Chapter 20: Addressing Perceived Conflict of Interest

Chapter 20: Addressing Perceived Conflict of Interest

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Description

Using hypothetical examples, Dr. Dmitrovsky explains mechanisms for addressing instances of perceived conflict of interest in the new era of research collaborations between academic institutions, pharma and the biotechnology industry. He first stresses MD Anderson's responsibility to adhere to high standards of transparency. He notes that MD Anderson has examined best practices from other institutions. Next he stresses that actual instances of conflict of interest are addressed and resolved via mechanisms already in place. He then talks about the need to develop processes for addressing perceived conflict of interest. He gives two hypothetical examples of perceived institutional conflict of interest. The first involves involvement of an academic institution in developing a drug after it has contributed to the Phase One clinical trial to validate knowledge about the agent. In another example, he talks about how an institution might respond if it has commercialized intellectual property, which then generates revenue: he sketches how those profits could be used to avoid perceived conflict of interest. Dr. Dmitrovsky then notes how valuable research collaborations are to advancing MD Anderson's mission, bringing down the cost of health care, and attracting new biotechology industries to the region.

Identifier

DmitrovskyE_04_20150707_C20

Publication Date

7-7-2015

City

Houston, Texas

Topics Covered

The University of Texas MD Anderson Cancer Center - Institutional Processes; MD Anderson Product Development and IP; Ethics; Institutional Processes; Devices, Drugs, Procedures; MD Anderson Culture; Institutional Mission and Values; The Business of MD Anderson; The MD Anderson Brand, Reputation; On Texas and Texans; Healing, Hope, and the Promise of Research

Transcript

Tacey A. Rosolowski, PhD:

Well, I had another topic I wanted to follow up on from yesterday. And this is a follow-up on your mention of ZIOPHARM. Is that how

Ethan Dmitrovsky, MD:

ZIOPHARMA.

Tacey A. Rosolowski, PhD:

ZIOPHARM Onco

Ethan Dmitrovsky, MD:

Z-I-O-P-H-A-R-M-A, ZIOPHARMA.

Tacey A. Rosolowski, PhD:

ZIOPHARMA, OK. And I looked that up online actually, and I found "ZIOPHARM Oncology,but that's a different company?

Ethan Dmitrovsky, MD:

Um, I'm not sure if it's a different company, yeah.

Tacey A. Rosolowski, PhD:

OK. OK, all right. Well, I'll double-check that with you later when I'm doing notes. And the issue that piqued my interest was when you were saying you were working on some issues of conflict of interest.

Ethan Dmitrovsky, MD:

Yeah.

Tacey A. Rosolowski, PhD:

And that's

Ethan Dmitrovsky, MD:

So our public institu I'm sorry. Finish your thought.

Tacey A. Rosolowski, PhD:

Well, I just wanted to kind of set the context.

Ethan Dmitrovsky, MD:

Yeah.

Tacey A. Rosolowski, PhD:

And that has been an issue even for the institution. And for individual faculty lives, it's clearly an issue. When I was talked to Leon Leach, interviewing him a year and a half ago or so, he was mentioning that given the new model of research that the institution is embracing, he said he thought it was really time to think about new ways to approach this issue. So I wanted to ask you I don't know if you can give me details about this particular agreement that you made, but kind of give some perspective on the issue of conflict of interest and how it's being resolved to facilitate the [inaudible] of research in this new era.

Ethan Dmitrovsky, MD:

So this is a new era that is intensely collaborative, one that will clearly have ever-increasing examples of partnership, both within the academy and beyond the academy, between biotechnology companies and pharmaceutical entities. And what we want to do, because we're a public institution we would do it even if we weren't a public institution but in an open and transparent way, to take stock of that truth and to learn from best practices. There are several institutions that have developed partnerships for many years. And example would be UCSF. Another example would be Stanford. Another example would be MIT or Harvard, where there have been these partnerships between faculty members, part of the university, and between biotechnology and pharmaceutical companies. And to learn from the best practices, but to embrace the fact, the truth, that we're a public institution, and we're held to a very high standard of transparency because public funds are used to support this institution, we are, understandably and I embrace this obliged to have processes and procedures and policies that are transparent, that would be able to be reviewed by any fair-minded person and say, "Well, you've made a really good faith effort to address any real or perceived conflict of interest.So those are the two topics.

Tacey A. Rosolowski, PhD:

Could you give me, just quickly, some examples of issues that might arise in this new, complex environment?

Ethan Dmitrovsky, MD:

Yeah, I'm going to kind of get there. That's where I

Tacey A. Rosolowski, PhD:

OK, sure.

Ethan Dmitrovsky, MD:

was going to go next, but I wanted to make two points. One is real conflict of interest, and the other is perceived. So we would never have a real conflict of interest stand, to the best of our ability, that if it were recognized as a real conflict of interest and we have robust procedures and policies in place to make that addressed right away. We have a robust compliance program. We have a faculty-led committee that reviews all potential conflicts of interest, and any real conflict of interest is really addressed readily by the institutional policies and procedure. Where it becomes germane for us to talk about is perceived conflict of interest, the second topic. And it's perceived in the mind's eye of the perceiver, so that perceived conflict of interest could be the perception of an individual faculty member that would want to recuse themselves from being part of a perceived conflict of interest. It might be a team member who wouldn't want to take part in an activity that would be perceived conflict of interest. It could be a stakeholder in the community. It could be a journalist. It could be UT system leadership. It could be a regent. It could and there are so many people in a public institution that appropriately can weigh in. So how do you address a perceived conflict of interest? So I'm not going to talk about the ZIOPHARM example, but I'd like to sort of give you a hypothetical. The reason I don't want to talk about the ZIOPHARM is that we're nearly there in addressing it, and I don't want to tell you something that may not be chiseled in stone as a way. But let me give you a very tangible example. Many times in the discovery cycle of moving a finding from the bench to the from the lab bench to the clinic, there are moments where more discovery would benefit a discoverer. So if you find, as an example, a new therapeutic target "targetin this sense means a protein or a receptor or a surface, growth factor receptor that had been uncovered by a scientist or a physician-scientist or a physician as an attractive target it might take a few years of work to validate whether you have a drug that could affect the target, whether that drug would be safe to administer, whether the drug actually tracks with the pathway that has been uncovered, and whether an agent that had been discovered would be safe to administer to patients from the toxicology point of view. And all that work needs to go on before there's ever a consideration of moving a drug into a patient population. That would be called a phase 1 clinical trial. Sometimes, there's a value to accelerate the discovery, to actually put your energies, to be confident that that drug target makes sense to affect benefits for patients by spending some time doing more discovery and more science. Many pharmaceutical or biotechnology partners don't have the resources to fully fund that discovery, and an institution might say, "Well, we'll partner with you.I'm giving you a hypothetical. This gives you a pretty good hypothetical example. So if the institution partners because you may have a small biotechnology company that can only help refine by more discovery so much, then the institution could be viewed as being in perceived conflict of interest, in moving forward in the clinical development of that compound. And these are the kinds of scenarios that are really germane to perceived conflicts of interest. So how could you recuse the institution from being perceived as not acting in an impartial way? So if you were to move forward in the clinical trial, I think it would be important to disclose that to any that fact to any patient who might consider entering onto the trial, to just transparently say, "Here's how this drug is being developed. It's being co-developed.And then, to give you some context, if that weren't co-developed, then maybe that drug might not ever see the light of day. So given the choice between never seeing that discovery potentially help patients and then having a path forward to sharing the development costs makes a logical sense. But it would make sense to disclose that. It would also make sense to not have any principal investigator who might personally benefit, having been a co-discoverer, to have any role in the trial. So you would have a firewall, and that would be a good response to and disclose this to any patient who might answer to say, "No one would personally benefit from this trial because they might have a patent that they would hold that might benefit from discovery should have any role in the trial.And should that trial even be reviewed by the institutional IRB, should there be a separate IRB that would look at those trials so that no member of the community would play a role? And maybe that IRB would say, "Well, you shouldn't even conduct that study at this institution.Maybe you would want to have a completely separate institution and their separate IRB review. And shouldn't you engage an ethicist, so that any patient concerned can be impartially and independent at the system, unassociated with the institution, could be an impartial party that could answer any questions raised by any party external, internal, patient, UT system and not have that person associated with the institution. Doesn't that begin to address perceived conflict of interest? So we would never tolerate or accept a real, but in this changing world, there are many perceived. So let me go beyond that. What if there's a scenario where there is some commercial advantage that comes back? So if you put in all of these safeguards, how do you address the perceived conflict of interest that there's a piece of equ of intellectual property, policy that there's a piece that goes to the institution? How do you recuse the institution from any real or perceived conflict of interest? Shouldn't you have a robust plan in place before any study is done, where there are safeguards maybe a blind trust, maybe an independent panel that would review? But most importantly, that you decide in advance that as if, for instance, maybe those funds could be used as an engine of discovery that would go right back to the faculty, so that more discoveries could be made. And how do you put in place a process and procedure where maybe those funds would never be under the would certainly never be under the institutional funds. There are funds that would go to the inventors. I'm talking about the institutional conflict of interest. Maybe you could put in policies and procedures where there would be no institutional view that could, per se, have a choice of where those funds would go. You would have a peer review panel. And this is what I'm talking about. All of these this hypothetical would be so that it would pass a fair-minded review of any internal, external, government agency, state agency, that we would have a transparent process, and then to disseminate those policies and procedures. And so not so long ago, these were topics that didn't come up. But now, because of the collaborative nature of science and medicine, they do come up. And I wanted to say but that's part of our social contract, right? Our social contract is to do everything we can to confine cancer to history in the city of Houston, the state of Texas, the nation, and the world, and it's part of our charge. So we must embrace that responsibility, but that would be hypothetical.

Tacey A. Rosolowski, PhD:

I'm also thinking, too, putting those practices in place it helps move the institution, the identity of an institution, into the future. There's a kind of new model for dealing with ethical dilemmas. They have been thought out. That's part of the institution stewarding its movement into a new environment.

Ethan Dmitrovsky, MD:

Right, and not only is your point it's an excellent point and a very appropriate point, but let's look at it from another point of view. So we'll do everything in our power to address a real or perceived conflict of interest, and what if we're successful? So that's the vulnerability of every decision you make has risks and benefit. One of the vulnerabilities is that the good name of the institution might be compromised if you don't have robust policies and procedures. So we're making a good faith effort to address that. Now, let's look at the flipside. What's the opportunity? Well, the opportunity is that we could serve the city of Houston and the state of Texas ever more so, because if we are able to through this cycle of discovery to move a discovery from the bench to the beside and ultimately into the community, then we will change practice for the benefit of cancer sufferers. That's a real, important goal. But at the same time, we might be able to see it foster advance a larger community of biotechnology and pharmaceutical entities to be in the city of Houston, in the state of Texas, that would be able to do more discoveries that will improve the public health, and at the same time become a source of employment and revenue for Houston and Texas. And that would be a social responsibility we would have to spawn new companies, biotechnology companies, that would create a vibrant community of discovery here in Texas. And this has already been accomplished with great success in Boston, in Cambridge, Massachusetts, in the Bay Area, and wouldn't it be wonderful if we could accomplish that in the heart of the country? And isn't that part of our social contract?

Tacey A. Rosolowski, PhD:

Absolutely. John Mendelsohn, when I spoke with him, was talking about the dream he had had in developing South Campus, hoping that that would be a center

Ethan Dmitrovsky, MD:

Yeah.

Tacey A. Rosolowski, PhD:

and the economy didn't enable that

Ethan Dmitrovsky, MD:

At that moment in time.

Tacey A. Rosolowski, PhD:

at that moment, but it seems like the moment has come to think about that as part of the institution's vision again.

Ethan Dmitrovsky, MD:

Well, not only is Dr. Mendelsohn's vision an appropriate one, but and perhaps, as you just said, because of health economics being in a place in its history where we need to be ever more effective and efficient and more cost-effective, then new discoveries may have another benefit of taking a very daunting cancer problem that may have had a pressing need for improved treatments to move into more effective treatments and will reduce the cost of that care, that we need to do all we can to drive down the cost of care, and discovery is an important tool.

Tacey A. Rosolowski, PhD:

Mm-hmm. Very important point, yeah.

Ethan Dmitrovsky, MD:

So we need to, as an institution, accept our responsibility to do all we can, to use every tool at our disposal to improve the lot of cancer sufferers. And the cycle of discovery eventually, that side does require, oftentimes, partnership with biotechnology and pharmaceutical partners, and so we need to have robust systems and policies in place to pass the real or perceived conflict of interest. I hope that scenario made sense.

Tacey A. Rosolowski, PhD:

Oh, it does. Thank you very much for responding so fully, because I think that will be a really useful

Ethan Dmitrovsky, MD:

Yeah.

Tacey A. Rosolowski, PhD:

a useful addition to understanding what's happening at the institution.

Ethan Dmitrovsky, MD:

And please use the word "hypothetical,because I don't want a particular

Tacey A. Rosolowski, PhD:

Sure.

Ethan Dmitrovsky, MD:

company to be presented, because it's in many cases, we want to be able to assure that people can discuss with us their needs in a private way. I don't want to attribute it to any particular company.

Tacey A. Rosolowski, PhD:

Absolutely. No, no, you were very clear about that, and I just wanted to again mention you'll have an opportunity to review your

Ethan Dmitrovsky, MD:

Yeah, sure.

Tacey A. Rosolowski, PhD:

transcript, and if you feel that's not been clear in any way

Ethan Dmitrovsky, MD:

No worries, thank you.

Tacey A. Rosolowski, PhD:

you'll have an opportunity to make an addition to that.

Ethan Dmitrovsky, MD:

Good.

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