In May 2011, the U.S. Food and Drug Administration approved a request by Nestle to be able to market its 100 percent whey-protein partially hydrolyzed infant formula as reducing the risk of eczema.
A new study, published in medical journal The BMJ, which reviewed information from 37 different trials from 1946-2015, involving 19,000 participants, argues that may have been a mistake.
Robert Boyle at Imperial College London and his co-authors wrote that there is no consistent evidence to support the claim that partially or extensively hydrolyzed cow’s milk formula — which involves treating milk with heat to break down proteins into what is theoretically believed to be smaller components that are less allergenic — prevents allergic or autoimmune diseases. They wrote that the evidence in support of a link was of “low quality” and that there were numerous “high or unclear” risks of biases and possible conflicts of interest in the positive studies.
Such formulas are widely recommended in many parts of the world for infants with a family history of allergic disease such as asthma, eczema, allergic rhinitis, food allergy, and the autoimmune disease type 1 diabetes.
“Our findings conflict with current international guidelines,” the authors wrote. They emphasized that those feeding recommendations be revised.
In addition, they said, conclusions of the FDA review “do not seem to be justified.” In fact, they said, the health claim was also approved before publication of one trial of the same formula with significantly negative results.
Writing in a commentary piece, Caroline Lodge from the University of Melbourne said that a critical component of the study was its focus on assessing the quality of the studies it reviewed.
“With increasing and necessary involvement of industry in medical science it is imperative that we take steps to ensure transparency and prevent commercial priorities from influencing published results,” Lodge said.
She also pointed out that efforts to promote this type of special formula may “unwittingly undermine efforts to promote …[nursing].”