A clinical trial into puberty blockers has been paused after the medicines regulator raised “new concerns directly related to the wellbeing of children”, the government said.
It comes after campaigners, including Harry Potter author JK Rowling, launched legal action against the government over the trial, which Ms Rowling described as “an unethical experiment on children who can’t give meaningful consent”.
Announcing the pause, a spokesperson for the Department of Health and Social Care said the Medicines and Healthcare products Regulatory Agency (MHRA) has raised “new concerns – directly related to the wellbeing of children and young people – and scientific dialogue will now follow with the trial sponsor”.
“As the evidence is now being interrogated by clinicians, preparations for the trial have been paused while the MHRA and clinical leaders work through these concerns,” the spokesperson said.
Researchers at King’s College London, who were set to lead the Pathways trial, previously said they were aiming to recruit around 226 young people aged between 10 and almost 16.
Recruitment to the study will be postponed until the issues have been resolved with the sponsor, King’s College, and it is concluded that it is “both safe and necessary”, the department spokesperson said.
A spokesperson for King’s College said: “The wellbeing and health of young people with gender incongruence and their families has been, and will remain, our priority, and we will continue to work with the MHRA to support their further review of the trial, which has been designed by world-leading academics with scientific rigour at its core.
“That rigour and ongoing scientific discussion is important for any clinical trial, particularly one as complex as Pathways, which aims to build an evidence base that can help young people and clinicians to make better-informed decisions in the future.”
‘Poor’ existing research on puberty blockers ‘benefits’
The trial was launched based on a recommendation by the Cass Review into children’s gender care, which concluded that the quality of research claiming to show the benefits of puberty blockers for children with gender dysphoria was “poor”.
Baroness Hilary Cass, a senior paediatrician, said even though her report “uncovered a very weak evidence base” for these benefits, a trial “was the only way forward” given that there are “clinicians, children and families who believe passionately in the beneficial effects”.
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She said a supervised puberty blocker trial is “better” than children buying puberty-suppressing drugs on the dark web.
Conservative leader Kemi Badenoch previously wrote to Health Secretary Wes Streeting that the clinical trial must be stopped “before more damage is done to children”.
While Mr Streeting admitted he was “uncomfortable” with puberty blockers being given to children, he said he had a responsibility to follow expert advice and that going ahead with the trial was “the right thing to do”.
