Correcting Misconceptions About the LEAP Study

FARE is committed to ensuring that individuals and families managing food allergies receive accurate, evidence-based information about the disease. Incorrect information can lead to worse outcomes and potentially dangerous errors when it comes to food allergy.

Recently, FARE has noted a number of misleading and inaccurate articles, summaries and blog posts about the Learning Early About Peanut Allergy (LEAP) study, which was published in the New England Journal of Medicine in February. The National Institutes of Health (NIH) and FARE primarily funded this study.

A recent blog post by author and speaker Robyn O’Brien contains a number of important technical inaccuracies and misrepresentations that FARE is compelled to publicly correct:

O’Brien denigrates the study because it “threw out 10% of at-risk babies before it even started,” She states “it is akin to conducting a diabetes study on sugar, funded by the sugar industry, and throwing out the diabetics before you start.”

FACT: LEAP is a study focused on the prevention of food allergy in children with risk factors for peanut allergy – not on the treatment of existing food allergies. The infants who were ruled out of the study were not included because there was evidence these children were already allergic to peanuts and could have experienced serious reactions if they were enrolled in the study.

O’Brien stated that the New England Journal of Medicine did not disclose that some funding for the study was provided by the National Peanut Board.

FACT: The authors of the study disclosed all of the study’s funders and their conflicts of interest; the authors of the accompanying editorial in the New England Journal of Medicine also disclosed conflicts of interest. The funding disclosures are listed at the conclusion of the study, in keeping with established protocols of leading peer-reviewed scientific journals. By titling the blog post, “Science for Sale: The Funding Behind the Latest Study on Peanut Allergy,” O’Brien implies that the study is largely funded by corporate or private interests, which is false. She fails to mention the vast majority of the study’s funding came from the National Institutes of Health and FARE. The National Peanut Board, a minority funder, was contractually prohibited from influencing any aspect of the study design or interpretation of the results. The complete list of funders can be found here.

O’Brien states that Allergen Research Corporation (ARC) raised nearly $17 million, including support from FARE, to create “synthetic peanuts.”

FACT: ARC is not creating a synthetic peanut. ARC is working to develop pharmaceutical-grade, standardized peanut protein that can be used to generate a U.S. Food and Drug Administration approved oral immunotherapy.  Oral immunotherapy is a promising approach currently being studied for the treatment of food allergy.  The lack of a standardized food allergen product is the main factor that has prevented an FDA-approved peanut oral immunotherapy. In 2011, FARE was a minority investor in ARC and provided seed funding to establish the company. This investment was one of a number of strategies FARE undertook to help advance research of promising new treatments. For more information about ARC, please visit www.allergenresearch.com.

FARE’s position is that the LEAP study, which was rigorously designed, helps to provide definitive answers on whether feeding a food can prevent food allergy in an infant at risk for developing allergy. We have publicly expressed caution about misinterpreting the study. Media coverage about the LEAP study was often very oversimplified and confused the results. We wish to reinforce that parents or caregivers should not suddenly start giving their children peanuts without discussing this with their physician, especially if there is a family history of food allergy or the child has eczema.

Additional information from FARE about the LEAP study:

 

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