Health Care Insider: An Overview of the Challenges Facing Precision MedicineNov 27, 2016
Precision medicine is the future of health care because it allows for customized treatment and prevention of disease. However, there are still some very important ethical, technical, social and legal issues that need to be ironed out. We asked Emily Coonrod and Jorge Contrearas to give us an overview of some of the concerns. Learn even more during the Precision Medicine Symposium December 1-2, 2016. It’s free and everyone is welcome. It’s also live streaming and will be archived on Youtube.
Interviewer: Understanding the issues around precision medicine, we'll examine that next on The Scope.
Announcer: These are the conversations happening inside health care that are going to transform health care. The Health Care Insider is on The Scope.
Interviewer: Precision medicine right now is in its infancy. And like the beginning of any journey, even one that has an exciting destination like precision medicine, there are a lot of questions that need to be answered along the way. And those conversations are going to dictate how we move forward and how precision medicine evolves. And today, we're going to give you an overview of some of those issues. And to help us understand, we have Emily Coonrod, she's the Associate Director for the Program in Personalized Health at University of Utah Health Care; and Jorge Contreras, he's an Associate Professor at the S.J. Quinney College of Law, here at University of Utah.
And they're the coordinators of an upcoming precision medicine symposium at University of Utah, which is sponsored by University of Utah Health Care, the S.J. Quinney College of Law and Huntsman Cancer Institute. And the symposium's on December 1st and 2nd. It's going to feature national and local precision medicine thought leaders, and you can either attend in person or it'll be live streamed and archived on YouTube. So, Emily and Jorge, welcome.
Jorge: Thanks very much.
Emily: Thank you.
Interviewer: Yes. So, before we start talking about the issues that are surrounding precision medicine, tell me what is precision medicine and how will it change health care? Let's start with Emily.
Emily: So we like to think of precision medicine as the right treatment for the right patient at the right time for the right cost. And that's something that has been pervasive in health care since its inception, but what's different about precision medicine is that we have an opportunity to look a little closer into the genetic cause of people's disease. And we also like to integrate that with the environment, nutritional or the socioeconomic factors that might be going into somebody's particular health care situation.
Interviewer: So it's a very exciting thing, so let's just go do it, right? But it's not quite that easy, right? Like with anything else, there are a lot of other issues. And so I did a little bit of research and it looks to me, and help me, let's define this before we go any further. It looks like some of the questions that could be raised are in these four different categories, which would be science and medicine, ethical, legal and social issues. So does that sound about right?
Jorge: Those are some pretty important categories. Sure.
Interviewer: Yeah, okay. So what we wanted to do here is talk about those four categories and kind of give us an overview for somebody that maybe has heard of precision medicine so we can understand them a little bit better. So what are some of the challenges right now, Emily, as far as science and medicine are concerned, when it comes to precision medicine?
Emily: So we're now capable of seeing the genetic make-up of a particular person, and this generates a lot of data. And we have tools to mine that data for specific variants and the genetic make-up that might be causing a person's disease or causing a person's tumor, or whatever it is we're looking for. However, the tools are still being developed and it's a lot of data, it's a lot of information to comb through, and so we're trying to understand how to most effectively use that capability of generating that data to really find medically actionable things that are happening to patients that can be intervened with therapies, and the right therapies.
Interviewer: Yeah. So we have all this information, but we might not quite know what that means to . . . how do you translate that into making somebody feel healthier or feel better?
Emily: Exactly. It's a translation issue, it's a clinical translation issue. So just because you have the data doesn't mean you know, necessarily, what to do with it.
Interviewer: Gotcha. So that's a challenge a lot of people are facing right now, is how do you take all this information that requires all this computing power, and then turn it into something that benefits the patient?
Interviewer: Yeah. Maybe, Jorge, you can tackle the category of ethical issues. Like, what's one of the bigger ethical issues?
Jorge: These issues actually tie together very nicely. So when you think about all of the large amounts of data that Emily's been talking about, you have to wonder, "What's going to happen to that data?" I mean, both legally and ethically, right? Who owns the data? Is it owned by the hospital that collected it? Is it owned by the lab, by researchers, by a pharmaceutical company who might make a deal with one of those entities?
And then, what can they do with it? How is that information going to be commercialized? Can you then start to receive mailers and spam about different products that might interest you, based on what your conditions might be or might be likely to be? And how can you be identified? Can you be re-identified through all of this data in more insidious ways, ways that might discriminate against you in terms of employment, your insurance and so forth?
Interviewer: Yeah. We'll get back to Emily here in a second with some of the social issues, but I wanted to throw the legal issues at you, Jorge, since the law is what you do. What are some of the legal issues when it comes to precision medicine that we'd want to consider?
Interviewer: Right. So one of the things that come immediately to mind is how is it regulated, right? What does the Food and Drug Administration, which regulates drugs and medical devices, do when a treatment could potentially be different for everyone, right? Right now, with a typical small molecule drug, the FDA requires clinical trials and they see if it's safe and efficacious, if it's dangerous, if it's going to kill you when you take it.
That's a lot harder to do when the dosage could be different, the dosage could change, the actual chemical composition could be different, based on what your genetic markers show. And so how does an agency sensibly regulate in this area? The FDA doesn't quite know this yet. We're all trying to figure this out.
Interviewer: Yeah. One of the categories that we also talked about, so we've hit science and medicine, the ethical, the legal, let's talk about social issues. Back to Emily here, for a second. Social issues, when it comes to precision medicine, at the beginning of this journey, what are some things that we're going to face that we're going to have to figure out?
Emily: Well, I think one of the biggest things is going to be access to this. So it's not as expensive now to sequence someone's entire genome as it was 10 years ago, certainly, but it's still expensive and insurance companies aren't paying for it as readily as they do other types of testing yet. So if we have this great new technology and this new testing capability that isn't accessible to a large group of people who may be uninsured, for example, then we have a problem on our hands. So I'd say that a big question facing us, as a community right now, is how to make this accessible to everyone.
Interviewer: Let's talk about the symposium that you have coming up a little bit and some of the people that are coming. What are some of the presentations that you're excited about?
Emily: Well, I'm really excited about the keynote speaker, Dr. Christopher Austin. He is the Director of NCATS, which is a division of the Nation Institute of Health that funds translational research. So just like we were talking about earlier, how do you actually translate this technology into the clinic? And so he is going to have, I think, some keen insights into that.
The other thing that I'm excited about is the way that this conference fuses the medical and scientific issues with the ethical, legal and social issues. So oftentimes, you have conferences that only look at one or two of those but not all together so I think we have a really exciting opportunity to really explore some of these things all in a day and a half.
Interviewer: Yeah, talk about the whole issue as opposed to just little pieces of it. Jorge, what are you excited about?
Jorge: Overall, it's a great program. There are some areas that we haven't touched on that are really pretty interesting, and one of which is how to communicate with people about genomic information. The level of education among the general public about some of these issues is not high, and we have to try to explain to the general public why it's beneficial both to participate in these research programs and also to participate in the kind of treatment regimes that are going to come out of it. And so how you do that in the effective, rational way is something that's going to be discussed in one of the panels.
And, of course, my personal favorite is a panel I'm moderating on patents in precision medicine, which seems like kind of an obscure thing but it actually turns out to be pretty important. The Supreme Court, in recent decisions, has hinted that it might be difficult to get patents on medical innovations that relate to methods of treatment. And that could have an important effect on the ability or the willingness of companies to create treatments, to do the research that's going to be needed in order to get these treatments on the market. So we'll have a whole panel of international experts discussing the IP and patent law aspects.
Emily: So the other unique topic that we will be discussing in our conference is who's going to pay for all of this? So this is a big issue that's facing our community. So we can do it, we're doing it in the research space, we're doing it in the clinical space, but insurance companies have been slow to take this up and have it be something that they will reimburse. So the last panel of the conference, I think, is really exciting because it's going to talk about issues around cost. Is precision medicine cost-effective? How is it cost effective? And exploring issues around payment.
Interviewer: And this symposium is open to the public?
Interviewer: And then, also, there are other ways to get it as well?
Emily: Right. So we're going to be livestreaming so if you can't join us on the University of Utah campus, you can tune in live and . . .
Emily: . . . yes. So the S.J. Quinney College of Law has a YouTube channel. You can Google that and you can find it there. So it'll be live streamed and then it'll be archived on the YouTube channel as well.
Jorge: And for any lawyers who attend, we have continuing legal education credit and continuing medical education credit for any physicians who attend so that's always a bonus. And it's free.
Interviewer: Well, that's pretty exciting, pretty exciting stuff. Somebody that leaves, what would you hope that they've accomplished if they've either watched online at YouTube or they've attended?
Jorge: Well, we certainly hope that they get a better appreciation of the intersections of all of these different areas and how they inter-relate, and how it's not just a question of doing more research for research's sake alone. This is an important area that could significantly improve human health, but has some serious cost and ethical and legal issues that need to be worked out. So be supportive in the legislature of your legislators when they're working on these things and give input and feedback to our programs.
Emily: I would just add that I would hope that people walking away from the conference would have a better understanding that this is real. This isn't the stuff of science fiction. We're doing it now, we're doing it all over the country, and it's probably something that either one person or a family member or a friend is going to run into.
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