Category: Bioethics

Cahn and Carbone on Selling Eggs for Research in California

I. Glenn Cohen 5 Comments

Naomi Cahn and June Carbone had a very nice op-ed in the L.A. Times on Saturday entitled “Leveling the Field for Human Egg Donors.” Their topic is a bill co-sponsored by four female Democratic legislators that would allow women to sell their eggs for research, just as men can sell their sperm. They largely endorse the bill, but make three interesting recommendations:

1) Better study and tracking of the health implications for donors. The hormones used have been associated with potentially severe reactions, and women undergoing egg retrieval risk infection and bleeding. There are currently no funds for research on the long-term effects, and little government oversight. California should require tracking and follow-up studies to assess the health risks of egg donation, regardless of the purpose for which the eggs are provided.

2) Researcher responsibility for ensuring that recruitment practices do not exploit women. Researchers should have a duty to oversee clinic recruitment practices and to report on their efforts.

3) Research protocol sensitivity to potential competition for a limited supply of donors. Researchers should prioritize efforts to acquire excess eggs rather than solicit new ones. Where recruitment of new donors is necessary, researchers should avoid practices that would limit the supply for reproductive purposes.

As always they are eloquent and thoughtful. On (2) I suspect our views on what counts as exploitation differ (for mine see this article).  Read More

The misconceived reverence for life

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By Nikola Biller-Andorno, MD, PhD

Times and again, individuals have asked courts in the United Kingdom, Ireland and other countries for permission to have someone help them end their lives. Diane Pretty, Tony Nicklinson and, most recently, Marie Fleming are among those who suffered from a serious disease that prevented them from acting on their wish by themselves. Their requests, highly publicized and intensely debated, were all turned down.

There are concerns about the legalization of assisted suicide, such as the danger of abuse, that merit attention. One of the core arguments against physician involvement is that medicine is about saving lives, not about ending them. This argument, with its underlying notion of an unconditional reverence for life, is flawed.

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Bioethicist Edmund Pellegrino Has Passed

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By Christopher Robertson

On June 13, 2013 Dr. Edmund Pellegrino died at the age of 92.  (Obituaries are available here and here.)  For bioethicists this is a time to reflect, but in particular affiliates of the Petrie Flom Center will recall that one of the very first events that that the PFC hosted was a distinguished panel to discuss the concept of human dignity in bioethics, featuring Martha Nussbaum, Nick Bostrom, Dan Brock, and Edmund Pellegrino.  (I recall attending the event as a student.)  The webcast is still available, at the bottom of the page, here.  This event commemorated the release of the Presidential Bioethics Advisory Commission’s new book on the topic of human dignity.  Dr. Pellegrino chaired the PBAC, and his contribution to the book is available online here.

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A Ruling from the 5th Circuit: Pregnancy and Breastfeeding ARE Related

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By Leslie Francis

A case from the employment discrimination world that might be of interest to health law folks is EEOC v. Houston Funding II, Ltd., 2013 U.S. App. LEXIS 10933 (May 30, 2013). The employee in the case, Donnicia Venters, was told that her position had been filled when she returned to work post partum and requested to use space in a back room to express milk. The issue in the case was whether firing Venters for expressing breast milk is sex discrimination under Title VII of the Civil Rights Act. The district court had concluded that it was not, as a matter of law, and the 5th Circuit reversed. Although at first glance this outcome is apparently a favorable one for women and children, it also reveals ongoing mismatches between anti-discrimination law in the US and the health needs of workers and their families.

The relevant detail of employment discrimination law is that the Pregnancy Discrimination Act (PDA) provides that discrimination “on the basis of” or “because of” sex includes discrimination on the basis of or because of “pregnancy, childbirth, or related medical conditions.” In holding that breastfeeding is a related medical condition of pregnancy, the 5th Circuit stated “Lactation is the physiological process of secreting milk from mammary glands and is directly caused by hormonal changes associated with pregnancy and childbirth.” Thus, on the 5th Circuit’s plain meaning interpretation of the statute, breastfeeding is within the PDA.

Other courts have reached conclusions less favorable to breastfeeding. The district court in Colorado wrote thus in deciding that a refusal to give breaks for breast feeding was not sex or disability discrimination: “A plaintiff could potentially succeed on a claim if she alleged and was able to prove that lactation was a medical condition related to pregnancy, and that this condition, and not a desire to breastfeed, was the reason for the discriminatory action(s) that she suffered.” Falk v. City of Glendale, 2012 U.S. Dist. LEXIS 87278 (D. Colo. 2012). Indeed, understaffing at the Glendale police department was so severe that no one was able to take breaks, even to use the restroom—so the court concluded that Falk’s problem was equal opportunity bad working conditions, not sex discrimination. Read More

Request for Comments from the Presidential Commission for the Study of Bioethical Issues

The Petrie-Flom Center Staff Leave a comment

The Presidential Commission for the Study of Bioethical Issues recently published a “Request for Comments on Issues Related to Incidental Findings That Arise in the Clinical, Research, and Direct-To-Consumer Contexts.” In this publication, the Bioethics Commission requests public comment on “the ethical, legal, and social issues raised by incidental findings that arise from genetic and genomic testing, imaging, and testing of biological specimens conducted in the clinical, research, and direct-to-consumer contexts.” You can read the full “Request for Comments,” which includes instructions on how to submit comments, online here.

Our Bodies, Our Cells: FDA Regulation of Autologous Adult Stem Cell Therapies

kvantassel 8 Comments

By Mary Ann Chirba, J.D., D.Sc., M.P.H. and Alice A. Noble, J.D., M.P.H.

Stem cells have been an endless source of fascination and controversy since Dolly the sheep was cloned in 1996. This month’s announcement of a cloned human embryo from a single skin cell [1] came on the heels of Sir John B. Gurdon and Dr. Shinya Yamanaka’s receipt of the 2012 Nobel for Physiology and Medicine for their work with induced pluripotent stem cells. Pluripotent stem cells can be embryonic or induced. Embryonic stem cells (ESCs) can generally be obtained from human embryos or by cloning embryos through somatic cell nuclear transfer (SCNT), as was done for Dolly.  Gurdon and Yamanaka demonstrated that pluripotent cells may also be formed by reprogramming adult cells to an embryonic state, resulting in induced pluripotent stem (iPS) cells without having to use eggs or cloning, or destroy embryos. However derived, pluripotent cells are capable of differentiating into virtually any cell type in the human body. This imbues them with great promise for scientific breakthroughs and medical advances, but also raises serious ethical, legal and safety concerns about their use.

Less controversial are “multipotent” adult stem cells (ASCs) which do not involve embryos or raise as many safety concerns as pluripotent cells.  ASCs are found throughout the body.  Their ability to differentiate is more limited than pluripotent cells but is vast nonetheless. The NIH’s clinicaltrials.gov site lists some 4500 ASC trials as compared with 27 for embryonic stem cells and 21 for induced pluripotent stem cells. Recent announcements of new stem cell treatments usually involve ASCs, such as last month’s news that a toddler born without a trachea received a new one made from her own adult stem cells.  It is therefore no surprise that ASCs have captured the attention of researchers, investors, physicians, patients and – increasingly – regulators, both here and abroad.

A growing number of physicians routinely offer treatments involving ASCs to their patients which can be performed in their offices.  Autologous adult stem cells, used to treat a variety of conditions, are harvested from the patient, processed, and returned to the same patient. It is no surprise that moving ASCs from laboratories to physician offices raises complex questions of law. We consider one of the more pressing ones: to what extent can the FDA regulate a physician’s ability to treat a patient with that patient’s own stem cells?  In the coming months, the D.C. Circuit Court of Appeals will hear oral arguments on this very issue in United States v. Regenerative Sciences.[2]

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More on Liability for Failure to Vaccinate

acaplan

As of Friday, June 28, this post is closed to further comments. We want to thank the many readers who have engaged in a vigorous and civil discussion on the recent posts to the Bill of Health that engage questions related to the debate over vaccines. In general, we do not moderate discussions on the site. However, due to an increasing number of comments that violate our policies regarding abusive and defamatory language and the sharing of personal information, we are closing these posts to comment.

Art Caplan discusses his recent Bill of Health post over at WBUR’s Here and Now.  Take a listen.

DNA Art

kvantassel Leave a comment

According to an article in the NYT, an artist has collected DNA samples from litter on sidewalks, such as chewing gum and cigarette butts, and used those samples to extract and sequence DNA that she then used to make computer models of their owners’ faces. She then printed 3-D masks that she is showing at her upcoming exhibit called Stranger Visions. The artist hopes her exhibit will spark a dialogue over genetic surveillance.

The NYT article explains that

[w]hile staring at the wall of her therapist’s office, the artist Heather Dewey-Hagborg noticed a strand of hair stuck in a hanging print. Walking home, she noticed that the subways and sidewalks were littered with genetic material on things like chewing gum and cigarette butts, some still moist with saliva. Curious about what she could learn, Ms. Dewey-Hagborg began to extract and sequence DNA from these discarded materials. Then — and here it gets a little eerie — she began to make computer models of their owners’ faces, using genetic clues to print 3-D masks that she concedes “might look more like a possible cousin than a spitting image.” Hanging these portraits along with the original samples, she says, is “a provocation designed to spur a cultural dialogue about genetic surveillance.” After the June exhibitions, Ms. Dewey-Hagborg will show her work early next year at the New York Public Library. She has also collaborated on a tongue-in-cheek project called DNA spoofing, which purports to offer ordinary people some techniques to avoid detection by scrambling their genetic material.

Talk and exhibition at Genspace in Brooklyn on June 13. Exhibition at QF Gallery in East Hampton, N.Y., opens June 29.

[Cross-posted from HealthLawProf Blog]

Liability for Failure to Vaccinate

acaplan 150 Comments

As of Friday, June 28, this post is closed to further comments. We want to thank the many readers who have engaged in a vigorous and civil discussion on the recent posts to the Bill of Health that engage questions related to the debate over vaccines. In general, we do not moderate discussions on the site. However, due to an increasing number of comments that violate our policies regarding abusive and defamatory language and the sharing of personal information, we are closing these posts to comment.

By Art Caplan

Measles are breaking out all over Britain.  Getting fewer headlines is the fact that measles are back in the USA too.  In fact they are in our region.  A mini-epidemic is raging in Brooklyn.  Measles for cripes sake!  The disease that many of us over 60 had as kids that should never occur is back with a vengeance.  The reason for the diseases reappearance is simple—failure to vaccinate.  Maybe it is time to get tough on those whose choices put others at risk.

For decades, there has been a safe, effective vaccine that works exceedingly well against the measles–95% full protection for a kid who has been vaccinated– and nearly equally well at preventing transmission to others.  The more people have been vaccinated the tougher it is for measles to gain a foothold.

NY City health officials have reported 30 cases so far–26 in Borough Park and four more in Williamsburg.  The NY Daily News reports that the consequences of this outbreak have been dire:

“There have been two hospitalizations, a miscarriage and a case of pneumonia as a result of this outbreak,” a Health Department spokeswoman said. “All cases involved adults or children who were not vaccinated due to refusal or delays in vaccination.”

So far the outbreak has been among religious Jews some of whom shun getting the vaccine for their kids out of fear it causes autism Dr. Yu Shia Lin of Maimonides Medical Center in Borough Park told The News.

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Sperm Donation, Anonymity, and Compensation: An Empirical Legal Study

I. Glenn Cohen 3 Comments

[Cross-Posted at Prawfsblawg]

In the United States, most sperm donations* are anonymous. By contrast, many developed nations require sperm donors to be identified, typically requiring new sperm (and egg) donors to put identifying information into a registry that is made available to a donor-conceived child once they reach the age of 18. Recently, advocates have pressed U.S. states to adopt these registries as well, and state legislatures have indicated openness to the idea.

In a series of prior papers I have explained why I believe the arguments offered by advocates of these registries fail. Nevertheless, I like to think of myself as somewhat open-minded, so in another set of projects I have undertaken to empirically test what might happen if the U.S. adopted such a system. In particular, I wanted to look at the intersection of anonymity and compensation, something that cannot be done in many of these other countries where compensation for sperm and egg donors is prohibited.

Today I posted online (downloadable here) the first published paper from this project, Can You Buy Sperm Donor Identification? An Experiment, co-authored with Travis Coan, and forthcoming in December 2013 in Vol. 10, Issue 4, of the Journal of Empirical Legal Studies.

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