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COVID-19’s Impact on Patient Centricity: an Interview with Deborah Collyar

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How has COVID-19 had an impact on patient centricity? Join Darshan Kulkarni and the mother of patient advocacy in research, Deborah Collyar, as they talk about the lessons that the pandemic has taught them in terms of patient centricity. We’ll also discuss the importance of terms such as self-isolation and physical distancing.

Narrator: This is the DarshanTalks Podcast. Before this week's episode, COVID-19's impact on patient centricity, an interview with Deborah Collyar, Darshan will introduce this episode with the recap for the week of Thursday, April 16, 2020.

Darshan: So as usual, this has been a very busy week. COVID has kept its control over the news for the most part. But that's not to say that it hasn't been busy for other things. So we're going to discuss some of the conversations that are happening in other areas but that seem to have COVID ramifications or that COVID seems to be influencing in some ways. One of them is the idea of false promotion. The FDA basically came out on April 8th, and they sent out an update saying that there was a seller who was marketing chlorine dioxide products to prevent or treat COVID-19 and that there was no proof to this. That was actually hugely problematic. They were marketing it as miracle mineral solution for prevention and treatment of novel coronavirus disease 2019. Obviously that became problematic.

Darshan: The other thing that was sort of interesting, similarly, is Dr. Stephen Hahn, who is a current director of the FDA, the commissioner of the FDA basically. He's the 24th commissioner. They issued a warning letter to Free Speech Systems LLC, doing business as InfoWars, for offering products fraudulently claiming to prevent, cure, diagnose, treat COVID-19, obviously hugely problematic. They were selling things like Super Blue Silver Immune Gargle, Super Silver Whitening Toothpaste, Super Silver Wound Dressing Gel, and Super Blue Fluoride-free Toothpaste, saying that they might help with the treatment or prevention of COVID-19. The FDA took the position that it's within their discretionary authority to stop this, so that was obviously a step in the right direction.

Darshan: Interestingly enough, there are concerns that it's not just companies that have their own agendas but also people. And on an April 9th article, Jill Adams, who's a freelance contributor, says that physicians who are self-promoting are hawking unproven COVID-19 pandemic treatments. As usual, it usually starts off with Dr. Oz, but there is some argument that a Dr. Vladimir Zelenko is also doing something similar, which I think is interesting. You probably want to be careful if people who are saying that they have a treatment for COVID-19, because the truth is anyone who had a treatment for COVID-19 would probably be making a lot of money. It's not that the government's just trying to hold off on treatments. If anything, they're promoting off-label things that even haven't been proven yet. So I would caution people and take such statements with a grain of salt.

Darshan: To change away a little bit, there have been other changes that are coming on. A lot of marketing changes obviously in general, one of which is the FDA put out a notice on the Prescription Drug Marketing Act. They put out a guidance document saying that they have some guidance on the donation of prescription drug samples to free clinics. That's going to be sort of interesting in the coming weeks to see how this gets incorporated. How should these free clinics that receive donated prescription drug samples be managed, if you will? And the FDA has a guidance on that.

Darshan: On April 6th, the Department of Justice announced that Georgia-based MiMedx Group will pay a $6.5 million penalty... I guess it's not a penalty, but to settle civil allegation that the company submitted false pricing data, defective pricing for its human tissue grafts. The settlement involved allegations that MiMedx knowingly submitted false statements and disclosures to the VA regarding their commercial pricing practices, and that enabled MiMedx to charge the VA inflated prices for its human tissue graft. So that's going to be one of the other things. Again, if you are involved in pricing, and I've seen this come up more often than not recently, something to be aware of.

Darshan: Another thing to look at has been just how pharma marketing is switching around based on what's going on with COVID-19. FiercePharma put out an article about it on April 7th, and they're basically taking the position that pharma is changing the way they're engaging. They're starting off, number one, by shifting the tone. They're already starting to say thank you to nurses, doctors, pharmacists, and others on the front lines. Pfizer, for example, is taking to video and talking about ambulance workers, nurses, doctors, scientists, with the ending statement, "Thank you for being our light." Merck's pinned tweet is a collage of employees saying thank you to the heroes in the front lines. Both AbbVie and Novartis are thank you notes to healthcare workers and to other frontline workers and helpers. So that's sort of changing the tone. Let's see how this plays out.

Darshan: There is overall this disconnect between the life sciences and pharma. It's sort of we'll invent a product and you healthcare people will just sort of prescribe it and use it. Maybe this speaks to how life sciences groups need to work more closely with healthcare groups, obviously not influencing treatment decisions but providing the appropriate education so that the appropriate treatment decisions can be made.

Darshan: Interestingly enough, there was one last piece of news that I thought was really interesting, which was on April 6th, Zach Brennan put out a writeup saying that the FDA drug review timelines reflect four key features, part of the GAO. Overall, the GAO found that there are four features, which is the NDA qualifies for priority review, which is four months less than their otherwise standard 10-month review; whether the NDA is for a new molecular entity, which adds two months to a review; whether the applicant submits a major amendment while the NDA is under review, and that can cause a delay by up to three months; and whether the NDA qualifies for one of the FDA's expedited pathways, and that can actually speed up review for certain drugs or for rare disease states. That's sort of interesting. If you are looking to file your application, what is the impact of that? So stay tuned, listen in. We should have more.

Narrator: This is the DarshanTalks Podcast. Regulatory guy, irregular podcast, with host Darshan Kulkarni. You can find the show on Twitter @darshantalks or the show's website at darshantalks.com.

Darshan: Hey everyone, this is Darshan on DarshanTalks. We have our guest, Deborah Collyar, and Deborah, as you may remember, has joined us before. She is, I remember, Debra, correct me if I'm wrong, but was it the mother of patient care? Is that how it is framed?

Deborah: No, not patient care, patient advocacy in research.

Darshan: Of patient advocacy in research. So we get to find out more about that. And how is COVID-19, or the coronavirus as everyone else is talking about, how is that affecting patient centricity, how is that affecting research? I know actually, Deborah, we spoke about all these different topics we want to talk about. We didn't actually talk about the impact of COVID-19 on research. Love to talk about that a little bit more. And I'm going to let Deborah, because I think starting with the mother of patient advocacy in research is a high title to start off with anyways. But do you want to talk a little bit more about yourself before we jump in further?

Deborah: Okay. Well, I was an executive in a computer company when I was diagnosed with my first cancer back in the early nineties, and that is when we were actually developing patient advocacy in cancers, primarily breast cancer to start with. And we did learn from the AIDS movement on that, and actually AIDS groups. And then some of us felt that it was important to use that in different ways. Patient advocacy covers lots of different things. Traditionally it's direct patient support or fundraising or political advocacy, sometimes watchdog advocacy, which is what the AIDS movement was really good at as well, putting issues on the table, bringing that to light and then having to discuss them.

Deborah: But I started, really, research patient advocacy, and I use both of those words, because we don't advocate for research by itself, we advocate for research that's more relevant and gets better results to people and patients. I've been involved in everything from translational research to basic, to clinical research, epidemiology, and to healthcare delivery research as well.

Darshan: So you haven't done much then?

Deborah: No. And I have to say, even though I'm not traveling, which is what I usually do, I am as busy if not more so since the COVID-19 days.

Darshan: Isn't that the weirdest part? I find myself being way busier. I know I'm going to have to hole myself up in my house and just work through so much more work. But you know what? Job security is one thing. I'm going to be okay with that. You said an interesting thing there, Deborah. I was thinking about this concept, you talked about how your own diagnosis with cancer, multiple times the AIDS epidemic taught us lessons. What lessons does it teach us in the case of COVID?

Deborah: Oh, so many. And we don't have enough time to talk about it, but I'll try to be succinct in what some of those lessons are. The first one is that words matter, and unfortunately when we have medical and research experts defining the words for us from the beginning, they're often wrong and confusing and create more fear than we need, and it's all unintentional. They mean the best.

Deborah: But an example of that is social distancing. That's the term that we're using, when in fact it's inaccurate, where we're physical distancing ourselves. That's a very different concept than social distancing. That's where a lot of the issues can come from and people feeling more angst and fear. You don't have to be distant socially, and people are finding new ways to interact and work with families and friends and even strangers, which is great, but it's like an extra hurdle that doesn't have to be there. I would love everyone to actually try to help us change to physical distancing, not social distancing.

Darshan: So hashtag #PhysicalDistancing.

Deborah: Yes. That is a hashtag on Twitter, by the way.

Darshan: Is it? I didn't actually know that, but I'm going to challenge you on that, Deborah, because I'm curious about your feedback on this. Was part of that intentional, in that was part of the idea, don't go trying to talk to strangers right now? We're trying to avoid spreading this, so social distancing not because we don't want you to connect only, but also we don't want you to build those relationships with strangers and then spread the virus. Is that part of that logic?

Deborah: Well, I think so, but again, physical distancing works for that as well.

Darshan: Fair.

Deborah: The problem is, in mental health, and it's the mental health of all of us, it's not just people who have mental health diseases or illnesses, it feels more like the other words that are being used. Self-isolation, okay, that's a little more accurate and descriptive when you've been exposed to COVID-19, but people are using that in the same way that we're using social distancing. And then there's quarantine. Well, people were quarantined who actually have COVID-19, but other people are using it now too. And so the words get confusing. The terminology of the definitions are sometimes overlapped, and that causes a lot more fear and angst that doesn't have to be there.

Deborah: Socializing can be done electronically and all the videos and all of that, as well as audio. That's a very different concept from a human standpoint, and it's important. There was just an article that came out this morning from Neuro Central, which is one of the groups that I subscribe to, and they're talking about the impact of the pandemic on mental health for all of us and giving people tips on what to do every day now that we're home, either working or not, and the difference in the terminology, the difference in how to set up new routines for yourself so that you can stay on top of where you want to be, rather than getting overwhelmed and guiltful for the entire time we're listening to everybody talking about COVID-19.

Darshan: Which is really interesting to me, because you mentioned two different things that I wanted to explore a little bit more. One was this idea of social isolation, and you used the term, you said it's not being used appropriately. Number one, I'd love to sort of understand what you meant a little bit more, because I think I didn't fully get what you were going with.

Deborah: Okay, I was talking about-

Darshan: Go ahead.

Deborah: Go ahead.

Darshan: Oh, well I'll let you finish that one. I'll ask the next one after.

Deborah: Okay. Self-isolation is the term I was using, not social isolation, but see how easy it is to get them all confused?

Darshan: Yes, absolutely.

Deborah: You know, self-isolation was actually brought up for people who have been exposed to COVID-19 but may not have it, so that they don't spread it, asking them to self-isolate. And what that means is it's a little bit more than the physical distancing that they're asking everyone to do. We're all being asked to stay at home, or most of us, at least in states that are sane. You know, there are 30 of us so far this day. Hopefully, the other 20 will figure it out. The isolation part is more stringent than the distancing. Those of us that have been in stay-at-home states can go out for groceries or medications or things like that. We can go on walks as long as we stay six to 10 feet away from other people. You can nod to people, you can say hello, things like that.

Deborah: Self-isolation is you have been exposed and you don't want to expose anyone else until you figure out if you actually have it or not. And so we're asking people to actually stay in their homes. So that's different. And then of course, if you have it, you're being quarantined, which means definitely stay in your home, don't interact with food delivery people and other things like that. Go ahead and get those services, but take extra precaution and steps. Go ahead.

Darshan: Go ahead.

Deborah: No, that's all right. Go ahead.

Darshan: No, which really took me to that second piece, which was you talked of self-isolation, you talked about quarantining, and then you talked about this need for developing your routines. It reminded me of this link that I read, because I tend to read Reddit a lot, and they talked about how they're bringing in CIA experts who have been captured and how do they deal with self-isolation, quarantining? Do you think that that is media hype, if you will, or do you think this is a time for more reasonable measures, or you think that is necessary at this time as a patient?

Deborah: I think that's really reasonable. Why shouldn't we learn from people who have gone through somewhat similar experiences? The entire world is going through this experience together. That's the amazing part of COVID-19. It's not just the US, even though we tend to only talk about ourselves, but it really is happening globally. At different levels, but everyone is experiencing it. And so I think those kinds of examples are very important.

Deborah: There are things people need to be thinking through right now. When we hear about COVID, instead of being fearful about the whole thing, let's use that as an opportunity to really think through what does this mean in my situation? How would I deal with certain things? And actually start to work through it. If we start to work through it, and that's one of the things that you learn when you have a serious illness, so those of us that are more from the patient community, while there's a lot of fear about how is this going to impact me? Am I at higher risk?

Deborah: And unfortunately there are a lot of people who are at higher risk who have chronic illnesses or different illnesses. The oncology community is one of those, unfortunately, especially those going through active treatment, because immune systems are compromised. Well, the same thing applies if you have a respiratory, a lung disease or a kidney disease or diabetes or autoimmune diseases. There are millions and millions and millions of people in this country and across the world who are already coping with some type of illness or disease, and they are at higher risk. We need to be helping them more with resources. And there are a lot of communities that are. The oncology community, for example, has been trying to put information together for cancer patients, both those of us that are long-term survivors as well as people going through active treatment.

Deborah: So that's the good news. But there are other things, like for instance, rural communities right now are just starting to get hit. And there's been a lot of reluctance, people thinking, oh, that's for someone else, not for me. Unfortunately that's not true. Good luck with that kind of thinking. But let's start thinking through what that means for rural communities. It means that you may have one nurse in your area. You may not even have a hospital in your local geographical area. So where do your emergencies go? Your emergencies go to major hospitals in major cities.

Deborah: So for instance, in the Midwest, Arkansas and Oklahoma, if you're not able to go to Oklahoma City because they're overcrowded, then you usually go to a place like Dallas. Well, guess what? Unfortunately, those medical centers are already overwhelmed with their own populations, so the traditional route for really sick people that need to get care may not work, and that's going to be a major problem.

Deborah: So we need to think through as a country how do we handle that? Telehealth, things like that. But the good news is, I'm hoping that there are some good things that will come out of COVID-19, and part of it, and you ask about research, this definitely applies to research, but also about medical [inaudible 00:20:27]. We have known about telemedicine now for oh, what, at least 15 years, but it hasn't taken hold very well. It will have to in COVID-19, and hopefully that will stick afterwards. There are many more ways that we can care for people and actually do research and clinical trials differently, that many of us had been pushing for. Telehealth is just one example.

Deborah: What we're calling decentralized clinical trials, we've been pushing that issue for years, trying to get more local care that people can experience, whether they're in an urban area or a rural area. There's no reason why a person has to spend three hours traveling in one direction to go to a medical site for a clinical trial, just to have a followup visit or just to have their labs or their MRI done. That's ridiculous. So hopefully there are things that we're learning there.

Deborah: There are ways that we need to change endpoints that actually make more sense from a patient standpoint. We need to really look at eligibility. There is no reason for a lot of times why we have the strict eligibility criteria in clinical trials that does not translate into the general population when that drug or device is commercialized. And then we have so much more we have to learn after the clinical trials. That's where real world data and real world evidence, which are not enough, come in. So real world data, these are other terms that get sloshed together all the time.

Deborah: The real world data are a tool, just like a biospecimen is a tool. It does not tell us anything in and of itself. It is not the great answer. We have to turn it into real world evidence, which is where the analytics come in, but that's not enough either. Really where we're going is, and I'm trying to coin this acronym RWA, what we want are real world answers. That's where everybody wants to go. That's where the medical community and the patient communities want to go. What are the answers that you can get from real world data and evidence? And if we get to that point, then that means we can actually use the interpretation of that analysis and evidence so that it can be used for better decision making and hopefully better treatments so that patients get better results. Notice, I'm not using the word outcomes either, because outcomes is a research word. That's what researchers get. People get results or don't. Those are all examples of words that matter.

Darshan: That's really interesting, which really brings us to the idea that COVID-19 is forcing us into a new medical health and clinical trial paradigm.

Deborah: I hope so.

Darshan: And if that's true, like in every change in paradigm, there is anxiety, there is build-up, there is coping with this new change. Two questions for you in this area. The first is, patients have to cope to this whole change, but the second one is, what constitutes patients here? Because what we've noticed with the COVID-19 situation is it's not people who are actually engaged in some kind of treatment that are necessarily the patients. It's everyone else as well, who's trying to avoid getting infected. If that's true, as a patient advocacy expert, as a patient centricity expert, where do you draw the line for patients, or do you say everyone is a patient and that includes people who don't have the disease yet?

Deborah: I think we have to go with the assumption on something like COVID-19 that everybody can be a patient. They aren't necessarily today, but they could be tomorrow. And that person may do just fine working through the disease, but many are not. A lot more people are having major problems with this illness compared to like the flu, et cetera, no matter who has said what, because we have a lot of misinformation out there, unfortunately, from our own government. And I'm trying to be nice, and that's as far as I'll go there. So that's part of dealing with this, is how do we handle with misinformation? Where do you go for reputable sources?

Deborah: And in something like this where we're all learning in real time, we have to be prepared to allow an evolution of the information to happen. We don't know from the beginning. We're all learning together. But we need to do that in a thoughtful, considerate way and help people understand that while we didn't know this before, we're learning more about this. And by the way, this isn't the last thing that we'll learn. And we may find out, for instance, masks, are they good or are they not good for everyone to wear? That is evolving and changing, and we still don't know the answer, but we go with hints and clues.

Deborah: An example of that also is on what to do... I'm going to switch back. Somehow you'll be able to fit this in. I talked about what to do in rural situations. Well, what to do for you and your family if someone gets COVID-19 and is sick enough to go to the hospital? Because a lot of people who have COVID-19 can actually handle that in their own homes. But there comes a point where breathing becomes a problem, and when breathing becomes a problem, you do actually need to go to the hospital, because that's where our healthcare workers are, who are desperately trying to take care of people, without the resources, by the way, that they need to protect themselves and their patients.

Deborah: And that's a real problem that is to me not only a national tragedy, it's a national black eye. We have got to get a better handle on this. And I'm really tired of seeing hospital administrators and government officials talk about how we're now handling this and we're taking care of this for everybody. They did a poor job. They fell down on the planning part of this, and this is not a theoretical exercise anymore, folks. This is real life that needs to be handled now. And now if you don't believe that, just watch Governor Cuomo every day, and other governors now too.

Deborah: I bring this up because it's really important for people to think through, okay, if I have to go to the hospital, what does that mean? That means my family, my partner cannot go in with me. I will be going into the hospital, be admitted in there alone. The medical team, the healthcare workers that are in there, which are healthcare heroes, which is a hashtag by the way that we need all use, are caring people who are trying their best with an overwhelming situation, and they are desperately trying to be there with people through their experiences, whether they get better or whether they die there.

Deborah: And one of the things that we have to know about the whole situation, if you're going in the hospital, you are, A, really sick. B, if you have to get on a ventilator, the studies that I've looked at, now, they are in a different population, that's with people that have a respiratory syndrome or disease, but only about 50% of them come out of the hospital. We don't know if COVID-19 has those same rates or if those rates may actually be worse.

Deborah: The preliminary information looks like it may be lower than 50% of people who go into the hospital will come out of the hospital. And that's a scary number, but it's something that you use those scary numbers in a way to think through, okay, what do I want to have happen to me? Am I okay with getting on a ventilator? This is an important question, because we don't have enough of them, and we hear that every day. That's not, again, a theoretical exercise. It's something each one of us needs to think through. Ventilators are important and they do keep people alive, but not everyone. And there may be problems that you can have, lots of problems.

Darshan: Here's the question though, Deborah. Speaking from the patient viewpoint, the patient lens, if you will, as you know, President Trump came out and said that he's going to use the Defense Act to basically get companies to make ventilators, one of which is a car-

Deborah: Well, he's talking about it, but is he really going to use it? Because he should have already.

Darshan: He has. One of them is actually a car company, I think it's GM, that was going to make ventilators. My question is, if that's true, as a patient, do you think that that's a good thing to have more ventilators or a bad thing that an unapproved ventilator is on the market? I mean, Tesla is saying the same thing.

Deborah: Right. We always want simple answers, and life is not simple. That's probably the best one-liner I can give you. Then we need more ventilators, absolutely. Who's going to run those ventilators? This is not a simple machine. You have to be trained in that. We are already at a shortage with healthcare workers, so we need to be thinking through that whole process. How are we gearing up for the extra manpower and womanpower that's going to be needed to run those ventilators? How are those going to be applied? What other resources do we have? We are not using all of our medically-trained staff. What about in the military, for example?

Deborah: And I know people are talking about that and that's great, but we haven't acted on any of that stuff yet. We need to be deploying people, and I don't use the war analogies easily. I think the war on cancer for example, was a really unfortunate image and concept, because we have not applied it the way we needed to. With COVID-19, it may be appropriate to be using that kind of analogy, in reality using our forces for this. But it's taking too long to come up with all of this, and we have people who have gone through the theoretical exercises on infectious diseases like this. I don't understand why we're not acting on this stuff faster than we are.

Darshan: Okay. Well, it's funny, I usually aim for these to be about 10 minutes, but this is such an interesting topic and you have such an interesting take on this, we're a little bit over, as you can imagine. But Deborah, any last words?

Deborah: Yes. Please think through what it means to go into the hospital alone, how you would handle that, how you would still be socially connected to your family when you are physically disconnected. How would you want to die is actually an important thing to think about. Do you really want to have CPR and put the health workers at risk as well as have major damage done to yourself? If your heart would stop, that can be while you're on a ventilator or it might be before you're on a ventilator, there are side effects of ventilators that can be long-term.

Deborah: All of these things are things that we need to think through, because our healthcare workers are going to have to prioritize who gets on them and who doesn't. And if you are older or sicker or you don't want to have things done to your body that may have ramifications for the rest of your life, then make sure the healthcare staff knows that. Have your paperwork in order and have it with you. That includes advanced directives, do not resuscitates, the POLST documents, the DNRs. There's all sorts of things that we actually need to be paying attention to and prepared for, in case you are in that worst situation. I hope and pray that people don't have to do this, but there is a reason why we should take the time now to learn about this and get prepared just in case. And be sure and prepare your family members as well. It's important for you to know what each family member wants so that you can try to relay that if needed.

Darshan: That's really succinct. Thank you. And Deborah, if people want to reach out to you, how can they reach out to you?

Deborah: Well, I'm available on social media @DeborahCollyar, and my name is spelled kind of weirdly, but I imagine you'll have that on the site.

Darshan: We will.

Deborah: I have an email that people can reach me with, and that is [email protected], because you have to have a sense of humor in this life no matter what.

Darshan: Well, thank you again, Deborah, for taking the time. This was wonderful as always. I hope we can have you on again.

Deborah: Well, thanks. I'd love that. This is always interesting, and I learned a lot in our conversations as well.

Darshan: Thanks. Pleasure talking to you guys.

Narrator: This is the DarshanTalks Podcast. Regulatory guy, irregular podcast, with host Darshan Kulkarni. You can find the show on Twitter @darshantalks or the show's website at darshantalks.com.

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