Wednesday, September 28, 20123-4:30 pm (reception to follow)Austin 111, Harvard Law SchoolExperimental breakthroughs within the field of regenerative medicine are reported in the media on a daily basis worldwide. Despite this progress, the overwhelming majority of clinical problems for which stem cell-based intervention offers hope remain therapeutically unproven, and a major gap exists between current public understanding and the availability of innovative therapies. This event will feature a distinguished panel of speakers addressing various aspects of medical tourism for stem cell therapy. Presentations will cover the state of stem cell science, historical context and comparisons related to earlier instances of medical utopianism, empirical data on the nature of stem cell tourism, how to address patient hopes in the realm of unproven therapies, and special issues related to stem cell tourism by parents for their children. The event will be moderated by M. William Lensch, Harvard Stem Cell Institute. Speakers and topics include:
There will be substantial time set aside for audience Q&A, and the conversation will continue after the event at an open reception. This event is free and open to the public. Co-sponsored by the Harvard Stem Cell Institute and the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School. |
Category: Petrie-Flom Center
Petrie-Flom Interns’ Weekly Round-Up: 11/10-11/16
By Hyeongsu Park and Kathy Wang
- States were supposed to tell the administration by this Friday whether to create health insurance exchanges, online markets for private health insurance subsidized by the federal government (NY Times article here). Last Friday, the Obama administration extended the deadline for plans for health insurance exchanges to December 14, but governors still had to submit “letters of intent” by Friday. However, on Thursday, the day before the deadline, the administration extended the deadline to submit “letters of intent” to December 14. As of November 15, several states remained undecided on the issue, including Tennessee, Pennsylvania, Idaho, New Jersey, Oklahoma, Arizona, and Florida.
- On November 13, nine Republican state lawmakers of Wisconsin said that they support a bill to arrest any federal officials who attempt to implement the Affordable Care Act in the state. However, Governor Scott Walker does not agree.
- On Wednesday, Barry Cadden, co-owner of the Framingham pharmacy whose drugs have been linked to the deadly meningitis outbreak that killed at least 32 people, invoked his Fifth Amendment rights and declined to answer questions during a congressional hearing on the outbreak.
- While lawmakers condemn compounding pharmacies for a deadly meningitis outbreak originated from contaminated medications, the top lobbyist representing these drugmakers says that Congress does not need new laws to oversee the compounding industry. A NY Times article reported that over two decades, these drugmakers have repeatedly avoided tougher federal oversight with the help of powerful allies in Congress.
- On Friday, the government said that Medicare premiums are going up from $99.90 a month to $104.90 a month in 2013.
- The Office of Inspector General under the U.S. Department of Health and Human Services reported that nursing homes billed about a quarter of claims incorrectly in 2009 and that taxpayers overpaid about $1.5 billion.
- ‘Fat tax,’ or a tax charged on foods high in saturated fats, was repealed after one year, in response to heavy criticism from industries. Also, the Danish tax ministry cancelled its plans for a sugar tax.
- In Ireland, the death of a woman who was reportedly denied an abortion even when she was having a miscarriage renewed the fight over the ban on abortions. On Wednesday, thousands of people rallied outside Ireland’s parliament to demand strict abortion rules be eased.
Reminder, TODAY – The Guatemala STD Inoculation Studies: What Should We Do Now?
TODAY
12:30-2:00
Wasserstein Hall, Classroom 3019
Harvard Law School
In the late 1940s, US and Guatemalan researchers conducted a host of experiments on vulnerable Guatemalan subjects, purposefully exposing them to, and infecting them with a number of STDs without their consent. The experiments were kept hidden for more than half a century, until they were discovered and exposed only recently by historian Susan Reverby. The US government has since apologized for what happened, but a class action suit brought on behalf of the Guatemalan subjects was dismissed in June and efforts to directly compensate the victims have not been forthcoming. Please join Harvard Law School’s Petrie-Flom Center and Human Rights Program for a panel discussion of the study and possible legal and political responses that may be available now, both domestically and from an international human rights perspective. Panelists will include:
- Susan Reverby, Marion Butler McLean Professor in the History of Ideas, Professor of Women’s and Gender Studies, Wellesley College
- I. Glenn Cohen, Assistant Professor of Law, Faculty Co-Director, Petrie-Flom Center, Harvard Law School
- Holly Fernandez Lynch, Executive Director, Petrie-Flom Center, Lecturer on Law, Harvard Law School
- Wendy Parmet, George J. and Kathleen Waters Matthews Distinguished University Professor of Law, Northeastern University School of Law
- Fernando Ribeiro Delgado, Clinical Instructor and Lecturer on Law, Human Rights Program, Harvard Law School
This event is free and open to the public. Lunch and refreshments will be served.
Reminder: Abstracts for Petrie-Flom Annual Conference Due 12/10/12
Just a reminder, abstracts for the Petrie-Flom Center’s annual conference – this year entitled “The Food and Drug Administration in the 21st Century” – are due no later than December 10, 2012. This one and a half day event will take place Friday and Saturday, May 3-4, 2013, at Harvard Law School in Cambridge, Massachusetts.
For further details, see the Call for Papers/Presentations.
Bill of Health Interview with Einer Elhauge on Health Care Reform
As you have already heard a few times on this blog, Professor Einer Elhauge, the Petrie-Flom Center’s Founding Faculty Director and Petrie Professor of Law at Harvard Law School, has a new book out on health care reform called Obamacare on Trial. The book collects various essays that Prof. Elhauge published in popular media outlets, along with several postscripts, and it has received all sorts of glowing praise.
Prof. Elhauge has graciously agreed to answer some questions for us in the first ever Bill of Health e-interview. Check it out:
Bill of Health: So, first things first, did the Supreme Court get it right in NFIB v. Sebelius?
Prof. Elhauge: The Supreme Court got the tax issue right, and I think the Medicaid expansion as well, but I think the Supreme Court got the commerce clause issue totally wrong. Worse, the way they got it wrong portends trouble for the future.
Bill of Health: What were you most surprised by in the SCOTUS decision?
Prof. Elhauge: The fact that a majority of the Supreme Court was willing to use a methodology that clearly expanded judicial discretion to overrule the political branches, and that no one really ever called them on it either on the Supreme Court or in the briefing.
Bill of Health: You’ve noted that you didn’t originally take the constitutional challenges to the Affordable Care Act seriously. Why do you think they were able to gain such traction?
Prof. Elhauge: I think the big problem was that the government never directly rebutted either the claim that purchase mandates were unprecedented or the dreaded broccoli hypothetical. Instead they tried to evade the question, I guess because they thought it was unfavorable to them, but the iron rule of litigation is that if you don’t discuss your problematic issues, then you leave your opponents to be the only one that discusses them, and they are sure to frame them in the way most unfavorable to you. The government’s unwillingness to engage this issue left the Supreme Court with the entirely false impression that Obamacare fundamentally changed the relationship between the individual and government, and that thus the government faced a heavy burden to justify the health insurance mandate. I think the government should’ve directly argued that in fact federal purchase mandates were not at all unprecedented, but rather that health insurance mandates went all the way back to the framers, who adopted two health insurance mandates in the 1790s in Congresses that had many framers on them. The government should’ve also pointed out that the argument that courts can, in the name of “limiting principles”, create brand-new restrictions on congressional power that have no basis in the Constitution in order to restrain the possibility that Congress might exercise a power in a silly way, like adopting a broccoli mandate, amounts to a remarkable usurpation of political power by the judicial branches. One could equally say that because Congress might pass silly laws like a law prohibiting the purchase of broccoli, the federal courts should impose a new constitutional limit that prevents Congress from ever restricting commerce. Or because Congress might tax 100% of our income to buy broccoli or go to war to get more broccoli, the Supreme Court should invalidate Congress’s power to tax or declare war. The “limiting principles” argument that was employed here ironically has no limiting principle and looks benign but is actually a wolf in sheep’s clothing.
Upcoming Event – The Guatemala STD Inoculation Studies: What Should We Do Now?
Tuesday, November 13, 2012
12:30-2:00
Wasserstein Hall, Classroom 3019
Harvard Law School
In the late 1940s, US and Guatemalan researchers conducted a host of experiments on vulnerable Guatemalan subjects, purposefully exposing them to and infecting them with a number of STDs without their consent. The experiments were kept hidden for more than half a century, until they were discovered and exposed only recently by historian Susan Reverby. The US government has since apologized for what happened, but a class action suit brought on behalf of the Guatemalan subjects was dismissed in June and efforts to directly compensate the victims have not been forthcoming. Please join Harvard Law School’s Petrie-Flom Center and Human Rights Program for a panel discussion of the study and possible legal and political responses that may be available now, both domestically and from an international human rights perspective. Panelists will include:
- Susan Reverby, Marion Butler McLean Professor in the History of Ideas, Professor of Women’s and Gender Studies, Wellesley College
- I. Glenn Cohen, Assistant Professor of Law, Faculty Co-Director, Petrie-Flom Center, Harvard Law School
- Holly Fernandez Lynch, Executive Director, Petrie-Flom Center, Lecturer on Law, Harvard Law School
- Wendy Parmet, George J. and Kathleen Waters Matthews Distinguished University Professor of Law, Northeastern University School of Law
- Fernando Ribeiro Delgado, Clinical Instructor and Lecturer on Law, Human Rights Program, Harvard Law School
This event is free and open to the public. Lunch and refreshments will be served.
Reminder, TODAY – Advances in HIV Prevention: Legal, Clinical, and Public Health Issues
TODAY!
12-1:30pm
Austin Hall, Room 111
Harvard Law School
On July 3, 2012, FDA approved OraQuick, the first at-home HIV test available for sale directly to consumers, allowing individuals to self-test and receive confidential results in about 20 minutes. Then on July 16, FDA approved once-daily Truvada, an already-approved HIV therapy, as the first agent approved for pre-exposure prophylaxis in uninfected, at-risk adults. These developments represent dramatic changes in the fight against HIV, and raise a host of legal, clinical, and public health issues. Please join us for a panel discussion of these issues with some of the preeminent leaders in the field, moderated by Robert Greenwald, Director of the Center for Health Law and Policy Innovation at Harvard Law School:
- Douglas A. Michels, President and CEO, OraSure Technologies, Inc.
- David Piontkowsky, Senior Director for Medical Affairs, HIV and HIV Global Medical Director, Gilead Sciences, Inc.
- Kenneth H. Mayer, Medical Research Director, Co-Chair of The Fenway Institute
- Kevin Cranston, Director, Bureau of Infectious Disease, Massachusetts Department of Public Health
- Mark Barnes, Senior Associate Provost, University Chief Research Compliance Officer, Harvard University
This event is free and open to the public. Lunch and refreshments will be served. Co-sponsored by the Petrie-Flom Center, the Center for Health Law and Policy Innovation, and the Fenway Institute.
Petrie-Flom Interns’ Weekly Round-up: 10/27 – 11/02
By Hyeongsu Park and Kathy Wang
- Uruguay’s Senate approved a bill that allows women to have abortions during the first trimester of pregnancy for any reason. Read the NY Times article about the topic here.
- Another NY Times article reported on October 27 that the nationwide health insurance plans sponsored by the federal government, included as part of the Affordable Care Act, will be available to consumers in every state soon. The article can be found here.
- On November 1, the U.S. Centers for Disease Control and Prevention (CDC) reported that 28 people have now died and 386 have been sickened in the ongoing fungal meningitis outbreak linked to contaminated steroid injections from a Massachusetts specialty pharmacy. Read the US News article about the outbreak here. Current case count for the multistate fungal meningitis outbreak, updated daily by the CDC, can be found here.
- The British Medical Journal has announced that, beginning in January, it will no longer publish the results of clinical trials unless drug companies and researchers agree to provide detailed study data on request.
- Researchers at the NYU Langone Medical Center in New York City are worried that cells, tissues, mice, and rats used for medical research may have been lost as the Medical Center has been without power since Monday after superstorm Sandy struck. Read an NPR article about the story here.
- The annual growth in spending on Medicaid slowed sharply last year as the economy began to improve, a survey by the Kaiser Family Foundation found. The slowdown is due not only to more measured enrollment growth but also to continued cost-cutting by states.
- In response to the recent meningitis outbreak, Massachusetts adopted new regulations on Thursday to keep a closer eye on compounding pharmacies, a class of drug supplier linked to the outbreak.
Institutional Corruption, Conflicts of Interest and Commitment, and Online Courses
I am writing this post from a terrific conference on Institutional Financial Conflicts of Interest In Research Universities, hosted at Harvard Law by the Petrie-Flom Center and the Edmond J. Safra Center for Ethics.
One set of fascinating questions that has been raised is when the university should reign in the ability of faculty members to take on directorships and other outside activities. While these issues have been well-known in the sciences and medicine, increasingly it has come home to roost in the law and other faculties. The Harvard Law School recently adopted a new conflicts of interest policy, as part of a Harvard-wide revision of its policies.
Here is a question that has received less discussion from what I have seen, though it may become more pressing given Coursera, EdX, and other online teaching venues. The New Yorker profile of my Harvard Business School colleague and world-renowned teacher Clayton Christensen reported that he has recorded videos lectures (complete with good-looking young men and women actors playing students and laughing at the right moments, what a perk!) for the University of Phoenix’s lecture series, for significant remuneration. Imagine that this series (or one of these other non-Harvard platforms) were to offer to pay half a million dollars to me to teach a 4-hour Civil Procedure (or health law or bioethics and the law course) that would in part mirror the teaching I do of the course at Harvard Law School. Should Harvard have a veto right over me doing so? Should it demand “a piece of the action” and revenue sharing agreements as a condition of letting me participate? After all, I am in some ways trading on my capitol for teaching at Harvard, and potentially also diluting the reputational value of Harvard instruction (the informercial would go “You don’t need to go to Harvard to get a lecture from a Harvard Prof! Only $9.99!”) How can the rules governing patent and other IP ownership in the life and other sciences help us develop a sensible policy? Would or should things be different if I gave these lectures for free on YouTube rather than selling them? [Disclosure: Harvard DOES have a policy on conflicts of commitment, though I am unaware of it speaking specifically to these issues about online lectures, but happy to be corrected].
TOMORROW: Einer Elhauge’s Obamacare on Trial – Book Talk and Panel Discussion
Obamacare on Trial
Book talk and panel discussion by Einer Elhauge, Carroll and Milton Petrie Professor of Law, Harvard Law School (and founding director of the Petrie-Flom Center)
Panelists:
- I. Glenn Cohen, Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics, Harvard Law School
- Abigail Moncrieff, Boston University School of Law (and former PFC fellow)
- Sanford Levinson, University of Texas at Austin Law School
- John McDonough, Harvard School of Public Health
Thursday, Nov. 1, 2012, 6:00 pm
Wasserstein Hall, Milstein East A
Harvard Law School
1585 Mass Ave, Cambridge, MA
Sponsored by the Harvard Law School Library