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Dr. David Gortler, a pharmacological expert and former FDA safety official, has sounded the alarm over a recent U.S government document promoting the use of puberty blockers and cross-sex hormones for transgender-identifying minors. Writing in Newsweek, Dr. Gortler argues that the government guidance was written by unqualified authors, relying on questionable psychological—not pharmaceutical—studies, in a process that “circumvented” FDA expertise.

The March 2022 guidance document, “Gender Affirming Care and Young People,” is the product of the Office of Population Affairs, a small office within HHS with no apparent expertise in off-label use of pharmaceuticals or in medical care for young people diagnosed with gender dysphoria. Even so, the OPA/HHS “guidance document” endorses “gender-affirming care” for minors, including the off-label use of hormones, claiming this approach results in “positive outcomes for transgender and nonbinary children and adolescents.” The guidance describes “gender affirming care… [as] an array of services that may include medical, surgical, mental health, and non-medical services” to assist individuals in “aligning their outward, physical traits with their gender identity.”

Assistant Health Secretary Dr. Rachel Levine claims that “there is no argument among medical professionals—pediatricians, pediatric endocrinologists, adolescent medicine physicians, adolescent psychiatrists, psychologists, etc.—about the value and the importance of gender-affirming care.” However, her claim ignores the increasing number of countries that have reversed course and no longer promote medical and surgical interventions as first-line treatment for transgender-identifying minors. For example, health authorities in Sweden, Finland, and France have changed policies, ending “gender-affirming” medical interventions in minors or restricting their use as experimental, as they acknowledge that the risks of medicalized “gender affirmation” outweigh the benefits, and urging psychotherapy as the first-line treatment. A recent UK evidentiary review (the “Cass Review”), along with psychotherapy groups in New Zealand and Australia, have raised similar concerns about the harms of gender-affirming care.

In addition, a group of international clinicians, the Society for Evidence Based Gender Medicine (SEGM), “fact-check[ed] the accuracy” of the OPA/HHS guidance, and found “many highly inaccurate” and “misleading” claims,” along with faulty reliance on poorly designed studies.

In its rush to promote the politicized policy, Dr. Gortler writes, the HHS/OPA office skipped over the usual public comment process, and ignored “pharmacological, genetic, medical, surgical, gynecological, endocrinological” and other evidence that undercut its “justification” for “gender-affirming” recommendations. Consequently, the government policy “represents a ‘feeling’ without any of the evidence-based justification.”

Parents and health-care providers, be forewarned.


Read SEGM’s full critique of the OPA/HHS guidance document here.
Read Dr. Gortler’s Newsweek column here. 
Read the government’s guidance document on “gender affirming care” here.