The Petrie-Flom Center is pleased to welcome our new 2014-2015 Student Fellows. In the coming year, each fellow will pursue independent scholarly projects related to health law policy, biotechnology, and bioethics under the mentorship of Center faculty and fellows. They will also be regular contributors here at Bill of Health on issues related to their research.
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.
Amidst news from Spain that a 75-year-old Catholic priest has received the experimental treatment ZMapp for Ebola, Art Caplan critiques what he describes as the “bad science” behind choosing its recipients:
ZMapp is not the answer to the Ebola epidemic ravaging West Africa. There is no chance of getting a significant amount of this drug made for many months. Deploying more health care workers, face guards, moon suits, gloves and antiseptic, along with restrictions on travel and burying the dead, is the only way to get the epidemic under control. [...]
The fact that a 75-year-old has been given the scarce drug is especially disturbing, not because he is 75 but because 75-year-olds do not have strong immune systems — something very important in battling a virus like Ebola. Moreover 75-year-olds often have other medical problems that complicate the ability of scientists to figure out if the drug is safe and if it is really working.
In testing unapproved, highly risky drugs like ZMapp, it is crucial that recipients not be so sick that they may well die regardless of whether they get the drug or not. Indeed, the recipients ought not be very sick so that side-effects can be seen and efficacy determined. To do that, doctors need to be able to monitor experimental subjects for months to make sure the drug does not damage their livers or cause any other fatal side-effect. So not every person infected with Ebola makes for the best recipient — younger, those more recently infected and those who can be closely monitored are among the “best” candidates.
You can read more of Art Caplan’s perspective on NBC News Health here.
Earlier this week, the World Health Organization, responding both to the international outcry over the rapidly rising number of Ebola cases and deaths across sub-Saharan Africa (and critiques of the speed of their action), and the news that western health care workers and ministry had found ways to get access to the untested-in-humans Ebola drug ZMapp, convened a panel of ethicists to offer recommendations on more widespread use of experimental Ebola treatments.
The issues considered by the ethicists included:
1) Whether it is ethical to use unregistered interventions with unknown adverse effects for possible treatment or prophylaxis. If it is, what criteria and conditions need to be satisfied before they can be used?
2) If it is ethical to use these unregistered interventions in the circumstances mentioned above, then what criteria should guide the choice of the intervention and who should receive priority for treatment or prevention?
We are excited to introduce Jonathan F. Will as a regular contributor to Bill of Health.
Jonathan is an Associate Professor of Law and is the founding director of the Bioethics & Health Law Center at Mississippi College School of Law. He is also on the affiliate faculty of the Center for Bioethics and Medical Humanities at the University of Mississippi Medical Center. Jonathan teaches upper level courses in Health Law and Bioethics, and has been voted 1L Professor of the Year for his section of Civil Procedure five times since joining MC Law’s faculty in 2009. In addition to commenting for the American Journal of Bioethics, his recent work focuses on reproductive rights and the implications of the nationwide personhood movement.
Much attention has been paid recently to the contradicting decisions issued on the Halbig and King cases, which challenged the Obamacare subsidies offered to individuals purchasing insurance on federal exchanges. In a piece for Politico Magazine, Abbe R. Gluck finds a weakness in the Halbig plaintiffs’ arguments, in their own words. As Gluck writes:
What’s less known, however, is that in the 2012 constitutional case, these same challengers filed briefs describing Obamacare to the court in precisely the way they now say the statute cannot possibly be read. Namely, they assumed that the subsidies were available on the federal exchanges and went so far as to argue that the entire statute could not function as written without the subsidies. That’s a far cry from their argument now that the statute makes crystal clear that Congress intended to deny subsidies on the federal exchanges.
I am not a fan of the “gotcha” flavor that some aspects of this case have taken on, but the challengers’ 2012 statements are relevant as a legal matter because what the government has to prove to win—as a matter of black-letter law under the Chevron doctrine—is that the statute is ambiguous. (Chevron says that federal courts defer to the relevant agency’s reading of the statute when a federal statute is unclear—here, that agency is the IRS.)
The challengers have spent more than a year arguing that no reasonable reader of text could construe the statute in any way other than denying federal subsidies to insurance purchasers on exchanges operated by the federal government. But what about their statements from 2012—statements then echoed by Justices Scalia, Kennedy, Thomas and Alito in their joint dissent to the Supreme Court’s ruling in the constituitional challenge, NFIB v. Sebelius?
You can read more, including the relevant passages from the NFIB v. Sebelius briefs, here.
By Alex Stein
As I wrote in my book with Ariel Porat, Tort Liability Under Uncertainty, our torts system must develop systematic remedy for wrongful inflictions of evidentiary harm.
The Florida Supreme Court’s recent decision, Saunders v. Dickens, — So.3d —- (Fla. 2014), is a case in point. Continue reading
As the WHO announced today that medical ethicists will convene next week in New York to discuss the use of experimental medicines in the West African Ebola outbreak, Art Caplan has a timely new opinion piece in the Washington Post asking why only white American victims of the Ebola outbreak have been treated with an experimental serum. Caplan argues that the decision was a question of economics:
The reasons for different treatment are partly about logistics, partly about economics and, partly about a lack of any standard policy for giving out untested drugs in emergencies. Before this outbreak, ZMapp had only been tested on monkeys. Mapp, the tiny, San Diego based pharmaceutical company that makes the drug stated two years ago: “When administered one hour after infection [with Ebola], all animals survived…Two-thirds of the animals were protected even when the treatment, known as Zmapp, was administered 48 hours after infection.”
But privileged humans were always going to be the first ones to try it. ZMapp requires a lot of refrigeration and careful handling, plus close monitoring by experienced doctors and scientists—better to try it at a big urban hospital than in rural West Africa, where no such infrastructure exists. [...]
But it’s about more than logistics. Drugs based on monoclonal antibodies usually cost a lot—at least tens of thousands of dollars. This is obviously far more than poor people in poor nations can afford to pay; and a tiny company won’t enthusiastically give away its small supply of drug for free. It is likely that if they were going to donate drugs, it would be to people who would command a lot of press attention and, thus, investors and government money for further research—which is to say, not to poor Liberians, Nigerians or Guineans. [...]
To get Caplan’s full perspective, read the full article.
In Part II of this blog on legal issues relating to the revival of phage therapy I discussed the US Supreme Court’s decisions in Myriad and Prometheus, which might present major obstacles to the patentability of phage-related technology (a more detailed analysis of the Myriad and Prometheus decisions is available here).
Yet, all is not lost. As indicated in Part II, Myriad does not directly affect the patentability of synthetically modified biological compounds and Prometheus would still allow patents on inventive applications of natural processes and correlations that add new features to “natural laws”. Thus there still seems to be considerable leeway for patenting within the area of page therapy.
One example, mentioned in a recent Nature article, could be the skillful selection and precise combination of different phages in order to attack one specific type of bacteria. Such selections, however, would face a tough battle to overcome the “additional features that add significantly more” and “not identical” thresholds set by Prometheus and Myriad. Another example with even better prospects for patentability relates to genetically modified phages that are – due to human intervention – enabled to target only specific bacteria. This technology was recently presented by MIT researchers at the 2014 American Society for Microbiology Meeting. The researchers led by Timothy Lu had genetically engineered phages that use a DNA-editing system called CRISPR to target and kill only antibiotic-resistant bacteria while leaving other susceptible cells untouched. The significant engineering and alteration of natural products and processes involved in such inventions would most likely meet both the Myriad and Prometheus standards.
Yet, while the USPTO has recently issued new patent eligibility guidance and the CAFC has begun to directly apply Prometheus and Myriad to reject patent claims in biotech cases (e.g. In re Roslin), many questions remain unsolved. In particular, it is still not sufficiently clear exactly how much modification is required to render a molecule or method sufficiently distinct from naturally occurring product and processes. And even if the patent-eligibility threshold could be met in extraordinarily circumstances, the claimed invention would still have to fulfil other patentability requirements such as novelty, non-obviousness and the written description-requirements. The threshold for these requirements, however, have been heightened in recent years (see e.g. KSR v. Teleflex (2007) , Nautilus (2014) etc.). Considering that phage therapy is almost a century old with a substantial common general knowledge and a state of the art employing routine methods, these crucial requirements might still prevent the patentability of many useful applications.
Check out the August 8th 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.
Three days ago I commented on a couple of legal issues raised in the recent Nature report “Phage therapy gets revitalized” by Sara Reardon. One challenge concerns the reluctance of pharma companies to broadly invest in the development of phage therapies. As pointed out in the report, this does of course very much (but not only) relate to the question of patentability. Various aspects might present obstacles to the patentability of technology relating to phage therapy. To not complicate the discussion and considering recent developments I decided to focus on some of aspects under US patent law.
Like in Europe, the first door to patentability that phage-related technology would need to pass concerns patent eligibility. In the last years the US Supreme Court has rendered an astonishing number of fundamental patent-decisions, including not less than four (!) landmark judgments on patent eligibility, i.e. Bilski v. Kappos (2010), Mayo v. Prometheus (2012) , AMP v. Myriad (2013) and Alice v. CLS (2014). Most relevant in this context are the decisions in Prometheus and Myriad.
Art Caplan has a new opinion piece on NBC News responding to the recent media coverage of Ebola. He makes the case that although this has been the worst recorded outbreak of the disease, citizens of developed countries have little reason to panic:
Ebola is not going to run amok in downtown Boston, Cape May or Myrtle Beach or anywhere else in the U.S. It is running amok in poor African nations because local authorities did not have the will or the resources to respond quickly, because no one confronted local funeral customs that expose people to Ebola, mainly because the world did not care much if hundreds died in poor, politically insignificant nations.
The harsh ethical truth is the Ebola epidemic happened because few people in the wealthy nations of the world cared enough to do anything about it.
Read the full article.
By Bob Bohrer
An interesting development, reported in FiercePharma and originally by Reuters, on litigation between AbbVie and GlaxoSmithKline over AbbVie’s price increases on one of its combination drugs for HIV– the FiercePharma link is here.
- 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.
We are excited to introduce Diana R.H. Winters as an occasional contributor to Bill of Health.
Diana has been an Associate Professor at Indiana University McKinney School of Law since 2012. She joined McKinney Law from Boston University Law School, where she was a Visiting Assistant Professor and the Health Law Scholar. Before that, Winters was an Assistant Solicitor General in the New York State Attorney General’s Office. Winters is also a founding board member of the Indianapolis (Indy) Food Council. She is currently researching the structure of food regulation, and the judicial review of health and safety regulation. She teaches Torts, Health Law, Environmental Law, and Food Law and Policy.
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.
Bill of Health Contributor Art Caplan and ethicist Kelly McBride have launched a new twice-weekly podcast, Everyday Ethics, in which they explore the moral dimensions of our everyday lives. Recent topics have included conflicts of interest on Dr. Oz, recent “Right to Try” laws, and Jenny McCarthy’s anti-vaccination campaigns.
You can access the podcast online here, or subscribe to it on iTunes.
We’re pleased to formally introduce Dr. Greg Curfman as a contributor to Bill of Health. Dr. Curfman is already a familiar face here as a regular guest, and we’re thrilled to officially welcome him.
Dr. Curfman is currently the executive director of the New England Journal of Medicine, a position he has held for 14 years. In his tenure at NEJM, he has founded and currently directs the Perspective section, which focuses on issues at the interface of medicine and society. His work at NEJM has played a critical role in driving the national dialogue on health care.
A board-certified internal medicine physician and cardiologist, Dr. Curfman is also an assistant professor of medicine at Harvard Medical School. He graduated magna cum laude from Princeton University and received an M.D. cum laude from Harvard Medical School. Dr. Curfman has previously served as the director of the coronary care programs at the Brigham and Women’s Hospital and Dartmouth-Hitchcock Medical Center, and was also medical director at the Cardiovascular Health Center at Mass General.
Dr. Curfman regularly publishes on current topics in health law and the regulation of medical products. His publications include: Continue reading
[Ed. Note: Cross-posted from Reproductive Rights Prof Blog]
Today, U.S. District Judge Myron Thompson issued a decision – following a 10-day bench trial – declaring unconstitutional Alabama’s admitting privileges requirement for abortion providers. The decision is remarkable in at least two respects. First, Judge Thompson employs a brilliant interpretation of Planned Parenthood v. Casey that is different from any lower court opinion I have seen and yet that is well-grounded in the decision. (He had already laid out this framework in an earlier ruling on summary judgment.) It resolves a longstanding puzzle about the undue burden standard, namely whether and how a court should factor in the state’s burden of justification for an abortion restriction when it conducts an undue burden analysis. Judge Thompson focuses in on a little-noticed aspect of Casey, namely its reliance on ballot-access case law. The Casey joint opinion analogizes to the states’ “substantial flexibility in establishing the framework within which voters choose the candidates for whom they wish to vote,” in order to explain why “not every law which makes a right more difficult to exercise is, ipso facto, an infringement of that right.” Yet, in describing the state’s power to regulate elections as “similar” to its power to regulate abortion, the Court suggests that its analysis in the ballot access cases is instructive in the abortion context.
Judge Thompson takes up this suggestion. He points out that, in the specific cases that the Casey joint opinion cites, the Court looked at whether the state’s interest in the election regulation was “sufficiently weighty” to justify the restriction it imposed. In Anderson v. Celebrezze, for example, the Court explained that, when analyzing constitutional challenges to specific provisions of a state’s election laws, the Court
must first consider the character and magnitude of the asserted injury to the rights . . . that the plaintiff seeks to vindicate. It then must identify and evaluate the precise interests put forward by the State as justifications for the burden imposed by its rule. In passing judgment, the Court must not only determine the legitimacy and strength of each of those interests, it also must consider the extent to which those interests make it necessary to burden the plaintiff’s rights. Only after weighing all these factors is the reviewing court in a position to decide whether the challenged provision is unconstitutional.
Judge Thompson applies this framework, first analyzing the burden that Alabama’s admitting privileges requirement would impose on abortion access in the state. Finding that the burden would be substantial, he then closely examines the state’s purported justifications for the law and concludes that they are “exceedingly weak.”