Chapter 05: Working With Research Protocols and Drugs for Research

Title

Chapter 05: Working With Research Protocols and Drugs for Research

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Identifier

AndersonR_01_20040518_C05

Publication Date

5-18-2004

Publisher

The Making Cancer History® Voices Oral History Collection, The University of Texas MD Anderson Cancer Center

City

Houston, Texas

Topics Covered

The University of Texas MD Anderson Cancer Center - Building the Institution; Leadership; On Leadership; Research; MD Anderson Culture; Growth and/or Change; Multi-disciplinary Approaches; Institutional Processes; Devices, Drugs, Procedures; The Business of MD Anderson; The Institution and Finances; Building/Transforming the Institution; Working Environment

Creative Commons License

Creative Commons Attribution-Noncommercial-No Derivative Works 3.0 License
This work is licensed under a Creative Commons Attribution-Noncommercial-No Derivative Works 3.0 License.

Disciplines

History of Science, Technology, and Medicine | Oncology | Oral History

Transcript

Lesley Williams Brunet:

Right. You talked about the investigational drugs. Before we get too far out from the early years, when you came in ’78, you’re even DT, [Development Therapeutic] of course was -- there were issues about investigational drugs.

Roger W. Anderson, PhD:

Right, there were.

Lesley Williams Brunet:

And I believe in ’81, you know, there was a problem.

Roger W. Anderson, PhD:

Right. And at that time LeMaistre [oral history interview] was the President. [Section Redacted]

Roger W. Anderson, PhD:

Yeah. But anyway, no, really we had a hundred -- and I think it helped that I had already established with some of those major physician groups and individuals a rapport. And so any of the transfer or the requirements that were put in place by pharmacy were no problem. We had no problem and we haven’t had any problem since then. It’s very understood that that’s the way it works and we have had zero issues. Once in a while you get some protocol adherence issues that get raised. A couple years back we had someone with leukemia and things like that. But it really is, it’s been very well-accepted and of course our responsiveness needs to be very high on that. We’re probably subject to audits, several per week, and it’s the audit on the inventory, it’s audit on, you know, on the lot number -- audits on the patient acceptance. All of those things and we are responsible keeping up with the up-to-date information about the protocol, about the drug information. Worked a lot in those earliest days with Dr. Gerald Bodey [oral history interview]. Although ID, infectious disease, he really got the responsibility to work with that. Dr. McKelvey. And I can remember lots of days working with both of them on issues of, be sure that we have all of our compliance issues lined up and we did and we do have that. That area has grown. I mean, we have 800 plus protocols today involving drugs.

Lesley Williams Brunet:

And I assume that’s one of the reasons why staff has increased because you have all these requirements, paper.

Roger W. Anderson, PhD:

Right. Yeah, in that particular area we have, I think it’s 10 people now. We started with like one person over there. And about half those people are pharmacists and about half the people are technicians. And then there’s a lot of investigational stuff that goes on though in each of our pharmacy locations. They only centralize the record keeping and the inventory and the drug information part of it, but the doses of those particular drugs get handled, dispensed, and in some of the record keeping done at all of our pharmacy locations. So it’s truly well beyond 10 people that are involved if you collectively added up all that time. But it’s 10 people that sit in that pharmacy location.

Lesley Williams Brunet:

That’s quite a (inaudible).

Roger W. Anderson, PhD:

Yeah, it is. It’s a huge responsibility and one that -- now actually it gets extended to the fact that those staff members participate in the Clinical Review Committee, the CRC, which was more the scientific review of every protocol so they have to sign off on that. So they review all those protocols several... I don’t know, dozens per week, almost, and then they also sit in our official members of the IRB, the Institutional Review Board. I don’t know if they still call it, surveillance comm-- that’s the old term.

Lesley Williams Brunet:

That’s the old term.

Roger W. Anderson, PhD:

That’s the old term. But IRB. And so we have two members from the pharmacy that are on the IRB which is more the humans subjects, of course, you know that. Review. And so that’s part of what they do, too.

Lesley Williams Brunet:

That’s a lot. Um, now, with McKinley, he was on that -- was it therapeutics? I’m trying to remember the name of the committee.

Roger W. Anderson, PhD:

Pharmacy and Therapeutics Committee.

Lesley Williams Brunet:

Pharmacy and Therapeutics, yeah, which we have some very interesting files on that.

Roger W. Anderson, PhD:

Yeah.

Lesley Williams Brunet:

Did that continue?

Roger W. Anderson, PhD:

Oh, yes, absolutely. And we have all the minutes from day one on that.

Lesley Williams Brunet:

OK, so you have -- they’re in your department?

Roger W. Anderson, PhD:

Yes they are. Yeah.

Lesley Williams Brunet:

And they’re permanent.

Roger W. Anderson, PhD:

They are, they are. And we have them, of course. We meet monthly now and we have minutes that follow that. Same basic things that were done way back when but are done still and that is the committee that addresses what drugs are on the formulary. And then it addresses guidelines for use now more than it used to and it might come up with ideas that have to do with restrictions. This can only be ordered by so and so. And then we have some preferential guidelines that say, you know, use this stroke first first or something, but yeah, that committee is extremely active.

Lesley Williams Brunet:

And who chairs it?

Roger W. Anderson, PhD:

Right now it’s Dr. Tedge Grover. (sp?)

Lesley Williams Brunet:

OK, does it --

Roger W. Anderson, PhD:

Always a physician.

Lesley Williams Brunet:

Always a physician, never the pharmacist.

Roger W. Anderson, PhD:

The pharmacist is not the chair. The pharmacist is always a member but only in the last -- and I think it’s been ten, 15, maybe 12 years. I think the last twel--

Roger W. Anderson, PhD:

There was a period of time where up through -- in all of McKinley’s time and up through a few of my years where the pharmacist was not even a [Vulgey] member. But we are now.

Lesley Williams Brunet:

And I thought that was very interesting. I sometimes felt like he didn’t -- and I’ve only really looked at the McKinley years -- he didn’t -- they didn’t give him as much voice as maybe I thought he should have or --

Roger W. Anderson, PhD:

Right. And I think that’s certainly evolved over the years and now we have pretty much, well, I’d say equal voice. Now, there are -- and I don’t know if I got the numbers exactly right. I think there are 14 members and so really a voting member’s pharmacist only has one vote. But in reality the way that we -- I don’t want to say orchestrate but the way we plan the meetings and the way we have input to the meetings and meet with the chair and meet with -- and in fact we’ve added task forces now, too, so by the time it gets to the committee for vote, pharmacy has had probably the dominant role in what comes forward.

Lesley Williams Brunet:

(inaudible)

Roger W. Anderson, PhD:

Right.

Lesley Williams Brunet:

Or at least having a greater voice --

Roger W. Anderson, PhD:

And there -- and nowadays there are sometimes pharmacist members that are representing the medical departments. For example, we may have a pharmacist there representing pediatrics and we may have a pharmacist there representing medicine. Because they are part -- we now have pharmacists that are on the staff of the medical areas.

Lesley Williams Brunet:

The clinical --

Roger W. Anderson, PhD:

Yeah, the clinical specialist. We have 40 of these people so they’re out in part of the medical divisions. Actually in some ways more than they are part of pharmacy, but you know, that’s by design.

Lesley Williams Brunet:

I’m really interested in those because I know there’s a --

Roger W. Anderson, PhD:

That’s been a huge growth.

Lesley Williams Brunet:

I’m not sure if we have time --

Roger W. Anderson, PhD:

Well, my time, I can go until 11:15 if that -- and we can do another time as well.

Lesley Williams Brunet:

If you want to do another time --

Roger W. Anderson, PhD:

I have -- I have time. I’m here through the end of June although I have lots of travels in June that I have to do, but --

Lesley Williams Brunet:

OK, and then you’re moving to -- Dallas?

Roger W. Anderson, PhD:

Dallas. I’ll have two locations. One of them’s in New Jersey and I’ll have an office there, too, but I convinced them not to leave Texas, so --

Lesley Williams Brunet:

Oh, that’s good.

Roger W. Anderson, PhD:

Since I’m not a native Texan, but I didn’t want to leave, so we’re going to live in Dallas. But the headquarters is really in New Jersey, of this (inaudible).

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Chapter 05: Working With Research Protocols and Drugs for Research

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