Gender-affirming care is not “experimental”

In 2022 alone, fifteen states introduced a total of 25 bills intended to restrict access to gender-affirming (GA) care to trans children and adolescents. (“Trans,” a common abbreviation for “transgender,” is used here as an umbrella term to describe people whose gender identity does not align with the gender to which they were assigned at birth, and GA care includes medical, surgical, mental health, and non-medical care intended to affirm trans people in their gender identity.) Some of these bills even go so far as to criminalize GA care; for example, the Alabama law would make it a felony punishable by up to 10 years in prison for medical providers found “guilty” of prescribing gender-affirming puberty blockers and hormones to people under age 19. As a result of these legislative efforts, over 58,000 trans youth could potentially lose access to GA care, depending on how many become law and in which states.

The predominant theme of these bills is the claim that GA care is “experimental.” This false claim is commonly used as the primary justification for outlawing such care. Indeed, Arkansas, Louisiana, and Ohio bills even share the very same name, the Save Adolescents from Experimentation (SAFE) Act, and the preambles of many of these bills characterize GA care as not just experimental but harmful, while also making false scientific claims about biology, sex and gender, gender dysphoria, and the psychological and medical care of gender dysphoria. In this, these bills are reminiscent of the strategy that antivaxxers have used to demonize COVID-19 vaccines in which they portray them as “experimental” and therefore dangerous, even to the point of making false claims that these vaccines violate the Nuremberg Code.

For example, Ohio HB454, Arkansas HB1570, and Louisiana HB570 are bills that are essentially largely copy-and-pasted from each other, and all three state that the use of GA hormones in “biological females”—terminology that is inaccurate, as explained here—results in an increased risk of breast and uterine cancers. Evidence is limited for these claims. Indeed, in available studies, transmasculine people (assigned female at birth—or AFAB—people who are on gender-affirming testosterone) have been found to have, if anything, a lower risk of breast cancer and endometrial cancer and certainly no increased risk of ovarian cancer compared to cis women. This is just the start of the bad and cherry-picked science used in these bills to justify outlawing GA care.

The bills also state:

The risks of gender transition procedures far outweigh any benefit at this stage of clinical study on these procedures.

This assertion is, quite simply, untrue. A systematic literature review of research from 1991 to 2017 noted 52 studies showing overall improvement in the well-being of trans people following GA medical and/or surgical interventions, four studies showing mixed or null findings, and zero studies that GA interventions cause overall harm. More recent studies confirm that gender-affirming care can be immensely beneficial in properly selected candidates.

Another common theme in these bills is the demonization of surgical procedures used for gender reassignment by at least implying—and often stating outright—that such surgeries are “genital mutilation” carried out on children. For example, Kansas SB214 would outlaw all “gender reassignment” surgeries for trans people under age 18 (the almost identical Idaho HB675 straight-out calls such surgeries “genital mutilation of a child”), exempting those youth with differences in sex development or who are intersex. To Kansas legislators, normalizing genitals is, apparently, more important than considering the harms of forced genital surgery. (Kansas lawmakers likely believe that making genitals look “normal” prevents “gender confusion”.) Ironically, intersex surgeries are not medically necessary, while in contrast gender-affirming surgeries can be. In addition, GA bottom surgery (a colloquialism for genital and reproductive system surgeries, including phalloplasty, vaginoplasty, hysterectomy, and metoidoplasty) is rare before patients are of legal age to provide informed consent themselves.

Ignoring these facts, Alabama SB184 and HB266 nonetheless state:

Some in the medical community are aggressively pushing for interventions on minors that medically alter the child’s hormonal balance and remove healthy external and internal sex organs when the child expresses a desire to appear as a sex different from his or her own.

There is a vast difference between gender affirmation and “aggressive pushing” of GA medical and surgical care. The latter description uses intentionally-fearmongering language that implies that doctors are somehow bullying children into transitioning and pushing their parents to provide consent for GA care. I would suggest that it is aggressive to outlaw and criminalize health care for those who are already marginalized. Additionally, once again it must be emphasized that genital surgery for gender reassignment is rarely carried out on patients with gender dysphoria who are under 18, intersex patients excepted.

The Alabama bill also claims:

Minors, and often their parents, are unable to comprehend and fully appreciate the risk and life implications, including permanent sterility, that result from the use of puberty blockers, cross-sex hormones, and surgical procedures.

Their parents are unable to comprehend? By that logic, we should outlaw everyone’s GnRH agonists, hormone therapy, and surgical procedures such as breast augmentation! Such is the quality of the arguments being made in support of these bills, right in the bills themselves!

Experimental medicine

The argument that GA care is experimental is not new but continues to re-emerge and be used to argue against offering such care to minors. As Ari Drennen, LGBTQ program director for Media Matters for America, noted on Twitter:

The new right wing angle of attack is that NO trans people should have access to hormone replacement therapy because it’s “experimental.” Trans people have literally taken cross-sex hormones since at least 1918. Governor DeSantis’ move is illegal, dangerous and based on lies.

What makes a medical or surgical intervention “experimental”, though, as opposed to standard of care or an accepted option? The American Psychological Association defines an experimental treatment as “an intervention or regimen that has shown some promise as a cure or ameliorative for a disease or condition but is still being evaluated for efficacy, safety, and acceptability”. In general, experimental medical care and surgical procedures are not considered an acceptable standard of care for the treatment of the condition for which they are being evaluated and are generally still undergoing clinical trials to assess them for efficacy and safety. Some will be found in these clinical trials to be safe and effective, while most others will not and be abandoned.

Here I will argue that gender-affirming medicine is, by definition, not experimental, no matter how often it is characterized explicitly as such in bills introduced in Alabama, Arizona, Kansas, Louisiana, Missouri, Oklahoma, and Ohio. I will begin by discussing examples of medicine that is still considered experimental for comparison. After that, I will further break down the tenants of efficacy, safety, and acceptability for GA care.

There are many areas of health care that employ experimental medicine. Examples include gene therapy trials for cancer treatment, or the use of bacteriophages for bacterial infections. Experiments in medicine are necessary to advance the study of treatments and is widely accepted. In contrast to the use of the term “experimental” to describe such investigational treatments, in trans health care, the term “experimental” seems to be used exclusively as a derisive tagline to dismiss GA care. The intent behind this disparaging and dismissive use is to promote the view is that the safety and efficacy of GA care is so much in doubt that it cannot be generally used and requires more clinical trials to evaluate its efficacy and safety before it can be recommended. Of course, there is also a not-so-subtle implication behind labeling GA care “experimental”, namely that it is also dangerous, which then often leads to further claims that clinical trials of GA care would be unethical. In essence, those promoting these bills seem to be deceptively conflating experimental medicine (i.e., unproven treatments) with “disproven” treatments, safe in the knowledge that most people outside of medicine will not know the difference.

Let us move on to consider the efficacy and safety of GA care.

Efficacy of gender-affirming medicine

The World Professional Association for Transgender Health (WPATH), considered by many to be the leader in promoting evidence-based trans health care, has endorsed GA surgery and medical therapy to be effective and often life-saving care. The treatment efficacy of GnRHa in delaying puberty in trans youth has been thoroughly documented in scientific studies and publications since the 1990s. Studies support the conclusion that trans children supported in their gender identity by their families have rates of depression comparable to their cisgender peers. Studies suggest that youth that access gender-affirming care have improved body satisfaction and self-esteem, which is protective against poorer mental health and supports healthy relationships with parents and peers. Research consistently demonstrates that trans youth affirmed in their gender identity by their families have significantly better health outcomes. Moreover, social and medical gender affirmation is inversely related to mental health problems in trans people.

Safety of gender-affirming medicine

It is essential to point out that puberty blockers, which are widely used to treat precocious puberty, seem only to be considered “experimental” and “dangerous” when used as part of GA treatment for pubescent trans youth. Some equate the use of off-label medications to experimental use of said medications. Off-label drug use is the common practice of prescribing an available medication for an indication that the FDA has not approved. Once medications are on the market, the FDA does not control or limit how health care providers prescribe them.

Off-label use of gender-affirming treatment, such as puberty blockers in youth, does not make the treatment “experimental”. Again, GnRH analogs have been the gold-standard treatment in children with central precocious puberty since the 1960s and used in trans youth since the 1980s. When used in cis children, puberty blockers “have an enviable track record of safety and efficacy“. Puberty blockers are used similarly in trans youth once they hit puberty to halt permanent changes. It should be emphasized that the effects of blockers are both temporary and reversible.

Standard of care and gender-affirming medicine

One thing that nearly all standard of care treatments for any condition have in common is that they are recommended and endorsed by major professional societies after evaluation of existing evidence in the peer-reviewed medical literature by an expert panel. While those who seek to deny science-based medicine view this argument as an “appeal to authority”, an appeal to such an authority is not a logical fallacy when the authority is legitimate. Personally, I like to look at an appeal to expert consensus as nothing more than a convenient shorthand for referring to the existing evidence base. Moreover, general expert consensus statements from such medical societies always include lengthy discussions of the evidence, including strengths and weaknesses, upon which consensus recommendations are based, often also graded by the strength of the evidence supporting each recommendation.

WPATH has been publishing standards of care (SOC) for trans health care since 1979, and GA care is endorsed by every major medical association. It is currently the standard of care for treating trans patients, be they an adult or adolescent. Contrary to a newly released and deeply flawed Heritage Foundation “study” that claims that access to GA care is associated with an increase in suicides (which was not even published in the peer reviewed medical literature), better quality research has consistently concluded that access to GA care can be lifesaving and improves mental health outcomes in trans youth. Indeed, trans youth thrive in supportive environments. Overall, the existing research base overwhelmingly supports an affirmative approach.

Indeed, even the American Medical Association (AMA)—definitely not a “woke” or even liberal organization—passed a resolution in 2008 supporting health insurance coverage for GA care of gender dysphoria that included the following passage:

Health experts in GID, including WPATH, have rejected the myth that such treatments are “cosmetic” or “experimental” and have recognized that these treatments can provide safe and effective treatment for a serious health condition.

The Dept. of Health and Human Services (HHS) has reaffirmed HHS support and protection of LGBTQ youth and has issued new guidance to clarify the topic of non-discrimination related to gender identity; as KFF.org, a ‘nonpartisan source of facts, analysis and journalism for policymakers, the media, the health policy community and the public,’ note:

Specifically, the guidance states that categorically refusing treatment based on gender identity is prohibited discrimination under Section 1557. The guidance also states that Section 1557’s prohibition against sex-based discrimination is likely violated if a provider reports parents seeking medically necessary gender affirming care for their child to state authorities, if the provider or facility is receiving federal funding. The guidance further states that restricting a provider from providing gender affirming care may violate Section 1557.

It is, quite simply, a misrepresentation of what a standard of care is in medicine and of what constitutes “experimental” medical interventions to argue that GA care is “experimental”. It is not. GA care is the current standard of care. That the evidence base is not as certain or settled as it is for, to cite examples, the evidence base supporting the current standards of care for various cancers, diabetes, hypertension, and the like does not make GA care for trans youth “experimental” any more than the same considerations make a lot of psychiatric care “experimental”. Moreover, that the standard of care will likely change in the future as new evidence accumulates does not make GA care now experimental, any more than the discovery that peptic ulcers are mainly due to bacteria (H. pylori) that can be well-treated with antibiotics rendered the past treatment of peptic ulcer disease somehow “experimental”.

Standards of care and clinical guidelines evolve and are regularly updated, which is why physicians have continuing education and board recertification requirements; it is imperative for us to stay on top of the latest available information. These evolving standards of care do not negate prior standards; both reflect the latest science-based evidence, and new standards of care supplant older ones as new evidence is accumulated. Indeed, new standards of care should supplant older ones based on evidence; if this were not the case, doctors would still be using bloodletting for nearly everything and commonly treating patients with concoctions that include cadmium and other toxic heavy metals.

Uncertainty in medicine

William Osler characterized medicine as “a science of uncertainty and an art of probability”.

Opponents of trans care often point to the lack of randomized control trials of gender affirmation, ignoring that such trials would be near-impossible to carry out and often unethical. RCTs can show whether a treatment is better than a placebo. In application, however, carrying out an RCT in which one group of trans youth is randomized to GA treatment and the other to placebo is arguably unethical because there would not be clinical equipoise between the groups; i.e., genuine uncertainty about which group, control or experimental, would fare better or worse, which would suffer more harm or more benefit. Let me elaborate with an example. Where puberty blockers can stop distressing characteristics of an unwanted puberty from developing, withholding them from a control group would likely intensify feelings of distress, depression, anxiety, and dysphoria. Also, how does one randomize and double-blind an RCT in which the group receiving GA interventions will always feel the physical effects of treatment? We know that gender-affirming hormones cause physical changes (or, as with blockers, the lack of pubertal changes), while the placebo group will not show these changes. An RCT to demonstrate the efficacy of gender-affirming therapy is redundant.

RCTs are also very difficult to carry out in small, historically under-researched, and minoritized populations. As noted by a publication of the Symposium on Evidence Based Medicine:

Small trials are methodologically challenging: the smaller a trial, the larger the treatment effect necessary for the results to be significant, so that it is easy to miss small effects that may be clinically, but not statistically, significant. Trials that show no statistically significant benefit are less likely to be published, and so less likely to make their way into systematic reviews and thus into the accepted evidence base. Other reasons why small studies that target disadvantaged populations are unlikely to be performed concern the funding of research and the comparative nature of many studies.

Further, although RCTs are considered the gold standard of medical evidence, they are not infallible; for example, patients in trials are not always representative of patients in the real world.

Upcoming research is evolving to include hard-to-reach and often omitted demographic groups and to work with instead of on trans people. There is a need for larger-scale studies that have questions about gender identity, notably absent in prior research, recruitment in rural areas as well as metropolitan, the inclusion of intersectional minorities overlooked and ignored by the system, and analysis of the specific factors that predict rejecting family behaviors and those that contribute to positive climates. Again, the existence of these gaps in our knowledge about who benefits most from GA care does not make GA care “experimental,” any more than uncertainty over which groups benefit most from different approaches to, for example, treating hypertension makes, for example, antihypertensive treatment “experimental.” People who are historically minoritized due to issues such as systemic racism have been excluded or underrepresented in studies on hypertension, aspirin use, diabetes, and cancer screening; further research will hopefully fill these gaps and inform new recommendations and guidelines. This does not make current hypertension guidelines, heart disease treatment and diabetes treatment, or preventive health measures “experimental”.

A closer look at some of the bills outlawing GA care

Trans Formations, a nonprofit “providing actionable information on harmful anti-trans legislation,” has detailed descriptions of all proposed, active, passed, and failed bills. The following are a few examples.

Alabama’s recent Vulnerable Child Compassion and Protection Act (V-CAP) makes the provision of gender-affirming care to minors a Class C felony punishable by a $15,000 fine or up to 10 years in prison or both. Thankfully, a federal judge has issued a preliminary injunction to stop Alabama from enforcing the legislation. Unfortunately, the law includes an unblocked provision requiring schools to tell parents if their child discloses to a school official that they might be trans, putting those with unsupportive home environments at risk.

Texas Gov. Abbott and Attorney General Paxton recently moved to categorize gender affirmation for youth as child abuse and investigate and criminalize families who support their trans children in receiving age-appropriate gender-affirming care. A temporary injunction has halted the investigations. Yale Law School and Yale School of Medicine have issued a report examining the claims underlying the reasoning of the Texas bill and found both errors of omission and inclusion and that the medical claims were not grounded in reputable science.

Florida Gov. DeSantis’ administration is recommending to the Florida Board of Medicine that they ban gender-affirming care for minors and all Medicaid recipients, meaning a ban on all trans-related care for adults and minors on state insurance. This two-pronged tactic ensures quick action and avoids legislative approval. Last year, DeSantis signed the “Fairness in Women’s Sports Act“, a law preventing trans girls from competing on girls’ high school and college sports teams. He recently made a proclamation declaring a cisgender woman the “rightful winner” in the NCAA’s first division swimming championship won by transgender woman Lia Thomas, and in March, signed the colloquially-titled “Don’t Say Gay” bill (the “Parental Rights in Education” bill), that restricts education on gender identity and sexual orientation in public schools.

On June 2, Florida State surgeon general and secretary of the Florida Dept of Health Joseph Ladapo sent a letter to the Florida Board of Medicine recommending against not just surgical and pharmaceutical GA interventions for trans adolescents, but even non-pharmacological interventions. Ladapo has created prior controversy with his anti-mask stance, opposition to vaccine mandates, promotion of quack COVID treatments such as hydroxychloroquine, and an emergency rule that discriminates against Black farmers applying for medical marijuana licensure. He has also recommended against COVID vaccines for healthy children aged 5 to 17, making Florida the first state to do so formally. His recommendation was cherry-picked from three studies which in fact concluded that vaccines are safe and effective.

In his recent letter to the state medical board, Ladapo wrote:

As State Surgeon General, I recommended against certain pharmaceutical, non-pharmaceutical, and surgical treatments for gender dysphoria. The recommendations are based on a lack of conclusive evidence and the high risk for long-term, irreversible harms from these treatments…The current standards set by numerous professional organizations appear to follow a preferred political ideology instead of the highest level of generally accepted medical science. Florida must do more to protect children from politics-based medicine. Otherwise, children and adolescents in our state will continue to face a substantial risk of long-term harm.

Ladapo sources guidance released on April 20 by the Florida Dept of Health, which directly contradicts federal guidance by the HHS and has already been refuted by more than 300 Florida health care professionals, as well as the report of an investigation conducted by the Agency for Health Care Administration, which was released on June 2.

The report summary, ironically titled “Let Kids Be Kids*”, has been condemned by WPATH and the United States Professional Association for Transgender Health (USPATH), which had also previously debunked research cited in the April 20^th guidance.
*writer’s note: unless they’re trans.

Prevent Child Abuse America, “the nation’s oldest and largest organization committed to preventing child abuse and neglect before it happens“, issued a statement reacting to the Texas AG’s opinion and in support of gender-affirming care:

Prevent Child Abuse America (PCA America) knows that providing necessary and adequate medical care to your child is not child abuse and that transgender and non-binary children need access to age-appropriate, individualized medical care just like every other child.

Regardless of the outcomes on a state and federal level, the current political debates have detrimental consequences. The Trevor Project’s National Survey on LGBTQ Youth Mental Health 2021 found that recent politics negatively impacted 94% of LGBTQ youths’ mental health. South Dakota was the first state to enact an anti-trans bill in 2022; 90% of LGBTQ youth in South Dakota are diagnosed with depression or anxiety.

As Adm. Rachel Levine, MD, U.S. Assistant Secretary for Health, has stated:

Trans youth in particular are being hounded in public and driven to deaths of despair at an alarming rate. Fifty-two percent of all transgender and nonbinary young people in the U.S. seriously contemplated killing themselves in 2020. Think about how many of them thought it was better to die than to put up with any more harassment, scapegoating and intentional abuse.

In addition, trans people are more than four times as likely as cis people to be victims of violence and inadequate police and legal protection. 74 elected law enforcement leaders and prosecutors summed up the criminalization of GAM in a joint statement:

Bills that criminalize safe and crucial medical treatments or the mere public existence of trans people do not promote public safety, community trust, or fiscal responsibility. They serve no legitimate purpose…we do not support the use of scarce criminal justice and law enforcement resources on criminalization of doctors who offer medically necessary, safe gender-affirming care to trans youth, parents who safeguard their child’s health and wellbeing by seeking out such treatments, or any individuals who use facilities aligned with their gender identity.

Conclusion: Politicians should not dictate medical care

Bills cannot claim to protect kids while harming them. Medical experts support gender-affirming care; politicians should not be interfering in medical decisions made between a health care provider and their patients. Contrary to the rationale used to justify bills outlawing GA care in adolescents and making such care more difficult for adults to access, even with the uncertainties in the evidence base for treating gender dysphoria and trans youth, GA care is not experimental. Rather, it is the standard of care. Laws seeking to ban GA care are no more science-based than laws seeking to make ivermectin available over-the-counter to treat COVID-19, to limit school vaccine mandates, or to license naturopathy and other pseudomedicine. They are, as recently retired SBM editor Jann Bellamy used to like to describe laws legalizing pseudomedicine, legislative alchemy.