STATEMENT OF DR. JAMES MASON

I am pleased to have this opportunity today to discuss the Public Health Service's efforts in combating the epidemic of AIDS and to review our financial commitment to these efforts. In my brief remarks, I would like to review what we have learned about AIDS since 1981 and to outline how we have used this knowledge to act responsibly and rapidly and to plot future strategies. Four PHS agencies--the Alcohol, Drug Abuse, and Mental Health Administration (ADAMHA); the Centers for Disease Control (CDC); the Food and Drug Administration (FDA); and the National Institutes of Health (NIH)--have made significant contributions to our understanding of the disease. Accompanying me today are Dr. Donald I. Macdonald, Administrator of ADAMHA; Dr. Donald R. Hopkins, Acting Director of CDC; Dr. Frank E. Young, Commissioner of FDA; and Dr. James Wyngaarden, Director of NIH. In their testimony, each will describe the efforts under way and the agency's plans for both the request made in the FY 1986 budget as well as those made recently for supplemental funds.

I would like to mention that the activities of the agencies are coordinated through a PHS Executive Task Force on AIDS chaired by the Assistant Secretary for Health which meets biweekly. This Task Force was established by former Assistant Secretary for Health Edward Brandt, and it continues to be an important forum to communicate, coordinate, review policy, and to formulate future plans for combating this dread disease. Within this Task Force, subgroups are charged with working within specific areas. These include the following:

O Vaccine Development and Therapeutic Intervention:

Dr. James Wyngaarden, NIH.

Chaired by

O Epidemiology and Prevention: Chaired by Dr. Donald Hopkins, CDC.

Blood and Blood Products: Chaired by Dr. Harry Meyer, FDA.

Psychological, Psychiatric, and Addictive Aspects: Chaired by

Dr. Donald Macdonald, ADAMHA.

Through these subgroups, the agencies coordinate their efforts in a number of areas, including blood donor studies and development of animal models. In testimony of the agency heads, you will hear of the role each agency plays in these activities. There are also three panels of the PHS Executive Task Force on AIDS which coordinate activities in information development, resources, and science.

Acquired immune deficiency syndrome is a disease of epidemic proportions and a national health problem unprecedented in recent history. There is little question that today we are witnessing an epidemic of fear. People from all walks of life feel threatened by AIDS, and they feel helpless in the face of an almost universally fatal disease. Secretary Margaret Heckler has made control of this disease our number one public health priority.

The first case of AIDS was reported to the Centers for Disease Control in June of 1981, although we now believe that the onset of the disease in the U.S. may go back to 1977. We do not know its origins. Some recent studies suggest that the disease existed in central Africa in the early to mid-1970s. The number of AIDS cases reported in the U.S. has doubled each year as shown in Chart 1. We know of over 13,000 reported cases, but we believe that as many as one-half million to one million persons in the United States are infected with the AIDS virus. Studies in homosexual men infected with the AIDS virus indicate that 5 to 10 percent will develop AIDS within two to five years after becoming infected. The case fatality rate among AIDS patients is high. Over 50 percent of

reported cases are known to have died. For those diagnosed with AIDS f two years or longer, the mortality rate is over 85 percent.

There is no doubt that the principal mode of transmission is through sexual contact. Chart 2 shows that nearly 75 percent of the AIDS cases among adults are related to sexual transmission. Most of these cases (about 74 percent) have occurred among homosexual or bisexual males. Another 1.2 percent have occurred among heterosexual partners of high risk groups.

Another major mode of transmission is through sharing of needles among 1 drug abusers. This mode accounts for from 17 to 25 percent of cases. There is some overlap between homosexual men who use IV drugs. The risk for transmission of the AIDS virus through transfusion of blood or blood products, which in the past accounted for 2.2 percent of AIDS cases, or through transfusion of clotting factor (0.8 percent of cases that occurred in persons with hemophilia) has been virtually eliminated. This is because a screening test, which detects antibody to the AIDS virus, i now used routinely by blood banks and plasma centers. In addition routine heat and chemical treatment render clotting factor free of the virus. In March 1983, the PHS issued guidelines recommending the voluntary avoidance of donation of blood and plasma by members of high-risk groups. Continued enforcement of these guidelines by centers provides an added layer of protection from acquiring AIDS through transfused blood, blood products, or clotting factor.

We now know that infected mothers can transmit the virus to their babies across the placenta and, likely, through breast milk. Although the AIDS virus has been isolated from human saliva and tears, there is no evidence that transmission has occurred through these routes.

There has not been a single case of AIDS reported to us in family members

of AIDS patients, except for sexual partners and children born to infected women. In studies of over 300 household contacts, not one person--other than a sexual contact or a child born to an infected mother--has become seropositive or developed AIDS as a result of living with AIDS patients. In studies of more than 1,472 health care workers, who have close contact with very ill, often hospitalized, AIDS patients, not one has developed AIDS or become seropositive as a result of contact with patients, other than through needle stick injury. Eighteen health care workers have had positive test results. Of these 18, all but three belonged to risk groups. The other three suffered needle stick injuries, and we continue to strongly urge people handling needles to observe the precautions PHS published in November 1982.

These studies allow us to say with a high degree of certainty that the AIDS virus is not spread through casual contact. This would include sharing of meals, coughing, or sneezing. We have done our utmost to get this message across to the public and the press in the past few weeks as concern has mounted about school children with AIDS.

Chart 3 shows our progress to date in combating this disease. It has

been remarkable.

We know who is at risk and how the disease is

transmitted. The weekly publication of the Centers for Disease Control, Morbidity and Mortality Report (MMWR), is one of our most rapid channels of communication to the Nation's public health community. The MMWR has carried our recommendations dealing with safety of the blood supply, personal behavior as a preventive measure, and use of the blood screening test. On August 20, we advised that in general, school-age children with AIDS should be allowed to attend school, while proposing a more restricted environment for younger children with the disease. These guidelines are provided to assist State and local decisionmakers. In addition to using the MMWR as a vehicle for communicating to the public

health community, we have embarked upon a major plan for the prevention and control of AIDS which will be published shortly in Public Health

Reports, the official journal of the PHS.

We understand the cause of AIDS. In 1984, a retrovirus, human T-lymphotropic virus, type III (HTLV-III)/lymphadenopathy associated virus, was identified as the cause of AIDS. It is unusual to have the cause of a disease identified so quickly, especially, as in the case of AIDS, where the discovery of a new agent was involved. In addition, scientists have made significant progress in describing the structure of the virus and understanding its effect in man.

Discovery of the AIDS virus allowed us to develop a test for use in blood banks and plasma centers to prevent transmission of the disease through transfusions of blood and blood products. The HTLV-III antibody test is now used to test every unit of blood or plasma in the United States. Heat and chemical treatments were developed to render clotting factor essentially free of AIDS virus, and as a result, hemophiliacs are provided an added layer of protection from acquiring the disease. Because of the long incubation period of AIDS, however, we will continue to hear of new cases in hemophiliacs and recipients of blood transfusions who were infected before the HTLV-III antibody and other preventive measures were available.

Regrettably, there is currently no effective treatment for those with AIDS. We have screened over 100 drugs and a number of them are in various stages of clinical testing. Some of the most promising drugs work by decreasing the spread of the virus in patients. You will hear from Dr. Wyngaarden and Dr. Young of their efforts to discover and bring to the market drugs of promise.