Is NZ’s transgender medicine guideline an example of regulatory failure?
This paper was presented at the recent Genspect Australia New Zealand Best Practice in Gender Care the inaugural event of Genspect in the region.
A recently completed investigation has found that the 2018 Guidelines for gender affirming healthcare for gender diverse and transgender children, young people and adults in Aotearoa, New Zealand was not written to comply with the requirements of commonly used Clinical Practice Guideline standards. This was allowed to happen because there is no accepted standard in New Zealand for how health guidelines are created. The guideline lacks important steps that all Clinical Practice Guidelines should have. Guideline recommendations should be based on evidence from a systematic review of the research literature. There should be a formal process for devising recommendations based on the quality of the evidence. Other steps such as addressing conflicts of interest and arranging for an external independent review are required. The guideline contains no information that any of these steps ever took place.
The Guideline’s treatment approach is also radically different to the international guideline published in 2012 by the World Professional Association of Transgender Health (WPATH SOC 7) that the New Zealand Guideline says it is based on. Originally published by Waikato University’s Transgender Health Lab the Guideline has been adopted by the Professional Association for Transgender Health Aotearoa (PATHA)* who promote its use. It has formed the basis for New Zealand’s health pathways for transgender medicine and other health policies. It was endorsed by, but has never been assessed by, the Ministry of Health.
Amongst the changes made as a result of the NZ Guideline 2018 is that clinicians have no longer needed to ask about the causes of gender distress, nor make a clinical diagnosis. The guideline proposes ‘affirmative’ care which means that it is enough to ‘recognise that each individual is the expert of their own gender identity’ and ensure that patients can provide consent to life-changing, and in many cases life-long, medication. Consent is a simple matter of ‘having several conversations between the person and clinician(s) before they start treatments that have an irreversible component’. In the Guideline distress, whether about the sexed nature of bodies; being gender non-conforming; or distress about gendered expectations of social roles are all equated with the effects of minority stress (which equates to the impacts of prejudice and stigma). But the WPATH guideline recognises other causes including transition itself. The Guideline also says the medical and surgical treatment is ‘medically necessary’ and yet each element is optional based on the individuals transition goals, and for some transgender people, entirely unnecessary.
As well as being non-compliant with any formal guideline process the Guideline makes medicalisation more likely to occur than WPATH SOC 7 by removing treatment criteria and failing to provide information on treatment risks. The evidence for the Guideline’s recommendations are mostly of low quality and sometimes completely absent. For example there is no evidence to explain why social transition is recommended when WPATH SOC 7 recognised that it is a controversial step. The four criteria that must be met in WPATH SOC 7 to prescribe puberty blockers are missing from PATHA’s Guideline. There is no explanation or evidence to explain why the advice that the majority of children with gender dysphoria will resolve their identity issues at puberty was removed. Neither the rationale for affirmative care (following the patient’s belief about themselves) nor dispensing with diagnosis is supported by any research evidence.
The impact of the PATHA Guideline being adopted is that many hundreds of New Zealand children and young people have been put onto a path of lifelong medicalisation. If the WPATH 2012 Guideline had been used instead most of them would have resolved their gender confusion with many becoming gay or lesbian adults.
The Ministry of Health should review the Guideline with urgency and, if their conclusions accord with those of the report, withdraw it. Quality clinical evidence should be guiding New Zealand’s approach to caring for people with gender confusion. The Ministry must ensure that it also addresses the regulatory gap where clinical guidelines can be written, and become accepted practice, that do not meet Clinical Practice Guideline standards and have never been independently assessed.
In the Ministry’s current work on an evidence brief on puberty blockers the approach is comprehensive and properly structured, unlike the PATHA Guidelines. There are worrying signs though. It appears that the Ministry was influenced to change direction. Relying on the feedback of un-named clinicians it extended the scope to include papers that address whether puberty blockers improve mental health and wellbeing. While such research is purported to exist much of it is of poor quality. To override the comprehensive evidence reviews that have already found many of those papers to be unconvincing would be a disaster for young gender confused New Zealanders. There is an important choice ahead. Will the Ministry be convinced by advice from people and groups it does not name, by cherry-picked studies and by PATHA, an organisation that has adopted a below standard medical guideline, and whose doctors are still claiming, contrary to many studies, that blockers are safe and reversible or will it decide in favour of the emerging international evidence? Time will tell.
You can read the full report here.
* PATHA was sent a copy of the draft report and asked for comments but they have not responded.