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)

Art Caplan: MA Should Legalize Physician-Assisted Suicide

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

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

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.

 

The Limits of Advance Directives

By David Orentlicher

While it is important for people to express their wishes about end-of-life care in advance, a court case in Hawaii reminds us that advance directives do not always ensure that patient’s wishes will be followed. Karen Okada wrote a living will, which the hospital ethics committee found to express a desire not to have a feeding tube in her current condition. A family member has objected, on the basis that he is acting in accordance with his authority as an appointed surrogate. Unfortunately, patients’ preferences can be frustrated by their families or their health care providers.

[Cross-posted from HealthLawProf Blog]

FDA Reprimands Genentech for “Drastically Overstat[ing] the Efficacy of Tarceva”

by Jonathan J. Darrow

On October 3, 2012, the FDA’s Division of Professional Drug Promotion issued an untitled letter to Genentech in connection with its cancer drug Tarceva.  Tarceva (erlotinib) was approved in 2004 for the treatment of non-small cell lung cancer, and has since been approved, in combination with Gemzar (gemcitabine), for the treatment of pancreatic cancer. Its approval letter reported a tumor response that was 9 times greater with Tarceva than with placebo (0.9% in placebo versus 8.9% in Tarceva), but relatively modest improvements in 1-year survival rates: approximately 8 of 10 patients on placebo did not survive 1 year, while about 7 of 10 patients on Tarceva did not survive (see page 6, line 102 of the approval letter).  A 2005 New York Times article was less than enthusiastic about Tarceva’s efficacy, noting that it (along with several other cancer drugs that were new at the time) “help[s] most patients only marginally . . . .”  Despite its modest efficacy, Tarceva was reported in the same New York Times article to cost almost $31,000 per year.  A number of patents are listed in the FDA’s Orange Book as covering Tarceva until 2020.

The recent untitled letter accused Genentech’s promotional materials of misleadingly indicating that Tarceva in combination with gemcitabine extended overall survival by 3.7 months in comparison with gemcitabine alone, when the actual increase in survival was only about 12 days.  The FDA characterized the discrepancy as “drastically overstat[ing] the efficacy of Tarceva.”  (The figure of 3.7 months was derived, according to the FDA, “from a retrospective, exploratory subgroup analysis that does not provide substantial evidence to support the efficacy claims cited . . . .”). In addition, the front cover of one of the promotional materials in question contained an image of an hourglass positioned on its side, presented with the claim: “Extending survival for moments that matter.”  Although the claim with its associated image may be literally true (“moments” is left undefined), the FDA characterized the image and claim as “drastically overstat[ing] the overall survival benefit for patients” because it “strongly suggests that time is standing still for the cancer patient because of Tarceva therapy.”  The FDA noted a number of other instances of misleading overstatement of efficacy or minimization of risk.

The October 3 Tarceva letter brings to 23 the total number of Drug Marketing and Advertising Warning Letters (and untitled letters) listed by the FDA’s Office of Drug Promotion as having been sent this year.

Art Caplan on Grace Lee

Unfortunately, these stories are like deja vu.  In his most recent MSNBC commentary, Art Caplan emphasizes that we all have the right to refuse medical care, even if others disagree and even if it means death.  Here’s his take:

Opinion: Daughter has right to die against parents’ wishes

When your time comes to die, you probably hope that you will be surrounded by loving family members and friends who will support you and help you leave this earth at peace with one another. Sadly, for 28 year-old SungEun Grace Lee, who is dying in a Long Island hospital, that is not happening.

Read More

Upcoming Event: Harvard Med School Public Forum

PRESCRIBING MEDICATION TO END LIFE

THURSDAY, OCTOBER 25, 2012 4:00 – 6:00 PM

Harvard Medical School Carl W. Walter Amphitheater Tosteson Medical Education Center 260 Longwood Avenue, Boston

Should a physician licensed in Massachusetts–at the request of a capable, terminally ill, adult patient (meeting certain conditions)–be allowed to prescribe medication that could end that person’s life?  The answers to this ballot question are just two: yes or no. The questions, though, are countless.

PANELISTS

Lachlan Forrow, MD, Chair, Massachusetts Expert Panel on End of Life Care

Carol Powers, JD, President, Community Voices in Medical Ethics, Inc.

Ellen Weinstein, JD, Assistant General Counsel, Boston Medical Center

Marcia Angell, MD, Signer, Initiative Petition for MA Death With Dignity Act

MODERATORS

Robert Truog, MD, Professor of Medical Ethics, Anesthesiology, & Pediatrics, HMS

Christine Mitchell, RN, Associate Director, Clinical Ethics, Harvard Medical School

Sponsored by the HMS Division of Medical Ethics

Rationing, Irrelevant Utilities, and Inter vs. Intrapersonal distribution

This blog post was prompted by discussions with Frances Kamm, Jonathan Wolff,  and others after a great presentation Jonathan gave on the Valuation of Life and Health in Government Policies.

To return to an issue I have discussed briefly in other work, the question is how we should count very small gains in health for large numbers of people, a sub-set of the aggregation problem.  As I put the problem in a footnote in my Article Beyond Best Interests, 96 Minn. L. Rev. 1187 (2012):

Utilitarians typically aggregate small harms to many people and count the sum. See, e.g., John Rawls, A Theory of Justice 23-24 (1971) (discussing the societal balance of present and future gains against present and future losses). The deontologist Frances Kamm has instead suggested that not all harms and benefits are equal, under what she calls the “Principle of Irrelevant Utility”: Suppose two almost identical individuals A and B are mortally ill and we have only enough serum to save one, but because of tiny differences in how much serum they need if we save A there will be enough serum left over to also cure person C’s sore throat, but if we save B there will not be. Kamm argues that it would be unjust in this circumstance to allocate the serum to A rather than B on this basis as opposed to holding a straight lottery between the two. If the sore throat is not enough to justify giving A preference over B when everything is equal, says Kamm, it is an “irrelevant utility” such that even if we could save not only C’s sore throat but a million such sore throats, for example, it would not matter; the utility bonus is irrelevant and therefore even aggregated in large quantities cannot count. Quite different, she claims, would be a case where in fact the serum enables us to save C’s leg, which would be a relevant utility. See F.M. Kamm, Morality, Mortality: Death and Whom to Save from It 144-63 (1993); Frances M. Kamm, To Whom?, 24 Hasting Ctr. Rep. 29, 31-32 (1994).

On the other hand, this principle may have counter-intuitive implications. To use an example suggested by John Broome, the National Health Service (the U.K.’s universal health care system) gives out millions of analgesics for headaches; at some level, due to health care rationing and fixed budgets, that means that someone’s life will not be saved.  John Broome, All Goods are Relevant, in WHO, Summary Measures of Population Health: Concepts, Ethics, Measurement and Applications 727, 727-28 (Christopher J.L. Murray et al. eds., 2002).

What came up over dinner, and I thought was particularly interesting, was the following question:

Read More

Symposium: Freedom of Choice at the End of Life, Nov. 16

By Nadia N. Sawicki

New York Law School’s Justice Action Center is hosting a symposium on elder law on Friday, November 16, titled “Freedom of Choice at the End of Life: Patients’ Rights in a Shifting Legal and Political Landscape.”   A number of Bill of Health bloggers (myself included) will be speaking at this event, which will address topics including legal and practical impediments to honoring end-of-life wishes, the practicalities of drafting and using advance planning tools, pain management and palliative care, futility, and ethical dilemmas in end-of-life care.  You can register here.