Alison HoltSocial Affairs Editor
BBCCampaigner Keira Bell told the BBC she believes planned clinical trials of puberty-blocking drugs for gender-questioning children are unethical and children will be “essentially harmed”.
Pathways trialled by King's College London researchers, will look at how to improve care for children under 16 in NHS gender clinics.
The UK's medicines regulator approved the start of the study in January and the research team says it was designed “to strict scientific and ethical standards”.
Ms Bell and her fellow campaigner, psychotherapist James Esses, have written advocacy letters to Health Secretary Wes Streeting and medical research organizations arguing it should stop.
The threat of legal action calls into question the safety and transparency of a clinical trial, if it is necessary, and whether it adheres to expected “ethical principles.”
The government says the trial will provide missing evidence about the risks and benefits of the drugs, and that there are many safeguards in place to protect young people.
Puberty blockers, also known as puberty suppressing hormones (PSH), are medications used to delay or prevent puberty.
They are used to treat some children and young people with gender incongruity (when someone's gender identity does not match their assigned sex at birth) or gender dysphoria when it causes significant distress.
The drugs were banned in the UK for treating gender-related disorders last year following a major review, concerns were raised about the lack of clinical evidence of their safety in children under 18 years of age.
The same reviewled by pediatrician Dr. Hilary Cass, said clinical trials are needed to provide conclusive evidence about whether the drugs are helpful.
Dr Cass recently told the BBC she was “very pleased” that the KCL team was carrying out the research.
The study will examine the physical and emotional effects of puberty blockers on around 220 children under the age of 16 attending NHS gender clinics in England, with each child taking part having to meet strict criteria.
Children will receive intensive support. The researchers say they will also monitor bone density and brain development.
Keira Bell was given puberty blockers and unisex hormones as a teenager. She regrets this and believes staff at the Tavistock Gender Identity Clinic, which is now closed, should have faced more serious problems.
In 2020, she sued the clinic. The High Court ruled that children under 16 were “unlikely to be able to give informed consent” to puberty blockers, but that decision was later overturned by the Court of Appeal, which ruled that doctors could judge whether young people could consent to treatment.
Ms Bell, 28, told the BBC: “Children will essentially suffer from this trial.”
It can affect children's fertility and sexual function, she said.
She added that her own experience with puberty blockers “made her extremely angry.”
“I didn’t know that I was essentially preventing my own mind from developing, because puberty doesn’t happen in a vacuum—it’s your whole body, it’s your brain sending signals to your body. So I didn’t understand any of it,” she said.
“There are children who have already walked this path – I am one of them. Why don't we monitor people like me?”
James Esses told the BBC there were questions about informed consent.
“Some of the kids who will be taking part in this trial are not even old enough to open a checking account or a Facebook profile,” he said.
Legal letters from the campaigners were delivered to the Human Research Authority (HRA) and the Medicines and Healthcare products Regulatory Authority (MHRA), which gave ethical approval to the puberty blocker trials.
Mr Streeting, as well as NHS England, King's College London and South West London and Maudsley NHS Foundation Trust have also been notified.
A Department of Health and Human Services spokesman said medical care “must always be based on sound evidence and the safety of children must come first.”
They added: “This study will help provide evidence that is currently lacking. Its approval was only given after extremely stringent safety checks and with many safeguards in place to protect the welfare of young people, including the approval of doctors and parents.”
In a statement, the MHRA said the safety of participants is “always” its priority and its role is to “carefully assess” clinical trial applications to ensure they meet “relevant regulatory standards for participant safety and scientific integrity”.
He said he also continually reviews approval of the trial as it proceeds.
A spokesperson for the Health Research Authority said the Pathways trial had “all necessary regulatory approvals required for it to commence.”
It explained that a research ethics committee, made up of people including health professionals and members of the public, reviews research proposals and gives an opinion on whether they are ethical.
The KCL research team said: “Clinical care should always be supported by robust evidence and this study will help improve understanding of how to treat and care for gender nonconforming young people.”
Children taking part in the study will require consent from their parents or legal guardians, as well as consent from the lead clinician and multidisciplinary team, the researchers said.
A spokesman for the charity Stonewall said it was “vitally important” that all LGBT+ people, including young people, have access to high-quality, evidence-based and timely health care.
