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?
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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.


How About a Clean-Air Shave?

By Scott Burris

Somewhere along the way, environmental law and public health law got separated.  Despite the importance of clean air and water to public health – not to mention parks, recreation, salubrious zoning – the two fields developed independently in the law. That’s changing in a lot of ways, and one very good example is a study proceeding now in New York City.

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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. Continue reading

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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The Absurd Consequences of Statutory Rape Law

By Michele Goodwin

Across the country, children under the age of fourteen are being convicted of rape for engaging in consensual sex with children of similar age.  In Utah, a child who commits “more than five ‘separate acts’ of sexual touching,” can be prosecuted for “aggravated sexual abuse of a child.” In South Dakota, a minor can be adjudicated a delinquent and guilty of first degree rape for one act of sexual penetration, regardless of consent.  Wisconsin’s law reads similarly.  To be clear, I am not referring to the Romeo and Juliet cases (the male is 18 and the girl is 16).  No, I’m speaking of children as young as eleven.  These adolescent violators now end up on sex offender registries—some for life.  In some states, including Utah, adolescent fondling is considered sexual abuse of a child as are: attempts to touch the buttocks, breasts, or “intent to arouse or gratify the sexual desire…”  Even consenting children will always be deemed “victims” in states that take this approach.

In 2011, J.L. was adjudicated a delinquent, charged with first-degree rape, and convicted under the South Dakota statutory rape statute.  J.L. had no prior convictions, nor other violations of the law that might suggest a propensity for crime, violence, or danger to the community.  Indeed, the first degree rape conviction did not stem from a violent, coercive sexual encounter with an adolescent, rape of an adult woman, or from forced sex with a child or infant.  Rather, according to the South Dakota Supreme Court, J.L., who was fourteen, “engaged in consensual sexual intercourse with his girlfriend [], who was twelve,” and only fifteen months his junior.  Ironically, in the state of South Dakota, J.L.’s conviction will result in legal and extra-legal penalties far more severe than that of an adult rapist who commits a sexually violent act against a college peer, a random woman, or during the commission of another crime.

For all the recent controversy about rape, its legal and political definitions, politicians have ignored the uneven, punitive punishments resulting from statutory rape laws’ harsh application against minors who fornicate with minors.  Indeed, no coherent framework has been offered by politicians that respond pragmatically to the empirical realities of adolescent sexuality.  Neither federal nor state legislatures offer a coherent, well articulated approach to militate against the harshest criminal punishments demanded by statutory rape provisions and sex offender registries.

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Petrie-Flom Interns’ Weekly Round-up: October 20 – October 26

  • The NY Times reported earlier this week on a split decision regarding a surrogacy case in New Jersey Supreme Court. The court’s decision held little clarity in interpreting who has parenthood claims to children conceived through surrogacy–the donors of the child’s genetic material or the adults who raise the child. Read the details and decision of the case here.
  • An opinion piece highlighted the growing trend and importance of nurses acting in the capacity of family doctors in order to promote access to health care. Clinics of nurse-practitioners have been important in allowing patients to save on health care costs, receive faster treatment and diagnosis, and connect more deeply to their healthcare providers.
  • In a time when the efficacy of mammograms still has not been firmly established, a new controversy has emerged as some state laws have mandated that clinics tell patients about dense breast tissue. The conflict emerges because there has been no conclusive evidence that dense breast tissue actually holds much significance. Critics are worried these laws will lead to a flurry of unnecessary tests and biopsies; however, there are many in the medical community that also support these laws, so opinion remains heavily divided.
  • Another article by the NY Times reported on a settlement of a nationwide class-action lawsuit that will allow patients with chronic conditions or disabilities to qualify for Medicare coverage of outpatient therapy, home care, and nursing homes. This has the potential to affect tens of thousands who are suffering from chronic disease and their families that have had to foot the often exorbitant financial bill.
  • On Thursday, a federal appeal court refused the appeal of Planned Parenthood in its attempt to obligate the the Women’s Health Program of Texas to fund its organization.
  • NPR reported on a very contentious issue in Massachusetts elections this year: the “Death With Dignity” ballot question, which, if voter-approved, would legalize physician-assisted suicide. In the US, only two states have already legalized this initiative. Critics on all sides fear the abuse of this provision and worry that it will send a damaging message on the value of life. On the other side, proponents argue for patients’ rights. Either way, the vote in Massachusetts, considered a pioneer in health care among the states, could set the stage for further national debates and decisions.

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.

The Uncertain Future of Probiotics

By Patrick O’Leary

In the October 22 edition of The New Yorker, Michael Specter wrote a fascinating article about the growing and exciting science of the human microbiome, the ecosystem of ten thousand or so bacterial species that call each of our bodies home. The hype around this particular field of scientific and medical inquiry is intense: Specter quotes David Relman of Stanford Medical school as saying that right now we are in the “beautiful, euphoric, heady early period” of the field, and notes that each week seems to bring additional symposia, publications, and grants for new research. All of this is for good reason. Promising studies have indicated that microbial therapy (the intentional introduction of certain bacteria into the body) can be an effective treatment for some diseases, while other researchers have suggested that a variety of modern diseases (like asthma, inflammatory-bowel disease, and some allergies) may be tied to changes in the human bacterial ecosystem. In some ways, this isn’t news: as Dr. Douglas Archer noted in an FDA advisory committee meeting on probiotics over a decade ago, using food with live cultures to treat disease is a longstanding practice dating at least as far back as 76 BC, when the Roman historian Plinio advocated using fermented milk to treat GI infections.  Continue reading

Legal Implications of the Meningitis Outbreak

If you’ve been following the fungal meningitis outbreak and wondering about the legal implications, take a listen to this audio interview with Glenn Cohen and personal injury lawyer Michael F. Barrett, hosted by Legal Talk Network’s Lawyer2Lawyer.  They discuss the litigation likely to stem from this outbreak (and some already pending), as well as the role of FDA and CDC in regulation.

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.

Life Extension: Forcing Criminals to Serve Their Time? (Part I)

By Yu-Chi Kuo

Former Penn State football coach Jerry Sandusky was recently sentenced to 30 to 60 years in prison for serial child sex abuse.  Sandusky had faced as great as a 400-year potential sentence during trial, but even the 30 year minimum term will likely exceed his natural lifespan all the same: at 68-years-old, Sandusky will probably die in prison long before serving his time. If he lives to the average life expectancy of 75, he will have served only a quarter of his minimum sentence.  In light of the vileness and severity of his crimes, Sandusky’s death may leave many victims and observers feeling that death provided an early exit from deserved punishment.

Curiously enough, Sandusky’s former employer patented and licensed a telomerase reporter system capable of monitoring the regulation of telomere maintenance. Telomeres are microcellular regions that protect against gene degradation and promote cell longevity. The maintenance (or lengthening) of telomeres through telomerase therapy is an exciting subfield of life-extension therapy that may radically lengthen human lifespans in future.

The arguments for and against this and other forms of human enhancement technology are fairly well combed-over in popular discourse: it’s unnatural; it’s sinful; it’s unfair; it’s arrogant. On the other hand, this and other subfields of gerontology profess some noble goals: to improve the ratio of “good years” with years of morbidity; to deliver unto humans a “gift” of possibly unlimited life.  But what if we inverted the concept of life extension therapy as a “gift,” and could administer it to criminals like Jerry Sandusky, in order to extend their remaining life up to the end of their sentence? Telomerase therapy may be a continual treatment; it could conceivably even be withdrawn to give the old man just enough “life” to watch the clock on his last day.
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