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A new UK clinical trial is being launched to evaluate the effects and safety of puberty-blocking medication for children and young people who question their gender identity. This initiative comes after the UK government banned the use of these drugs for gender-related treatments in minors last year due to concerns highlighted in a comprehensive review about the insufficient clinical evidence regarding their safety in under-18s. The upcoming study, led by researchers at King’s College London, aims to involve approximately 220 children under 16 years old who are undergoing puberty. The trial will assess how these drugs influence physical, emotional, and social health.
The decision to proceed with the trial has stirred debate, with some experts and campaigners questioning the ethics behind it. Professor Emily Simonoff, the principal investigator and a child and adolescent psychiatry professor at King’s College London, emphasized the research’s intent, stating, “We know there are ongoing societal discussions about gender transition, but this research is focused solely on informing and improving healthcare by better understanding how to support the physical and mental health of young people with gender incongruence.” Puberty blockers, or puberty suppressing hormones, are used to pause the onset of puberty and have previously been prescribed to young individuals experiencing gender incongruence—a mismatch between their gender identity and the sex assigned at birth—or gender dysphoria, when this discrepancy causes distress.
Since the publication of the Cass review, conducted by paediatrician Dr. Hilary Cass, the prescription of puberty blockers to under-18s has been restricted to clinical trials, reflecting ongoing uncertainties about the drugs’ safety. The UK government’s indefinite prohibition prevents these medications from being prescribed privately or through the NHS for gender questioning youths outside of research contexts. The new trial, named Pathway, will recruit children currently receiving gender services with a diagnosis of gender incongruence. Participants must have reached puberty but be younger than 16, and will undergo a rigorous evaluation process including thorough medical and psychological assessments. Consent will require that the young person demonstrates sufficient understanding of the treatment’s potential effects, alongside approval from a parent or legal guardian. Continuous psychological support will be provided throughout.
Within the structured design of the Pathway trial, participants will be randomly divided into two groups: one beginning puberty blockers immediately and the other starting treatment after a 12-month delay. Although there is no minimum age specified for starting medication, researchers acknowledge puberty typically begins around age 11 for girls and 12 for boys. The study will monitor critical factors such as bone density, brain development, and mental health over time. Ethical approval has been granted for the trial, which is expected to commence in January with the recruitment of five to six children per month. Initial findings from the study are anticipated in approximately four years. Complementing this trial, a larger observational study involving 3,000 children will evaluate the effectiveness of various types of support available to gender-questioning young people.
The trial has already sparked controversy and legal challenges. Keira Bell, who famously challenged the Tavistock gender clinic after receiving puberty blockers and cross-sex hormones as a teenager, demands that the trial be stopped immediately. She has threatened judicial review proceedings at the High Court if the trial continues. Bell criticized the study as “disgusting,” pointing out that these drugs were banned precisely because they were deemed “unsafe.” Her previous legal case saw the High Court assert that under-16s were unlikely to provide informed consent to puberty blockers, a decision that was subsequently overturned by the Court of Appeal, which ruled that doctors could determine if a young person is competent to consent. Some clinicians associated with the Clinical Advisory Network on Sex and Gender have also questioned the ethical basis of the trial. Meanwhile, Stonewall, an LGBTQ+ rights charity, has called for access to the best possible medical care for trans youth based on sound evidence, urging the government and policymakers to prioritize healthcare investment and ensure that the voices of trans young people and their families are central to decision-making
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