Not ethical

Puberty blockers have lost the support of Italy's official advisers on bioethics

Photo by Cassidy Dickens on Unsplash

The National Bioethics Committee of Italy has recommended that puberty blockers be restricted to independent clinical trials, expressing doubt about the capacity of minors to give informed consent and stressing the role of psychological methods as first-line treatment.

“In view of the uncertainty about the risk/benefit ratio of blocking puberty with [the drug] triptorelin, the [committee] hopes that prescriptions will only be made within the framework of trials promoted by the Ministry of Health,” said the committee, an advisory body known by its Italian acronym CNB.¹

On Monday, the CNB issued a 20-page report in response to a December 2023 request from the ministry for an ethical opinion on the use of puberty blockers for gender dysphoria. The ministry’s written request noted the shift to caution in Nordic countries, and the interim findings of England’s Cass review.

The opinion of the CNB, endorsed by a “large majority” of the expert members, cited “insufficient” scientific data on the use of puberty blockers with gender-distressed minors and said it was up to the ministry to fund independent studies of higher quality.

The CNB also found that data on puberty blocker use provided by Italy’s regions was “very poor and fragmentary.” It said all clinical decision-making should be “thoroughly documented” and a national registry should be set up to track treatment.

“If the data contained in the English Cass review caused a stir due to the sensational increase in the number of admissions to the gender dysphoria treatment centre at the Tavistock clinic, which had risen from 208 cases in 2011 to over 5,000 in 2021, the Italian context is even more surprising due to the absolute lack of data,” the Italian parents’ group GenerAzioneD said in a commentary on the CNB opinion.²

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Video: England’s Cass review has had an international impact, as well as inspiring an indefinite ban on puberty blockers in the UK, discussed here by Naomi Cunningham of the UK group Sex Matters, which defends biological reality

Safeguards ignored

Meanwhile, the Italian Medicines Agency (AIFA) is yet to report following its own puberty blocker review.³

Blockers for gender dysphoria are provided free of charge under Italy’s National Health System following a determination by the AIFA in 2019. The AIFA had relied on a 2018 opinion by CNB that this off-label drug use was ethical, with certain safeguards.⁴

Those safeguards—including psychiatric support—were reportedly not being followed at the gender clinic of Florence’s Careggi hospital, according to Senator Maurizio Gasparri, who last December raised questions about rushed medical treatment.

An audit of the clinic by Ministry of Health inspectors in January led to the opening of a criminal investigation. In March, a roundtable of Italy’s health and family ministries was set up to develop new guidelines for gender dysphoria treatment, starting with puberty blockers.

Given that blockers are still AIFA-approved and funded, the new more cautious position of the CNB, at this point, appears to be a recommendation only, according to an Italian medical writer who goes by the pseudonym Agata Rossi.

“I imagine an announcement from AIFA regarding a change in prescribing guidelines will follow soon,” she told GCN.

“However, as there is now ‘official’ concern regarding the use of puberty blockers for gender dysphoria due to the dearth of evidence, it would put any paediatric endocrinologist in an untenable position, from an evidence-based medicine point of view, should they prescribe them—especially as psychological support including psychiatry is now recommended.”

“Girls with gender dysphoria in Belgium can have their breasts removed from the age of 16. We do not realise how exceptional this is in the European context. Outside of Belgium, only the Netherlands allows this. In Belgium, there is also no legal age limit for administering testosterone or oestrogen to children with gender dysphoria. This happens from the age of 16, and sometimes even earlier. At much younger ages, such children in Belgium can also obtain ‘puberty blockers’.”—Joren Vermeersch, opinion article, De Standaard, 16 December 2024

“[Puberty blockers] are GnRH analogues: chemical substances that halt the natural production of male and female hormones in children’s bodies. They are administered to children with gender dysphoria to prevent their bodies from naturally developing sex characteristics, pending a surgical transition… In 2022, 684 children aged 9 to 17 were prescribed this [puberty blocker] treatment [in Belgium], a 60 percent increase compared to 2019.

“GnRH analogues were not developed for this purpose. They were approved as medication for temporarily delaying puberty in children who begin puberty at an unhealthily early age, and for treating endometriosis and hormone-sensitive cancers like prostate cancer and certain breast cancers. In other words, they were designed to remedy real and dangerous physical conditions. Today, they are prescribed long-term in Belgian gender clinics to physically healthy children. This is done off-label, contrary to the official instructions.”

Gold standard

Italy’s updated CNB opinion said the gold standard for drug approval studies was a double-blinded, randomised controlled clinical trial. There were “several solutions” to the dilemma of blinding, whereby children given a placebo on the brink of puberty would soon realise they were not part of the blocked group.

The CNB said the proposed research was “not an invitation to increase prescriptions in order to support a trial, but to limit the use of the drug, which is unfortunately already legitimised, as much as possible, by only including it in rigorous studies and well-defined therapeutic paths.”

“Even where [puberty blocker] administrations take place outside trials, that is, in the event of a refusal of consent or following specific clinical evaluations by the doctor, which must always be documented, the CNB recommends that the same criteria be followed as for trials, and that in any case all data always be forwarded to a dedicated registry.”

England’s final Cass report, issued in April, was a point of reference in the expert hearings that shaped the majority opinion of Italy’s bioethics committee.

The CNB majority cast serious doubt on the capacity of minors to consent to puberty blockers.

“We believe that the decision to start a gender transition early risks predisposing a minor to persist in the transition process,” the majority opinion said.

“We also think that a child, especially one in a state of distress and with significant co-morbidities such as those often associated with gender dysphoria, is unlikely to be fully aware of the consequences of gender transition for his/her future life: Many of the changes envisaged and undertaken are irreversible, and the disruption of fertility is often unavoidable.

“Consequently, under these conditions, informed consent risks being reduced to a merely formal act, which makes it ethically unacceptable to allow minors to undertake gender transitions.

“[And] the lack of certain data on the risk/benefit ratio of triptorelin for gender dysphoria makes the situation even more problematic with respect to one of the cardinal principles of bioethics: First, do no harm.”

The majority opinion also noted that puberty blocking had been allowed on the questionable assumption that it was reversible and gave more time for diagnosis, whereas the data showed that almost all the children started on blockers went on to cross-sex hormones supposed to be taken lifelong.

The CNB majority recommended that puberty blockers “should only be prescribed after psychological therapies/psychosocial and possibly psychiatric interventions have failed.”

These non-invasive interventions were necessary before, during and after puberty blockers; and a multidisciplinary team should evaluate and follow-up patients, the majority said.

“We have heard firsthand from colleagues (both in bioethics and philosophy) that while they think the issues surrounding sex, gender, and health care are interesting and important, they are unwilling to engage with them publicly out of fear of social and professional opprobrium”—Philosophers Alex Byrne and Moti Gorin, book chapter ‘A Deafening Silence: Bioethics and Gender-Affirming Healthcare,’ forthcoming

“The fear is palpable and manifests in various ways: as supportive but furtive asides over drinks at conferences; in confidential, supportive emails containing subtly apologetic admissions that the author feels uncomfortable making their agreement known publicly; as nervous requests from colleagues about what they might expect from students or administrators were they to include readings by gender-critical authors on their syllabi; as colleagues’ willingness to read and comment constructively on paper drafts followed by hesitation about and in some cases outright unwillingness to accept public recognition for their efforts (for example, in the acknowledgments section of the published paper).

“These anecdata are not exactly the horrors of the gulag, but nevertheless are symptoms of an unhealthy intellectual climate.”

Lights on

The report of Italy’s CNB includes a dissenting statement by Maurizio Mori, professor of moral philosophy and bioethics at Turin University, who argued for continued use of puberty blockers in line with the old CNB opinion from 2018.

His dissent cited the “right to self-realisation” of minors, claimed that blockers reduced the risk of suicide, and suggested that any talk of psychiatric intervention in gender dysphoria entailed “pathologisation” and “stigma.”

“This pathologisation of interventions in gender dysphoria does not correspond to the equality of an ethic appropriate to high criteria of civilisation,” he said.

He disputed the relevance of the Cass report, citing a journal article characterising it as an exercise in “cis-supremacy.”

“In the UK, it appears that there has been a 4,000 per cent increase in referrals to the extent that services have had to cease operations. Here, the situation is different and no ‘trans epidemic’ is expected,” he said.

In 2018, writing in defence of the “balanced and wise” CNB opinion endorsing puberty blockers, Professor Mori dismissed any suggestion that chemical interruption of a normally timed puberty went against nature.

He drew a parallel between puberty blockers and “electric light [which] illuminates the night and in so doing, creates new opportunities for human life, without at all upsetting the natural order of light/darkness.”

1. Il Comitato Nazionale per la Bioetica (CNB).

2. In October, parents from GenerAzioneD had a private audience with Pope Francis where they shared their concerns about the increasing number of children with gender distress and the risks of the “affirmation-only” response.

3. L’Agenzia Italiana del Farmaco (AIFA).

4. The only dissenting voice in 2018 was Assuntina Morresi, an associate professor of physical chemistry at the University of Perugia.