The UK government has indefinitely extended its ban on the private sale and supply of puberty blockers for gender dysphoria, based on advice from the Commission on Human Medicines (CHM) which said that there is currently an unacceptable safety risk in the prescription of puberty blockers to children and young people under 18.
NHS provision of puberty blockers to this group was stopped in March this year following advice from the Cass Review. Today’s ban indefinitely closes a loophole whereby private prescribers, including those based overseas, could prescribe puberty blockers to under 18s.
Health and Social Care Secretary Wes Streeting said:
“Children’s healthcare must always be evidence-led. The independent expert Commission on Human Medicines found that the current prescribing and care pathway for gender dysphoria and incongruence presents an unacceptable safety risk for children and young people.
Dr Cass’ review also raised safety concerns around the lack of evidence for these medical treatments . We need to act with caution and care when it comes to this vulnerable group of young people, and follow the expert advice.
We are working with NHS England to open new gender identity services, so people can access holistic health and wellbeing support they need. We are setting up a clinical trial into the use of puberty blockers next year, to establish a clear evidence base for the use of this medicine.”
CAN-SG welcomes ban and commends Wes Streeting’s commitment to safe evidence led healthcare for children
CAN-SG strongly welcomes this ban and commends Wes Streeting’s statement that children’s healthcare must always be evidence-led and avoid unacceptable safety risks. We welcome the commitment to provide new holistic health and wellbeing support services for children and young people with gender incongruence, based on the recommendations of the Cass Review.
Where we disagree with Wes Streeting is the idea that there can be a safe, ethical and reliable clinical trial that could establish a clear evidence base for the use of puberty blockers.
Scientific grounds to justify a new trial not established
In CAN-SG’s view the scientific grounds that would justify a new puberty blockers trial have not been established.
UK regulation of clinical trials is clear that trials should only be initiated if the anticipated benefits justify the risks. As the Cass Report points out, there is no clear rationale for how blocking puberty might help children presenting with gender dysphoria, and existing evidence doesn’t demonstrate benefits even to short-term mental health and well-being.
Legal duty to minimise risk to a child’s stage of development
UK law also stipulates that clinical trials should minimise any foreseeable risk to a child’s stage of development. Given that puberty blockers by definition disrupt a crucial natural phase of human development, the anticipated benefits must be tangible and significant to justify the risk to children.
Researchers should prioritise other research avenues
Since the Early Intervention trial was conducted, we now know more about the risks to health these drugs pose, and this should give pause to researchers.
Rather than diving into a drug trial, we want to see other research prioritised that would ensure that any potential future drug research is safe and justifiable. This would include retrieval and analysis of outcome data from people already treated with puberty blockers via the GIDS clinic, investigation into the causes of the changes to the characteristics of children presenting with gender dysphoria over the last decade, investigation into the possible causes of gender dysphoria, and the relationships between GD and autism spectrum disorders, same-sex sexual orientation, history of trauma, and other social factors.
Research into safer interventions should be prioritised
Such research will help us to better understand gender dysphoria, and generate better management strategies that meet the needs of children today. There is insufficient research into psychological/psychosocial treatments, and this should be prioritised over physical treatments that carry greater risks.
Clinical, ethical and scientific concerns must take priority
In pushing ahead with a puberty blockers trial, we are concerned that political interests are being prioritised over clinical, ethical and scientific concerns, and over the health and well-being of children.
The BBC has published an article outlining some of the possible trial PB trial designs. None of the proposed designs is capable of answering the important questions about puberty blockers, nor achieving the necessary ethical standards for research in children. CAN-SG will publish a more detailed critique of the ethics and feasibility of the proposed puberty blocker trial very soon.