Category: Publications

Most-Cited Health Law Scholars in Web of Science, 2013-2017

The Petrie-Flom Center Staff Leave a comment

By I. Glenn Cohen, Mark A. Hall, David M. Studdert

This is a companion post to Most-Cited Health Law Scholars in WestLaw, 2013-2017. As noted there, health law is a broad and fundamentally interdisciplinary field that spans bioethics, biotechnology, medical malpractice, health care finance and regulation, health policy, and public health.  The Westlaw citation search partially accounted for this breadth by including leading health law scholars in schools of public health and medicine.  However, two major limitations remain—both especially important in our field—which prompted this additional citation analysis.

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Challenges for Journals—Encouraging Sound Science

The Petrie-Flom Center Staff Leave a comment

This post is part of a series on emerging research challenges and solutions. The introduction to the series is available here, and all posts in the series are available here.

By Barbara A. Spellman, Professor of Law and Professor of Psychology, University of Virginia School of Law

Journals and scientists should be BFFs. But currently they are frenemies. Or, in adult-speak:

Journals play an important role in ensuring that the scientific enterprise is sound. Their most obvious function is to publish science—good science, science that has been peer-reviewed by experts and is of interest to a journal’s readership. But in fulfilling that mission, journals may provide incentives to scientists that undermine the quality of published science and distort the scientific record.

Journal policies certainly contributed to the replication crisis. As businesses, publishers (appropriately) want to make money; to do so they need people to buy, read, and cite their journals. To make that happen, editors seek articles that are novel, that confirm some new hypothesis, and that have clear results. Scientists know that editors want articles with these qualities. Accordingly, scientists may (knowingly or not) bias the scientific process to produce that type of result.

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Petrie-Flom Panelists Contribute to new Guiding Framework for Designing and Implementing Serious Illness Programs

The Petrie-Flom Center Staff Leave a comment

By Mark Sterling

As part of the Project on Advanced Care and Health Policy, the Petrie-Flom Center hosted two convenings on Critical Pathways to Improved Care for Serious Illness.  Through roundtable discussions and working sessions at these convenings, expert panelists reviewed innovative programs designed for the aging population with chronic illnesses, focusing on those with declining function and complex care needs.  These convenings contributed to the development of a framework to guide healthcare providers in developing and scaling programs to deliver high quality care to individuals with serious illness, which is of increased importance given the growth of this population and the development of alternative payment models.  The convenings were held in March and June, and the panelists, agendas, slide decks, and related program materials remain available on the Petrie-Flom website (Session 1 & Session 2).

C-TAC, which collaborates with Petrie-Flom on the Project on Advanced Care and Health Policy, now has published a Report, Toward a Serious Illness Program Design and Implementation Framework, to help providers develop, replicate, and scale programs across a variety of serious illness populations and settings.  The Report’s Framework provides steps to allow healthcare organizations to assess evidence-based options for each facet of care model design and implementation.  As noted in the Report, the Framework is designed to:

  • Inform serious illness program development, replication, and scaling;
  • Integrate with care model payment design;
  • Inform care model and proforma simulator development;
  • Inform other aspects of design and development such as policy, standardized measurement, and regulatory analysis.

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The Problematic Patchwork of State Medical Marijuana Laws – New Research

Temple University Center for Public Health Law Research 2 Comments

By Abraham Gutman

The legal status of medical marijuana in the United States is unique. On one hand, the Controlled Substance Act of 1970 classifies marijuana as a Schedule I drug with no acceptable medical use and high potential for abuse. On the other hand, as of February 1, 2017, 27 states and the District of Columbia have passed laws authorizing the use of medical marijuana. This discrepancy between federal and state regulation has led to a wide variation in the ways that medical marijuana is regulated on the state level.

In a study published today in Addiction, our team of researchers from the Temple University Center for Public Health Law Research and the RAND Drug Policy Research Center finds that state laws mimic some aspects of federal prescription drug and controlled substances laws, and regulatory strategies used for alcohol, tobacco and traditional medicines.

In the past, studies on medical marijuana laws have focused on the spillover effect of medical marijuana to recreational use and not on whether the laws are regulating marijuana effectively as a medicine. Using policy surveillance methods to analyze the state of medical marijuana laws and their variations across states, this study lays the groundwork for future research evaluating the implementation, impacts, and efficacy of these laws.

The study focuses on three domains of medical marijuana regulation that were in effect as of February 1, 2017: patient protections and requirements, product safety, and dispensary regulation.

Here’s some of what we found:

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Contracting to counter gene patents – a 21st Century solution to access and innovation

Genetics in Medicine Leave a comment

By Sarah Ali-Khan and E. Richard Gold

As Precision Medicine becomes a reality, molecular tests are an increasingly critical part of patient care. While patients and their physicians would like to maximize access, they have confronted a roadblock in the form of patents covering genes and methods of diagnosis. Many hoped that the landmark 2013 Supreme Court of the United States decision in Myriad v AMP spelled the end of these patents, but the number of gene patents has actually increased since that decision. This is because, while limiting the availability of patents over genomic DNA, the court decision was narrow, leaving substantial grey zones such as over cDNA or where the patent covers a sequence of DNA used in a particular way. Patent agents have been assiduous in exploiting these grey zones to file for and obtain patents over molecular tests. This development points to continued adverse consequences of gene patents not only in the US, but around the world. Our recently published GIM article ‘Gene patents still alive and kicking: their impact on provision of genetic testing for Long QT syndrome in the Canadian public health-care system’, not only examines the impact of gene patents in one country, Canada, but shows how 21st Century contracting can provide a nuanced and pragmatic means to enabling both access and innovation around patented genetic tests.

In Nov 2014, in the first Canadian instance of a public interest ‘test case’ in intellectual property and public health, The Children’s Hospital of Eastern Ontario (CHEO) challenged five patents held by Transgenomic Inc. over a genetic test for Long QT Syndrome (LQTS), a potentially fatal cardiac disorder most commonly striking in children and youth. Widely reported, settled in March 2016, and named as one of the year’s cases having the most impact on intellectual property, the case produced the CHEO Public Health Access Agreement. The Agreement does not itself alter law– gene patents remain valid in Canada. Rather, it constitutes a contractual agreement between parties to the litigation, allowing for efficient, no-cost test implementation. The Agreement explicitly states that Transgenomic will freely grant a license to test the LQTS-associated genes to any entity providing services within Canada’s public healthcare system. That is, except for a marginal private market, all LQTS in Canada can now be provided free. Read More

New Research: Legal Epidemiology in the Literature

Temple University Center for Public Health Law Research Leave a comment

It’s a rainy day on the East Coast; what better way to get through the damp than four new legal epidemiology articles? Our colleagues have published papers examining vaccine policies, telehealth reimbursement policies, scope of practice laws for health care providers, and the field of legal epidemiology as a whole:

Legal Epidemiology: The Science of Law
T Ramanathan, R Hulkower, J Holbrook, M Penn – The Journal of Law, Medicine and Ethics

The Latest in Vaccine Policies: Selected Issues in School Vaccinations, Healthcare Worker Vaccinations, and Pharmacist Vaccination Authority Laws
L Barraza, C Schmit, A Hoss – The Journal of Law, Medicine & Ethics

Legal Mapping Analysis of State Telehealth Reimbursement Policies
KE Trout, S Rampa, FA Wilson, JP Stimpson – Telemedicine and e-Health

Expanding Access to Care: Scope of Practice Laws
K Hoke, S Hexem – The Journal of Law, Medicine & Ethics

Fantastic New Resource on Regulation

Scott Burris Leave a comment

Peter Drahos and a roster of the minds that have made RegNet at the Australian National University the hub of regulatory research and theory have put (it seems) all they know into a new, FREE ebook, Regulatory Theory: Foundations and Applications.  It is a comprehensive account of the field, written to serve both as a reference for the essentials and a text book for classes in regulation and governance.  It even has a chapter on regulatory research methods in public health by this correspondent.

I am hoping to conduct a serial book review over the next couple of weeks. Here goes:

The first chapter is an introduction to the field by Drahos and Martin Krygier. It usefully orients the reader to the breadth of the field, a breadth that reflects the spread of regulatory activity beyond the state and across networks. Attention to those two phenomena, indeed, is properly presented as the foundation of the field.  There is a bit of intellectual history, highlighting the sigificance of Ayres and Braithwaite’s Responsive Regulation, and the emergence of RegNet as an intellectual gathering place. (I saw that first hand, and had a little experience of RegNet collegiality, when I spent a semester there and ended up writing an article on Nodal Governance with Drahos and Clifford Shearing — still my most downloaded paper.) Read More

DUE TOMORROW, 9/9! Call for Harvard Submissions to Journal of Law & the Biosciences

The Petrie-Flom Center Staff Leave a comment

image001The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School collaborates with Stanford and Duke Universities to publish the Journal of Law and the Biosciences (Oxford University Press), an online, open-access, peer-reviewed journal. JLB includes a Notes & Developments section, comprised of brief summaries and commentary on recent legislation, regulation, and case law written by graduate students at the collaborating schools. The Petrie-­Flom Center is responsible for providing the Notes & Developments for one issue per annual volume.

We are currently seeking Harvard graduate students and postdoctoral fellows from any school to contribute papers to be published in JLB’s Notes & Developments section in early 2017. We will consider student papers that will be generated specifically for JLB, as well as papers that have been (or will be) initially written as student notes or course papers and edited for this particular purpose. JLB Notes & Developments are limited to 5000 words, including footnotes and references, and should be on a topic of relevance to law and the biosciences, in particular a topic of relatively recent concern, controversy, or change. They should focus on describing the issue at hand, explaining why it is relevant to scholars, and providing analysis and questions for further consideration. For recent examples of submissions by Harvard students, check out the April 2016 issue of the JLB. Read More

Recent Developments in Off-Label Promotion

crobertson 1 Comment

By Chris Robertson

July has been a busy month for those following the controversy around off-label promotion of drugs and devices.  As many on this blog know, federal law requires that prior to marketing any drug or device, companies must prove to the FDA’s satisfaction that it is safe and effective for all intended uses.  If the company reveals that it intends unapproved uses,  sales of the drug or device are illegal.  Nonetheless, physicians can prescribe “off-label,” and companies are free to sell for those known-but-not-intended purposes.

This carefully-wrought policy may seem convoluted, but it serves important epistemic and economic purposes, as I have argued elsewhere.  This month, I have a new draft paper on SSRN, assessing recent assertions of a First Amendment right to promote for uses not approved by the FDA, and consider whether such a right would be equally applicable to drugs that have no FDA-approved label at all. I worry that the entire pre-market approval regime may be at stake. Feedback on that intentionally-provocative analysis is quite welcome.

On Wednesday, two medical device company executives, were convicted of promoting a product “to deliver steroid medications to patients’ sinuses, though it was only approved by the U.S. Food and Drug Administration for keeping sinuses open.”  The prosecutors thought the case was particularly egregious, because the company had intended the broader use to deliver medicine all along, but sought to mislead the FDA, denying it the chance review the safety and efficacy of the real intended use.  The jury instructions and verdict form  are particularly interesting, to see how the government’s trial strategy avoids the holding of a Second Circuit case of Caronia, which overturned a conviction on First Amendment grounds.  I’ll return with some analysis later. Read More

Separating sheep from goats- a European view on the patent eligibility of biomedical diagnostic methods

Timo Minssen Leave a comment

By Timo Minssen

New publication on the patentability of biomedical diagnostics out:

Abstract: This brief comment complements Dan Burk’s excellent paper ( Dolly and Alice, J Law and the Biosciences (2015), 1–21, doi:10.1093/jlb/lsv042 ) by providing a very brief summary of the European approach regarding patents on medical diagnostic methods. This serves as the basis for a comparative discussion of the current US approach and its’ impact on biomedical innovation. We are concerned that unless the Supreme Court clarifies its two-part test and adopts a more holistic interpretation of the eligibility-test, global standards for medical diagnostic patents will diverge to the detriment of advanced therapies and ultimately patients worldwide. In case that the current US eligibility doctrine prevails without further Supreme Court clarification, we highlight the need for developing a more flexible, well-calibrated system for alternative and complementary forms of drug development incentives. In addition to a better-funded and well-administered prize system (an interesting option for some areas of diagnostics that we did not elaborate upon), our paper highlights the need for an improved and more flexible system for regulatory exclusivities in this sector.

Citation: Separating sheep from goats: a European view on the patent eligibility of biomedical diagnostic methods Timo Minssen; Robert M. Schwartz Journal of Law and the Biosciences 2016; doi: 10.1093/jlb/lsw019