Darshan
Welcome to another episode of DarshanTalks. I'm your host Darshan Kulkarni. It's my mission to help you trust the products you depend on. As you know, I'm an attorney. I'm a pharmacist, I advise companies with FDA regulated products. So if you think about drugs, wonder about devices consider cannabis or obsessive pharmacy. This is the podcast for you. I have to say, I'm an attorney, but I'm not your attorney. I'm a pharmacist, but I'm not your pharmacist. So this is not legal advice. It's not clinical advice. I don't know these podcasts are these live streams with a lot of fun. And I find myself learning something new every single time to know someone's listening. So if you like what you hear, please like, leave a comment. Please subscribe. If you have questions, please ask the questions while we're having conversation. And if you'd like the conversation itself, please share it, we would appreciate that. If you want to find me, please reach out to me on twitter at DarshanTalks, or just go to our website darsan talks calm. Our podcast today is fun. As always, we've had the guests, our guests on before he is the executive director of the heart valve voice us. And he is a very prolific speaker. And he has, and he apparently has spent the weekend working on his backyard, which he does not want to talk about. I think we all had that weekend where we just sort of went, this is the last summer. And we none of us want to look at our laptops. And sounds like some of us actually do something productive. So Carlos, our guest today, like I mentioned is the executive director at the heart valve voice us which I'm going to ask him more about john lewis. Hey, john, how are you?
John
I'm great Darshan, how are you?
Darshan
I don't know I am. I'm weird thing that he knows hopefully is just a passing thing. But not too bad. None of the other hand, have been busy and haven't done a few different things. So when we start, can you talk a little bit about the idea of insurance policies and getting all sort of your organization set up and ready? I'm not sure what a very brief discussion about which was the idea that as someone who's advocating for patients, you're only doing good and some people who are doing good. Gonna kind of go Yeah, I shouldn't be saying that. None of that makes sense. So it's about First of all, the heart valve voice us. Tell us more about above? Where are the areas you find vulnerabilities and how do you decide which insurances you're going to get? And let's kind of go from there.
John
Sure, I heart valve voice us is a patient advocacy organization supporting obviously, patients with heart valve disease, we are trying to extend that a little bit into patients that may have other What are commonly referred to as structural heart issues. So what we find is that people with heart valve disease frequently experience things like a fib or other heart diseases like that are associated with the vowels or that affects the vowels. So we run a patient community called my valve my voice, so patients can interact with each other, share their experiences, we provide a lot of resources there we are in the process of revamping the resources we provide what we've tried to do is curate a best of set of resources from many different of our partners from mended hearts, the American Heart Association, others that we interact with professional medical societies that have information on heart valve disease to make it easy for patients, when they're searching for information, whether it is symptoms or treatment options or aftercare to be able to find those rather than looking at a list of you know, 300 different links on a search. So we're in the process of doing that to support patients, we also get so that's one area kind of the awareness of the disease and supporting the communities, patient communities related activities is one big bucket for us. Another bucket is in the policy area where we engage in policies that affects the access to and reimbursement for an approval of various heart valve treatments. And that may be true CMS put through Medicare because many heart valve patients are tend to be Medicare beneficiaries that tend to be older, or through private insurers. We just saw recently for instance, where anthem one of the larger BlueCross BlueShield. providers, I think they're in 13. States recently revised its policies to come more in line with with the other private insurers in terms of their coverage of transcatheter aortic valve replacement for tabber or Tavi that it's called to fall more in line. And we had we had encouraged them, let's say that it advocated to them to do so. So we're active on the policy side, and we have some plans for next year that I don't want to get into too much. But we think there's a real opportunity to improve the action. And then kind of a third area that we focus on is in the area of research and providing access to patients and Research Services. So it may be a, in our case, generally a medical device company, it could be a pharmaceutical company, but generally a medical device company that may want a patient for that, to play an advisor on their clinical trial, or to have input into the design of that clinical trial. There may be companies that want to do patient surveys or patient preference surveys, and we can go out to our patient community and and and promote those surveys. And then we are venturing into the area of clinical trial recruitment, and trying to speed up that process and facilitate that process. It's very difficult. Very difficult. A lot of areas, it's particularly difficult in the area of heart valve disease. And we think with the credibility we've established with the patient community we built in the outreach we've done, we can be an effective partner to responsibly help recruit patients and spread awareness about clinical trial opportunities. So those are kind of the three buckets we generally operate.
Darshan
It sounds like you have a permanent wide net. What I found interesting some things that pretty early on were you said you're actually expanding the scope. It's not just about heart valve voice anymore. It's about structural defects. You talk a little bit about it also relation a third, if you are, my question to you is we are a nonprofit, how not make that decision as to our scopes too narrow, or we want to expand the scope of that decision made? Is it more of a, we just asked our board and that's where we're going or you're sort of trending something you're asking people or how does that conversation happen?
John
Yeah, it's really I guess, if you looked at it from a marketing sense, it would be it would be kind of, you know, following the trends, but when we look at our at our patient population, who often have multiple conditions, when we look at the the funders, our funders on the corporate side of business, they they have heart valve businesses, but they're usually in encased within larger structural heart business units that deal with other issues around the heart, in addition to heart valves, and so looking at it from both sides, it's how can we best serve that patient community? And how can we attract the funding for that patient community and then when you when we look at things like screening for heart valve disease, the screening generally, would be after you've, you've had say a stethoscope check. detected a murmur or some irregularity with your heart, maybe it's your family physician or cardiologist, you would probably go for an echocardiogram and we can't you know, we can't know at this point whether that echocardiogram is going to show a heart valve issue or some other related issue so it's, it's it's really just kind of a practical decision about the pathway for that patient and making sure that they get the best diagnosis and care they can get. And we will work you know we have no interest in in changing our name we are heart valve voice and we want to spread awareness about the symptoms of heart valve disease and the treatment options for heart valve disease, but the reality is that many Patients so that the symptoms of heart valve disease can mirror the symptoms of many other diseases and of the heart, and, you know, dizziness, lack of energy. Some people just feel like they're getting older and and we're trying to knock down that myth and really encourage people to explore those symptoms and get a proper diagnosis. So it it may or may not be heart valve disease. Oftentimes, it may be, but it may be some other structural heart problems. So that's kind of how we're, it's a very subtle addition, I won't say change of direction, but kind of expansion that we're, we're going to. So it's interesting,
Darshan
you talk about this idea that and correct me if I'm wrong, what I'm hearing you say, heart lung disease is a diagnosis. And that's great, and you're helping those people. However, they don't find out that diagnosis until further along the process. What you're trying to do is help people a little earlier on the process, is the heart valve disease. Great, you know, there many ways, there are other structural differences, and you might be able to help those patients as well, in that in that pathway, is that is that accurate?
John
Exactly. So I think the, you know, the subtle change would be, we can say, hey, you need to go get checked for heart valve disease, well, that may be true, but we what we're what we really want to say is you need to get properly diagnosed, it may be heart valve disease, or it may be something else. So it's just a very subtle change. Because, you know, we can't we can't diagnose patients, certainly weekend, especially advocacy organization remotely or through or through, you know, a chat or patient community or a Facebook page, we need to, they need to actually consult with their doctors, and we want to encourage them to do that. We want to make them aware that heart valve disease could be could be what they're encountering. But it could be other things as well. So we want to encourage them to pursue the diagnosis and the screening for whatever may be bothering them. If it ends up being marked off disease, and we've got for them, but yes,
Darshan
so right now they've had a bunch of different advisors Do you find that advisors you work with will have to change over time to to reflect this additional scope?
John
I don't think so, it's again, there, you know that the other structural heart diseases are so closely related, there are from the, you know, clinician side of it from the, whether it's an interventional cardiologist or or a thoracic surgeon or cardiac surgeon, the treatments may they deal in treatments for heart Rouse and other structural heart issues generally. So it's really, again, looking at the patient looking at the the device manufacturers looking at the clinicians, these are, you know, very related kind of topics. So it's not, it's a, you know, I don't know, I guess in marketing terms, maybe call it a brand extension, maybe it's not even that much, but it's just, it's just kind of dealing with the reality of the patient population we're engaging with, that they may have heart valve disease, they may have something that looks like heart valve disease. They may have multiple conditions that that like that have more symptoms that require similar treatment, or
Darshan
while we're talking as you can tell, I pulled up a copy of your, your website and I just kind of think it is such an interesting descriptor of sort of where heart valve disease is going. And a lot of things you talk about is this idea of resources for doctors and patients during the covid 19 pandemic. have not found that there has been a drop in diagnoses for patients during this time and person in Lebanon right now. Or is that is that rebound? not there yet.
John
Yeah, It's, it's interesting. So there's been and there's been a lot of research done on this, not necessarily particular. And by the way, we're in the, we're in the midst of a revamp of the website. So that will be next time we talk hopefully we'll get in that will look different. The and these things are always we're always take more time or more difficult than you think. And I've been through it so many times now. The there's been a lot of research done over the last year or so on the effect of the pandemic that we've seen. So you know, we're seeing less visits to the doctor, something came out, I think, this morning from one of the, the large insurers that, you know, they're starting to see a drop off in claims, again, people just not going to the doctor for for whatever, then we have some research that has been done that is shown fewer people have gone or we're going for all types of imaging, ultrasounds, echocardiograms, etc, which is, so if you look at this as a funnel, where a person would first go to their maybe their general practitioner, or maybe their cardiologist, because they're having some symptoms, then there would be referred to some type of imaging for further diagnosis, and then, and then possibly, for eventual treatment, surgical intervention, a transcatheter procedure in the case of heart valves, and a drop off there. So I think what we had seen, and then there's data that supports this, what we had seen was the number of procedures and the number of screening exams, were back up to pre COVID levels. You know, maybe six months ago or so we're starting to get back up there, once the vaccines were introduced, and the elderly population in particular, those over 65 have, I think, an 80% plus vaccination rate at this point. So they were really getting back into their care, then, you know, just in the last well, month or two months, with the Delta variant that has backed up hospitals again, and filled ICU again, and put another pause on elective procedure. So now we're going backwards, and saying a number of procedures that were scheduled, and a number of appointments that were scheduled now being rescheduled or delayed or cancelled again, and we had run a campaign through from February through July, called just go where we were encouraging patients who had missed appointments, who had missed procedures, because of COVID, to make sure they re engaged with their doctors, with their cardiologists, and other providers to make sure they were going to reschedule those procedures and reschedule those appointments, so that they can stay in that, that, that that treatment journey. And it was a very successful campaign. And we, you know, we hoped we hoped it was over. And now we don't know if we're going to have to run it again next year, but or run some other type of campaign. So that's been discouraging that we kind of thought we were getting back to normal levels and the people who had had procedures, particularly those who have already been diagnosed, and that had procedures canceled, we're getting back into their, their, their treatment and getting those procedures scheduled, and now maybe bumped again. So that's discouraging.
Darshan
So I find it interesting that you talk about having to run the same campaign to bring awareness to the situation. I guess. One of the things that sort of jumped out at me, as you can see on the screen right now, is this idea that you're responding to a senator essentially commenting on a proposal from CMS, and you're advocating for it for your patients. Do you have the opportunity Do you guys engage with with other advocacy groups or with the government to actually get funding for these types of outreach efforts? And and how, how does the government or other groups or deal with that? Do they kind of go local, put money down this path already? We're not interested in going down this again, or is it it's an important issue and we kind of want to encourage that.
John
Yeah, that's that's the Because obviously every disease organization, every advocacy group, every patient group would, you know, wants more funding for their for their particular disease getting, you know, government funding for that or for government funding for awareness campaigns is is is difficult we we have not pursued that in in any large way we have worked with the National Institutes of Health with two on events to raise awareness, but not not on major campaigns. So that's not a path we have taken, we do regularly engage with a number of other advocacy groups, we manage something called the heart valve disease policy taskforce where we collectively look at things like you were just referencing on our website, CMS policies around New new treatments for mitral valve disease, or aortic valve disease. And soon we'll be seeing new treatments for tricuspid valve disease coming, coming through the FDA approval process and into the the Medicare payment stream. So there is that opportunity. And we are looking at ways to possibly, you know, kind of formalize this taskforce a little more, but there's certainly opportunities there. We also have very cooperative relationships with a number of organizations where we try to amplify each other's messages, whether it's through social media, whether it's through podcasts, whether it's through videos, and sharing information. So you know, we're involved now with an effort with the American Heart Association, on a campaign they're running on aortic stenosis, where we're trying to amplify that message. We have every year in February, there is heart valve disease Awareness Day, that's run by one of our partners, the Alliance for aging research, that gets involved in a lot of other disease areas. But heart valve disease is one of them that we we work closely with them on that initiative, which they started before or around the time heart valve voice was was forming. So they've been on that issue for a while. And we want to support that any way we can. We have a group of international partners that we work with, through through the heart. We have a group of international collaborators we work with, as well, there is a heart valve voice in the UK, there's a heart valve voice in Canada, in Japan, in other countries and other disease and other groups that focus on heart disease throughout Europe, and and Mexico, in Israel and elsewhere that we work with, collectively on our on a regular basis. And coming up in Europe. In the middle of this month is heart valve. heart valve disease Awareness Week, which, which is separate from what we do in the US. But we will certainly to the extent it's applicable, and appropriate, we'll be amplifying those messages in the US even though the us is we have our own valve disease day. Separate from the European week. So we work collaboratively with a lot of organizations.
Darshan
I don't want to touch this because I
John
have a hard heart because the organization is the umbrella organization.
Darshan
There you go. And we'll make sure that we remind everyone's global heart health. So the thing that jumps out at me and I'm afraid to sort of touch this right now because we're significantly over time already, as you know, I about 1520 minutes or 24 minutes already, but the company jumped out at me is this. By the way, it's global heart calm. I got that wrong. But here's a nice little blurb for people. One of the things you mentioned you guys do is this idea of providing access to patients. For for a lot of these groups, besides imagine for medical device companies, like you said, but also for pharma and for anyone else who sort of needs a patient voice, if you will. The question I have is when you're having these conversations, have you not I didn't know you talked about recruitment, but I got a lot of interviews around blockchain and around these decentralized ledger technologies and the idea of patient, patient advocacy groups could use blockchain to not only provide access to patients, but get paid for doing that in a way that is transparent. And patients and patient advocacy groups could benefit from that process. And I talked with technologists and they're like, this is gonna be amazing, it's gonna change the world. On the ground, you got one of running an organization that is exactly that target group. Do you think that the world is ready for blockchain and patient advocacy? Or are we still a few years away?
John
I would say we're still a few years away. I don't, I don't. And I'm certainly not a blockchain expert. As much as I've tried to educate myself around at the end, I think we have to separate a couple of functions. So I think blockchain has, I think, is being employed in some areas of clinical research more around the security of the data itself for that, for that trial, and the the, the chain of control of that data and the security of that data that is generated from the clinical trial participants. So you know, blockchain there, I think is is applicable, and that's probably where it's being used. Now, although I don't think yet, to a great extent, but it certainly is being used in terms of what we can offer. In in pure outreach, I don't know if blockchain is necessarily applicable, it's more traditional marketing channels, if you will, social media, email marketing, getting the word out that a particular survey is open or a particular clinical trial may be recruiting or something like that. And there's a a patient recruitment firm, called antidote that that we are partnering with, on these recruitment operations, because we don't have the back office capacity to screen patients, to connect them to research sites, but we do have the capacity and the credibility to go out and, and make patients aware of these opportunities. And we're very careful about how we would do that. And, and what we would make available, it's not just, you know, in an open it open door, you know, pay us X dollars, and we'll do x I mean, it's it's, it's, we really have to be comfortable with the research that's being done with who's doing the research with whether there's been patient input into the design of the research, etc. So, so I don't think blockchain is applicable on that front end, but I know it is being used on the on the back end, where obviously, the integrity of the data for the clinical trial that hopefully will eventually end up with the FDA is, is is of utmost importance.
Darshan
So as you know, I can keep going, this will we can, this is just always a fun conversation. But we are well past our timeline. So as you know, I like to ask a couple of questions. My first question is discussed, what would you like to ask the audience?
John
What would I like to ask the audience? I would, I would like to ask the audience how they feel about the aspects of Medicare eligibility age lowered, currently being debated in Congress.
Darshan
I'm going to give you my personal view, as I always do, I'm a big fan of including as many people as possible into Medicare and the government pay payment, not because I think government payers are the greatest in the world, but I think it's important that we provide access to care. We're one of the only developed countries that don't allow that and attended that's concerning. I have a feeling that a lot of people will disagree with me and say that they should I mean, that's that's that right? But I think that it's, we already pay a lot of money in insurance. And the ability to cover people would be useful as we continue. But that raises some many thorny issues like how do you how do you cover the cost of care? And what care should be covered, etc, etc, etc. And that'll become conversations we need to have as we continue. Um, the second question was something you've learned in the last month?
John
Well, I'm not sure I'm not sure I learned this for the first time. But it's certainly been reinforced that you as much as you want to plan for the future and think ahead. You need to be adaptable and flexible in that planning. And, and, you know, I guess I did not say I, maybe, maybe some, you know, some of our infectious disease experts saw this, but I did not see this whipsaw coming in, in COVID. That we would be actually in many ways in a worse position in September 2021, even with the availability of vaccines than we were in September of 2020. And that, you know, that is it's, it's discouraging, but you have to adapt to that reality. And, and move ahead.
Darshan
One last question, what is something that made you happy in the last week, we know it's not gardening, or backyard work.
John
It's actually it actually has made me happy. So it without getting into a lot of a lot of detail, we live in a in a rural area where we don't have a lot of city services, we do have municipal water, we do not have municipal sewer. So the project of this week was putting in a new drain field. So a septic tank, and many loads of sand, and new and new piping. And we've actually and this is this is something else, I guess I learned in the last week or so it, we actually, largely because of climate change, our water table has has gone up has risen 15 inches here, so we have had to essentially raise our backyard 15 inches, and that's a lot of sand. And so that's, that's what we've been observing this week. So did it make me happy, it makes me happy that we are preventing some potential future flooding of our property. And, and, and making our property more secure. So that is, you know, in some ways makes me happy doesn't make me happy to write the check. But it was it was it was it was time and these things. These things are supposed to last 20 years and ours lasted 40. So I guess we're we're okay.
Darshan
That's pretty good. And as you know, the thing I usually ask is, how can people reach you? I'm going to flash it on the screen. But how can people reach you jump?
John
Yeah, emails, emails a good way. I'm on Twitter at J. Lewis DC. We have Facebook page heart valve us. I believe it is if you search heart valve voice us and there I would caution because we have heart valve voice in the UK and other heart valve voices make sure you're on the US one if you're if you're in the US. Those are the best ways to get to us. And then through our website, you can get to our patient community, the my valve my voice community, which at some point, maybe it's a standalone site, and we're working, working through those details now.
Darshan
Awesome. Thanks again. Johnson. Wonderful having you on. As always, I do hope you'll consider coming back. This was awesome. Thank you again.
John
Thank you very much.
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
