Office of NIH History
In Their Own Words: NIH Researchers Recall the Early Years of AIDS
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Hannaway: From 1989 to 1993, you assisted in the design and conduct of intramural research on symptoms of HIV-infected adults, and this was during the early years of the National Center for Nursing Research [NCNR], which was initially set up in 1986 and then became the NINR in 1993, and comprised a portion of the intramural program of that center. Could you discuss your activities in this connection?

Grady: When the NCNR started, the first director wanted the NCNR to look like the other institutes in terms of having both an extramural program and an intramural program. She was exploring in 1989-1990 the possibility of creating an intramural program and decided to put a relatively small collaborative program out of her office in HIV and hired a person to do that. In the first few months that she was here, that person, Mary Roca, spent a lot of time with me, because I was in the clinic and I knew a lot not only about the clinic operations, but also about the HIV clinical area from a nursing perspective. We spent hours discussing possible research questions and priorities, how it would work in this environment, and so on.

One day she said to me, “How would you like to come work for me?” It was right at the time when my second child was born, and she made it even more attractive by saying I could work part time, so I did it. I went to work for her in helping her set up the program and in putting together the first couple of studies.

We did two major studies in those days. One was looking at nutritional aspects, because it was my and many other people’s observation that nutritional problems were a big problem in AIDS. What was not known at the time was why. When did these things start to happen, what happened first, and was there a way to intervene to prevent them or to at least minimize them? So we put together a pretty complicated, longitudinal study of several cohorts of patients that were being seen here and followed them by documenting their nutritional status, their immune status, and clinical status over time to determine when and how these things changed.

Then the second study came out of, again, a clinical observation. We had been doing studies in the clinic with AZT from early on, and were among the first groups to notice that some people who had been taking AZT for a long period of time developed these rather profound muscle weaknesses. We wanted to understand that phenomenon better, so we put together a protocol to study people who had clinically determined myopathy and follow them prospectively to see how it impacted on both their muscle strength, but also other symptoms and functional abilities. Those are the two main studies that Mary was the principal investigator for, and I helped her do them.

Then in 1994, she left, and I was supposed to take over some of her work and also justify my existence by writing some more. So I put together another protocol, because one of the issues that I had been concerned about from the beginning of this disease, but also in many other diseases, is fatigue. It is a very prevalent symptom, one for which nobody knows what the heck to do about and, for some people, it is the most annoying symptom that they have. It ruins their life because they cannot do anything.

Hannaway: They have no energy to do anything.

Grady: No energy. So I put together, again, a small descriptive study of fatigue and had, because of the population available to me here, an interesting model, I thought, in terms of IL-2 patients, because IL-2, among other things, in most people causes a very debilitating fatigue. But that is transient. They start their IL-2, and by the next day they are flat. They cannot do much. But the day the IL-2 is stopped, within 24 hours they feel pretty good. That fatigue phenomenon was of interest.

But the other thing was that, as I was talking to patients, they would say, “The mouth sores go away pretty quickly, the fluid retention goes away,” some of the other things that IL-2 causes, “but it takes me a long time to get my energy back.” I wanted to see both how this worked during the IL-2, but also what happened in between cycles and whether or not it ever came back. So that was what that study was about.

Harden: Let us see if we can move into your current work in bioethics. We have touched on a number of issues already that pulled you in this direction, but how did you actually decide to go and get a degree in it? We also noted that you were a member of the Bioethics Liaison Group during this period also. Can you go back and bring us up to date on the bioethics the way we went through nursing?

Grady: Again, it would be hard to pinpoint when I first started to be interested in things that I would now call bioethics that I may not have always called, but certainly I was. When [Dr.] John Fletcher was here in–well, when I first came, he was here. He was doing some things that I found very interesting, and occasionally I would volunteer to work with him on such and such a project. When this Bioethics Liaison Group was created, the Nursing Department, I think, had two slots, and I lobbied hard to get one of them, which I did, though not immediately. Then when I was thinking about going back to school, John was a major influence in that regard in terms of studying ethics, because I was not sure that is what I wanted to study. What I ended up with was a degree in philosophy, and philosophy to me seemed sort of fluffy. I hate to say that, but it was true.....

Harden: In a sense.

Grady: Right.

Harden: Remote, yes. Fluffy, I would never.

Grady: Well, maybe remote is a better word. I mean, I was very concrete. My education had been very concrete. I was doing these things, and I thought perhaps it might have been better for me to do public policy or something like that, because I was definitely interested in the public policy aspects of some of this, and those were the bigger-picture questions about health care issues. But the more I thought about it and the more I looked at programs, the more philosophy started to appeal to me. And fluffy would not be the word I would use today to describe it.

Hannaway: That was your initial reaction.

Grady: Intense is probably a better word. So I decided to get a degree. Certainly, Georgetown has a very good philosophy department, but also a reputation for the health care-related ethical questions that I was definitely interested in, and I had the added advantage of being close, so it seemed like a good place to try to go. I was happy and lucky to get in.

It was an interesting time, because I was studying philosophy, I was still working here at the Commission during those years, too, and I was having children all at the same time. There was a lot going on.

Harden: Yes.

Grady: All of which, in many ways fed into each other. There were certainly issues that I was dealing with clinically and in the Commission that were ethical issues. They were blatantly so in some cases and not so blatantly so in others. And having children–I do not know if either or both of you have children–gave life a different dimension and a different perspective than I had had previously. I think that added to my appreciation of philosophy, to tell you the truth. There were moments when I was thinking, “What am I doing trying to do all this?” and I have some great stories about going into labor in the middle of metaphysics class. But in other ways, it all sort of came together.

As I was studying philosophy, of course, I continued to be interested in the things I was doing clinically. When I first started to get ready to do a dissertation, my topic was not going to be anything to do with HIV. I was interested in studying something related to something I had seen here, the participation of women in research and whether that was an injustice issue or some other issue; I had talked to several people in terms of trying to recruit a committee and was not getting too far. There were some people who were not that interested and other people thought it was not philosophical enough. There were lots of things going on.

Then I went to [Dr.] Leroy Walters, who ultimately was my mentor, and had a long conversation with him one day about, “What should I do?” And he said, “Maybe you should start thinking about a different topic and think about something that is related to your work.” I said, “Well, there are about 200 that I could think of,” issues that I thought of in my work that might be... And he said, “Tell me about them.” I said, “All of them?” He said, “Yes. Tell me about them.” So I started to talk about all these things that I had thought about or seen in clinical medicine, and when I started to talk about vaccines, he said the pitch or something, the enthusiasm changed. He said, “That is the one. That is the one you have got to do.”

And that was a clinical thing. It started in the clinic, we did the first Phase I HIV vaccine study, which was, at the time, leading-edge science. It was very exciting in that regard. But I know that I remember many a day sitting in the clinic with the other nurses and some of the investigators and saying, “Who in their right mind would ever volunteer for this thing?” “How are we ever going to do this study?” We put together in the clinic a small study to study the motivations of people who were participating in this vaccine study, because it seemed like brand-new, first-time, Phase I, and the four pages of theoretical risks were just unbelievable. So that was one thing.

Then, at the Commission, thinking and talking about the importance of developing a vaccine and thinking about, if we have trouble getting people into this early Phase I study, or I think we should, what happens when you get to the stage of trying to figure out if it works? How do you do that? So I started getting interested in that whole subject, and the rest turned out to be my dissertation, which other people liked enough, too, to publish.

Harden: It certainly addresses the most up-to-date question with regard to AIDS. The therapies are nice, but they are expensive and they are not going to solve the problem in the Third World.

Grady: Right.

Harden: And the vaccine has to be pursued. So I would expect that your book has probably generated a lot of interest for people working in that area.

Grady: It has, although it is interesting. I think there is more interest today in late 1996, early 1997, than there was in 1993, when I actually finished that, 1994.

Harden: That is the way you sell books.

Grady: Yes.

Harden: All right. So we have brought you virtually up to where you are now. You are now responsible for planning and management of the bioethics program, which has grown considerably since John Fletcher was the only bioethicist at the NIH, is my recollection.

Grady: That is right.

Harden: But a part of your responsibility involves participation in the Institutional Review Board of clinical protocols. Could you comment on how your training as a nurse and as a bioethicist informs the way you approach that duty?

Grady: That duty. Yes, I can. From early on in studying ethics, but probably predating my study of ethics, I have been interested in the ethics of research, I think from being here, from watching it, from thinking about what it is. So I spent a fair amount of time studying that in terms of what has been done and written in the past, which gives me, perhaps, an advantage in the IRB [Institutional Review Board] work in the sense that I have thought about some of the issues of research more than a lot of people on the IRBs have. I have had the opportunity to read about them, talk about them, write about them, and so on.

I think in all that I have done and hope to do in ethics, the fact that I am a nurse gives me a distinct advantage in that I can understand the other side, if you will. From the perspective of designing research and putting together a study that answers an important question, and being clear about methods and, putting protection in for human subjects, in some respects that is also abstract even though some of the people who do it are in contact with the patients as well. But some people on the IRBs are not. Yet there are certainly things that you need to look at in the abstract. But then to be able to envision in a more real way what the person at the other end who is participating in this research is experiencing I think gives me an advantage. I think the perspective that I contribute at IRB meetings and in a lot of other things that I do is a blend of those two.

Harden: Are you the first person with training as a nurse that has sat on the Clinical Center IRB?

Grady: Well, the Clinical Center does not have an IRB, so it is the other NIH IRBs, for each institute. Interestingly, I have actually done this through the Bioethics Department before. And there have been at least one or two other nurses, in the time that I am aware of, anyway.

Hannaway: I actually had a follow-up question to something that you remarked on earlier. You mentioned the clinical trials for AZT. Were you involved with the patients who were part of those trials as well as the ones for the vaccine?

Grady: Yes.

Hannaway: Can you just tell us a little about that, because there has been a lot of discussion about AZT and how when it was in the Phase II trial, the decision was made to alter the nature of the trial, so to speak. But I was interested in the Phase I.

Grady: Yes, because that is really what we did here, the Phase I. And at the time, it was no different than any of the other things that we were testing in Phase I, some of which did not work and some of which did, so there was nothing special about it as a category of research, in a way.

But the difference, perhaps, is that there were people who were enrolled in that early Phase I study who stayed with us for a long time and, as AZT became more accepted, either stayed on it because they tolerated it well and it was accepted, or had to get off it because they could not tolerate it well and tried something else. There were some of them who rolled over into other studies where they added things without taking the AZT away. Then there were people like the ones that we ended up on this myopathy study, who at the time may or may not have still been on AZT, but many of whom, though not all, were from that original cohort and had been on it for a long time.

What we have certainly learned about since is a lot of the community reaction to AZT and how people hate it. We did not see that so much because we was early, nobody knew enough about it to hate it, and the people who came here were the ones who were willing to try it anyway, so we did not get that kind of attitude from the patients that were here.

Hannaway: It is only longer term that this has become more apparent and longer-term effects have become more apparent, obviously, too.

Harden: Do you want to make any final comments? We did not really get you to talk too much about your book, in your view, after having written this, on the future of AIDS vaccines. Are we going to get one soon?

Grady: I hope we are going to get one. I do not know that I will comment on the “soon” part. It is hard to say. I mean, right now everybody’s looking carefully at canarypox and hoping for something there. From what I have read about it, it certainly looks as though it has some potential in terms of being able to stimulate both cellular and humoral immunity, and that is, at least to the degree that we understand immunopathogenesis at all, those seem both to be necessary in this particular case. But whether or not they are adequate and whether or not the canary pox will elicit adequate responses is still, of course, questionable.

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