UK Puberty Suppression Trial Unethical And Inappropriate For Aotearoa

The Professional Association for Transgender Health Aotearoa (PATHA) welcomes further research into gender-affirming healthcare for young people. However, PATHA is concerned about ethical and methodological issues identified in the research protocol for the United Kingdom’s PATHWAYS clinical trial on the use of reversible pubertal suppression for transgender children and youth experiencing gender incongruence. These concerns include the harms of delaying care for the control group, the invasiveness of extensive tests, the limited ability to capture longer-term impacts of reversible pubertal suppression, and concerns around consent.

Minister of Health Simeon Brown has announced that Aotearoa’s new restrictions on the prescription of GnRH analogues (a type of medication that reversibly pauses puberty) will be in place until the release of the results of the UK’s trials, expected in 2031. The purported justification for New Zealand’s ban is the limitations in the quality of academic evidence for the use of reversible puberty suppression in treating gender dysphoria or incongruence. Based on the research protocol for this trial, PATHA strongly believes that the PATHWAYS clinical trial will not provide the quality of evidence Brown is looking for.

“We welcome additional research on the experiences of transgender children accessing reversible puberty suppression, and the outcomes of that care,” says Dr Elizabeth McElrea, GP specialist in gender affirming care and PATHA Vice-President. “But there are concerning issues with this research protocol. This trial will not provide the evidence our Minister of Health is seeking, and we have significant ethical concerns regarding the harm it will cause. The trial protocol involves subjecting vulnerable young people to over 50 detailed questionaires, including questions on trauma and suicide, multiple intimate genital examinations and multiple MRI brain scans. There is no rationale or ethical justification for exposing young people to this level of harm. We already know the effects of these medicines, over decades of safe prescribing. This trial is a cruel and discriminatory method of further isolating and harming a generation of transgender children and young people.”

Ethical concerns

These clinical trials are unlikely to demonstrate the true benefit of reversible pubertal suppression, and instead are highly likely to capture the harms of delaying or withholding treatment. It seems highly likely to PATHA that the mental health and quality of life among children made to wait an additional year or being randomised into the control group without access will deteriorate. We fear for the impacts of this trial on those groups, given both the immediate disappointment and the effects of a further year (or more) of physical puberty. In line with research ethics, if harm from withholding the treatment is identified during the trial, the trial should be stopped, and the control groups should be offered the treatment.

The UK clinical trial will be the only way transgender children can access reversible pubertal suppression in the NHS. The World Medical Association’s Declaration of Helsinki on medical research, which should be upheld by anyone engaging in medical research, makes it clear that “free and informed consent is an essential component of respect for individual autonomy” and that “participation by individuals capable of giving informed consent in medical research must be voluntary”. The New Zealand National Ethical Standards for Health & Disability Research and Quality Improvement also state that “non-maleficence requires researchers to avoid causing harm to individuals and communities,” that “participants’ consent in research must be voluntary,” and that “the consent process must protect participants from coercion, deception, manipulation or other undue influence”. A patient cannot meaningfully consent to a trial when that trial is the only way for them to access the care they need.

We also have ethical concerns about relying on a UK trial to guide care in Aotearoa which is very culturally different from the UK. Gender diversity has always been an accepted part of Te Ao Māori. Healthcare in Aotearoa should not be guided by a substandard UK trial which has minimal relevance to Aotearoa and our cultures.

Trial design concerns

The primary aims of prescribing reversible pubertal suppression for people experiencing gender incongruence are to prevent the irreversible effects of puberty. They also give children and young people time to explore their gender identity. The full positive benefits of reversible pubertal suppression are unlikely to be captured during this two-year trial period. Whilst the trial may identify some more immediate impacts, such as a reduction in distress for those who had started experiencing physical changes, in general, much of the benefit of reversible pubertal suppression is found in adulthood when people don’t have physical changes which are incongruent with their gender (for example, preventing breast growth in a trans-masculine person or voice deepening in a trans-feminine person). These huge benefits in adulthood will not be captured by the UK trial, though the trial is likely to show the negative impacts on the group forced to delay access for one year.

“I consider reversible pubertal suppression to be one of the most important decisions of my life. It has prevented many unwanted changes and allowed me to live a more fulfilling adult life. I consider them to be one of my life-savers” – Transgender Adult

Additionally, a large number of the measures used in the study are unlikely to capture the effects of reversible pubertal suppression or are likely to be confounded by other factors in a young person’s life. The primary measure of the study is a screening tool called Kidscreen, which asks questions like “have you had enough time for yourself?”, “have you felt lonely?”, and “have you had fun with your friends?”. The answers to these questions are unlikely to have relevance to reversible pubertal suppression, as benefits are more realised later in life rather than in the first years of treatment. These questions are more likely to be impacted by other changes in the child’s life, causing confounding of study data. The assessments contain many outdated and pathologising questions.

The secondary measure used by the study is intended to measure the impact of reversible pubertal suppression on gender dysphoria. Reversible pubertal suppression is not intended to resolve gender dysphoria, as it simply prevents further changes due to puberty, rather than bringing a patient’s body in alignment with their gender identity. A reduction in gender dysphoria is usually found with gender affirming hormone therapy when people are older, and not usually anticipated with reversible pubertal suppression. To assess impact on gender dysphoria it does not make sense to assess pubertal suppression as a standalone intervention rather than as one part of a bigger and longer term picture of gender affirming care.

Additionally, the scale used to assess gender dysphoria, the Utrecht Gender Dysphoria Scale - Gender Spectrum (UDGS-GS) includes a number of statements that are not likely to be impacted by puberty suppression or confounded by other factors, including “I feel hopeless if I have to stay in my assigned sex” and “I always want to be treated like my affirmed gender.” The UDGS-GS scale has been long discredited in Aotearoa due to its wording and subsequent distress this can cause participants.

“The trial will exclude those with severe or profound depression, suicidality and self harm. Young people who are already suffering profound distress will have no option for care,” says Dr Rona Carroll, a GP specialist in gender affirming care and member of PATHA’s Executive Committee. “A deterioration in mental health of young transgender people is already being witnessed in the UK. Recent research from the University of London showed that the UK government’s decision to ban puberty suppressing medication was ‘significantly, extensively and relentlessly harming trans children and young people’. The risk of some sourcing illegal medicines without clinical oversight is high.”

“It’s totally inappropriate for the New Zealand Ministry of Health to be looking to the UK and these trials for guidance and evidence,” says Jennifer Shields, PATHA President. “Earlier this year the Lemkin Institute for Genocide Prevention issued a red flag alert about the UK’s stance on transgender rights, citing the UK’s ban on reversible puberty suppression for transgender children. This trial is unethical, will not produce the evidence that the minister purports to want, and I don’t think Aotearoa New Zealand should be endorsing it.”

It remains unprecedented, unethical and discriminatory to withdraw access to a medication for one group of people when there is no evidence of harm. Whilst the Minister of Health waits many years for the results of a poorly designed overseas trial which may never eventuate, access to reversible pubertal suppression for a generation of children and young people in Aotearoa will be completely withdrawn.

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