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

 The EU has proposed a strengthening of European prohibitions against compensating donors of "substances of human origin" (SoHOs).  Here's an op-ed in VoxEU considering how that might effect their supply.

Consequences of unpaid blood plasma donations, by Axel Ockenfels and  Alvin Roth / 4 Nov 2023

"The European Commission is considering new ways to regulate the ‘substances of human origin’ – including blood, plasma, and cells – used in medical procedures from transfusions and transplants to assisted reproduction. This column argues that such legislation jeopardises the interests of both donors and recipients. While sympathetic to the intentions behind the proposals – which aim to ensure that donations are voluntary and to protect financially disadvantaged donors – the authors believe such rules overlook the effects on donors, on the supply of such substances, and on the health of those who need them.

"Largely unnoticed by the general public, the European Commission and the European Parliament’s Health Committee have been drafting new rules to regulate the use of ‘substances of human origin’ (SoHO), such as blood, plasma, and cells (Iraola 2023, European Parliament 2023). These substances are used in life-saving medical procedures ranging from transfusions and transplants to assisted reproduction. Central to this legislative initiative is the proposal to ban financial incentives for donors and to limit compensation to covering the actual costs incurred during the donation process. The goal is to ensure that donations are voluntary and altruistic. The initiative aims to protect the financially disadvantaged from undue pressure and prevent potential misrepresentation of medical histories due to financial incentives. While the intention is noble, the proposal warrants critical analysis as it may overlook the detrimental effects on donors themselves, on the overall supply of SoHOs, and consequently on the health, wellbeing, and even the lives of those who need them. We illustrate this in the context of blood plasma donation.

"Over half a century ago, Richard Titmuss (1971) conjectured that financial incentives to donate blood could compromise the safety and overall supply. This made sense in the 1970s, when tests for pathogens in the blood supply were not yet developed. But Titmuss’ conjecture permeated policy guidelines worldwide, despite mounting evidence to the contrary. Although more evidence is needed, a review published by Science (Lacetera et al. 2013; see also Macis and Lacetera 2008, Bowles 2016), which looked at the evidence available more than 40 years after Titmuss’ conjecture, concluded that the statistically sound, field-based evidence from large, representative samples is largely inconsistent with his predictions.

"Getting the facts right is important because, at least where blood plasma is concerned, the volunteer system has failed to meet demand (Slonim et al. 2014). There is a severe and growing global shortage of blood plasma. While many countries are unwilling to pay donors at home, they are willing to pay for blood plasma obtained from donors abroad. The US, which allows payment to plasma donors, is responsible for 70% of the world’s plasma supply and is also a major supplier to the EU, which must import about 40% of its total plasma needs. Together with other countries that allow some form of payment for plasma donations – including EU member states Germany, Austria, Hungary, and the Czech Republic – they account for nearly 90% of the total supply (Jaworski 2020, 2023). Based on what we know from controlled studies and from experiences with previous policy changes, a ban on paid donation in the EU will reduce the amount of plasma supplied from EU members, prompting further attempts to circumvent the regulation by importing even more plasma from countries where payment is legal. At the same time, a ban will contribute to the global shortage of plasma, further driving up the price and making it increasingly unaffordable for low-income countries (Asamoah-Akuoko et al. 2023). In the 1970s, it may have been reasonable to worry that encouraging paid donation would lead to a flow of blood plasma from poor nations to rich ones. That is not what we are in fact seeing. Instead, plasma supplies from the US and Europe save lives around the world.

"In other areas, society generally recognises the need for fair compensation for services provided, especially when they involve discomfort or risk. After all, it is no fun having someone stick a needle in your arm to extract blood. This consensus cuts across a range of services and professions – including nursing, firefighting, and mining – occupations, most people would agree, that should be well rewarded for the risk involved and value to society. To rely solely on altruism in such areas would be exploitative and would eventually lead to a collapse in provision. Indeed, to protect individuals from exploitation, labour laws around the world have introduced minimum compensation requirements rather than caps on earnings. In addition, payment bans on donors, even if they’re intended to protect against undue inducements, raise concerns about price-fixing to the benefit of non-donors in the blood plasma market. In a related case, limits on payment to egg donors have been successfully challenged in US courts. 1

"In addition, policy decisions affecting vital supplies such as blood plasma should be based on a broad discourse that includes diverse perspectives and motivations. Ethical judgements often differ, both among experts and between professionals and the general public, so communication is essential (e.g. Roth and Wang 2020, Ambuehl and Ockenfels 2017). Payment for blood plasma donations is an example. We (the authors of this article) are from the US and Germany, countries that currently allow payment for blood plasma donations while most other countries prohibit payment. On the other hand, prostitution is legal in Germany but surrogacy is not, while the opposite is true in most of the US. And while Germany currently prohibits kidney exchange on ethical grounds, other countries – including the US, the UK, and the Netherlands – operate some of the largest kidney exchanges in the world and promote kidney exchange on ethical grounds.

"The general public does not always share the sentiments that health professionals find important (e.g. Lacetera et al. 2016). This tendency is probably not due to professionals being less cognitively biased. In all areas where the question has been studied, experts such as financial advisers, CEOs, elected politicians, economists, philosophers, and doctors are just as susceptible to cognitive bias as ordinary citizens (e.g. Ambuehl et al. 2021, 2023). Recognising the similarities and differences between professional and popular judgements, and how ethical judgements are affected by geography, time, and context, allows for a more constructive and effective search for the best policy options.

"In our view, the dangers of undersupply of critical medical substances, of inequitable compensation (particularly for financially disadvantaged donors), and of circumvention of regulation by sourcing these substances from other countries (where the EU has no influence on the rules for monitoring compensation to protect donors from harm) are at least as significant as those arising from overpayment. Carefully designed transactional mechanisms may also help to respect ethical boundaries while ensuring adequate supply. Advances in medical and communication technologies, such as viral detection tests, can effectively monitor blood quality and ensure the safety and integrity of the entire donation process – including the deferral of high-risk donors and those for whom donating is a risk to their health – without prohibiting payment to donors. Even if it is ultimately decided that payments should be banned, there are innovations in the rules governing blood donation that have been proposed, implemented, and tested that would improve the balance between blood supply and demand within the constraints of volunteerism; non-price signals, for instance, can work within current social and ethical constraints.

"As the EU deliberates on this legislation, it is imperative to adopt a balanced, empirically sound, and research-backed approach that considers multiple effects and promotes policies to safeguard the interests of both donors and recipients.

References

Asamoah-Akuoko, L et al. (2023), “The status of blood supply in sub-Saharan Africa: barriers and health impact”, The Lancet 402(10398): 274–76.

Ambuehl, S and A Ockenfels (2017), “The ethics of incentivizing the uninformed: A vignette study”, American Economic Review Papers & Proceedings 107(5), 91–95.

Ambuehl, S, A Ockenfels and A E Roth (2020), “Payment in challenge studies from an economics perspective”, Journal of Medical Ethics 46(12): 831–32.

Ambuehl, S, S Blesse, P Doerrenberg, C Feldhaus and A Ockenfels (2023), “Politicians’ social welfare criteria: An experiment with German legislators”, University of Cologne, working paper.

Ambuehl, S, D Bernheim and A Ockenfels (2021), “What motivates paternalism? An experimental study”, American Economic Review 111(3): 787–830.

Bowles S (2016), “Moral sentiments and material interests: When economic incentives crowd in social preferences”, VoxEU.org, 26 May.

European Parliament (2023), “Donations and treatments: new safety rules for substances of human origin”, press release, 12 September.

Iraola, M (2023), “EU Parliament approves text on donation of substances of human origin”, Euractiv, 12 September.

Jaworski, P (2020), “Bloody well pay them. The case for Voluntary Remunerated Plasma Collections”, Niskanen Center.

Jaworski, P (2023), “The E.U. Doesn’t Want People To Sell Their Plasma, and It Doesn’t Care How Many Patients That Hurts”, Reason, 20 September.

Lacetera, N, M Macis and R Slonim (2013), “Economic rewards to motivate blood donation”, Science 340(6135): 927–28.

Lacetera, N, M Macis and J Elias (2016), “Understanding moral repugnance: The case of the US market for kidney transplantation”, VoxEU.org, 15 October.

Macis M and N Lacetera (2008), “Incentives for altruism? The case of blood donations”, VoxEU.org, 4 November.

Roth, A E (2007), “Repugnance as a constraint on markets”, Journal of Economic Perspectives 21(3): 37–58.

Roth A E and S W Wang (2020), “Popular repugnance contrasts with legal bans on controversial markets”, Proc Natl Acad Sci USA 117(33): 19792–8.

Slonim R, C Wang and E Garbarino (2014), “The Market for Blood”, Journal of Economic Perspectives 28(2): 177–96.

Titmuss, R M (1971), The Gift Relationship, London: Allen and Unwin.

Footnotes: 1. Kamakahi v. American Society for Reproductive Medicine, US District Court Northern District of California, Case 3:11-cv-01781-JCS, 2016.

Blood use in the U.S., in JAMA

 Here are a collection of articles, some of which suggest that we may in the not so distant future face a shortage of whole blood in the U.S., the need for which is so far filled by uncompensated donors (unlike the need for plasma, which is presently filled by compensated donors...).  One issue is that apparently ambulance companies aren't easily compensated for beginning transfusion on the way to the hospital, which could save lives.

Original Investigation Caring for the Critically Ill Patient Red Blood Cell Transfusion in the Intensive Care Unit Senta Jorinde Raasveld, MD; Sanne de Bruin, MD, PhD; Merijn C. Reuland, MD; et al. "RBC transfusion was common in patients admitted to ICUs worldwide between 2019 and 2022, with high variability across centers in transfusion practices." Editorial: Precision in Transfusion Medicine ; Matthew D. Neal, MD; Beverley J. Hunt, MD "blood transfusion practice has come a long way, but further efforts toward precision medicine are required to ensure that patients receive the most effective components. These products should be matched to patients as individuals who have unique antigens and a variable host response, and how to use the appropriate blood components in different clinical settings must be understood." Caring for the Critically Ill Patient Small-Volume Blood Collection Tubes to Reduce Transfusions in Intensive Care: The STRATUS Randomized Clinical Trial Deborah M. Siegal, MD; Emilie P. Belley-Côté, MD, PhD; Shun Fu Lee, PhD; et al. Caring for the Critically Ill Patient Emergency Department Resuscitative Endovascular Balloon Occlusion of the Aorta in Trauma Patients With Exsanguinating Hemorrhage: The UK-REBOA Randomized Clinical Trial Jan O. Jansen, PhD; Jemma Hudson, PhD; Claire Cochran, MSc; et al. Editorial: Contemporary Adjuncts to Hemorrhage Control ; Samuel A. Tisherman, MD; Megan L. Brenner, MD Caring for the Critically Ill Patient Early and Empirical High-Dose Cryoprecipitate for Hemorrhage After Traumatic Injury: The CRYOSTAT-2 Randomized Clinical Trial Ross Davenport, PhD; Nicola Curry, MD; Erin E. Fox, PhD; et al. Editorial: Contemporary Adjuncts to Hemorrhage Control; Samuel A. Tisherman, MD; Megan L. Brenner, MD Special Communication Red Blood Cell Transfusion: 2023 AABB International Guidelines Jeffrey L. Carson, MD; Simon J. Stanworth, MD, DPhil; Gordon Guyatt, MD; et al. Earn CME credit Viewpoint From Product to Patient—Transfusion and Patient Blood Management Matthew A. Warner, MD; Linda Shore-Lesserson, MD; Carolyn Burns, MD "Recent years have also exposed vulnerabilities in blood inventories. As the most prominent example, the COVID-19 pandemic led to cancellations of many community-based and mobile blood collections, culminating in the declaration of a national blood crisis by the American Red Cross for the first time in history. In response, the American Medical Association, in partnership with the American Hospital Association and American Nurses Association, issued a joint statement in January 2022 describing the worst blood shortage in more than a decade and urging blood donation from all eligible persons. Not long after, the AABB, in collaboration with 17 leading US health care and blood collection organizations, launched the Alliance for a Strong Blood Supply to track and coordinate information and public communications about blood inventories and explore mechanisms to improve blood supply resilience." The Bloody Transfusion Problem John B. Holcomb, MD; William K. Hoots, MD; Travis M. Polk, MD "Preventable death after injury is a national crisis. Worldwide, injury accounts for more deaths than malaria, tuberculosis, and HIV combined and is increasing.1 Trauma is largely a condition of young people and is the leading cause of life-years lost between 1 and 75 years of age, and costs to the US are estimated at $4.2 trillion a year.2 As is always the case, lessons learned on recent battlefields have improved civilian care, and the most impactful intervention has been the increased use of blood products as a primary resuscitation fluid. "During the past decade several large, prospective, multicenter, randomized, federally funded studies have improved outcomes and changed practice.3,4 Transfusing blood as early as possible to patients with hemorrhagic shock saves lives, and fewer patients die from exsanguination when receiving a balanced transfusion of platelets, red blood cells, and plasma or whole blood. This is true in the hospital but is especially so in the prehospital setting, where blood products decrease mortality from 33% to 23%.4 When all indicated blood products are available and given early, deaths due to hemorrhage decrease and care is cost-effective. However, of the 2045 hospitals to which the American Red Cross supplied blood components in 2019, 33% did not routinely have platelets ready to transfuse to bleeding patients, and more than 78% of those hospitals are in a rural setting.4 Emergency medical services (EMS) agencies and hospitals that do not have all blood products immediately available cannot provide optimal care. Unfortunately, the blood products required to save lives are not uniformly available to all persons, and implementation of these proven lifesaving interventions is uneven, largely because of supply and policy reasons. "To remedy this disparity, we believe there are 3 significant hurdles to overcome: (1) enabling a reliable strategy for insuring an adequate blood product supply by developing new shelf-stable blood products and by providing greater financial support for donor blood collection and processing; (2) insuring adequate reimbursement for current and new blood products in the hospital setting and removing the limitation of prehospital provider scope of practice and ability to bill for all blood products; and (3) sustaining consistent and appropriate research funding for trauma studies of hemorrhagic shock in both pediatric and adult populations.  ... "Blood collection and processing centers are operating at a loss because remuneration has not kept pace with ever-increasing costs of regulatory required infectious disease testing. ... "More than 55 000 additional donors will be required for just the prehospital blood program implementation.6 Increasing the blood supply will require novel solutions combining remuneration for donors, increased reimbursement for blood collection centers, modern efforts to recruit younger donors, and streamlined regulatory and financial reimbursement pathways for new blood products that are shelf stable at room temperature for years. ... "scope of practice, reimbursement barriers, and the inability to bill for transfusions provided in air or ground ambulances are significant obstacles to the widespread availability of prehospital blood programs." Redefining Blood Donation—Path to Inclusivity and Safety Pampee P. Young, MD, PhD; Paula Saa, PhD Video: Gay and Bisexual Men Can Now Donate Blood—Why This Matters "The journey to establish equitable blood donation policies can be likened to the myth of Theseus navigating the Labyrinth. Just as Theseus ventured into the complex maze to save Athenians from the Minotaur, the blood industry has been navigating the intricacies of research, regulation, and public sentiments to secure a safe blood supply and equitable policies. With the advancements in testing and the changing policies as our guiding thread, we are dedicated to ensuring fairness, equality, and safety, led by evidence and a deep commitment to humanity." Editorial Precision in Transfusion Medicine Matthew D. Neal, MD; Beverley J. Hunt, MD Contemporary Adjuncts to Hemorrhage Control Samuel A. Tisherman, MD; Megan L. Brenner, MD Medical News & Perspectives Could Universal Donor Blood Be Made in the Laboratory? Bridget M. Kuehn "In the face of chronic national and international blood supply shortages, scientists are renewing efforts to achieve the holy grail of transfusion—laboratory-made universal donor blood." JAMA Revisited The Status of Blood Transfusion "Originally Published September 29, 1923 | JAMA. 1923;81(13):1114- 1115." JAMA Patient Page Blood Donation Kristin Walter, MD, MS Video: Gay and Bisexual Men Can Now Donate Blood—Why This Matters Video Gay and Bisexual Men Can Now Donate Blood—Why This Matters

The EU considers tightening bans on compensating donors of Substances of Human Origin (SoHO)

 Peter Jaworski considers an  EU proposal this month to harmonize across the EU bans on paying donors for Substances of Human Origin (SoHO).  Presently Germany, Austria and Chechia allow payment to plasma donors.

The E.U. Doesn't Want People To Sell Their Plasma, and It Doesn't Care How Many Patients That Hurts. The United States currently supplies about 70 percent of the plasma used to manufacture therapies for the entire world.  by PETER JAWORSKI 

"The European Union looks like it might take the foolish step of banning financial incentives for a variety of substances of human origin, including blood, blood plasma, sperm, and breast milk. The legislation on the safety and quality of Substances of Human Origin includes an approved amendment that says donors can only be compensated for "quantifiable losses" and that such donations are to be "financially neutral." This legislation is supposed to harmonize the rules across the 27 member countries, promote safety, with the ban on financial incentives intended to avoid commodification and the exploitation of the poor. 

...

"Already the E.U. is dependent on plasma collected in the United States for around 40 percent of the needs of its 300,000 rare disease patients. They're not as dependent as Canada because Germany, Austria, Hungary, and the Czech Republic allow a flat-fee donor compensation model and so are able to have surplus collections that contribute 56 percent of the E.U. total. The remaining 23 countries, each of which runs a plasma collection deficit, manage just 44 percent. 

"So what is likely to happen if the new rules make this flat-fee donor compensation model illegal? Will safety improve and commodification and exploitation be avoided? No, the E.U. will just become even more dependent on the United States."

Compensating kidney donors: a call to action by Brooks and Cavanaugh in the LA Times

 Here's a clarion call for compensation of living kidney donors, from two nondirected kidney donors.  It's not the first, and very likely not the last, given the difficulty of modifying the existing law.  But it makes the case very clearly (and proposes that a tax credit spread over ten years might be the way to move foreward).

Opinion: A single reform that could save 100,000 lives immediately BY NED BROOKS AND ML CAVANAUGH, JULY 9, 2023 

"Never in the field of public legislation has so much been lost by so many to one law, as Churchill might’ve put it. The National Organ Transplant Act of 1984 created the framework for the organ transplant system in the United States, and nearly 40 years later, the law is responsible for millions of needless deaths and trillions of wasted dollars. The Transplant Act requires modification, immediately.

"We’ve got skin in this game. We both donated our kidneys to strangers. Ned donated to someone who turned out to be a young mother of two children in 2015, which started a chain that helped an additional two recipients. And Matt donated at Walter Reed in 2021, after which his kidney went to a Seattleite, kicking off a chain that helped seven more recipients, the last of whom was back at Walter Reed.

"Ned founded, and Matt now leads, an organization that represents nearly 1,000 living donors

...

"eight years ago, when Ned donated, the number of living kidney donors was 6,000. With all the work we’ve done since, the number of living donors is still about 6,000 annually. In the United States, nearly 786,000 people suffer from end-stage kidney disease, more people than can fit in the 10 largest NFL stadiums combined.

...

"More Americans die of kidney disease than of breast or prostate cancer, and one in three of us is at risk. This illness is widespread, but what makes it worse is the staggering financial burden borne by everyone. The head of the National Kidney Foundation testified in March that Medicare spends an estimated $136 billion, nearly 25% of its expenditures, on the care of people with a kidney disease. Of that, $50 billion is spent on people with end-stage kidney disease, on par with the entire U.S. Marine Corps budget.

...

"The National Organ Transplant Act prohibits compensating kidney donors, which is strange in that in American society, it’s common to pay for plasma, bone marrow, hair, sperm, eggs and even surrogate pregnancies. We already pay to create and sustain life

...

"The ethical concerns regarding compensation are straightforward. Nobody wants to coerce or compel those in desperate financial straits to do something they would not have done otherwise. The challenge, then — until artificial or nonhuman animal substitutes are viable options — is to devise a compensation model that doesn’t exploit donors.

"Compensation models have been proposed in the past. A National Institutes of Health study listed some of the possibilities, including direct payment, indirect payment, “in kind” payment (free health insurance, for example) or expanded reimbursements. After much review, we come down strongly in support of indirect payment, specifically, a $100,000 refundable federal tax credit. The tax credit would be uniformly applied over a period of 10 years, in the amount of $10,000 a year for those who qualify and then become donors.

"This kind of compensation is certainly not a quick-cash scheme that would incentivize an act of desperation. Nor does it commoditize human body parts. Going forward, kidney donation might become partly opportunistic rather than mostly altruistic, as it is now. But would it be exploitative? Not at all."

...

Ned Brooks and ML Cavanaugh are living kidney donors, and Brooks is the founder of the Coalition to Modify NOTA.

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Here are all my posts that mention Ned Brooks, starting with this one:

Friday, February 26, 2016

A Freakonomics listener was inspired to become a non-directed kidney donor by the podcast on kidney exchange

Africa continues to suffer severe shortages of blood and plasma

 Blood and plasma are in short supply in Africa, partly due to the insistence, by the WHO and others, that  blood and plasma be supplied domestically from unpaid donors. (Much of the world buys blood plasma from the United States, where donors can be paid.)

Here's an update from the Lancet:

The status of blood supply in sub-Saharan Africa: barriers and health impact, by Lucy Asamoah-Akuoko Bernard Appiah  Meghan Delaney  Bridon M'baya  Claude Tayou Tagny  Imelda Bates Published:June 13, 2023DOI:https://doi.org/10.1016/S0140-6736(23)01164-9

"Sub-Saharan African countries continue to struggle with chronic, year-round blood shortages, limiting their ability to support patients and deliver on the health-related Sustainable Development Goals (SDGs).1 Most blood recipients in sub-Saharan African countries are children and women around the time of childbirth,2 so achieving the health-related SDGs depends on blood and blood product availability to reduce maternal mortality, end preventable deaths of newborn babies and children younger than 5 years, and achieve universal health coverage. Blood shortages in sub-Saharan Africa can have devastating consequences. An estimated 70% of 287 000 pregnancy-associated deaths in the world in 2020 occurred in sub-Saharan African countries,3 predominantly due to obstetric haemorrhage. Insufficient blood supply for transfusion contributes substantially to such maternal deaths in hospitals in sub-Saharan Africa.4 Blood transfusions are also essential for managing sub-Saharan Africa's high rates of traffic accidents5 and childhood anaemia, which is commonly due to infections such as malaria, helminthiasis, and haemoglobinopathies. Sub-Saharan Africa is home to more than 75% of the 300 000–400 000 babies born each year globally with sickle cell disease;6 blood shortages contribute to 50–90% of these children dying before their fifth birthday.7

...

"But there are several barriers to achieving an adequate and sustainable blood supply in sub-Saharan Africa. The average number of blood donations across the WHO African region is less than 6 units per 1000 population, with some countries such as Cameroon, Eritrea, and Madagascar collecting less than two units per 1000 population.8 Insufficient blood supply in sub-Saharan African countries is due to many factors, including inadequate organisation, regulation, and coordination of national blood services, and challenges with geographical distribution of blood for transfusion. There are also cultural barriers and stigma associated with knowing HIV status9 that deter some voluntary blood donors, compounded by inefficient donor recruitment programmes, and inadequate funding and sustainable financing models for blood services. Several sub-Saharan African countries including Kenya, Lesotho, Malawi, and Uganda, built their national blood transfusion services on the back of HIV funding from donor agencies such as President's Emergency Plan for AIDS Relief, The Global Fund to Fight AIDS, Tuberculosis and Malaria, and the EU, but this funding has reduced considerably.

...

"WHO recognises three types of blood donors: voluntary non-remunerated blood donors (VNRBD); family replacement blood donors (FRD) who donate blood for family members, friends or acquaintances; and paid donors. In high-income countries such as Denmark and the UK, the use of VNRBD ensures reliability of adequate national blood supply. In the WHO Africa region, the number of VNRBD increased from 1·89 million in 2008 to 3·42 million in 2018 (increasing total donations from 2·41 million units to 4·46 million units).11 Despite this, donations from VNRBD are unable to meet the demand for blood in many sub-Saharan African countries. For example, of 21 sub-Saharan African countries with more than 80% VNRBD, only five (Botswana, Mauritius, Namibia, South Africa, and Eswatini) have met the minimum blood requirement of 10 units per 1000 population2—a target that, although globally adopted, is not based on robust evidence.12 Paid donors have a lower safety profile as compared with VNRBD and do not contribute to achieving adequate an cd safe blood supply.13"

********

And here is reference 13, a WHO pamphlet published in 2010 calling on all donations to achieve self sufficiency in unpaid blood donation

13. WHO, 2010, "Towards 100% voluntary blood donation: a global framework for action"  

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Earlier:

Monday, May 18, 2020

Plasma and plasma products (such as antibodies) are a big business (and the U.S. dominates the international market)

Blood money: plasma and ambivalence

 The Guardian has a long review of the book Blood Money, by Kathleen McLaughlin, who is dependent on blood plasma, but suggests reasons to be ambivalent about the American market for paid plasma.

‘It’s gamified’: inside America’s blood plasma donation industry. In her new book Blood Money, Kathleen McLaughlin uses a personal lens to examine an industry that rewards mass plasma donation  by David Smith

"So who is the typical blood seller and why do they do it? McLaughlin had expected to find the poorest of the poor but, it transpires, most of them are screened out because a plasma donor must have a permanent address.

“What I found instead was a lot of people who, say, 25 years ago would have been middle class, and they just don’t make enough money for that lifestyle any more. I get the sense that one of the biggest demographics is college students. We’re talking about like big public universities where there are a lot of students who don’t come from wealthy backgrounds; I’ve talked to people who use this money to buy books, to pay to go out for a night, for ‘beer money’.

“You will also find people in communities like Flint, Michigan, where I spent a lot of time, who used to be able to expect to have this very normal American middle-class lifestyle and wages and benefits no longer keep pace with that. There are people doing it to buy groceries and to pay for housing. There are also people who are selling plasma to take a vacation."

...

"And whereas donating blood for free is lauded, donating it for money is stigmatised. “If you think about blood donation, it’s something that we consider quite heroic. If you go to the Red Cross and donate blood, you’re saving a life, you’re not getting paid for it.

“But somehow this practice of donating plasma for pay comes with a pretty heavy stigma. A lot of the people I interviewed who do sell plasma had not told their families that they do it because they were afraid of what their families would think: there would be some kind of judgment or their families would be worried about their health or concerned that they don’t have enough money.

‘The stigma is entirely linked to the fact that we stigmatise poverty in the United States. We look down on it. We don’t respect people who aren’t wealthy in the same way that we respect wealthy people. It’s been interesting for me to see the way that people view selling plasma as being somehow problematic and that’s definitely contributed to the fact that this industry is kind of hidden.”

"Still, should we make a moral judgment about the blood industry? It is not, after all, pushing an addictive substance like opioids, but rather is helping the health of people in America and around the world, McLaughlin included. She replies: “We need to ask ourselves that. From my perspective as someone who depends on this substance, what people are doing is incredibly altruistic.

“I also think a lot of people are being financially coerced to do it and, the way the system is set up, you get paid more per donation for each donation you make. It’s gamified in such a way that people are encouraged to donate quite often and because it is a hidden industry, most Americans haven’t really considered if this is who we want to be.

“If you know that there are potentially millions of Americans who have sold their plasma to pay for things like groceries and vacations, are you OK with that? For me, it’s more a matter of getting people to think about it, that our economic situation is such that this is part of our fabric now and are we comfortable with being that way or do we want to think more deeply about how we can make this more feel more of a choice for people?”

"She adds: “The industry itself isn’t necessarily the problem. The problem is that we have let this industry become a part of people’s incomes. I don’t know that that’s the kind of society we want to be.”

“It’s these places where people are economically fragile, not necessarily desperately poor. The kind of fragility that we didn’t have 25 or 30 years ago when there were more social-safety protections.”

Reconsideration of covid convalescent plasma

Recently Statnews reported that Covid convalescent plasma (CCP) may in fact be useful in preventing severe illness, despite the fact that earlier clinical trials did not show success in reversing severe illness:

Covid convalescent plasma: the ‘little engine that could’  By Michael J. Joyner, Nigel Paneth and Arturo Casadevall

"Unlike monoclonal antibodies, which can be defeated by new SARS-CoV-2 variants, CCP collected from vaccinated donors after recent breakthrough infections (VaxCCP) evolves with the variants and retains the ability to neutralize them. What makes CCP an even more promising therapy is that there are now many potential donors available in the U.S. who have been vaccinated and had recent breakthrough infections.

...

"An array of data, including randomized controlled trials and careful retrospective studies, show a clear survival benefit when CCP is given to immunocompromised individuals who test positive for SARS-CoV-2. There are also impressive case reports and case series showing that Covid convalescent plasma, especially VaxCCP, is effective in patients with smoldering Covid-19.

...

"the early “major” RCTs that tested the efficacy of CCP on survival in hospitalized patients tested the wrong use case. These studies treated patients who were too sick for too long to benefit from antibody therapy. But the major “negative” trials all showed evidence of effectiveness among people who received CCP earlier, who were not already desperately ill, who were immunocompromised, or who received the most antibodies. Unfortunately, these positive signals, which were consistent with impressive real-world data on Covid-19 and CCP, were buried under the top-line results."

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Earlier posts on convalescent plasma

Moral certainties versus moral tradeoffs

 An article and a commentary in PNAS raise the possibility that  economists and psychologists and moral philosophers concerned with morally contested transactions may be able to engage in more useful discussions. A problem is that economists mostly think about tradeoffs while many moral philosophers (or at least those who write about medical ethics) often think of morality as involving absolutes. (This is clearly illustrated in discussions about repugnant transactions, such as those involving compensation of donors of blood plasma or kidneys, for example.)

The PNAS article is   

Guzmán, Ricardo Andrés, María Teresa Barbato, Daniel Sznycer, and Leda Cosmides. "A moral trade-off system produces intuitive judgments that are rational and coherent and strike a balance between conflicting moral values." Proceedings of the National Academy of Sciences 119, no. 42 (2022): e2214005119. https://doi.org/10.1073/pnas.2214005119

"Significance: Intuitions about right and wrong clash in moral dilemmas. We report evidence that dilemmas activate a moral trade-off system: a cognitive system that is well designed for making trade-offs between conflicting moral values. When asked which option for resolving a dilemma is morally right, many people made compromise judgments, which strike a balance between conflicting moral values by partially satisfying both. Furthermore, their moral judgments satisfied a demanding standard of rational choice: the Generalized Axiom of Revealed Preferences. Deliberative reasoning cannot explain these results, nor can a tug-of-war between emotion and reason. The results are the signature of a cognitive system that weighs competing moral considerations and chooses the solution that maximizes rightness.

"Abstract: How does the mind make moral judgments when the only way to satisfy one moral value is to neglect another? Moral dilemmas posed a recurrent adaptive problem for ancestral hominins, whose cooperative social life created multiple responsibilities to others. For many dilemmas, striking a balance between two conflicting values (a compromise judgment) would have promoted fitness better than neglecting one value to fully satisfy the other (an extreme judgment). We propose that natural selection favored the evolution of a cognitive system designed for making trade-offs between conflicting moral values. Its nonconscious computations respond to dilemmas by constructing “rightness functions”: temporary representations specific to the situation at hand. A rightness function represents, in compact form, an ordering of all the solutions that the mind can conceive of (whether feasible or not) in terms of moral rightness. An optimizing algorithm selects, among the feasible solutions, one with the highest level of rightness. The moral trade-off system hypothesis makes various novel predictions: People make compromise judgments, judgments respond to incentives, judgments respect the axioms of rational choice, and judgments respond coherently to morally relevant variables (such as willingness, fairness, and reciprocity). We successfully tested these predictions using a new trolley-like dilemma. This dilemma has two original features: It admits both extreme and compromise judgments, and it allows incentives—in this case, the human cost of saving lives—to be varied systematically. No other existing model predicts the experimental results, which contradict an influential dual-process model."

Here is their first example:

"Two countries, A and B, have been at war for years (you are not a citizen of either country). The war was initiated by the rulers of B, against the will of the civilian population. Recently, the military equilibrium has broken, and it is certain that A will win. The question is how, when, and at what cost.

"Country A has two strategies available: attacking the opposing army with conventional weapons and bombing the civilian population. They could use one, the other, or a combination of both. Bombing would demoralize country B: The more civilians are killed, the sooner B will surrender, and the fewer soldiers will die—about half from both sides, all forcibly drafted. Conventional fighting will minimize civilian casualties but maximize lives lost (all soldiers).

"More precisely: If country A chooses not to bomb country B, then 6 million soldiers will die, but almost no civilians. If 4 million civilians are sacrificed in the bombings, B will surrender immediately, and almost no soldiers will die. And, if A chooses an intermediate solution, for every four civilians sacrificed, approximately six fewer soldiers will die.

"How should country A end the war? What do you feel is morally right?"

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Here is the followup commentary:

Lieberman, Debra, and Steven Shenouda. "The superior explanatory power of models that admit trade-offs in moral judgment and decision-making." Proceedings of the National Academy of Sciences 119, no. 51 (2022): e2216447119.

"We make “moral” decisions each day (should I stay and help my graduate student with her thesis thereby delaying dinner for my children? And if I do stay, how long is acceptable until the trade-off tips in favor of my children—30 min? An hour? Longer?). There are costs associated with every act, and part of the human condition is that we seek to balance our duties to everyone in our social network.

"Moral judgments, as the above example illustrates, lead to intermediate, compromise solutions. For this reason, the value of moral dilemmas like the trolley problem that yield only binary outcomes is limited to the superficial exploration of normative theories within philosophy—not the underlying mental software driving moral cognition

...

"As a philosophical tool, the trolley problem playfully probes certain (limited) contours of moral decision-making. But, as a methodology imported from philosophy into cognitive science to illuminate moral cognition, the translation is impoverished because it yields only binary, extreme solutions and prevents moral trade-offs or compromise judgments. "

Blood Money, by John Dooley and Emily Gallagher

 Are paid plasma donors being exploited? Here's a paper that suggests not, but rather that the payments that plasma donors receive can improve their financial well being not merely by providing additional income, but also by helping them avoid going into expensive debt.

 Dooley, John and  Emily Gallagher, Blood Money (October 11, 2021). Available at SSRN: https://ssrn.com/abstract=3940369 or http://dx.doi.org/10.2139/ssrn.3940369

Abstract: "Little is known about the motivations and outcomes of sellers in remunerated markets for human materials. We exploit dramatic growth in the number of commercial blood plasma centers in the U.S. to study the individuals who sell plasma. We find sellers tend to be young and liquidity constrained with low incomes and credit scores; they also report less access to traditional bank credit. Plasma centers absorb demand for non-traditional credit. The opening of a nearby plasma center reduces payday loan inquires and transactions by 13–18% among young borrowers. Meanwhile, foot traffic increases by over 9% at both essential and non-essential goods establishments when a new plasma center opens nearby. Our findings suggest that, at least in the short-term, constrained households use the discretionary income from plasma centers to smooth consumption without appealing to high-cost debt."

HT: Mario Macis

Canadian Blood Services to start paying Canadian plasma donors

 CBC news has the story, which seems to mark a turning point in a long struggle with repugnance for paying donors.

Canadian Blood Services signs agreement with private company to boost national plasma supply.  Some advocates calling for the resignation of Canadian Blood Services leaders over agreement. by Stephanie Dubois 

"Canadian Blood Services (CBS) is partnering with a private healthcare company to boost Canada's national blood plasma supply, the organization announced Wednesday.

...

"CBS has signed an agreement with Grifols, a company headquartered in Spain, which specializes in producing plasma medicines, the national blood collection organization said in a news release.

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"Grifols will help CBS meet national targets for plasma supply by both collecting paid-for plasma and by turning Canadian plasma into immunoglobulins —a form of specialized medications called plasma protein products– for Canadian patients. 

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"Health Canada says on its website there's currently "not enough plasma collected in Canada to meet the demand," and most of the plasma products distributed by CBS and Héma-Quebec are purchased from U.S. manufacturers and made from U.S. paid-donor plasma. "

Canadian Blood Services in talks around paid donations of plasma

Canadian Blood Services in talks around paid donations of plasma as supply dwindles. by Christopher Reynolds

"Canadian Blood Services is in talks with companies that pay donors for plasma as it faces a decrease in collections.

"The blood-collection agency issued a statement on Friday saying it is in “ongoing discussion with governments and the commercial plasma industry” on how to more than double domestic plasma collection to 50 per cent of supply.

"Canadian Blood Services has previously cautioned that letting companies trade cash for plasma - a practice banned in British Columbia, Ontario and Quebec - could funnel donors away from voluntary giving.

"The bulk of the non-profit agency's supply currently comes from abroad, including via organizations that pay donors."

HT: Frank McCormack

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The Globe and Mail adds some detail:

Canadian Blood Services eyes getting plasma from paid donors amid supply challenges by Chris Hannay

"Industry observers say the most likely commercial partner for CBS is Grifols, an international pharmaceutical company headquartered in Spain. The company purchased a large-scale plasma processing facility in Montreal in 2020, and in January bought an existing for-profit plasma donation centre in Winnipeg.”

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See my full set of posts on plasma in Canada