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
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
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
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
- 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
- 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.
The Office of AIDS Research requests a consolidated appropriation of
$1,540,765,000 for NIH AIDS research through the OAR. The budget authorities
provided to the Office of AIDS Research, allowing us to make resources available where
the greatest opportunities lie, are even more critical today as the scientific opportunities
are constantly changing. We are grateful to the Committee for your continued support for
AIDS research and for providing us the flexibility critical to meeting these enormous
scientific challenges. I would be pleased to answer any questions.