On Friday 19 June, the Medicines and Healthcare Products Regulatory Authority (MHRA) announced that it had reached agreement with King’s College London, which would allow the PATHWAYS clinical trial to proceed. The announcement came four months after the Government said the trial would be paused due to safety concerns raised by the MHRA. It was also confirmed that ethics approval for the trial has also been provided by the Health Research Authority. The minimum age of recruitment would be 11 for girls and 12 for boys. Consent would have to be provided by a parent/guardian, and the child under 16 would also need to provide their assent (agreement) to take part.
Last week following an Opposition Day Debate on puberty blockers, 270 Labour MPs shamefully voted against a Conservative motion to block the Pathways Trial, under which clinicians can make irreversible changes to the bodies of children as young as 11.
Richard Fuller MP said:
It is staggering that so many law makers feel it is ok to give puberty blockers to children, irreversibly changing their lives. I have no doubt that as a country we will hang our heads in shame when history judges this state-sponsored abuse of vulnerable children who are in no position to give informed consent to such barbarism.
Despite Labour MPs’ shameful decision, the Conservatives will not stand by and allow this to continue. We will use every parliamentary tool at our disposal not just to pause this trial, but to bring it to an end. Only the Conservatives are prepared to stand up for common sense and put the welfare of children first.
The MRHA said that recruitment to the trial would not take place until at least 1 August 2026, “due to legal proceedings”. This refers to a legal challenge, brought by James Esses and other campaigners, which is seeking an emergency injunction against the Government. If this is granted, the trial would be halted while a judicial review is heard in Court.
In a letter to the trial sponsor King’s College London in February, the MHRA raised concerns about the clinical trial, including the minimum age of participation, safety monitoring and withdrawal criteria. The MHRA on 19 June stated that the modified protocol would “strengthened safeguards,” including the introduction of minimum ages of entry to the trial, more clearly defined discontinuation measures around safety for bone health, cognition and vaginal bleeding and more detailed information for participants on fertility preservation. Last week, the latest Secretary of State for Health and Social Care, James Murray MP, delivered a statement in Parliament to explain the Government’s decision to support progressing the clinical trial. He stated that 226 children and young people were expected to take part in the clinical trial over five and a half years, with each participant being offered puberty blockers for up to 24 months.
The new protocol would mean that “at the first sign of negative impacts, action will be taken,” highlighting criteria around safety monitoring, bone density, fertility and cognitive function. However, James Murray also stated that there was no published scientific evidence proving irreversible changes from using puberty blockers.
