What would an ethical clinical trial into puberty blockers look like?

In light of the Cass Review, the new use of puberty blockers for children is now pretty much restricted to those enrolled in clinical trials in the UK. The Cass Review underscored the lack of consensus and the significant gaps in knowledge surrounding the use of puberty blockers, prompting a more cautious and scientifically robust approach to their application, if they were ever to be used in the future. There are currently no trials, just plans to design and start them.

Before any clinical trials for puberty blockers proceed post-Cass Review, there are essential clinical questions that must be addressed. These questions are critical to ensuring that any trial is ethical and can help inform future clinical decisions. These are the questions that must be answered before any ethical trial can take place.

1. Identifying Persistent Trans Identities

Which children will maintain their trans identities into adulthood? This is fundamental as only those likely to persist should be considered for radical treatments due to the profound and potentially destructive consequences of these medical interventions. High confidence in predicting persistence is crucial to avoid imposing unnecessary treatments on children who might naturally desist.

2. Alternative Interventions for Adolescent Distress

What other interventions can alleviate the distress leading to trans ideation? We know most children presenting at gender clinics present also with complex psychological needs and conditions, including autism, trauma and distress over their emerging sexuality. Trans identities may be a coping mechanism for these conditions. Understanding which psychological treatments are beneficial and for whom they work is essential. Current conversion therapy bans threaten this research, potentially stifling clinical interventions that could relieve distress without resorting to life-altering medications.

3. Impact of Halting Natural Puberty

What are the long-term effects of stopping natural puberty on brain and body development? Preliminary evidence suggests potential losses in maturity and developmental issues. Detailed studies are necessary to understand these impacts fully.

4. Clinical Purpose of Puberty Blockers

What is the clinical purpose of using puberty blockers in this cohort? The Cass Review highlighted a lack of consensus. Whether intended as ‘time to think,’ to reduce psychiatric distress, or for cosmetic reasons, each potential usage has significant problems. Evidence suggests children don’t use the time to reconsider options, and the ‘cosmetic window’ is very narrow.

5. Safety and Effectiveness of Adult Cross-Sex Hormones

Is the subsequent use of adult cross-sex hormones safe and effective? Puberty blockers are not standalone treatments but part of a pathway. Comprehensive evaluations of the overall clinical benefits and risks are necessary.

6. Long-Term Regret Rates

What are the long-term regret rates? While this may correlate with question one, even persistent trans identities can experience regret due to factors like loss of sexual function.

7. Methodological Quality of Trials

Any trial must have the methodological quality and size to address serious clinical questions. If trials cannot resolve treatment effects from confounders, and be generalisable (for example), the risks to participants are unjustifiable. Low-quality trials with serious methodological issues must be avoided.

8. Comprehensive Understanding of Past Usage and Outcomes

Before any new trials start, we must ensure that any lessons can be drawn from historical use. This might involve much better follow up of adults who took puberty blockers as children. So far, attempts to collect this data from clinics has been met with resistance. Hillary Cass found most centres refused to help her form the linkage between child records and adult records so that outcomes could be recorded against treatments.

Ethical Considerations

For a clinical trial of puberty blockers to be ethical, it must ensure:

1. Autonomy

How can children consent to trials when so much is unknown? Potential harm to future sexual well-being and enjoyment, which they cannot fully grasp, complicates consent.

2. Non-Maleficence

Clinicians have noted that the puberty blocker/cross-sex hormone pathway can lead to permanent loss of sexual function, infertility, developmental issues, and even cancer. Do these harms outweigh the benefits?

3. Beneficence

Treatments must provide significant benefits. Do puberty blockers dramatically improve outcomes, justifying their use over waiting until adulthood for cross-sex hormones?

4. Justice

Is this an appropriate use of medical resources? Are we diverting attention from more fundamental needs like better mental healthcare for all children?

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For these reasons, I cannot envisage any trial (at least in the next few decades) being a just and ethical experiment to impose on distressed children. The huge difficulties here for me highlight the true nature of the use of puberty blockers here. Puberty blockers are not being used for meaningful clinical purposes but are seen by some as ideological treatments. They symbolise a sacrament – a ritualistic baptismal entry into the world of ‘trans’ identities.

Given the significant ethical and clinical concerns, we must remain vigilant. We must challenge proposals for such trials and ensure that vested interests do not compromise the well-being of distressed children. It is imperative to demand thorough answers to these critical questions before considering ethical approval for puberty blocker trials.