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Testimony on Office of Aids Research's FY 1998 Budget by Dr. William E. Paul
Director, Office of Aids Research
National Institutes of Health
Accompanied by
Dr. Jack Whitescarver, Deputy Director, OAR
Ms. Wendy Wertheimer, Senior Advisor, OAR
Ms. Donna Adderly, Senior Budget Analyst, Office of Financial Management
and
Dr. Harold Varmus, Director, NIH
Mr. Dennis P. Williams, Deputy Assistant Secretary, Budget, HHS

U.S. Department of Health and Human Services

Before the House Appropriations Committee, Subcommittee on Labor, Health and Human Services, Education and Related Agencies
March 20, 1997

Mr. Chairman, this has been a year of progress and promise in AIDS research, a year clearly demonstrating the dividends made possible by our national investment in biomedical science. So striking was this progress that Science Magazine named the "New Weapons Against HIV" as the breakthrough of the year, and Time Magazine named Dr. David Ho, an NIH-supported investigator and a member of our OAR Advisory Council, as its Man of the Year, the first time a scientist has been so honored since 1960.

After many years of slow and incremental advances against a relentless epidemic, we can take collective pride in the dramatic changes that have occurred just since our hearings here last year. Protease inhibitors, a new class of drugs, used in combination "cocktails" with other antiretroviral therapies, have been shown to dramatically diminish the amount of HIV in the blood of an infected individual. Receptors for molecules called chemokines have been identified as critical co-factors for HIV infection. Individuals who have defects in one set of these receptors are protected from HIV-infection despite exposure to the virus. These findings provide an entirely new approach for the development of anti-HIV therapies.

These critical advances have brought a sense of hope and renewed vigor to the AIDS research community and to our patients. But it is essential to point out that the news, while good, cannot lead to complacency. The covers of some magazines may fantasize about the "end of AIDS," but, Mr. Chairman, the end of this pandemic is nowhere in sight.

The new drugs, while promising, are not a panacea. We do not know how long the benefits of the drugs will last, whether the virus will become resistant to the drugs, or whether such drug-resistant strains of the virus could be transmitted. It is far from clear that immune function of treated individuals will be restored without additional intervention. There are many people for whom the new drug regimens have not been effective or for whom the side-effects are not tolerable. Access to and affordability of the therapies is also problematic. Although the virus has been brought to undetectable levels in the blood and in some lymphoid tissues, it is still not known whether there are other sanctuaries where the virus may reside in the body.

The sobering fact is that we have made virtually no progress against the devastating spread of the epidemic around the globe. AIDS is the number one cause of death among young adults in the United States. Rates of increases in AIDS cases in the U.S. are greatest for women, adolescents, persons infected through heterosexual contact, minorities, and injecting drug users. More than 29 million men, women, and children around the world have been infected with HIV; over 3 million of those infections occurred in just the past year. More than 90% of these infections occur in the poorest parts of the world, in countries without the resources or the health care systems to benefit from our successes in the development of anti-HIV drugs. AIDS has brought about a significant decline in overall life expectancy in many African countries, threatening the economies of these already poor nations and robbing them of their workforce. A safe and effective AIDS vaccine is an urgent global public health imperative. Without a vaccine, AIDS will soon overtake tuberculosis as the leading infectious cause of death in the world. Thus, we can take no solace from our advances nor can we diminish our urgent search for better therapies and for a protective vaccine.

Three years ago, the prospects in AIDS research appeared dim. The International AIDS Conference in Berlin left many scientists and patients dismayed. After the initial burst of knowledge about the virus and development of the original reverse transcriptase inhibitors, progress had slowed, and the pipeline of new potential drugs or vaccines seemed empty. The OAR convened a small group of eminent scientists, including a number of Nobel Laureates. We asked them to help us identify the critical gaps in our knowledge about AIDS and to suggest what steps could be taken to open new scientific opportunities and move the science forward.

That meeting was held at the Stone House of the Fogarty International Center, and has proven to be a pivotal moment for AIDS research. At the meeting, the late Dr. Bernard Fields stated his firm conviction that further advances against the virus would require the NIH to shift its priorities and its resources to bring about what he termed a "rededication to fundamental science." Without this basic knowledge, the pipeline would remain empty.

The OAR examined all NIH AIDS research funding to determine the best way to bring about this rededication to fundamental science. In every budget since that year, we have increased the proportion of funding for basic research. The OAR has placed greater emphasis on investigator-initiated science, increasing the number of research grants by 50% between FY 1994 and this FY 1998 request. This has encouraged innovation from a wider group of investigators.

Another important initiative emerged from the "Stone House" meeting. Dr. Phillip Sharp, a Nobel Prize winner, presented the idea that in order to plot a course for the future, we needed to understand all of the facets of the existing AIDS research program, which by then already had spanned all of the NIH institutes and centers. He suggested that a critical evaluation of the entire program was necessary, to assure that the most promising areas of science are being supported, that the critical scientific questions are being addressed, and that the most effective use is being made of federal AIDS research resources.

As you know, that discussion led to the evaluation of the entire AIDS research program, a review of unprecedented scope and breadth, lead by Dr. Arnold Levine of Princeton University. The report of that review, commonly known as the Levine Report, has provided guidance to the NIH for strengthening our AIDS research program to move more effectively and efficiently toward our goal of preventing and curing AIDS. This report is not sitting on a shelf gathering dust. The recommendations helped frame the OAR's final distribution of the FY 97 appropriation, and are reflected in our research plan and budget request for FY 98. An implementation process is underway. I would like to update you on some of the changes that have already occurred.

The highest recommendation of the Levine Report confirmed what OAR had already set in place, that is, the need to increase investigator-initiated research. The report also recognized that only a truly effective preventive anti-HIV vaccine can limit and eventually eliminate the threat of AIDS. Thus, the next priority of the reviewers was the need to restructure and reinvigorate the AIDS vaccine program, with leadership and guidance from eminent non-government scientists.

We have taken two important steps to carry out this critical recommendation. Nobel Laureate Dr. David Baltimore has been recruited to lead this effort, and he has gathered a group of outstanding scientists to serve with him. Their charge is to stimulate the integration of basic research advances in immunology and vaccine science to energize the development of new HIV vaccine strategies. To facilitate this effort, OAR has made a major financial investment in AIDS vaccine research. The FY 98 budget request represents a 33.6% increase for vaccine research over FY 96, a sign of our commitment to this effort. The President also highlighted the importance of this effort in his State of the Union address.

Some have argued that a protective anti-HIV vaccine is simply not possible because of the variability among the viruses that are being transmitted in any given population, because of the high mutation rate of the virus, and because the principal cells that are infected are themselves essential to a highly effective immune response. But, as an immunologist, I believe there is persuasive evidence that a protective immune response can be induced and that an effective vaccine is possible. I also believe that the government has a unique role and obligation to support the basic research needed for the development of a successful vaccine.

The Levine Report stresses the need for greater emphasis on prevention of HIV infection. In addition to a stronger vaccine research effort, the report urged NIH to develop a Prevention Science Agenda combining biomedical interventions -- such as microbicides, female-controlled barriers, methods to prevent mother-to-child transmission, and STD prevention and treatment -- with behavioral interventions. OAR convened a group of experts, chaired by Dr. James Curran of Emory University, to assist us in identifying the most promising areas for additional investment. OAR will provide additional resources to the institutes to fund proposals devoted to HIV prevention.

With these actions, OAR believes that the necessary balance has been established between research to develop treatments for those who are infected and to develop vaccines and other prevention methods for those who are at risk. This balance is a delicate one, and may shift as science progresses.

Thus, the FY 98 budget request for AIDS research has been crafted to reflect the recommendations of the Levine Report and the broad consensus on the current scientific opportunities. The scientific priorities that have framed this request are:

• A rededication to fundamental science, emphasizing investigator-initiated research;
  
  
• A stronger vaccine research and development effort with the goal of bringing products to clinical trials as soon as warranted;
  
  
• An augmentation of research efforts to better understand the human immune system;
  
  
• An emphasis on prevention science research, including enhanced studies of risk-taking behavior and the development of strategies to avert infection;
  
  
• A vigorous therapeutic research program, emphasizing both drug discovery and an efficient clinical trials system, with additional emphasis on increased participation of women and minorities.

Mr. Chairman, we are reaping the rewards of years of work by dedicated scientists. Those who met at the Stone House set a new course for AIDS research, building a stronger foundation of basic science and relying on the ingenuity and creativity of investigators. Following that course, we have gained new knowledge of the basic biology of HIV and developed new targets for therapies and vaccine development. But we cannot diminish our efforts, for we are just beginning to unlock the mysteries of this disease. The science of AIDS is moving forward and opening whole new areas of research that can advance the treatment and prevention not only of AIDS, but of a vast number of other diseases as well.