- Søren Rud Kristensen et al, Long-Term Effect of Hospital Pay for Performance on Mortality in England, N Engl J Med
- David Hyman & Charles Silver, Double, Double Toil and Trouble: Justice-Talk and the Future of Medical Malpractice Litigation, SSRN/DePaul L.Rev.
- George Annas, Medical Marijuana, Physicians, and State Law, N Engl J Med
- Erik Wallace et al, Hospital Relationships With Direct-to-Consumer Screening Companies, JAMA
- Marc Ginsberg, Informed Consent and the Differential Diagnosis: How the Law Overestimates Patient Autonomy and Compromises Health Care, SSRN
- Lawrence Gostin & Aliza Glasner, Cigarettes, Vaping, and Youth, JAMA
- Erin Fuse Brown, Fair Hospital Prices are Not Charity: Decoupling Hospital Pricing and Collection Rules from Tax Status, SSRN
- Wendy Parmet, Beyond Paternalism: Rethinking the Limits of Public Health Law, SSRN/Conn. L.Rev.
Last week I blogged about recent publications concerning the global battle against anti-microbial resistance (AMR). I did not mention a recent paper published in the June 2014 issue of Nature, which describes how European and U.S. researchers and authorities are increasingly considering clinical research in unconventional areas to fight AMR. The news-report “Phage therapy gets revitalized” by Sara Reardon concentrates on the use of viruses (bacteriophages) to battle bacteria. The idea is not new, but apart from some applications in the former Soviet Union, it never was established as a major research area elsewhere. In particular the paper examines the European Phagoburn project, which is the first large, multi-centre clinical trial of phage therapy for human infections, funded by the European Commission. It involves a phase I-II trial of using viruses for the treatment of bacterial infection following burns. The European Union (EU) is contributing €3.8 million (US$5.2 million) to the Phagoburn study demonstrating that it is taking the approach seriously. Meanwhile, the US National Institute of Allergy and Infectious Diseases announced in March 2014 that it regards phage therapy as one of seven key areas in its strategy to fight antibiotic resistance.
So far Western practice has concentrated on treating complex or unidentified infections with broad-spectrum antibiotics. These antibiotics would typically eliminate multiple types of bacteria, including those who have beneficial effects to the human organism. Despite resulting in direct negative consequences for patients, e.g. gastrointestinal disorders, these “atomic bomb” approaches can result in biological niches where resistant “bad bugs” can prosper. This is the reason why scientists are turning towards more targeted approaches. This is where phage therapy comes into play. Like “guided missiles”, phage-therapy has the ability to kill just species of bacteria or strain. Quoting the US virologist Ryland Young and the head of the scientific council at the Eliava Institute in Tblisi (Georgia), Mzia Kutateladze, the Nature report explains how nature offers an almost unlimited source of different phages and that so far no identical phages have ever been found. For this reason it is fairly simple to identify a particular phage for a bacterial target. If the bacterium should become resistant against that particular phage, researchers would modify the viral cocktails that are used for treatment by adding or substituting phages. At the Eliava Institute such updates occur – according to the report – approximately every 8 months and the scientists would not be fully aware of the precise combination of phages in the cocktail.
In light of these advantages the recent interest of US and EU stakeholders in phage therapy comes as no surprise. However, the scientific and legal challenges confronting these projects are complex. After all we are talking about viruses here, which triggers alarm bells with regard to public perception, safety concerns, and the regulation of relevant research. It also appears questionable if – or under what circumstances – regulatory authorities would be willing to grant market approval for such a rapidly changing product like in the case of e.g. influenza vaccines. Another significant problem for the development of new phage therapies, also addressed in the paper, lies in the reluctance of pharmaceutical companies to invest into the field. The potential obstacles for more private involvement in phage therapy are many and range from considerable risks of failure, reputational damage, and unforeseeable side-effects to insufficient certainty with regard to intellectual property protection and guarantees of a profit.
One of my previous blogs discussed the growing threat of antimicrobial resistance (AMR). I concluded that antimicrobial resistance is a growing and complex threat involving multifaceted legal, socio-economic and scientific aspects. This requires sustained and coordinated action on both global and local levels.
A recent medical review on drug resistant tuberculosis supports these findings and provides further fodder to the debate. In their study, which was published in April 2014 in The Lancet – Respiratory Medicine, the authors analyzed the epidemiology, pathogenesis, diagnosis, management, implications for health-care workers, and ethical and medico-legal aspects of extensively drug-resistant tuberculosis and other resistant strains. In particular, the authors discussed the increasing threat of functionally untreatable tuberculosis, and the problems that it creates for public health and clinical practice. The paper concludes that the growth of highly resistant strains of tuberculosis make the development of new drugs and rapid diagnostics for tuberculosis—and increased funding to strengthen global control efforts, research, and advocacy—even more pressing.
This was also recognized in the recent WHO’s Global Surveillance Report on AMR, which was published this April. It is the first WHO report that studied the problem of AMR on a global level. Noting that resistance is occurring across many different infectious agents, the report concentrates on antibiotic resistance in seven different bacteria responsible for common, serious diseases such as bloodstream infections (sepsis), diarrhoea, pneumonia, urinary tract infections and gonorrhoea. The results demonstrate a wide-spread growth of resistance to antibiotics, especially “last resort” antibiotics. In particular the report reveals that this serious threat is no longer a mere forecast for the future. AMR is a contemporary problem in every region of the world and has the potential to affect anyone, of any age, in any country. Consequently the WHO report concludes that antibiotic resistance is now a major threat to public health that needs to be tackled on a global level.
- Louise Trubek et al, Transformations in Health Law Practice: The Intersections of Changes in Healthcare and Legal Workplaces, SSRN/Ind. HLRev
- Kevin Outterson, Clinical Trial Transparency — Antidote to Weaker Off-Label-Promotion Rules, N Engl J Med
- Jonathan Adler, The Conflict of Visions in NFIB v. Sebelius, SSRN/Drake LRev
- Lindsay Wiley, Sugary Drinks, Happy Meals, Social Norms, and the Law: The Normative Impact of Product Configuration Bans, SSRN/Conn LRev
Check out the July 25th edition of the Petrie-Flom Center’s biweekly e-newsletter for the latest on events, affiliate news and scholarship, and job and fellowship opportunities in health law policy and bioethics.
Should litigants in products liability or other litigation be able to subpoena data from clinical trials to help prove their case? Does it matter whether the clinical trial is ongoing, finished recruiting but still analyzing data, or published? Michelle Mello and I have an invited commentary on this issue in JAMA Internal Medicine “Clinical Trials and the Right to Remain Silent” with our analysis and recommendations. We are discussing a real case from Yale where a subpoena was sought for data from a placebo-controlled trial of pioglitazone conducted there, where the person seeking the data had sued the manufacturer and believed she had been injured by pioglitazone but was not a clinical trial participant. In the same issue of JAMA IM, Yale gives its own account about how it handled the case here. Dr. Kernan (the investigator) and I also have a nice interview podcast on the issue.
The Petrie-Flom Center is pleased to announce publication of Human Subjects Research Regulation: Perspectives on the Future (MIT Press 2014), co-edited by Petrie-Flom Center Faculty Director, I. Glenn Cohen, and Executive Director, Holly Fernandez Lynch. This edited volume stems from the Center’s 2012 annual conference, which brought together leading experts in a conversation about whether and how the current system of human subjects research regulation in the U.S. ought to change to fit evolving trends, fill substantial gaps, and respond to identified shortcomings.
The book is currently available from MIT Press and Amazon, in hardcover and paperback. We will be hosting a book discussion at Harvard Law School on October 22, and in Baltimore on December 5 at Public Responsibility in Medicine and Research (PRIMR)’s annual Advancing Ethical Research Conference. Details will be announced shortly.
From the book jacket:
The current framework for the regulation of human subjects research emerged largely in reaction to the horrors of Nazi human experimentation, revealed at the Nuremburg trials, and the Tuskegee syphilis study, conducted by U.S. government researchers from 1932 to 1972. This framework, combining elements of paternalism with efforts to preserve individual autonomy, has remained fundamentally unchanged for decades. Yet, as this book documents, it has significant flaws—including its potential to burden important research, overprotect some subjects and inadequately protect others, generate inconsistent results, and lag behind developments in how research is conducted. Invigorated by the U.S. government’s first steps toward change in over twenty years, Human Subjects Research Regulation brings together the leading thinkers in this field from ethics, law, medicine, and public policy to discuss how to make the system better. The result is a collection of novel ideas—some incremental, some radical—for the future of research oversight and human subject protection.
After reviewing the history of U.S. research regulations, the contributors consider such topics as risk-based regulation; research involving vulnerable populations (including military personnel, children, and prisoners); the relationships among subjects, investigators, sponsors, and institutional review boards; privacy, especially regarding biospecimens and tissue banking; and the possibility of fundamental paradigm shifts.
Contributors Adam Braddock, Alexander Morgan Capron, Ellen Wright Clayton, I. Glenn Cohen, Susan Cox, Amy L. Davis, Hilary Eckert, Barbara J. Evans, Nir Eyal, Heidi Li Feldman, Benjamin Fombonne, Elisa A. Hurley, Ana S. Iltis, Gail H. Javitt, Greg Koski, Nicole Lockhart, Holly Fernandez Lynch, Michael McDonald, Michelle N. Meyer, Osagie K. Obasogie, Efthimios Parasidis, Govind Persad, Rosamond Rhodes, Suzanne M. Rivera, Zachary M. Schrag, Seema K. Shah, Jeffrey Skopek, Laura Stark, Patrick Taylor, Anne Townsend, Carol Weil, Brett A. Williams, Leslie E. Wolf
For a more information, including the full table of contents, check out the book on the MIT Press website
- Kevin Schulman et al, Shifting toward Defined Contributions — Predicting the Effects, N Engl J Med
- Richard Bonnie, The Impending Collision Between First Amendment Protection for Commercial Speech and the Public Health: The Case of Tobacco Control, SSRN
- Ann Marie Marciarille, The Medicaid Gamble, SSRN/J Health Care L & Pol
- Erika G. Martin et al, Liberating Data to Transform Health Care New York’s Open Data Experience, JAMA
- Melissa M Goldstein & Daniel Bowers, The Patient as Consumer: Empowerment or Commodification? SSRN/JLME
- Carrie H. Colla et al, First National Survey Of ACOs Finds That Physicians Are Playing Strong Leadership And Ownership Roles, Health Affairs
- Young MJ, Scheinberg E, Bursztajn H. Direct-to-Patient Laboratory Test Reporting: Balancing Access With Effective Clinical Communication, JAMA
- Amitabh Chandra et al, The Economics of Graduate Medical Education, N Engl J Med
The Journal of Law and the Biosciences, the new open-access journal launched this year by the Petrie-Flom Center and Harvard Law School in partnership with Duke University and Stanford University, has published several articles in recent weeks by Harvard Law School students:
- Nicholas Meyers, Cook v. FDA and the importation and release of lethal injection drugs, J Law Biosci first published online May 2, 2014.
- Ashish M. Bakshi, Gene patents at the Supreme Court: Association for Molecular Pathology v. Myriad Genetics, J Law Biosci first published online May 2, 2014.
- Adriana Lee Benedict, State-level legislation on follow-on biologic substitution, J Law Biosci first published online May 2, 2014.
- Komal Karnik, FDA regulation of clinical decision support software, J Law Biosci first published online April 28, 2014.
Check out these articles, and learn more about the Journal of Law and the Biosciences!
Petrie-Flom Faculty Director I. Glenn Cohen appeared on The Rachel Maddow Show last night to discuss his recent opinion piece in JAMA, coauthored with Robert D. Truog and Mark A. Rockoff (both of Harvard Medical School), on “Physicians, Medical Ethics, and Execution by Lethal Injection.” In the piece, Cohen et al. argue that medical specialty boards should withdraw board certification from members who participate in executions.
From the interview:
…we think it [execution] is totally incompatible with the role of the doctor. A doctor is about healing. A doctor is about soothing pain. A doctor is not meant to be conscripted by the state to make what is the involuntary killing of another person look as though it’s a medical procedure, like getting your teeth pulled or putting your dog to sleep. It’s kabuki theater, Rachel, and we think doctors should stand up. Whatever your position is on capital punishment, it’s wrong to make this procedure look like medicine. That’s not what it is. [...]
Watch the full interview.
Petrie-Flom Student Fellow Michael Young has coauthored a new piece with Ethan Scheinberg (Harvard Law School) and Harold Bursztajn (Harvard Medical School) now available through JAMA, “Direct-to-Patient Laboratory Test Reporting: Balancing Access With Effective Clinical Communication” The article discusses ethical and clinical implications of a 2014 HHS ruling allowing patients direct access to completed medical laboratory reports.
From the article:
Check out the Friday the 13th edition of the Petrie-Flom Center’s biweekly e-newsletter for the latest on events, affiliate news and scholarship, and job and fellowship opportunities in health law policy and bioethics.
- Ashish M. Bakshi, Gene patents at the Supreme Court: Association for Molecular Pathology v. Myriad Genetics, J. L. & Biosci
- Lindsay F. Wiley, The U.S. Department of Agriculture as a Public Health Agency? A ‘Health in All Policies’ Case Study, SSRN/J Food L and Pol
- David Orentlicher, Thad Pope & Ben Rich, The Changing Legal Climate for Physician Aid in Dying, SSRN/JAMA
- Kristin Madison, Building a Better Laboratory: The Federal Role in Promoting Health System Experimentation, SSRN/Pepperdine L.Rev.
In the U.S., the right to health is often held up as a utopian legal principle that other countries manage to embrace and that we shortsightedly spurn. What I learned working on a new project is that the right to health does not always lend itself to admirable ends. In some countries, a formal right to health is not used to advance equity but rather for the opposite. In other words, having a right to health can lead to a less equitable distribution of health care resources because, for example, people who are better able to navigate the legal system can claim more resources for themselves.
This insight and others are featured in an excellent book that just came out from Cambridge Press, The Right to Health at the Public/Private Divide: A Global Comparative Study, edited by Colleen M. Flood, University of Toronto, Faculty of Law and Aeyal Gross, Tel-Aviv University, Faculty of Law. This book is worth reading, in part, because it features chapters on countries that are not the usual suspects, including Hungary, Venezuela, Nigeria, New Zealand, and Taiwan. Two of the chapters are by U.S. health care scholars: one I wrote on the U.S. system and the Affordable Care Act (A Vision of an Emerging Right to Health Care in the United States: Expanding Health Care Equity through Legislative Reform) and one Christina Ho wrote on China (Health Rights at the Juncture between State and Market: the People’s Republic of China).
In my chapter, I argue that while the U.S. does not have a formal right to health, the ACA could provide the vision and foundation for an evolving American conception of a right to health care.
By Prof. Dr. med. Dr. phil. Nikola Biller-Andorno
Director, Institute of Biomedical Ethics, University of Zurich, Switzerland
Safra Network Fellow, Harvard University (13-14)
Visiting Professor, Div. Medical Ethics, Harvard Medical School (12-14)
It is amazing how much heat a report can draw that simply states what has been all over town for some time now: We do not know if mammography screening does more good than harm, we do not even know for sure if it does any good at all.
The Swiss Medical Board, an independent health technology assessment initiative that was started in 2008, stated that based on the empirical data availability the introduction of mammography screening all over Switzerland could not be recommended.
As could be expected the report drew fire. Curiously, one of the chief complaints was that it was “unethical” to upset women who might no longer know if screening was good for them or not.
This sounds just a little bit paternalistic – particularly given that we know that most women seriously overestimate the benefits of screening when making their decision, a point that my colleague Peter Juni and myself illustrate in a Perspective piece published on May 22, 2014 in the New England Journal of Medicine.
Check out the May 30 edition of the Petrie-Flom Center’s biweekly e-newsletter for the latest on events, affiliate news and scholarship, and job and fellowship opportunities in health law policy and bioethics.
- George P. Smith II, Re-Negotiating a Theory of Social Contract for Universal Health Care in America or, Securing the Regulatory State? SSRN/Cath U. L. Rev.
- Mark Rothstein, The Latest Challenge to Health Privacy: Health Care Consolidation, SSRN/Hastings Center Bioethics Forum
- Nathan Cortez, Regulating Disruptive Innovation, SSRN/Berkeley Tech L J
- Rob Cunningham, The Payment Reform Paradox, Health Affairs
Looking for new opportunities in the fields of health law, policy, and bioethics? Look no further!
This spring, we’ve added a new opportunities section to the resources on the new Petrie-Flom website. This page features opportunities in health law and bioethics including jobs, fellowships, graduate programs, seminars, calls for abstracts and submissions—and more! These opportunities are updated in real time, full posts remain active on the website until their deadline passes, and past posts are visible in our opportunities archive.
If you have opportunities that you would like to share with the Petrie-Flom community via our website and/or our biweekly e-newsletter, please contact us at firstname.lastname@example.org.