FY 1986 AIDS Budget

Explanation of Amendment Items

Health Resources and Services:

National Health Service Corps $5.5 million of
the $50 million requested in 1986 is in excess of
current requirements. This amendment can occur
because of increased acceptance of obligated
doctors to work in private placement settings
rather than as Federal employees. We are now
projecting that 1,140 new doctors in 1985 and
an additional 1,065 in 1986 will accept private
assignments.

Centers for Disease Control:

CDC Equipment Purchases $3.5 million of the
$5.5 million requested to purchase equipment for
the new Atlanta virology laboratory currently
under construction can be delayed. Completion of
the facility is anticipated in 1987, and further
equipment purchases will be considered in
subsequent budgets.

National Institutes of Health:

NIH Extramural Facilities Grants - $10.1
million of the $13.1 million requested for
facilities assis-tance grants in cancer, heart and
eye research can be reduced in 1986. Academic
departments receive these funds to renovate
research plants. The heart and eye programs ($6.6
million) are relatively new programs. The cancer
program will be funded at $3.0 million in 1986,
which is consistent with the appropriated levels
in 1984 and previous years.

NIH Buildings and Facilities - $9.9 million for
continued modernization of the Clinical Center
($7.4 million) and further design of renovations
to laboratory facilities ($2.5 million) on the NIH
campus. Both of these projects are long-term
rehabilitation efforts. The Clinical Center
project began in 1979 and was expected to extend
over 10 years. To date $33.3 million has been
appropriated for the estimated $87 million project.
The NIH also began in 1981 the rehabilitation of
six older laboratory buildings. A total of $23.6
million has been provided to date and the project
is expected to require at least 10 years to
complete.

In the case of both projects, the expectation is
that NIH would only forego the added 1986 appropri-
ations. The design and contracting of projects
from prior year funding will continue as planned
(funds usually remain unobligated for two years
due to the long construction time tables).
Despite this funding delay in 1986, we still
intend to complete the total project.

Indian Health Service:

O

IHS Tribal Management Incentive Awards - The $5
million requested in 1986 can be eliminated.
These funds were requested for the first time in
1986 to provide added administrative costs for
contracts with tribes to manage health programs.
Deferral of these extra administrative overhead
payments will not diminish our long-term efforts
to encourage tribes to take greater responsiblity
for the operation of health programs.

General Departmental Management:

Building Renovations - $3.8 million can be
deleted in 1986 from the GDM account. This
amount was included for renovations and
modifications to our office building to achieve
space savings. Necessary modifications can be
minimized and other savings may occur during the
year that should allow us to continue our efforts
to reduce office space in the Office of the
Secretary.

Current
Revised President's
Budget Amended
FY 1984 Estimate Redirection Estimate Request Redirection Amendment Request

Mr. WAXMAN. Our first witness is Dr. James Mason, the Acting Assistant Secretary for Health, Department of HHS, and the Director of the Centers for Disease Control.

Dr. Mason has led the Public Health Service's efforts on AIDS and initiated the reevaluation of resources that led to Friday's budget announcement.

Dr. Mason, let me welcome you and the others with you to this hearing today, and let me thank you for your work.

Before we go further, let me try to outline an important part of today's hearing that may be confusing.

There are two types of AIDS treatments we are discussing today: AIDS taxes the immune system and makes the immune system itself sick. After this attack, the body then gives way to a variety of other illnesses, which all have their own signs and indications. They are really symptoms themselves, so when we speak of treatment for AIDS, we can be speaking of either of two different things: Treatment for one of the AIDS-related infections such as pneumonia or skin cancer; or treatment of the immune collapse itself.

Everyone would prefer to treat the underlying AIDS. No drug is equal to the body's natural defenses against disease, but AIDS is an elusive and difficult illness, and for the sake of those who are desperately sick now, the treatment of the infections is also an important goal.

Dr. Mason, please proceed and tell us what we are doing and how well we are doing and what the chances are for those who are looking for some hope.

STATEMENT OF JAMES O. MASON, M.D., Dr.P.H., ACTING ASSISTANT SECRETARY FOR HEALTH, PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES, ACCOMPANIED BY GEORGE J. GALASSO, ASSOCIATE DIRECTOR FOR EXTRAMURAL AFFAIRS: AND SAMUEL BRODER, ASSOCIATE DIRECTOR, CLINICAL ONCOLOGY PROGRAM, DIVISION OF CANCER TREATMENT, NATIONAL CANCER INSTITUTE

Dr. MASON. Thank you, Mr. Chairman.

I am pleased to provide an update of the Public Health Service's [PHS] activities involving drug research and testing in the treatment of the acquired immunodeficiency syndrome [AIDS]. I will discuss some of the difficulties of research in this area, describe the impact of the discovery of the causative agent, and outline current and past efforts of the PHS regarding the treatment of AIDS.

With me today are Dr. George J. Galasso, Associate Director for Extramural Affairs; Dr. Samuel Broder, Associate Director, Clinical Oncology Program, Division of Cancer Treatment, National Cancer Institute [NCI]; Dr. Clifford Lane, Deputy Clinical Director, National Institute of Allergy and Infectious Diseases [NIAID], National Institutes of Health [NIH]; and Dr. Elaine Esber, Director, Office of Biologics Research and Review, Center for Drugs and Biologics, Food and Drug Administration, [FDA].

Before the causative agent was known, therapy for AIDS patients was quite empirical. Special emphasis was given to agents known to stimulate the immune system, to treatment of infectious

complications, and to the treatment of Kaposi's sarcoma. After the discovery in May 1984 that the etiological agent was a human retrovirus, the philosophy of selecting new agents for treatment changed.

Scientists could now direct therapeutic efforts to the underlying causative agent. However, the problem was complicated by the fact that AIDS may directly or indirectly affect many organ systems, and there may be a long incubation time before fulminant AIDS develops.

The virus destroys the immune system, rendering the patient susceptible to a variety of infections by opportunistic organisms. Research on treatment modalities must be focused in three directions simultaneously: The development of (1) antiviral agents to inhibit the replication of HTLV-III, (2) a means of reconstituting the immune system, and (3) a means of treating the opportunistic infections and cancers that afflict these patients.

There are many difficulties in doing clinical research on AIDS therapy. In addition to identifying the appropriate drugs and establishing the appropriate dosage, additional studies are needed to select the optimal combinations of various agents in order to assure that the drugs chosen are not antagonistic. The determination of the endpoint of drug effect may be technically difficult.

For example, one endpoint for an antiretroviral agent would be cessation of viral shedding. Virus isolation and quantitation is extremely difficult, time consuming, and expensive; therefore, an intense effort has gone into searching for alternate modes of detecting viral levels in the patient with AIDS.

Important new developments show progress in this area. This technology, which is in its infancy, will develop into a methodology by which we will be able to rapidly screen large numbers of patients for the AIDS virus and be able to follow changes in the virus levels during treatment with potential antiretroviral compounds.

As we have learned more about the molecular biology of viral replication, we have been able to identify virus-specific components against which chemical agents could be directed without harming the cell. All of the antiviral agents developed to date have come about through serendipity, but the potential for developing a targeted antiviral agent exists.

The chart on my left which shows retrovirus growth, illustrates several areas where we can target therapy.

The AIDS virus is unusual in that it produces and utilizes a special enzyme called reverse transcriptase. Thus, interference with the action of this enzyme is a potential approach to the therapy of an infection with the AIDS virus, and has been one of the prime focuses of AIDS antiviral therapy to date.

There are several other agents which can be used to inhibit viral replication that are shown on the next chart.

The first step in infection of the cell is attachment of the virus to a specific receptor site on the cell surface. Agents could be developed which would react with the virus or the cell surface to prevent attachment and entry. Antibodies function in this manner. After entry, the virus is uncoded and the RNA released.