Narrator
Welcome to MedEvidence where we help you navigate the truth behind medical research with unbiased evidence. Proven Facts. Powered by ENCORE Research Group and hosted by cardiologist and top medical researcher Dr. Michael Koren.
Dr. Michael Koren
Hello, I'm Dr. Michael Koren
Dr. Trevor Greene
Good afternoon. I'm Dr. Trevor Greene.
Dr. Michael Koren
And I'm really excited to have Trevor here today. And the reason for that is that we're going to talk about a case that you and I were involved with about ten years ago. And it was so interesting because we were asked to recruit black patients for studying in congestive heart failure. And Trevor and I are both cardiologists and are colleagues.
Dr. Michael Koren
We've worked together for many, many years. And so we had a situation where we wanted to get African-American patients engaged in the idea of doing a Phase one congestive heart failure study. So let's share the details of that with the audience and then let's you and I have a discussion about what the issues were, what the dilemma was, and how we approached it.
Dr. Trevor Greene
The first slide is a pharmaceutical company, wishes to reformulate an innovative heart failure product. The product appears to have specific advantages in African-American patients. The sponsor has engaged ten sites over six months and has enrolled four patients in this study that requires 16 black patients. The sponsor reaches out to your site. This Phase one study involves several overnights.
Dr. Michael Koren
It's so interesting request. They're coming to us because they have been unsuccessful elsewhere. And they came to Jacksonville, where we're sitting right now. Jacksonville has a population with about 25, 30% African-American. Is that about right?
Dr. Michael Koren
And so we obviously have people in our community that would qualify for the study. Congestive heart failure is something that we treat every single day. There are plenty of patients. So the question is how to get these folks interested in clinical research. So the question that was posed, how do you help the sponsor resolve the problem of recruiting African-American patients with heart failure?
Dr. Michael Koren
And of course, we want to do this in a scientifically valid way, in a culturally sensitive way, and also help our population understand what's in it for them. So let's let's jump into what we might do under these circumstances. What are your thoughts? Just share with the audience what you would do. What we did ultimately and what the challenges are and what the solutions could be.
Dr. Trevor Greene
Well, the the way we approach it back then about 10 to 15 years ago was that we thought that the black population was not involved as well as we as we thought they should. Yes. And one of the techniques we used back then was the use a physician or engage a physician, particularly someone who looks like them to deliver the message.
Dr. Trevor Greene
And thinking back on it, it went over very well. It was very well. The the advantage that I brought to the conversation back then was that I was doing this on a regular basis by going to churches. Going to the functions will be Lyons or Sorority Engagement Group. Right. Community engagement. And I found that the feedback was I was very nice.
Dr. Trevor Greene
They enjoyed doing it because it was it was good to interact with all adlib no writing in and open up the forum. So when we reached out to a similar cohort of people who knew that I do this stuff anyway, right? It was easy to get people the kind of build.
Dr. Michael Koren
The trust factor.
Dr. Trevor Greene
And and and it did. And it did work out pretty nicely.
Dr. Michael Koren
Yeah. So let's, let's explore a few issues. One black versus African-American. So again, my experience is that some people prefer one versus the other, and there are some differences there. So why don't you comment on those?
Dr. Trevor Greene
Yeah, there are indeed some differences. Black. Black is African. Right. Yeah, we we got the term of African American because there's Italian-American and Irish-American and that kind of stuff. But interestingly enough, when you do look at the diaspora in this neck of the woods to get a really pure black person, if you will, you really actually have to go to Africa.
Dr. Trevor Greene
Okay. No, because the majority of people who are here in this country are really not. They're really not very many pure people to begin with in terms of genetic. Yes. I happen to have a colleague who was actually doing these kind of studies and discovered that they're really not really pure African people living here. It doesn't matter how black you look.
Dr. Trevor Greene
Exactly. And, of course, that was before we got into the kind of genetics that we have now right. Where we can really parse out this kind of stuff. Right. But but in the big picture, the concept of getting African-Americans to participate in in the studies without even drilling down to that specificity. Right. Was a was a hurdle in itself.
Dr. Trevor Greene
Yeah. Born out of history.
Dr. Michael Koren
Yeah.
Dr. Trevor Greene
Given the given the experiences that we had had coming through to the thirties and forties, antecedent from terms from.
Dr. Michael Koren
Saying, well, the legacy of slavery of course. Yeah. Yeah. So but it's interesting points to just to comment on that a little bit more. There are differences between African patients. There are differences between those patients and people that come from the Caribbean. Based on your accent, people might picked up that you have a little bit of background there.
Dr. Michael Koren
Indeed. Versus people who grew up in the United States, either inner cities or the South. All those have different cultures that can affect health consequences.
Dr. Trevor Greene
Yes, absolutely. And the the important word you mentioned there is cultures. We all we all we all look black. Well, when we start to speak, you can tell a West Indian, which is a generic term for the Caribbean people from a person who grew up in the South. Right. And then the experiences of of the the West Indian in terms of engaging with with the government, engaging with civil society is slightly different from the from the way black Americans do in the South, for obvious reasons.
Dr. Trevor Greene
Right. And the question is, how can you how can you overcome that? And and so when I go out to talk to people, I also have to remember that as a Caribbean person, our coming out of the West Indies, I am not really treated as black, black with a fascinating concept. Okay. Well, I was I was sitting at a meeting and someone said to me, Well, well, are you really black?
Dr. Trevor Greene
That's how I look at it. What are you talking about? But what they were trying to say is that the experiences that they that came out of slavery for an African-American was I was hearing that he is was much different from and there are many, many reasons for that. But that still overlays the barrier to getting the people right to participate in the study.
Dr. Michael Koren
Right. And that is such a fascinating point, because often when we think about things scientifically and from a physiological viewpoint, we want diversity because we know that certain products may work differently with people in people with different genetic makeup. But then you also have to think about the cultural things that will be very different. So the diet of an African-American may be way different than the diet of somebody from Nigeria, for example.
Dr. Michael Koren
And so all these things should be part of the thought process when you're a clinician, especially in something like heart failure, where salt content is so important, and many of the dietary elements to taking care of these patients and and helping them get to the value proposition of being in research where we talk all about this.
Dr. Trevor Greene
What is that? Yeah, well know, you want some in the last three sentences. A really powerful stuff. And I'll give you a classic example. Yeah. I personally would that my primary care physician today. Okay. This morning. Right. And he said to me, well, you know, your blood pressure is still a little high. You are on Valsartan. But I find that Amlosartan works better in African Americans.
Dr. Trevor Greene
This works better in black. Okay. And it was like, this is interesting. I knew Valsartan work better than Losartan, but I didn't realize that Amlosartan works even better. It's funny. Again, this is coming from a physician who is not African. Actually South American. Right. Right. And he recognized the difference. Okay. And that difference does not only pertain to black people, it also pertains to people from the Asian diaspora.
Dr. Trevor Greene
You know, you have a little Filipino lady and you're not going to start on 25 milligrams of Carvedilol. You just wipe her up.
Dr. Michael Koren
Exactly.
Dr. Trevor Greene
So. So those. And when I present the to the Africans in this in that kind of context, I also want to point out to them that we are not picking on you specifically, but there are indeed differences between between people. I always just as every body is different and everybody is different.
Dr. Michael Koren
So that that's a good one. So let's talk about what we did specifically when we had this challenge. So you and I got together and we we did an outreach program. And you describe it how we got people together.
Dr. Trevor Greene
We what? We came here. We first of all, we reach out to people in the in the group that we mention. And the office got in contact with people who I know in my practice. Right. We invited them to come here for an afternoon. Lecture. I think it lasted about 45 minutes.
Dr. Michael Koren
Most Yeah, it was about 30 minutes.
Dr. Trevor Greene
It went on a little longer than we thought because they were having fun. They were so engaged. I Mean, this is good stuff. Yeah. Yeah. And they really. They really got into it. Yeah. So to my colleagues out there who might be hearing this, one of the one of the easy ways to get people to engage African-American, engage is actually be engaged with them.
Dr. Trevor Greene
Yeah. Yeah. Invite them to these things. And if they hear some person that looks like they're speaking about stuff that they are far more aware of, far more easier to to get into the concept. So reaching out. Yeah.
Dr. Michael Koren
So just remind you. So we wanted to bring in, you know, at least a dozen people and we reached out through your practice, I think, to about 30. And you actually made some phone calls directly to ask people to come. And that was fabulous. The doctor being directly involved is is the most powerful way to get people to do things, of course.
Dr. Michael Koren
And we had I think I remember about eight people that showed up. Yeah. Yeah. And some of them brought family members. So it was the target patient and other people that came in. And we talked about clinical research that may be appropriate for their family members. So that was good. And we got a bunch of people in the room and you start talking about heart failure.
Dr. Michael Koren
And I was more of the clinical trial expert, but it was really one of the interesting things was one of the patients spoke up and looked around and made the observation, There's all black people in this room. Is there a reason for that?
Dr. Trevor Greene
I remember that. They did.
Dr. Michael Koren
Yeah. Yeah. Yeah. So that was a little bit interesting because there's like a little bit of tension there that are we trying to, like, sneak a bunch of black people in here? Do some.
Dr. Trevor Greene
Some especially.
Dr. Michael Koren
Scrupulous research. Yeah. Yeah. And you helped handle it, but. But that just shows you how people are thinking We had to address that issue.
Dr. Trevor Greene
Yeah, I think what we did at that point, if I remember well, we actually, first of all, we laughed about it. Yeah. So we kind of brought down the temperature quite a bit as well. Exactly. And it's just a very special effort to get you guys in to see us. Right. So giving them a kind of a special feeling right now.
Dr. Trevor Greene
You are the avant garde of this group. Exactly. You know, that's why I call you personally, because they know that you can now go out there and speak to all your friends, and particularly at churches and everything else, you know, And and I think to engage the African American pastor. Priests. Yeah. They have a very powerful role in their communities.
Dr. Trevor Greene
And and they have quite a few of them in in our practice. And it is through them actually, that we develop a lot of, a lot of contacts. Yeah. So people felt very comfortable with that. Yeah.
Dr. Michael Koren
And we also talked about the physiology of heart failure. Remember, we were looking at something that was a combination of Hydralazine and nitrates. Yes. And how that certain blood pressure medications may work differently based on your genetic background. Same thing with heart failure drugs. And this was a really important thing to understand for everybody. So not only are you doing it for yourselves, but you're doing for other black people, right?
Dr. Michael Koren
And then ultimately helping us understand where there are differences and whether or not and of course, there may not be differences in many cases. Yeah. So that was very powerful. So let's go just through the bullet points. I think we covered most of this, but we want to create an event that shared the educational message, but it was also engagement and it was.
Dr. Trevor Greene
Fun and it was fun.
Dr. Michael Koren
It was a lot of fun. So that was great. And, you know, the fun part is really important. You know, I've been to presentations where everybody's really uptight and and you're just giving this dry message and that doesn't get anybody interested. So enjoying yourself, I think is really important.
Dr. Trevor Greene
And yeah, well, one of the things that came up from that was that we were adlibbing, so we were we weren't reading slides. We were it was a, it was a free flowing. Yeah, it was very free flowing. They got to ask questions whenever.
Dr. Michael Koren
You know, it's about half of it was question with question. Yeah. That was, that was the best part.
Dr. Trevor Greene
That was I like it. And I do love free freelancing like that. When I go to speak to the groups, this is what I do. Absolutely.
Dr. Michael Koren
No, it's more genuine.
Dr. Trevor Greene
And it's more genuine.
Dr. Michael Koren
Yeah, Yeah. And the other thing that's important and this is something that doesn't always happen, but it's important that you compensate physicians for what they do. So and actually, you taught me this. We were talking about recruiting African-Americans for COVID 19 vaccine studies. And, you know, we asked a simple question, is that people coming to, quote, ask for your patients, but don't they want your services, right?
Dr. Michael Koren
And they should they should pay for your services. So it's the dilemma here is that it's illegal and unethical to get paid for referrals. So we never do that.
Dr. Trevor Greene
We can't do.
Dr. Michael Koren
That. That's not Absolutely not. By the way, lawyers can do that. Realtors can do that. Accountants can do that. But doctors don't do that. Okay. So we're a different we're a different category. We have higher ethical standards. But that doesn't mean to say that we can't pay you for talking to the patients. We can't pay you for doing consulting work to help us hone what we're doing with the with the particular study.
Dr. Michael Koren
So you have to pay people, physicians for their professional services. And then I think we cover this, but we explain to the African-American population that attended that they're valued for the project for very important scientific reasons. I think we address the historical issues. We haven't mentioned Tuskegee yet, but everybody knows that that is this horrible incident that occurred that has conditioned a lot of people to think negatively about medical research.
Dr. Michael Koren
And we always remind them that literally that started in the early 1930s is a horrible 40 year observational experiment. But on the heels of that, there are a lot of changes in the laws that protected people, but most importantly, the whole risk benefit profile of research has dramatically changed. So if you were studying a new molecule in the 1950s, you didn't have the same tools that we have to know that there were specific to the target, that that can be tested in animals, that can do toxicity studies on these things where that risk is much higher than nowadays when we work with these incredibly specific biologics and other things that just hit their target and
Dr. Michael Koren
nothing else. And the overall value proposition has changed where the benefit is much higher and the risk is much lower. So by being fearful of the risk is actually preventing people from gleaning the benefits of doing clinical research.
Dr. Trevor Greene
And that's exactly, you know, one of the ways that we kind of kind of overcame that was literally be open about Tuskegee So we didn't we didn't treat it as something that should be swept under the carpet. Right? We face it right upfront. Yes, it happened. We identified it. We were able to say to them, look, you know, out of a behind every dark cloud there's a silver lining.
Dr. Trevor Greene
And the silver lining is now the opportunity to realize that we have moved the situation to such a place where you have the informed consent. You know, there's so many standards.
Dr. Michael Koren
That right layers of protection.
Dr. Trevor Greene
And therefore we can now move on, you know, understanding that we are cognizant of the fact that bad things happen. But by virtue of the fact that black physicians are going to be involved, we can kind of override and get people comfortable.
Dr. Michael Koren
Yeah, absolutely. Absolutely. So the conclusion of the case, I think, is on the next slide, which is six of the remaining 12 patients were enrolled at your site to fill the study for the sponsor. So they started by getting a request from the sponsor saying they were having the hardest time enrolling the study. And, you know, through our efforts, we were able to help out this study and get the answers for the rest of the world.
Dr. Trevor Greene
And then six over 12 is a 50% success rate.
Dr. Michael Koren
That's tremendous. Yeah.
Dr. Trevor Greene
Jesus only had a 10%. So. So you're well ahead of the game.
Dr. Michael Koren
Well, I think we'll end on that note. I can't be that.
Narrator
Thanks for joining the MedEvidence podcast. To learn more head over to MedEvidencedot.com or subscribe to our podcast on your favorite podcast platform.