Crackdown

Petition urges the FDA to take action to protect vulnerable children from the use of off-label puberty blocker drugs

Photo by leah hetteberg on Unsplash

America’s drug regulator, the FDA, has been asked to take urgent action on the unapproved use of hormone suppression drugs to block the natural but unwanted puberty of transgender-identifying children.

“Although this use has not been approved by the [Food and Drug Administration], the FDA must not turn its back on the potential harm to children,” says a citizen petition filed with the agency.

“Despite the widespread—and rapidly growing—use of these drugs in this population [of children with the distress of gender dysphoria], and despite serious known and potential risks from these drugs, this use has never been evaluated for safety and effectiveness by the FDA.”

The petitioners include child and adolescent psychiatrist Dr Miriam Grossman, paediatric endorcinologist Dr Quentin van Meter and the groups Genspect, Detrans Help, FAIR in Medicine and the Gender Dysphoria Alliance.

The webpage hosting the petition is open to public comment. The FDA acknowledged receipt of the petition on September 5.

“Puberty blockers, or gonadotropin-releasing hormone (GnRH) agonists, are a class of drugs that are FDA-approved for treating certain cancers, endometriosis, and, in pediatric populations, central precocious puberty. Brand name puberty blockers include Lupron Depot-PED, Supprelin LA, Fensolvi, Synarel, and Triptodur. These drugs suppress the release of sex-specific hormones—testosterone in males and estrogen in females. When given to children in the early stages of puberty, they delay sex-related changes normal to adolescent development, such as deepening voice in males and breast development in females.”—citizen’s petition to the FDA, September 2023

The petitioners urge the FDA to—

• commission the National Academies of Sciences, Engineering, and Medicine (NASEM) to undertake a transparent and unbiased systematic review of the evidence for trans puberty blocker drugs

• issue requests for long-term registry studies of the children given trans puberty blockers, given that long-term data “is critically important and sorely missing”

• create a webpage disclosing the known and potential risks of off-label puberty blockade to “help to counter widespread confusion and misinformation about this use”

“Many in the medical profession and the media continue to represent the off-label use of puberty blockers as ‘well established’ and ‘lifesaving’,” the petition says.

“While the FDA has taken an aggressive stance against medical misinformation in other contexts, it has done nothing to counter these misrepresentations.

“What is most concerning is that, because puberty blockers are not FDA-approved in children with gender dysphoria, there is no demonstrated benefit of the drugs to justify these risks.

“This is why Sweden, Finland, the UK, Norway and other countries have all turned against the use of puberty blockers and other medical interventions as a front-line treatment of gender dysphoria, recognizing this use as experimental.

“The [American] public deserves the truth from its government about the potential harms of these drugs and the lack of established benefit.”

Puberty blockers are used off-label for gender dysphoria internationally, although brand names may vary from country to country.

Video: Paediatrician Dr Julia Mason and clinical psychologist Dr Erica Anderson discuss puberty blockers

Misinformation

“The FDA can address the misinformation surrounding the off-label use of puberty blockers in children by commissioning a systematic review of existing peer-reviewed studies by NASEM with the goal of developing an authoritative assessment of the evidence,” the petition says.

The citizen’s petition says the gender-affirmative treatment model used in the United States lacks the safeguards imposed by the Amsterdam gender clinic which in the late 1990s pioneered the use of puberty blockers followed by cross-sex hormones and surgery.

“Because of the prevalence of the affirmative model in the US, the number of children with gender dysphoria receiving puberty blockers has also risen sharply, more than doubling between 2017 and 2021,” the petition says.

“These drugs are known to interfere with bone development and fertility (when followed by cross-sex hormones) and serious concerns exist about their effect on long-term bone health and neurocognitive development.

“What is most concerning is that this [poorly understood] safety profile is currently tolerated in drugs prescribed to children for which the benefit is highly uncertain.”

The petition notes the vulnerability of dysphoric children, who have “higher rates of other psychological and developmental conditions, including autism, eating disorders and depression.”

“US District Court judges have been asked to compel the FDA to reveal what it knows about the off-label use of puberty blocker drugs by gender clinicians.”—news report, Gender Clinic News, 16 March 2023

This week’s citizen petition also calls upon the FDA to warn drug companies and health providers of the consequences of unlawful promotion of puberty blockers for children with dysphoria.

“Puberty blockers have been marketed directly to teenagers with promotions that characterize the drugs as a safe way to ‘put puberty on hold,’ without disclosing any of the required risk information,” the petition says.

“For example, a Planned Parenthood ad that first aired in 2022 depicts two cartoon teenagers speaking directly to potential users, stating—

‘[p]uberty blockers are safe and can give you more time to figure out what feels right for you, your body, and your gender identity,’ and ‘[y]our gender identity is real. You should be the one to decide what changes you want to make to your body’

The petition says, “Pharmaceutical companies that promote their drugs for off-label uses have paid multi-million-dollar settlements to avoid civil and criminal judgments.

“But the potential for harm to users doesn’t depend on who runs the ad: off-label promotions by practitioners that oversell the benefits of an off-label use and fail to disclose the risks have the same potential to deceive consumers.”

GCN has contacted the FDA for comment