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."

Cryopreservation of organs for transplants, and Sebastian Giwa in Forbes

 Forbes has a long, interesting, somewhat breathless story about the progress and promise of freezing organs for transplants, including not only the usual eight organs, but also bone marrow/blood stem cells. It focuses on one of the entrepreneurs in the field, Dr. Sebastian (Seb) Giwa, and his colleague Jedd Lewis among others

New Breakthroughs In Cryopreservation Poised To Transform Organ Transplantation, by Alex Zhavoronkov, PhD, Jul 5, 2023

"To understand how this came about I delved into the career of the founder and CEO of Sylvatica Biotech, Dr. Sebastian Giwa (called “Seb” by his friends). Seb is credited by many as the chief architect of the surge of scientific interest in cryopreservation over the last several years.

Sebastian Giwa, PhD, MBA 

BRIDGET BENNETT

...

"Trying to donate organs (without cryopreservation) is a lot like trying to donate perishable (non-canned) food: there are certainly a lot of starving people in the world, but good luck finding a recipient for every single ounce before it expires. 

...

"[Organ Preservation Alliance]  partnered ... to publish position papers, including a peer-reviewed article in Nature Biotechnology outlining the need for an organ cryopreservation research effort. The paper was co-authored with all of the major U.S. transplant societies and a star-studded lineup of scientists including Robert Langer, George Church, and Ed Boyden, and even Nobel Prize-winning economist Alvin Roth – whose work has focused on finding new ways to ameliorate the organ shortage. It is currently in the top 1% of the most widely read scientific articles published since its release.

...

"Donor bone marrow is lifesaving for many kinds of  cancers and a variety of other blood diseases. Successful bone marrow transplants have been performed since the 1950s, but the challenge is finding a source of bone marrow to transplant – especially since donors and recipients must be matched for genetic factors even more precisely than some organ transplants.

...

" if bone marrow could be cryogenically banked, why not procure it from deceased organ donors who were already providing hearts, livers, and other organs for transplantation? There are nearly 40,000 such donors worldwide each year, and each could potentially donate enough marrow for multiple patients in need. For many patients, when a transplant was needed the matching bone marrow would already be available in the bone marrow bank.

"From the perspective of the deceased organ donor and the OPOs, this would be like providing an opportunity to donate an additional lifesaving organ. Traditionally, each donor can provide up to eight lifesaving vital organs: a heart, two lungs, two kidneys, a liver, intestines, and a pancreas. In essence, bone marrow would be the ninth. And if a donor could provide bone marrow to multiple recipients, this might even double the number of lives that each donor could save.

...

"Alex: What’s something we haven’t covered that excites you about what cryopreservation can do for the organ shortage?

"Seb: In the long-term, one of the things that I’m most excited about is how these technologies can remove barriers to developing transplant systems in new countries. Most of the world still doesn’t have access to deceased donor transplantation. For instance, Africa has 16% of the world’s population but only 0.5% of transplants are done there. Meanwhile the U.S. has less than 5% of the world’s population but does about 25% of the world’s transplants. Many developed countries, like my father’s home country Ghana, have limited live kidney donation programs. But they don’t have deceased donor programs, which are needed to carry out large numbers of kidney and liver transplants as well as any sort of heart or lung transplantation.

"That’s partly because the logistical demands to source organ donations prospectively require so much infrastructure: a waitlist, rapid matching of donors to recipients, OPOs that need to be overstaffed in order to deal with unpredictable surges in organs available, rushed activities that require tight coordination between donor hospitals, OPOs, transplant centers, and even third party service providers like organ couriers. Many organs have also needed expensive transportation (private jets and helicopters).

"It’s a very different situation when there’s a source of cryopreserved hearts, livers, etc., that can be donated in a much more flexible way and are simply waiting to be matched to patients. Even things like Doctors without Borders and perhaps “OPOs without Borders” become possible for transplantation, helping train and develop new organ recovery, heart, lung, and liver transplant programs. So many more possibilities open up when you don’t need to create every part of a transplant system from scratch and have all of those parts acting in synchrony on Day 1."

**************

Here's the original article referred to:

The promise of organ and tissue preservation to transform medicine 
 Sebastian Giwa, Jedediah K Lewis, Luis Alvarez, Robert Langer, Alvin E Roth, George M Church, James F Markmann, David H Sachs, Anil Chandraker, Jason A Wertheim, Martine Rothblatt, Edward S Boyden, Elling Eidbo, W P Andrew Lee, Bohdan Pomahac, Gerald Brandacher, David M Weinstock, Gloria Elliott, David Nelson, Jason P Acker, Korkut Uygun, Boris Schmalz, Brad P Weegman, Alessandro Tocchio, Greg M Fahy, Kenneth B Storey, Boris Rubinsky, John Bischof, Janet A W Elliott, Teresa K Woodruff, G John Morris, Utkan Demirci, Kelvin G M Brockbank, Erik J Woods, Robert N Ben, John G Baust, Dayong Gao, Barry Fuller, Yoed Rabin, David C Kravitz, Michael J Taylor & Mehmet Toner

Nature Biotechnology 35, 530–542 (2017) doi:10.1038/nbt.3889
Published online 07 June 2017

Abstract: The ability to replace organs and tissues on demand could save or improve millions of lives each year globally and create public health benefits on par with curing cancer. Unmet needs for organ and tissue preservation place enormous logistical limitations on transplantation, regenerative medicine, drug discovery, and a variety of rapidly advancing areas spanning biomedicine. A growing coalition of researchers, clinicians, advocacy organizations, academic institutions, and other stakeholders has assembled to address the unmet need for preservation advances, outlining remaining challenges and identifying areas of underinvestment and untapped opportunities. Meanwhile, recent discoveries provide proofs of principle for breakthroughs in a family of research areas surrounding biopreservation. These developments indicate that a new paradigm, integrating multiple existing preservation approaches and new technologies that have flourished in the past 10 years, could transform preservation research. Capitalizing on these opportunities will require engagement across many research areas and stakeholder groups. A coordinated effort is needed to expedite preservation advances that can transform several areas of medicine and medical science.

************

Here's a recent related post:

Wednesday, June 28, 2023

Freezing, thawing and transplanting a rat kidney: a first step towards organ banking

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)

The World Health Organization (WHO) at 75

 An editorial in Nature considers the complicated history of  the World Health Organization. 

The WHO at 75: what doesn’t kill you makes you stronger. The World Health Organization is emerging from the peak of the pandemic bruised. Its member states must get back to prioritizing universal health care.

"When thinking about the WHO’s 75 years, it’s worth remembering the time and circumstances of its creation. In the aftermath of the Second World War, the newly established United Nations and its specialized agencies, including the WHO, were designed to future-proof the world from another global conflict. Around 80 million people died during the two world wars, many from famine or disease.

"The WHO deserves more money for its core mission — and more respect

"The WHO’s founding constitution states unequivocally: “Health is a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity. The enjoyment of the highest attainable standard of health is one of the fundamental rights of every human being without distinction of race, religion, political belief, economic or social condition.”

"And yet, the agency’s creators chose not to prioritize robust systems of universal health care that would meet these goals. This absent focus is one factor in why infectious diseases continue to impact populations in low- and middle-income countries. The eradication of smallpox in 1980 was a big win. But for other diseases, the agency and its donors have been unable to reach targets, including in the elimination of HIV and AIDS, malaria and tuberculosis.

"The WHO does, however, have a consistent record for establishing itself as the go-to organization for setting global standards for the efficacy, safety and quality of vaccines and medicines. As we have seen during the pandemic, the agency is central to alerting the world to new infectious diseases, helped in no small measure by the revolution in biomedicine and health data, especially genomics."

In general I think the WHO does important work reasonably well, but I have reservations about their policies concerning blood and transplants, which seem to me to reflect some now outdated repugnance to the complexities of “Substances of Human Origin (SoHO)." (Not that these issues don't remain complex.)

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.”

Donate blood or organs to pay a traffic fine or shorten a prison term?

I spend a lot of my time thinking and writing about repugnant transactions and controversial markets, and some of that intersects with my work on blood and organ donation and transplantation (particularly on the controversial issue of compensation for donors, and how that might intersect with varieties of coercion). But today's post is about two proposals that mix all these things together. (My guess is that many people will find them differently repugnant: think of them as a quick test of your own views.)

In Argentina, a municipal judge proposes blood donation to pay traffic fines, and in Massachusetts several legislators co-sponsor a bill to allow bone marrow (blood stem cell) donation or organ donation to reduce prison sentences.

First, blood donation and traffic fines:

 Mario Macis points me to this story in La Nacion, about a city in the Argentine province of Salta:

En una ciudad de Salta las multas de tránsito se pueden pagar con una donación de sangre  [In a city of Salta, traffic fines can be paid with a blood donation]  (English from Google Translate)

"In the city of Tartagal, Salta, it is possible to pay a traffic ticket with a blood donation . The measure, taken two months ago, generates both support and questioning.

...

"The judge of the Court of Misdemeanors of the Municipality of Tartagal, Farid Obeid , proposed in a ruling last August that those who had traffic fines could pay them with their own blood donation or from third parties on behalf of the offenders.

"It was then determined that donations be made in hospitals, voluntarily and only once; that is to say that repeat offenders cannot opt ​​for blood donation.

...

"The ruling received support and criticism, the latter basically from the health sector. Oscar Torres, president of the Argentine Association of Hemotherapy, Immunohematology and Cellular Therapy , sent a letter to the Deliberative Council of Tartagal indicating that the measure removes the "spirit of solidarity and altruism from blood donation" 

Here's a related story about the ongoing debate (also using Google translate):

Controversy over an unusual municipal project: they claim that fines can be paid with blood. "This controversial project was presented to the Deliberative Council of Tartagal, and criticism has already begun"

***********

And here's the new bill proposed in Massachusetts (don't hold your breath waiting for it to be passed into law). It's in English, so the phrase about the necessary "amount of bone marrow and organ(s) donated to earn one’s sentence to be commuted" isn't a translation error; I think it's just awkward (i.e. not meant to be chilling). (But the discussion of donated "organ(s)" makes me think of Kazuo Ishiguro's novel "Never Let Me Go"). 

Bill HD.3822, 193rd (Current), An Act to establish the Massachusetts incarcerated individual bone marrow and organ donation program

"Section 170. (a) The Commissioner of the Department of Corrections shall establish a Bone Marrow and Organ Donation Program within the Department of Correction and a Bone Marrow and Organ Donation Committee. The Bone Marrow and Organ Donation Program shall allow eligible incarcerated individuals to gain not less than 60 and not more than 365 day reduction in the length of their committed sentence in Department of Corrections facilities, or House of Correction facilities if they are serving a Department of Correction sentence in a House of Corrections facility, on the condition that the incarcerated individual has donated bone marrow or organ(s). 

...

"The Bone Marrow and Organ Donation Committee shall also be responsible for promulgating standards of eligibility for incarcerated individuals to participate and the amount of bone marrow and organ(s) donated to earn one’s sentence to be commuted. Annual reports including actual amounts of bone marrow and organ(s) donated, and the estimated life-savings associated with said donations, are to be filed with the Executive and Legislative branches of the Commonwealth. All costs associated with the Bone Marrow and Organ Donation Program will be done by the benefiting institutions of the program and their affiliates-not by the Department of Correction. There shall be no commissions or monetary payments to be made to the Department of Correction for bone marrow donated by incarcerated individuals."

Simultaneous HT to Ron Shorrer, Kim Krawiec, Akhil Vohra

Donating blood while gay

 The Washington Post brings us up to date:

FDA to ease blood donation ban on gay men, allow monogamous to give. By Laurie McGinley, Teddy Amenabar and  Fenit Nirappil 

"Gay and bisexual men in monogamous relationships will no longer be forced to abstain from sex to donate blood under federal guidelines to be proposed in coming days, ending a vestige of the earliest days of the AIDS crisis.

"The planned relaxation of restrictions by the Food and Drug Administration follows years of pressure by blood banks, the American Medical Association and LGBT rights organizations to abandon rules some experts say are outdated, homophobic and ineffective at keeping the nation’s blood supply safe."

"The new approach eliminates rules that target men who have sex with men and instead focuses on sexual behaviors by people, regardless of gender, that pose a higher risk of contracting and transmitting HIV"

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

Kidney news from Cambridge on possibility of removing blood type barriers

 Here's some very preliminary kidney news (a press release) in The Guardian and at Cambridge, that could have the potential to have an impact sooner rather than later in helping potential transplant recipients with blood type O, who can only receive blood type O kidneys (which can be received by patients of any blood type)...  

Researchers change blood type of kidney in transplant breakthrough University of Cambridge team’s work could significantly increase supply of organs for people with rarer blood types

"University of Cambridge researchers used a normothermic perfusion machine – a device that connects with a human kidney to pass oxygenated blood through the organ to better preserve it for future use – to flush blood infused with an enzyme through the deceased donor’s kidney.

"The enzyme removed the blood type markers that line the blood vessels of the kidney, which led to the organ being converted to type O."

*******

https://www.cam.ac.uk/stories/kidneybloodtype

The scientists mentioned are Professor Michael  Nicholson and PhD student Serena MacMillan .

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

MR on repugnance for compensating blood donors, carried to an absurd conclusion

 Alex Tabarrock had a great post at MR the other day, via Peter Jaworski, called A Bloody Waste.

Here's how it began:

A Bloody Waste

by  Alex Tabarrok June 7, 2022 at 7:25 am in 

• Economics
 
• Law
 
• Medicine

"Hemochromatosis is a disorder in which extra iron builds up in the body. A potential treatment is phlebotomy so patients with hemochromatosis want to donate blood and donate regularly. The American Red Cross, however, does not permit people with hemochromatosis to donate blood. Why not? The blood is safe and effective. The blood of these patients doesn’t have much, if any, extra iron (the iron builds up in the body not so much in the blood per se). The “problem” is that people with hemochromatosis benefit themselves by giving blood and for this reason their blood is considered tainted by the American Red Cross."

Plasma donations at the border

Here's a WSJ story about the confluence of two controversial transactions, immigration and compensation for plasma donors.

Block on Blood-Plasma Donors From Mexico Threatens Supplies. U.S. officials say crossing border to donate for a fee isn’t allowed with a visitor visa  By Mike Cherney,  Renée Onque and Daniela Hernandez

"Pharmaceutical companies and U.S. officials are fighting over whether to allow people to cross the border from Mexico to be paid for giving blood plasma, a critical ingredient in treatments for some neurological and autoimmune diseases.

"Up to 10% of plasma collected in the U.S. usually comes from Mexican nationals who enter on visitor visas and are paid about $50 to donate, according to legal filings from pharmaceutical companies. Last June, U.S. border officials indicated they would stop the roughly 30-year practice because they viewed it as labor for hire, which isn’t allowed under a visitor visa.

"The pharmaceutical companies that collect plasma have asked federal courts in Washington, D.C., to overturn the decision, which came just as U.S. plasma donations were disrupted by the Covid-19 pandemic. Some companies have argued that the payment compensates donors for their time and commitment rather than for the plasma itself, and isn’t in exchange for any actual work.

...

"The U.S., which provides much of the global plasma supply, is one of the few countries that allows payments to plasma donors, and supporters of the policy say that helps to ensure enough plasma is collected. Two big plasma companies, Australia-based CSL Ltd. and Spain-based Grifols SA, have invested millions of dollars in collection centers near the U.S.-Mexican border.

...

"A spokesperson for U.S. Customs and Border Protection declined to discuss the litigation.

...

"The agency said pharmaceutical companies could increase payments to attract more domestic supply and that Mexicans could still donate plasma without getting paid."

Shortages of blood, and breast milk

 The pandemic is putting strains on many supply chains, including those for donated (unpaid) medical supplies like blood and breast milk.  The pandemic is impacting both potential donors, and the ability of blood banks and milk banks to staff drives for additional supplies.

Here's a statement from the American Red Cross:

Red Cross: National blood crisis may put patients at risk

"The American Red Cross is facing a national blood crisis – its worst blood shortage in more than a decade. Dangerously low blood supply levels are posing a concerning risk to patient care and forcing doctors to make difficult decisions about who receives blood transfusions and who will need to wait until more products become available.

"Blood and platelet donations are critically needed to help prevent further delays in vital medical treatments, and donors of all blood types – especially type O − are urged to make an appointment now to give in the weeks ahead.

"In recent weeks, the Red Cross had less than a one-day supply of critical blood types and has had to limit blood product distributions to hospitals. At times, as much as one-quarter of hospital blood needs are not being met.

"Pandemic challenges

"The Red Cross continues to confront relentless challenges due to COVID-19, including about a 10% overall decline in the number of people donating blood as well as ongoing blood drive cancellations and staffing limitations. Additionally, the pandemic has contributed to a 62% drop in blood drives at schools and colleges.

************

Here's a story on breast milk from the Guardian:

‘Now, now, now. We need help now’: US warning over breast milk shortage as donations plunge. Demand for breast milk has surged during the pandemic, but supply from milk banks has fallen as people head back to work.  by Melody Schreiber

"“​​Demand has been surging in hospitals, primarily,” said Lindsay Groff, the executive director for the Human Milk Banking Association of North America (HMBANA). “At the same time, supply has dipped.”

"At all 31 milk banks in the US and Canada associated with HMBANA, milk donations are declining, down as much as 20% in some places.

"Milk bank directors say they’re not at a crisis point yet, but they will be if shortages continue.

“There’s no need to panic,” Groff said. But if “you feel compelled to help someone [by donating breast milk] – now is the time. Now, now, now, we need help now.”

"Donated breast milk can help medically fragile infants – those that are “too small and too soon and too sick”, as Kim Updegrove, executive director of Mothers’ Milk Bank at Austin, puts it – to overcome a range of potentially devastating conditions, from prematurity complications to heart and stomach problems. Necrotizing enterocolitis, an inflammation of the intestines, is a leading cause of death for premature babies, but breast milk can help prevent it.

...

" the pandemic has increased the need for donor milk. Studies have shown that contracting Covid-19 during pregnancy when you’re not vaccinated increases the chance of having a premature baby, who might then benefit from donor milk. Parents who become very ill from Covid are often unable to care for their babies or to pump milk for them.

Blood donation, risk groups, and blood tests

 Before blood tests were developed for hepatitis virus and later for HIV, it made sense to screen potential blood donors by whether they were members of broad risk categories.  As tests have improved (and I think we still don't have those for prion based diseases like mad cow disease), it makes more sense to rely on testing, although risky behavior that might have recently resulted in infection, not yet detectable by blood tests, is still a screening factor.

All this is by way of saying that the current U.S. limitation on donation by homosexual men is out of date. Martha Gershun points me to this recent op-ed in the Baltimore Sun:

As a sexually active gay man, I can’t donate blood or tissue in America. That’s ridiculous | By GREG BRIGHTBILL

"My blood type is O negative, I am healthy, I can run a half-marathon, I do not smoke or use drugs, I only have two to three drinks a week, and I am in a committed relationship. Yet, due to homophobic stereotypes and outdated policies, gay men like myself  -- termed “MSM” or “men who have sex with men” -- cannot freely donate blood and soft tissue in America.

"According to the most recent Food and Drug Administration guidance, updated last year, MSMs must undertake a three-month deferral from male-to-male sexual activity before blood donation. Shockingly, that’s an improvement on the original full ban on blood donation implemented in 1985 (for any male who had a sexual encounter with another male after 1977) and the 2015 version of the policy, which required a 12-month deferral.

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In the UK, the guidelines have been changed, this month, to reflect the increased availability of testing. Here's the latest from the UK's NHS Blood and Transplant:

Landmark change to blood donation eligibility rules on today’s World Blood Donor Day  

"New eligibility rules that will allow more men who have sex with men to donate blood, platelets and plasma come into effect this week, marking an historic move to make blood donation more inclusive while keeping blood just as safe."

"From today (Monday) – World Blood Donor Day – the questions asked of everyone when they come to donate blood in England, Scotland and Wales will change. Eligibility will be based on individual circumstances surrounding health, travel and sexual behaviours evidenced to be at a higher risk of sexual infection.

"Donors will no longer be asked if they are a man who has had sex with another man, removing the element of assessment that is based on the previous population-based risks.

"Instead, any individual who attends to give blood - regardless of gender - will be asked if they have had sex and, if so, about recent sexual behaviours. Anyone who has had the same sexual partner for the last three months will be eligible to donate.

...

“We screen all donations for evidence of significant infections, which goes hand-in-hand with donor selection to maintain the safety of blood sent to hospitals. All donors will now be asked about sexual behaviours which might have increased their risk of infection, particularly recently acquired infections. This means some donors might not be eligible on the day but may be in the future."

...

"Under the changes people can donate if they have had the same sexual partner for the last three months, or if they have a new sexual partner with whom they have not had anal sex, and there is no known recent exposure to an STI or recent use of PrEP or PEP. This will mean more men who have sex with men will be eligible to donate.

"Anyone who has had anal sex with a new partner or with multiple partners in the last three months will be not be able to give blood right now but may be eligible in the future. Donors who have been recently treated for gonorrhoea will be deferred. Anyone who has ever received treatment for syphilis will not be able to give blood."

The rise and fall of convalescent plasma as a treatment for Covid

 The NY Times follows the story:

The Covid-19 Plasma Boom Is Over. What Did We Learn From It?  The U.S. government invested $800 million in plasma when the country was desperate for Covid-19 treatments. A year later, the program has fizzled.  By Katie Thomas and Noah Weiland

"In those terrifying early months of the pandemic, the idea that antibody-rich plasma could save lives took on a life of its own before there was evidence that it worked. The Trump administration, buoyed by proponents at elite medical institutions, seized on plasma as a good-news story at a time when there weren’t many others. It awarded more than $800 million to entities involved in its collection and administration, and put Dr. Anthony S. Fauci’s face on billboards promoting the treatment.

"A coalition of companies and nonprofit groups, including the Mayo Clinic, Red Cross and Microsoft, mobilized to urge donations from people who had recovered from Covid-19, enlisting celebrities like Samuel L. Jackson and Dwayne Johnson, the actor known as the Rock. Volunteers, some dressed in superhero capes, showed up to blood banks in droves.

...

"But by the end of the year, good evidence for convalescent plasma had not materialized, prompting many prestigious medical centers to quietly abandon it. By February, with cases and hospitalizations dropping, demand dipped below what blood banks had stockpiled.

...

"All told, more than 722,000 units of plasma were distributed to hospitals thanks to the federal program, which ends this month."

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There were also parallel private efforts that mobilized convalescent plasma donation through social media, and via faith based organizations.  I followed some of the science in a series of posts on plasma and plasma donation more generally.  I should note that, although convalescent plasma hasn't emerged as a treatment for Covid-19, it continues to have many very well documented life-saving uses.

Nicola Lacetera, on The Ethics and Economics of Paying Plasma Donors

Nicola Lacetera is among the leaders in studying public views about compensating donors of various sorts. Here he discusses the plasma supply, which is particularly timely given the growing availability of convalescent plasma for Covid-19. (30 minutes)

Peter Jaworski on The Case for Voluntary Remunerated Plasma Collections

Peter Jaworski makes the case for allowing compensation of plasma donors in the wealthy nations of the British Commonwealth:

Bloody Well Pay Them: The Case for Voluntary Remunerated Plasma Collections
BY PETER JAWORSKI JUNE 14, 2020

Here's the executive summary ( a long summary of a long paper):

"•Blood plasma is used in a wide, and growing, range of life-saving therapies. It is now being trialled to treat Covid-19, including by the United Kingdom’s National Health Service.

• There are significant global shortages of blood plasma. Demand is growing at a rate of 6-10% per year. Three-quarters of people do not have access to the appropriate plasma therapy, largely outside of developed countries.
• Shortages are significantly exacerbated by the World Health Organisation’s policy — adopted by the United Kingdom, Australia, New Zealand and some Canadian provinces — to rely exclusively on Voluntary Non-Remunerated Blood Donations (VNRBD).
• The United Kingdom imports 100% of its supply of blood plasma, Canada (84%), Australia (52%), and New Zealand (13%). They are increasingly dependent on imports for blood plasma from countries that remunerate donors. This inflates the global blood plasma price, making it unaffordable for low to middle income countries.
• The United States, which allows remuneration of donors, is responsible for 70% of the global supply of plasma. Together with other countries that permit a form of payment for plasma donations — including Germany, Austria, Hungary, and Czechia —they account for nearly 90% of the total supply. The dependence on a small number of countries is a serious health security threat.
• Non-remunerated donations are estimated to be 2-4 times more expensive than remunerated collections, because of the expense of recruiting and retaining donors, including through marketing. Australia, for example, could save $200 million annually by importing all blood plasma.
• There are significant global shortages of plasma therapies. The growing global demand cannot be met without remuneration.
• The evidence is clear that remunerating individuals for blood plasma donations is safe, would ensure a secure supply of plasma, does not discourage non-remunerated blood donations, and would provide significant patient benefits, including peace of mind.
• In order to ensure a safe, secure, and sufficient supply of plasma therapies, the United Kingdom, Canada, Australia, and New Zealand should adopt Voluntary Remunerated Plasma Collections (VRPC):
• VRPC means individuals are paid, in cash or in-kind, to give plasma of their own free will. It also means collections using modern deferral and testing techniques, such as deferring higher-risk donors and advanced viral detection tests.
• VRPC would allow the Canzuk countries to at the very least become self-sufficient, and potentially contribute to the humanitarian goal of increasing the global supply of blood plasma for low to middle income countries."

Here's a description of the historical setting:

"On June 11, 2009, the World Health Organization (WHO) issued “The Melbourne Declaration on 100% Voluntary Non-Remunerated Donation of Blood and Blood Components.”  The Declaration was a re-commitment to, what they call, “Voluntary Non-Remunerated Blood Donations” or VNRBD,” as well as to World Blood Donor Day, celebrated every June 14th.  The Declaration set a target date for achieving 100% VNRBD in safe, secure, and sufficient blood and blood products, including plasma-derived medicinal products. That target date was 2020.
...
"This year will end without a sufficient supply of plasma based on 100% non-remunerated plasma collections, neither will 2030. With each passing year from 2009 to the present, the world has moved further from that target, and closer to being nearly entirely dependent on the United States."

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Before publishing the paper, Jaworski solicited some supportive quotes to use as blurbs.  Here's mine:

Nobel Prize winning economist Alvin Roth says of the current over-reliance on the US’ paid donor market:
“I find confusing the position of some countries that compensating domestic plasma donors is immoral, but filling the resulting shortage by purchasing plasma from the U.S. is ok.”

Blood and plasma: a brief history, from 1628

With all my discussion of convalescent plasma for Covid-19 this week*, here's a historical perspective on the technology and changes in medical practice since the discovery of blood circulation in 1628 that allows blood and plasma to be used in medicine.


A history of blood transfusion: a confluence of science—in peace, in war, and in the laboratory
by Kevin R. Loughlin
Hektoen International, Volume 12, Issue 2 – Spring 2020.

"Since 1628 when William Harvey discovered the circulation of blood, there had been hope that blood transfusion would be possible.
...
"After Harvey’s discovery, transfusion attempts began. In 1665 Richard Lower kept dogs alive by transfusing blood from other dogs.2 In 1667 French physician Jean Denys transfused nine ounces of blood from the carotid artery of a lamb into the vein of a young man. He continued the practice until the third patient so treated, died.3 Denys was sued by the wife of the deceased patient, who presumably died from a hemolytic reaction, but was exonerated. However, the French Parliament, the Royal Society, and the Catholic Church subsequently issued a general prohibition against transfusions.4

"It would not be until 1818 when transfusions were seriously considered again. A British obstetrician, James Blundell, performed a human blood transfusion in the setting of a postpartum hemorrhage.5 However, the debate over transfusions continued over the remainder of the nineteenth century. In 1849 C.H.F. Routh reviewed all the published transfusions to date and remarked in the Medical Times that of the 48 recorded cases, 18 had a fatal outcome and concluded that the mortality rate was unacceptably high.5 The next major advance in transfusion therapy would wait until the turn of the century.

"Karl Landsteiner was an Austrian physician and immunologist. While working at the University of Vienna, he became interested in blood serum work, specifically the factors that led to hemagglutination of red blood cells. This resulted in two landmark publications in 1900 and 1901 that described the evidence of blood groups that he named A, B, and C.6,7 These would later be modified to A, B, and O. Two years later, two of his colleagues, Alfred Von Decastelo and Adriano Sturli, would add a fourth blood type, AB.8,9 Landsteiner would be awarded the Nobel Prize in 1930 for his elucidation of the blood groups.

... in 1912, Doctor Roger Lee demonstrated that O blood could be given to a person of any blood type (universal donor) and that a person with AB blood could receive blood from any blood group (universal recipient).
...
"As blood transfusions became more widespread in medical practice, the concept of establishing blood banks became attractive. In the 1930s Bernard Fantus at Cook County Hospital20 and Carl W. Walter at Peter Bent Brigham Hospital started blood banks. In Boston, Walter’s efforts were viewed with such skepticism and disdain that his facility was relegated to a basement room at Harvard because some trustees thought the storage and use of blood was “immoral and unethical.”21 Fifteen years later he invented the plastic blood bag, which greatly facilitated transfusion therapy.21
...
"In 1940 Edwin Cohn developed ethanol fractionation, the process of breaking down plasma into component products. Albumin, gamma globulin, and fibrinogen were isolated to become available for clinical use.

"In 1944 dried plasma became available for the treatment of combat injuries. Component transfusion therapy became more widely used as the war progressed. The Red Cross concluded its World War II blood program in 1945 after 13 million pints had been collected.11

"In 1961 platelet concentrates became recognized for reducing mortality from hemorrhage in cancer patients. In 1964 plasmapheresis was introduced as a means of collecting plasma for fractionation. In 1971 Hepatitis B surface antigen (HbsAg) testing of donated blood began and in 1992 testing of donor blood for HIV-1 and HIV-2 antibodies commenced.
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*here's a recap of my earlier coronavirus posts relating to plasma this week:

Sunday, May 17, 2020

Cascades of convalescent plasma for Covid-19, and chains of exchanges, by Kominers, Pathak, Sönmez, and Ünver

Monday, May 18, 2020

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

Wednesday, May 20, 2020

Convalescent plasma collection and distribution

Buying and selling blood plasma, with focus on Canada, continued

Peter Jaworski writes:

"I had a video with Big Think come out recently where I defend paying for plasma against a number of objections. It’s a bit on the long side (17 minutes), but I thought you might be interested in posting it to your blog: https://bigthink.com/videos/paid-plasma-ethics

"I also had an opinion piece on the same topic published in the National Post (with Kate Vander Meer, who is a patient that used plasma therapies): https://nationalpost.com/opinion/opinion-on-covid-19-canada-needs-to-pay-plasma-donors-to-protect-its-domestic-supply?video_autoplay=true"

From the video transcript:

"Out of all the countries in the world only the ones that pay people to make that donation are self-sufficient in plasma therapies. And even the ones that pay not all of them are, in fact, sufficient. So there are only seven countries in the world that legally permit paying people for plasma donations – Germany, Austria, Hungary, Czechia or the Czech Republic, parts of Canada. And I'll talk about Canada in a second. The United States, of course, and China. Those are the seven countries in the world that permit payment. Every other country that does not allow payment for plasma donations imports plasma therapies that make use of plasma primarily from Americans. Germans as well, but primarily Americans. "
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And here's the op-ed:

Opinion on COVID-19: Canada needs to pay plasma donors to protect its domestic supply
Kate Vander Meer and Peter Jaworski: In order to ensure that enough people are willing to give plasma to meet the ever-expanding need, we must urgently adopt a pay-for-plasma model here at home

"There’s no evidence that anything other than paying for plasma will work. According to an expert panel formed by Health Canada in 2018, paid donors in countries that permit payment are responsible for providing 89 per cent of the plasma used to make therapies, with the United States alone providing 70 per cent of the global supply. The panel also revealed that no country in the world that forbids paid donations collects enough plasma to meet its needs — not one!"

Plasma donation, "convalescent plasma" and Covid-19 antibodies

Blood plasma is a big source of antibodies for people who don't make their own, and in these days of Covid-19 pandemic, antibodies are again in the news. As the number of recovering patients grows, can the antibodies they produce be of help in stemming the spread of the disease, or in curbing its intensity?

Here's a just published report of a quite preliminary study from China, in the PNAS:

Effectiveness of convalescent plasma therapy in severe COVID-19 patients
by Kai Duan, ... Xiaoming Yang (46 authors)
PNAS first published April 6, 2020 https://doi.org/10.1073/pnas.2004168117
Contributed by Zhu Chen, March 18, 2020 (sent for review March 5, 2020; reviewed by W. Ian Lipkin and Fusheng Wang)


"Significance: COVID-19 is currently a big threat to global health. However, no specific antiviral agents are available for its treatment. In this work, we explore the feasibility of convalescent plasma (CP) transfusion to rescue severe patients. The results from 10 severe adult cases showed that one dose (200 mL) of CP was well tolerated and could significantly increase or maintain the neutralizing antibodies at a high level, leading to disappearance of viremia in 7 d. Meanwhile, clinical symptoms and paraclinical criteria rapidly improved within 3 d. Radiological examination showed varying degrees of absorption of lung lesions within 7 d. These results indicate that CP can serve as a promising rescue option for severe COVID-19, while the randomized trial is warranted."
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Here's a story from the WSJ:

Coronavirus Survivors Keep Up the Fight, Donate Blood Plasma to Others
National Covid-19 project seeks volunteers to aid the seriously ill; ‘I feel obligated to help’
By Amy Dockser Marcus

"The Mount Sinai Hospital in New York, where Mr. Sherman volunteered to donate plasma, is one of 34 institutions around the country participating in the National Covid-19 Convalescent Plasma Project, which is seeking blood-plasma donations from recovered patients who have a confirmed Covid-positive test and are at least 21 days out from the onset of symptoms.
...
“The biggest problem is not the lack of donors,” said Arturo Casadevall, a professor at the Johns Hopkins Bloomberg School of Public Health, in Baltimore, and one of the organizers of the national project. “It is the logistics of figuring out how people who want to participate can actually donate.”

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And here's a plasma industry press release:

Global Plasma Leaders Collaborate to Accelerate Development of Potential COVID-19 Hyperimmune Therapy

"Osaka, JAPAN, and King of Prussia, PA, USA – April 6, 2020 –  Biotest, BPL, LFB, and Octapharma have joined an alliance formed by CSL Behring (ASX:CSL/USOTC:CSLLY) and Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) to develop a potential plasma-derived therapy for treating COVID-19. The alliance will begin immediately with the investigational development of one, unbranded anti-SARS-CoV-2 polyclonal hyperimmune immunoglobulin medicine with the potential to treat individuals with serious complications from COVID-19.
...
"Developing a hyperimmune will require plasma donation from many individuals who have fully recovered from COVID-19, and whose blood contains antibodies that can fight the novel coronavirus. Once collected, the “convalescent” plasma would then be transported to manufacturing facilities where it undergoes proprietary processing, including effective virus inactivation and removal processes, and then is purified into the product."

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My other posts on plasma, mostly focused on repugnance to compensation for donors. Here's one that explains some of the underlying medical issues:

Thursday, July 11, 2019

Plasma shortage alert from the IDF--the Immune Deficiency Foundation