHO) to address TB – which infects nearly eight million persons per year. Worldwide, TB kills two million people each year and is the leading cause of death for one-third of persons infected with HIV. Further, we work with the WHO and other partners to address malaria, which kills an estimated one million children in the developing world each year.
Today, I will provide you with an overview of HHS activities and, I hope, reinforce your long-standing, demonstrated commitment to U.S. support in this essential endeavor.
Three HHS operating divisions are most actively involved in fighting AIDS, TB, and malaria worldwide. The National Institutes of Health (NIH) has a strong research portfolio in the areas of HIV and TB, including vital efforts to develop a vaccine to prevent HIV infection and new treatment technologies and strategies. NIH also trains U.S. and foreign scientists as a critical part of its mission. The Centers for Disease Control and Prevention (CDC) has engaged in international applied AIDS research and programmatic efforts since the beginning of the pandemic and supports bilateral and multilateral efforts to address TB and malaria. And the Health Resources and Services Administration (HRSA), through a cooperative agreement with CDC, works to train health care workers internationally to care for people living with HIV and AIDS.
While there is not time today to go over all that we do to address HIV, TB and malaria, permit me to briefly illustrate how, at HHS, the pieces fit together into a strategic plan to combat AIDS around the globe.
Research on AIDS
The United States has been the world's leader in research and practical assistance to battle HIV/AIDS, and the NIH's budget confirms that commitment. In fiscal year 2003, the NIH will devote over $2.7 billion to AIDS research, with over $250 million to be spent on AIDS research and training efforts abroad.
To conduct clinical research on vaccines for HIV/AIDS, the NIH supports the HIV Vaccine Trials Network — or HVTN — a network of 16 domestic and 13 international sites. Directly and through collaborations with investigators, mostly university-based, the HVTN also supports laboratory research worldwide to ensure that vaccines are developed against a variety of HIV strains found in different parts of the world. The HVTN currently is conducting a phase II clinical trial in Haiti, Brazil, and Trinidad/Tobago. The NIH is working with the CDC in several countries to identify cohorts of populations at risk for HIV infection and build the infrastructure necessary to conduct large-scale efficacy trials of potential vaccine candidates worldwide when they become available.
The NIH supports a growing portfolio of university-based biomedical and behavioral research for the discovery, development, preclinical testing, and clinical evaluation of interventions to prevent HIV transmission, slow disease progression, and limit disease mortality. NIH-sponsored programs target studies in Africa, Asia, Latin America and the Caribbean on factors related to HIV transmission and the mechanisms associated with HIV disease progression. The HIV Prevention Trials Network — or HPTN — is a worldwide collaborative network designed to conduct research in 16 international and nine domestic sites on promising and innovative biomedical/behavioral strategies for the prevention or reduction of HIV transmission among at-risk adult and infant populations.
A critical element of NIH's research portfolio is the efforts to strengthen — or create — the research infrastructure of developing countries as well as the capacity of in-country investigators to conduct clinical trials of therapeutic and preventive strategies. These strategies include treatment for opportunistic infections such as TB, AIDS vaccines, and interventions to prevent mother-to-child transmission.
Capacity-building for international research is a critical issue in all the countries where the NIH funds research activities. The NIH focuses its efforts in three essential areas:
Training Research Scientists — It is critical to the success of international studies that foreign scientists be full and equal partners in the design and conduct of collaborative studies. To help build capacity in developing countries, the NIH, through the Fogarty International Center, funds the AIDS International Training and Research Program (AITRP) to offer research training to foreign scientists through grants to U.S. universities. The program has provided training in the U.S. for scientists from developing countries in Africa, Asia, Latin America and the Caribbean. Training courses have been conducted in 60 countries. Over 200 senior investigators and health officials in Africa have been trained through the AITRP, and thousands at more junior levels. It is no wonder that Dr. Salim Abdool-Karim, Deputy Vice Chancellor for Research and Development at the University of Natal in South Africa and Principal Investigator of a highly successful Fogarty AITRP grant, has described this program as the pre-eminent model of capacity-building for developing countries.
Laboratory Capacity — NIH-supported HIV-related research helps to build laboratory capacity in developing countries, where the research is conducted, through purchase of laboratory equipment and transfer of research technology.
Comprehensive International Program of Research on AIDS (CIPRA) — The NIH has launched CIPRA to provide long-term support to developing countries to plan and implement a comprehensive HIV/AIDS prevention and treatment research agenda relevant to their populations, and to enhance the infrastructure necessary to conduct such research. Through this initiative, funding will be provided directly to foreign institutions for HIV research that is relevant to the host country.
A safe and effective HIV preventive vaccine is essential to controlling the AIDS pandemic. But, while we have made tremendous progress in vaccine development, the deployment of a vaccine is likely years away. Other biomedical interventions, such as microbicides, are likewise not yet proven or ready for widespread use. Thus, research is ongoing to further develop vaccines and other biomedical interventions.
In the interim, the world's best — and only — hope for controlling the epidemic is through sound prevention programs. And care and treatment programs are essential to helping the millions already infected to diminish the likelihood of infecting their partners, furthering the aims of prevention and helping to keep productive workers and citizens alive.
I will now discuss some of the prevention, care, and treatment work HHS staff are performing in countries hardest hit by this terrible disease. HHS scientists, public health experts, and specialists in AIDS care and treatment form a critical component of the U.S. Government's inter-agency response to the international HIV/AIDS pandemic.
Prevention, Care and Treatment
CDC's highly trained physicians, epidemiologists (who have special training in the causes, distribution and control of disease in populations), virologists and other laboratory scientists, and public health advisors (who are experts in the science and practice of protecting and improving the health of a community through a variety of measures, including preventive medicine, health education, disease control, refugee health, and sanitation) are providing technical assistance to host-country governments and others working to prevent and control HIV/AIDS, under the direction of our U.S. Ambassadors in the field.
CDC staff is often located directly in host-country Ministries of Health or their affiliated National AIDS Control Programs. Working in close proximity with public health and medical colleagues for both government and non-governmental organizations allows CDC experts to enhance their services to host-country programs. They are also often co-located with USAID colleagues, promoting complementary programming between the two agencies.
In addition to CDC employees, the HHS Global AIDS Program currently has nearly 400 locally employed staff, who serve in a range of capacities, from research scientists, laboratory technicians, nurses, and midwives to computer specialists, statisticians, sociologists, and support staff. One of the primary goals of the HHS Global AIDS Program is to develop in-country capacity to address HIV/AIDS. Local staff are employed to form a national cadre of trained professionals who can share their knowledge with others, developing an ever-growing cadre of trained personnel.
The Global AIDS Program was first funded in fiscal year 2000. It builds on HHS's long and successful history of global initiatives to promote health. For example, in Thailand, CDC staff worked with the Thai government to develop a national mother-to-child HIV prevention program, the first of its kind in the developing world. As a result of this effort, testing has been implemented in all public hospitals and it is estimated that perinatal transmission has been reduced to less than 10 percent preventing more than 1,000 HIV infections in children each year.
All of this work now forms the foundation for HHS support for and involvement in the President's Emergency Plan. I commend the leadership that the House of Representatives has shown in taking action to stem the tide of the HIV/AIDS epidemic by passing the historic authorizing language last week.. As you know, the legislation stated that "HIV/AIDS is first and foremost a health problem." HHS stands ready to direct its expertise in health and HIV/AIDS to effectively implement the President's vision that the House of Representatives has adopted.
The Plan is focused on 14 of the hardest-hit nations, accounting for nearly 50 percent of all HIV infections in the world — and nearly 70 percent of HIV infections in Africa and the Caribbean. This five-year plan is expected to prevent seven million new infections — 60 percent of the projected new infections in the targeted countries. At least two million HIV-infected people will be treated with anti-retroviral drugs, and care will be provided to millions more HIV-infected individuals and AIDS orphans.
Implementation will be based on a "network model" being employed in countries such as Uganda: a layered network of central medical centers that support satellite centers and mobile units, with varying levels of medical expertise as treatment moves from urban areas to rural communities. The model will employ uniform prevention, care, and treatment protocols and prepared medication packs for ease of drug administration. It will build directly on clinics, sites, and programs established through HHS, USAID, non-governmental organizations, faith-based groups, and willing host governments.
Make no mistake – the U.S. is the unquestioned world leader in health care and HIV/AIDS prevention, care and treatment. HHS is a leader in the compassionate delivery of health care and HIV/AIDS services to those in need, and we stand ready to focus the full force of our expertise in health care and HIV/AIDS in support of the Emergency Plan — including the development of a health care network. For many years, HHS has supported domestic community-based networks for health care and HIV/AIDS, often in very resource-poor settings, with great success. Through HRSA and CDC, HHS supports comprehensive prevention, care and treatment programs established by communities for communities. These programs include training to enhance capacity and accountability.
As we have already started with the planning and implementation of the international Mother and Child HIV Prevention Initiative, we are eager to work closely with the Department of State and USAID to develop a unified U.S. Government strategy that will make the President's bold vision a reality.
I want to explain how we arrived at the goal of putting two million people on anti-retrovirals. Some claim this number is too small, given the more than 20 million people estimated to be HIV-positive in our 14 target countries. First, let us remember that the World Health Organization endorsed a world-wide target to put three million people on anti-retrovirals by 2005.
Second, our goal is based on field experience and research. The President's Plan projects that 50 percent of patients who are HIV-infected in the 14 target countries will enter voluntary counseling and testing programs during the five years of the program. This projection is supported by data both from Brazil and in the U.S. So, approximately 10 million HIV-infected persons in our 14 target countries will be diagnosed with HIV-infection and receive counseling. Appropriate medical care will be available for these persons through the Emergency Plan.
Most important is the fact that according to medical criteria and international guidelines, an estimated 20 percent of HIV-infected persons in resource-limited settings require anti-retroviral therapy at any one time. Twenty percent of 20 million infected would be four million, but remember that we estimate that only half of the infected population will come in to receive testing to find out their status and receive medical attention. Therefore, approximately two million of the 10 million persons who are diagnosed with HIV infection in our 14 countries will require anti-retroviral therapy during the five years of the program.
Because those with advanced disease who are very sick are most likely to come in for care through the plan, it is possible our partners in the Plan will treat more than two million people with anti-retroviral therapy. If more than two million people require such therapy, the Emergency Plan will provide it. If this scenario occurs, economies of scale should allow for a reduction in the price of anti-retroviral medications and certain laboratory tests to keep the Plan within the budget the President has requested.
I know there has been some discussion lately about a recent literature review that has concluded that unsafe injections and medical practices might be responsible for a greater share of HIV infections in Africa than previously thought. While there is some debate about the report's conclusions, however high the percentage of infections in Africa contributed by unsafe injections and medical practices really is, I want to assure you that the President's Emergency Plan for AIDS Relief in Africa and the Caribbean has a component to reduce transmission from unsafe injections and medical practices. Each and every infection with a dirty needle is wholly preventable and should be prevented. Under the President's initiative, prevention activities will be directed at all modes of transmission, including improving safe blood supplies, and the Emergency Plan will have the flexibility to adjust resource allocation based on scientific data as it becomes available.
In addition, the Emergency Plan will enhance the medical capacity and infrastructure in the countries participating in the program; these activities in and of themselves should have a "spill-over" effect to promote safer medical practices. Finally, it is important to note that the Emergency Plan is committed to providing medical care and treatment, including anti-retoviral therapy, for those who are infected with HIV regardless of how they acquired the virus. However a person obtained HIV, the President's bold and compassionate Plan will provide the necessary care and treatment.
Although the President's Emergency Relief Plan will not begin until the next fiscal year, the first stage of this unprecedented effort is already underway. The President's Mother and Child HIV Prevention Initiative, which has already begun in the same 14 countries — and is serving as the foundation for the larger Emergency Relief Plan — is jointly implemented by HHS and USAID. HHS and USAID staff have worked with host governments and NGOs to develop preliminary country-specific plans of action that will accomplish the following:
We expect that this initiative will reduce mother-to-child HIV transmission by 40 percent among the women treated. A second goal of the initiative is to improve health care systems to provide care and treatment not only to mothers and babies, but to fathers, children, and their broader communities. Strengthening health care systems is essential to the success of the President's Emergency Relief Plan.
HRSA is lending its strength to this initiative through the training of health care providers and the facilitation of partnerships between U.S. hospitals and clinics and their counterparts in the 14 countries ("twinning"). HRSA also supports broader HIV/AIDS international training initiatives through an interagency agreement with CDC.
The Mother and Child Prevention Initiative demonstrates that theU.S. Government — when its departments and agencies work together toward a common goal — can make a difference. Already, HHS and USAID field staff, working with U.S. Embassies, Ministries of Health and other major partners, have completed assessments of baseline activities in all 14 countries and the Caribbean region. In consultation with U.S. Ambassadors in-country, HHS and USAID field staff have submitted a unified U.S. Government strategy to prevent mother and child HIV transmission in 12 of the 14 target countries and the Caribbean region.
Ten initial program proposals have been approved by a multi-agency Steering Committee led by HHS and USAID under the auspices of the White House Office of National AIDS Policy. Joint HHS and USAID workgroups to develop a volunteer health care corps and twinning, monitoring, evaluation and procurement initiatives have made great progress. We have also begun high-level discussions with the Peace Corps to determine how best we can integrate their volunteers into this effort. These initiatives are being developed with the potential to support the Emergency Plan. The interagency collaboration engendered by the Mother and Child HIV Prevention Initiative, and the development of a unified U.S. Government strategy in-country and at the headquarters level, has provided the foundation to implement the Emergency Plan for AIDS Relief in Africa and the Caribbean.
The President's Emergency Plan also increases our pledge to the Global Fund to Fight AIDS, Tuberculosis and Malaria to $1.65 billion. The U.S. pledge is almost 50 percent of the total $3.37 billion pledged to date. Our fiscal year 2003 commitment alone accounts for 42 percent of all resources available to the Fund this year ($350 million of a total $832 million pledged or in the bank), and the U.S. is responsible for 32 percent of the Fund's cash on hand. With the exception of Germany and Ireland, major donor countries have not increased their initial pledges, which in most cases extend over several years.
This January I was elected to serve as Chair of the Fund's Board. I am committed to mobilizing additional resources from both donor nations and the private sector.
The U.S. strongly supported the creation of the Global Fund, and we will continues to support its efforts through technical assistance to partnerships as they develop proposals for the Fund and implement and monitor Global Fund-financed programs. This is a perfect example of how our bilateral programs lend additional support to the efforts of the Global Fund. Above and beyond the $1.65 billion, the U.S. supports the Global Fund in Geneva and in-country, lending our expertise, our lessons learned, our facilities, our partners, and, in some cases, our own personnel.
I have encouraged our donor partners on the Board to do the same. The United Kingdom, Sweden, Germany, Canada, and others all have overseas development agencies with the ability to both lend support to Country Coordinating Mechanisms, and to inform the Secretariat on technical issues such as monitoring and evaluation practices. The U.S. is setting an example for the kind of response necessary if the world is going to have an affect in the fight against AIDS, tuberculosis, and malaria.
Mr. Chairman, for too long, people in the developing world have seen a diagnosis of HIV infection as a death sentence. And so it has been. But with the promise of care and treatment, we're making learning your HIV status not a death sentence, but a stepping stone to needed care. Those infected will be able to receive treatment — and essential prevention and support services to keep them from transmitting the virus. For the uninfected, vital prevention services will teach them how to remain HIV-free, emphasizing the ABCs of HIV prevention:
Many have praised Uganda as an example of an effective ABC program that has had an incredible impact. This praise is well-placed, and I join President Bush in commending the Ugandans for their diligence and compassion. We are heartened to see that behavior-based preventive programs can and will work given adequate support.
Uganda's success — and success in the fight against HIV/AIDS — is possible because of the hope engendered by the availability of care and treatment. We at HHS, in partnership with USAID and other organizations, are making good on our promise to bring this care and treatment to those who need it most. We are providing the essential training, technical assistance and financial support to governments and scientific institutions around the globe to help them help their people. None of this would be possible without the continued support of members of this Committee and your colleagues in the House and Senate.
Global Control of TB and Malaria
Thus far, I have focused on HIV and AIDS in this testimony. Let me now make a few comments regarding HHS's contributions to the global control of tuberculosis and malaria. HHS's approaches to both TB and malaria are similar to that of HIV/AIDS, but are more limited in terms of scope and resources.
Both NIH and CDC work to address TB. TB is a global emergency and a leading infectious killer of young adults worldwide. Approximately one-third of the world's population is infected with the bacterium that causes TB and 80 percent of active TB cases originate in 22 high-burden countries. As I noted earlier, TB accounts for one-third of deaths among persons with AIDS. Basic research on TB, including research on a vaccine, is conducted at NIH. CDC supports applied research, including operational research to improve programs and clinical research to evaluate new drugs and diagnostics, and program implementation.
All TB research depends upon the creation of a solid base of scientific knowledge about M. tuberculosis and an understanding of how TB develops from an infection with this bacterium. The National Institute of Allergy and Infectious Diseases (NIAID) plays a key role in the global fight against TB by conducting and supporting research -- and providing research resources -- to advance the understanding of TB and translate basic research findings into useful medical interventions such as therapeutics, diagnostics and vaccines. NIAID supports this ambitious research agenda in collaboration with partners around the world in countries such as Mexico, Brazil, Peru, Uganda, Tanzania, and South Africa.
In the past few years, these energetic partnerships and multinational collaborations have resulted in an enormous return on the NIAID commitment to fighting tuberculosis, not only in terms of new research findings, but also in developing enhanced research capacity worldwide. Scientific advances have facilitated the creation of novel drug candidates, treatment regimens and vaccine candidates that are rapidly progressing toward human studies. For example, three new TB vaccine candidates are being developed and will enter safety testing in humans in the near future, and the value of new TB treatment strategies is being assessed.
In addition to addressing HIV and TB coinfection through the Global AIDS Program, CDC works closely with USAID, international organizations, and 16 countries around the globe to control TB. International partners include the WHO and the International Union Against TB and Lung Diseases (IUATLD). Collaborative efforts include the Stop TB Partnership, technical support to USAID, and technical assistance to specific countries. Technical assistance is focused on countries that contribute most to U.S. cases, are high burden countries, have high rates of multi-drug resistant TB (MDR-TB), are of strategic importance (e.g. countries participating in the HHS Global AIDS Program), or provide opportunities to improve diagnosis and treatment of TB, MDR-TB, and HIV-associated TB.
Spearheaded by the WHO and its international partners, including HHS, a proven effective national case management strategy has been applied increasingly in developing nations. This strategy is termed DOTS — Directly Observed Therapy, Short-Course — which emphasizes consistent drug supply, microscopic based diagnosis, and direct observation of each dose of life saving medication. The World Bank has ranked DOTS as one of the most cost-effective of all health interventions. CDC works with WHO and other partners to expand the current DOTS strategy so that people with TB have access to effective diagnosis and treatment, and to adapt this strategy to meet the challenges of HIV and multi-drug resistance.
CDC and NIH are also involved actively in research on global malaria prevention and control. NIH is engaged in research both domestically and globally with a focus on malaria vaccine development and optimal use of the information on newly characterized malaria genome and the mosquito vector genome. CDC continues to work on U.S. domestic prevention and monitoring and on global collaborations with Ministries of Health, U.S. universities and schools of public health, and non-governmental and faith-based organizations in the prevention and control of malaria in malaria-endemic settings – — mostly in sub-Saharan Africa. In fact, much of the HHS global work on malaria is in the same setting where HIV prevention work is underway.
The HHS effort in malaria is widely collaborative with the Department of State, USAID and the Department of Defense. The U.S. leadership in the Global Fund to Fight AIDS, TB, and Malaria has been especially well-received in the malaria community.
Currently available control strategies for malaria have proven to be highly effective in saving lives. Effective antimalarial treatment exists that cures infection and disease. Effective prevention exists, as evidenced by the 20 percent reduction in child mortality with the use of insecticide-treated bed nets in Africa. Use of insecticide treated bed nets and preventive treatment can alter the impact of malaria dramatically in pregnant women and their newborns, improving newborn birth weight and reducing anemia in the mother and the newborn, and saving lives.
Finally, as with TB, malaria must also be seen in the context of HIV and AIDS prevention and control. Recent studies have shown that malaria and HIV interact broadly. Malaria causes anemia and the needed blood transfusions can be a source of HIV transmission. HIV-infected pregnant women contract the disease disproportionately and exhibit more severe complications, conferring a greater risk to the developing fetus and the newborn. Most recently, studies suggest that malaria is more severe in HIV-infected adults and that malaria may stimulate HIV viral replication, with potentially greater increased risk for HIV transmission. The widespread co-existence of malaria and HIV in Africa likely means that each is making the other worse and that addressing both is a good policy.
U.S. responses to SARS epidemic
Finally, Mr. Chairman, I would like to briefly address a timely subject that I know weighs on the minds of everyone concerned with public health — Severe Acute Respiratory Syndrome, or SARS. We're still finding out about the nature of the SARS virus and how it may be treated, so I don't want to provide purely speculative information here. What I would like to report is that HHS has been aggressively seeking cooperation on research and treatment with SARS-affected nations from the moment it was identified as a serious threat to global health.
Our partnership with one of the nations worst affected by SARS — the People's Republic of China — is a prime example of our determination. From the very beginning, HHS leadership and personnel have worked closely with Chinese authorities to provide assistance and support in their efforts to understand and contain this disease. On February 28th, I met with Vice Minister Ma in my office to express our concern about and offer assistance for what then appeared to be an avian flu in Southern China. In March, we sent CDC staff to China as part of the WHO team in Beijing. Since then we have had at least one, and sometimes up to three CDC staff working with WHO on SARS in China. On April 3rd, I called then-Minister of Health Zhang Wenkang to encourage China to accept and use the international assistance being offered by WHO. And this past Monday, I spoke with Vice Premier and new Minister of Health Wu Yi about this epidemic. I offered her a menu of options for more assistance focused not only on SARS, but also on public health epidemiology, laboratory, and surveillance training and capacity building. Our bilateral commitment to work with China on this and other epidemics is firm and long term.
I thank you again, and welcome any questions you have for me.
Last Revised: May 7, 2003