adult and child hands holding red heart, organ donation concept image.

Opt-in vs. Opt-out Organ Donation Schemes: Evidence from the US and UK

By James W. Lytle

We need to encourage organ donation. In the U.S. alone, even with a record number of about 40,000 transplants in 2019 and some progress made towards closing the gap, approximately 108,000 Americans are on the waiting list.

In considering the best way to increase organ donation, much of the debate has focused on how to make organ donor registries more successful: nothing facilitates the prospect for organ donation more than knowing that a potential donor has already indicated their intention to donate.

Should registries, like those in the U.S., require people to elect to join (the “opt-in” approach) or should they presume consent to organ donation and register everyone except those who explicitly “opt-out,” as is the case in certain other countries?

I asked two transplant professionals, one from the U.S. and one from Wales, to help consider this question and related issues involving organ donation.

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organ transplant

New Regulations for Organ Procurement Organizations Pose Concerns

By Alexandra Glazier

The United States has one of the highest organ donation and transplant rates in the world. A poorly crafted regulatory change could disrupt our world-leading system and put patients at risk.

Recently, new performance regulations for organ procurement organizations (OPOs) were promulgated by CMS in the last stretch of the Trump Administration, which should be reviewed by the incoming Biden Administration.

While there is widespread support for reform to the system of organ donation and transplantation, including consensus that changes to the CMS metrics measuring OPO performance are warranted, there are significant differences in opinion on how that can be accomplished best.

Bipartisan groups and delegations of both Democrats and Republicans, donor families, the medical community, and donation and transplant professionals as well as OPOs have raised a range of concerns about specific aspects of the proposed and final regulations, making suggestions on how the regulations could be improved to achieve the goal of transplanting more patients.

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Adult and child holding kidney shaped paper on textured blue background.

New Regulation Aims at Accountability for Organ Procurement Organizations

By James W. Lytle and Abe Sutton

Facing a looming deadline for the adoption of pending proposed rules, the Trump Administration finalized a host of healthcare regulations, including highly anticipated regulations addressing drug pricing and Stark Law/anti-kickback rules. Within this flurry of regulatory activity, the Centers for Medicare & Medicaid Services (CMS) also finalized an important, but not as widely discussed, proposal that seeks to hold Organ Procurement Organizations (OPOs) more accountable for their performance.

While some of these last-minute actions by the outgoing administration may ultimately be reversed or revised by the Biden Administration, this rule was associated with a well-regarded Advancing American Kidney Health initiative that has been “widely hailed by health care groups, patient advocacy organizations and Democrats,” making it “the most broadly popular health initiative of Trump’s presidency.” While its fate is not entirely certain, the recently issued final rule may be one of the few last-minute legacies of the Trump Administration likely to be more warmly received by its successor.

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Adult and child holding kidney shaped paper on textured blue background.

Nudging Organ Donation in the United States

Cross-posted from Harvard Law Today, where it originally appeared on November 13, 2020. 

By Chloe Reichel

Nationally and globally, demand for organ transplants outstrips supply. In the United States last year, 19,267 donors made a record-setting 39,718 transplants possible, but nearly 109,000 Americans still remain on the organ transplant waiting list.

Cass Sunstein ’78, Robert Walmsley University Professor and former Administrator of the White House Office of Information and Regulatory Affairs in the Obama administration, believes “Nudge theory” might help bridge this gap between supply and demand.

Sunstein joined scholars and leaders in transplant services on Friday, Nov. 6 to discuss strategies to boost rates of organ donation at “Nudging Organ Donation: Tools to Encourage Organ Availability,” an event hosted by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School.

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bloody zombie hands grasping air

Considerations for a Zombie Apocalypse: The Definition of Death Among the “Walking Dead”

While there has been a great deal in the literature that discusses the ethics of neurologic, cardiopulmonary and biologic death in the context of organ donation, there has been very little attention to this application with regard to zombies. Zombies are often referred to as “living-dead” which creates both a scientific, operational, and ethical conundrum with regard to classification. To date, there is no definitive answer as to whether zombies are truly “dead” or whether they are “living” or that they exist along the spectrum of conscious to coma, from living to dead. In the event of a zombie apocalypse, it is currently unclear whether or not zombies could be considered suitable organ donors.

Zombies: A Definition and Brief History

Zombies are a class of “living dead” that also includes vampires, ghouls, mummies, and wights. The term “zombi” was reportedly first used by the poet Robert Southey in his description of Brazilian history. One of the earliest references to zombies dates back to Mesopotamia in the Descent of Ishtar when the goddess Ishtar threatens to “raise up the dead, and they shall eat the living.”

Since then, there have been hundreds, if not thousands, of descriptions of undead, zombies, and reanimated humans in comics, books, television programs, and movies. Some cultures have an extensive history of zombies, the most well-described and studied being the Haitian Zombies of Voodoo.

Zombies are further divided into subcategories: zombies reanimated by black magic (Voodoo), those created by sorcery (necromantic), viral- induced (Solanum) and those created by mutation from radiation (atomic). There have been case reports of drug-induced zombies, but these were later re-classified as this state was reversible without intervention. There is a movement to utilize the more descriptive terminology Ataxic Neurodegenerative Satiety Deficiency Disorder (ANSDS).

Culturally, the term differently-animated has been used as a more politically correct term for identifying zombies. The varied terms, means by which zombification can occur and the newer, more descriptive and politically correct terminology however, has done little in the way to describe the actual physiologic state of zombies. This requires a more in-depth analysis of what we do and do not know about zombie biologic and specifically neurologic function.

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State-Level Solutions to Discrimination in Organ Transplants 

By Emily Largent

organ transplant
Doctors in North Dakota perform a kidney transplant. (Photo by ndguard/Flickr)

In recent years, alleged instances of discrimination against people with disabilities in organ transplantation have captured public attention.

In 2012, for example, the parents of Amelia Rivera, a child with Wolf-Hirschhorn syndrome, alleged that they were told their daughter was not a candidate for a kidney transplant because of her “mental retardation.” The Children’s Hospital of Philadelphia denied “disqualify[ing] transplant patients on the basis of intellectual ability.” Nevertheless, more than 51,000 individuals signed a change.org petition demanding that the hospital “allow the life saving [sic] transplant four-year-old Amelia Rivera needs to survive.”  Ultimately, Rivera received a living donor kidney transplant from her mother.

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Bioethicist Art Caplan: A New Mind-Body Problem

A new piece by Bill of Health contributor Arthur Caplan, with Lisa Kearns, in The Hastings Center Bioethics Forum:

Not since Rene Descartes gazed from his garret window in early 17th-century Paris and wondered whether those were men or hats and coats covering “automatic machines” he saw roaming the streets has the issue of personal identity and your cranium been of such import. Descartes feared a world that he alone occupied due to deception by the devil. Today we face a different mind-body challenge in the form of a devil we know: Italian neuroscientist Sergio Canavero. He recently announced that the first human head transplant is imminent.

For bioethicists, the moral critiques of this surgery practically write themselves: Are we merely our bodies? How can a person so ill as to wish to trade in his lifelong corporeal companion be considered competent to consent to such a drastic procedure? How can family members consent to donate a body that they could very well run into — and recognize — at the beach or gym? What if a left-handed person received a right-handed body? What if a lifelong Chicago Bears fan woke to find himself attached to the green-and-gold-tattooed torso of a former Packers fan? Would transplant recipients need to buy whole new wardrobes? Who will pay? […]

Read the full article here!

The First Human Body Transplant – Ethical and Legal Considerations

By Ana S. Iltis, PhD

brain_glowingprofileTo what lengths should we go to preserve human life? This is a question many are asking after hearing that three men plan to make medical history by conducting the first human head transplant. Or, rather, whole body transplant. Italian neurosurgeon Dr. Sergio Canavero and Chinese surgeon Dr. Xiaoping Ren plan to provide a Russian volunteer, Valery Spiridonov, a new body. During the procedure, Spiridonov’s body and head would be detached and, with the help of a crane, surgeons would move the head and attach it to the donor body.  But is this ethical? What role might law and regulation play in monitoring them or in assessing their conduct after the fact?

Critics call the plan crazy, unethical, and sure to fail. The likelihood of success is very low and the risk of Spiridinov dying is high. Spiridonov says that as soon as animal studies confirm the possibility of survival, the risks will be worth taking. He has Werdnig-Hoffmann Disease, a genetic disorder that destroys muscle and nerve cells. He is confined to a wheelchair and has lived longer than expected. Body transplantation offers him the best chance at a life worth living. Read More

Patenting Bioprinting Technologies in the US and Europe – The Fifth Element in the Third Dimension

By Timo Minssen

I am happy to announce the publication of our new working paper on  “Patenting Bioprinting Technologies in the US and Europe – The 5th element in the 3rd dimension.” The paper, which has  been co-authored by Marc Mimler, starts out by describing the state of the art and by examining what sorts of bioprinting inventions are currently being patented. Based on our findings we then discuss what types of future innovations we can expect from the technological development and how far these would and/or should be protectable under European and US patent laws.

The paper is forthcoming in: RM Ballardini, M Norrgård & J Partanen (red), 3D printing, Intellectual Property and Innovation – Insights from Law and Technology. Wolters Kluwer, but the working paper is already available on SSRN. Read More