Tuesday, August 19, 2014
Guest Blogger Visiting Assistant Professor Valerie Gutmann Koch: Ventilator Allocation in a Pandemic
In 2014, the New York State Task Force on Life and the Law, the state’s bioethics commission, will release its updated Allocation of Ventilators in an Influenza Pandemic, which enunciate a comprehensive clinical and ethical framework to guide distribution of ventilators in the event of a severe public health emergency using objective medical criteria, with the ultimate goal of saving the most lives. These guidelines are the product of seven years of hard work by the Task Force and its staff and were developed by incorporating comments, critiques, feedback, and values from numerous stakeholders. They draw upon the expertise of multiple workgroups and committees with special knowledge in scarce resource allocation, pediatric and neonatal medicine, ethics, law, and policy. The 2014 version of these guidelines will not only include an updated clinical protocol for allocation of ventilators to adults; they will also include first of their kind protocols for allocation of ventilators to two important and previously unaddressed segments of the population: pediatric patients and neonates.
Guest Blogger Associate Dean and Associate Professor Joanna K. Sax: The Regulation of Dietary Supplements
How have the massive amounts of dietary supplements on the market evaded significant regulatory oversight for so long? Dietary supplements are regulated as food, which means that for practical purposes the FDA only has the ability to pull them off the shelves upon a showing that they are harmful.
Many consumers use dietary supplements for the same purposes that someone may use a non-prescription drug. Some consumers actually feel safer using a dietary supplement because it is labeled as “natural,” rather than using an FDA approved over-the-counter drug. This doesn’t and shouldn’t make sense. Many natural things are harmful – would you eat any wild mushroom? Tobacco in in cigarettes is natural. Just because something is natural doesn’t mean that it is safe. Conversely, just because something isn’t “natural” in a drug doesn’t mean it is unsafe.
Thursday, August 14, 2014
Biolaw section of the Association of American Law Schools (AALS)
Monday, January 5, 2015, 10:30 a.m. to 12:15 p.m.
The 2014 west African outbreak of the Ebola virus is the most severe epidemic attributed to this pathogen since 1976, when international health officials began keeping records on Ebola. As of August 2014, the total number of suspected cases has approached 2,000, and the number of suspected deaths has exceeded 1,000. The World Health Organization has designated the health crisis as one of international concern. The law has a strong stake in containing this outbreak and preventing future episodes of this kind.
The Biolaw section of the AALS invites papers addressing issues of law and policy arising from the Ebola outbreak. Such issues may include (but by no means are limited to) the following:
- Why was the international legal and public health community so slow to recognize the 2014 Ebola outbreak? Human beings are supremely attuned to threats posed by other humans (such as war or terrorism), but far less prepared for threats deemed "natural" or "environmental." How should law accommodate and/or offset this biological predisposition?
Wednesday, August 13, 2014
It probably depends on who you ask. Proponents of fracking laud the energy independence, creation of jobs, environmentally friendly nature of natural gas, national security and economic benefits. Opponents to fracking have concerns about the impact to the environment, public health issues, and water use. Each side dismisses the other side’s arguments.
Perhaps a primer on hydraulic fracturing, known as fracking, is helpful. Fracking is the process of creating long vertical wells below the earth’s surface and then horizontal wells that break open the shale and allow the natural gas to be released and captured. Fracking uses millions of gallons of water to create these wells. A proprietary mix of chemicals in the water is used to create the fissures in the shale. Since the shale is far below the surface, proponents of fracking were able to convince Congress to exempt the industry from the Safe Water Drinking Act, which is now affectionately called the Halliburton Loophole.
The problem with assessing proponents and opponents positions on fracking is the lack of scientific data. While it may be true that the fracking wells are far below the surface, leaks in the fracking wells could impact the aquifers. The EPA is conducting a large scale drinking water impact study, with results that are eagerly anticipated to be released later this year. It could be that, for example, drinking water is/has been contaminated, but that with new regulations and novel innovations, these wells could be made safe such that drinking water is not contaminated. But, we don’t know if there is a problem without the scientific studies and if there is a problem, we need to determine if science/innovation can address the problem.
Tuesday, August 12, 2014
Theodore M. Hammett, Son H. Phan, Julia Gaggin, Patricia Case, Nicholas Zaller, Alexandra Lutnick, Alex H. Kral, Ekaterina V. Fedorova, Robert Heimer, Will Small, Robin A. Pollini, Leo Beletsky, Carl Latkin, Don C. Des Jarlais, Pharmacies as Providers of Expanded Health Services for People Who Inject Drugs: A Review of Laws, Policies, and Barriers in Six Countries, 14 BMC Health Services Res. (2014).
Cathryn Miller-Wilson, Medical-Legal Partnerships: Origins and Ethical Lessons, 93.3 Neb. L. Rev. (Forthcoming 2015).
E. H. Morreim, In-House Conflict Resolution Processes: Health Lawyers as Problem-Solvers, 25 The Health Lawyer 10 (2014).
Jonathan D. Kahn, Privatizing Biomedical Citizenship: Risk, Duty, and Potential in Circle of Pharmaceutical Life, 15 Minn. J. of Law, Sci. & Tech. 791 (2014).
From the ASLME Insider:
The American Society for Law, Medicine & Ethics (ASLME) is pleased to announce the first annual bioIP New Scholars Workshop on May 7, 2015 at Boston University School of Law.
The Workshop will offer a unique opportunity for three new scholars (in their first decade of teaching) to present their draft scholarship for in-depth critique and commentary by respected senior scholars in the field.
Tuesday, August 5, 2014
Guest Blogger Visiting Assistant Professor Valerie Gutmann Koch - FDA Announces Plans to Regulate LDTs (But What About DTC Genetic Tests?)
Oversight of direct-to-consumer (DTC) genetic tests and laboratory developed tests (LDTs) in general has garnered increasing attention in the media. Most recently, on July 31, pursuant to the 2012 Food and Drug Administration Safety and Innovation Act (FDASIA), the FDA notified Congress that it intends to issue draft guidance for the oversight of LDTs – diagnostic tests (including genetic tests and tests for rare conditions) developed and performed by a single laboratory. The FDASIA requires the FDA to provide at least 60 days’ notice before publishing any draft guidance on the regulation of LDTs.
FDA’s decision to exercise its jurisdiction over LDTs as medical devices has been discussed and even expected for almost a decade. In June 2013 FDA Commissioner Margaret Hamburg called for more active FDA regulation of LDTs, stating that the Agency’s risk-based framework for regulating such tests was under development. Hamburg noted that the FDA has discretion in overseeing certain LDTs as devices. Although historically “they were relatively simple, low-risk tests performed on a few patients being evaluated by physicians at the same facility as the lab,” she explained that they now warrant oversight because they have become “more sophisticated and complex.”
HealthLawProf Blog is very pleased to welcome the second of our bloggers for the month of August, Visiting Assistant Professor Valerie Gutmann Koch. The following is her short bio:
Valerie Gutmann Koch is Visiting Assistant Professor at IIT Chicago-Kent College of Law and Lecturer in Law, Medicine, and Ethics at the MacLean Center for Clinical Medical Ethics at the University of Chicago. She also serves as Special Advisor to the New York State Task Force on Life and the Law, the state’s bioethics commission; she previously served as the Senior Attorney to the Task Force. Professor Koch's research interests focus on the issues arising at the intersection of law, medicine, and ethics, with a focus on emerging technologies in medicine and science and the legal challenges they pose. Previously, she practiced in the IP litigation practice at Kirkland & Ellis LLP. Professor Koch received her Juris Doctor from Harvard Law School, and she graduated magna cum laude with an A.B. from Princeton University's Woodrow Wilson School of International Affairs and Public Policy. Her recent research can be found on SSRN.
I read a lot of press and listen to the politics surrounding genetically modified (GM) foods; but it appears that there is a lack of understanding that almost all of our food supply is integrated with GM crops. I imagine that many readers of this blog already know this, so this may simply be background for some of you.
The focus of the debate appears to be on GM foods that contain some sort of exogenous genetic modification that allows them to be pest or insect resistant, either through DNA or RNAi. That is, a specific DNA or RNAi sequence is inserted into the seed that is known to interfere with a biochemical reaction that allows, for example, the crop to be resistant to a specific type of pest.
But, the reality is that almost all of our crops are genetically modified, if not through the insertion of exogenous DNA or RNAi, then through various husbandry techniques. For example, seeds may be hit with UV radiation, which causes double stranded DNA breaks and subsequent mutations. These seeds are then selected for desired traits, such as pest resistance or other hardy characteristics. So, then through husbandry techniques, the seeds are grown into crops with mutations to the endogenous DNA. For these crops, we know that they demonstrate some sort of feature that is desirable to the farmer (or consumer), but we have little idea about what other mutations they may carry.
HealthLawProf Blog extends a big welcome to one of our guest bloggers for the month of August, Associate Dean and Associate Professor Joanna K. Sax:
Joanna Sax is an Associate Professor of law, the Associate Dean for Research and Faculty Development, and the co-Director of the Institute of Health Law Studies at California Western School of Law. Professor Sax has a J.D. Ph.D. from the University of Pennsylvania. Her Ph.D. is in Cell and Molecular Biology. Professor Sax combines her background in biomedical science and her legal education to focus on ways to incentivize the advancement of science. She also has expertise in the policies of the Food and Drug Administration; although she focuses on the food side. Professor Sax joined the faculty at California Western School of Law in 2009. She teaches Contracts, Trusts & Estates and a seminar entitled Law, Science & Medicine.
Thursday, July 31, 2014
On July 29, 2014, the U.S. Court of Appeals for the Fifth Circuit issued an as-applied ruling in a case involving Mississippi’s statute requiring that all physicians affiliated with a Jackson clinic providing abortion services have admitting and staff privileges at local hospitals. All local hospitals were unwilling to grant privileges to two of the clinic’s physicians who were involved most directly in abortion services because of the nature of their practices. Had the state’s statute been enforced, the clinic—Mississippi’s only facility offering abortion services—would have been ordered to close.
Mississippi’s argument was that ordering the clinic to close would not impose an undue burden on Mississippi women’s constitutional rights because women would be able to travel to nearby states for abortion services. The Fifth Circuit reasoned to the contrary: “Mississippi may not shift its obligation to respect the established constitutional rights of its citizens to another state. Such a proposal would not only place an undue burden on the exercise of the constitutional right, but would also disregard a state's obligation under the principle of federalism—applicable to all fifty states—to accept the burden of the non-delegable duty of protecting the established federal constitutional rights of its own citizens.” Jackson Women’s Health Organization v. Currier, 2014 WL 3730467 (July 29, 2014).
Sunday, July 27, 2014
HealthLawProf Blog would like to thank our June guest bloggers Associate Dean and Professor Alicia Ouellette, Professor Erin Fuse Brown, Professor Seema Mohapatra, and Professor Wendy Mariner. Here is a short recap of their posts:
Associate Dean and Professor Alicia Ouellette posted the following: Legal Issue or Culture War: Conversion Therapy in the Courts and Beyond, The World Cup and Health: If You Can’t Stand the Heat, Don’t Play in Manaus, Sterilization in the California Prisons and the Medicaid Rules: Under and Over Protecting Women
Professor Erin Fuse Brown posted the following: IPAB May Be A Super-Independent Agency, But It Is Constitutional, Hospitals Using ACA to Justify Cuts in Charity Care, The Health Implications of Piketty’s Inequality, The Hidden Costs of Narrow Networks, Guest Blogger Professor Erin Fuse Brown: Surprise! The Doctors at Your In-Network Hospital are Out-of-Network
Professor Seema Mohapatra posted the following: The Soda War Continues, Tennessee’s Criminalization of Drug Use by Pregnant Women, E-Cigs and Advertising, Genetic Testing of College and Professional Athletes-Legal? Required?, Facial Recognition Technology, Genetic Diseases, and Privacy
Professor Wendy Mariner posted the following: Who Has Jurisdiction Over Sugary Drinks?, Take Care of Your Health at Penn State... Or What?, Hobby Lobby – Part 1: Five Supreme Court Justices Write Corporate Fiction, Hobby Lobby – Part 2: Do Religions Get Their Own Facts?
HealthLawProf Blog is pleased to post the following introduction to a very interesting Symposium published by the North Carolina Law Review entitled "Health Care Decisions in the New Era of Health Care Reform:"
Optimal decision making in health care often proves challenging. Health care providers often confront multiple treatments for each condition with limited evidence as to which interventions work best; moreover, treatment decisions can implicate questions of ethics and personal values that may not be answerable by clinical expertise alone. Fragmented delivery systems lead to insufficient coordination among providers in managing patients’ overall care. Patients face significant informational disadvantage not only in dealing with clinical information, but also in making choices regarding health care insurance coverage. Payers must make reimbursement and coverage decisions with incomplete information about the value and cost effectiveness of many treatments. Governmental officials must make complex regulatory decisions in managing a health care system with seemingly endless demand, escalating costs, and limited resources.
Saturday, July 26, 2014
Having spent a good part of my career focused on research ethics issues, I have read with interest the reports and fallout about Facebook’s “emotional contagion” experiment. It’s not often that you get an example of research gone awry that affects so many.
If you’ve missed this story, here’s the nutshell version: in 2012, Facebook conducted an experiment involving some 700,000 of its users to determine whether manipulating their newsfeeds to show items with more positive or negative words would affect their emotions. (Facebook is always sorting – via algorithms – users’ newsfeeds; this just used a different algorithm to do so.) The hypothesis was that if a user viewed more positive messages, their posts would contain more positive words and vice versa. The news feeds were manipulated for a week, and the study found an effect, although a small one. The study was published on June 17th in the Proceedings of the National Academy of Science.
An early post from our Guest Blogger of the Month for September, Professor Diana Winters:
Legal commentators have spent a lot of time this week sparring over statutory interpretation and the contrasting readings of the ACA by the Halbig and King courts. The potential consequences of these cases demonstrate just how high the stakes of this enterprise can be.
With less fanfare, the Second Circuit decided a case yesterday that may too have large consequences for the health and welfare of the public. In NRDC v. EPA, the court reversed a district court’s decision to require FDA to hold hearings on the withdrawal of approval for the use of two antibiotics—penicillin and tetracyclines—in animal feed. This issue has enormous public health consequences, but the consequences of this case extend beyond antibiotic use, to agency practice in general. The opinion sanctions egregious agency delay and a tremendous lacuna in decision making.
The University of Pittsburgh School of Law invites applications for a full-time faculty position at the rank of Assistant, Associate or Full Clinical Professor to teach in and direct the School’s Health Law Clinic. While this position is not in the tenure stream, it is part of a system of contracts progressing to renewable long-term contracts. The position will begin on July 1, 2015.
The Clinic’s primary mission is to provide an experiential learning opportunity for our students, while also providing legal services to low-income individuals involved in health-related litigation or advocacy. Duties of the Clinical Professor include classroom teaching, including the possibility of teaching doctrinal courses; supervision of second- and third-year law students as they represent clients and participate in community projects; administrative duties relating to the Health Law Clinic; community outreach and fundraising; and participation in faculty governance of the School of Law. The candidate hired for the position will have the opportunity to shape the future direction of the Clinic. Therefore, all candidates should be prepared to present a vision of the type of clinic that they would hope to implement. Examples might include a medical-legal partnership, a clinic focusing primarily on representation of applicants for disability benefits in Medicaid or Social Security administrative hearings, or other focused areas of representation or advocacy.
Qualifications include admission to practice in Pennsylvania or willingness to seek admission to the Pennsylvania bar; substantial experience in the field of health law and, preferably, clinical pedagogy; excellent supervisory and communication skills; the ability to work effectively with students, clients, and other constituents; and an interest in developing clinical experiences for students in the Health Law Clinic within a community that supports interdisciplinary collaboration and innovative teaching opportunities.
To apply, please submit a letter of interest, resume, and list of two or three references to Professor Ben Bratman, Chair, Clinical Appointments Committee, at firstname.lastname@example.org. Write “Health Law Clinic Application” in the subject line of the email. The deadline for applications is September 4, 2014.
The University of Pittsburgh is an Affirmative Action/Equal Opportunity Employer and values equality of opportunity, human dignity, and diversity. Recruitment is subject to approval by the University’s Provost.
Friday, July 25, 2014
Like the recent Supreme Court decision in Hobby Lobby, the D.C. Circuit’s ruling earlier this week in Halbig v. Burwell is being hailed by conservatives and bemoaned by liberals as a death knell for Obamacare. Unlike the decision in Hobby Lobby, however the D.C. Circuit’s ruling is not the end of the matter, and many liberals are finding hope in the ruling of the 4th Circuit the same day, the probability of an en banc hearing in the D.C. Circuit, and the ultimate possibility of a favorable Supreme Court decision. In an earlier post in HealthLawProf, I decided to take seriously the possibility of damage control from a limited reading of Hobby Lobby. It is pretty much universally agreed—and I believe correctly—that it is not possible to do similar damage control by giving a limited reading to Halbig v. Burwell. If the ruling stands, that tax subsidies are not available to people purchasing coverage through the exchanges in the states that are letting the federal government do the work, many important other provisions of the ACA will be untenable, including the penalties for large employers not offering insurance whose employees receive subsidies and likely the individual mandate itself. But I think it is possible to undermine Halbig in a way not generally recognized by the liberal critics who argue (correctly) that the statutory provision at issue is ambiguous: argue that the jurisprudence of the majority opinion in Halbig is internally inconsistent. Here’s how.
Under D.C. Circuit precedent, the court must “uphold an agency action unless we find it to be ‘arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law.’” So, the question for the court was whether the IRS rule permitting individuals purchasing insurance through federally-run exchanges was arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law. In concluding that it was, Judge Griffith’s opinion for the court reasoned that it was not in accordance with law. That is, Judge Griffith found that there was no ambiguity in the relevant provision of ACA that permitted the IRS to interpret the statute as it did. Here's where much of the criticism takes him on. But there’s more to say.
In reaching the conclusion that the statutory language is not ambiguous, Judge Griffith purported to rely on a literalist approach to statutory interpretation. But he did not in fact rely consistently on such an approach—nor could he have done so. The problem is that in order to formulate the literalist question to answer, Judge Griffith had to resolve several issues in a manner that was not literalist at all.