March 11, 2022
On this episode of Talking Pediatrics, we welcome Adriene Thornton, health equity manager at Children’s Minnesota, for her first episode as guest host. Join Adriene as she interviews Dr. Zeke McKinney, a well known physician advocate and clinical researcher in areas of health equity.
Listen as these two health equity experts explore race-based medicine, equity and representation in clinical research trials and how social determinants of health lead to health disparities.
Adriene Thornton
Health Equity Manager
Transcript
Dr. Angela Kade Goepferd: This is Talking Pediatrics, a clinical podcast by Children’s Minnesota, home to the kid experts, where the complex is our every day. Each week, we bring you intriguing stories and relevant pediatric health care information, as we partner with you in the care of your patients. Our guests, data, ideas and practical tips will surprise, challenge, and perhaps change how you care for kids.
Welcome to Talking Pediatrics. I’m your host, Dr. Angela Kade Goepferd. On this episode of Talking Pediatrics, we welcome Adriene Thornton, health equity manager at Children’s Minnesota, for her first episode as guest host. Join Adriene as she interviews Dr. Zeke McKinney, a well known physician advocate and clinical researcher, about areas of health equity. Listen as these two health equity experts explore race-based medicine, equity and representation in clinical research trials, and how social determinants of health can lead to health disparities.
Adriene Thornton: Good afternoon, good morning, good evening, everyone, depending on which time zone you are in. I am Adriene Thornton, and I am your host. For my inaugural podcast, I am very excited to have Dr. Zeke McKinney. We have done several podcasts together, we were tied at the hip doing education and doing town hall meetings for the community related to COVID-19 and vaccines and how it was impacting the Black community. He is the program director of the Health Partners Occupational and Environmental Medicine Residency. He is an affiliate assistant professor at the University of Minnesota School of Public Health. He is a research investigator at the Health Partners Institute. He is the president of Central State’s Occupational and Environmental Medicine association, and he is the president of the Twin City’s Medical Society.
Welcome, Dr. Zeke, thank you for doing my inaugural podcast.
Dr. Zeke McKinney: Thank you so much for having me, sister Adriene. As you mentioned, we’ve been tied at the hip for a while now, so this seems only fitting.
Adriene Thornton: Let’s talk about the importance of Black people specifically participating in clinical trials and how that impacts health disparities, because I think people don’t equate the two to being related. For instance, when I was in Atlanta, because I’m from Georgia, and there was a study going on related to high blood pressure and medications to treat Black people to decrease high blood pressure, and what they found is that one of the may drugs that all doctors were prescribing really brought your blood pressure down, but it resulted in kidney failure for Black people. It didn’t result in kidney failure for as many white people, but a great number of Black people ended up having kidney failure after long term use. Can you talk about, from your standpoint as a medical investigator, why is it so important that Black people actually participate in clinical trials?
Dr. Zeke McKinney: Yeah, I’d say there’s actually a number of reasons. One of them is what they would call race-based medicine. There’s a lot of things in medicine, and actually kidney function is a really interesting example, that are based on research that wasn’t really done in large numbers of people who weren’t white. Conclusions were drawn on small sample sizes, and unfortunately, didn’t work out so well.
I would say number two is it’s just an optics issue. If I said, “Okay, I have this magical new drug or this magical new COVID-19 vaccine and we only tested in white people,” that would be scary for communities of color. Inversely, if we only tested in the communities of color, that would be pretty scary too.
Adriene Thornton: I think a lot of people fear the people who are doing the investigations because they think there’s nothing that protects them. People often think about, of course, the Tuskegee experiment, although there were a number of experiments done on Black people aside from that. But what we can tell them is that there are protections in place. I know that in 1993, the federal government said, “Hey, if you are getting federal funds, you have to include women and underserved communities in your trials because we want to have nice representation from all of those groups.” What was the impact of that change in the government rules compared to where we are now? Are we starting to see more Black people participate in clinical trials, and is it making a difference in terms of health equity or improving health disparities?
Dr. Zeke McKinney: Well, first of all, I think seeing more Black people or people of color in positions of power running these studies helps engagement in that way. I think that change in ’93 that you’re referring to has increased people’s awareness that this is something we need to be cognizant of. As a consequence, greater engagement efforts have been made in communities to try to get people to participate.
But honestly, I think changes even prior to that have made a big difference and people aren’t talking about those enough. You mentioned Tuskegee. I think that’s what the Black community goes to really quickly about reasons to be concerned about engaging in health care or engaging in health care research, but a lot of research protections came out of that. I don’t think that makes up for the atrocities of Tuskegee, and I’m not saying that. I am saying there is a silver lining.
Similarly, I wish it didn’t take the murders of George Floyd, Daunte Wright, and Amir Locke for us to think about and consider the role of systemic racism as it pertains to law enforcement violence, but again, I’d like to think, wherever they are, George Floyd, Daunte Wright and Amir Locke are happy that their deaths weren’t completely in vain.
Adriene Thornton: I think a lot of times people don’t understand the different phases of a clinical trial. When we’re talking about clinical trials, they’re like, “Yep, yep. They didn’t do enough studying. They didn’t look at the information or the data enough. I don’t trust it.” Can you just give us a really high level brief synopsis of the four phases of a clinical trial?
Dr. Zeke McKinney: Before the phases, there’s phase zero. Phase zero studies are really just to find out if drugs do what they’re supposed to do. This is a few tiny, small doses of a new drug or a vaccine or whatever in a few people. Phase I clinical trials are really focusing on is this treatment going to be safe for people, and so it’s not even about whether or not it’s effective, it’s about pushing the dosing to find out how safe is this and how safe can it be. Then when you get to Phase II, and this is where you start expanding the numbers, we’re talking maybe hundreds, maybe thousands, it’s more about, hey, does this thing do what we expect it will do? Now that we’ve figured out what safe dosing is, does it actually have the desired effect? Usually, it’s maybe up to a hundred people.
Then Phase III clinical trials are where they get really big, and this is the ones that people heard about with COVID vaccines, tens of thousands of people. We know what the right dose is, we know that it’s relatively safe, and now we want to find out in a large population is the effect that we anticipate still found, and again, are we seeing any adverse events that we didn’t expect or that were, for example, much more rare, so you weren’t going to see them in a hundred people, but you might see them in 10,000 people. Then of course, Phase IV, as you mentioned, isn’t technically a “phase”, but it’s the drug or the vaccine is out in the world, how did people respond to it?
Adriene Thornton: We know that minority either overrepresented in the Phase I portion of clinical trials. What is the danger to our community if we’re overrepresented in Phase I, but then we don’t really show up for Phase II and III?
Dr. Zeke McKinney: When you’re talking about Phase I trials, where, a handful of people, maybe 10, maybe 20 or something, if you have five Black people, that’s generally speaking going to be overrepresented of many populations here in the United States. Then to your point, inversely, if you’re in Phase II and III and you’re talking about hundreds of thousands of people and if you don’t have tens or hundreds of Black people or communities of color, then they’re going to be underrepresented. The danger there is that we may end up, again, deriving conclusion about communities of color, which ultimately may portend what people do down the road without actually having the data to back it up. We’ve seen this happen a bunch of times and that’s where the problems really come up, unfortunately.
Adriene Thornton: I have heart disease, I have hypertension, I am moving into high cholesterol, but I’m eating my oatmeal every day so hopefully we’ll solve for that, but I have lots of conversations with my primary care physician because I’m like, “Okay, you’re prescribing this medication. How does this impact Black people?” Fortunately, my physician is a minority physician, he’s actually Latino, and he has an intimate knowledge of that. I don’t know if it’s because he’s Latino or because he’s just a great doctor, but he gets it and he doesn’t argue with me, he doesn’t get frustrated with me. He actually usually knows the answer, and if he doesn’t, he’ll say, “You know what? I don’t know, let me check it out and then we’ll talk about it,” but usually he is very aware of the differences between the medications.
The one he put me on to prevent me from having strokes, he put me on nystatin and he said, “Well, this is the one that we found that works best for Black people to prevent you from having strokes when you have all these different risk factors.” Even though I still questioned taking the drug, I felt much more comfortable knowing that he already knew this information. He had already looked at the clinical trials, he looked at the data, he’d done his research. He wasn’t just prescribing the run-of-the-mill drug for me, he was prescribing the one that he thought would work best for me.
We know for your study, it’s between 20 and 30% are minorities, which to me sounds like a really high number. Is that a large number? Is that a standard? Is that enough, or do we need more of our people of color participating in clinical trials?
Dr. Zeke McKinney: I would say it’s a pretty good number, considering some of the barriers that you’ve described in terms of people’s interest or lack thereof in engaging in these trials. I’d say, in a perfect world, we would have exactly parity with what is the proportion of different communities in our population represented therefore in our study. I think we did a good job here at our particular site, simply because I was an investigator and I was hitting the streets and talking to Black people and people of color and saying, “Hey, here’s why you want to be involved.” Not everywhere has that, but I think overall these studies, I think, wanted to do a good job so that there was confidence in these vaccines. Let’s go back to first principles. People will ask, “Well, wait a second. Is there biologically something different for somebody who’s Black or somebody who’s Latino or Latina?”
Adriene Thornton: Some studies have said no, but I think we have enough drug tests out there to say yes, there’s not biologically necessarily a difference between the people, there’s a difference in how we respond to different drugs.
Dr. Zeke McKinney: It’s not, I think, a difference in biology, there’s nothing different between Black people, white people, Latino, Latina people. I think there may be stuff at the level of genetics that we just don’t understand yet. But the difference is there are structural that affect Black people or Latino or Latina people in such a way that then manifests as different health outcomes or, for example, different responses to drug treatments, but it’s not at the level of genetics. It’s not biological, Black people aren’t different than white people in any way like that.
Adriene Thornton: Just to be clear, we’re talking about diet, we’re talking about environment, we’re talking about historical trauma. All of that impacts how we respond to drugs. That’s what you’re talking about, is those things are different in different communities and that can determine how we respond to different drugs.
Dr. Zeke McKinney: Right. The technical term would be social determinants of health. That’s people’s access to healthcare, to health insurance, to a healthy neighborhood to live in, to safe transportation, to safe employment, to stable housing, to food, you name it, and like you said, to have or not have access to the stressors of being a person of color. All of those things lead to the health outcome differences that we see in communities of color, higher rates of chronic diseases, higher rates of all cause mortality. I mean, it turns out JAMA just published a study where they showed all cause mortality for Black people had a relative risk of like 1.27, meaning if you’re Black, you’re just 27% more likely to die for any reason.
Adriene Thornton: What do you say to people when you’re trying to explain to them, maybe not even convince them, but give them the information they need to make an informed decision about participating in clinical trials?
Dr. Zeke McKinney: You said my first aspect of my pitch is, which I’m not here to convince anybody of anything, I’m here to give you the best information to make a decision that’s consistent with your health goals or what you want to achieve in life. But as it pertains to research, look, I think COVID-19 is about the best example you’re ever going to have, because if you remember back in March of 2020 and April and May, everyone kept saying, “What can I do to get this thing over with?” and the answer is, hey, this was something that everybody could do. Everyone could participate and lend their own body and their own health and their own time and energy to try to give better information to the world so we knew how this stuff would work.
For a Black person, it’s important because other Black people will have to trust and know that Black people were involved upfront. That’s really critical, and then I think it’s even doubly important to have Black researchers to say, “Hey, by the way, I’m not going to let people abuse you. If I see that happening, I’m going to be the first person jumping up there, getting mad about it.”
Adriene Thornton: That is one aspect that we don’t talk enough about. We need our children to become researchers in the future. Become a doctor, become a nurse, be a cashier, but become a researcher. We need you to become researchers so that we can continue to protect our people from the inside.
Dr. Zeke, as usual, it has been wonderful talking with you. We could talk for hours and hours. Thank you, listeners. Talk to you next month.
Dr. Zeke McKinney: Thank you, sister Adriene. Thank you, children. Thank you, listeners.
Dr. Angela Kade Goepferd: Thank you for joining us for Talking Pediatrics. Come back each week for a new episode with our caregivers and experts in pediatric health. Our executive producer and showrunner is Ilze Vogel. Episodes are engineered, produced, and edited by Jake Beaver. Lexi Dingman is our marketing representative. For more information and additional episodes, visit us at childrensmn.org/talkingpediatrics, and to rate and review our show, please go to childrensmn.org/survey.