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The Need for Research Specific to Lactating People

Published on August 30, 2022 in Cornerstone Blog · Last updated 5 months 3 weeks ago


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 Diane L. Spatz, PhD, RN-BC, FAAN

Diane L. Spatz, PhD, RN-BC, FAAN

Editor’s Note: Diane L. Spatz, PhD, RN-BC, FAAN, is a professor of Perinatal Nursing and the Helen M. Shearer Professor of Nutrition at the University of Pennsylvania School of Nursing and a Nurse Scientist in the Center for Pediatric Nursing Research and Evidence Based Practice at Children’s Hospital of Philadelphia. Contact her by spatz [at] (email).

At a meeting held in June at the National Academies of Sciences Engineering Medicine (National Academies) in Washington, D.C., I served as the only PhD prepared nurse on the planning committee for this conference. This two-day meeting served as a follow-up to the Congressional Taskforce on Research Specific to Pregnant Women and Lactating Women (PRGLAC), which I served on from 2017 to 2020. The goal of this workshop was to create actionable changes to ensure the inclusion of both lactating people and pregnant people in research and best practices for doing so.

Healthcare professionals, federal agencies representatives, community advocacy groups, as well as pharmaceutical company representatives attended the meeting.  It is notable that pharmaceutical companies were involved in both PRGLAC and the National Academies meetings because we currently have no medication that is approved by the Food and Drug Administration (FDA) to treat low milk supply in the U.S. At every meeting, I have brought up the topic that we need to have a treatment option in the U.S. for low milk supply.

In 2020, about 3.6 million people gave birth in the U.S. with over 80% initiating breastfeeding, thus representing almost 3 million people who are lactating. One of the major concerns of lactating people is either perceived insufficient milk supply or actual insufficient milk supply. Parents reported concerns about infant crying and fussing, the infant feeding frequently, and difficulty with latching, in a recent U.S. study about perceived insufficient milk supply. All of these are common concerns of new parents and could indicate that milk supply could be compromised.

The first hour, first three to five days, and first two weeks are all critical for activating prolactin receptor sites in the breast and for coming to volume. If the lactating person does not come to volume during the critical window, milk supply could be suboptimal for the rest of their lactation journey with no FDA approved treatment option. With the current state of formula shortages in the U.S., it seems evident that we need an FDA approved medication to treat milk supply.

A clinical trial has been initiated to evaluate a medication to treat low milk supply but only in mothers of preterm infants; however, even with this trial, it would be years before a product came to market. At the National Academies meeting, I urged representatives of the FDA to consider prioritizing the treatment of milk supply and consider looking into what strategies could be developed to help more women sooner based on options available globally.