Pennsylvania breast milk law could harm premature newborns | Opinion

As a neonatologist, I am deeply troubled and concerned by the current draft of the Keystone Mothers’ Milk Bank Act under consideration in the state House of Representatives. If the bill passes in its current form, extremely premature infants being cared for in neonatal intensive care units (NICUs) in Pennsylvania could be cut off from one of the most important, lifesaving products available: a nutritional fortifier made from 100% donor breast milk. The result would be swift, and devastating; babies may die needlessly, and NICU costs would soar.

Let me be clear. This concern is not hyperbole or catastrophizing. The data on this issue are indisputable. Extremely premature infants have intense nutritional needs that are difficult to meet. This requirement is why the American Academy of Pediatrics (AAP) recommends adding a fortifier to mother’s milk or pasteurized donor milk to provide the needed protein, calories, and minerals to support growth in preemies born weighing less than 3 pounds, 4 ounces.

Fortifiers made from cow’s milk are available, but they are potentially dangerous. Cow milk fortifier is associated with a substantial increase in life-threatening complications, so much so that NICUs often delay giving cow milk fortifier to preemies. Two randomized clinical studies have demonstrated that for every 10% increase in the volume of milk containing cow milk given to premature infants weighing less than 2 pounds, 12 ounces, the risk of a common, life-threatening complication called necrotizing enterocolitis (NEC) increases by 11.8%; NEC requiring surgery by 20.6%; and sepsis by 17.9%.

Prolacta Bioscience — whose medical advisory board I serve on a voluntary basis to support their mission — changed clinical practice and substantially reduced the risk when they developed Prolact+H2MF, a fortifier made exclusively from donor breast milk. They are currently the only manufacturer of fortifiers made exclusively from donor breast milk. Research shows that providing extremely premature infants an exclusively human milk diet during the early postnatal period is associated with lower risk. It also substantially lowers hospital costs since a single case of NEC or sepsis can cost upward of $250,000 to treat.

With a fortifier made from human milk, extremely premature infants face a much lower risk of immediate, life-threatening complications and can be given fortifier sooner, thus providing better nutritional support during a period of incredibly intense development.

This bill was introduced with the intention of regulating human milk banks. Yet as written, the Keystone Mothers’ Milk Bank Act threatens access to these lifesaving donor breast milk-based fortifiers in Pennsylvania NICUs.

Prolacta respects the mothers who provide this lifesaving milk from their own bodies. They understand that pumping milk takes time and effort, and as a result, Prolacta pays mothers for the excess breast milk they provide.

But Keystone Mothers’ Milk Bank Act, as drafted, prohibits “remuneration of value provided to a milk donor by an entity.” Effectively, this could mean that Prolacta would not be able to operate in Pennsylvania. Such an event would be an unmitigated disaster for Pennsylvania NICUs’ most fragile premature infants.

There’s more. NICUs currently rely on donor breast milk to feed preemies when a mother’s milk is unavailable, but the Keystone Mothers’ Milk Bank Act could allow adulterated and improperly handled breast milk to reach NICU babies. The standards for screening, processing, and storing breast milk in the current iteration of the bill are not stringent enough. They fail to reference the basic but comprehensive safety standards put forth by the U.S. Food and Drug Administration (FDA).

Most alarmingly, there is no mandate to screen breast milk for opiates or nicotine, two substances that can kill a fragile preemie. As the AAP recommends, procedures regarding the handling of breast milk by milk banks should be in the hands of the FDA and the Centers for Disease Control and Prevention, which have the resources to both implement and enforce strict, up-to-date regulations. Regulations must not be left to the devices of individual, unregulated entities, regardless of how well-meaning their intent may be.

I urge legislators to heed the warnings of experts in neonatology regarding this bill. We all have the same good intentions: give our youngest, most fragile patients what they need in the safest way possible. The bill, in its current form, will make that goal more difficult to achieve.

Mitchell Goldstein is a practicing neonatologist and professor of pediatrics at Loma Linda University Children’s Hospital. He is not paid for his services to Prolacta. There is an honorarium made to the fellows training program at Loma Linda.