Category: Bioethics

Commentary from OPTN/UNOS Kidney Transplantation Committee Chair, John Friedewald

The Petrie-Flom Center Staff Leave a comment

Related to Nikola’s post below on the proposed revisions to the deceased donor kidney allocation policy, Al Roth has posted some interesting commentary from OPTN/UNOS Kidney Transplantation Committee Chair John Friedewald (in response to a query on a list serve):

“The current proposal for kidney allocation from the UNOS kidney committee is what it is not because it was the first thing we thought of, and “wow, it’s perfect” but rather it is the product of 8 years of trial and error, consensus building, and compromise.  To state that EOFI takes into account both equity and efficiency would seem to suggest that the current UNOS proposal does not.  How could this be?  We have tried over 50 different methods of allocation and simulated them (which has not happened yet with EOFI).  And with each simulation, we view the results and how the system affects all sorts of different groups (NOT just age, but blood type, ethnic groups, sensitized patients, the effects on organ shipping, the effects on real efficiency in the system (the actual logistics).  And we have seen that some methods of allocation can generate massive utility (or efficiency in your terminology).  We can get thousands of extra life years out of the current supply of organs.  But in each instance, we have made concessions in the name of equity.  The current proposal does not increase or decrease organs to any age group by more than 5% (compared to current).   This has been our compromise on equity.  What we see in utility/efficiency is an extra 8000+ years lived each year with the current supply of organs.  So the current policy has done a tremendous amount to balance equity and utility.  And we have left thousands of life years lived on the table in the name of equity.  Now you may argue that we have not done enough in that regard, but rest assured, we have given equity hundreds of hours of consideration.

UNOS Proposes a New Kidney Allocation System

nandorno Leave a comment

By Nikola Biller Andorno

The Kidney Transplantation Committee of the Organ Procurement and Transplantation Network (OPTN)/United Network for Organ Sharing (UNOS) has put forward a proposal that would substantially revise the existing national allocation system for kidneys from deceased donors. It would also dissolve alternate local kidney allocation systems, which were put in place to study various allocation methods, some of which have been incorporated into the new proposal.

The proposal contains a number of provisions. Whereas the current allocation system is focused on the time a patient has been on the waiting list for a kidney, the new proposal suggests a tiered system: The 20% of kidneys that are ranked highest with regard to the likely duration of functioning once transplanted will be matched with the 20% of candidate recipients who are expected to have the longest time to benefit from a transplant. The logic behind this suggestion – like many others driving health policy considerations these days – is an attempt to maximize utility. Although the attempt to extract the most benefit out of a precious, scarce resource is certainly in keeping with good stewardship, the proposal raises concerns about fairness: What about patients who have a lower life expectancy due to age, disability, coexisting conditions, or socioeconomic status? Will they be deprioritized, with an increased risk of either dying before they get a transplant or of receiving a transplant that may not last for long? This would mean a departure from current policy, which focuses on waiting time, and it would also diverge from policies for other organs, such as livers, in which urgency is of primary concern and very sick patients are prioritized. On the other hand, stratifying organs for transplantation is not entirely new: in an attempt to reduce the number of discarded organs, several European countries have established so-called ‘old-to-old’ programs, which match the kidneys of donors 65 years of age or older with recipients of a similar age.

At the same time, the OPTN/UNOS proposal aims to promote equality of opportunity for the remaining 80% of potential recipients, by calculating their waiting time from the onset of end-stage kidney failure rather than from the date when they were added to the waiting list and by correcting for biological factors such as uncommon blood type or high immune-system sensitivity.

The proposal can be expected to undergo careful scrutiny by the different stakeholders. There is a period for public comment running through December 14, 2012. Have a look at https://optn.transplant.hrsa.gov/news/newsDetail.asp?id=1579 and contribute to the debate.

A Question of Insurance Fraud?

Temple University Center for Public Health Law Research Leave a comment

By Scott Burris

No, I mean it: this is a question to Bill of Health readers who know about the law on this topic.

This week, a colleague handed me a palm card she’d been given at a subway station here in Philadelphia. “Cash for diabetic test strips” it read.  Comparing prices on the company’s website with prices on Wal-Mart’s pharmacy page, it looked like the test-strip buyer pays about 20 cents on the dollar for “pre-owned” test strips.

The palm card and the website both stipulate that the strips be unexpired and in their original, unopened, factory-sealed boxes.

So, one asks, are there enough people out there who buy more diabetic test strips than they need, and are willing to take an 80% loss to ensure they are used by someone else? That seems unlikely.

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Upcoming Event – Patients with Passports: Medical Tourism, Law, and Ethics

kparas Leave a comment
Wednesday, October 10, 2012
4:00pm
Radcliffe Gymnasium
18 Mason Street
Cambridge, MA

Please join us for a presentation of the 2012-2013 Radcliffe Fellows Series.

Bill of Health Co-Editor I. Glenn Cohen will discuss the growing phenomenon of medical tourism, the practice of citizens of one country traveling to seek medical care in another country. He will examine the emerging legal and ethical issues brought up by the many varieties of medical tourism—for services that are legal in the destination and home country, for services that are illegal in the home country but legal in the destination country, and for services that are illegal in both places.

TOMORROW: Glenn Cohen on Action Speaks! Diamond v. Chakrabarty

kparas Leave a comment

Tomorrow, Wednesday, October 3 at 5:30 pm, Bill of Health co-editor I. Glenn Cohen will participate in a live national broadcast on Actionspeaksradio.org regarding Diamond v. Chakrabarty, the 1980 case that first established the right to patent life.

For information on how to listen or attend the recording live in Providence, RI, click here. And for some background from Glenn on the case and current issues, click here and here.

Social Inequality in Clinical Research

srivera Leave a comment

by Suzanne M. Rivera, PhD

For a variety of reasons, racial and ethnic minorities in the US do not participate in clinical research in numbers proportionate to their representation in the population.  Although legitimate mistrust by minorities of the healthcare system is one reason, institutional barriers and discrimination also contribute to the problem.  The equitable inclusion of minorities in research is important, both so that they receive an equal share of the benefits of research and to ensure that they do not bear a disproportionate burden.

Under-representation is not just a question of fairness in the distribution of research risks.  It also creates burdens for minorities because it leads to poorer healthcare.  Since participation in clinical trials provides extra consultation, more frequent monitoring, and access to state-of-the-art care, study participation can represent a significant advantage over standard medicine.  To the extent that participation in research may offer direct therapeutic value to study subjects, under-representation of minorities denies them, in a systematic way, the opportunity to benefit medically.

For many years, our system for drug development has operated under the assumption that that we can test materials in one kind of prototypical human body and then extrapolate the data about safety and efficacy to all people.  That’s a mistake; the more we learn about how drugs metabolize differently based on genetics and environmental factors, the more important it becomes to account for sub-group safety and efficacy outcomes.  More recently, greater emphasis has been placed on community-based participatory research.  This movement toward sharing decision-making power between the observer and the observed is a critical step for addressing both the subject and researcher sides of the inequality equation.

Upcoming Event: “Office and Responsibility – A Symposium in Honor of Professor Dennis Thompson”

kparas Leave a comment

Our colleagues at the Edmond J. Safra Center for Ethics, the Department of Government, and the FAS Dean’s Office at Harvard are sponsoring an exciting event next Thursday and Friday, October 11-12, 2012, in honor of Professor Dennis Thompson. The symposium is free and open to the public

For information on the lineup of speakers and presentations, visit the Symposium webpage.

“The New Normal” and Reproductive Technology and the Law

I. Glenn Cohen Leave a comment

Inspired in part by attending the “Baby Markets Roundtable” (an annual gathering of reproductive technology and the law scholars) this week at Indiana Bloomington, I wanted to share a few thoughts on the new NBC television show The New Normal. The series is a sitcom that follows the lives of a gay male couple (David and Bryan) who decide to employ a surrogate (Goldie), who herself has a young child through a prior relationship (Shania). The last cast member that is part of the family is the Goldie’s fairly right-wing grandmother known as “Nana.”

First the good: This is one of the few portrayals of surrogacy on TV, period. With a few exceptions, usually surrogacy comes in as a plot-of-the-week on lawyer shows when something has gone wrong. Here is one of the few positive, normalizing, portrayals of surrogacy.

Now the not-so-good:

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NEJM: Cutting Family Planning in Texas (and more)

Holly Fernandez Lynch Leave a comment

Our friends over at the New England Journal of Medicine just alerted us to a new perspectives piece addressing the impact of cutting family planning funds in Texas (the piece was also picked up by Politico).  The authors interviewed 56 leaders of organizations throughout the state that provided reproductive health services using public funding before cuts went into effect, and what they found was disturbing:

  • Most clinics have restricted access to the most effective contraceptive methods because of their higher up-front costs (choosing pills over IUDs or subdermal implants).
  • Clinics have started to turn away those who canot pay, when previously their visits would have been covered by public funds, and women who can pay the newly instated fees are choosing less effective methods and fewer tests to save money.
  • A number of clinics have lost their exemption from Texas’ law requiring parental consent for teens under 18 who seek contraceptives.

Overall, the authors conclude that laws intended to defund Planned Parenthood in an attempt to limit access to abortion (even though federal and state funding cannot be used for abortion anyway) have resulted in policies limiting women’s access to range of preventative reproductive health services and screenings.

Alta Charo weighs in via a NEJM podcast, discussing the future of reproductive health care for women in the US, particularly in light of upcoming elections (as well as the article we discussed last week on conscientious action, and other general issues in reproductive health policy).  Take a listen!

And one more NEJM plug for now: our Bill of Health blogger Kevin Outterson also has a podcast online discussing the record-breaking settlements of pharmaceutical fraud cases and the need for further regulation.

Some Thoughts on Sandel’s “What Money Can’t Buy”

Cansu Canca Leave a comment

By Cansu Canca

Last Wednesday, I went to Michael Sandel’s lecture introducing his new book What Money Can’t Buy: The Moral Limits of Markets. His talk focused on two main arguments: There should be certain norms that govern our relationship with certain goods; and markets corrupt these norms.

I think Sandel’s position fails in three respects:

  1. The book does not provide a theoretical basis for these norms. In other words, the book does not explain where these norms come from, which norms are suitable for which relationships, or how they are violated.
  2. Given the lack of theoretical basis, the book cannot identify a stopping point for its suggestion to preserve and cultivate virtues related to these norms. There would seem to be many more activities to which the book’s suggestions could be expanded, yet even Sandel does not seem willing to go there. To the extent one accepts it, Sandel’s argument thus proves too much.
  3. Instead of presenting a theoretical basis, the book proceeds by analogy. But the analogies seem unconvincing in that their source and target situations seem materially different.

Let me flesh out these points.

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