Parents of transgender children have launched legal action against the Government in a bid to stop a controversial trial of puberty blocking drugs.
They are taking action against the Department of Health and Social Care (DHSC), headed by Wes Streeting, and the Health Research Authority (HRA).
It is claimed the ethical approval process for the trial, which is being led by researchers at King’s College London, ‘contained serious flaws’.
Campaigners had previously sent a legal letter in December to regulatory bodies, the Government and the trial researchers calling for it to be halted.
They have now launched formal action and are 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 for the trial.
Researchers at the time said they were aiming to recruit around 226 young people aged between 10 and almost 16.
The trial is being undertaken following a recommendation by the Cass Review into children’s gender care.
It concluded that the quality of research claiming to show the benefits of puberty blockers for youngsters with gender dysphoria was ‘poor’.
Baroness Hilary Cass, who led the 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 she added 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.
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.
Rowling has criticised the trial as ‘an unethical experiment on children who can’t give meaningful consent’.
Tory leader Kemi Badenoch previously wrote to Mr Streeting, the Health Secretary, 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 the Cabinet minister 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, which is made up of parents and guardians of children and young adults who identify as trans or non-binary.
It also includes 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.
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’.
A DHSC spokesperson said: ‘Medical care must always be based on solid evidence, and children’s safety must come first.
‘The expert Cass Review – which was accepted by the last government and this one – recommended a ban on puberty blockers for gender incongruence and that clinical research be carried out to address a lack of scientific evidence.
‘This trial will help provide the evidence that is currently lacking.
‘Its approval came only after extremely rigorous safety checks and with multiple safeguards in place to protect young people’s wellbeing – including clinical and parental approval.’
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.’
