Campaigners have escalated their efforts to stop a controversial puberty blocker trial for children by launching formal legal action against the government. This move follows a legal letter sent in December to regulatory bodies, the government, and trial researchers, which called for the trial to be halted immediately.
High Court Challenge and Recruitment Concerns
The claimants are seeking permission in the High Court to challenge the decision that granted approval for the trial. They have also stated that they will, if necessary, request a pause in recruitment while legal proceedings are ongoing. The trial, led by researchers at King's College London, aims to recruit approximately 226 young people aged between 10 and nearly 16.
Background and Cass Review Recommendations
This trial was initiated following a recommendation from the Cass Review into children's gender care. The review concluded that the quality of research demonstrating the benefits of puberty blockers for youngsters with gender dysphoria was poor. Baroness Hilary Cass, who led the review, noted that her report uncovered a very weak evidence base for the benefits of such medication. However, she argued that a supervised trial was the only way forward to clarify the situation, given the strong beliefs held by some clinicians, children, and families.
Baroness Cass emphasized that a controlled trial is better than children resorting to purchasing drugs on the dark web. Despite this, the trial has faced significant opposition from various quarters.
High-Profile Opposition and Ethical Concerns
Notable figures have voiced their opposition to the trial. Harry Potter author JK Rowling signed a petition urging the government to cancel it, describing the trial as an unethical experiment on children who can't give meaningful consent. In January, Paul Mason, the lead bishop for healthcare for the Catholic Bishops' Conference of England and Wales, expressed concern that vulnerable children should not be part of such an experiment.
Mason stated: 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.
Political and Governmental Responses
Conservative leader Kemi Badenoch previously wrote to Health Secretary Wes Streeting, urging him to stop the medical trial before more damage is done to children. Streeting has admitted to feeling uncomfortable with the use of puberty-suppressing hormones on young people but maintained that it is his responsibility to follow expert advice. He asserted that proceeding with the trial is the right thing to do.
Claimants and Legal Basis
The claimants in the legal action include the Bayswater Support Group, which consists of parents and guardians of children and young adults who identify as trans or non-binary. They are joined by psychotherapist James Esses and Keira Bell, who began taking puberty blockers at age 16 before later detransitioning and has spoken about the long-term effects of such treatments.
They are taking action against the Health Research Authority (HRA) and the Department of Health and Social Care (DHSC), alleging that the ethical approval process for the trial contained serious flaws. Esses commented: 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.
He added: 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.
Trial Details and Regulatory Approvals
Puberty blockers are not prescribed on the NHS to children for gender dysphoria treatment, following a ban in early 2024 that was made permanent in December of that year with agreement from devolved governments across the UK. The trial, launched last year, will involve the youngest patients typically aged 10 to 11 for girls and 11 to 12 for boys, with a maximum age of consent at 15 years and 11 months.
In the trial, one group will receive puberty blockers for two years, while the other will receive the drugs after a one-year delay. Researchers indicated that the first results are expected around four years after the trial begins, and some young people may remain on the drugs beyond the trial if deemed clinically appropriate.
Official Statements and Defense
An HRA spokesperson stated that the trial has all the necessary regulatory approvals that it needs to begin. They explained: 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. The spokesperson declined to comment on ongoing legal proceedings.
A King's College London spokesperson strongly refuted claims that the study is scientifically unsound or that it bypassed the ethics process. They confirmed that the study has completed all necessary ethics and approvals processes, with the research team submitting relevant information to the Research Ethics Committee and undergoing review by independent scientists.
The spokesperson noted: 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.
