Appeal to the FDA: no more silence on puberty-blocking drugs

A petition asks the US drug agency -which has never authorised the off-label use of these substances for girls and boys with dysphoria- to counter the misinformation that propagates these treatments as effective and safe and to demand studies to prove it.Between 207 and 2021, the number of minors treated has more than doubled and the FDA can no longer pretend it is blind.
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On its website Gender Clinic News Bernard Lane gives news of a important petition addressed to the FDA (Food and Drug Administration, a drug regulatory body in the United States) to undertake aurgent action on the unapproved (off-label) use of hormone suppressant drugs to stop puberty in girls and boys who identify as transgender. Although this use has never been approved by the FDA, it is not possible for the institution to ignore the possible harm to minors who are subjected to these treatments.

Let us remember that while all over Northern Europe there is a slowdown, in Italy puberty blockers are regularly prescribed -the number of minors in treatment is not known- and that the Italian Society of Paediatrics claims that the use of these drugs does not cause permanent problems to children. Also for the president of the Italian Society of Endocrinology Annamaria Colao the drug that blocks puberty 'if used correctly has no side effects or irreversible effects'.

Following is the translation of thearticle by Bernard Lane.

Despite thewidespread - and rapidly growing - use of these drugs in this population [of children with gender dysphoria], and despite the serious risks known and potential from these drugs, this use has never been evaluated from the point of view of safety and effectiveness by experts'.  

The signatories of the petition include child and adolescent psychiatrist Miriam Grossmannpaediatric endocrinologist Quentin van Meter and the groups Genspect, Detrans Help, FAIR in Medicine and Gender Dysphoria Alliance.

"Puberty blockers, or gonadotropin-releasing hormone (GnRH) agonists, are a class of drugs FDA-approved for the treatment of certain cancers, endometriosis and, in paediatric populations, premature puberty. Branded 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 oestrogen in females. When administered to children in the early stages of puberty, they delay sex-specific changes normal in adolescent development, such as deepening of the voice in males and breast development in females'.

The petitioners urge the FDA to

- mandate the National Academies of Sciences, Engineering and Medicine (NASEM) to undertake a transparent and impartial systematic review of the evidence in favour of puberty-blocking drugs 

- emanate requests for long-term studies on children given transpuberal drugs, as long-term data "are of fundamental importance and severely lacking"

- create a web page disclosing the known and potential risks of off-label puberty blocking to "help counter widespread confusion and the disinformation on this use'

"Many in the medical profession and in the media continue to portray the off-label use of puberty blockers as 'well-established' and 'life-saving''', states the petition.

"Although the FDA has taken an aggressive stance against medical misinformation in other contexts, never did anything to counter these false statements. "What is more worrying is that since puberty blockers are not FDA approved for children with gender dysphoria, there is no proven benefit of the drugs to justify these risks."

"This is why Sweden, Finland, the UK, Norway and other countries have all opposed the use of puberty blockers and other medical interventions as first-line treatment of gender dysphoria, recognising this use as experimental.

"The [American] public deserves its government to tell the truth on the potential harms of these drugs and the lack of established benefits

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

"The FDA can address the misinformation surrounding the off-label use of puberty blockers in children by commissioning a systematic review of peer-reviewed studies existing by NASEM with the aim of developing an authoritative evaluation of the evidence,' the petition states.

The petition states that the gender affirmation treatment model used in the US lacks guarantees imposed by the Amsterdam gender clinic that pioneered the use of puberty blockers followed by cross-sex hormones and surgery in the late 1990s.

"Due to the prevalence of the affirmative model in the United States, the The number of children with gender dysphoria receiving puberty-blocking drugs has increased significantly, more than doubling between 2017 and 2021'..

"It is well known that these drugs interfere with bone development and fertility (if followed by cross-sex hormones) and there are serious concerns about their effect on long-term bone health and neurocognitive development

"What is most worrying is that this [poorly understood] security profile is currently tolerated in medicines prescribed for children for which the benefit is highly uncertain.'"

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

The petition also calls on the FDA to warn pharmaceutical companies and health professionals of the consequences of illegally promoting puberty blockers for children with dysphoria.

"Puberty blockers were marketed directly to adolescents with promotions that designate them as a safe way to 'pause puberty', without disclosing any of the necessary risk information,' the petition states. "One example, thePlanned Parenthood ad broadcast for the first time in 2022 , a cartoon representing two teenagers speaking directly to potential users, stating: "The [p]uberty blockers are safe and can give you more time to understand what is right for you, your body and your gender identity'. e 'our gender identity is real'. You should decide what changes you want to make to your body".

The petition states: 'Pharmaceutical companies promoting their drugs for off-label uses have paid multimillion-dollar settlements to avoid civil and criminal judgments.  But the potential harm to users does not depend on who publishes the advertisement: promotions by professionals who overestimate the benefits of off-label use and fail to disclose the risks have the same potential as misleading consumers.

 (translation and adaptation by Marina Terragni)

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