This is the second of three episodes of “Innovation and Protection: The Future of Medical Device Regulation,” a podcast miniseries created to replace the 2020 Petrie-Flom Center Annual Conference in light of the COVID-19 pandemic.
Cross-posted from Written Description, where it originally appeared on April 7, 2020.
The escalating pandemic has caused devastating shortages not only of ventilators and personal protective equipment like masks, but also of essential medicines needed to treat COVID-19 patients. As detailed by STAT and the New York Times, prescriptions for painkillers, sedatives, anesthetics, and antibiotics are up, but the rate at which prescriptions are filled and shipped to hospitals is down. The FDA helpfully tracks drug shortages, but this doesn’t solve the problem. With the sudden spike in hospitalized patients with COVID-19 symptoms, physicians are using these drugs faster than manufacturers are making them.
What is causing these drug shortages?
Big data continues to reshape health. For patient privacy, however, the exponential increase in the amount of data related to patient health raises major ethical and legal challenges.
In a new paper in Nature Medicine, “Privacy in the age of medical big data,” legal and bioethical experts W. Nicholson Price and I. Glenn Cohen examine the ways in which big data challenges the protection (and the way we conceive) of health care privacy. Read More
How will artificial intelligence (AI) change medicine?
AI, powered by “big data” in health, promises to transform medical practice, but specifics remain inchoate. Reports that AI performs certain tasks at the level of specialists stoke worries that AI will “replace” physicians. These worries are probably overblown; AI is unlikely to replace many physicians in the foreseeable future. A more productive set of questions considers how AI and physicians should interact, including how AI can improve the care physicians deliver, how AI can best enable physicians to focus on the patient relationship, and how physicians should review the recommendations and predictions of AI. Answering those questions requires clarity about the larger function of AI: not just what tasks AI can do or how it can do them, but what role it will play in the context of physicians, other patients, and providers within the overall medical system.
Medical AI can improve care for patients and improve the practice of medicine for providers—as long as its development is supported by an understanding of what role it can and should play.
Four different roles each have the possibility to be transformative for providers and patients: AI can push the frontiers of medicine; it can replicate and democratize medical expertise; it can automate medical drudgery; and it can allocate medical resources.
Join us in wonderful Copenhagen at our CeBIL Kick-Off Conference: ”Innovation Gaps on Life Science Frontiers? From Antimicrobial Resistance & the Bad Bugs to New Uses, AI & the Black Box”. The Conference marks the start of the Novo Nordisk Foundation’s Collaborative Research Programme in Biomedical Innovation Law which is carried out within a unique network of international core partners, including internationally renowned experts at Harvard Law School’s Petrie Flom Center, Harvard Medical School/Brigham & Women’s Hospital, University of Cambridge, University of Michigan, and UCPH’s Department of Food and Resource Economics (IFRO).
Leading international experts, including i.a. our distinguished Bill of Health colleagues Glenn Cohen, Aaron Kesselheim; Nicholson Price, and Kevin Outterson, will discuss legal, economic, societal and scientific aspects of selected Life Science areas.
Time: Monday, 5 March 2018 09:00 – 18:00 (followed by a reception in the Gobelin Hall)
Venue: The Ceremonial Hall (Festsalen), University of Copenhagen, Main Building, Frue Plads 4, DK-1168 Copenhagen K
Biomedical innovation is experiencing changes of epic proportions. Rapid progress in many scientific areas, such as gene editing, pharmacogenomics, artificial intelligence and big data-driven precision medicine, has greatly advanced the promises and opportunities of the health and life sciences. Nevertheless, the total number of truly new and innovative drugs receiving market approval is unsatisfactory. At the same time, some of the more innovative therapies that actually could reach patients have become extremely expensive or ethically problematic. These new technological possibilities raise many complex scientific, legal and ethical issues affecting many stakeholders, such as medical practitioners, regulators, patients and the industry.
To support the in depth study of these developments, the Novo Nordisk Foundation has awarded a grant of DKK 35 million for a new Collaborative Research Programme in Biomedical Innovation Law (CeBIL). CeBIL’s overall aim is to help translate ground-breaking biomedical research into affordable and accessible therapies by scrutinizing the most significant legal challenges to biomedical innovation and public health from a holistic cross-disciplinary perspective. CeBIL is hosted by a new Centre for Advanced Studies at the University of Copenhagen’s Faculty of Law. The research is carried out within a unique network of international core partners, including internationally renowned experts at Harvard Law School, Harvard Medical School, University of Cambridge, University of Michigan, and UCPH’s Department of Food and Resource Economics (IFRO). Moreover, CeBIL will collaborate with a broad network of stakeholder organizations and international experts within law, economics, life science, medicine, sociology and pharmacy.
This Kick-Off Conference marks the start of CeBIL which opened its’ doors on January 1st, 2018. Reflecting the research projects that will be at the focus CeBIL’s research during the first 5 years, leading international experts will discuss legal, economic, societal and scientific aspects of selected life science areas and debate future challenges and opportunities.
October 17, 2016 5-7 PM
Hauser Hall, Room 104
Harvard Law School, 1575 Massachusetts Ave., Cambridge, MA
Presentation: “Regulating Black-Box Medicine.” To request a copy of the paper in preparation for the workshop, please email Jennifer Minnich at jminnich at law.harvard.edu.
Nicholson Price is an Assistant Professor at the University of Michigan School of Law, where he teaches Patents, Health Law, and first-year Property, among other courses. He was previously Assistant Professor at the University of New Hampshire School of Law. From 2012 to 2014 Nicholson was an Academic Fellow at the Petrie-Flom Center, where he studied innovation in the pharmaceutical industry, personalized medicine, and the issues surrounding secondary findings in genomic research. His work has been published in Science, the Harvard Journal of Law and Technology, Nature Biotechnology, the Boston College Law Review, and the Hastings Center Report, among others.
Nicholson received his JD from Columbia Law School in 2011, where he was a James Kent Scholar, was Submissions Editor of the Columbia Science and Technology Law Review, and twice received the Julius Silver Note Prize. He received his PhD in Biological Sciences, also from Columbia University, in 2010. He holds an AB in Biological Sciences from Harvard College. After law school, he clerked for Judge Carlos T. Bea of the U.S. Court of Appeals for the Ninth Circuit, and was a Visiting Consortium Scholar at the UCSF/UC Hastings Consortium on Law, Science and Health Policy.
Drug prices have been making waves in the news recently. The most recent case is the huge price hikes of the EpiPen, which provides potentially life-saving automatic epinephrine injections to those with severe allergies. Mylan, which makes the EpiPen, has raised its price some 450% over the last several years. The EpiPen is a particularly problematic—and media-friendly—story because the emblematic use case is the kid in school who can’t breathe because she came into contact with peanuts. Jacking up the price on something that’s not optional—for parents and for schools—seems heartless. Thoughtful pieces have pointed out how the EpiPen price increases demonstrate problems with our health care system and drug/device approval system in general.
Other big recent cases that have hit the news include huge increases in the price of insulin, and, of course, Turing Pharmaceuticals’/Martin Shkreli’s ~5000% price hike on the drug Daraprim. The EpiPen and Daraprim are especially notable because patents mostly aren’t involved—the effective monopoly appears to come from the delay or challenge in getting generic products approved by FDA (although the EpiPen itself also seems tough to make). And, of course, drug prices aren’t regulated in the US the way they are in much of the world.
These stories seem crazy, cruel, and fascinating. And they raise (for me, anyway) the question: what’s changed? This seems like a relatively new phenomenon. But FDA’s had a backlog for a while, and drug prices have long been unregulated. Read More
By Timo Minssen
Please find below my welcome speech at last-weeks mini-symposium on “Legal dimensions of Big Data in the Health and Life Sciences – From Intellectual Property Rights and Global Pandemics to Privacy and Ethics at the University of Copenhagen (UCPH). The event was organized by our Global Genes –Local Concerns project, with support from the UCPH Excellence Programme for Interdisciplinary Research.
The symposium, which was inspired by the wonderful recent PFC & Berkman Center Big Data conference, featured enlightening speeches by former PFC fellows Nicholson Price on incentives for the development of black box personalized medicine and Jeff Skopek on privacy issues. In addition we were lucky to have Peter Yu speaking on “Big Data, Intellectual Property and Global Pandemics” and Michael J. Madison on Big Data and Commons Challenges”. The presentations and recordings of the session will soon be made available on our Center’s webpage.
Thanks everybody for your dedication, inspiration, great presentations and an exciting panel discussion.
“Legal Dimensions of Big Data in the Health and Life Sciences – From Intellectual Property Rights and Global Pandemics to Privacy and Ethics”
The 21st Century Cures Act is a big deal; the House passed it handily, and we’re still waiting to see what the Senate does. A lot has been written about what it does in terms of changing FDA review processes, and a fair bit about the lovely increase in funding for NIH (see Rachel Sachs’ blog posts here, here, and here). These are tremendously important.
But another provision in the bill has been getting much less play: the way it changes HIPAA to enable large-scale research, which is also a big deal all by itself. Read More
[Ed. Note: On Friday, May 2 and Saturday, May 3, 2014, the Petrie-Flom Center hosted its 2014 annual conference: “Behavioral Economics, Law, and Health Policy.” This is an installment in our series of live blog posts from the event; video will be available later in the summer on our website.]
Our third panel, moderated by PFC Academic Fellow Matthew Lawrence, addresses the use of behavioral economics techniques to control health care costs. Speakers are Christopher T. Robertson, Brigitte Madrian, Ameet Sarpatwari, Anupam Jena, and Jim Hawkins. (Many projects are co-authored, but I’m only listing the presenters here)
The first speaker is Professor Christopher T. Robertson, coming from Arizona Law but visiting Harvard and the PFC this year, speaking on Cost-Sharing as Choice Architecture. He starts by talking about the cost side of cost sharing, which we know works in reducing consumption from empirical evidence; from the RAND study, it reduced use without reducing health. More recent studies also confirm this. But cost sharing presents four problems:
- Underinsurance relative to ability to pay
- Indiscriminate reductions in health care (more of an ax than a scalpel)
- An unfair tax on sickness (more tentative if we can solve the first two)
- The burden of deciding.