A High Court hearing is underway to determine whether a controversial trial involving puberty blockers should be paused until a legal challenge is resolved. Campaigners are seeking an injunction to stop the trial from enrolling participants, which is currently scheduled to begin on August 1.
The core of the legal challenge asserts that regulators acted unlawfully in approving the study, with campaigners expressing concerns about inadequate safeguards and the potential for long-term physical and mental side effects on the children involved.
The proposed trial, led by King’s College London, aims to recruit approximately 226 children. Some of these participants, aged as young as 11, would receive drugs to halt their body’s natural development. This trial was commissioned by former health secretary Wes Streeting, who had previously placed an indefinite ban on such drugs due to safety concerns identified by the Commission on Human Medicines.
However, Streeting supported the Pathways trial, which is intended to investigate the side effects of these drugs, a recommendation stemming from the Cass Review into the treatment of children experiencing gender dysphoria. The Cass Review concluded that existing research on the benefits of puberty blockers for young people with gender dysphoria was of poor quality.
The trial faced an earlier setback in February when the Medicines and Healthcare products Regulatory Agency (MHRA) raised safety concerns and initially proposed restricting participation to those aged 14 and over. Researchers announced last month, however, that recruitment would resume with a lower age threshold after regulators agreed to it.
Lawyers for the campaigners argued in court that a brief delay of three to four months would cause minimal prejudice to the safety and interests of potential child participants, which they stated should be the paramount consideration. They also contended that proper safeguards were not followed in the trial's design.
"However compelling the scientific need for a clinical trial may be, arising from that dearth of reliable evidence, that cannot displace the safeguards embedded in the regulations for the protection of child participants in a proposed clinical trial," stated Angus McCullough KC, representing the campaigners.
The campaigners bringing the case include the Bayswater Support Group, comprised of parents and guardians of transgender and non-binary children and young adults, psychotherapist James Esses, and Keira Bell, who began taking puberty blockers at 16 and later detransitioned.
Lawyers for the government and King’s College London argued that the MHRA’s decision represented a considered balance of risks and benefits. Julian Milford KC, for the government, stated that the MHRA acknowledged the potential benefit for participants in allowing them to transition gender through hormone therapy before developing secondary sex characteristics. Andrew Sharland KC, for King’s College London, added that the trial's premise is to investigate the benefits and risks in a state of clinical and scientific uncertainty.
Jenni Richards KC, representing the Health Research Authority (HRA), countered that the claim that a research ethics committee did not consider the trial group to have direct benefits was "unarguable," noting that eligibility criteria require clinicians to believe participants have a "reasonable prospect of benefiting."
The hearing before Mr. Justice Chamberlain is expected to conclude soon.