Commentary: There is a hidden cost to the Abbott verdict for premature babies
Published in Op Eds
In the neonatal intensive care unit, nutrition is our most powerful healing tool. Most of what we do, from incubators to ventilators, simply buys time and treats complications while premature infants grow. Without growth and nutrition, these children would not survive.
As a neonatologist, I treat infants weighing just over 1 pound. I see the ribs under their skin as they fight for breath. For these newborns, growth is so crucial to survival that every calorie, nutrient and electrolyte is meticulously calculated and prescribed daily.
Necrotizing enterocolitis, or NEC, is a devastating complication of prematurity that weighs heavily on our minds. From the moment we introduce the first drops of milk into a newborn’s stomach, we do our best to balance the risks and benefits of every nutritional decision. The exact cause of NEC remains unknown. It occurs in infants who are formula-fed and breastfed and those who have never been fed at all. The prevailing medical theory is that breast milk provides biological protection against NEC, rather than formula being a cause of the disease.
The recent verdict in Cook County ordering Abbott Laboratories to pay $70 million in compensatory and punitive damages related to four cases of NEC has the potential to drastically change that risk-benefit analysis for preterm infants far beyond the Chicago area.
We know that mothers’ own milk is the best diet to prevent NEC. However, mothers of preterm babies often have difficulty supplying an adequate amount of milk. This is partly because of the premature interruption of pregnancy and associated complications, but also due to logistical challenges and social inequities. Mothers who are Black, low-income or non-English-speaking are statistically less likely to provide breast milk during the NICU stay.
Furthermore, the milk from some mothers may contain infections or drugs, which can harm the newborn.
The next best option for preventing NEC is donated human milk. In the Chicago area, Mothers’ Milk Bank of the Western Great Lakes screens, tests and processes donated milk before dispensing it to hospitals. Since this is a scarce resource, most NICUs reserve it for the smallest preterm newborns and cannot provide it throughout an infant’s entire hospital stay.
The final pillar of neonatal nutrition is formula specifically designed for preterm infants, such as Abbott’s Similac Special Care. These “inpatient formulas” are intended to be used under medical supervision and are widely used in premature newborns. According to the American Academy of Pediatrics, most preterm infants born weighing less than 3 pounds receive some formula feeds during their NICU stay. This is not unique to the United States; comparable preterm formulas are used in many other high-income countries.
Neonatologists understand this hierarchy of risk. If we could, we would provide a mother’s own milk or donor milk to every baby. However, preterm formulas are a vital necessity. Responses to litigation that reduce access to these products will worsen outcomes for some of the most vulnerable members of our society.
Abbott has warned that litigation could jeopardize production of some preterm formulas. This will reduce the availability of nutritional options necessary for preterm infants to survive. I struggle to imagine how the neonatology community will adapt if these products vanish. Most substitutes will not deliver the protein, calories and micronutrients necessary to support the growth and development of premature newborns. Without preterm formulas, we risk poorer neurodevelopmental outcomes, longer hospitalizations and potentially preventable deaths.
I sympathize greatly with the families in this lawsuit and all who have been affected by NEC. I have diagnosed many infants with NEC and stood side by side with their parents through the disease and its complications. However, outcomes will be worse and more children will suffer if we see therapeutic options restricted in response to litigation.
Altering the packaging or including a warning label is not the solution. A warning label is a blunt instrument in a setting where parents are not choosing a product off a shelf. These formulas are used in hospitals, under medical supervision, when mother’s milk or donor milk is unavailable. Instead, our focus should be on educating parents and removing the barriers to providing breast milk.
As clinicians, we can improve our communication around nutritional options while compassionately explaining the risks and benefits of each. As health care institutions, we can reinforce systems that support lactation, especially in marginalized populations. As a community, we can promote breast milk donation and support local milk banks to increase the availability of donor milk.
If we want fewer NEC tragedies, the target is not a manufacturer. It is access: access to lactation support, access to donor milk and access to an effective formula backstop when neither is possible.
Preterm formulas are a medical bridge. If we let that bridge collapse, those who fall first will be our smallest patients.
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Dr. Alexander Crider is a Chicago-area neonatologist and assistant professor of pediatrics. Crider asserts he has no financial relationship with Abbott, Reckitt/Mead Johnson or any infant formula manufacturer.
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