Last week, the U.S. Department of Health and Human Services (HHS) issued an official document entitled "Gender-Affirming Care and Young People." The document purported that the use of “gender-affirming” hormonal and surgical interventions for youth struggling with gender dysphoria is “crucial to overall health.” In light of the proposed rule announced by the HHS earlier this year mandating the provision of hormonal and surgical interventions, the debut of this official document carrying the official HHS seal is noteworthy.
Below, we fact-check the accuracy of the claims made in the newly-released HHS document. We also reflect on the process used by HHS to arrive at the conclusion that the “gender-affirming” care pathway must be scaled widely—at precisely the same time that a growing number of public health authorities (Sweden, UK, Finland) have come to the opposite conclusion and intend to tightly regulate the access of such interventions for youth.
HHS and the Office of Population Affairs
The HHS is a U.S. federal administrative agency that describes its mission as enhancing “the health and well-being of all Americans, by providing for effective health and human services and by fostering sound, sustained advances in the sciences underlying medicine, public health, and social services.” The HHS has authority from the Congress to make and enforce regulations specific to health care. These regulations, known as “rules,” are binding for healthcare entities that accept federal funding. For all practical purposes, these healthcare entities include nearly every physician, medical office, clinic, and hospital as nearly all accept federally subsidized Medicare, Medicaid, and private insurance purchased on exchanges.
The HHS is comprised of agencies and divisions. The document in question, entitled “Gender-Affirming Care and Young People,” was prepared by the HHS’s Office of Population Affairs (OPA), which resides within the Office of the Assistant Secretary for Health (OASH) led by Dr. Rachel Levine. The OPA website describes its charter this way:
The Office of Population Affairs (OPA), in the Office of the Assistant Secretary for Health, administers the Title X family planning, Teen Pregnancy Prevention, and Embryo Adoption Awareness programs. OPA advises the Secretary and the Assistant Secretary for Health on a wide range of reproductive and adolescent health topics, including teen pregnancy prevention, family planning, and sterilization, as well as other population issues.
Fact-checking the HHS OPA Document “Gender-Affirming Care and Young People”
The HHS OPA document makes some accurate claims, and many highly inaccurate ones. Below we fact-check the accuracy of the claims and reflect on the process used by HHS to arrive at such strong and significant claims.
The HHS accurately describes “gender-affirming care” as a series of interventions that are “aligning the outward, physical traits with their gender identity” through a cascade of progressively irreversible interventions starting with social transition, proceeding to endocrine interventions (puberty blockers and cross sex hormones) and culminating in surgery. Unfortunately, a number of the claims made in the document range from overreaching to highly misleading. Some of the key inaccuracies are outlined below:
- Misstatements of the effects of social transition on well-being. The document wrongly asserts that social transition improves functioning. In fact, the study cited by the HHS document (Sievert, et al., 2021) failed to find benefits of social transition. The study’s conclusion is apparent in its title: "Not social transition status, but peer relations and family functioning predict psychological functioning in a German clinical sample of children with Gender Dysphoria." More generally, the scientific debate about whether social transition is helpful, neutral, or harmful for a gender-dysphoric adolescent long term is not yet settled.
- Unsupported claim of the reversibility of puberty blockers. The document erroneously claims that puberty blockers are fully reversible and provides no citation to support this statement. While puberty blockers used to halt early (precocious) puberty have been shown to be reversible, no such studies exist for puberty blockers administered to stop normally timed puberty. The Cass review, currently being conducted in the UK to evaluate how to best care of gender-dysphoric youth, recently made this noteworthy statement in its interim report: “it is important that it is not assumed that outcomes for, and side effects in, children treated for precocious puberty will necessarily be the same in children or young people with gender dysphoria.” Concerns have been raised that puberty blockers are psychologically irreversible (since over 95% of all treated youth proceed to cross-sex hormones), that they may harm bone development, may permanently alter the brain, and that it is not yet known how they affect other vital organs, all of which undergo significant structural changes during uninterrupted puberty. In contrast to HHS’s confident assertions, its counterpart in the UK, the NHS, recently updated its guidance, removing statements about the reversibility of puberty blockers. Instead, the NHS now says: “Little is known about the long-term side effects of hormone or puberty blockers in children with gender dysphoria.”
- Inaccurate statement regarding the age eligibility for surgeries. The document incorrectly claims that "gender-affirming" surgeries are “typically used in adulthood or case by-case in adolescence.” This obscures the fact that, according to WPATH draft recommendations due to be finalized later this year, mastectomies are recommended to be broadly available starting at age 16 (and have been performed on children as young as 13 in this NIH-funded study), and surgeries to remove testes can be provided at 17.
- Overreaching claims of "proven benefits" of gender transition on adolescent mental health. The document mistakenly claims that "gender-affirming" hormones and surgeries have been proven to improve the mental health of adolescents. This overreaching statement is supported by three references: two studies based on non-probability samples incapable of determining causality due to their cross-sectional design, and one publication that refers to "emerging evidence" that such interventions improve mental health. It is notable that these claims of benefits coming from cherry-picked studies do not hold up when the entire body of evidence is properly evaluated in a systematic and reproducible way. Several recent systematic reviews of evidence conducted by public health authorities in European countries including the UK, Finland, and Sweden concluded that there is a lack of convincing evidence for the mental health benefit for children and adolescents of either puberty blockers or cross-sex hormones. The Swedish health authority came to an even more stark conclusion, stating, "the risks of puberty suppressing treatment with GnRH-analogues and gender-affirming hormonal treatment currently outweigh the possible benefits, and that the treatments should be offered only in exceptional cases."
- Omission of any discussion of risks. All treatments have potential benefits and harms. The HHS document only describes the potential benefits of "gender-affirming" care, with no mention of potential or known harms. Besides the risks to bone, cardiovascular health, and the risk of regret, the document conspicuously ignores risks to reproductive health. This omission is surprising considering that the Office of Population Affairs’ key focus is on adolescent reproductive health as well as issues of sterilization. When puberty blockers are administered in early puberty and followed by cross-sex hormones, sterility is expected. Even when fertility preservation is an option, most gender-dysphoric adolescents, particularly females, reject fertility preservation procedures. There are serious ethical questions about whether adolescents can be considered competent to waive their future reproductive rights at an age when they are unlikely to be able to appreciate or predict the importance of fertility to their adult selves.
- Conflation of distinctly different concepts. The HHS conflates “non-binary” and “transgender” presentations of gender dysphoria in youth. Publicly funded health systems in other part of the Western world, including Sweden and Finland, recognize that a much more conservative approach is needed for youth with non-binary identities. This is because the research that gave rise to the practice of early transition only studied youth with clear cross-sex identities. In addition, the document conflates four very different interventions: social affirmation, puberty blockers, hormone therapy, and "gender-affirming" surgeries. These interventions have different mechanisms of action and different outcomes, yet they are all considered together under the umbrella of “gender-affirming care.”
- Misleading information on the incidence of suicide and suicidality. The document cites alarmingly high rates of suicidal ideation in youth with gender dysphoria. These claims come from a low quality, non-probability online survey. Further, the document strongly implies that provision of "gender-affirming" hormones and surgeries will reduce suicides. In contrast, recent research from one of the world’s largest pediatric gender clinics estimated the rate of suicide in trans-identified youth as 0.03% over a 10-year period, which is comparable to youth presenting for care with mental health problems. Further, no study to date has demonstrated that transition reduces the rate of serious suicide attempts.
Reflections on the Process
From the perspective of evidence-based decision making, there are concerns about the manner in which this guidance was developed:
- Inadequate literature review. Claims about the effects of interventions should be supported by the best available evidence, which usually comes from systematic reviews that consider and appraise all available evidence. None of the nine studies cited meet these criteria. Because of the high likelihood of bias, picking and choosing specific articles to support a viewpoint is not an acceptable strategy for evidence-based decision making. Notably, recent comprehensive systematic reviews of evidence found the risk/benefit ratio of pediatric gender transition to be highly uncertain. In addition to the nine cited references, the document also provides three additional sources of information. The first is the Endocrine Society practice guidelines, evidence-based guidelines that adhere to key methodological standards. Scrutiny of this document reveals the following: (1) low or very low certainty/quality evidence supporting most recommendations, and (2) recommendations about providing puberty blockers and cross-sex hormones are graded as weak recommendations, and consideration of balancing benefits and harms is included in the recommendation. If anything, this source highlights the nuance and complexity of decisions about "gender-affirming" care, which are not reflected in the HHS document. The second source is a policy statement from the American Academy of Pediatrics, and the third is the WPATH Standards of Care version 7. These documents have been critiqued by researchers for their lack of rigor. They contain narrative reviews of literature that do not appear to have been collected systematically, as well as recommendations that were not developed using rigorous methodological standards. As such, they share similar limitations to those inherent in the HHS document, particularly the risk of bias.
- Biased recommendations that do not acknowledge the low quality of evidence. The evidence base for hormonal and surgical interventions for youth is widely recognized as low to very low quality by all systematic reviews to date. The designation of "low quality/low certainty evidence" means that there is a high likelihood that the patients will not experience the effects of the proposed interventions. In the context of providing puberty blockers and cross-sex hormones, this designation signals that the body of evidence asserting the benefits of these interventions is highly unreliable. When recommendations are based on low quality evidence, they can only be graded as "conditional." The “conditional” nature of recommendations has important implications for patients, physicians, and policymakers. Specific to policymaking, which is HHS’s prerogative, a “conditional recommendation” means that “there is a need for substantial debate and involvement of stakeholders.” None of this is reflected in the document, which strongly recommends to treat gender-distressed youth with hormones and surgeries.
- Failure to consult a range of stakeholders with diverse views. To date, there has been no attempt by HHS to gather feedback from a wide range of clinicians and patients with diverse experiences with "gender-affirming" care—not only those who claim its benefits, but also those who have experienced or are concerned about the harms. This includes the growing number of professionals who offer options for noninvasive resolution of gender-related distress, young detransitioners who assert that they have been harmed by "gender-affirming" interventions, as well as parents concerned that risks of "gender-affirming" interventions for youth outweigh the benefits. Considering only one side of a complex issue compromises the objectivity and credibility of the recommendations.
- Lack of identification or acknowledgement of alternatives. The document presents "gender-affirming" care as the only option for gender-diverse children and adolescents. The HHS fails to acknowledge that there are other treatment options for these youth such as psychotherapy. Treatment decision-making requires awareness, assessment, and comparison of all relevant options, and should be provided in this document.
Even though the HHS document is carefully worded and does not make explicit recommendations, is it very likely that the public will infer from it that the only reasonable option is to provide "gender-affirming" care to gender-diverse children and adolescents. This incomplete representation of the relevant issues is likely to mislead the public to believe that this is the best and only alternative, particularly when no other alternatives are mentioned. The public is also likely to erroneously assume that the risks of affirmative care are low. Patients and families are not capable of providing valid informed consent when the information they receive is inaccurate and incomplete.
All gender-diverse, gender-dysphoric, or gender-incongruent people deserve respect, compassion, and high-quality, evidence-based care exemplifying “conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients.” Unfortunately, because the quality of evidence in gender medicine is very low, what constitutes high-quality care is far from clear. Our concern for gender-dysphoric youth is compounded by a recent surge of minors and young adults with a new, poorly understood presentation of gender dysphoria, complicated by multiple mental health issues. Administering irreversible interventions that are not based on high quality reliable scientific evidence to a cohort of youth for whom they were never intended only intensifies the risk and potential for poor outcomes.
HHS counterparts in a growing number of European countries are rigorously evaluating how their health systems should care for the skyrocketing numbers of gender-dysphoric youth. Increasingly, these countries are advising against and sharply limiting unfettered access to pediatric gender transition and are instead prioritizing mental health support as the first line of treatment. For example, Dr. Hilary Cass, who is leading the UK Cass Review tasked with evaluating how to care for gender dysphoric youth, has conducted an exemplary process of policy development. Sweden and Finland also adhered to rigorous policy development processes to address this complex matter. Most recently, the National Academy of Health in France has signaled a move in a similar direction.
On its website, the HHS states: “While HHS is a domestic agency working to protect and promote the health and well-being of the American people, the interconnectedness of our world requires that HHS engage globally to fulfill its mission.” It is our hope that the HHS can leverage the findings of these progressive countries as they choose to prioritize the long-term health of youth rather than yielding to political agendas and expediency.