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Elena Medo pioneered the sale of breast milk, then lost everything - The Washington Post

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About a week before Christmas in 2014, Elena Medo received the opening salvo against her latest breast milk company. She was at her new office in Lake Oswego, a suburb of Portland, Ore., when she got a cease-and-desist letter. Prolacta Bioscience, the breast milk product company she founded in 1999 and then parted ways with in 2009, was instructing her new company, Medolac, to stop using its trade secrets.

Medo, then 61, was used to dealing with adversity. As the veritable founding mother of the breast milk industry, she had spent her life charting a controversial path to selling breast milk to hospitals. Medo had been accused of exploiting women to make money and of creating inequalities that hurt babies from poor families. But the products that she’d sold have also been credited with improving the outcomes for tens of thousands of premature babies in hospital neonatal intensive care units.

The irony of this latest challenge was that it wasn’t coming from Medo’s traditional detractors, the nonprofit milk banks. Instead, it was from her former company, which under the stewardship of a new CEO had sidelined her, she claimed, and taken an even more commercial tack to profiting from the sale of breast milk. The timing couldn’t have been worse: Medolac, which Medo had founded just five years earlier, had recently gotten its first couple of hospital accounts and was working on new products.

Medo figured that Prolacta was just trying to scare away the competition, and she was confident that if her former company took further legal action, she would be vindicated. Still, the letter was a damper on holiday celebrations that year. Medolac was a family enterprise; Medo’s daughter Adrianne Weir managed its affiliated milk bank, and other relatives performed various company roles. The adults tried to put on a happy face for the children, and they mostly succeeded. But the lawsuit came up enough times that Medo’s grandchildren began to yell out, “No-lacta!”

Medo didn’t respond to the letter, hoping the issue would just go away. She had no idea what trade secrets she could have stolen. But a few weeks later, it was clear that Prolacta was serious. In January 2015, Prolacta filed a lawsuit against Medolac. Rather than being quickly resolved the legal case has dragged on for more than seven years; according to Prolacta, the next motions are set for June and July. In the meantime, Medolac went bankrupt last year, which Medo says was fallout from the battle.

“Of course the company was losing money when you have a lawsuit that’s sucking the blood out of the organization,” she told me, in an exasperated tone.

Medo blames the lawsuit for blocking her from her lifelong dream: serving sick babies by supplying them with nature’s best nutrition, breast milk. But her story is more complicated than that. Medo’s efforts to commodify breast milk raise numerous interesting questions about how we value the work of women, both as providers of income and unpaid caregivers. Even the terminology of her trade — “human milk products” or “therapeutics” is how both Prolacta and Medolac refer to what they sell — hints at the uneasy relationship between women’s bodily labor and commerce. Medo’s vacillation between moneymaking and altruism has profoundly shaped this new industry. It also reflects a struggle at the heart of being a woman today.

Breast milk is revered as the ideal food for newborns and a sign of motherly nurture. It’s one of the first forms of communication between a mother and her child, between a mother’s body and the child’s developmental, nutritional and immunological needs. The composition of the milk changes depending on the time of day, over the course of a feeding and over periods of time. Years of scientific research and medical promotion of breastfeeding have led us to term it “liquid gold.”

But producing milk is also a sizable investment in time and energy. A nursing woman should consume more calories than a pregnant one, and nursing a newborn infant can typically take up to four hours each day in about eight to 12 sessions. It’s real time and effort that’s not always treated as such because it’s so intimately connected with societal expectations of women to be innate nurturers.

“It’s sort of gendered work that women are expected to do based on altruism. And as a way of being a good woman and a good mother … you give up yourself and you give and you keep giving and you find joy in giving,” says Shannon K. Carter, co-author of “Sharing Milk: Intimacy, Materiality and Bio-Communities of Practice.”

Medo’s story begins at the intersection of this expectation to nurture and her own professional ambition. In 1982, three weeks after the birth of her third child, she returned to her job at the Vancouver Stock Exchange with a hospital-grade breast pump that weighed nearly 30 pounds. On her commute, she lugged it in a cardboard box labeled “breast pump rental,” first on a bus, then a ferry, finally on a roughly 10-block walk. Even worse, the pump didn’t effectively remove milk from her breasts, so she started to lose supply.

“Many are aware of the aggressive way [Medo] used legal action to silence her critics,” says breastfeeding advocate Jodine Chase.

Medo grew up in Garden Grove, Calif., the daughter of a machinist father and homemaker mother. She’d always had an entrepreneurial streak; in her freshman year at the University of California at Irvine, she saw a flier on a kiosk for a book called “The Lazy Man’s Way to Riches” and ordered it. One of the book’s main messages — that, even if you were working for a boss, you should try to build something of your own — hit home.

“I remember the example they gave: It doesn’t have to be a cure for cancer,” she says. “You can buy little hair barrettes and paint them.”

She went on to sell crocheted purses, hiring classmates to make them, and earning enough to limit her waitressing hours and travel during a semester abroad. Medo left college early to start a family, graduating years later (she would eventually have four children). But her daily struggle with the breast pump made her start thinking about how to build a lighter one that could imitate a baby’s suck to stimulate milk production. In college, she had briefly been an art minor, and had learned to cast metal and different polymers. So she developed a flexible funnel to replace the hard appendage on her pump. Using parts from other medical products, she produced a pump that was only five pounds. It was crude-looking, but it worked.

Some of her colleagues at the stock exchange saw her pumping in the bathroom and asked if they could have one too. She made a few more to rent out. Eventually, she started providing them through local home health-care dealers and planned to keep her pump business as a side job. But a couple of years later, in 1984, she filled out forms from the Food and Drug Administration to reach a wider market and developed new models for her company, which would eventually be called White River Concepts. At its peak, White River made about $4 million in sales per year, Medo says.

Not everyone was a fan of her pumps, however. Lactation consultants at La Leche League International, a nonprofit breastfeeding advocacy organization, preferred competing ones because some mothers reported that the White River pumps caused discomfort. When Medo heard they were disparaging her product, she sent individual consultants letters threatening legal action to get them to stop and accused some of being involved with her competitor Medela. “We tried to avoid [lawsuits],” Medo tells me, but the episode gave her a reputation as a ruthless businessperson.

“Many are aware of the aggressive way she used legal action to silence her critics,” says Jodine Chase, a longtime breastfeeding advocate based in Edmonton, Alberta, who runs the blog Human Milk News. “I think this contributed to the lack of public debate when she started commercializing breast milk, though many privately expressed concern that it was inappropriate.”

It was through her work with breast pumps that Medo came up with the idea of selling breast milk as its own product. In the mid-1990s, while visiting hospitals that used her devices, she learned from doctors about the need for breast milk for premature babies. A perfect storm of events was causing an extreme shortage at the time. The HIV crisis had prompted the closure of many milk banks in the 1980s because people were afraid of the spread of infection through bodily fluid. As neonatology improved, babies could be saved at earlier and earlier stages of prematurity, and new research showed the value of an exclusive breast milk diet, especially for these babies.

Typically at that time, for the smallest and most vulnerable preemies, a cow’s-milk-based fortifier was used in addition to their mother’s milk or donor milk to help them gain weight. But it came with severe risks. It has been correlated with an increased chance of developing an intestinal infection called necrotizing enterocolitis that can destroy intestinal tissue and, in the most severe cases, cause death.

In 1999, Medo started a new company, Prolacta, to develop a breast-milk-based fortifier. At various points while she was developing her product, she met with a doctor from Sweden who had made a small amount of breast milk concentrates for his research, and another in Italy, who made freeze-dried breast milk protein concentrate for his patients. The processes they used were standard in the dairy industry, but they had never been used on a large scale for breast milk. Medo started making presentations to investors, who were interested in her idea. In 2002, she got her first infusion of venture capital, which helped her to build the company’s first 15,000-square-foot processing plant, in Monrovia, Calif. By 2005, the company was collecting breast milk.

Medo developed milk depots, collection sites with freezers for storing milk, in some cases partnering with midwifery clinics and hospital lactation departments. These sites raised awareness for milk donation, screened donors and sold milk to Prolacta, which would test and process it, then sell the resulting fortifier to hospitals. At the time, Prolacta charged as much as $45 an ounce for a liquid concentrate that arrived at a hospital frozen until ready to be used, at which time a mother’s own pumped breast milk or donor milk was added. (Today, Prolacta’s product is not sold by the ounce, the company says. Instead, cost varies by gestational age and weight, and averages $120 per day.)

Prolacta funded and administered research that showed that use of the fortifier significantly reduced the risk of necrotizing enterocolitis in extremely premature infants, and the product took off. NICUs increasingly adopted breast-milk-based fortifiers. A 2016 study published in the Journal of Perinatology found 4.5 fewer days of hospitalization for infants with very low birth weights receiving Prolacta’s products, along with donor milk, as part of an exclusive breast milk diet, compared with those receiving cow’s-milk-based fortifiers. Currently, nearly 40 percent of all Level 3 and 4 NICUs, which treat the sickest babies, use Prolacta’s fortifiers.

But in some circles, there remains suspicion about whether fortifiers are as beneficial as reported. “That body of evidence, while there’s some strong randomized controlled trials, is colored by the fact that much of that research has been industry sponsored,” says Diane Spatz, professor of perinatal nursing at the University of Pennsylvania.

In addition, nonprofit milk banks worried that a for-profit company would funnel the limited supply of breast milk toward those who could pay more, as opposed to those with the greatest need. “They are saddened by the idea that this product that they believe in very strongly and think would benefit a lot of babies would be less accessible if allocated on the basis of company profit rather than patient need,” says Kara Swanson, a law professor at Northeastern University and the author of “Banking on the Body.” “In the history of U.S. medicine, there has never been enough banked breast milk for all the babies that might benefit.”

There was also controversy over the fact that women were encouraged to become “donors” to Prolacta, language that suggested that they were supplying milk to a nonprofit when, in reality, their raw product was being processed and sold at a markup to hospitals. After news reports about this emerged, detractors — including those in the milk bank community — criticized the company for not properly informing women, and Prolacta’s first public relations crisis erupted.

Wet nurses have existed throughout history, but in the past, whenever there’s been a transaction for these services, the commercial advantage has been to employers. Early wet nursing in the United States relied on enslaved labor or on poor, unwed mothers who often had to abandon their own babies to nurse those of wealthier women. Later, in the early 1900s, a new model of “mother’s milk stations” developed that tried to maximize the benefit for both the milk supplier and recipient, by providing a decent wage to the supplier and a sliding scale to the recipient.

But over time, the widespread use of formula reduced the value of women’s milk, and women’s work opportunities increased. By the 1970s, most milk banks in America began operating on a system in which women gave their breast milk to the banks as a donation. For some, it was empowering, a form of resistance against formula companies and anti-capitalist support that women could give one another. But it limited the population of women supplying milk and perpetuated the gendered idea of women’s altruism as more noble than financial compensation.

Medo’s failure to disclose the sale of donor breast milk caused an uproar because she was asking mothers to donate milk, piggybacking off the nonprofit milk-banking model, while also seeking corporate profit. In response, Medo quickly revised some of the wording on the company’s website and consent forms. Looking back, she feels she could have done better. “That was a mistake in hindsight. That should have been made a lot more clear that the company was for-profit,” she says. “We were far from perfect.”

“As a woman entrepreneur, I was very distraught when they brought a man in to run the company,” says Elena Medo.

But soon enough, Medo found herself bemoaning corporate forces. According to a written statement Prolacta sent me, by the end of 2005 the board was having concerns about Medo’s ability to raise funding and run the company. With her agreement, they decided to transition to a new CEO. Medo disputes that she had trouble fundraising but acknowledges that she agreed to give up some control. She was replaced and demoted to chief strategic officer, and in October 2006, a new CEO stepped in. “As a woman entrepreneur, I was very distraught when they brought a man in to run the company,” she says. “But I decided that I would just muscle through it.”

The new CEO, Scott Elster, came from the company Baxter, which sells human blood products. What has made blood different from milk, business-wise, is that certain proteins in blood plasma, when separated from blood, are used as lifesaving therapeutics, and paid donation helps to keep up with the demand. As in the blood industry, Elster saw a parallel long-term symbiotic relationship between the nonprofit milk banks and Prolacta’s for-profit venture.

But Medo felt that Elster didn’t understand some of the sensitivities of the breast milk business. For example, she says he asked about placing minimum ounce limits on women who were milk suppliers, which Medo deemed unfair because sometimes unforeseen incidents caused women to lose supply. “I said, ‘You know how it is when you have little kids: Maybe the toddler and the school-aged kids have gotten chickenpox, and Mom’s not pumping and/or Dad lost his job,” Medo says. “You can’t mandate a certain amount of milk production.”

Prolacta wrote me in response, “When Prolacta was a struggling startup with serious cash flow issues, a myriad of options were discussed in the pursuit of a sustainable milk bank operation, given the high cost to qualify donors.”

Medo’s professional concerns were intensified by the degree to which she felt Elster was sidelining her. After returning from a business trip, she says, she found he’d essentially cut her office in half and she had no air conditioning or light switch. Prolacta counters that Medo was aware that the space was being allocated to better accommodate the growing workforce and all errors were addressed before the project was completed. “Needing an antagonist for her narrative, and with none of her prior board members still active, Medo has pinned her ire on the CEO who was appointed more than six months after Medo willingly stepped down from the role,” Marjorie Guymon, one of Prolacta’s attorneys, wrote me.

Medo quit her job in the summer of 2008 and agreed to stay on as a consultant. At a February 2009 meeting, she ended her working relationship with Prolacta.

Shortly after, Medo started the company that would become Medolac. She decided not to sell another fortifier because she suspected hospitals weren’t going to switch from Prolacta, so she decided to create something new: a breast milk that, thanks to a process called retort sterilization that is used by brands like Capri-Sun to make their products shelf stable, didn’t need to be frozen. Eliminating refrigeration costs, she believed, could help make her product more affordable and waste less milk.

Once she had a product, Medo needed to figure out how to bring in a supply of milk. This time, instead of partnering with or creating milk depots, on Mother’s Day 2013, her daughter Adrienne started a co-op milk bank called Mothers Milk Cooperative. The milk suppliers had a larger stake in the organization. They were members who could vote, sit on the board, and receive one share of stock and dividend payments in profitable years. Most notably, the women could either choose to donate or receive $1 an ounce in return.

Medo had come to the conclusion that if she or anyone else was going to make money off women’s bodily products, then paying the women was the way to show them they were valued. Women were already selling their own milk online, a practice that many clinicians say is unsafe. In a 2013 article published in the journal Breastfeeding Medicine, Medo asked why “should women be expected to give freely of an increasingly valuable substance they independently produce, own, and control when the present system allows others to profit from their generosity?”

Once again, Medo’s practice became the norm among for-profit companies. Although Elster said in a 2011 Wired article that “We have to make it altruistic. … Otherwise, there’ll be a picture of a mom on the front page of the New York Times saying, ‘I sold my milk for crack,’ ” Prolacta started paying milk suppliers in 2014. In response to a question about why the company changed course, Elster credited changes in science. “At that point in time (2011), testing wasn’t available to ensure the safety of the milk for the fragile infants who rely on this nutrition for their health and development,” he wrote me.

But this payment model eventually led to Medolac’s next big public scandal. In partnership with the Clinton Global Initiative, the company attempted to launch a program to expand its milk donation program in Detroit. In its marketing materials it said that paid donation would extend breastfeeding in African American communities and encourage women to maintain a healthy lifestyle since the milk would be screened.

Breastfeeding advocacy groups attacked Medolac’s message as being patronizing and insensitive to Black women. They criticized Medolac products’ high cost for hospitals and wrote about the importance of feeding Detroit’s own children. Facebook and Instagram posts used the hashtag #StopMedolac. “A lot of people were outraged that she was targeting this specific population, with high infant mortality rates and all sorts of social issues, to try to take milk out of their community,” says Summer Kelly, president-elect of the Human Milk Banking Association of North America. “I think it’s obvious how problematic that is.”

Though Medo’s approach in Detroit angered the community, some scholars, such as Linda Fentiman, an emeritus law professor at Pace University, also advocated paying milk providers. As Fentiman noted in a journal article, breast milk was already being commodified, so it was only fair that the women who provided it should also benefit, and it would give them a way to earn money without having to leave their baby. “To me, the question really is: Is $1 an ounce enough?” she told me recently.

Medolac continued its existing payment system, but in January 2015 Prolacta filed suit, arguing Medo stole important customer lists. Because of the costs of the company’s litigation with Prolacta, Medo posted a message on Medolac’s website, saying that payments to suppliers would be delayed. Critics from many of the same organizations that questioned her paid donation model now criticized her for withholding payment to those it was promised to.

Medolac eventually made it into about 85 hospitals and was earning nearly $2 million a year in sales, according to court documents, but the allegations from Prolacta continued to mount. The company said that Medo had co-opted standard operating procedures that Prolacta had spent years perfecting, but Medo argues that much of the information Prolacta considers proprietary is well known in the industry.

“These are really important precedent-setting kinds of cases: What do we do with human milk and this kind of tissue?” says law professor Mathilde Cohen.

Unable to raise the necessary operating capital while paying legal fees that, according to Medo’s attorney, Joseph Bakhos, would eventually reach at least $5 million, the company began falling behind with vendors. Many of them sued, and it was hard to raise more money. In March 2021, Medolac filed for bankruptcy. Because it couldn’t pay employees to manage its freezer, ounces and ounces of breast milk spoiled, enough for 5,000 feeds, according to her daughter Adrienne.

“Absolutely heartbreaking,” Medo says tearfully about the episode. “I can’t even talk about it.”

Chris Kroes, another of Prolacta’s attorneys, argues that Medolac was never a viable company to begin with and the lawsuit wasn’t the reason for these financial problems. “Elena Medo and [her daughter] constantly attempt to present themselves as victims who are being pushed around by a bigger company. ... The facts demonstrate the opposite,” he wrote me.

Prolacta, meanwhile, sued another new breast milk product company, Ni-Q, for patent infringement; the case was dismissed. Ni-Q later filed suit, asking a court to hold Prolacta’s patent invalid, which the judge agreed to do. Ni-Q added an antitrust claim, saying the company used a fraudulent patent to maintain a monopoly over the breast milk industry. An Oregon judge gave the claim a green light, but Ni-Q did not pursue it. (Prolacta maintains it was a baseless claim.)

Prolacta seems “to have been quite tenacious in going after different companies,” says Carolyn Prouse, a Queen’s University geographer and political economist. “These are really important precedent-setting kinds of cases: What do we do with human milk and this kind of tissue? How do we regulate it, and how do we regulate patents around it?”

As the leadership of Prolacta and Medolac await trial, other players have shown up at the scene, including international, for-profit breast milk companies that are raising new ethical questions such as whether women in developing countries should be allowed to sell their milk to American women. Prolacta recently announced that it had begun a clinical trial in Japan, a precursor to introducing its fortifier to hospitals there.

In this country, where federal law did not require employers to give workers unpaid breaks to pump until 2010, lactation advocates and other stakeholders have been pushing for more government support for breastfeeding. Tellingly, however, progress on social and legal protections for nursing women has been slow. In the meantime, profitable new milk products have emerged in a largely unregulated market. “Donor human milk is great when babies don’t have milk,” says Mathilde Cohen, a professor at the University of Connecticut School of Law. “But the fundamental problem in our culture is that most people don’t even have the ability to provide milk for their own baby because of how messed up the system is.”

As Medo, 68, sees it, the woman without whom commercial milk banking wouldn’t exist has been edged out of it, at least for now. But she is still committed to finding a way back in the game. Prolacta, she says, feeds only a minority of babies in NICUs, which means there’s a large market, and more competition is needed to drive down prices. Currently, she is raising money to pay back the milk suppliers and explore new options for reopening the milk co-op.

She’s had time to think about what the best model is and has concluded that it wouldn’t be possible to create products like hers at a nonprofit because of the quantity of investment needed. On the other hand, a for-profit model involves high salaries and other limitations that mean not all of the money goes to babies. A for-profit model could work, she’s convinced, if it has the right stewardship with a clear mission of social responsibility.

In many ways, the challenges she has faced in her business are the same as those faced by many women: trying to make the best of a market economy while being expected to give freely of their emotional and bodily labor when the system isn’t built to value it. Modern motherhood, with its expectation of endless unpaid giving, is nearly impossible to balance with the bottom-line-driven culture of the American workplace. Women often end up in the uncomfortable position of delaying professional advancement — and losing out to men — or relying on less-privileged women to fulfill caretaking needs.

Medo sees herself as someone trying to do good. Her aim, she told me again and again, is to serve babies by stepping up to meet a growing demand for breast milk. And yet, as her critics have repeatedly asked: Does capitalizing on other women’s labor distort that aim and increase the chance for exploitation? Medo doesn’t deny the danger, but she blames the system, not herself, for the difficulty navigating the competing demands of altruism and the marketplace.

“I guess it’s more of an issue with capitalism than anything else,” she says.

Sushma Subramanian is a journalism professor at the University of Mary Washington and the author of “How to Feel: The Science and Meaning of Touch.” This article was produced as part of the Knight Science Journalism Fellowship Program at MIT. Carly Stern assisted with fact-checking.

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