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Harden: Would you describe the process through which NIAID shifted its priorities? Here we have a large institute in which the investigators are all working on their own problems, and all of a sudden this huge institution needs to redirect itself. Tell me how it's done.
Hill: During that period, I moved from an extramural to an intramural position, so I was not in the office of the NIAID director, but I could see what happened in the intramural program. The first people who began to look at it were people like Dr. Fauci, who were interested in diseases of immunoregulation and immunodeficiency. Not long after–or at about the same time–that the first cases of the Kaposi's sarcoma were described by Dr. Mike [Michael] Gottlieb, and I really don't know the history here–you might have to get that from Dr. Fauci–but not long after the first description of Kaposi's in this population, Dr. Fauci began to look at patients, who were later known as AIDS patients. I'm not sure that his looking at them predated the description of the California cases, because he was looking at people who had strange immunodeficiencies. But very soon after that, there was stepped-up activity in the intramural program. Because of Dr. Fauci's efforts, Dr. Sell, who very quickly began to see this as a concern, developed his contract, and several laboratories began working on the problem–people like Dr. Robert Purcell, who was involved in hepatitis and saw possible similarities. There were a few people who became aware that this was a new research area that needed to be moved into.
One of the good things is the strength of NIH in having an intramural program. You can immediately redirect your intramural activities, because if a scientist is interested, then he has only to get his lab chief and his scientific director to agree. It's not like the extramural program, where it could take a number of months to advertise the new idea and then almost a year to get an award granted. The intramural program can react very quickly. Gradually people within the intramural program saw AIDS as a disease that they should be working on: Dr. Fauci's lab, Dr. Sell and a couple of other people. I think that Dr. Mal [Malcom] Martin came a little bit later into this.
Harden: Was their interest in this disease in part stimulated because the CDC, which was the first line of reaction to this disease, wasn't getting anywhere in their efforts to identify an etiological agent? NIH doesn't usually look into every questionable disease event.
Hill: I'm not sure that this approach was much different from the others. You've written about serendipity in science. In researching Rocky Mountain spotted fever you have seen how research on it led to the discovery of the organism that causes Lyme disease. Something was observed that was similar to ongoing work. I have actually shown a little prejudice here, in that I have looked at AIDS strictly from an NIAID perspective. Dr. Bob [Robert] Gallo and the other [National] Cancer Institute [NCI] retrovirologists, who were looking at the viral etiology of a number of lymphomas tested HTLV. HTLV stood for “human T-cell lymphoma virus” or “leukemia virus.” I think the “L” initially stood for “leukemia“ virus, and then, at some point it was changed to “lymphotrophic” virus. I think it was after the AIDS retrovirus was described. So you had people who were looking at viruses that caused some sorts of tumors and immune deficiency. I think Tony Fauci looked at some of these patients and saw that they had problems with their T cells. He then immediately asked Bob Gallo, who was working with a virus that affected T cells, to look at them, also.
Now, I'm not sure of the connections. You can get this information from Dr. Fauci and Dr. Gallo. What you had were people who saw something happening that was similar or at least showed a relationship to something that they were looking at both immunologically and virologically. NIH's normal response is that if the investigators see something of interest, they continue research in that area. I don't think there was any point where any NIH policy decision was made that we were going to work on the disease. What happened is that investigators who were studying this general type of immune deficiency or a virus that caused this type of Tcell defect saw the similarities with AIDS and immediately began pursuing it because of their personal interest. I think that individual scientific interest generated the intramural program's moving into that area. There was no special policy decision until a little bit later on.
Harden: When did it become clear that there was considerable public pressure for the government to do something? Can you recall a particular discussion within the NIH about what should be done and how it should coordinated? I know that Dr. Bob [Robert] Gordon headed a coordinating committee, and I'm sure the NIAID had one with the NCI.
Hill: I was actually not privy to a lot of that, because I worked as the associate director to Dr. Sell. In that role there was a period of time when I served as the intramural AIDS coordinator for NIAID, when I did coordinate what was going on intramurally between, for example, Mal Martin's lab and somebody else's. Occasionally I sat in on meetings that had to do with NIH, but I was really not privy to the discussions within NIH, or to that extent within the institute itself. So I can't help you much prior to about 1984, which was when I came in to this office.
Harden: Who was the NIAID person on the overall NIH committee?
Hill: Well, I don't know, but somebody like Jack Whitescarver, who was the assistant to Dr. Krause, would maybe know. I would imagine that he, because of his interest, may have been involved.
Harden: Could you outline the particular steps that NIAID has taken against AIDS since you became involved at the institute level?
Hill: From my perspective, most of the steps have been strictly in getting funding for research and involvement. I came with Dr. Fauci in 1984. Tony Fauci came into the directorship with a very strong personal involvement and interest in AIDS and with a very strong commitment that this institute should make a major and leading push. By that time– that is, in 1984–we knew that AIDS was an infectious disease of the immune system, which predisposed those infected to other infectious diseases and tumors, and that AIDS was sexually transmitted. It also held an interest for those people working on international tropical medicine. So from the standpoint of the institute's and Tony's personal interest, there was no doubt that this institute could make AIDS research.
In doing so, there was increased involvement in the intramural program. There was an increase in requests for money through our appropriation process. I think that the fiscal year 1984 hearings may be the first year that the word AIDS appeared in the congressional appropriations hearings report language. You may want to check that out. Now, retrospectively, we've gone back and reported funding back in 1982, because there were intramural scientists working on this disease. There were people like Bob Gallo, Tony Fauci and others who were doing work. We, in fact, started that contract in the intramural program in 1983, but we didn't know what we were looking for. We started the extramural Multicenter AIDS Cohort Studies in 1983. This study followed cohorts of homosexual men over a period of time to see what caused the disease. This was funded with money the institute chose to use for that purpose. It came, in part, from our Infectious Diseases Program and in part from our Immunology, Allergic and Immunologic Diseases Program. Both extramural and intramural programs used their current funding to support this kind of work. After Dr. Fauci became director, several opportunities arose for supplemental funding in a fiscal year or increased funding in an upcoming fiscal year. It began to move fairly quickly from that point on, but the institute needed to make a major push.
In the early days, the Cancer Institute was the major spender of money on AIDS, and we were a smaller player. It gradually moved to the point where we were receiving sixty nine to seventy percent of NIH's money [for AIDS]. Basically, this was because we saw AIDS as our mission, and we made a commitment to work on it. The single biggest factor in that link was probably in fiscal year 1986, when we got a supplement. Then we were also allowed to amend that budget, and so we got a second amended budget. But a major push occurred, I think, not very long after Rock Hudson's death in 1985. Up until that point, we had gotten signals from downtown that we should either ask for amended budgets or ask for supplements to our budget to do AIDS research, which the institute did. The problem is that we would never ask for more than we knew we could absorb without destroying our other programs. What would happen, in spite of the Congress's interest, was that the administration might say, “Tell us what you need to do AIDS research.” We might provide a dollar amount, and they might say, “That's very important, it has high priority. Take it out of your other areas.” It was the Congress then that would go in and cover us and give us additional money. There was one fiscal year we needed some extra money, and Senator [Alan] Cranston put in a special bill that gave us the money to bail us out because we had put money into AIDS research and fell short in other areas. If you go back and look at the history, you'll find that in the past few years the administration requested additional money for AIDS, new money. What they did was agree that it was very high priority but that we had to take it out of other areas.
For a number of years, it was the Congress who put in more each year. In fiscal year 1986, I believe, we had already put in for a modest amendment because, again, we didn't want to be told to take it out of the other areas. After Rock Hudson died, we got a signal from the Department [of Health and Human Services, DHHS] that they would be receptive to a much larger request. We made a very crucial decision in the NIAID that we would go for broke. That decision was made in this office. Dr. Fauci and his staff made the decision to go for it. Yvonne du Buy and I were very much involved in putting together a major increase in our program. The major increases were in what we called the “AIDS Treatment Evaluation Unit,” modeled upon our existing vaccine evaluation units for other diseases; in epidemiology; and in the intramural program, which Dr. Fauci supported. He looked at the program and he pushed it. We decided that the only way we would make a major push in this area was by going for broke and ask for so much more money that everybody would know that if they made us take it out of our existing budget, that they would totally destroy our other programs. We were afraid to do that before then, and other institutes were afraid to do it as well. Over one weekend we put together a huge new program, I can't remember the dollar figures right now, but it was a big percentage over anything we had ever done. It would be very interesting for you at some point if we could go back and pull out the figures to show you, and to sit down and take the budget tables from fiscal year 1984 compared to the budget table for 1986 and 1987 when we were working with a regular budget, a supplemental budget, and two amended budgets in one fiscal year. I could explain to you how those things happen, because what we did was to agree on the amount we needed and ask for it. It was so much that if they told us to, as we expected them to, to take it out of our existing program, it would wipe out the rest of the research on infectious disease and immunology in this institute. It was a gamble that we took.
In discussions with the Cancer Institute and some other institutes, we decided we would all go for this. There was a meeting in Building 1, in which we sat around the table and decided whether to go for this or not, and the other institutes backed out. They weren't willing to put it on the line, even the Cancer Institute. There may be people who will dispute this version of history, but in that meeting our position was that we were not going to back down. We would take this by ourselves if we have to. The NIAID and Dr. Fauci pushed and supported it. The NIAID really pushed for a major increase and it worked. Congress appropriated the money. That was the second amendment in the fiscal year 1986, resulting in the second amended budget which was the single biggest increase at any point. These later increases have been big, but at that time it was a major, major push and it worked. Suddenly the other institutes began to want some of that money because it came back to the Office of the Director of NIH for distribution. We had put together this big program, had come back with the money, and suddenly people were talking about re-evaluating where the needs were. It was very interesting politics at that period because we were the only institute willing to stick our necks out, and then when we got the money, everybody suddenly came along and said they needed some of it. And there were moves on the part of Building 1 to look at the “renewed request” because there were several months between the time we made the push and when we got the money. I think that if you explore some of that from an internal angle it would be very interesting.
Harden: I would like to go on with this a bit. I think it is difficult for the average American citizen to comprehend the idea of $4 or $5 billion dollars. Furthermore, you knew that you couldn't cure or prevent AIDS simply by throwing money at it. Obviously, when you put this program together, you had major areas of work envisioned. Could you describe some of them?
Hill: We had identified a number of areas as major foci. There was hope for a vaccine at that time, more I think, than what there is now. Epidemiology, natural history, and pathogenesis–how the disease developed–were parts of this new program. We made a major push in all of these areas– basic research, pathogenesis of the disease, how the virus causes the disease, more studies on the virus itself. All of those were components of this new program.
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