
Chapter 15: Leading Initiatives to Improve Research Quality
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Description
In this chapter, Dr. Keating discusses his roles as Associate VP for Clinical Investigations (1990−1995). He begins the chapter noting the lack of formal administrative structure in the Department of Developmental Therapeutics, where there were no real heads for the different types of solid cancers: once the Department was dissolved, Dr. Keating headed the leukemia family.
Next, Dr. Keating describes his work as Associate VP for Clinical Investigations, which involved examining protocols from all departments in the institution. He looked at the quality of research, the treatment of patients, and how each project fit in with the mission of the institution, setting up committees to improve research and guarantee patient safety. Dr. Keating explains why he accepted this role, sketching in the process a difficulty that Dr. J Freireich had with a clinical trial and the administration’s lack of support for the research project. Dr. Keating expresses his believe that “bureaucracy kills.” He sketches recent changes at MD Anderson that have increased bureaucracy and elevated the cost of running clinical trials.
Next, Dr. Keating talks about his passion for improving the quality of research and lists the areas in which he feels he had the biggest impact during his role in Clinical Investigations. He talks about the high cost of running clinical trials because of the price of drugs.
Identifier
KeatingM_02_20140520_C15
Publication Date
5-20-2014
City
Houston, Texas
Interview Session
Topics Covered
The Interview Subject's Story - The Administrator; The Administrator; Critical Perspectives on MD Anderson; Obstacles, Challenges; Controversy; Growth and/or Change; MD Anderson and Government; Critical Perspectives; MD Anderson Culture
Transcript
Tacey Ann Rosolowski, PhD:
I had a number of questions I wanted to ask you about your administrative roles. Do you want to talk about that today? And I wanted to confirm, since it’s ten of four, did you want to stop at four or do you want to go to four-thirty today?
Michael Keating, MD:
I’ll go until we finish.
Tacey Ann Rosolowski, PhD:
Okay, great. Great.
Michael Keating, MD:
Initially, we had a very loose structure administratively in Developmental Therapeutics, so there was Dr. Freireich, who ran the program, and there were people in charge of the infectious disease and leukemias and immunotherapy, etc., but there wasn’t a head of various subtypes of solid cancers. So I would, for example, develop the database and run a number of the new studies in the leukemia group, but Dr. McCredie, Ken McCredie, was in charge of the whole program. It wasn’t until later when it was broken up into Hematology that I was sort of supervising the leukemia program after Dr. McCredie died, but I had no administrative title, no formal title until I then went and spent some years working as an associate vice president for what was called Clinical Affairs.
Tacey Ann Rosolowski, PhD:
That was from 1990 to 1995?
Michael Keating, MD:
Yeah. And they didn’t want to call it Clinical Research because they thought that clinical trials were not really research. Anyway, I did that for a period of time.
Tacey Ann Rosolowski, PhD:
What was your role in that? It sounded like a very interesting position.
Michael Keating, MD:
It was.
Tacey Ann Rosolowski, PhD:
So tell me about that.
Michael Keating, MD:
Well, one of the things was that we had all about protocols that were coming from all over the institution, and they were of varying quality and they had to be looked at and evaluated by the quality of the research and the risk to human subjects and whether it fitted into what we considered the mission of the institution. So I used to sit on what they called the Surveillance Committee at that point, and it’s now the Institutional Review Board, and there always used to be these arguments about whether it was good science or not. The IRB, their job was to protect human subjects, so that it was a misnomer that they were arguing about things. So we thought that it was important to set up a Clinical Research Committee that would have reviews of the protocols and figure out ways to make them better and safer, and then they would go to the IRB and be evaluated for the human subjects elements of it. And I did that for, as you say, about five years and set up these committees.
Tacey Ann Rosolowski, PhD:
Can I ask you why? Why were you selected to head this, to take on this role, and why did you accept?
Michael Keating, MD:
I accepted for two reasons. Dr. Freireich and I had significant conflict with the administration because there was an episode where I felt we were very wrongly accused of getting around some concept that the National Cancer Institute had for the right way to do things, and it was because we broke out care of our patients with leukemia into what they called the induction process to get them into remission and then the post-remission things. In one of the areas, we were using an investigational drug, and the others we weren’t, and the NCI didn’t like that. We’d been through the whole review process, and when we were challenged by the NCI, we were not supported by the administration. So we got disturbed by that.
Tacey Ann Rosolowski, PhD:
Why do you think the administration didn’t support you?
Michael Keating, MD:
Because the administration rolls over anytime the feds come and threaten them. And, you know, anytime you take a dollar from the government, they own you. I have a patient whose husband and his wealthy friends run an alcohol and drug recovery program, and the rule is never to accept any money from the government, because they’ll be in your face all the time telling you what to do and how to do it. And we have that situation right now. Everything we do has to follow all the federal rules, as well as the Texas rules, as well as the University of Texas rules, as well as the drug company rules. We should have some t-shirts made that state that “Bureaucracy Kills.” It kills the spirit of the investigators; it kills drugs; it kills patients because all the rules slow down the development of potentially lifesaving treatments. And it’s, I think, a terrible feature of our research right now. Most of the rules are making the conduct of clinical trials enormously expensive, so that the companies have a sense of justification in charging a lot of money because they have to fulfill these rules. When you start breaking down the cost of clinical research, the cost of the drug, and the cost of the investigators, etc., it’s relatively trivial, but when you look at the cost of documentation, it’s phenomenal. For example, a Medicare visit here, it costs more to document the visit than you can charge. So every Medicare visit to the clinic is a loss. And you try and say, well, why don’t see everyone free of charge? That’d be good because you wouldn’t be losing money, but that’s a felony because you’re undercutting the market. So it’s a catch-22. You can’t win for losing it. So the reason that I was fairly passionate about improving the quality of research and I thought that there were too many things that were rate-limiting to getting protocols approved in a high-quality fashion, so when Dr. Jim Cox invited me to come and do that, Jim was a radiation therapist, Dr. Gershenson, David Gershenson, was a gynecologic surgeon, and they needed someone that was doing medical oncology, and so I was flattered. They gave me this massive salary increase of about $5,000. (laughter) These days, you become a vice president and they crank you up by another 100,000 or something. But it’s a new day. So I decided it was a good thing to do.
Tacey Ann Rosolowski, PhD:
What were some of the big, big things that you had an impact on during that period?
Michael Keating, MD:
I think it was the expectations of success, because you can write generic studies and say, “We’re going to do this and we’re going to give it to these patients, and we’re going to succeed,” but you can cherry-pick the patients that come along and say, “We’ll only give it to the good patients,” and you’ll get a very good result. But that doesn’t provide you with a whole lot of information, so that there had to be a greater specification of which patients the cost benefit was going to be favorable for the patient; that is, that the downside of the research was negated by the possible benefit of a substantial number of patients, that they had to get an expectation of an outcome in the particular subsets. There were also reporting mechanisms that had to be put in place, and there had to be a relationship established with the Food and Drug Administration. One of the things that I learned in that process is that the FDA, by and large, is not a malignant organization, that they have to satisfy their bosses, who are Congress, and if they give you a call and they say that ,“We’re being concerned about this,” we’ll say, “Okay, I’ll investigate that and I’ll get back to you within a day or two.” And you call them and say, “This is what we did. We agree with you that we didn’t do it very well in the last little period of time, and we’ve put these safeguards in place, and we’ll contact you in a month or two and let you know how it’s going.” And they were quite satisfied with that. So you just write a little note. So that most of the people don’t want to inhibit progress, but they’re still very apprehensive. You know, anytime something goes wrong with a drug, Congress has hearings now, and they’re very visible hearings and they’re very stressful hearings to go through. So I think that the uninformed scrutiny that’s put in place is not helpful at all. I think at the present time a lot of the things that we do in medicine are now ruled by minority opinions, that very vocal people will say that you can’t do this and you can’t do that, and you have to do this, and you have to have the right number of people that are physically impaired and the right distribution of ethnic subvarieties and things likes this. Again, it’s a silly thing, but I was coming in one morning and they were talking about the number of Hindus, Indians, that were at TCU, Texas Christian University, and they were complaining that the university was not providing resources for the Hindus. And there was a tiny number, less than twenty, at the whole university, but they wanted the same sort of resources given to them as others, that they had to have their society. And one of the other students, who was actually a—I think it was Hindu, he said, “Look. Didn’t they read the title of the university? It’s Texas Christian University. It’s not the Texas Christian Hindu Buddhist, dah, dah, dah University, etc. If you come here, you come here knowing what it’s all about. So read their mission statement and what their value system is and things like that.” So I think that we’re in a very delicate place right now, that we’re about to be priced out of being able to conduct clinical research because of the tremendous cost per patient. We’re going to develop a number of drugs that are now unaffordable by our culture, and so that there’s going to be more and more of a difference between the haves and the have-nots, so that the Affordable Care Act will set a level, and if you can afford to buy it above that level, you can. Except in the UK, in that their system actually made it a felony to prescribe some drugs just because you had the money to buy them.
Tacey Ann Rosolowski, PhD:
Wow. That’s quite a statement.
Michael Keating, MD:
It was actually Viagra, because they thought it was going to bankrupt the system, that so many people would be wanting to be using the little blue pill. So they thought that this was going to go on for the rest of the life of these men, and it was going to cost a hell of a lot of money—a heck of a lot of money, and said that they only approved it for situations where it couldn’t work, so that people would get disenchanted by it and the doctors would be punished if they prescribed it outside those boundaries.
Tacey Ann Rosolowski, PhD:
Huh. Interesting.
Michael Keating, MD:
So one of things that’s very obvious to me at the present time is that doctors are singled out in every way as being more punished than any other profession. You know, everyone imagines that all the people that are doing clinical research for drug companies are getting very, very rich in the process, and we have the Sunshine Law so that you can get on a public website and see every dollar that every doctor in the United States ever got from a drug company. Can you imagine any other profession being willing to put up with that? It’s just crazy.
Tacey Ann Rosolowski, PhD:
Very interesting, very interesting. Any final statements you want to make about that period when you were associate vice president for clinical investigations? What did you feel you’d accomplished at the end of that, and what did you feel you’d left undone?
Michael Keating, MD:
I think what had been put in place was a coordinated strategy for getting a protocol, a high-class protocol, through. What I think was not as well done was the evaluation of the success and failure of the different protocols, because some of them were just an idea that someone had, and after a period of time, they lost interest in them. There were a number of protocols that were a cooperative group, protocols or drug company protocols, and when the group or the company lost interest in it, they withdrew support. I thought there were a lot of ways that we could have been a lot better at documenting the success and failure of particular studies, but also the success and failure of our improving an outcome or lack of improving an outcome of treatment of various diseases. There’s an article that was published in some newspaper today that even though there are more patients with lung and prostate and breast cancer these days than some others, pancreatic cancer, because of the lack of successful treatment, is going to become the leading killer of patients with cancer by the year 2030. And this was a tumor that no one was very interested in at all because there’s no successful treatment and it’s a debilitating condition, short half life. Doctors like to have successes, and if you’re all the time dealing with something that’s a catastrophic outcome, that really is debilitating to the morale of the person. So they have to be very altruistic, committed person to stick it out.
Tacey Ann Rosolowski, PhD:
Can I ask you, though, I mean, because I’ve heard stories, talking to people for these interviews, where they’ve said, “Oh, you know, this was a rare cancer, no one had studied it. There was no cure. It was an opportunity, a niche for me.” So why has pancreatic cancer not had that kind of attention from researchers interested in pushing boundaries?
Michael Keating, MD:
I think that almost everything that was tried in the other gastrointestinal tumors didn’t work for pancreas, and it’s a very inaccessible tumor in that it’s tucked away at the back of the abdomen. You can’t palpate it and you can’t measure it easily without scanning, etc. It’s in a situation where it blocks a lot of important ducts, and people get all these complications so they have to have a lot of procedures done. It’s a very labor-intensive process, and I think that’s the main thing. When I tried to get people interested in Fludarabine in chronic lymphocytic leukemia, one of the fellows that I’d approached was a very bright guy and said, “No, it’s the most boring disease on the planet, and no one ever gets famous for working on CLL.” So they were the criteria that he was using to see if he would have an interesting career and if he’d become famous. And so I was lucky enough to be left with this orphan, and it becomes more and more interesting and I become more and more famous.
Tacey Ann Rosolowski, PhD:
(laughs) So there.
Michael Keating, MD:
So yeah, stick it in your ear. I’ll show you.
Recommended Citation
Keating, Michael MD and Rosolowski, Tacey A. PhD, "Chapter 15: Leading Initiatives to Improve Research Quality" (2014). Interview Chapters. 1183.
https://openworks.mdanderson.org/mchv_interviewchapters/1183
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