Cancel the clinical trial into puberty blockers & safeguard vulnerable children

The government is aware of the potential irreversible impact (physical and emotional) of puberty blockers, having acknowledged an 'unacceptable safety risk’ following the Cass Review. Yet, hundreds of children are about to be given puberty blockers under a government-sanctioned trial.

We want this trial to be cancelled. We believe that the answer for children feeling dis-ease in their bodies (many of whom are autistic) is the passage of time and natural progression of puberty, coupled with explorative therapy. We believe that the answer is never medicalisation that can harm brain development, bone growth, sexual functioning, and lead to infertility, and that to put children on a path towards such harm is the antithesis of safeguarding. Let us not be written into history as the country that knowingly harmed vulnerable children.

It is essential for the Government and the NHS to be guided by expert clinical advice and act with caution and care when it comes to supporting children and young people living with gender incongruence. The independent Cass Review concluded that the rationale for early puberty suppression remains unclear, and that there is not enough clinical evidence for the safe and effective routine use of puberty suppressing hormones to treat gender incongruence in under-18s. For that reason, this Government supported and extended indefinitely the ban on their use outside of research. Despite these restrictions, some young people are going to great lengths to source these drugs from unregulated providers, in the absence of scientific evidence.

The Cass Review recommended that a programme of research be established to underpin the design and delivery of NHS gender care. It specifically recommended this include a clinical trial into puberty suppression in young people with gender incongruence. This recommendation addresses the lack of evidence about the relative benefits and harms of this treatment option, particularly when provided alongside an updated model of NHS care incorporating holistic assessment and a comprehensive and tailored package of psychosocial support.

The study protocol is available on the National Institute for Health and Care Research (NIHR) website: https://fundingawards.nihr.ac.uk/award/NIHR167530

The bar for a UK clinical trial to be approved is extremely high, with the PATHWAYS trial going through rigorous rounds of scientific, clinical, ethical and regulatory review. It was approved by an independent NIHR funding committee. The final protocol was subject to rigorous approval processes through both the Medicines and Healthcare products Regulatory Agency and the Health Research Authority – including review by an independent Research Ethics Committee.