• Published on Aug 20, 2020

Video Transcript

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JOHN WHYTE: You're watching Coronavirus in Context. I'm Dr. John Whyte, chief medical officer at WebMD.

COVID-19 has shown us how disparities still persist. Part of the way to solve the problem of disparities is to have more people in clinical trials that represent our communities, and we're not there. And-- and to find out how do we do get there and what we can do, I've asked two experts to join me.

The first is Dana Dornsife. She's the President and CEO of the Lazarex Cancer Foundation. And Glenn Ellis, he is a Visiting Scholar at the National Bioethics Center at Tuskegee University. Thank you both for joining me.

GLENN ELLIS: Thank you.

DANA DORNSIFE: Thank you, John.

JOHN WHYTE: Now, we have all had conversations outside of today's interview about the challenges of enrolling minorities in clinical trials or-- or the fact that there is a low number. So, Dana, let's start with you. Why do we see so few minorities in clinical trials?

DANA DORNSIFE: Well, you know, there are a myriad of reasons why. Um, I think first and foremost in relation to minority participation is, you know, we just have a history of-- of medical abuse and atrocities that have taken place over the years, and that has just created a very deep-rooted fear of-- of the medical, um, institutions in general, um, but also mistrust and um, a-- really, there's not a high degree of-- of confidence and understanding around the benefit of actually participating in clinical trials.

Add to that the burden of-- of participating in trials, and, um, you know, we see a 5% participation.

JOHN WHYTE: Well, I was going to say that. You know, we all know the drug-trial snapshots that publishes, uh, from FDA who participates in clinical trials. Glenn, we're seeing 3% to 5% or less African Americans in cancer trials. And we know that if you found standard therapy and don't enroll in a trial, you know, it's going to impact your mortality. So-- so why are we still here in 2020 when we're seeing 3% or 5%?

GLENN ELLIS: Well, I think you can't have this kind of conversation without acknowledging and looking at the entire medical and health-care system. So clinical research is a part of the entire system. So it's not like things that we're seeing and these types of outcomes are only existing within the context of the clinical-research domain. They are consistent, the same types of dismal outcomes you can find at any level throughout the entire process from primary care all the way through to clinical trials and, unfortunately, even in terms of death-- how we die in this country. So we're seeing that as a consistent pattern.

As it specifically relates to, uh, clinical research, I think we have to broaden our understanding about some of the rationale and the reasonings behind it. So of course there clearly are documented and justifiable reasons to have mistrust and to have fear, et cetera, because we have a-- a record that shows what our experience has been and the experiences of other underserved, uh-- members of other underserved communities. However, we also know that the evidence is showing us that we don't even get the opportunity to know about clinical trials.

JOHN WHYTE: Is it that they don't know about it because, you know, you just can't go to clinicaltrials.gov and figure it all out, or is it because they were not offered it in terms of, you know, a physician or, you know, a nurse recruiter or someone didn't think that they'd be able to participate? What's going on there, I mean, when you say that?

GLENN ELLIS: The correct answer is D, all of the above.

JOHN WHYTE: OK.

GLENN ELLIS: That's the correct answer because what-- and this is all doc-- this is all data-driven research that has reflected these types of trends and patterns in this-- in this area.

What we know for sure is that, for the most part-- well, first of all, there are no PIs of color in this country worth mentioning at all in terms of numbers, right? 1%, 2% or something that's even more-- I forget what that is off the top of my head. However, the majority of PIs that are involved in clinical research, many of them recruit from their practices or from the practices that are associated with their institutions, which by definition and by-- by trend we know, as we talked about how these in-- inequities travel throughout the entire spectrum of the health-care and medical field.

So the fact that these people are typically not even a part of those practices or part of those patient populations that are so easy to excess-- access for a-- a-- a private-- I mean a personal investigator. So what would be required to fix this is going to be an extra effort outside of the norm of what we know about how protocols are carried out.

JOHN WHYTE: Right. But there are things even that we can do now. And, Dana, you and I met several years ago when you came to FDA, and you said you're noticing that people aren't able to participate in some clinical trials because of the travel that's required. Every city doesn't have a cancer center. Every city doesn't have, you know, clinical trials going on. Talk to us about what you noticed and what you've done about it.

DANA DORNSIFE: Um, well, shoutout to you, John, for helping us navigate through that, uh, new guidance language that was so important to helping to address this barrier with the FDA.

Um, so sadly, you know, poverty disproportionately affects our communities of color. And because of that, any additional burden-- financial burden that someone needs to bear in order to participate in a clinical trial is going to be a barrier.

Though, uh, we specifically went to the FDA and said, look, we have to be able to reimburse patients for out-of-pocket travel expenses because unless we do that, these patients will never be able to actively participate in cancer clinical trials, nor will we ever create a platform of equitable access. And fortunately with your help, we were able to successfully navigate that with the FDA, and today we have language that says yes, we can. It's permissible to, um, uh, reimburse patients for their travel expenses, and that's what Lazarex has been doing since 2006.

And I'm happy to report to you that with our impact program, um, we have 63% minority participation from households that 53% of the time are earning less than $25,000 a year. So we are clearly hitting the sweet spot and helping these patients who are most at risk to gain access and stay engaged in their fight with cancer through clinical trials.

JOHN WHYTE: And congratulations on that. You gave me credit, but you deserve all the credit for-- for raising it and-- and being dogged about addressing it.

You know, Glenn, we're hearing about COVID disproportionately impacting people of color. We're saying we need to do better. You know, I'm not even sure-- maybe you know-- what's happening in vaccine trials. You know, we're talking about getting more people of color, marginalized communities involved. But as you know, all too often no one is held accountable if you don't meet those numbers. Is-- is that going to change given, you know, where we are in terms of COVID raising awareness?

GLENN ELLIS: Regrettably, we have to look at the dismal record in that area prior to this pandemic and prior to this vaccine-development, um, race, so to speak.

I think what happens is looking at it now, there was no effort-- and I have looked high and low and overturned stones over. There was no effort to make sure that this was an inclusive population for these vaccine trials.

And more importantly and what's really troubling for me as it relates to these continual inequities that we talk about throughout the continuum of our system in this country, who's going to get it first? The logic-- a medical logic would say the most vulnerable population should be protected. The evidence has shown us through this pandemic that that means that the Black and brown communities in this country should be the fir-- first in line. But I think it's not a stretch of the imagination for all of us to say that's not going to happen based on what we know.

JOHN WHYTE: How do you fix it, Glenn?

GLENN ELLIS: Pardon me?

JOHN WHYTE: Wave your magic wand. What-- what would you do first?

GLENN ELLIS: Well, first I would go and buy a magic wand. [LAUGHS]

But here's the problem. I think that we don't have enough systemic political will to address these problems because, regrettably, we're the only developed country in the world where our public-health and medical system is tied to the free market. So that introduces another-- a set of dynamics that makes it virtually impossible because he who controls the goals makes the rules, right?

So when we look at if our economy and our commerce is tied to the prospering ability of our business models and medicals care, the right thing to do will never win. So I don't know. I'm-- I'm perplexed because I think it will only-- the only solution is going to require-- that will be required is that we have to have a collective political will in this country by all stakeholders, from families to patients to researchers to health-care professionals, legislators, policymakers, the business community, our educational system.

We have to have a collective consciousness that says this is not who we are. This is not who we want to be anymore because we've already said this is who we are, but we have to say that. And until that's said, there's no-- nothing can change because the system is too, you know, structured.

JOHN WHYTE: Well, Dana's very focused on disrupting the system, and you've had your own conferences on-- on being disruptors. One area that has come up is are we going to see more and more clinical trials done in the home, and will not address some of the inequities? What are the disruptors that you're seeing might be successful?

DANA DORNSIFE: Well, I think the answer to your question is, um, potentially I do believe that we, um, can capitalize on the challenges that COVID-19 has thrown, um, to the medical community.

For years and years, John, we've been talking about decentralizing or conducting virtual trials, right? However, it's never happened. Why has it never happened? Because we didn't have a unifying force like COVID-19 that demanded we all-- all the stakeholders that Glenn just, you know, listed, right? COVID-19 is demanding that we all work together on a-- a cohesive solution to help our cancer patients continue to access their clinical trials and their-- their treatments to stay alive.

JOHN WHYTE: Glenn, are you as hopeful as Dana is about the future?

GLENN ELLIS: Well, I benefit from Dana's hope, but it doesn't totally resolve all of the lack that I have because the important work that Lazarex is doing is for a specific segment of the population because all Black and brown people don't have financial issues.

DANA DORNSIFE: Correct.

GLENN ELLIS: But all Black people are, in this regard, dealing with the impact of this structural racism, which we haven't talked about, because there are people who don't, once again, even know about the clinical trials even exist. So that has nothing to do with economics.

JOHN WHYTE: That's right.

GLENN ELLIS: There are people who are not-- and just by example-- I'm based here in Philadelphia. Some Black doctors, medical doctors, had to moonlight on the side in order for the African American and Latino communities in Philadelphia to be tested. That wasn't just poor African Americans and poor Latinos and Hispanics. That was both-- all of these communities. There were entire zip codes where 80% of the people that were in zip codes that were overwhelmingly white zip codes, 80-- over 80 plus percent of those people have been tested. And just less than a mile or so away in another zip code that was more-- overwhelmingly, uh, Black or brown, over 80% of the people had not been tested.

We're not talked about in separate countries. I'm talking about within the same city.

JOHN WHYTE: Sure.

GLENN ELLIS: So I'm just saying that we have to understand the magnitude of the problem.

One of my challenges that I wrestle with is constantly feeling that there's a reduction of the scope of this problem and there's a lack of willingness to acknowledge that the structural and historical racism in our medical system that's well-documented over the last 3, 400 years that we don't acknowledge that this is a bigger problem and [INAUDIBLE].

JOHN WHYTE: But do you think that's starting to be told now with George Floyd's murder, with Black Lives Matter? Do you feel that's starting to be told?

GLENN ELLIS: No because I think what-- what is allowing it to start to be told is when conscientious people like yourselves with the platforms that you have are willing to allow the access of this type of dialogue. And I think, like everything else in life, it's a-- it's a-- it's an evolution, and it's a snowball rolling down the hill.

But if we don't collective-- the Danas and the Glenns of the world don't get the initial push of the snowball down-- that little small, handheld snowball will never be a boulder by the time we get to the bottom of that hill. So I think that it's the collectiveness that we all are committed to, but I think that we have to single out and acknowledge what you do with this platform and what it starts to do to help to make the good and right kinds of information available to the people and the kinds of entities that have the power, influence, and ability to start to make this turn of the Titanic, so to speak, when I look at our health care system.

Because I'm realistic. None of this stuff is going to go away overnight, but we have to start that snowball. Thank you, Dana, and thank you, Dr. Whyte.

JOHN WHYTE: Well, that's a good point, and we all have a lot of work to do. And I want to thank both of you for taking the time to share your insights to help, you know, push us in terms of what we need to do. And I'll look forward to having you both back to see how we're doing over time. So thank you.

GLENN ELLIS: My pleasure.

DANA DORNSIFE: Thank you so much.

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