- Samantak Ghosh, The Taking of Human Biological Products, SSRN/Calif L. Rev
- Mark Rothstein & Abigail Shoben, Does Consent Bias Research? SSRN/Am.J.Bioethics
- David Hyman, Why Did Law Professors Misunderestimate the Lawsuits against PPACA? SSRN/U. Ill. L. Rev.
- Aaron S. Kesselheim, et al, Distributions of Industry Payments to Massachusetts Physicians, NEJM
By Scott Burris
The latest issue of the Journal of Health Politics, Policy and Law showcases the range of projects and researchers filling out the field of Public Health Law Research. An excellent introduction by the editors, Michelle Mello and Wendy Parmet, says it better than I could, but here’s a taste:
Two studies look at public health policy-making – Abiola et al on HPV vaccination, and VanSickle-Ward and Amanda Hollis-Brusky on statutory ambiguity in contraceptive mandates. Two studies evaluate local legal interventions to address lead poisoning – a sweeping ordinance in Rochester and a novel specialty enforcement court in Philadelphia. Sampat and Amin quantitatively examine the impact of a provision of Indian patent law that was widely expected to prevent evergreening, finding signs that the law on the books may not be working as advertised in practice. Finally, Cannon and colleagues bring new methods and attention to the question of whether zoning laws can deliver better health, in this instance through increasing the walkability of neighborhoods.
The group of authors includes doctors, lawyers, economists, sociologists, historians and health researchers. Mello and Parmet offer some pithy thoughts on what all this shows us about the current state of PHLR’s development. Worth a read.
- Stephanie Morain & Michelle Mello, Survey Finds Public Support For Legal Interventions Directed At Health Behavior To Fight Noncommunicable Disease, Health Affairs
- J.D. Boudreau, M.A. Somerville, & N. Biller-Andorno, Physician-Assisted Suicide, NEJM
- Thomas Frieden, Government’s Role in Protecting Health and Safety, NEJM
- Susan Dentzer, The ‘Triple Aim’ Goes Global, And Not A Minute Too Soon, Health Affairs
[Ed. Note: Posting on behalf of John Robertson]
Glenn Cohen and Eli Adashi have an interesting Sounding Board piece in the latest NEJM[i] on made-to-order embryos for sale. A California clinic offering this option has garnered enormous publicity. It might, however, have stimulated more bioethical thinking than actual demand for its services.
On the bioethical side, Glenn and Eli survey the relevant issues and conclude that what is most “new and unique here is the lack of clear legal guidance as to the parentage of the embryos in question.”[ii] My impression is different– existing laws give sufficient support about parentage, if anyone wants to use them. The clinic creating the embryos from separate gamete donations will have dispositional control of them, but no parenting questions arise until the embryos are gestated and brought to term. True, there are few state laws on embryo donation as such. But in states with no specific embryo donation laws, those who have commissioned gestation will most likely have rearing rights and duties once a child is born until they arrange for an adoption.[iii]
Nor would the gamete donors in such states be able to claim rearing rights or be subject to rearing duties after such a birth. Most states recognize gamete donor relinquishment of rearing rights and duties in resulting children with their consent to donation. After the birth of a child, the gamete donors ordinarily would have no right to change their mind and acquire rearing rights or be subject to rearing duties, whether the donation was of sperm or egg separately or both combined into an embryo.
One aspect of this transaction that is ethically unique is that divvying up embryos created from the same egg and sperm donor would lead to different recipients giving birth to full rather than half siblings, as is the usual situation with gamete donation (it could happen with excess embryos donated after successful IVF by an infertile couple, but that is rarer). Whether it creates a higher risk of full sibling consanguinity would depend on clinic practices in distributing embryos from the same batch to different recipients. As Glenn and Eli note, donor registries might solve this problem, but none yet exist in the United States.
The New England Journal of Medicine just published a new article by me (and my frequent co-author Dean Eli Adashi) entitled “Made-to-Order Embryos for Sale — A Brave New World?” As we note in the article:
The proliferation of commercial gamete sources (e.g., sperm and oocyte banks) has opened the door to a made-to-order embryo industry in which embryos are generated with a commercial transaction in mind. This prospect of a for-profit embryo bank is no longer theoretical. Indeed, as recently as November 2012, the Los Angeles Times reported on one such clinic that “sharply cuts costs by creating a single batch of embryos from one oocyte donor and one sperm donor, then divvying it up among several patients.” The report went on to state that “the clinic, not the customer, controls the embryos, typically making babies for three or four patients while paying just once for the donors and the laboratory work.
The paper then analyses the legal and ethical issues raised by the development of these kinds of banks. In so doing, a key question we ask is how this practice is similar or different from embryo donation (sometimes called “embryo adoption”), the sale of sperm and eggs for reproductive purposes, and the use of sperm and egg to produce stem cell lines that require embryo destruction.
This one is sure to be controversial, and while this short piece in the New England Journal is now published I would love to hear readers’ thoughts as I may write more on the subject.
- Dan Burk, Edifying Thoughts of a Patent Watcher: The Nature of DNA, SSRN/UCLA Law Review Discourse
- Wendy Mariner, The Affordable Care Act and Health Promotion: The Role of Insurance in Defining Responsibility for Health Risks and Costs, SSRN/Duquesne L.Rev.
- Benjamin Eidelson, Kidney Allocation and the Limits of the Age Discrimination Act, SSRN/Yale LJ
- Wendy Mariner & George Annas, Limiting “Sugary Drinks” to Reduce Obesity — Who Decides? NEJM
Dr. Yanna Lambrinidou and Dr. Marc Edwards
It is generally safe to assume that, when it comes to contaminants in drinking water, consumers are protected by regulation and proactive water utilities.
One noteworthy exception is the federal law promulgated to protect the public from lead at the tap. Known as the Lead and Copper Rule (LCR), this law splits responsibility for minimizing exposures between utilities and consumers. The rationale for this “shared responsibility” approach is that in the majority of cases lead leaches into water from lead service lines (LSLs) (i.e., the pipes that connect water mains to individual homes) and lead-bearing home plumbing materials (e.g., lead solder, leaded brass). These sources of lead are often partly or fully inside the home – LSLs and lead solder were used routinely until 1986, and the use of leaded brass will continue to be legal until 2014. Moreover, differences in plumbing and water usage (e.g., volume, flow), make lead leaching in every house unique. Under the LCR, utilities are required to monitor a small number of homes considered “high risk” for lead in water, but consumers are responsible for having their own water tested and for adopting health-protective water-use practices that minimize the risk of exposure.
When utilities detect elevated lead levels in more than 10% of the homes they sample, they must tell consumers how to avoid exposure by, for example, flushing stagnant water before use and avoiding consumption of hot tap water (especially for reconstituting infant formula). They must also implement a LSL replacement program. Although full LSL replacement is the only way to eliminate the risk from lead pipes, the LCR requires utilities to replace only the portion of a LSL that they own. The consumer-owned portion of the line is left in place, unless homeowners agree to pay for its removal, which can cost several hundred to several thousand dollars.
I have a new paper on the Supreme Court’s decision on the Affordable Care Act, just published in the European peer-reviewed philosophy journal Ethical Perspectives. It is available for free download here. Here is the abstract:
While NFIB v. Sebelius largely upheld the Affordable Care Act (ACA), it did not do so as as to the proposed expansion of Medicaid. Seven of the nine U,S, Supreme Court Justices (all except Justices Ginsburg and Sotomayor) endorsed a ‘coercion’ argument that gave individual States a right of objection grounded in the Constitution’s Spending Clause, wherein individual states could refuse to expand Medicaid as demanded by the federal government without being directly penalized by a denial of federal funding. Two Justices in dissent focused on the lack of judicial administrability of such a standard, and suggested it would open up a Pandora’s box of future constitutional challenges without any clear rules.
In this article, part of a symposium on philosophical analysis of the Court’s decision published in the peer-reviewed journal Ethical Perspectives, I discuss what I see as a more fundamental question: by what theory is the Medicaid expansion coercive, and even if coercive, by what theory is it coercive in a problematic way that justifies constitutional redress?
The Court’s failure to address this issue stems, in part, from confusion over what it means for an offer to be coercive. In some sense, Justice Kagan seemed to recognize this issue in a question to Paul Clement, the lawyer for the challengers to the ACA, at oral argument: “Why is a big gift from the federal government a matter of coercion?” Kagan asked. “It’s just a boatload of federal money for you to take and spend on poor people’s health care,” Kagan added. “It doesn’t sound coercive to me, I have to tell you.” The exchange is all the more curious because, despite her scepticism, Kagan signed on to the Court’s holding that the Medicaid expansion was coercive.
I will examine this issue by first discussing whether Medicaid itself and the ACA’s expansion are coercive (as stand-alone offers). I will then examine whether the offer to change from the existing Medicaid program to the ACA’s Medicaid expansion was problematic. I will analyze these questions under the assumption that the Court is not committing a category error by treating States as the kinds of entities subject to this kind of coercion inquiry. In my conclusion, however, I briefly consider whether that assumption is warranted.
- Jason Kanter & Robin Feldman, Understanding and Incentivizing Biosimilars, SSRN/Hastings LJ
- Eric Stecker, The Oregon ACO Experiment — Bold Design, Challenging Execution, NEJM
- Sharon Silow-Carroll & Jennifer N. Edwards, Early Adopters of the Accountable Care Model: A Field Report on Improvements in Health Care Delivery, Commonwealth Fund
- Scott Burris & Evan Anderson, Legal Regulation of Health-Related Behavior: A Half-Century of Public Health Law Research, SSRN/Ann. Rev. Law & Social Science
- David Hyman & Bernard Black, Public Reporting of Hospital Infection Rates: Not All Change is Progress, SSRN/Jurimetrics
- Jonathan Adler, The Future of Health Care Reform Remains in Federal Court, SSRN
- David Shern & Wayne Lindstrom, After Newtown: Mental Illness And Violence, Health Affairs
- Allison Hoffman & Howell Jackson, Retiree Out-of-Pocket Healthcare Spending: A Study of Consumer Expectations and Policy Implications, SSRN/AJLM
- Eric Stecker,The Oregon ACO Experiment — Bold Design, Challenging Execution, NEJM
- Nicole Huberfeld, Heed Not the Umpire (Justice Ginsburg Called NFIB), SSRN/U. Pa. J. Const. L. Height. Scrutiny.
- Lance Gable, Evading Emergency: Strengthening Emergency Responses through Integrated Pluralistic Governance, SSRN/Oregon L.Rev.
- Susan Wolf, The Challenge of Nanomedicine Human Subjects Research: Protecting Participants, Workers, Bystanders, and the Environment, SSRN/JLME
The edited volume stemming from the Petrie-Flom Center’s 2011 Annual Conference – The Globalization of Health Care: Legal and Ethical Issues, I. Glenn Cohen, ed. (Oxford University Press, 2013) – is now available for purchase through the publisher, Amazon, or other outlets. You can also download the introduction and front matter for free here.
The Globalization of Health Care: Legal and Ethical Issues is the first book to offer a comprehensive legal and ethical analysis of the most interesting and broadest reaching development in health care of the last twenty years: its globalization. It ties together the manifestation of this globalization in four related subject areas – medical tourism, medical migration (the physician “brain drain”), telemedicine, and pharmaceutical research and development, and integrates them in a philosophical discussion of issues of justice and equity relating to the globalization of health care. The time for such an examination is right. Medical tourism and telemedicine are growing multi-billion-dollar industries affecting large numbers of patients. The U.S. heavily depends on foreign-trained doctors to staff its health care system, and nearly forty percent of clinical trials are now run in the developing world, with indications of as much of a 10-fold increase in the past 20 years. NGOs across the world are agitating for increased access to necessary pharmaceuticals in the developing world, claiming that better access to medicine would save millions from early death at a relatively low cost. Coming on the heels of the most expansive reform to U.S. health care in fifty years, this book plots the ways in which this globalization will develop as the reform is implemented. The book features leading academics from across the world and different academic disciplines (law, philosophy, medicine, public health, government, business and geography) and outside academia to provide an international and interdisciplinary perspective.
TOC below the fold:
According to officials, the worst of this year’s devastating flu season should be over in most parts of the country. But in early January, the flu had hit 47 of 50 states. According to the CDC, a total of 78 influenza-associated pediatric deaths have been reported. Throughout this terrible flu season, there’s been much talk about vaccination mandates for health care workers.
States have started passing legislation regulating health care worker flu vaccination, and an increasing number of hospitals have started implementing policies in attempt to reach the Healthy People 2020 goal of having 90 percent of health care workers vaccinated. Only two-thirds of health care workers were vaccinated against the flu last year. This can leave patients at risk and hospitals short-staffed because of absenteeism.
- Max Mehlman, Professional Power and the Standard of Care in Medicine, SSRN/Arizona State L.J.
- Mark Rothstein, HIPAA Privacy Rule 2.0, SSRN/JLME
- Benjamin Sommers & Arnold Epstein, Governors and the Medicaid Expansion — No Quick Resolution in Sight, NEJM
- Thad Pope, Clinicians May Not Administer Life-Sustaining Treatment Without Consent: Civil, Criminal, and Disciplinary Sanctions, SSRN/J.Health & Biomedical L.
by Adriana Benedict
Last week, the World Health Organization (WHO), World Intellectual Property Organization (WIPO) and World Trade Organization (WTO) released a trilateral study on Promoting Access to Medical Technologies and Innovation: Intersections between public health, intellectual property and trade. According to the official summary of the book, the publication is aimed at policy makers and is divided into four parts:
I. Fundamentals: the background of health policy and medical technology, the work of the three organizations, the burden of disease that challenges health policy, and the factors shaping that policy. Much attention has been paid to diseases such as HIV/AIDS, malaria and tuberculosis, but noncommunicable diseases such as cancer, diabetes and heart diseases are a rising challenge.
II. The Policy Context: the international framework, linking health policy, intellectual property and trade, the contributions of economic analysis, and the use of traditional medical knowledge in research.
III. Innovation in Greater Detail: the evolution of research and development, alternative ways of promoting innovation for neglected diseases, the role of intellectual property rights, with examples.
IV. Access: how to ensure pharmaceuticals and other medical technology reach the people who need them: pricing policies, taxes and import duties, procurement, regulation, technology transfer, local production, patents, compulsory and voluntary licences, trade agreements, and competition policies, etc.
In her remarks at the launch of the publication, WHO Director-General Dr. Margaret Chan emphasized the importance of the public interest not only in public health, but also intellectual property and trade policy. Importantly, Dr. Chan noted that it “is worth considering” an extension of the TRIPS Agreement (WTO Agreement on Trade-Related Aspects of Intellectual Property) transition deadline (currently set to July 1, 2013) for least-developed countries (LDCs) to implement the agreement’s provisions.
Typically, we would avoid such a shameless plug for our researchers — we’d be a little more subtle. But, we can’t help it this time. This book is the best $10 you’ll spend all year.
A little less than a month ago, Johns Hopkins University convened more than 20 of the world’s leading experts on gun violence and policy to summarize their research and recommend policy changes. This 282-page book features empirical research from the leading experts in the field covering the topics of mental health and gun violence, gun law enforcement, high-risk guns, international case studies of responses to gun violence, the Second Amendment, public opinion on gun policy, and concludes with a summary of the recommendations for reforms to Federal policies.
Chapter 3, “Preventing Gun Violence Involving People with Serious Mental Illness,” features research conducted by Jeffrey Swanson, PhD, and his team of researchers based at Duke University. The research presented was funded by PHLR and the National Science Foundation.
Seriously. Check it out.
- Maxwell Mehlman, Patrick Lin & Keith Abney, Enhanced Warfighters: Risk, Ethics, and Policy, SSRN
- Evelyn Tenenbaum, Revitalizing Informed Consent and Protecting Patient Autonomy: An Appeal to Abandon Objective Causation, SSRN/Oklahoma L.Rev.
- Richard Frank, Using Shared Savings to Foster Coordinated Care for Dual Eligibles, N Engl J Med
- Seth A. Seabury et al, On Average, Physicians Spend Nearly 11 Percent Of Their 40-Year Careers With An Open, Unresolved Malpractice Claim, Health Affairs
- Douglas L. Rogers, After Prometheus, Are Human Genes Patentable Subject Matter? SSRN
- Douglas McCarthy et al, Recasting Readmissions by Placing the Hospital Role in Community Context, JAMA/Commonwealth Fund
- John Robertson, Paid Organ Donation and the Constitutionality Of the National Organ Transplant Act, SSRN/Hastings Const. L.Q.
While attending the annual Advancing Ethical Research Conference of Public Responsibility in Medicine and Research (PRIM&R) last month in San Diego, I had the opportunity to hear a talk by Dr. John Ioannidis, in which he debunked commonly accepted scientific “truths.” Calling upon his own work, which is focused on looking critically at published studies to examine the strength of their claims (see his heavily downloaded 2005 paper “Why Most Published Research Findings Are False”), Ioannidis raised important questions for those of us who think about research ethics, and who oversee and manage the research conducted at universities and scientific institutes across the country.
Ioannidis persuasively argued that our system for publishing only studies with statistically significant positive findings has resulted in a bizarre kind of reality where virtually no studies are ever reported that found “negative” results. Negative results are suppressed because nobody is interested in publishing them. Editors and reviewers have a major role in this problem; they choose not to publish studies that are not “sexy.” This artificially inflates the proportion of observed “positive” results and influences the likelihood a scientist will even write up a journal article because she knows what it takes to get published.
But isn’t there an ethical obligation to publish so-called negative results? In human research, people give their time and undergo risks for the conduct of a study. Their sacrifices are not meaningful if the results are never shared. Furthermore, negative results tell us something important. And if they are not published, some other research team somewhere else may unknowingly repeat a study, putting a new batch of subjects at risk, to investigate a question for which the answer is already known. Finally, to the extent a study is conducted using taxpayer dollars, the data derived should be considered community property, and there are opportunity costs associated with unnecessarily repetitive work. Continue reading
- David Orentlicher & William David, Concussion and Football: Failures to Respond by the NFL and the Medical Profession, SSRN/FIU L.Rev.
- Benjamin Sommers & Arnold Epstein, U.S. Governors and the Medicaid Expansion — No Quick Resolution in Sight, NEJM
- Jonathan Kahn, The Troubling Persistence of Race in Pharmacogenomics, SSRN/JLME
- Alicia Ouellette, Health Reform and the Supreme Court: The ACA Survives the Battle of the Broccoli and Fortifies Itself Against Future Fatal Attack, SSRN/Alb. L. Rev.