Chapter 05: IRBs and a Few Words about the Growth of Multi-disciplinary Care
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Description
Dr. Buzdar begins this chapter with an explanation of why ethical review boards (the first IRBs) were established after the Second World War. MD Anderson was in the forefront of the movement, and established the first ethics committee in 1966. Dr. Buzdar served on the IRB for a decade. Dr. Buzdar then talks about the power of the IRB, which operates as an independent and final authority in determining whether a protocol can proceed. He gives an example of immunotherapy trials using CAR T cells [chimeric antigen receptor T cells], a treatment that has very serious side effects, leading in some cases to death. Dr. Buzdar describes the unique (in the nation) initiative that MD Anderson has undertaken to monitor and treat these patients for side effects. He notes the value of immunotherapy for patients who are resistant to every other known treatment. Dr. Buzdar also explains that the immunotherapy protocols represent efforts in multidisciplinary care and research. This, he says, is MD Anderson's unique system. He describes how multidisciplinary care works and how it gives rise to research. This has also necessitated a move away from the traditional axiom, "do no harm," he states.
Identifier
BuzdarA_01_20170210_C05
Publication Date
2-10-2017
Publisher
The Making Cancer History® Voices Oral History Collection, The University of Texas MD Anderson Cancer Center
City
Houston, Texas
Interview Session
Topics Covered
The University of Texas MD Anderson Cancer Center - Building the Institution; The Researcher; Research; Overview; MD Anderson Impact; MD Anderson Impact; Institutional Processes; Understanding Cancer, the History of Science, Cancer Research; The History of Health Care, Patient Care; Building/Transforming the Institution; Multi-disciplinary Approaches; Patients; Patients, Treatment, Survivors; Ethics; Research
Transcript
Tacey A. Rosolowski, PhD:
Wow. Now, what was kind of the atmosphere? I've heard so many people describe this period of time at MD Anderson, the '70s, as sort of a unique period in the institution's research culture and research history. What do you recall about the spirit or atmosphere of the time?
Aman Buzdar, MD:
I think there is nothing unique in the '70s. The only uniqueness is because of the Second World War and prior to that --the Nazis carrying out all these experiments on the prisoners, without their consent, in the name of science. Subsequently, the Belmont Report and documents which were created, that you have to have ethics board which should review the research, participants should be volunteers, instead of being just coerced into the research. That's why these things came in the late '70s or mid-'70s. So, prior to that, there was still lesser checks and balances in the research, even though at MD Anderson, being a very unique place, the first IRB over here, it was called the Ethics Committee, was in 1966. I have even a slide and I pulled out the record of the first committee. People think that, Oh, we sometimes disapprove. Even in the first committee, there was X number of studies, I think seven, which were reviewed, and one was deferred.
Tacey A. Rosolowski, PhD:
Really? Okay. So even then, there was starting to be oversight.
Aman Buzdar, MD:
Oh, there was. MD Anderson was actually in the forefront. They were proud of having voluntarily, before it became mandatory that you need to have these ethics committees or IRBs.
Tacey A. Rosolowski, PhD:
Why do you think that was?
Aman Buzdar, MD:
Because the thing was, it was evolving through the regulatory processes, but I think had tremendous oversight to bring these things over here.
Tacey A. Rosolowski, PhD:
Yeah, it's really interesting. Now, your own interest in ethics and -- you're obviously very devoted to this particular dimension of research culture, and I'm wondering, what is it about your own background that's led you to kind of focus on that area?
Aman Buzdar, MD:
I think because I have carried out hundreds of clinical trials, so I have seen what is required. Then I was asked to serve as a member of one of the IRB committees, and subsequently, after years -- it used to have one ethics committee, IRB-- I chaired that committee for almost ten plus years, as chair. People think that, Oh, the chair is the one who decides everything. It is not. The chair is there to moderate the meetings. As a chair, you don't even vote. But, whatever the committee decides, that decision is binding, and the institutional leadership can't overrule that, because these committees are mandated by the federal regulations and they are there to protect the human subjects and oversee the research.
Tacey A. Rosolowski, PhD:
Have there been instances when executive leadership has upheld the value of a particular study that the IRB has turned down for a variety of reasons? And I'm not asking you to be specific. I'm just interested if that situation has ever arisen.
Aman Buzdar, MD:
I think that over the years, it is a two-way street. Since I've been involved for a long time, in the beginning, when I was asked, Dr. Hickey was still here, and I had to go and once, I was asked to chair the committee and it was the only committee. The first thing I went, there was a meeting which was being organized by OHRP, which is the Office of Human Risk Protection, under HHS. So I went and attended the meetings and after that, I sat down with Dr. Hickey, I said, Let me just make sure that you and I are on the same page. Administration, at times, feels that they run the institution, I said, but these committees, once you appoint, they are independent and their decisions cannot be revoked. You could say that -- let's say the protocol is approved by the IRB. MD Anderson may decide that we don't want to do that research over here, but if the protocol is rejected by the IRB, administration cannot say, We are going to do it anyway. That is a binding decision and it cannot be challenged.
Tacey A. Rosolowski, PhD:
Right. Well, I'm just thinking, because you know, I know that there can be many different ways of looking at what the "research protocol" or the research portfolio of an institution should be like, and I could imagine that there might be certain instances when the executive leadership might strongly support a particular research or line of study which needs further review.
Aman Buzdar, MD:
The institution may support it, but still, from the regulatory point of view, they have to go through all the same steps.
Tacey A. Rosolowski, PhD:
Absolutely.
Aman Buzdar, MD:
Over there --the institution, yes, the institution can decide, we want to address X area. Today, we are looking at biologics and immunotherapy and things like that, but they have their own unique side effects and we have to look at it. We have even set up some committees. Actually, from four to five-thirty today, we sit down and I sit every week with our cancer experts, because some of these therapies cause very unique side effects, including death of the patients.
Tacey A. Rosolowski, PhD:
Wow.
Aman Buzdar, MD:
And we have developed a unique system to help identify these patients early on and treat these patients early on, so that maybe we can avoid some of these unfortunate incidences of deaths. I think in my opinion and everybody who is in this committee --this is the first within the whole nation, we have set it up, and we have submitted a manuscript which is under review. We have trained --there are only two, three floors within the hospital where these patients can be admitted. All the nurses, all shifts have been trained, how to look for the side effects, who to call, because the thing is, a patient one minute may be saying, Oh, I have a headache, and the patient may become confused. If you do some type of active intervention, a lot of times the patients will come out of it, but if you don't recognize it, a patient may be deceased within a day or so.
Tacey A. Rosolowski, PhD:
My word.
Aman Buzdar, MD:
Or within a few hours.
Tacey A. Rosolowski, PhD:
Wow, wow, that's amazing.
Aman Buzdar, MD:
So those are the things again, as the science has advanced, we are now at the cutting edge. This is a committee which is called CAR T Cells Committee which is, even today, I have a meeting, I think at four to five-thirty.
Tacey A. Rosolowski, PhD:
And I'm sorry, what's the name of the committee again?
Aman Buzdar, MD:
Here, I can show you.
Tacey A. Rosolowski, PhD:
Oh, Cartox Cell Therapy Group. Thank you.
Aman Buzdar, MD:
So this has been a unique institutional initiative which we started over here, since we had "“ because here, and at some of the other institutions where this therapy was being done, some of the patients had problems, that we have implemented this. We have in this meeting, all of our cancer specialists who treat these patients; our neurologists, our pathologist, our radiologist, our nurses, and all patients who are in the hospital, we go patient by patient. I have a list today, which we will talk about it. I don't participate in the discussion, but I sit there and help guide if there is anything from the regulatory point of view that my office needs to do.
Tacey A. Rosolowski, PhD:
So, I mean that's a great illustration of how, in certain ways, things haven't changed so much from those days in the '70s, when you still had a problem that had to be dealt with aggressively, and you had to look for the impact on the patients. Probably, that's a situation that won't ever go away in oncology.
Aman Buzdar, MD:
Well because the thing is, when you have these -- well, just to give you an example of these treatments. These are so new treatments, that we are giving to the patients who have their disease, which is resistant to every known therapy. Unfortunately, if we don't do anything, they're going to die very shortly. But, with these therapies, more than half of the patients, more than half of the patients, going into complete remission, means their disease disappears.
Tacey A. Rosolowski, PhD:
Gosh.
Aman Buzdar, MD:
But, some of the patients get into very serious complications and we have set up this oversight group to discuss, identify, and see that how can we recognize early on, how can we intervene early on, and prevent the worst outcomes, meaning the death of the patient.
Tacey A. Rosolowski, PhD:
Very interesting, yeah. Would you like to kind of go back in time and tell me about the next phase of your research?
Aman Buzdar, MD:
Yeah, there are several things. In my research, I think things which I don't consider my research. I think of it as team research, our group research, I think of that as the best way to say it, because there is not one person at MD Anderson who does. This is MD Anderson's unique system: we do everything as a team approach, and what we -- this is our backbone, is multidisciplinary approach. Even from day one when we came, even in the earliest days, you had patients with breast cancer. Surgeons, medical oncologist, radiotherapist, and the patient, we will see the patient, review the patient, everybody looked after the patient, and we came back, discussed what is the best, and the doctor who is the family doctor, will go and tell the patient. That was when I came in the '70s, and it was even before then, and even it is today, in every discipline, that is our approach.
Tacey A. Rosolowski, PhD:
And I know that that is something that was really established here. Gabriel Hortobagyi talked about how hard he worked to try to establish that. Why do you think MD Anderson was able to institute a kind of approach like that, which has now become pretty common in other institutions.
Aman Buzdar, MD:
I think on paper it may be common in other institutions, but still it has, in some places, wrong roles. So the thing is yes, a patient is seen by me, let's say as a medical oncologist. Next week, I say, Okay, you need to see the surgeon and radiotherapist, and set up an appointment, the patient will go to other groups. Then, the thing is once, if you are sitting together, looking at the same patient, at the same time, the surgeon looks at it from different angle, medicine people look at it from different angle, radiotherapist looks at it from -- whereas if they are seen in a sequence, without other people's input and a real discussion, you come up with a very narrow slice of tunnel vision. Whereas we do it, see the patient at the same time, discuss it in the same room, make the decision and communicate to the patient at the same time, which is unique, whereas in a lot of other places, that's the way I described it [the sequential way], that's how it happens.
Tacey A. Rosolowski, PhD:
Now, when you came in the mid-'70s, was it kind of a revelation, for you to sit in on some of these meetings, and were they the same then as they are now?
Aman Buzdar, MD:
Oh, they are the same, because the thing is, it is very candid discussion. The thing is, everybody expresses their opinion, and then it is made, that what is in the best interest of the patient, which modality and what sequence and what modality should be utilized, in which sequence, and what modality will have very little to contribute.
Tacey A. Rosolowski, PhD:
Now, were there some ways in which those team meetings had an influence on the shape of clinical trials or on research questions that were asked?
Aman Buzdar, MD:
Oh yeah, there was always the question. The thing is, in the earlier phases, it used to be, I shall do no harm to the patient. Unfortunately when you're doing research, at times you have to accept some of the risks, which may be known, or may be even unknown. I think at times --the example I gave you, because at that time, the FAC combination caused a lot of nausea, vomiting, and patients lost their hair temporarily, that surgeons well, they would tell me point blank, "Dr. Buzdar, you are killing these patients." That's why they were reluctant to send the patients. We had to show them that here is X number of patients which we treated and X number of them are alive, free of disease. It took several years for people to recognize that yes, these things are here to stay and over the decades then, supportive care modality has become available. Now, nausea and vomiting is a very rare problem. In those days, that was one of the major problems. "ƒ
Recommended Citation
Buzdar, Aman U. MD and Rosolowski, Tacey A. PhD, "Chapter 05: IRBs and a Few Words about the Growth of Multi-disciplinary Care" (2017). Interview Chapters. 566.
https://openworks.mdanderson.org/mchv_interviewchapters/566
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