Precision Medicine: Who Will Own the Data?

In this segment of the inaugural Medicine 3.0 conference, panelists discuss how precision medicine will affect the ownership of patient data, and how the movement to be more precise in diagnosing and treating conditions will be of particular help in the care of African American, Hispanic, and female patients.

This transcript has been edited for clarity.

Eric J. Topol, MD: We're really thrilled to have the chance for Medscape to bring us together and talk about precision medicine, and in particular how this is affecting and will affect the future of care.

We have a real innovative cast of characters: Dr Cheryl Pegus is currently heading up the Innovation Center at New York University; Maurie Markman is president of medicine and science at Cancer Treatment Centers of America; Greg Weidner is medical director for primary care innovation and proactive health at the Carolina Health System, which is one of the leading progressive health systems in the United States; and my colleague, who is medical director and chief medical editor at WebMD, Dr Michael Smith, who is also an internist and up on everything.

Now we're going to open it up to questions.

Question: I have a question about data ownership, as we're talking about precision medicine and how data are being used to change how medicine is delivered. Some of the data are going to be monetized, and ownership becomes more important at that point. On the basis of your experiences, what do you see for the future? How do you think discussions [of ownership] will go?

Maurie Markman, MD, MS: This is an incredibly complex conversation that even some organizations, such as the American Society of Clinical Oncology (ASCO), are having. The argument is that these may very well be public data, but the smart individuals can then use those data to come up with new and novel patentable, copyrightable strategies. So, the data are public, and obviously you don't have that direct ownership. But [you do have] the intellectual ability to take a look at a vast amount of data and then find something of value that you can use to create new knowledge or a new product.

I think what we have now is a problem where [certain] people hold the data, and they just want to keep them [for themselves] and they want to sell them. So in that silo, it's not of value. But we do have to recognize that you have to pay for all of these data. So the argument is how to pay for them after they've been made public.

Dr Topol: I feel really strongly about this and just cowrote a paper in Nature Biotechnology^[1] on how patients need to own their own data. There's lots of rationale for that, but it is five- to 10-fold more likely that your electronic medical data [will be] hacked than it is likely that you've ever accessed those data. And there's an epidemic of electronic medical data hacking, and the chance of them being hacked is markedly reduced when those data are compiled into single units or family units. Also, they're your data and that's something that you should own because you paid for it, and it's your body.

Other questions from our group here?

Question: Treatment algorithms have become such a part of medical practice nowadays. I have a question: We have been using data from a lot of large, cooperative National Institutes of Health (NIH) studies with homogenized populations. Should we be looking more specifically at genetic variables in those populations specifically because, for example, African Americans have various different responses to medications than other populations, and sometimes they are significantly underrepresented in these studies? We are being forced to use these specific treatment algorithms that are coming down the pike in regard to the American Heart Association and the American College of Cardiologists.

Cheryl Pegus, MD, MPH: I think that's right on target, and it's the subpopulation analyses of these studies that are really important. One of the original studies was ALLHAT,^[2] and it was one of the first studies that looked a large African American population, and looked at the types of treatments that were more amenable to and caused a greater impact in that population. Most recently, we've been seeing studies that been looking at how you modulate treatments in [underrepresented] populations.

I think you're going to see more of that. I'm a past president of the American Heart Association in the Northeast, and we've created specific research centers that are looking at health disparities, and that are looking at doing specific clinical studies in these areas. We have a genome/phenome study that has a very large African American population and a large female population, which is [another group] we've not looked at. So I would say that the data, and collecting those data and getting those treatments to those populations, are there.

On the other side of this is the pharma companies. They're actually very focused on developing drugs that are looking at some of these genomic ties.

And then the third umbrella—which I'm going to bring up every time I open my mouth—is how you go ahead and make sure you engage an insurer so that you're getting paid for simultaneously. That's actually occurring at the American Heart Association level. So for all of these new centers that have been set up, there are insurers who are agreeing on what the reimbursement model will look like as the results come out, even in early trials. And you have researchers sitting with clinicians, sitting with data analysts, determining what that algorithm will look like so that we're giving the right treatment to the right patient population.

It's taken a long time—ALLHAT was a long time ago—but we're getting there.

Dr Topol: Just to amplify a little bit on this, because it's such a central aspect of precision medicine—matching up drugs with the right person. It's not just about the usual drugs that that you touched on. It's also about, for example, people with infections and when to give antibiotics. Today, we wait days before cultures come back; but in the future, we'll be able to do immediate sequencing of the blood or whatever particular body fluid is relevant, and define not only what the organism is but also the anticipated resistance from genomic libraries. The whole field of infectious diseases can be rebooted in Medicine 3.0; that's a part of precision medicine that's different from the way we give antibiotics today, which is pretty loose.

Dr Markman: I'd just like to add that as anyone who's dealt with cancer patients knows, our therapies are very toxic, and we sort of take it as a given that one third of patients or one quarter of patients will experience a particular toxicity. And why do the others not? Well, clearly there's some genomic genetic characterization, and we're increasingly learning that. We're learning why some people get neuropathy from some of our drugs.

And in the pediatric area, to circle back to cardiology, increasingly we're able to understand why some kids are so sensitive to the effects of the drugs and they have cardiac effects later. We're talking about children who are cured of their malignancies, only to go on 15 or 20 years later and suffer some serious cardiac effects.

We need to be able to do this as part of routine care to help select or avoid drugs, but it's not being done because there's no one paying for it. It's not standard of care, and we have got to figure out a way to include it.

Dr Topol: This is one of the things that drives me crazy. We've got all this knowledge. We know who's going to get neuropathy from her drug; we know who's going to have cardiotoxicity from the studies. But we don't test anybody today. It's just extraordinary. We don't use the knowledge to improve care. Talk about imprecision medicine.

Question: We talk about African Americans. The Latino community's genetic composition is quite heterogeneous. Some people are more closely related to African Americans, some are more American Indian, and some Latinos are more [Caucasian)]. What are the implications for this community, which is the number one minority community and is suffering disparities? How does [precision medicine] apply to such a diverse, heterogeneous community?

Michael W. Smith, MD, MBA, CPT: I think we can speak conceptually, and we can speak realistically. So conceptually, you know that one of the big initiatives of the President's is the precision medicine initiative. This million-plus cohort of people that is going to have incredible amounts of data, and in theory, it's supposed be a representative sample of the United States. Anybody can be part of the data sample conceptually—but realistically, it's voluntary. People can put themselves into the running to be part of cohort, but no one's going to say it has to be 10% African American, 10% Hispanic, and 10% of these different ethnic groups in the Hispanic population.

So in theory, we going to have access to all these different ethnicities, and even children are supposed to be in the cohort. But in reality, I don't know that anyone can say at this point that we'll have a representative sample, since we haven't even started enrolling into the cohort; that's not even supposed to start happening until next year.

Dr Topol: They're working on it; they haven't resolved that yet. But to Michael's point, there's millions of people who are either already enrolled or getting enrolled in various biobanks, and there are other initiatives around the world. And we're going to have enrollees representing all ancestries and ethnicities, and sharing of these data is a central theme that will be helpful in the future to get this on track.

Dr Pegus: And when we're aware of these programs and these studies, how do we make sure that physicians in the community are letting their patient populations know that this is available and you should be registering? And how are we sharing this information so that all physicians know this is happening? I did a quick survey over the past week or so asking whether people knew about this initiative, and very few physicians are fully aware of it. I think there's an opportunity for us to make sure that—as leaders and, frankly, people who know the importance of this—we're making sure that everyone else is also aware.

Dr Topol: I'm glad you pointed that out, because not only would we like to see the medical community support this, but what's particularly attractive is that the people who are enrolling will be getting their own data—which is unusual, because that hasn't happened typically in clinical studies in this country. This is a new look.

Thanks very much to a great panel.

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