A High Court decision has cleared the way for a controversial puberty blocker trial to begin recruiting participants as young as 11. Campaigners had sought an injunction to halt the trial, which they described as "deeply unethical and highly dangerous," arguing that regulators acted unlawfully in approving it and that insufficient safeguards were in place for the children involved.
Mr Justice Chamberlain declined to grant permission for a judicial review, stating that questions concerning the trial's safety, ethics, and scientific design are primarily matters for specialist regulators. He indicated the court should be hesitant to interfere with such assessments. The claimants expressed outrage at the ruling and are considering an appeal.
The Pathways trial, commissioned by former health secretary Wes Streeting and backed by the government, is set to involve approximately 226 children. These participants will be given drugs that temporarily halt the physical changes of puberty. This trial was recommended by the Cass Review into the treatment of gender-dysphoric children, which found the research supporting the benefits of puberty blockers for young people to be of "poor" quality.
Puberty blockers are drugs that suppress hormone production, pausing adolescent development such as the onset of menstruation or the growth of facial hair. The trial's eligibility criteria allow for girls as young as 11 and boys as young as 12 to participate, following adjustments by regulators after initial safety concerns were raised in February. At that time, the Medicines and Healthcare products Regulatory Agency had suggested restricting the trial to individuals aged 14 and over.
Critics of the trial, including psychotherapist James Esses and Keira Bell, who previously took puberty blockers and later detransitioned, voiced concerns about the potential for irreversible harm, including impacts on fertility and cognitive development. Bell stated, "The protection of children should be an inviolate principle, but this clinical trial tells a different story. I know first-hand how much this process breaks you."
Lawyers representing the campaigners argued that the scientific need for the trial could not override the regulatory safeguards designed to protect child participants. They highlighted the regulators' acknowledgment that the benefits of the treatment for individual participants remained uncertain and that serious risks of harm were known.
Conversely, legal representatives for the Health Research Authority and King's College London, which is leading the trial, defended the regulatory process. They argued that the trial's premise, which involves identifying which participants may benefit from the treatment, is the basis for its ethical and scientific justification. The research team welcomed the court's decision, emphasizing that the study has strict eligibility requirements and that all participants will receive significant psychological and social support. They stated that the trial is designed to provide much-needed evidence on the potential benefits and risks of puberty suppression to improve NHS care.