Kim Thiboldeaux 00:10
Welcome to The Cancer SIGNAL, a new podcast presented by GRAIL where we discuss the impact of early cancer detection, the science behind multi-cancer early detection and insight into how this approach has the potential to shift the cancer paradigm. I’m your host, Kim Thiboldeaux. We’re so pleased today to be welcoming Dr. Gary Puckrein. Dr. Puckrein is President and Chief Executive Officer of the National Minority Quality Forum, a not for profit organization that he founded in 1998. NMQF addresses the critical need for strengthening preventable illness in minority populations through prevention, early detection, and control of disease complications. Dr. Puckrein graduated Phi Beta Kappa from Brown University, where he received his master’s degree and doctorate. He has received many awards and honors including being named a visiting scholar and fellow at the Smithsonian’s National Museum of American History, and a visiting fellow at Princeton University. Dr. Puckrein also created and launched Minority Health Today, which serves the needs of clinicians practicing in minority communities. Thank you for joining us, Gary Puckrein.

Dr. Puckrein 01:16
So great to join you, this afternoon.

Kim Thiboldeaux 01:18
So, Gary, today, we want to dig into the impact that health disparities in cancer among underserved and marginalized communities have on health outcomes. I want to talk about the critical need for diversity and clinical trials, which is an area I know you’re very passionate about. And also a little bit about, you know, where we’re seeing some bright spots what’s being done to advance health equity in cancer. But let’s start by introducing our listeners to you. Tell us about you and the National Minority Quality Forum and what led you to start this organization.

Dr. Puckrein 01:48
So as my resume would suggest my doctorate’s in actually history so I’m marauding in these spaces, but in a lot of sense, what we do in healthcare is historic. And my interest really started with data. What sometimes gets lost in the sauce here, is there are about 38,000 zip codes where people live, 70% of African Americans live in 2500 zip codes. 70% of Hispanics are in 2500 zip codes, and 50% of Asians are in 1500 zip codes. No one was collecting that data in those minority communities, you know, and so, our work really started in collecting health data down at the zip code level. It’s HIPAA compliant. And it also gave us insight into what was happening in minority communities. Where were they being challenged with disease, who’s treating them, what do the outcomes look like? What kind of medical interventions were they getting? So we’ve been collecting that data now for over 20 years. We have a database of over 5 billion patient records. We collect data on about 160 million lives per year. So we really have a very good sense of how the healthcare system is performing in minority communities.

Kim Thiboldeaux 03:09
Well, I appreciate that overview. And I know that you know, data is king when it comes to healthcare. And so I applaud your vision and in founding the organization and gathering that tremendous data. Gary, when we look at cancer, specifically, we know that certain groups continue to be at increased risk of both developing and dying from certain cancers. What factor plays a role in that, give us some insight.

Dr. Puckrein 03:34
So there’s a lot going on in cancer, it’s sort of emblematic of, of life in America these days. So a lot of minority communities unfortunately, live in environments that are carcinogenic, that have higher risk for cancer. And so it’s not surprising that their incidence of cancer are higher in those communities. Even with that higher incidence, and by geography, we can tell where those communities are, we don’t do the screenings that we could. In fact, I was just reading a note in the press today about a judge who is reversing the Obama Care screening. I mean, you know, when you look at something like that, you gotta scratch your head and say, Is this about ideology? Are we taking care of people? I mean, there’s got to be some recognition here of that. Healthcare is essential. And so, obviously, the fact that we’re now going to reverse preventative services in those communities, we were going to elevate their risk even further for cancer. And that’s part of the issue, that the healthcare system is not responsive to patients at risk in those communities. And even when they’re diagnosed that are getting diagnosed late, and then they run into a healthcare system that’s got prior authorization, step therapy god knows what else we can throw at you. And so they don’t get access to the care that they should need. So at the end of the day, are we surprised that their mortality rates are higher? No.

Kim Thiboldeaux 05:16
Yeah. And I know, we know, Gary, you know, the impact of these later stage diagnoses, right? We’re looking at more deaths, right from the, and even from some preventable cancers, right?

Dr. Puckrein 05:27
Absolutely. Exactly. Exactly the point. Colorectal – great example, right?

Kim Thiboldeaux 05:31
Great example.

Dr. Puckrein 05:32
We could diagnose that early if we wanted to. But we don’t.

Kim Thiboldeaux 05:36
Yeah, and that’s one that certainly preventable, treatable, screenable. Yeah, and pulling back on screenings, I agree, is certainly not the answer. So Gary, I know you know a bit about multi-cancer, early detection, and these new blood tests, you know, that are emerging, that are screenings for many cancers, early detectors of many cancers. What role do you think MCED could play into possible solutions as we talk about screening, particularly our communities of color?

Dr. Puckrein 06:08
So I view the MCEDs as the beginning of the war, the end of the war, on cancer. It isn’t the end of the war, but it’s the beginning phases of the end of the war, it’s diagnosing patients when they’re asymptomatic, before the cancer has spread, when it is local, because the other cancers are shedding DNA into the into the blood and we can detect them early. So if you think about those communities with high incidence of cancer, and you started to use those MCEDs in those communities, whether it be in a place with environmental pollutants, you can quickly imagine that we could diagnose those patients at stage one and two, and really alter the course of cancer in those in those communities.

Kim Thiboldeaux 07:00
Gary, I know you have thoughts about the current healthcare system and how it’s, you know, not working for our communities of color in particular. So, in your estimation, what can be done to accelerate access to MCED for underserved and marginalized communities? You know, we have a pathway here that, you know, we’re not we’re looking at some access challenges and barriers. Are there things you see that could happen, that could accelerate that access that you’re describing?

Dr. Puckrein 07:28
So first of all, your audience needs to know that the majority, nearly 45% of African Americans and Hispanics are getting their health care out of federal government, either in the Medicare and Medicaid program. Neither of those programs reimburse for MCEDs. And so right now, you know, the affluent can go get those tests. And so we are on the precipice of having poor people walk around with tumors and rich people getting their cancers diagnosed before they’re even symptomatic, if you can imagine what that ugly world will look like. So the challenge is, how do we get those screenings paid for in programs like Medicare and Medicaid? And as you would imagine, it takes an act of Congress to do that.

Kim Thiboldeaux 08:27
Literally, literally.

Dr. Puckrein 08:30
And so that’s the point, right? That we are severely challenged by just the mechanisms of our healthcare system. To get that, get those tests out to people right now, which is what we should be doing, right? It’s what COVID taught us. We can fly the plane and build a plane simultaneously. We can learn as we go. And we’re not doing that. So one of the things that we’re doing at the National Minority Quality Forum is we are putting together a national demonstration project that includes traditional testing for cancer – colorectal, the prostate cancer, breast, lung, all the traditional stuff. But we also want to use the MCEDs. Because what we want to do is target those communities like Flint, Michigan, where we managed to poison people in the water, or down there Mississippi or cancer alley in Louisiana. Go into those communities with the MCEDs, try to see if we can wrap our arms around some of the legislators whose constituents we’re trying to help and see if we can’t document that by using these, this new science, that we are able to find cancers at the early stage, get patients into treatment, and come out the other side having stage shift – moving patients from late stage diagnosis of cancer to early stage. I believe in facts on the ground. Whatever is going on with our legislators, we want to create facts on the ground. And in doing that we make the case that this is science and try to make sure that we don’t end up with this lopsided world in which the affluent, you know, get their cancers treated and poor people are walking around with all kinds of tumors.

Kim Thiboldeaux 10:25
And so in your assessment, Gary, in some ways, the science and technology of MCED is sort of far outpacing the current infrastructure of our healthcare system.

Dr. Puckrein 10:35
Well, that is our problem right now. Healthcare financing and delivery system can’t keep pace with the science. It is a luddite community over there. And they wallow in saying that we can’t pay for technology, we can’t get it to everybody. And they run around the hallway and keep saying that. Meanwhile, the American public is suffering, particularly minority and underserved populations. And we don’t want it anymore. Whatever they’re doing, we’re saying that the healthcare financing and research system has to be reimagined and cancer sounds like a great place to do that reimagining because we have great science in terms of detection. And we have great science in terms of treatment. And we need to make sure that we bring those two things together and get better outcomes for Americans.

Kim Thiboldeaux 11:24
Yeah, well said, Gary, thank you. I just want to take our last few minutes to pivot to clinical trials. Gary, I know there’s a, you know, been a push to have greater diversity in clinical trials on the part of the FDA and other, you know, institutions and investigators. What are our barriers to increasing diversity in trials? Why is it so important to have that diversity? And then what are our barriers? What do we need to do to get there?

Dr. Puckrein 11:50
So the clinical trial situation is sort of emblematic of our legacy healthcare system. It was born during a period when inequities in the system by custom, and by law, were okay. And so historically, by accident, maybe we recruited minorities in clinical trials, but we certainly did not do it deliberately. And so when you take a look down in minority communities, you find that even though places like Johns Hopkins in East Baltimore, which is the minority community, and many of those hospitals and research centers are literally in minority communities, they do not open the door and let them in to do clinical trials. So we started to do some work with Janet Woodcock when she was acting commissioner of FDA. We actually did an article with her to talk about training community clinicians to be principal investigators, because they were in community, they were touching the patient. And so that’s what we’ve decided to do. We launched something called the Alliance for Representative Clinical Trials. We have recruited now 15 sites to do clinical trials. We are focused on cancer clinical trials. And the idea is to literally put those trials in community. You get away from the transportation issue, the trust issue. And even more importantly, at the end of the day, clinical trials ought to be part of routine care, particularly in cancer care. And so we want to make sure that communities have access to those trials and the data that comes out of it because that data is critical for treatment.

Kim Thiboldeaux 13:39
Aside from that pilot that you’ve described, that you’re working on, which sounds really exciting, Gary, are you seeing other solutions around the country to encourage participation? Is it whether it’s through providers, through health systems, through nonprofits, you know, where else are you seeing progress?

Dr. Puckrein 13:55
So two things have happened – last May FDA issued some guidance that said to innovative companies that they had to present a plan for their trials to make sure their trials were diverse. So that was a signal to innovative companies that a new sheriff was taking a look at diversity in clinical trials. And then in the IRA bill that everyone talks about, Congress stepped in and mandated that the Secretary to FDA make sure that there was a diversity plan for clinical trials, and also that those plans were being implemented. So those two things have really changed the landscape. Innovative companies are now thinking hard about their clinical trials, because they know how when they come to market, or these come to FDA, they’re going to have to show data that they’ve done the work of diversifying those clinical trials. And just by the way, CMS in its coverage, evidence coverage decision has decided that, oh, if the trials are not diverse, we can’t provide coverage. And so CMS is also putting pressure on diversity in clinical trials. So the landscape has changed essentially, and I think, innovative are certainly taking a look at diversifying the clinical.

Kim Thiboldeaux 15:20
Good. I like to hear and I like those examples. Gary, I know there have been events over the past few years that have sort of laid bare the inequities in our country, issues around racism, inequities, certainly through the murders of George Floyd and Breonna Taylor, certainly through COVID, we’ve learned a lot about particularly health inequity in our country. Are you seeing progress there? Have these issues been able to shine a light so that we’re making the investment? We’re making progress? And we’re talking about the right things?

Dr. Puckrein 15:52
What I would say is, we’re doing a great job talking about it, right? Oh, everybody’s talking about it? Most of the companies have got someone on their staff that is looking at the issue. I don’t think we have a plan yet. I don’t think we’ve come together. At the end of the day, at least from the vantage point I sit from, the healthcare system has to be reimagined. It is one that’s built on rations, that it gave itself permission a long time ago to say that certain people should have and certain people should not. So it’s a tiered healthcare system. And you can’t get to equity if you’re in a tiered healthcare system. It’s just not possible, right? And it’s not that we want to take away from those who have. No, we want to make sure that everybody has, I think we have the capacity to do that. We spend $4 trillion a year on healthcare. By 2030, we’ll spend $6 trillion. That’s a lot of potatoes, right? To walk away and say that we can’t take care of everybody. I don’t believe it. I think the numbers are there, we’re just not spending wisely. And I think we all need to sharpen our pencils and sit around the table and make everyone in the healthcare system present their value. You have to be transparent, and show us that you’re actually helping patients.

Kim Thiboldeaux 17:14
Talk a little bit more as we wrap up. Gary, talk a little bit more about that. Because I, you know, I like that language of reimagining the healthcare system, reimagining what it is so that there is equal access for all. Are there examples that you have or just talk more about what needs to happen to start to move that conversation forward, from conversation to action? You know, how do we get there?

Dr. Puckrein 17:37
Um, I think one of the things that gives me hope is that when I talk to payers, because in our conversations with payers, we’ve said, there’s not going to be any equitable healthcare if you guys are not at the table, right? And he’s just, you got to be there. You got to be involved and engaged on this. I think they are interested in talking about how do we pay for outcomes, as opposed to performance measures, but literally, outcomes for patients. I think that’s something that they’re exploring. Actually in Medicaid programs, and some of the states – California, Massachusetts by way of example – are exploring, paying for outcomes. I think that’s the transition. I think, when we start to pay for outcomes and bring transparency on top of it, it starts to move us in the right direction. And if you think about it for very long, the minute we start paying to keep each other healthy, we have transformed American society in some immeasurable ways that will eliminate a lot of the foolishness that we see going on today. So I’m optimistic about it. I think the conversation has started. I think everybody realizes it’ll be a journey, that a lot of lessons to be learned, lots of advocacy needed. But I think I think we’re on our way.

Kim Thiboldeaux 19:09
And I think that, to your point, I don’t think anything else matters if we’re not healthy, right?

Dr. Puckrein 19:15
It doesn’t. I mean at the end of the day, right? It doesn’t, you can hoard all that gold if you want to. But if you ain’t healthy, it doesn’t matter.

Kim Thiboldeaux 19:24
Yeah. And Gary talk about the importance of involving all of the right people in these conversations just in closing, because sometimes I see a lot of business people or bureaucrats or others at the table chatting, and then there aren’t patients at the table. We talk about outcomes, what are the outcomes that matter to patients? What are the outcomes that matter to consumers? Right when we talk about outcomes.

Dr. Puckrein 19:49
I see patient advocates as the catalyst in the system. Because you’re absolutely right, what we have right now is a bunch of financial risk managers sitting around the table, divvying up the pie and, and quarreling with each other about who gets what share of the pie and totally missing patients. Totally don’t understand what patients, it’s not even in their calculation. But you look at their models. There’s nothing in there, but they like to talk about patient centrality. But hey, they’re not talking about the centrality. They’re talking about, I need to get more of the pie than you got, and has nothing to do with us. And minority communities and others are suffering because of that. I think enough’s enough. We have to be dead centered on patients, the system has to be built around. We call it mitigating patient risk – keep me out of the hospital, keep me out of the emergency room, keep me from disability, keep me from dying, improve the quality of life. That is the mission of healthcare, all that other stuff ain’t healthcare. I don’t know what that is, but it ain’t healthcare.

Kim Thiboldeaux 20:56
Right. And it’s not just about the absence of illness, but it’s also about the presence of wellness. Why do I want to be well, to do all those things I want to do in my life, right?

Dr. Puckrein 21:07
Exactly the point and not in the moment, but in the future as well, right? That’s the point. So when that judge says we don’t want to pay for preventative services, the unimaginable consequences of that is just stunning. Just stunning that a grown man would sit there in a court of law and say something like that. It’s just unbelievable.

Kim Thiboldeaux 21:31
Yeah, yeah. Well, I appreciate so much, Gary, you joining today. I appreciate your thoughts about reimagining the healthcare system. I hope you will come back and continue the conversation. There’s so much to talk about.

Dr. Puckrein 21:47
Kim, you know, I always enjoyed talking with you and certainly very excited about the work and in MCEDs. They are going to transform cancer care. We need to get them out to community. You know when President Kennedy was asked, so why do you, why do you want to go to the moon, he said, Because I’m unwilling to postpone. And I say that the same thing here. We’re unwilling to postpone the access to these MCEDs in community.

Kim Thiboldeaux 22:17
Hear, hear, Gary. This is The Cancer SIGNAL presented by GRAIL. I’m Kim Thiboldeaux. Please rate our podcast or leave a review and subscribe to learn more about the impact of early cancer detection on future episodes.

Important Safety Information
The Galleri test is recommended for use in adults with an elevated risk for cancer, such a those aged 50 or older. The Galleri test does not detect all cancers and should be used in addition to routine cancer screening tests recommended by a healthcare provider. Galleri is intended to detect cancer signals and predict where in the body the cancer signal is located. Use of Galleri is not recommended in individuals who are pregnant, 21 years old or younger, or undergoing active cancer treatment.
Results should be interpreted by a healthcare provider in the context of medical history, clinical signs and symptoms. A test result of “No Cancer Signal Detected” does not rule out cancer. A test result of “Cancer Signal Detected” requires confirmatory diagnostic evaluation by medically established procedures (e.g. imaging) to confirm cancer.

If cancer is not confirmed with further testing, it could mean that cancer is not present or testing was insufficient to detect cancer, including due to the cancer being located in a different part of the body. False-positive (a cancer signal detected when cancer is not present) and false-negative (a cancer signal not detected when cancer is present) test results do occur. Rx only.

Laboratory/Test Information
GRAIL’s clinical laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and accredited by the College of American Pathologists (CAP). The Galleri test was developed, and its performance characteristics were determined by GRAIL. The Galleri test has not been cleared or approved by the Food and Drug Administration. GRAIL’s clinical laboratory is regulated under CLIA to perform high complexity testing. The Galleri test is intended for clinical purposes.