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."

###########

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
 

########

*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). 

#########

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.

. 

The market for (ethical) pornography

 Will regulation, lawsuits and competition for creators increase the supply of ethical porn?

Wired has the story:

The Sticky Dilemmas of Pornhub’s Next Chapter
Videos of minors. Illegal data collection. Lack of oversight. Lawsuits. Problems have dogged the popular porn site for years. Is its promise of transparency enough for a reset? By Jason Parham

"Kekesi empathized with the performers. It’s part of her job. As vice president of brand and community at Pornhub, the monstrously popular adult entertainment site, she puts in plenty of face time with creators, as well as fans of the platform, the press, and critics. 

...

"She was thrust into the role in 2023, following a particularly turbulent period for the company. On some level, Pornhub has always been controversial—it comes with the territory—but the problems of the platform in recent years represented an existential threat.

"Rumblings began in 2019, when the owners of the GirlsDoPorn and GirlsDoToys websites were charged in a sex trafficking conspiracy for deceiving and forcing women to perform in adult films, which they then uploaded online, including to platforms like Pornhub. In March 2020, Senator Ben Sasse of Nebraska urged the US Department of Justice to open an investigation into Pornhub, citing incidents from “the past year,” including the GirlsDoPorn case. A New York Times column by Nicholas Kristoff that December brought even more attention to accusations that Pornhub hosted videos depicting sexual abuse, including of children. At first Pornhub denied any wrongdoing, but reaction swiftly snowballed.

"In Canada, where Pornhub is based, a parliamentary committee launched an investigation into the allegations. Visa and Mastercard suspended payment processing. Dozens of women sued Pornhub’s parent company, then called MindGeek and since renamed Aylo Holdings, alleging it had created and profited from a “bustling marketplace for child pornography, rape videos, trafficked videos, and every other form of nonconsensual content.”

...

"Pornhub has taken steps to address at least some of these problems. Following the Times article, it scrubbed the site of all “unverified content,” Kekesi said. Now anyone who wants to upload content to Pornhub has to not only verify their own identity; they also must supply proof of consent for everyone who appears in the scene, including documentation, IDs, and other paperwork. Pornhub also started issuing annual “transparency reports,” which it now does twice a year, publishing its content moderation practices. 

...

"Already, 12 US states have instituted age-verification laws around porn consumption. Because PornHub doesn’t want to open itself to litigation under these new laws, it went on the offensive, blocking all access to its site in those states regardless of age.

...

"In general, though, porn is more accessible than ever. Platforms like OnlyFans customize desire for a small fee. The riskier side of the social media site X operates in the vein of the former Backpage.com, where creators use the app to promote their work, engage with fans, and find gigs. That has also meant more competition for Pornhub. Kekesi never says it outright, but this is likely why the company has made a noticeable effort to appease the concerns of adult creators. “We are catching up and trying to be more visible and more present with the creator community,” she said."

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.

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“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.

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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."