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SEGM

@segm_ebm

Dec 16

🚨 Italy's National Bioethics Committee (CNB) just updated its stance on puberty blockers (PB) for gender dysphoria. The November 2024 guidance states that PBs should only be provided after mental health internvetions failed, and only in the context of proper research trials./1

The Italian National Bioethics Committee's (CNB) key recommendations are:

* Puberty blocker prescriptions for gender dysphoria should occur only after the documented failure of psychotherapy or psychiatric interventions.

*All clinical assessments must be multidisciplinary, and decisions thoroughly documented.

*Clinical trials should follow the double-blind, randomized, controlled model, ensuring robust data.

*Use of puberty blockers outside clinical trials for this indication must adhere to the same rigorous criteria, with all data transmitted to a national registry. /2

The translated text, abstract (machine-translation):

The answer to the question posed by the Ministry of Health concerns strictly and solely the use of the drug in the context indicated by the question.

As a result of expert hearings and the evaluation of available literature, the CNB highlighted, in general, the insufficiency of scientific data on the use of puberty blockers and the need to strengthen them. Consequently, the CNB stresses the need for the Ministry of Health to take charge of funding independent clinical studies aimed at obtaining decisive data on the efficacy and risks of drug administration, of higher quality than those already carried out, which do not appear adequate to the objective.

From an ethical perspective, regarding trial design, the CNB recalls that the gold standard for clinical trials for drug approval is a double-blind, randomized controlled clinical trial. The CNB recommends that clinical evaluations should be multidisciplinary, and the prescription of tryptorelin should only occur following a finding of ineffectiveness of a psychotherapeutic/psychological, and possibly psychiatric, course. The decision-making process should always be thoroughly documented in all its steps.

Given the uncertainty about the risk-benefit ratio of triptorelin puberty blockade, the CNB would like to see prescriptions only within the scope of trials sponsored by the Ministry of Health.

Even where administrations occur outside of trials, that is, in the case of denial of consent or as a result of specific clinical evaluations by the physician that should always be documented, the CNB recommends that the same criteria indicated for trials be followed, and that in any case all data always be submitted to a dedicated registry. This is also in light of the fact that, at the moment, data on the use of tryptorelin reported by the regions (i.e., on its use during the period 2019-2023) are lacking and fragmentary.

The opinion was approved by a large majority of those present, with 4 of the non-voting members joining, and was accompanied by one dissenting note, one abstention note, and two explanations of vote, one of which was signed by 15 members, and the other by 7.
/3

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SEGM

@segm_ebm

Oct 31

A new investigation by @BMJ_latest examines the influence of top @WPATH officers over the development of new @WHO TGD (trans-identified and gender diverse) clinical practice guidelines for adults, which includes the vulnerable subgroup of young adults. /1 bmj.com/content/387/bm…

.@SEGM_EBM has repeatedly raised concerns about the robustness of the WHO guideline process, as @writingblock reports. /2
segm.org/world-health-o…

These concerns include a rushed guideline development process, biased panel composition, unmanaged conflicts of interest, and lack of transparency. /3
segm.org/WHO-TGD-Guidel…

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SEGM

@segm_ebm

Oct 22

The recent criticism of the Cass Review, misrepresented as "Yale critique," is not a genuine scientific effort but an attempt to influence U.S. litigation in youth gender medicine, new BMJ peer-reviewed paper by leading UK medical professionals finds. /1

segm.org/Cass_Integrity…

Last July, the so-called Integrity Project posted a "critique" of Cass Review. The authors, including notable gender medicine activists McNamara, Olson-Kennedy & Turban, alleged that the Cass Review is invalid as it "misuses data and violates its own evidentiary standards." /2

The Integrity Project’s “critique” of the Cass Review follows the same pattern established in the Project's earlier attacks on other evidence appraisals efforts. The Integrity Project's go-to tactic is to discredit the work by labeling it "misinformation" & "pseudoscience." /3

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SEGM

@segm_ebm

Jul 19

A new study of insurance records from Germany suggests that the diagnosis of gender dysphoria in youth aged 5-24 is usually not permanent. Over 60% of youth diagnosed with "Gender Identity Disorder" no longer have the diagnosis after 5 years. /1

segm.org/gender-dysphor…

Like other Western countries, Germany has experienced a rapid rise of gender dysphoria in young people in the last decade. Adolescent females have the highest prevalence of gender dysphoria, increasing 12-fold in a decade. /2

Besides the low diagnostic stability of the diagnosis of gender dysphoria in adolescents/young adults, other notable finding are that young adults are similarly affected as adolescents, and that overall gender dysphoric youth have higher rates of mental health co-morbidities./3

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SEGM

@segm_ebm

Jun 20

The World Health Organization @WHO just announced its updated plans for the transgender guidelines. The new deadline to comment is July 5th. This timing is challenging, as it coincides with the UK & French elections and the US Independence Day celebrations.

As stated previously, the upcoming guideline will address the care for gender-dysphoric adults, who, like all patients, deserve access to evidence-based care informed by evidence-based clinical practice guidelines. The Cass Report identified the group of gender-dysphoric young adults as a key vulnerable group. England has initiated a Cass-style inquiry into the care for this vulnerable population.

In this context, proceeding with developing guidelines that bypassed systematic evidence reviews, and instead will rely on WHO's previous HIV-focused recommendations that promote wide access to hormones (as WHO's documentation suggests), is alarming.

/1

who.int/news/item/20-0…

The prior guideline development group (GDG) composition was called out for being biased. A cursory review of the updated GDG suggests that members with conflicts of interests will continue to serve on the GDG, but several new members have been added. /2
who-decides.org

Importantly, no process changes have been announced, despite the profound problems in the process we wrote about:/3
segm.org/WHO-TGD-Guidel…

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SEGM

@segm_ebm

May 10

The 128th German Medical Assembly 2024 just passed 2 resolutions: to restrict puberty blockers, cross-sex hormones, and surgeries for gender-dysphoric youth under 18 to controlled clinical trials; and to restrict the self-id laws to those over 18. This is a major development. /1

The first resolution focuses on "gender-affirming care" for youth. The resolution, upvoted by the majority of physician delegates, stated:

"The 128th German Medical Assembly 2024 calls on the Federal Government to only permit puberty blockers, sex-change hormone therapies or gender reassignment surgery in under 18-year-olds with gender incongruence (GI) or gender dysphoria (GD) in the context of controlled scientific studies and with the involvement of a multidisciplinary team and a clinical ethics committee and after medical and, in particular, psychiatric diagnosis and treatment of any mental disorders.
The therapy results of any interventions of this kind must be followed up sociologically, medically, child and adolescent psychiatrically, socially and psychologically over a period of at least ten years and the evaluation results incorporated into the revision of the
'Guideline on gender incongruence and gender dysphoria in childhood and adolescence:
diagnosis and treatment.' "

The justification stated:

"The current medical evidence clearly and unambiguously states that puberty-blocking drugs
(PB), opposite-sex hormone treatments (so-called cross-sex hormone administration [CSH]) and gender reassignment surgery (e.g. a mastectomy) do not improveGI/GD symptoms or mental health in minors with GI/GD. These are irreversible interventions in the human body in physiologically primarily healthy minors, who cannot give informed consent in the absence of evidence for such measures. Such interventions also
influence the human psyche, especially in minors during their development.

Most minors who receive PB and CSH later wish to have sex surgery. The use of interventions such as PB or CSH administration is a form of experimental medicine on children, which is very likely to be followed by interventions in the child's body, such as the amputation of the breast or penis, and which result in the loss of reproductive capacity and a reduction in the ability to experience sex, including anorgasmia.

A child or adolescent is not in a position to decide for themselves - without medical advice and parental consent - on the use of PB or CSH before the end of puberty and the physical maturation process and before the age-typical age-role conflicts or body image disorders of puberty have been overcome, especially in the absence of medical evidence for their
respective clear and sustainable benefits in this very population.

Gender or sex dissatisfaction is most common at around the age of eleven, and the frequency of this
symptomatology then decreases with age. The clear majority of minors show no persistent gender or sex dissatisfaction over the course of their lives.

The administration of PB, CSH and the performance of gender reassignment surgery must not be made dependent solely on the will of a developing child or adolescent. Given the existing evidence on the treatment of GI/GD, concern for the child's welfare must
prevail. " /2

The second resolution dealt with self-id laws and resolved that minors should not be allowed to "self-identify" into a chosen sex without a prior specialist child and adolescent psychiatric diagnosis and consultation.

It resolved:

"The 128th German Medical Assembly 2024 calls on the Bundestag to amend the Self- Determination Act to the effect that under-18s may not be permitted to provide or have provided information on their gender and marital status in the personal register without prior specialist child and adolescent psychiatric diagnosis and consultation".

The justification stated:

On 12.04.2024, the Bundestag passed the law on self-determination with regard to gender registration (so-called Self-Determination Act). It provides for the repeal of the Transsexuals Act (TSG), which has been in force since 1981. Contrary to the recommendation of the German Medical Association, the change of gender entry and first names for "transgender" as well as "non-binary" and intersex persons will be regulated in a joint administrative procedure, i.e. no longer in two different laws, each with different requirements, as was previously the case. It was decided that, in future, every person who has reached the age of 14 will be able to undergo a transsexual transition. The child should be able to obtain a legally binding declaration from the registry office that the information on their gender and marital status in the register of persons is replaced by another designation or deleted - unconditionally, i.e. without any examination of the seriousness, truthfulness and permanence of the wish and without an obligatory psychiatric-psychotherapeutic consultation. For a person who is legally incapable or has not yet reached the age of 14, their legal representatives should make the declaration. In the event that the latter refuse to do so, the declaration should be made by the family court as an alternative, provided that the change of gender and first names is not contrary to the best interests of the child.

From a medical, sexological and biological perspective, a person's gender is a reality that can be determined on the body and in the vast majority of cases is unambiguous, not freely available, but unchangeable. Gender is biologically binary, and the concept is
separate from that of gender identity. In rare cases, a person's subjectively perceived gender identity deviates from their objectively given physical gender. The Self-
Determination Act attempts to find a solution to the associated internal conflict (gender incongruence) and a problem of primary procedural law by equating the category of gender under civil status law - logically inconclusive - with the psychological construct of
"gender identity". This should be criticized:

-the lack of differentiation between a person's subjective sense of belonging, including the self-categorization derived from this, and their actual physical-biological gender,

-the equation of gender identity and civil status in the official birth register,

-the inadequate differentiation between intersexuality/DSD ("variants of sex development") and transsexuality.

From a medical/psychotherapeutic and sexological point of view, civil status law is not the right instrument to guarantee the self-determination of people affected by gender incongruence, to promote their egalitarian treatment and to protect them from discrimination
in everyday life. " /3

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