HHS Guidance on Trans Pharmacology Raises More Questions Than It Answers | Opinion
Gender Affirming Care in Young People. The document claims to outline an established standard of care on how to proceed with social, pharmacological and surgical "affirmation" of children and adolescents who identify as transgender.
When announcing the new document, Assistant Secretary for Health Rachel Levine went so far as to state "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."Levine's extreme statement was rightly rebuked by physicians and members of Congress for not being appropriately based in evidence.At first glance, the HHS/OPA document gives the impression that anyone and everyone should just start writing prescriptions and scheduling surgical procedures upon request.
Observant scientists and clinicians will notice the document is most remarkable for what it doesn't say.As a pharmacologist, pharmacist and research scientist who has dedicated his life to drug safety, drug development and evidence-based clinical and non-clinical science and medicine, I have some important questions—starting with who the authors of this document are, and what academic credentials they have.Puberty blockers and cross-sex hormones for gender transition are all off-label, non-FDA-approved use.
I'd be curious what published studies were the basis for the HHS/OPA recommendations regarding the use of those drugs. Were existing FDA- and non-FDA drug safety databases reviewed to assess risk to gender-appropriate and gender-incongruent application and administration?
