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Puberty blocker trial will go ahead after ‘reassurances’, says Health Secretary

A controversial puberty blocker trial will go ahead after increased safeguards are put in place, the Health Secretary has said, but admitted he is “troubled” by the risks it poses.

Last year Dr. The research, launched following Hilary Cass’s 2024 review into child gender care, has been paused since February due to regulatory concerns and legal challenges.

The trial faces fierce opposition from prominent figures including Conservative Party leader Kemi Badenoch and Harry Potter author JK Rowling.

Health Minister James Murray told Parliament on Monday that clinical evidence will be important on which future decisions will be based.

Mr Murray said: “I have felt uncomfortable and uneasy about some of the difficulties this issue raises.

“But for me, following clinical advice, basing future decisions on clinical evidence, is the right way to proceed in the context of having received the firmest assurances about the safeguards in place to protect the young people taking part in this trial from harm.”

Cass Review leads to sweeping changes including ban on puberty blockers
Cass Review leads to sweeping changes including ban on puberty blockers (PA Archive)

Conservative shadow health secretary Dr Caroline Johnson had called for it to be canceled due to concerns about its impact on children.

Mr Murray said better monitoring gave him the belief it was safe for the trial to proceed.

He said: “Pathways is one of the most scrutinized clinical trials in the UK in recent times. We should expect nothing less when talking about the health and wellbeing of some of our country’s most vulnerable children.

“But as Dr Cass points out, we need to build the evidence base to show whether treatments are safe and produce the positive outcomes young people and clinicians expect from them.

“So my view is that it is most appropriate to proceed with the trial.”

Dr Johnson said the effects of the trial drugs could cause serious harm in children.

He said: “We have a fundamental principle in medicine: First do no harm. So I would say to the Secretary of State for Health, please cancel this experiment before vulnerable children suffer unnecessary, irreversible harm under his watch.”

The researchers said the UK-wide clinical trial aims to provide evidence of how the timing of treatment affects quality of life, mental health, physical development, cognitive function and gender-related distress.

A clinical trial has been recommended by the Cass Review, which concluded that the quality of studies claiming to show the benefits of puberty blockers for young people with gender dysphoria was “poor”.

When the trial launched in November, it was initially planned to include about 226 people ages 10 to almost 16.

Ms Badenoch has previously called for the investigation to be halted and vowed at the weekend to “force a vote not just to pause this trial, but to stop it completely”.

Ms Rowling reposted the Conservative Party leader’s comment on social media: “It is NOT okay to experiment on 11-year-olds and make irreversible changes to their bodies.

“We must protect children from dangerous ideology. Conservatives will not sit back and let this happen. I refuse to believe MPs would allow this to continue if given the chance.”

“That’s why we’re going to hold a vote not just to pause this trial, but to stop it altogether.”

The trial was paused in February and the Medicines and Healthcare products Regulatory Agency (MHRA) recommended that participants be at least 14 years old.

On Friday, the medicines regulator confirmed that an “amended protocol” had been agreed, including “strengthened measures” such as introducing minimum ages for children taking part in the trial.

King’s College London (KCL) researchers conducting the trial said no children would be recruited until after August 1 due to ongoing legal proceedings.

Mr Murray expressed his own discomfort with the matter but said continuing with the hearing was the best course of action.

“I will not pretend that I do not continue to be disturbed and disturbed by this. I believe that the only way for us all to come to a fair and settled conclusion on this, the only way for us to move forward as a country on this difficult and sensitive issue, is to do so based on the clinical evidence that we trust.”

“With strengthened criteria for monitoring children’s welfare and withdrawing from the trial, there are now intensive reviews and robust mechanisms in place to prevent harm to young people who participate.

“On that basis, I believe we need to follow the advice of clinical experts and seek clinical evidence that will give us confidence to know that our future decision on this issue is correct.”

A campaign group and two individuals are seeking to take legal action against the Health Research Agency (HRA) and the Department for Health and Social Care (DHSC), claiming the trial’s ethical approval process “contained serious flaws”.

The next hearing of the case will be held at the Supreme Court on July 27.

No child could participate without parental consent, the researchers said Friday, adding that young people would need to meet all 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 has shown that 260 primary school-age children are waiting for care at NHS gender clinics in England.

At least one child is aged six or under, according to a Freedom of Information request made by the PA to NHS England.

There are three gender services for children in England, established following the closure of the Gender Identity Development Service (Gids), run by the Tavistock and Portman NHS Foundation Trust, in 2024.

Data showed there were 4,079 children waiting to be seen at one of three services at the end of March this year.

Overall numbers on the national waiting list have fallen by a third compared to the previous 12 months, and the average wait for a first appointment is just under two years.

There is no minimum age requirement for gender care and the NHS has previously said they want to ensure parents with very young children are given support where necessary.

Clinics will 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 Wales has no dedicated children’s gender clinic.

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