Genspect 2nd submission of concerns to the World Health Organisation (WHO) regarding the development of a guideline on the health of trans and gender diverse people

Genspect is an international organisation that promotes a healthy approach to sex and gender. Our organisation includes professionals, trans people, detransitioners and parent groups who work together to advocate for a non-medicalised approach to gender diversity. Our vision is to move beyond a medical understanding of gender identity and gender distress that typically leads to invasive medical interventions, and toward a deeper understanding of gender and identity. We believe that there are many routes that may lead to the development of distress over an individual’s sex and gender. Equally, there are just as many routes out of such distress.

On the 5^th of January 2024 Genspect submitted our concerns to the WHO regarding aspects of the announcement of the development of a WHO guideline on the health of trans and gender diverse people. On the 15^th of January, the WHO responded to feedback from Genspect, and other communities and stakeholders by extending the deadline for feedback, and providing an FAQ document.

Rather than alleviating Genspect’s concerns, the WHO’s response and FAQs have compounded them.

Genspect contends that the proposed guideline’s scope and the foundational elements the WHO intends to build upon are inherently flawed, posing a potential risk that the guideline may not effectively benefit its intended end users.

The WHO states that one of the five areas that the WHO guideline on the health of trans and gender diverse people will focus on is “provision of gender-affirming care, including hormones relating to adults”.

One of key issues concerning Genspect is that the WHO has already issued a guideline that discusses how access should be expanded to gender-affirming hormones to individuals who desire them, before there is robust evidence that gender-affirming hormones themselves are beneficial and without transparency on the low quality of the underlying evidence. This is counterintuitive; quality evidence demonstrating the benefits of an intervention should precede the issuance of a WHO guideline endorsing the expansion of access to this intervention. Systematic reviews are the foundation of a trustworthy guideline (Block, 2023). End-users cannot provide informed consent if they are not informed about uncertainties and limitations of the evidence underpinning the intervention they are consenting to (Levine et al., 2022).

The FAQs issued by the WHO state that the “proposed guideline builds on more than 10 years of WHO work on trans and gender diverse people’s health” and links to 3 items:

1. The International Statistical Classification of Diseases and Related Health Problems (ICD) 11^th edition information about gender incongruence and transgender health.
2. Consolidated guidelines on HIV prevention, testing, treatment, service delivery and monitoring: Recommendations for a public health approach  (World Health Organization, 2021).
3. 2022 WHO guideline on self-care interventions for health and well-being (World Health Organization, 2022)

Gender-affirming care, including hormones is referenced in these three items, but critically none of the three recognise the significant professional disagreement worldwide regarding gender-affirming care (Block, 2023) and the mounting evidence of significant numbers of detransitioners who feel they were harmed by gender-affirming care (D’Angelo, 2018; Expósito-Campos, 2020; Exposito-Campos & Roberto, 2021; Hall et al., 2021; Irwig, 2022; Jorgensen, 2023; Littman, 2021; Littman et al., 2023; Marchiano, 2021; Vandenbussche, 2021; Withers, 2020).

Two studies examining detransitioner experiences report that detransitioners who transitioned relatively recently felt they had been rushed to medical gender-affirmative interventions with irreversible effects, often without the benefit of appropriate, or in some instances any, psychological exploration (Littman, 2021; Vandenbussche, 2021).

Another recently published study (co-authored by Genspect Director Stella O’Malley), explored the experiences of 78 detransitioners who began transitioning around 17 years of age and identified as transgender for an average of five years (Littman et al., 2023). 62.82% of participants in the study had taken hormones. The authors reported “Although most participants recalled receiving information about the risks and benefits of cross-sex hormones, a majority did not feel the information they were provided about risks was adequate”. Most participants had obtained cross-sex hormones from clinical practices using the “informed consent” model of care, but even under this model many believed that the information provided was not adequate: 66.7% felt they were inadequately informed about risks and 31.3% felt they were inadequately informed about benefits (Littman et al., 2023). Only one participant reported that a clinician provided information about alternatives to hormones, 75% reported they received inadequate information about hormones.

More and more legal cases of detransitioners who feel that they were harmed by the care that was provided to them are emerging. A wide range of detransitioners’ stories are available from Genspect: our annual Detrans Awareness Day; detransitioner interviews on our website (e.g. Sinead Watson, Laura Becker, Lukasz Sakowski, Ethan, Chris, Steven A. Richards, M); and detransitioner stories in the mainstream media (e.g. Ritchie Herron, Chloe Cole, Keira Bell) and at our Bigger Picture conferences in Killarney, Ireland in April 2023 and Colorado, USA in November 2023. Genspect offers funding for therapy for detransitioners with our Beyond Trans initiative and through this programme our team has significant insight into the issues facing this minority within a minority.

The recent emergence of an increasing number of reports from detransitioners who feel they were harmed by gender affirming care, demonstrates the need to improve the strength of the evidence base and public information around healthcare for people experiencing gender distress, many who have accessed gender affirming care in clinical settings have had negative experiences.

The FAQs issued by the WHO on 15^th January recognise that “the evidence base for children and adolescents is limited and variable regarding the longer-term outcomes of gender affirming care for children and adolescents”. What is remarkable is that the WHO did not recognise that the evidence base on outcomes for gender affirming care including hormones for adults is also limited and variable. 

The 2022 WHO guideline on self-care interventions for health and well-being (cited by the WHO as work that the proposed guideline is built upon), introduces “Self-administration of gender-affirming hormones for transgender and gender-diverse individuals” as a new key consideration and states “The principles of gender equality and human rights in the delivery of quality gender-affirming hormones are critical to expanding access to this important intervention“ (p. xxii). The 2022 WHO self-care guideline also states that “Health systems must be designed to support individuals to seek the interventions they desire in affirming their gender identity” (p. 54) and goes on to describe gender-affirming hormone therapy as a gender-affirming intervention.

These statements give readers of the self-care guideline the impression that there must be well established robust empirical evidence of the benefits of gender-affirming hormone therapy – otherwise why would the WHO be issuing a guideline that says individuals who desire it must be supported by health systems and that access must be expanded to this important intervention?

Evidence of the benefits of gender-affirming hormones is not robust.

A 2018 systematic review and meta-analysis on the impact of both gender-affirming hormones and surgeries on quality of life for adults found only two studies out of 29 with low risk of bias, 20 had moderate risk of bias and 7 had a high risk of bias (Nobili et al., 2018). Only one of the 29 studies recorded longitudinal^[1] data relating to quality of life for gender-affirming hormones, this longitudinal study only followed participants for one year after treatment initiation (Manieri et al., 2014). Longitudinal studies evaluate long-term effects of an intervention and are particularly important for interventions that have permanent irreversible effects. 

A 2021 systematic review of evidence gender-affirming hormone therapy funded by the World Professional Association of Transgender Healthcare (WPATH) found that the strength of evidence that gender-affirming hormones improve quality of life, depression and anxiety for transgender people is low, and found insufficient evidence to draw any conclusion of the impact of gender-affirming hormones on death by suicide of transgender people (Baker et al., 2021). The image below shows the strength of evidence for each outcome measure reviewed by Baker et al. (2021) as reported in their peer reviewed systematic review.

Gender-affirming hormone therapy causes irreversible changes, and has been associated with the risk of serious adverse health effects including: bone health complications (Boogers et al., 2023), impacts on cardiovascular health (Masumori & Nakatsuka, 2023; Nota et al., 2019), endocrine complications (Islam et al., 2022), fertility complications (Bailie et al., 2023) and other biomedical risks and uncertainties e.g. kidney function (Millington et al., 2022).

Further examination of the 2022 WHO self-care guideline shows that the section on key considerations for use of self-administration of gender-affirming hormones for transgender and gender-diverse individuals examined the following PICO^[1] question: “Should self-administration of gender-affirming hormones be made available in addition to health worker administration?”.  Note the framing of the question suggests that making gender-affirming hormones available is already a given – what is being examined is just whether self-administration of gender-affirming hormones should be made available. The self-care guideline reported that a systematic review was carried out to answer this question and that “The extant literature was reviewed in three areas relevant to this question: effectiveness of the intervention, values and preferences of end users and health workers, and cost information”.

What may not be clear to anyone who reads the self-care guideline and does not read the underlying systematic review, is that the systematic review did not assess whether gender-affirming hormones themselves have beneficial outcomes for end users – it only reviewed the “evidence for self-administration compared to health worker-administration of gender-affirming hormones” (p.82, Kennedy et al., 2022).

With regard to the question of whether gender-affirming hormones themselves have beneficial outcomes for end users, the Kennedy et al. (2022) systematic review states that “Gender- affirming hormone therapy has been defined as medically necessary by the World Professional Association for Transgender Health” and refers to the Baker et al. (2021) systematic review (referred to earlier) that found low strength of evidence that gender-affirming hormones improve quality of life, depression and anxiety.

Regarding the “medically necessary” claim, Kennedy et al. (2022) cited the WPATH Position Statement on Medical Necessity of Treatment, Sex Reassignment, and Insurance Coverage in the U.S.A. issued in 2016 that states: “The current Board of Directors of the WPATH herewith expresses its considered opinion based on clinical and peer reviewed evidence that gender affirming/confirming treatments and surgical procedures, properly indicated and performed as provided by the Standards of Care [WPATH Standards of Care version 7 (SOC7)], have proven to be beneficial and effective in the treatment of individuals with transsexualism or gender dysphoria”.

Note that this WPATH 2016 opinion that claimed to be based on peer reviewed evidence was issued five years before the Baker et al. (2021) systematic review that was funded by WPATH, that found the strength of evidence that gender-affirming hormones improve quality of life, depression and anxiety for transgender people is low, and found insufficient evidence to draw any conclusion of the impact of gender-affirming hormones on death by suicide of transgender people.

The World Professional Association for Transgender Health (WPATH) Standards of Care Version 7 (SOC7) are not evidence-based. The WPATH website clearly states that Standards of Care Version 8 (SOC8) is the first version being developed using an evidence-based approach. This means that all preceding WPATH Standards of Care including SOC8’s predecessor SOC7 (referred to by the WPATH Board of Directors in their 2016 Position Statement that defined gender -affirming treatment as medically necessary) were not developed using an evidence-based approach. Furthermore, a systematic review of clinical guidelines for trans/gender diverse people found that SOC7 “contains no list of key recommendations or auditable quality standards” (p.6) and many recommendations are “flexible, disconnected from evidence and could not be used by individuals or services to benchmark practice” (p.8, Dahlen et al., 2021). The Dahlen et al. (2021) review included 12 guidelines in total, and reported whether reviewers would recommend the guideline be used and gave each guideline an overall assessment. Five out of six reviewers said they would not recommend SOC7 be used, one said it should be used if modified, SOC7 received an overall assessment of 31% (Dahlen et al., 2021). For comparison three WHO guidelines – all for HIV treatment and prevention – were included in the Dahlen et al. (2021). review and for all three a majority of reviewers said they would recommend the guideline be used, and the three WHO guidelines received overall assessments of 83%, 72% and 94% respectively.  

It should be noted that, despite claims by WPATH that SOC8 was developed using an evidence-based approach, serious flaws have been identified with SOC8 that undermine this claim (Block, 2023; Dahlen et al., 2022; Sinai, 2022). Trustworthy guidelines are expected to be transparent about all commissioned systematic reviews including how many reviews were done and what the results were, but neither were made clear in SOC8 recommendations, and several instances have been noted in which the strength of evidence used to justify a SOC8 recommendation was at odds with the findings of WPATH’s systematic reviewers (Block, 2023). Other issues with SOC8 seriously undermine WPATH’s trustworthiness and credibility including: the sudden removal of all age requirements for medicalization and surgical procedures days after its publication (despite there being no new evidence to support that recommendation); the inclusion of a chapter on eunuchs that includes a recommendation to “affirm” and refer for surgical castration in order to prevent users attempting self-castration (Coleman et al., 2022; Sinai, 2022). A chapter on ethics, that was included in the draft version of SOC8, was deleted from the final version, when it is ethics and empirical evidence – rather than end users threatening harm to themselves should treatment be withheld – that should guide every medical treatment.

These issues raise serious questions about WPATH’s trustworthiness and credibility.

The WHO are recognised globally as professionals committed to integrity and excellence in health, with a steadfast commitment to science and are trusted to care for the world’s health, it is therefore vitally important that the evidence underpinning guidelines issued by the WHO can be trusted.  The fact that the WHO has already issued a guideline that advocates for the expansion of access to gender-affirming hormones that was developed with underpinning evidence of benefits and harms based upon a WPATH opinion and a systematic review that found low quality evidence is gravely concerning.

The WHO self-care guideline (that the WHO state the proposed guideline is built upon) notes that the Guideline Development Group (GDG) for the self-care guideline identified an urgent need for further research on the self-administration of gender-affirming hormones. Unfortunately, the GDG did not identify an urgent need for further research on the benefits and harms of gender-affirming hormones themselves and did not recommend that end users should be made aware of the low-quality evidence-base. To be fair to the self-care guideline GDG, according to the WHO Handbook for Guideline Development (World Health Organization, 2014) the GDG’s powers are limited as the GDG merely finalizes the scope and key questions of the guideline after the Guideline Steering Group (GSG) has already drafted them, and so the GDG may have been constrained from expanding the scope to ask this vital question. 

The WHO announced the scope of the proposed guideline for healthcare for trans and gender diverse people on 28th June 2023 and said that meetings would be held with the GDG in October and November 2023. The WHO has also said that the proposed guideline builds on more than 10 years of WHO work on trans and gender diverse people’s health. As Genspect highlighted in our 5^th January 2024 feedback to the WHO, the scope and GDG membership are heavily biased towards medical gender-affirming care and does not recognise the significant professional disagreement regarding gender-affirming care and the perspectives of professionals who are critical of gender-affirming care to balance the gender-affirming viewpoint and provide diverse perspectives (e.g. Genspect, CAN-SG, SEGM, Therapy First).  And as we have shown here the evidence base underpinning some of the work already done by the WHO on trans and gender diverse people’s health appears to have pre-emptively skipped ahead to recommending expanding access to care before identifying via a thorough examination of the evidence exactly what type of care that access should be expanded to.

At this late stage in the guideline development process based upon all the work the WHO says this guideline builds upon, we believe that replacing a few members of the GDG to bring in detransitioner perspectives and perspectives of others critical of gender affirming care will likely have little effect on the recommendations of the proposed guideline as the GDG may have already agreed (as other GDGs have agreed for other guidelines) that if any decisions require a vote, the vote would only need to be carried by a 60% majority and so if the scope has already been finalized new members in the GDG are unlikely to be able to change it. 

We also believe that creating an external review group that includes detransitioner perspectives and perspectives of others critical of gender affirming care will also likely have little effect on the recommendations of the proposed guideline at this stage as the Who Guideline Development Handbook says that the role of the external review group is to review “the final guideline, its role is to identify any errors or missing data and to comment on clarity, setting-specific issues, and implications for implementation – not to change the recommendations formulated by the GDG. If external review group members have major concerns regarding one or more recommendations, the GDG should meet to discuss and address them.” (p.29, World Health Organization, 2014)”. Since we believe changing some members of the GDG to reduce bias and creating an external review group that balances different perspectives are likely to have very little power to alter the direction of this guideline at this stage Genspect believe a more fundamental course correction is required.

Genspect urges the WHO to:

1. Commit to their principles of integrity and excellence in health and go back to first principles  revisiting and revising the scope of this proposed guideline based upon the feedback received from ourselves and other groups concerned about the current direction of the guideline.
2. Commit to science and the principles of evidence-based medicine regarding any interventions for trans and gender diverse people that the WHO is considering recommending rather than relying upon other groups to provide their opinion of the evidence.
3. Where research is lacking, recommend research be carried out urgently and until strong research exists make it known to end users that research is lacking.  
4. Endeavor to ensure that the guideline development process in this controversial and highly sensitive area is as transparent and balanced as possible to reassure all perspectives that their views are being fairly represented.

The World Health Organization is trusted to care for the world’s health. Given the considerable controversy in this field, we urge WHO to carefully consider their current approach to the development of a guideline on the health of trans and gender diverse people.

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[1] In a longitudinal study researchers gather data from people who received a treatment over a prolonged period of time

[1] PICO stands for Population, Intervention, Comparator and Outcome and is used to facilitate the identification of relevant information when researching an intervention (Aslam & Emmanuel, 2010)

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