Chapter: 08 The Office of Research Protocol and the Department of Medical Specialties

Chapter: 08 The Office of Research Protocol and the Department of Medical Specialties

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Description

In this segment, Dr. Bodey talks about how he established the Office of Research Protocol, which provided oversight for clinical studies. He then talks about the purpose of the Department of Medical Specialties, which he headed (1987 – 1995): to address the cardiac, neurological, gastrointestinal, and other medical issues which might arise for a cancer patient. He talks about his long-term goals for that department and notes that he was not able to secure the resources to create a truly independent department also involved in research.

Identifier

BodeyGP_02_20130626_C08

Publication Date

6-26-2013

City

Houston, Texas

Topics Covered

The University of Texas MD Anderson Cancer Center - Building the InstitutionMD Anderson Snapshot On Research and Researchers Understanding Cancer, the History of Science, Cancer Research MD Anderson History

Transcript

Tacey Ann Rosolowski, PhD:

Yes, so thank you. I did want to ask you about a few other issues as we go on here. In 1981 and ’83, you were involved in setting up an Office of Research Protocol. You were also the first director for that office. I wondered if you could tell me about that.

Gerald P. Bodey Sr., MD:

Not much. I don’t remember much about it. But there was an effort to have an organized activity in the institution.

Tacey Ann Rosolowski, PhD:

Why was it felt that it was needed at that time in the early eighties?

Gerald P. Bodey Sr., MD:

So people knew what was going on. So somebody didn’t go and decide to do some protocol and treat people with dog dirt or something or other.

Tacey Ann Rosolowski, PhD:

Oh, right.

Gerald P. Bodey Sr., MD:

You know, that certain rules and regulations were being followed. I mean, there are restrictions on what you can do with investigational drugs and so on. That’s how it got set up. I don’t remember whether or not there was some particular episode that somebody violated. I think that happened actually, but I don’t remember for sure. You know, you had to be sure that patients were giving their permission to do this study if you used investigational drugs, and the company supplying the drugs needed to know—the FDA or somebody at the NCI or whatever. So there was a certain amount of bureaucracy associated with all of this. They finally decided that they needed to have an office that supervised that. It wasn’t a big job, but I have just vague recollections that somebody did something they shouldn’t have done. That’s what really put it to the floor.

Tacey Ann Rosolowski, PhD:

So how did you go about setting it up? What was involved with that?

Gerald P. Bodey Sr., MD:

Not much, just having certain rules and regulations. If somebody had a new protocol, they had to submit it to us. I think we may have had a group that reviewed these things. It wasn’t just me. But they had to have permission before they could start doing a study.

Tacey Ann Rosolowski, PhD:

And it’s kind of amazing that that was really new in the institution. How did people react to that sudden requirement?

Gerald P. Bodey Sr., MD:

They didn’t have any choice. I don’t—I think most people didn’t mind. They recognized the importance of it. So I don’t think there was—I don’t remember that there was a lot of antagonism about it.

Tacey Ann Rosolowski, PhD:

I mean, it’s kind of surprising that there wasn’t any oversight before that. Was that something that was happening at institutions nationwide in the early eighties—that suddenly there were offices to regulate research?

Gerald P. Bodey Sr., MD:

I don’t remember if actually anything came out of the NCI or FDA or whatever, but it was not at all unusual for people to just be doing studies and not having any kind of major supervision until this sort of thing. Then, as I say, I don’t remember if it originated from the NCI or not, but eventually, through NCI, it became necessary for everybody, basically. Then of course, hospitals themselves—institutions wanted to have certain—be sure that certain things were being done so you weren’t going out and doing something that was immoral or whatever.

Tacey Ann Rosolowski, PhD:

It’s kind of incredible now, from the vantage point of today, to think there was a time when there wasn’t oversight, because there is so much of it now.

Gerald P. Bodey Sr., MD:

Well there wasn’t anywhere near as much in the way of research being done with new drugs and that sort of thing back in those days.

Tacey Ann Rosolowski, PhD:

Right. I suppose that’s certainly true. That’s certainly true. Another role that you served was as chair of the Department of Medical Specialties. And I wondered if you could tell me about what that involved.

Gerald P. Bodey Sr., MD:

When was that?

Tacey Ann Rosolowski, PhD:

It was 1987 to 1995.

Gerald P. Bodey Sr., MD:

Medical Specialties was everybody except the cancer specialists. So we had—and medical doctors, not surgeons. So we had some endocrinologists and pulmonary specialists and people like that that were available to take care of complications and that sort of thing. Medical Specialties was these other specialties of medicine that we had to have people take care of—cardiologists, things like that. It wasn’t a big-time endeavor at that time. Now it’s much larger than it was then.

Tacey Ann Rosolowski, PhD:

Okay, so here were the—let’s see, these were the specialties that were included: pulmonary medicine, cardiology, infectious diseases, dermatology, nephrology, and general internal medicine. Now, what was going on before the creation of this department?

Gerald P. Bodey Sr., MD:

There wasn’t any kind of an organized structure to it. The cardiologists—there was one of them, and pulmonologists and so on. Actually, cardiology and pulmonary were combined, initially. I separated them. But there was less oversight as to what was being done. And also by having this, we were able to try to strengthen these areas to have enough personnel to provide proper services and make sure that the proper services were being provided and that sort of thing. You know, if you have a unit where everybody is focusing on taking care of cancer, some of these other things may not be addressed as well as they could be. So somebody—but once we had this set up—and actually most of these areas were already in existence, it was just that they were combined and put under my supervision. But by having these people, and if somebody developed kidney failure, you had somebody to take charge and see that that was addressed. So it really wasn’t anything terribly dramatic, but it was something that was needed in order to be providing the maximum care to the patients and not just focus on their cancer, because many of these patients then developed other side effects. Some of the drugs had side effects that needed to be paid attention to and so on.

Tacey Ann Rosolowski, PhD:

Now did any research—was there any research done in that department?

Gerald P. Bodey Sr., MD:

Yes, but not a great deal.

Tacey Ann Rosolowski, PhD:

What kinds of questions would they have looked at?

Gerald P. Bodey Sr., MD:

That’s a long time ago.

Tacey Ann Rosolowski, PhD:

I was just sort of wondering, like a general theme.

Gerald P. Bodey Sr., MD:

I don’t know. I really don’t know how much was done. Most of it was really a service oriented—so it wasn’t quite like the chemotherapy programs where research was an integral part of the department. In these cases, most of what they were doing was providing necessary services and not really doing research. Now, I’m not saying that nobody did any research, but there wasn’t a great deal. I think perhaps maybe the department that did the most of it was Endocrinology.

Tacey Ann Rosolowski, PhD:

I hadn’t read that. So Endocrinology was also part of this?

Gerald P. Bodey Sr., MD:

Yes.

Tacey Ann Rosolowski, PhD:

Interesting. When you took on—solidified this and took on the role, what were your long-term goals for the department? And did you feel like you had achieved them?

Gerald P. Bodey Sr., MD:

The long-term goals were to make—to expand the department and provide other services in addition to the ones we were. Some of the services were actually provided from the medical school and not within MD Anderson itself. So my long-range objective was to make these departments independent and strong and well provided and providing good service and also, where possible, doing some research. Now, I didn’t accomplish a great deal of that because they didn’t give me the resources to do it, but that was the long-range goal.

Tacey Ann Rosolowski, PhD:

Why do you think the resources weren’t available for that?

Gerald P. Bodey Sr., MD:

Because it’s a cancer hospital, so not everything, but most everything, was focused on cancer. You know, you had all kinds of people involved. You had radiologists, surgeons, internists that were doing cancer—pediatricians. They were the ones that got top priority, and that’s the way it should be. But we were hoping to get enough support that we could strengthen these, never really intending that they were going to be competitive with cancer but that we were providing good service, and also the possibility of maybe doing some research in conjunction with that.

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Chapter: 08 The Office of Research Protocol and the Department of Medical Specialties

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