Baby Formula Risks May Be Missed Due To Clinical Trials Lacking Independence and Transparency: Report

Amid a growing number of Enfamil and Similac lawsuits, alleging the manufacturers failed to disclose the baby formula NEC risk, a new study highlights the overall lack of scientific rigor in infant formula clinical trials.

The findings of a new study are critical of the manufacturers of baby formula, warning clinical trials they have funded are biased and have undermined breastfeeding, which reinforces allegations raised in dozens of Similac lawsuits and Enfamil lawsuits filed in recent months by parents of premature infants diagnosed with NEC (necrotizing enterocolitis).

Researchers from the United Kingdom indicate that the explosion in use of baby formula, which often supplants the use of breastfeeding for newborns, has come amid “an almost universal lack of transparency” and the cherry-picking of evidence by researchers funded by the baby formula industry. Their findings were published on October 14 in The BMJ.

Infant formula is specially formulated to account for the specific needs of infants and can be their sole source of nutrition. If the formula does not contain the appropriate vitamins, minerals and nutrition for a growing infant, the child can experience serious malnutrition and side effects.

In recent years, health experts have raised concerns over the use of formula, especially among premature infants, due to the link between cow’s milk baby formula and necrotizing enterocolitis (NEC), which is a devastating disease that occurs when the wall of the intestine is invaded by bacteria, leading to destruction of the bowel and often requiring emergency surgery while the baby is still in NICU.

Concerns About Infant Formula Clinical Trial Procedures and Selective Reporting

While products like Similac and Enfamil have been aggressively marketed for use among premature infants, increasing evidence has found that baby formula risks of NEC are substantially greater, leading health experts to recommend breast milk instead of formula whenever possible. However, studies funded by baby formula manufacturers continue to extoll the virtues of formula, which researchers in this latest study say have raised suspicions among pediatricians and nutritionists about how those clinical trials are being conducted.

“Associations for the nutrition industry cite their investment in world class research and development, but several groups from academia and regulatory science have raised concerns about the conduct and reporting of formula milk trials,” the researchers noted. “Some have suggested that trial procedures might contravene the International Code of Marketing of Breast-milk Substitutes, for example, by providing free formula to participants.”

To analyze the validity of the studies, the researchers conducted systematic reviews of studies in several databases involving clinical trials that compared two or more different formula products for children ages three and under, which were published between January 1, 2015, and December 31, 2020. They also looked at trials which were registered in the International Clinical Trials Registry for all trials published since January 1, 2006.

Not only did the researchers find 73 trials published between 2006 and 2020 that fit the criteria of the study, involving 13,197 children in total, but they also found another 111 unpublished trials involving 17,411 children, whose results never saw publication.

According to their analysis of these baby formula clinical trials, the risk of bias was high in 80% of the published trials, primarily due to selective reporting and inappropriate exclusions of data. In 69% of the published trials, authors came to favorable primary outcome conclusions benefitting the use of formula, and in 92% of the published studies researchers made favorable abstract conclusions. Only one trial the researchers investigated reported adequate support for breastfeeding, while in 16% of the trials, the decision not to breastfeed the children was established before the study began.

“In this systematic evaluation of formula milk trials, we found an almost universal lack of transparency, and evidence of selective reporting between and within trials,” the researchers concluded. “The widespread and increasing use of formula in children at a sensitive period of development emphasizes the importance of scientific rigor in this area of clinical investigation. Our findings suggest that recent formula trials lack that scientific rigor, and published outcomes are biased by selective reporting.”

The researchers pointed to the large body of unpublished studies and the evidence within them as further evidence of bias by industry-funded research, suggesting they may be abandoning these studies when they do not show the desired results.

Lawsuits Over Failure to Disclose NEC Baby Formula Risks

The findings come as a growing number of families have decided to pursue a baby formula NEC lawsuit against the makers of Similac and Enfamil, alleging that Abbott and Mead Johnson knew or should have known that the formula and fortifiers were unreasonably dangerous for premature babies, yet the companies continued to sell and distribute the products without providing adequate warnings to parents, hospitals and medical providers.

The lawsuits also claim the use of these formulas has displaced breast milk that infants would have otherwise received, robbing them of a primary defense against NEC, since studies have shown breast milk can serve as a protective measure.

As recently as 2016, Abbott advertised some Similac formulas as being specifically for premature and low birth-weight infants, the lawsuits note, despite the known dangers.