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The U.S. Department of Health and Human Services (HHS) has acted appropriately in restricting the routine use of puberty blockers, cross‑sex hormones, and surgical transition in minors. This position does not rest on moral claims or political ideology. It rests on ordinary pediatric standards of evidence, replicated biological risk signals, unresolved confounding, and federal research‑ethics law. Pre‑pubertal and early‑pubertal children constitute a protected population under 45 CFR 46, mandating precaution, requiring heightened safeguards when interventions are irreversible, developmentally time‑sensitive, or lack durable evidence of benefit. The current evidence base for pediatric medical transition fails to meet those standards. This article reviews the strongest available data demonstrating harm signals, the absence of causal evidence for claimed mental‑health benefits, and the consistency of international evidence‑driven policy responses. Restriction under research‑level governance is therefore not discriminatory; it is the default ethical response required in pediatric medicine.
Pediatric medicine requires higher evidentiary thresholds
In pediatric care, the evidentiary bar rises—not falls—when interventions interfere with fertility, skeletal maturation, or neuroendocrine development. Unlike adult medicine, pediatric decision‑making must account for developmental plasticity, long time horizons, and the ethical inability of minors to provide legally valid informed consent for irreversible trade‑offs.
Puberty blockers (gonadotropin‑releasing hormone agonists, GnRHa), cross‑sex hormones, and surgery directly alter biological processes that normally consolidate during adolescence: peak bone mass accrual, reproductive maturation, cardiometabolic programming, and adult sexual anatomy. Under standard pediatric governance, such interventions require clear, durable benefit demonstrated through robust designs, adequate follow‑up, and clinically meaningful endpoints. The current literature does not provide that level of evidence.
Multiple independent systematic reviews conducted for national health authorities in the United Kingdom, Sweden, Finland, and Norway have converged on the same conclusion: evidence for mental‑health benefit in minors is low or very low certainty, with high risk of bias, short follow‑up, and inability to draw causal conclusions. In pediatrics, the absence of evidence is not neutral when interventions are irreversible.
Children are a federally protected class under 45 CFR 46
U.S. federal research regulations explicitly classify children as a protected population. Subpart D of 45 CFR 46 requires that research involving children expose them to no more than minimal risk unless there is the prospect of direct benefit that justifies the risk, or unless the research addresses a serious problem affecting children and is conducted with additional safeguards.5
When clinical practice proceeds in the absence of adequate evidence of benefit, it functionally becomes experimentation. Interventions that permanently alter fertility potential, skeletal development, and adult anatomy—without established long‑term benefit—would not pass Institutional Review Board (IRB) review if proposed prospectively under these regulations. HHS policy aligns with this legal and ethical framework by restricting routine clinical use and emphasizing caution consistent with research‑level oversight.
Biological harm signals from puberty suppression are documented
Bone mineral density and accrual
A prospective observational study of 44 adolescents in the UK treated with GnRHa (Carmichael et al., 2021) reported progressive declines in lumbar spine BMD z‑scores from −0.3 at baseline to −1.5 at 24 months, and hip BMD from −0.5 to −1.4.6 The same study noted that height z-scores fell, reflecting growth suppression, and BMI z-scores increased by 36 months.
In a national UK cohort of 140 adolescents (Joseph et al., 2019), lumbar spine BMAD z-scores dropped from −0.72 to −1.12 after one year of GnRHa, and hip BMD z-scores declined from −0.46 to −0.90.7 Absolute BMD values remained stable, confirming a failure to accrue bone mass at age-expected rates.
Navabi et al. (2021) studied 59 adolescents in Canada and found significant declines in lumbar spine BMD z-scores (−0.48) and total hip (−0.40) after treatment.8 Mean android fat percentage increased by 3.6%, and gynoid fat by 2.9%, altering body composition during a sensitive period.
Dutch data (Schagen et al., 2020) showed that in transgirls treated with GnRHa for 24 months, lumbar spine BMD z-scores fell from −0.67 to −1.26 (early pubertal) and −0.33 to −0.92 (late pubertal), with multiple individuals falling below −2.0.9 Vlot et al. (2017) found that lumbar spine BMAD z‑scores fell significantly (p < 0.01) and bone turnover markers were suppressed.10
These effects are not cosmetic: lower peak bone mass predicts higher lifetime fracture risk, especially in post-menopausal females and aging males. No long-term data demonstrate full skeletal recovery.
Cross‑sex hormones introduce additional pediatric risks
Following puberty suppression, most adolescents proceed to cross-sex hormones. This introduces measurable cardiometabolic and hematologic changes.
In a U.S. cohort of 72 adolescents treated with testosterone, Jarin et al. (2017) documented significant increases in hemoglobin (from 12.8 to 15.9 g/dL), hematocrit (from 38.1% to 47.0%), and BMI (from 25.2 to 27.1 kg/m²), alongside a drop in HDL from 55.3 to 42.6 mg/dL.11
Stoffers et al. (2019) studied 62 Dutch adolescents and found increases in systolic blood pressure (+6.9 mmHg), hemoglobin (+3.5 g/dL), and hematocrit (+10.1%), with persistent reductions in HDL and acne reported in 89% of participants.12 Crucially, even after 24 months of testosterone, lumbar spine BMD z‑scores remained below baseline.
These markers are well-established indicators of cardiovascular and hematologic risk, particularly concerning when exposure begins in adolescence.
Early suppression alters anatomy and forces more invasive surgery
van de Grift et al. (2020) studied 116 transwomen and found that early GnRHa (Tanner 2/3) reduced penile length by 4.8 cm compared with non-suppressed controls, and led to an 84-fold increased likelihood of requiring intestinal vaginoplasty instead of penile inversion (OR 84.0, 95% CI 10.9–647.6).13
This is a profound and irreversible developmental trade-off initiated before minors can legally consent to the surgical consequences.
Suicide prevention claims do not meet causal standards
The most frequently asserted justification for early medical transition is suicide prevention. This claim collapses under scrutiny.
No study demonstrates a causal reduction in suicide mortality in minors attributable to puberty blockers, hormones, or surgery. Existing studies rely on self‑reported distress or ideation, short recall windows, and symptom proxies such as single questionnaire items. These measures cannot establish causal protection against suicide death.
In one of the most widely cited Swedish population cohort studies, Dhejne et al. (2011) followed 324 individuals who underwent surgical sex reassignment and matched them to controls. The suicide death rate in the postoperative group was nearly 20 times higher than in the general population: hazard ratio (HR) = 19.1 (95% CI: 5.8–62.9) for completed suicide. The study also found elevated rates of psychiatric hospitalization (HR = 2.8; CI: 2.0–3.9), substance use (HR = 2.0), and mortality from all causes (HR = 2.8) in the sex-reassigned group.
Contrary to claims that surgery or hormones reduce suicide risk, the Bränström and Pachankis (2020) study in the American Journal of Psychiatry initially reported a decrease in mental health treatment utilization after gender-affirming surgery. However, following formal reanalysis and correction, the authors acknowledged that the protective effect did not meet significance for psychological treatment use or suicide attempts. These corrections effectively nullified the original conclusions used to promote the claim that surgery reduces suicidality.
A 2021 report by the UK Government’s Equality and Human Rights Commission also noted the absence of high-quality evidence showing that puberty blockers or cross-sex hormones reduce suicide deaths or improve long-term mental health outcomes in children and adolescents.
7. Confounding by indication is severe and unresolved
The strongest observational studies available—such as Turban et al.—have failed to account for selection effects. Adolescents who access early transition are more likely to have stable family support, higher income, and fewer psychiatric comorbidities. These factors independently predict better mental health.
For example, Turban et al. (2020) used cross-sectional survey data from the U.S. Transgender Survey but did not adjust for psychiatric diagnoses, social support, or concurrent therapies. Respondents self-selected, reported retrospective treatment timelines, and answered outcome measures not designed for causal inference.
As the Cass Review (UK) and systematic reviews by NICE and the Swedish SBU emphasize, no available evidence disentangles psychosocial support from the treatment effect. This renders current observational claims about benefit methodologically invalid.
Systematic reviews confirm evidence certainty is very low
A 2025 systematic review and meta‑analysis published in Archives of Disease in Childhood (Miroshnychenko et al.) included 10 studies and rated the certainty of evidence as very low for depression, dysphoria, global functioning, and BMD.16 The review explicitly reported the absence of suicide-death and sexual-function data. High attrition and bias risks were noted.
This is not a marginal concern—it is a systemic failure of the evidence base.
European policy changes reflect evidence‑based caution
Finland (2020), Sweden (2022), and the UK (2024) have restricted pediatric transition outside of research protocols. All policy shifts followed comprehensive national evidence reviews.
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Finland’s PALKO guidance reclassified puberty suppression and hormones as investigational, to be administered only in tightly controlled research settings.
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Sweden’s National Board of Health and Welfare limited hormone use to exceptional cases and emphasized psychosocial support first-line.
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The UK’s Cass Review recommended that puberty blockers only be used in research settings pending long-term outcome data.
These shifts reflect best practices under uncertainty—not ideological suppression.
Conclusion
HHS policy on pre‑pubertal puberty blockers, surgery, and early medical transition reflects normal pediatric ethics, federal research law, and evidence‑based governance. Biological harm signals are replicated across jurisdictions. Claimed mental‑health benefits are unproven at the level required for irreversible interventions. Suicide‑prevention claims lack causal support. Children are a protected class under 45 CFR 46, and interventions of this magnitude cannot be ethically normalized in the absence of durable benefit.
Restricting routine pediatric medical transition is not discrimination. It is the correct clinical response to uncertainty, developmental vulnerability, and an inadequate evidence base.
References
1. National Institute for Health and Care Excellence. Evidence review: Gonadotrophin releasing hormone analogues for children and adolescents with gender dysphoria. NICE; 2020.
2. Cass H. Independent Review of Gender Identity Services for Children and Young People. NHS England; 2024.
3. Finnish Health Authority (PALKO/COHERE). Medical treatment methods for dysphoria related to gender variance in minors. 2020.
4. Swedish National Board of Health and Welfare. Care of children and adolescents with gender dysphoria. 2022.
5. U.S. Department of Health and Human Services. 45 CFR 46—Protection of Human Subjects. Subpart D.
6. Carmichael P, Butler G, Masic U, et al. Short‑term outcomes of pubertal suppression in a selected cohort of 12‑ to 15‑year‑olds with persistent gender dysphoria in the UK. PLoS One. 2021;16(2):e0243894. doi:10.1371/journal.pone.0243894
7. Joseph T, Ting J, Butler G. The effect of GnRH analogue treatment on bone mineral density in young adolescents with gender dysphoria. J Pediatr Endocrinol Metab. 2019;32(10):1089‑1096. doi:10.1515/jpem‑2019‑0046
8. Navabi B, Tang K, Khatchadourian K, Lawson ML. Pubertal suppression, bone mass, and body composition in youth with gender dysphoria. Pediatrics. 2021;148(4):e2020039339. doi:10.1542/peds.2020‑039339
9. Schagen SEE, Wouters FM, Cohen‑Kettenis PT, Gooren LJG, Hannema SE. Bone development in transgender adolescents treated with GnRH analogues and subsequent gender‑affirming hormones. J Clin Endocrinol Metab. 2020;105(12):e4904‑e4913. doi:10.1210/clinem/dgaa570
10. Vlot MC, Klink DT, den Heijer M, et al. Effect of pubertal suppression and cross‑sex hormone therapy on bone turnover markers and bone mineral apparent density in transgender adolescents. Bone. 2017;95:11‑19. doi:10.1016/j.bone.2016.11.008
11. Jarin J, Pine‑Twaddell E, Trotman G, et al. Cross‑sex hormones and metabolic parameters in adolescents with gender dysphoria. Pediatrics. 2017;139(5):e20163173. doi:10.1542/peds.2016‑3173
12. Stoffers IE, de Vries MC, Hannema SE. Physical changes, laboratory parameters, and bone mineral density during testosterone treatment in adolescents with gender dysphoria. J Sex Med. 2019;16(9):1459‑1468. doi:10.1016/j.jsxm.2019.06.014
13. van de Grift TC, van Gelder ZJ, Mullender MG, et al. Timing of puberty suppression and surgical options for transgender youth. Pediatrics. 2020;146(5):e20193653. doi:10.1542/peds.2019‑3653
14. Dhejne C, Lichtenstein P, Boman M, Johansson ALV, Långström N, Landén M. Long‑term follow‑up of transsexual persons undergoing sex reassignment surgery: cohort study in Sweden. PLoS One. 2011;6(2):e16885. doi:10.1371/journal.pone.0016885
15. Bränström R, Pachankis JE. Reduction in mental health treatment utilization among transgender individuals after gender‑affirming surgeries. Am J Psychiatry. 2020;177(8):727‑734. doi:10.1176/appi.ajp.2019.19010080
16. Miroshnychenko A, et al. Puberty blockers for gender dysphoria in youth: a systematic review and meta‑analysis. Arch Dis Child. 2025. doi:10.1136/archdischild‑2024‑327909
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