Category: 2012 Election

Twitter Round-Up (11/4-11/10)

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By Casey Thomson

[Ed. Note. 11/12/12: Just to be clear, retweeting should not be read as an endorsement of or agreement with the content of the original tweet.]

With Election Day now come and gone, our bloggers were tweeting this week about the results, in addition to the greater happenings in health law and ethics. Read below for this week’s round-up:

  • Arthur Caplan (@ArthurCaplan) retweeted a post about the recent clinical trial done on chelation, a “fringe” heart disease treatment whose popularity often hinges on a patient’s distrust of conventional medicine. Evidence of the treatment’s effectiveness looks to be marginal, at best. (11/4)
  • Michelle Meyer (@MichelleNMeyer) retweeted an article that explained the problems in the intersection between neuroscience and law, namely how emerging technologies in neuroscience are not being used appropriately to understand criminal behavior. The author advocates for a renewed look at how neuroscience and law can work together, not only to evaluate defendants effectively, but also to customize plans that can serve the interests of both the defendant and the public. (11/5)
  • Dan Vorhaus (@genomicslawyer) linked to a new piece he co-authored on clinical data and genetics, entitled “The Next Controversy in Genetic Testing: Clinical Data as Trade Secrets?” (11/6)
  • Michelle Meyer (@MichelleNMeyer) aptly summarized the results of Massachusetts’ ballot questions with her tweet: “Sick folk in MA can now smoke pot but, it seems likely, not have the aid of their doc in controlling the timing & nature of their death.” (11/6)
  • Daniel Goldberg (@prof_goldberg) linked to a study done on children with epilepsy  and their families. Goldberg noted that the study’s results indicate a serious “ethically pernicious” problem that in fact worsens the condition of those afflicted with epilepsy more so than may be originally perceived: stigmatization. (11/7)
  • Frank Pasquale (@FrankPasquale) tweeted a blog post that talked of the need to increase the FDA’s power in order to curb the fungal meningitis outbreak now affecting individuals nationwide. Lamentations of the state-based system’s inability to handle the problem had undertones of concern for future situations similar to this one sprouting up again. (11/8)
  • Frank Pasquale (@FrankPasquale) also published a news update from Georgia, where legislators are ending the discount on license renewal prices that had previously been given to motorists who signed up to be organ donors. While many expressed fear that the policy would decrease the number of donors, others in the medical community admitted that there had been no demonstrated link between the policy and increases in donor sign-ups. (11/10)

Bill of Health Interview with Einer Elhauge on Health Care Reform

Holly Fernandez Lynch Leave a comment

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.

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The Contraceptives Coverage Saga Continues…

Holly Fernandez Lynch Leave a comment

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…

Bending the Cost Curve, Not Just Talking About It

Nicolas P. Terry Leave a comment

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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Art Caplan: MA Should Legalize Physician-Assisted Suicide

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Weighing in on Question 2, Massachusetts’ ballot initiative on physician-assisted suicide, Art Caplan says we should vote “yes”:

Mass. should legalize physician-assisted suicide

Of the numerous ballot initiatives that will be decided at the state level on Tuesday, none is more hotly contested than the Massachusetts bill to decide whether to legalize physician-assisted suicide. The citizens of Massachusetts, my home state, should vote to legalize.

The proposed measure allows terminally ill patients to be given access to lethal drugs. A terminally ill patient is defined as someone with six months or less to live. The patient’s terminal diagnosis and mental competency must be attested to by two doctors. Patients would have to make a request to their doctor twice orally and once in writing. The written request would have to be witnessed.

Yet even with such restrictive conditions, opponents of the proposal say doctors should never, as a matter of professional ethics, intentionally hasten the death of one of their patients, even one who is terminally ill. The codes of medicine and nursing ethics reject helping patients die.

Keep reading…

Politics in Practice: Intense Conversations in Intensive Care

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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

The Petrie-Flom Center Staff Leave a comment

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:

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

Physician-Assisted Suicide in MA

Holly Fernandez Lynch 1 Comment

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.

 

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

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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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Sherley v. Sebelius and the Future of Stem Cell Research

The Petrie-Flom Center Staff Leave a comment

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.