"Benefiting" "Donors": An Open Letter to President Barack Obama, ...

[Clark]

http://www.ustransplantopenletter.org/openletter.html

An Open Letter to President Barack Obama, Secretary of Health and Human Services Sylvia Mathews Burwell, Attorney General Eric Holder and Leaders of Congress

HOW TO END THE WAIT FOR ORGAN TRANSPLANTS

The U.S. policy on organ transplants is failing to meet the needs of both patients and donors. Its goal is to save the lives of those with organ failure and to protect the rights and health of those giving organs. But it is not working for those with kidney failure (End-Stage Renal Disease, or ESRD) and they are a significant majority of those waiting for organ transplants.

The government-sponsored waiting list for kidney transplant has grown to more than 100,000 names.1 Each year, 7,000 people on that list either die or become too ill to receive a transplant.2 And the problem is only getting worse: while 35,000 patients are added to the waitlist annually,3 only 17,000 transplants are performed.4

We support current efforts to prevent diabetes and hypertension and to make the donation process fairer and more efficient, but they will not resolve the shortage. Additional approaches must be tried. Sadly, transplant policy has been governed by an unsubstantiated assumption: that donors cannot receive benefits for donating without being exploited or coerced. It is critical to examine that assumption. We hereby call for the swift initiation of evidence-based research on ways to offer benefits to organ donors in order to expand the availability of transplants.

THE PATH FORWARD

Increasing the number of transplants will save lives – our primary goal. This is a rare area of health care where better care will actually help reduce spiraling health care costs. Each transplant saves the health care system more than $100,000 compared to the cost of dialysis.5 Medicare guarantees dialysis and transplant coverage for all patients with kidney failure regardless of age – fully 7 percent of Medicare’s budget. On average, for each year a patient has a working transplant instead of dialysis, Medicare saves $55,000.

All pilot studies should of course adhere to the high ethical standards currently in place for non-compensated donors. These include guaranteeing informed consent, medical appropriateness of the donation, psychological suitability, and absence of coercion. Pilot programs would include appropriate waiting periods to give potential donors time for reflection.

To ensure equality, private transactions between individuals should remain prohibited. Transplants and benefits should be distributed by a government or government-authorized nonprofit such as the United Network for Organ Sharing (UNOS). While cash incentives are not necessarily unethical, a cautious approach would model benefits on those provided by the GI Bill, such as fully comprehensive life-long health care coverage, disability and life insurance for living donors and funeral benefits for deceased donors. Living donors should be assured priority access to a transplant if needed. Additional benefits such as a pension contribution, tax credit, or charitable contribution in the donors’ names should also be explored, particularly when those benefits will appeal to donors across the financial spectrum. Giving an organ need not fall disproportionately on people with lower incomes.

THE KIDNEY FAILURE EPIDEMIC

We write with a sense of urgency as the human cost of kidney failure is so high. More than 600,000 patients suffer from ESRD,6 a condition that left untreated results quickly in death. Dialysis is the treatment used by more than two-thirds of these patients,7 and while it achieves a modest extension of life (on average eight additional years for patients 45 to 49), it can be debilitating and complications regularly ensue.8

Transplantation is medically acknowledged as the preferable treatment.9 Transplants provide a longer life span, lower rates of complication, and better quality of life than dialysis. But not enough organ donors are available. And as is too often the case, indigent and minority patients are more poorly served.

African Americans,10 Hispanics,11 and Native Americans12 are all disproportionately more likely to need a transplant but less likely to be referred to a transplant center. In fact, tens of thousands of patients medically suitable for transplants never make it to the waiting list.13 The most recent data show that once on the list, African Americans wait 40 percent longer to receive a kidney than whites do, and Hispanic candidates wait 50 percent longer.14

The shortage drives organ trafficking, where mostly poor and uninformed people in the global south are recruited to sell their organs, often to patients in the global north. Such transplants are often performed under coercive, exploitative, and unsafe conditions. The World Health Organization has estimated that about 10 percent of all organ transplants worldwide each year are the result of trafficking.15

CURRENT EFFORTS ARE INADEQUATE
Five years ago, the National Kidney Foundation launched “End the Wait,” a ten-year campaign promising that by 2019, no one with end stage renal disease who was eligible for a transplant would wait more than one year before receiving one.

We are at the halfway mark of this campaign. It was initiated with the best of intentions, but no progress has been made. In 2009, the average wait time for a kidney was 2.8 years;16 today it’s 4.3.17 More than 77,000 people were on the waiting list then;18 today more than 100,000 are. Last year, there were 11,200 transplants from deceased donors; five years before, it was 10,600.19 Last year, we saw 5,700 transplants from living donors, compared to 6,000 five years previously.20 More patients are dying, fewer are receiving transplants, and more and more people need kidneys.

CONCLUSION

We applaud the President’s declaration that 2014 is a “year of action” when he will use executive powers and the regulatory process to ensure the health and well-being of Americans and end unnecessary health expenditures. As part of this process, we call on the President to take executive action on organ transplantation and initiate pilot studies on benefits to donors.

We call on HHS to develop the necessary regulatory process for conducting such studies and to implement them.

We call on the Attorney General to smooth the way for such pilot programs by recognizing that they are consistent with the intent of the National Organ Transplant Act.

Finally, we call on Congress to pass legislation that allocates the necessary funding for these programs and clears the way for their implementation.

Kidney disease has for too long been neglected by all branches of government. It is time to act.

Initiating signers*:


Nir Eyal, Associate Professor of Global Health and Social Medicine, Harvard Medical School and Harvard University
Julio Frenk, Dean, Harvard School of Public Health, Harvard University
Michele B. Goodwin, Chancellor’s Chair in Law, University of California-Irvine Law School
Lori Gruen, Professor of Philosophy, Feminist, Gender, and Sexuality Studies, and Environmental Studies at Wesleyan University
The Very Reverend Gary R. Hall, Dean, Washington Cathedral
Douglas W. Hanto, Professor of Surgery and Associate Director Vanderbilt Transplant Center, Vanderbuilt University, Tennessee
Frances Kissling, President, The Center for Health, Ethics and Social Policy
Ruth Macklin, Professor of Bioethics, Albert Einstein College of Medicine
Steven Pinker, Johnstone Family Professor, Department of Psychology, Harvard University
Lloyd E. Ratner, Professor of Surgery, Columbia University
Harold T. Shapiro, President Emeritus, Princeton University
Peter Singer, Ira W. DeCamp Professor of Bioethics, Princeton University
Andrew W. Torrance, Professor of Law, University of Kansas and Visiting Scholar MIT Sloan School of Management
Robert D. Truog, Director, Center for Bioethics, Harvard University, Harvard Medical School
Robert M. Veatch, Professor of Medical Ethics at the Kennedy Institute of Ethics, Georgetown University

http://www.ustransplantopenletter.org/signers.html has a dozen that self identify as donors.

[Clark]

When is a "donor" a "seller"? What of enforceable minimum standards for true informed consent? That includes the long term longitudinal studies not yet adequately performed and published for both donors and rejected/withdrawn donor candidates? What of the donors and families of donors already suffering due to complications? Too many still unanswered questions for my taste.

[Clark]

http://www.whitehouse.gov/contact/submit-questions-and-comments

In response to an open letter from ustransplantopenletter.org: When does an organ "donor" became a "seller"? Who will be a lawful broker? As repeatedly noted by ACOT and OPTN actions, what of enforceable minimum standards for true informed consent? That include long term longitudinal studies not yet adequately performed and published for both donors and rejected/withdrawn donor candidates? What of the donors and families of donors already suffering due to complications over the past 55 years? Please demand of the professional transplantation industry that they take ownership of their responsibility for the dignity of all who set foot on nthe path to become a donor, and the long term consequences of engaging in a business relying on the willingness of citizens to sacrifice themselves in this way. I am a donor and a past public representative to the OPTN/UNOS Board of Directors. Thank you for your time and attention. Learn from actual donors at livingdonorsonline.org/.

[Clark]

Sent to my senate and house reps, too.

[Clark]

http://medicalxpress.com/news/2014-11-experts-urge-donation-policies.html

Experts urge US to change organ donation policies
by Kerry Sheridan
A group of more than 300 prominent doctors, religious leaders and ethicists on Wednesday urged President Barack Obama to change the current system for organ donation, saying too few people get life-saving transplants.
In an open letter to the Obama administration, the group called for the government to start researching ways to make organ donation more appealing to the general public, in order to end a chronic shortage of organs that is getting worse each year.
"Sadly, transplant policy has been governed by an unsubstantiated assumption: that donors cannot receive benefits for donating without being exploited or coerced," said the letter signed by experts at Harvard, Columbia, Georgetown and Princeton universities along with scholars, religious leaders and ethicists.
"It is critical to examine that assumption."
The group does not take a position on what kind of approach might work, and only asks that US agencies like the National Institutes for Health and Health and Human Services start scientific studies on the matter.
It suggests that the government avoid cash incentives, but pursue a highly regulated approach that considers how to give people benefits for offering to be a living donor, such as life-long health insurance, tax credits, tuition assistance or pension contributions.
For those who donate after death, researchers should look into the possibility of paying funeral costs or making charitable donations in their names, it said.
"Giving an organ need not fall disproportionately on people with lower incomes," the letter said.
Current US policy prohibits people who give an organ from receiving anything for their donation.
However, women are routinely paid for donating their eggs or for serving as surrogate mothers.
When it comes to kidneys, the US shortage has ballooned in recent years. In 2009, 77,000 people were on the waiting list; more than 100,000 are today.
About 17,000 kidney transplants are performed annually. Each year, some 7,000 people die or become too sick to receive a transplant.
The problem disproportionately affects minorities such as African Americans and Hispanics, who typically wait four to five times as long for a transplant as whites do.
"The current system is the system that discriminates against poor people," said Frances Kissling, president of the Center for Health, Ethics and Social Policy in Washington, and the former leader of Catholics for Choice.
"We don't help those people by closing our eyes to the ethical problems that exist. We need to solve the ethical problems," she told AFP.
Experts say any change must avoid fueling the organ trafficking trade, which the World Health Organization says is responsible for about 10 percent of global organ transplants each year.