Category: Bioethics

Reproducing After One’s Suicide

I. Glenn Cohen 2 Comments

If you live long enough you really do see it all. News.Com.Au reports that an Australian judge has permitted a widow to extract sperm from the body of her husband who recently committed suicide to be used for In Vitro Fertilization (IVF) of the woman. According to the report “The woman, whose name has been suppressed, had spent the past two years trying to conceive and recently began in vitro fertilisation (IVF) treatment when her husband, who suffered from severe bouts of depression, committed suicide.”  From the article there is a report on some of the reasoning of the court

Under the Human Tissue and Transplant Act, a designated officer at a hospital (usually a senior doctor) may authorise a request from a next of kin for the removal of human tissue from a deceased person for medical procedures. Judge Edelman said sperm fell under that scope. The only restriction is when a person dies in sudden or suspicious circumstances. In those cases permission needs to be given by the State Coroner who did not object to the sperm being removed and stored. Because of the short turnaround time for the hearing, Judge Edelman said the Health Minister did not have an opportunity to appear at the proceeding. He said the Minister would have an opportunity to be represented at any future hearing concerning the use of the sperm for IVF.

This case raises a number of very interesting questions.

First, I think the court’s reasoning distinguishing the extraction of sperm (permitted) versus its eventual use through IVF (which seems may be subject to prohibition later) interestingly implicitly makes a distinction I have drawn in my own work between a bodily integrity right related to one’s reproductive material and a non-use right I have called “The Right Not to Be a Genetic Parent?” The Court seems to suggest a default rule where extraction is permitted as a matter of course (no posthumous bodily integrity) but perhaps a different rule as to the Right Not to Be a Genetic Parent. Second, the case raises the more general question of the nature of the interests of the would-be genetic parent in posthumous reproduction. In The Right Not to Be a Genetic Parent I argued that the strongest argument for such a right is connected to what I call “attributional parenthood,” the attribution by the genetic parent, the child, and third-parties of parenthood to him/her on the basis of the genetic tie. Posthumous parentage, though creates some special problems with this argument. As I suggest in a rather lengthy footnote (n. 64) in that article:

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Genetic Testing as Social Networking

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By Elizabeth Sepper

In the market for discount genetic testing?  Want to share your genetic markers with friends?  No?  You might soon be alone.

Last week, I got an email from the mega-discounter Groupon advertising 68% off a “DNA Self-Discovery Kit.”  The company, ConnectMyDNA, allows Groupon users to send in a cheek swab and receive back information on their genetic markers and how those markers compare to people around the world (what they call a “Gene RingTM”).

The big selling point:  sharing results with friends on social media and making new connections to people with similar genetic markers.  ConnectMyDNA’s website says, “You can use your Gene Ring™ as your personal badge anywhere you’d like—on your business card, email signature, or you can even create a cool T-shirt!”

This all seems fairly harmless.  But I wonder if sharing genetic information will represent the next step in the race to the bottom of privacy expectations.  People already regularly disclose extensive medical information related to illness, recovery, and injury on Caringbridge, Facebook, and public blogs.  As genetic tests come down in price and become more commercially available, will genetic information be next?  How will law and ethics respond to protect family members who share genetic information or shield those predisposed to disease from discrimination in this context?  Today, genetic screening raises ethical issues and contention among family members at risk, for instance, for hereditary breast or ovarian cancer.  Tomorrow, sharing one’s genome with Facebook friends, twitter users, and the public may be the norm.

At $28,000 a Dose, How Effective Is Acthar?

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By Jonathan J. Darrow

In a well-researched, recent post, Patrick O’Leary addresses the FDA’s efficacy requirements as applied to an old drug, Acthar (corticotropin), that was first approved in 1952 and granted an orphan designation in 2010 for the treatment of infantile spasms. The initial approval therefore occurred before the Drug Amendments of 1962, which instituted a “new” statutory requirement of efficacy (more on this below). O’Leary points out that Acthar’s “grandfather” status does not entirely exempt it from the FDA’s efficacy requirements, and that the drug did survive an efficacy evaluation under the DESI program. But how effective is Acthar?

Neither O’Leary nor the New York Times article on which his post is based dig very far into the clinical trial data accepted by the FDA as supporting the efficacy of the drug as a treatment for infantile spasms, and I was curious to know what the evidence says about Acthar in this regard. Clinical trial data is presented—or perhaps more accurately, “buried”—in Section 14 of a drug’s FDA-approved label; in the case of “H.P. Acthar Gel” (NDA 022432), that label can be found here. What does the clinical trial data reveal?  The section is brief, just half a page, and notes that of “[t]hirteen of 15 patients (86.7%) responded to Acthar Gel as compared to 4 of 14 patients (28.6%) given prednisone (p<0.002).”  Nonresponders were then given the other treatment, with the following results. “Seven of 8 patients (87.5%) responded to H.P Acthar Gel after not responding to prednisone,” while “[o]ne of the 2 patients (50%) responded to the prednisone treatment after not responding to Acthar.”  As the p-value (0.002) indicates, the first figures, at least, are statistically significant.  These figures were also better than I expected: 86.7% efficacy with Acthar does seem much better than 28.6% efficacy with prednisone.  Read More

American Society for Bioethics and Humanities – Call for Proposals

The Petrie-Flom Center Staff Leave a comment

The 2013 ASBH Call for Proposals is now open. Details regarding the call can be found on the ASBH homepage (www.asbh.org). There you will find a link to the abstract submission site as well as a PDF containing the submission guidelines, including instructions for the Student Paper Competition. Abstracts will be accepted until 4:00 pm (CST), March 4, 2013.

Call for Applications: Fellowship in Medical Ethics, 2013-2014

The Petrie-Flom Center Staff Leave a comment

Harvard Medical School, Division of Medical Ethics

Fellowship in Medical Ethics, 2013-2014

The Division of Medical Ethics at Harvard Medical School supports research and teaching on ethical issues in medicine, health, and healthcare policy and practice.  The Fellowship in Medical Ethics is open to physicians, nurses, lawyers, social workers, and others in academic fields related to medicine or health with a serious interest in medical ethics and a wish to further their knowledge of the history, philosophical underpinnings and contemporary practice of bioethics.

Fellows attend a weekly three hour seminar designed to explore a wide range of issues, including ethical theory, clinical ethics, research ethics, and selected topics in public health ethics. Most weeks there is extensive reading and a brief paper. During the year, fellows participate in the intellectual life of the Division of Medical Ethics and are eligible to participate in Harvard University courses with permission of the course instructor as well as monthly division Faculty Seminars and various public programs in medical ethics sponsored by the Division.

Fellows must have external salary support.  The fellowship fee is $4,000.  Most Fellows receive this support from their sponsoring institutions, and The Division of Medical Ethics will assist applicants who would like help approaching their sponsoring institutions with such a request.

Fellows are selected on the basis of their previous academic achievement and the contribution they are likely to make as researchers, clinicians, and teachers in medical ethics.  Applicants should submit a curriculum vitae and a letter of not more than 750 words, describing the reasons for their interest in the Fellowship, including any particular topics or questions they are most interested in exploring. This letter is an important opportunity for applicants to tell us about themselves, their interests, and their motivations in pursuing training in medical ethics.  Applicants should also provide two letters of reference and a third letter from their supervisor or key senior staff person, demonstrating institutional support for the candidate’s involvement in the HMS Fellowship and likely opportunities the candidate will have to contribute to bioethics at their home institution, upon completion of the Fellowship.

Deadline for submission of application materials is April 15, 2013.  Three copies of all application materials should be sent to:  Professor Mildred Solomon, Fellowship Director c/o Helena Martins Harvard Medical School, Division of Medical Ethics, 641 Huntington Ave, 2nd Flr, Boston, MA  02115.  If you have any questions please contact Helena at helena_martins@hms.harvard.edu or 617-432-3041.

Who Pays? The Wage-Insurance Trade-off and Corporate Religious Freedom Claims

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By Elizabeth Sepper

Happy new year to all and thanks to the Bill of Health for the opportunity to blog this month!

The first day of 2013 saw yet another ruling in the contraception coverage controversy.  And yet another private corporation—this time a real estate management company owned by the billionaire founder of Domino’s pizza—won a temporary injunction against the mandate on religious freedom grounds.  The company’s claim boils down to this:  the Affordable Care Act forces it to pay, through its insurance plan, for healthcare (in this case contraception) to which it objects as a matter of religion.  Let’s bracket, for the moment, the question of whether an artificial entity can have religious beliefs, let alone a conscience, and ask “what wrong with this argument?”

At heart, it misses a basic fact of health economics:  health insurance, like wages, is compensation that belongs to the employee.  Study after study shows that employers pay in wages whatever they don’t pay in health insurance premiums.  Most recently, a study of Massachusetts’ health reform found that firms offering health insurance pay wages lower by an average of $6,058 (nearly exactly the cost of annual health insurance premiums).  Each employee’s actual “salary” is wages plus the employer share of the health insurance premium.  So, when a corporation purchases a health insurance plan that its employees (and their family members) may or may not use to buy contraception, it is no more paying for contraception than it does when employees use their wages to buy it.

Unfortunately, this basic fact about employer-sponsored insurance is invisible to the public.  Employees are ignorant of the effects of insurance on wages and see insurance as a gesture of goodwill with employers reaping the benefits.  This year for the first time, W-2s must list the total annual premium paid toward health insurance (thanks to the Affordable Care Act).  It’s a first step.  But I suspect that it will do little to change our societal perception of employer-sponsored insurance.  In the litigation over contraceptive coverage, I fear that courts may continue to overlook the fact that insurance (and the healthcare it buys) is paid for by employees, not employers.  If so, the courts will only open the door to future challenges to employees’ healthcare decisions, whether paid for with insurance or wages.

‘Frankenfish’ far less scary than fast food

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By Art Caplan [cross-posted from his NBCNews Vitals column]

Two big events recently took place in the world of food: The Food and Drug Administration decreed that genetically engineered salmon wouldn’t harm the environment and McDonald’s announced that its McRib sandwich is back on the menu.

The FDA’s announcement paves the way for the first approval of a genetically engineered animal for humans to eat – and it was met with a good deal of highly critical wailing and groaning by Consumer’s Union, National Geographic and many other advocacy groups who are wary of genetically engineered food.

The McRib’s return was greeted with a few snickers by late night comedians and overwhelmingly happy faces on the millions of Americans who eat at one of the 13,000 McDonald’s restaurants from Maine to Hawaii every day. This, as my grandmother would have said in Yiddish, is “fakakta”—completely screwy.

If you like salmon, and I do, should you worry much about the safety of eating genetically engineered salmon?  No. The FDA said it could not find any valid scientific reason to prohibit the sale of the fish.

If you like the McRib, and I do, should you worry a lot about eating it?  Oh yeah.

Keep reading…

Sterilizing incompetent drug-addicted women

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By Cristiane Avancini Alves

A court in Brazil recently held that the mother of a drug-addicted adult woman (who is pregnant and who already has three children) may seek the court’s authorization for the tubal ligation of her daughter provided the daughter is unable to manage her own affairs. The Brazilian health system has received an increasing number of requests for sterilization in the last years, but according to the Family Planning Law, which is based on the principle of informed consent, sterilizations in such circumstances may only be carried out if the woman is legally incompetent.

Such cases clearly raise a number of concerns. For example, sterilization should generally be considered to be an irreversible procedure which deprives the woman of her fertility, and it does nothing to treat the woman’s addiction or help her avoid resorting to prostitution in order to obtain drugs.

One approach to the problem is so-called “dialogical assistance”. This involves the consideration of each case by physicians, psychiatrists and social workers who assess the woman and establish her competence and informed consent to sterilization, and only then consider approaching the courts to authorize sterilization. This procedure can indicate a practical application of patient autonomy and the beneficence principle in social and legal spheres.

Not too late for that ethically inclined law and society loved one’s stocking

Temple University Center for Public Health Law Research Leave a comment

Nicky Priaulx of Cardiff and Anthony Wrigley of Keele have edited the latest volume in the Ashgate book series, “Ethics, Law and Society.”  Matthew Weait and I have contributed a piece on the ethics of sex with HIV, but the book covers a wide range of contemporary health/ethics/legal questions, including cloning, organ procurement, surrogacy, confidentiality in family courts, informed consent, and the place of child-rearing men in a gendered world.  Robin West says it “provokes, intrigues, and enlightens, suggesting multiple paths for the futures of the related fields of bioethics, the study of care and caregiving, and the ethics and law of reproduction and reproductive technologies.”

Details on the paper and e-book are here.