June 5, 2000
The Clinton Administration has responded aggressively to the significant threat posed by HIV/AIDS with increased attention to research, prevention, and treatment. Overall funding for AIDS-related programs within HHS has increased by 150 percent under the Clinton Administration, with funding for AIDS care under the HHS Health Resources and Services Administration's Ryan White CARE Act increasing by 358 percent and assistance for the purchase of AIDS drugs increasing by 965 percent. The FY 2001 budget includes $9.2 billion in total HIV/AIDS funding within HHS.
At the same time, the Administration has sharpened the focus of its AIDS programs, establishing a new Office of National AIDS Policy at the White House, and signed legislation creating a permanent Office of AIDS Research at the National Institutes of Health (NIH). The Administration also convened the first-ever White House Conference on HIV and AIDS in December 1995, released the first National AIDS Strategy in December 1996, and prepared the first federal biomedical research plan in 1997. In May 1997, President Clinton announced a comprehensive AIDS vaccine research initiative designed to lead to the development of an AIDS vaccine within 10 years, and in 1998, the Food and Drug Administration approved the nation's first large-scale trial for an AIDS prevention vaccine. In addition, President Clinton announced the Millennium Vaccine Initiative on May 31, 2000 which calls for sharp increases in vaccine research at the National Institutes of Health, new investments for the purchase and delivery of existing vaccines and a substantial tax credit for the private sector to speed the development of new vaccines.
Recognizing the unique situation facing Africa, President Clinton signed an Executive Order on May 10, 2000 which assists sub-Saharan African governments that promote access to HIV/AIDS pharmaceutical and medical technologies. This order will give sub-Saharan governments the flexibility to bring life-saving drugs and medical technologies to affected populations.
Today, HIV research efforts are making real inroads. New drugs are providing vast improvements in the treatment of HIV and AIDS, and new treatment guidelines released by HHS are giving health professionals much needed guidance to help standardize care of individuals living with HIV and AIDS. As a result of these more powerful anti-HIV drugs, the National Center for Health Statistics announced on October 5, 1999, that HIV/AIDS mortality has declined more than 70 percent since 1995, and AIDS cases are no longer among the top 15 causes of death, a fall from 8th place in 1996. Overall, the age-adjusted death rate from HIV infection is the lowest since 1987.
This reflects the greatly improved treatments for those living with HIV. But transmission of the disease continues, and effective prevention efforts are still crucially important.
The trends in AIDS death rates are uneven across racial and ethnic groups. In 1998, President Clinton declared HIV/AIDS to be a severe and ongoing health crisis in racial and ethnic minority communities and announced a comprehensive new initiative in collaboration with the Congressional Black Caucus to improve the nation's effectiveness in preventing and treating HIV/AIDS in the African-American, Hispanic and other minority communities. On June 16, 1999, the Administration announced that Detroit, Philadelphia and Miami would be the first of 11 U.S. metropolitan areas to receive special technical assistance from federal Crisis Response Teams to help combat the spread of HIV/AIDS among racial and ethnic minority populations. The Crisis Response Teams are meeting with local officials, public health personnel and community-based organizations that work with racial/ethnic minority persons living with HIV/AIDS to help them develop targeted strategies to curb the rapid spread of HIV/AIDS among minority populations in their communities.
The President's FY 2001 budget proposes an increase of $66 million, for a total of $795 million, for programs focused in two areas - domestic prevention and global AIDS. This increase in funding for HIV activities at the Centers for Disease Control and Prevention (CDC) will be used to encourage individuals at risk to avoid behaviors that can result in the transmission of the disease. Internationally, the President's budget includes $61 million for CDC, an increase of $26 million, or 74 percent, to continue efforts to prevent the spread of HIV in developing nations. It is estimated that currently there are 22 million adults and 1 million children living with HIV/AIDS in the Sub-Saharan region of Africa.
The FY 2001 budget will also invest an additional $125 million, for a total of $1.72 billion, in the Ryan White Program, an increase of almost 8 percent over last year's funding level, to provide primary medical care and other crucial support services for people living with HIV and AIDS among increasingly vulnerable populations. This increase will allow an additional 2,900 persons to receive drug therapy through the AIDS Drug Assistance Program (ADAP). These drugs have helped to decrease the progression of HIV to AIDS as well as improve the quality of life for people living with HIV/AIDS.
The FY 2001 budget also requests a total of $2.1 billion for AIDS-related research at the NIH. This is an increase of $105 million, or 5.2 percent over the FY 2000 level. It represents a 97 percent increase in funding for NIH AIDS-related research since FY 1993.
Further, the FY 2001 budget requests $128.4 million for the Substance Abuse and Mental Health Services Administration (SAMHSA) to address substance abuse and mental illness specifically as they relate to HIV/AIDS. This is an increase of $14.8 million, or 13 percent, over the FY 2000 level. The majority of this funding will be used for the HIV set-aside of the Substance Abuse Block Grant and Targeted Capacity Expansion programs for substance abuse treatment, prevention, and HIV/AIDS services focused on building infrastructure in racial and ethnic minority communities highly impacted by the HIV/AIDS epidemic.
Under President Clinton, a wide array of initiatives has been undertaken including:
AIDS Policy. In 1993, the President created the Office of National AIDS Policy within the White House to advise him on AIDS policy issues and coordinate interdepartmental activities.
AIDS Conference. On December 6, 1995, the President convened the first White House Conference on HIV and AIDS, bringing together more than 300 experts, activists, and citizens from 37 states, the District of Columbia, and Puerto Rico for a full day of discussions of key issues.
Advisory Council. In 1995, the President created the Presidential Advisory Council on HIV and AIDS to provide him and his Administration with expert outside advice on ways in which the Federal government should respond to the HIV/AIDS epidemic. A National Leadership Forum was conducted in August 1996 to improve collaboration on preventing substance abuse and the spread of HIV/AIDS. President Clinton asked that a meeting of state and local individuals involved in both public health and substance abuse prevention be convened to develop an action plan that integrates prevention of HIV/AIDS and substance abuse.
AIDS Strategy. On December 17, 1996, the Clinton Administration released the first National AIDS Strategy, establishing goals for the nation and opportunities for immediate progress. During each year of this Administration, the NIH has prepared a comprehensive strategy for HIV-related research.
AIDS Vaccine Initiative. On May 18, 1997, President Clinton challenged the nation to commit itself to the goal of developing an AIDS vaccine within the next ten years. The President also announced a number of important initiatives to help fulfill this commitment, including high-level international collaboration, a dedicated research center for AIDS vaccine research at NIH, and outreach to scientists, pharmaceutical companies, and patient advocates to maximize the involvement of both private and public sectors in the development of an AIDS vaccine. As of June 1998, NIAID-supported researchers had evaluated 27 vaccine candidates and 12 adjuvants (substances incorporated into a vaccine that boost specific immune responses to the vaccine) in more than 3,000 volunteers in phase I/II clinical trials. On June 3, 1998, the Food and Drug Administration granted permission to VaxGen Inc. for the nation's first phase III clinical trial for an AIDS prevention vaccine. The trial of the vaccine, called AIDSVAX, will include at least 5,000 volunteers from the U.S., Canada and Europe and will last up to five years. A separate phase III trial of AIDSVAX in Thailand will enroll 2,500 volunteers.
NIH has increased funding for AIDS vaccine research by 100 percent since the President's challenge in 1997, resulting in the award of new grants to foster innovative research on HIV vaccines, including vaccine design and development, and the invigoration and reorganization of the NIH vaccine clinical trials effort. Construction of the new intramural Vaccine Research Center is expected to be completed this summer. In February 1999, NIH-supported investigators initiated the first AIDS vaccine trial in Africa. The AIDS Vaccine Research Committee, chaired by Nobel laureate Dr. David Baltimore, continues to provide critical advice on all aspects of the NIH AIDS vaccine development program.
Research. In one of his first acts in office, President Clinton signed the National Institutes of Health Revitalization Act of 1993, placing full responsibility for planning, budgeting, and evaluation of the AIDS research program at NIH in the Office of AIDS Research. The President requested and received the first federal plan for biomedical research on AIDS.
NIH clinical trials continue to study new antiretroviral drugs and combinations of therapies to prevent disease progression and HIV-associated opportunistic infections and malignancies. NIH has also implemented guidelines requiring the inclusion of women and minorities in clinical trials.
NIH-supported research was pivotal to discovering and defining the importance of the HIV protease enzyme. NIH-supported scientists helped determine the precise three-dimensional structure of HIV protease, a crucial step in designing drugs that block the action of the enzyme. NIH also supported researchers who helped drug-screening efforts by developing simple, rapid tests to measure the inhibition of protease activity. These accomplishments set the stage for NIH's collaboration with the pharmaceutical industry in developing the new class of anti-HIV drugs known as protease inhibitors. NIH worked closely with industry as they designed, produced, and clinically tested protease inhibitors. This collaboration helped speed product development. NIH-supported investigators conclusively demonstrated that triple-drug combinations with a protease inhibitor and two other anti-HIV drugs were more effective than one- or two-drug regimens for long-term suppression of HIV. Basic researchers at NIH laboratories have helped explain why HIV can rebound in patients who discontinue combination therapy, and continue to open new avenues for drug development.
NIH researchers demonstrated the benefits of AZT therapy for preventing mother-to-infant transmission of HIV. A recently completed NIH study in Uganda demonstrated the effectiveness of another less expensive therapy, nevirapine, in decreasing risk of perinatal HIV transmission.
Drug Approvals. Since 1993, the FDA has approved 11 AIDS drugs and 22 drugs for AIDS-related conditions, and accelerated approval to record times. Included in those approvals are a new class of drugs known as protease inhibitors, which have proven to be dramatically effective in the treatment of HIV disease. In March 1997, the FDA approved the first protease inhibitor with labeling for use in children.
Prevention. HIV prevention efforts in the United States have significantly reduced the incidence of HIV infections. Prevention initiatives have helped slow the rate of new HIV infections in the United States from more than 150,000 in the late 1980s to approximately 40,000 today. Specifically, the number of U.S. infants who acquire AIDS from mother-to-child transmission dropped by 75 percent from 1992 to 1998.
Both the CDC and the NIH conduct prevention research to assure that prevention efforts are based on sound behavioral and biomedical science. In addition, the CDC supports several community prevention programs, working with local health departments and organizations to provide technical assistance and build capacity in governmental and non-governmental organizations delivering HIV prevention services.
On June 18, 1998, the National Institute of Mental Health (NIMH) at the NIH announced that the NIMH Multisite HIV Prevention Trial found that even among persons considered hardest to reach, educational sessions that motivate and offer specific strategies to reduce high-risk sexual behaviors can cut those behaviors in half. The National Institute on Drug Abuse at the NIH has also conducted research on understanding the trends in HIV transmission among drug users and their sexual partners, as well as ways to reduce viral spread. As a result, innovative models of outreach have been developed to help stem the spread of HIV among this at-risk population.
The Substance Abuse and Mental Health Services Administration's (SAMHSA) Center for Mental Health Services (CMHS) funds Project Shield, the HIV/AIDS High-Risk Behavior Prevention/Intervention Model for Adolescents/Young Adults and Women Program. Project Shield is a four year, multi-site effort which is developing, implementing and evaluating a community-focused intervention to reduce high-risk behaviors among individuals at high risk for HIV-infection. SAMHSA also supports specialized Targeted Capacity Expansion grants to increase the capacity of minority community-based organizations to provide integrated substance abuse prevention and HIV prevention services.
Substance Abuse. More than one-third of all AIDS cases are directly or indirectly attributable to substance abuse. Current evidence indicated that substance abuse treatment greatly reduces risk behaviors associated with the transmission of HIV. SAMHSA currently supports a Community-Based HIV/AIDS Outreach program that targets high risk injecting drug users and two Targeted Capacity HIV programs that support HIV/AIDS and substance abuse treatment and expansion to racial and ethnic communities in high AIDS case rate areas. It is the goal of the latter two programs to assist the targeted communities to develop the infrastructure to proportionately share in the federal resources allocated for HIV/AIDS. In addition, SAMHSA's Substance Abuse Prevention and Treatment Block Grant HIV set-aside provides funds for HIV counseling and testing in states with high AIDS care rates.
Mental Health. SAMHSA's Center for Mental Health Services (CMHS) has a High Risk Prevention/Intervention Program, designed to develop and test, through a series of pilot studies, a single model for a brief, short-term prevention/intervention protocol, to encourage and enable adolescents/women who engage in high-risk behaviors associated with HIV/AIDS transmission to change these behaviors. In addition, CMHS has a Treatment Adherence, Health Outcomes, and Associated Costs Study. It is a collaborative effort of six bureaus/center/institutes and is designed to determine the effectiveness of treatment adherence models, health outcomes, and costs associated with the provision of integrated mental health, substance abuse, and HIV/AIDS primary care services for people living with HIV/AIDS who have both a mental disorder and a substance abuse disorder. The CMHS also has a program designed to disseminate to mental health care providers state of the art knowledge about how to identify and treat the psychosocial and the neuropsychiatric sequelae of HIV/AIDS and to develop knowledge on how to be more effective in its dissemination. It is also designed to pilot test an HIV/AIDS ethics curriculum.
Surveillance. CDC works with state and local health departments to track the number of AIDS cases in different areas. In December 1999, after extensive work with state health departments and community HIV/AIDS organizations, CDC released guidelines to assist states in designing and implementing effective HIV surveillance systems. These guidelines include specific standards for both quality and confidentiality, reflecting CDC's responsibility to balance the need for better data with legitimate concerns about confidentiality and security. They also stress the continued importance of anonymous testing as an essential component of any surveillance system.
While the guidelines set out strict confidentiality and quality standards for HIV surveillance data, they do not dictate the type of surveillance system used to gather those data. CDC does believe that, based on its review of currently available studies of name-based reporting systems, that such systems are most likely to provide data that meets the quality standards. However, a state can use any surveillance system that meets the performance criteria specified by CDC.
Racial and Ethnic Minorities. While racial and ethnic groups account only for about 25 percent of the U.S. population, they account for more than 50 percent of all AIDS cases. While overall AIDS deaths are down, AIDS remains the leading killer of African-American males age 25-44. In early 1998, the President revealed a major, new Federal initiative to eliminate racial and ethnic disparities in HIV/AIDS and five other key areas of health. In FY 1999, CDC funded the first phase of the Racial and Ethnic Approaches to Community Health 2010 (REACH) program at $10 million. This demonstration program will enable multiple communities to design and test community-tailored interventions to improve the health of minority populations. In FY 2000, Congress has appropriated $30 million to continue and expand the REACH demonstrations. In addition, Congress has provided increases in several public health programs such as Community Health Centers that, in partnership with community, advocacy and tribal organizations, would expand and adapt proven public health strategies to better reach minority populations.
In 1998, President Clinton declared HIV/AIDS to be a severe and ongoing health crisis in racial and ethnic minority communities and announced a comprehensive new initiative in collaboration with the Congressional Black Caucus to improve the nation's effectiveness in preventing and treating HIV/AIDS in the African-American, Hispanic and other minority communities.
The NIH has implemented a series of guidelines, policies, and programs to ensure that HIV-infected individuals from the most at-risk populations for HIV/AIDS are enrolled and accrued into federally-sponsored AIDS studies. In 1994, NIH implemented revised Guidelines on the Inclusion of Women and Minorities in Clinical Research, requiring applicants to address the appropriate inclusion of women and minorities in clinical research. Applications that fail to meet these requirements, as evaluated by peer review, are barred from funding.
The FY 1999 and FY 2000 Public Health and Social Services Emergency Fund appropriations provided $50 million to address the high-priority HIV prevention and treatment needs of minority communities heavily impacted by HIV/AIDS. Utilizing these funds, significant steps have been taken to respond to this threat through enhancements in technical assistance, research, treatment and prevention initiatives. The President's FY 2001 budget proposal continues this important funding.
Ryan White CARE Act. HRSA's HIV/AIDS Bureau administers the Ryan White CARE (Comprehensive AIDS Resources Emergency) Act, which was enacted in 1990 to provide primary care and supportive services for low-income, underinsured and uninsured individuals and families affected by HIV/AIDS. Since FY 1991, $7.5 billion has been appropriated for CARE Act programs. The AIDS Drug Assistance Program (ADAP) authorized under Title II of the CARE Act, provides medications to low-income persons with HIV. HRSA funding for this program has increased by 965 percent under the Clinton Administration.
On May 20, 1996, President Clinton signed a five-year reauthorization of this program, continuing funding authorization for the program until the end of the year 2000. The FY 2001 budget includes $1.7 billion for Ryan White CARE Act activities to support medical care and supportive services for vulnerable populations. For the ADAP program, the budget proposal includes $554 million, a 5 percent increase over FY 2000.
Needle Exchange. Scientific research supported by NIH has shown that needle exchange programs can be an effective component of a comprehensive strategy to prevent HIV and other bloodborne infectious diseases in communities that choose to include them, and do not encourage the use of illegal drugs. The Administration has communicated what has been learned from the science so that communities can construct the most successful programs possible to reduce the transmission of HIV, while not encouraging illegal drug use.
Perinatal Transmission. Following the release of research findings from an NIH-sponsored AIDS clinical trial that indicated that use of AZT by HIV-infected pregnant women dramatically reduced the rate of HIV transmission from mother to infant, the U.S. Public Health Service issued guidelines recommending routine counseling and voluntary HIV testing for all pregnant women. For those found to be HIV infected, the use of AZT during pregnancy is recommended. In developing countries, where this AZT regimen is too costly and difficult to administer, the rate of mother-to-infant HIV transmission continues to rise. NIH researchers continue to search for simpler and less-expensive ways to prevent mother-to-infant transmission of HIV which can be used globally.
Treatment Guidelines. HHS regularly releases updates and draft guidelines for treating HIV-infected adults, including pregnant women, adolescents, children, and infants with antiretroviral drugs. The guidelines, developed by panels of AIDS clinicians and researchers, reflect the current state of knowledge about HIV disease and antiretroviral drugs, and will help standardize and improve the quality of care for HIV-infected persons in the United States.
Housing. The Department of Housing and Urban Development has established the National Office of HIV/AIDS Housing to assist people with HIV/AIDS to pay for housing. Funding for the Housing Opportunities for Persons with AIDS program has increased by 10 percent. On December 1, 1998, Vice President Gore announced that he would release $200 million in funds to assist communities around the country to prevent individuals affected by HIV/AIDS and their families from becoming homeless. This represents a $21 million increase for the HUD program in FY 1999. In addition, HUD and HHS have launched collaborative efforts to combine housing assistance, medical and social services for people living with HIV/AIDS, including testing outreach programs and other special efforts for people with multiple diagnosis.
Water Safety. The CDC and the Environmental Protection Agency issued guidelines recommending steps to purify drinking water to protect vulnerable populations against Cryptosporidium, which can be fatal to those with compromised immune systems.