Category: Human Tissue

Anonymity is Not Privacy (and Why it Matters)

jskopek 1 Comment

Anonymity is not just an aspect of privacy and recognizing their difference reveals a powerful and poorly understood set of legal tools for facilitating and controlling the production of public goods.  This is the central claim of my newest article (SSRN draft available here).

Three examples illustrate the scope of the under-explored ways in which anonymity is currently used in our law.

  • The first is from June 1997, when many residents in the Boston neighborhood of Allston learned to their anger that Harvard University had spent the previous 8 years secretly acquiring over 50 acres of Allston real estate.  It did so using buying agents, which can generally protect their principal’s anonymity—even by falsely stating that they are not agents.
  • The second is from Election Day 2012, when many voters who had shared photos of their completed ballots on Facebook and Twitter learned, to their surprise, that they had violated their states’ elections laws in doing so.   They did not know that anonymity in voting was not just a right, but also a requirement.
  • The third is from a 2006 lawsuit over the control of thousands of tissue samples being used in research at Washington University.  When many of the research participants sought to withdraw their tissue from future research, in response to what they saw as a breach of their consent, they were shocked to learn that the university could refuse and extinguish their rights of withdrawal by anonymizing their tissue samples.

These varied uses of anonymity in our law—as a right when purchasing land, a requirement in voting, and a trigger than extinguishes rights in biomedical research—may appear to be unrelated.  But I argue that they are in fact all part of a cohesive and previously unrecognized class of rules that use anonymity not to protect privacy, but rather to incentivize or control the production and circulation of information and other socially desirable goods. Read More

Racism in Transplant Denial? Or Too Few Hearts To Go Around?

Michele Goodwin Leave a comment

By Michele Goodwin

Anthony Stokes, a fifteen year old kid from Decatur County, Georgia, is expected to die in a matter of months, according to his doctors at the Children’s Healthcare of Atlanta.  Maybe, they say, he will live for six months.  Who knows?  Anthony suffers from an enlarged, increasingly less functional heart.  His condition is not unusual, and a reasonably effective cure is at hand: a heart transplant. (Learn more about Anthony’s story here.)

However, Anthony has become the latest victim of a dysfunctional U.S. transplantation system, which tempts Americans with a transplant waiting list, but kicks them off if they become too sick or too old.  The problem is that there are too few organs to meet demand, and this perennial problem receives far too little attention from Congress.  Indeed, the U.S. transplantation list, coordinated by the United Network for Organ Sharing, UNOS, (a private organization that coordinates significant aspects of the U.S. transplant system) is so overcrowded that patients increasingly turn to black markets in India, China, Pakistan, South Africa, and other countries if they hope to survive.  (Learn more about that here.) Congressional hearings document Chinese prisoners dying and shortly thereafter Americans receiving organs.

Anthony’s family and some local organizations claim that racism is behind doctors refusing to place the boy on the transplant list.  Anthony is African American.  They ask, what is the harm in letting him on the list?

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Henrietta Lacks and the HeLa genome

W. Nicholson Price Leave a comment

By Nicholson Price

A few days ago, NIH announced an agreement with the family of Henrietta Lacks.  When she was being treated for an aggressive tumor, cells were taken without her consent or knowledge and used to create the HeLa cell line, which is tremendously widespread in biomedical research today – the story is well-chronicled in Rebecca Skloot’s The Immortal Life of Henrietta Lacks. The announcement raises some interesting questions about precedent and keeping information partitioned once it’s been released. Read More

Art Caplan on the NIH’s Agreement Regarding Control of Henrietta Lacks’ Cells

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Art Caplan has a new opinion piece up at nbcnews.com on the longstanding controversy over the use of the cells of Henrietta Lacks, a poor African American woman who died of cervical cancer in 1951, for research that has generated billions of dollars through scientific research over more than six decades. This research was conducted without Lacks’ or her family’s consent. According to a new NIH agreement with the Lacks family:

Lack’s genome data will be accessible only to those who apply for and are granted permission. And two representatives of the Lacks family will serve on the NIH group responsible for reviewing biomedical researchers’ applications for controlled access to HeLa cells. Additionally, any researcher who uses that data will be asked to include an acknowledgement to the Lacks family in their publications.

The new understanding between the NIH and the Lacks family does not include any financial compensation for the family. The Lacks family hasn’t, and won’t, see a dime of the profits that came from the findings generated by HeLa cells. But this is a moral and ethical victory for a family long excluded from any acknowledgment and involvement in genetic research their matriarch made possible.

Read the full article here.

Anthony Weiner, Sexting, Medicalization, and Legal Moralism, Or (To Be Provocative) “What’s So Wrong About Sexting?”

I. Glenn Cohen 1 Comment

Like most people, I am both amused and shocked by the latest Anthony Weiner sexting revelations and scandal. It is like a car crash where it is hard to look away even though you know you should.

Most germane to Bill of Health’s readership, I am fascinated by the “medicalization” of Weiner’s behavior by some sectors, this CNN clip with therapists is to me a good example. The words “sexual addiction,” “exhibitionism,” comparisons to alcoholism, “not in control of his actions” are bandied about. This to me has fascinating echoes of the medicalization of homosexuality in the 70s and also the medicalization of the choices made by the transgendered. There like here the strategy is fraught. The patient has to perform the “sick role” as a way of excusing himself from responsibility and/or earn governmental support.

The comparison, though, prompts the following question (and yes I am purposefully trying to be provocative so take it with the appropriate grain of salt): As with homosexuality, what is the underlying problem here that calls out for condemnation? Is this merely legal moralism rearing its head again? What’s so Wrong About Sexting?

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Thinking about brain death

shahse 6 Comments

By Seema Shah

It astonishes me how many people do not realize the controversial nature of “brain death” and the fact that it is not the same as death. There is a substantial body of literature showing that brain death is not the equivalent of death. The President’s Council on Bioethics issued a white paper in 2008 acknowledging the deficiencies with our current approaches to determining death. The literature on the topic is fascinating—some brain dead individuals have gestated babies successfully to viability and gone through puberty. Many brain dead individuals can heal wounds, regulate their body temperatures, and persist on ventilators for many years. (If you are unfamiliar with this literature and want to read further, see the citations provided below.)

Frank Miller and I have argued that best the way to think about the status quo is that brain death is a status legal fiction, much like the legal construct that a corporation is a person. A corporation is similar enough to a person that it is convenient to treat corporations as persons under the law, rather than writing an entirely new body of law meant to apply to corporations alone. We have argued that brain death is similar to death—Frank Miller and Bob Truog express this by saying that a person who is brain dead is “as good as dead.” For this reason, we can ethically and legally treat the two states in the same way for the purposes of determining death and allowing vital organ transplantation.

There are many open and interesting questions about brain death that I will be exploring on this blog for the next few weeks. Michael Nair-Collins has a recent article in the Kennedy Institute of Ethics Journal that argues that the current approach to determining death in the U.S. is paternalistic and, presumably, unjustified. He cites as evidence the kinds of information that are shared with people deciding whether to become organ donors. But is this true, or is there evidence that the public is able to distinguish between brain death and death? Kenneth Kasper, Frank Miller, and I are investigating this at the moment, and we are finding some surprising answers in the literature. Read More

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

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.

U.S. Supreme Court Upholds Constitutionality of DNA Collection Upon Arrest (Maryland v. King)

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By Michelle Meyer

The U.S. Supreme Court ruled this morning, in Maryland v. King, that it is constitutional under the Fourth Amendment’s protection against “unreasonable” searches and seizures for the state to compel collection of DNA from arrestees. The probable cause required to arrest someone under the Fourth Amendment permits fingerprinting and taking photographs during the booking process, and the Court held that collecting DNA (limited to 13 loci in supposed “junk DNA”) was not relevantly different. The decision was 5-4, with Kennedy writing for the Court and joined by Chief Justice Roberts and Justices Thomas, Alito, and Breyer. Justice Scalia dissented in his usual spirited way, joined by Justices Ginsburg, Sotomayor, and Kagan.

I suspect that one or more Bill of Health bloggers will have some analysis of this decision once they’ve had the chance to digest it. In the meantime, here is a still-relevant primer I co-authored in 2004 on legal and ethical debates involving DNA and the criminal justice system (including issues related to both offender DNA databases and post-conviction access to potentially exculpatory crime scene DNA). Note that Justice Breyer, in addition to being the Court’s resident patent expert (except him to play a large role in the upcoming Myriad gene patenting decision), has been following debates about DNA and the criminal justice system for some time. He authored Chapter 2 of the book I just linked to.

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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