Patients and Clinical Guidelines Deserve High-Quality Evidence, Not Politics
- La Petite Sirène
- Jun 10, 2025
- 6 min read
Patrick Hunter & Kathleen A. Goonan
Pages 81-84 - The American Journal of Bioethics - Volume 25, 2025
Publié en ligne : 6 juin 2025
Medicine must be practiced one patient at a time, and should not be practiced based on group identity, politics, social justice, or other ends in mind. The individual patient’s welfare is paramount before all other considerations, and to insure this medical practice should be based on the best available evidence, ideally utilizing trustworthy clinical practice guidelines (CPG) developed with the best available evidence in a transparent manner. This is not happening with gender medicine.
Vulnerable patients, distressed by their biological sex and often with other co-morbid issue such as depression, anxiety, neurodivergence, past sexual trauma, family trauma, or emerging homosexuality, are seen as a homogenous group—a political group—and only offered one treatment option, which is social, hormonal and surgical transition. This sole treatment option is the result of clinical practice guidelines—the World Professional Association for Transgender Health (WPATH) guidelines in particular—that are based on low quality evidence, developed in a manner that lacks rigor and transparency, motivated by sociopolitical ends, and not the patient’s welfare. The harms occurring are real and are a serious ethical scandal that the medical profession must address.
Gender medicine, synonymous with social, hormonal and surgical “sex transition,” lacks evidence to support these interventions. Multiple systematic evidence reviews show that patient benefit is of low or very low certainty. When WPATH commissioned their own systematic evidence reviews they also “found little to no evidence for children and youth” (Boe v. Marshall Exhibit 173 Citationn.d., 23). WPATH leadership then took the extraordinary step to suppress the publication of these findings. WPATH’s treatment guidelines are not based on sound evidence, medical reasoning or ethics. Vulnerable patients are treated by WPATH and like-minded activist clinicians as a homogenous identity group and not as distinct individuals. Patient autonomy, justice and welfare are jeopardized as a consequence.
Low certainty medical evidence means patient benefit is uncertain and outcomes may be significantly different than what is hoped for. Indeed, harms and regret are occurring and are not being adequately measured or addressed. These include sterilization, loss of sexual function, removal of healthy body parts, and permanent medical and surgical complications. In no other medical field would this be considered acceptable.
Systematic reviews are the highest evidence standard and vital for trustworthy CPG development. Systematic reviews from Finland, Sweden, England, Germany, and Canada all find the evidence for youth “sex transition” to be wanting. Individual studies can misrepresent what is known but systematic reviews analyze all the relevant studies, grade their quality, and place the relevant evidence in context. Three studies Kirby (Citation2025) cites on “Benefits of GAC” illustrate why systematic reviews are important.
THE AMSTERDAM STUDY
There are multiple problems with the papers by de Vries et al. (Citation2014) from the Amsterdam gender clinic. First, they report on a small, biased sample of their patients. One hundred and eleven (111) youth were treated with puberty blockers, yet the 2011 interim report included 70, and the final 2014 report included only 55. For 50.5% started on puberty blockers, outcomes go largely unreported.
Second, for the 15 youth from the 2011 interim report that were excluded from the 2014 final report we know a few things. Two refused to participate, two failed to return study questionnaires, and one dropped out of care. These five might be today’s detransitioners. Three patients developed diabetes and obesity and were excluded from surgery. One patient died from necrotizing fasciitis after a vaginoplasty (de Vries et al. Citation2014, 697). When 20% of patient outcomes go unreported and worse case scenarios are excluded serious bias exists, and a study’s validity is questionable (Dettori Citation2011). The Dutch studies are guilty of both.
Third, de Vries et al did not demonstrate psychological improvements in the 55 subjects. This often-repeated claim is wrong. Psychological outcomes were reported for only 32 of the 55 that had surgery (58%). These 32 represent only 29% of the 111 that were begun on puberty blockers. The incomplete and selective reporting is now an even greater problem. For these 32 youth, anxiety, depression, and anger scores did not improve. The Dutch reported single digit improvements in the 100-point Child Global Assessment Scale (de Vries et al. Citation2014, tbl. 3). These single digit improvements are probably clinically insignificant, and the ongoing loss of study participants make this data and any conclusions suspect.
The Dutch papers are the foundation upon which youth gender medicine was built. Selective reporting, high rates of patient drop out, exclusion of worse case scenarios, and no meaningful psychological improvement are just a few of the issues that make the Dutch conclusions biased and invalid.
MASTECTOMY PAPER (Olson-Kennedy et al. Citation2018)
In this National Institutes of Health (NIH) funded study, sixty-eight double mastectomies were done on women under 25 years of age. Olson-Kennedy et al concluded that after mastectomy, subjects were no longer uncomfortable with their breasts. Two girls were 13, five were 14, seven were 15, and seven were 16 years old. The follow up period was less than two years for 85% (n = 58), and less than one year for 43% (n = 29) (Olson-Kennedy et al. Citation2018, tbls. 2 & 3).
The authors acknowledge that their “Chest Dysphoria Scale” was not validated and study results may not correlate with patient outcomes (Olson-Kennedy et al. Citation2018, 435). Teenagers had healthy breasts amputated, conclusions about psychological outcomes were made less than 2 years after surgery, and a non-validated scale was used. If a mastectomy is regretted once, it is a worst-case scenario.
A 20-year-old woman is suing Olsen-Kennedy (The Economist Citation2024). She regrets her transition that began at 12 with puberty blockers, testosterone at 13, and a mastectomy at 14. Regarding mastectomy regret, Olson-Kennedy states “if you want breasts at a later point in your life you can go and get them” (Olson-Kennedy Citation2018). This statement indicates a profound misunderstanding of human biology, human suffering, and the ethical practice of medicine.
In a New York Times interview Olson-Kennedy admits her puberty blocker research failed to show patient benefit. She is withholding publication of her NIH funded research because it might “be weaponized” (Ghorayshi Citation2024). Withholding research findings is also unethical.
EVIDENCE OF BIAS
In 2018, WPATH commissioned Johns Hopkins University (JHU) to conduct systematic evidence reviews to inform the development of the eighth version of their Standards of Care (SOC8). In September 2020, JHU reported to an NIH official that “we found little to no evidence about children and adolescents.” In the same email, JHU reported “we have been having issues with this sponsor trying to restrict our ability to publish (Boe v. Marshall Exhibit 173 Citationn.d., 23).” The lead author of SOC8 described WPATH’s relationship with JHU as “very constraining” (Boe v. Marshall Exhibit 190 Citationn.d., 8). In October 2020, JHU complained to WPATH leadership that their publications “are not subject to approval by WPATH nor subject to policy of WPATH” and that “academic freedom and intellectual property prohibit any restrictions/approvals regarding publishing” (Boe v. Marshall Exhibit 167 Citationn.d., 90–91).
WPATH made a SOC8 draft available to Admiral Levine, at that time the United States Assistant Secretary of Health and Human Services. Two months before SOC8’s release, Admiral Levine met with WPATH leadership via Zoom and asked that age limits be removed because they would “result in devastating legislation for trans care” (Boe v. Marshall Exhibit 186 Citationn.d., 12 & 29). Age limits were then removed without evidence to support this change.
Eli Coleman is the first author of SOC8 and past president of WPATH. Five months after the publication of SOC8 he wrote WPATH colleagues, offering his strategic plan to address the critics who “see WPATH as an activist organization that is biased and self-serving” and he acknowledged that “(a)ll of us are painfully aware there are many gaps in research to back up our recommendations.” Coleman lists eight groups attacking WPATH. These includes parents, academics and scientists, the “pressure in health care to provide evidence-based care,” and “the increasing number of regret cases and individuals who are vocal in their retransition process who are quick to blame clinicians for allowing themselves to transition despite an informed consent process” (Boe v. Marshall Exhibit 190 Citationn.d., 6). He appears to be blaming the people that have been harmed. Nor can informed consent occur when WPATH policy suppresses the truth about the evidence.
Trustworthy clinical practice guidelines are developed with the best available evidence in a transparent manner. WPATH knew the evidence did not support their guidelines, suppressed that information, and their SOC was developed with political and legal goals in mind. This is unacceptable and unethical.
Advocates for gender affirming care claim children and adolescent have a right to poorly evidenced hormonal and surgical interventions. Harm and regret, including the sterilization of minors and loss of sexual function, is happening. It is reasonable to expect reports of harm will increase in the coming years and we must ask why this is tolerated. Patients, parents and medical professionals deserve to know the truth about the lack of evidence.
Those concerned with youth transition recognize the lack of evidence, want to limit patient harms, and seek a safer, holistic, and compassionate treatment for those suffering from gender dysphoria. This will not happen if politically motivated bias drives out balanced discussion and development of evidence.
Providing poorly evidenced treatments with uncertain outcomes and with real and serious risks should be considered experimental and should be the exception and not the rule. To do otherwise would be an injustice to this vulnerable population.
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