Darshan
Hey everyone, welcome to another episode of DarshanTalks. I'm your host Darshan Kulkarni. It's my mission to help patients trust the products they depend on. And as part of that, we talk to patients to find out what makes them trust a product. And what makes them go Yeah, not quite for me. As you may know, I'm an attorney. I'm a pharmacist, and I advise companies with FDA regulated products. So you can think about drugs, wonder about devices, consider cannabis or obsess over pharmacy. This is a podcast for you. I do have to say, as a lawyer, it's not legal advice. I in fact, do these podcasts with a lot of fun. And I find myself learning something new each time. So be great to know if someone's actually listening. So if you like what you hear, please like, leave a comment, please subscribe. If someone likes these podcasts, please feel to share it out with them. If you want to find me, please reach out to me on twitter at DarshanTalks, or just go to our website at DarshanTalks calm. Our podcast today is going to be really exciting because we're going to talk with with a group that is a patient advocacy group, and we're going to learn from what's happening in the database. So if you are in clinical research, you're trying to figure out how you engage with people in a way that's meaningful in a way that is appropriate, whether you're whether you're a medical science liaison, a clinical trial coordinator, if you're a sponsor, or if you are another patient advocacy group, you probably will care about today's discussion. Our guest today is the executive director for the heart valve voice us and I have been told to clarify it is not in the US. It is just us. So our guest for today is john lewis. Hey, john, how are you?
John
Thank you, darsana. Very good. Thank you.
Darshan
It's good to have you on. Before we start, let's start with the beginning, which is what is the heart valve voice us? And why the US? Sure?
John
Sure. The original heart valve voice was founded in in the UK and I worked very closely with my colleague there and there have since been branches, if you will, in the US, we're about five years old. There's a relatively new branch in Canada, Mexico, Japan, Australia, and some other countries and we work when we can they want to make sense collectively. So heart valve voice was founded. Because there really was not a patient advocacy group or a way to connect heart valve patients to connect with heart valve patients and provide support for heart valve patients, the some of the manufacturers in the space try to do it. But that's always that's always tricky. So as an independent nonprofit organization, it's really our mission to provide support for those patients raise awareness about the disease. Increase activity in the policy area to make sure policy is supporting patients in that area to provide training in patient advocacy to expand research opportunities for hardwell patients and heart valve disease is just not a very well known disease unfortunately, and it's it's I like to say a part of my job is we have a very narrow focus. That's the good part about my job and the bad part about my job sometimes because it's a bit restrictive but that narrow focus really helps us and the fact is heart valve disease affects about one in eight people 75 years or older so it tends to be a disease of older people and they often dismiss the symptoms as just a sign of aging that slowing down or you know, I can't come I'm not moving as well or I'm not as sharp and that's really not it and it's often heart valve disease it's just you know weakens people and dizzy spells or tiredness or what have you. And but it's one of those diseases that because it happens later in life and because there's not a lot of awareness about it, even in the the clinical community, even sometimes amongst cardiologists. The patients really have to advocate for themselves to have this diagnosed and because they're often not exclusively, but often older, they may have a lot of other conditions they're dealing with, they may have a febrile high blood pressure, you know, any number of other. We call them coexisting conditions. We don't like the term comorbidities. So these other coexisting conditions, so they really have to advocate for themselves to get the treatment to get the diagnosis and the treatment they need. And that was ultimately why heart valve voice was was bad. And, you know, we've spread our wings a bit in the policy area and in education and training of patients and community building.
Darshan
It raises so many questions, so many things I want to get into so so I hope you won't mind if we dig into each piece a little bit and see where it takes us. Let's start with the beginning, which is how do you get your funding,
John
we get our funding from different sources, we get some foundation funding, we get some direct corporate funding, and we get some of called quasi government funding. For instance, the patient centered Outcomes Research Institute, we're wrapping up a two year grant from them in the next month or so, which was actually designed to train patients, in our case Art Bell patients in research, advocacy, to train them how they can participate in if it's an FDA review panel, or a focus group for a clinical trial or an advisory panel to make sure clinical trials design with patients interested in mind and with outcomes that are meaningful to patients, or an institutional review board. So we've been training, we've been going through these training sessions now, when this was conceived, we thought these training sessions would be live, we had to move to a virtual model last spring, for obvious reasons. And I think that's actually worked out very well, because it was always part of this vision that that this training would be online after the live event, and we just never had the live event. But now the training is all online. And we've been getting really good, robust feedback and we supplement it with live interactive sessions like this, we do one with a panel faculty members, we do one specifically on telling your story, training patients to tell their story most effectively. And and and understanding the audience you're speaking to, do you have two minutes with a congressional staffer? Or do you have 15 minutes that, you know, an FDA advisory panel meeting or something like that, so in those different scenarios, and getting them to really hone down their story, so it's most effective and most impactful? So we get funding from from those, those different sources. One of the challenges as a small nonprofit is always fundraising, it's been a particular challenge in the last year and a half. With on one hand, you just, you know, not being able to get out and press the flesh and meet with potential funders and explain what we do as a relatively new and not that well known organization. And with a limited focus. On the other hand, there's been a real recognition that during this pandemic, there's a great need for patient education, and too many other and we've all seen, you know, commercials of public service announcements, or what have you from other disease organizations and in other disease areas to encourage patients to not, you know, just don't give up on your care Don't, don't, they're just pack it in. Because especially in the earlier days of the pandemic, when there were real restrictions on visiting the hospital, we saw heart valve procedures labeled as elective and, and we pushed back on that, because if you're 75 years old, and you've got a, you know, a leaky heart valve, I don't know what's elective about that, you know, it's it's, we thought that was pretty critical. So we've been able to raise some funding for a campaign, we launched in February called just go, that actually built off when we're talking about some of the global or global relationships that built off a
John
something that an organization called Global heart hub, which is an umbrella organization of similar advocacy groups from around the world, throughout Europe and Japan and Latin America and US and Canada. That so that just go campaign was started last summer, to encourage patients to get treated if they were having symptoms of a heart attack, for instance, or a stroke. And we know many patients didn't there is just this fear of going to an emergency room. And and obviously, the risk of of not getting a heart attack treated was greater than the risk of contracting the COVID potentially. So that campaign started last summer as we went into this year, we realized that there was a segment of heartfelt patients who may have been diagnosed immediately prior or around the start of the pandemic or may have had their personal You're scheduled whether it would be a transcatheter procedure or, or, or surgery procedure may have had that procedure scheduled for, you know, let's say last June or you know, sometime last spring or summer, and those were bumped because they were they were deemed elective because hospitals were were closed up, there was limited capacity. And now there was this backlog of patients who had not gone for follow up appointments or had not gone for their treatments. And how did we reach out to them to re engage them. So in February, we began this just our version, specific version of the disco campaign targeted at those people who have been diagnosed but not yet treated as a very difficult patient population to reach. Were very successful through social media and through some innovative online, more really market research or political polling type tactics to, to reach these patients. And it's been very successful. And we went out with a public service announcement a couple of weeks ago as kind of the second phase of that campaign. And that will be wrapping up hopefully this summer. I mean, we, you know, it's one of those things like the, the campaign was designed to run as long as it needed to run and we're hoping it wouldn't need to run that long. Because, you know, we want to get the patients back into their back in with their physicians or get them treated. And we're probably not quite through the whole funnel yet. So, but, but we think we've gotten the message out there. And we know, we've had good engagement. And we know, we've gotten a lot of people who have been treated in the last year who, you know, we'll never know, if they were treated because of the campaign. But we know we had a lot of people involved in the campaign who have gotten the treatment or gotten their follow up appointments with their, with their doctors.
Darshan
One of the things we try to do in this podcast, or this live stream, is to give it a little bit of pearls that I think have been a ton of pearls in general. But one of the pros I'm personally really interested in, how do you tell your story, right? You made a mention to that early on? And you said it depends on do you have to 30 seconds? Or do you have 15 minutes, but imagine there's some common threads? And I don't know, if you've actually listened to your own the actual lectures there, I'm making an assumption that you have, but I'm just curious if you know, how should someone begin to tell their story.
John
It's, it's, it's a little difficult with, and I'm a communicator, by by training, and by nature, so so this is very close to me and with with patients, because you don't want to, you don't want to cut them off. And they're so passionate about their story and about their circumstances and about the obstacles they overcame to you know, to get treatment or to get diagnosed when sometimes it was difficult. And what we tried to do is provide them and we bring in a professional in this, she's she works at our PR agency, she teaches Communications at one of the colleges in Washington, and to get it to give them a framework to tell their story in a in a cohesive direct fashion we can often have, and with apologies to patients out there, patients can often wander and, and, and go off in different directions and really elongate their story because it's all important to that. And what we try to do in this training, is to focus them into more of a step story. This is, this is who I am, this is this is why I thought I something was wrong with me. This was how I got treated. And this is how I'm living now, and I'm really shortening that but but you know, a beginning a middle and an end, essentially, as any story should have. And to have them understand, you know, the other part of that is to have them understand whether they're speaking to a potentially a physician audience or an audience of, you know, medical professionals, or are they speaking to a, you know, 25 year old congressional staffer who's not going to have any idea what aortic stenosis is, but you know, hey, I had a heart problem. And you know, something was wrong and I wasn't breathing right. I went to my doctor and they couldn't figure it out and eventually I got diagnosed and then I got this great new treatment I'd really like Medicare to pay for, you know, so can you tell a story like that and That's that. That's the essence of of that type of training.
Darshan
That's really cool. Because I, what I heard you say, without quite saying exactly these words, you mentioned the beginning, middle and end, which I thought was really good. It comes down to focus, it comes down to planning, it comes down to cutting out the pieces that are incredibly important to you, but may not necessarily translate well into the story. So, so I think that that's amazing. But yeah, well, I think I take pride in the fact that I can have a conversation with most people, I have a really good time doing it. But that is that same skill set is the problem I have when someone tells me now cut it down and make it five seconds, like, correct.
John
Right, right. Right. Right. Which is, which is why I go back to my communications training. It's like three points. So those three points I want to make in and out. But sometimes I obviously we've been talking for a while, sometimes I can ramble as well. But
Darshan
yeah. So the other question I have, one of the things you mentioned is the audience is one in eight people over the age of 75. Me lined up suffering from heart valve, heart valve disease, if you will. So my question to you is very specific audience. How do you have the oxygen to speak when there are people with cancers and people with heart with sort of heart disease or breast cancer? You know, there's the humans in the patient advocacy world? How do you get the oxygen to speak?
John
That's a real challenge. And it's and what we've found and what's been really what I've been learning from over the last, almost two years now I've been in this job is we don't have the type of passion, obviously, we have some very passionate patient advocates within within the heart valve community. But it's not, it's not what you would see in cancer, it's not what you would see in the rare disease community. And part of that is part of that maybe age. Part of that may be because and this is something I've talked to a lot of people about religion in the past week, but ongoing, a psychology of a patient psychology of, well, I had a bad heart valve, and now I've got a new heart valve, so I'm okay. And that's really not the case, they need ongoing treatment ongoing treatment plan. So it's, it's much different than other disease areas, if you look at cancer, diabetes, or other areas where the patients know it's chronic, because they have to manage it every day. And with a heart valve disease, that once they've been treated, that may not necessarily be the case, or at least that's not their perception, and they may be dealing with, with other issues as well. So they, they put the heart valve aside and say that's been fixed. And, you know, it's interesting, because have got into these discussions to some clinicians and on one hand clinician see this need, rightfully, for this ongoing care of the patient with this disease with heart valve disease, but I've had a conversation with clinicians to have, hey, just because this has gotten easier to do, you know, this is this is not, don't treat it like an oil change. You know, this is not you're in you got a new valve, and you're out and see you later if it's not. And that's the kind of the patient engagement piece that's sometimes missing. So it's so we we struggle there in the bigger space. I mean, there's other heart organizations out there, obviously, we work with many of them, we work with mended hearts, and women heart and with the American Heart Association, which is, you know, the big dog in the area, and they've got many, many times our resources, but that doesn't mean that there aren't areas where, you know, we can help them and we do and, and, you know, we share resources with them, they share resources with us, one of the things we're trying to do now as we revamp our website is to bring in resources for many different organizations that are specific to heart valve disease. So it's one place where a patient can go.
Darshan
So what I'm hearing you saying is you can't necessarily fight for oxygen, what you can do is you can work with others who also have a similar problem and create a coordinated front, which enables the issue of getting the press the importance that it should. Is that fair? Okay. Yeah, I'm guess one of the questions I've wondered, and this is to a man with a hammer, everything looks like a nail. But from a legal compliance standpoint, one of the issues that has been popping up is how should patient advocacy groups will Work with groups with industries like pharma. There are obviously ways to do it right? There are ways that can get you into trouble. And that's not just the patient advocacy group, but the pharma company itself. How have you seen it done right? What are some of the guardrails? You follow? to do it? Right?
John
Yep. It's it's, it's a, it's a, it's a good question. And it's, and I look at it. And I may be a little more, and even prior to coming into this position, a little more open minded or broader view of this is, what is what is the ultimate benefit being delivered to patients? And is that is that the true focus of the relationship. And if it is, then maybe it's not as important where the money comes from. And there should be there has to be clear ethical lines about what the the pharma company or the medical device company who's ever funding a particular campaign or outreach effort or what have you can influence and can't influence there, there are lines drawn, and when we work with companies in this area, it is very clear what what they can influence and what they can't, and what information we will share back and what we want. And I think that's important, too, to establish. So I think you have to look at the ultimate benefit being delivered to the patient, versus where the money's coming from. And if there seems to be some taint, or or stepping over the line that that can be exposed, but it's the same way I view any type of conflict of interest or, or perceived conflict of interest, like I, I worked in Washington for a long time I was I was a lobbyist. So there's this perception that well, gee, we shouldn't allow lobbyists, who may really know the subject matter that they work in, whether it's health care, or energy, or, you know, pick a pick a, pick a subject, we shouldn't allow lobbyists to work in an administration, well, then you're just cutting yourself off from this huge pool of talent. And because you're presuming that you know that this person or this group of people are corrupt. And and I just, I just don't buy into that. So I think, you know, you've got to weigh this. And there are clearly examples of companies or individuals going over those lines, often, and and we've seen it in pharma, we've seen it in other places, but but let's look at the book, look at the big picture. And let's look at how it's benefiting patients.
Darshan
It's very interesting. And again, there are some rules and stuff we and we can talk about that offline, but it's it, I think you're right, in that in the end, you want to look at what is the goal you're trying to achieve? And is this? Is this the goal that all of the parties share, as you walk in? Or is there something else up? Because one of the things that the FDA and DOJ start thinking about, as I'm sure you know, is do you have? Do they have board seats? And what is the impact of board seats? And is the funding contingent? Are their competitors or still are all on your board? Or is it just one group and their voice matters more? Each of which will be interesting to delve into. But but i think i think the the the question that came out from what you just told me is um, how does it lobbyist land up doing what you're doing?
John
I get to that I address your your board issue tickets as an example there. So we do not have funders on our board. But but by design, however, we do have positions on our board who do research that is funded by medical device companies. So this gets back to my point about do we want that expertise which we desperately need? Or are we going to say, well, gee, you know, Dr. Smith gets money from XYZ company so he's tainted so we don't want his advice. Well, then who are we going to get advice from you know, and and, again, it's that presumption, I guess the presumption you're an attorney, that presumption of innocence rather rather than presumption of guilt. And and so we get around that so how did a lobbyist and I was never right. I would never I lobbied and I was a registered lobbyist. I wasn't a lobbyist lobbyist. But my my career I look at my career. And it makes sense to me, it may not make sense to a lot of other people. And I mentioned earlier that I'm a communicator by nature. So I started out in journalism, moved into PR, then did marketing and Investor Relations. And, and, and then started doing more government affairs type work, and then evolved into patient advocacy. So I see all of this as communications, I think I've done one thing in my career and just applied my core skill in different areas. And over the last several years, I really developed a passion for patient advocacy and patient engagement. And seeing how this was evolving in the pharma area, among regulators and the medical device areas way behind, and we could talk more about that, in terms of patient engagement, but it was, it was something I was very interested in, in pursuing, at a deeper level, professionally, and I was also looking for the opportunity to to run an organization, I'd been senior in senior positions at other organizations, but really wanted to be in the, in the CEO role, if you will, somewhere and plot the strategy and implement the strategy and direct the organization and I deal with, you know, our financials and our whole scope of work. So that's what brought me to this to this job.
Darshan
I guess my question that, that came out of what you just said, and I know were technically well beyond time, but I'm gonna ask you one last question, because I'm just curious. Several years ago, as you know, the sunshine Act came out. And the sunshine act basically tells you, what physicians are being paid how much like different drug companies and device companies. For some physicians, that was a purification process where they basically said, look, see, I get no money from pharma, I get no money from device companies, I'm quote unquote, pure, you can trust me. other individuals came out and said, Look, I get so much money from pharma so much money from medical device companies, they know what they know that I know what I'm talking about. So I must be trusted. And then then there are patient advocacy groups who are looking at the same sets of physicians. What is and I don't mean this as heart valve voice us his opinion, this is a john lewis seeing and talking to other people in the patient advocacy world, how is the sunshine act viewed
John
the sunshine act and understanding its intent, versus how it's actually interpreted and and when I was when I was lobbying we call it you know, we called it the bagel act, because it got down to such a level of reporting that if you know, if a pharma company bought a doctor, a bagel, they had to, they had to report that, you know, the $2.50, or whatever. And it was really it. So I think, and one of the things we did, and it was getting research, payments for research, separated out of that database from other payments. And that was something I worked on from a lobbying standpoint with my prior organization, because we thought that was very essential not to mix research in with other consulting or travel or what have you. So I guess the question is, if you're a patient, if this if this information is meant to be used by patients, and I'm not sure many patients use it, I'd like to see data on that. If this information is by patients, to your point, do I want to go to a physician who was involved? who specializes in my disease? And who was involved in the development of a new drug for my disease, and is very knowledgeable about that? Or do I want to go to a physician who's not and and, and that's, that's, that's way over simplifying, but let the patient make that decision. And if I see, oh, this, this doctor has gotten all of this money from all of these companies, and he's been on trips to Hawaii and you know, and like, okay, let's get a grip on or is it you know, is this part of their professional development and knowledge gaining and, and again, back to, you know, our opening part of the conversation, there are things that are appropriate, and I think actually Be encouraged in terms of interaction between industry and and clinicians. And there are things that are clearly inappropriate. And it may have been better to say, here's what's inappropriate. And let's, let's call that illegal. But we chose to Shawn funshine, on on these activities in a way that I'm not sure many people really understand other than some of the organizations that were really, you know, lobbying for this kind of thing.
Darshan
So, let me rephrase the question. The sunshine act, I think, based on the GAO report, costs, I think they said it was a billion dollars to implement between the various costs, the initial jump off, and then the continuing costs, from a patient advocacy viewpoint where you are, where the cost of the valves is important. Was this was this a billion dollars well spent?
John
I don't think it was built in the big scheme of things, I don't think the billion dollars is a significant number, right? If you look at, you know, the industry, the issues I had, and we had more with this was the type of reporting the detail of reporting, which put into place a compliance mechanism that that didn't exist previously. So a pharma company or medical device company, they knew what they were paying to who, how they categorize that may have met, and when you're getting into tracking individual meals, and we're getting into situations where a doctor goes to a medical conference, a legitimate medical conference, continuing medical education, and the luncheon is sponsored by a pharma company, and at the buffet, and they say, I can't eat the buffet, that that's where we get ridiculous. Okay, so was it was money well spent? I don't think the money was the issue. I think it's it's the overall sense of, of compliance and knowing the rules. And actually, I would say in the last few years, I have not heard that many complaints. Certainly, some of the concerns have not come to fruition, but some of some of them have I mean, I think it's had a real effect on on some CME programs. It's limited those. And, and again, I just don't know how useful this information is, or if it's used in the proper context. You're mute.
Darshan
Next time you come on, we need to talk about conflicts of interest, because I think that'd be an interesting conversation to sort of break down a little bit more as well. This was amazing. JOHN, thank you so much for coming on. I do have a couple of questions for you. I could go on. First question. Based on what we discussed. What is something you'd like to ask the audience?
John
I guess something I'd like to ask the audience if especially to the extent there are industry, folks out there or even clinicians out there is is when you're, when you are considering your patient engagement. Ask yourself how sincere that is. Because if it's not sincere, don't do it. So that would be my question for the for the audience to ask themselves the question.
Darshan
So the question is, are you when you ask for patient engagement? Do you actually want it?
John
Yes. Do you actually want it? Are you going to, are you going to treat it? Respectfully and honestly, and frankly, part of that conversation, too, is is being straight with the patient and saying, we do want your input, it doesn't mean we're going to do everything you say, there may be there may be medical reasons, clinical reasons, lots of compliance reasons why we're not going to, you know why we can't just cede control to patients because we are professionals, you know, running this, this this clinical trial or running this program, but if you're if it's just tokenism, then then just then just don't pretend
Darshan
I love it. So to private personal questions, what was something that made you happy in the last week?
John
Last week, last Friday, my wife and I went out to dinner in a restaurant for the first time since that March 13 2020. So that is I wasn't overjoyed, but it's nice. It was certainly a nice experience. If we're looking at the past week yet.
Darshan
I 100% agree. I think that was I just did the same thing with my girlfriend. So no 100% What is one thing you learned in the last month?
John
You know, I learned and it's really, it's, it's an ongoing education for me around so much bigger conversation in the country, in learning. I mean, I've been a, I'm a, I'm a privileged white guy. I've had resources and education and opportunities. And and, and I appreciate that. And I acknowledge that. But learning from patient conversations when we're talking about diversity, equity and inclusion, and I made the point, I made the point of call yesterday that it's like, so now we, so we've gone from diversity and diversity, equity inclusion, but now we're just that we just have to use shorthand Dei, right? Which I find offensive. If we're, if we're really serious about it, you know, back to my comment about if you're gonna do patient engagement, be sincere about it, we're going to talk about diversity, equity inclusion, and not just short handed to Dei, right. So but but in hearing a story, I won't I won't get into the specifics or who this was, but in hearing stories of this happened to be a black woman patient, about what they experienced in the health care system, and the presumptions that are made, you know, or can be made in the stereotypes that are just that they have to combat every day. And I don't, and I said, you know, sometimes, too, it's just bad service. And you can see it in, you know, other areas, I mean, not just healthcare, sometimes it's just bad service. But even if it's just bad service, if you're coming from a perspective where you have been discriminated against or disrespected through your life, then you know, you're not even going to accept Well, everybody else who's getting bad service, too, right? You're gonna take it more personally. And that was that was, you know, eye opening to me as as I guess we evolve in this, you know, this educational journey to dei?
Darshan
Fair enough, fair enough. Let me do one thing. Let me summarize a conversation, first of all, so during a conversation, we really talked a little bit about what the role is of Heart, heart valve voice us how you guys connect with the different heart, but heart valve voices across the world. That's that should be a tongue twister right there. But But you talked about the impact you have, you're talking about policy, you're talking about connecting patients, you're talking about training, research, opportunities, disease, awareness, talking about comorbid conditions, research, advocacy, and you were talking about telling your story. I love that you gave us a little bit of feedback on on what telling your story could feel like, I mean, you talked about being focused, you talked about the Who am I? Where, where here's where I thought I was the case where what I thought was wrong with me, here's how I was treated. And here's how I'm living now that that sort of short snippet of my story is is a beautiful way to capture where we were going. You talked about the awareness, he talked about the fact that one out of eight people over the age of 75 suffer from heart valve issues. You talked about the idea of patient education. You talked about the the justo campaign as well, which I thought was really interesting. You talked about your past as a lobbyist and how that's played into the the efforts you've made. And the communication skills you've learned throughout that has translated into work you do now. The other part of it is you talked about the sunshine act. We had a really great discussion about both sides of it, what are the implications of it hasn't been worth it, etc. And we talked about whether it was worth it. Did I miss anything?
John
That's a lot.
Darshan
No, I think I think awesome. JOHN, if people want to reach you, where can they find you?
John
They can reach me my email is john J. Chen at heart valve voice dash us.org or They can go to our website. I'm on Twitter at Jay Lewis DC, on LinkedIn, if anyone's interested, so we'd be happy to connect with anyone who has questions or any patients who are interested in getting more information or getting involved in the organization.
Darshan
Wonderful. And if you want to reach me, you can find me at DarshanTalks on Twitter or find me on our website DarshanTalks calm. If you like this podcast, you'd like this interview, please share, please spread John's voice. Tell people the kind of great work he's doing. So feel free to subscribe. They'll be more we'll be bringing john back hopefully again. And this was just wonderful. So john, thank you so much for coming, but coming on for the first time, and hopefully, hope to see you back soon.
John
This is the DarshanTalks podcast, regulatory guy, irregular podcast with hosts Dr. Shaun Kulkarni. You can find the show on twitter at DarshanTalks or the show's website at DarshanTalks.com
