cannot give you the precise figure, I believe it is very close to 40 patients have been entered in several different centers, I would expect we would probably have close to 100 different patients at various centers within the near future.

Mr. WAXMAN. Cofactors, as I understand it, only about one of 10 or 20 people who have antibodies and who perhaps even have the virus will come down with AIDS.

Can you describe the Public Health Service's work to find the catalyst or cofactor that causes some people to get sick and others not? If HTLV-III is so difficult to test and treat, would it be possible to test and treat cofactors instead?

Dr. MASON. This whole concept is one we are giving a lot of attention to. It is not unusual to have the circumstances that you described with AIDS. With poliomyelitis, for every 100 that are infected, depending upon the age of those individuals, only anywhere from one to 30 may develop paralytic-poliomyelitis or other clinical evidence of illness. Thus, even without cofactors it wouldn't be unusual to have this heterogeneity in the clinical manifestation of the disease.

On the other hand, we do not want to close our eyes to the possibility that cofactors do exist. In our epidemiological studies, we try to link anything we can find, for example, marijuana. We are looking at whole series of items that may be used or not used by AIDS patients so see if there is something else doing damage to the immunological system.

There could be other infectious agents, bacteria, viruses, and efforts are underway to try to identify those, either in the laboratory or epdemiologically.

Mr. WAXMAN. Is that a serious theory that some scientists are now looking at, that marijuana may well be a factor in why the AIDS virus takes off?

Dr. MASON. It is known that cannabis in and of itself has an immunosuppressive effect, so there is at least the theoretical thought, that if you have two agents identified of each other that are both immunosuppressive, that the interaction of the two may have an additive or synorgistic effect; and so cannabis and a whole series of other things that may be contributing to immune suppression have to be looked at.

Mr. WAXMAN. When you describe that possibility, has there been research on this subject yet?

Dr. MASON. It is being looked at very carefully. NIH, CDC and others are looking into this and other possibilities. I don't believe at this point in time we are able to say there is a causal effect, or even a related effect; those things have to be sorted out.

Mr. WAXMAN. Well, Dr. Mason, with this new budget request sent to us as of last Friday, do you expect that that will allow for full screening of drugs.

Dr. MASON. I will have to ask my associates. I assumed it would, when I put the budget together.

Dr. GALASSO. Again, we have to emphasize the differences between phase I and phase II. Phase I requires small numbers. We don't have anything ready for larger trials.

There have been several promising leads, Suramin is one of the best leads, but as of yet there is no single drug available which is

doing some clinical good to the patients and that warrents larger scale studies. However, there is no way we can predict that within 6 months we won't have exciting new agents, but it is unlikely that we will be in large efficacy trials.

So based on what we know, what we can expect, the answer is, yes, that all of the agents worthy of consideration are in the pipeline. Some of these are being developed by Dr. Broder. Others are currently in phase I testing. If we suddenly find something that is unexpected, then we will have to come back for more funds.

Mr. WAXMAN. If you have some promising new antiviral drugs, will you have enough money to start the research on it, to try to find out whether that promise is really there or to at least reach a conclusion that it is not there?

Dr. GALASSo. Yes.

Mr. WAXMAN. Mr. Nielson.

Mr. NIELSON. I would like to welcome Dr. Mason, he used to be the director of health in the State of Utah.

I am sorry I didn't hear your testimony.

I am trying to follow up on the requests already asked. How significant is the private sector's involvement in investment in fighting AIDS?

Dr. MASON. It is hard of me to quantitate how significant it is. We have tried within government to do everything we possibly can to facilitate work in both the private and public sectors. As soon as Dr. Gallo isolated the AIDS virus and developed a test for the diagnosis of this disease, it was immediately, farmed out to the private sector.

We have knowledge that the private sector is heavily involved, in both vaccine and chemotherapeutic research, and we are doing everything we can to encourage that kind of involvement. It is not until they get to the point that an IND, or some professional assistance is required at the Federal level, that we really get to know what is going on in the private sector. But based upon our interactions and that of the Food and Drug Administration, CDC, and NIH, there is considerable private sector interest and work.

Mr. NIELSON. You are satisfied it has been given fairly high priority.

Dr. MASON. It is a high priority.

Mr. NIELSON. How soon do you believe the AIDS vaccine can be developed in the use of clinical trials?

Dr. MASON. Giving a specific date is very difficult.

The retrovirus that causes AIDS is a relatively new virus. It is much more difficult to work with than viruses such as polio or influenza or hepatitis, and in our prevention and control strategy, we have made an assumption that a vaccine or therapeutic agent will not be available until 1990. In putting together a prevention and control strategy based-

Mr. NIELSON. You mean available to the public?

Dr. MASON. Available to the general public. One that is found to be effective and worthwhile in general treatment.

Mr. NIELSON. OK, how much before that will you get into clinical trials before 1990?

Dr. MASON. It is possible that clinical trials may begin in a couple of years. Basically with regard to Suramin, we are ap

proaching that stage now, and as each drug becomes ready for phase I trials, we will move into it immediately.

Mr. NIELSON. Suramin, how long before it can become available? Dr. MASON. Well, let's not present an overly optimistic impression with regard to Suramin, because while it is true, that it is currently being administered to a few patients, that it does inhibit virus replication, while the patient is still receiving the drug— but the virus returns after they stop giving the drug. Then you can recover the virus again.

That is why I stated in my testimony, that we may need combination therapy.

As of yet, we don't see anything on the direct horizon that looks like it is as effective a drug as we would want.

Any other feelings that you would like to add?

Mr. NIELSON. I wasn't suggesting that 1990 was being overly optimistic. I think that is quite depressing if it will be that many years to have public availability.

Let me ask you, do you believe that HHS has given this sufficient priority?

Dr. MASON. I think HHS is giving it top priority.

Mr. NIELSON. What can we do to facilitate that? This is one thing Congress is interested in doing.

Dr. MASON. I think Congress has been very responsive to our needs. There is a letter directed very recently to the chairman of the Budget Committees asking for reauthorization authority and right now that would be the most favorable thing Congress could do.

Mr. NIELSON. Is there anything that you can try to do to isolate it in terms of localizing it. There are certain areas of the country that seem to have more AIDS than the others. Is there a way of isolating that?

Dr. MASON. Let me talk about that.

Mr. NIELSON. I wondered about that.

Dr. MASON. The incubation period of AIDS is very long and from the evidence to date, once a person is infected they may remain infected for the rest of their lives and it is very, very difficult to take a person who has a virus in their bloodstream and isolate them. Where would you isolate them? What kind of civil liberties and freedoms would you remove from them.

It isn't like measles or mumps where the period of viral infection lasts a week or 2 or 3 at the longest. There may be those who carry the virus in their bloodstream as long as they live.

What we are attempting to do immediately to control the disease is through education and information. First of all identify people at high risk for this disease, let them understand how this disease is transmitted, and do everything that can be done at the local, State, and Federal level to encourage people to adapt behaviors that would restrict transmission of this virus from person to person. Mr. NIELSON. Thank you, Mr. Chairman.

Mr. WAXMAN. Thank you, Mr. Nielson.

Well, Dr. Mason, some of us have been pressing for a long time to get the funds and research. We have been disappointed in the past at the slow pace in which the funds have been forthcoming.

Congress, of course, on a number of occasions-notwithstanding administration requests for less-has come in with more funding for this. But this dramatic turnaround by the Reagan administration just last Friday to ask us for a 50-percent increase in funds for AIDS research impresses me with the fact that you must share our conviction that this AIDS epidemic is a very serious matter, and that it must be treated with a great deal of urgency.

Dr. MASON. Indeed we do.

Mr. WAXMAN. Thank you very much. We appreciate your testimony. We look forward to working with you.

We have to pursue every aspect open to us to learn how not just to simply identify those who may be carrying antibodies, but to treat those who have the disease and try to prevent the disease from spreading any further.

Thank you very much for your testimony.

For our next witnesses, I would call Dr. James Oleske, assistant professor of pediatrics and director, division of allergy, immunology and infectious diseases at the University of Medicine and Dentistry of New Jersey, and Dr. Michael Gottlieb, acting chief of the division of immunology and allergy, Department of Medicine at UCLA School of Medicine.

Your prepared statements will be made part of the record. We welcome you to the committee. We would ask you, and I believe all the witnesses were informed of this fact earlier, we would like you to summarize the testimony in around 5 minutes and try not to be much more than 5 minutes, so we will be able to complete the agenda of witnesses and have questions and answers. Dr. Oleske.

STATEMENTS OF JAMES M. OLESKE, M.D., M.P.H., ASSISTANT PROFESSOR OF PEDIATRICS, DIRECTOR, DIVISION OF ALLERGY, IMMUNOLOGY AND INFECTIOUS DISEASES, UNIVERSITY OF MEDICINE AND DENTISTRY OF NEW JERSEY; AND MICHAEL S. GOTTLIEB, M.D., ACTING CHIEF, DIVISION OF IMMUNOLOGY AND ALLERGY, DEPARTMENT OF MEDICINE, UCLA SCHOOL OF MEDICINE

Dr. OLESKE. I will try to emphasize the points in the short time I have, that I have made in my statement.

Amad died and his mother died 6 months later from that disease we now know as AIDS. At the time we first saw Amad, we didn't know what to call the disease. My best recollection in caring for Amad was that Medicaid disallowed payments to the hospital because we couldn't come up with a specific diagnosis. I spent most of my time calling ambulances trying to see if they would in fact take Amad to the hospital. Usually they declined.

I spent a good deal of time talking to our pharmacy trying to convince them to release medications for use in treatment of Amad's condition in that period of time, both as an inpatient and outpatient.

George, on the other hand, is now a 5-year-old boy who was as ill as Amad was 3 years ago, but for whatever reason is beginning to recover. He is still ill, but now well enough probably to go to school.

My recollections of Georgie is the same, it was a constant battle trying to find ways of supporting therapy and care and support for these children.

Over the last 4 years, our group in Newark who had taken care of over 45 children with AIDS has received only $75,000 in additional support for the care of patients with AIDS.

I am impressed with the $46 million shown on the board there for extramural programs. Certainly that money never filtered down to the clinical care centers in Newark, NJ. I think it is important that we address the issue of how to treat patients with AIDS.

We leave the area of just supportive care and encouragement, and begin to look at specific therapies. Certainly I support the idea of specific viral therapies in cases with AIDS because clearly unless we rid the body of the virus, all other treatments seem to be futile. Personally, I feel that good supportive care, what we have done for the last 4 years, including nutrition, care of ongoing infections are as important as some of the immunoregulatory substances outlined at this hearing.

So to me combination therapy is, continue the supportive care we have plus antiviral specific therapy programs. Unfortunately, the support for clinical care of patients and treatment with supportive measures is not funded. I also feel that a good portion of the moneys that are becoming available should be directed toward education.

Clearly we are many years away from the development of a vaccine and that is unfortunate, but probably a reality that 1990 is in fact a realistic date.

There are some educational programs that could be developed to try to reach patients in risk groups to try to encourage them and to educate people in how to reduce risk of AIDS. Granted, this is only secondary prevention but it is clearly an avenue that has been little supported. We need moneys to be involved in patient education, especially for those patients in risk groups.

I would like to approach the subject of children, children with AIDS are clearly orphans, both to this disease and orphans to the programs who take care of AIDS. Little money is given to AIDS as it pertains to the pediatric patients. Children are always the orphans of drug programs. We are now trying to develop a program for the treatment use of ribavirin in the therapy of AIDS patients. Instead of encouragement we have only met roadblocks. In trying to apply for treatment programs, it appears clear to me that we must make some dramatic turns in how we approach a disease with the epidemic proportions of AIDS. I think some of these changes would include, instead of the passive reception of programs from outside scientists to the NIH and FDA, rather outreaching from these agencies that have the facilities and the abilities to develop treatment programs to the clinical investigators.

Right now it goes the other way. It is difficult sometimes for somebody like myself, busy taking care of patients, to take the 3 months it takes to write up a protocol. It is a shame we don't have ways of facilitating the development of treatment programs that can go out into the regional centers where the patients are that have AIDS and I don't have any simple answers, but it appears