Regulated and black market marijuana in Germany

 The FT has the story:

Germany becomes Europe’s largest regulated cannabis market.  Critics are calling for legislation to be tightened two years after the drug was partially liberalised,  by Aysun Bora 

"Legal marijuana imports have increased sixfold since 2024, according to data from the Federal Health Institute. That year, the leftwing government led by then-chancellor Olaf Scholz passed laws allowing adults to possess and privately cultivate cannabis, while also expanding legal sales to users with a prescription.
 ...

"Despite the partial legalisation, more than half of weed consumers do not rely on medical prescriptions to get the drug.

“Social supply”, meaning purchasing cannabis through social contacts, makes up 35.2 per cent of the market, even as selling the plant without a medical prescription remains illegal. The next biggest source, at 21 per cent, is for consumers to grow their own, according to a study conducted in the second half of 2025.
 

The Paradox of Protection: Overregulation Threatens Living Kidney Donation in Mexico,

 Protections intended to thwart organ trafficking may inadvertently also "protect" legitimate patients and donors from receiving life-saving medical care.

The Paradox of Protection: How Overregulation Threatens Living Kidney Donation in Mexico, by Francisco J. Reyna-Sepulveda and Javier Sanchez-Maldonado, Transplantation, Publish Ahead of Print, July 27, 2026. | DOI: 10.1097/TP.0000000000005860 

 

 

"Globally, unrelated and nondirected living kidney donations have become important mechanisms for expanding transplant access.1 Structured programs in the United States and Spain support unrelated donation through rigorous psychological evaluation, independent donor advocacy, and transparent oversight systems.3,4 For example, nondirected donors serve as critical initiators of kidney paired donation chains, substantially amplifying transplant opportunities beyond a single donor-recipient pair.3-5 However, a recent regulatory shift in Mexico threatens to effectively preclude these pathways in practice, leaving living kidney donors (including living liver donors) with genuine altruistic intent declined and vulnerable patients losing critical access to life-saving transplants.

"WHEN ALTRUISM REQUIRES PROOF
"On August 4, 2023, the National Transplant Center and the Federal Commission for Protection against Health Risks issued a High Health Directive (Alta Directiva Sanitaria), establishing mandatory standardized protocols for Mexican transplant centers.6 This directive emerged in response to well-documented regional concerns regarding organ trafficking, transplant tourism, regulatory gaps, and the “legal simulation” of donor-recipient relationships. These concerns are entirely legitimate and align with the principles articulated by the Declaration of Istanbul on Organ Trafficking and Transplant Tourism.7 

...

"Although the directive does not explicitly outlaw nondirected donation, its evidentiary requirements effectively preclude it at the committee level. As a result, viable donor candidates may be categorically declined for regulatory rather than medical reasons.  

...

"Although data isolating the exact proportion of donor evaluations declined solely for documentation rather than medical or psychosocial factors are currently unavailable, Mexican National Registry data highlight a concerning sign.9 During the 12 mo preceding the directive’s publication, 438 unrelated living donor kidney transplants were performed nationally, compared with 354 during the subsequent 12 mo—a 19% decline. " 

...

"This directive severely limits Mexico’s potential to establish domestic paired-exchange networks or participate in cross-border paired kidney exchanges. The Global Kidney Exchange model, for instance, incorporates pairs from middle-income countries into US-initiated chains to overcome financial and immunological barriers.10 This approach has been accompanied by ethical discussion in the transplant literature, particularly regarding concerns about potential inducements and unintended exploitation.10" 

...

"Ultimately, the critical question is not whether expanding living kidney donation should be permitted, but whether a transplant system can be considered ethically complete if a viable living kidney donor candidate is categorically declined for regulatory rather than medical reasons." 

Civil society, state and market by Bowles and Carlin in Annual Review of Economics

 Sam Bowles and Wendy Carlin propose that we should think of civil society as the third leg in regulating economic life, along with government and markets. (They use kidney exchange as an example to indicate what they mean.) 

The Governance Triangle: Economic interactions in civil society, the state, and the market, Bowles, Samuel; Carlin, Wendy; (2026), Annual Review of Economics. 

"Abstract: Interactions in civil society – in firms, families, neighborhoods, identity groups, and other face-to-face settings – have in common that relationships are personal and enduring, and as a result, identity and other-regarding preferences are important motivations (for better or worse). Here we add civil society to markets and states as a third form of governance of the economy, creating the governance triangle. We provide evidence that themes related to civil society have assumed substantially greater importance in economic research since the 1970s. We use a standard principal-agent model of employment in private firms to reveal three characteristics of interactions in civil society: the role of face-to-face interactions, social norms, and the private exercise of power. We show that market failures and other coordination problems can sometimes be more successfully addressed by civil society than by state or market governance. Civil society may have comparative institutional advantage where information available to state and market actors is limited, restricting the reach of complete contracts and enforceable government regulations, conditional on conflicts of interest being modest. When based on us-versus-them forms of identity, however, civil society governance may promote preferences antithetical to a liberal and democratic society." 

 

 

"To illustrate the meaning of points in the triangle, we have placed the kidney exchange model proposed by Alvin Roth and his collaborators (the red dot) in the governance triangle ((Roth et al 2006).) They designed a mechanism connecting those needing a kidney replacement to altruistic donors of kidneys. Such donors are most often an immediate family member of someone whose kidney is not a match for their loved-one needing the transplant. Roth’s algorithm enables long chains of unrelated matched donors and recipients, thereby widening access to transplants because they do not have to be conducted bilaterally (the donor giving to a particular match) and contemporaneously.

"As an illustration of the nexus of synergistic institutions in the triangle, we represent the kidney donor mechanism, the red point, by a weight of 0.3 on the state (which regulates the exchanges, including prohibiting sales), 0.2 on the market (which provides associated medical services), and 0.5 on civil society (for the centrality of altruistic and ethical motivations underlying the initial contribution of the kidney.)... By relating the characteristics of behaviour and the allocation mechanisms involved to the three pure types, other institutions and policies can be located inside the triangle."

########

Note that this representation in a triangle is in a barycentric coordinate system, which has only become a readily recognizable tool in various applications in economics in the last half century or so.  Wikipedia dates their introduction to 1827.

Regulation after a first occurrence : Cornell bans students from skinning bears in a dormitory kitchen

 It turns out that Cornell had no rule preventing students from skinning bears in a communal dormitory kitchen.  But now they do. (A lot of regulation works like that... keep an eye on AI...)

Students Skinned a Bear in a Dorm. Cornell Realized It Should Ban That.
After two Cornell University students skinned a black bear in a communal kitchen last year to make a meal, the school changed the rules.  By Miles G. Cohen

Sports Betting, Prediction Markets, and ‘Repugnant Transactions’--a conversation at Covers.com

 I was recently interviewed at the gambling hyper-site Covers.com about the growth of sports gambling both on dedicated sites and on prediction markets.

A Nobel Laureate Talks Sports Betting, Prediction Markets, and ‘Repugnant Transactions’ by Geoff Zochodne -  "Nobel Prize-winning economist Alvin E. Roth has published a new book that can help put the raging debates about sports betting into a very relatable context." 

"It’s not often, or ever, you see a Nobel Laureate writing about his ties to match-fixing. 

That is until you see Nobel Prize-winning economist Alvin E. Roth writing in his new book that he feels “a certain connection” to point-shaving. It's just for reasons that have less to do with economics or match-manipulation and more because of a shared name.

Another Alvin Roth, nicknamed "Fats," was banned from the NBA because of a college basketball point-shaving scandal that came to light in the early 1950s.

“He (Fats) was also sentenced to jail, but a judge permitted him to join the army instead,” Roth writes in his recently released book “Moral Economics: From Prostitution to Organ Sales, What Controversial Transactions Reveal About How Markets Work.”   

...

Roth spoke to Covers over the phone recently about his book and his framework for approaching “repugnant transactions,” which, yes, can include sports betting. 

“Remember that when I say something is repugnant, I don't mean that I don't like it or that you shouldn't like it,” Roth said. “I mean that some people don't like it, and I think that gambling falls squarely into that category. Lots of people like to gamble, and lots of people, other people, think they shouldn't be allowed to, so it's a repugnant transaction, and there have been laws of all sorts allowing or banning it. And we've gone back and forth with the United States on lotteries, and more recently on sports betting.”  

...

“I fear that online gambling will have much to teach us about addiction,” Roth writes.  

...

Again, gambling is not the focus of Roth’s work. Nor are prediction markets, which critics often describe as a new form of gambling. Yet Roth says one of the things he writes about is that it is hard to ban something in a given jurisdiction when it’s legally available and within reach in another jurisdiction.

“And, of course, the internet makes everybody a neighbor to everybody else,” Roth says. 

In other words, the fact that prediction markets have popped up offering de facto sports wagering in states that have yet to legalize sports betting is not some new phenomenon. It’s all in keeping with society’s ongoing tug-of-war with morally contested markets. You can ban, you can regulate, but somebody will probably be unhappy in the end with what you’ve done and may still seek out what you’ve forbidden or restricted.  

The moral economics of prediction markets, in the NYT

 As part of it's Dealbook feature, the NYT yesterday included this conversation about The moral economics of prediction markets

"The economist Al Roth, a professor at Stanford University, shared a 2012 Nobel Prize for his work in market design and matching theory. He spoke with Sarah Kessler about his latest book, “Moral Economics,” which offers a framework for understanding controversial markets, and how it applies to prediction markets. The conversation has been edited and condensed.

Your book explores what you call repugnant markets — meaning some people don’t think they should exist — like prostitution, surrogacy and drugs. How do prediction markets fit in?

When I think about repugnance and prediction markets, I think back to when Darpa proposed a policy prediction market that became characterized as a terrorist prediction market, and people really objected to that.

That objection was sort of misplaced. It would be great if terrorists who were planning attacks wanted to tip their hand by betting on them in advance. But also, if you were a terrorist who knew about the 9/11 attacks in 2001, and you wanted to make money, you wouldn’t bet on a prediction market. You would short United Airlines and American Airlines.

What do you make of all the reports of insider trading on prediction markets?

The reason we forbid insider trading in securities markets is to give people confidence in them. Securities markets have an important financial function that is threatened by insider trading, and I’m not sure that prediction markets necessarily do.

What worries me about the current state of prediction markets and Washington insiders is more the blurring of private and public functions. I don’t think that being an associate of the president should allow you to bet on a Truth Social post by President Trump. That is very bad public policy, but not necessarily an indictment of prediction markets per se.

Do you have an opinion on whether prediction markets should be regulated by the C.F.T.C. or state gambling authorities?

Futures markets, like securities markets in general, play other roles in society. If you’re a farmer who’s growing wheat, a futures market allows you to sell your wheat before you’ve planted it, which allows you to buy the fertilizer and make plans. That’s one role for federal regulators.

The contract has a delivery date. It says on a certain day a freight car is going to deliver potatoes to me. If, for example, someone tried to corner the potato market by reserving all the freight cars so that you wouldn’t be able to deliver on the contract, the regulator could intervene.
With prediction markets, there’s nothing that has to be delivered. It’s just that someone has to adjudicate whether the bet was a yes or a no. That requires maybe some kind of regulation, but that seems more like a customer relations thing.

Is there anything that you would change about the design of prediction markets?

I have some ideas about what we can do about gambling and addiction. An appropriate regulator or consumer protection agency could start to require that apps allow you to put a limit on your betting.

Before the game starts, you can say to the app: When I’ve lost a hundred dollars, shut down. Don’t let me make any more bets.

And that might help some people just the way bartenders are supposed to stop serving you if you’ve had too much to drink. "

How to regulate legal marijuana?

 The New York Times editorial board thinks about the current environment for (now legal) marijuana, and calls for more careful regulation, and federal taxation:

It’s Time for America to Admit That It Has a Marijuana Problem 

"Thirteen years ago, no state allowed marijuana for recreational purposes. Today, most Americans live in a state that allows them to buy and smoke a joint. President Trump continued the trend toward legalization in December by loosening federal restrictions.

This editorial board has long supported marijuana legalization. In 2014, we published a six-part series that compared the federal marijuana ban to alcohol prohibition and argued for repeal. Much of what we wrote then holds up — but not all of it does.

At the time, supporters of legalization predicted that it would bring few downsides. In our editorials, we described marijuana addiction and dependence as “relatively minor problems.” Many advocates went further and claimed that marijuana was a harmless drug that might even bring net health benefits. They also said that legalization might not lead to greater use.

 

It is now clear that many of these predictions were wrong. Legalization has led to much more use. Surveys suggest that about 18 million people in the United States have used marijuana almost daily (or about five times a week) in recent years. That was up from around six million in 2012 and less than one million in 1992. More Americans now use marijuana daily than alcohol. 

...

"The unfortunate truth is that the loosening of marijuana policies — especially the decision to legalize pot without adequately regulating it — has led to worse outcomes than many Americans expected. It is time to acknowledge reality and change course." 

 

Transplant problems and public support for organ donation

 The Kidney Transplant Collaborative is worried about the status of kidney transplants in the US.  Here's the statement they published this month, which expresses concern about a drop in deceased donations.

LOSING TRANSPLANTS FOR ALL THE WRONG REASONS: A STATISTICAL ANALYSIS OF THE REDUCTION IN KIDNEY TRANSPLANTS IN RESPONSE TO REPORTS OF OPO FAILURES

"The kidney transplant waitlist has long exceeded the supply of available kidney organs. The waitlist today includes more than 94,000 Americans, with more than 28,000 deceased and living kidney transplants occurring in 2025. Even more troubling, recent events seem to have led to a decline in overall kidney transplants from 2024 to 2025, driven by a decline in deceased donor transplants. This represents the first time in the 21st century that we see an annual isolated decline in deceased donations and deceased donor kidney transplants, even while living donor kidney transplants increase and the kidney discard rate declines, the latter reflecting increased use of available deceased donor kidneys.

...

"What has caused this unprecedented and isolated decline in deceased kidney donations? While policymakers have been appropriately focused on maintaining the integrity of the
deceased donor process, an unanticipated effect of recent oversight efforts of the kidney transplant system and accompanying negative media reports has shaken the deceased donor
landscape and may have possibly caused the reduction in deceased donor rates. Given this emerging trend, the importance of increasing living donation has come into even sharper focus. Policymakers and all stakeholders in the kidney transplant process will need to focus on the impact of the recent oversight efforts and take clear measures to responsibly increase kidney transplant rates, most likely via a focus on living kidney donor supportive policy.

...

"Unreported until now, however, is the negative impact that this recent Congressional focus may be having on kidney transplant levels themselves. The impact is measurable – from 2024 to 2025, there were 116 fewer kidney transplants. This is due to 218 fewer deceased donor kidney transplants and an increase of 102 living donor kidney transplants for 2025 as compared to 2024 – the first time this century that there appears to be an isolated decline of deceased kidney donations driving the decrease in overall kidney transplants.

...

"Recent, highly publicized revelations involving OPOs have had a serious and harmful effect on public trust in organ donation. As a result, fewer individuals and families appear willing to consent to organ donation after death. Data from the OPTN Transplant Metrics National Dashboard shows that the number of kidneys recovered from deceased donors remained steady during the first half of 2025. However, beginning in June 2025, the number of deceased donors began to decline, and that decline has continued to accelerate. In 2025, a total of 15,274 deceased donors underwent kidney recovery, compared to 15,937 during 2024 for a net percentage change of negative 4.2%."

HT: Martha Gershun
 

 

Surrogacy stories (state regulators, take note)

 Surrogacy in the U.S. has become well established, with commercial surrogacy legal in almost all US states.  But problems sometimes occur, often of a financial nature, which suggest that in many places the regulatory oversight is still insufficient. (It's natural new regulations should be applied to newish markets as they experience fixable problems...)

Here are three recent stories that I recommend to the attention of regulators. 

WSJ:

Surrogacy Is a Multibillion-Dollar Business—but Surrogates Can Be Left With Big Debts
Booming fertility industry, a new target of private-equity and other investors, is largely unregulated, leaving the women giving birth with few financial or legal protections  By  Katherine Long

 

NBC

 How a top-tier surrogacy agency became an FBI target
Dozens of clients and surrogates were left panicked and in the dark after the agency’s owner seemingly disappeared. One intended parent, Mariana Klaveno, is missing $66,000. By Kenzi Abou-Sabe, Alexandra Chaidez, Liz Kreutz and Andrew Blankstein

 

NYT:

A Surrogacy Firm Told Parents-to-Be Their Money Was Safe. Suddenly, It Vanished.
Surro Connections held itself out as a reliable business. Now, clients have lost as much as tens of thousands of dollars meant to compensate women carrying their pregnancies.  
By Sarah Kliff

Surrogacy, and escrow accounts

 Surrogacy contracts involve a long term relationship, focused on a nine month pregnancy.  So commercial surrogacy depends on secure financial arrangements, which generally require funds to be held in escrow.  The WSJ article below documents that these escrow accounts are insufficiently regulated in some states, which can cause serious problems for surrogates and intended parents when the account holders are dishonest or careless.

Surrogacy Is a Multibillion-Dollar Business. Sometimes the Money Goes Missing.  "The growing industry has little regulation and many cases of financial abuse; escrow funds taken to pay gambling debts, buy bitcoin." By Ben Foldy
 

"Escrow companies, used in the majority of surrogacies, can handle millions of client dollars with almost no oversight, according to a Wall Street Journal review of court filings and interviews with parents and surrogates.

...

"The lack of regulation means that parents and surrogates frequently have little legal recourse and dim hopes of recovering lost funds. Already-pregnant surrogates must carry through with labor that they know they may not be paid for, while potentially being on the hook for medical bills they may not be able to afford. Parents face the prospect of messy litigation from unpaid surrogates. One couple whose surrogacy funds disappeared due to fraud before they were able to successfully transfer an embryo said they gave up hope for a pregnancy.

“Holding other people’s money is usually such a highly regulated industry,” said Andrew Bluebond, an attorney in Texas who helped Gallozzi look into what happened at SEAM. The surrogacy community’s relatively small size and intimate domain, Bluebond said, fostered a false sense of financial security.

“Rather than using the safeguards other industries use, they let their trust betray them,” he said. 

...

"Surrogacy has exploded into a multibillion-dollar industry, driven by increasing rates of infertility, expanded insurance coverage, the growing prevalence of LGBTQ families and an influx of couples from countries where the practice is illegal, including China. Last week, President Trump announced a deal aimed at lowering the price of medications used in IVF. 

There were around 10,850 transfers of embryos to surrogates in the U.S. in 2023 involving clinics reporting to the Society for Assisted Reproductive Technology, which says it represents clinics that perform around 95% of all procedures. That was up from 8,461 in 2021. The group’s data and other analyses expect an annual growth rate of about 15% over the coming years. About half of those embryo transfers resulted in successful deliveries.

Despite the growth, there are no federal laws regulating the financial or other aspects of surrogate pregnancies, and the practice is subject to a patchwork of state regulations. In Louisiana, for example, compensating surrogates is outlawed entirely. In a handful of other states, the contracts that often accompany surrogacy arrangements are legally unenforceable. 

...

"Last month, the nonprofit Society for Ethics in Egg Donation and Surrogacy, which functions as a kind of industry best-practices group in lieu of regulation, passed new guidelines for escrow accounts, although they have no binding power. The suggestions recommend escrow providers have relevant credentials, are subject to audits by certified accountants and have more than $10 million in bond coverage. " 

 

Regulating markets for antiquities, to more effectively compete with black markets (Kremer and Wilkening in JEP)

 Bans on illegally recovering, selling, and exporting archeological antiquities often result in black markets.  Michael Kremer and Tom Wilkening explore how markets might be regulated to be more effective.

Kremer, Michael, and Tom Wilkening. 2025. "Protecting Antiquities: A Role for Long-Term Leases?" Journal of Economic Perspectives 39 (3): 127–48. 

Abstract: In order to preserve cultural patrimony for future generations, most countries ban exports of antiquities. However, this may drive trade underground, particularly in low-income and low-state capacity contexts, and cause irreversible damage to cultural heritage. We argue that complementing export bans with fixed-duration, long-term leases can strengthen incentives for maintenance and revelation of antiquities, while preserving cultural patrimony. Allowing only leases rather than sales limits potential losses from corrupt deals between foreign collectors and government officials. Standardized contracts with set lease lengths, insurance requirements, and care requirements may also be necessary to limit corruption and establish a well-functioning market.

Market design podcast on NPR's Planet Money (with Alex Teytelboym)

 Alex Teytelboym comments throughout a program about market design on NPR's Planet Money:

 The episode focuses on the design of markets regulated by governments, and  touch on the regulation of fisheries, and on the spectrum incentive auction (about which they interviewed Glen Weyl instead of Paul Milgrom).

##########

Earlier related posts:

Monday, February 16, 2009  Sustainable fisheries

Sunday, January 30, 2011  Fishing as an endangered but protected transaction

Tuesday, July 24, 2018  Design of fisheries--EURO Excellence in Practice Award to Bichler, Ferrell, Fux, and Goeree

Friday, July 9, 2021 Fishery regulation involves onboard observers at sea--a very dangerous job

 ##########

 Monday, March 9, 2020 Paul Milgrom et al. on the incentive auction--two recent papers, and two pictures

 Monday, June 15, 2020  Paul Milgrom corrects the record on spectrum auctions and market design

 

 

 

 

The science and politics of vaping in the U.S

 The Washington Post has the story:

FDA lets Juul market vapes in the U.S. three years after trying to ban them
Federal regulators first announced a ban of Juul products in 2022, although a court order allowed them to stay on store shelves while the company filed an appeal.  By David Ovalle and Shannon Najmabadi
 

"The Food and Drug Administration has authorized Juul Labs to market its electronic cigarettes, years after the agency tried to ban the company’s products amid outcry over its role in fueling the popularity of vapes among young people.

"The agency, after reviewing scientific data provided by the company, concluded that Juul’s electronic cigarette device and refillable cartridges in tobacco and menthol flavors can help adult cigarette users reduce smoking or switch to less harmful products, outweighing the risk to youth.

...

"The news comes a few days after the Vapor Technology Association, an industry group, said it launched a seven-figure ad campaign urging President Donald Trump to draw a distinction between vape products targeting youths and “safer, adult-focused alternatives” touted as smoking-cessation tools. Trump previously offered enthusiastic support for vaping and promised to protect the industry while campaigning in 2024.

...

"A 2024 Centers for Disease Control and Prevention survey found vapes were the most common tobacco product used by middle- and high-schoolers. About 1.6 million students use electronic cigarettes, according to the survey — and nearly 90 percent of those who vape prefer the flavored liquids, the survey reported.

Thursday’s Juul decision drew immediate outcry from public health groups that assert vapes are addictive and can harm the development of maturing brains."

Organ donation after circulatory death: the NYT recounts some disturbing cases

 The NYT has a disturbing story this morning about organ donation after circulatory death. These are cases in which a decision has been made to remove the patient from a ventilator, in anticipation that they are irreversibly dying.  If death (via cessation of heartbeat and breathing) occurs almost immediately after removal, the patient may still be a viable organ donor, and otherwise not.  Organ procurement organizations (OPOs) are not supposed to be involved until after death has been declared, but apparently in some small hospitals they get involved earlier, and have sometimes pressured physicians to proceed prematurely.

A Push for More Organ Transplants Is Putting Donors at Risk
People across the United States have endured rushed or premature attempts to remove their organs. Some were gasping, crying or showing other signs of life.  By Brian M. Rosenthal and Julie Tate, July 20, 2025

"Across the United States, an intricate system of hospitals, doctors and nonprofit donation coordinators carries out tens of thousands of lifesaving transplants each year. At every step, it relies on carefully calibrated protocols to protect both donors and recipients.
 

"But in recent years, as the system has pushed to increase transplants, a growing number of patients have endured premature or bungled attempts to retrieve their organs. ...  a New York Times examination revealed a pattern of rushed decision-making that has prioritized the need for more organs over the safety of potential donors.

...

"Most donated organs in the United States come from people who are brain-dead — an irreversible state — and are kept on machines only to maintain their organs. Most donated organs in the United States come from people who are brain-dead — an irreversible state — and are kept on machines only to maintain their organs. Circulatory death donation is different. These patients are on life support, often in a coma. Their prognoses are more of a medical judgment call.

"They are alive, with some brain activity, but doctors have determined that they are near death and won’t recover. If relatives agree to donation, doctors withdraw life support and wait for the patient’s heart to stop. This has to happen within an hour or two for the organs to be considered viable. After the person is declared dead, surgeons go in.

"The Times found that some organ procurement organizations — the nonprofits in each state that have federal contracts to coordinate transplants — are aggressively pursuing circulatory death donors and pushing families and doctors toward surgery. Hospitals are responsible for patients up to the moment of death, but some are allowing procurement organizations to influence treatment decisions.

"Fifty-five medical workers in 19 states told The Times they had witnessed at least one disturbing case of donation after circulatory death.

"Workers in several states said they had seen coordinators persuading hospital clinicians to administer morphine, propofol and other drugs to hasten the death of potential donors.

...

"Circulatory death donation used to be largely forbidden. That began to change in the 1990s, when a dying patient asked the University of Pittsburgh Medical Center to remove her life support and donate her organs. The hospital honored her wishes, then spent two years creating guidelines for future cases. Use of the practice gradually spread.

"Procurement organizations attributed the procedure’s recent growth to technological advances. Dozens of employees at the organizations said it was largely because of government pressure.

"Citing the number of Americans waiting for organs, H.H.S. said in 2020 that it would begin grading procurement organizations on how many transplants they arranged. The department has threatened to end its contracts with groups performing below average, starting next year. Many have raised their numbers by pursuing more circulatory death donors."

Prolific sperm donation and incest risk in the Netherlands

 The Guardian has the story:

‘Medical calamity’: dozens of Dutch sperm donors fathered at least 25 children.  Discovery that clinics have been breaking rules raises genetic risks in such a small, densely populated country  by Jon Henley 

"At least 85 sperm donors in the Netherlands have fathered 25 or more children, the national gynaecology and obstetrics organisation has said, after a new registration system showed fertility clinics have been breaking existing rules on sperm donation for decades.

"The NVOG said on Monday that some clinics had deliberately used sperm batches more than 25 times, exchanged sperm without the necessary paperwork or donors’ knowledge, and allowed the same donors to donate sperm at multiple clinics.

“The number of so-called ‘mass donors’ should be zero,” gynaecologist Marieke Schoonenberg told the TV show Nieuwsuur. “On behalf of the whole profession, we wish to apologise. We didn’t do things as they should have been done.”

"A law aimed at reducing the risk of involuntary incest and inbreeding should have barred donors from fathering more than 25 children in the Netherlands since 1992, but proved difficult to enforce because of strict privacy laws.

"The limit was lowered to 12 in 2018, but the means to enforce it – a national register of donors and mothers with a code system ensuring sperm from the same donor cannot be used in more than 12 conceptions – came into force, retroactively, only in April.

“As a result, we now know, for the first time, the exact number of children per donor,” Schoonenberg said. Since 2004, when donors’ right to anonymity was lifted, the data showed there had been at least 85 “mass donors” (defined as at least 25 conceptions) in the Netherlands, she said.

"Most were biological father to between 26 and 40 children, Schoonenberg said, although several had between 50 and 75. Among them were at least 10 fertility doctors, including Jan Karbaat, who illegally fathered at least 81 children at his clinic.

"The most prolific donor was Jonathan Jacob Meijer, the subject of the Netflix documentary The Man with 1,000 Kids, who is known to have fathered at least 550 children worldwide. More than 100 of Meijer’s children were conceived in Dutch clinics.

"Ties van der Meer, of Stichting Donorkind, a foundation that helps children trace their donor fathers, said the findings were a “medical calamity”. The data meant there were probably at least 3,000 children in the Netherlands with 25 or more half-brothers and sisters, he said."

FDA Proposes Reducing Nicotine to Nonaddictive Level in Cigarettes: I see 5 possible futures

 Here's the FDA press release:

FDA Proposes Significant Step Toward Reducing Nicotine to Minimally or Nonaddictive Level in Cigarettes and Certain Other Combusted Tobacco Products
Agency Encourages Public Input on Proposal That Aims to Prevent Millions of Premature Deaths 

 " the U.S. Food and Drug Administration issued a proposed rule that, if finalized, would make cigarettes and certain other combusted tobacco products minimally or nonaddictive by limiting the level of nicotine in those products. If finalized, the United States would be the first country globally to take such a bold, life-saving action to prevent and reduce smoking-related disease and death. The FDA first announced its intent to propose such a ruleExternal Link Disclaimer in 2018, and today’s announcement is an important next step in the rulemaking processExternal Link Disclaimer. The agency intends to seek input on the proposal, including through public comment and the FDA’s Tobacco Products Scientific Advisory Committee"

#########

Here are some predictions of possible outcomes of this proposal.

1. (p>.5) No new regulation: We soon see Trump-branded, musk-flavored high-nicotine cigarettes.  (no lives saved)

Conditional on the proposals being enacted (i.e. p<.5)

2.  Cigarette makers find workarounds (nicotine supplements you can add to your smokes, new organic chemicals functionally equivalent to nicotine, etc. (few lives saved)

3. Black markets emerge: get your full-nicotine cigarettes at the same time you get your Mexican coca cola made with sugar instead of corn syrup. (some lives saved)

4. Smokers switch to non-combustables: Big Tobacco becomes Big vaping, chewing, and under-lip snus, snuff, and oral nicotine pouches. (maybe significant lives saved, but no decrease in nicotine addiction, and maybe substantial increase. Lung cancer down, oral cancers up.)

5. (low probability but we can hope): Smokers quit, and few young people start to smoke: tobacco use drops so low that deaths attributable to smoking drop below those attributable to alcohol or opioids.

Sports gambling presents problems for gamblers, athletes, and sports

 Sports betting has some potentially dire implications both for betters and for athletes and sports. Gamblers can find in-app gambling while the game is going on addictive."Prop" bets on the performance of particular athletes during the game, can also subject athletes to pressures that may be at odds with their incentives arising simply from the rules of the game. And this may open up sports to gambling and point-shaving scandals that have been vigorously suppressed in the past.

Here's a variety of headlines (in sufficient number that I won't summarize the accompanying stories, but you can click through to see them).

The Guardian:

‘A serious disease’: Congress weighs federal gambling crackdown amid growing concerns
With sports betting now legal in 38 states, experts worry that gambling addiction is on the rise  by Callum Jones 

NPR:

The president of the NCAA calls for a ban on 'prop bets' in college sports,  by Becky Sullivan
Becky Sullivan

The Atlantic:

Legalizing Sports Gambling Was a Huge Mistake. The evidence is convincing: The betting industry is ruining lives.  By Charles Fain Lehman

Paul Krugman's substack:

America the Addicted. Gambling — on sports, stocks and crypto — is the new opioids.  by Paul Krugman

Regulating emerging technologies

 Here's a recent RAND report, on the current diverse attempts to regulate emerging biotechnologies, focusing on organoids,* embryos, genes, and neurotechnology:

State-of-play and future trends on the development of oversight frameworks for emerging technologies
Part 2: Technology oversight report, by Sana Zakaria, Ioli Howard, Eva Coringrato, Anna Louise Todsen, Imogen Wade, Devika Kapoor, Alec Ross, Katarina Pisani, Chryssa Politi, Martin Szomszor, Salil Gunashekar, Dec 16, 2024 

"This RAND Europe study commissioned by Wellcome explores the current and future oversight frameworks for emerging technologies, focusing on organoids, human embryology, engineering biology and neurotechnology. 

...

"Key Findings:

Lack of specific frameworks for organoids

• There is an absence of specific regulatory frameworks for organoids, with current oversight relying on broader stem cell and biomedical regulations. Emerging mechanisms, such as Japan's consent-to-govern approach, are gaining traction to address ethical challenges, particularly around donor consent and privacy concerns.

Challenges in human embryology oversight

• Existing frameworks, like the UK's Human Fertilisation and Embryology Act, are outdated and not designed for new technologies such as AI in embryo selection. Disparate national regulations complicate international collaboration, and there is a need for frameworks to adapt to scientific advancements and public interest.

Fragmented oversight in engineering biology

• The global landscape features disparate oversight mechanisms, creating obstacles for international collaboration. There is a need for alignment across diverse applications and jurisdictions, with potential solutions including cross-sector collaboration and international biosecurity measures.

Neurotechnology oversight gaps

• Current regulations do not address the unique challenges posed by neurotechnologies, such as data privacy and dual-use concerns. Ethical guidelines, like Chile's neurorights, offer proactive models, but there is a need for stronger post-market surveillance and international guidelines to prevent misuse.

Priority considerations for future oversight

• The report outlines eight priority considerations, including developing interconnected oversight networks, ensuring equity, harmonizing international governance, fostering public involvement, and integrating adaptive and anticipatory strategies into oversight frameworks."
  

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* "Organoids are three-dimensional structures that are derived from stem cells and are capable of self-organising into structures that mimic the key functional, structural and biological complexity of an organ."

Regulating nicotine is a cat and mouse game

 Attempts to regulate (and tax) cigarettes and related nicotine-addicting products are a cat and mouse game. Many laws regulate "tobacco," "nicotine," or "flavorings," and all of these have close substitutes that might fall outside of the law, such as synthetic (non-tobacco) nicotines, and coolants other than menthol that might not be considered flavorings.  California legislators are amending laws to fill those gaps.

California’s Visionary Tobacco Bill—Will the FDA Follow?  by Sven E. Jordt, PhD1,2; Sairam V. Jabba, DVM, PhD, JAMA, 2024

"The state of California has been a consistent leader in tobacco control, with one of the lowest smoking rates in the nation. On September 28, 2024, Gavin Newsom, governor of California, signed Assembly Bill 3218, which will further strengthen tobacco control in the state.1 The signed legislation will close 2 loopholes left open by California’s 2022 legislation that restricts sales of most flavored tobacco products, including menthol cigarettes and youth-appealing flavored e-cigarettes. The tobacco industry immediately exploited these loopholes to continue selling flavored tobacco products in the state. Similar loopholes remain in the legislation of other states and in federal regulations. Are other states and the US Food and Drug Administration (FDA) set to follow California’s example, or will California’s advance result in an even wider divide in tobacco control in the US?

...

"The tobacco industry argued that California’s flavor ban does not apply to non-menthol cigarettes because the cooling sensations imparted by odorless cooling agents do not represent a banned “characterizing flavor,” meaning a distinguishable taste, aroma, or both. However, current scientific definitions of the term flavor, also adopted by the flavor chemical industry, include the entire range of sensations perceived during product consumption, including physical traits such as cooling sensations.4 In California’s new bill, legislators adopted this definition, clarifying the term characterizing flavor to include “a cooling sensation distinguishable by an ordinary consumer during the consumption of a tobacco product.”

...

"The second loophole addressed by California’s new bill pertains to emerging e-cigarette products in which nicotine is replaced with chemical analogues such as 6-methyl nicotine.5,6 In both state and federal regulatory statutes, a tobacco product is narrowly defined as being derived from tobacco or nicotine. Manufacturers claim that this definition does not apply to products containing 6-methyl nicotine, because its chemical formula differs from that of nicotine. Manufacturers advertise that FDA review of their products is not required, flavor bans do not apply, and that the products are exempt from tobacco taxes, offering them in youth-appealing flavors such as rainbow fruit, blue razz ice, or strawberry apple lemon.5,6 California’s new legislation closes this loophole by extending the legal definition of nicotine, adding “and includes nicotinic alkaloids and nicotine analogs.”

New rules for evaluating transplant centers

 Historically, transplant centers ('hospitals') have been primarily evaluated on the one year graft survival on the transplants that they do.*  Now Medicare announces it will test a new model, that will emphasize the number of transplants conducted ("achievement"), in addition to somewhat less emphasis on the ratio of deceased donor kidneys accepted or rejected ("efficiency") and graft survival ("quality").

Medicare Program; Alternative Payment Model Updates and the Increasing Organ Transplant Access (IOTA) Model.  A Rule by the Centers for Medicare & Medicaid Services on 12/04/2024 

"a. Proposed IOTA Model Overview

"End-Stage Renal Disease (ESRD) is a medical condition in which a person's kidneys cease functioning on a permanent basis, leading to the need for a regular course of long-term dialysis or a kidney transplant to maintain life.[2]

"The best treatment for most patients with kidney failure is kidney transplantation. Nearly 808,000 people in the United States are living with ESRD, with about 69 percent on dialysis and 31 percent with a kidney transplant.[3]

"Relative to dialysis, a kidney transplant can improve survival, reduce avoidable health care utilization and hospital acquired conditions, improve quality of life, and lower Medicare expenditures.[4 5]

"However, despite these benefits of kidney transplantation, evidence shows low rates of ESRD patients placed on kidney transplant hospitals' waitlists, a decline in living donors over the past 20 years, and underutilization of available donor kidneys, coupled with increasing rates of donor kidney discards, and wide variation in kidney offer acceptance rates and donor kidney discards by region and across kidney transplant hospitals.[6 7] 

...

"The IOTA Model will be a mandatory model that will begin on July 1, 2025, and end on June 30, 2031, resulting in a 6-year model performance period comprised of 6 individual performance years (“PYs”). The IOTA Model will test whether performance-based incentives paid to, or owed by, participating kidney transplant hospitals can increase access to kidney transplants for patients with ESRD, while preserving or enhancing quality of care and reducing Medicare expenditures. CMS will select kidney transplant hospitals to participate in the IOTA Model through the methodology proposed in section III.C.3.d of this final rule. As this will be a mandatory model, the selected kidney transplant hospitals will be required to participate. CMS will measure and assess the participating kidney transplant hospitals' performance during each PY across three performance domains: achievement, efficiency, and quality.

"The achievement domain will assess each participating kidney transplant hospital on the overall number of kidney transplants performed during a PY, relative to a participant-specific target. The efficiency domain will assess the kidney organ offer acceptance rate ratios of each participating kidney transplant hospital relative to a national ranking or the participating kidney transplant hospital's past organ offer acceptance rate ratio. The quality domain will assess the quality of care provided by the participating kidney transplant hospitals via a composite graft survival ratio. Each participating kidney transplant hospital's performance score across these three domains will determine its final performance score and corresponding amount for the upside risk payment that CMS would pay to the participating kidney transplant hospital, or the downside risk payment that would be owed by the participating kidney transplant hospital to CMS. The upside risk payment will be a lump sum payment paid by CMS after the end of a PY to a participating kidney transplant hospital with a final performance score of 60 or greater. Conversely, beginning in PY 2, the downside risk payment will be a lump sum payment paid to CMS by any participating kidney transplant hospital with a final performance score of 40 or lower. There is no downside risk payment for PY 1 of the model.

...

"The three performance domains will include: (1) an achievement domain worth up to 60 points, (2) an efficiency domain worth up to 20 points, and (3) a quality domain worth up to 20 points.

"The achievement domain will assess the number of kidney transplants performed by each IOTA participant for attributed patients, with performance on this domain worth up to 60 points. The final performance score will be heavily weighted on the achievement domain to align with the IOTA Model's goal to increase access to kidney transplants to improve the quality of care and reduce Medicare expenditures. The IOTA Model theorizes that improvement activities, including those aimed at reducing unnecessary deceased donor discards and increasing living donors, may help increase access to kidney transplants."

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CMS gives a high level overview here: Increasing Organ Transplant Access (IOTA) Model

and later today there's a webinar you can register for:

"The CMS Innovation Center will be hosting a welcome webinar to present an overview of the model on December 18, 2024, from 2 to 3 p.m. ET. Register to attend: https://cms.zoomgov.com/webinar/register/WN_hvGDyZTxQ5eNhX1OBolevA
 

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*see Wednesday, October 2, 2024 Regulation of Organ Transplantation and Procurement (Chan and Roth in the JPE)

That paper suggests desirable regulations  would coordinate transplant and OPO incentives, and link them both to the health outcomes of all patients attributable to a given transplant center (and not just those patients who were transplanted). 

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quick update (from the Q&A following the webinar): 

this is viewed as an experiment on roughly half the transplant centers, but there isn't currently a commitment about what to do after the projected 6 years of the experiment.

. all transplant patients are considered, but payments are only for Medicare fee for service patients

achievement: . each center's target for annual transplants will be it's average number over the three years ending a year before the beginning of the experiment...(at least that was the answer for the first year).

    . both deceased and living donor outcomes will be included in the achievement metric.

quality: .the first year will consider one-year graft survival, and year n will consider graft survival for the first n years.

OPOs: there are no requirements for OPOs within the IOTA model 

risk adjustment: not for year 1, they are hoping to have risk adjustment measures in subsequent years.

.