Category: Organs

Undocumented Organ Transplants

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By Brad Segal

Manuel—not his real name—was admitted to the hospital with decompensated heart failure. As a child he had scarlet fever which, left untreated, had caused the valves of his heart to calcify and stiffen. Over time, pumping against increased resistance, his heart’s contractions began to weaken until finally, they lost all synchrony and the normal function of his heart spiraled out of control. At this stage, his fate was tied to whether or not he would receive a new heart in time.

He was in his 30’s and had no other illnesses. From a medical perspective, Manuel was the ideal candidate for a cardiac transplant. But a decade ago Manuel crossed the United States border in pursuit of a better life. As an undocumented immigrant, he was ineligible for the insurance coverage necessary to pay for a heart transplant. After being thoroughly evaluated by the hospital’s transplant center, given his modest financial resources and inability to obtain new insurance coverage, Manuel was not placed on the waiting list for a new heart.

The average heart transplant costs about a million dollars to perform. Subsequent follow-up care adds another $30,000 annually. Health insurance will usually cover most, if not all, of these costs. But uninsured patients are kept off transplant lists on the grounds that the inability to pay for care allegedly jeopardizes an organ’s long-term success. Read More

Chimeras with benefits? Transplants from bioengineered human/pig donors

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By Brad Segal

In January of this year, Cell published a study modestly titled, Interspecies Chimerism with Mammalian Pluripotent Stem Cells. It reports success bioengineering a mostly-pig partly-human embryo. One day before, Nature published a report that scientists had grown (for lack of a better word) a functioning genetically-mouse pancreas within the body of a genetically-modified rat. The latest study raises the likelihood that before long, it will also be scientifically possible to grow human organs within bioengineered pigs.

The implications for transplantation are tremendous. But hold the applause for now. Imagine a chimera with a brain made up of human neurons which expressed human genes. Would organ procurement without consent be okay? That troubling possibility raises  questions about whether manufacturing chimeras with human-like properties for organs is even appropriate in the first place. Here’s what University of Montreal bioethicist Vardit Ravitsky told the Washington Post:

“I think the point of these papers is sort of a proof of principle, showing that what researchers intend to achieve with human-non-human chimeras might be possible … The more you can show that it stands to produce something that will actually save lives … the more we can demonstrate that the benefit is real, tangible and probable — overall it shifts the scale of risk-benefit assessment, potentially in favor of pursuing research and away from those concerns that are more philosophical and conceptual.”

I respectfully disagree. Saving more lives, of course, is good. Basic science is also valuable – even more so if it might translate to the bedside. This line of research, though, is positioned to upend our entire system of transplantation, and so its implications go beyond organ supply. In this post I will argue that to assess this technology’s implications for organ procurement in particular, there is good reason to focus on harms, not benefits. Read More

Organs and Overdoses (Part II): ‘Higher risk’ donors

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By Brad Segal

In my last post I characterized how overdoses from the surging opioid epidemic have become the fastest-growing cause of mortality among organ donors. In this update, I raise one potential consequence with ethical and policy implications: so-called donor-derived infections. To be clear, I focus primarily on organ recipients as deaths from drug overdose, and drug addiction more broadly, should be prevented regardless of any implications for transplantation. With this in mind, consider how the population of injection drug users shoulders a heavy burden of HIV, hepatitis B (HBV) and hepatitis C (HCV) (Table 1). First I will focus on screening guidelines, and then will move on to transplantation of organs known to carry an infection. table-1

Screening guidelines can help reduce the incidence of donor-derived infections, but the lab tests recommended in any policy must balance two potential concerns. First, lab tests have a rate of false negative results. Transplants of these organs will accidentally increase donor-derived infections. The policy question, then, is whether or not transplanting organs donated by individuals with higher risk of recent disease exposure will expose an unacceptable proportion of recipients to infection. This unintentional harm could undermine a duty of non-maleficence to organ recipients. Further complicating a potential screening policy is that the basic lab tests for HIV, HBV, and HCV detect the presence of human antibodies, which work well among a low-risk population, but antibodies might not appear in the blood until weeks after infection (Table 2).Recent infections are better detected by nucleic acid amplification (NAT) testing.To mitigate risk of infection,then, transplant screening policies should require a heightened level of surveillance among donors with a history of illicit drug use. Read More

Organs and Overdoses: The Numbers (Part I)

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By Brad Segal

The surging opioid epidemic is a threat to the nation’s public health. This year the CDC reported that mortality from drug overdose reached an all-time high, with the annual death toll more than doubling since 2000. Yet in the backdrop of this epidemic, the country also faces ongoing shortages of a different sort–too few organs for transplantation. Every day, approximately 22 people die while waiting for an organ to become available. To some it is not a surprise–or at least not inconceivable–that the fastest-growing source of organ donors is being fueled by the national spike in drug overdoses. This first post will help delineate the scope and scale of the situation. My follow-up will discuss the ethical considerations and ramifications for public policy.

To start: the numbers. The Organ Procurement and Transplantation Network (OPTN) makes domestic transplant data publicly available online, which currently extends from 1994 to September 30th, 2016. Two decades ago, 29 organ donors died from a drug overdose.* In just the first nine months of this year, that number has climbed to 888 donors. Even with a quarter of the calendar year left to be counted, 2016 has already surpassed previous record set in 2015 (Figure 1).

figure-1
Figure 1

One might question whether this trend is an illusion–perhaps a rise in the incidence of donors who had overdosed reflects an increasing number of transplants. But the data suggest the opposite. Also plotted in Figure 1, the percentage of total organ donors who died from overdose (maroon diamonds, right-sided Y axis) has not remained constant–instead, the percentage has steadily increased. Two decades ago, overdose caused the deaths of 0.6% of all organ donors; this year, it is the cause of death among 12.0% of organ donors nationwide. The rising percentage means that not only are more victims of drug overdose donating organs, but that the pool of organ donors is increasingly composed of such individuals. Read More

Is Gaming the Transplant List an Ethical Dilemma?

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By Shailin Thomas

NPR recently published a thought-provoking piece discussing an ethical dilemma doctors face when treating patients in need of organ transplants. Transplant list priority is designed to depend upon the relative sickness of patients, allocating organs to those who need them most. However, instead of lab results or other direct measures, the list uses the treatment a patient is receiving as a proxy for her condition. As a result, doctors have the ability to move their patients up the list by prescribing — or over-prescribing — more extreme and invasive treatments.

It’s understandable why this temptation exists — doctors go into medicine to heal, and I imagine it’s difficult to refrain from taking an action which could very well save a patient’s life. But should this be an ethical dilemma?

Bumping a patient up the transplant list could certainly save a life, but that life could come at the expense of another’s. The problem is that organ transplants are inherently zero-sum — if one patient goes up on the list, another must come down. If one person gets an organ, that means another doesn’t. Furthermore, over-treating to influence transplant priority has consequences that reach beyond any individual patient, potentially furthering inequality in the transplant system and contributing to unsustainable health care spending. Read More

Uterus Transplants: Challenges and Potential

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[Cross posted at the OUPBlog]

By John A. Robertson

The birth of a healthy child in Sweden in October, 2014 after a uterus transplant from a living donor marked the advent of a new technique to help women with absent or non-functional uteruses to bear genetic offspring. The Cleveland Clinic has now led American doctors into this space, performing the first US uterine transplant in February, 2016 as part of an Institutional Review Board (IRB)-approved series of ten transplants using cadaveric donors. Dallas and Boston medical centers have also been approved for this program, as will other programs as progress continues. An estimate of 50,000 American women are potential clients.

The path to womb transplants, however, will not be easy. On 7 March, the Cleveland Clinic celebrated its transplant with a media announcement full of joy and celebration. Two days later in a decidedly different key, the Clinic informed the world that the organ was surgically removed because the recipient had “suddenly developed a serious complication.” One can only imagine the disappointment of the patient and medical team, who had smiled so happily in media coverage. Of course, early failure is not surprising with innovative surgery, and no doubt the Cleveland clinic will proceed with other patients. The case is a reminder that the road to success is long, and initial steps should be closely monitored by IRBs, as is occurring in Cleveland, Sweden, and elsewhere. Read More

Fundraising and the Delayed Kidney Transplantation: A Loophole in the Ban against Commercialization?

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By Cansu Canca

In April, a kidney donation from an unrelated living donor was put on hold in South Portland, Maine. The reason was unusual: the generosity of the community.  In response to an online fundraising for the donor, 768 people contributed over $49,000—well beyond what can reasonably be called “compensation.” The hospital thus had to ask the question: Is the donation procedure in conflict with the law now that the donor stands to profit from it? After initial media coverage, there was no further news about this case. On Monday, however, it was announced on the fundraising page that the transplant is back on track and due to happen in two weeks. Does that mean that we now have a loophole in the ban against commercialization of organs?

The case is unprecedented. There are and have been other online fundraisers to compensate donors. But this is the first time that the unpredictable powers of the internet kicked in (remember the guy who raised $55,000 to make a potato salad?). The law prohibits any monetary payments to organ donors. The situation poses two questions: What should be done in this particular case, and how should fundraising for organ donors be regulated going forward?

It appears that the first question was somehow resolved even though we don’t know how: Did the hospital decide it was not a problem after all, or did the donor agree with the hospital’s reported initial suggestion of donating the “excess” money to some other organization? In either case, what follows remains problematic.

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Bioethicist Art Caplan: A Potential Solution to the Shortage of Solid Organs for Transplantation

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A new opinion piece by contributor Art Caplan along with Stephen Wall and Carolyn Plunkett, in JAMA:

In the United States, the majority of deaths occur unexpectedly, outside hospitals or in emergency departments. Rarely do these deaths provide opportunities for organ donation. In Europe, unexpected deaths provide substantial numbers of transplantable organs through uncontrolled donation after circulatory determination of death (UDCDD). UDCDD considers decedents candidates for donation even when death is unexpected, regardless of location, as long as preservation begins after all life-sustaining efforts have been exhausted.

More than 124 000 patients are wait-listed for organs in the United States, a number that increases annually despite attrition from 10 500 who die or become too sick for transplantation.1 United States policy currently promotes organ recovery from 3 sources; neurologic deaths, controlled circulatory deaths, and live donors for kidneys and partial livers.

However, these approaches are incapable of meeting increasing US demand for transplants. During controlled donation after circulatory determination of death (CDCDD), the time from cessation of life support to circulatory arrest often exceeds 60 minutes. Prolonged hypotension leads to irreparable organ damage, thus limiting the effect of CDCDD on organ supply. Live donation primarily affects kidney supply; it is unlikely that altruistic donation will ever meet demand. Although many changes in public policy regarding cadaveric donation are debated (markets and presumed consent), none is likely to become law or make substantial differences in organ supply. […]

Read the full article here.

Monday 2/23: HLS Health Law Workshop with Robert Truog

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HLS Health Law Workshop: Robert Truog

March 2, 2015 5:00 PM
Griswold Hall, Room 110 (Harvard Law School)
1525 Massachusetts Ave., Cambridge, MA [Map here.]

Download the Presentation: “Defining Death: Getting It Wrong for All the Right Reasons”

Robert D. Truog is Professor of Medical Ethics, Anaesthesiology & Pediatrics at Harvard Medical School and a Senior Associate in Critical Care Medicine at Children’s Hospital Boston. Dr. Truog received his medical degree from the University of California, Los Angeles and is board certified in the practices of pediatrics, anesthesiology, and pediatric critical care medicine. He also holds a Master’s Degree in Philosophy from Brown University and an honorary Master’s of Arts from Harvard University. Dr. Truog’s major administrative roles include Director of Clinical Ethics in the Division of Medical Ethics and the Department of Social Medicine at Harvard Medical School, Director of the Institute for Professionalism and Ethical Practice at Children’s Hospital, and Chair of the Harvard Embryonic Stem Cell Research Oversight Committee (ESCRO). Dr. Truog has published more than 200 articles in bioethics and related disciplines, including recent national guidelines for providing end-of-life care in the Intensive Care Unit. He is Principle Investigator on an R0-1 grant from the NIH to improve end-of-life care in pediatric intensive care units. In his role as Director of the Institute for Professionalism and Ethical Practice, he conducts research and develops educational initiatives related to communication and relational skills. He lectures widely nationally and internationally. His writings on the subject of brain death have been translated into several languages, and in 1997 he provided expert testimony on this subject to the German Parliament. Dr. Truog is an active member of numerous committees and advisory boards, and has received several awards over the years, including The Christopher Grenvik Memorial Award from the Society of Critical Care Medicine for his contributions and leadership in the area of ethics.

What’s Wrong with Selling Organs (and a Taxonomy of Taboo Trade/Commodification Objections)

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By I. Glenn Cohen

Many people – non-philosophers especially, but some philosophers as well – loosely use the term “commodification” as an objection to a “taboo trade”. By “taboo trade” I mean the sale of a good or service such as an organ, sperm, egg, surrogacy, prostitution, etc.

This is unhelpful since it means that people often talk past each other and substitute rhetoric for reason.

In my own work I have tried to disentangle various separate objections falling within this family. This is also important in determining what, if any, form of regulation might help combat or minimize the ethical concern. It is also important because it helps us see that some forms of regulation might improve matters as to one of the ethical objections while at the same time worsen matters as to another one of the ethical objections.

For this blog post I wanted to share my taxonomy of ethical objections drawn from a recent paper I did on objections to buying and selling organs and the potential ways various regulatory tools can and cannot be used to deal with them: Regulating the Organ Market: Normative Foundations for Market Regulation, 77 Law and Contemporary Problems (forthcoming Nov 2014)  In the paper itself it is set out more formally with supporting citations, here I present just excerpts more informally.

While I illustrate the taxonomy of arguments using the buying and selling of organs, in fact the same categories can be used for any taboo trade (prostitution, selling eggs, commercial surrogacy, etc):

1. Corruption

The basic idea behind what I have elsewhere called the “corruption” argument is that allowing a practice to go forward will do violence to or denigrate our views of how goods are properly valued. This argument is sometimes labeled the “commodification” argument, but because that term is also used in a way that encompasses some of the other arguments I discuss below, I prefer the more specific label of “corruption.” The American Medical Association, among others, has voiced this kind of objection in the domestic organ-sale context, suggesting paying kidney donors would “dehumanize society by viewing human beings and their parts as mere commodities.”

We can distinguish two subcategories of this objection, which I have elsewhere called “consequentialist” and “intrinsic” corruption. “Consequentialist corruption” justifies intervention to prevent changes to our attitudes or sensibilities that will occur if the practice is allowed —for example, that we will “regard each other as objects with prices rather than as persons.” This concern is contingent and to be successful must rely on empirical evidence, in that it depends on whether attitudes actually change. By contrast, “intrinsic corruption” is an objection that focuses on the “inherent incompatibility between an object and a mode of valuation.” The wrongfulness of the action is completed at the moment of purchase irrespective of what follows; the intrinsic version of the objection obtains even if the act remains secret or has zero effect on anyone’s attitudes.

2. Crowding Out  Read More