Chapter 04: Formative Experiences Random Controlled Trials at the NCI
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Description
Dr. Bodey discusses issues with randomized controlled trials involving infectious diseases and cancer patients. The NCI stopped funding these projects due to limited resources and questions about their usefulness. He mentions that randomized controlled trials are challenging due to the need for available units and the lack of significant improvement in solid tumor patients.
He also talks about his multiple administrative roles at the institution and the complexities of managing overlapping responsibilities within a medical institution.
Identifier
BodeyG_01_20030303_C04
Publication Date
3-3-2003
City
Houston, Texas
Interview Session
Gerald P. Bodey, Sr, MD , Oral History Interview, March 03, 2003
Topics Covered
The Researcher; The Administrator; Devices, Drugs, Procedures; Obstacles, Challenges; On Research and Researchers
Transcript
Lesley Williams Brunet, CA:
You were saying that was unusual to have it built into the system. Now, I understand that it’s very expensive. Is that accurate? Gerald P. Bodey, Sr, MD Well, one of the things that concerned people in the administration in particular is that we have a kitchen up there with an autoclave, and all the fruit and everything was handled out of that kitchen. That becomes an expensive proposition. For many years—well, in the course of the number of nurses per patient and all that were agreed and housekeeping and everything—
Lesley Williams Brunet, CA:
That I could understand, but the kitchen?
Gerald P. Bodey, Sr, MD :
Our food preparation was a major undertaking because everything was specially prepared, autoclaved, and wrapped, and so it was a lot of work. Initially for quite a few years, we had support from a grant from the National Cancer Institute. And then at some point, they just informed us that they had decided they were no longer interested in supporting anything related to infections in cancer patients so—
Lesley Williams Brunet, CA:
Do you know why? Gerald P. Bodey, Sr, MD —we didn’t even need to bother applying for a renewal because they weren’t going to fund anything anymore.
Lesley Williams Brunet, CA:
Do you know why? Gerald P. Bodey, Sr, MD Well, the Cancer Institute had limited resources, and they just felt they had gotten as much out of that, I guess, as they were going to get. And there was a certain amount of controversy as to how useful it was, and some people were rather vehement that they didn’t think it was worthwhile. It was very difficult to do studies of randomized comparative trials between a patient in the unit and a patient outside. You know, if you do a randomized study that means you have to have a unit available when your patient comes in, and that wasn’t always the case. It was full. The objective was to keep it as full as we could. But, it wasn’t feasible, really, to do that. I mean, you couldn’t afford to keep a unit open for three weeks—I mean two weeks—because a patient was randomized outside, and you had a unit available, and he qualified to be in it. So doing a randomized trial was not feasible. We did do some other types of studies that showed that it was of benefit. We then initially focused on leukemia, but then we went into some work with solid tumors. We did several randomized trials with solid tumors where we looked to reduce the risk of infection, and by so doing, we were able to give higher doses of chemotherapy to patients. If we gave higher doses of chemotherapy, would it reduce higher response rates, longer duration response, that sort of thing? What we found was that, yes, we could give higher doses of chemotherapy because the patients were not infected, but the response rates and duration of the response was not greatly influenced by the ability to give the higher doses. So that program was abandoned. We did studies in sarcoma and lymphomas, breast cancer, and focused on diseases where there was a reasonable complete remission rate for the disease. We did one on oat cell carcinoma of the lung also, but the results were pretty much the same that, yes, you could get higher doses. Yes, you didn’t have as many infections. But unfortunately it didn’t affect the outcome. So that ended up being abandoned. From that point on, after we lost our funding and all of that, the leukemia service had one half of the unit, and the Beaumont Transplant Service had the other half. As I said, that continued up until they created this new hospital, and now they have HEPA filtration throughout the hospital. They do have a special unit for the patients with acute leukemia, but it doesn’t have laminar airflow. It just has the filtered air. Excuse me.
Lesley Williams Brunet, CA:
Okay. You ready for a question now? Gerald P. Bodey, Sr, MD Yeah.
Lesley Williams Brunet, CA:
You were pausing. Let me just go back and clarify a few things. What years did you go to Washington? You— Gerald P. Bodey, Sr, MD I was at the National Cancer Institute from June or July 1962 to June 1965. Then from ’65, ’66, I was at University of Washington. I came down here in August 1966.
Lesley Williams Brunet, CA:
So, you were still at NCI when Dr. Frei actually left? Gerald P. Bodey, Sr, MD Yes. He left a little before I finished up there, and I think Dr. Freireich came down here about the time I went to Seattle. So he was here about a year or a little more than a year longer than I.
Lesley Williams Brunet, CA:
Well, do you remember when you first heard that he was leaving? Gerald P. Bodey, Sr, MD Well, he called me in his office and told me. We knew that Dr. Frei was coming down here. That sort of got out. Then Dr. Freireich called me into his office to inform me that Dr. Frei had offered him a job, and he was going to come down here. He wanted me to come along and several other people. Dr. Hersh came, and Dr. (???) (inaudible) (s/l Myron Kiran), who was a pediatrician up there, came down. So there were several of us who came down from NCI.
Lesley Williams Brunet, CA:
How did you feel about them leaving NCI? Gerald P. Bodey, Sr, MD Well I was leaving anyway, so it didn’t really make too much difference.
Lesley Williams Brunet, CA:
So your going to Washington was— Gerald P. Bodey, Sr, MD I had made that decision before—
Lesley Williams Brunet, CA:
—way before that? Gerald P. Bodey, Sr, MD —way before this all happened.
Lesley Williams Brunet, CA:
Oh, okay. What I was trying to get at was whether you went to Washington because of events at NCI. Gerald P. Bodey, Sr, MD No. I had a requirement to be there for two years to fulfill my military requirement. That was a training program. It was a two-year program. But then I decided to stay on an extra year. I had not completed my residency, and that sort of served as my fellowship. I hadn’t completed my residency, so I had to do another year of that. So I had always intended to leave at the time that I left.
Lesley Williams Brunet, CA:
I see. Okay. You’ve answered some of my questions. When you headed up the center pavilion unit—and you may have already answered this. I just want to make sure you were no longer head of the leukemia service. Is that right? Gerald P. Bodey, Sr, MD 0:08:02 .4 I was both. I was sort of titular head, but I mean, we had leukemia patients over there. We actually had some portable laminar airflow rooms that the NCI was interested in studying, and we had something like six or eight of those units over in the center pavilion. That was part of why we moved over there because we had no place to put them in the old hospital. But that unit at the center pavilion had both acute leukemia patients and solid tumor patients, with a larger number of them being solid tumor patients. That was also at the time that we began doing our studies in high-dose chemotherapy in solid tumor patients. That began right around that same time. So I actually ended up taking over the chemotherapy in 1975.
Lesley Williams Brunet, CA:
Right. I had that. Okay, ’75. Gerald P. Bodey, Sr, MD So before that time, there was never any kind of official position being chief of acute leukemia. I mean, Dr. Freireich was clearly the one in charge of it, but I was the one who did a lot of the clinical work. He became the Chairman of Developmental Therapeutics when Dr. Frei left here. His major interest has always been in acute leukemia, so he and I worked on it closely together for all those years. I never had an official title. It was always an unofficial sort of thing, and it wasn’t until I took over the chemotherapy that I had an official title of being chief of something.
Lesley Williams Brunet, CA:
Okay. No wonder it’s so confusing at times. For someone to study this, it’s— Gerald P. Bodey, Sr, MD Then you know on top of that, I did infectious disease. I was a chief of Infectious Disease, but only in the Department of Developmental Therapy, until Dr. LeMaistre decided to make it an institutional program. And so, I did consulting on some of the other services, but just a modest amount of—
Lesley Williams Brunet, CA:
I know especially during that time infectious disease was the leading cause of death for, let’s say, for all cancer or—yeah. Gerald P. Bodey, Sr, MD Yeah. Excuse me. Go ahead and ask your question, or do you want me to start digressing?
Lesley Williams Brunet, CA:
You can digress. I know Dr. Freireich called you the world’s authority on infectious diseases.
Recommended Citation
Bodey, Gerald P. MD and Brunet, Lesley W., "Chapter 04: Formative Experiences Random Controlled Trials at the NCI" (2003). Interview Chapters. 979.
https://openworks.mdanderson.org/mchv_interviewchapters/979
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