America Has an Organ Shortage. Could Paying Donors Close the Gap? Podcast from BYU radio.

 Here's a podcast on the shortage of organs for transplant, and on the controversies about compensating organ donors, and plasma donors.

America Has an Organ Shortage. Could Paying Donors Close the Gap?   Top of Mind with Julie Rose | BYU radio
 

"There are more than 100,000 people on the waitlist for an organ transplant. Every day 17 of them die. Most organs for transplant come from deceased donors. But the organs in highest demand for transplantation are kidneys and livers – both of which can be donated while a person is still alive. So, we could save thousands of lives each year if more people were willing make a living organ donation. Some advocates say giving donors money would increase organ donations enough to eliminate the entire waitlist. But federal law makes it illegal to buy or sell organs. Ethicists have real concerns about coercion and exploitation, too. In this podcast episode, we're exploring America's organ shortage and asking whether paying donors could close the gap.  
Guests:
David Galbenski, liver transplant recipient and co-founder of the Living Liver Foundation (https://livingliver.org/)

Elaine Perlman, kidney donor, Executive Director of Waitlist Zero and leading advocate for the End Kidney Deaths Act (http://waitlistzero.org/)

Kathleen McLaughlin, journalist and author of Blood Money; The Story of Life, Death, and Profit Inside America's Blood Industry

Al Roth, Nobel-prize winning economist, Stanford University, expert in market design and game theory (https://marketdesigner.blogspot.com/)"

I'm interviewed at the end of the podcast, starting at minute 39:

x

Kim Krawiec interview about WHO demands for national self sufficiency in blood donation and kidney exchange

 The University of Virginia takes note of the recent Krawiec & Roth paper I blogged about in August.

Here is their interview with Kim about the paper:

WHO Stifles International Blood and Organ Donations, Argue Professors. Professor Kimberly Krawiec, Nobel Prize Winner Alvin E. Roth of Stanford Argue World Health Organization Policies Need Revision

Here are the first two Q&As

"What motivated you to critique the WHO principles of self-sufficiency and nonremuneration in organs and blood? ​

"The severe shortage of both blood products and transplantable organs, especially kidneys, was our motivation and has motivated much of our other work, both together and separately. In the United States alone, the organ transplant waiting list is approximately 100,000 people, and if current trends continue, it will only grow in the coming years.

"Shortages of blood products present a similar challenge. Although wealthy countries are typically able to satisfy domestic whole blood needs, the vast majority of low- and middle-income countries (LMIC) are not. As a result, in many LMIC, shortages of blood for transfusion contribute to maternal death, death from traffic accidents and complications from childhood anemia. Moreover, even wealthy countries experience seasonal shortages of whole blood or deficiencies in some blood components, such as platelets, which are harder to collect and have a shorter shelf life.

The shortage of plasma-derived medicinal products (PDMPs) is particularly severe and entirely preventable. PDMPs are life-saving treatments for multiple acute and chronic conditions for which there are no alternative treatments. Yet these life-saving therapies are unavailable to much of the world’s population. The United States, one of the few countries to pay plasma donors, supplies 70% of the world’s plasma needs, with Germany, Austria, Hungary, Czechia and Latvia (which also permit some form of payment for plasma donors) supplying another 20% of the world total. In other words, a handful of countries supply plasma to the rest of the world, including other wealthy countries. Meanwhile, LMIC who can neither collect and process their own nor afford to purchase blood products on the open market (or are prevented from doing so under the terms of the foreign aid that supports their health system) simply do without, to the detriment of their citizens.

"How do current WHO policies on organ and blood donation contribute to this problem?

"WHO policy mandates both national (or sometimes only regional) self-sufficiency and an absence of remuneration for both blood products and transplantable organs — what we refer to in the paper as “the twin principles.” These twin principles are unhelpful separately and unworkable together. Their effect on blood products is particularly stark — no country that fails to compensate donors is self-sufficient in plasma collection and few LMIC collect sufficient supplies of whole blood.

"The self-sufficiency mandate presents a real hurdle to progress in transplantation, especially for smaller countries and LMIC. This is especially the case because some of the most exciting and promising developments for increasing the availability of transplants have been in kidney exchange, a mechanism that leverages in-kind exchange, rather than financial compensation, to encourage and facilitate donation among those with willing but incompatible partners. But kidney exchange works best when a large pool of patient-donor pairs can engage with one another. So, requiring that transplantation be contained within national boundaries unnecessarily limits access to transplants that could be achieved only by cross-border exchange."

Regulation of Organ Transplantation and Procurement (Chan and Roth in the JPE)

 Here's a new paper (in final form, online ahead of print) on how organ transplants are regulated.  The paper uses an experiment to make several points about the design of current regulations.  One of them is that transplant centers are incentivized to be risk averse, since they are measured only by the outcomes of the transplants they perform, and not on the outcomes for patients they decline to transplant (so they are reluctant to transplant risky kidneys or risky patients).

Regulation of Organ Transplantation and Procurement: A Market-Design Lab Experiment by Alex Chan and Alvin E. Roth, Journal of Political Economy, online ahead-of-print .

 Abstract: We conduct a lab experiment that shows that current rules regulating transplant centers (TCs) and organ-procurement organizations (OPOs) create perverse incentives that inefficiently reduce both organ recovery and beneficial transplantations. We model the decision environment with a two-player multiround game between an OPO and a TC. In the condition that simulates current rules, OPOs recover only the highest-quality kidneys and forgo valuable recovery opportunities, and TCs decline some beneficial transplants. Alternative regulations that reward TCs and OPOs together for health outcomes in their entire patient pool lead to behaviors that increase organ recovery and appropriate transplants.

Here's what transplants look like in our experimental environment:

And our results are robust to big changes in parameters:

Kidney exchange in Brazil: prelude

 Yesterday I flew home from a busy visit to Brazil, with Mike Rees and Dr. Gustavo Ferreira.  

On Wednesday we all traveled to the capital, Brasilia, meeting with government ministries and agencies about how to move kidney exchange forward there.

Our most promising meeting on Wednesday was with the company that organizes the hospitals associated with Brazil's Federal universities. We talked about research possibilities

Wednesday Aug 7: Brazilian Hospital Services Company

Our most important meeting was on Thursday with the Ministry of Health  We talked about how clinical trials of kidney exchange in Brazil could help guide changes in Brazil's organ transplant laws and regulations.

Thursday: Brazil Ministry of Health, August 8 2024

On Friday we traveled to Juiz de Fora where we participated in a transplant symposium at the Santa Casa hospital there

On Saturday we had an exciting finish to the trip, but it's not my story to tell yet, so I'll blog again after there is an official announcement.

Earlier:

Tuesday, February 27, 2024

Stanford Impact Labs announces support for kidney exchange in Brazil, India, and the U.S.

Surrogacy in Israel

In Israel, where commercial surrogacy is legal, surrogates are more and more coming from educated and religious communities. 

Haaretz has the story:

Married, Educated, Not in It for the Money: The New Profile of Israeli Surrogate Mothers. Who are the Israeli women who wish to be pregnant and give birth for others? The answer to that question has changed dramatically over the past decade  by Ronny Linder

""I'm a little tired of women telling me how disadvantaged all surrogates are, so I thought of starting a thread just for surrogates, with: name + our occupation + town. I'll go first." This is what one moderator of an open Facebook surrogacy group wrote, about a year ago – and the responses came pouring in: a computer programmer from Tekoa, a sociolinguistics Ph.D. from Kfar Sava, a school principal from Jerusalem, a postgraduate student of gender studies from Hatzeva, a lawyer from Gush Etzion, an oncology nurse from Mevasseret Zion and so on and on.

"The post and the responses to it, written in reaction to the prevalent perception that views surrogacy as bearing the potential for exploitation of disadvantaged women who must "hire out" their uteruses for money, largely reflects the great transformation, over a few short years, in the profile of surrogate mothers and of the entire field in Israel. 

...

"Since the surrogacy law was legislated in 1996, almost 1,300 children have been born in Israel through surrogacy procedures. In recent years, the number has averaged around 80 children per year. Data collected by the Health Ministry about surrogate mothers between 2022 and 2023, reveals the changes in the profiles of women who choose to take on the task, as compared with the last study, in 2010. That study, which reviewed surrogate mothers during the years 1996-2010, was conducted by Etti Samama as part of the work for her doctoral thesis in health-system management at Ben-Gurion University. To compile recent data, Adam Ringel and Eti Dekel, for many years the national supervisor of the surrogacy law, collected information from 246 cases – 90 percent of the cases filed with committee in the last couple of years. 

...

"The data indicate a fundamental change in the socio-economic status of women who choose to become surrogates. In terms of education, while in 2010 the majority of surrogate mothers had a high school education (70 percent), nearly one fifth (18 percent) had less than 12 years of schooling, and only 7 percent had academic degrees. Less than a decade and a half later, however, the picture has been transformed: 65 percent of surrogate mothers have an academic degree, and only about one fifth have only a high school education (14 percent) or less than 12 years of schooling (8 percent). The proportion of those with academic degrees among surrogates is significantly higher than that group's share of the population, which is 38 percent.

"A similarly changed picture emerges in terms of employment: In 2023, only 2.5 percent of surrogates were unemployed, compared with 25 percent in 2010. No less interesting is the finding regarding geographical dispersal of surrogates, as compared with the general public: In recent years, almost half (45 percent) of them come from kibbutzim, moshavim and organized communities – compared with just 12 percent in 2010.

...

"An absolute majority of surrogates come from [the world of] religious Zionism, on the one hand, or are secular women from kibbutzim and other organized communities, on the other," Ringel elucidates. "These two groups are seemingly worlds apart, but in the world of surrogacy, you see the resemblance between them. These are independent, strong women, with a fully developed values-based worldview, who are looking to do something big for others, who see surrogacy as a calling, as female empowerment and as the ultimate giving."

"What happened between 2010 and 2024 that led to such dramatic change in the profile of surrogate mothers? Experts in the field ascribe the change mainly to the opening up of the option for married women to become surrogates, beginning in 2010 – a move that significantly increased the pool of potential surrogates and also changed their socio-economic backgrounds.

"This is indeed a transformation: in 2010, all surrogates were unmarried women, 75 percent of them divorced, the rest single (and a few widows). In contrast, in 2022-2023, 80 percent of surrogates were married or in relationships, and only 20 percent were divorced or single.

...

 "There was always an altruistic element with surrogates, but ever since married and more affluent women entered the picture – the economic part became more of a bonus, rather than the main motive," Dekel points out."

Growth pains for legal marijuana, in Germany and New York

Transitioning from a thriving black market for marijuana to a regulated legal market isn't so easy.

The Guardian has the story from Germany, where so far clubs, but not shops, have been legalized:

Cannabis legalisation hampered by most German of substances: red tape. Activists say the rollout of laws permitting recreational use of the drug has been hampered by a ‘bureaucratic monster’  by Deborah Cole

"Joints now mingle openly with pints among fans watching the European football championship in host nation Germany, which in the spring became the first big EU country to legally allow personal recreational use of cannabis.

"That is, provided the fan is over 18, only carrying a small amount of the narcotic, not smoking in the stands of a stadium and not in possession of more than three plants at their officially registered home.

...

"The hotly disputed law passed by Olaf Scholz’s three-party coalition, which took effect in April, legalised cultivating up to three plants for private consumption, the possession of 50g (1.75oz) of cannabis at one time at home and 25g in public.

...

"A key phase began on 1 July with the establishment of registered cannabis clubs, which proponents say are vital to assuring the smooth path towards legal weed and supplanting the underworld street trade.

...

"In order to thwart drug tourism, members must have lived in Germany for six months, sign up to a club for a minimum of three months and have a clean criminal record for narcotics.

"Clubs are dependent on fee-paying members to start operating but are not allowed to advertise, said Marten Knopke of the Cannabis Social Club Leipzig, thus robbing them of a key source of capital needed to rent offices and land for growing purposes. Consumption on club premises is also verboten.

“We are subject to more restrictions than any alcohol company,” Knopke said, echoing a frequent complaint from the cannabis scene about drinking, which kills more than 60,000 people in Germany each year. “The government has also made it really difficult for us to stand up to the hidden [narcotics] market.”

...

“There are no shops where you can buy, meaning they [foreign tourists]" will end up buying something on the underground market, which is very dangerous in Berlin,” because of contaminated drugs and the role of the mafia in the trade, he said."

********

And here's the New York Times on New York:

The Real Problem With Legal Weed, By Charles Fain Lehman

"When New York legalized recreational marijuana in 2021, the future seemed bright. ...

"Three years later, things are not going to plan. Gov. Kathy Hochul has called New York’s legalization rollout “a disaster.” Mayor Eric Adams has spent months demanding that Albany fix the current system. “What happened?” The New Yorker recently asked in a feature on the collapse of the state’s marijuana “revolution.”

...

"There are around 140 recreational dispensaries operating statewide — about one for every 148,000 New Yorkers. Instead of shopping legally, New Yorkers tend to get their weed from the illegal shops that now blanket the state. Estimates suggest that there are anywhere from 2,000 to 8,000 in New York City alone, with uncounted more from Ithaca to Oneonta. Recent crackdowns have temporarily sealed more than 400 stores — only a small fraction of the total in the city.

"These shops undercut the legal stores, offering the same high at a fraction of the price. And they attract crime: There were 736 robbery complaints at unlicensed shops last year, according to the New York Police Department. Shootings are not uncommon, including the killing of a 36-year-old man captured on video last April.

"They also sell to teenagers, as The Times has reported. Teachers, prevention experts and pediatricians have raised the alarm about high schoolers smoking or vaping marijuana at school."

Do Americans Drink Too Much? Politics and science in the debate over guidelines

 The WSJ has the story:

 Do Americans Drink Too Much? Alcohol Is Driving a Debate in Washington. Agencies, lobbyists and lawmakers are fighting over alcohol guidelines due to be updated next year By Kristina Peterson  and Julie Wernau 

"For nearly three decades, federal dietary guidelines have said it is safe for men to have two or fewer drinks a day, and for women to have one. That could change next year when the Agriculture and Health and Human Services departments update recommendations that are part of federal dietary guidelines.

...

"Alcohol-industry officials and lobbyists have sent materials to government officials questioning the research methods of scientists drafting the recommendations. Alcohol companies have spent millions of dollars lobbying lawmakers, more than a dozen of whom wrote to HHS and USDA on May 30 demanding more information on the process. 

“We don’t want arbitrary decision-making by these agencies that’s not rooted in real science,” said Rep. Andy Barr (R., Ky.), who is co-chair of the Bourbon Caucus, a bipartisan group of lawmakers. The group was founded in 2009 by a lawmaker from Kentucky, which considers itself the birthplace of bourbon, and now has around 40 members. 

...

"Guiding Americans to drink less would be a blow to an industry that is already losing some customers. Younger generations have moved away from alcohol over health concerns. For the first time, the U.S. has more daily cannabis users than alcohol users. 

“If they want us to drink two beers a week, frankly they can kiss my ass,” Sen. Ted Cruz (R., Texas) said on Newsmax in August of the potential for lower alcohol-consumption guidelines. 

...

The six-member HHS panel includes three researchers whose studies have demonstrated that any amount of alcohol can be harmful: Tim Naimi, director of the Canadian Institute for Substance Use Research; Jürgen Rehm, senior scientist at the Center for Addiction and Mental Health; and Kevin Shield, an independent scientist who runs a World Health Organization center on addiction."

Nicotine is hard to ban: Juul wins a reprieve from the FDA, and illegal vapes flood the market

 Here are two stories by Jennifer Maloney at the WSJ:

FDA Rescinds Juul Ban, Opening Door for Federal Clearance. E-cigarette maker’s products have stayed on market pending appeal of 2022 ban.. By  Jennifer Maloney

"The Food and Drug Administration rescinded its 2022 ban on Juul Labs’s e-cigarettes. The agency hasn’t yet reached a final determination on whether they can stay on the U.S. market, but the move opened the possibility for federal clearance.

The FDA in 2022 ordered Juul to halt its sales, then stayed the order pending the vaping company’s appeal. The agency said Thursday that it was placing Juul’s products back under scientific review, essentially moving them back to their regulatory status before the ban. 

...

"Juul’s products remain on the market. The FDA didn’t give a timeline for a final decision on whether they can stay there. Juul is the No. 2 e-cigarette maker in the U.S.

Juul and other e-cigarette manufacturers in 2020 were required to submit scientific research to demonstrate that their vaping products exposed users to fewer carcinogens than cigarettes and that the benefit of helping adult smokers switch to a safer alternative outweighed the potential harm of hooking young people on nicotine.

...

"The FDA ban, though it was quickly put on hold, sent Juul into a financial tailspin. The company narrowly averted bankruptcy. Juul has since submitted next-generation vaping products for FDA review. They aren’t yet for sale in the U.S."

###########

U.S. Pledges Crackdown on Illegal E-Cigarettes. FDA and DOJ form task force to go after fruity, disposable vapes flooding the market.  By Jennifer Maloney

"Big tobacco companies and their critics agree on at least one thing: The illegal, fruit-flavored, disposable vapes that are popular among teenagers have flooded the U.S. market and federal regulators haven’t done enough to stop it.

"The Food and Drug Administration and Justice Department said Monday they are stepping up enforcement by forming a multiagency task force to go after the illegal distribution and sale of e-cigarettes.

"Disposable vaping devices, almost none of which are authorized for sale by the FDA, represent more than 30% of U.S. e-cigarette sales in stores tracked by Nielsen, according to an analysis by Goldman Sachs. Many of them are imported from China. Breeze Pro and Elfbar, both of which were ordered off the market last year by the FDA, remain the top two disposable e-cigarette brands in the U.S.

"Njoy is the only disposable vaping brand authorized for sale by the FDA." 

Organs, tissues, and medical devices are regulated very differently

 Here's an article in JAMA by a Michigan doctor and his Congresswoman, on the lack of regulation for some substances of human origin.

Urgent Need for Regulatory Oversight of Human Cells, Tissues, and Cellular and Tissue–Based Products, by Robert P. Dickson, MD; Deborah A. Dingell, MS, JAMA. 2024;331(20):1703-1704. doi:10.1001/jama.2024.6834

" In 2021, an outbreak of M tuberculosis occurred in the US when contaminated bone graft material was implanted into 113 patients, 77% of whom developed clinically apparent tuberculosis.

...

[Again in 2023] "the Centers for Disease Control and Prevention (CDC) had identified additional tuberculosis-infected patients who had received implants of the same product, harvested from the same donor. At final count, 36 patients in 7 states had undergone implantation of bone graft tissue contaminated with M tuberculosis.

...

"Given the rigorous safety testing required of most medical therapies, how could 2 lethal outbreaks of tuberculosis occur in as many years, arising from the same product, distributed by the same company?

"The answer lies in the FDA’s designation of this product as a human cells, tissues, and cellular and tissue–based product (HCT/P) (Table). This class of therapies, which includes bone grafts, skin grafts, and stem cells, is not subject to the same regulatory standards as pharmaceuticals, biological products (such as blood products and monoclonal antibodies), or organ transplants. This designation has profound regulatory and clinical consequences

Text of the new EU regulations on Substances of Human Origin

 Kim Krawiec points me to this newly published document, with the 'final' regulations intended to prevent compensation of donors of Substances of Human Origin (SoHO), such as blood plasma.  How this will effect the five EU member states that compensate plasma donors remains to be seen, as these regulations are now scheduled to go into effect only in 2027.

REGULATION (EU) 2024/… OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL … on standards of quality and safety for substances of human origin intended for human application 

After a quick read, I think these are the sections of the new regulations that are most relevant to their elements of market design, and compensation to donors.

(4)… safety standards are to be based on the fundamental principle that the human body or its parts as such are not to be a source of financial gain.

…

(26) Solid organs are excluded from the definition of SoHO for the purposes of this Regulation and, thus, from the scope of this Regulation. Their donation and transplantation are significantly different, determined, inter alia, by the effect of ischemia in the organs, and are regulated in a dedicated legal framework, set out in Directive 2010/53/EU of the European Parliament and of the Council

…

(57) Article 3 of the Charter prohibits making the human body and its parts as such a source of financial gain. The use of financial incentives for SoHO donations can have an impact on the quality and safety of SoHO, posing risks to the health of both SoHO donors and recipients and therefore to the protection of human health. Without affecting the responsibilities of the Member States for the definition of their health policy, and for the organisation and delivery of health services and medical care, SoHO donation should be voluntary and unpaid, and be founded on the principles of altruism of the SoHO donor and solidarity between donor and recipient. Such solidarity should be built from the local and regional levels up to the national and Union levels, aiming for self-sufficiency of critical SoHO, and spreading the responsibility for donation evenly across the Union population to the extent possible. Voluntary and unpaid SoHO donation contributes to the respect for human dignity and to protecting the most vulnerable persons in society. It also contributes to high safety standards for SoHO and therefore to the protection of human health, increasing public trust in donation systems. AM\P9_AMA(2023)0250(244-244)_EN.docx 49/306 PE748.903v01-00 EN United in diversity EN 

(58) It is recognised, including by the Council of Europe Committee on Bioethics in its ‘Guide for the implementation of the principle of prohibition of financial gain with respect to the human body and its parts from living or deceased donors’ from March 2018, that while financial gain should be avoided, compensation should be able to be acceptable to prevent SoHO donors being financially disadvantaged by their donation. Therefore, compensation to remove any such risk is deemed appropriate as long as it endeavours to guarantee financial neutrality and does not result in a financial gain for the SoHO donor or constitute an incentive that would cause a SoHO donor to not disclose relevant aspects of their medical or behavioural history or to donate in any way that could pose risks to their own health and to that of prospective recipients, in particular by donating more frequently than is allowed. It should be possible for compensation to consist of the reimbursement of expenses incurred in connection with SoHO donation or of making good of any losses, preferably based on quantifiable criteria, associated with the donation of SoHO.

Whatever the form of compensation, including through financial and nonfinancial means, compensation schemes should not result in competition between SoHO entities for SoHO donors, including cross-border competition and in particular between SoHO entities collecting SoHO for different purposes, such as the manufacture of medicinal products versus human application as a SoHO preparation. The setting of an upper limit for compensation at national level and the application of compensation that is financially neutral for the SoHO donor have the effect of removing any incentive for SoHO donors to donate to one SoHO entity rather than another, significantly mitigating the risk that compensation differences might result in competition between SoHO entities, in particular between public and private sectors. It should be possible for Member States to delegate the setting of such conditions to independent bodies, in accordance with national law. Prospective SoHO donors should be able to receive information regarding the possibility of having their expenses reimbursed or of receiving compensation for other losses, through information tools, such as website 'Question and Answer' pages, information email addresses, telephone lines or other such neutral channels of factual information dissemination. However, because of the risk of undermining the voluntary and unpaid character of SoHO donation, references to compensation schemes should not be included in advertising, promotion and publicity activities that form part of SoHO donor recruitment campaigns, for example using advertising billboards or posters, on television, newspaper, magazine or social media advertisements or similar.

(59) SoHO entities should not offer financial incentives or inducements to potential SoHO donors or to those giving consent on their behalf as such an action would be contrary to the principle of voluntary and unpaid donation. Refreshments and small gifts, such as pens or badges, should not be considered as inducements and the practice of offering them to SoHO donors is acceptable as a recognition of their efforts. On the other hand, rewards or benefits, such as payment of funeral expenses, or payment of health insurance unrelated to the SoHO collection, should be considered as inducements, and as such contrary to the principle of voluntary and unpaid donation and should not be permitted.

(60) This Regulation is not meant to cover research using SoHO when that research does not involve human application, for example in vitro research or research in animals. However, SoHO used in research involving studies where they are applied to the human body should comply with this Regulation. In order to avoid undermining the effectiveness of this Regulation, and in particular in view of the need to ensure a consistently high level of protection for SoHO donors, and sufficient availability of SoHO for recipients, the donation of SoHO that will be exclusively for use in research without any human application should also comply with the standards concerning voluntary and unpaid donation set out in this Regulation.

…

(68) In cases where the availability of critical SoHO or products manufactured from critical SoHO depends on potential commercial interests, such as those related to the production and distribution of plasma-derived products, there is a risk of not having the interests of patients and research at the forefront, and thus to jeopardise the quality and safety of SoHO, SoHO donors and recipients. There could even be situations in which some products with low profitability are no longer produced, thereby hampering their accessibility for patients. Therefore, by considering all reasonable efforts for an appropriate and continuous supply of critical SoHO, Member States contribute to limiting the risk of shortages of products manufactured from critical SoHO.

(69) The exchange of SoHO between Member States is necessary for ensuring optimal patient access and sufficiency of supply, particularly in the case of local crises or shortages. For certain SoHO that need to be matched between the SoHO donor and the SoHO recipient, such exchanges are essential to allow SoHO recipients to receive the treatment they need in the optimal timeframe. This is for instance the case of hematopoietic stem cell transplants, for which the level of compatibility between the SoHO donor and the SoHO recipient has to be high, which requires coordination at a global level, so that each SoHO recipient has as many options as possible to identify a compatible SoHO donor.

##########

“Next steps (from the European Commission): 

The Council will now formally adopt the new European Health Data Space regulation which is expected to be published in the Official Journal in autumn. It will then become applicable in different stages according to use case and data type.

The Council will also formally adopt the new revised legislation to increase the safety and quality of substances of human origin, which will become applicable in 2027.

#####

Earlier:

Monday, April 22, 2024

Plasma donation in the EU: compensated and uncompensated

The NFL embraces sports gambling for fans but not for players

 The Superbowl is in Las Vegas, and gambling is being embraced by the NFL for fans, but not for players and other NFL employees.

The NYT has the story:

N.F.L.’s Rapid Embrace of Gambling Creates Mixed Signals. The league is pushing to popularize and benefit from sports betting while still trying to guard against the potential pitfalls for its players, employees and fans.  By Jenny Vrentas

"Since the Supreme Court struck down, in 2018, a federal law that effectively banned sports betting outside Nevada — a prohibition once backed by the N.F.L.’s commissioner, Roger Goodell — the N.F.L. has embraced the gambling industry. It has forged partnerships reportedly worth nearly $1 billion over five years with sports betting companies, and permitted a sports book to operate inside one of its stadiums. Now it even has a team in Las Vegas, which the league shunned for decades because any affiliation was seen as a threat to the integrity of the game.

"Yet the embedding of sports gambling so quickly into the culture of the league has resulted in jarring contradictions. The N.F.L. is pushing to popularize and benefit from sports betting while still guarding against the potential pitfalls that it long condemned. While the league donates money to promote responsible gambling, its broadcasts are peppered with advertisements for sports betting companies. The N.F.L. is part of a growing apparatus that encourages casual fans to regularly place wagers on games, while punishing league employees — most notably players — who might do the same.

...

"Americans legally wagered more than $115 billion on sports in 2023, according to the American Gaming Association, the national trade group for the gambling industry. Nearly 25 million more Americans bet on sports last year than in 2018, the group said, and the number of states where betting on sports is legal will reach 38 this year.

...

"[A] report projected that around $1.5 billion would be legally wagered on next Sunday’s Super Bowl, more than 1 percent of the money bet legally on all sports last year.

...

"n 2021, the year the N.F.L. struck deals with its three sports book partners, it gave the National Council on Problem Gambling a three-year, $6.2 million grant that was used in part to modernize the help line that appears at the bottom of betting ads. The league’s contribution is a small fraction of what gambling companies pay to be part of the N.F.L.’s marketing apparatus, but it is the largest grant in the council’s history and exceeded the nonprofit’s grant total over the previous four years, according to tax filings.

...

"The league’s approach to gambling violations within its own ranks, though, remains punitive. For decades, sports leagues have believed that gambling could damage the integrity of results — with worries over a player’s throwing a game because of a bet, for instance — so the focus has been on enforcement and punishment over prevention and treatment.

"The N.F.L. prohibits league and team personnel from betting on any sport, while players are allowed to bet on sports other than the N.F.L., as long as they do not do so at the team facility or while on team or league business. While in Las Vegas for the Super Bowl, members of the Kansas City Chiefs and the San Francisco 49ers and the hundreds of league employees, many staying at Caesars Palace, are not permitted to play casino games and may enter a sports book only if passing through to another part of the hotel."

The DOJ on competition for workers

 A lot of market design is done by regulators, and some of that is done to enforce existing laws.  Here's a report from the Department of Justice, focusing on four cases involving payment to workers (including authors of books).

Athey, Susan, Mark Chicu, Malika Krishna, and Ioana Marinescu. "The Year in Review: Economics at the Antitrust Division, 2022–2023." Review of Industrial Organization (2024): 1-20.

"In this review article, we report on five enforcement matters that expanded the scope of enforcement by the Division. The first four enforcement matters highlight a number of the Division’s actions to protect labor market competition in criminal and civil merger and non-merger cases. These include: criminal enforcement against a provider of contract health care staffing services that allocated nurse employees through a no-poaching agreement and agreed to fix the wages of those nurses; civil enforcement to stop an e-Sports league from effectively imposing a salary cap on its players; civil enforcement to stop a conspiracy among poultry processors to share information about worker compensation; and the successful challenge of a merger between two of the largest book publishers in the U.S., which preserved competition for books that will benefit authors."

Reporting and misreporting from Organ Procurement Organizations (OPOs)

 Because there are shortages of organs for transplant, it is important to measure how successful Organ Procurement Organizations (OPOs) are at recovering and transplanting organs.  But sometimes definitions can get in the way, and this was the case in islet transplants from deceased donors, into patients with diabetes.  Pancreatic islets are the cells that produce insulin, and it was (and I think still is) regarded as an experimental procedure to transplant islets from a deceased donor's pancreas, rather than the whole pancreas.  So islet transplantation was classified as a research activity.

To encourage this use of deceased donor pancreases, recovery of a pancreas "for research" was counted as a transplant. But some OPO's have heavily gamed this, reporting that they recovered a pancreas when the "research" wasn't connected to transplantation.  That loophole is now being closed.

Here's a January 18 memo from HHS, CMS, Center for Clinical Standards and Quality

Organ Procurement Organization (OPO) Conditions for Coverage – Definition Clarification 

"Background:

"The OPO CfCs are intended to drive improvements in organ procurement and transplantation through, among other provisions, the donor and transplantation outcome measures. OPOs are required to report data related to pancreata procured for research, and this data is incorporated into calculations used to assess compliance with the donor and transplant outcome measures and are used for re-certification purposes. To facilitate accurate reporting of data related to pancreata donors, the term “donor” is defined in CMS regulation to specify that, among other requirements, an individual would be considered a donor even if only the pancreas is procured and is used for research or islet cell transplantation.

"CMS has noted a significant increase in the number of pancreata procured since this definitionwas revised in 2020, raising questions about the interpretation of this definition by OPOs and how this definition is applied to reporting data related to donors of pancreata used for islet cell research. There is a concern that the increase in pancreata procured may not reflect a meaningful increase in pancreata being actually used for islet cell research, and instead may reflect pancreata procured for other purposes. This memo is clarifying that the pancreata must be used for islet cell research. 

...

"In summary, this memo is clarifying that consistent with the Pancreatic Islet Cell Transplantation Act of 2004, only pancreata procured by an OPO and used for islet cell transplantation or research shall be counted"

What's ahead for U.S. organ allocation in the coming year

 Here's the December announcement from HRSA of their plans for reforming organ procurement and allocation this year.  

Organ Procurement and Transplantation Network (OPTN) Modernization Initiative. HRSA's approach to securing best-in-class expertise and an independent Board of Directors, December 2023 Updates

"At every step of the modernization process, HRSA has been committed to robust competition for the first-ever multi-vendor solicitations for OPTN contracts, and we were pleased that Congress supported our vision for fundamental reform through passage of the bipartisan Securing the U.S Organ Procurement and Transplantation Network Act. For more than a year, we have pursued a fundamental sea change in how the OPTN operates in order to improve the performance, transparency, independence, and accountability of this life-saving system for patients – the first time in the nearly 40-year history of this program that any Administration has advocated for this type of fundamental reform to break up the monopoly. Below is an update on the progress made to date and details regarding next steps. 

...

"A key element of HRSA’s OPTN Modernization Initiative is the President’s Fiscal Year 2024 Budget proposal to more than double investment in organ procurement and transplantation with a $36 million increase over Fiscal Year 2023 for a total of $67 million. In light of the uncertainty regarding full-year appropriations for Fiscal Year 2024, as well as the upcoming holidays and HRSA’s commitment to providing at least 60 days for potential bidders to respond to solicitations, HRSA plans to issue the solicitations in January 2024.

...

"1. Launching an Independent OPTN Board of Directors

"Current practice: For nearly 40 years, the Board of Directors for the Organ Procurement and Transplantation Network (OPTN) has been comprised of the same individuals who serve as the Board of Directors for the private entity that has held the OPTN contract. No formal requirements existed to protect against conflicts of interest resulting from this shared role.

"Under HRSA’s OPTN Modernization Initiative:

"HRSA will issue a solicitation in January 2024 for independent non-profit organizations to bid on supporting an independent OPTN Board of Directors in order to ensure mission-driven governance, strong conflict of interest policy, and that the system remains a public good not a private asset. The organization awarded the OPTN Board Support Contract will not be awarded any other OPTN contract.

...

"2. Robust Competition for First Ever Multi-Vendor Solicitations to Support Best-in-Class Vendors for OPTN IT, Operations, Communications, Research and Evaluation

"Current practice: Across the nearly 40-year history of the OPTN, all functions of the OPTN have been managed by a single vendor and not competed based on technical expertise in areas like IT or operations. This does not serve patients well and does not allow the system to keep pace with modern technology.  

"Under HRSA’s OPTN Modernization Initiative:

"Phase 1 — Competitive Transition Contracts:

"In January 2024, HRSA will release solicitations open to all non-profit and for-profit organizations for proposals for OPTN work related to information technology management, operations, data analytics/research, and communication.

"These contracts will support the transition from the legacy OPTN system to a modernized system and approach while ensuring uninterrupted access to the organ matching system and related processes in order to support transplantation and prevent unnecessary risk while protecting patients. As such, we refer to them as Competitive Transition Contracts.

...

"Phase 2 — Next Gen Contracts:

"In Summer 2024, HRSA will issue solicitations open to all non-profit and for-profit organizations for proposals for the OPTN Next Gen contracts.

"The Next Gen contracts will prioritize human-centered design practices and will focus on developing a truly modern organ matching technology solution that is highly reliable, secure, and user-friendly."

######

So the plan is to start this month with bids for contracts to manage the transition from the current system to the 'next generation' system, and to follow those in the summer with bids to design the next generation system. (If that seems out of order to you, you're not the only one.)

Deceased organ donation in the Economist (article and letter to the editor)

 Here's a recent article on deceased organ donation, in The Economist, followed by a letter to the editor from Alex Chan and me.

In America, lots of usable organs go unrecovered or get binned. That is a missed opportunity to save thousands of lives

"More than four-fifths of all donated organs and two-thirds of kidneys come from dead people (who must die in hospital); living donors can give only a kidney or parts of a lung or liver. Whereas some countries, such as England, France and Spain, have an opt-out model, in America donors must register or their families must agree. Persuading them will always be hard: Dr Karp’s hospital gets consent from about half of potential donors.

...

"Responsibility lies partly with some of the 56 nonprofit Organ Procurement Organisations (opos), like LiveOnNY, that do the legwork. Brianna Doby, a researcher and consultant, advised Arkansas’s opo in 2021 and was astounded to learn that most calls about potential donors went unanswered outside the nine-to-five workday and at weekends. Other opos, by contrast, sent staff to hospitals within an hour of an alert about a prospective donor.

...

"Yet unrecovered organs are not the only reason America could do more transplants. A surprising number of organs from deceased donors end up in the rubbish: more than a quarter of kidneys and a tenth of livers last year.

...

"Hospitals are often risk-averse, too. Discard rates are higher for organs of lower quality.

...

"For elderly recipients, getting older or otherwise risky kidneys generally means better odds of survival than staying on dialysis. But hospitals dislike using them for two reasons. First, they can lead to more complications and thus require more resources, eating into margins. Second, if the recipient dies soon after the transplant, hospitals suffer—a key measure used to evaluate them is the survival rate of recipients a year after transplant. According to Robert Cannon, a liver-transplant surgeon at the University of Alabama at Birmingham, hospitals succeed by being excessively cautious and keeping patients with worse prospects off waiting lists."

#########

And here's our followup letter to the editor, published November 2:

Organ-donation economics

"More than 110,000 Americans are waiting for an organ transplant and over 5,000 died waiting for an organ in 2019. Close to 6,000 recovered organs were discarded. “Wasted organs” (September 23rd) correctly pointed out that the responsibility lies in part with non-profit Organ Procurement Organisations and in part with the excessive caution exercised by transplant centres when deciding who to conduct transplants for and which kidneys to use.

"Numerous initiatives in Congress, and more proposed by various non-governmental agencies, such as the Federation of American Scientists and the National Academies of Sciences, Engineering and Medicine, among others, have been focused on tweaking how the performance of organ procurers and transplant centres should be measured while keeping in place the system that put us in today’s quagmire. As we indicate in our recent paper (conditionally accepted at the Journal of Political Economy), such approaches that keep regulations fragmented are bound to be inefficient, given that the incentives and opportunities facing organ procurers and transplant centres are intertwined.

"We show that “holistic regulation”, which aligns the interests of organ procurers and transplant centres by rewarding them based on the health outcomes of the entire patient pool, can get at the root of the problem. This approach also leads to more organ recoveries while increasing the use of organs for sicker patients who otherwise would be left without a transplant.

"In the end increasing access to kidney transplantation will require the improvement of the entire supply chain of organs. This means boosting donor registrations and donor recoveries from the deceased. It also means increasing living donations, and co-ordinating donations through mechanisms like paired kidney donations and deceased-donor-initiated kidney- exchange chains.

Alex Chan, Assistant professor of business administration, Harvard University

Alvin E. Roth, Professor of economics, Stanford University

####

And here's the paper referred to in our letter, on Alex's website:

Regulation of Organ Transplantation and Procurement: A Market Design Lab Experiment, by Alex Chan and Alvin E. Roth

Abstract: "We conduct a lab experiment that shows current rules regulating transplant centers (TCs) and organ procurement organizations (OPOs) create perverse incentives that inefficiently reduce both organ recovery and beneficial transplantations. We model the decision environment with a 2-player multi-round game between an OPO and a TC. In the condition that simulates current rules, OPOs recover only highest-quality kidneys and forgo valuable recovery opportunities, and TCs decline some beneficial transplants and perform some unnecessary transplants. Alternative regulations that reward TCs and OPOs together for health outcomes in their entire patient pool lead to behaviors that increase organ recovery and appropriate transplants."

The underbelly of the global art market (NYT)

 Art is not just art, it's also an investment opportunity, and one that evades many of the regulations that apply to investments recognized as securities.

The NY Times has the story, which is long and interesting throughout.  It follows an investigation begun by the lawyer Claude Dumont Beghi .

The Inheritance Case That Could Unravel an Art Dynasty/How a widow’s legal fight against the Wildenstein family of France has threatened their storied collection — and revealed the underbelly of the global art market.  By Rachel Corbett

"First, she drew up a list of known assets, which soon zigzagged into a chart of far-flung bank accounts, trusts and shell corporations. Over the course of several years, she would fly around the world to tax havens and free ports, prying open the armored vaults and anonymous accounts that mask many of the high-end transactions in the $68 billion global art market. Multimillion-dollar paintings can anonymously trade hands without, for example, any of the requisite titles or deeds of real estate transactions or the public disclosures required on Wall Street. She would learn that the inscrutability of the trade has made it a leading conduit for sanction-evading oligarchs and other billionaires looking to launder excess capital. 

...

"Independent of any national jurisdiction, free ports allow traders to ship and store property without paying taxes or customs duties. If a dealer buys a painting in one country, he can ship it to a free port without paying import taxes; then, when he is offered the right price, he can sell it there too, without paying capital gains. It has been estimated that $100 billion worth of art and collectibles are held in the Geneva free port alone, to say nothing of those in Zurich, Luxembourg, Singapore, Monaco, Delaware or Beijing.

...

"many of their practices are commonplace in high levels of the art trade, which a 2020 U.S. Senate subcommittee called the “largest legal, unregulated market.” Unlike financial institutions, art businesses are not expressly subject to the Bank Secrecy Act, which requires firms to verify customers’ identities, report large cash transactions and flag suspicious activity. A study from the U.S. Department of the Treasury last year cited a figure estimating that money laundering and other financial crimes in the art market may amount to about $3 billion a year. (Britain and the European Union, however, have implemented anti-money-laundering regulations that require stricter due diligence in art transactions there.)

"According to a report by Art Basel and UBS, auction houses did about $31 billion in sales last year. They say that they know who their clients are, but those may just be the names of art advisers or other intermediaries. And collectors’ insistence on anonymity, long framed as genteel discretion, hasn’t budged. The buyer of the most expensive artwork ever sold at auction, Leonardo da Vinci’s $450.3 million “Salvator Mundi,” registered at Christie’s a day before bidding with a $100 million down payment, identifying himself as one of 5,000 princes in Saudi Arabia. A few weeks later, it was revealed that the true buyer was Crown Prince Mohammed bin Salman — who was reportedly displaying the painting on his superyacht — and that a little-known cousin of his bought it as a proxy." 

Growing pains for legal marijuana, in California and beyond

The market for legal marijuana in the U.S. is suffering from (literal) growing pains, as large scale legal cultivation runs into both crop diseases, and zoning issues.

As a crop that is legal at the state level in many states, but still illegal under federal law, large cannabis farms don't get some of the benefits regarding the spread of plant diseases that are provided for other crops by the U.S. Department of Agriculture.

The WSJ has the story:

Cannabis Industry Confronts Billion-Dollar Threat: Weak Weed. Pathogen spreading among crops is cutting recreational drug’s potency, forcing growers to cull ‘dudded’ plants.  By Dean Seal

"A pathogen is contaminating cannabis crops around the country and threatening to leave billions of dollars of losses in its wake. 

"Cannabis researchers and experts are sounding the alarm for what is known as hop latent viroid, or HLVd, and cultivators are stepping up efforts to discover whether their plants are infected. The pathogen can drastically reduce the potency of the psychoactive compounds in marijuana, a phenomenon that growers have long called “dudding.”

...

"Plant pathologists and cannabis experts say the spread of the viroid was likely accelerated by the popularity of weed from California, which legalized cannabis for medical use in 1996.

"The spread also reflects the evolution of the cannabis business into a major agricultural crop. The risk of a new disease expanding increases for any crop that goes from low to high production, as cannabis has in the past two decades, said Jeremy Warren, Dark Heart’s director of plant science.

“You saw the spread happen in the legal states first, like California, where you started having bigger grows and bigger greenhouses that are making thousands and tens of thousands of plants,” Warren said. “In that system, it’s harder to maintain sanitation and it’s easier for a pathogen to take off.”

"The U.S. Agriculture Department typically sets quality standards and inspection requirements for agricultural products, but marijuana’s illegality at the federal level keeps it out of the agency’s purview."

*******

And big farms mean that agriculture and expensive housing may rub shoulders in California. Here's the Guardian on Santa Barbara County.

A beachside city became California’s legal cannabis capital. Not everyone is stoked  by Nicholas Schou

"Thanks to the most lenient policies in California for recreational marijuana, Santa Barbara county is now the state’s undisputed capital of legal cannabis, boasting more acres than the storied Emerald Triangle of Humboldt, Trinity and Mendocino counties.

"Santa Barbara voters overwhelmingly backed California’s legalisation of recreational marijuana in 2016, with hopes that the cannabis boom would bring tax revenue and new jobs to the county. The transformation has been fast and furious. Santa Barbara county is now home to around a third of all cultivation licenses issued in California, despite making up only 1.8% of the state’s land, with some megafarms stretching over dozens of acres.

"But the sudden influx of growers has inspired a broad coalition of frustration that spans local high schools, uber-wealthy homeowners and the region’s influential wine industry, who argue the pungent industry threatens to ruin their cherished lifestyle in a region dubbed the “American Riviera”.

...

"The tensions underscore a wider drama playing out in California over the promises of legal weed. Despite broad public support for bringing the industry out of the shadows, seven years on the illicit market is thriving, businesses are struggling to turn a profit, and many on the frontlines of the transition say they have yet to enjoy the returns.

"In fact, for the first time, officials in Santa Barbara are acknowledging that if market trends continue, the cost of the program both to public finances and to quality of life may outweigh any actual benefits.

...

"California’s cannabis market has been operating in a quasi-legal sphere since 1996, when medical marijuana was decriminalized. In 2016, advocates for Proposition 64 successfully argued that decriminalizing all cannabis use would create lucrative tax schemes and rewrite the historic injustices of policing such a widely used drug.

"But Prop 64 allowed cities to choose whether to allow cannabis businesses or not. Many refused to, banning both cultivation and dispensaries. Others, with varying degrees of success and scandal, sought to cash in on the “green rush”.

...

"Santa Barbara is alone among counties in that it taxes farmers based on the value of the marijuana they sell, as opposed to the acreage of their farms. While that strategy works when cannabis values are high, the industry has experienced a massive decline in profitability during the past year. With the sale price of cannabis in the state at roughly a third of its value just a year or so ago, many corporate investors have pulled out of the market entirely, and the number of licensed growers in Santa Barbara county has declined by about 25%.

"As a result, the county is expecting to earn just $7.5m in cannabis tax revenue this year, a 54% decline from 2022 and only half the $15.2m that was expected to fund the county’s latest budget, according to a county report."

The Cost of Inaction and the Urgent Need to Reform the U.S. Transplant System: participant statements

 Yesterday's Senate Finance committee hearings on The Cost of Inaction and the Urgent Need to Reform the U.S. Transplant System are on video, and the following witness statements (delivered beforehand) are now also available.

If you only have time to read one, I'd recommend clicking on the testimony of Matthew Wadsworth, the President And CEO of the OPO, Life Connection of Ohio.

Witnesses 

---

1. LaQuayia Goldring
   Patient
   Louisville , KY
   • Download Testimony
2. Molly J. McCarthy
   Vice Chair & Region 6 Patient Affairs Committee Representative
   Organ Procurement and Transplantation Network (OPTN)
   Redmond , WA
   • Download Testimony
3. Matthew Wadsworth
   President And CEO
   Life Connection of Ohio
   Kettering , OH
   • Download Testimony
4. Raymond J. Lynch, MD, MS, FACS
   Professor Of Surgery And Director Of Transplantation Quality And Outcomes
   Penn State Health Milton S. Hershey Medical Center
   Hershey , PA
   • Download Testimony
5. Donna R. Cryer, JD
   Founder And CEO
   Global Liver Institute
   Washington , DC

**********

Thursday, July 20, 2023

Senate Finance Subcommittee on Health Care --testimony on organ transplants, going on now