COMMENTARY

Despite High-Profile Scandals, Conflict-of-Interest Reporting Remains Challenging, Scattershot

Chadi Nabhan, MD, MBA; Elias J. Jabbour, MD; S. Vincent Rajkumar, MD

Disclosures

February 11, 2020

This transcript has been edited for clarity.

Chadi Nabhan, MD, MBA: I'm Chadi Nabhan, a hematologist and medical oncologist, and currently chief medical officer at Aptitude Health. Welcome to Medscape Oncology Insights.

Today I have the pleasure of having two phenomenal physicians joining me. Elias Jabbour, MD, is a professor in the Department of Leukemia at MD Anderson Cancer Center; and Vincent Rajkumar, MD, is a professor in the Division of Hematology at Mayo Clinic and a world expert in myeloma. However, we're not talking myeloma. We're not talking leukemia. We are not going to talk about medicine or oncology, but about conflict of interest (COI).

Last year, you probably heard a lot about COI at a major National Cancer Institute–designated cancer center. You read a lot about it in the lay press, in medical journals, and on social media. The lay press and media may have sensationalized the information, and I think there are always two sides to each story.

You can make everybody have a COI, in which case no one has a COI.

My goal today is not to understand that story specifically, but more broadly, to understand what COI is. What is the definition of COI? Do we have a uniform definition so we can tackle the problem? If a problem exists, we need to define it and we need to understand its implications and applications. My guests today will be challenged to try to reach that uniform definition, because ultimately we would like to move forward to do whatever possible for our patients.

What Is Conflict of Interest?

Nabhan: I think you have had easier topics in the past when people challenged you about leukemia and myeloma. Dr Rajkumar, we're just trying to reach a definition. When we talk about COI, do you think there is a uniform definition to that concept?

S. Vincent Rajkumar, MD: Conflict of interest is when you make a recommendation and there is a real or perceived reason which is different from the stated one. For example, if you say one drug is better than the other, is your statement based on the actual evidence or is there another underlying factor? Is it because you are getting some support from the company that made that drug? Or perhaps nonfinancial because you really want to see this drug succeed because it advances your academic career? That is where the conflict lies.

There are two aspects. Number one, is there a conflict or not? And if so, is that conflict okay? And number two, has the conflict been disclosed and disclosed appropriately? We are struggling with both of those things and I don't think we have a uniform definition of what is a significant financial or nonfinancial COI. And we don't have a definition on what needs to be disclosed and what does not need to be disclosed. As a result, sometimes you can make everybody have a COI, in which case no one has a COI. Your goal of trying to reach a uniform definition of what constitutes a significant COI and what kind of disclosure is needed is really critical.

The nonfinancial [conflict of interest] is huge.

Elias J. Jabbour, MD: I agree. It's not a white-and-black, wrong-or-right situation. Our mission is to provide the best healthcare for the patient with the highest integrity in a way where we are not biased with what we are doing. My goal is to provide the best care, the safest treatment based on evidence—period.

As Vincent said, "We're doing this research and it's paid by somebody." We go to the advisory board meetings or we get access to new drugs—we need that to be happening. But whether this conflict is financial or not, it does not affect my treatment decision.

Our disclosures should be first to the patient to whom we are treating. Then we need to come up with a solution on how to make it uniform. With all of this news in the media, it's like if you don't disclose, you're a criminal or you are not doing the right thing. We all are here to do the right thing and we all are good people; we should make these rules simple and encourage people to disclose and be transparent, and come forward without making it so complicated.

Nonfinancial Conflict of Interest

Nabhan: Financial conflicts are a little bit easier to understand. But the nonfinancial piece is interesting. If you are the principal investigator on a clinical trial that you are offering to a patient, you may overhype the importance of the trial because it will advance your academic career. If we knew it was going to work, it would not be a trial, right? It would be standard of care.

Do you feel that there is enough understanding in the public about the nonfinancial part? I hear a lot about the financial piece, and personally I have been vocal in trying to say that there is also a nonfinancial piece.

Rajkumar: The nonfinancial piece is huge. The nonfinancial piece could be just that you are the principal investigator and you want to see your trial succeed and succeed in the biggest way possible. Your academic career advancement may also be based on editorials and other articles you write on somebody else's trial.

But for original research, it's very easy to understand because whoever is reporting the trial is the principal investigator. The audience knows that this person did the trial, and of course they are going to show it in the best way. That is kosher.

Where we have to take a step back with nonfinancial COI is to challenge the American Society of Hematology (ASH) or American Society of Clinical Oncology (ASCO) when they decide on state-of-the-art treatments—for example, having a trial's principal investigator become the judge and present an editorial point of view in a major education session or a major scientific session, and say that this is the next standard of care. That is where we really need to say, "Is this the best person?" They have a significant nonfinancial COI. When we choose people for editorial-type roles, whether it be writing an editorial or a review article in a journal or presenting a major education session, we need to at least consider the nonfinancial COI. If we still think that is the best person, then we need to disclose it.

Jabbour: Vince, I'd like to challenge you on that. Today when you submit your study, a process is already in place whereby peer reviewers go through the process, challenge your paper, and try to improve what you have done.

Rajkumar: That is completely okay because that is the original research. [I'm talking about when] you are then going to write the editorial in NEJM saying why your study is now the best.

Jabbour: But that is when you publish your paper. Let's say you have a randomized phase 3 trial going to NEJM and the editorial office of the journal reaches out to the reviewers and asks if somebody is willing to write an editorial piece added to your paper.

Rajkumar: That is okay. That is where I agree with you. So I write a randomized controlled trial in the NEJM. I'm the best person to write it. I led the trial. That is fine. They get an external editorialist to write an editorial. That is fine too. But tomorrow at the ASH meeting or the ASCO meeting or in subsequent reviews and editorials, if I'm the same person promoting that concept, that is where the nonfinancial conflict is, because suddenly I move from becoming the researcher to becoming the judge. The marketer. And that should be at least disclosed. If possible, people should be chosen who don't have such serious COIs as being an editorialist discussing their own paper.

Jabbour: Then I want to discuss these people who don't have conflicts. All investigators and all academics have inherent nonfinancial conflict. No disrespect, but it's hard to find people who are not conflicted.

Mitigating Potential Conflict of Interest

Nabhan: That was going to be my next question. We are all obviously in the business of providing patients with the best care possible. Nobody is disputing this. To do that, there needs to be a collaborative effort between academic institutions, community oncology, the pharmaceutical industry, patient advocacy groups, and policy makers. All of these stakeholders need to somehow work in a harmonized way. How do we execute that type of work while assuring that the COI, if it exists, is not really interfering with what Vincent mentioned earlier about taking care of patients? We clearly need the collaboration. Academia needs industry to be able to get some of these drugs that otherwise you wouldn't have access to, and industry needs academia because they need the intellect as well as the clinical trials. How do we do that?

Rajkumar: People need to keep two fundamental things in mind. Number one, those of us who are concerned about COI are not saying, "Don't work with industry." I probably work with industry closer than most people whom I interact with. I work with a lot of different companies in various roles.

Number two, no one is saying, "Receiving money for services provided is wrong or having a conflict is wrong." When there is a significant financial COI, no one is able to know whether a recommendation you made is influenced or not influenced by that conflict. That is where the problem is, and that is where two things need to happen. Number one, for certain things, there should be no conflict. If I am running a trial for a company, I should not hold stock in that same company. I should not be getting millions of dollars from the same company. I should be free of COI.

But certain things are okay. I might have been involved in two or three advisory boards, participated in a few investigative meetings, received some honoraria. And you can have the conflict because after all, you did the study, so you will have research payments reported against you. You would have had honoraria paid to you for investigative meetings and advisory boards. That is all okay, and that is disclosable.

What we need to distinguish is, what is the type of conflict you should never have if you are the principal investigator of a trial? And what is the type of conflict that is okay to have but needs to be disclosed?

And finally, in what types of articles, like NEJM reviews or editorials, is it better to have people who do not have significant financial or significant nonfinancial COI so that the audience really gets an unbiased perspective?

I agree that it's getting increasingly hard to find people without COIs, either financial or nonfinancial. Vinay Prasad and I wrote an article in which we proposed a threshold of $10,000 per company per year, where below that is okay for being an editorialist or to write a review, but above that is considered significant financial COI. You can still do research, you can still report trials, everything, but you might not be the best person to write a review or an editorial on that same topic.

Nabhan: Eli, is there a threshold, in your opinion?

Jabbour: The editorialist—to judge the work of others—should have the highest unbiased view because they are affecting the lives of so many people. Otherwise, how can you do it? The principal investigators should minimize their conflicts as well. The idea is not to bias your strategy. You don't want to take a patient off or on study because you are conflicted somehow.

My proposal would be to standardize it for everybody across the nation, not $10,000 in Arizona, $25,000 in Texas, and $75,000 in New York. We should have some common rules applied to everybody, and everybody should be judged by the same standard.

Nabhan: Because these rules vary currently, correct?

Rajkumar: They vary. I think the US Food and Drug Administration and National Cancer Institute have a threshold of $25,000. We have proposed $10,000. The NEJM sets $10,000 as a threshold for significant financial COI. Nowadays, it's not possible to completely avoid COI, particularly payments showing up in the Open Payments program and things like that. Because even if you write a paper with a particular trial, just for transfer of value, you will have dollars reported against your name.

Open Payments and Sunshine Act: Help or Hindrance?

Nabhan: You brought up an excellent point, which is Open Payments. The Open Payments program, which was conceived based on the Sunshine Act, reports the payments that physicians receive either personally or from grants and so forth. I'm not going to bias you about my own opinion on the system of Open Payments; I'm curious about yours. Do you think that the Sunshine Act or the Open Payments system helped or hurt the process of COI?

Rajkumar: The intent was good but the way that it has been implemented is not correct. Either it is seen as having so many mistakes that somebody could brush off the whole thing as flawed—saying, for example, "the numbers are not correct"—or it is not granular enough and thus not putting payments in the right perspective.

For example, it may be reported that a person received a million dollars from a company, but that was actually payment to the institution for a clinical trial that they ran. That is the actual cost of the work done. It's not possible to distinguish whether this person received a research payment for his lab, a clinical trial payment, or a personal payment to take home. I don't think it is helpful the way it's implemented and the way it's currently done.

Nabhan: We need to differentiate institutional versus personal COI. What do you think about Open Payments, Dr Jabbour?

Jabbour: My first experiences were so confusing.

Nabhan: Exactly the same here.

Jabbour: I made this money or I had lunch somewhere—it was completely confusing.

What I advocate is transparency, regardless of the Sunshine Act or Open Payments. Each one of us should come forward in a transparent way and say, "This is what I did." Nobody is a criminal. Nobody is coming to you because you disclosed. I tell my colleagues to overdisclose and we will fix it, rather than to hide it and pretend they did nothing wrong. We're not lawyers. We are normal people who have a good mission and a good aim. I always encourage people to come forward, tell me what they did, and I will help them. [We will figure out] whether they can or can't do it.

Nabhan: I'm curious about whether you think the Sunshine Act has done that.

Jabbour: The intention was good but the way it's done is not good. I stopped following. I don't know what is in it. I submit what I want. I don't know what is important anymore because it's so hard to track.

For example, we have a trial. Because of the policy of the pharmaceutical company, they need to hire a medical writer to write a poster for [a medical meeting]. You discover a $3500 transfer of value for something I could have done myself for no fee. I do [these things] anyway—this is what I do for a living.

Patient Advocacy Groups

Nabhan: But that's the policy of the industry.

I want to tackle one other topic which is important to our patients, some of whom might be watching: patient advocacy groups. With drug costs rising, advocacy groups have tried and attempted to help patients with educational efforts or financial assistance. But to do that, they sometimes have to work with pharma and industry to get grants and so forth. What are your thoughts? Do you think this partnership between industry and patient advocacy is good or bad, or is there a happy medium?

Rajkumar: It's a very challenging question. When you wear the hat of a doctor, patient advocacy groups and industry support of them is very useful. It brings awareness. It helps them learn more about their disease. Sometimes it helps them navigate copay assistance programs and so on.

On the other hand, when you wear a policy hat, you see where it can go wrong. The voice of the patient protesting against the high price of drugs or COIs or anything else can be silenced if that same group is getting a significant chunk of their revenue from pharmaceutical company efforts.

Jabbour: You brought up something very important: We all should be held to the same standard. I'm a physician prescribing, and I'm [seen as] conflicted. You think in our medical societies, when they receive funds from pharmaceutical companies or others, that they are not biased? Why am I biased but they are not biased?

Nabhan: What societies?

Jabbour: All societies: patient advocacy, nonprofit organizations, etc.

Nabhan: That is a good question.

Jabbour: Even at ASH and ASCO, everybody should be held to the same standard. It's not only the physician who is conflicted; it's everybody else. Societies will not thrive without the support of pharma. What is the fine line where we say there is a conflict? In my mind, we need people to be held accountable to the same standard, whether it be a president, physician, patient advocacy group, society, or nonprofit.

Nabhan: Vince, I like how you said in terms of COI, if your treatment decision somehow is based on anything but the proper evidence and the proper patient needs, whether for academic promotion for your trial or personal payments, that is conflict. That even if disclosed, it's inappropriate. Appropriate conflict could exist, but we need to disclose it and have some firewalls. Did I capture this?

Rajkumar: That captured it very well. I propose a working group with the goal of coming up with a uniform definition of COI and uniform disclosure standards. I challenge all of us to see if we could create a think tank that could put together a white paper on what is financial and nonfinancial COI, and what is acceptable and what is not acceptable.

Nabhan: That would be a great project. Final thoughts from both of my guests.

Jabbour: This is a great start. I look forward to this white paper. It will be very important. All I want is the highest transparency possible; everything should be disclosed and everybody should be held to the same level.

Nabhan: You guys have been absolutely wonderful. I promise that next time we will talk a little bit about myeloma and a tiny bit about leukemia.

Dr Chadi Nabhan practices hematology and medical oncology in Chicago, Illinois, and is executive vice president and chief medical officer of Aptitude Health. Elias Jabbour, MD, is professor in the Department of Leukemia at the University of Texas MD Anderson Cancer Center in Houston, Texas. S. Vincent Rajkumar, MD, is the Edward W. and Betty Knight Scripps Professor of Medicine at Mayo Clinic in Rochester, Minnesota.

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