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.