Why I'm sounding the alarm on the next puberty blockers scandal
Few issues in contemporary medicine have generated as much controversy as the use of puberty blockers in gender distressed children. The Government, responding to the findings of the Cass Review, has rightly banned the prescription of these drugs. Many other countries have, too.
However the Government last week announced an £11 million clinical trial of these medicines to gather evidence of their effects. This raises a fundamental question: can a clinical trial of puberty blockers on children experiencing gender distress be done ethically? The answer, upon scrutiny, is a resounding 'no'.
I have witnessed firsthand the grave dangers posed by the rush to medicalise childhood gender distress. As a former psychiatrist at the Tavistock and Portman NHS Trust, I was one of the whistleblowers who raised concerns about the practices at the now shuttered Gender Identity Development Service (Gids). What we uncovered was a service driven more by ideology than by robust clinical reasoning. Many distressed children, often same-sex attracted and with autistic comorbidities, were put on a medical pathway to transition by some clinicians who had been captured by 'trans' ideology and, as a result, cast aside ordinary sound clinical judgment. A clinical trial risks repeating these ethical failures.
These trials are governed by rigorous ethical and legal standards, designed to protect participants from harm. The foundation of these standards is the Declaration of Helsinki, alongside the Good Clinical Practice guidelines and the UK's Medicines for Human Use (Clinical Trials) Regulations. These frameworks exist to ensure that the benefits of any new medical intervention outweigh the risks.
The Cass Review has made it clear that the evidence base for the safety and effectiveness of puberty blockers is extraordinarily weak, and that their risks are significant. Existing studies suggest serious concerns, including negative impacts on bone density, cognitive development, and future sexual function. Further, over 95 per cent of children started on a medical pathway will proceed to cross sex hormones and many to surgical intervention. Thus starting any child on PBs is freighted with that knowledge, and of course the ethical implications of that knowledge.
To be clear, the prescription of puberty blockers in the context of a trial would, in effect, introduce a known risk of systemic physical harm to a physically healthy child. To put it mildly, this is a divergence from normal clinical trial practice.
One of the core principles of medical research is that a clinical trial must seek to answer a question that cannot be resolved by other means. Yet in the case of puberty blockers, safer research avenues remain unexplored. We should be conducting robust long-term follow-up studies of those who have already undergone such treatment, qualitative research into the experiences of the growing numbers of detransitioners, and further animal studies to understand the biological impact of these drugs on adolescent brain development.
Another major ethical concern is the question of informed consent. Children under 16 cannot legally provide informed consent for a Clinical Trial of an Investigational Medicinal Product, meaning that parental consent would be required. Yet, given the politicised environment surrounding gender identity, it is difficult to see how true informed consent can be obtained. For example, parents, subjected to trans activist narratives claiming that refusal to provide puberty blockers increases their child's risk of suicide, will not be in a position to make a free and uncoerced decision.
The argument that puberty blockers prevent suicide is completely unsubstantiated. For example, a recent Finnish study found no significant difference in suicide rates among youth diagnosed with gender dysphoria when adjusted for mental health comorbidities. In the UK, Professor Louis Appleby, the leading authority on suicide prevention, has called for caution on the use of false assertions as regard risk of suicide in this group . Informed consent is meaningless when it is obtained under conditions of misinformation and fear.
There are moments in medical history when the imperative to 'pause and reflect' must override the drive to push forward. Now is one such moment. Given the absence of an established safety profile, the lack of high-quality evidence supporting their efficacy, and the well-documented risks, any such trial would violate our ethical and regulatory frameworks.
The medical community, politicians, and regulators need to draw a line under this scandalous piece of medical history. Instead of experimenting on confused children with medical interventions that do more harm than good, we should be dedicating our resources to understanding and addressing the root causes of gender distress, researching psychosocial treatments and following up on the 9,000 children who went through Gids. Let us not repeat mistakes of the past.
Dr David Bell is a retired consultant psychiatrist and was a Governor of the Tavistock and Portman NHS Foundation Trust
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