Event 11/13 – Massachusetts: A Community Approach to Quality, Affordable Health Care

On behalf of our colleagues at Harvard Law School’s Center for Health Law and Policy Innovation, we wanted to let you know about the following event:

Massachusetts: A Community Approach to Quality, Affordable Health Care

Tuesday, November 13th

6 – 7:30pm (food provided)

Wasserstein 1015, Harvard Law School, Cambridge, MA

Six years after passing the groundbreaking health care access law that became the model for national reform, Massachusetts has once again led the nation through legislation setting a limit on the growth of health care cost.  What progress has the state’s health care community made on cost so far, and what will it take to improve quality and meet the new cost growth standards?  Come hear the perspective of Andrew Dreyfus, President and CEO of Blue Cross Blue Shield Massachusetts and leader of the company’s efforts to create one of the largest commercial payment reform initiatives in the nation.

Politics in Practice: Intense Conversations in Intensive Care

By Erin Talati

As Holly Lynch describes in her recent post, the upcoming election brings a number of bioethics questions directly to the public. Two of the three ballot questions in Massachusetts invite discussion and debate on the controversial issues of physician-assisted suicide and the medical use of marijuana. The introduction of these issues as ballot initiatives offers physicians the opportunity for rich discussion on important topics with their patients. But, how much should physicians and other health care providers share with patients regarding their own views on these issues?
Read More

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)


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

Bleg: IRBs & Health Disparities Research

By Michelle Meyer

As most readers of this blog well know, health disparities of various kinds are rampant in the U.S. — in obesity, infant mortality and morbidity, cardiovascular health, and many other areas. In most cases, however, we seem to know more about the extent of health disparities than we do about what causes and what is most likely to ameliorate them.

To rectify this situation, we need to conduct research — and lots of it. Typically, however, health disparities research will have to occur with the same populations who are most likely to be considered vulnerable and in need of extra protections from research. Often, moreover, health disparities research will need to occur in the clinical setting (as opposed to the lab), where patients normally rightly expect that everything done there is designed to serve their individual best interests, rather than to produce generalizable knowledge. Health disparities research might involve research methodologies that are relatively unfamiliar to IRBs, such as community-based participatory research (CBPR), which blurs the traditional distinction between investigator and subject on which the regulations are built. To the extent that disparities are thought to derive from provider discrimination or bias, researchers may face difficulties from a research review system that is designed to protect all “subjects,” including professionals who are incompetent or worse. Eventually, health disparities research scales up to multiple research sites, which usually requires approval from multiple, often conflicting, IRBs. Many interventions to address health disparities, finally, will take the form of public policy rather than clinical treatment. If we want such policies to be evidence-based (and we should), they will have to be tested, perhaps in ways that raise legal or ethical issues (say, randomizing a state’s Medicaid recipients to receive or not receive particular benefits, or randomizing the businesses in a jurisdiction to be required to display nutrition information on the food they sell — or not).

I’m delighted to have received so many comments, both on- and offline, on my last IRB post from those with experience in the research trenches. As I begin a new project along these lines, I would be very interested in hearing again from both researchers and research reviewers with experience in health disparities research, whether you have struggled with these or similar issues (or have abandoned research plans at least partly out of fear of such problems), or have experienced smooth sailing. Feel free to leave comments here, anonymously if you wish, or contact me directly at mmeyer at law dot harvard dot edu. Many thanks in advance.

Physician-Assisted Suicide in MA

Next Tuesday, those of us registered in Massachusetts will have the opportunity to vote on “Question 2” – prescribing medication to end life, otherwise known as physician-assisted suicide.  As described by the state secretary, “This proposed law would allow a physician licensed in Massachusetts to prescribe medication, at a terminally ill patient’s request, to end that patient’s life. To qualify, a patient would have to be an adult resident who (1) is medically determined to be mentally capable of making and communicating health care decisions; (2) has been diagnosed by attending and consulting physicians as having an incurable, irreversible disease that will, within reasonable medical judgment, cause death within six months; and (3) voluntarily expresses a wish to die and has made an informed decision.”  There are, of course, a number of other safeguards built in, such as the need to make the request twice, separated by 15 days, in the presence of witnesses.  However, there could probably be stronger safeguards to protect individuals who are experiencing depression and anxiety, and might have preferable alternatives to physician-assisted death.

The proposed law is similar to measures already in place in Oregon and Washington state, where statistics show relatively low uptake and certainly not the sort of slippery slope that critics seem to be worried about.  In today’s NY Times, however, Zeke Emanuel describes 4 myths about physician-assisted suicide that might give some pause to people like me who plan to vote “Yes” on Question 2.  In the end, though, it strikes me that preserving room for maximal choice in these difficult end-of-life situations is for the best.

Without delving into the merits, which has been done very well elsewhere, let me just make a quick note about something else that struck me re: Question 2, which was the pamphlet of materials I received at home about the ballot measure.  It came from the state secretary, had an excellent, understandable summary of the law and what it would do, and included brief statements for and against written by selected advocates.  I thought this was an incredible mechanism to promote informed voting and deliberative democracy – and because I always have human subjects research ethics on the brain, it made me think of the possible ways this approach could be adapted to improve informed consent.  Perhaps traditional consent forms could be accompanied by a brief neutral statement about a study from the IRB, followed by short statements pro and con about the decision to participate. Just a thought.

And finally, one more note: we’re having a bioethics-heavy election day in Massachusetts this year.  Question 3 is about whether we should eliminate state criminal and civil penalties for the medical use of marijuana by qualifying patients.


Conflicting Interests in Research: Don’t Assume a Few Bad Apples Are Spoiling the Bunch

by Suzanne M. Rivera, Ph.D.

In August of 2011, the Public Health Service updated its rules to address the kind of financial conflicts of interests that can undermine (or appear to undermine) integrity in research.  The new rules, issued under the ungainly title, “Responsibility of Applicants for Promoting Objectivity in Research for which Public Health Service Funding is Sought and Responsible Prospective Contractors,” were issued with a one-year implementation period to give universities and academic medical centers sufficient time to update their local policies and procedures for disclosure, review, and management (to the extent possible) of any conflicts their researchers might have between their significant personal financial interests and their academic and scholarly activities.

The rules were made significantly more strict because a few scoundrels (for examples, click here, and here) have behaved in ways that undermined the public’s trust in scientists and physicians. By accepting hundreds of thousands, even millions, of dollars from private pharmaceutical companies and other for-profit entities while performing studies on drugs and devices manufactured by the same companies, a few bad apples have called into question the integrity of the whole research enterprise.  This is a tremendous shame.

Having more than one interest is not bad or wrong; it’s normal.  Everyone has an attachment to the things they value, and most people value more than one thing.  Professors value their research, but they also want accolades, promotion, academic freedom, good parking spots, and food on their tables.  Having multiple interests only becomes a problem when the potential for personal enrichment or glory causes someone (consciously or unconsciously) to behave without integrity and compromise the design, conduct, or reporting of their research. Read More

Reflections on a Recent Study Showing Sperm and Egg Donor as Übermensch/Uberfrau

Last week, I sat on a panel at the Mid-Atlantic Law and Society Association, with my wonderful colleagues Kim Mutcherson, Gaia Bernstein, Rene Almeling, and Cynthia Daniels on sperm donor anonymity. [NB: as in most of my work I will use the term “donor” because it is used in common parlance while acknowledging that “seller” is more accurate].

Among other topics discussed, Cynthia shared with us a new paper she has just published in Signs, co-authored with Erin Heidt-Forsythe, the contents of which I found fascinating and I think some BOH readers may as well. They examined the characteristics of 1,156 sperm donors from the top twelve sperm banks in the U.S., and found them to be very much (in my view) that of the ubermensch and uberfrau (in the Nazi conception of the term, not necessarily the original Neitzchean).

Among other findings they note that 44% of sperm donors are above 6 feet tall compared to 10% of American men; 61.9% have healthy weight in Body Mass Index (BMI) terms, as compared to 32% of the U.S. population; 62% had a college or higher degree compared to 26% in the U.S. population and only 2% of sperm donors had high school as their highest level of educational attainment compared to 32% of American men.

They also found that African-American and Latino donors, both underrepresented groups in sperm donor pools compared to the U.S. population, were much more likely to be listed as being on the light or medium skin tones for those groups rather than the dark side, again in variance with the distribution in the general population

They then compared these findings to a similar review of 359 egg donors recruited from eight fertility clinics.

Read More

Upcoming Event – Advances in HIV Prevention: Legal, Clinical, and Public Health Issues

Monday, November 5, 2012
12-1:30 pm
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.