The Contraceptives Coverage Saga Continues…

Well, hopefully we’ll know the fate of the ACA by tonight.  But even if President Obama wins, there will still be uncertainty about the fate of the contraceptives coverage mandate.

A number of employers claim that the mandate violates their rights to religious freedom by requiring them to offer free coverage for medical products and services they find objectionable, and the administration has taken a number of steps to offer accommodations.  But as a neutral law of general applicability, the mandate doesn’t violate the First Amendment under SCOTUS jurisprudence, and even under the Religious Freedom Restoration Act, there’s a strong argument that the mandate is ok, either on the grounds that it does not actually impose a substantial burden on religious exercise or that  it is supported by a compelling government interest.

Nonetheless, federal courts have reached different conclusions as to the mandate’s permissibility.  In July, a federal district judge in Colorado issued a preliminary injunction blocking enforcement of the mandate against a religious employer running a secular (HVAC) business, while in September, a federal district judge in St. Louis rejected a similar challenge by the religious owner of a mining company.  Last week, a federal district judge in Detroit also issued a preliminary injunction against enforcement, indicating that while neither side had shown a strong likelihood of success on the merits, “The loss of First Amendment freedoms, for even minimal periods of time, unquestionably constitutes irreparable injury.”  Several other challenges to the mandate remain pending.

So let’s just add this to the list of uncertainties that will remain after the results of today’s election are in – and to the list of reasons why employer-based health care really ought to be abandoned in favor of a single-payer, public system.

There, now that ought to get some discussion started…

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.

 

Penn Fellowship in Advanced Medical Ethics

The Department of Medical Ethics and Health Policy at the University of Pennsylvania Perelman School of Medicine invites applications for a new postdoctoral Fellowship in Advanced Biomedical Ethics, beginning in September 2013.  The mission of this 2-year Fellowship is to train scholars and future leaders in academic biomedical ethics.  Fellows will participate fully in the life of the Department of Medical Ethics and Health Policy, which is among the world’s leading bioethics departments.  They will have full access to the intellectual resources of the larger Penn community.

Applications are invited from scholars with doctoral degrees in hand (PhDs or equivalent, JDs, MDs), or who will have received such degrees by September 2013.  Doctorates may be in any relevant field, including but not limited to philosophy, political science, psychology, sociology, economics or anthropology.

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Should Researchers Have a Professional Code of Ethics?

by Suzanne M. Rivera, Ph.D.

I was giving a workshop presentation at the annual meeting of the National Council of University Research Administrators and my co-presenter raised an interesting idea. Tommy Coggins of the University of South Carolina was talking about the importance of integrity for preserving the public’s trust in the research enterprise, and he pointed out that, unlike physicians, attorneys, and accountants, researchers do not have a unifying professional code of ethics.  Instead, they are subject to a patchwork of regulations, policies and laws, most of which were promulgated by grant funding agencies and therefore are enforceable only in cases where tax payer dollars are involved.  Although discipline-specific societies, such as the American Psychological Association, have their own ethics codes, researchers as a profession are not asked to adhere to a shared set of standards for their conduct.

And it’s true— there is no unifying code that all researchers (spanning the range of disciplines from anthropology to zoology) must swear to uphold.  And maybe it’s not realistic to expect that people whose jobs entail such a variety of different activities (working with data sets, lasers, yeast, mice, human participants, super colliders, etc.) could find sufficient common ground on which to cobble together a code.  But I wonder if it’s worth a try.  Given the current atmosphere of distrust that has resulted in new rules for increased transparency and oversight of researchers’ financial interests, perhaps the time is right to think explicitly about ethical standards for research.  Not merely avoiding “FFP” misconduct, but an affirmative duty to behave with integrity.

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Bending the Cost Curve, Not Just Talking About It

By Nicolas Terry

When the 2012 history of health care is written, which date will have the largest entry, November 5 or 6? Of course, many (but not that many) provisions of the Affordable Care Act will live or die depending on how the election affects control of the White House and Senate. But, November 5 may end up having more significance because that is the date Massachusetts’s new health care spending legislation, here, takes effect.

Signed into law by Governor Patrick on August 6, 2012, the new law now has its own website, here, the promise of a a ton of data, here, and in Brandeis University economist Stuart Altman, here, a chair for its Health Policy Commission (HPC).

Thomas Lee, here, notes “the 349-page law that was just passed in Massachusetts created 25 new boards, task forces, and commissions, and 266 new appointees are going to be enlisted to monitor and enforce compliance with spending caps, oversee provider performance improvement plans, and certify Accountable Care Organizations (ACOs).”

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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.

Twitter Round-Up: What Our Bloggers Are Tweeting About (10/28-11/3)

By Casey Thomson
[Ed. Note: Several of our bloggers are active on Twitter.  In a new feature, we’ll be posting some highlights of their tweets each week so you can stay in the know – or think about following them directly!]
  • Dan Vorhaus (@genomicslawyer) linked to Bloomberg’s article on the current underutilization of genetic tests for Lynch Syndrome, responsible for potentially 3% of all cases of colon cancer. Authors Langreth and Lauerman note that the lack of testing is but one example of the tendency to avoid such tests due to “doctors’ ignorance and financial disincentives.” (10/29)
  • Daniel Goldberg (@prof_goldberg) shared Iona Heath’s article on the problematic nature of current breast cancer screening awareness programs, discussing how women are not given enough information to decide if the potential treatments that follow are indeed worth the psychological devastation often invoked. (10/30)
  • Michelle Meyer (@MichelleNMeyer) retweeted an editorial on medical genetic paternalism. The post by Razib Khan discussed how physicians deciding whether to tell parents about unforeseen genetic test results of their children can be considered not only an act of malpractice, but also morally wrong. (10/30)
  • Einer Elhauge (@elhauge) linked to a new review of his acclaimed book, Obamacare On Trial by the National Law Review. (10/31)
  • Daniel Goldberg also tweeted a review by Boddice of Javier Moscoso’s new book, Pain: A Cultural History. (10/31)
  • Arthur Caplan (@ArthurCaplan) linked to news about China’s promised initiative to reduce the dependence on death row inmates for organs. A new national organ donation system, based on a system previously piloted by the Red Cross Society of China, could take effect as soon as early 2013. (11/2)
  • Arthur Caplan also posted on the Vatican’s announcement to hold its second “International Adult Stem Cell Conference,” revisiting this complicated issue. (11/2)
  • Arthur Caplan additionally linked to a report on the debate and complications regarding feeding tube use, as published by Krieger of Mercury News. (11/2)

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].