Breast milk donation--Guinness World Record

 While 'altruism isn't enough' when it comes to SoHOs as Sally Satel reminds us, it's well worth celebrating.  

Here's some news from the Guinness World Records

Big-hearted mom donates record levels of breastmilk to help over 350,000 premature babies
By Vicki Newman

"A kind-hearted mom has helped hundreds of thousands of premature babies by donating more than 2,600 litres of breastmilk.

"Alyse Ogletree (USA) has reclaimed the record for largest donation of breastmilk by an individual with an incredible 2,645.58 litres (89,457.85 US fl oz; 93,111.55 UK fl oz) as of July 2023.

"The 36-year-old, from Texas, first broke the record back in 2014 with a measurement of 1,569.79 litres (53,081 US fl oz; 55,249 UK fl oz).

"Her donations were all made to Mothers' Milk Bank in North Texas, although she’s donated even more that didn’t count towards her total, to close friends and Tiny Treasures Milk Bank.

...

"She had no idea that donating milk was a thing until she found that she was making more than a normal amount of it.

"She explained: “I was overproducing and throwing away milk, unaware overproduction was unique and other mothers struggled.

“Our first child, Kyle, was in the hospital, and I was filling the nurses’ freezer. A nurse asked if I was donating, which I didn’t know was possible, and that is when I learned about it.

...

"Alyse, who is also mom to Kage, 12, and Kory, seven, and has been a surrogate for another, went on: “I got pregnant with my second, Kage, I was excited I would donate again.

“A few months into the pregnancy, there was a news article about someone breaking a Guinness World Record[s title] for donating milk. I did the math and realized I would break that record within three months of donating again if my production rate was as it was before.”

...

"She donated again following the birth of youngest son Kory and again after she acted as a surrogate mom.

“It’s one of the best feelings in the world,” she said.

...

"Visit the Mothers' Milk Bank website to learn more about donating breastmilk."

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

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

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

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

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

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

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

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

##########

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

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

#########
 

Earlier:

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

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

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

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."

Markets in human milk, placenta, and feces

I've blogged earlier about markets for breast milk, but here is an article that considers them also in connection with placenta and feces: 

The Law of Self-Eating—Milk, Placenta, and Feces Consumption by Mathilde Cohen, Law, Technology and Humans, 3(1), pp.109-122.

"Milk, Placenta, and Feces 

"Since antiquity at least, there have been markets in human milk. Until the twentieth century, they relied primarily on wet nurses hired (or forced) to nurse infants directly on the breast.14Ancient Egyptian, Greek, and Roman pharmacopeias called for human milk as a therapeutic substance to treat burns as well as ailments affecting the ears, eyes, and genitals.15Traditional Chinese medicine  employed  human  milk  in  a  variety  of  preparations  to  cure  diseases,  such  as  debilitation,  arthritis,  rheumatism, voicelessness, amenorrhea, eye infections, and poisoning.16

"Today, markets in human milk continue to thrive.17Such markets assume two main forms: 1) informal markets through which people give or sell their milk peer-to-peer via their social circles or online; and 2) formal markets whereby profit or non-profit organizations, such as milk banks and commercial human milk companies, collect, process, and distribute milk to hospitals and a few outpatients for a fee. Human milk is sought after by three main categories of consumers: infants, adults, and researchers.

...

"Placenta

"Human placentas are used for spiritual, nutritional, medical, pharmaceutical, and cosmetic purposes. Placentophagy, or the act of eating one’s placenta after childbirth, has been practiced in the Global North since the beginningof the home-and natural-birth movement in the 1970s.22It is not an unprecedented phenomenon. Indeed, historian Jacques Gélis reported that:

    "Placentophagy, the custom of eating the newly expelled placenta,     has existed at various times amongst people of very different         cultures. From the sixteenth century onwards, European travellers to     the new world were much struck by this custom, which they         unfailingly reported.23

"According to Gélis, placentophagy was also practiced in Europe; however, “doctors and churchmen  were  more  and  more repelled, from the end of the seventeenth century onwards, by this custom . . . so ‘repugnant to humanity."  In the past decade, placentophagy has reemerged as a mainstream practice in the U.S., where it has been described as “anew  American  birth ritual.25

"Few randomized controlled trials have corroborated the benefits of placentophagy. However, placenta eaters are motivated by the hope of obtaining nourishment, hastening post-birth recovery, warding off postpartum depression, facilitating lactation, as well as spiritual motives, such as connecting with the baby and the environment. Placentas can be eaten raw or cooked."

...

"Minimally processed placental membranes have significant commercial and medical potential to treat, among other indications, eye diseases and acute and chronic wounds. The for-profit American company MiMedx also “grinds up amniotic tissue from placenta into an injectable product to treat tendinitis, strains, and other ailments.”29Much  like  human  milk,placentas  are increasingly seen as reservoirs of stem cells and thus are attractive to the field of regenerative and tissue engineering, and, more recently, as potential sources for treating coronavirus patients."

...

"Feces

"Excrement is typically regarded as disgusting; however, the medical use of human and animal feces has a long record. Heinrichvon Staden notes that:

"Most prominent among the ingredients in the Hippocratic pharmacological ‘dirt’ arsenal is the excrement of various animals. ..  .  the  belief  in  the  therapeutic  usefulness  of  excrement  was  shared  by  ancient  Mesopotamian,  Egyptian,  Greek,  Chinese, Talmudic, and Indian healers. . . . There is, therefore, abundant evidence that . . . ‘excrement therapy’—was a cross-cultural phenomenon extant already in the ancient world.32

"In Chinese medicine, human feces were used 1,700 years ago as a “suspension by mouth for patients who had food poisoning or severe diarrhea.”33

"Fast forward to the twentieth century, the community of microorganisms that dwell in the human gut has been shown to play a crucial role in human health. Fecal microbiota transplantation (“FMT”) was first identified in the modern scientific literature in 195834and has rapidly grown in popularity since the early 2010s. FMT consists in the delivery of processed stool from a healthy donor into the intestinal tract of a sick person via an enema, colonoscopy, naso-duodenal tube, capsules, or other means. As microbiologist Mark Smith and his colleagues noted, “the goal is to displace pathogenic microbes from the intestine by re-establishing a healthy microbial community.”35FMT  has  proven  strikingly  effective  in  treating Clostridium  difficile, a potentially lethal infection that most commonly affects older adults in hospitals or in long-term care facilities, typically after the  use  of  antibiotics."

...

"Despite these differences, milk, placenta, and feces share two sets of core similarities that justify their grouping in this analysis. First, milk, placenta, and feces are tissues that can be severed from the body without harm or risk of harm. Notably, milk and feces  are  replenishable  bodily  substances,  while  the  placenta  is  a  transient  organ  expelled  from  the  body  during  childbirth. Thus, far from constituting “corpse medicine”42(i.e., medicine that uses human materials obtained from dead bodies), the use of such substances can be characterized as living food or medicine. There are also no adverse health effects associated with the act of donation. Quite the opposite, good health requires that people eject the milk, placenta, and feces they produce from their bodies.  

...

"Second, these three products have similar channels of circulation, including via private, domestic consumption, peer-to-peer markets, medical and research institutions, and global markets in foods, drugs, and cosmetics. This wide scope for circulation is possible due to the potential for DIY treatments alongside higher tech uses involving special processing and expertise. Milk, placenta, and feces are collected, processed, and distributed by banks similar to other tissue banks; however, aspiring consumers can  also  obtain  milk,  placenta,  and  feces  and  use  them  on  their  own.  Unlike  blood  transfusion  or  organ  transplantation,  no professional expertise or complicated equipment is necessary to achieve basic forms of consumption. Milk, placenta, and fecescan be obtained directly from their producersafter some screening (or not) and consumed as is or minimally processed at home. Conversely, bio-banks systematically screen donors, subjecting them and their samples to a battery of tests, before processing their  products  in  various  ways;  for  example,  by freezing,  thawing,  pooling,  enriching,  freeze-drying  (in  the  case  of  milk), irradiating (in the  case of placenta), encapsulating (in the  case of stool). This is a fast-evolving field.

...

"No uniform perspective  has emerged on the  legal  classification of the  various body materials consumed by humans. In this respect, milk, placenta, and feces provide a case in point, as they do not fit neatly within the standard legal classifications for comparable products, such as foods, drugs, tissues, cosmetic ingredients, or waste products. Different countries have adopted contrasting legal regimes—or no regimes at all—to regulate these substances.

...

"In  the  so-called  post-colonial  era,  the  law  of  self-consumption  illustrates  the broader phenomenon of a “jurisprudence of disgust,” to use an expression that Alison Young developed to describe the legal censorship of provocative or “obscene” artwork.71A  significant  dimension  of  contemporary  law  making  can  be  characterized  as  a  response  to  what  is  considered disgusting around or among us, which reflects an endeavor to confine and tame what repulses us. This is particularly obvious in the context of what legal scholar Kim Krawiec calls “taboo trades” (and economist Alvin Roth dubs “repugnant markets”); that is, the exchanges and transactions of products that are considered culturally immoral and uncaring, such as those involving organs, babies, sex, drugs, and corruption."

Artificial breast milk may be on the cellular agriculture horizon

 Cellular agriculture isn't just aspiring to produce meat; now breast milk is queueing up as a (still distant) possibility.

The New Yorker has the story:

Biomilq and the New Science of Artificial Breast Milk. The biotech industry takes on infant nutrition. By Molly Fischer

"New ventures in the world’s oldest food reflect our era’s enthusiasm for tech-based solutions to perennial human problems."

...

"The process of making breast milk in a human body begins during pregnancy, when hormonal changes prompt mammary cells to multiply. After delivery, two of the pregnancy hormones—estrogen and progesterone—drop off, while prolactin remains. This spurs the mammary cells to draw carbohydrates, amino acids, and fatty acids from the mother’s bloodstream, and to convert these raw materials into the macronutrients required to feed a baby. In Biomilq’s case, the mammary cells come from milk and breast-tissue samples provided by donors, and the cells multiply in vitro under the care of a team of scientists tasked with keeping them “happy.” The cells are then moved to a hollow-fibre bioreactor—a large tube filled with hundreds of tiny porous tubes that are covered in a layer of the lab-grown cells. As nutrients flow through the small tubes, the cells secrete milk components into the large tube, where they collect.

"Describing the results as “milk components,” not “milk,” is a crucial distinction. Biomilq has demonstrated that its technology can produce many of the macronutrients found in milk, including proteins, complex carbohydrates, and bioactive lipids, but it cannot yet create them in the same ratios and quantities necessary to approximate breast milk. Other elements of breast milk are beyond the scope of the company’s ambition. A mother’s antibodies, for example, are present in her milk, but they aren’t produced by the mammary cells, and, because Biomilq’s product will come from a sterile lab environment, it won’t offer any kind of beneficial gut bacteria.

...

"“It’s as fraught as abortion,” Jacqueline Wolf, an emeritus historian of medicine at Ohio University and the author of a history of breast-feeding and formula in the U.S., aptly titled “Don’t Kill Your Baby,” told me. “There’s almost nothing that raises more social issues than infant feeding.” Wolf dates the emergence of what became known as “the feeding question” to the eighteen-seventies, when mothers across the country began raising concerns about their milk supply. “The big change that was sparked by urbanization and industrialization was suddenly having to pay attention to a mechanical clock,” she said. Earlier infant-care manuals had advised feeding a baby when he showed signs of hunger. Now medical advice put infants on feeding schedules as rigid as railway timetables. But, as Wolf pointed out, “to build up a milk supply, you need to put the baby to the breast often, especially in the first few months.” The women complaining that they lacked sufficient milk were not, as one theory had it, suffering from the ill effects of too much education during puberty. Rather, they were following advice unwittingly engineered to fail.  

...

"By the nineteen-forties, most mothers were giving birth in hospitals, where orderly routine—babies in nurseries, bottles on schedules—often took priority over the personal attention required to initiate breast-feeding. 

...

"Commercial infant formula from brands such as Similac and Enfamil took off in the fifties—a modern amenity that sat comfortably alongside Betty Crocker cake mix and Cheez Whiz. (Formula had also made it easier for women to work outside the home.) At the same time, the decade saw the rise of some of breast-feeding’s most influential evangelists. The La Leche League was founded in 1956 by seven Catholic housewives in the Chicago suburbs who wanted to create a forum for breast-feeding mothers to share questions and advice. La Leche occupied a tricky cultural position, at once radical and conservative: on the one hand, it encouraged women to claim control of their bodies and to defy voices of institutional authority; on the other, the intended result of this rebellion was a world in which a mother’s place was unequivocally at home.

...

"Meanwhile, the alternative to breast-feeding—formula—began to take on a sinister light. An industry that had presented itself as a best friend to mid-century mothers showed a different face in its dealings abroad. New reports linked Nestlé’s aggressive marketing of formula to infant deaths in the Global South, making the case that the company’s product had been pushed on families who lacked the resources (such as clean water) to bottle-feed safely. Instead of a scientifically perfected modern convenience, formula became “The Baby Killer,” in the words of one influential pamphlet. A years-long global boycott of Nestlé ensued. In 1981, the World Health Organization adopted a resolution that aimed to ban the promotion of substitutes for breast milk. The U.S. was the only country in opposition. (Today, Nestlé stresses its compliance with W.H.O. code.)

...

"products intended to provide complete infant nutrition (that is, formulas) must clear more hurdles than other foods. A new product must, among other things, undergo what are essentially clinical trials, which can involve recruiting hundreds of babies to participate.

...

"The distribution of human breast milk has traditionally taken place at nonprofit milk banks, and recent attempts to introduce commerce into this transaction have stirred controversy. In 2014, a company called Medolac, selling shelf-stable human milk, announced that it would expand its milk-bank program in Black communities in Detroit. The plan was scrapped after backlash from community groups and activists, who called out the company for its low pay in comparison with its pricing and for reinforcing historical injustice. (At the time, the company denied allegations of exploitation.) Biomilq seems keen to avoid any impression of similar obliviousness. Egger told me that the company has encouraged employees to read Andrea Freeman’s “Skimmed,” an account of racial inequities perpetrated by the formula industry. And even as Biomilq describes itself as “women-owned” and “mother-centered,” it also notes that “lactation is not only for cisgender biological mothers.” 

********

Related posts on breast milk.

The market for (and marketing of) baby formula

 The Lancet has a series of articles on baby formula.  It begins with this editorial, and is followed by three articles:

Unveiling the predatory tactics of the formula milk industry, The Lancet, Published: February 07, 2023 DOI:https://doi.org/10.1016/S0140-6736(23)00118-6

"For decades, the commercial milk formula (CMF) industry has used underhand marketing strategies, designed to prey on parents' fears and concerns at a vulnerable time, to turn the feeding of young children into a multibillion-dollar business. The immense economic power accrued by CMF manufacturers is deployed politically to ensure the industry is under-regulated and services supporting breastfeeding are under-resourced. These are the stark findings of the 2023 Breastfeeding Series, published in The Lancet today."

******

VOLUME 401, ISSUE 10375, P472-485, FEBRUARY 11, 2023 Breastfeeding: crucially important, but increasingly challenged in a market-driven world, by Prof Rafael Pérez-Escamilla, PhD  Cecília Tomori, PhD Sonia Hernández-Cordero, PhD Phillip Baker, PhD Aluisio J D Barros, PhD MD France Bégin, PhD Donna J Chapman, PhD Laurence M Grummer-Strawn, PhD Prof David McCoy, PhD Purnima Menon, PhD Paulo Augusto Ribeiro Neves, PhD Ellen Piwoz, PhD Prof Nigel Rollins, MD Prof Cesar G Victora, PhD MD Prof Linda Richter, PhD on behalf of the 2023 Lancet Breastfeeding Series Group†  Open Access Published: February 07, 2023 DOI:https://doi.org/10.1016/S0140-6736(22)01932-8

"When possible, exclusively breastfeeding is recommended by WHO for the first 6 months of life, and continued breastfeeding for at least the first 2 years of life, with complementary foods being introduced at 6 months postpartum.9 Yet globally, many mothers who can and wish to breastfeed face barriers at all levels of the socioecological model proposed in The Lancet's 2016 breastfeeding Series."

 VOLUME 401, ISSUE 10375, P486-502, FEBRUARY 11, 2023 Marketing of commercial milk formula: a system to capture parents, communities, science, and policy by Prof Nigel Rollins, MD  Ellen Piwoz, ScD Phillip Baker, PhD Gillian Kingston, PhD Kopano Matlwa Mabaso, PhD Prof David McCoy, DrPH  Paulo Augusto Ribeiro Neves, PhD  Prof Rafael Pérez-Escamilla, PhD  Prof Linda Richter, PhD  Prof Katheryn Russ, PhD  Prof Gita Sen, PhD  Cecília Tomori, PhD  Prof Cesar G Victora, MD  Paul Zambrano, MD  Prof Gerard Hastings, PhD  on behalf of the 2023 Lancet Breastfeeding Series Group  Open Access Published:  February 07, 2023 DOI:https://doi.org/10.1016/S0140-6736(22)01931-6

"Despite proven benefits, less than half of infants and young children globally are breastfed in accordance with the recommendations of WHO. In comparison, commercial milk formula (CMF) sales have increased to about US$55 billion annually, with more infants and young children receiving formula products than ever. "

 VOLUME 401, ISSUE 10375, P503-524, FEBRUARY 11, 2023 The political economy of infant and young child feeding: confronting corporate power, overcoming structural barriers, and accelerating progress by Phillip Baker, PhD Julie P Smith, PhD Prof Amandine Garde, PhD Laurence M Grummer-Strawn, PhD Benjamin Wood, MD Prof Gita Sen, PhD Prof Gerard Hastings, PhD  Prof Rafael Pérez-Escamilla, PhD  Chee Yoke Ling, LLB  Prof Nigel Rollins, MD Prof David McCoy, DrPH  on behalf of the 2023 Lancet Breastfeeding Series Group†  Open Access Published: February 07, 2023 DOI:https://doi.org/10.1016/S0140-6736(22)01933-X

"The first and second papers in this Series8,  9 present several reasons for the global rise of CMF in human diets, including the CMF industry's exploitation of parental anxieties; ubiquitous marketing; and absent or inadequate protection and support for breastfeeding within health-care systems, work settings, and households. In this Series paper, we look further upstream and examine the root causes of low worldwide breastfeeding rates10 to understand why so many women and families are prevented from making and implementing informed decisions about feeding and caring for infants and young children; why so many policy makers and health-care professionals are co-opted by CMF marketing and other commercial forces; and why so many countries have not prioritised and implemented policies to protect, promote, and support breastfeeding. It is important to note that we use the terms women and breastfeeding throughout this Series for brevity, and because most people who breastfeed identify as women; we recognise that not all people who breastfeed or chestfeed identify as women."

**********

Among my previous posts on milk are some noting that there are shortages of human breast milk, and that in many places the sale of breast milk is banned (in some places out of concern that poor mothers would sell their milk instead of feeding their children, and in some places out of concerns that the sale of breast milk is repugnant even from mothers who produce milk in excess to their children's needs.)  

Thus (in different times, places, and circumstances) there is repugnance both to the sale of mothers' milk and to the sale of substitutes for it.

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.

Breast milk and the marketing of breast milk substitutes during the pandemic

 

Here's an article in the Lancet:

Marketing of breastmilk substitutes during the COVID-19 pandemic by Christoffer van Tulleken, Charlotte Wright, Amy Brown, David McCoy, and Anthony Costello, October 08, 2020DOI:https://doi.org/10.1016/S0140-6736(20)32119-X

"It is of concern that the US$70 billion infant formula industry has been actively exploiting concerns about COVID-19 to increase sales, in violation of the WHO International Code of Marketing of Breast-milk Substitutes (the Code)1 and national law in many countries.

"Globally, infants who are not exclusively breastfed are 14 times more likely to die than infants who are exclusively breastfed.2 Lockdown measures have diminished household income, and the UN World Food Programme estimates that by the end of 2020, 265 million people may be facing food insecurity,3,  4 making breastfeeding even more important. Public bodies that are independent of industry influence, including WHO5,  6 and the Royal College of Paediatrics and Child Health,7 have unanimously asserted that no evidence exists to suggest breastfeeding increases the risk of infants contracting COVID-19, and that skin-to-skin contact remains essential for newborn health and maternal health.

"By contrast, large manufacturers of breastmilk substitutes have inappropriately positioned themselves as sources of public health expertise, and suggested various unnecessary hygiene measures, the use of expressed breastmilk, and the separation of mothers from their babies. Such recommendations undermine breastfeeding and thus increase the risk of infant death. Baby Milk Action and the International Baby Food Action Network8 have documented numerous infringements of both the Code and laws associated with COVID-19."

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

Covid-19 convalescent plasma is a new thing in the world, that came into existence only when the first human was infected and recovered from the Covid-19 disease that is now pandemic. It isn't clear yet whether it will be clinically valuable, but recovered antibodies have been valuable for some other diseases, so there's excellent reason to hope that will be the case now too.  And as the number of people grows who have recovered from Covid-19, it is likely that the supply of antibodies is growing much faster, since antibody-containing plasma can be donated once a month or so. (There are  ongoing studies of antibody production by recovered patients, examining how long the antibodies remain at high levels, post-recovery). Of course, most of that supply is sequestered in the blood of recovered patients, so there's a non-trivial issue of collection and distribution.

As readers of this blog know, many countries prohibit the sale of plasma. Will Americans continue to support a commercial market for Covid-19 convalescent plasma in the current pandemic?  A distinguished group of market designers has written a paper considering how to apply techniques developed for kidney exchange to the task of collecting convalescent plasma from recovered Covid-19 patients, if it becomes impossible to buy and sell it. In particular, they consider how to create chains of donations, without using money, to overcome the shortages they anticipate.

Here's an easy to read account by Scott Kominers, one of the authors.

How to End the Plasma Shortage for Coranavirus Patients

Scott Duke Kominers, Bloomberg News  May 11, 2020

"convalescent plasma is in short supply: although it’s hard to estimate precisely, some statistics suggest the U.S. may need twice as much as we have on hand.

"In a new paper, Parag A. Pathak, Tayfun Sonmez, M. Utku Unver and I propose a market design strategy that could help close the gap. Our approach makes use of two special features of the way plasma donation works.

"First, convalescent plasma is collected from recently recovered patients, which means that today’s patients become tomorrow’s prospective donors, assuming they manage to beat the virus. ... That suggests the shortage isn’t from lack of potential supply.

"Second, plasma donation is more than one-for-one: the typical donor can give enough plasma at one time for multiple treatments, and they can potentially donate more than once. As a result, assuming plasma therapy does help patients recover, there is a so-called flywheel effect: the more we use the treatment, the more plasma is available -- provided enough recovered patients are willing to donate.

"Many people would like to donate plasma to help a loved one, but can’t for various reasons:  Their blood types might be incompatible or they might live far away and be unable to travel. To address these sorts of obstacles, my collaborators and I suggest that each plasma donor could receive a voucher that can be used to give a family member or friend priority for plasma treatment. Because donation is more than one-for-one, it’s possible to honor vouchers while still increasing the pool of plasma available to treat other patients.

...

"A similar analysis suggests a role for a pay-it-forward system, where we make a point of treating patients who pledge to donate plasma, assuming they recover and are medically able to do so. Because recovered patients can typically donate more plasma than was needed for their own treatment, this again can help increase the plasma supply in the long run. As a result, my collaborators and I show that, somewhat paradoxically, prioritizing patients who pledge to donate can still end up expanding treatment for the patients who are unable to pledge, or just choose not to.

"Both of these policies are similar to systems we’ve used to expand kidney donation in the U.S.: Priority vouchers are sometimes granted when a living donor gives a kidney to a third-party before one of their family members needs a transplant. And pay-it-forward incentives are used in kidney exchange chains, where a patient with a medically incompatible prospective donor receives a kidney from a third-party donor, and then their donor later gives a kidney to some other patient."
******
Here is the paper itself:

Paying It Backward and Forward: Expanding Access to Convalescent Plasma Therapy Through Market Design
Scott Duke Kominers, Parag A. Pathak, Tayfun Sönmez, M. Utku Ünver
NBER Working Paper No. 27143
Issued in May 2020

Abstract: COVID-19 convalescent plasma (CCP) therapy is currently a leading treatment for COVID19. At present, there is a shortage of CCP relative to demand. We develop and analyze a model of centralized CCP allocation that incorporates both donation and distribution. In order to increase CCP supply, we introduce a mechanism that utilizes two incentive schemes, respectively based on principles of “paying it backward” and “paying it forward.” Under the first scheme, CCP donors obtain treatment vouchers that can be transferred to patients of their choosing. Under the latter scheme, patients obtain priority for CCP therapy in exchange for a future pledge to donate CCP if possible. We show that in steady-state, both principles generally increase overall treatment rates for all patients—not just those who are voucher-prioritized or pledged to donate. Our results also hold under certain conditions if a fraction of CCP is reserved for patients who participate in clinical trials. Finally, we examine the implications of pooling blood types on the efficiency and equity of CCP distribution.

Here's some of the motivation for their model:

"There is an active debate in economics and philosophy on the appropriate role of market-based

mechanisms with compensation for human products used in medicine or medical research like kidneys, blood, blood products, sperm, breast milk, bone marrow, and other.11 Since, as far as we know, there is no current market where infected patients can buy CCP or where recovered patients can sell CCP, we do not consider this possibility as part of our model.

...

"Because CCP is a form of plasma, a natural question is whether a compensated market for CCP will develop. In our model, there is no option to pay to receive CCP or be paid for donating CCP, but a donor can designate the voucher in our model to particular patient in need. As a result, our model of CCP falls between the two extremes described above. We expect that in a crisis moment, there is unlikely to be an active compensated market for CCP (even though it may be impossible to fully prohibit resale of vouchers). If a price-based market does develop, society may deem it unacceptable."

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

I am more optimistic than they are about the likely available supply of convalescent plasma if it proves useful, through existing commercial channels. My optimism is based on the large thriving commercial market for plasma and plasma-derived antibodies in the U.S., and around the world.  I'll try to blog about the general plasma and antibody (immunoglobulin) market tomorrow, and perhaps more on Covid-19 antibodies later this week.

Regulation of human and animal milk, in the U.S. and France

Here's an article full of interesting observations:

Mathilde Cohen, Regulating Milk: Women and Cows in France and the United States, 65 American Journal of Comparative Law, 469 (2017)


"Much like nineteenth-century milk reformers lobbied for a safe cow's milk supply in the cities, twenty-first-century public health officials are calling for the regulation of human milk.
...
"Milk is peculiar, however, in that, unlike other embodied forms of labor, it is also a food, cutting across species in two ways.15 Humans do not typically eat other humans' body parts or bodily fluids, yet human milk is their primal food.' 6 Humans do not typically turn to animals for sex cells, wombs, or sex, yet they commonly consume animal milk.
...
"The analogy between human and animal milk is sure to offend some. Much of human life and thinking, especially in Western cultures such as France and the United States, is concerned with distinguishing humans from other animals.
...
"I argue that some of the social and legal norms that have shaped the relationship
of the French and Americans to animal milk equally apply to human milk.
Why compare the United States to France? These are two of the biggest dairy consuming and producing countries in the world, 26which regulate animal milk production with little concern for animal welfare. Yet, the French and Americans entertain different cultural and regulatory approaches to human and animal milk, presenting us with a puzzling chiasm. The American sanitary regulation for animal milk is stricter than the French, resulting in a federal ban on raw milk.27 France, the birthplace of pasteurization, 28 is laxer, in part because raw milk is a necessary ingredient in its prized cheeses. With respect to human milk, the picture is reversed. The United States is the more permissive country, a land of no law, where American women can freely trade their milk. In France, human milk is so stringently governed that French women are prohibited from giving their milk to others, even for free, unless they turn to state-controlled milk banks."
...
p486. "In France, at the peak of the wet-nursing profession in the 1880s, close to 100,000 infants were placed in the care of wet nurses-about 10% of the children born in the country at the time."
...
p494. "Under French law the sale of human milk is illegal because milk is considered a bodily part similar to an organ.153 Article 16-1 of the French Civil Code states, "The human body, its elements and its products may not form the subject of a patrimonial right."54 Lactariums possess the exclusive right to process and distribute human milk.1 55 They are prohibited from paying donors for their milk 156-which, incidentally, has resulted in a state of near-constant shortage. Before the HIV/AIDS crisis, lactariums did compensate donors "for the time spent for the milk donation." 157 Since 1992, donors can no longer be indemnified. 158 The official explanation for this shift is that compensation would be contrary to the principle of gratuity of contracts pertaining to bodily parts."
...
p506. "The milk-sharing website, OnlyTheBreast.com, hosts wet-nursing classified ads. A recent example read:
'I am a Surrogate who is due to deliver any time in the next 2-3 weeks. I am an over producer and will not have a child to feed so I am looking for a local family who is in need and would like to provide their baby with liquid gold. I am looking to nurse a baby during work hours (M-F) and can provide pumped milk for over nights and weekends. Occasional weekend feeds can be .'
**************

See my other posts on breast milk.

Compensation for kidney donors debated in WSJ

Familiar positions, clearly stated, pro and con compensation for donors.
There are other reasons put forward for not rewarding organ donation, but the one espoused here (preserving "the ability for one to aspire to virtue") is perhaps the one I have the least sympathy with, as it seems to value the hope of heaven more than saving earthly lives...

How to Provide Better Incentives to Organ Donors
Three experts discuss strategies to address the shortage of organs available for people who need transplants

"We talked about options for increasing organ donation with Sally Satel, a doctor and fellow at the American Enterprise Institute and the beneficiary of two kidney donations; Alexandra Glazier, chief executive of New England Donor Services, which coordinates organ and tissue donation in six New England states and Bermuda; and Andrew Flescher, a professor of public health and English at the State University of New York at Stony Brook, and author of “The Organ Shortage Crisis in America.”
...
"WSJ: The gap between the number of people who need organs and the number of organs available continues to grow. Why is our current model failing to bridge that gap?

DR. SATEL: Having studied the issue for 12 years, since my first kidney transplant, I am convinced that the only solution—before technology makes donation from people obsolete, and it will—is to compensate potential organ donors.

PROF. FLESCHER: The way forward is living donation. Roughly 100,000 out of 120,000 folks who need an organ need a kidney, which can be procured from a living donor, as most of us are born with two kidneys. We need a way of getting everyone to care about the plight of folks on dialysis, not through any coercive measure, of course, but through simple exposure.

MS. GLAZIER: There is no question that need outpaces the supply significantly. That said, it’s important to recognize that the number of deceased organ donors in the U.S. has increased 26% in the past five years (2012-2017) and the number of organs transplanted has increased 28% over the same period. In the New England region, the increase was more than double this rate over the same time period.

...

"PROF. FLESCHER: I certainly do not think paying living donors is the way to go.

DR. SATEL: But what is left? I suppose the real question is what is so aversive about enrichment of some kind? Surely, we do it with plasma, egg, sperm, body, as in donations in medical schools, maternal surrogacy, breast milk, hair. We already pay for body products. And, of course, my colleagues and I do not recommend lump-sum cash, because we do not want to attract desperate, impulsive people who may regret acting. Instead, rewards could include things like tax credits, lifetime health insurance, a contribution to a 401(k) account or a tuition voucher.

PROF. FLESCHER: The introduction of money for a precious good comes at the cost of the ability for one to aspire to virtue, if not as hero, than as a civic-minded, socially conscious neighbor, free to act, and to be perceived as acting, out of the motive to offer help to one in need.

...

"WSJ: Sally, can you please sum up the central tenets of how compensation for living donors would work?

DR. SATEL: The principles of a system of compensation are these: 1. Informed consent. 2. Ensuring health protection, before and after. 3. An ample reward—something trivial amounts to exploitation. 4. Respect for autonomy of people who know what is in their best interest. 5. Expression of gratitude for the lifesaving act they performed.

I suggest a waiting period of six to 12 months to ensure that the would-be donor is sure he or she wants to proceed. And a noncash reward, because a cash reward will appeal to impulsive decision makers, and we need to avoid that.