Clinical trial into puberty blockers paused after ‘new concerns’ from regulator
It comes after legal action was launched against the Government after campaigners including Harry Potter author JK Rowling expressed their opposition.
A clinical trial into puberty blockers for children has been paused after the medicines regulator warned it should have a minimum age limit of 14 because of the “unquantified risk” of “long-term biological harms”.
The Medicines and Healthcare products Regulatory Agency (MHRA) will now discuss the concerns, related to the wellbeing of children and young people, with trial sponsor King’s College London next week and recruitment to the trial will not start until the issues have been resolved.
The pause comes after legal action was launched against the Government after politicians and public figures including Harry Potter author JK Rowling expressed their opposition.
The writer, who has campaigned to repeal transgender rights in the UK, described the trial as “an unethical experiment on children who can’t give meaningful consent”.
A Department of Health and Social Care spokesperson said: “We have always been clear about the red lines regarding this trial – ensuring the safety and wellbeing of the children and young people involved and always being led by the clinical evidence.
“The MHRA has now 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.
“This trial will only be allowed to go ahead if the expert scientific and clinical evidence and advice conclude it is both safe and necessary.
“The safety and wellbeing of children and young people have always been the driving consideration in every decision we have made regarding this trial and always will be.”
The trial, led by researchers at King’s College London, was to be undertaken following a recommendation by the Cass Review into children’s gender care, which concluded that the quality of research claiming to show the benefits of such medication for youngsters with gender dysphoria was “poor”.
Baroness Hilary Cass, who led that review, has previously said her report “uncovered a very weak evidence base” for the benefits of puberty blockers for children and young people with gender dysphoria, but that “given that there are clinicians, children and families who believe passionately in the beneficial effects, a trial was the only way forward to make sense of this”.
In November researchers said they were aiming to recruit around 226 young people aged between 10 and almost 16.
The senior paediatrician said a supervised puberty blocker trial is “better” than children buying drugs on the dark web.
In a letter from the MHRA, they express concern about the current age limit of the trial, asking for it to be raised to 14 from 10.
The letter reads: “Since potentially significant and, as yet, unquantified risk of long-term biological harms is present to participants and biological safety has not been definitively demonstrated in this proposed cohort, at the very least, there should be a graded/stepwise approach starting with those aged 14 as the lower limit of eligibility.
“Future trials may consider lowering the threshold depending on the findings of the initial trial.”
Conservative leader Kemi Badenoch previously wrote to Health Secretary Wes Streeting saying the medical trial must be stopped “before more damage is done to children”.
On Friday, Claire Coutinho, shadow equalities minister, said the Health Secretary has “ignored warnings” and called the pause a “huge win”.
Mr Streeting has, in the past, admitted to feeling “uncomfortable” with puberty-suppressing hormones being used on young people, but added it is his responsibility to follow expert advice and said going ahead with a trial is the “right thing to do”.
A spokesperson for King’s College London 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.”
Bayswater Support Group (BSG), which describes itself as a group for parents and guardians of children and young adults who identify as transgender or non-binary, has called for the trial to be stopped entirely.
A spokesperson for BSG said: “We welcome the pause of this clinical trial and the decision to halt recruitment for further scrutiny of potential harms, but it must not be amended and restarted. It should be stopped.”
