COVID-19 Webinar Series Session 8 – Advancing Prevention and Treatment: A Conversation with Dr. Mark McClellan

12:00 p.m. – 12:05 p.m.     Welcome and Introductions

Sarah J. Dash, MPH, President and CEO, Alliance for Health Policy, @allhealthpolicy

12:05 p.m. – 12:30 p.m.    Moderated Discussion

Mark McClellan, M.D., Ph.D., Director and Robert J. Margolis, M.D., Professor of Business, Medicine, and Policy, Margolis Center for Health Policy, Duke University; Former Commissioner, U.S. Food and Drug Administration; Former Administrator, Centers for Medicare and Medicaid Services

(This is an unedited transcript. For accurate quotes and presentations, please refer to the full-event video.)   0:06 Good afternoon, everybody. I’m Sarah – president and CEO of the Alliance for Health policy. And I want to welcome you to week 4 of our covid-19 webinar series for those who are not familiar with the alliance. We are a non partisan resource for the policy Community dedicated to advancing knowledge and understanding of Health policy issues. We launched this series to provide insight into the status of the covid-19 response and shed light on remaining gaps that must be addressed to limit the severity in the United States. 0:36 Alliance gratefully acknowledges the National Institute for Healthcare Management foundation and the Commonwealth fund for supporting our covid-19 webinar series. You can join the conversation on Twitter using the hashtag all health-wise and follow us at all Health policy. We want you to all be active participants. So please get your questions ready. And here’s how you do it. You should see a dashboard on the right side of your web browser that has a speech bubble icon with a question mark you can use that icon to share any technical issues. You might be experiencing as well as to submit questions. 1:06 Or the panelists at any time during the broadcast finally check out our website all Health policy dot-org for background materials and a recording of today’s webinar, which will be made available soon today. I am so pleased to be joined by dr. Mark McClellan to discuss steps that policymakers can take to speed the development and evaluation of medical products to track treat and prevent covid-19. Mark is the Robert J Margolis professor of business medicine and policy and founding director of the Duke Margolis Center for Health policy at Duke. 1:36 Diversity here earlier served as commissioner of the US Food and Drug Administration and administrator of the centers for Medicare and Medicaid services mark. Thank you so much for joining us today. 1:48 I’m going to start with an opening question and again for the audience if you have questions to share it at any time and we’ll do our best to leave it in. Okay, Mark. So social distancing measures are in effect in most though not all parts of the country. The Health Care system is bracing for a surge in cases. 2:04 I want to start by asking you to help us to look ahead what can policymakers private sector do now to reverse the trajectory of the virus and set up an infrastructure for tracking testing treatment of 19 so that we can safely return to some degree of normalcy first off Sarah. Thanks to you and the alliance for being such an important resource at a challenging time. The lines is always been great for keeping policymakers up-to-date and supporting effective legislation on a wide range of Health Care issues, but we really need this now. So it’s a pleasure to be on with you and so many of your listeners. You’re right. 2:45 This is the way pandemics start it always by Definition you don’t have any effective treatments it sometimes you only know what the agent is. 2:53 And so though only in the main things the critical things to do or all about physical distancing and isolation and we’ve taken those measures like the rest of the world who have pretty extreme and unprecedented level II agree were probably not doing all that we could and all parts of the country to prevent this initial spread of the virus and as a result of that we’re seeing the people Now in many parts of the country and in others it may well come later. It’s not like any part of us is immune to the threat of covid-19 and people are understandably focused on getting through this really horrible situation with with so many deaths and so many people affected but but you’re right that we will get beyond that. We’ve already got a number of diagnostic tests that are available. 3:43 Those are going to keep getting better both for identifying who has an active infection and increasingly important who’s been previously exposed and and may now be immune that’s going to help with moving beyond where we are. Now we talked about in a previous report that Scott Gottlieb and some of our collaborators issue through the American Enterprise Institute about a week ago a pathway to reopening that puts a big emphasis on using better diagnostic tests. 4:15 Get ahead of the epidemic the point where we can actually the identify any new outbreaks early and do contact tracing using this much expanded diagnostic test capacity to contain the epidemic and avoid big surges like what we’re experiencing now never want to live through that again, but the real ball game is about the treatments and the eventual solution to this is probably going to be a vaccine or multiple vaccines that help people become immune at a Odd enough level in every community that the virus just can’t effectively spread and have an impact but that’s going to take a while. So in the meantime, there’s some very promising treatment options in development. So some of this is just what clinicians are learning is they take care of more patients. What’s the best way to support an individual with an advanced respiratory problems? That’s way to ventilate things like that. We’ll learn more about that and especially how can we bring? 5:18 Effective treatments to bear and the shorter term so that’ll include so-called antiviral drugs including both existing drugs that may have activity against the virus and and new drugs like Gilly ads from the severe that Lowdown viral replication or keep it from having as much of an impact on the on the person who’s infected there also are immune based Therapies in development people have heard about how the growing number of individuals who have recovered. 5:48 Bird from covid-19 infection about the possibility possibility of viewing using serum from these individuals which contain immune globulins that do successful. It can potentially successfully fight off the infection so called convalescence serum. We’re still learning about whether and how that works. 6:07 It hasn’t always been a slam dunk successes in previous infections important questions the answers were there too, but then new technologies that enable monoclonal Versions just synthetic rapidly manufactured versions of antibodies against the virus. 6:25 So those are in development to and potentially important type of treatment and then a third category is drugs for very seriously ill patients who seem too many cases have a kind of an intense immune response that goes beyond fighting the virus and starts damaging the lungs and other parts of the body and this Action is something that so-called immune mediating drugs that’s different than antibodies. But in the immediate and drugs may be able to help with so some of those are in development as well and the real challenge for policy makers and the the clinical Community is how do we learn which of these treatments work as quickly as possible? 7:08 It’s not just a matter of trying to make available treatments that may work but really learning about quickly and under these very difficult circumstances, which ones are really going to make difference Thanks Mark. That’s a great overview. 7:22 And it’s really kind of amazing that Justin in this relatively short time period we already know so much about the different kinds and different categories of drugs that might work and treatments that might work but tell us so you ran the FDA and CMS you’ve written white papers on this on this topic with Scott Gottlieb and others tell us what kind of infrastructure is needed to really Answer that question about how we know what works and what’s safe what’s effective. How do we how do we parse through all of this? And what kind of infrastructure is needed at the at the federal and other levels? We’ve got some good models Scott and I called for really an intense effort to take those existing models and bring them to a different level of intensive activity just because so much is at stake in terms of health and economic impact of this. 8:20 Virus it really deserves an unprecedented level of attention. A lot of that is happening. So the FDA has many established programs to work closely with product developers who are working on new kinds of treatments, especially smaller companies who may not have biotech companies. 8:39 You may not have that much experience with the development process and a lot of people think of FBA is being like a gate check at the end where okay, how long is it going to take to Review and application and get it approved. But that’s really the wrong way to think about the way the development process works. There are many steps that need to happen to get to safe and effective evidence evidence that product is safe and effective that can be accelerated. This can happen through things like close consultation with the FDA. They have so-called breakthrough programs and other programs to Interactive. 9:20 Extensively with companies are thinking about how to design studies. How going to get as quickly as possible to study results based on no more not having to do necessarily a very large study, but it’s a very well-designed study. 9:35 There are lots of there’s lots of expertise that the agency can bring to bear also very important is as Federal funding to help support these efforts that can come through the National Institutes of the National Institute of allergy and infectious disease and also, And an agency called Barda which does Advanced research and development for medical countermeasures. It’s part of the assistant secretary for preparedness and response has office. So those organizations have been helping and pumping in additional resources to start getting testing underway in the hopefully conclude it to the point where you can see that a treatment is is really safe and effective in the shortest amount of time possible. 10:20 Also though, it’s not just a matter of proving that a treatment works are getting good enough evidence that a treatment works. There’s also a challenge of manufacturing. So many of these biologics involve complex processes it again, especially a small companies are involved. 10:34 They may not be ready to scale up and it can often take months after a a drug is approved for the manufacturing facilities to come online and be certified and so they’re also important steps under way now to basically try to You that manufacturing processes at the same time as you’re doing the studies to show the treatment does work well enough to be approved and made widely available. But Sarah here’s the challenge in all of this is that because there are so many urgent unmet needs for treatments. There is an intensive pressure and understandable trip pressure to make these treatments available. 11:16 Even before we have very good evidence on whether they were work and hydroxychloroquine is an example ain’t many people who are listening today or familiar with where there are some there was a very limited amount of evidence before not evidence that I personally think is is compelling enough to encourage people to use this treatment broadly, but there is a been a lot of demand for the drug and that’s complicated getting some of these studies done. 11:49 So something else That’s gotten I called for and I are in our approach to this problem was making sure that there’s a good process for emergency access for people who don’t have any alternatives and want help but that there’s at the same time a really efficient way of getting the clinical study evidence that’s needed. And you know, I think looking ahead were probably going to see a few treatments that will show some promising evidence not just Hyderabad rocks. 12:20 Chloroquine, but some of the other types of drugs that I mentioned and there’s any a lot of pressure to make those available for for broad emergency use so looking ahead since covid-19 patients or diverse their many different uses for potential drugs ranging from prophylaxis to treatment of early uncomplicated cases to treatment of the most severe patients. 12:43 It’s going to be important to set up ways to learn more about these treatments when they’re on the market and that’s something Payers like CMS can make a difference where healthcare providers that are part of clinical research networks to develop so-called real world evidence can make a difference and I see those being important issues in the coming weeks as we get more treatments that look like they may work to really understand how to use them as well as possible as effectively as possible and the more of these treatments where we can develop that good evidence the better. 13:20 Russian we’re going to be to actually really affect the course of this epidemic. Thanks Mark and you already anticipated one of our audience questions about hydroxychloroquine and whether the evidence is sufficient. So I want to ask you to just follow up on this question of you know emergency access as well as getting the efficient clinical evidence that we really need. Can you put a little bit of a finer point on that? Like what are some of the steps to putting that process in place? 13:49 So One step is that tight collaboration between FDA the product developers and the private sector niaid and Barda among other groups to make sure that the most promising agents are getting into clinical trials that are well designed and what we say in the the lingo as well powered. 14:14 That means they have enough patients involved or collecting the right data to To answer questions about key in points on Effectiveness and safety. We make sure that those trials are really being done as quickly and efficiently as possible because again, the world doesn’t want to wait they want access to treatments that even might work if there’s nothing else available. So continued attention to that and policymakers asking the question with all the top, you know, 20 or 30 or 50 drug candidates are all of them in trials that are ongoing. 14:50 Track for completion rapidly. They’re all of them in Trials have enough enrollment that are well designed using these good good clinical study principles. So that’s one important part to watch but the other four for a treatment like hydroxychloroquine, that’s you know, it’s already on the market. It’s an existing drug. We’ve seen what happens. So there’s now a shortages of the drug understandably is lots of people are trying it. 15:17 There are people who Who have conditions like serious diseases like lupus who are now having trouble accessing it. 15:26 And this is a this is a condition where the drug has been proven to be safe and effective and not only are questions about the effectiveness of hydroxychloroquine with are also questions about the safety particularly for people who have heart disease and might be using it as some have suggested with an antibiotic called azithromycin that together can cause irregular heart rhythms and serious problem, so Isn’t actually happening. Now. My hope is that the clinical trials of clinical studies that are being done in the real world will provide good answers about the impact of hydroxychloroquine in the coming weeks. But example of one is a trial called hero that my colleagues at Duke the Duke Clinical Research Institute or helping to lead this involves by smartphone enrollment a lot of Frontline healthcare workers around the country. 16:20 That’s a great way to get good evidence in the real world and this tough situation that we’re dealing with. My hope is well is that as other treatments come to Market and my guess is again very come to Market with some evidence but not great evidence that will find a way to both learn more about them through practical real-world studies. Like I just mentioned but they’ll also did do a good job of tracking safety. I understand there already are a number of reports of adverse. 16:50 Events happening again for people have heart problems in the why who are using hydroxychloroquine. So this is where this is the difference between getting out of this epidemic fast and getting out of its lower the attention to getting good clinical evidence quickly under a very challenging real world situation where people want access to treatments that might work. We the same time have to pay a lot of attention dealing with that reality. 17:20 To developing the real evidence on which treatments do work and especially since you know doesn’t look like we’ve got a Magic Bullet yet. Hopefully one of these treatments coming along will be what is work. So well people just get up and leave the hospital or not develop complications. I wouldn’t count on that. I think we’ve gotta count on the need to try out a lot of these treatments quickly and again get real evidence not just hope for the best with emergency. 17:50 Is only thanks so there are a couple of audience questions that pertain directly to the so one is whether you can discuss the timeline for getting these novel Therapeutics first of all, obviously to the evidence, but then to get them to a large number of patients or to the right patients are there things that FDA and others can do to accelerate the approvals as you said safely and with good evidence. Yeah. 18:14 There are a number of steps like mentioned a lot that FDA is taking for any any, excuse me for any manufacturer that is developing a new treatment. They need to be working closely with FDA and these other experts and governments around funding and around supporting effective trials as early as possible. And I think an important from the policy side thing to track is just how many well-designed trials are being run. 18:45 What is their expected date of completion and if we really done all that we can to Enroll enough patience and design the trials well, so that that time comes as soon as possible their number of groups including the we’re collaborating with that are trying to help with this effort faster cures with the Milken Institute has a nice clinical trial tracker that they’re trying to expand and make richer to include these key elements. Like how well is the study going in terms of enrolling enough people and getting the completion. There’s work being done by a group called a clinical trials. 19:20 Transformation initiative also part of Duke that is helping to develop more standard ways of doing them clinical trials in the covid-19 era. So if we could create a platform for of a typical approach that any new product developer might use hopefully will be a lot of clinical organizations willing to raise their hand and participate in those studies. So I a network supported by standard efficient approaches for doing these trials wide. 19:49 We’re On on this, but you know, I don’t think work all the way there yet. And then also very important with the key question about your we actually can be able to get the treatment so that people who need them are remember that when these treatments become available either with emergency use access like for hydroxychloroquine or for some of the other drugs that do go through these trials. There will be a lot of unanswered questions maybe about different populations people in different subgroups. 20:20 Older individuals those with other conditions or ethnic backgrounds where we’re just not going to have great evidence of the time they get to Market and that’s why it’s so important. I think for payers to be involved in supporting using the data that they collect from claims and and working with health systems that have good electronic records and that can potentially participate in these clinical study networks to help make sure we’re learning more about the treatments. 20:50 That are on the market and this attention to real-world evidence for the treatments that do make it to Market either through emergency use or with some initial indications for approval is another area where I hope we can see some more policy attention and some more steps from the private sector Healthcare organizations and and payers as they come out of this surge right now. 21:15 This is a key part of the of the response and getting the epidemic under Control as quickly as possible. That’s great. And let me let me ask you a couple more collaboration questions because we’ve had some more come in from the audience. So one has to do with International collaboration, you know, how can International collaboration help us and in particular somebody asked about the World Health Organization solidarity trial which pulls data from clinical trials in four different treatments from around the world. How can International collaboration help us and then I’ll just pack on, you know, philanthropic collaboration the Zuckerberg. 21:50 Foundation and the Gates Foundation are teaming up to try to accelerate finding treatments that work talk about how that works. Yeah, so great great question. So everything I talked about in terms of the importance of Designing clinical studies efficiently in a way that deals with the reality of a real world where there’s going to be a lot of pressure for just just access to drugs, even when the evidence is limited. It’s the same principle of the global level is what I was talking about. 22:20 For the United States. So the who has worked with the National Institute of allergy and infectious disease and and with the FDA and other Regulatory Agencies, I believe to try to encourage the use of common efficient approach to doing these trials. Everybody doesn’t have to reinvent the wheel and so then it becomes easier as you said like in the solidarity study to pool data across sources to add in new drugs as well. 22:50 Sense suggests that some of the ones that are being tested now aren’t that useful? Well, let’s not try to have to start a whole new clinical trial from scratch. Let’s just plug those drugs into this existing Network. So absolutely the same principles I’ve talked about the u.s. Level are important at the global level one other issue. That’s very important for Global public health is we can’t forget this epidemic will not be under control and the US will not be protected until there’s control and protection throughout. 23:20 At the planet and so not only do we need to develop good evidence, but we really need to be thinking ahead about availability of the treatments that work. I’m very pleased to see some efforts like one supported by Barda and some of the companies are involved in manufacturing vaccines to not wait until the clinical studies are done to start planning for and ramping up major manufacturing capacity. 23:48 And I think that’s an area where More Global collaboration and support from the US would be would be really helpful and with respect to the foundation’s, you know, it’s great to seeing there’s like now billions of funding literally coming in from all kinds of philanthropic sources around the country and around the world to try to test out new therapies. 24:11 It would be great if that funding can be integrated into these networks to know everybody wants to help and Everybody wants to do it quickly if we can help foundations like Chan Zuckerberg plug into some of these clinical trial networks and coordinate on the studies. They’re doing so that they don’t overlap with and they really compliment studies that are being done by other organizations. That would be really helpful. 24:39 It’s hard to do at a time like this when everybody is under so much time pressure for action, but I think it would really help make sure that the all this foundations Poor goes trials that are well designed that are efficient and they are really help maximize and leverage those funds to develop better addicted to let us know what we need to know about whether these treatments really work. 25:05 Thanks. Well in the in the time we have left I spent a lot of time on treatments are just super important. I want to make sure we get a chance to talk about testing and to some extent, you know vaccines as well. Talk about your thoughts there at what point are we going to have enough capacity to test a large enough part of the population? Can you talk a little more about the serologic testing? You know, what are the big important next steps around testing around surveillance and around back. 25:34 In development. Yeah, so we need to get to a national covid-19 surveillance system in this country as quickly as possible along with them colleagues including it’s got Gottlieb and others Farzad mostashari Caitlin rivers and Lauren syllabus. We have a report coming out shortly. I think that tomorrow on a lot of detail on what we think is needed for an effective surveillance system. I think we’re getting there in terms of testing capacity. 26:04 Cassity for whether or not people are infected with the virus and we have a lot of steps described in this report to make sure those tests are done on the right people. 26:13 The information is shared electronically rapidly and we really get from where we are now, which is some pilot efforts around the country to start try to do testing every where it’s needed and do the the need of contact for racing something that’s much more systematic and backed by the CDC with funding and So supported by payers to not only do right testing but but report the information on the other side of testing is is so-called serologic test. 26:46 These are tests for exposure and whether or not someone is immune has strong enough immune response to the infection that they won’t get it again those tests right now are coming to Market fast with again emergency use authorization and there they can be quite helpful in determining just how widespread covid-19 has been in our communities. I think it’s a lot wider spread than most people are aware of based on the positive test so far, but we just don’t know need to fight figure that out quickly very important for future planning. There is still work to do though on those serologic tests to make sure that their quantitative enough and accurate enough to give people confidence about when they get a certain test result that they really are immune. 27:34 And that’s an area to where we need back to the same theme more real-world testing so that the tests are going to be out there there. They’ve been emergency authorized for use to identify people who may have been exposed to take it to the next level be confident about whether they’re actually immune we need to do some further testing in practice in the real world on how reliable this test actually are. 28:00 And the sooner we can get out the sooner we can get this piece of the of the it’s taken care of. 28:07 Thanks, Mark. Well, there is so much more to talk about and I want to acknowledge that there have been a lot of audience questions coming in. You answered a lot of them. Some of them we haven’t gotten to I want to invite our audience that if you have additional questions to contact the alliance and we will do our best to answer them in future webinars Mark before we close. I just want to ask you just real quick. What’s the thing to look for in the next week? I think you’re going to start seeing the coming weeks more emergency access to other. 28:35 Initially beneficial treatments so this will start to look better. But again, the fall question you should ask is do we really know if these treatments work well enough to be used widely and how can we learn more quickly in this in this very messy setting of a rapidly developing real world epidemic the other piece hopefully, there’ll be some some good news in terms of moving past this really tough surge that the country is living through the early evening. 29:04 We’re not through the the Started yet by any means. We’re not even there and many parts of the country but it does look like these intense social distancing steps physical distance and steps are working and that gives us a foundation if we take the further steps we talked about. I really good surveillance system and its task to accelerate evidence on promising treatments and hopefully before too long a vaccine to really recover from this this epidemic so some good things to look at. 29:35 Head to and what’s really a extraordinarily difficult situation. We will be keeping our eyes peeled for those those developments. Dr. Mark McClellan. Thank you so much for joining the Alliance for Health policy today. Thank you for answering our questions. We are incredibly grateful and we will be posting some of the resources that you mentioned on our website and hope we can talk again another time. 29:59 Alright great to be with you and and and Beth which is to everyone who’s working so hard on responding to the covid-19 pandemic Thank you.