Arguments against paying for plasma and other Substances of Human Origin (SoHO)

 Substances of Human Origin (SoHO) have a growing, often lifesaving role in modern medicine, from breast milk for premature babies, to kidneys for transplant, to blood and blood plasma, which the World Health Organization categorizes as an essential medicine for a wide variety of ailments and injuries.  However concern for protecting the donors of SoHO from exploitation has led to a considerable debate about whether donation must always be uncompensated, and motivated purely by altruism.
 

Two important cases are donation of kidneys and of blood plasma. Payment to donors of kidneys for transplant is banned almost everywhere, but a few countries (among which the U.S. is prominent) allow payment to plasma donors. Kidneys are in short supply, so patients with kidney failure very often die prematurely without receiving a transplant, but among high and middle income countries almost no one is today dying from a shortage of plasma and plasma products.  That isn’t because countries that don’t pay plasma donors generate sufficient supply for their domestic needs, it is because they can import plasma pharmaceuticals from countries that do pay donors, chiefly the U.S. which exports tens of billions of dollars of plasma products annually.
 

Here's an article arguing that payment for plasma and other SoHOs is always and everywhere wrong and should be stopped. (The  authors seem to agree with the WHO that countries should raise enough plasma domestically from unpaid donors, although no country has yet managed to do this.)  Furthermore, they suggest that companies that collect and process plasma must be nonprofits.

Prevention of Trafficking in Organs, Tissues, and Cells by Martin, Dominique E. PhD1; Capron, Alexander M. LLB2; Fadhil, Riadh A. S. MD3; Forsythe, John L. R. MD4; Padilla, Benita MD5; Pérez-Blanco, Alicia PhD6; Van Assche, Kristof PhD7; Bengochea, Milka MD8; Cervantes, Lilia MD9; Forsberg, Anna PhD10; Gracious, Noble MD11,12; Herson, Marisa R. PhD1; Kazancioğlu, Rümeyza MD13; Müller, Thomas PhD14; Noël, Luc MD15; Trias, Esteve MD16; López-Fraga, Marta PhD17 Transplantation, October 22, 2024. | DOI: 10.1097/TP.0000000000005212
 

“It is essential that all national laws “concerning the donation and human application” of human organs, tissues, and cells, as well as all derived therapies, conform to the principle of financial neutrality, prohibiting financial gain in the human body or its parts.9,70 Healthcare professionals, service providers, and organ, cell, and tissue procurement organizations, as well as other industry stakeholders involved in processing, manufacture, storage, and distribution of SoHOs and SoHO-based therapies, are all entitled to “reasonable remuneration” for their work and coverage of the costs associated with various sector activities.66,71 However, what may be considered a reasonable and proportionate remuneration in this context is ill defined. There have been reports of service providers and professionals generating disproportionate profits from such activities, creating potential financial conflicts of interest in service provision and potentially violating ethical norms and legal standards prohibiting trade in SoHOs.30
 

“Development of innovative therapies using human cells and tissues has increased, with the potential therapeutic value of these resources spurring commercial interests that, in some cases, has led to practices in which donated SoHOs are treated as commodities.30,72–75 Furthermore, some SoHOs may undergo substantial processing, resulting in these therapies being regulated outside the regulatory framework governing the transplantation of organs, tissues, and cells as such, and rather being considered as medicines, where commercial profits are expected and guide the production and distribution activities.74,75
 

“Mechanisms should be developed to ensure that strategies used in donor recruitment, which may involve actual or perceived financial incentives, are routinely disclosed and open to scrutiny.70 Transparency of practice is also required to enable scrutiny of the fees charged to cover costs of procuring, processing, storing, manufacturing, and distributing cells, tissues, and SoHO-based therapies and to assess the potential influence of financial interests on decision-making about the use of SoHOs in particular SoHO-based therapies, or distribution of SoHO-based therapies.74 These measures would furthermore help to facilitate equitable access to treatments for all patients.21
…
Box 1, first recommendation
“Recommendations for action to prevent trafficking in SoHOs
•    1. All countries should establish laws that prohibit payment for donation of SoHOs, trafficking in SoHOs, and trafficking in human beings to obtain SoHOs.
o    a. Legislation should prohibit activities that make the human body or its parts a source of financial gain exceeding the recovery of the costs of obtaining, processing, storing, and distributing those parts or the products made from them and of ensuring the sustainability, safety, and quality of donation and transplantation systems.”

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They also suggest that there is widespread human trafficking in SoHO, although they acknowledge that there isn’t a lot of data to support this:

“since 2010, there have been few empirical studies of organ trafficking, with more recent studies often consisting of qualitative interviews or surveys with individuals who participated in organ trafficking or were victims of human trafficking for organ removal several years earlier.7,32,52 Legal case analyses have focused primarily on seminal cases that detail activities that occurred in the early 2000s.33,38 Much of what is known about current trafficking activities is gleaned from sporadic media reports, which make clear the global prevalence of organ trafficking.”

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Earlier:

Wednesday, August 28, 2024  WHO Says Countries Should Be Self-Sufficient In (Unremunerated) Organs And Blood, by Krawiec and Roth

Monday, April 22, 2024 Plasma donation in the EU: compensated and uncompensated

Saturday, November 4, 2023  The EU proposes strengthening bans on compensating donors of Substances of Human Origin (SoHOs)--op-ed in VoxEU by Ockenfels and Roth

Italy criminalizes surrogacy from abroad

 Italy has banned its citizens from accessing surrogacy in other countries where it is legal.  It will be interesting to see how they enforce this. (But of course gay couples will have fewer opportunities to skirt the law than couples who could pretend to have had a pregnancy..)

The NYT has the story:

Italy Criminalizes Surrogacy From Abroad, a Blow to Gay and Infertile Couples. The new law was pushed by the party of Giorgia Meloni, Italy’s conservative prime minister. by Emma Bubola

"Italy passed a law on Wednesday that criminalizes seeking surrogacy abroad, a move the country’s conservative government said would protect women’s dignity, while critics see it as yet another crackdown by the government on L.G.B.T. families, as the law will make it virtually impossible for gay fathers to have children.

"Surrogacy is already illegal in Italy. But the government of Prime Minister Giorgia Meloni has vowed to broaden the ban to punish Italians who seek it in countries where it is legal, like in parts of the United States."

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Earlier:

Thursday, August 22, 2024  Surrogacy under continued attack in Italy

Should fox hunters be a protected minority?

 The NYT reports on the question:

Fox Hunters in the U.K. Want Protected Status Under Discrimination Law. A lobbying group is preparing a bid to define hunting with animals as a protected belief. Many experts have questions.  By Amelia Nierenberg

"English fox hunters have tried, for years, to push back against a nearly 20-year-old ban on their beloved sport.

"The centuries-old tradition of using packs of dogs to chase and kill foxes — or any wild mammals — became illegal in England in 2005, after a long parliamentary struggle driven by campaigners and lawmakers who opposed it on animal welfare grounds.

"So far, the law has stood, and fox hunting remains hugely unpopular among the general public: 80 percent of people in Britain think it should remain illegal, according to YouGov, a polling company.

"Now, a pro-hunting activist has a new plan of attack.

"Ed Swales, the activist, founded Hunting Kind, a lobby group that aims to protect hunting with dogs and other forms of hunting, in early 2022. He wants to use Britain’s Equality Act — which protects people from discrimination because of their age, race, sexuality or religion, among other things — to classify a pro-hunting stance as a protected belief.

...

“We’ve been doing this for millennia,” he said. Hunting is “literally part of our cultural heritage.”

"Hunting itself is not illegal in England. Shooting deer, rabbits, duck and some other animals is allowed during hunting seasons, with permission from the landowner and a gun license.

...

"Last year, Chief Superintendent Matt Longman, England’s police lead on fox hunting, said that illegal hunting was “still common practice,” with trail hunts frequently taking place in natural fox habitats.

...

"In 2007, a belief in fox hunting was explicitly denied protection in Scotland’s courts, where a judge found that “a person’s belief in his right to engage in an activity which he carries on for pleasure or recreation, however fervent or passionate,” did not compare to protected beliefs or religion, and therefore would not be covered under human rights law.

"And in 2009, the European Court of Human Rights unanimously ruled that the ban on fox hunting with dogs did not violate human rights."

Black markets in everything bagels (in S. Korea)

 South Korea is not a hub of everything bagels, it turns out. In fact they are banned.

The NYT has the story:

Why Everything Bagel Seasoning Was Banned in South Korea. The seasoning is sold by Trader Joe’s, a brand whose popularity has skyrocketed in the region in recent years.By Eve Sampson

"Food containing poppy seeds, “including popular bagel seasoning blends,” is considered contraband in South Korea, according to the U.S. Embassy, making the coveted topping a forbidden treat.

...

"As more travelers have tried to bring the popular seasoning mix into South Korea, local news and social media sites have reported in recent weeks on an increase in confiscations at airports.

"Poppy seeds are not opiates but may be contaminated by the plant’s fluid, which contains opiates, when they are harvested. 

...

"In South Korea, poppy seeds are banned because they are considered a narcotic.

...

"South Korea is among the few countries with laws regulating poppy seeds. The United Arab Emirates bans the seed, and Singapore requires anyone wishing to import poppy seeds to submit a sample for opiate testing.

"In the United States, there has also been mixed messaging about poppy seeds. In 2023, the Department of Defense warned members of the military that eating poppy seeds could result in a positive drug test, despite the military previously feeding service members poppy seed breads in ready-to-eat meals."

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."

Participating in the Haj through the black market

 Saudi Arabia is a bit more open to tourism than it used to be, and that may be making it easier for black market operators to bring pilgrims on the Haj to Mecca without paying the required fees and getting the customary accomodations.

The NYT has the story:

Pilgrim Deaths in Mecca Put Spotlight on Underworld Hajj Industry  Most of the more than 1,300 people who died making the Islamic pilgrimage were not formally registered, a Saudi official said. That left them with little access to protection from the brutal heat.  By Emad Mekay and Vivian Nereim

"The deaths of more than a thousand pilgrims in Saudi Arabia for the hajj have put a spotlight on an underworld of illicit tour operators, smugglers and swindlers who profit off Muslims desperate to meet their religious duty to travel to Mecca.

"While registered pilgrims are transported around the shrines in air-conditioned buses and rest in air-conditioned tents, undocumented ones are often exposed to the elements, making them more vulnerable to extreme heat. 

...

"the Saudi health minister, Fahd al-Jalajel, said that 83 percent of the more than 1,300 deaths occurred among pilgrims who had not had official permits.

“The rise in temperatures during the hajj season represented a big challenge this year,” he said. “Unfortunately — and this is painful for all of us — those who didn’t have hajj permits walked long distances under the sun.”

...

"because so many of the pilgrims who died this year were performing the pilgrimage without official documentation, their deaths exposed the underworld of unlicensed tour operators, smugglers and swindlers who take advantage of pilgrims desperate to perform the hajj, helping them evade the regulations.

...

"In interviews with The New York Times, hajj tour operators, pilgrims and relatives of the dead said the number of undocumented pilgrims appeared to have been driven up by rising economic desperation in countries like Egypt and Jordan. An official hajj package can cost more than $5,000 or $10,000, depending on a pilgrim’s country of origin — far beyond the means of many hoping to make the trip.

"But they also described easily exploited loopholes in Saudi Arabia’s regulations that allowed undocumented pilgrims to travel to the kingdom with a tourist or visitor visa several weeks ahead of hajj. Once they arrive, they find a network of illegal brokers and smugglers who offer their services, take their money and sometimes abandon them to fend for themselves, they said."

Buying exit from Gaza

 It's hard to leave Gaza.

The NYT has the story:

When the Only Escape From War in Gaza Is to Buy a Way Out . For many Palestinians, securing approval to exit the territory is possible only after raising thousands of dollars to pay middlemen or an Egyptian company.  By Adam Rasgon

"The only way for almost all people in Gaza to escape the horrors of the war between Israel and Hamas is by leaving through neighboring Egypt.

"And that is usually a complicated and expensive ordeal, involving the payment of thousands of dollars to an Egyptian company that can get Palestinians on an approved travel list to cross the border.

...Over the past eight months, an estimated 100,000 people have left Gaza, Diab al-Louh, the Palestinian ambassador to Egypt, said in an interview. Though some managed to get out through connections to foreign organizations or governments, for many Gazans, exiting the territory is possible only by way of Hala, a firm that appears to be closely connected to the Egyptian government.

...

"Other pathways out of Gaza exist, but many of them require large payments, too. One route is to pay unofficial middlemen in the enclave or in Egypt, who demand $8,000 to $15,000 per person in exchange for arranging their departure within days, according to four Palestinians who either made the payments or tried to.

...

"Hala charges $5,000 to coordinate the exits of most people 16 and older and $2,500 for most who are below that age, according to seven people who have gone through this process or tried to do so."

Black markets for cigarettes in Gaza

 The WSJ has the story:

At $25 Each, Cigarettes Are Turning Gaza Aid Trucks Into Targets  By Stephen Kalin, Dov Lieber and Fatima AbdulKarim

"A group of Palestinian men approached a United Nations warehouse in central Gaza last week and demanded access to aid stored inside. The gang wasn’t interested in food, fuel or medicine. It wanted something it considered far more valuable: contraband cigarettes hidden in the humanitarian cargo.

"The incident, described by a U.N. official, is emblematic of a significant new impediment to aid deliveries in the enclave. Rampant cigarette smuggling—fueled by high prices for tobacco—has become the latest manifestation of a breakdown in law and order that is slowing the delivery of lifesaving assistance.

"Aid trucks and storage depots have become targets for Palestinian smugglers seeking to retrieve illicit smokes stashed inside shipments by their accomplices, say U.N. and Israeli officials. Other local criminals are also attacking vehicles they suspect have cigarettes hidden somewhere on board, they say.

"Cigarettes sell for as much as $25 apiece in isolated Gaza, so getting hold of even a pack can be enormously profitable.

...

"A second U.N. official said that on Tuesday, three armed men arrived at another U.N. warehouse in central Gaza, demanding to search through the aid. They found the cigarettes they were looking for in a box of aid. The Wall Street Journal viewed a picture of the box with a U.N. logo ripped open, exposing cartons of Karelia cigarettes inside.

“Cigarettes have become like the new gold in Gaza,” the official said."

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."

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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." 

Paying college athletes before it was legal

 Yesterday I blogged about the new NCAA rules on allowing college athletes to be paid: The ban on paying college athletes is history

It will no doubt shock you to learn that payments were made long before they were legal.  

The Guardian has a book review about that:

Hot Dog Money: behind the bribery scandal that rocked college basketball. A new book looks back at the federal investigation that found bribery and corruption within a major industry, by Andrew Lawrence, Tue 4 Jun 2024

"On 26 September 2018, 10 prominent US college sports figures were arrested in connection with a federal investigation into fraud and corruption. Specifically, the government alleged that business managers and financial advisers had bribed basketball coaches to secure business with NBA-bound players, and that a senior executive with Adidas had further conspired with them to funnel payments to high school players and their families in exchange for their commitment to Adidas-sponsored college sports programs.

"The scandal – which ensnared the top NBA draft pick Deandre Ayton, hall of fame coach Rick Pitino and Kobie Baker, the associate athletic director at Alabama, one of the country’s premier talent factories – was a black eye for the NCAA, the keystone cops who style themselves as virtuous defenders of amateurism in college sports while reaping billions off the backs of student-athletes, the majority of them Black and quite economically disadvantaged. The extent of the scheme wasn’t fully understood until one of the schemers, a middle-aged moneyman named Marty Blazer, was turned into an FBI informant. 

...

"Lawson’s latest nonfiction book, Hot Dog Money, is Blazer’s Goodfellas story – one largely told from Lawson’s one-on-one interviews with Blazer

...

"He was a mid-level financial adviser making six figures trading stocks and bonds with a client roster that slowly grew to include select members of the NFL’s Pittsburgh Steelers. The story of William “Tank” Black, the powerful football agent indicted for running a Ponzi scheme fueled with Detroit coke money, sparked Blazer’s larger ambitions.

"Blazer teamed up with an agent and recruited football players from Pennsylvania colleges with the aim of attaching himself to future pros. That’s where the “hot dog money” came in. Blazer didn’t just pass cash-filled envelopes under the table. He sent money home to players’ struggling families, supplied them with luxury cars, paid for lavish trips to Miami and Las Vegas, and comped their inevitable strip club binges. Sometimes he’d arrange to have girls flown in for parties closer to campus. “The girls are being trafficked, the kids are being trafficked,” says Lawson. “Forget morality, how do you even describe the decency of it all? This is what the swirling of a flushing toilet looks like.”

"In a typical hot dog money scheme, a college player receives cash in the form of a forgivable loan with the understanding that the bagman’s aboveboard services will be retained once the player turns pro; depending on the player, the bagman can make his money back many times over in boring management fees. A proudly devoted husband and father of three, Blazer was more interested in helping his clients make the most out of a corrupt system and went the extra mile to look out for them, paying for information that could help clients avert potential disaster.

Proposed age-adjusted smoking ban in the U.K.

 The BBC has the story, about a proposal to ban smoking for everyone currently under the age of 18. (What could go wrong?)

What is the UK smoking ban, how will it work and when will it start? By Aurelia Foster, BBC News

"Prime Minister Rishi Sunak effectively wants to ban smoking in the UK.

MPs have voted to back the government's plans to create a "smoke-free generation", and reduce the number of smoking-related deaths.

What is the smoking ban?

The restrictions will apply to the sale of cigarettes in the UK rather than the act of smoking itself.

Under the new law, each year the legal age for cigarette sales - currently 18 - will increase by one year.

It means that people born in or after 2009 will never be able to legally buy cigarettes, leading to an effective ban.

The law will not affect those who are allowed to buy cigarettes now.

To crack down on under-age sales, the government says it will introduce £100 on-the-spot fines for shops in England and Wales which sell tobacco and vapes to under-age people.

Local authorities will retain the proceeds to reinvest into enforcement of the law.

This would be on top of £2,500 fines that courts can already impose.

The government says it will spend £30m on enforcement, which will include tackling the availability of cigarettes on the black market.

The new rules will apply in all duty free shops in the UK, but anyone buying cigarettes abroad would be able to bring them back to the UK as long as they were legally acquired elsewhere.

The government aims to have the new system in force by 2027.

Mr Sunak wants to work with the governments of Wales, Scotland and Northern Ireland to introduce the legislation across the UK."

HT: Oğuzhan Çelebi

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Earlier: 

Thursday, March 14, 2024

New Zealand repeals anti-smoking law that would have prevented tobacco sales to anyone born after 2008