UK Puberty Blocker Trial for 220 Minors Sparks Legal Battle Over Ethics and Consent

A new NHS-backed clinical trial, set to administer puberty blockers to approximately 220 children under the age of 16, is facing imminent High Court action in the United Kingdom. The "PATHWAYS TRIAL," led by King's College London, aims to assess the impact of these drugs despite a prior ban on their general use due to safety concerns raised by the Cass Review. Researchers involved in the study assert that it has received ethical approval.

The trial will involve children already diagnosed with gender incongruence, randomly assigning them to receive puberty-suppressing hormones either immediately or after a 12-month delay. The study intends to track effects on participants' bone density, mental health, and brain development. Professor Emily Simonoff, the study leader, stated that the research is "focused solely on informing and improving healthcare by better understanding how to support the physical and mental health of young people with gender incongruence."

However, the initiative has drawn strong criticism and a legal challenge from Keira Bell, who detransitioned after taking blockers as a teenager, and psychotherapist James Esses. Bell described the trial as "disgusting" in a recent social media post, threatening High Court action alongside Esses. Their lawyers have formally warned the Health Research Authority (HRA) and Medicines and Healthcare products Regulatory Agency (MHRA) that the trial is "unethical and unlawful."

The controversy stems from the UK's indefinite ban on prescribing puberty blockers to under-18s outside of research settings, enacted after the independent Cass Review found "remarkably weak" evidence for their benefits. Dr. Hilary Cass, who led the review, has expressed support for the trial as a necessary step to gather robust evidence. Critics, including Bell and Esses, argue against using vulnerable children as "guinea pigs" for drugs with unproven benefits and potential long-term harms.

The legal challenge also revives concerns about informed consent, echoing a previous High Court ruling in Bell's case against the now-closed Tavistock clinic, which initially stated that under-16s were unlikely to give informed consent for such treatments. Although that ruling was later overturned on appeal, campaigners maintain that minors cannot fully comprehend the lifelong implications of puberty blockers. The PATHWAYS TRIAL is funded by NHS England and the National Institute for Health and Care Research (NIHR) with an investment of £10.7 million.