'Unlawful'

Health ministry was warned over promotion of puberty blockers

Photo by Julie Ricard on Unsplash

The gist

New Zealand’s Ministry of Health was warned it could be breaking the law by publicising the off-label use of hormone suppression drugs to interrupt the puberty of transgender-identifying children.

The government’s own regulator, Medsafe, raised this risk last September when ministry officials were discussing a more cautious website reference to puberty blockers.

The ministry’s website previously had claimed these drugs were “a safe and fully reversible medicine” for children with gender distress. Known as GnRH analogues, these hormone suppression drugs have various approved uses; trans puberty blocking is not one of them.

“If the ministry advocated that certain medicines be used off-label, this could come in for criticism as a potential breach of the [Medicines Act 1981],” Medsafe’s manager of compliance, Derek Fitzgerald, said in an email exchange with ministry officers obtained under the Official Information Act by Simon Tegg of the group Fully Informed.

Section 20 of the Medicines Act prohibits the advertising of an off-label—or unapproved—use of a medicine.

A legally qualified health practitioner, who looked into this issue and spoke on condition of anonymity to avoid harassment by trans activists, told GCN that in her opinion there is no question but that the ministry is in breach of the Act.

“The [ministry] should be a trusted source of health advice,” she said.

“The fact that this particular drug, used in this way, is specifically prescribed to disrupt a normal and important physiological process in children—puberty—that alone should attract a very high standard of scrutiny.”

In 2022, there were 771 minors prescribed drugs to suppress natural hormones, a rise of 462 per cent since 2012, according to data from the medicine-funding body Pharmac reported this month by the NZ magazine Listener.

In the same magazine last year, emeritus professor of epidemiology Charlotte Paul wrote that she was “surprised to discover that puberty-blocking hormones are not approved for use for [the distress of] gender dysphoria, not by Medsafe here [in New Zealand], nor by the US Food and Drug Administration, nor the European Medicines Agency.

“It is probably because there is simply insufficient evidence available about benefits and harms. It also means that extra precautions are required.”

Last September, when Medsafe’s Mr Fitzgerald cautioned health ministry officials about public statements on puberty blockers, he said it was “important to note that where potentially controversial matters are concerned, there may be extra scrutiny of the legality of the ministry’s actions.

“You may wish to obtain a legal opinion on the information the ministry publishes/wishes to publish on this.”

The penalty for an individual advertising an unapproved drug use is a maximum prison term of six months or a fine up to $20,000; for a body corporate, the maximum fine is $100,000.

A spokesman for the ministry told GCN that in publishing information on puberty blockers, “the ministry is satisfied that it has complied with the law at all times.”

The legally qualified health practitioner who spoke to GCN noted that the ministry administered the Medicines Act and said this raised “the problem of the ministry marking its own work” in determining whether or not it had breached the Act.

The ministry did not answer when asked if it had acted on Medsafe’s suggestion to seek legal advice.

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The detail

The NZ health ministry’s updated public statement on puberty blockers, which now appears on a Health NZ webpage, reads in part—

“Puberty blockers are a medicine that can be used to halt the progress of potentially unwanted puberty-related physical changes. Blockers are sometimes used, with the guidance of a clinician who specialises in their use, from early puberty through to later adolescence to allow time to fully explore gender health options.”

Before September last year, the ministry’s reference had said—

“Puberty blockers are a medication that can be used to halt the physical changes of an unwanted puberty. Blockers are a safe and fully reversible medicine that may be used from early puberty through to later adolescence to help ease distress and allow time to fully explore gender health options.”

Despite the shift to more cautious wording, both references amount to the advertising of an unapproved drug use and are in breach of the Medicines Act, in the opinion of the legally qualified health practitioner.

She said this was the case notwithstanding ministry officials having decided to remove some clinical detail and the specific puberty blocker drug names, Leuprorelin and Goserelin, when drafting the new website reference. These cuts were made partly to accommodate Medsafe’s warning of a potential breach of the law.

“The Royal New Zealand College of General Practitioners… appears to support puberty blockers for gender dysphoria, saying they can help to reduce distress and allow time for young people to mature before making decisions on permanent gender-affirming options”—journalist Ruth Brown, news report, Listener, 13 May 2023

“Medical director Dr Luke Bradford says a core principle of medicine is first do no harm, but ‘not starting blockers where beneficial, should not be considered a neutral act, with the risk of lifelong unwanted physical changes causing distress and the potential for a negative impact on mental health’.”

Evidence check

Last September, taking into account growing concern about puberty blockers in Sweden and other European countries, the NZ health ministry ordered the preparation of an “evidence brief” on this treatment for the condition of gender dysphoria, in which a distressed young person rejects their birth sex.

The evidence brief—put together by the evidence, research and innovation branch of the ministry, potentially in consultation with outside experts—was reportedly due for release this month. GCN has sought confirmation of this timing from the ministry.

Hormone suppression drugs known as GnRH analogues are used internationally—without regulatory approval—to interrupt the natural puberty of children who identify as trans or non-binary.

“Doctors have wide prescribing rights. These rights are only limited by their scope of practice—but patients have rights too,” the legally qualified health practitioner said.

She pointed out that “Medsafe, the Medical Council of NZ, and the Health and Disability Commissioner all advise that a higher standard of consent is required when the doctor is prescribing an off-label medicine.”

Approved uses for GnRH analogues include central precocious (or premature) puberty, prostate cancer and endometriosis.

Gender clinicians and activists suggest that the longer history of premature puberty suppression should reassure sceptics of trans puberty blocking, but this analogy has been rejected as misleading by England’s Cass review of gender dysphoria care.

Suppressing the natural puberty of children who identify as trans or non-binary arouses strong disagreement within medicine; treatment is sometimes begun as young as 8-10 years of age. Known side-effects include low bone density, while the effect on the developing adolescent brain is unknown.

“In New Zealand, the Medical Council issues guidelines for unapproved medicines, or those unapproved for particular uses. Unapproved medicines must be subject to monitoring, to prior discussion with a senior colleague, and the patient must be given extra information about risks and benefits—including that the medicine was being prescribed for an unapproved indication. None of this (apart from monitoring height and bone density) is mentioned in the New Zealand guidelines for gender-affirming healthcare [issued in 2018 by the Professional Association for Transgender Health Aotearoa]”—Professor Charlotte Paul, Listener, 3 September 2022

Gender insiders

Last September’s email exchange involving ministry officials also shows that New Zealand’s Professional Association for Transgender Health Aotearoa (PATHA) wanted a “gender-affirming” clinician to be involved in reworking the ministry’s public reference to puberty blockers. It appears that the drafting was too far advanced for this intervention.

Like its international counterpart WPATH, PATHA is a hybrid professional/trans activist lobby; the gender-affirming treatment approach promoted by PATHA is controversial.

PATHA’s 2018 treatment guidelines claim that, “Puberty blockers are considered to be fully reversible and allow the adolescent time prior to making a decision on starting hormone therapy.”

From 2020 until the September 2022 change in wording, the ministry’s webpage linked to this PATHA document. It was not clear who had requested the link, according to an email exchange within the ministry last August.

“The Ministry of Health has not gone through any formal process to review or endorse the PATHA guidelines,” a spokesperson said recently.

“ ‘[Trans hormone suppression] was sold as a kind of pause button, allowing you to put puberty on hold while you can think about whether you are really in the wrong body. That’s the theory.’ Patrik Vankrunkelsven, director of the Belgian Center for Evidence-Based Medicine, strongly questions that so-called ‘reversibility’ ”—news report, VRT

“ ‘We now see that 98 per cent go through with the transition [after starting on blockers]. Claiming that it is reversible, or a pause button, is just not right. Puberty inhibitors are a trap that kids get stuck in, denying them the chance to change their mind’.”

Systematic

Apart from the evidence brief to be published on the ministry’s website, deputy chief science advisor Dr Sayali Pendharkar suggested in the August-September 2022 email exchange that, “We should undertake a formal systematic review and meta-analysis on evidence-to-date on puberty blockers similar to UK, Sweden, Finland.”

(This discussion of NZ’s own systematic review was put off, however, with the officials concentrating on the immediate task of updating the website reference to blockers and commissioning the medium-term evidence brief.)

In an email last September, Dr Pendharkar also advised a “conversation with PATHA to update their guidelines (dated 2018) particularly in light of the NICE review.”

The 2020 review by the UK National Institute for Health and Care Excellence (NICE) contributed to the review of dysphoria care led by paediatrician Dr Hilary Cass.

In its search of the medical literature for evidence on puberty blockers, NICE found 525 references, but after screening for quality, only nine studies were eligible for review. Even with these studies, the results were rated as “very low certainty”.

A systematic review is the gold standard for assessing the quality of evidence while minimising bias, and would carry more weight than an evidence brief.

Sweden’s review led to a new, more cautious policy on gender medicine in 2022, as well as a paper published last month in the journal Acta Paediatrica, with corresponding author Professor Mikael Landén of the Karolinska Institute and University of Gothenburg.

“Against the background of almost non-existent long-term data, we conclude that GnRHa [puberty blocker] treatment in children with gender dysphoria should be considered experimental treatment rather than standard procedure,” Professor Landén said in a media statement.

“This is to say that treatment should only be administered in the context of a clinical trial under informed consent.”

Note: GCN sought comment from PATHA