Check out the March 7 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.
American University Washington College of Law’s seventh annual Health Law & Policy Summer Institute will run from June 16 to June 28. The Institute’s flexible schedule includes day, evening, and online courses focusing on: (1) pharmaceutical law, (2) bioethics, (3) health care fraud and compliance, and (4) the economics of health care reform.
The O’Neill Institute for National and Global Health Law at Georgetown University is pleased to present two programs this summer: (1) Emerging Issues in Food and Drug Law and (2) U.S. Health Reform – The Affordable Care Act. Now in its third year, the Summer Programs will convene leading practitioners, policymakers, advocates and academics in global food and drug law and US health reform for a series of interactive lectures, panel discussions, and case studies. Held during consecutive weeks, July 14-18 (Emerging Issues in Food and Drug Law) and July 21-25 (US Health Reform – The Affordable Care Act), interested participants may attend one or both programs. Additional details, including schedule, speakers, online application, and program fees may be found here. Questions may be directed to email@example.com.
The Hamline University School of Law Health Law Institute is pleased to offer a variety of condensed health law courses taught by academic and industry experts in Saint Paul, MN. Courses include: (1) Health Care Compliance Institute, (2) Biotechnology Policy, (3) Elder Law, and (4) Health Care Fraud and Abuse. Courses will run from May 27th through June 28th. Additional information, including the application and course descriptions can be found here.
Official Press Release:
Atlanta – Georgia State University College of Law and its Center for Law Health & Society have selected 10 faculty fellows to participate in the Future of Public Health Law Education: Faculty Fellowship Program. The program is funded by the Robert Wood Johnson Foundation to foster innovations and build a learning community among those who teach public health law at professional and graduate schools. For more information, visit law.gsu.edu/phlfellowship.
The fellows, chosen from across the country, will develop interdisciplinary courses and programs in public health law at their respective universities during the fellowship year. Their projects will strengthen interdisciplinary education in public health law and promote collaborations with public health agencies and organizations in the fellows’ communities.
The fellows are:
In January, the Food and Drug Administration (FDA) approved the use of the PillCam COLON 2 as a minimally-invasive means of viewing the colon, a development that is sure to be welcomed by U.S. patients who currently undergo an estimated 14 million colonoscopies each year. While the approval represents a major step forward, the PillCam is unlikely to supplant current procedures just yet.
The colon has traditionally been examined via optical colonoscopy, a procedure perceived by many to be uncomfortable and embarrassing that involves insertion through the rectum of a 5-6 foot long flexible tube as part of an examination that can take 30 to 60 minutes. Air must be pumped in through the rectum in a process called “insufflation.” Sedatives and pain medication are generally used to help relieve discomfort. In contrast, the PillCam COLON contains a power source, light source, and two tiny cameras encapsulated in an easy-to-swallow pill that produces no pain or even sensation as it moves through the colon. Reflecting the absence of discomfort, one report from a clinical researcher noted that a few patients have insisted on X-rays to confirm that the device had passed in their stool (FDA Consumer). The pill takes about 30,000 pictures before passing naturally from the body, which usually occurs before the end of its 10-hour battery life.
The safety record of capsule endoscopy, the category to which the PillCam COLON belongs, so far appears to compare favorably with the alternatives. Capsule endoscopy may be less likely to produce accidental colonic perforations or other serious complications, which occur in less than 1% of traditional colonoscopies despite the best efforts of the treating physician. Tears of the colon wall can in turn “rapidly progress to peritonitis and sepsis, carrying significant morbidity and mortality.” (Adam J. Hanson et al., Laparoscopic Repair of Colonoscopic Perforations: Indications and Guidelines, 11 J. Gastrointest. Surg. 655, 655 (2007)). Splenic injury or other serious complications also occur rarely with optical colonoscopies. Unlike “virtual colonoscopy,” which uses computed tomography (CT) to peer into the body, capsule endoscopy does not involve bombarding the body with radiation. A leading study published in the New England Journal of Medicine reported no serious adverse events among 320 subjects given the PillCam COLON, and concluded that use of the device was “a safe method of visualizing the colonic mucosa through colon fluids without the need for sedation or insufflation.” Continue reading
I think it is fair to say that the conventional wisdom surrounding the administration’s decision to temporarily allow insurance companies to continue selling plans that do not meet the minimum standards established by the ACA to its existing beneficiaries (a.k.a., the “like it / keep it” fix) is that this decision was primarily motivated by political pressures.
Perhaps the conventional wisdom here is at least partially right. But I want to develop an additional explanation that has lurked within the news coverage — one that sounds in policy and legislative strategy (and happens to be related to a paper I’m currently writing). In short, I think it’s feasible to explain the administration’s fix as a policy that was designed to forestall an unpalatable legislative proposal that, in the president’s eyes, would have had adverse consequences for the ACA. As one might imagine, this basic strategy of using administrative leeway to preempt undesirable legislation is not novel. In fact, after the jump, I’ll recount how it was used by President Reagan to the same effect. But the larger point I want to make here is that, while some policy analysts have criticized the administrative fix due to the complications it creates for the law, when viewed in light of the alternative legislation it may have replaced, the administrative fix might be viewed as a sounder policy than we would otherwise think.
By Nathaniel Counts
In On Liberty, John Stuart Mill asserted that “[t]he only purpose for which power can be rightfully exercised over any member of a civilized community, against his will, is to prevent harm to others.” This has since become known as the harm principle and is foundational for much of American political discourse, especially for libertarianism and civil rights. At the time of Mills’ writing, On Liberty having been published in 1859, this logic could protect a lot of conduct that involved consenting adults or did not appear to directly impact others. If the harm principle was controlling, we could never have a soda ban. Today however, with our advances in social science, clear lines of harm and no harm have become fuzzy.
Few people buy cigarettes in a vacuum. Someone offers you cigarettes or you see other people smoking and then you buy cigarettes. This phenomenon, in which we make decisions based on the decisions of others in relationship to our esteem for them (if we see someone we respect smoking, we will be more likely to smoke; if we see someone we do not respect smoking, we will be less likely to smoke) is called social signaling (The Origin, Development, and Regulation of Norms is a great article on a related topic, the generation of norms, which explains this phenomenon quite well).
Tuesday, March 11, 2014, 12:00pm
Wasserstein Hall 3018, Harvard Law School, 1585 Massachusetts Ave.
The DSM is the reference used by clinicians, researchers, and insurers to diagnose and classify mental disorders, with the intent to provide specific, objective criteria by which to assess symptoms and determine whether to pay for treatment. The American Psychiatric Association released the manual’s fifth edition in May 2013, nearly twenty years after the fourth edition, to substantial public and professional criticism. Please join us for a discussion of the new revisions and their implications for patients, medical practice, research, and the law.
- Steven E. Hyman, Director of the Stanley Center for Psychiatric Research at the Broad Institute and Harvard University Distinguished Service Professor of Stem Cell and Regenerative Biology
- Anne Becker, Maude and Lillian Presley Professor of Global Health and Medicine, Harvard Medical School
- Nita Farahany, Professor of Law, Professor of Genome Sciences & Policy, and Professor of Philosophy at Duke University
- Moderator: I. Glenn Cohen, Professor of Law, Harvard Law School; Faculty Co-Director, Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics
This event is free and open to the public. Lunch will be provided. For questions, contact firstname.lastname@example.org or 617-496-4662.
This event is supported by the Oswald DeN. Cammann Fund.
Global Health Governance will be publishing a special issue on a proposed Framework Convention on Global Health (FCGH) in December 2014. The proposal for an FCGH would create a new international framework, grounded in the international human right to health, that would support health at the national and global levels.
[Ed. Note: On Friday, the Petrie-Flom Center, the Food Law and Policy Clinic (a division of the Center for Health Law and Policy Innovation), the Food Law Lab, and the Harvard Food Law Society (with support from the Top University Strategic Alliance and the Dean's Office at Harvard Law School) co-sponsored a conference at HLS called "New Directions for Food Safety: The Food Safety Modernization Act and Beyond." This week, we will be sharing a series of blog posts from the event, and video will follow shortly.]
By Jason St. John, JD candidate, Harvard Law School
The third conference session, “Regulating Farm Production: From 0 to 60,” was moderated by Robert Greenwald, Director of the Center for Health Law Policy and Innovation at Harvard Law School. To make the presentations more cohesive, the presenters divided each of their fifteen-minute presentations into two seven-minute presentations. The panel discussed the FDA’s proposed Produce Safety rule under the Food Safety and Modernization Act (FSMA), the rule’s focus on produce and growing of food, and the large question of whether FSMA makes our food safer.
Please join us on February 27 at 2:00pm in Wasserstein 1019 at the Harvard Law School as we launch Professor Frances Kamm’s latest book, Bioethical Prescriptions: To Create, End, Choose, and Improve Lives (Oxford University Press, January 2014). The book showcases Professor Kamm’s articles on bioethics as parts of a coherent whole, with sections devoted to death and dying; early life (on conception and use of embryos, abortion, and childhood); genetics and other enhancements (on cloning and other genetic technologies); allocating scarce resources; and methodology (on the relation of moral theory and practical ethics).
- Frances Kamm, Littauer Professor of Philosophy & Public Policy, Harvard Kennedy School of Government; Professor of Philosophy, Faculty of Arts & Sciences, Harvard University; Former Senior Fellow, Petrie-Flom Center
- Norman Daniels, Mary B. Saltonstall Professor of Population Ethics and Professor of Ethics and Population Health, Harvard School of Public Health
- Thomas (Tim) Scanlon, Jr., Alford Professor of Natural Religion, Moral Philosophy, and Civil Polity, Faculty of Arts & Sciences, Harvard University
- Moderator: Christopher T. Robertson, Visiting Professor of Law, Harvard Law School; Associate Professor, James E. Rogers College of Law, University of Arizona
This event is free and open to the public. For questions, please contact email@example.com or 617-496-4662.
Sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics; Edmond J. Safra Center for Ethics at Harvard University; and the Countway Library of Medicine at Harvard Medical School; with support from the Oswald DeN. Cammann Fund.
Peter Orszag has a nice piece on the future of medical malpractice reform. In it he gives a big shout-out to former Petrie-Flom fellow (now Cornell Law Prof) Mike Frakes and discusses papers Mike worked on while at the Center. Hopefully policymakers are listening. From Orszag’s piece:
Capping damages for medical malpractice can do little to solve this problem, but changing the standard against which doctors are evaluated would. In particular, doctors should have a safe harbor from malpractice suits if they follow evidence-based protocols published by a professional medical association. The Center for American Progress and others have proposed exactly this type of approach, and have also provided details about how it could work.
Professor Michael Frakes of Cornell Law School has done pathbreaking research on the benefits of moving away from customary-practice rules. In a new analysis, Frakes and Anupam Jena, a professor of health-care policy at Harvard Medical School, examine how malpractice laws affect mortality rates, avoidable hospitalizations, adverse events to mothers during childbirth and other measures of health-care quality. They then assess two types of reforms: changes to damages caps and changes to the local customary-practice standard.
In connection with our work on a sponsored research project with the National Football League Players Association, the Petrie-Flom Center seeks to hire a Senior Law and Ethics Associate immediately. (Please note that this is a distinct position from the one we recently advertised working with Harvard Catalyst on clinical and translational research.)
We are seeking a full-time doctoral-level hire (J.D., M.D., Ph.D., etc. in law, ethics, public health, social science, or other relevant discipline) with extensive knowledge of and interest in legal and ethical issues related to the health and welfare of professional athletes. The position will be funded for at least two years, with renewal likely for an additional year or more.
View the full job description and apply here.
For questions, contact firstname.lastname@example.org or 617-496-4662.
Patent applicants seeking to gain global patent protection beyond their home country borders need a better comparative knowledge of key elements of the patent laws of the several countries. Professor Timo Minssen in his superb doctoral thesis directly challenges the seemingly identical statutory and treaty standards for patentability in Europe and the United States in his comparative study of the laws of Europe and the United States with respect to the treaty standard of an “inventive step.” Timo Minssen, ASSESSING THE INVENTIVENESS OF BIOPHARMACEUTICALS UNDER THE EUROPEAN AND U.S. PATENT LAWS (Goteborg, Sweden: Ineko AB 2012). Professor Minssen’s doctoral thesis represents required reading for anyone seeking to unmask the subtle differences between American and European practice (emphasis added).
In yesterday’s NY Times Op-Ed page Marcy Darnovsky writes about FDA’s consideration of mitochondrial manipulation therapies later this week. As she describes it:
The F.D.A. calls them mitochondrial manipulation technologies. The procedures involve removing the nuclear material either from the egg or embryo of a woman with inheritable mitochondrial disease and inserting it into a healthy egg or embryo of a donor whose own nuclear material has been discarded. Any offspring would carry genetic material from three people — the nuclear DNA of the mother and father, and the mitochondrial DNA of the donor.
As she writes in her opinion:
Some media accounts about these techniques have misleadingly referred to “saving lives,” as if they were aimed at people who are sick and suffering. Others have failed to note how very few women would be candidates for even considering them. And they could turn to safer and simpler alternatives. An affected woman could adopt or use in vitro fertilization with another woman’s eggs. Of course, the resulting child would not be genetically related to her, but neither would the child be put at grave risk by an extreme procedure.
The F.D.A. advisory panel says that its meeting will consider only scientific aspects of mitochondrial manipulation and that any “ethical and social policy issues” are outside its scope. But those are precisely the issues that we must address. Simply being able to do something doesn’t mean we should do it.
That conclusion is a bit pat, though I don’t fault her too much given how tight op-ed word limits are, and maybe a tad reactionary. I do think she raises an interesting point about how this is not saving lives, though I think so for different reasons.
Check out the February 21 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.
This one-day conference will bring together experts in food law and regulation to discuss a range of issues including food safety, agriculture, risk regulation strategy, and international issues.
- Keynote: Peter Barton Hutt, Harvard Law School/Covington & Burling
- Alli Condra, Food Law and Policy Clinic, Harvard Law School
- Marsha Echols, Howard University School of Law
- Jacob E. Gersen, Food Law Lab, Harvard Law School
- Lewis Grossman, Washington College of Law, American University
- Ching-Fu Lin, Petrie-Flom Center, Harvard Law School
- Sharon Mayl, Senior Advisor for Policy, FDA Office of Foods and Veterinary Medicine
- Kuei-Jung Ni, Petrie-Flom Center, Harvard Law School/Institute for Technology Law, National Chiao Tung University, Taiwan
- Margot Pollans, Resnick Food Law and Policy Program, UCLA School of Law
- Michael Roberts, Resnick Food Law and Policy Program, UCLA School of Law
- Denis Stearns, Seattle University School of Law
- Stephanie Tai, University of Wisconsin School of Law
For the full agenda, including paper titles, please visit our website.
This event is free and open to the public, but space is limited and registration is required. To register, please click here.
For questions contact email@example.com or 617-496-4662.
Sponsored by the Petrie-Flom Center; the Food Law and Policy Clinic (a division of the Center for Health Law and Policy Innovation); the Food Law Lab; and the Harvard Food Law Society; with support from the Top University Strategic Alliance and the Dean’s Office at Harvard Law School.
On the misuse of antibiotics
“We should think of this as a global resource that needs to be conserved and taken care of. So antibiotics should never be used inappropriately. In the country right now, we have something on the order of 23 million people who are getting antibiotics for ear aches. Most of those situations would resolve on their own in a couple of days. We also give antibiotics many times for people just because they have some sort of a common cold — it’s estimated 18 million prescriptions a year — doesn’t help anyone who has the common cold. It’s a complete waste.”
On the rise of antibiotic-resistant bacteria
“It’s frightened people for more than a decade. You mentioned at the top the 23,000 Americans who are dying from resistant infections. The CDC said on top of that, there’s another 14,000 dying from a horrible disease, intestinal disease, called Clostridium difficile [C-diff] in the United States. Together, that’s larger than the number of people who die in this country each year from AIDS. And we’re not — as bad as things are now, the more troubling aspects, or what might happen in five or 10 years if some sort of a pathogen was resistant to everything we had got out to the population. It sounds like a Hollywood movie.”
You can listen to the full interview here.
In November of 2013, CMS became concerned that hospitals and other providers might help their patients purchase insurance by contributing to their premium payments or cost-sharing obligations. The motivation for providers was clear: if the amount they could expect to receive from an uninsured patient (likely very little, if anything) was less than the difference between the reimbursements from an insurer and the contribution the provider made to the patient’s insurance payments, it would be profitable for providers to contribute. CMS’s concern was also clear: if hospitals began paying for their patients’ insurance, they would likely be cherry-picking the sickest patients with the highest expected reimbursements, which would skew the risk pool for all consumers. So CMS issued a guidance discouraging insurers from accepting those third-party payments from providers.
What CMS did not say was that insurers should stop accepting all third-party payments. This was a point that CMS has had to clarify in light of the decision by several insurers in Louisiana–including BlueCross BlueShield of Louisiana (BCBS-LA), the largest insurer in the state–to refuse third-party payments from anyone (aside from immediate family members/blood relatives or legal guardians). Importantly, this includes the government, which provides grants through the Ryan White Program to low-income citizens with HIV/AIDS. The motivation for insurers is clear: they don’t want to have to continue paying for expensive medical care required by people with HIV/AIDS. But this desire runs directly contrary to the government’s intention to help provide insurance coverage through Ryan White grants to people with HIV/AIDS who could not otherwise afford it.
After the jump, I’ll discuss the Louisiana insurers’ response to CMS’s clarification:
By Nathaniel Counts
If, out of concern for public health, the government banned potato chips today, a lot of people would get very angry. Only some of these people would be angry because they missed potato chips. For most it would be the principle of the thing – the government should not interfere with our autonomy to eat whatever we want, as long as it does not harm others, and some days this will include potato chips. I would posit that the autonomy at issue here is a narrow understanding of autonomy, and one that we should be suspicious of.
Imagine yourself in the biggest Costco in the world. It has every food in existence and they are all placed equidistant from you, and you may survey the scene and choose whatever food you most desire and then eat it. This would be true autonomy. The world we live in, however, is deeply constrained and we should question how meaningful our autonomy is.
In reality, every time someone who came to the Costco before you made a purchase, the store owners moved the product a little bit closer to you, and manufacturers began shipping more variants of it. The decisions that determined the composition of your commercial world were made over hundreds of years by individuals with no understanding of health – diet and exercise, hypertension and heat disease all being foreign concepts until recently. Today potato chips, in all their variety, take up quite a lot of shelf space, and healthful foods are hard to come by.
February 19, 2014 12:00 PM Wasserstein Hall 1015
1585 Massachusetts Ave., Cambridge
In the pharmaceutical industry, patents are the preeminent incentive for innovation in developing new drugs. But patents aren’t the whole story; regulatory agencies also offer different forms of exclusivity—enforced by the agencies themselves—to encourage different forms of innovation in the industry. This panel will discuss actual and potential roles for those rewards in the context of developing new drugs, new uses for old drugs, and new ways to make drugs, in both the United States and the European Union. Panelists include:
- Benjamin N. Roin, Hieken Assistant Professor in Patent Law, Harvard Law School; Faculty Co-Director, the Petrie-Flom Center
- W. Nicholson Price II, Academic Fellow, the Petrie-Flom Center
- Timo Minssen, Associate Professor, University of Copenhagen Faculty of Law; Visiting Scholar, the Petrie-Flom Center
- Moderator, Aaron Kesselheim, Assistant Professor of Medicine, Harvard Medical School; Director of the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital
This event is free and open to the public. Lunch will be served. For questions, contact firstname.lastname@example.org or 617-495-2316.