The lack of diversity in clinical trials must be exposed and improved upon.
In this episode of Bite the Orange, Bindu Kalesan, founder of Tury Health, talks about underrepresentation and a lack of diversity in clinical trials. Dr. Kalesan points out that drugs on the market have yet to be adequately tested on People of Color or women, leading to unknown effectiveness and side effects for these populations, and emphasizes the need for community participation and a comprehensive approach to address this manufactured problem. She explains how Tury Health seeks to connect Black women with breast cancer to clinical trials and empower consumers by democratizing health data and providing personalized care. Bindu also touches upon challenges in securing funding and the importance of shifting towards a people-centric approach in clinical trials and healthcare.
Tune in to learn about the urgency of inclusivity in clinical trials and the mission of Tury Health to improve health outcomes for marginalized populations!
FULL EPISODE
BTO_Bindu Kalesan: Audio automatically transcribed by Sonix
BTO_Bindu Kalesan: this mp3 audio file was automatically transcribed by Sonix with the best speech-to-text algorithms. This transcript may contain errors.
Emmanuel Fombu:
Welcome to Bite the Orange. Through our conversations, we create a roadmap for the future of health with the most impactful leaders in the space. This is your host, Dr. Manny Fombu. Let's make the future of healthcare a reality together.
Emmanuel Fombu:
Good morning, good afternoon, good evening, ladies and gentlemen. Welcome to another episode of Bite the Orange. And today, we have a very special guest who is the founder of Tury Health, and that is Dr. Bindu Kalesan. Welcome to the show, Bindu.
Bindu Kalesan:
Thank you. Thank you so much for having me.
Emmanuel Fombu:
So thank you. So tell us about yourself for those that don't know you.
Bindu Kalesan:
Yeah, so I've been a clinical epidemiologist and a biostatistician for a really long time, for more than 20 years, and you've mentioned that you're a thoracic surgeon, so that was my research area, like mainly interventional cardiology, that's where I started doing a lot of clinical trials, a lot of clinical research. And then, just as you mentioned, I found out, oh my God, this is why am I here, and I really had this existential crisis. And while I was doing my PhD, I realized, I did a lot of clinical trials, there were nobody who was, who people of color in clinical trials, like zero. And then I realized, so all the drugs which are being manufactured right now and is on the market, none of them have been tested on people of color, known to be effective, and we don't know their specific side effects, the adverse events for those drugs either. So first of all, I ... other people kind of laughed at me, and some of sometimes was doctors themselves, clinicians alike, let's see, how is that possible? But it is possible. And this is a whole lot of things that, which went one by one. It just didn't make sense. It's not just something that we can turn around and just say, oh, this is a system and talk about it in a very judgmental fashion, but we're also part of that system.
Emmanuel Fombu:
You're spot on, on this. Myself, I think we have similar backgrounds in terms of working in pharma, right? You're working in, I think you're working pharma as well, but you have a background in clinical research, and I did the same as well. And I realized early on in my career when I first joined Pharma that we were doing all this things that I don't think were very effective of how we did it. One, what you just addressed about minorities did not, and women, not being represented in clinical trials to a significant amount. Like, it's really bad, right? I've seen studies with 10,000 patients, for example, for cardiovascular studies, and then you have 2% African-Americans and even like 1% women represented in the studies, right? Which is not the real-world evidence. So I think there's a much better way of going about doing this. And so, was that a similar experience that you've had? Because I think there's a much better way we can do this.
Bindu Kalesan:
We can, but that's where most of the complexities are. So my company is trying to deal with that problem. I'm not saying we're going to fix the problem because it's a huge problem, and we need multiple little steps but towards a common goal and cohesive steps. That's very difficult because right now, what we are trying to do, like the entire world is trying to, fix the systems, by using technology, technology alone cannot fix something like this because this has been a manufactured problem. It's been carefully manufactured because FDA comes out, approves the drugs, and regardless of our sex and race, we all get the drug if we fit the indication, right? So why is there not something like, oh, not tested and known to be effective on Brown people or Black people, on women? We don't have that, right? So this has been a manufactured issue. So how do we really get into that? How do we really crack that ... shell? It needs a lot of community participation, community efforts, community outreach. It's a, we need a multi-pronged approach. And the problem I'm finding is that you go to VCs for capital, for funding, they're like, and let me tell you, I'm being blunt here, even with VCs who say they are putting money away for specific for health inequities, it's the same story because they find, oh, these people are doing too much. Yeah, you got to do too much in order to do, to actually solve it. Not just be, talking the talk, but actually doing, practitioners. Being a practitioner is a lot more difficult than just being, saying things, oh, we are addressing health equity.
Emmanuel Fombu:
I'd like to actually highlight that point that you mentioned. I, during my time in pharma. I remember one time we had a challenge, right? How do we improve diversity in clinical trials? And I, we had a big advisory board that I led, spent a couple hundred thousand dollars getting this thing together, went in, ... the board, got all the insights. We had a big booklet published on all the findings, right? No one ever read it. I remember bringing it back in, and it was like the box was checked. We did it, right? We asked the question, but nothing I could change on the ground level to actually influence what happens, right? So you would think that with technology that you can actually expand the things, bring other people from around the world to participate in clinical trials, right? So, for example, if I wanted more Blacks in studies, there's a whole continent called Africa where there's a massive population of Blacks. My family's from Cameroon, for example, and when I look the maps, right, and you look at where pharma has, there are, the entire sub-Saharan Africa with hundreds of millions of people, right? It's like there's no research taking place there. There's absolutely nothing taking place in the world. It's like completely grayed out, right? And you think technology people have phones there today, right? Do you think, even with decentralized clinical trials and all this blah, blah, let's talk about that will be reaching out to those communities? But we don't. Like most digital health companies are based in Boston and San Francisco in the US, right? Like the whole Middle East all blurred out, right? What do you ... say yourself?
Bindu Kalesan:
Yes, that is like a much bigger challenge also because FDA puts those challenges in place. And number one, we have a lot of medical mistrust towards, people don't trust it. I'm being a clinical epidemiologist and doing clinical studies, if someone comes to me to participate in a clinical trial, I'd say no. In a heartbeat, I'd say no, because I don't trust what is presented. I don't trust the system enough so that I will participate in this trial. What do we learn on from it, right, as consumers? We are consumers. You can't just say, oh, you participate in a clinical trial, just go away. Just, you participate, we're doing you a favor. No, it's the people who are participants in the trial, we're doing them a favor, and you don't pay them enough, number one, you don't treat them, you don't provide them with information that is required for them to make good changes in their lives so that they can go from sickness to health, and it's always about getting that Band-Aid approach. Let's just put a Band-Aid on it and then send people packing. And I don't think that, for lack of a better word, non-white people are okay with that.
Emmanuel Fombu:
I agree with you, and it's something that everyone talks about, right on time, but nothing ever happens about this, right? So it's not, everyone says it's up to, every research paper comes out, and they say, oh, sorry, we didn't have enough patient population. And then, they want to do rural evidence studies. But with that being said, for those listening that are not necessarily in the medical field or not experts in it, you have a very unique, solid background. So what is an epidemiologist, and what do you guys do? Because I think you have a ... on this topic, right? You're not just another person just talking about it. You actually have a degree on this. I want to highlight that part ... of that.
Bindu Kalesan:
Yeah, yeah. People didn't know what an epidemiologist is. You know what we do until COVID came along, right? So now people think, Oh, we're people who go behind pandemics and epidemics, but we're more than that. We're methodologists who, we figure out how to do the studies correctly so that we can minimize biases. And then we're the ones who come up with, okay, this is how you design a study to answer this specific problem, this specific research question, right? So, in the end, we have a lot of say in how and who are the people who go into these trials. But the baseline is what the companies want to do because clinical trials are so expensive. To enroll one person now, in this world where it is largely white, it takes about $6,500 to know one person in a clinical trial. And a clinical trial costs anywhere between multiple millions, like from 8 to $66 million, and around, median is around $30 million per trial. That's a lot of money. And also, this specific industry is very price insensitive, so we've got to keep a lot of things in mind when we design a trial. It's not just pure science, I have to be honest about it. Unless and until we are all honest about all these things, we're not going to make a change. And within, and people think that all this means, oh, she is just, oh, this will all cost us more money. Yes, it will cost you money. Because also FDA says, no more can you come up with a clinical trial and say, oh, here we go, 100% white population. When the disease is more prevalent in Black population. You can't do that anymore, you have to minimum have a representative population, a racially representative sample size to ... to start with.
Emmanuel Fombu:
But then the question becomes now, does having a small amount of patients from a certain group that can actually still power the study in the right way?
Bindu Kalesan:
Exactly.
Emmanuel Fombu:
Correct, what you represent, which is not represented as this minority. So then, to have this improvement of at least, the last study only had 5%, now we have 7%. That's not what we're asking for here. We're saying, represent people equally.
Bindu Kalesan:
Yeah, exactly.
Emmanuel Fombu:
... one country, you should have these studies not in a place in the world that we intend to sell the drug.
Bindu Kalesan:
Yeah, and say that: known to be effective only in white people.
Emmanuel Fombu:
Yes, and not even all white people, because at the same time, we know that just because the p-value is less than 005 does not mean that the drug works in every single person, still ... like a subcategory with big personalizing ... and think people saw this during COVID. ... the vaccines. Some people still got sick. It does not mean that it's a 100% cure for everything or prevents everything, but you still have to go on that personalized way of doing things ... about, you know, making everything else with that. With that being said, so Tury Health is your new venture that you started, right? So how did the idea come about, and what was the problem you're trying to solve here? I know you mentioned about the problems, but what was the thing that drove you to say, hey, let's watch Tury Health?
Bindu Kalesan:
So our overall mission was, we looked at people, and people were all getting sicker and sicker, where, despite all the innovations, we're not getting healthy. If we don't, we're not in health. So overall, we wanted to improve the health of people, mainly people of color. Because cumulatively none of the drugs, we know that none of the drugs work for us. Like in my population, you go to India, there's, the best kind of business now is to have kidney dialysis centers because there are so many people with diabetes, and they say they're all being treated with medicines tested on white population. We don't have medicines which are tested on Indian population, and it's the same thing all over the world, right? So that health is health in its truest form. That is what our overall mission is. But to start with, we know the main problem is health inequities, so we start with Black women with breast cancer. They are the most marginalized people in the entire world, right? So we start from there. We start where the need is at the maximum, that is where the need is. And then I was thinking, oh, what we wanted to do was connect Black women with breast cancer to clinical trials directly, and for that, you can't just have a technology. You need people, you need trust, you need to build that. It's a community approach, it is an outreach. And all this has to be done, which is not what is done right now. Like you basically turning from the current tradition and you're seeking a new way of, So the DCTs, decentralized clinical trials, is where we're going to with this. But we want that to be more focused on people of color because we are the global majority. It should, the drugs should be for the global majority.
Emmanuel Fombu:
And I like that term, global majority, because a lot of times we live in, if you live in the Western world, a lot of times, people get ... the minority in the Western world as a ... minority in the rest of the globe, for example, India has over a billion people, and so, calling India a minority population is not necessarily a fair classification of what's happening, calling an African in the same light. So I like that. I like the mission of things going. And I recently actually interviewed a clinician out of Cameroon on the podcast, and he mentioned that even in Cameroon, we didn't even have electronic medical records. We don't have EHR systems, right? And so you have a whole part of the globe that's completely like out, cut off from data or data and insights that you can have. Like your target population, you mentioned Black women with breast cancer, for example, I know a lot of Black women in Cameroon, for example, that have breast cancer, and I bet you they were far worse off than those that are in the US just for access to clinical trials. Why can't we participate in clinical trials, especially with a decentralized model? Does that matter? Because the whole idea of a decentralized model, now going back to the same sites that we go to before and using the same site to use technology, it's that the wrong approach, right? The, ... this band-aid. It's a grassroots movement, a way of thinking, and ... process, but it's not technology solving the problem.
Bindu Kalesan:
Yeah, so instead of, ... you hit the nail on the head there, we are site-centric right now. We want to be actually people-centric. We're not even going to patient-centric. Trials don't have to be this expensive. Number one, we can actually do it for one-sixth of the cost, one-sixth, and which means we can improve the sample size a lot more, make sure different sects of the population are included, different races are included, women are included, right? So in order to do that, we have to bring down the cost of the trials, which means that we will be able to do that in a decentralized fashion. And we start with people rather than the sites. Where all the money goes into the sites, we start with money, go directly to people, and we share.
Emmanuel Fombu:
Do you think that model is broken in terms of how studies are done? Once you design a protocol and you pass it out to clinical offices, then they go out and get a CRO and these CROs, even though they offer this technology pieces, I think they're from the same old boys club where the same standard places they go to, the same sites to go to, right, and so what do you think?
Bindu Kalesan:
I think, number one, that model is not working, but we have a problem as we'd like to keep on going with the same models which don't work, right? Because there is a reason why these models exist. So these models are not going to be discarded, it, by whoever is in charge. What we need to do, at least this is what I understand, we need to step out and just create another model that works, ignore, and that is what we're doing. We're just ignoring what is going on.
Emmanuel Fombu:
... different, and that's the reason why the podcast is called Bite the Orange. And so I call it Bite the Orange, because the idea is we know that this doesn't work, but we still keep doing the exact same thing over and over again. But if we're there to bite the orange, even though the skin is bitter, our change is hard, but never like the inside of the orange. So that's all I get behind it. And so I'm sure anyone listening ... done exactly why we wanted to have Bindu on the podcast because it's exactly the presentation of what we're talking about here. But something else I want to bring up also. I went on your website to do research prior to our call, and I realized you have a very specific approach when you look at things, right? So you look at health and wealth as something that they talk about. You talk about a very unique manner as well, about running from sick care to healthcare, which I think is our current system. And you talk about empowering consumers, and I'd like you to ... people are not patient-driven because we can all be patients across the journey, right? Not, no disrespect to anyone that wants to feel like the patient is okay, but ... be patients will not be patient, patient, being a patient is not a permanent state of mind. It's not a permanent condition. We are people first, and you said people get rewarded for their data by ... data platform. So tell me how you solve this problem and this unique solution that you're bringing in. And so, someone listening, how do they, what should drive them to join behind that ...?
Bindu Kalesan:
So how many times have we gone in, like each of us have gotten them, make money online, right? And we're all seeing all sorts of shady things going on, but what we want to do is truly democratize health data. So when they join on our platform, first, they get registered, and it's all available right now. Just register on the platform, and once it's, once they're registered, we talk to them, person to person, having a proper talk, and we find out what exactly they want to do, but that's also in the form that we give them for registration. So if they tell us, oh, I'm only interested in joining clinical trials, that's fine, we'll connect them to clinical trials. But if they say, we are also interested in doing some additional research studies, we pay them, we pay people. So we're currently building this because we're building it on a blockchain platform where people can have their own data vault, and their health data can be very secure. They're secured in that data vault. And the more health data that they provide us, based on the questions we ask, we give them money, we pay people. So they can make anywhere between like even more than they spend on Netflix a year. We pay them between $200 to $600 a year. So we also start to work with companies to do research studies. Every time their data is reused, they still get a cut of it. So as of now, what has been happening, the third parties take all the people's data, do research, they make tons of money. There's several companies doing that, and what we want to do is share profits.
Emmanuel Fombu:
No, so wait, so what you're saying is I can literally come right now on the platform, and you sign up to ...? Is the app in the app store?
Bindu Kalesan:
Yeah, right now, we're starting at a step-by-step. So you go on our website, sign up, you register.
Emmanuel Fombu:
That's very helpful ... All right. We'll have that in our show notes.
Bindu Kalesan:
Yes, TuryHealth.com, and then you just scroll down a little bit. There's a lady who will tell you what exactly we're trying to do, and then sign up, you register. The moment you sign up, we will give you an email, we'll email you, and then we'll set up a time to talk, and we'll explain the whole thing, what we're trying to do, and you're given several options. If you're only interested in clinical trials, we'll need, ... clinical trials are a very delicate game so ....
Emmanuel Fombu:
So is there any trial with Black with breast cancer, in African-Americans? Is that ...?
Bindu Kalesan:
When you start with Black women with cancer, ..., yeah, but that doesn't mean that no other people with other diseases can sign up. It's free to sign up. But if, we want to be perfecting that part because I think need is right there, the need is there. And we want to also make sure that, the Black population has always been used and abused in medical research. We don't want that happening. We want Black women to get back what they've given. And I feel they're, fundamentally, Black women has just really raised all of us. Like I'm here in this country because Black Americans stood up and they did something for the country, for themselves. So we're, everyone, every immigrant is here to make a better situation for ourselves and our families because of that. So it's time for a whole lot of us to give back.
Emmanuel Fombu:
Which is quite impressive. Another interesting part is, so how are you able to compensate that a user ... like third-party people, they get their data from you, they get compensated, and then you share that with the community, and that's quite incredible. I think that idea of sharing datasets makes it very unique. I think because you're going the website-based model, you can literally open up to anyone in the world to show up. You can connect them, ..., with that.
Bindu Kalesan:
And also we provide them with specific health data. So people are really wanting to get information. So let's say very specifically, a woman with breast cancer who's undergoing a breast reconstruction, that's a specific need for that woman and the information that she needs so that she can just deal with the whole process. So that was what we call this health literacy. So wanting to be able to use the information in a way that they can better their lives and also what is happening to them at that moment, right? So we also provide information. So that is where the rest of it, like from healthcare, from sick care to healthcare came up. We want to be able to support them, not just a Band-Aid, we're not the Band-Aid situation. It's about personalized care, personalized healthcare needs, like how do we support them? How do we provide them the information? So how many people? I know a whole lot of people who go to the doctor and get a diagnosis, and they're like flustered. We're at our most vulnerable stage in our lives when they get a diagnosis. Who's there to help them? Who's there to help them? Let them know, you get a diagnosis of MS. What are the questions you ask? You haven't even heard of MS before this, what can you ask? So being that patient advocate, all that will be included into that platform, but that's a long way. But we are building it up slowly, starting with Black and connecting them to breast cancer trials.
Emmanuel Fombu:
I mean, that's quite fascinating, and it happens today, when we recording, it's actually International Women's Day. So Happy Women's Day.
Bindu Kalesan:
Oh, ....
Emmanuel Fombu:
Which is great, so I like the way the conversation went. It was a great conversation to have on a day like this. But I also noticed you have a podcast as well, right? Podcasts?
Bindu Kalesan:
So I started it, and then I got turned off. But I need to go get back and do that because, for me, it's mostly about hearing about what people want to talk about. It's not, I don't want to hear any more from people who are the experts. I don't want to hear it. I've heard enough of them. I don't want to hear myself.
Emmanuel Fombu:
... the conversation go, and you have a couple of episodes on your website, so anyone can go in and listen to those episodes. So probably motivate Bindu to continue recording the podcast episodes, right? And we all subscribe and follow through with it, because you want to have those conversations. And myself, I got in a point where I was not interested in talking to companies based on how much money they raise, which is what the competition is about these days, right? Oh, if you raise a $10 million series A ..., and then everyone talks about those things because everything is driven by what the VCs are interested in, not necessarily what the patients are interested in. And so, with that being said, what challenges have you faced so far?
Bindu Kalesan:
Oh, we don't get funded. That is our main challenge, and that's okay. We figured out how to get around that, so we will raise our own funding, which also means we don't get to dilute our, and we don't get to do whatever VCs want to, want us to do. So we know now how we can raise money, how we can make money to fund what we need to do. And for us, it's mainly about getting, collaborating with people who really thinks like us, who wants the same things that we want, not people looking for a quick fix to make more money. And unfortunately, many of these VCs, and I apologize if I'm angry at you people, even Black VCs, they don't care about this, I'm sorry. It's mostly, I realized talking to them, they're like, oh, do your thing. They're like, oh, it's too, you're doing too many things. It's about health. Health is not about putting an electric car on the ...
Emmanuel Fombu:
You know, this is ... A lot of times, we're talking like people in general. People always say, oh, you have to narrow down and focus on one thing and one thing, right? And they all give me the two-minute summary, and I go, no, the problem is not, the solution is not this Band-Aid solution. So you have to be someone that is patient to listen to someone and support them along their journey, and believe in the cause. It's not just about, oh, there's one solution. What's one solution you pick? Yes, you could focus on one area, like breast cancer and Black women, start your business, and then grow up and do other things. But that's to be that interest, but it's beyond profits upfront as well. So these investments get, the question becomes how do you scale? No, that's not the point. You have to build the right model first, if you go to the next step, and you can not support. People at that point, how do you expect people to be represented in the ...?
Bindu Kalesan:
And don't you think that's a reason why none of the digital, new digital health innovations have really done anything? They've done nothing, nothing. And I'm sorry, I know people say, oh, those people have created a lot. No, we're actually losing more years of life. Our life expectancy has reduced, and there are more people sicker and more people with mental health issues. So what has it done? And do you still have the same fragmented system? The traditional fragmented system also creep into digital health, it's really sad. I just ...
Emmanuel Fombu:
... and I'll take it one step further. We talk about clinical trials representation, that's one piece. We talk about how many women, first of all, are represented in the venture capital world, ...? And so the same issue we discussed with clinical trials, the same diversity issue that's in the same people that invest, in the same issues that we find across the trials. So those, and those are reflected in how we do research and how we do things, right? How many people are represented in this world doing it? So I think it's a whole kind of system revamp. We have to call people out. We can't keep pretending and just say, oh, it doesn't happen and just keep talking about things that don't exist. So if anyone is listening, I think we should definitely jump on board and support Bindu on this amazing ... that she has with Tury Health.
Bindu Kalesan:
Thank you. Thank you so much. I really appreciate it.
Emmanuel Fombu:
Man, it's great having you on the show, Bindu, and I would love to have you again to see how you're progressing. And, of course, hopefully, we have your contact information on there and expect some of the listeners, please jump on board, sign up. I encourage people to signup, Bindu, and let's push Bindu to get her podcast going and we'll follow it through, right, Bindu?
Bindu Kalesan:
Yes, absolutely, absolutely. We will get to you guys too. We want to be able to interview people and know what people want for their health. That is more important. I think VCs need to really hear that. People don't want what VCs want. I'm sorry. That's the final thing. People don't want what you want to offer. I'm so sorry.
Emmanuel Fombu:
It's not about people and patients.
Emmanuel Fombu:
Thank you for listening to Bite the Orange. If you want to change healthcare with us, please contact us at info@EmmanuelFombu.com or you can visit us at EmmanuelFombu.com or BiteTheOrange.com. If you liked this episode and want more information about us, you can also visit us at EmmanuelFombu.com.
Sonix is the world’s most advanced automated transcription, translation, and subtitling platform. Fast, accurate, and affordable.
Automatically convert your mp3 files to text (txt file), Microsoft Word (docx file), and SubRip Subtitle (srt file) in minutes.
Sonix has many features that you'd love including automated subtitles, automatic transcription software, generate automated summaries powered by AI, secure transcription and file storage, and easily transcribe your Zoom meetings. Try Sonix for free today.
Bindu Kalesan:
A clinical and digital health epidemiologist, and data scientist, with a passion for clinical research and public health. Over 17 years of experience working globally in healthcare, academic institutions, pharmaceuticals, and medical device companies, combining cross-functional competencies in clinical research, data analysis, and data management.
Things You’ll Learn:
Clinical trials lack diversity, excluding People of Color and women, leading to knowledge gaps in drug effectiveness and side effects for these groups.
The underrepresentation of minorities in clinical trials is a manufactured problem, demanding intentional efforts for inclusive research and testing.
Addressing health inequities requires a multifaceted approach with community participation, outreach, and technological advancements.
A people-centric model in healthcare is crucial.
Securing funding for initiatives targeting health inequities takes work.
Collaboration with like-minded individuals and organizations is very much needed.
Tury Health connects Black women with breast cancer to trials and revolutionizes healthcare through empowerment and personalized support.