A controversial puberty blocker trial is set to go ahead after increased safeguards were put in place, the Health Secretary has said, although he admitted he was “uncomfortable” about the risks posed by it.
The research, launched last year in the wake of Dr Hilary Cass’ 2024 review into children’s gender care, has been paused since February, amid regulatory concerns and a legal challenge.
The trial faces staunch opposition from some public figures such as Conservative leader Kemi Badenoch and Harry Potter author JK Rowling.
Health Secretary James Murray told Parliament Monday that clinical evidence would be important on which to base future decisions.
Mr Murray said: “I have felt uncomfortable and uneasy about some of the challenges raised by this matter.
“But for me, following the clinical advice, basing future decisions on clinical evidence, is the right way to move forward in the context of me having received the most robust assurances about the safeguards which are in place to protect young people involved in this trial from receiving harm.”
Conservative shadow health minister Dr Caroline Johnson had called for it to be cancelled amid concerns about the impact on children.
Mr Murray said improved monitoring had given him the belief the trial was safe to go ahead.
He said: “Pathways is rightly one of the most scrutinised UK clinical trials of recent times. We should expect nothing less when we are talking about the health and wellbeing of some of the most vulnerable children in our country.
“Yet as Dr Cass has made clear, we have to build the evidence base to show whether treatments are safe and whether they produce the positive outcomes that young people and their clinicians want from them.
“So my view is that proceeding with the trial is, on balance, the most appropriate way forward.”
Dr Johnson had said the effects of the trial drugs could cause serious damage to children.
She said: “In medicine we have a founding principle … first do no harm. So can I say to the Health Secretary, please cancel this trial before vulnerable children suffer unnecessary, irreversible harm on his watch.”
Researchers have said the UK-wide clinical study aims to provide evidence on how the timing of treatment affects quality of life, mental health, physical development, cognitive function, and gender-related distress.
A clinical trial was recommended by the Cass Review, which had concluded that the quality of research claiming to show the benefits of puberty blockers for youngsters with gender dysphoria was “poor”.
The trial was originally intended to involve about 226 people aged between 10 and almost 16 when it was launched in November.
Mrs Badenoch had previously called for the research to be halted, and at the weekend vowed to “force a vote, not just to pause this trial but to stop it completely”.
Ms Rowling reposted the Tory leader’s social media comment, which read: “It is NOT ok to experiment on kids as young as 11 and make irreversible changes to their bodies.
“We must protect children from dangerous ideology. Conservatives will not just sit back and let this happen. I refuse to believe MPs, if given the chance, would let this continue.
“That is why we will force a vote, not just to pause this trial but to stop it completely.”
The trial was paused in February and the Medicines and Healthcare products Regulatory Agency (MHRA) recommended participants should be at least 14 years old.
On Friday, the medicines regulator confirmed it had agreed a “modified protocol” to the trial, including “strengthened safeguards” such as the introduction of minimum ages of children taking part.
Researchers at King’s College London (KCL), who are running the trial, said no children will be recruited until after August 1, amid ongoing legal proceedings.
Mr Murray spoke of his own unease on the topic, but said continuing with the trial was the best course of action.
He said: “I will not pretend that I do not continue to feel discomfort and unease about this. I believe the only way for us all to come to a fair and settled conclusion on this matter, to move forward as a country on this difficult and sensitive issue, is to do so on the basis of clinical evidence in which we trust.
“Thanks to the strengthened criteria now in place for monitoring children’s wellbeing and withdrawing them from the trial, there is now intense scrutiny and robust mechanisms to prevent harm coming to young people who take part.
“It is on that basis that I believe we should follow the advice of clinical experts, and seek the clinical evidence that will give us the confidence to know that where we settle on this matter in the future is right.”
A campaign group and two individuals are seeking to take legal action against the Health Research Authority (HRA) and the Department of Health and Social Care (DHSC), claiming the ethical approval process for the trial “contained serious flaws”.
The case is next due at the High Court on July 27.
Researchers said on Friday it remained the case that no child could take part without parental consent and added that young people would continue to need to meet all the other eligibility criteria including “demonstrating a good understanding of the intervention and its possible benefits and risks”.
Meanwhile, new data obtained by the Press Association showed 260 children of primary school age are waiting for care at NHS gender clinics in England.
At least one child is aged six or younger, according to the Freedom of Information request by PA to NHS England.
There are three children’s gender services in England, set up in the wake of the closure in 2024 of the Gender Identity Development Service (Gids) which had been run by the Tavistock and Portman NHS Foundation Trust.
There were 4,079 children waiting to be seen at one of the three services at the end of March this year, the data showed.
Overall numbers on the national waiting list have fallen by a third on the previous 12 months and the average waiting time for a first appointment is just under two years.
There is no minimum age requirement for gender care, and the NHS previously said they wanted to ensure parents of very young children were given support where necessary.
The clinics do not prescribe puberty blockers, which have been banned on the NHS for the treatment of gender dysphoria since 2024.
The national waiting list covers England and Wales because the latter does not have its own dedicated children’s gender clinic .
