Human infection (challenge) trials for a covid-19 vaccine--Reason magazine interviews Josh Morrison (video)

 Reason magazine has a video story about human challenge trials, starring Josh Morrison, the founder of 1Day Sooner.  I make some comments as well.

 

 You can also find the video at reason.com here (along with a partial transcript), and on YouTube here.

**************

See all my posts on vaccines here.

Josh Morrison and health policy activism: kidneys and covid

Here's a profile of Josh Morrison, one of the most interesting health care policy activists I've encountered.  I first met him when he was the general counsel of the kidney exchange organization The Alliance for Paired Kidney Donation, and since then he's created new organizations (with evocative names) and new policies.

One Man’s Quest to Infect People With Covid-19 for Science

Inside the movement to launch a human challenge trial for Covid-19

by Andrew Zaleski

"Morrison donated a kidney in 2011, months into his job as a corporate attorney. A few years later he abandoned the law for a more mission-driven career helping people find kidney donors, eventually starting the nonprofit Waitlist Zero in 2014.

"In his telling, his parents “really hated” the idea of being a live organ donor. What he’s planning next terrifies them: Morrison wants to give himself Covid-19 for the sake of science.

...

"The 35-year-old from Brooklyn is the leader of 1Day Sooner, a grassroots organization he co-founded in the spring with a radical idea: Speed up vaccine testing by giving the coronavirus to willing recruits. Including Morrison and his co-founder, 22-year-old Stanford human biology graduate Sophie Rose, more than 30,000 people from 140 countries are signed up — a pool of applicants offering to enlist in what’s known as a human challenge trial.

...

"Human challenge trials involve deliberately infecting small groups of vaccinated volunteers. In a time of social distancing, mask-wearing, and the public’s general leeriness of contracting Covid-19, some researchers, doctors, and ethicists say challenge trials are worthwhile. Unlike traditional Phase 3 clinical trials, which sign up thousands of participants, inject some with a vaccine and others with a placebo, and then wait for people to encounter the virus in everyday life, there’s no waiting on people to catch a virus in a challenge trial. This means it can be completed in weeks instead of months or years, potentially yielding data on vaccine efficacy much more quickly.

"On July 15, human challenge trials for the coronavirus received their biggest endorsement. Adrian Hill, director of the Jenner Institute at the University of Oxford in the U.K., announced that Oxford scientists — already hard at work on a promising coronavirus vaccine — want to launch a challenge trial."

Open letter supporting human challenge trials for COVID-19 vaccines

Here's the website of the advocacy organization 1 Day Sooner (where you can read about human challenge trials, and volunteer for one). It was founded by Josh Morrison (who also founded the kidney transplant donor advocacy organization Waitlist Zero) and Sophie Rose.

Here's the open letter they recently sent to Dr. Francis Collins, at the National Institutes of Health
 Challenge Trials for COVID-19

Here's the press release:
1Day Sooner Open Letter Press Release
"15 NOBEL LAUREATES, OVER 100 PROMINENT FIGURES, AND OVER 2,000 1DAY SOONER VOLUNTEERS SIGN OPEN LETTER TO DR. FRANCIS COLLINS IN SUPPORT OF COVID-19 HUMAN CHALLENGE TRIALS

"Adrian Hill, Director of the Jenner Institute at the University of Oxford, writes that “Oxford’s Jenner Institute and 1Day Sooner are collaborating on work towards the production of a COVID-19 human challenge virus,” and “collaborative human challenge studies should be feasible and informative in the coming months.”

I'm one of the signers of the open letter, and the quote that goes along with my picture in the press release is
“A safe and effective vaccine will be incredibly valuable, and the sooner the better.  Challenge trials make sense. We should prepare carefully, and proceed bravely and gratefully.”
************

Earlier posts:

Friday, May 29, 2020

Human Challenge Trials for COVID-19 vaccines

Friday, May 8, 2020

Human Challenge Trials (aka Controlled Human Infection studies) for corona virus vaccines

Human Challenge Trials for COVID-19 vaccines

Yesterday I blogged about trying to speed up vaccine development and distribution by taking some of the risk out of it for pharma companies via an advanced market commitment, and today let's consider again one of the proposals being discussed  for speeding up the testing process.

Here's a white paper proposing some steps to further consider and prepare for human challenge trials (aka controlled human infection studies)  to speed up the testing of potential Covid-19 vaccines.It is put out by the organization 1 Day Sooner, which seeks to promote such trials, and has started assembling a list of volunteers in case challenge trials should become practical, to help vaccines become available sooner.

Evaluating use cases for human challenge trials in accelerating COVID-19 vaccine development
Linh Chi Nguyen , Christopher W Bakerlee, T. Greg McKelvey, Sophie M Rose, Alexander J Norman, Nicholas Joseph, David Manheim,, Michael R McLaren, Steven Jiang, Conor F Barnes, Megan Kinniment, Derek Foster, Thomas C Darton, Josh Morrison; for the 1Day Sooner Research Team

Abstract: Recently, human challenge trials (HCTs) have been proposed as a means to accelerate the development of an effective SARS-CoV-2 vaccine. In this paper, we discuss the potential role forsuch studies in the current COVID-19 pandemic. First, we present three scenarios in which HCTs could be useful: evaluating efficacy, converging on correlates of protection, and improving understanding of pathogenesis and the human immune response. We go on to outline the practical limitations of HCTs in these scenarios. We conclude that, while currently limited in their application, there are scenarios in which HCTs would be vastly beneficial and, thus, the option of using HCTs to accelerate COVID-19 vaccine development should be preserved. To this end, we recommend an immediate, coordinated effort by all stakeholders to (1) establish ethical and practical guidelines for the use of HCTs for COVID-19; (2) take the first steps toward an HCT, including preparing challenge virus under GMP and making preliminary logistical arrangements; and (3) commit to periodically re-evaluating the utility of HCTs amid the evolving pandemic.

Here's the main experimental design element:

"In HCTs, a relatively small number of healthy volunteer participants are administered a vaccine candidate or a placebo. However, unlike in conventional trials, consenting HCT participants are then administered an infectious dose of pathogen, and the outcomes of this infection is tracked. By challenging participants with pathogens under close observation in a clinical setting, HCTs can provide a unique opportunity to assess efficacy of a vaccine candidate."

And here are their concluding recommendations:

"To preserve the option to implement HCTs in scenarios such as this, we recommend an immediate, coordinated effort by all stakeholders to address the considerations outlined in this manuscript and make the necessary preparations. These include:
 1. Convening experts to discuss the ethical and practical considerations associated with HCTs for COVID-19, concluding in a set of  recommendations and guidelines for their use in the present pandemic and their role in the licensure process (which, notably, could provide guidance that is broadly useful in the event of future pandemics, too),
2. Taking the first practical steps toward an HCT, including preparing challenge virus under GMP and making preliminary arrangements with volunteers, vaccine developers, regulators, academic institutions, and clinical researchers to run HCTs in situations where they are expected to be highly useful,
3. Keeping informed of the evolving situation, periodically conducting a systematic reevaluation, and adjusting course based on the progress of the pandemic and the outcomes of the first drug and vaccine trials.

"HCTs have the potential to considerably shorten the COVID-19 pandemic, saving many lives and enabling economies and societies to return to normality. But we must act now to ensure this opportunity is not missed."
********

It's an admirably careful and balanced paper for one with a policy recommendation, and it sets the stage for a useful and timely debate.

As an experimenter,  I have one reservation about the proposed controls. In the passage I quoted above, they said " healthy volunteer participants are administered a vaccine candidate or a placebo," i.e. the control is a placebo.  That strikes me as potentially controversial given that the next step of the experiment is to infect the participants with Covid-19.  I might prefer a study in which the control for one vaccine was a different potential vaccine, so that no subjects were (relatively) sure to contract the disease.

But this doesn't detract from the usefulness of the preparations they recommend: conducting further discussions, and taking initial practical steps.
********
Here is my earlier post on this subject:

Friday, May 8, 2020 

Human Challenge Trials (aka Controlled Human Infection studies) for corona virus vaccines

*********

Here's a similar in spirit paper, considering when and why human challenge trials might be appropriate, put out by the World Health Organization

Key criteria for the ethical acceptability of COVID-19 human challenge studies
WHO Working Group for Guidance on Human Challenge Studies in COVID-19
Authors:  WHO

"Overview: This document aims to provide guidance to scientists, research ethics committees, funders, policy-makers, and regulators in deliberations regarding SARS-CoV-2 challenge studies by outlining key criteria that would need to be satisfied in order for such studies to be ethically acceptable."
*******

Here's a news story from CNN, complete with some anecdotes about the sometimes sketchy history of human challenge trials:

Thousands of people want to be exposed to Covid-19 for science
By Robert Kuznia

"Human challenge studies date all the way back to the first vaccine, for the highly lethal smallpox disease. The vaccine was developed in the late 18th century by physician Edward Jenner, who aimed to put a piece of folklore to the test: that milkmaids seemed to contract a milder form of the disease, called cowpox.
"In an experiment that today would warrant steep criminal charges, Jenner took pus from the scab of a milkmaid and inserted it into an incision on the arm of an 8-year-old boy. The child, James Phipps, developed a headache, chills and other mild symptoms, but when directly exposed to smallpox -- again through incisions on the arm -- he proved impervious."
**********

Here's an op-ed from the Washington Post, by the philosophers Richard Yetter Chappell and Peter Singer:

Pandemic ethics: The case for experiments on human volunteers

They conclude:
"We are ethicists, not medical or biological scientists. When it comes to factual beliefs about the pandemic, we defer to expert scientific opinion, as everyone should. But what we ought to do with the facts we have, and how we should go about seeking facts we still lack, are ethical questions. Ethicists have a crucial role to play in this debate.

"There is too much that we don’t know about covid-19. The longer we take to find it out, the more lives will be lost. (That’s why the website asking for vaccine volunteers is called “1 Day Sooner.”) If healthy volunteers, fully informed about the risks, are willing to help fight the pandemic by aiding promising research, there are strong moral reasons to gratefully accept their help. To refuse it would implicitly subject others to still graver risks."
***********

And here's a  post  from the Volokh Conspiracy (pointed out to me by Frank McCormick) focusing on the question of paying volunteers for human challenge trials:

The Moral Case for Testing Coronavirus Vaccines through "Challenge Trials" on Paid Healthy Volunteers
Doing so can potentially save many thousands of lives. And moral objections to this practice are weak. The issues here are very similar to the longstanding debate over whether we legalize organ markets.  by ILYA SOMIN .

He concludes:
"Like others who risk their lives to benefit others, challenge trial volunteers deserve our gratitude, and proper compensation for their efforts. And there is no good moral justification for forbidding them to take those risks. To the contrary, we should move ahead with challenge trials as soon as feasible. Every day of delay could literally be a matter of life and death—a great many lives and deaths."

Effective altruism and (non-directed) kidney donation

In their Christmas day discussion, the podcast Here Be Monsters considers the Quality Adjusted Life Years (QALYS) that can result from non-directed kidney donation, and how that qualifies it as a form of effective altruism.

December 25, 2019 Here Be Monsters HBM127: QALYs

"In 2014, a post showed up on effectivealtruism.org’s forum, written by Thomas Kelly and Josh Morrison.  The title sums up their argument well: Kidney donation is a reasonable choice for effective altruists and more should consider it. 

They lay out the case for helping others through kidney donation.  Kidney disease is a huge killer in the United States, with an estimated one in seven adults having the disease (though many are undiagnosed).  And those with failing kidneys have generally bad health outcomes, with many dying on the waitlist for an organ they never receive.  There’s currently about 100,000 people in the country on the kidney donation waitlist.  An editorial recently published in the Journal of the American Society of Nephrology estimated that 40,000 Americans die annually waiting for a kidney. 

The previously mentioned post on the EA forums attempts to calculate all the goods that kidney donation can do, namely adding between six and twenty good years to someone’s life.  Quantifying the “goodness” of a year is tricky, so EAs (and others) use a metric called “Quality Adjusted Life Years” or QALYs. 

The post also attempts to calculate the downsides to the donor, namely potential lost wages, potential surgery complications, and a bit of a decrease in total kidney function.  

The post concludes that kidney donation is a “reasonable” choice.  By the EA standards, “reasonable” is pretty high praise; a month or so of suffering to give about a decade of good life to someone else, all with little long term risk to the donor.  

On this episode, Jeff interviews Dylan Matthews, who donated his kidney back in 2016.  His donation was non-directed, meaning he didn’t specify a desired recipient.  This kind of donation is somewhat rare, comprising only about 3% of all kidney donations.  However, non-directed donations are incredibly useful due to the difficulty of matching donors to recipients..."
*********
The discussion of kidneys and effective altruism starts about minute 7 in the podcast:

Kidney matching podcast: Jeremiah Johnson interviews me and Josh Morrison

On the Neoliberal Podcast (49 minutes):
Kidney Matching featuring Dr Alvin Roth & Josh Morrison

Josh Morrison, who donated one of his kidneys as a non-directed donor, is a founder of Waitlist Zero.
*******

The audio connection seemed to change my voice a bit: here's an unusual comment, forwarded to me by a twitter-literate colleague:

Replying to @ne0liberal @JoshMorrison @waitlistzero

Dr Roth has the velvetiest voice I’ve ever heard

(if you find voices entertaining, you can compare it to the audio in yesterday's post, where I thought I sounded more like myself.)

Reducing disincentives to living organ donation in New York State

Josh Morrison of Waitlist Zero is pictured in this encouraging story:

Albany considers bill to pay live organ-donors' costs
Supporters want to remove economic barriers that they say keep many potential donors from coming forward

"A new bill could make New York the first state in the country to directly compensate living organ donors—who typically donate a kidney or a portion of their liver to a transplant patient—for lost wages, child care and other expenses.

The Living Donor Support Act, introduced by Democratic Assemblyman Richard Gottfried of Manhattan and Republican Sen. Kemp Hannon of Long Island, chair of the Senate Health Committee, has broad support from lawmakers. It already unanimously passed Hannon’s committee, and it has 18 Senate co-sponsors and 27 Assembly co-sponsors.

In addition to helping donors with expenses, the bill seeks to increase education about the option of living transplants for patients, who are disproportionately poor and members of minority groups.

“Our goal is to make transplants easy to ask for and easy to give,” said Josh Morrison, executive director and co-founder of Waitlist Zero, a Brooklyn-based nonprofit that championed the bill. Morrison donated one of his own kidneys as a good Samaritan five years ago at the age of 26.

For dialysis patients in particular, getting a kidney transplant from a living donor could save money and improve their quality of life, but patients often aren't informed of that option, Morrison said."


HT: Frank McCormick

A kidney donor at 18 who is now a medical student feels he didn't give sufficiently informed consent (and some reactions)

Here's the story in the Washington Post: At 18 years old, he donated a kidney. Now, he regrets it.

"Five years after the surgery, when I was 23 and getting ready to go to medical school, I began working in a research lab that was looking at kidney donors who had gone on to develop kidney failure. For that research, I talked to more than 100 such donors. In some cases, the remaining kidneys failed; in others, the organ became injured or developed cancer. The more I learned, the more nervous I became about the logic of my decision at age 18 to donate.

"And then in 2014, a study looking at long-term risks for kidney donors found that they had a greater risk of developing end-stage renal disease. Another study that same year raised the possibility that they may face a heightened risk of dying of cardiovascular disease and all-cause mortality (although this point remains controversial).

"Other studies and surveys, though, suggest that the risk, while greater, isstill fairly small.

"The truth is, it is hard to get good numbers about what happens to donors. Hospitals are required to follow them for only two years post-donation, which does not catch such long-term complications as chronic kidney disease, cardiovascular issues or psychiatric issues. There is no national registry for kidney donors or other large-scale means of tracking long-term outcomes."

************

Here are some responses posted on Trio (TRANSPLANT RECIPIENTS INTERNATIONAL ORGANIZATION)

Response to living kidney donation regret Washington Post news story

CATEGORIES // General Interest, UNOS News

A recent news story appearing in the Washington Post talked about an 18 year old living kidney donor's concerns and regret for that donation.  In a response to that, TRIO board member, Josh Morrison, offers his own thoughts on that concern based on his altruistic living kidney donation.  Photo is of Josh and his unrelated recipient, John, whose story is shared in Josh's article linked below (along with a link to the original 'regret' story).

RELATED ARTICLES

• The original 'concern &regret' Washington Post story
• Josh's response article  (Almost all kidney donors are proud, like me. So why did one negative story go viral? Updated by Josh Morrison Oct 11, 2016
• Letter to the Editor by another 'no regrets' living donor  (I donated a kidney. I have no regrets.)

*********

Here's a different take on nondirected donation (and the resulting chains...)

These six people donated their kidneys to complete strangers and saved 140 lives in the process — here’s why

Compensation for kidney donors? The comments on the Washington Post discussion are now complete...

I've updated my earlier post

The Washington Post discusses compensation for organ donors 

to reflect the subsequent discussions, below. (See the original post for whole discussion, which now seems to be complete)

Sally Satel is first:  Generosity won’t fix our shortage of organs for transplants

Taking the opposite point of view (but arguing that we should do more to reduce financial disincentives to donating, by paying for donor expenses): Francis Delmonico and Alexander Capron December 29, Our body parts shouldn’t be for sale

Scott Sumner's headline and sub-headline also speaks for itself:  The moral case for paying kidney donors:  We can save lives and cut costs with one change in policy. 

Will lab-grown kidneys fix our transplant waiting lists?: Benjamin Humphreys is optimistic that they will, eventually.
It’s time to treat organ donors with the respect they deserve: Josh Morrison is a kidney donor and the executive director of WaitList Zero, a nonprofit devoted to representing living donors and supporting living donation.

Scott Carney disagrees, on practical grounds (he thinks that a legal US market would foster badly regulated overseas markets): If you’re willing to buy a kidney, you’re willing to exploit the poor: Legalizing the sale of kidneys in America would lead to a booming black market everywhere else.

Nancy Scheper-Hughes, who has spoken to many black market kidney sellers, thinks that legal markets couldn't funcion much differently: The market for human organs is destroying lives We don't have "spare" kidneys. They shouldn't be up for sale.

The Washington Post discusses compensation for organ donors

Frank McCormick alerts me that the Washington Post yesterday took the recent article he coauthored in the American Journal of Transplantation as a jumping off point to discuss the pros and cons of addressing the shortage of transplantable kidneys by allowing the government to pay donors (the article proposed that only the government could pay, and considered payments of $45,000 for a living donor kidney).

 The  WaPo starts with a general description of the opposing positions:  Compensation for organ donors: A primer.

Their brief discussion sets the stage with lots of links (and will be familiar to readers of this blog who have been following my several posts on  compensation for donors).  

They end with this promise of more discussions, which I'll link to below as they appear (spoiler--Sally Satel is pro compensation, and Frank Delmonico doesn't think it's a good idea):

"Over the next few days, we’ll hear from:

Sally Satel, resident scholar at the American Enterprise Institute and practicing psychiatrist at the Yale University School of Medicine,

Francis Delmonico, Harvard Medical School professor of surgery at the Massachusetts General Hospital, and Alexander Capron, professor of law and medicine at the University of Southern California,

Scott Sumner, economist at Bentley University and blogger at The Money Illusion,

Benjamin Humphreys, program director at the Harvard Stem Cell Institute,

{Josh Morrison, who wasn't on the original list but is a great choice...}

Nancy Scheper-Hughes, founder of Organ Watch and anthropology professor at University of California, Berkeley."

Sally Satel is first:  Generosity won’t fix our shortage of organs for transplants

Taking the opposite point of view (but arguing that we should do more to reduce financial disincentives to donating, by paying for donor expenses): Francis Delmonico and Alexander Capron December 29, Our body parts shouldn’t be for sale

Scott Sumner's headline and sub-headline also speaks for itself:  The moral case for paying kidney donors:  We can save lives and cut costs with one change in policy. 

Will lab-grown kidneys fix our transplant waiting lists?: Benjamin Humphreys is optimistic that they will, eventually.
It’s time to treat organ donors with the respect they deserve: Josh Morrison is a kidney donor and the executive director of WaitList Zero, a nonprofit devoted to representing living donors and supporting living donation.

Scott Carney disagrees, on practical grounds (he thinks that a legal US market would foster badly regulated overseas markets): If you’re willing to buy a kidney, you’re willing to exploit the poor: Legalizing the sale of kidneys in America would lead to a booming black market everywhere else.

Nancy Scheper-Hughes, who has spoken to many black market kidney sellers, thinks that legal markets couldn't funcion much differently: The market for human organs is destroying lives We don't have "spare" kidneys. They shouldn't be up for sale.

Four recent calls for removing disincentives for organ donation

There are a number of efforts underway to reduce the financial dis-incentives to kidney donation, with more or less emphasis on opposition to, and how removing dis-incentives is different from, compensating donors.

The first I'll mention is a March 13 blog post from Kenneth A. Newell, the president of the American Society for Transplantation:  Why all the talk about incentives?
Here's his whole post:

Last summer, the ASTS and the AST held a workshop to discuss the financial barriers faced by living organ donors. All of us who are engaged in the practice of living donor transplantation realize that the entire healthcare delivery system (providers, hospitals, insurers, and the government), as well as the recipient and society as a whole, benefits financially from the practice of living donation. Disturbingly, the donors are the group most at risk for adverse financial events. In many cases, donors incur expenses related to travel, meals, and lodging, as well as lost wages. In addition to these concrete financial consequences, living donors also face very real concerns about the loss of employment and the impact their donation will have on future insurability. Programs such as the HRSA-funded National Living Donor Assistance Center (NLDAC) provide critical support to those donors with the most extreme financial need, but this support is limited to travel and travel-related expenses.

The aim of the first meeting was to explore whether the AST and the ASTS could articulate a common vision on the topic of financial disincentives and incentives as they pertain to organ donation. The two societies agreed to work to remove all financial disincentives to organ donation, and consider pilot projects to study what some might consider to be true incentives. These ideas are more fully articulated in a New York Times editorial authored by Daniel Salomon and Alan Langnas, as well as in a manuscript soon to be published in the American Journal of Transplantation.

As a second step, representatives of the two societies met last month in Minneapolis to discuss how the goals articulated at the first meeting could be operationalized. Presentation topics included the perspective of payers, overviews of NOTA and NLDAC, and consideration of how changes to NOTA could be effected. Attendees discussed where the societies might draw the line between the removal of disincentives and the provision of true incentives for living organ donation, and how an expanded program to remove all disincentives for all living donors might be administered (assuming that funding could be obtained). This second meeting focused almost entirely on the removal of financial disincentives with the goal of making the donor financially whole. This position was recently advanced by the AST Best Practices in Living Donation Consensus Conference. At this second meeting, there was little discussion about incentives or pilot projects to test the impact of true incentives, as these are more controversial and will require substantially more effort and time to engage a broader set of transplant stakeholders. In other words, both the AST and the ASTS agreed that the task of operationalizing the original workshop’s ideas must be strictly pragmatic and start with those changes that are largely agreed upon now: removing all disincentives.

So why all of the talk about incentives (and disincentives)? Because any changes to the current financial practices of organ donation will require the AST and the ASTS to engage in ongoing discussions with a larger set of stakeholders: patient groups, transplant professionals, government leaders, and society as a whole. Any changes must have the support of these groups as well as our membership, and any changes must meet the real needs of patients, donors and their families.

Over the next several months, the AST will reach out to our membership and these other groups to discuss the removal of financial disincentives, the definition of true incentives, and the challenge of possibly testing incentives in pilot projects. The conversation starts here: please share your opinions in the comment section.

Next, the open letter linked and excerpted below, is from the Declaration of Istanbul Custodian Group and signed by many prominent opponents of compensation to donors: the first signer is Frank Delmonico.
An Open Letter to HHS Secretary Burwell on Ethically Increasing Organ Donation

"In 1984, Congress passed the National Organ Transplant Act (NOTA). That statute not only established the Organ Procurement and Transplantation Network but also enshrined in law a principle that had guided the development of organ transplantation worldwide over the previous 30 years: organs from living and deceased donors are precious gifts, and should not be bought and sold as market commodities.

Remove the Obstacles to Donation

The growing demand for transplants currently exceeds the supply of donated organs. In the previous decade, a collaborative effort among the Department of Health and Human Services, organ procurement organizations, physicians, and community groups produced a 25% increase in the number of deceased donor organs. Yet, over the course of the past ten years in the United States, the number of kidney transplants (which account for more than two thirds of all transplants) made possible by living donors has declined by approximately by a thousand.One major reason for this decline is that living donors in the United States incur on average more than U.S. $6000 in out-of-pocket costs. Potential donors may not be able to afford these expenses and may either be unaware of, or not meet the strict requirements for, programs that cover some but not all of donors' financial costs and losses.If the United States wants to increase organ donation, we should begin by removing these financial disincentives. We are aware that some people have recently called on the President and Congress to repeal, or at least suspend, NOTA's prohibition on paying organ donors. However, when it looked at “Ways to Reduce the Kidney Shortage” (September 2, 2014), the New York Times rightly concluded that “there are lots of reforms that could be made without resorting to paying for kidneys.”

The post goes, on, you should read the whole thing, but here are the two concluding section heads:
Appoint a New Task Force on Organ Donation and Transplantation
and
Financial Incentives for Donation Would Violate Global Standards and Will Not Work
****************

Below is a statement from an organization whose very name reflects the complicated politics: it is called STOP ORGAN TRAFFICKING NOW!, and it describes its goal as "Working to Remove Barriers to Living Donations". That is, it is an organization seeking to remove disincentives to donation, that wants to distinguish itself from black markets, and perhaps from those proposing compensation. (Forming coalitions is hard, and politics is incremental...)

The SOTN Proposal In Simplest Terms
"• Increase penalties for organ brokering at home and abroad.
• Follow original intent of NOTA and have Medicare help patients in greatest medical need first and according to UNOS current wait list criteria by:
(a) paying expenses of donors willing to give to top match in their region, and
(b) paying the Organ Procurement Organizations (OPOs), which currently match deceased donor organs with recipients, to arrange living matches as well.
• Allow 501(c)(3) public charities (and recipients themselves) to cover all donation related expenses – The same expenses that currently can be deducted from state income taxes at the state level. Charities can help any donor, not just those giving to front of the list.
• Create living donor registry that puts donor AND one relative to the front of the list at any time donor chooses."
**************

Finally, I'm keeping an eye on a newly formed organization called Waitlist Zero, in part because its co-founder and executive director is Josh Morrison, a young lawyer and kidney donor (who thinks of kidney donation as an example of effective altruism), with whom I had the privilege to work when he was the general counsel at the Alliance for Paired Donation (Mike Rees' kidney exchange organization).

Here is their statement of goals, principles and policies:

Our Goals. We come together as a coalition to advocate that the Health Resources and Services Administration:

1. Publicly support the goal of increasing living kidney donation;
2. Allow grant funding, including that pursuant to 42 U.S. Code §274f–1(b), to go to projects intended to increase living kidney donation;
3. Allocate such funds in rough parity between living and deceased donation projects; and
4. Include metrics and goals related to the increase of living donation on HRSA’s FY 2016 Annual Performance Report.

Our Principles. Collectively, the Coalition believes:

• Deceased donation alone can never end the deadly kidney shortage, and any policy that takes that shortage as given is morally unacceptable.
• Living donation is a noble choice that is not right for everyone, but donors themselves can benefit from the better health of their loved ones and the psychic gains to donation. Since studies show the vast majority of living donors do not regret donating, federal policy should presume donation to be a positive choice worth promoting.
• Informed consent must be maintained for every kidney transplant. Any effort to coerce or pressure someone into donating is unacceptable.
• Improvements are always possible, but the current transplant system does an excellent job of ensuring informed consent for the thousands of living donors who give each year.
• Government programs to increase living donation should not and will not impinge on the ability of transplant centers to ensure informed consent and guarantee the absence of coercion.

Our Policies. Collectively, the Coalition hopes that HRSA’s support for increasing living kidney donation will lead to policies along the lines of the following:

• Donors should not be worse off for having donated. Government should: (1) guarantee the reimbursement of donor lost wages, (2) provide health insurance coverage to alleviate risks of donation, and (3) devote appropriate resources to ensure long-term donor follow-up.
• Transplant awareness and education should be increased for the public, patients, and patient families. All patients and patient families should receive comprehensive transplant education before they go on dialysis (when possible) and immediately thereafter (when necessary). Access to paired kidney donation should be universal.
• Members of the Coalition may have different views as to the advisability of incentives for living donation, but the Coalition believes there are many ways the federal government can increase living donation that do not raise the controversy of incentives, and this campaign is not intended to promote the adoption of incentives.

HT: Frank McCormick, et al.

Kidney Exchange and Operations Research: Edelman award presentation (video)

Here are all the 2014 Edelman Award Presentations, including the one my colleagues and I gave on kidney exchange, on March 31. Ours is the second from the top (the winning entry is first), and to see the video you have to scroll to the bottom of the description or our lecture (reproduced below) and click on "View Presentation." (I couldn't figure out how to embed it here.)

The video of our presentation (35 minutes) is more elaborate than most of the lectures I've done, since it includes some video footage. I joined Josh Morrison of the Alliance for Paired Donation and Itai Ashlagi of MIT in making the presentation.  Mike Rees spoke in some of the videos. Ross Anderson and David Gamarnik joined us to answer questions, and Tayfun Sonmez and Utku Unver joined for the celebratory dinner later in the day. (For our efforts, we are all 2014 Edelman Laureates.)

Alliance for Paired Donation with Boston College, Stanford University and MIT: Kidney Exchange

Presented by: Josh Morrison, Alvin E. Roth, Itai Ashlagi Authors: Alliance for Paired Donation:  Michael A. Rees, Michael.Rees2@utoledo.edu; Josh Morrison,joshcmorrison@gmail.com; Boston College: Tayfun Sönmez,sonmezt@bc.edu; M. Utku Ünver, unver@bc.edu MIT: Itai Ashlagi, iashlagi@mit.edu; Ross Anderson, rma350@gmail.com; David Gamarnik,gamarnik@mit.edu Stanford University:  Alvin E. Roth, alroth@stanford.edu Abstract: Many end-stage renal disease sufferers who require a kidney transplant to prolong their lives have relatives or associates who have volunteered to donate a kidney to them, but whose kidney is incompatible with their intended recipient. This incompatibility can be sometimes overcome by exchanging kidneys with another incompatible donor pair. Such kidney exchanges have emerged as a standard mode of kidney transplantation in the United States. The Alliance for Paired Donation (APD) developed and implemented an innovative operations research based methodology of non-simultaneous extended altruistic donor (NEAD) chains, which, by allowing a previously binding constraint (of simultaneity) to be relaxed, allowed better optimized matching of potential donors to patients, which greatly increases the number of possible transplants. Since 2006, the APD has saved more than 220 lives through its kidney exchange program, with more than 75% of these achieved through long non-simultaneous chains. The technology and methods pioneered by APD have been adopted by other transplant exchanges, resulting in thousands of lives already saved, with the promise of increasing impact in coming years. The percentage of transplants from non-simultaneous chains has already reached more than 6% of the total number of transplants from live donors (including directed living donors) in the last year. We describe the long-term optimization and market design research that supports this innovation. We also describe how the team of physicians and operations researchers worked to overcome the skepticism and resistance of the medical community to the NEAD innovation.