Campaigners launch legal action in bid to stop puberty blocker trial

Legal action against the UK Government has been launched in a bid to stop a trial into puberty blockers for children.

Campaigners sent a legal letter in December to regulatory bodies, the Government and the trial researchers calling for it to be halted, but have now launched formal action.

As well as seeking permission in the High Court to challenge the decision which saw the trial granted approval, the claimants said they will “if necessary” ask for recruitment to be paused while legal proceedings are under way.

Confirmation came in November that ethical and regulatory approval had been granted, and researchers at the time said they were aiming to recruit around 226 young people aged between 10 and almost 16.

The trial, led by researchers at King’s College London, is being 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”.

The senior paediatrician said a supervised puberty blocker trial is “better” than children buying drugs on the dark web.

But a number of high-profile names have expressed their opposition, including Harry Potter author JK Rowling who has signed a petition launched by one of the campaigners urging the Government to cancel the trial.

The writer described the trial as “an unethical experiment on children who can’t give meaningful consent”.

A leading Catholic bishop also voiced concern in January that “vulnerable children should not be part of an experiment” of this kind.

Paul Mason, lead bishop for healthcare for the Catholic Bishops’ Conference of England and Wales (CBCEW), said: “It is important that medical science progresses in the hope of providing better care to people affected by serious conditions.

“However, strong ethical boundaries must govern all experimentation and medical treatment. In effect, the children of today will be used instrumentally in the hope that the results of the study might benefit other children in the future.”

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”.

Mr Streeting has 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”.

The claimants in the legal action are Bayswater Support Group – made up of parents and guardians of children and young adults who identify as trans or non-binary – as well as psychotherapist James Esses and Keira Bell, who began taking puberty blockers when she was 16 before later “detransitioning” and who has spoken of the long-term effects such treatments had on her.

They are taking 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”.

Mr Esses said: “We have given Wes Streeting and the relevant bodies every possible opportunity to pull the plug on this abhorrent trial.

“Even in the face of strong evidence of harm, consistent concerns from clinicians, and hundreds of thousands of members of the public petitioning them to stop, it is business as usual.

“The recruitment of children is due to commence imminently, yet the conspiracy of silence continues. If they won’t safeguard children of their own accord, we will compel them to do so.

“The rest of the world is looking on. We will not allow the UK to become the country that knowingly destroyed the lives of vulnerable children.”

Puberty blockers are not prescribed on the NHS to children for the treatment of gender dysphoria, after a ban earlier in 2024 was made permanent in December of that year with the agreement of devolved governments across the UK.

Launching the trial last year, researchers said the youngest patients involved will typically be 10 to 11 for girls and 11 to 12 for boys, with a maximum age of consent at 15 years 11 months.

One group will be given puberty blockers for two years, while the other will be given the drugs after a one-year delay.

Researchers said the first results would be expected around four years after the trial had begun and added that some young people could remain on the drugs beyond the trial if deemed “clinically appropriate”.

An HRA spokesperson said the trial had “all the necessary regulatory approvals that it needs to begin”.

They added: “The application we received for the trial was reviewed in line with well-established legal and national policy frameworks by a properly constituted research ethics committee for clinical trials.

“Research ethics committees review research proposals and give an opinion about whether the research is ethical.

“The committees are made up from people who come from a range of backgrounds, including healthcare professionals and members of the public.

“We are unable to comment on any ongoing legal proceedings.”

A King’s College London spokesperson said: “We strongly refute the claim that this carefully designed study is scientifically unsound or that it bypassed the ethics process and we can confirm that the study has completed all the necessary ethics and approvals processes. As part of this process the research team submitted the relevant information to the Research Ethics Committee and has been reviewed by independent scientists.

“Randomised controlled clinical trials are the most robust method to determine whether a medicine or intervention is effective. They are commonly used to understand the benefits and risks of a medicine including for participants under the age of 18.

“Use of puberty suppression to treat young people with gender incongruence has not previously been subject to rigorous evaluation of benefits and risks, despite being prescribed widely. Existing evidence about the impact of puberty suppression to treat young people with gender incongruence is inconsistent.”