- Mark A. Rothstein, From SARS to Ebola: Legal and Ethical Considerations for Modern Quarantine, SSRN/Indiana Health L.Rev.
- R. Alta Charo, The Supreme Court Decision in the Hobby Lobby Case; Conscience, Complicity, and Contraception, JAMA Intern. Med.
- W. Nicholson Price II, Incentives, Intellectual Property, and Black-Box Personalized Medicine, SSRN/Harv. J. L. & Tech
- Mark William Osler, 1986: AIDS, Crack, and C. Everett Koop, SSRN/Rutgers L.Rev.
- Amanda Zibners Naprawa & Dorit Rubinstein Reiss, Medical Advice and Vaccinating: What Liability? SSRN
- Michele Goodwin, Fetal Protection Laws: Moral Panic and the New Constitutional Battlefront, SSRN/California L Rev
- Anna B. Laakmann, When Should Physicians Be Liable for Innovation? SSRN/Cardozo L Rev
- Caroline Sayer & Thomas H. Lee, Time after Time — Health Policy Implications of a Three-Generation Case Study, N Engl J Med
By Christine Baugh
The most recent issue of the Journal of Law Medicine and Ethics (generously made available for free by the American Society of Law Medicine and Ethics) included several articles examining state concussion laws. One theme that arose across the articles is that although concussion-related legislation is on the books in all 50 states and the District of Columbia, the extent to which it is creating an improvement in youth and adolescent athlete health outcomes is unclear.
In their article titled “State experiences implementing youth sports concussion laws: challenges, successes, and lessons for evaluating impact” Kerri McGowan Lowrey and Stephanie Morain interviewed stakeholders (e.g., officials at state departments of public health, state athletic associations) at a majority of states with concussion laws in order to understand how the laws had been implemented. Although previous research in the area (see, for example: Hosea Harvey’s piece in the American Journal of Public Health) presented concussion legislation as relatively homogenous, McGowan Lowrey and Morain’s approach provided critical insight. They found that while the state laws are relatively uniform in their construction, there is substantial variation in their implementation. In particular, McGowan Lowrey and Morain reported variation in compliance with the statutes, variation in how much stakeholders were included during formative stages in the legislation’s composition, and variation in what constituted concussion education.
In another article in the issue, my colleagues Emily Kroshus, Alexandra Bourlas, Kaitlyn Perry, and I specifically examined the concussion education and acknowledgement provisions of state concussion laws. This investigation was conducted in two parts: first we examined what the statute mandated and then we examined what the high school athletic association and/or department of education in that state actually provided for education. Similar to McGowan Lowrey and Morain, we found that implementation did not always match statute. In some promising cases the education provided exceeded the information minimally required by statute. In other situations, the concussion information was provided in such a way that it was required to be returned with a parent signature. In cases like this, compliance with one part of the statute (mandating acknowledgement of receipt of information) may have been compromising another (providing concussion education). Although the education and acknowledgement tenets were relatively similar across states, more heterogeneity was found in the implementation of these aspects of the statutes.
In general, these two studies suggest that the approach for examining statute, and particularly its efficacy, needs to be designed to address implementation stage information. Strict examination of the statutory language obscures critical implementation-level differences. These concussion-related statutes, enacted now in every state, are ostensibly supposed to reduce risk and improve athlete health outcomes. The extent to which they are reliably accomplishing this goal is unclear. What is clear is that implementation of the laws, and enforcement in cases where schools do not abide by statute, are necessary precursors to consistent efficacy. Although it is important that all states have taken steps toward protecting the health and safety of youth and adolescent athletes, approving a statute is not the final step toward this aim. Further research is needed to understand what health effects the current laws are having and critically where improvements can be made in this important area of public health law.
[This post reflects my own views only. It does not necessarily represent the views of the Petrie-Flom Center or the Football Players Health Study at Harvard University.]
- Jorge L. Contreras, Narratives of Gene Patenting, SSRN
- Sharona Hoffman, Citizen Science: The Law and Ethics of Public Access to Medical Big Data, SSRN/Berkeley Tech LJ
- James Hodge & Kellie Nelson, Active Shooters in Health Care Settings: Prevention and Response Through Law and Policy, SSRN/JLME
- David Orentlicher, Abortion and Compelled Physician Speech, SSRN/JLME
By Christine Baugh
The recent concussion and sport special issue of the Journal of Law Medicine and Ethics (generously made available free by the American Society of Law Medicine and Ethics: HERE), edited by new Bill of Health contributor David Orentlichter, includes a number of important works discussing legal and ethical issues related to mild traumatic brain injury sustained through sport. One of the most thought provoking articles in the issue is a piece by Kathleen Bachynski and Daniel Goldberg titled Youth Sports & Public Health: Framing Risks of Mild Traumatic Brain Injury in American Football and Ice Hockey. This piece delves into the important issues of cultural and normative influences on the framing (and thus public understanding) of the risk of brain injury in sport. At the heart of the paper is the assertion that, “The framing of risk is not a neutral, apolitical enterprise,” and that in the United States and Canada highly influential institutional actors such as football and ice hockey leagues have played a formative role in the cultural valuation of the risks inherent in these activities.
Bachynski and Goldberg provide a variety of examples where the overarching questions such as “Are contact sports too risky?” or “What is an appropriate level of risk?” are deferred for easier alternatives. Addressing more focal issues are: State concussion laws which mandate secondary prevention measures, advancement in protective equipment which promises to mitigate risk of injury, rule changes made by sports leagues which aim to make inherently dangerous activities somewhat less dangerous. Rather than addressing the broader risk questions, the implicit assumption in these more focused efforts is that risks are acceptable as long as they are managed. Through what Bachynski and Goldberg assert are concerted efforts on behalf of major stakeholders (e.g., major sports leagues), this has been the predominant frame for risk assessment in contact sports.
Unfortunately, this method of framing risks is not without consequences. Bachynski and Goldberg argue that this framing may alter our understanding of the scope of the problem as well as the most appropriate interventions or solutions. This frame may also inappropriately downplay the need to address the broader moral, social, and political questions that arise from concussions in contact sports. For example, the authors pose the following question, “At what age can players consent to risks of head trauma and associated elevated risks of chronic degenerative neurological disease?”
Answering this question could require a complex weighing of the scientific evidence of the long-term risk of neurodegeneration and balancing it against a variety of factors such as the paternalistic desire to control the population’s ability to partake in self-injurious behavior and the need to protect an individual’s autonomy. (We do, after all, regularly let individuals partake in other dangerous activities—e.g., downhill skiing or driving a car.) We would need to think about questions such as: Should we treat the risk of brain injury differently than bodily injury? Should the risk of delayed or chronic injury be weighed differently given humans’ known difficulty in assessing risk in the distant future? What does scientific evidence have to say about the nature of the risk across age ranges? However, under the current framing these questions are not the ones being addressed. Bachynski and Goldberg’s article elucidates the first step toward addressing concussions from sport: appropriately framing the problem.
[This post reflects my own views only. It does not necessarily represent the views of the Petrie-Flom Center or the Football Players Health Study at Harvard University.]
- K. Rai, G. Rice, Use patents can be useful: The case of rescued drugs, SSRN/Sci. Transl. Med
- Seema K. Shah, Piercing the Veil: The Limits of Brain Death as a Legal Fiction, SSRN/Mich J L Ref
- Rebecca Haffajee, Wendy Parmet & Michelle Mello, What Is a Public Health “Emergency”? N Engl J Med
- Kristin Madison, Health Regulators as Data Stewards, SSRN/N.Carolina L.Rev.
- Tim Jost, Subsidies and the Survival of the ACA — Divided Decisions on Premium Tax Credits, N Engl J Med
- Andrea M. Sisko et al, National Health Expenditure Projections, 2013–23: Faster Growth Expected With Expanded Coverage And Improving Economy, Health Affairs,
- Craig B. Garner, Medicare: The Perpetual Balance between Performance and Preservation, SSRN/J Contemp L&Pol
- Larry Levitt, A To-Do List for the New CEO of the Federal Health Insurance Marketplace, JAMA
- Julie Donohue, The Impact and Evolution of Medicare Part D, N Engl J Med
- Lois Shepherd, The End of End-of-Life Law, SSRN/North Carolina L.Rev.
- Frank Pasquale, Private Certifiers and Deputies in American Health Care, SSRN/NC L. Rev.
- Peter J. Neumann et al, Updating Cost-Effectiveness — The Curious Resilience of the $50,000-per-QALY Threshold, N Engl J Med
- 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.