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Harden: I would like to have those figures at some point when you can get them.
Henderson: Okay. I can get them for you.
Harden: As you said, for the early patients who were very sick, it took many resources just to keep them alive, let alone to study them. What effects did this have on the allocation of resources here in the Clinical Center, and did it have an impact on other studies that were being done?
Henderson: That is a fascinating question. I doubt that you will ever be able to determine the answer. My suspicion is that you could get “polar” answers depending on whom you ask. To retreat to an earlier question, when we were talking about why we might, or might not, be studying HIV or AIDS at the Clinical Center, one of the early concerns was that if we used up a substantial amount, a substantial fraction, of Clinical Center resources, that might actually interfere with some of the institutes' existing research agendas. They, after all, have very important disease interests and research agendas as well. I think that concern was expressed. Whether we actually got that far is hard to pin down. My own view is that we did not. I think that the work of the institutes progressed at a reasonable pace in the Clinical Center with AIDS superimposed, to some extent. The exceptions might be in the Allergy and Infectious Diseases Institute service where they turned many of their resources over to AIDS because it was a fascinating infectious disease problem. If it were any other infectious disease, they would have done the same thing, I think, just because of that. That was probably appropriate. Also in the Cancer Institute, where they had Dr. Gallo's investment, a huge epidemiology program, which was terrific, and then the early therapy trials as well, a large portion of the institute’s resources was committed to AIDS research.
Other than those two institutes, I think the work of the institutes actually progressed normally, but you might be able to find institute clinical or scientific directors who would tell you that they felt as though it ate up too much of the budget and that it kept them from doing important things.
Harden: It certainly became a political discussion.
Henderson: Oh, we have not even touched on that. We focused on care, or the hospital, but certainly there were political aspects. It was fascinating from the start because it had everything all tumbled together.
Harden: Would you elaborate a little on that? Being in the hospital epidemiologist's position, I imagine that you were constantly on the hot seat about this.
Henderson: Yes, ma'am.
Harden: You have already talked a little about the press. Would you comment more on the press?
Henderson: I never felt as if the press were my ally. I always felt that the press, given the choice of being first and scooping the competition, or of being correct, would choose to be "first.”
AIDS was an incredibly political disease from the start. We had people from both sides of the aisle in Congress come out here, some lauding what we were doing, others, such as Congressman [William] Dannemyer from California, lambasting us for wasting the government's money on projects like this. We were always, I think, at the NIH level, very cautious about how the disease was managed, and I think the NIH scientists did a great job. The science of this disease has always been our pursuit and they just kept their eye on the ball. The quality of the work that has been done here really speaks eloquently to the whole approach that the NIH took. As I know you know, there were huge political issues, but every time we needed money to study the disease the politics just bubbled right to the top.
Harden: Would you explain a little more about your study on the risk of transmission in the hospital? Can you give us some details?
Henderson: Following the AIDS epidemiology meeting that was sponsored by NIAID, Al Saah and I sat in my office, which was down in the B1 unit in the A-wing of the Clinical Center, down by the telephone operators. We drew up a plan for a study, which was based on the premise that eventually someone would figure out what caused this disease and that whatever it was that was causing this disease was likely to be something to which humans would make an antibody response of some kind. If we had serum in a refrigerator, or in a freezer, then we ought to be able to figure out whether any of our health care workers had gotten infected or not.
What we did was to design an elaborate, fifty-some page questionnaire asking health care workers exactly what sorts of procedures they were doing with AIDS patients. We thought that ultimately, since we would have collected serum samples over time, that someone would develop a test that we could use to measure them, and then we could go back and look to see what procedures in the hospital were associated with a risk for transmission. That was the overall design of the study. The questionnaire itself was overwhelming and, although it is a credit to the anxiety that was prevalent among the staff, virtually everyone completed those questionnaires dutifully, nearly 100 percent. For years they did that while we were collecting the data. Of course, it turned out that the questionnaires were absolutely useless because the risk is associated with parenteral exposures, and it is a 3 in 1,000 risk; the other things that people do with patients in the institution really present very little risk at all. There is always some risk, but we have this huge file of epidemiologic data about what health care workers did. Someday I will figure out something to do with the data.
The other part of that project, and sort of my hidden agenda, was that I was worried about our staff. I was incredibly appreciative of the people, like Barbara Baird, who were down in the trenches doing this work. If something happened to them, I wanted to be sure that we could make certain that we could show that it was a direct result of working with patients, or that it arose as a result of an on-the-job exposure. We wanted to be sure that we were protecting them as best we could. That is part of the job of the hospital epidemiologist. The agenda in starting that study had two parts.
It also offered the people working in the trenches some support. The fact that we would be out there looking for this with the expressed intent of protecting them as best we could I think sent the right message. That message of health care worker advocacy is a very important part of a good program in hospital epidemiology. Those were our goals in starting that study. We also wanted to determine what the risk was.
Rodrigues: I think you have already touched upon the question that we planned on asking next. This has to do with looking back at what was being written about NIH, what was being said about NIH at meetings, on Capitol Hill, and by advocacy groups. Probably the most prevalent position was that NIH was not doing enough, not making the resources available, and so on. But I think the story you are telling us is somewhat at odds with that. Looking back, what is your view on all that? Do you think that the criticisms were valid?
Henderson: Let me just say that I have a very narrow and parochial view based on what was going on in the Clinical Center and the Intramural Research Program. I am not sure that you can throw any more successful money at the programs that were ongoing in the Clinical Center and have anything else come out of it. I think that we learned an important lesson from the “War on Cancer.” It was that sometimes it does not help to put more money into a program. If you go back and look at the “War on Cancer,” there were grants funded that were just a waste of money. I think that in this building, at least, we had the right people working in the right way with the right intensity on AIDS. You could have made these programs a small bit larger perhaps, but I do not think we could have done much more in this building than we were doing.
Now I cannot speak from a broader NIH perspective about whether the research agenda ought to have been tailored to fund more outside grants in the Extramural Program. I do not know what goes on in all of the other 48 or so buildings on campus, whether more money should have been funneled into that. Certainly at that time I was not privy to any of those numbers. But looking at the Clinical Center, I think that we were working hard and probably could not have either safely or efficiently worked a whole lot harder on the issue, especially understanding that all of the institutes had their own work that is ongoing. Admittedly we had an HIV epidemic, but we still had patients with rheumatoid arthritis and patients with all of these other diseases. The NIH is not the “National Institute of HIV Infection,” it is the National Institutes of Health. We were, I think, obligated to commit substantial resources to HIV but, at the same time, we had to keep the other research agendas moving along. I think that we did that.
My own view is that, on balance, the leadership at NIH did a great job, and that we had a lot of money funneled into AIDS and most of it went to good solid investigators who knew what they were doing.
Rodrigues: One of the things that we have been looking at is the fact that the larger NIH–the Extramural Program, in particular–was not set up to be a rapid deployment system for investigating new diseases. It is designed to very carefully and thoughtfully evaluate proposals.
Rodrigues: We were essentially being criticized for not having some kind of rapid deployment system when it was never designed that we would have one from the beginning.
Henderson: That is correct.
Hannaway: You have said that you have a parochial viewpoint from the Clinical Center and as a hospital epidemiologist but, in fact, your publications suggest that you have had a much larger role. You have written articles for dentists, nurses, and a variety of other health care personnel which have appeared in general journals, like Clinical Topics, in which you try to discuss the general issues of the possibilities of infection and so on for such workers. Could you comment on your more public role as a spokesman upon these topics?
Henderson: Sure. I think the way that happened was because of what I said earlier, that we were primarily driven by science. We started systematically collecting information at a time when most people were not collecting that kind of information, but were thinking about it. We began to get some concept of risk very early on, in fact, very shortly after Dr. Gallo developed his first serologic test. We had 531 samples assessed by that serology, and so we had some idea early on about what that risk might be. But that is a story in itself.
Hannaway: Please tell us. We would like to know.
Henderson: Just after Dr. Gallo was confident that he had the serology, we persuaded his laboratory to run our samples. I got the samples and the results back, and I cannot remember what day of the week it was, but it was late in the afternoon. Out of our five hundred and some samples, we had 50 or 60 positive samples. I did a quick analysis of the data with what information we had about exposures from the questionnaires that I told you about. There were several people on the list who had exposures and it looked as if there might be an association. We were very frightened.
Now, at that time, that serology was the very first generation ELISA[enzyme-linked immunosorbent assay]. We were doing a Western blot test as well, and our samples were very far down the waiting list for Western blots. In 1985, Dr. John Decker was the director of the Clinical Center, and I came to Dr. Decker with this paper with the results and said, “You have got to help me. I am very worried about our staff. These results are what we got from Dr. Gallo's laboratory, and it looks like we have got 50 or 60 people infected and we cannot get the Western blots done.” So that was my first trip ever to Building 1. I went to Building 1 with Dr. Decker and sat with Dr. [James] Wyngaarden. [Dr.] Vida Beaven was there, and I cannot remember who else was in the room, talking about trying to get the Western blots. [Dr.] Ed Rall was also there. They ended up calling Dr. [Vincent] DeVita, the director of NCI, who was in Ocean City. They were able to track him down from Wyngaarden's office. Dr. DeVita called Dr. Gallo, and Dr. Gallo called the fellow who was doing the serologies, and we got our Western blots. Happily, they were all negative.continued on Page 05
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