Comment from Jeremy Jones

I am Jeremy Jones, a pediatrician and clinical professor of primary care at Marian University Tom and Julie Wood College of Osteopathic Medicine in Indianapolis, Indiana. I am commenting to urge the FDA to conduct a comprehensive investigation into the alleged safety and benefits of estrogen use in males seeking feminization, and to issue a Black Box warning based on estrogen’s well established elevated cardiovascular risk profile in this population. There are many systematic reviews that have failed to convince me and other health professionals of any positive outcomes related to hormone use in female and male minors. There is no scientific literature that can show any evidence of the benefit of estrogen use in males in particular. Actually, several studies highlight the concerning adverse deleterious effects that estrogen use plays on several organ systems in males. These well-defined risks include venous thrombo-embolism, infertility, cognitive impairment, psychological decline, metabolic alterations, autoimmune disorders, and cancers. There is no medical reason to give estrogen when the number and severity of risks, both physically and morally, are recognized. For these reasons, I strongly encourage the FDA to fulfill its mission under 21 C.F.R. § 201.80(e) to mandate the appropriate Boxed Warning.