FDA knew 'gender affirming' puberty blockers increase 'suicidality' in 2017, promotes them today

Five months before the Food and Drug Administration issued a health warning on puberty blockers widely used off-label to treat minors with gender confusion, undermining a Department of Health and Human Services office that claimed "early gender affirming care is crucial to overall health and well-being," an FDA leader acknowledged other health concerns.

Pediatric patients exposed to "gonadotropin-releasing hormone agonists," most with central precocious puberty (CPP) and "a handful … transgender kids using the drugs off-label," had an "increased risk of depression and suicidality, as well as increased seizure risk," Division of General Endocrinology clinical team leader Shannon Sullivan told colleagues.

The 2017 safety review by the FDA's Division of Metabolism and Endocrinology Products (DMEP), cited by Sullivan, contradicts claims by American medical groups and Assistant Secretary for Health Rachel Levine that gender affirming care is "suicide prevention," as the government's highest-ranking transgender official said at the 2022 Out For Health Conference.

It also undercuts Sullivan's own call to approve puberty blockers for "gender transition" in the same Jan. 25, 2022, email chain.

Kids aren't the only ones at risk, according to an study in April by University of Texas Medical Branch researchers in the peer-reviewed journal Cureus, which found gender-affirming surgery in adults is "significantly associated with elevated suicide attempt risks."

Members of the World Professional Association for Transgender Health, whose Standards of Care play an outsized role in American medicine, swapped candid stories about young patients or colleagues developing life-threatening medical conditions or even dying after years of gender-affirming treatment, in leaked forum discussions.

A “16 y/o patient…found to have two liver masses… the likely offending agents were the hormones…”

The problem is that drugs can cause tumors, even, apparently, in people as young as 16 years old. pic.twitter.com/IAat1gaKXR

— Michael Shellenberger (@shellenberger) March 4, 2024

Sullivan, her colleagues on the email chain and the FDA did not respond to Just the News requests for further context, why Sullivan supported the drugs' approval for gender transition in spite of the FDA's findings and whether it all boils down to insurance coverage.

"Legal and insurance contexts" were major factors in the removal of age minimums for even transgender surgery in WPATH's Standards of Care 8 in 2022, according to the prepubescent children chapter's lead author. Levine's staff pressured WPATH behind the scenes to drop the age minimums entirely, according to discussions exposed in litigation.

The National Institutes of Health hired another cheerleader for puberty blockers and Levine ally, Texas Children's Hospital pediatrician-in-chief Dr. Catherine Gordon, as clinical director of its National Institute for Child Health and Human Development last fall, without noting her life's work in gender-affirming care and related conflicts with Texas GOP elected officials.

America First Legal obtained the FDA emails through Freedom of Information Act litigation and shared them with Just the News after The Daily Signal posted two screenshots from the FOIA production.

They mention the FDA updating the "product labeling" for GnRH agonists based on the 2017 review but also a new "potential signal of a serious risk regarding intercranial hypertension in children treated for CPP" in an ongoing review.

That apparently refers to the "risk of pseudotumor cerebri" the FDA added to GnRH agonists including Lupron – which rose to prominence as a pricey sex-offender castration drug with severe side effects – and Supprelin LA on July 1, 2022. 

The agency found a "plausible association" between the drugs and the adverse event in six cases, all girls 5-12, one of whom was receiving "transgender care."

Kaiser Health News touted GnRH agonists to treat gender dysphoria in August 2016, claiming they had been used to treat precocious puberty "safely for decades." One family put their son who identified as a girl on Lupron and Kaiser Permanente covered it, the nonprofit reported, without mentioning Lupron's use for sex offenders.

By February 2017 KHN was reporting just the opposite in collaboration with the Center for Investigative Reporting, noting 10,000 adverse-event reports about Lupron filed with the FDA while saying nothing about gender-affirming care.

"In the interviews with women who took Lupron to delay puberty or grow taller, most described depression and anxiety," KHN and CIR said. "Several recounted their struggles, or a daughter’s, with suicidal urges." 

Women in their 20s who took Lupron a decade or more earlier developed bone-thinning, osteoporosis and a cracked spine, chronic pain and degenerative disc disease, and total hip replacement, according to the report. 

The FDA told the outlets it was reviewing "nervous system and psychiatric events," as well as potentially fatal seizures, associated with GnRH agonists including Lupron.

Five years later, Reuters reporter Chad Terhune asked the FDA about the off-label use of Lupron and Supprelin LA in gender-confused children in light of its 2017 safety review of GnRH agonists, prompting the Jan. 25, 2022, email chain obtained by America First Legal.

"There are questions about bone health, brain development and fertility. Did anything come out of that?" Terhune asked. "Has FDA done anything in relation to their off-label use for gender dysphoria in children?"

Sullivan's boss Theresa Kehoe, who had directed the division for a little over a year, asked her for "some history here" to answer Terhune's questions.

"DMEP did do a safety review" following the KHN article "in which adults with histories of CPP attributed multiple complaints to prior use of a GnRH agonist," Sullivan, who joined the FDA in 2016 and still teaches medicine at Georgetown, responded. "The complaints were extensive and variable, and included fibromyalgia type symptoms, infertility, [polycystic ovary syndrome], and weight gain, among others."

Sullivan's team reviewed "suicidal ideation/depression, seizures, and bone health," finding no effect on the latter "after factoring in catch-up growth," she said. (The KHN/CIR report said bone problems came much later in women they interviewed.)

🚨SHOCKING EXPOSÉ🚨

Our litigation just exposed that Biden’s FDA recommended approving puberty blockers to minors despite noting that these drugs are associated with an “increased risk of depression and suicidality.”

DETAILS: pic.twitter.com/IfNc8ZQaaX

— America First Legal (@America1stLegal) August 1, 2024

The agency issued safety-related labeling changes for "the entire class" for the increased risk of depression, suicidality and seizure, she said.

Without grappling with the tension between the review's findings and her own preference, Sullivan said there was "definitely a need for these drugs to be approved for gender transition," citing her participation in a Division of Urology, Obstetrics, and Gynecology "patient listening session with trans kids and separately with trans adults."

Like WPATH's reversal on age minimums, Sullivan justified approval on the basis that insurance would then cover the drugs, which are "expensive out of pocket." No company has yet sought such approval, but Sullivan's understanding is that "DUOG would take these applications if and when if and when any come in" to the FDA.

"It seems we cannot talk about off label indications (transgender)," Kehoe responded. She suggested language from a "safety perspective" about the updated product labeling for CPP based on the 2017 review, ongoing monitoring for adverse events and the recently discovered "potential signal" about intercranial hypertension.

"I don't know if it's accurate to say that we made labeling updates based on review of that safety signal, since the seizures/psych reviews were ongoing at the time we were made aware of the KHN article," responded Chief of Project Management Staff Elisabeth Hanan.