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?
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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.

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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.

Is a Move Towards Freezing Oocytes a Move Towards Less Legal Liability for IVF Clinics? — Reflections from ASRM Annual Meeting Round 1

It was an exciting time to attend the annual meeting of the American Society for Reproductive Medicine in San Diego this week.  Just before the meeting, ASRM reclassified cryopreservation of oocytes for future use, removing the procedure’s “experimental” label. The possibility of increased uptake of this procedure raises many ethical issues (some of which I hope to discuss in a later post), but it also presents the potential to sidestep a number of legal liabilities and ethical issues associated with frozen embryos which are not implicated by frozen gametes. This begs the question: Is a move towards egg freezing in lieu of freezing embyos a safeguard against some types of liability for IVF clinics?  I think this may be the case.

Perhaps most importantly, frozen oocytes will not implicate personhood laws.  Advocates of personhood laws, such as vice presidential candidate Paul Ryan, have come under fire by pro-choice and feminist groups for their attempts to ascribe legal rights to embryos and fetuses.  However,  IVF clinics and clinicians should also be concerned.  It is an unanswered legal question if an IVF clinician or embryologist could be found guilty of manslaughter if there was an accidental thaw of a cryotank full of embryos.  There have been no such criminal proceedings brought against an IVF clinic — yet.  Freezing eggs would guard IVF clinics in states with personhood laws from this kind of criminal liability. Another question implicated by personhood laws is whether there is a doctor-patient relationship between a newly-created or frozen embryo. If one exists, then negligence claims regarding proper storage of embryos could become medical malpractice claims; if frozen gametes are mishandled it is unlikely such a relationship could exist.  Litigation against the Oschner Fertility Clinic (which has now closed) brings some of these issues to life.

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Fixing Genes Using Cloning Techniques

One more from Art Caplan:

Fixing genes using cloning technique is worth the ethical risk

A team of scientists at the Oregon National Primate Research Center and the Oregon Health & Science University are reporting a remarkable advance in the treatment of inherited genetic disease in the journal Nature.

They show it is possible to repair a tiny part of a human egg cell that, when broken, causes a host of awful inherited genetic diseases.  Those diseases cause disability and the death for many children and adults.  What is equally remarkable is that the treatment they report is illegal in Britain, Germany, Costa Rica, Norway and Sweden and would be illegal to provide using federal dollars in the United States.

What did the Oregon scientists do?  And why is it so ethically controversial?

Keep reading…

Art Caplan on Liability for Non-Vaccinators

Art Caplan has a new article out in the Journal of Law, Medicine, and EthicsFree to choose but liable for the consequences: should non-vaccinators be penalized for the harm they do?” (subscription required)

Here’s the abstract: Can parents who choose not to vaccinate their children be held legally liable for any harm that results? The state of laboratory and epidemiological understanding of a disease such as measles makes it likely that a persuasive causal link can be established between a decision to not vaccinate, a failure to take appropriate precautions to isolate a non-vaccinated child who may have been exposed to measles from highly vulnerable persons, and a death. This paper argues that, even if a parent chooses to not vaccinate a child under a state law permitting exemptions, that decision does not create complete protection against liability for the adverse consequences of that choice.

Sherley v. Sebelius and the Future of Stem Cell Research

Glenn Cohen, and his co-authors Jeremy Feigenbaum and Eli Adashi, have a new piece out in JAMA today, Sherley v. Sebelius and the Future of Stem Cell Research.  Here’s a brief excerpt:

While enactment of “personhood” bills would constitute the most significant threat to hESC research, the outcome of the 2012 presidential election will also play a large role in where the science goes. Should President Obama be reelected, the status quo will in all likelihood be maintained. Much less is known as to policies that might be pursued by a potential Romney Administration. Still, former Governor Romney is on record opposing the proposition of creating a human embryo through “cloning” or “farming” for the sole purpose of research, ie, “when the sole purpose of its creation is its sure destruction.” Romney is also on record in support of a constitutional amendment that establishes life as beginning at conception. All told, these positions, seconded by Congressman Paul D. Ryan (R, Wisconsin), the Republican vice presidential candidate, and echoed by the Republican Party platform, could substantially alter the prospects of hESC research.

Apart from the aforementioned considerations, the future success of stem cell research cannot be ensured absent the following provisions. First, the derivation of hESC cell lines, especially disease-specific lineages, must proceed apace. Such in vitro models permit a detailed interrogation of the molecular pathology of recalcitrant maladies, allow for the identification of druggable targets, and enable the testing of candidate therapies. Policies intent on limiting publicly funded hESC research to existing cell lines—as advocated by former President George W. Bush—run the risk of curbing progress while shifting the onus of underwriting to the private sector. Second, hESC lines, the current gold (if ideologically contentious) standard, cannot as yet be replaced by the (ideologically more neutral) human-induced pluripotent stem cell (hiPSC) lines of adult origin. Indeed, the molecular signatures and the safety profile of current hiPSC lines are sufficiently distinct from those of hESC provenance so as to qualify their imminent application in the clinical arena. Policies designed to favor hiPSC research—as espoused by Romney—may prove premature and unduly proscriptive.

Take a look at the whole Perspectives piece here.