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Rodrigues: It's interesting the way things evolved. You mentioned that you got involved slowly, and that's consonant with the picture we see emerging from documents and other interviews. I think that it was the function of the particular interests in unusual diseases and background in immunology of the various investigators, that led them to pick up quickly on these cases. Because of their professional and intellectual curiosity, they began pursuing it, and eventually, programs and organized efforts began to take form around those projects.
Whitescarver: You're absolutely right. That's how it got started extramurally as well. Grantees took money away from their ongoing projects if those projects were, in some respect, related to their new interest in this unusual disease. Cancer [NCI] got involved because of Kaposi's. In one of the first meetings we had–I can't remember the details, but it was a huge meeting–we didn't know much about what we were talking about. We were just trying to gather facts and to determine how to focus efforts. What would be the most important areas to pursue? This was before the agent was identified. Al [Dr. Albert] Sabin was the person who summed that meeting up. It would be interesting to get hold of the minutes of that meeting. We were looking for guidance on what we should be doing intramurally–where some things were already being done–and what we should be doing insofar as putting RFAs [Request for Applications] and program announcements out. We still did not have any special appropriation for these efforts.
Harden: What I'm trying to determine is the way in which a realization came into the institute's understanding that this was a larger problem than just a few isolated cases. Could you comment on that and talk about the mechanism of issuing RFAs and RFPs [Request for Proposals] versus principal investigators just writing in to say, “I want to do this" on the grant proposal?
Whitescarver: Dr. Krause has always been a very strong believer in investigator-initiated research, saying that the breakthroughs come from those novel efforts. That was going to go on whether or not there was any specific AIDS program. People who were interested in getting into AIDS would do it on their own just by sending in meritorious applications without any kind of RFA or RFP. There was early interest in doing some directed research by contract, particularly by those looking for the causative agent. Until one had that, one couldn't really do much of anything as far as therapeutics, without doing it shotgun style. Also, there was early interest in treating the opportunistic infections and in immune modulation. In order to do that, one had to focus on the most frequently observed opportunistic infections, and we did put RFAs out for candidiasis and some of the other rare diseases. In this country, infectious diseases certainly raised their ugly heads when it came to immunocompromised individuals. There were meetings pulled together on that issue as well. This was just to get RFAs out on it.
We were identifying the most obvious things that we needed to know at that point. We needed to find out what was causing it, whether it was an infectious disease, and what the predisposing factors were. We were still investigating whether co-factors predisposed the individual to infection. Another question was what specifically were they dying with? Because we saw that infectious diseases were killing most patients, we decided to attack from that arena, so research in that area made up much of the first targeted efforts.
Rodrigues: The records indicate that the first RFA was a joint one between NIAID and NCI. Did the fact that NCI was the first institute to start activity with the RFA create any problems in terms of defining the responsibilities between NIAID and NCI?
Whitescarver: No. The institutes worked together early on, because finances required it. We thought we could do more if we combined our efforts. Jack [Dr. John] Killen was with the Cancer Institute at that time, and I was with the Allergy Institute. We each sent an institute representative on these site visits, and there was cooperation from the very beginning on those early RFAs. We wanted some sort of control over the research, but nobody had any contract money. We decided to use the cooperative agreement mechanism, which could be funded out of the grant monies.
Harden: The topic of relations among the various institutions and agencies in government has received a lot of criticism in the popular press. How would you characterize the interchange of information and the cooperation among the CDC [Centers for Disease Control and Prevention], NIAID, NCI, FDA [Food and Drug Administration] and any other agencies like the PHS [Public Health Service], during the early years?
Whitescarver: There was no involvement of other PHS agencies outside of the CDC. The CDC was sluggish except for counting, but I wasn't involved in this, so I don't have the details. I do know that there was a bumpy road between the CDC and the NIAID on the Zaire project. That got started when the Belgians came to us and asked our help in setting up a research effort in Kinshasa. The international infectious disease group met in Vienna that year. Krause, Dr. Peter Piot, the Belgian minister of health, Tom [Dr. Thomas] Quinn and others met over lunch to discuss our research effort in Zaire. After that point, I was not involved. The State Department had to get involved and, consequently, the CDC got involved. [Dr.] Jonathan Mann and [Dr. Joseph] McCormick were the representatives from CDC. The CDC then came on very strong as if they were going to take over, and that created a hell of a lot of problems in Zaire. It has survived beautifully, however. That was the first international effort. There was very little cooperation between agencies in the beginning of this. I don't know of other agency involvement except the CDC and NIH.
Harden: Did this retard efforts?
Whitescarver: I think it probably slowed things down. Africa was going to be complicated anyway. But whether it was a significant slowing or not, I don't know.
Harden: Within the country, what could have been done with better cooperation?
Whitescarver: We probably would have been on site earlier, had there been better cooperation on this end. Since my job is at the NIH, I heard all the things that CDC was doing wrong. If you talked to the CDC, they'd probably tell you all the things that NIH was doing wrong. Nonetheless, one couldn't say, “Here's a beautiful example of cooperation between two agencies for the common goal.” I don't think anybody would say that was the case. I don't think that would happen now. I'm quite convinced that it wouldn't happen now because of the high visibility. It wouldn't happen if any new disease came along and cut through the agencies. Agencies meet all the time now, and tell each other what they're doing. I just don't think it would happen now.
Rodrigues: I found some of the documents where NIAID was sponsoring some meetings with the Haitians and with other delegations coming here. Was that initiative initiated by the Haitians?
Whitescarver: Yes. It was initiated by the Haitians, who were looking for help. It became very sensitive. The minister of health and a few others came out here and told us about the way they saw the problem in Haiti, and then we sent a group down there. Krause headed the group that went down. Tom Quinn and some CDC people went as well. Nothing ever came of that like it did in Africa. But it certainly helped the Haitians out, and that finally led to declassifying Haitians as an “at-risk” group. It was the behavior of the Haitians that put them at risk. This was very difficult to undercover. They just wouldn't admit it.
Rodrigues: Jumping back a little bit, we were talking about the CIRIDs and how some of the work that was supported under those centers began to be sensitive to the emergence of AIDS. How about some of the other work that NIAID was doing in the sexually transmitted disease areas? Did those programs and activities eventually become integrated with the evolution of the AIDS program at NIAID?
Whitescarver: Because there was a great deal of interest in co-factors, a lot of proposed co-factors were studied under the STD [Sexually Transmitted Diseases] program. Also, the STD clinics, particularly among the gay and lesbian communities–I'm thinking specifically of Los Angeles–had support from other agencies. They invited NIAID people to come down and talk to the groups there in Los Angeles. Krause made one or two speeches; Ken Sell also went out there for some speeches. So, the STD program got linked to health care delivery, which, I guess, was funded by HRSA [Health Resources and Services Administration]. They looked for opportunities and research efforts with the individuals coming into the STD clinics where they were picking up a lot of AIDS.
Rodrigues: I would like to ask you about the political climate and its effect on the Institute's policies. There were several hearings taking place. [Theodore] Weiss had a hearing; Dr. Krause testified at that. There was a report, which came out some months later, that was primarily critical of the CDC, but it also mentioned NIH. Would you say that political activity was creating the pressure being felt, or was the pressure due to the fact that you had to wait for scientific knowledge to be able to move forward rationally or to expand the effort?
Whitescarver: Political pressures were certainly felt early on because Tim Westmoreland [congressional aide to Rep. Henry Waxman and chief counsel to the House Subcommittee on Health and the Environment]–I remember this vividly–called us to come down and talk to him about AIDS and what the NIAID's effort was in it. Krause and Sell went down to talk to Tim. It was interesting that both Dr. Sell and Dr. Krause talked about the overall NIAID effort in virology and immunology as basic research endeavors that would provide answers for dealing with the new disease. It did not suit Tim Westmoreland at all. Tim was very straightforward and made it quite clear that his impression of what they were telling him was that they were building a story of excuses for why they didn't have a more targeted effort toward AIDS. Krause's defense was that a lot of all the great scientific breakthroughs came from a free-ranging effort and this was what they were supporting. They were supporting the broad base of virology, with greater emphasis on STD research and immunology. But it was quite clear that this was not sufficient as far as Tim was concerned.
Harden: This was before the agents had been identified, so the target was still being looked for?
Whitescarver: Right. The agent was identified about the time I was leaving government. I think that the NIAID's position on that was, “This is terrific, but we need to confirm this. You do not make an all-out proclamation based on four papers.” The NIAID took a conservative stand on the announcement and waited before it started developing any programs that involved the retrovirus that had been identified as the cause of AIDS.
Rodrigues: I thought it was interesting that in 1983, apparently, Dr. Krause met with several community groups concerned with AIDS.
Whitescarver: This is what I was talking about. At the time, Steve Shulte became quite an advocate, and then he became mayor of West Hollywood. He arranged for Krause to come out to the Gay and Lesbian Community Services Center and talk about AIDS. The NIAID picked up on it. We'd never done any outreach activities and had no mandate to do it. Therefore, we did not have a real, legal base for spending money in outreach activities. But we felt that it was terribly important to get information out. We targeted physicians, nurses and all para-professionals, as well as dentists, first. I started that program in the fall of 1983, I believe. The first meeting was in October, and we had a contract in place already. We used that contract to have the first meeting at Masur auditorium on a Saturday for physicians and nurses in the area and for all kinds of other people. It was a full house. It was such a great success that we decided to do more, and the next one we held downtown [Washington, DC] at the Hilton. I remember calling Ed [Dr. Edward] Brandt. Shelly Lengel was his information officer, and we'd cleared what we were going to do with her. She didn't see anything wrong with it, but she wasn't terribly optimistic. I was so pleased with the turnout and the questions that were coming off the floor after these presentations that I called up Dr. Brandt and asked him if he could come down to show his support to the community. He did come to the Washington Hilton. He was late–people were beginning to leave– but nonetheless, Ed Brandt did come.
That contract is still going, and the NIAID is still using it for outreach and education activities. We had meetings in Los Angeles, in Chicago, in [Washington] D.C., and, I think, in Miami. We hit about ten cities with the same kind of program. We modified it a little bit by putting on workshops, and we catered to specific interest groups. The goal was to get the truth out about AIDS, and to get rid of the myths associated with it. There were people being kicked out of restaurants, losing their jobs, because they were looked upon as lepers of sorts, who could pass the disease around. Physicians wouldn't work with them and ambulance drivers wouldn't pick up anybody whom they thought looked like an AIDS patient.
Rodrigues: One of the concerns of the early years was the safety of laboratory investigators working with an unknown pathogen. Was that an NIAID issue with which you were concerned?
Whitescarver: Certainly. Before we knew what the agent was, it was a real concern. But NIAID had worked with so many highly infectious and lethal agents that working with the unknown AIDS pathogen just posed the problem of finding the best way to handle it. The first thing our scientists did was to handle it the same way they handled the hepatitis B virus.
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