Critics of the Government’s flagship puberty blocker trial have vowed to force the Government into a dramatic U-turn after Northern Ireland pulled out of the controversial research.
The decision by Stormont has fuelled momentum against one of the most explosive culture and medical rows in Britain – and intensified pressure on Health Secretary Wes Streeting to halt the £10.7million study across the rest of the UK.
Northern Ireland’s Health Minister Mike Nesbitt announced he was suspending participation in the UK-wide “Pathways” puberty blocker trial – which will involve children as young as ten – while a judicial review works its way through the courts.
He said: “Having taken account of the ongoing judicial review into the UK Government’s clinical trial of puberty blockers, I have decided to suspend Northern Ireland’s agreement to participate in the UK-wide Pathways trial until the legal process has concluded.
“Should the trial ultimately be given the green light to proceed, I shall take the views of executive colleagues before any potential lifting of the pause.”
His intervention came just days after campaigners launched High Court action aimed at stopping the trial before any children are recruited.
The study plans to enrol around 220 children under 16 experiencing gender distress. Participants will be randomly assigned either to begin puberty blockers immediately or after a 12-month wait. They will be monitored for up to two years, with follow-up into early adulthood.
Researchers say the trial will assess physical health, brain development, mental wellbeing and quality of life – aiming to plug what has been widely acknowledged as a serious evidence gap.
Ministers have been told to stop the trial over health and safeguarding fears | GETTY
Last year, paediatrician Dr Hilary Cass concluded in a landmark review there was little high-quality evidence supporting the routine use of puberty blockers in children. She said a properly conducted clinical trial could address the evidence gap.
Mr Streeting, who banned the routine prescribing of puberty blockers for under-18s outside research settings last year, has repeatedly insisted the new trial is the responsible, evidence-led way forward.
But critics say pressing ahead risks repeating past mistakes.
Clinical psychotherapist James Esses, who is bringing the judicial review alongside detransitioner Keira Bell, said Northern Ireland’s decision was “extremely heartening”.
“It is extremely heartening to see the Government in Northern Ireland take heed of our concerns and strong judicial review against the trial,” he said.
“It is such a shame that the UK is fractured on this issue but extremely heartening to see the Government in Northern Ireland take heed of our concerns. If Wes Streeting continues to push forward on this trial, we will compel him to stop. We do not believe there is an ethical basis for this research and we believe there are serious flaws in the ethical process it went through.”
Mr Esses is among the campaigners preparing to seek an emergency injunction to prevent recruitment beginning – expected within the next few months – until the judicial review is heard in full.
The backlash has also gathered political momentum. A cross-party group of MPs and a peer have written to Streeting demanding an immediate pause, warning the study could prove a “dangerous mistake” that could “devastate the physical, psychological, sexual and reproductive health of over 200 vulnerable children”.
More than 137,000 people have signed a parliamentary e-petition opposing the trial. The issue will be debated in the Commons on March 9.
Among those voicing concern is Conservative leader Kemi Badenoch, who previously described the proposal as “activist ideology masquerading as research”.
However, Mr Streeting has continued to defend the research. He recently told BBC Radio 4’s Today programme the trial had “ethics and safety at its heart”.
He said: “I am following clinical advice in this area and I have tried to do my best to take the politics out of it entirely and resist political pressure.
“We are following the Cass review, commissioned by the previous Conservative government. In opposition, we accepted all of the recommendations, and we want it to work in a bipartisan way. That is the approach we are now taking in Government.
“It was Hilary Cass who sounded the alarm about the prescription of puberty blockers for this patient group without adequate evidence. She also recommended this trial.
“And just to reassure people, the process of setting up this trial has gone through some of the most rigorous checks in terms of ethics, safety and clinical oversight.”
He also stressed: “It will not be the case that a child, young person, can say ‘I want to be on this trial’ and then they’re on it. They have to go through rigorous assessment in terms of their physical health and their mental health. Their parents will need to be involved and consenting.
Medical leaders backing the trial say the Cass review made clear that the absence of high-quality data is itself a safeguarding risk. They argue that banning treatment outright without gathering robust evidence would leave young people and doctors in limbo.
A Department of Health and Social Care spokesperson said the Government is implementing the recommendations of the Cass review and that the trial has undergone independent ethical approval, with safeguards in place to protect participants.