SANTA ANA, Calif. – A Southern California company looking to profit from the sale of human breast milk has breast-feeding advocates questioning its ethics and safety.
Prolacta Bioscience opened the nation’s first commercial milk-processing plant this week in Monrovia, about 15 miles northeast of Los Angeles. The company will pay hospitals for volunteer mothers’ donated milk, pasteurize it in its 15,000-square-foot facility and sell it back to hospitals at a to-be-determined mark up.
Lactation experts are concerned about how the company will fit into the traditionally nonprofit donor-milk market. The Orange County Breastfeeding Coalition has plans to open a milk-donation depot at University of California Irvine next year, and Children’s Hospital of Orange County recently opened its own location. Collected milk is sent to the Mothers’ Milk Bank in San Jose, Calif., for sterilizing at a processing cost of about $3 per ounce.
Prolacta intends to set up its own network of banks at hospitals nationwide.
CHOC will not work with Prolacta, said Mary DeNicola, nurse practitioner and lactation consultant.
“In order to assure the safety of the milk for our babies, we will only deal with companies that are in compliance with the Human Milk Banking Association of North America guidelines,” DeNicola said.
To buy milk from anywhere else would be like buying drugs that were not FDA approved, DeNicola said.
The association, which sets safety guidelines for screening, sterilizing and distributing donor milk, does not endorse for-profit milk banks. Commercialized banks could lead mothers to donate milk for personal gain while denying their own infants’ needs, according to the association’s recent statement.
Prolacta’s plant meets FDA regulations for food production facilities and has a state-issued license for milk banking, CEO Elena Medo said.
The for-profit debate is unnecessary because Prolacta doesn’t plan to pay milk donors, Medo said.
Other incentives, including free electric breast pumps, will be offered to the volunteer donors.
“It is our policy at this point not to pay donors. We really believe in a nonprofit donor bank system,” Medo said. “I’m surprised that some of those folks aren’t more supportive because we’re all on the same page.”
Prolacta’s large-scale plant can help meet the need for donated milk while taking the burden off the country’s nine smaller banks, Medo added. The San Jose bank distributed 174,794 ounces of breast milk in 2004, of which 10,000 ounces were prescribed by doctors at CHOC.
Prolacta’s facility can treat more than 10 million ounces each year, or a month’s supply for 100,000 babies who are born at very low birth weights.
Hospitals have responded “quite well” to Prolacta’s launch, Medo added. The University of Rochester Medical Center in New York has signed up, and several other hospitals are in negotiations with the company.
Women often donate breast milk for babies who cannot be fed by their own mothers. Breast milk is generally considered superior to formula because of its bacteria-fighting antibodies. Studies have shown breast-fed babies have lower rates of allergies, asthma and obesity.
Sick mothers, adoptive mothers and those who don’t produce enough milk have all used donated milk. Premature infants, whose mothers’ milk has yet to come in, also benefit from donor milk.
Established milk banks popped up in the 1940s and grew to about three dozen by the late 1970s. Many banks shut down in the 1980s due to the AIDS scare. Today’s mothers need another option, said Prolacta’s Medo.
“Donor milk is really not available to most babies in the U.S.,” Medo said. “Under the current model of total nonprofit, the milk-banking arena has not expanded. I think it’s exciting that more babies will be able to receive milk.”
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