US Health Swears Off Gender Meds for Kids
America's federal health authorities have aligned with Europe's more cautious position on care for gender-distressed minors
On May 1, the US Department of Health and Human Services (HHS) published its 409-page Gender Dysphoria Report outsourced to independent researchers. What follows is a lightly edited excerpt from the report’s discussion of key ethical questions raised by gender medicalisation of minors. Below this excerpt is a sample of commentary on the report—Bernard Lane
Ethics of paediatric medical transition
The norms of medicine require clinicians to protect and promote the health and well-being of their patients. This means they must abstain from providing non-beneficial interventions even when such interventions are requested by patients.1
Clinicians must ensure, insofar as reasonably possible, that any interventions they offer to patients have clinically favourable risk/benefit profiles relative to the set of available alternatives, which includes doing nothing.
Systematic reviews of the evidence for benefit of hormonal or surgical intervention in the treatment of gender dysphoria in adolescents have concluded that this evidence is of low or very low certainty.2
This means that the true effects of the interventions may or are likely to be substantially different from the effects reported in the studies. In other words, the best available evidence indicates that puberty blockers, cross-sex hormones, and surgery have not been shown to improve mental health outcomes.
There is increasing recognition of the risks and harms associated with paediatric medical transition, which are supported by clinical research or grounded in established biological theory.
While the value or disvalue of some outcomes, such as hirsutism in females, may be determined primarily by the preferences or tastes of patients, other possible outcomes, such as impaired cognitive function, greater susceptibility to hormone-sensitive cancers, cardiac disease, reduced bone density, sexual dysfunction, infection, and infertility are objectively detrimental to health.
Such medical harms, or plausible risks thereof, should not be imposed on children or adolescents in the absence of a reasonable expectation of proportionate medical benefit.
Although a favourable risk/benefit profile is necessary to justify an intervention, it is not sufficient. The intervention must be favourable relative not only to doing nothing but also to other known alternatives.
With respect to paediatric medical transition, a relevant alternative is some combination of psychotherapeutic interventions. Like the evidence for hormonal and surgical interventions, evidence regarding alternative approaches to gender dysphoria is sparse and inconclusive, though there is good reason to believe that psychotherapy can be an effective intervention.
Regarding the potential harms of psychotherapy for adolescents with gender dysphoria, a systematic review of the evidence found no evidence of negative or adverse effects in any of the studies examined.
One possible objection is that although the evidence supporting hormonal and surgical interventions is of low or very low certainty, this does not prove that the interventions are ineffective. For all we know, the interventions may be more effective than researchers have reported. The methodological weaknesses of the studies do not prove inefficacy— they tell us only that we cannot infer much of anything about beneficial effects.
The same limitations apply to evidence on harms—after all, because there are no well-designed randomised controlled trials3 of paediatric medical transition, it follows that there are no such trials demonstrating sexual dysfunction, infertility, bone density loss, impaired cognitive function, susceptibility to hormone-sensitive cancers, and other potential harms.
Some argue that in the face of uncertain evidence both for benefit and for harm, patients themselves (and their families), with expert clinicians providing relevant clinical information, should decide how to proceed. Medical decisions under uncertainty, the reasoning goes, should be made by those with the greatest personal stake in the outcome. In paediatrics, this means children and adolescents, supported (usually) by their families.
This objection properly expresses concern for patient health and well-being as well as respect for the developing decision-making capacity of children and adolescents (and the greater capacity of their guardians). But it fails, for two reasons.
First, the objection understates the cumulative case for evidence of harm. We can be certain in the ordinary sense of “certain” that these interventions cause harm, even if we do not have “high certainty” evidence in the technical sense employed in evidence-based medicine.
We do not need results from randomised controlled trials to be certain that removing an adolescent’s breasts will eliminate or substantially impair capacity for breastfeeding. Nor do we need trials to establish that puberty blockers and cross-sex hormones stunt growth of the penis, increasing the risks associated with future surgery.
And apart from any systematic reviews of published studies, basic human physiology indicates that blocking puberty early4 and following with cross-sex hormones will negatively impact fertility. That advocates of paediatric medical transition recommend fertility counselling before undergoing these interventions is evidence that they, too, anticipate the risk of infertility and regard it as a harm.
Other forms of evidence, such as indirect evidence from research on adults, also contribute to the case that these interventions cause harm. Finally, research on paediatric medical transition has focused largely on potential benefits to mental health, with less attention given to potential physical harms, compounding the problem of publication bias.
Second, even granting that the uncertainty of the evidence makes it impossible to assign precise values to the probabilities or magnitudes of various potential outcomes, it does not follow that clinicians are dependent on their patients to guide clinical decision making.
Rather, the obligation to avoid serious harm justifies a precautionary approach, particularly in the absence of evidence for a proportionately serious threat to the patient’s health without the intervention.
The unfavourable risk/benefit profile distinguishes paediatric medical transition from many other off-label uses of drugs and medical devices. Advocates for transition point to the prevalence of off-label prescribing in paediatrics, but the legitimacy of some off-label uses does not license the prescription of any pharmaceutical to any patient for any reason.
The favourable risk/benefit threshold, or, more minimally, the precautionary threshold, must be met irrespective of whether the intervention has regulatory approval.
Off-label use of an intervention is sometimes justifiable based on studies of the intervention in a different patient population or for a different indication. Such use may be warranted when there is a reasonable expectation of benefit, when there are no superior alternatives, and when the prognosis, absent medical intervention, is predicted to be worse for the patient than the negative effects of the off-label drug.
This is decidedly not the situation with paediatric medical transition. The natural history of paediatric gender dysphoria is poorly understood, and decades of research has shown that early-onset gender dysphoria usually resolves without medical intervention. There is no compelling evidence that the same will not prove true in the case of adolescent-onset symptoms, and limited evidence suggesting it will.
And in any case, it is widely acknowledged that clinicians are unable to distinguish patients whose gender dysphoria will persist from those whose dysphoria will resolve.
Further, there are concerns about the role medicalisation itself may play in contributing to the persistence of the conditions being treated, and less invasive and less risky interventions are available. Lastly, medical intervention has known and plausible harms, and decades of research conducted by leading academic institutions have failed to produce reliable evidence of medical benefit.
More data?
A natural response among researchers to the absence of higher quality evidence is to conduct more and better research. Whether and how such research should be conducted, however, is a matter of significant ethical controversy. One controversy concerns randomised controlled trials, the “gold standard” for clinical research.
Some proponents of paediatric medical transition claim that randomised controlled trials on the effects of puberty blockers or cross-sex hormones would be infeasible and unethical. With respect to feasibility, because the effects of paediatric medical transition interventions are so apparent, it is not possible to blind5 researchers and participants in an randomised controlled trial for which the control group receives only psychotherapeutic support.
Some worry that many adolescents would refuse to participate in a study that does not guarantee they receive hormonal interventions, or that they would drop out if randomised to the control group. These challenges may be harder to overcome in the current climate in which adolescents have been led to believe that hormonal and surgical interventions are well supported by the evidence and even lifesaving.
However, randomisation does not require blinding, and until a randomised controlled trial is attempted, speculation about how potential participants will respond is just that—speculation.
With respect to research ethics, one objection to conducting randomised controlled trials is that such research would violate the principle of equipoise. In their textbook, Principles of Biomedical Ethics, Beauchamp and Childress explain that—
“The community of reasonable physicians is … in a state of ‘clinical equipoise’” when “no one knows, prior to conducting the research, whether it is more advantageous to be in the control group or in the experimental group … In this model, no patient, then, will receive something known to be less effective or to have a higher risk than an available alternative.”
Advocates for paediatric medical transition allege that it would violate the principle of equipoise to conduct a randomised controlled trial in which the control group receives only psychological counselling, “given the numerous studies associating adolescent gender-affirming interventions with improved mental health.”
This allegation is unfounded, however, because it mischaracterises the state of the science. Indeed, if equipoise were violated, it plausibly would be in the other direction, given the more certain evidence of harm.
In the end, while their reasons differ, there may be a point of agreement between proponents of paediatric medical transition and some of its critics concerning the impermissibility of conducting randomised controlled trials for hormonal or surgical interventions for paediatric gender dysphoria.
It is not clear that hormonal or surgical interventions for gender dysphoria can ethically be offered in a trial, irrespective of trial design. Currently, researchers in the UK are planning a puberty blocker trial. It has not yet received official ethics approval, and details regarding the trial’s design, which outcomes will be studied, what the inclusion and exclusion criteria will be, and so on, have not been published.
Some critics of paediatric medical transition already are raising concerns about the proposed study. They worry about prescribing puberty blockers even in research settings given the recognised inability of clinicians to distinguish between patients whose gender dysphoria will persist into adulthood from those whose dysphoria will resolve on its own.
Since most adolescents who take puberty blockers go on to cross-sex hormones, and since it is hormones and surgery that provide the sought-after physical characteristics in paediatric medical transition, it is unclear whether puberty blockers are a stand-alone treatment and should be studied as such.
Other critics point out that safer types of research—for example, research into various psychotherapeutic approaches—have yet to be explored with this population of patients. They also point out that US gender clinics have yet to collect longitudinal data on existing patients.6 There are other important ethical problems to consider.
The Nuremberg Code is a foundational and internationally accepted statement of norms guiding human subjects research and it includes the following—
“The experiment should be so designed and based on the results of animal experimentation and a knowledge of the natural history of the disease or other problem under study, that the anticipated results justify the performance of the experiment.”
This suggests that, insofar as paediatric medical transition poses risks that can be explored through animal studies, such studies should be conducted before these treatments are further tested on humans. Animal studies could help clarify how hormonal interventions affect fertility, brain development, bone development (including future risk of fracture), and cardiovascular outcomes. Such studies also could help clarify to what extent and under what conditions fertility can be recovered after suppression by hormonal interventions.
The World Medical Association’s Declaration of Helsinki is another foundational and internationally accepted statement of guidance for human subjects research. It says—
“All medical research involving human participants must be preceded by careful assessment of predictable risks and burdens to the individuals and groups involved in the research in comparison with foreseeable benefits to them and to other individuals or groups affected by the condition under investigation. Measures to minimise the risks and burdens must be implemented. The risks and burdens must be continuously monitored, assessed, and documented by the researcher.
“Physicians and other researchers may not engage in research involving human participants unless they are confident that the risks and burdens have been adequately assessed and can be satisfactorily managed.”
It is not ethical to subject adolescents to hormonal and surgical interventions used in paediatric medical transition, even in a research trial, until and unless the state of the evidence suggests a favourable risk/benefit profile for the studied intervention, and the researchers have well-grounded confidence that the foreseeable “risks and burdens have been adequately assessed and can be satisfactorily managed.”
The state of the science does not support a favourable risk/benefit profile, nor does it give researchers a basis for confidence that the risks of paediatric medical transition can be satisfactorily managed.
Finally, the Belmont Report, authorised by the National Research Act of 1974 and published in 1979 by the United States National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, is a landmark statement of ethical principles to guide human subjects research in the United States.
The Belmont Report affirms that research on humans should not be conducted until and unless that research is “justified on the basis of a favourable risk/benefit assessment” arrived at through “systematic, non-arbitrary analysis of risks and benefits.” It continues—
“Thus, there should first be a determination of the validity of the presuppositions of the research; then the nature, probability and magnitude of risk should be distinguished with as much clarity as possible …
“It should also be determined whether an investigator’s estimates of the probability of harm or benefits are reasonable, as judged by known facts or other available studies … [and] When research involves significant risk of serious impairment, review committees should be extraordinarily insistent on the justification of the risk (looking usually to the likelihood of benefit to the subject … ).”
The presuppositions that guide paediatric medical transition have not been shown to be valid; the nature, probability and magnitude of risks associated with such transition have not been distinguished with sufficient clarity; transition proponents’ estimates of the probability of harm and benefit have not been shown to be reasonable, as judged by known facts and available studies; and the risks of serious impairment that transition involves have not been shown to be justified.
For these reasons, administering paediatric medical transition to adolescents, even in a research context, is in tension with well-established ethical norms for human subjects research.
Commentary on the HHS Gender Dysphoria Report
The report’s strongest section was its overview of systematic reviews of the evidence confirming that “the primary studies [on paediatric medical transition] have serious limitations, leaving uncertainty about both benefits and harms,” Mark Helfand, professor of medicine at Oregon Health Sciences University told the British Medical Journal.
“However, [Professor Helfand] pointed to a double standard in elevating psychotherapy as an intervention—the report devoted an entire section to it—even though this too lacked strong evidence,” the BMJ reported.7
“The authors note that while there’s no strong evidence one way or another on the question of whether psychotherapy can alleviate gender dysphoria—in part because research into this area has been stunted by the frequent claim that anything short of medical transition is ‘conversion therapy’—there is strong evidence that psychotherapy can alleviate many of the symptoms often associated with gender dysphoria, like anxiety and depression. It follows, they argue, that psychotherapy should play a larger role in the treatment of youth with gender-related concerns…”—opinion article, Jesse Singal, The Dispatch, 1 May 2025
“This report misrepresents existing research and disregards the expertise of professionals who have been working with transgender and gender-diverse youth for decades.”—statement, the World Professional Association for Transgender Health, 2 May 2025
“Honest medical practitioners and experts have known from the beginning that child transgender treatments are risky and largely experimental. Yet honesty was never the goal for many activists, as the HHS report also shows.”—opinion article, Drs Stanley Goldfarb and Roy Eappen of Do No Harm, The New York Post, 1 May 2025
“The HHS has released a comprehensive report on the evidence, ethics, and clinical realities of treating gender dysphoria in youth. In a field marked by deep polarization and political overtones, this report stands out and deserves to be read and judged on its own merits.”—tweet, the Society for Evidence-based Gender Medicine, 2 May 2025
“[Release of the HHS report is] a watershed moment that affirms the concerns we’ve long raised. A US health agency now acknowledges poor evidence, real harms, and the urgent need for more responsible care for gender-distressed youth.”—tweet, Genspect, 3 May 2025
“‘I am glad that authorities in the US are finally taking into account what’s been going on in Europe in recent years,’ said Erica Anderson, a child psychologist and former president of the US Professional Association of Transgender Health. She has been vocal about her concerns that youth gender clinics have moved away from careful mental health assessments as the population of children seeking gender treatments has grown.”—news report, The New York Times, 1 May 2025
“[President] Trump has made hostility to gender ideology central to his political platform, and the [HHS] findings are expected to become highly politicised, with MAGA critics seizing on them to attack liberal doctors, who in turn are likely to criticise the [HHS] report.”—news report, The Times, 1 May 2025
“However, the independent researchers who conducted the [HHS] review, some of whom are political critics of Trump, hope for a fairer hearing from rank-and-file doctors around the world and have avoided making policy recommendations.
“‘For those who don’t support Trump—and that includes some of the authors—the choice is between bad and worse—bad is letting the Trump administration address this, worse is allowing this field of medicine to go completely unregulated and see kids sterilised and have breasts amputated with zero accountability,’ said a source close to the process.
“The 409-page report, whose authors remain anonymous, fearing threats and other reprisals, cites dozens of studies to support what they describe as ‘growing international concern’ about gender treatment for children.
“The four-year review for NHS England by the [British] paediatrician Baroness Cass has had a ‘profound influence of the international debates,’ they say. Although Cass has been criticised in the US by doctors in favour of ‘gender-affirming’ care, the [HHS] review says these attacks are ‘ridden with misrepresentations of the Cass review and contain multiple factual errors’.”
“The HHS report notes that major medical associations, the American Academy of Pediatrics, the Endocrine Society, the American Psychological Association, the American Academy of Child and Adolescent Psychiatry, the American Psychiatric Association, all continue to support what is known as gender-affirming care—that is, quick social and medical transitioning of gender dysphoric minors.”—news report, The Free Press, 3 May 2025
“The report questions this ‘apparent consensus.’ The authors note this unanimity is ‘driven primarily by a small number of specialised committees,’ adding that ‘it is not clear that the official views of these associations are shared by the wider medical community, or even by most of their members.’
“The report also notes that ‘there is evidence that some medical and mental-health associations have suppressed dissent and stifled debate about this issue among their members’.”
This excerpt from the HHS report begins at P219 in Chapter 13 on Ethical Considerations.
Chapter 5, from P79, discusses the systematic reviews. A short summary of the Swedish review and a link to its peer-reviewed paper are here.
A randomised controlled trial delivers high-quality evidence about the effects of a treatment by randomly assigning participants to a treatment group and a control group.
At Tanner Stage 2 of puberty, as early as age 8 for girls and 9 for boys.
Blinding refers to concealing which participants are assigned to the treatment group and which are in the control group, thereby minimising bias.
Lack of long-term data is a feature of youth gender clinics internationally. In the UK, critics of the proposed puberty blocker trial also argue that the priority should be to complete the “data linkage study” proposed by Baroness Cass, whereby the outcomes for the estimated 2,000 children given blockers at the Tavistock centre would be tracked through NHS adult clinics (most of which had refused to allow access to patient data for this purpose).
The HHS report notes the different risk/benefit ratios of psychotherapy and medical transition (see from P250). The report acknowledges the “very low certainty” of the evidence for psychotherapy as a direct treatment for gender dysphoria, but highlights the unclear causal relationship between dysphoria and the mental health conditions that typically come with it. For those conditions, non-invasive treatments including psychotherapy do have demonstrated benefits, the report argues.
An extraordinarily helpful and hopeful development. I hope Mr Butler reads this and that the PM’s commitment to ´kindness’ will entend to the protection of children from this horror. Thank you so much Bernard for your diligence and dedication to exposing this scandal.
Pretty sure that infertility results from the removal of the reproductive organs, some of which are done on minors....and some of these harms do not result in the absence of the interventions, a controlled study isn't needed. Ditto for some of the mastectomy outcomes.
They haven't studied the harms, perhaps they have no motivation? For instance, the consent forms or other information pages by the affirmative MD's tell patients taking estrogen to assume they will be infertile (permanently) after a few years, so much so that there was an excited NYT article about how maybe some fertility could be recovered--https://www.nytimes.com/2022/10/21/science/sperm-retrieval-essm-transgender-fertility.html .
They didn't bother studying it, didn't check. But they all assume it is the case that these people become infertile, and these are the MDs saying one should have these interventions in some cases! But they didn't do a study.
In comparison, for psychotherapy the HHS report notes, as you mention:
"'neither systematic review suggested that there is indication of harm
from psychotherapy.' One of the SRs concluded:
Most analyses of mental health, psychological and/or psychosocial outcomes
showed either benefit or no change, with none indicating any negative/ adverse
effects of the interventions offered."
Perhaps the long term UK outcomes that the Cass Review tried to get and which apparently will become available at some point would also be useful, or maybe the US could also start keeping track of the thousands of minors who have been started on this pathway since 2007! Or their histories until now could be studied. Perhaps those taking them already can be enrolled in the experiment after being properly informed of the risks/alternatives/how little is known (which probably didn't already happen, in the US). Or a record search can be done through insurance, long term. The experiment is being done --perhaps the outcomes should be gathered and studied!!