We’re pleased to introduce and welcome Elizabeth Sepper as a guest blogger for the month of January. Elizabeth is an associate professor at Washington University School of Law. She is a health law scholar whose work explores the interaction of morality, professional ethics, and law in medicine.
By Nir Eyal
By Hyeongsu Park and Kathy Wang
- On December 21, a federal judge ordered Alabama to stop isolating prisoners with HIV, ruling in favor of a group of inmates in a class-action lawsuit.
- The Food and Drug Administration moved a big step closer to approving the first genetically engineered animal — a fast-growing salmon — by concluding that the salmon would have “no significant impact” on the environment.
- Richard S. Foster, who as chief actuary of the Medicare program for the last 18 years nettled presidents of both parties with his projections of rapid growth in federal health care spending, will retire next month.
- The Food and Drug Administration conferred with public health officials from 50 states about how to strengthen regulations on drug compounding companies in the wake of a national meningitis outbreak.
- As part of the Hospital Value-Based Purchasing Program, Medicare disclosed bonuses and penalties for nearly 3,000 hospitals as it ties almost $1 billion in payments to the quality of care provided to patients.
- The French government has announced that it will introduce legislation allowing assisted suicide and some forms of euthanasia.
- A Time magazine article questions the Chinese treatment of opiate addiction by destroying a region of the brain which feels pleasure. Although China’s Ministry of Health banned this treatment, neurosurgeons are still using it to treat drug addiction. The article raises a number of ethical concerns regarding informed consent and questions the effectiveness of the treatment.
Two big events recently took place in the world of food: The Food and Drug Administration decreed that genetically engineered salmon wouldn’t harm the environment and McDonald’s announced that its McRib sandwich is back on the menu.
The FDA’s announcement paves the way for the first approval of a genetically engineered animal for humans to eat – and it was met with a good deal of highly critical wailing and groaning by Consumer’s Union, National Geographic and many other advocacy groups who are wary of genetically engineered food.
If you like salmon, and I do, should you worry much about the safety of eating genetically engineered salmon? No. The FDA said it could not find any valid scientific reason to prohibit the sale of the fish.
If you like the McRib, and I do, should you worry a lot about eating it? Oh yeah.
By Scott Burris
Between budget cuts and “nanny state” attacks, it’s easy to feel that public health is a perennial political loser. As for the courts, the first two constitutional amendments alone are throwing up enough barriers to reasonable health regulation to keep us on the defensive for years. In this series of posts about how public health protagonists are faring in these politico-legal contests, I will criticize our side. There’s a great deal we do wrong, or at least fail to do well, and those failures are the first place to look if we want to stop being under-appreciated, underfunded and over-invalidated. But before I put on the hair shirt, I will don satin with a post devoted to the very positive things there are to say about public health law and those who theorize and study it.
Make a list of the biggest health threats that have faced our people in the last fifty years. That list will certainly include lung cancer, cardiovascular disease, motor vehicle crashes, gun violence, communicable diseases, lead poisoning, mental illness and, more recently, drug overdose and obesity. Now consider what law has done or is doing to address these threats.
- Barbara Evans, Why the Common Rule is Hard to Amend, SSRN
- Ann Marie Marciarille, Let Fifty Flowers Bloom: Health Care Federalism after National Federation of Independent Business V. Sebelius, SSRN/UMKC L.Rev.
- Tim Jost, Religious Freedom and Women’s Health — The Litigation on Contraception, NEJM
- Elizabeth Sepper, Taking Conscience Seriously, SSRN/Va L Rev
Cross-posted at HealthLawProfs
By Cristiane Avancini Alves
A court in Brazil recently held that the mother of a drug-addicted adult woman (who is pregnant and who already has three children) may seek the court’s authorization for the tubal ligation of her daughter provided the daughter is unable to manage her own affairs. The Brazilian health system has received an increasing number of requests for sterilization in the last years, but according to the Family Planning Law, which is based on the principle of informed consent, sterilizations in such circumstances may only be carried out if the woman is legally incompetent.
Such cases clearly raise a number of concerns. For example, sterilization should generally be considered to be an irreversible procedure which deprives the woman of her fertility, and it does nothing to treat the woman’s addiction or help her avoid resorting to prostitution in order to obtain drugs.
One approach to the problem is so-called “dialogical assistance”. This involves the consideration of each case by physicians, psychiatrists and social workers who assess the woman and establish her competence and informed consent to sterilization, and only then consider approaching the courts to authorize sterilization. This procedure can indicate a practical application of patient autonomy and the beneficence principle in social and legal spheres.
Nicky Priaulx of Cardiff and Anthony Wrigley of Keele have edited the latest volume in the Ashgate book series, “Ethics, Law and Society.” Matthew Weait and I have contributed a piece on the ethics of sex with HIV, but the book covers a wide range of contemporary health/ethics/legal questions, including cloning, organ procurement, surrogacy, confidentiality in family courts, informed consent, and the place of child-rearing men in a gendered world. Robin West says it “provokes, intrigues, and enlightens, suggesting multiple paths for the futures of the related fields of bioethics, the study of care and caregiving, and the ethics and law of reproduction and reproductive technologies.”
Details on the paper and e-book are here.
By Hyeongsu Park and Kathy Wang
- Pennsylvania governor Tom Corbett joined other Republicans in vowing not to set up a state-wide health care exchange, citing a lack of resources and preparation in order to do so. In making this decision, the Corbett administration will be allowing the Presidential administration to take charge of its exchange. This decision comes amidst large debate that basically broke down along partisan lines, with Democrats strongly pushing for a state-specific exchange.
- Even as some states have been resisting setting up these health care exchanges, other states are moving ahead and have already garnered conditional approval for their health insurance marketplaces. These nine states, all of which are headed by Democratic governors, have expressed strong interest in carrying out the health care overhaul as swiftly as possible. Other states have been attempting to bargain for a partial expansion of Medicaid, although they have largely been met by rejection from the administration.
- The European Institute of Bioethics released a study last week on the state of Belgium’s legalized euthanasia law, which was worded with the intent to protect the vulnerable. However, the report found several failings in the law and corresponding processes, finding on-going abuses in several areas.
- In Australia, the most recent bioethics debate has been around overseas commercial surrogacy, as authorities attempt to reconcile legalized commercial surrogacy and the potential exploitation of women and the protection of surrogates, commissioning parents, and children.
- Last week, AP reported that there are “fewer health care options for illegal immigrants,” highlighting a controversial point in the newly passed health care bill. Since most states do not question immigration status, it has been difficult to establish the cost of treatment of illegal immigrants.
- In the ever-controversial debate about abortion laws, Wisconsin and Michigan have recently joined the fray. In Wisconsin, its chapter of Planned Parenthood intends to sue over abortion medication. Meanwhile, in Michigan, two bills limiting abortion moved closer to becoming law.
- Meanwhile, overseas, the Irish government made a statement on Tuesday suggesting it would allow abortion under limited circumstances. This action is seen largely as a response to comply with demands of the European Court of Human Rights. In addition, in the Philippines, a bill intended to expand birth control to give access to the poor and those who live in rural areas was finally passed through legislation, pushing through much religious and sociopolitical challenge. As a country that is 80% Catholic, this measure had been debated for over a decade with strong opposition from the Church.
- Last Friday, the Supreme Court decided that it would rule on a case regarding generic medicines, which has the potential to answer longstanding questions as to whether pharmaceutical companies buying out generics is a violation of antitrust law. These “pay-for-delay” deals are largely intended to allow pharmaceutical companies to continue to charge higher prices for their brand-name drugs.
- A NY Times article highlights alternative methods of addressing the problem of a shortage of doctors, primary care physicians in particular, by relying on other medical professionals and expanding their capacities. Initiatives to allow non-doctors to take a larger role in medical care seem to be promising ways of filling this supply gap.
- In the aftermath of the legalization of marijuana in Colorado and Washington, federal inaction has allowed marijuana proponents in California to renew their challenge of federal government closures of one of the state’s largest marijuana dispensaries.
By: Gaia Bernstein
[cross-posted from Concurring Opinions]
Egg and sperm donations are an integral part of the infertility industry. The donors are usually young men and women who donate relying on the promise of anonymity. This is the norm in the United States. But, internationally things are changing. A growing number of countries have prohibited egg and sperm donor anonymity. This usually means that when the child who was conceived by egg or sperm donation reaches the age of eighteen he can receive the identifying information of the donor and meet his genetic parent.
An expanding movement of commentators is advocating a shift in the United States to an open identity model, which will prohibit anonymity. In fact, last year, Washington state adopted the first modified open identity statute in the United States. Faced by calls for the removal of anonymity, an obvious cause for concern is how would prohibitions on anonymity affect people’s willingness to donate egg and sperm. Supporters of prohibitions on anonymity argue that they only cause short-term shortages in egg and sperm supplies. However, in a study I published in 2010, I showed that unfortunately that does not seem to be the case. My study examined three jurisdictions, which prohibited donor gamete anonymity: Sweden, Victoria (an Australian state) and the United Kingdom. It showed that all these jurisdictions share dire shortages in donor gametes accompanied by long wait-lists. The study concluded that although prohibitions on anonymity were not the sole cause of the shortages, these prohibitions definitely played a role in their creation.
In a new article, titled “Unintended Consequences: Prohibitions on Gamete Donor Anonymity and the Fragile Practice of Surrogacy,” I examine the potential effect of the adoption of prohibitions on anonymity in the United States on the practice of surrogacy. Surrogacy has not been part of the international debate on donor gamete anonymity. But the situation in the United States is different. Unlike most foreign jurisdictions that adopted prohibitions on anonymity, the practice of surrogacy in the United States is particularly reliant on donor eggs because of the unique legal regime governing surrogacy here. Generally, there are two types of surrogacy arrangements: traditional surrogacy and gestational surrogacy. In a traditional surrogacy arrangement the surrogate’s eggs are used and she is the genetic mother of the child, while in gestational surrogacy the intended mother’s eggs or a donor’s eggs are used and the surrogate is not the genetic mother of the conceived child. Most U.S. states that expressly allow surrogacy provide legal certainty only to gestational surrogacy, which relies heavily on donor eggs, while leaving traditional surrogacy in a legal limbo. Without legal certainty, the intended parents may not be the legal parents of the conceived child, and instead the surrogate and even her husband may become the legal parents. Infertility practitioners endorse the legal preference for gestational surrogacy also for psychological reasons, believing that a surrogate who is not genetically related to the baby is less likely to change her mind and refuse to hand over the baby.
By Scott Burris
Early in January, Lindsay Wiley and the Network for Public Health Law will convene a group of health law professors and (and a few colleagues from public health law practice) in Washington. They will be spending a couple of days advancing a conversation about how academic health lawyers can make a bigger contribution to the cause of improving the level and distribution of health in the United States. The conversation will pick up where a smaller group, organized by Wendy Parmet and Leo Beletsky, left off last Summer. You can read more about that meeting here.
The impetus for these meetings has been a sense that there is a well-organized and well-funded legal effort to blunt key initiatives in public health – and that it seems to be winning. And that “our side” is not putting up much of a fight. Whether it is the creeping First Amendment or the shrinking Commerce Clause – or just the battle for public hearts and minds – many of us law professors shared the feeling that we needed to rethink our game, not just in the short term, but for the long haul.
The discussion in January will be addressing three questions essential to that rethink: (1) where are we now? (2) where would we like to be in 20 or 30 years? and (3) what will we have to do to get there? In advance of the meeting, we are thinking about these questions, and I have taken on the task of offering some thoughts on question 1, in the form of a series of blog posts over the next three weeks. These will be personal essays, describing my own perhaps confused thoughts. I consign them to ablog as much for future deniablilty as present dissemination. I’ll be happy to have comments.
Boston is a great city for health policy. On Jan. 25, BU Law hosts a conference on New Legal Challenges to Global Tobacco Control. Just a month later, Harvard hosts its own conference on the Global Governance of Tobacco (details here).
The BU Law conference (announcement here; detailed schedule here) will focus on challenges rooted in constitutional law (First Amendment litigation in the US attacking FDA-required graphic images on tobacco packs); trade mark law (plain packaging in Australia); and global trade and investment treaties such as the Hong Kong-Australia Bilateral Investment Treaty and the WTO Agreements. Speakers include some of the world’s leading public health experts on this topic:
- Matthew Allen, Allen + Clarke Policy and Regulatory Specialists
- Micah Berman, New England School of Law
- Scott Burris, Temple University Beasley School of Law
- Julien Chaisse, The Chinese University of Hong Kong
- Richard Daynard, Northeastern University School of Law
- Samantha Graff, NPLAN
- Jane Kelsey, University of Auckland Faculty of Law
- Lara Khoury, McGill University Faculty of Law
- Mark Levin, University of Hawai’i at Manoa William S. Richardson School of Law
- Jonathan Liberman, Cancer Council Victoria
- Benn McGrady, Georgetown University Law Center
- Ted Mermin, Public Good Law Center
- Kevin Outterson, BU School of Law
- Robert Stumberg, Georgetown University Law Center
- Allyn Taylor, Georgetown University
- Tania Voon, University of Melbourne Law School
- George Annas, BU School of Law and BU School of Public Health
- Leonard Glantz, BU School of Law and BU School of Public Health
- Wendy Mariner, BU School of Law and BU School of Public Health
- Alexandra Roberts, BU School of Law
- Keynote Speaker: Dr. Michael Siegel, BU School of Public Health
The conference is open to everyone; see the schedule for details. The conference papers will be published in the American Journal of Law & Medicine.
I grew up in a family of gun hobbyists. One of my older brother’s most treasured Christmas presents from childhood is a rifle that was used in WWII; my dad had a collection of several dozen handguns, shotguns, and rifles, including a semi-automatic AR-15 “assault rifle” and a pearl-plated revolver and holster that he bought with a “Sheriff” badge just for fun; my younger brother is an ex-Marine. Throughout childhood, I spent every weekend of hunting season (and many summer weekends besides) on a West Texas ranch, shooting dove, quail, ducks, and exploding targets attached to grapefruits and ice blocks. And when I went to babysit my niece and nephew for a week in Austin, my brother’s first task was to show me where all of the house’s handguns were kept and how to open the safes he kept them in.
I don’t own a gun myself, and I don’t have any plans to get one. But I understand the utility of guns for both recreation and defense. Of course, as a scholar of health law and constitutional law, I also understand how complex the questions are that guns present for public health and individual liberty. But, as usual, my sense is that there is an obviously correct approach to those complex questions: an approach that seeks balance and optimization. A ban isn’t the right answer, from a policy or constitutional perspective, but in light of the very real dangers that guns present, neither is a strong Second Amendment bar to regulation. Of course, this view represents the current state of the law in both legislation and Supreme Court precedent; the balanced view is inconsistent only with the debate’s heated rhetoric. Here are a few thoughts:
By Cristiane Avancini Alves
In my previous post, I mentioned that Brazil does not have a specific law about advance directives. Nevertheless, a recent Resolution of the Federal Board of Medicine addresses this subject. It indicates that so-called “advance directives of will” are the set of desires, previously and expressly manifested by the patient, about the treatment he wants (or does not want) to receive when he is unable to express his will in a free and autonomous manner. Two points must be highlighted: the physician will not follow any patient’s directive that could violate the Medical Ethical Code, and the patient’s wish will overrule the intervention of his family regarding his decision.
The Resolution clearly expresses that “advance directives of will” mean what the phrase itself indicates: a direction, not a closed document that cannot be modified or that must be blindly followed. Time is significant in this context. For example, rapid biomedical development and the new possibility of cure can change the patient’s treatment course, regardless of a prior directive. Besides that, our personal believes about life and death can also change. Unfortunately, these elements have been misrepresented by the media. One of the most important Brazilian magazines dedicated a special report to the subject, but the headline was: “I decide my end”. No. That’s not what the Resolution affirms. The report continues by saying that the expression “advance directives of will” is a “pompous” name for “vital testament”. No. The title is not pompous, but rather accurate – reflecting simply that the document is a previous direction made by the patient. Moreover, advance directives of will cannot be related to testament, since the directive’s effects will occur during life, not after it – as it is for the legal meaning for testament.
Overall, the issues that came up here are indicative of broader issues related to how the media and public understand their rights, and the importance of word choice and clarity to that understanding.
“I have an absolute right to drive any vehicle I want, on any road, at any time, at any speed, and under any conditions.”
That’s an argument few people would take seriously. And few people would take seriously the argument that we should ban or substantially limit automobile use, despite the fact that America suffers more than 30,000 motor vehicle deaths every year.
The Public Health Law Research program’s Strategic and Targeted Research Program funds research to fill critical gaps in the public health law evidence base. As part of this effort, PHLR is offering dissertation grants to train doctoral students in public health law research methods, including the development of legal datasets. PHLR invites current PhD students in accredited doctoral degree programs to apply.
Dissertation grants will be awarded for up to $20,000 each for 12 months maximum, and they include qualitative or quantitative studies of the health effects of specific laws or regulations and/or related underlying mechanisms of effect, and mapping studies that create a multi-jurisdictional dataset of laws suitable for quantitative research.
Up to $100,000 will be available under this program. Learn more about the call for proposals and how to apply: http://phlr.org/strp
By Art Caplan (cross-posted from his Vitals column on NBCNews)
The mass murder of 20 children and six adults Friday in Newtown, Conn., has provoked yet another round of recrimination, finger pointing and breast-beating. Was the shooter mentally deranged? If there was more gun control, would this have happened? Did violent video games play any role? What we fervently want as we continue to reel from a story whose misery seems to know no bounds is to find a clear cause – a reason why this happened – so that we can fix it.
We hope to see something in all the stories, analyses, commentaries, Facebook postings and Twitter speculation that gives us the reason behind what happened and thus a guarantee that if we understand and act on it then no 6 year old or her parent need to worry ever again what might happen at their school. We hope that no college, hospital or mall will ever again have a reason to practice drills for “shooters” and no play or movie-goer grow anxious over who has snuck into the theater with evil intent.
But, there is no simple answer. We have ourselves to blame for where we find ourselves in terms of mass shootings. Our culture is too far down the road of tolerating and even extolling violence. We do so in our popular entertainment, we permit the mass marketing of violence to young kids, and we thrill to it in too many of our sports. A lot of people make a lot of money selling violence. I doubt that will change.
The Harvard Global Health Institute will be co-hosting a conference on The Governance of Tobacco in the 21st Century: Strengthening National and International Policy for Global Health and Development at Harvard on February 26-27, 2013. The conference program is available here, and additional information can be found here. Space is limited. Please register by January 10.
For further information, contact Monique Bertic email@example.com
By Adriana Benedict
The 2012 Global Congress on Intellectual Property and the Public Interest has just come to a close in Rio de Janeiro, Brazil. The conference brought together global leaders in intellectual property-related fields like access to medicines, access to knowledge, internet freedom, innovation and development, and open educational resources. I was invited to participate in the various sessions concerning access to medicines, which focused on two sides of this global health challenge.
The first part of the access discussions focused on best practices and threats in the use of TRIPS flexibilities in developing countries. Participants emphasized the need to look beyond the usual focus on compulsory licenses to set new priorities for understanding and leveraging less-developed flexibilities such as patentability criteria, patent opposition mechanisms and parallel importation. An important overarching theme in these discussions was reframing flexibilities as rights, as they carry the same legal status as the intellectual property rights which make them necessary.
The other side of the discussions focused on innovation and research and development (R&D) for the developing world, primarily through recent advances by the WHO CEWG report in promoting a binding convention in this realm. At the forefront of these proposals is the notion that incentives for innovation should be de-linked from product prices in order to address the needs of the developing world. Participants emphasized that, moving forward, advocates should be careful to ensure that public and institutional debates on alternative R&D models do not narrow their focus from neglected populations to neglected diseases.
This week, the New York Times Sunday Review has an editorial arguing that the shortage of primary care physicians could be reduced if we drew more heavily upon other professions, including pharmacists and nurse practitioners, who may be able to provide care more efficiently. The Affordable Care Act’s efforts to increase insurance coverage and eliminate cost-sharing for preventative care, will only exacerbate the shortage of primary care physicians. More to the point, the editorial alleges that various state and federal laws create barriers to the sort of integration of healthcare professionals to address the shortage.
Those “scope of practice” laws were enacted to either protect consumers from incompetent healthcare or protect physicians from competition in the healthcare marketplace, or likely some mixture of both. We know where mainstream physicians stand anyway. In the words of the American Medical Association’s own newsletter, “physicians [have] fought a blitz of scope-of-practice expansions by other health professionals on legislative, legal and regulatory fronts.”
The shortage of physicians is also a product of the number of young doctors that our medical schools are producing. Although several new schools have launched in recent years, others are have actually shrunk due to budget cuts.