Aaron Kesselheim is a physician and an Assistant Professor of Medicine at the Harvard Medical School. He will be speaking at the Petrie-Flom Health Law Workshop on Monday, November 18, at 5:00pm, on “Do March-In Rights Protect Public Interests in Medical Products Arising from Federally-Funded Research?”
For more details on the workshop, including information on how to obtain a copy of the paper, please visit the Petrie-Flom Center’s website.
On Friday, October 4, the Tulsa Law Review hosted a symposium titled “Health Law Policy: Legal Issues in the Evolving Healthcare Market” honoring the work of Petrie-Flom Center Founding Director Einer Elhauge. I. Glenn Cohen, current Faculty Co-Director of the Petrie-Flom Center, and Christopher T. Robertson, Visiting Professor at Harvard Law School and former Petrie-Flom Academic Fellow spoke at the event.
For more information, including a link to the event videos, click here.
By Scott Burris
(Second in a series of posts on the George Project session at APHA last week.)
Lindsay Wiley, who has been writing some interesting stuff lately about the democratic foundations of public health, used her talk to discuss Building and Honoring Coalitions in Controversial Times. Part of the George discussion has been directed to changing the public health law conversation from a set of complaints about setbacks to an exploration of new possibilities. In thinking about the pivot from challenges to opportunities, Wiley has been focusing on opportunities to protect and strengthen coalitions across progressive advocacy communities and with other potential allies.
This issue arises in a range of contexts: from health and environmental issues surrounding food production, marketing, and labeling to employers’ and private health plans’ efforts to cut costs by providing incentives for healthy behavior. Wiley’s presentation focused on recent tensions between public health advocates and civil rights, anti-poverty, and anti-hunger groups. Within the public health community, she argued, we in public health law tend to automatically see public health goals as compatible with broader social justice goals. We claim social justice as the moral foundation of public health practice and advocacy. But over the last few years – intensifying in the last several months – that synergy has been threatened.
Wiley discussed three recent controversies: the soda industry’s framing of the legal challenge to the NYC soda portion rule as a civil rights issue; anti-hunger and anti-poverty groups’ vehement opposition to proposed restrictions on the use of SNAP benefits to purchase unhealthy foods and beverages; and opposition to primary enforcement seatbelt laws based on concerns about racial profiling. Wiley’s examination of these events suggests that in some instances, the public health community needs to work more closely with civil rights and anti-poverty groups to promote a more progressive, ecological approach to public health issues and to make the case for health disparities as a civil rights and anti-poverty issue (rather than simply claiming civil rights or anti-poverty as public health issues). In other instances, public health advocates may be picking the wrong battles altogether, siding with groups who want to penalize socially and economically disadvantaged communities without working to facilitate healthier options in those communities. But in some instances, public health advocates have been able to forge compromises that result in a true win-win: promoting public health goals while also achieving reforms in other areas.
Like Wendy Parmet’s talk, described yesterday, Lindsay Wiley’s challenges the comfortable notion that public health is automatically given credit for its high moral standards and good social intentions. She doesn’t say we can’t occupy the moral high ground, but we may have to work harder to get there, and she has some practical ideas about how to do it.
Tomorrow: Renee Landers’s talk.
By Scott Burris
The “George Project” is a loose collaborative of law professors working to promote the fair and effective use of law for public health. It has been described here. Last week, four George participants formed a panel to report on their intellectual adventures in the sometimes dicey world of public health law. This week, I will report on their comments in a series of posts.
Wendy Parmet’s presentation, Beyond Paternalism: Public Health as Preemption, began by noting the agreement among George collaborators on the need to respond to the normative attacks being waged against public health laws. At the moment, the most salient of these is the “nanny-state critique,” which condemns public health law as inappropriately paternalistic. After reviewing some of the responses that scholars have offered to that charge, Parmet focused on the one recently proposed by fellow Georgians Lindsay Wiley and Micah Berman (and Doug Blanke) — namely that we need to frame public health as a manifestation of the democratic process. Parmet developed that theme by arguing that public health law is not simply a restriction of liberty, as the nanny-state critique presumes; it is also a manifestation of citizens’ positive liberty to self-govern. Or, to put it another way, public health law is the product of citizens exercising their rights to self-governance to provide the conditions by which they can be healthy.
After suggesting that public health can be viewed as an exercise of self-governance, Parmet looked briefly at two recent public health law cases. New York Statewide Coalition of Hispanic Chambers of Commerce v. N.Y.C. Department of Health, 110 A.D. 3d 1 (N.Y. App. Div. 2013), struck down New York City’s ban on large sugary sodas. Cleveland v. Ohio, 989 N.E.2d 1072 (Ohio. App. 2013), struck down an Ohio state law designed to preempt a Cleveland ordinance banning trans fats. In comparing the two cases, Parmet focused on the fact that the court in the New York case emphasized what it saw as the overreaching of a public health agency; in the Ohio case, the court noted that the state was improperly undermining the power of the city council to protect the health of Cleveland’s citizens. Although these are only two state law cases that depend on the particularities of state law, Parmet asked whether the fact that the New York City regulation emerged from an administrative agency without legislative support while the Cleveland ordinance was enacted by the city’s council was significant? Could it be that laws that emerge from a democratic process are more secure than equally paternalistic administrative regulations? More broadly, might the paternalism critique be masking a discomfort with the bureaucracy, expertise, and the administrative state?
Parmet concluded by arguing the public health needs to look in the mirror. Have we in public health undermined our own cause by treating public health law as a technical tool that experts can apply to achieve scientifically-validated outcomes? In so doing, have we lost sight of the fact that public health law is or should be a tool that citizens can use to improve the health of their own communities?
My own talk, which I will describe in a later post, was also about how public health is popular, but in the less profound sense of that word. What I really liked about this panel, and Wendy Parmet’s talk exemplified this, was the willingness not only to point out how courts and commentators are neglecting the democratic roots of public health, but also how we in public health may be settling for overly simplified (and empirically false) explanations for our legal and political setbacks.
Tomorrow: Lindsey Wiley’s talk.
Please join the Petrie-Flom Center for a lecture by Neil Flanzraich on responsible pricing strategy, access to care, clinical trial design, outsourcing, and other topics that raise thorny but crucial issues for pharmaceutical and biotechnology companies. There will be substantial time for Q&A.
Mr. Flanzraich graduated from HLS in 1968, and was appointed by Dean Martha Minow as an Expert in Residence at the Harvard Innovation Lab (i-lab) in fall 2012. He is the Executive Chairman of Kirax Corporation and the Executive Chairman of ParinGenix, Inc., both of which are privately owned biotech companies. He previously served as the Vice Chairman and President of Ivax Corporation, an international pharmaceutical company, which was sold to Teva in 2006 for an enterprise value of $10 billion.
For more information, please visit our website.
By Melissa Lopes, Fellow, Division of Medical Ethics, Harvard Medical School and Director of Research Policy and Compliance, Office of the Vice Provost for Research, Harvard University
Paul Appelbaum’s keynote address was both reflective and forward-looking in nature. He reflected back on his late ‘80s groundbreaking research introducing the concept of “therapeutic misconception” and challenged the audience to apply the results of such research to the examination of efforts to reduce this phenomenon. Therapeutic misconception manifests itself in the incorrect belief on a research participant’s part that their individualized needs will determine their treatment in clinical research and/or an unreasonable belief regarding the nature or likelihood of benefit based on the research participant’s misunderstanding of research methodology.
In a new piece at the Huffington Post, Bill of Health Contributor Dov Fox explores “The Forgotten Holding of Roe v. Wade“ — that states have a valid reason to regulate reproductive conduct because of an interest in “potential life.”
That “the State may [legitimately] assert” that interest, Roe held, “as long as at leastpotential life is involved,” explains why the government may, as a constitutional matter, restrict stem cell research that destroys human embryos, for example, whether or not those frozen embryos might otherwise be brought to term. That the fetus “represents only thepotentiality of life,” on the other hand, and accordingly lacks any interests of its own under the Constitution, explains why states may not, as many have tried, accord the legal status of personhood to human life beginning at conception.
The potential-life holding helps to resolve these and many other disputes over embryo contracts, fetal pain, and sex selection, for example, as I show in a forthcoming article. Arecent lawsuit exemplifies the enduring significance of Roe‘s potential-life holding. The case marks the first-ever federal challenge to fetal protection laws that punish women for using drugs during pregnancy.
Health Law Opportunities at Harvard Law SchoolWasserstein Hall 3019
1585 Massachusetts Ave., Cambridge, MA
1Ls and 2Ls will have the opportunity to learn more about different classes and extracurricular activities available at Harvard Law School that relate to health law. Opportunities range from classes on FDA regulation, healthcare access, and food policy, to internships and research assistance. Panelists will include:
This event is free. Lunch will be served.
Cosponsored by the Center for Health Law and Policy Innovation, the Harvard Food Law and Policy Clinic, and the Petrie-Flom Center.
By Deborah Cho
With the implementation of the Affordable Care Act, many consumers can now (or eventually…) head to HealthCare.gov to compare health insurance plans to find one that fits their needs. Health insurance plans, however, can be complicated and fraught with exceptions and exclusions that consumers learn of only when it is too late and medical bills have already started to pile up. Consumers are directed to consult member handbooks to learn their plan’s terms and conditions, but these handbooks are often nearly a hundred pages in length and densely packed with information.
Nonetheless, patients are held responsible for understanding and abiding by the terms of their plans, even if those terms are confusing and hard to fully appreciate. For example, patients are expected to know what types of medical care require prior authorization from their insurance carriers and that they must obtain approval before receiving that care. If these steps are not taken in the correct order, payment can be denied and the patient may be left to foot the bill for the services. Similarly, patients must understand that their policies may fully cover only in-network providers and must additionally know who is in-network and who is not. Because the member handbook and/or benefits document allegedly provide adequate notice, the patient is out of luck if he is not aware of these conditions.
The outcome is similar even when a medical provider or the provider’s staff does something to indicate that the medical care in question is covered by the patient’s insurance plan. This can be as simple as suggesting a specific procedure to help with the patient’s condition or even merely referring the patient to a particular specialist. A patient may accept care on the understandable yet incorrect assumption that an action recommended by his treating physician is automatically covered by his insurance plan. Though providers often verify that costly care will be covered by a patient’s insurance in order to ensure proper compensation, the instances when this does not happen can be financially devastating to patients.
So who should be responsible for knowing the ins and outs of these health insurance policies?
Video of the lecture is now available online.
Last Friday, Princeton ethicist Peter Singer joined Petrie-Flom for a lecture on “Ethics and Animals: Where are we now?” Singer began his talk with a historical look back at various religious and philosophical views of the relationship between humans and animals. He traced the lineage of thought from the view of dominion, which entails the idea that man has been granted free reign over animals by God (first found in Genesis, and also espoused by Aristotle); to the notions developed by Thomas Aquinas and Immanuel Kant, who believed that abuse of animals was not itself morally problematic except to the extent that it may inculcate bad habits in those who practice it; to the early English Utilitarians, who recognized the capacity of animals to suffer; to Charles Darwin, whose groundbreaking theory of evolution muddied previous distinctions between human and non-human animals.
Singer went on to discuss modern views of proper animal treatment. He articulated the prevailing view that humans have some obligations to treat animals well and without cruelty, but that human interests exceed those of animals. Singer then laid out his main principle regarding the treatment of animals—that of equal consideration of interests. In other words, the interests of non-human animals should be considered equally with human interests. To favor human interests over animal interests is a speciesist stance, similar in nature to other –isms, like racism and sexism, and equally morally indefensible, in Singer’s view. Singer carefully noted that while equal consideration of interests would mandate better treatment of many animals, such as those raised as livestock, his principle does not imply that humans and animals should receive the same treatment.
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