Article

Breast-milk donor models are flawed: A path forward to meet demand

Breast milk is internationally recognized by the World Health Organization (WHO), the American Academy of Pediatrics (AAP) and the Canadian Pediatric Society (CPS) as an important source of sustenance for infants. As such, an entire industry has developed around breast-milk donations with demand far outstripping supply.

The three main institutions vying for breast-milk donations (non-profit milk banks, for-profit milk banks and online milk sharing) have demonstrated an unwillingness to collaborate with one another, expending time and finances to discredit each other for control of the donor-milk market. The downstream effects of this divisiveness are most felt by mothers and their babies, who end up caught in the middle, unable to access the breast milk they need.

The demand for breast/donor milk is large and increasing for the pediatric/neonatal populations and for premature and lower-birth weight infants treated in the Neonatal Intensive Care Unit (NICU):

–   In 2013, Human Milk Banking Association of North America (HMBNA) supplied 3 million ounces, satisfying a fraction of the 9 to 64 million needed.

–   In 2011, the four leading peer-to-peer milk-sharing websites had more than 13,000 postings.

–   As of July 2015, one website that permits peer-to-peer selling of breast milk claimed to have 49,000 members and 2 million liters within its network.

These statistics are generally believed to be an underrepresentation, due to the many nonpublic ways of communicating.

There are several reasons for the increasing demand for donor milk.

1) Increased recognition of breast milk’s benefits: Formula fails to undergo compositional changes over time and doesn’t contain: cytokines, hormones, enzymes, growth factors, antibodies (mothers vaccinated against or infected with COVID-19 have breast milk with antibodies against the virus) and overall anti-inflammatory properties. Breast milk guards against many complications that severely low birth-weight infants are prone to: sepsis, feeding intolerances, re-hospitalization and damage and necrosis of an infant’s gut/Necrotizing Enterocolitis (NEC).

2) Increasing prematurity rates: One study notes that in 65 European, American and Australasian countries between 1990-2010, preterm births increased from 2 to 2.2 million. Despite an overall reduction in total births, prematurity rates were increasing in 74 per cent of countries.

3) Relatively low breastfeeding rates: Despite an estimated 5 per cent of women being physically incapable of breastfeeding, far more have difficulty doing so. In a study examining prenatally set goals by 3,000 women, 60 per cent intended to breastfeed exclusively. Despite only 1 per cent stating they wanted to breastfeed exclusively for less than a month, 42 per cent ended up doing so. In the NICU setting, many mothers experienced delays in lactation and/or had difficulty expressing sufficient breast milk, with only 27 per cent of NICU mothers in one study being able to do so, even with the aid of lactation consultants.

4) Cost effectiveness: A breast-milk bank costs $800,000 to set up and $500,000 annually to run. These institutions confer dual benefits in that they decrease pediatric morbidity and mortality and are associated with a health-care savings of $1.25 million, which more than offsets the costs associated with milk banks.

5) Formula shortages: Supply-chain issues and safety recalls in 2022 led to a 43 per cent out-of-stock percentage in the U.S. in May and had effects in Canada as well. This issue was compounded by inflation, which led to increases in online milk sharing, an estimated 20 per cent increase in calls to HMBANA, and/or families resorting to:

  1. Switching between different available formulas, exposing their child to potential intolerances.
  2. Using online homemade formula recipes that could be nutrient deficient.
  3. Diluting formula with water, which cannot be processed by a baby’s kidneys.

To meet the demand, numerous institutions have formed that can be grouped into three categories that vary in their philosophies: non-profit milk banks, for-profit milk banks and online milk sharing. These differences come down to issues of accessibility and safety; their pros/cons are summarized below. For additional details, statistics and references, please refer to the table.

Non-profit milk banks

In Canada and the U.S., most non-profit milk banks are accredited and/or affiliated with  HMBANA, a non-profit organization that represents these milk banks. These institutions process unpaid breast-milk donations from the public and prioritize at-cost breast milk to vulnerable populations that will benefit most. The altruistic intentions from donors and non-profit milk banks are thought to provide the safest breast milk, which can be a transmission vector for disease. However, this model comes at the cost of decreased accessibility for those who either aren’t eligible or can’t afford it.

For-profit milk banks

For-profit milk banks pay donors for their breast milk and empower mothers. This, along with the for profit-nature of these companies, increases costs. However, this may be offset by introducing additional milk to the market, reducing childhood morbidity and mortality and taking advantage of economies of scale to help reduce the high processing costs per ounce. In addition, these organizations inject additional funding into the field that develop new breast-milk technologies that ultimately benefit society and potentially further reduce health-care expenditure. For-profit milk banks increase accessibility by selling to a wide variety of customers; this may come at the cost of diverting from those that need it the most. There also are safety concerns of this paid donation model in that: (1) mothers may divert their supply away from their babies, though this is viewed as paternalistic, and companies have means to mitigate this risk and (2) the milk may be more likely to be tainted, though this model exists in Europe and the milk is tested. For the latter, some are concerned that companies’ intent to maximize profits may lead to cost-cutting and lead to unsafe practices. These companies have been criticized for some of their philanthropic initiatives that have been viewed as exploitative; using misleading marketing terminology; and anti-competitive behavior.

Online milk sharing

These are organizations that use Facebook or classified advertising to connect families with excess breast milk with those that are in need. They believe that everyone should have access to breast milk, should be able to make an-informed choice, and that informal sharing is safe given its long history and track record (wet-nursing, etc).

As per their guidelines, these virtual institutions do not get involved in these arrangements, but do provide instructions on how to best share breast milk and screen donors. Most do not permit selling of breast milk, but may allow recipients to cover the cost of bags, fuel, etc. They believe that the personal and direct nature of this interaction can be protective in that recipients can ask more personalized questions and donors’ altruistic intentions are further motivated by directly seeing the benefit of their donation.

There is no means for these groups to enforce their instructions and overall, there is a lack of research and support from health-care associations, with most discouraging the practice and refusing to provide risk mitigation advice. The current body of research has shown high rates of bacterial, viral and non-human milk contamination (to increase volume).

Advocates of milk sharing have been critical of this research, saying it’s not reflective of real-life practice as researchers paid for the breast milk and excluded sellers that wanted to communicate, eliminating the potential to screen.

Nonetheless, some obstacles to safe online milk sharing include recipient hesitancy to properly screen donors and ask personal questions, and donors being unaware of milk contamination through improper mishandling or storage or being symptomatic/unaware of their disease status.

Despite non-profit milk banks, for-profit milk banks, and online milk sharing each being adamant about the effectiveness of their models and beliefs, their unique benefits and drawbacks seem to be targeting different types of donors.

Increasing the donation rate, overcoming the numerous systemic issues that surround breastfeeding and donor milk, and following evidence-based research should be the focus to increase overall supply and not the negative rhetoric. As stated by the podcast Freakonomics in their How important is breastfeeding really episode, the current ways of pressuring/promoting breastfeeding have been counterproductive and harmful to maternal mental health.

We need to decrease the intensity of the pressure (i.e., you’re not a bad parent if you don’t breastfeed) but increase the intensity of support. The same should be done in the field of donor milk.

 

 

Institutions Pros Cons
Non-profit milk banks (1)  Milk is prioritized according to the greatest medical need and benefit.

(2)  The altruistic motivations that focus on health rather than profits provide the greatest level of safety. Donations to a milk bank have viral contamination that are below the population’s prevalence for these diseases.

(3)  Milk is priced according to the break-even cost/on a cost- recovery basis. In addition, greater efficiencies can be had if the milk bank is processed by blood banks, as they already have most of the infrastructure in place (similar testing protocols, experience recruiting human-derived products, etc).

(1)  The milk is not accessible to most of the public:

–        27 per cent of HUMBANA’s milk is prescribed to non- hospitalized children with medical issues.

–        If available, the cost is prohibitive if charged to the parents and not covered by the hospital and/or insurance. For a 3.6 kg infant requiring 20 ounces/day at $3-$5/ounce, this would amount to $1,800-$3,000/month versus $200/month for formula.

Milk banks are often perceived as having an unfair distribution model with hypocritical values due to being against the selling of breast milk, yet receive free milk donations that are sold back at a prohibitive cost, especially in cases where parents are charged. However, as stated in the “Pros” section, milk is prioritized and these fees don’t always allow banks to break even.

(2)  Banks degrade a few of the milk’s nutrients and fail to eliminate all pathogens via holder pasteurization. However, banks see this loss of nutrients as a tradeoff for increased safety and they screen for heat- resistant and existing pathogens.

(3)  To ensure that the costs of screening and processing are worth it, milk banks often require a minimum donation of 100 ounces, limiting the number of eligible donors. One study found that the median amount of milk offered on milk-sharing Facebook pages was 90 ounces. Thus, the donation model is limited in its economies of scale.

For-profit milk banks

+ Online milk sharing

(1)  Tapping into unmet markets and increased accessibility:

–      For-profit milk banks: Able to achieve economy of scale by tapping into an unmet market of mothers that wouldn’t, can’t afford and/or aren’t eligible to freely donate their milk. In an industry that deals in small

quantities that result in high processing fees per ounce,

(1) These models divert milk supply from non-profits and the most vulnerable pediatric populations as some companies do not prioritize newborns and sell to anyone (recreational users, bodybuilders, etc.).This reduces the non-profits’ economies of scale and increases costs. However, it appears that each of the three models attract different donor types, resulting in an overall increase in milk supply:
paid donors give three-fold more milk and for longer periods of time. One estimate states there is a minimum of 10 to 20 million ounces of supply that doesn’t come to market because mothers aren’t being paid to give it and that only the top 10 per cent of moms who can afford to take on this economic burden and time commitment donate. As such, even when factoring in the profit margin, for-profits may be able to offer their milk at competitively lower prices.

–     Informal online peer-to-peer milk sharing: Mothers may feel more at ease providing fellow mothers with milk at a cheaper price than milk banks do. The online process is simpler and more personal than a milk bank as donor and recipient can communicate, sympathize, connect directly and the donor can witness the results of the donation on the infant.

(2) Empowering mothers by compensating them for their time.

–        Even with the emergence of for-profit milk banks and online milk-sharing websites, HMBANA’s milk output has steadily increased year after year.

–        The U.S. has an estimated donation rate of 1 per cent out of the total pool of mothers.

(2) Compensation remains controversial due to concerns of:

–        The milk’s pathogenic content or it being adulterated with non- human milk to increase volume. However, companies have extensive testing, with one stating that fewer than 10 per cent of shipments they receive from donors don’t pass their standards.

–        Mothers diverting milk supply away from their own infants to make a profit. However, people argue this is a paternalistic view. Nonetheless, companies prevent this by:

o   Requiring that the child of the donor mother be 6 months or older and/or a note from the child’s pediatrician to certify the baby is healthy.

o   Instituting a 90-day payment waiting period.

Advocates for compensation state that paid programs have existed successfully elsewhere, notably in Denmark.

For-profit milk banks (1) Facilitates the raising of capital and development of innovations that ultimately benefit pediatric populations, such as:

–     A human milk-based fortifier: NICU babies require a fortifier to enhance and standardize the nutrient content of breast milk to satisfy their additional caloric needs in small volumes to accommodate their underdeveloped stomachs. Normally, this fortifier is cow-based and does not satisfy the NICU gold standard of a 100 per cent human milk diet. However, this fortifier costs $5,600-

$10,000 per infant hospital stay. In a hospital that pays

$25,000/year for donor milk for all babies, costs would

(1)  There are concerns that the focus on profits will undermine safety and ethics to cut costs and increase profit. These companies have been accused of:

–        Using misleading terminology and marketing themselves as a socially responsible company, not making it clear they profit from the milk.

–        Anti-competitive behaviour and trying to monopolize the milk banking industry through litigation and accusations of stealing trade secrets and client lists.

–        Stockpiling millions of ounces of breast milk.

jump to $500,000 with the fortifier to only serve the hospitals’ 50-70 extremely premature infants received annually. Companies justify this cost by claiming:

o   They charge the hospitals or medical insurers, not the parents.

o   Overall, hospitals save money by preventing complications from cow-based fortifiers.

o   These milks are highly processed, with 1 ounce of fortifier requiring 10 ounces of donor milk.

–     Sterile shelf-stable milk: One company has developed a commercially sterile homogenized human donor milk that doesn’t contain any viable microorganisms (vegetative cells, spores, and toxins) and can survive pasteurization. This has a three-year shelf life at room temperature and once opened, lasts a week. Thus, hospitals save money on refrigeration costs during storage and in frozen express overnight shipping. The latter requirement can add 30- 100 per cent to the cost. It’s in a ready-to-use simple format that makes it similar to formula and more suitable for home use.

(2) Companies usually have philanthropic programs that donate or provide milk at a reduced cost to the needy, like donating milk to premature, sick and orphaned infants in South Africa. However, some of these initiatives have come under scrutiny for exploitation.

One former company sold breast milk bought from Cambodian women to the U.S. This doubled the median income of a Cambodian family and gave the company 100 per cent control of its supply chain as donors were required to donate in pre- determined clinics. Cambodia banned the selling and export of human breast milk, a move that was backed by UNICEF, which stated that this practice was exploitative since Cambodian babies already lack proper nutrition.
Online milk sharing (1) Advocates argue that informal milk sharing is a long-standing and safe practice done for generations (e.g., wet nursing, religious traditions, etc). They believe in: informed choice; that families can weigh the risks and benefits; a woman’s right to share her breast milk with whomever she chooses; and that all

children have the right to a “biologically normal nutrition.” They

(1) Many organizations discourage informal milk sharing, including the AAP and the CPS, as they consider it an unnecessary risk of transmission relative to the benefits. However, more institutions are providing guidelines for informal milk sharing.

(2) Individuals may be exposed to online misinformation.

(2) Free and/or most affordable, costing 1.5 times to 10 times less than milk banks at a price of $0.50-2/ounce. (4) Recipients take on safety risks in that they may post identifiable information and when the transaction is made, this either requires an exact address for milk to be shipped or a face-to-face exchange.

 

The comments section is closed.

Authors

Adamo Anthony Donovan

Contributor

Adamo Anthony Donovan, is a McGill PhD student in Experimental Medicine with a research focus on the diaphragm muscle in respiratory disease. He is passionate about humanizing medicine and city design.

James Andrew Dixon

Contributor

James Andrew Dixon, MSc, MD,CM, is a pediatrics resident training at the Montreal Children’s Hospital. He has a passion for technology in medicine and is interested in health-care system innovation, patient safety and quality improvement.

Stephanie M. Hwang

Contributor

Stephanie M. Hwang, MSc(A), is a (soon-to-be) registered nurse, working in the pediatric intensive care unit. She has a passion for providing quality patient care to all and utilizing evidence-based practice to optimize the health and well-being of individuals and their families. When not at the hospital, she can be found going for hikes with her dog and photographing the beauty of the world around us.

Robert Mackalski

Contributor

Robert Mackalski, PhD, is an assistant professor of practice at Jefferey S. Raikes School of Computer Science and Management. He is a marketing and branding specialist who splits his time among teaching, case writing, academic research on branding, and in support of organizations through advisory work.

Republish this article

Republish this article on your website under the creative commons licence.

Learn more