Genspect 3rd submission of concerns to the World Health Organisation (WHO) regarding the development of a guideline on the health of trans and gender diverse people
By Genspect
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 5th 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 15th 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. Genspect submitted additional concerns on February 2. On June 20, the WHO opened a new consultation round, adding six members to their Guidelines Development Group (GDG) to enhance expertise in endocrinology, bioethics, mental health, and health policy/service delivery.
While we acknowledge these additions, we remain deeply concerned about the guideline development process. Recent developments in the field reinforce our view that continuing on the current path risks producing unbalanced guidelines not informed by current evidence, potentially damaging WHO’s reputation. Of particular concern is that 10 of the 26 GDG members are associated with the World Professional Association for Transgender Health (WPATH), with several holding or having recently held leadership positions in that organization.
This submission outlines our ongoing concerns, highlights significant new developments in the field, and offers recommendations for ensuring the WHO guidelines are comprehensive, ethically sound, and based on the best available evidence.
Summary of Ongoing Concerns from Previous Submission
In our previous submission, we highlighted several key issues which remain ongoing concerns:
a) Lack of robust evidence supporting gender-affirming interventions for adults:
• A 2018 systematic review by Nobili et al. found only two out of 29 studies with low risk of bias in assessing quality of life impacts of gender-affirming hormones and surgeries for adults. 20 had moderate risk of bias and 7 had high risk of bias.
• Only one of the 29 studies recorded longitudinal data relating to quality of life for gender-affirming hormones, following participants for just one year after treatment initiation (Manieri et al., 2014).
• A 2021 WPATH-funded systematic review by Baker et al. found low-strength evidence that gender-affirming hormones improve quality of life, depression, and anxiety for transgender people, and insufficient evidence to draw any conclusion on the impact on death by suicide.
• Gender-affirming hormone therapy is associated with serious health risks, including bone health complications, impacts on cardiovascular health, endocrine complications, fertility complications, and other biomedical risks such as effects on kidney function (Boogers et al., 2023; Masumori & Nakatsuka, 2023; Islam et al., 2022; Bailie et al., 2023; Millington et al., 2022).
b) Insufficient consideration of detransitioner experiences:
• Studies show many detransitioners felt rushed into medical interventions without adequate psychological exploration (Littman, 2021; Vandenbussche, 2021).
• A recent study of 78 detransitioners (Littman et al., 2023) found:
– 62.82% had taken hormones
– 66.7% felt inadequately informed about risks of cross-sex hormones
– 31.3% felt inadequately informed about benefits
– Only one participant reported receiving information about alternatives to hormones
– 75% reported receiving inadequate information about hormones
c) WHO’s premature endorsement of expanded access to gender-affirming hormones:
• The 2022 WHO guideline on self-care interventions advocates for expanding access to gender-affirming hormones without acknowledging the limited evidence base (World Health Organization, 2022).
• The guideline states health systems “must be designed to support individuals to seek the interventions they desire in affirming their gender identity,” implying well-established benefits that are not supported by current evidence (Kennedy et al., 2022).
d) Concerns about WPATH’s influence and credibility:
• WPATH Standards of Care Version 7 (SOC7) were not developed using an evidence-based approach (Dahlen et al., 2021).
• A systematic review found that SOC7 “contains no list of key recommendations or auditable quality standards” and many recommendations are “flexible, disconnected from evidence and could not be used by individuals or services to benchmark practice” (Dahlen et al., 2021).
• Issues with SOC8 include lack of transparency about commissioned systematic reviews and sudden removal of age requirements for medicalization after its publication (Block, 2023; Dahlen et al., 2022; Sinai, 2022).
• WPATH’s 2016 position statement on medical necessity was issued before their own 2021 systematic review found low-quality evidence (Baker et al., 2021).
e) Limitations of the WHO guideline development process:
• The GDG’s powers are limited in expanding the scope of the guideline, as per the WHO Handbook for Guideline Development (World Health Organization, 2014).
• The scope and GDG membership are heavily biased towards medical gender-affirming care and do not recognize significant professional disagreement regarding gender-affirming care (Block, 2023).
• Adding detransitioner perspectives or creating an external review group at this late stage may have little effect on the recommendations, as the external review group’s role is not to change recommendations formulated by the GDG (World Health Organization, 2014).
The Cass Review
The publication of the final Cass Review report in April 2024 represents a significant development in the field of gender medicine. While primarily focused on youth gender medicine in the UK, its findings have important implications for adult care and the WHO’s guideline development process:
a) Lack of evidence for medical interventions: The review found no robust evidence that “gender affirming” medical interventions improve the wellbeing of gender-distressed children and young people. This absence of evidence in youth populations raises critical questions about the evidence base for adult interventions.
b) Quality of research: The systematic reviews conducted by the University of York for the Cass Review revealed a pervasive issue of poor-quality research in the field. Out of 50 studies on puberty blockers, only one could be classified as high quality. For cross-sex hormones, out of 53 studies, 52 were classified as low or moderate quality. This highlights a widespread problem of poor methodology and potential bias in gender medicine research, which likely extends to studies on adult populations.
c) Circular evidence base and WPATH’s role: Crucially, the Cass Review identified a circular pattern of mutual citation among professional associations producing guidelines for the care of gender distressed individuals, with WPATH playing a central role in this process. The review stated that this created “an apparent consensus on key areas of practice despite the evidence being poor”.
The review demonstrated how WPATH had effectively laundered inadequate evidence for its positions, manufacturing a host of phantom citations that all lead back to the same severely limited and poor-quality research base. This circularity was shown to explain why there has been an apparent consensus on key areas of practice despite the evidence being poor.
This finding is particularly concerning given that ten of the current 26 WHO GDG members are associated with WPATH, with several holding or having recently held leadership positions in the organization. It raises serious questions about the independence and robustness of the evidence base being used in adult gender medicine guidelines, and whether the WHO GDG may be at risk of perpetuating this circular citation pattern in their own guidelines.
d) Overemphasis on medicalization: The Cass Review noted an overemphasis on medicalization at the expense of evidence-based psychological interventions. This observation is highly relevant to adult care, where a similar trend towards rapid medicalization may be occurring. Given WPATH’s historical promotion of medical interventions, the presence of numerous WPATH-affiliated members on the WHO GDG raises concerns about whether non-medical approaches to managing gender distress in adults will be adequately considered.
e) Importance of comprehensive assessment: The review emphasized the need for holistic assessment of individuals presenting with gender distress, including addressing co-occurring mental health issues and neurodevelopmental conditions. This principle is equally applicable to adult care and should be central to the WHO’s guideline development process. However, WPATH’s Standards of Care have been criticized for not adequately emphasizing this comprehensive approach, which again raises concerns about the influence of WPATH-affiliated members on the WHO GDG.
f) Lack of long-term follow-up data: The Cass Review noted a significant gap in long-term follow-up data on individuals who have undergone gender-affirming interventions. This lack of data is a concern for both youth and adult populations and should be addressed in the WHO’s guidelines. However, WPATH has historically downplayed the need for such long-term data, which may influence the WHO GDG’s approach to this issue.
These findings from the Cass Review compound our existing concerns about the WHO guideline development process. The heavy representation of WPATH-affiliated members on the GDG, combined with the Cass Review’s critique of WPATH’s role in creating a circular and poorly-evidenced consensus, raises serious questions about the potential for bias in the WHO guidelines.
Furthermore, the Cass Review’s findings reinforce our earlier concerns about the WHO’s premature endorsement of expanded access to gender-affirming hormones in their 2022 guideline on self-care interventions. The review’s emphasis on the lack of robust evidence and the potential risks of hormonal interventions underscores the need for the WHO to reconsider its position on this issue.
WPATH Files
The WPATH Files, published in March 2024, provide evidence of concerning practices within the World Professional Association for Transgender Health:
a) Disregard for mental health concerns: Clinicians discussed treating patients with serious mental health conditions, including dissociative identity disorder, complex PTSD, and schizophrenia, without adequate consideration of these comorbidities. Some clinicians boasted about performing gender surgeries on patients with major depressive disorder, CPTSD, and even those who were homeless or struggling with basic hygiene.
b) Ignoring physical harms: Members discussed a wide array of physical harms arising from gender medicine without pausing or reconsidering treatment recommendations. These include vaginal pain, atrophy and bleeding, liver tumors in teenagers treated with testosterone, painful orgasms, loss of sexual function, and various complications from surgeries.
c) Promotion of radical interventions: WPATH has advocated for experimental procedures like “nullification” surgery and custom genital surgeries without evidence of benefit. Discussions included consideration of providing amputations to people with body integrity disorder.
d) Approach to detransitioners: The Files reveal a troubling attitude towards detransitioners, with some WPATH members describing them as having “an active agenda against the rights of trans people” and being “problematic”.
e) Informed consent issues: An audio recording acknowledges that children and young people do not have the basic knowledge of biology, fertility, and sexual development to give informed consent to puberty blockers. Despite this, discussions about manipulating insurance codes to secure funding for treatments are evident.
WPATH Alabama Case Documents
Documents from a U.S. lawsuit in Alabama unsealed June 2024 revealed deeply troubling practices by WPATH leadership:
a) Suppression of unfavorable research: WPATH suppressed systematic reviews commissioned from Johns Hopkins University (JHU) that did not support WPATH’s plans to recommend wide access to hormones and surgeries. The documents show that WPATH leadership went to great lengths to prevent the publication of reviews whose conclusions did not align with their agenda.
b) Manipulation of research process: WPATH engaged in a series of actions that severely compromised the integrity of the research process:
• Forced JHU to withdraw completed manuscripts that didn’t meet WPATH’s desired conclusions. This occurred after WPATH learned of two systematic reviews submitted for publication in July 2020, which they found problematic.
• Instituted a new policy requiring WPATH’s approval for all future JHU publications related to the project. This policy was implemented in August 2020, following the withdrawal of the “problematic” reviews.
• Implemented a special checklist for reviews, including criteria such as whether the review positively contributes to promoting transgender interventions and if it includes transgender people as authors. This checklist was part of the new approval process.
• Required two levels of approval – first at the proposal stage (approving anticipated conclusions) and then at the final manuscript stage. This allowed WPATH to control the content at multiple points in the process.
• Reserved the right to alter content while requiring a disclaimer stating WPATH had no influence over the process. This created a situation where WPATH could influence the content while publicly denying such influence.
c) Circular evidence base: The documents reveal a circular pattern of mutual citation among professional associations producing guidelines for the care of gender distressed individuals. This created an “apparent consensus on key areas of practice despite the evidence being poor,” as noted in the Cass Review.
d) Unmanaged conflicts of interest: The documents confirm unmanaged conflicts of interest and activism-driven agendas within WPATH. JHU expressed concerns about unmanaged WPATH conflicts of interest in the process, noting that many SOC8 members were expected to have competing interests.
e) Lack of understanding of Evidence-Based Medicine (EBM): The communications show that the WPATH team did not appear to understand fundamental concepts of EBM, with JHU having to explain key aspects multiple times.
f) Abandonment of systematic reviews for crucial topics: The documents reveal that WPATH abandoned plans for systematic reviews on important topics such as adolescent decisional capacity to consent when it became clear that the data would not support their desired conclusions.
These revelations from the Alabama case documents severely undermine the scientific process and evidence-based medicine principles. They raise serious questions about the objectivity and reliability of WPATH’s Standards of Care and cast significant doubt on the appropriateness of WPATH’s representation on the WHO’s GDG.
The suppression of research and manipulation of the publication process are particularly concerning. They suggest a systematic effort to control the narrative around gender-affirming care rather than allowing for open scientific inquiry and debate. This approach is antithetical to the principles of evidence-based medicine and could lead to guidelines that do not accurately reflect the current state of scientific knowledge.
Recommendations for WHO
In light of the ongoing concerns and significant new developments outlined in this submission, we urge the WHO to take the following actions:
1. Suspend the current guideline development process and conduct a comprehensive, independent review of all available evidence. This review must include the findings of the Cass Review and critically examine the limited and often low-quality evidence base for adult gender-affirming interventions.
2. Address the serious ethical concerns raised by the WPATH Files and Alabama case documents regarding WPATH’s conduct. Given WPATH’s significant representation on the GDG, these ethical lapses cast doubt on the integrity of the guideline development process. Reduce the number of WPATH-affiliated members on the GDG and include a more diverse range of experts, including those critical of rapid medicalization approaches.
3. Re-evaluate the guideline scope to ensure it adequately addresses non-medical approaches to managing gender distress. The current overemphasis on medicalization, as highlighted by the Cass Review and reflected in adult gender medicine, should be balanced with evidence-based psychological interventions.
4. Implement a robust process for evaluating the quality of evidence used in the guidelines. Given the pervasive issue of poor-quality research identified in both youth and adult studies, ensure that only high-quality evidence informs the guidelines’ recommendations.
5. Address the lack of long-term follow-up data on individuals who have undergone gender-affirming interventions. Recommend and prioritize long-term studies to fill this critical gap in knowledge for both youth and adult populations.
6. Ensure the guidelines emphasize the importance of comprehensive assessment of individuals presenting with gender distress, including addressing co-occurring mental health issues and neurodevelopmental conditions, as often overlooked in current adult care practices.
7. Develop clear protocols for informed consent that fully disclose the limitations of the current evidence base and potential long-term risks of gender-affirming interventions. These should reflect the experiences of detransitioners who report feeling inadequately informed about risks and alternatives.
8. Incorporate guidance on supporting detransitioners and individuals who experience regret after transition. This should include recommendations for ongoing care and addressing potential physical and psychological impacts of detransition.
9. Reconsider the WHO’s previous endorsement of expanded access to gender-affirming hormones in light of the new evidence presented and the serious health risks associated with hormone therapy in adults.
10. Implement full transparency in the guideline development process. This should include public disclosure of all conflicts of interest, release of all evidence reviews used, and clear acknowledgment of the limitations in the current evidence base for both youth and adult populations.
By implementing these recommendations, the WHO can develop guidelines that prioritize scientific rigor, patient safety, and ethical practice. This approach would ensure that the resulting guidelines are comprehensive, evidence-based, and truly serve the best interests of individuals experiencing gender-related distress.
The development of guidelines for the health of gender-questioning individuals carries profound implications for countless people worldwide. The potential harms of rushing into expansive recommendations without a solid evidence base are significant and could impact lives irreversibly. We implore the WHO to prioritize scientific integrity, balanced perspectives, and patient safety in this process.
Given the considerable controversy and rapidly evolving landscape in this field, we urge WHO to carefully reconsider its current approach to the development of a guideline on this topic. By addressing the concerns raised in this submission and implementing our recommendations, the WHO can develop guidelines that uphold the highest standards of evidence-based medicine while safeguarding the wellbeing of all individuals seeking care for gender-related distress.
References:
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