A leading endocrinologist with the Food and Drug Administration recommended pursuing approval for puberty blockers for youth with gender dysphoria despite acknowledging that they raised the risk of depression and suicidality, according to internal emails.
Shannon Sullivan, the clinical team leader at the FDA’s Division of General Endocrinology, recommended to her supervisor in January 2022 that the agency approve puberty blockers to treat adolescents with gender dysphoria following a safety review that showed negative mental health results.
Puberty blockers, which are used to treat various conditions, including precocious puberty, are not approved by the FDA as part of a gender transition medical plan for minors, but they are often prescribed off-label for this purpose, which is legal.
In the leaked email, Sullivan explained that the FDA’s Division of Urology, Obstetrics, and Gynecology conducted a review of adolescent patients prescribed puberty blockers off-label and found an ”increased risk of depression and suicidality, as well as increased seizure risk.”
But in the next paragraph, Sullivan explained that puberty blockers should be approved regardless of these concerns.
“There is definitely a need for these drugs to be approved for gender transition, as they are typically not covered by insurance and are expensive out of pocket,” Sullivan wrote.
Sullivan's emails were obtained through a lawsuit discovery process from the nonprofit advocacy group America First Legal and published by the Daily Signal.
Neither Sullivan nor the FDA responded to the Washington Examiner’s request for comment at the time of publication.
The use of puberty blockers for gender transition of minors has become increasingly controversial in recent years.
Since 2021, 25 states have enacted some form of restrictions on medically transitioning minors.
Although the specifics of each state’s regulations vary, they often prevent transgender minors from being treated with puberty blockers, cross-sex hormones, and surgeries.
There is limited evidence on the long-term effects of puberty blockers on minors for the treatment of gender dysphoria or youth transgender patients.
In the United Kingdom, the National Health Service permanently banned puberty blockers from being prescribed to treat gender dysphoria due to little evidence of their success, and the ban was held up in court earlier this week.
The NHS made the decision following the publication of the Cass Review, an independent review of the literature thus far on gender transition medicine for minors conducted by leading British pediatrician Hilary Cass.
The Cass Review highlighted that, from the limited available evidence, puberty blockers may reduce psychological functioning in patients due to the changes in brain chemistry that occur during puberty.
“The focus on puberty blockers and beliefs about their efficacy has arguably meant that other treatments (and medications) have not been studied/developed to support this group, doing the children and young people a further disservice,” Cass wrote in the final report.
The U.K.’s Labour Party health minister said this week that he is interested in pursuing clinical trials for puberty blockers to treat gender dysphoria to build the body of knowledge on their long-term effects.
CLICK HERE TO READ MORE FROM THE WASHINGTON EXAMINER
The U.S. Department of Health and Human Services has previously come under scrutiny for hasty judgments on youth transgender medicine decisions.
Leaked emails from the office of the Assistant Secretary of Health Rachel Levine showed that she pressured a leading international health organization into dropping age requirements for minors to obtain gender transition surgeries.
Most Popular
Comments / 0