Beneath the culture wars surrounding gender-affirming care are increasingly disturbing reports of organizations putting their thumbs on the guidelines being offered to clinicians. Two reports in the British Medical Journal by their investigative reporter are troubling, and the actions described, if true, put clinicians and patients at risk and ill-serve our legislators who have little expertise in navigating the concept of guidelines, let alone their findings.
The earlier investigation lays out the divergent way our experts, from the American Academy of Pediatricians (AAP), the Endocrine Society, and the World Professional Association for Transgender Health (WPATH) [1], have developed their guidance on the issue. That guidance is at odds with one another and with guidance developed in other countries, notably and most recently, the Cass Review from the UK.
From Opinion to Consensus
In our not-too-distant past, guidance on treatment for many conditions was found in the opinions of grey-haired experts sharing their clinical experience with the halo of expertise covering any underlying bias in approach. Guidelines were an attempt to turn these expert opinions into an evidence-based consensus.
“An evidence-based recommendation requires two steps, an unbiased, thorough, critical systematic review of all the relevant evidence, [and] some commitment to link the strength of the recommendations to the quality of the evidence.”
- Mark Helfand MD, MPH, Professor of Medicine at Oregon Health and Science University
Criticisms of systematic reviews often center around the diversity of opinion brought to review and the subsequent, entangled, cherry-picking of studies to provide “the relevant evidence.”
The current investigation by the BMJ centers on the most recently published guidelines for gender-affirming care by WPATH, their eighth revision. I would note at this juncture that it might be better to refer to guidelines as evidence-informed because our understanding of disease changes with time; it is not static, as the phrase evidence-based implies. The basis of the WPATH guidelines came from an independent systematic review done by faculty at Johns Hopkins. But as the BMJ article details, WPATH sent a letter to Johns Hopkins lead investigator, Karen Richards, PhD, indicating,
“It is paramount that any publication based on the WPATH SOC8 data is thoroughly scrutinized and reviewed to ensure that publication does not negatively affect the provision of transgender healthcare in the broadest sense.”
Moreover, the BMJ article alleges that Admiral Rachel Levine, MD, Assistant Secretary for Health, “asked authors to remove minimum age recommendations for gender-related hormones and surgeries.” While WPATH initially declined the request, further pressure by the AAP resulted in the WPATH removing the age restriction. The culture warriors can posit whatever intent they wish to those requests; I would be content saying it allows for clinical judgment, but irrespective of intent, it does reflect “the smoking thumb,” in this instance.
The GRADE system is an accepted means of mapping the quality of a study [2] in making recommendations. That mapping has caveats that allow weak evidence to result in strong recommendations and strong evidence to result in weak recommendations.
“Calling a treatment recommendation ‘evidence-based’ should mean that a treatment has not just been systematically studied, but that there was also a finding of high-quality evidence supporting its use. Weak evidence “doesn’t just mean something esoteric about study design, it means there’s uncertainty about whether the long-term benefits outweigh the harms.”
- Mark Helfand MD, MPH
The methodology underlying GRADE’s approach to recommendations,
“stresses the necessity to consider the balance between desirable and undesirable consequences and acknowledge other factors, for example, the values and preferences underlying the recommendations. As patients with varying values and preferences for outcomes and interventions will make different choices…” [emphasis added]
Without an explicit description of the values and preferences of those making the recommendations, the whole enterprise of systematic review and recommendation based upon the quality of information stands on shaky ground, and the use of the term evidence-based misinforms at a minimum and is a lie in the extremes. As Gordon Guyatt, MD, Professor in Health Research Methods, Evidence and Impact at McMaster University, the originator of the term evidence-based medicine, said to the BMJ,
“ ‘Evidence itself never tells you what to do,’ says Guyatt. That’s why guidelines must make explicit the values and preferences that underlie the recommendation.”
The current investigation by the BMJ concerns the fact that two members of WPATH sit on the committee formulating the WHO guidelines on gender-affirming care, arguing that their actions in drafting their own guidelines make them suspect and cast unnecessary shade on the WHO’s efforts.
There is no consensus
When we take a global look, there is no clear consensus on transgender care for adolescents under the age of 18. We don’t know because we simply do not have enough research to draw valid conclusions. Case reports, media coverage tugging at your emotions, and “studies” grounded implicitly in “my experience” are not evidence-based; they are barely evidence-informed.
I stand with the clinicians, in this instance, Dr. Guyatt,
“I think most people would say that adults thinking of transitioning should be allowed to make the decision, and the medical care to help them transition should be made available to them. While there may be only low-quality evidence of benefit, it seems to me a very value and preference sensitive decision.”
The same holds for adolescents, although the decision-making is complicated by concerns over their ability to fully consent without parental involvement. What I continue to be puzzled by is why a recommendation that adolescent treatment be carried out in a research setting gets so much pushback. We have no other way to learn about the harms and benefits to guide our clinical judgment.
True consensus on transgender healthcare remains elusive, especially for adolescent care, where research is limited and often conflicting. The push to incorporate all treatment recommendations as "evidence-based" can mask uncertainties, especially when critical data on long-term impacts is sparse. A call for research-driven, transparent guidelines is essential—particularly if we aim to offer care that genuinely balances benefits with risks, guided by robust evidence and an honest accounting of values behind every recommendation.
[1] WPATH is an “international, multidisciplinary, professional association whose mission is to promote evidence-based care, education, research, public policy, and respect in transgender health. One of the main functions of WPATH is to promote the highest standards of health care for TGD people through the Standards of Care (SOC).”
[2] The GRADE approach rates evidence in four levels, from very low to high. It uses five factors—risk of bias, imprecision, inconsistency, indirectness, and publication bias, to lower the certainty of the evidence. Despite this, it is not entirely objective and is subject to all-too-human bias in judging these factors.
Sources: Gender dysphoria in young people is rising—and so is professional disagreement BMJ DOI: 10.1136/bmj.p382
Dispute arises over World Professional Association for Transgender Health’s involvement in WHO’s trans health guideline BMJ DOI: 10.1136/bmj.q2227
Chuck Dinerstein, MD, MBA
Director of Medicine
Dr. Charles Dinerstein, M.D., MBA, FACS is Director of Medicine at the American Council on Science and Health. He has over 25 years of experience as a vascular surgeon.
