How might we increase the number of lifesaving transplants from living kidney donors? Might we one day be able to reward donors? And what might we do until then, while we wait for something that will eventually replace human organ transplantation? Here's the published account of last year's symposium.
Abstract: Virtually all clinicians agree that living donor renal transplantation is the optimal treatment for permanent loss of kidney function. Yet, living donor kidney transplantation has not grown in the United States for more than 2 decades. A virtual symposium gathered experts to examine this shortcoming and to stimulate and clarify issues salient to improving living donation. The ethical principles of rewarding kidney donors and the limits of altruism as the exclusive compelling stimulus for donation were emphasized. Concepts that donor incentives could save up to 40 000 lives annually and considerable taxpayer dollars were examined, and survey data confirmed voter support for donor compensation. Objections to rewarding donors were also presented. Living donor kidney exchanges and limited numbers of deceased donor kidneys were reviewed. Discussants found consensus that attempts to increase living donation should include removing artificial barriers in donor evaluation, expansion of living donor chains, affirming the safety of live kidney donation, and assurance that donors incur no expense. If the current legal and practice standards persist, living kidney donation will fail to achieve its true potential to save lives.
#######
Links to videos of the symposium presentations are here:
Here's a call for action, in The Lancet Gastroenterology & Hepatology:
Joint statement in support of hepatitis C human challenge studies by Harvey J Alter, Eleanor Barnes, Mia J Biondi, Andrea L Cox, Jake D Eberts, Jordan J Feld, T Jake Liang, Josh Morrison, Charles M Rice, Naglaa H Shoukry, David L Thomas, Jennifer Van Gennip, Charles Weijer, on behalf of other signatories †, Published:September 20, 2023 DOI:https://doi.org/10.1016/S2468-1253(23)00314-X
"We, the 121 undersigned, believe that human challenge studies among adult volunteers will be critical in the development of hepatitis C vaccines.
...
"Despite the advent of safe and highly effective direct-acting antiviral (DAA) treatments, the ongoing toll of hepatitis C remains high among low-income and middle-income countries and vulnerable populations such as people who inject drugs. Millions of new infections occur annually, outpacing cures in some regions,1 with progress further disrupted by the COVID-19 pandemic. Without a change in strategy and the development of new tools, we will not reach the ambitious goal set out by WHO of elimination of viral hepatitis as a public health threat by 2030. This will require an effective hepatitis C vaccine—“the best insurance for the future”, as highlighted by a recent announcement of the White House national hepatitis C elimination programme.2
...
"Human challenge studies for a hepatitis C vaccine could accelerate vaccine development dramatically. The effort to establish the model and test an initial vaccine candidate could take as little as 3 years. If that candidate fails, subsequent studies to test others could provide evidence of efficacy as quickly as 1 year.
"It is only because of the remarkably effective treatments that we can now consider human challenge studies for hepatitis C. With DAAs, cure rates of people without cirrhosis are reliably over 98%, with highly effective salvage regimens for the few who do not respond to a first course of therapy.5, 6 We are confident that in the era of DAAs, human challenge studies can be done in accordance with the highest ethical and safety standards. Healthy volunteers providing fully informed consent would be infected for at most 6 months before treatment and would be free to go about their lives with the right to request treatment and withdrawal from a study at any time. Acute infection causes no or few symptoms in most, and unlike in most challenge studies, where the risk of transmission necessitates quarantine of participants, the risk of passing hepatitis C to others is very low in day-to-day life.
"The impact of a vaccine would be enormous: reducing transmission, preventing cirrhosis, and most importantly, markedly reducing the rate of liver cancer, the world's second-most deadly cancer in terms of total fatalities.7 The global success of hepatitis B vaccine in achieving these goals exemplifies the importance of an effective hepatitis C vaccine. With the prospect of such a significant advance, we have confidence that people will volunteer to participate in hepatitis C challenge studies, and with such a strong team of experts worldwide, we are confident this approach will lead to the development of a successful hepatitis C vaccine."
Subject: Governor Hochul Has Signed
the Living Donor Support Act!
"Hello!
I am delighted to
inform you all that the New York State's Living Donor Support Act (LDSA, S.
1594) was signed by Governor Hochul today.
New York is
becoming the best state for organ donation!
Thank you for your
advocacy in support of this legislation. The LDSA will save more New Yorkers'
lives.
Waitlist Zero's
Executive Director Josh Morrison wrote the legislation. State Senator Rivera
from The Bronx and Assembly Member Gottfried from Manhattan sponsored the bill.
This spring, a team
from the NKDO, NKF, DOVE, LiveOn New York, and Waitlist Zero lobbied for the
bill's passage in Albany. Soon after, the LDSA was unanimously passed by both
houses.
This new law
creates the opportunity for New York's living donors to avoid going into debt
to donate. Living donors will be reimbursed for their lost wages and
out-of-pocket expenses. New York will be the first state in the country to
offer this opportunity for donation to be cost neutral for donors.
Currently the
Federal Government only reimburses when both the recipient and donor
make less than 350% of the poverty line (around $47,000). The LDSA will
reimburse the lost wages of donors who make up to $125,000 as well as the costs
of donation (travel, childcare, etc).
In addition, the
LDSA will ensure that all potential recipients will be educated about
transplantation.
There are currently 8,569 people on New York's transplant wait lists, 7,234 of whom are awaiting a kidney. With the LDSA, we anticipate that far more New Yorkers will benefit from a living organ donation.
Because the National Living Donor Assistance Center (NLDAC) is a payer of last resort, the NY law will replace NLDAC for NY donors who do meet the means test, and so it will also allow the NLDAC budget to go further.
********
Update: Frank McCormick writes to alert me that, like the authorization for NLDAC, the NY State law (https://www.nysenate.gov/legislation/bills/2021/S1594) "requires that the Program shall be payer of last resort..." I hope that this doesn't turn into a competition to be the payer of last resort in a way that might cause some NY donors to fall between the cracks, and not be reimbursed either by NLDAC or the State of New York.
Covid is still with us, new vaccines are needed and will likely continue to be needed into the forseeable future, and the case for human challenge trials to speed selection among promising candidates is stronger than ever. Two veteran advocates make the case:
"Two years ago, the prospect of deliberately infecting fully informed volunteers with COVID-19 to aid in vaccine research and development was controversial. We and many others argued that the risks were justifiable, and the reservations of some bioethicists did not deter nearly 40,000 people from over 160 countries from expressing interest in volunteering for these investigations, called human challenge trials. Yet in the end, while they have been extensively pursued in the U.K.*, there were no such studies in the U.S.
"We have made great strides against COVID-19 illness in the form of vaccination and treatments, but there are still thousands of deaths in the U.S. every week.
...
"The White House hosted a summit on the issue in July, showcasing the myriad ways researchers are going about developing new vaccines. There are hundreds of candidates in early stages around the world, but the resources devoted to COVID-19 vaccine research are a fraction of what they were 2 years ago. Human challenge trials can greatly speed the selection of the most promising in this field of candidates, providing scientific and economic benefits over uniform reliance on large field studies.
...
"The use of human challenge trials offers the greatest promise for testing intranasal vaccines for their ability to reduce infection and transmission. In the case of a live attenuated vaccine, something as simple as regular nasal swabbing can reveal just how much of the live virus is present in the nose over time -- and how much would spread when a patient sneezes, for example.
...
"There are obviously risks to COVID-19 challenge studies, and it was on these grounds that initial proposals for such research faced opposition. However, the risk of death is now lower than it was early on in the pandemic given better immune protection garnered from both vaccination and natural exposure, and various treatments options further reduce the risk.
Of course, long-COVID still looms large, but this risk can also be managed by selecting trial participants at lower risk of serious illness, as more severe COVID-19 illness is correlated with lingering post-COVID symptoms. Ultimately, if COVID-19 becomes endemic, long-COVID may well be a threat to everyone, whether or not they sign up for a challenge trial -- all the more reason we must act quickly to develop vaccines that stop transmission.
"We believe that volunteers are perfectly capable of considering these risks rationally. Those who decide to make a potential sacrifice for the good of humanity should be lauded, not dismissed as naive. (Notably, a study of the nearly 40,000-strong prospective volunteers organized by 1Day Sooner showed that their risk tolerance was the same as a control group, and they were driven primarily by altruistic motivations.)"
"Stanley Plotkin, MD, is professor emeritus in pediatrics at the University of Pennsylvania, a veteran vaccinologist, and a board member of 1Day Sooner, an organization that advocates on behalf of challenge trial volunteers. Josh Morrison, JD, is co-founder and president of 1Day Sooner, and a founder of Waitlist Zero and the Rikers Debate Project."
there are four COVID challenge studies announced or underway
in the UK, though only imperial [the study above] has published results. Besides the imperial
one, there’s an Oxford reinfection study,
"Morrison first became familiar with this kind of direct public health participation when he read about kidney donations in the New Yorker when he was a law student in 2009. In the piece, people explained why they gave their kidneys to strangers in need — though there was slight risk to donors, the reward and benefit for the recipients was more than worth it. Two years later, he donated a kidney himself.
...
“The basic logic of my work in general is to try to use a sort of identity politics to get better political decision-making,” Morrison told me. “So with kidney donation, the theory is if kidney donors are more empowered in the political system as a sort of identity group, then the system will treat donors better and that will mean more people donate.”
On May 7, 2022 the University of Chicago hosted a Symposium on "The Future of Living Donor Kidney Transplantation: Evolving National Perspectives in Kidney Transplant "
Philip Held, one of the organizers, has provided the following guide, concluding with a link to an elegant Data Handbook that gives direct access to each talk.
"A
Symposium: The Future of Living Kidney Donor Transplantation
Earlier this year, we presented a virtual
symposium on the Future of Living Kidney Donor Transplantation. A
primary focus was on the ethics of rewarding organ donors with an opening
presentation by:
·Janet Radcliffe
Richards, a philosopher and ethicist from Oxford University.
Other speakers and
topics included:
·Nobel Laureate Alvin
Roth Ph.D. of Stanford University who laid out the case forpaired
kidney donation (aka kidney exchange), the only major technical improvement in
transplantation in years.
·Frank McCormick, Ph.D. presented recently published (Value in
Health) research showing how the government can completely end the kidney
shortage and save more than 40,000 kidney failure patients each year from
premature death by rewarding living kidney donors.
The Symposium took place on May 7,
2022. It was hosted by John Fung M.D. Ph.D. at the University of
Chicago’s Transplantation and Transplant Institute and was funded by the
National Kidney Donation Organization (NKDO) and WaitListZero.
This Symposium presented a broad education on
the subject of living kidney donation, and indeed was presented for Continuing
Medical Education (CME) credits by the University of Chicago.
The audio-visual recording of the entire University
of Chicago’s CME symposium is available, for free. Access is extremely easy and
one can access any and all presentations with 3 simple clicks starting with 2
clicks here: Data Handbook."
If you prefer you can binge on the sessions in order:
My talk, called "Kidney Exchange (and Kidney Controversy)" is the first half hour of the video below of the second of three symposium sessions.
The first session of the symposium is below, starting with an intro by Philip Held, focusing on some of the inequalities that we see in dialysis and transplant, followed by the philosopher Janet Radcliffe-Richards (starting at minute 17:15), and then Sally Satel (at 59:30), and then a round table discussion starting at 1:12.
In the discussion I asked Dr. Radcliffe Richards (who has been a tireless advocate of thinking more clearly about the tradeoffs involved in preventing compensation of donors) what experience she could share about when and how she had been successful in convincing people to change their minds. She replied "I don't regard myself as an expert in mind changing, except with people who are happy to follow arguments."
Session 3 is below, including talks by Martha Gerson, Thomas Peters, Arthur Matas, John Roberts, and Josh Morrison.
These and other videos have been assembled by NKDO.
On Saturday I'll be taking part in a medical education webinar, open to the general public, on avenues to increase the availability of safe, ethical and legal kidney transplants. Some will find it controversial*, even repugnant, since one of the big topics is the ethics of compensating kidney donors. (I'll be talking about some of the incremental improvements that have been and can be pursued while that discussion goes on. Some of those have also had to overcome some opposition...)
May 7, 2022; Virtual; Admission Is Free (join at the link above)
7AM-10 AM (PDT); 9AM-12Noon (CDT); 10AM-1PM (EDT)
Session 1: Ethics of Gifting or Compensation of Donors
Topic
Presenter (s)
Comments
Time (mins.)
Item
Cu
mul.
Ethics of Compensating (“Rewarding”) Donors
Janet Radcliffe Richards
World renown philosopher/ethicist. (Oxford). Book: the ethics of transplants why careless thought
costs lives
30
30
Questions, Comments, and Recap Session 1
CON: Asif Sharfuddin M.D. FASN FAST PRO: Sally Satel M.D. M.S.
30
60
Session 2: Living Donor Transplant Issues
Cost-Benefit Analysis of Compensating (“Rewarding” Kidney Donors
Frank McCormick Ph.D.
How the Government Can End the Kidney Shortage and Save More than 40,000 Kidney Failure Patients Each Year by Compensating Living Kidney Donors. Total economic value to kidney recipients is $76B/yr. Net savings to the taxpayers is $7B/yr.
15
75
Current Status and Future Developments in Kidney Exchange Programs
Alvin Roth, Ph.D.
Nobel Laurette
Living donor organs are being increasingly allocated by paired and exchange organ programs; This is the only major technical improvement in transplantation in
years;
15
90
Session 2: Living Donor Transplant Issues Cont’d
Decreasing Barriers and Increasing Access for Living Donation
Cody Maynard; Independent Living Donor Advocate (NKDO)
Immediate actions we can take to increase the pool of living donors.
10
100
Discussion and Recap of Session 2 (John Fung, M.D, Ph.D.)
10
110
Break
10
120
Session 3: More Living Donor Transplant Issues
Experiences of a Living Kidney Donor;
Martha Gershun, MBA
Author of a recent book with J.D. Lantos MD: Kidney to Share.
10
130
U.S. Public Attitudes Towards Compensating Donors
Thomas Peters M.D.
Two peer reviewed studies show that 70% of US population support compensating donors $50K.
10
140
Risk and Safeguards for Living Donors
Arthur Matas, M.D., Ph.D.
Screening donors is essential. Risks are small but not zero.
15
155
The Limits of Increased Counts of Deceased Donor Transplants
John P. Roberts M.D.
Ignorance is common: Increasing the Deceased Donor pool is constrained by the limits of brain-
dead donors; <2% of U.S. deaths.
10
165
WaitList Zero’s role in Living Donation
Josh Morrison J.D.; Founder of WaitList Zero
“Thanks for helping us, we were lost!” comment by a recipient, pointing to the need for education regarding living donors.
10
175
Discussion and Recap Session 3 (Thomas Peters M.D.)
10
185
Recap and Summary of the Symposium Glenn Chertow M.D., MPH
20
205
* Part of the controversy is that some advertisements for the webinar were deleted, here are some tweets on the subject:
"In an age of masking, compulsive hand sanitizing and plexiglass dividers, it seems inconceivable that for more than 40 years people enthusiastically signed up — and were often put on a waiting list — to have respiratory viruses, including coronaviruses, dripped into their noses.
"They were volunteers at the Common Cold Unit, set up in 1946 by the British government’s Medical Research Council.
...
"the Common Cold Unit established and refined a model for so-called human challenge studies that paved the way for the first Covid-19 human challenge study just completed in Britain, where young, healthy and unvaccinated volunteers were infected while researchers carefully monitored how their bodies responded.
"Then, as now, there were those who decried deliberately infecting or “challenging” healthy volunteers with disease-causing pathogens. It violates the medical principle of “do no harm.” The trade-off is a unique opportunity to discover the causes, transmission and progression of an illness, as well as the ability to more rapidly test the effectiveness of proposed treatments.
...
"“The key benefit of human challenge studies is that they are controlled — everyone gets the same virus, the same amount and they are in the same environment,” said Dr. Christopher Chiu, professor of infectious diseases at Imperial College London and chief investigator in Britain’s Covid challenge study.
...
"In the United States, the regulatory hurdles to conduct challenge studies mean there are precious few, mostly for finding better treatments for malaria, cholera and influenza. Ethicists and regulators are more comfortable approving clinical trials where subjects are given a treatment, say a drug or vaccine, to see if it helps improve a condition volunteers already have, or could prevent them from developing later.
...
"Dr. Fauci’s office said the institute has no plans to fund Covid-19 human challenge trials in the future. Many bioethicists support that decision. “We don’t ask people to sacrifice themselves for the good of society,” said Jeffrey Kahn, director of the Johns Hopkins Berman Institute of Bioethics. “In the U.S., we are very much about protecting individual rights and individual life and health and liberty, while in more communal societies it’s about the greater good.”
"But Josh Morrison, a co-founder of 1Day Sooner, which advocates on behalf of more than 40,000 would-be human challenge volunteers, argues it should be his and other people’s right to take risks for the greater good. “Most people aren’t going to want to be in a Covid challenge study, and that’s totally fine, but they shouldn’t project their own choices on other people,” he said."
The AJB invites commentaries on its target articles, and the comments on our article on payments in human infection challenge trials have now appeared. (If I've done this right, you can read them by clicking on the links below.) This is from The American Journal of Bioethics, Volume 21, Issue 3 (2021)
Our target article points out that while much of the medical ethics literature focuses on the claim that payments can subject potential participants, particularly poor people, to undue influence or coercion by being too large, there can be a countervailing concern that payments that are too small can be exploitative, and that this might often be the greater ethical concern.
The commentaries are all brief, but there are nine of them, so let me recommend to my regular market design readers that two that might be rewarding to begin with are those by Julian Savulescu, and by Seán O’Neill McPartlin & Josh Morrison.
Posts
