Abstract
Hormone therapy is medically necessary for many transgender individuals. The U.S. Food and Drug Administration (FDA) and pharmaceutical companies' failure to guarantee a supply of injectable estrogen in 2016 and 2017 for transgender individuals is a violation of their right to comprehensive medical treatment, free of discrimination. A series of advocacy actions eventually led to all formulations of injectable estrogen being restored to market; however, long-term solutions to supply interruptions of injectable estrogen are needed. Long-term solutions should address the lack of federally funded research and, consequently, evidence-based practice on hormone therapy for gender affirmation.
Highlights
Hormone therapy is a medically necessary intervention for many transgender individuals.[1]
Patients report that injectable estradiol may offer faster, earlier breast development
According to the U.S Food and Drug Administration (FDA), a shortage of estradiol valerate began on August 10, 2016 and was fully resolved on June 12, 2017.6 the Callen-Lorde Community Health Center in New York City reported shortages in July 2016, when they received none of the 20 and 40 mg/mL formulations in their weekly drug shipment, and were told that the shortage would last until at least October 2016
Summary
Hormone therapy is a medically necessary intervention for many transgender individuals.[1] Studies have shown that gender affirmation through hormone therapy can improve psychological adjustment and quality of life, including reduced anxiety and depression, higher self-esteem, and improved social functioning.[1,2,3] The class of estrogen used for feminizing therapy is estradiol and is commonly delivered to transgender women through a patch, oral or sublingual tablet, or injection.[4]. There are no studies evaluating the benefits or risks of injectable estradiol, resulting in a lack of empirical data.[5] Patients report that injectable estradiol may offer faster, earlier breast development (personal communication, Dr Tim Cavanaugh [Director of Transgender Health] and Dr Alex Gonzalez [Medical Director], Fenway Health, 2016). Patients who do not achieve adequate feminization or adequate circulating blood concentrations of estradiol through oral and transdermal estrogen are often referred to injectable forms
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