We publish our conversations with inspirational individuals in the healthcare industry to promote the innovation discourse and support framework. We spoke with W. Nicholson Price II, J.D., Ph.D., Assistant Professor of Law at University of New Hampshire School of Law and Affiliated Faculty at Harvard Law School’s Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics. Dr. Price’s research interests lie at the intersection of law and the life sciences, including innovation policy and emerging technology regulations

Dr. Price explained his bottom-up thinking process, current work on black-box medicine, intriguing ways of how regulatory and pharmaceutical intellectual property policies have developed in our healthcare system, and more. A transcript of our conversation is below.

Healthcare Innovators We want to learn how students can innovate not only after getting an advanced degree but how they can begin innovating just with their bachelors. I’d love to chat about your own career, what your feelings are about health innovation, and what you’ve been up to recently.

Dr. Price: Definitely! Happy to chat.

Healthcare Innovators Great! Can you tell us briefly about yourself? How have you gotten to where you are now? I know you have a very impressive academic and publication record. We’d love to hear about those.

Dr. Price: Sure, it seems I am the counterexample to what you guys are looking for because my path was a lot of education. Starting in junior or senior year of college, I realized I wanted to work on innovation policy.

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Dr. Price: I knew I wanted to work on innovation policy – the law side – so I put together a joint degree program at Columbia where I completed a JD and a PhD over the course of seven years. I learned to think like a lawyer in the first year of law school. I then took a four and a half year leave of absence to get a PhD in biology before returning to law school. Throughout that time, I tried to integrate the two fields. I stayed involved in the law field as much as I could while I was doing the scientific work.

The point of it was, at least in my view, that one of the challenges is scientists and lawyers feel like they speak different languages and they don’t talk to each other very much. I wanted to be someone who could really talk to both sides because I’d been a scientist and I was also trained as a lawyer. I then did a clerkship in the Ninth Circuit where I worked for a judge for a year and then did a fellowship at the Petrie-Flom Center for Health Policy, Biotechnology and Bioethics at Harvard Law School. I was there for two years. After that, I got a job at [the University of New Hampshire] where I still work on issues of how law can help shape the development of science and drive innovation forward. I also study how new scientific developments change law, although I do more on the former than the latter.

Healthcare Innovators Awesome, awesome. You brought up the fact that you are the antithesis to our aim about education. We do value education, but we are very interested in learning about this thinking process you’ve cultivated after going through all that. For example, I was reading your articles about pharmaceutical manufacturing and patent trolling, I think that kind of thinking is something I have never considered. I didn’t know there was a lack of innovation in the manufacturing part of the pharmaceutical industry because it is very counterintuitive; the drug has lots of innovation, but the actual manufacturing does not. That is one of the reasons I hoped to talk to you. I really like your thinking process and your published work so far.

Dr. Price: Thanks. Most people follow a top down approach on the academic side. The top down approach is when you look at the current literature, determine where there are holes, and determine how you can fill in theories to address the real world. My approach is much more bottom up. I talk to people in the real world and find out where there are problems. I then think about what the policy aspects are and what the legal aspects are that are helping to cause those problems, are preventing people from solving them, or might help to solve them. For drug manufacturing, the problem was “We’ve got a lot of quality problems in drug manufacturing.” When I dug a little deeper, I found that the [manufacturing] field is not doing much in the way of innovation and is using old technology. The question then was, “Why? Why don’t we see this type of manufacturing process innovation like we do in drug creation?” We see it in the food industry, the car industry, and the electronics industry – all areas where people are very good at manufacturing.

In the 1970s, we weren’t creative at manufacturing, but now, we are really good at it. My question was, “What is it about the drug industry that is making [manufacturing innovation] not work?” Part of the problem is the combination of high regulatory barriers to change and the creation of incentives for innovation. It is hard and risky to get manufacturing changes through FDA, so manufacturers decide there is no need to do it. The intellectual profit system, which normally creates incentives for innovation, does not work well for manufacturing processes because it is difficult to enforce those patents. That is one example and that is my M.O. – looking at personalized medicine. I went to medical conferences and listened to people discuss personalized medicine. I started thinking how the law is reacting to this science and how it is going to shape it going forward. That is my process. I look for problems or things that I find unusual about the real world and then try to find out what the legal and policy side of that story is.

Healthcare Innovators Amazing. Thank you so much for that.

Dr. Price: Sure.

Healthcare Innovators Going off of that, could you talk about what areas you’re looking into now? You’ve had quite a few publications. What can we expect from you in the next few years? What grips you now?

Dr. Price: Right now most of my work focuses on big data in medicine and what I call “black-box medicine.” Black-box medicine is the use of machine learning and big data in medicine to help make recommendations, make diagnoses, or suggest new treatments. In a way, black-box medicine is not transparent and is not understood. Essentially, it tells patients, “We think you’re at a heightened risk of a stroke according to artificial intelligence machine learning. We believe that, but we don’t know why, because there are many unclear factors that we do not understand that may be actionable medical information.” There is so much data in medicine and there are more sophisticated ways now to find patterns.

I think there is going to more use of algorithms that we don’t really understand. I’m interested in the intellectual property side of that; how we regulate this type of medicine, how we might think about getting it into use, if we think it’s a good thing, how we deal with making sure it’s high quality, and balancing that with patient privacy.

A related project I’m working on with Professor Becky Eisenberg at the University of Michigan is about the use of big data by healthcare payers like insurers or integrated systems. We normally think about supply side innovation in the medical industry wherein drug companies come up with new drugs or medical devices.

There is also a role for the demand side in innovation. Insurance companies have different incentives for what they want. They are interested in which drugs are more cost-effective or which drugs will work for particular patients and not for others. If you can avoid prescribing a drug that’s not going to work for somebody, you don’t have to spend the money for it. If there are two drugs that work the same, and one of them is cheaper, then you’d rather do the cheaper drug. If a drug is toxic and has some rare side effects, drug companies might not always have the right incentives to find them. Health care payers might be in a better position. This is a different type of innovation that we don’t normally think about, and so this project is looking at where is this going on, and how the federal government can help to facilitate it.

Healthcare Innovators It certainly sounds like you think big data is the next big thing. Do you think that’s the biggest opportunity for future generations if they wish to make an impact?

Dr. Price: I think big data is a very big area. I think it’s an area where there’s a tremendous amount of potential but also chance of error. It’s easy to come up with false correlations and data that aren’t real. I think that’s a really exciting area for people to really dive into this. I think it’s important to have at least some basic sense of how code works and statistics. I also think a challenge going forward is cost. We have been focused in this country on a health policy level on access. That’s what the Affordable Care Act is about. There are some spending provisions in there as well. More and more we’re worried about spending. There is no limit to the amount of money you can spend on healthcare, but there is a limit to the amount we can afford to spend. Figuring out how to do things in a cost-effective way efficiently is a really big challenge. That’s more of a policy challenge and there are innovations around that. Some of them will be technological innovations, some of them will be payment innovations, and some of them will be ways to set up the incentives right.

Healthcare Innovators Okay, awesome. You didn’t mention anything related to pharma. That is one of your primary interests in terms of research, what do you think is big for pharma going forwards?

Dr. Price: I would say there are a couple things that are big in pharma. One is personalized medicine. We’re getting there and this is the combination of pharma and big data. That is to say, how do we make sure the right patients are getting the right drug, at the right dose, and at the right time, as NIH puts it. We also have to make sure that treatments are really tailored. For a long time the medical paradigm has been to run clinical trials to see if it affects the average. That’s not the way drugs work in real people in the human body; people are not averages. Figuring how to deal with that is going to be a big ongoing task for pharma. It’s challenging because the incentives are weird. If companies find out that their drug doesn’t work for half of the population, they’ve just lost half their market. They have to figure out a way to recoup that – whether it’s higher prices or exactly how you do it. That’s an important step going forward.

Mental health is also a huge potential area for pharma, but the problem is brain drugs are really hard to make. We’ve seen a disturbing pattern of some big pharma entities saying they’ll no longer make brain drugs. That’s a big challenge because it’s an area of tremendous potential despite tremendous difficulty.

On the counter side, we see a lot of action into late stage cancer drugs. It’s hard to put a value on the last few months of somebody’s life extending that time. Having had friends who have died of cancer, the end of life is incredibly precious. From a systemic perspective, it’s hard to justify spending tens of thousands or hundreds of thousands of dollars on treatments that may or may not extend life by a couple of months. There are strong incentives for companies to do that research.

There is a wonderful paper by Eric Budish, Ben Roin, and Heidi Williams from MIT. The patent clock starts ticking on drugs when companies file a patent, which is generally pretty early in the process. Companies only start making money on that drug once it’s approved. A side effect of this is companies focus on a clinical trial that happens quickly. If what you want a clinical trial to happen quickly, companies tend to focus on people that are dying really quickly. End stage cancer diseases get clinical trials really fast, in a span of months, so the clinical trials are short. If you’re talking about trying to prevent the onset of Alzheimer’s or other neurodegenerative diseases, clinical trials take a long time. These drugs are much, much less attractive in terms of the economics of the patent system, the regulatory exclusivity system, and the regulatory approval system. This is where I think we examine the policy choices we’ve made that are impacting science this way and ask how we think about changing that.

Healthcare Innovators That’s incredibly fascinating. Based on your input on the patent system, big data, and policy, what advice would you give to students that wish to make a change now in the healthcare system? So suppose someone is in college, what can they do to further educate themselves and actually to make an impact in healthcare going forwards? So would it be to do work somewhere, do research in personalized medicine? What would you do if you were in an undergraduate’s position?

Dr. Price: Tough question. I would try to read from different sides of the story. I think in terms of education, look at what do the drug companies say, what the insurers say, what the academics say, and what policy makers say about the same issue. Just looking at one side of the picture, you’re almost always going to get a skewed version because everybody has their own incentives and their own view of the world. Seeing different sides of the picture is key and understanding the numbers is really important. Basic statistics and basic economics go a long way in helping you to see what’s going on.

In terms of making a difference, I don’t think I have a great answer for that. I could see working for a policy shop or since you’re at Georgetown, trying to intern for politicians to be interesting or a potential useful task. The hard bit is figuring out a way to make policy ideas win-win; that’s not easy to do. The incentives are often aligned directly against each other and if you want to make positive change, you have got to figure out either a way to make the story so overwhelming that you can get it through, or find some way of framing it and setting it up that most people are happy. Trying to get ideas from the drawing board into real implementation is a really hard challenge.

Healthcare Innovators That sounds terrific, Dr. Price. You’ve given us such amazing information so far. I can’t thank you enough for speaking with us. Like I mentioned, we are a relatively new group, and we’re just excited to get all of this information out there from individuals and just inspiring people like yourself that are making a difference in the health system today.

Dr. Price: Well, thank you very much.

About the speaker

Dr. Price’s research interests lie at the intersection of law and the life sciences, including innovation policy and emerging technology regulations. Dr. Price’s work has been published in Science, Nature Biotechnology, the Boston College Law Review, the Cardozo Law Review, the Harvard Journal of Law and Technology, the Hastings Center Report, and Genetics in Medicine. His work is also forthcoming in the Iowa Law Review and the Washington Law Review. Learn more about Dr. Price at http://nicholsonprice.org.

W. Nicholson Price II, J.D., Ph.D.
Assistant Professor of Law at University of New Hampshire School of Law
Affiliated Faculty at Harvard Law School’s Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics