A planned clinical trial to assess the safety of puberty blockers in children with gender distress poses too many ethical and methodological problems to proceed.
That was the verdict from experts discussing their concerns at a webinar on 16 September organised by the Clinical Advisory Network on Sex and Gender (CAN-SG), a group of UK and Irish clinicians calling for higher standards of evidence based care in transgender medicine.
At the event, chaired by the retired psychiatrist David Bell, a whistleblower of poor care at the now closed Tavistock Gender Identity Development Service, speakers said that the proposed Pathways trial—currently undergoing ethical assessment—could not be justified and should not be approved. But Hilary Cass, who led a landmark review for the NHS into gender identity services for children and young people, told The BMJ that the trial, which is running behind schedule, was still justified.
Speaking at the event, Sinead Helyar, CAN-SG member and a clinical trial manager who has worked on trials in the NHS for more than 10 years, argued that there were simply too many ethical concerns. She highlighted how UK legislation specifically required clinical trials to minimise foreseeable risks regarding children’s development and how it prohibited studies where there was a risk of disabling injury.
“Children enrolled with any research programme by …