Do No Harm: 0 High-Certainty Studies Support Pediatric Gender Drugs

A contentious hearing before the U.S. Senate Committee on Health, Education, Labor, and Pensions (HELP) has reignited the political and medical debate over gender-affirming care for minors. On June 10, 2026, Dr. Kurt Miceli, chief medical officer of the watchdog group Do No Harm, testified that systematic reviews of pediatric medical transition show “very low certainty evidence of benefit” in the context of “significant harms” and called on Congress to “codify safeguards” to protect children with gender dysphoria. His testimony specifically targeted three major U.S. medical societies—the American Academy of Pediatrics (AAP), the Endocrine Society, and the American Medical Association (AMA)—accusing them of endorsing treatments that are irreversible and lack robust scientific support. None of the societies have responded to requests for comment, and the HELP Committee has also remained silent, leaving the legislative path uncertain. The hearing marks a significant escalation in a years-long battle over the standards of care for transgender youth. While the AAP, Endocrine Society, and AMA currently support access to puberty blockers, hormone therapy, and in some cases surgery for adolescents, a growing number of systematic reviews and government-led inquiries—most notably the UK’s Cass Review—have raised serious concerns about the quality of evidence underpinning these interventions. The Cass Review, published in final form in 2024, concluded that the evidence for hormonal interventions in youth was remarkably weak and that the benefit-risk profile remained uncertain. Do No Harm’s testimony mirrors those findings, emphasizing that “the risks are great, and the consequences irreversible and lifelong in many cases,” and urging medical societies to “re-evaluate their radical position statements.” The push for federal safeguards represents a strategic shift. To date, the U.S. has seen a patchwork of state-level bans and restrictions on youth gender medicine—over 20 states have enacted such laws, while others have codified protections for access. A federal law would potentially preempt these state-level variations, creating a uniform national standard. For healthcare providers, such legislation could carry profound implications: it could limit the standard of care for minors, impose new liability risks for noncompliance, and force hospitals and clinics to discontinue certain services. For health insurers, a federal mandate could reshape coverage policies, potentially eliminating reimbursement for puberty blockers and cross-sex hormones in pediatric populations. The biopharmaceutical industry also faces direct exposure. Several FDA-approved drugs are commonly used off-label for pediatric gender dysphoria, including leuprolide acetate (Lupron) for puberty suppression and various testosterone and estrogen formulations for hormone therapy. A federal crackdown would not immediately revoke FDA approvals, but it could dramatically shrink the addressable market. Moreover, the testimony’s focus on “very low certainty evidence” could pressure the FDA to revisit its regulatory approach to pediatric gender medicine, potentially requiring more rigorous randomized controlled trials for new indications—a costly hurdle for drug developers. While the market for gender-affirming pharmaceuticals is relatively small, estimated in the low hundreds of millions of dollars globally, the symbolic impact on biotech investment could be broader if investors perceive heightened political and regulatory risk in any area of hormone-based medicine. The silence of the major medical societies is notable. Historically, these organizations have defended current guidelines, citing ethical obligations to provide affirming care and preventing harm from untreated gender dysphoria. Their decision not to engage publicly with Do No Harm’s testimony may reflect a strategic calculation to avoid amplifying a relatively small advocacy group, but it leaves a communication vacuum that could be filled by less moderate voices. If Congress moves forward, the societies will almost certainly be called to testify, setting up a high-stakes confrontation. Looking ahead, the HELP Committee’s next steps are unclear. The committee could draft legislation, hold additional hearings, or take no action. The political calculus is complex: with the 2026 midterm elections approaching, some lawmakers may see a federal ban as a rallying cry for their base, while others may view it as government overreach. Meanwhile, the medical community is increasingly divided, with some clinicians breaking ranks to express concerns about the evidence base. The coming months will likely see intensified lobbying from both sides, with Do No Harm seeking to build a legislative coalition and medical societies mounting a defense of current standards. The outcome will not only shape pediatric gender medicine in the U.S. but could also serve as a bellwether for the role of evidence-based medicine in politically charged healthcare decisions.