Misguided

A gender treatment guideline in New Zealand appears to have achieved influence beyond its merits

Photo by Andrew Neel on Unsplash

New Zealand’s 2018 “gender-affirming” treatment guideline cannot justify the extreme medicalisation it recommends and would never have been promoted by the country’s Ministry of Health had there been a proper assessment of its robustness.

This is the opinion of retired public servant Jan Rivers who reviewed the document drawing on her career concerned with management of accurate information and knowledge.

She presented her findings at the November 10 “Best practice in gender care” webinar, the inaugural public event for Genspect in Australia and New Zealand.

As a lesbian, Ms Rivers declared her worries about same sex-attracted youth “being persuaded that they’re in the wrong body” and subjected to hormonal and surgical treatments that may sterilise them, impair their sexual function and make them lifelong medical patients.

“Where the impacts of medication and surgery are so extreme, it’s not appropriate that they be managed through a guideline which has never been given a proper appraisal by parties other than those whose interests are in the very medicine that they’re developing the guideline for,” she said.

A Ministry of Health webpage titled “Providing health services for transgender people” used to link health professionals to the guideline, which claims puberty blockers are “fully reversible” and says there is “good evidence” they improve mental health.

Following a restructure, the main public health provider Health New Zealand took over responsibility for that webpage and its continued promotion of the guidelines, which were endorsed by the Professional Association for Transgender Health Aotearoa (PATHA) and thereby became known as “the PATHA guidelines”.

Earlier this year, after the NZ government had reacted to Europe’s shift to caution on gender medicine by abandoning its online claim that puberty blockers are “safe and fully reversible”, the health ministry adopted the ambiguous public position that it had “not gone through any formal process to review or endorse the PATHA guidelines.”

A ministry-commissioned evidence brief on “the clinical outcomes, including safety and long-term impacts, of puberty blockers in gender-dysphoric adolescents” is due to be published by the end of this month. The plan was to assess the quality of evidence offered by all the studies included in the brief.

“The PATHA guidelines were not within the scope of the evidence brief,” a ministry spokesman told GCN on Tuesday.

Health NZ had contracted PATHA to update the guidelines by August 2024, according to the agency’s group manager for primary care, Astuti Balram. The 2022 NZ budget allocated $250,000 for this project.

“The updated guidelines will reflect international guidelines and research, include language updates and provide more information about non-binary healthcare needs,” Ms Balram told GCN.

She did not answer the question whether or not Health NZ endorsed the PATHA guideline but said, “We have a responsibility to ensure our healthcare professionals have the information they need to provide care, in line with international best practice.”

Simon Tegg, of the group Fully Informed, said the NZ health bureaucracy had “put the cart before the horse, contracting a new set of guidelines without knowing if the evidence is strong enough to support recommendations.”

“Normally evidence-based medicine specialists wouldn’t even consider creating a clinical guideline unless the first cut of an evidence review showed it to be worthwhile.

“The question now is if the Ministry’s evidence brief shows that puberty blockers are not ‘safe and fully reversible’, will Health New Zealand publish guidelines that recommend their routine usage in primary care on the basis of an 11 year-old’s self-declared transgender status?

“Perhaps the presumptive new Health Minister, Dr Reti, has an opinion about this and can knock a few heads together to sort out the contradictions.”

“A year ago, I called for a review of the use of puberty blocking hormones for children with gender dysphoria ... The past year has seen a lot of frank and fair discussion—and action—overseas. Regret over gender transition and detransition are widely discussed. More countries are taking action to restrict the use of puberty blocking hormones. But in New Zealand, next to nothing has happened. It is becoming even easier to access these hormones. Standard medical safeguards are being discarded.”—Emeritus Professor of Epidemiology Charlotte Paul, North & South magazine, December 2023

Influence beyond competence

In her Genspect talk, Ms Rivers said she believed the status and influence achieved by the PATHA guidelines revealed a failure of regulation.

“There appears to be no standard in our health system for creating clinical practice guidelines,” she said. “Self-selected groups of clinicians can create documents that purport to be guidelines without aligning them to international good practice.

“Where responsibility lies in the New Zealand medical system is a very vexed question,” she said, citing among the potentially implicated bodies the Ministry of Health, Health NZ, the regulatory Medical Council, the Health and Disability Commissioner, the drug funding agency Pharmac and the Royal New Zealand College of General Practitioners.

Ms Rivers said she saw NZ parallels in the plight of the American Academy of Pediatrics (AAP).

In potentially historic litigation, detransitioner Isabelle M Ayala has not only sued health providers for malpractice but also alleges that conspiracy and fraud produced the AAP’s 2018 affirmation-only treatment policy.

“… finding no evidentiary support for their radical positions, [the AAP] nonetheless prepared and authored a ‘policy statement’… proposing an entirely new model of treatment, which not only misrepresented or misleadingly presented its purported evidentiary support but was also rife with outright fraudulent representations,” says the complaint filed in the US state of Rhode Island, last month.

Ms Rivers said: “Like the PATHA guidelines, a diagnosis-free affirmation approach to assessment [as recommended by the AAP policy statement] has left many young American people adrift in bodies that are not what they hoped for, and which now, changed forever, cause them pain and distress.”

She said the potential targets for litigation in NZ would need to be analysed, should a detransitioner or parent emerge willing to bring a case.

On November 8, Pharmac announced it was seeking feedback on a proposal to fully fund a testosterone gel product—Testogel, supplied by Pharmaco—without restriction. The agency noted that one of the uses for the drug was “testosterone-based gender-affirming hormone therapy.”

Pharmac said: “We would want to support equitable access and use of funded testosterone gel. In particular, we are interested to know what we could do to support Māori, Pacific peoples, disabled people, as well as people [biological females] using testosterone gel as part of gender-affirming hormone therapy.”

A data sheet hosted by the NZ regulator Medsafe says, “The safety and efficacy of this medicine in males under 18 years have not been established.”

Four international systematic reviews of research on testosterone as a cross-sex hormone for minors have found the evidence to be weak and uncertain.

“By deceiving [its pediatrician members] about the science of gender medicine and infantilizing them with unicorn-themed propaganda, the AAP is not only undermining the public’s trust in its authority as a scientific organization. It is also creating legal risk for pediatricians who, perhaps in good faith, rely on its guidance.”—researcher Leor Sapir, City Journal, 31 October 2023

Video: NZ National Party politician Simon Bridges questions paediatrician Dr Andrew Marshall about puberty blockers two years ago. Dr Marshall cites suicide risk as a rationale for these drugs; a contentious claim.

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Buyer beware

Ms Rivers said the PATHA guidelines were widely cited across the NZ health system.

Apart from their seeming endorsement by the health bureaucracy, she said the guidelines had influenced HealthPathways information relied on by health professionals; a 2022 ban on “conversion therapy”; school policy and materials enabling social transition and promoting puberty blockers; rules for professional bodies; and mandatory gender affirmation of children in foster care.

Creation of the PATHA guidelines was led by the Transgender Health Research Lab of Waikato University’s psychology academic Dr Jaimie Veale, who is also PATHA’s president.

After Ms Rivers wrote to the university citing the reach of the guidelines and their flaws, acting deputy vice-chancellor Professor Karin R Bryan replied: “The matter of whether external organisations elect to adopt those guidelines and recommendations, and how they apply them is not something that the University of Waikato has control of.

“External organisations have the responsibility to oversee the type and extent of advice that they provide to their clients, and the resources that they use to provide that advice.”

In the Genspect webinar, Ms Rivers said there was “a big disconnect” between the university promoting the guideline as evidence-based advice to the health bureaucracy while implying no responsibility for its adoption or effects.

She said the PATHA guidelines did not measure up to international methodologies for the creation of a trustworthy and transparent clinical guideline.

She noted that representatives of the transgender community were “front and centre” in development of the guidelines. 

“It is quite unusual, surely, for the treatment group to determine their own healthcare services in quite this way, especially when most of the patients [affected by the PATHA guidelines] are children or young people.

“Imagine heart surgery or diabetes treatment run like this.”

“Rigorous observational studies show that puberty blockers improve the mental health and wellbeing of transgender young people, lowering depression and suicidal ideation and increasing quality of life.”—a new Project Village information sheet for young people and parents, funded by the NZ Marsden Fund of the Royal Society, citing a handful of contested studies such as Tordoff et al 2022 and Turban et al 2020.

“Against the background of almost non-existent long-term data, we conclude that GnRHa [or puberty blocker] treatment in children with gender dysphoria should be considered experimental treatment rather than standard procedure. This is to say that treatment should only be administered in the context of a clinical trial under informed consent.”—Professor Mikael Landén, who took part in Sweden’s systematic review of the evidence base, April 2023

How was the guideline guided?

Ms Rivers said: “The PATHA guideline fails completely to identify that the population [targeted by its treatment recommendations] are a rapidly growing group with a change in cohort, including many post-pubertal young women with multiple mental health issues.

“The biggest gap, though, is the lack of evidence that a literature review was ever carried out [during development of the PATHA guidelines].

“There’s no information about the [literature] search criteria. There’s no criteria for assessment of articles found. There’s no methodology for this described for how recommendations were derived from evidence.

“I do believe that if the Ministry of Health had assessed the guidelines before they presented them on their own website, they would have sent the authors back to the drawing board.”

Ms Rivers described as unusual the guideline’s idea of informed consent as “reaffirm[ing] the self-determination of the transgender person and their knowledge of their needs, identities, and self.”

Under the heading “Spiritual Health” the guideline cites three references to support its claim that, “It is increasingly apparent that, in Aotearoa [NZ] pre-colonial Māori society, people of diverse genders and sexualities were both accepted and valued within whānau [extended family].”

Ms Rivers said: “When I searched the three references cited, I found nothing that substantiated the claim that was made about diverse genders. There may be such information, but it certainly wasn’t in the documents that were cited in this guideline.”

“Evidence shows that taking puberty blockers does not influence the choice to subsequently take hormones.”—Project Village information sheet, citing Nos et al 2022

“Puberty blockers are more than a ‘pause button’: roughly 98 per cent of children who take them go on to take cross-sex hormones. A 2021 study from the UK [Carmichael et al 2021] found that only 1 out of 44 children placed on puberty blockers did not continue to take cross-sex hormones. Similarly, a Dutch study [Wiepjes et al 2018] reported that only 1.9 per cent of adolescents who started puberty suppression treatment abandoned this course and did not take cross-sex hormones. In fact, in a different Dutch study [de Vries et al 2011], ‘[n]o adolescent withdrew from puberty suppression, and all started cross‐sex hormone treatment, the first step of actual gender reassignment’.”—StatsForGender.org

Worse than WPATH?

The PATHA guidelines were presented as complementary to the then current standards of care (SOC-7) issued by the World Professional Association for Transgender Health.

However, Ms Rivers said the NZ guideline repeatedly “makes more extreme recommendations” than SOC-7 and often failed to give evidence or explanation for these departures from the supposed international benchmark.

“In the WPATH standards of care, it’s accepted that co-morbid mental health conditions may impact any [gender] treatment unless they’re well controlled,” she said. “In PATHA, poor mental health is no bar to gender medicine.”

“The WPATH standards of care argue for medical diagnosis to exclude other [non-gender] causes of cross-sex identification, such as psychosis or trauma. The PATHA guidelines do not even use the word diagnosis in relation to a decision to provide social transition and gender medicine.

“In the WPATH standards of care, it’s recognised that the large majority of pre-pubescent children who take on a cross-sex identity will desist [re-embracing their birth sex].

“In the PATHA guideline, it says merely that ‘some previously gender-expansive children may shift along the gender spectrum to find their gender identity more aligned with the sex assigned at birth’. No evidence is supplied for this change of emphasis.”

Ms Rivers said she believed that the radical departures of the NZ guideline from the WPATH document were mostly the result of the decision to give “primacy to views and wishes of transgender adults” in developing the guideline, notwithstanding its application to children.

GCN has sought comment from PATHA and Dr Veale.