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Chronic Challenges

Transcript of BioCentury This Week TV Episode 177




Dr. Robert Temple, Deputy Center Director for Clinical Science and Acting Deputy Director, Office Of Drug Evaluation And Research, FDA


Anand Parekh, Deputy Assistant Secretary for Health (Science & Medicine), Office of the Assistant Secretary for Health


Ms. Myrl Weinberg, CEO, National Health Council


Products, Companies, Institutions and People Mentioned

Digital Infuzion, Inc.

Centers for Medicare and Medicaid Services

Independence at Home Act

Veterans Administration

National Institutes of Health

Agency for Healthcare Research and Quality



Steve Usdin, Senior Editor




STEVE USDIN: Medicine traditionally treats one disease at a time, but more than a quarter of adults have more than one chronic condition. This week, improving care for multiple chronic conditions. I'm Steve Usdin. Welcome to BioCentury This Week.


NARRATOR: Connecting patients, scientists, innovators, and policymakers to the future of medicine -- BioCentury This Week.


STEVE USDIN: Modern medicine is set up to treat one disease at a time. Physicians specialize in particular diseases. And clinical trials of new drugs often exclude patients with multiple diseases. But life isn't that simple. 26% of American adults have two or more chronic conditions, like arthritis, diabetes, hypertension, and asthma.


The number increases to 68% for seniors in Medicare. And patients with more than one chronic disease account for 2/3 of America's healthcare bill. Truly coordinated care is the prescription, both for the individual patient and the economy. But it's a long way from reality.


KENNETH THORPE: Since 1985, about 80% of the growth of Medicare spending is due to an increase in the prevalence of chronic disease. So today, about a quarter of Medicare patients are diabetic. That's double since the mid-1980s. Another 25% are pre-diabetic.


Yet there's nothing in the Medicare program that is really designed to effectively prevent the progression towards diabetes. And there's certainly no care coordination in the original Medicare program designed to keep diabetic and other chronically ill patients healthy.


STEVE USDIN: To discuss the challenges posed by multiple chronic conditions and efforts to improve care, I'm joined by Dr. Anand Parekh, HHS Deputy Assistant Secretary for Health, Dr. Bob Temple, Deputy Director of FDA Center for Drug Evaluation and Research, and Myrl Weinberg, CEO of the National Health Council, a patient advocacy organization. Dr. Parekh, how big is the problem of multiple chronic conditions, and is it getting bigger? Staying the same? Or getting smaller?


ANAND PAREKH: Thank you for your question, Steve. So the Centers for Disease Control and Prevention now estimates that one in four American adults have multiple or two or more concurrent chronic conditions. Why this matters is that on average, as the number of chronic conditions increase, all of those outcomes that we care about, from hospitalizations to re-admissions, mortality, adverse drug events, functional status, all worsen.


And from the cost side of the equation, it's estimated that that 1/4 of the American population results in 2/3 of US healthcare costs.


STEVE USDIN: And Myrl, from the perspective of patients, why is having multiple chronic conditions different? And is it something that the healthcare system has to change or adjust to handle better?


MYRL WEINBERG: It's very different. And so we represent people who have multiple chronic conditions. And for example, a person that might have diabetes, a heart condition, be overweight. And so these are the very people they need a lot more medicines and they need a lot more care from a variety of doctors. And right now, in most cases, their care is provided through multiple healthcare providers, all of whom treat one disease at a time.


And so their care isn't coordinated, it costs too much, and usually their health outcomes aren't as good as they would be if we changed the system and had better coordinated care, information shared across all the healthcare providers. And they really looked at the whole person.


STEVE USDIN: And Dr. Temple, when we're talking about drug development, it's easy to say, well, you should incorporate patients with all kinds of conditions in drug trials and know what's going to happen, is it actually easy to do in practice?


ROBERT TEMPLE: It can be done. What you have to do is not exclude them, for reasons that aren't very good. So we did a study of drugs that were examined in 2011. We found that people with psychiatric illnesses were excluded from many trials. If you do that, you'll never find out whether the drug makes the psychiatric condition worse.


So we're urging, in various ways, to have people use fewer exclusions.


STEVE USDIN: And if you have fewer exclusions, then also, doesn't it also suggest that you have to pay attention to more different things?


ROBERT TEMPLE: Yes. Well, one of the things you do when you examine your total database on a drug is, you look at the subsets of people who have another disease, who are on another drug, and you try to see whether anything either related to effectiveness or safety changed in those people.


STEVE USDIN: And when we're talking about multiple chronic conditions, are they usually totally independent variables, or are there things that go together, and they go together because, for example, the same kind of lifestyle issues may be causing multiple things to go wrong?


ANAND PAREKH: So there are an array of chronic disease risk factors driving a majority of chronic diseases in this country -- tobacco use, poor nutrition, lack of physical activity. All of those risk factors can drive an array of different chronic conditions. Many chronic conditions go together. So they share the same path of physiology.


Others are discordant. Take the example of asthma and arthritis, two separate chronic conditions that aren't related from a physiological standpoint. So it really depends.


STEVE USDIN: And is it is also partly a function of our success in treating acute illnesses better so people live longer, they kind of pile up these conditions as they age?


MYRL WEINBERG: I would think so. One example we talk about is people with HIV/AIDS, who used to not live long. Now, they live really much longer. And what we find is, they're developing now multiple other conditions. And so we don't know yet from the research that's being done, we don't really know how to treat those conditions and how that will interact with their HIV/AIDS treatment regimen.


STEVE USDIN: Dr. Temple, is it partly also an issue in some cancers and HIV, where new drugs are not curing the diseases, they're really turning them into manageable chronic diseases for life?


ROBERT TEMPLE: Well, that happens all the time in oncology. There are very few solid tumors that you can actually cure, except by surgically removing them. So yes, you are very interested in what that does to your arthritis or to the other conditions you have. The main interest we have I think can be described as interactions.


You want to see if a drug for one disease does something bad to another disease, does something good to another disease, whether the new drug has a relationship to the drugs that they're already on and makes them less effective or more effective, things like that. That's what we look for in the analyses of the results.


Well, you won't be able to do that unless they're in the trials.


STEVE USDIN: I want to talk about that, and really get on to some of the ideas about solutions for the challenges posed by multiple chronic diseases right when we come back.


NARRATOR: You're watching BioCentury This Week.




STEVE USDIN: We're back with Dr. Anand Parekh, Dr. Bob Temple, and Myrdl Weinberg, with some ideas for improving care for people with multiple chronic conditions. Dr. Parekh, HHS recognized that this was an issue some years ago. In 2010, you created a strategic initiative or framework for dealing with multiple chronic conditions. What did you do, and how far along have you gotten on that?


ANAND PAREKH: Steve, we very quickly realized that given the importance of this area, that we needed to create a national road map to coordinate our efforts internally to collaborate with external stakeholders. And that's what we launched after considerable public input in December of 2010, the strategic framework for multiple chronic conditions, which has, as a vision, to improve the health status and quality of life of individuals with multiple chronic conditions.


There are four essential goals. The first is to foster health systems change, the second, to empower individuals, the third, to equip providers, and the fourth, to enhance research. There are 15 objectives, and there are actually 45 approaches or strategies that we believe both the public and private sector need to lead to improve the health of this population. And we're three years into implementation now.


STEVE USDIN: That's a lot of moving parts. One of those moving parts is the FDA and the issue that Dr. Temple alluded to earlier, which is trying to avoid unnecessarily excluding patients with multiple conditions from trials. Dr. Temple, can you talk about, first, you commissioned a study I think that gave some insight into what the practice has been. Can you talk about that, and then what you're doing now to try to change things?


ROBERT TEMPLE: This study, which is available online, was carried out by a company called Infusion. What it did was look at the new drug applications for 2010, and looked to see who was excluded by protocol -- that is, the plan for the study said nobody with this, and then who was left out when it turned out and you looked at the data, how many people had this or that. Inclusion was not terrible, but there were some noticeable things.


And a lot of people with psychiatric illnesses were excluded. Well, that's a problem, because a lot of drugs could make a psychiatric condition worse. And you'd want to know that if it did. So we are trying to discourage those things. And the two things we did was, we provide documents to our staff called good review practice guidance that encourages them to behave in a certain way.


We wrote one on what to do during the drug development process, what questions to ask, what to look at. And it emphasizes fairly strongly that you want to try to avoid unnecessary exclusions. Patients are left out of trials because people think they're going to die or have something terrible, and it will be attributed to the drug, and that'll be confusing. But you don't really have to do that in a properly controlled study.


You can have people with other conditions, and you can account for any differences you see. So we are very strongly paying attention to unnecessary exclusions. The other very important thing is that an international document including the elderly has pointed out that elderly should not be defined to 65 anymore. And that's at least partly my fault, because I wrote some of those documents when I was 45.


It now says specifically, you should look at the over 75 population. And that, of course, is 75-year-olds or the people who have multiple chronic conditions, or a lot of them.


STEVE USDIN: So 75 is the new 65?


ROBERT TEMPLE: Something like that, which works for me. And I think that's going to make quite a difference. I think the world and the industry and investigators will try to do that. They already do have over 75-year-old people in most cardiovascular trials. But in other areas, you might not.


So that's going to make a difference, I think. I think we'll see broader populations.


MYRL WEINBERG: Another thing that I think that is really important that's just starting to happen, and we're seeing the benefits, is having the patients absolutely involved from the beginning of the research and development process, that their perceptions about the disease or diseases and how it affects them have been found to help researchers really identify what's the right question to ask, from the patient's point of view, and how should the study be designed so that the outcomes have real world application and actually meet the needs of the patients for whom the products are intended.


STEVE USDIN: So there's been a lot of success in the past with creating incentives for drug companies to look at particular areas. A lot of them have been for acute diseases that are really serious or fatal. Do we need to have new incentives, or would it help to have new incentives to get drug companies to do more on these really big public health issues and chronic diseases?


MYRL WEINBERG: Well, I certainly think so. And as you know, we have some legislation introduced that would look at new ways for FDA and researchers to conduct the research and have drugs approved. And it would allow for products that right now have no patent -- it's probably hard for people to understand -- but products that would never be developed to come forward and be brought forward in a manner that the company can find ways to develop it into new products for people with rare diseases, such as epilepsy, ALS, Lou Gehrig's disease, really places where we have no products right now that are very successful.


So we'll be able to actually move those forward.


STEVE USDIN: Thanks. We're going to talk about that and more about improving care for patients with multiple chronic conditions in just a moment.






NARRATOR: Now back to BioCentury This Week.


STEVE USDIN: We're talking about improving the lives of patients with multiple chronic conditions with Dr. Anand Parekh, Dr. Bob Temple, and Myrl Weinberg.


Dr. Parekh, part of the initiatives in the strategic framework is some work that is being done at NIH and some other parts of HHS. They complement what FDA is doing. Can you talk about that a little bit?


DR. ANAND PAREKH: What we're trying to do is expand the knowledge base to take care of individuals with multiple chronic conditions. So to complement the work with FDA, we're really excited that both NIH and the Agency for Healthcare Research and Quality are investing in patient centered outcomes research and comparative effectiveness research, so we know what works and what doesn't work for the multiple chronic conditions population. As an example, AHRQ has invested in a multiple chronic conditions research network of 45 grantees across the country that are researching these areas. NIH is also instituting new multi-institute funding opportunity announcements focused on this population as well. So I think this research will add to the knowledge base of how you care for individuals with multiple chronic conditions.


STEVE USDIN: So part of what AHRQ is doing, I think, and what a lot of people are interested in, Dr. Temple, is the idea of looking at multiple chronic conditions post market, in their real world settings. That's another one of things that's easier to say than to do, isn't it?


DR. ROBERT TEMPLE: Well, post marketing studies that could get a company another claim and expand their use are pretty attractive, and people like to do that. For, just as an example, all of the drugs that lower your LDL cholesterol have been approved based on their ability to lower the cholesterol. But every single one of them -- maybe up until the most recent -- have then done a trial to see that you can reduce the heart attack rate or stroke rate. So there's a tremendous incentive to do that because then you can put on your label that you can reduce the likelihood of a heart attack. So you can get them done. Broader use is an attractive matter, or a novel use that no other company or drug has. So there's some incentive to do those things.


STEVE USDIN: So, I want to switch over and talk about the way that healthcare is delivered in this country. And of course, the biggest thing that's changed right now is the environment we're going to, is the Affordable Care Act. Myrl, is there something happening there that is going to be important for patients with multiple chronic conditions?


MYRL WEINBERG: Well there are a lot of things in that act that are of great benefit to people with multiple chronic conditions. I guess one thing I'd want to point out is that this entire system, for it to work well and in the way we've described, depends on us being able to share information appropriately across providers and with the patient. So clearly, having meaningful electronic health records that are shared across the population will be beneficial.


The other thing I'd like to point out is that we all know we're dealing with how to help people find the right plan for them -- especially if they have multiple chronic conditions -- in the new state healthcare marketplaces. And so it's a huge priority for my organization, the National Health Council, and all our patient groups, and we are trying to do that help through a new website, And on that website, unlike anyplace else, a person can actually go in and estimate their cost based on their usage of different providers, all the medicines they use, and really get a look at what plans in their state come closest to meeting their need. The one thing we know is that people are likely to pick a plan because the premium's lower. And it may cost them a lot more because they haven't done a really good job of figuring out what the rest of the costs would be.


STEVE USDIN: Very quickly also -- we just have a few seconds left -- there's some things that CMS, the agency that manages Medicare, is doing. They're supposed to help in the treatment of patients with multiple chronic conditions.


DR. ANAND PAREKH: CMS is launching, has launched several innovative care delivery and payment models focused on individuals with multiple chronic conditions. Accountable care organizations are one example. Patient centered medical homes, health homes. There are other models such as the Independence at Home Act, focusing on frail elders with multiple chronic conditions.


Also in 2015, CMS is set to start a new payment for eligible providers who provide chronic care management services to individuals with multiple chronic conditions. So because of the Affordable Care Act, you're seeing more of a value on care management and care coordination. That can only help people with multiple chronic conditions.


STEVE USDIN: And really, that last part what you were talking about is about paying physicians more if they're treating patients with multiple chronic conditions.


DR. ANAND PAREKH: Treating people multiple chronic conditions requires a lot of work. A lot of work not only in a clinic setting, but then behind the scenes. Calling hospitals, calling other providers, all this work previously wasn't truly compensated to the level that was needed. So you're seeing this increased value now.


STEVE USDIN: We're talking about multiple chronic conditions. It seems like one of the things that's going to move things forward is better use of information technology. I'm wondering, in the three spheres that we're talking about here, if you each have ideas on that.


Dr. Temple, is there a way that information technology, health information technology, is going to help us in understanding multiple chronic conditions better?


DR. ROBERT TEMPLE: Well one possibility, and there's tremendous interest in this, is using information already collected by healthcare systems to actually carry out controlled trials. That is, people would be randomized, but the information that goes into the outcomes and that determines whether they're better or worse, would be information that's already collected.


The advantage of this sort of thing is that you could do, for a considerable reduction in cost, a very large study. And of course, it's insight to. It's a study of the real world conditions, and that's attractive to a lot of people.


So people are exploring that. We have some drug companies who are actually interested in trying it. And we'll see. It's somewhat uncharted territory, although many aspects of when the VA does studies sort of resemble that. They collect a lot of information.


STEVE USDIN: The Veterans Administration?




STEVE USDIN: And Myrl Weinberg, what about the use of technology to help people communicating with each other and learning how to treat themselves?


MYRL WEINBERG: Right. It's critically important, and we're making progress, but I think it's not nearly fast enough. We talk a lot about electronic health records and personal electronic health records. And so we are working on those as a nation, and having that information and it be comprehensive. It's not just the tests or the codes, but it's really the information about you and your lifestyle, and it's shared easily wherever you are in the world.


I think the other thing to note is that there are a lot of new apps that people are using in their everyday life without working with a healthcare provider that really are helping them self-manage their disease much, much better than they would have in the past.


DR. ANAND PAREKH: I'll add to Myrl's comments. Because of the Medicare and Medicaid electronic health record incentive program, thousands of providers are now increasingly adopting electronic health records, and meaningfully using electronic health records, which will only help, particularly people with multiple chronic conditions, given their coordination needs.


STEVE USDIN: So how effective is that and are there ways that electronic health records, technology can be used better to help manage and to create, for example, this coordination of care that you've talked about?


DR. ANAND PAREKH: I think information flow is critical. And right now, our system is still heavily fragmented. So by providers having interoperable health records, they can easily find out the patient that they're caring about what happened to them at a hospital, what happened to them at a visit with another physician. So that information flow is there with electronic health records.


STEVE USDIN: All right. Well, thanks. We're going to come back with some ideas of new steps to improve care for patients with multiple chronic conditions.


NARRATOR: Every month, BioCentury This Week will feature Profiles and Innovation, a special segment highlighting the stories of innovators whose work is improving lives and transforming the world of healthcare.




STEVE USDIN: We're back with Dr. Anand Parekh, Dr. Bob Temple, and Myrl Weinberg. Dr. Parekh, looking forward, what are the steps that the ACA, all the things that HHS -- quickly some bullet points of things that we should expect going forward for multiple chronic conditions.


ANAND PAREKH: Right now, we are in the midst of an open enrollment period for the health insurance marketplaces. Already nine million Americans, many of whom who have multiple chronic conditions, are receiving health insurance through private health insurers as well as through Medicaid, are learning about their new eligibility stature for Medicaid. So getting access to care is critical for individuals with multiple chronic conditions.


So up until March 31, we hope that as many Americans with multiple chronic conditions can get health insurance. So that's the first. There are two additional areas that we're looking at in 2014. And the first is, as the knowledge base expands on how to care for individuals with multiple chronic conditions, making sure that that information gets in clinical practice guidelines so frontline providers know how to care for individuals who have multiple conditions, and also then creating quality measures for this population to ensure that the quality of care for this population is increasing. And finally, we've also launched a new education and training program, working with various professional societies -- medicine, nursing, pharmacy, social work -- to ensure that this generation and the next generation of healthcare providers are competent in caring for individuals with multiple chronic conditions.


STEVE USDIN: Dr. Temple, the changes that FDA has put in place, are we going to be able to know whether they're having an effect in really changing the way that drugs are developed so that they're more likely to include patients with multiple chronic conditions in trials and get this information into the system?


ROBERT TEMPLE: We should be able to detect it. Just to take an obvious matter, many, many study protocols exclude everybody over 75. We would like to see that end. There's just no reason to do it, and it's perfectly visible that'll happen. And I suppose we could relook at another group of new drug applications in a couple of years and see if, in fact, the frequency of other chronic conditions increases compared to the study we just did. That will take a little while before we see it, but we are asking all of our reviewers to pay attention during the drug development process to unnecessary and excessive exclusions.


So we'll be able to track that.


STEVE USDIN: And Myrl, your thoughts on things going forward-looking?


MYRL WEINBERG: So I think the most important thing is, for all of this to work for the patient, we need to go back to the thought of the patient at the center of care. And one of the very concrete things that we propose whatever model you're using is that we must have an individual care plan for each individual done by their healthcare team and done with the patient and their family caregiver so that we take into account that individual circumstance, their lifestyle, their preferences and needs.


And then we will really have truly patient-centered care that will result in the best outcomes for that individual, at the lowest cost.


STEVE USDIN: Thanks, Myrl. That's this week's show. I'd like to thank my guests, Dr. Anand Parekh, Dr. Bob Temple, and Myrl Weinberg. Remember to share your thoughts about today's show on Twitter. Join the conversational by using the hashtag #biocenturytv.


I'm Steve Usdin. Thanks for watching.