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SEGM

@segm_ebm

Feb 4

A new peer-reviewed article examining the criticisms of the Cass Review, just published. The authors found that the primary source of the criticism, a non-peer-reviewed paper published on the Yale Law School website, contains numerous inaccurate and misleading claims.
Link👇/1

The link to the article is below:

/2tandfonline.com/doi/full/10.10…

The authors of the new publication conclude:
"The Cass Review’s careful, balanced investigations and judgments were a comprehensive, evidence-based response to the controversies in this pediatric clinical arena. Recently-published critiques of the Review have contained incorrect or inadequately contextualized claims. Because accurate information about medical interventions is essential to informed consent, it is important to correct errors in potentially influential publications." /3

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SEGM

@segm_ebm

Dec 16, 2024

🚨 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, 2024

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, 2024

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, 2024

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, 2024

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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