Chapter 16: The New Committee on Drug Side Effects

Chapter 16: The New Committee on Drug Side Effects

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Description

In this chapter, Dr. Buzdar explains the function of the Committee on Drug Side Effect, created six months previously, as a response to the serious [rapid and life-threatening] side effects possible with immunotherapy such as CAR T-cell therapy. He explains the special procedures used to deliver care to these patients and the training that the teams receive to watch appropriately for signs of side effects. He also explains that he and others are working with Informational Technology and Epic to put a red banner on these patients' electronic medical records to alert all teams that they require special monitoring. Dr. Buzdar notes that all unexpected events are reported to his Office [Clinical Research]. The first immunotherapy side effect was "alarming" and he met with division heads to talk about how to manage and prevent these side effects. They responded quickly to set up a system to manage these patients. In the final minutes of the interview, Dr. Buzdar talks about retirement and the contributions he is pleased to have made to the institution.

Identifier

BuzdarA_02_20170216_C16

Publication Date

2-16-2017

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; Building the Institution; MD Anderson History; Research; Devices, Drugs, Procedures; Multi-disciplinary Approaches; Patients; Patients, Treatment, Survivors; Technology and R&D; Leadership; Discovery and Success

Transcript

Tacey A. Rosolowski, PhD:

Very interesting. Are there other committees that you've worked on, that have kind of created these sorts of changes? That's really fascinating.

Aman Buzdar, MD:

Our other committee, which is still a work in progress, is as the therapies are evolving, there are unique side effects which are happening. Some of these biologic therapies, what we call CAR T-cells, these are the T-lymphocytes which are especially programmed, and they are now able to identify cancer and kill the cancer when you infuse it after programming these lymphocytes. But, sometimes, and I think we talked briefly about it, sometimes these cells can also attack the normal tissue, and there is some of the side effects which became clear to us in rare patients. Patients having massive side effects in their brain, and unfortunately, we lost a couple of patients. We have now set up a separate system that it puts a huge red flag. I have to work with the IT people and with the committee. We meet every Friday from four to five-thirty, every week. We have made it so that every doctor knows, who touches the patient, that this patient is receiving this specific CAR T-cell therapy. Sometimes these patients can be -- things can change on a dime. The patient could be sitting like you and I are talking, and the next minute the patient may be comatose, or have a massive seizure and need to be intubated. There are ways we could reverse it if we identify it. So now what we do is we do these therapies and we have a total plan of action, which is again, first in the nation. We are actually submitting, and it is -- our approach has been so much streamlined, that there is a manuscript which we wrote on it. It is being -- it is under review in a journal, where we have how to evaluate these patients. We admit the patients on specific floors, where every nurse --because there are three shifts of nurses, every shift works for eight hours-- all the nurses working on those floors, all three shifts, we have to educate them that you need to be aware of this and here is the phone number and here is the red banner, who to contact and what to do in the meantime. There are specific steps that is just done, it's a work in progress, and it is already done, so that if a patient receives the therapy, they stay in the hospital. There are appropriate floors where they are monitored, the nurses are educated, doctors are educated, we meet. All the doctors who are treating these patients, we meet and review every patient who is on these therapies, every week.

Tacey A. Rosolowski, PhD:

Wow. And how long has that program been in effect?

Aman Buzdar, MD:

It has been less than six months, because we had unfortunate incidents over here and in other places, where some of the patients very quickly went downhill and died.

Tacey A. Rosolowski, PhD:

Wow, amazing.

Aman Buzdar, MD:

So we have put this and I think we are now able to save a number of patients who would have otherwise, without this, could have been -- not survived. Now, by treatment, (snaps his fingers) they recover.

Tacey A. Rosolowski, PhD:

That's amazing. You know, and I'm just connecting this kind of process, with the process that you described with creating the algorithms. It seems that was such valuable experience, to kind of put everything in paper, get it all down to a system that you could kind of adopt that approach.

Aman Buzdar, MD:

This is the same.

Tacey A. Rosolowski, PhD:

It's the same thing.

Aman Buzdar, MD:

It is the same thing. Now there is who to contact, call the neurologist, here, document the side effects.

Tacey A. Rosolowski, PhD:

But did the experience of going through and putting in place, those algorithms, sort of give everyone the valuable experience, that they knew quickly, how to approach something like this?

Aman Buzdar, MD:

I think how this thing evolved is because every unexpected event is reported to my office, that is my responsibility. My responsibility after that is that if these unexpected events are totally not previously observed, we have to report it to the regulatory agencies. Once the first event came up, we became alarmed and I, with the help of our leadership, Dr. Dmitrovsky and Dr. Wilding, we met, together with the division heads of Cancer Medicine. We set up a committee, we said we need to sit together, talk about it, how to manage these patients, identify these problems early on, and how can we maybe possibly prevent it. And it was with this effort as a team again, that that's how this thing evolved, that very quickly, we were able to not only get a handle on this, but set up a system which is again, unique. Now, the drug companies want to know how we manage these things. It is becoming"¦ My role is just as an administrator, to provide the support, but the science behind it and all the thinking behind, it is the people who are actually disease experts.

Tacey A. Rosolowski, PhD:

Sure. But I think also, I mean what I'm seeing is a really consistent, organized mindset of how to organize this as a workflow and bring all these different people together. That seems to be something that's been repeated over and over at this institution, based in that multidisciplinary care, you know how do we not work piecemeal but bring these teams together to bring different perspectives and expertise.

Aman Buzdar, MD:

Well, yeah, it was a challenge, because just to put this red banner, that this patient is on CAR T-cells, it was --

Tacey A. Rosolowski, PhD:

Not enough.

Aman Buzdar, MD:

No, it was a major act of God, because in Epic, Epic is a very structured medical record. I say I want to have this thing, it should be you click on it and it should hit you in the face. So, we are to go and meet with -- I said, I will meet with anybody and everybody. We had to go and convince everybody that why it is important and it is in the best interests in enhancing the safety of the patient.

Tacey A. Rosolowski, PhD:

So the minute the record comes up, bang, there's that red there.

Aman Buzdar, MD:

It shows. It is a red banner. The patient is on CAR T-cells. Then, if you click on it, it tells who is the doctor to call, what are the things which you can't do, and what are the things, if things happen, then there is a whole things. It's almost like a dominos stand up, then you can"¦

Tacey A. Rosolowski, PhD:

So you had to really convince people to put that red banner on there.

Aman Buzdar, MD:

Oh, it was a challenge, because the thing is, human nature is that you don't want to change, we want to keep it this way. We had to go and meet with the teams, to convince them that this is in the best interest and the safety of the patient.

Tacey A. Rosolowski, PhD:

And these were people in IT that were kind of pushing back?

Aman Buzdar, MD:

Everybody wants to keep the box as it is. (both laugh)

Tacey A. Rosolowski, PhD:

Yeah, yeah. Well tell me, Dr. Buzdar, what are some things -- do you have plans to retire?

Aman Buzdar, MD:

I enjoy it but I think yes, I am thinking of it.

Tacey A. Rosolowski, PhD:

Yeah? And what are you going to do after you retire?

Aman Buzdar, MD:

I have a lot of things to do. We have family, we have a place in Galveston, we like to travel, but I have traveled a lot, because I have been around, so I have seen practically every part of the globe I wanted to see.

Tacey A. Rosolowski, PhD:

So you have no big -- you're not going to learn French or, you know? (both laugh)

Aman Buzdar, MD:

No. Nothing like that.

Tacey A. Rosolowski, PhD:

Well as you think about what legacy, what would you like people to carry on doing once you've decided to"¦?

Aman Buzdar, MD:

I don't want any legacy. I think the thing is, my outlook at life is I am here, I am fully committed. Once I am gone, my name should be erased, then as if there was nobody here, because I'm not looking for any legacy.

Tacey A. Rosolowski, PhD:

But is there something that you've put in place, not necessarily the people attached your name to it, but are there things that you've put in place that you want to see continue?

Aman Buzdar, MD:

I think a lot of things which we talked about, that they have now become things we talked about, the treatments, the standard of care, things which we did as an institution, these are things here to stay.

Tacey A. Rosolowski, PhD:

Right.

Aman Buzdar, MD:

Of course, as the knowledge evolves, things change, and medicine is evolving at a dizzying pace, that things are going to change. What is today's standard, in a year it may be a historic treatment and there may be new therapies.

Tacey A. Rosolowski, PhD:

What has -- we've talked about the various ways in which you've worked for this institution and worked with the institution, to make it more effective. What has the institution done for you?

Aman Buzdar, MD:

I think the one thing, you hear different things from different people. I think this institution is very unique. Institution will provide everything if you are trying to do something for the good of the patient, for the group goodness. At times, human nature is that we always want to see what is my best interest. I look at it, what is in the best interest of the institution, what is in the best interest of the patient, and how can we advance the science and how can we stay in compliance with the regulations. That is my current responsibilities and I take it very seriously.

Tacey A. Rosolowski, PhD:

Is there anything else that you'd like to add?

Aman Buzdar, MD:

No, I think it was a pleasure talking to you, thank you very much.

Tacey A. Rosolowski, PhD:

Well, thank you, it was a pleasure talking to you too, and I've learned about a lot of things I didn't know before, so thank you for that. Well, I wanted to just say for the recorder that I am turning off the recording at quarter of eleven. Thank you so much.

Aman Buzdar, MD:

Thank you, thank you, good to see you.

Tacey A. Rosolowski, PhD:

Yeah, it's good to see you too. [End of Interview]

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Chapter 16: The New Committee on Drug Side Effects

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