A clinical trial investigating the use of puberty blockers for children in England has been paused after the Medicines and Healthcare products Regulatory Agency (MHRA) raised “new concerns directly related to the wellbeing of children and young people,” the Department of Health and Social Care announced Saturday. The move follows legal challenges brought by campaigners, including author J.K. Rowling, who have described the trial as potentially harmful to young people.
The Pathways trial, led by researchers at King’s College London, aimed to recruit approximately 226 participants aged between 10 and almost 16. Researchers intended to gather data on the efficacy and safety of puberty blockers, a treatment used to pause the physical changes of puberty, for children experiencing gender dysphoria. Recruitment has now been postponed pending further review by the MHRA and clinical leaders, according to a department spokesperson.
The pause comes after the Cass Review, an independent review of gender identity services for children and young people in England, highlighted a “very weak evidence base” supporting the benefits of puberty blockers. Baroness Hilary Cass, who led the review, nevertheless recommended a trial as the best path forward, stating it was “better” than children seeking these drugs through unregulated sources like the dark web. Sky News reported on the concerns.
The trial’s design was intended to address the gaps in existing research identified by the Cass Review. A spokesperson for King’s College London emphasized that the wellbeing of young people remains their “priority” and that they will cooperate with the MHRA’s review, noting the trial was developed by “world-leading academics with scientific rigour at its core.”
The decision to pause the trial has ignited further debate surrounding the use of puberty blockers for young people. Conservative Party chair Kemi Badenoch had previously urged Health Secretary Wes Streeting to halt the trial, expressing concerns about potential harm to children. Even as Streeting acknowledged his own discomfort with the use of puberty blockers, he initially defended proceeding with the trial based on expert advice. The Express & Star detailed the political pressure surrounding the trial.
J.K. Rowling publicly welcomed the pause, describing the trial as “an unethical experiment on children who can’t grant meaningful consent.” Her intervention, alongside that of other campaigners, underscores the deeply divisive nature of this issue. The Telegraph reported on Rowling’s response.
The MHRA and clinical leaders are now tasked with evaluating the newly raised concerns and determining whether the Pathways trial can proceed safely and ethically. The future of the trial, and the broader debate surrounding puberty blockers for children, remains unresolved.
