OUR DAILY THREAD: Baby Formula For Disaster

Hungry, hungry HIPAA

THE SET-UP: Two leading baby formula makers have been locked in a troubling competition to “brand” America’s preterm infants before they leave the Neonatal Intensive Care Unit (NICU).

According to a new deep dive by Kaiser Health News, two companies—Abbott Laboratories and Mead Johnson—have been waging a “high-stakes corporate battle” for domination of the surprisingly amoral world of neonatal nutrition. It’s a sordid tale epitomized by eavesdropping sales reps who target NICUs, just waiting for opportunities to exploit “vulnerable mothers” with underweight premmies. Their main objective is to “brand” babies before they head home:

In internal documents and other material from litigation reviewed by KFF Health News, formula makers described hospitals as gateways to the much larger retail market because parents are likely to stick with the brand their babies started on. Products used in the NICU help win hospital contracts, and hospital contracts help establish brand loyalty, according to court records.

If nothing else, it is a vivid reminder of the polysemous nature of the word “branding.”

Honestly, the motivation to brand babies differs little from the motivation brand livestock. It’s just business, after all. And that business depends upon being the first brand a baby tastes. If successful, an Abbott Labs sales presentation claims, the first brand a baby tastes becomes the baby’s go-to formula 74% of the time. That’s why reps often make sure newborns get the first taste for free.

You gotta hook ‘em early. Really-really early.

Abbott proposed doing just that with its self-explanatory “first-bottle-fed” strategy. It’s simple enough, but it requires reps to be at the hospital so they can pounce on opportunities to sear Abbott’s brand onto a hungry newborn:

One Abbott document … said more than half of first feedings happen at night, adding, “Nighttime is the right time to drive your business.”

And if Abbott’s night-crawling sales reps can convert nearly two-thirds of the newborns into reliable consumers? It could generate $1.5 billion in sales and big bonuses for the reps who push the most product.

Not to be outdone, a Mead Johnson “University” training document envisions a sales rep skulking around NICU’s hallways until the rep “overhears patient information.” Titled “Advanced NICU Skills,” it helps the representative identify opportunities by imagining a scene set in the rep’s “most important NICU”:

“You overhear the HCP’s” — health care providers, apparently — “stating all of the notes,” it said. “There may be some information that may help you to position your products as a resource for this patient and to handle any objections that the HCP may present you with.”

That’s one way to find the wounded animal in the herd. And if you think that analogy is a bit of a stretch … a Mead Johnson strategy document outlining a “plan to win the hospital war” identified hospitals as ”inflection points for vulnerable moms.” And yes, they are particularly vulnerable when they’ve just given birth to a vulnerable preterm baby. One person’s vulnerable child is another person’s market opportunity. In this case, the moneymaker is human milk fortifier:

Fortifier, a product tailored to preemies, is meant to augment mother’s milk when babies are born prematurely and a mother’s milk alone doesn’t deliver enough nutrition.'

Sounds both reasonable and necessary, right?

Not if you are a parent whose brand loyalty inadvertently put their young child back into the hospital where that loyalty was first established:

In hundreds of lawsuits, parents of sickened or deceased preterm infants have alleged that formula designed for preemies has caused necrotizing enterocolitis, or NEC, a devastating condition in which immature intestinal tissue can become infected and die, spreading infection through the body.

Lawsuits also accuse the manufacturers of failing to warn parents of the risk.

One of the cases on which this article is based, Watson v. Mead Johnson, resulted in a $60 million judgment against Mead Johnson. Another, Gill v. Abbott Laboratories, et al., resulted in a $495 million judgment against Abbott. The third, Whitfield v. St. Louis Children’s Hospital, et al., resulted in a jury verdict in favor of Abbott and Mead Johnson, but the judge found errors and misconduct on the part of defense counsel, faulted his own performance, and granted the plaintiff a new trial.

The cases have involved children like Robynn Davis, who was born at 26 weeks, lost 75% to 80% of her intestine to NEC, suffered brain damage — and, at almost 3 years old, couldn’t walk, couldn’t really talk, and was eating through a tube, as Jacob Plattenberger, an attorney representing her, described in court in 2024.

An attorney for Abbott, James Hurst, said in court that Robynn suffered a catastrophic brain injury at birth, 10 days before she received any Abbott formula, and that her NEC resulted not from formula but from many health problems.

In at least three cases, a federal judge has granted summary judgment in favor of Abbott — ruling for the company before the lawsuits even reached trial.

The formula makers have repeatedly denied fault.

The formula makers have also sought to obscure fault or place it at their competitor’s doorstep. They’ve both done it with a number of questionable studies that could be generously described as “cozy.” Here’s a look at how the sausage is made:

In 2017, Abbott exchanged a series of messages with researchers at Johns Hopkins University about a study on how the composition of infant formula might affect NEC in mice. The email thread became an exhibit in the Whitfield case.

Abbott was both funding and collaborating on the work, a later publication in a scientific journal shows.

Forwarding a draft of the resulting paper to Abbott, David Hackam, chief of pediatric surgery at the Johns Hopkins University School of Medicine, said in one of the emails, “We hope you like it.” He also requested help from Abbott in filling in information.

“The manuscript looks great!” Abbott’s Tapas Das wrote in May 2017, after a back-and-forth.

But Abbott had some changes, the email thread shows.

“We (VM & DT) made some edits in the text especially to soften a bit with the statement ‘infant formula seems responsible for developing NEC,’” Das wrote.

“Instead, we thought if we could state as ‘infant formula is linked to severity of NEC’. So we made changes throughout the text emphasizing on severity of NEC by infant formula rather than development of NEC by infant formula,” Das wrote.

The Abbott co-authors “proposed routine edits to the article for scientific accuracy and for the consideration of the other authors, some of the most well-respected NEC researchers in the world,” [Abbott spokesperson Scott] Stoffel said.

“Abbott regularly collaborates with and publishes studies with leading NEC scientists for the benefit of both premature infants and the entire scientific community,” Stoffel said.

Amazingly, consumers have to rely on the industry’s heavily-massaged science for answers to questions that may imperil the industry’s bottom line. That’s because…

FDA oversight of infant formula is limited. The agency doesn’t approve the products or their labeling. Whether to report adverse events — illnesses or deaths potentially related to the products — to the FDA is largely at manufacturers’ discretion.

Ironically, the gutting of scientific research by the MAGA-MAHA alliance will make the public even more dependent upon companies that fund, staff and rewrite studies of thier products:

The business of infant formula further spotlights a central contradiction in the Trump administration’s health policies. When it comes to food and medical products, the administration has criticized industry-funded research as unworthy of trust. Yet under Kennedy, it has disrupted, defunded, or sought to cut government-funded research, which could leave industry-funded research with a larger and more influential role.

Another avenue is a subscription to Consumer Reports.

The venerable consumer watchdog sent shockwaves through the industry last year when it tested 41 formulas for BPA, acrylamide, inorganic arsenic, lead, cadmium and mercury. Although it generated a lot of handwringing, very little has been done at the national level to address CR’s findings.

So, they did it again … this time their scientists “detected contaminants at potentially concerning levels in 26 of the 49 formulas” they tested. - jp

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We Tested 49 More Baby Formulas for Lead and Arsenic
https://www.consumerreports.org/babies-kids/baby-formula/liquid-baby-formula-contaminants-test-results-a8639602154/

Profits over Patients
https://thefulcrum.us/health/profits-over-patients-us-healthcare-system-costs-outcomes

For-profit healthcare is booming: See where private equity owns nearly 500 of America’s hospitals
https://www.businessinsider.com/map-shows-private-equity-owned-hospitals-by-state-2026-3