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Keira Bell, a campaigner who previously underwent treatment with puberty blocking drugs as a teenager, has expressed strong concerns about an upcoming clinical trial involving these medications for gender-questioning children. Speaking to the BBC, she described the trial as unethical and warned that it could cause harm to participating children. The study, known as the Pathways trial and led by researchers at King’s College London, aims to enhance care for young people under 16 attending NHS gender clinics.
The UK medicines regulator has greenlit the trial to begin in January, emphasizing that the study adheres to strict scientific and ethical standards. Nonetheless, Bell and psychotherapist James Esses have issued legal letters to Health Secretary Wes Streeting and relevant medical research bodies demanding the trial be halted. Their objections focus on concerns regarding the trial’s necessity, transparency, safety, and whether it sufficiently respects ethical principles.
Puberty blockers—or puberty suppressing hormones—are drugs intended to delay or halt puberty. They are sometimes administered to children experiencing gender incongruence, where a person’s gender identity differs from their sex assigned at birth, or gender dysphoria, which involves distress caused by this incongruence. These treatments were banned last year in the UK for gender-related purposes after a significant review highlighted a lack of solid clinical evidence on their safety for those under 18. However, the same review, conducted by paediatrician Dr Hilary Cass, recommended further clinical trials to establish clear evidence about the drugs’ effects. Dr Cass expressed enthusiasm for the King’s College trial, seeing it as a necessary step forward.
The study plans to follow approximately 220 children under 16 from NHS gender clinics across England, providing extensive support, and closely monitoring aspects such as bone density and brain development. Critics like Bell, who received puberty blockers and cross-sex hormones during her teenage years, regrets her treatment and believes medical professionals should have offered more challenge during her time at the now-closed Tavistock Gender Identity Clinic. Bell recalled feeling uninformed about the broader impact of puberty suppression, stating, “I didn’t know that I was essentially trapping my own mind from developing,” and raised questions about follow-up care for individuals like herself. James Esses also raised concerns about the capacity of children entering the trial to give informed consent, noting that some participants are not even old enough for activities like opening a bank account or social media profiles.
The legal complaints submitted by Bell and Esses have been sent to regulatory bodies responsible for ethical approvals, including the Human Research Authority and the Medicines and Healthcare products Regulatory Authority, as well as to Health Secretary Wes Streeting, NHS England, King’s College London, and the South West London and Maudsley NHS Trust. A spokesperson from the Department of Health and Social Care emphasized that children’s well-being and safety are paramount and affirmed that this trial was approved only after rigorous safety assessments and with multiple safeguards, including consent from both clinicians and parents. The MHRA underscored its commitment to participant safety and ongoing review of the trial’s conduct, while the Health Research Authority confirmed that the Pathways trial has all the necessary regulatory permissions and was scrutinized by a Research Ethics Committee comprised of healthcare professionals and public members. Meanwhile, King’s College London researchers highlighted the importance of grounding clinical care in robust evidence and said the study aims to improve understanding of treatment and care for young people with gender incongruence. A representative from the charity Stonewall affirmed the importance of accessible, evidence-based healthcare for all LGBTQ+ individuals, including young people
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