The U.S. Endocrine Society (ES) is updating its clinical practice guidelines on “gender-affirming care.” ES, however, appears to be putting its thumb on the scale in favor of medical interventions by appointing experts with serious conflicts of interest to its guideline-development group, ignoring its own standards for how to write trustworthy medical recommendations, and trying to keep the process hidden from the public.
On January 4, Yahoo! Finance reported that ES had decided to appoint John Pang, a surgeon from Align Surgical Associates, Inc., a California-based clinic that specializes in “gender-affirming” surgeries, to its Guideline Development Panel tasked with updating its existing gender medicine guidelines. Because the article concerned Pang and a colleague at Align who was appointed contributing editor at the prestigious journal Plastic and Reconstructive Surgery, and not the ES guideline group, it flew under the radar of those of us following the U.S. gender medicine debate.
Two weeks ago, a colleague alerted me to the Yahoo article, and I decided to write about what was going on at ES. On Wednesday, February 21, I sent the ES media-relations team a notice of my intent to write about the new guideline group and included a list of questions about their process, why they hadn’t made it public, and what they were doing to manage conflicts of interest. I pointed out a 2022 article in which ES explained its commitment to increase transparency and adopt a more rigorous method of guideline development, and asked whether they were planning to adhere to the standards announced in that article. I asked them to respond by Monday, February 26, at 5:00 p.m. EST—a request from which they could reasonably infer that my article would run in the following day or two.
I received no response, but on Monday, at 5:48 pm EST—less than an hour after that deadline passed—CNN published an article by Jen Christensen, a reporter and vice president of NLGJA: The Association of LGBTQ+ Journalists, titled “First on CNN: Major Medical Society Re-Examines Clinical Guidelines for Gender-Affirming Care.” The article is yet another puff piece for the controversial medical treatments and celebrates ES’s role in promoting them. In fact, it’s a particularly lazy puff piece. Christensen makes the usual unsubstantiated claims about “medical necessity” and “evidence-based individualized care,” not mentioning why European countries have taken a more cautious approach. The short piece reads like it was put together hastily—almost in a state of panic. Christensen quotes Joshua Safer, a WPATH endocrinologist chairing the guideline-development group, who assures her that “we’ve been following our usual guideline process that we apply to anything that we do, whether it’s diabetes or thyroid etc., to transgender medical care.”
Did ES panic about being exposed for something that it was apparently trying to keep quiet—and get in touch with an allied journalist at a major news outlet, one whom it knew would toe the activist line and vouch for its process? Obviously, I can’t prove that such a thing happened, but the timing of the CNN piece certainly seems suspicious—as does Safer’s unprompted assurance that ES is following its own guideline-development procedures. What exactly is ES up to?
While gender clinicians frequently tout the consensus among almost two dozen American medical associations in favor of pediatric sex-trait modification, ES is one of only three groups (the others being the American Academy of Pediatrics and the World Professional Association for Transgender Health) to have issued treatment recommendations based on cited research. ES’s current guidelines, published in 2017, recommend pubertal suppression and hormonal treatments for adolescents, despite recognizing the “low” or “very low” quality of evidence supporting these recommendations.
Experts have questioned the soundness of ES’s guidelines. Last year, Gordon Guyatt, a world-renowned expert in evidence-based medicine at McMaster University in Canada, told the British Medical Journal that ES’s 2017 guidelines have “serious problems.” Similarly, of a panel of six evidence-evaluation and guideline-development experts convened in 2021, only one concluded that ES’s guidelines were trustworthy in their current form.
For reasons not entirely clear, ES’s 2017 clinical practice guidelines made recommendations on behalf of surgery, not just hormonal interventions, and the appointment of a plastic surgeon to its guidelines panel suggests that it might do so again.
The appointment of Align Surgical’s John Pang undoubtedly constitutes a major conflict of interest. The most obvious type of conflict of interest is financial. Pang’s practice, and by extension Pang himself, stand to benefit directly from a recommendation to provide gender-affirming surgeries. (The practice specializes in unusual genital surgeries such as “nullification,” “penis-preserving vaginoplasty,” and “vagina-preserving phalloplasty.”) Moreover, hormonal treatments are often a steppingstone to surgery. A 2018 study led by Johanna Olson-Kennedy, a prominent “gender-affirming” clinician, found that girls’ discomfort with their breasts (“chest dysphoria”) increased with every month they were on testosterone. The researchers noted “a common clinical phenomenon” in which “a honeymoon period after testosterone initiation . . . quickly becomes eclipsed by the greater disparity between a more masculine presentation and a female chest contour.” Thus, even recommendations on behalf of hormones would likely benefit Pang and his employer. Conversely, if the data indicate that, for example, mastectomies for minors are not a beneficial intervention, or that surgeries should be provided only after extensive evaluations, Pang’s practice stands to lose business.
Align Surgical promises clients that it is “quite adept at working with most insurance plans.” Public and private insurance programs usually cover procedures (and under Section 1557 of the Affordable Care Act may be compelled to do so) when these are considered “medically necessary.” A strong recommendation from ES on behalf of hormones and surgeries would help ensure that clients can access the expensive and experimental procedures that Align Surgical performs. Insurance companies can then spread risk and recover costs by raising premiums for everyone else.
Evidence-based medicine also recognizes nonfinancial conflicts of interest. A leading textbook on evidence-based medicine notes, for example, that such nonfinancial conflicts “may have even greater effect than financial conflicts,” and “include intellectual conflicts (e.g., previous publication of studies relevant to a recommendation or strongly held views) and professional conflicts (e.g., radiologists making recommendations about breast cancer screening or urologists recommending prostate cancer screening).” Pang, a member of the hormone- and surgery-promoting World Professional Association for Transgender Health (WPATH), has both financial and intellectual conflicts. He has published research supportive of medical interventions. One of his studies, for example, which examines whether estrogen use in trans-identified males increases risk for perioperative complications, concluded that “estrogen [hormone therapy] suspension is not necessary for the transfeminine patient undergoing gender-affirming surgery.”
Ideally, a guideline-development committee would be free of conflicts. The panel would include experts in research methods and evidence evaluation as well as subject-area experts. In practice, however, including subject-area experts on such committees almost always introduces intellectual conflicts of interest, requiring committees to balance competing perspectives. This doesn’t always happen, of course; recently, we learned that the World Health Organization convened a guideline-development group on “gender-affirming” hormones and gender self-identification that was made up almost entirely of advocates for hormones and gender self-identification. Of the 21 empaneled experts, 17 had significant conflicts of interest.
A 2022 article, “Enhancing the Trustworthiness of the Endocrine Society’s Clinical Practice Guidelines,” published in ES’s Journal of Clinical Endocrinology & Metabolism, laid out ES’s intended steps to ensure that its guideline-development process was more transparent and methodologically rigorous. Explicitly noting the trade-off between subject-area expertise and minimizing actual or perceived bias, ES adopted the National Academy of Medicine’s recommended standards, which prefer a more aggressive conflict-of-interest management strategy, even if this means loss of subject-area expertise. ES’s clinical guidelines committee, which oversaw the policy change, “trust[ed] that its guidelines [would] achieve full credibility via methodological rigor and transparency.” Assuming ES’s current panel is made up of experts who share Pang’s opinions and have similar conflicts, it is almost certain to make recommendations that contradict the direction or strength of the evidence.
In evidence-based medicine, “discordant recommendations” are recommendations in favor of an intervention where evidence for that intervention’s safety and efficacy is weak. Such recommendations are generally discouraged, but a number of scenarios exist where they are acceptable.
An example of such a scenario is when non-treatment with a proposed intervention is likely to lead to death. Despite repeated claims about “trans youth” being at high risk of suicide if not given access to hormones and surgeries, evidence suggests that the elevated rates of suicide and suicidality (the two are distinct) in this population are very likely due to coexisting mental health problems, which are extremely common among the trans-identified, and not because of gender dysphoria or transgender “minority stress.” A recently published Finnish study, arguably the most important so far on the question of gender medicine in relation to suicide, shows that suicide is, thankfully, a very rare event and is better explained by the comorbid conditions. Last year, ES’s president drew criticism from 21 international experts when he used the “suicide prevention” narrative to defend his organization’s approach. As noted by Guyatt, a major flaw of ES’s 2017 guideline is that it did not invoke any of the exceptions that would justify the “discordant recommendations,” making its guideline non-transparent and untrustworthy.
In evidence-based medicine, recommendations for or against treatment are never based on studies alone; patients’ “values and preferences” are also relevant. Values and preferences are especially important where the quality of evidence is poor. Ideally, the ES guideline panel’s members would rely on high-quality research on the values and preferences of those who experience or are candidates for a medical intervention. In gender medicine, however, patients’ values and preferences have not been systematically researched. Instead, those preferences are conveyed to survey proctors by clinicians who are themselves “gender-affirming” and who believe strongly in the value of hormonal and surgical interventions. This introduces a serious risk of bias in the characterization of values and preferences.
ES’s 2017 guidelines for adolescents prioritized “avoiding an unsatisfactory physical outcome” over “avoiding potential harm from early pubertal suppression”—likely an assumption about how the most determined and satisfied trans-identified adult patients would rank these two outcomes. A more rigorous guideline-development process would systematically collect evidence of values and preferences from all individuals who go through transition procedures as minors and from parents who are involved in these decisions, not just from patients who happened to come out satisfied.
Such a process would track outcomes into adulthood to see whether or how these values and preferences change. For example, the values and preferences of a 20-year-old woman who had a double mastectomy at age 16 may change a decade later, when the meaning of her inability to breastfeed begins to dawn on her. The same goes for teenagers who give up their future fertility, believing “I can always adopt.” In a recently presented Dutch research study, 20 percent to 30 percent of the respondents in the carefully chosen cohort indicated that they regret having lost their fertility. A significant number are single and in their thirties.
Assembling a guideline-development panel of experts with different viewpoints is therefore necessary not only for a more objective assessment of the quality of evidence but also for a more rigorous examination of values and preferences. For example, a 2022 study published in the ES’s Journal of Clinical Endocrinology & Metabolism found a hormone discontinuation rate of up to 30 percent—some of it possibly due to harms experienced from hormones. A panel that includes detransitioners and the clinicians who treat them will likely reach different conclusions than a panel in which only “affirming” clinicians and trans-identified patients are represented.
It’s noteworthy that most of the authors of ES’s 2017 clinical practice guidelines were also big names at WPATH. Two—Peggy Cohen-Kettenis and Louis Gooren—were Dutch pioneers of pediatric gender medicine. Despite the perception that ES and WPATH are separate entities, and that recommendations on behalf of “gender-affirming care” are not just made by trans advocacy groups but also by run-of-the-mill U.S. medical groups, the truth is that WPATH members used ES as a guise for embedding hormonal interventions as an accepted standard of care in the United States.
ES’s actions—which include repeated evasion of transparency and accountability, willingness to speak only with ideologically aligned journalists, and appointment of a president who is himself a gender clinician and whose views are out of step with those of his international colleagues—do not inspire confidence that its new guidelines will be ethical, trustworthy, and in accordance with well-established principles of evidence-based medicine.
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