Florida Medicaid

Generally Accepted Professional

Medical Standards Determination on
the Treatment of Gender Dysphoria

June 2022

Ron DeSantis, Governor

Simone Marstiller, Secretary
Contents
Contents ............................................................................................................................................1
Introductory Remarks and Abstract ....................................................................................................2
Health Service Summary ....................................................................................................................4
Literature Review: Introduction..........................................................................................................9
Literature Review: Etiology of Gender Dysphoria .............................................................................. 10
Literature Review: Desistance of Gender Dysphoria and Puberty Suppression ................................... 14
Literature Review: Cross-Sex Hormones as a Treatment for Gender Dysphoria .................................. 17
Literature Review: Sex Reassignment Surgery ................................................................................... 23
Literature Review: Quality of Available Evidence and Bioethical Questions ....................................... 27
Coverage Policies of the U.S. and Western Europe ............................................................................ 31
Generally Accepted Professional Medical Standards Recommendation ............................................. 37
Works Cited ..................................................................................................................................... 39
Attachments .................................................................................................................................... 45

1
Introductory Remarks and Abstract
Generally Accepted Professional Medical Standards

The Secretary of the Florida Agency for Health Care Administration requested that the Division of Florida
Medicaid review the treatment of gender dysphoria for a coverage determination pursuant to Rule 59G-
1.035, Florida Administrative Code (F.A.C.) (See Attachment A for the Secretary’s Letter to Deputy
Secretary Tom Wallace). The treatment reviewed within this report included “sex reassignment
treatment,” which refers to medical services used to obtain the primary and/or secondary physical
sexual characteristics of a male or female. As a condition of coverage, sex reassignment treatment must
be “consistent with generally accepted professional medical standards (GAPMS) and not experimental
or investigational” (Rule 59G-1.035, F.A.C., see Attachment B for the complete rule text).

The determination process requires that “the Deputy Secretary for Medicaid will make the final
determination as to whether the health service is consistent with GAPMS and not experimental or
investigational” (Rule 59G-1.035, F.A.C.). In making that determination, Rule 59G-1.035, F.A.C., identifies
several factors for consideration. Among other things, the rule contemplates the consideration of
“recommendations or assessments by clinical or technical experts on the subject or field” (Rule 59G-
1.035(4)(f), F.A.C.). Accordingly, this report attaches five assessments from subject-matter experts:

 Attachment C: Romina Brignardello-Petersen, DDS, MSc, PhD and

Wojtek Wiercioch, MSc, PhD: Effects of Gender Affirming Therapies in
People with Gender Dysphoria: Evaluation of the Best Available
Evidence. 16 May 2022.
 Attachment D: James Cantor, PhD: Science of Gender Dysphoria and
Transsexualism. 17 May 2022.
 Attachment E: Quentin Van Meter, MD: Concerns about Affirmation of
an Incongruent Gender in a Child or Adolescent. 17 May 2022.
 Attachment F: Patrick Lappert, MD: Surgical Procedures and Gender
Dysphoria. 17 May 2022.
 Attachment G: G. Kevin Donovan, MD: Medical Experimentation
without Informed Consent: An Ethicist’s View of Transgender Treatment
for Children. 16 May 2022.

Abstract

Available medical literature provides insufficient evidence that sex reassignment through medical
intervention is a safe and effective treatment for gender dysphoria. Studies presenting the benefits to
mental health, including those claiming that the services prevent suicide, are either low or very low
quality and rely on unreliable methods such as surveys and retrospective analyses, both of which are
cross-sectional and highly biased. Rather, the available evidence demonstrates that these treatments
cause irreversible physical changes and side effects that can affect long-term health.

Five clinical and technical expert assessments attached to this report recommend against the use of
such interventions to treat what is categorized as a mental health disorder (See attachments):

 Health Care Research: Brignardello-Petersen and Wiercioch performed

a systematic review that graded a multitude of studies. They conclude

2
 that evidence supporting sex reassignment treatments is low or very
low quality.
 Clinical Psychology: Cantor provided a review of literature on all aspects
of the subject, covering therapies, lack of research on suicidality,
practice guidelines, and Western European coverage requirements.
 Plastic Surgery: Lappert provided an evaluation explaining how surgical
interventions are cosmetic with little to no supporting evidence to
improve mental health, particularly those altering the chest.
 Pediatric Endocrinology: Van Meter explains how children and
adolescent brains are in continuous phases of development and how
puberty suppression and cross-sex hormones can potentially affect
appropriate neural maturation.
 Bioethics: Donovan provides additional insight on the bioethics of
administering these treatments, asserting that children and adolescents
cannot provide truly informed consent.

Following a review of available literature, clinical guidelines, and coverage by other insurers and nations,
Florida Medicaid has determined that the research supporting sex reassignment treatment is insufficient
to demonstrate efficacy and safety. In addition, numerous studies, including the reports provided by the
clinical and technical experts listed above, identify poor methods and the certainty of irreversible
physical changes. Considering the weak evidence supporting the use of puberty suppression, cross-sex
hormones, and surgical procedures when compared to the stronger research demonstrating the
permanent effects they cause, these treatments do not conform to GAPMS and are experimental and
investigational.

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Health Service Summary
Gender Dysphoria

Frequently used to describe individuals whose gender identity conflicts with their natural-born sex, the
term gender dysphoria has a history of evolving definitions during the past decades (Note: This report
uses the term “gender” in reference to the construct of male and female identities and the term “sex”
when regarding biological characteristics). Prior to the publication of the Fifth Edition of the Diagnostic
and Statistical Manual of Mental Disorders (DSM-V), the American Psychiatric Association (APA) used
the diagnosis of gender identity disorder (GID) to describe individuals who sought to transition to the
opposite gender. However, behavioral health clinicians sought a revision after determining that using
GID created stigma for those who received the diagnosis. This is despite the APA having adopted GID to
replace the previous diagnosis of transsexualism for the exact same reason (APA, 2017).1

When crafting its new definition and terminology, the APA sought to remove the stigma of classifying as
a disorder the questioning of one’s gender identity by focusing instead on the psychological distress that
such questioning can evoke. This approach argues that individuals seeking behavioral health and
transition services are doing so due to experiencing distress and that gender non-conformity by itself is
not a mental health issue. This led to the adoption of gender dysphoria in 2013 when the APA released
the DSM-V. In addition to using a new term, the APA also differentiated the diagnosis between children
and adolescents and adults, listing different characteristics for the two age groups (APA, 2017).

According to the DSM-V, gender dysphoria is defined as “the distress that may accompany the
incongruence between one’s experienced or expressed gender and one’s assigned gender.” As for the
criteria to receive the diagnosis, the APA issued stricter criteria for children than adolescents and adults.
For the former, the APA states that a child must meet six out of eight behavioral characteristics such as
having “a strong desire to be of the other gender or an insistence that one is the other gender” or “a
strong preference for cross-gender roles in make-believe or fantasy play.” The criteria for adults and
adolescents are less stringent with individuals only having to meet two out of six characteristics that
include “a strong desire to be the other gender” or “a strong desire to be rid of one’s primary and/or
secondary sexual characteristics.” The APA further notes that these criteria can also apply to young
adolescents (DSM-V, 2013).

In 2021, the Merck Manual released a slightly different definition for gender dysphoria, citing that the
condition “is characterized by a strong, persistent cross-gender identification associated with anxiety,
depression, irritability, and often a wish to live as a gender different from the one associated with the

1
The concept of gender being part of identity and disconnected from biological sex originated during the mid-
twentieth century and was publicized by psychologist John W. Money. His research asserted that gender was a
complete social construct and separate from biology, meaning that parents and/or caregivers could imprint on a
young child (under three years) the identity of a boy or girl. In 1967, Money’s theories led to a failed experiment
on twin boys where physicians surgically transitioned one to appear as a girl. The twin that underwent sex
reassignment never fully identified as a female. However, Money never publicly acknowledged this and reported
the experiment as a success. Furthermore, he promoted his conclusions across the scientific community,
concealing what actually unfolded. As a result, Money’s ideas on gender fluidity served as a basis for performing
procedures on children with hermaphroditic features or genital abnormalities. The case reveals how the
understanding of a concept (e.g., gender) at any given time can lead to incorrect medical decisions with
irreversible consequences (Gaetano, 2015).

4
sex assigned at birth.” Additionally, the Merck Manual further states that “gender dysphoria is a
diagnosis requiring specific criteria but is sometimes used more loosely for people in whom symptoms
do not reach a clinical threshold” (Merck Manual, 2021). This definition is largely consistent with the
DSM-V but does not emphasize the distress component to the same extent. 2

Like other behavioral health diagnoses classified in the DSM-V, gender dysphoria has the following
subtypes:

 Early-Onset Gender Dysphoria: This subtype begins during childhood and persists through
adolescence into adulthood. It can be interrupted by periods where the individual does not
experience gender dysphoria signs and may classify as homosexual (DSM-V, 2013).
 Late-Onset Gender Dysphoria: Occurring after puberty or during adulthood, this subtype does
not begin until late adolescence and can emerge following no previous signs of gender
dysphoria. The APA attributes this partially to individuals who did not want to verbalize their
desires to transition (DSM-V, 2013).

Further studies have identified additional subtypes of gender dysphoria. In 2018, Lisa Littman
introduced the concept of a rapid-onset subtype. Classified as rapid-onset gender dysphoria (ROGD), it
features characteristics such as sudden beginnings during or following puberty. However, it differs from
the DSM-V definitions because ROGD is associated with other causes such as social influences (e.g., peer
groups, authority figures, and media). In other words, adolescents who had no history of displaying
typical gender dysphoria characteristics go through a sudden change in identity following intense
exposure to peers and/or media that heavily promotes transgender lifestyles (Littman, 2018). While
more long-term studies are needed to confirm whether ROGD is a temporary or long-term condition,
Littman’s study has initiated discussions regarding potential causes of gender dysphoria as well as
introduced a potential subtype.

Additionally, the frequent use of gender dysphoria in clinical and lay discourse has led to a fracturing of
the definition. Studies on the topic frequently do not apply the DSM-V’s criteria for the diagnosis and
overlook certain key features such as distress. In a 2018 review by Zowie Davy and Michael Toze, the
authors evaluated 387 articles that examine gender dysphoria and noted stark departures from the
APA’s definition. They further asserted that the APA intended to “reduce pathologization” by
establishing a new definition for gender dysphoria in the DSM-V. This in turn would reduce diagnoses,
although as Davy and Toze note, the tendency for the literature to diverge from the APA’s definition
may result in increased numbers of individuals classified as having gender dysphoria when they do not
meet the DSM-V's criteria (Davy and Toze, 2018). This further raises the question of whether individuals
are receiving potentially irreversible treatments for the condition when they might not actually have it.

The current usage of gender dysphoria is the result of discussions spanning across decades as
demonstrated in the past editions of the DSM. Until 2013, the APA considered having gender identity
issues a mental disorder by itself regardless of the presence of psychological distress. That perspective
has since shifted to only consider the adverse psychological effects of questioning one’s gender as a
disorder. In addition, the APA considers gender as part of one’s identity, which is not subject to a
diagnosis. Whether the APA has shifted its terminology and criteria for gender identity issues due to

2
Following the release of the Florida Department of Health’s guidelines for treating gender dysphoria, Merck
removed its definition for “gender dysphoria” from the Merck Manual (Fox News, 2022).

5
emerging clinical data or cultural changes is another question. In 1994, the APA replaced transsexualism
with gender identity disorder as part of the “effort to reduce stigma” (APA, 2017). This raises questions
about what influences decisions to revise definitions and criteria; is it social trends or medical evidence?

Behavioral Health Issues Co-Occurring with Gender Dysphoria

Because gender dysphoria pertains directly to the distress experienced by an individual who desires to
change gender identities, secondary behavioral health issues can co-occur such as depression and
anxiety. If left untreated, these conditions can lead to the inability to function in daily activities, social
isolation, and even suicidal ideation. Studies do confirm that adolescents and adults with gender
dysphoria report higher levels of anxiety, depression, and poor peer relationships than the general
population (Kuper et al, 2019). Other associated conditions include substance abuse, eating disorders,
and compulsivity. A significant proportion of individuals with gender dysphoria also have autism
spectrum disorder (ASD) (Saleem and Rizvi, 2017). Although the number reporting secondary issues is
increased, individuals diagnosed with gender dysphoria do not necessarily constitute the entire
population that is gender non-conforming (i.e., does not identify with natal sex), and no information is
available breaking down the percentage of those who are non-conforming with gender dysphoria and
those who are non-conforming with no distress. Additionally, available research raises questions as to
whether the distress is secondary to pre-existing behavioral health disorders and not gender dysphoria.
This is evident in the number of adolescents who reported anxiety and depression diagnoses prior to
transitioning (Saleem and Rizvi, 2017).

Furthermore, conventional treatments for secondary behavioral health issues are available. These
include cognitive behavioral therapy, medication, and inpatient services. The APA reports that
treatments for these are highly effective with 80% to 90% of individuals diagnosed with depression
responding positively (APA, 2020). In addition, a high percentage of adolescents diagnosed with gender
dysphoria had received psychiatric treatment for a prior or co-occurring mental health issue. A 2015
study from Finland by Kaltiala-Heino et al noted that 75% of children seeking sex reassignment services
had been treated by a behavioral health professional (Kaltiala-Heino et al, 2015).

Diagnosing Gender Dysphoria

Prior to the publication of the DSM-V, diagnosing individuals experiencing gender identity issues
followed a different process. Behavioral health clinicians could assign the diagnosis based on gender
non-conformance alone. That has changed since 2013. Today, non-conforming to one’s gender is part of
personal identity and not a disorder requiring treatment. This change has led professional associations
to shift the diagnostic criteria for gender dysphoria to focus on the distress caused by shifting identities
(DSM-V, 2013).

For adolescents, the APA identifies “a marked incongruence between one’s experienced/expressed
gender and natal sex, of at least 6 months’ duration” as the core component of gender dysphoria (DSM-
V, 2013). What the APA does not elucidate is the threshold for “marked.” This raises questions as to
whether practitioners exercise uniformity when applying the diagnostic criteria or if they do so
subjectively. For example, the WPATH’s Standards of Care for the Health of Transsexual, Transgender,
and Gender Non-Conforming People provides guidance on the processes mental health practitioners
should use when assessing for gender dysphoria but offers no benchmarks for meeting diagnostic
criteria (WPATH, 2012).

6
Such processes include evaluating for gender non-conforming behaviors and other co-existing mental
disorders like anxiety or depression. This involves not only interviewing the adolescent but also the
family in addition to reviewing medical histories. WPATH also asserts that gender dysphoria assessments
need to account for peer relationships, academic performance, and provide information of potential
treatments. This last component is necessary because it might affect an individual’s choices regarding
transitioning, particularly if the information does not correspond to the desired outcome (WPATH,
2012).

The diagnosis of gender dysphoria is a relatively recent concept in mental health, being the product of
decades of discussion and building upon previous definitions. Instead of treating gender non-conformity
as a disorder, behavioral health professionals acknowledge it as part of one’s identity and focus on
addressing the associated distress. Considering the new criteria, this changes the dynamics of the
population who would have qualified for a diagnosis before 2013 and those who would today. Given
that desiring to transition into a gender different from natal sex no longer qualifies as a disorder,
behavioral health professionals are treating distress and referring adolescents and adults to therapies
that are used off-label and pose irreversible effects.

Current Available Treatments for Gender Dysphoria

At present, proposed treatment for gender dysphoria occurs in four stages, beginning with psychological
services and ending with sex reassignment surgery. As an individual progresses through each stage, the
treatments gradually become more irreversible with surgical changes being permanent. Because of the
increasing effects, individuals must have attempted treatment at the previous stage before pursuing the
next one (Note: late adolescents and adults have already completed puberty and do not require puberty
blockers). Listed in order, the four stages are as follows:

 Behavioral Health Services: Psychologists and other mental health professionals are likely the
first practitioners individuals with gender dysphoria will encounter. In accordance with clinical
guidelines established by the World Professional Association for Transgender Health (WPATH) 3,
behavioral health professionals are supposed to “find ways to maximize a person’s overall
psychological well-being, quality of life, and self-fulfillment.” WPATH further discourages
services for attempting to change someone’s gender identity. Instead, it instructs practitioners
to assess for the condition and readiness for puberty blockers or cross-sex hormones while
offering guidance to function in a chosen gender. WPATH does assert that the clinicians do need
to treat any other underlying mental health issues secondary or co-occurring with gender
dysphoria (WPATH, 2012). However, the organization provides conflicting guidance because it
also advises practitioners to prescribe cross-sex hormones on demand (Levine, 2018).
 Puberty Suppression: Used only on individuals in the earliest stages of puberty (Tanner stage 2),
preventing pubertal onset provides additional time to explore gender identities before the
physical characteristics of biological sex develop. This treatment is intended to reduce distress
and anxiety related to the appearance of adult sexual physical features. To suppress puberty,
pediatric endocrinologists inject gonadotropin releasing hormone (Gn-RH) at specific intervals
(e.g., 4 weeks or 12 weeks). The Gn-RH suppresses gonadotropin receptors that allow for the

3
The World Professional Association for Transgender Health asserts that it is a professional organization. However,
it functions like an advocacy group by allowing open membership to non-clinicians (WPATH, 2022).

7
 development of primary and secondary adult sexual characteristics. Prior to receiving puberty
suppression therapy, individuals must have received a diagnosis of gender dysphoria and have
undergone a mental health evaluation (Kyriakou et al, 2020).
 Cross-Sex Hormones: For adults and late adolescents (16 years or older), the next treatment
phase recommended is taking cross-sex hormones (e.g., testosterone or estrogen) to create
secondary sex characteristics. In men transitioning into women, these include breast
development and widening around the pelvis. Women who transition into men experience
deeper voices, redistribution of fat deposits, and growing facial hair. According to the Endocrine
Society, late adolescents who qualify for cross-sex hormones must have a confirmed diagnosis
of gender dysphoria from a mental health practitioner with experience treating that population.
Some physical changes induced by these hormones are irreversible (Endocrine Society, 2017).
 Sex Reassignment Surgery: Sometimes referred to as “gender affirming” surgery, this treatment
does not consist of just one procedure but several, depending on the desires of the transitioning
individual. Primarily, sex reassignment procedures alter the primary and secondary sexual
characteristics. Men transitioning into women (trans-females) undergo a penectomy (removal of
the penis), orchiectomy (removal of the testes), and vulvoplasty (creation of female genitals).
Other procedures trans-females may undergo include breast augmentation and facial
feminization. For women that transition into men (trans-males), procedures include mastectomy
(removal of the breasts), hysterectomy (removal of the uterus), oophorectomy (removal of the
ovaries), and phalloplasty (creation of male genitals). Because of the complexities involved in
phalloplasty, many trans-males do not opt for this procedure and limit themselves to
mastectomies. Additionally, the effects of sex reassignment surgery, such as infertility, are
permanent (WPATH, 2012).

While some clinical organizations assert that they are the standard of care for gender dysphoria, the U.S.
Food and Drug Administration (FDA) currently has not approved any medication as clinically indicated
for this condition (Unger, 2018). Although puberty blockers and cross-sex hormones are FDA approved,
the FDA did not approve them for treating gender dysphoria, meaning that their use for anything other
than the clinical indications listed is off-label (American Academy of Pediatrics, 2014). As for surgical
procedures, the FDA does not evaluate or approve them, but it does review all surgical devices (FDA,
2021). In addition, the Endocrine Society concedes that its practice guidelines for sex reassignment
treatment does not constitute a “standard of care” and that its grades for available services are low or
very low (Endocrine Society, 2017).4

4
Disagreement over how to treat gender dysphoria, gender identity disorder, and transsexualism has persisted
since sex reassignment surgery first became available in the 1960s. In a 2006 counterargument, Paul McHugh
highlights how individuals seeking surgery had other reasons that extended beyond gender identity, including
sexual arousal and guilt over homosexuality. In addition, he asserts that undergoing sex reassignment procedures
did not improve a patient’s overall behavioral health and that providing a “surgical alteration to the body of these
unfortunate people was to collaborate with a mental disorder rather than to treat it” (McHugh, 2006).

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Literature Review: Introduction
Currently, an abundance of literature and studies on gender dysphoria is available through academic
journals, clinical guidelines, and news articles. Similar to other mental health issues, the material
addresses a broad range of topics consisting of available treatments, etiology (i.e., causes), risks,
benefits, and side effects. Although most stories reported by the media indicate that treatments such as
cross-sex hormones and sex reassignment surgery are the most effective, research reveals that
numerous questions still exist. These include what are the long-term health effects of taking cross-sex
hormones, what are the real causes of gender dysphoria, and how many individuals that transition will
eventually want to revert to their natal sex. Additionally, much of the available research is inconclusive
regarding the effectiveness of sex reassignment treatments with multiple studies lacking adequate
sample sizes and relying on subjective questionnaires. While much of the scientific literature leans in
favor of cross-sex hormones and surgery as options for improving the mental health of individuals with
gender dysphoria, it does not conclusively demonstrate that the benefits outweigh the risks involved,
either short or long-term. What studies do reveal with certainty is that sex reassignment surgery and
cross-sex hormones pose permanent effects that can result in infertility, cardiovascular disease, and
disfigurement. All of this indicates that further research is necessary to validate available treatments for
gender dysphoria. Thus, physicians, who recommend sex reassignment treatment, are not adhering to
an evidence-based medicine approach and are following an eminence-based model.

The following literature review addresses the multiple facets of this condition and presents areas of
ongoing debate and persisting questions. Beginning with the condition’s etiology and continuing with
evaluations of puberty blockers, cross-sex hormones, and surgery, the review explains each area
separately and in context of gender dysphoria at large. Additionally, the review provides an analysis on
available research on mental health outcomes as well as the condition’s persistence into adulthood.
Taken as a whole, the available studies demonstrate that existing gender dysphoria research is
inconclusive and that current treatments are used to achieve cosmetic benefits while posing risky side
effects as well as irreversible changes.

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Literature Review: Etiology of Gender Dysphoria
What causes gender dysphoria is an ongoing debate among experts in the scientific and behavioral
health fields. Currently, the research indicates that diagnosed individuals have higher proportions of
autism spectrum disorder (ASD), history of trauma or abuse, fetal hormone imbalances, and co-existing
mental illnesses. Also, experts acknowledge that genetics may factor into gender dysphoria. Another
potential cause is social factors such as peer and online media influence. At the moment, none of the
studies provides a definite cause and offer only correlations and weakly supported hypotheses. In
addition, evidence favoring a biological explanation is highly speculative. However, the research does
raise questions about whether treatments with permanent effects are warranted in a population with
disproportionately high percentages of ASD, behavioral health problems, and trauma.

In a 2017 literature review by Fatima Saleem and Syed Rizvi, the authors examine gender dysphoria’s
numerous potential causes and the remaining questions requiring further research. In conclusion, the
pair indicate that associations exist between the condition and ASD, schizophrenia, childhood abuse,
genetics, and endocrine disruption chemicals but that more research is needed to improve
understanding of how these underlying issues factor into a diagnosis. Throughout the review, Saleem
and Rizvi identify the following as potential contributing elements to the etiology of gender dysphoria:

 Neuroanatomical Etiology: During fetal development, the genitals and brain develop during
different periods of a pregnancy, the first and second trimesters respectively. Because the
processes are separate, misaligned development is possible where the brain may have
features belonging to the opposite sex. The authors identify one study where trans-females
presented with a “female-like putamen” (structure at the base of the brain) when
undergoing magnetic resonance imaging (MRI) scans.5
 Psychiatric Associations: Saleem and Rizvi identify multiple studies reporting that
individuals with gender dysphoria have high rates of anxiety and depressive disorders with
results ranging as high as 70% having a mental health diagnosis. In addition, the pair note
that schizophrenia may also influence desires to transition. However, the review does not
assess whether the mental health conditions are secondary to gender dysphoria.
 Autism Spectrum Disorder: Evidence suggests a significant percentage of individuals
diagnosed with gender dysphoria also have ASD. The authors note that the available studies
only establish a correlation and do not identify mechanisms for causation.
 Childhood Abuse: Like the above causes, Saleem and Rizvi note that those with gender
dysphoria tended to experience higher rates of child abuse across all categories, including
neglect, emotional, physical, and sexual.
 Endocrine Disruptors: Although this cause still requires substantial research, it is a valid
hypothesis regarding how phthalates found in plastics can create an imbalance of
testosterone in fetuses during gestation, which can potentially lead to gender dysphoria.
The authors point to one study that makes this suggestion.

5
Research on neuroanatomical etiology for gender dysphoria remains highly speculative due to limitations of brain
imaging (Mayer and McHugh, 2016). In addition, neuroscience demonstrates that exposures to certain
environments and stimuli as well as behaviors can affect brain changes (Gu, 2014). Furthermore, available research
indicates that male and female brains have different physical characteristics but cannot be placed in separate
categories due to extensive overlap of white/grey matter and neural connections (Joel et al, 2015).

10
Saleem and Rizvi’s review reveal that gender dysphoria’s etiology can have multiple factors, most of
which require treatments and therapies not consisting of cross-sex hormones or surgery. (Saleem and
Rizvi, 2017).

Out of the research on the condition’s etiology, a large portion focuses on the correlation with ASD. One
of the more substantial studies by Van der Miesen et al published in 2018 evaluates 573 adolescents and
807 adults diagnosed with ASD and compares them to 1016 adolescents and 846 adults from the
general population. The authors’ findings note that adolescents and adults with ASD were approximately
2.5 times more likely to indicate a desire of becoming the opposite sex. Although the methodology used
to reach this conclusion consisted of surveys where respondents had a choice of answering “never,”
“sometimes,” or “often,” the results correspond with those of similar studies. Van der Miesen et al also
indicate that most responses favoring a change in gender responded with “sometimes.” Additionally,
the authors do not state how many in their sample group actually had a gender dysphoria diagnosis.
(Van der Miesen et al, 2018).

Another study by Shumer et al from 2016 utilizes a smaller sample size (39 adolescents) referred to an
American hospital’s gender clinic. Unlike Van der Miesen et al’s research, Shumer et al evaluate subjects
with a diagnosis of gender dysphoria for possible signs of ASD or Asperger’s syndrome. Their findings
revealed that 23% of patients presenting at the clinic would likely have one of the two conditions.
Possible explanations for the high percentage are the methods used to gather the data. Shumer et al
requested a clinical psychologist to administer the Asperger Syndrome Diagnostic Scale to the parents of
the sample patients, four of whom already had an ASD diagnosis. The authors conclude that the
evidence to support high incidence of gender dysphoria in individuals with ASD is growing and that
further research is needed to determine the specific cause (Shumer et al, 2016).

Research indicating a strong correlation between ASD and gender dysphoria is not the only area where
new studies are emerging. Discussions about the effects of prenatal testosterone levels are also
becoming more prevalent. One such example is Sadr et al’s 2020 study that looks at the lengths of the
index and ring fingers (2D:4D) of both left and right hands of 203 individuals diagnosed with gender
dysphoria. The authors used this method because prenatal testosterone levels can affect the length
ratios of 2D:4D. By comparing the ratios of a group with gender dysphoria to a cohort from the general
population, Sadr et al could assess for any significant difference. Their results indicated a difference in
trans-females who presented with more feminized hands. For trans-males, the difference was less
pronounced. The results for both groups were slight, and the meta-analysis that accompanies the study
notes no statistically significant differences in multiple groups from across cultures. However, Sadr et al
further assert that the evidence strongly suggests elevated prenatal testosterone levels in girls and
reduced amounts in boys may contribute to gender dysphoria, requiring additional research (Sadr et al,
2020).

In addition to biological factors and correlations with ASD, researchers are exploring psychological and
social factors to assess their role in gender dysphoria etiology. This literature examines a range of
potential causative agents, including child abuse, trauma, and peer group influences. One such study by
Kozlowska et al from 2021 explores patterns in children with high-risk attachment issues who also had
gender dysphoria. The authors wanted to assess whether past incidents of abuse, loss, or trauma are
associated with higher rates of persons desiring to transition. As a basis, Kozlowska et al cite John
Bowlby’s research on childhood brain development, noting that the process is not linear and depends

11
heavily on lived experiences. The study further acknowledges that biological factors combined with life
events serve as the foundation for the next developmental phase and that early poor-quality
attachment issues increase the risk for psychological disorders in adolescence and adulthood. Such
disorders include mood and affective disorders, suicidal ideations, and self-harm. Kozlowska et al also
cite other studies that indicate a high correlation between gender dysphoria and “adverse childhood
events” and further assert that the condition “needs to be conceptualized in the context of the child’s
lived experience, and the many different ways in which lived experience is biologically embedded to
shape the developing brain and to steer each child along their developmental pathway” (Kozlowska et
al, 2021).

For their study, Kozlowska et al recruited 70 children diagnosed with gender dysphoria and completed
family assessments going back three generations. This in-depth level was necessary to ascertain any and
all events that could affect a child’s developmental phases. Additionally, the researchers individually
assessed the diagnosed children. To establish comparisons, Kozlowska et al performed assessments on a
non-clinical group and a mixed-psychiatric group. Their results demonstrate that children with gender
dysphoria have significantly higher rates of attachment issues as well as increased reports of “adverse
childhood events” such as trauma (e.g., domestic violence and physical abuse). Furthermore, the
authors indicate that a high proportion of families reported “instability, conflict, parental psychiatric
disorder, financial stress, maltreatment events, and relational ruptures.” These results led Kozlowska et
al to conclude that gender dysphoria can be “associated with developmental pathways – reflected in at-
risk patterns of attachment and high rates of unresolved loss and trauma – that are shaped by
disruptions to family stability and cohesion.” The study also cites that treatment requires “a
comprehensive biopsychosocial assessment with the child and family, followed by therapeutic
interventions that address, insofar as possible, the breadth of factors that are interconnected with each
particular child’s presentation” (Kozlowska et al, 2021).

This recent study raises questions regarding the medical necessity of gender dysphoria treatments such
as puberty blockers and cross-sex hormones for adolescents. If high percentages of children diagnosed
with gender dysphoria also have histories of trauma and attachment issues, should conventional
behavioral health services be utilized without proposing treatments that pose irreversible effects?
Would that approach not provide additional time to address underlying issues before introducing
therapies that pose permanent effects (i.e., the watchful waiting approach)?

Aside from the notion that childhood abuse and adversity can potentially cause gender dysphoria, other
possible explanations such as social factors (e.g., peer influences and media) may be contributing
factors. Research on rapid onset gender dysphoria (ROGD) links this phenomenon to peer and social
elements. In an analysis utilizing parent surveys, Lisa Littman asserts that the rapid rise of ROGD is not
associated with the traditional patterns of gender dysphoria onset (i.e., evidence of an individual’s
gravitation to the opposite sex documented over multiple years) but rather exposure to “social and peer
contagion.” Littman uses this term in the context of definitions cited in academic literature, stating that
“social contagion is the spread of affect or behaviors through a population” and that “peer contagion is
the process where an individual and peer mutually influence each other in a way that promotes
emotions and behaviors that can potentially undermine their own development or harm others.”
Examples of the latter’s negative effects include depression, eating disorders, and substance abuse.
What prompted this study is a sudden increase of parents reporting their daughters declaring
themselves to be transgender without any previous signs of gender dysphoria. Littman also indicates

12
that these parents cite that their daughters became immersed in peer groups and social media that
emphasized transgender lifestyles (Littman, 2018).

In addition to identifying characteristics of ROGD, the study examines social media content that provides
information to adolescents regarding how to obtain cross-sex hormones through deception of
physicians, parents, and behavioral health professionals. Such guidance includes coaching on how to fit
a description to correspond to the DSM-V and pressures to implement treatment during youth to avoid
a potential lifetime of unhappiness in an undesirable body. Littman further states that “online content
may encourage vulnerable individuals to believe that non-specific symptoms and vague feelings should
be interpreted as gender dysphoria.” The study also notes that none of the individuals assessed using
the parental surveys qualified for a formal diagnosis using the DSM-V criteria (Littman, 2018).

The survey responses revealed similar data to Kozlowska et al’s study with 62.5% of the adolescents
having a mental health or neurodevelopmental disorder. Furthermore, the responses indicate a rapid
desire to bypass behavioral health options and pursue cross-sex hormones. 28.1% of parents surveyed
stated that their adolescents did not want psychiatric treatments. One parent even reported that their
daughter stopped taking prescribed anti-depressants and sought advice only from a gender therapist.
Littman’s research further reveals that 21.2% of parents responded that their adolescent received a
prescription for puberty blockers or cross-sex hormones at their first visit (Littman, 2018). These
responses indicate that practitioners do not uniformly follow clinical guidelines when making diagnoses
or prescribing treatment.

In the discussion, Littman proposes two hypotheses for the appearance of ROGD. The first states that
social and peer contagion is one of the primary causes, and the second asserts that ROGD is a
“maladaptive coping mechanism” for adolescents dealing with emotional and social issues. While the
surveyed parents did not report early signs of gender dysphoria, a majority noted that their daughters
had difficulty in handling negative emotions. Littman concludes that ROGD is distinct from gender
dysphoria as described in the DSM-V and that further research is needed to assess whether the
condition is short or long-term (Littman, 2018). What the study does not explore, but raises the
question, is what proportion of those being treated for gender dysphoria are adolescents with ROGD.

Littman’s study along with the others reveal that the causes of gender dysphoria are still a mystery and
could have multiple biological and social elements. Because of this ongoing uncertainty, treatments that
pose irreversible effects should not be utilized to address what is still categorized as a mental health
issue. That allows adequate opportunity for individuals to receive treatment for co-existing mental
disorders, establish their gender dysphoria diagnoses, and understand how cross-sex hormones and
surgery will alter the appearance of their bodies as well as long-term health.

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Literature Review: Desistance of Gender Dysphoria and Puberty
Suppression
The World Professional Association for Transgender Health (WPATH) and the Endocrine Society both
endorse the use of gonadotropin releasing hormones (Gn-RH) to suppress puberty in young adolescents
who have gender dysphoria. Both organizations state that the treatment is safe and fully reversible. In
addition, they state that delaying pubertal onset can provide extra time for adolescents to explore the
gender in which they choose to live. The associations further state that puberty suppression is necessary
to prevent the development of primary and secondary sexual characteristics that can inhibit successful
transitions into adulthood (WPATH, 2012; Endocrine Society, 2017). Of the two groups, WPATH offers
clinical criteria an individual should meet to qualify for puberty suppression such as addressing
psychological co-morbidities and assessing whether gender dysphoria has intensified (WPATH, 2012).

Neither organization explains that the majority of young adolescents who exhibit signs of gender
dysphoria eventually desist and conform to their natal sex and that the puberty suppression can have
side effects. Both organizations neglect to mention that using Gn-RH for gender dysphoria by altering
the appearance is not an FDA-approved clinical indication. Furthermore, the research used to justify
puberty suppression is low or very-low quality and little information is available on long-term effects
(Hruz, 2019). Additionally, in his assessment, Quentin Van Meter explained that physical differences
between central precocious puberty and natural onset puberty demonstrate that Gn-RH does not have
permanent adverse effects for those treated for the former but can for the latter such as insufficient
bone-mineral density and neural development (Van Meter, 2022). Also, as recently as May 17, 2022,
during a U.S. Senate Committee on Appropriations hearing, Lawrence Tabak, acting director of the
National Institutes of Health, responded to Senator Marco Rubio, acknowledging that no long-term
studies are available evaluating the effects of puberty blockers when used for gender dysphoria (U.S.
Senate Committee on Appropriations, 2022).

Currently, some studies provide weak support for this treatment but leave too many questions as to its
effectiveness and medical necessity, especially considering how many children decide against
transitioning. In addition, puberty blockers halt development of primary and secondary sexual
characteristics and deny opportunities for adolescents to adapt and become comfortable with their
natal sex. Instead, puberty blockers can serve as a potential “gateway drug” for cross-sex hormones by
denying them the experience of physically maturing (Laidlaw et al, 2018).

A 2013 study by Steensma et al offers data on the percentage of children who opt not to transition after
experiencing gender dysphoria. The authors follow 127 adolescents (mean age of 15 during the
evaluation period) for four years who had been referred to a Dutch gender dysphoria clinic. Out of this
cohort, 47 (37%; 23 boys and 24 girls) continued experiencing the condition and applied for sex
reassignment treatment. The other 80 adolescents never returned to the clinic. Because this clinic was
the only one that treated gender dysphoria in the Netherlands, Steensma et al assumed that those who
did not return no longer desired transitioning. The study indicates one of the key predictors for
persisting gender dysphoria was the age of first presentation. Older adolescents that started going to
the clinic were more likely to persist, while younger adolescents tended not to follow through. Steensma
et al provide further insight into other predicting factors, particularly on how each individual views his or
her gender identity. The authors note that adolescents who “wished they were the other sex” were
more likely to become desisters and that those who “believed that they were the other sex” persisted

14
and later sought sex reassignment treatment (Steensma et al, 2013). While the study focuses on factors
that contribute to the condition’s persistence or desistance, it raises the question as to whether puberty
suppression is necessary when age plays such an important role regarding the decision to transition.

WPATH and the Endocrine Society state that the primary reason for initiating pubertal suppression is not
to treat a physical condition but to improve the mental health of adolescents with gender dysphoria.
However, available research does not yield definitive results that this method is effective at addressing a
mental health issue. The “gold standard” for medical studies is the randomized-controlled trial (RCT).
Because RCTs utilize large sample sizes, have blind testing groups (i.e, placebos), and use objective
controls, they can offer concrete conclusions and shape the array of established treatments. In addition,
RCTs require comparisons between cohort outcomes and ensure that participants are randomly
assigned to each group. These measures further reduce the potential for bias and subjectivity (Hariton
and Locascio, 2018).

Presently, no RCTs that evaluate puberty suppression as a method to treat gender dysphoria are
available. Instead, the limited number of published studies on the topic utilize small sample sizes and
subjective methods (Hruz, 2019). A 2015 article by Costa et al is one such example. The study asserts
that “psychological support and puberty suppression were both associated with an improved global
psychological functioning in gender dysphoric adolescents.” To reach this conclusion, the authors
selected 201 children diagnosed with the condition and divided them into two groups, one to receive
psychological support only and the other to get puberty blockers in addition to psychological support.
Costa et al did not create a third group that lacked a gender dysphoria diagnosis to serve as a control. To
assess whether puberty suppression is an effective treatment, the authors administered two self-
assessments (Utrect Gender Dysphoria Scale and Children’s Global Assessment Scale) 6 to the groups at
6-month intervals during a 12-month period. Because the study relies heavily on self-assessments, the
conclusions are likely biased and invalid. Another problem that is also present and common throughout
articles supporting puberty suppression is the short-term period of the study. Costa et al’s conclusions
may not be the same if additional follow-ups occurred three or five years later (Costa et al, 2015). This
further raises the question whether low-quality studies like Costa et al’s should serve as the basis for
clinical guidelines advising clinicians to prescribe drugs for off-label purposes.

Aside from questionable research, information regarding the full physical effects of puberty suppression
is incomplete. In a 2020 consensus parameter prepared by Chen et al, 44 experts in neurodevelopment,
gender development, and puberty/adolescence reached a conclusion stating that “the effects of
pubertal suppression warrant further study.” The basis for this was that the “full consequences (both
beneficial and adverse) of suppressing endogenous puberty are not yet understood.” The participating
experts emphasized that the treatment’s impact on neurodevelopment in adolescents remains
unknown. Chen et al explain that puberty-related hormones play a role in brain development as
documented in animal studies and that stopping these hormones also prevents neurodevelopment in
addition to sexual maturation. The authors further raise the question whether normal brain
development resumes as if it had not been interrupted when puberty suppression ceases. Because this

6
Behavioral health practitioners use the Children’s Global Assessment Scale (CGAS) to measure child functioning
during the evaluation process to determine diagnoses. Available evidence indicates that the CGAS is not effective
for evaluating children who experienced trauma and presented with mental health symptoms (Blake et al, 2006).

15
question remains unanswered, it casts doubt on the veracity of organizations’ assertions that puberty
suppression is “fully reversible” (Chen et al, 2020).

In addition to the unanswered questions and low-quality research, puberty suppression causes side
effects, some of which have the potential to be permanent. According to a 2019 literature review by De
Sanctis et al, most side effects associated with Gn-RH are mild, consisting mostly of irritation around
injection sites. However, clinicians have linked the drug to long-term conditions such as polycystic
ovarian syndrome, obesity, hypertension, and reduced bone mineral density. While reports of these
events are low and the authors indicate that Gn-RH is safe for treating central precocious puberty (Note:
De Sanctis et al do not consider gender dysphoria in their analysis), the review raises questions about
whether off-label use to treat a psychological condition is worth the risks (De Sanctis et al, 2019).

Furthermore, De Sanctis et al cite studies noting increased obesity rates in girls who take Gn-RH but that
more research is needed to gauge the consistency. Additionally, the authors note that evidence is strong
regarding reduced bone mineral density during puberty suppression but indicate that the literature
suggests it is reversible following treatment (De Sanctis et al, 2019). While research leans toward the
reversibility of effects on bone mineral density, the quantity of studies available on this subject are
limited. Also, no long-term research has been completed on how puberty suppression affects bone
growth. This is significant because puberty is when bone mass accumulates the most (Kyriakou et al,
2020). One example of a complication involving bone growth and Gn-RH is slipped capital femoral
epiphysis. This condition occurs when the head of the femur (i.e., thighbone) can slip out of the pelvis,
which can eventually lead to osteonecrosis (i.e., bone death) of the femoral head. Although the
complication is rare, its link to puberty suppression indicates that the “lack of adequate sex hormone
exposure” could be a cause (De Sanctis et al, 2019).

The current literature on puberty suppression indicates that using it to treat gender dysphoria is off-
label, poses potentially permanent side effects, and has questionable mental health benefits. The
limited research and lack of FDA approval for that clinical indication prompt questions about whether
medications with physically altering effects should be used to treat a problem that most adolescents
who experience it will later overcome by conforming to their natal sex. Additional evidence is required
to establish puberty suppression as a standard treatment for gender dysphoria.

16
Literature Review: Cross-Sex Hormones as a Treatment for Gender
Dysphoria
Currently, the debate surrounding the use of cross-sex hormones to treat gender dysphoria revolves
around their ability to improve mental health without causing irreversible effects. It is not about
whether taking cross-sex hormones can alter someone’s appearance. The evidence demonstrating the
effectiveness of cross-sex hormones in achieving the secondary sexual characteristics of the opposite
sex is abundant. Also, the overall scientific consensus concludes that individuals who take cross-sex
hormones will reduce the primary sexual function of his or her natal sex organs. What researchers
continue evaluating are the short and long-term effects on mental health, impacts on overall physical
health, and how the changes affect the ability to detransition. Of these, benefits to mental health
overshadow the other discussions. Prescribers of cross-sex hormones focus so heavily on behavioral
health outcomes that they de-emphasize that these drugs cause permanent physical changes and side
effects that can lead to premature death (Hruz, 2020). Some clinical guidelines such as WPATH’s do not
even indicate that some of the changes are irreversible.

Like puberty suppression, the Endocrine Society and WPATH provide guidance on administering cross-
sex hormones to individuals with gender dysphoria. Both organizations state that this treatment should
not be administered without a confirmed diagnosis of gender dysphoria and only after a full
psychosocial assessment. In addition, behavioral health practitioners must ensure that any mental
comorbidities are not affecting the individual’s desire to transition. WPATH and the Endocrine Society
further state that clinicians should administer hormone replacements such as testosterone and Estradiol
(estrogen) in gradual phases, where the dose increases over several months. For trans-females, the
organizations state that progesterone (anti-androgen) is also necessary to block the effects of naturally
produced testosterone (WPATH, 2012; Endocrine Society, 2017). When taking cross-sex hormones,
trans-males need increased doses for the first six months. After that, the testosterone’s effects are the
same on lower doses. Once started, individuals cannot stop taking hormones unless they desire to
detransition (Unger, 2016).

Although the two groups provide similar guidance, they vary on statements that can have significant
impact on long-term outcomes, particularly regarding age. According to WPATH’s standards, 16 years is
the general age for initiating cross-sex hormones, but the organization acknowledges that the treatment
can occur for younger individuals depending on circumstances (WPATH, 2012). This differs from the
Endocrine Society, which states no specific age for appropriateness and explains the disagreements in
assigning a number. The group highlights that most adolescents have attained sufficient competence by
age 16 but may not have developed adequate abilities to assess risk (Endocrine Society, 2017). This
raises the question whether adolescents can make sound decisions regarding their long-term health.
Additionally, the varying guidance raises an issue with WPATH not only using age 16 as a standard but
also indicating that younger adolescents are capable of making that choice.

WPATH’s guidance also does not stress the irreversible nature of cross-sex hormones, citing the
treatment as “partially reversible” and not indicating which changes are permanent. Furthermore, parts
of WPATH’s information are misleading and directly conflict with guidance issued by clinics and other
sources. One such example consists of WPATH stating that “hormone therapy may (emphasis added)
lead to irreversible changes.” This statement is misleading in light of existing research, which indicates
that multiple physical changes are permanent. In addition, WPATH claims that certain effects of cross-

17
sex hormones such as clitoral enlargement can last one to two years when it is actually irreversible
(UCSF, 2020). WPATH also does not explain the risks to male fertility, noting that lowered sperm count
or sterility is “variable.” The University of California at San Francisco (UCSF) provides starkly different
information by stating that trans-females should expect to become sterile within a few months of
starting cross-sex hormones. UCSF also advises trans-females to consult a sperm bank if they may want
to father children after transitioning (WPATH, 2012; UCSF, 2020). Below is a chart that outlines the
effects of cross-sex hormones and identifies which ones are reversible or permanent.

Physical Changes Effectuated by Cross-Sex Hormones

Physical Changes in Trans-Males (Female-to-Male Transitions)
Physical Change Reversible or Irreversible
Oily Skin or Acne Reversible
Facial and Body Hair Growth Irreversible
Male-Pattern Baldness Irreversible
Increased Muscle Mass Reversible
Body Fat Redistribution Reversible
Ceasing of Menstruation Reversible
Enlarged Clitoris Irreversible
Vaginal Atrophy Reversible
Deepening of Voice Irreversible
Physical Changes in Trans-Females (Male-to-Female Transitions)
Body Fat Redistribution Reversible
Decreased Muscle Mass Reversible
Skin Softening or Decrease in Oiliness Reversible
Lower Libido Reversible
Fewer Spontaneous Erections Reversible
Male Sexual Dysfunction Possibly Irreversible
Breast Growth Irreversible
Decrease in Testicular Size Reversible
Decrease in Sperm Production or Infertility Likely Irreversible
Slower Facial and Body Hair Growth Reversible
7
Sources: UCSF, 2020; WPATH, 2012; Endocrine Society, 2017

The above chart demonstrates that trans-males and trans-females experience different effects from
cross-sex hormones that can cause myriad issues in later life. For example, trans-males who opt to
detransition may face challenges related to permanent disfigurement (e.g., facial hair and deepened
voices). Trans-females, on the other hand, may not endure the same issues pertaining to visible physical
changes but might become despondent over being unable to reproduce. This can occur regardless of
whether the transitioning individual is satisfied with sex reassignment. Given that the clinical guidelines
do not provide uniform information on the permanent effects of cross-sex hormones, clinicians are
unable to make sound recommendations to patients. This treatment can supposedly alleviate symptoms

7
This chart consists of conclusions regarding physical changes made by three different clinical organizations. If one
organization determined that a physical change was irreversible, that was sufficient to meet the criteria to be
listed as “irreversible” in the chart.

18
of distress. However, cross-sex hormones’ permanent effects also have the potential to cause
psychological issues.

Arguments favoring cross-sex hormones assert that the desired physical changes can alleviate mental
health issues in individuals with gender dysphoria but do not consider that hormones used in this
manner, like puberty blockers, are off-label. While the FDA has approved estrogen and testosterone for
specific clinical indications (e.g., hypogonadism), it has not cleared these drugs for treating gender
dysphoria. Additionally, these arguments do not acknowledge that the U.S. Drug Enforcement
Administration (DEA) lists testosterone as a Schedule III controlled substance, meaning that it has a high
probability of abuse (DEA, 2022). Furthermore, evidence of psychological benefit from cross-sex
hormones is low-quality and relies heavily on self-assessments taken from small sample groups (Hruz,
2020).

A 2019 study by Kuper et al seeks to demonstrate that adolescents desiring cross-sex hormones have
elevated rates of depression, anxiety, and challenges with peer relationships. To make their findings, the
authors provided questionnaires to 149 adolescents who presented at a gender clinic in Dallas, Texas
and concluded that half of the sample group experienced increased psychological issues. One problem
with the study is that it relies on parent or self-assessments such as the Youth-Self Report, Body-Image
Scale, and the Child Behavior Checklist. While these assessments have strong reliability, the sample is
cross-sectional, consisting of gender dysphoric individuals who presented for an initial visit at the clinic.
Also, Kuper et al do not directly link these psychological symptoms to gender dysphoria but rather
insinuate a strong connection. Without an analysis of the longitudinal histories of the participants, the
study cannot demonstrate whether gender dysphoria was a direct cause of the psychological issues,
which could possibly result from trauma, abuse, or family dysfunction. Kuper et al’s study only presents
weak correlation between adolescents who report symptoms of distress and gender dysphoria. While
the authors do not claim that the participants’ psychological problems caused the condition, they fail to
explicitly state that no demonstrable relationship exists and explain that their findings are “broadly
consistent with the previous literature” (Kuper et al, 2019).

Additionally, a more comprehensive literature review from 2019 by Nguyen et al evaluates the effect of
cross-sex hormones on mental health outcomes. Although the authors argue that the evidence supports
the treatment, they do note that available studies use “uncontrolled observational methods” and “rely
on self-report.” The review also asserts that “future research should focus on applying more robust
study designs with large sample sizes, such as controlled prospective cohort studies using clinician-
administered ratings and longitudinal designs with appropriately matched control groups.” All of these
are characteristics of RCTs. While Nguyen et al highlight flaws in the studies in their conclusion, they do
not emphasize them in their analysis, opting to focus primarily on results. Another problem with the
studies selected for the review is the short-term periods for evaluation. Out of 11 studies Nguyen et al
discuss, only one tracks its participants for 24 months. The others only follow their cohorts for 6 or 12
months (Nguyen et al, 2019). Without long-term data to support assertions that cross-sex hormones
substantially improve the mental health of individuals with gender dysphoria, the review cannot make
definitive conclusions on the treatment’s benefits.

Basing their stances on this low-quality evidence, clinical associations such as the American Academy of
Pediatrics (AAP) and the American Psychology Association endorse the use of cross-sex hormones as
treatments for gender dysphoria. In particular, the AAP discourages use of the term “transition” and

19
asserts that medical treatments used to obtain secondary characteristics of the opposite sex are “gender
affirming.” This decision mirrors the DSM-V’s interpretation of gender being part of identity. The AAP
further states that taking cross-sex hormones is an “affirmation and acceptance of who they (i.e.,
patient) have always been” (AAP, 2018). The American Psychological Association also takes a similar
stance in its Resolution on Gender Identity Change Efforts by asserting that medical treatments such as
puberty suppression, cross-sex hormones, and surgery improve mental health and quality of life and
reinforce the notion that transitioning and seeking sex reassignment therapies do not constitute a
psychological disorder (American Psychological Association, 2021). Stances like these can substantially
influence practitioners and their treatment recommendations. Given that low-quality evidence serves as
the basis for supportive positions, this raises questions about whether clinicians can make informed
decisions for their patients that will promote the best outcomes.

James Cantor published a critique in 2020 of the AAP’s endorsement of “gender affirming” treatments,
arguing that the organization did not base its recommendations on established medical evidence. He
asserts that the AAP’s position is based on research that does not support intervention but rather
supports “watchful waiting” because most transgender youths desist and identify as their natal sex
during puberty. Cantor further argues that the AAP not only disregards evidence but also cites “gender
affirming” interventions as the only effective method. To conclude, he states the organization is
“advocating for something far in excess of mainstream practice and medical consensus” (Cantor, 2020).

Given those evidentiary problems, those who rely on the AAP’s endorsement as a basis for “gender
affirming” treatments are practicing eminence-based medicine as opposed to evidence-based medicine.
Eminence-based medicine refers to clinical decisions made by relying on the opinions of prominent
health organizations rather than relying on critical appraisals of scientific evidence (Nhi Le, 2016). While
it is true that the AAP has more knowledge than a lay person and a degree of credibility in the medical
community, the opinions of such organizations are not valid unless they are based on quality evidence.

Research on sex reassignment also does not adequately address the reasons for and prevalence of
detransitioning. Although no definite numbers are available regarding the percentage of transgender
people who decide to detransition, research indicates that roughly 8% decide to return to their natal
sex. The reasons range from treatment side effects to more self-exploration that provided insight on
individuals’ gender dysphoria. In a 2020 study by Lisa Littman, 101 people who had detransitioned
provided their basis for doing so. Out of the sample group, 96% had taken cross-sex hormones and 33%
had sex reassignment surgery. The average age for transitioning was 22 years, and the mean duration
for the transition was 4 years. This indicates that even allowing additional time beyond the
recommended age of 16 years can still lead to regrets. The study also raises the question as to whether
individuals who transitioned at 16 or younger wanted to detransition in greater numbers. The author
further offers reasons why these individuals sought cross-sex hormones and surgery, which include
having endured trauma (mental or sexual), homophobia (challenged to accept oneself as a homosexual),
peer and media influences, and misogyny (applicable only to trans-males). To obtain the results, the
participants responded to a survey that asked about their backgrounds (e.g., reasons for transitioning,
mental health comorbidities), and motivations for detransitioning. Littman noted that half of the women
(former trans-males) had a mental health disorder and/or had experienced trauma within a year of
deciding to transition. Men (former trans-females) reported much lower numbers of behavioral health
issues and trauma after de-transitioning. Additionally, 77% of men surveyed identified as the opposite
gender prior to transition, whereas just 58% of women had (Littman, 2020).

20
Of the reasons cited for detransitioning, the majority (60%) noted that they became more comfortable
with their natal sex. Other reasons included concerns over complications from the treatments, primarily
cross-sex hormones, and lack of improved mental health. Other less-cited explanations include concerns
about workplace discrimination and worsening physical health. The study also notes that approximately
36% of participants experienced worse mental health symptoms. Based on the findings, Littman
concludes that more research is needed in tracking the transgender population to obtain accurate
percentages of those who decide to detransition and that men and women reported varying reasons for
deciding to transition and later return to their natal sex. The author notes that higher rates of trauma
and peer group influences might have contributed to women’s decisions, which Littman attributes
partially to rapid onset gender dysphoria (Littman, 2020). What the study also indicates is that cross-sex
hormones are not a validated treatment for gender dysphoria. Nearly all of the participants had taken
them and decided against maintaining the physical changes. Given that the majority of surveyed
detransitioners cited that they were comfortable with their biological sex, the study indicates that
gender dysphoria is not necessarily a lifelong issue. This necessarily raises doubts about whether cross-
hormones, which cause permanent physical damage, is justified.

In addition to the psychological factors, cross-sex hormones pose significant long-term health risks to
transitioning individuals. Currently, little information is available given that researchers have not had
adequate time to study the effects in this population. However, use of hormones for other conditions
has yielded data on how these drugs can affect the body and the cardiovascular system in particular.
Because of the high dosages required to achieve physical change and the need to continuously take the
drugs, cross-sex hormones can potentially harm quality of life and reduce life expectancy for
transitioning individuals. According to Dutra et al, trans-females are three times more likely to die from
a cardiovascular event than the general population. In their 2019 literature review, Dutra et al examined
the results of over 50 studies evaluating the effects of cross-sex hormones on not only transgender
individuals but those with menopause and other endocrine disorders, all of which indicate that use of
estrogen or testosterone can increase risks for cardiovascular disease. Throughout their review, Dutra et
al cite examples of trans-females having higher triglyceride levels after 24 months of cross-sex
hormones and how researchers halted a study on estrogen due to an increase in heart attacks among
participants. Another article the authors reference indicates a higher risk for thromboembolisms (i.e.,
blood clots) in trans-females. For trans-males, Dutra et al explain that research shows significant
increased risk for hypertension, high cholesterol, obesity, and heart attacks. One study noted that trans-
males have a four times greater risk of heart attack compared to women identifying as their natal sex.
Dutra et al conclude that most transgender individuals are younger than 50 and that more studies are
needed as this population ages. They do note that available studies indicate that cross-sex hormones
pose dangers to long-term cardiovascular health (Dutra et al, 2019).

In sum, the literature reveals that the evidence for cross-sex hormones as a treatment for gender
dysphoria is weak and insufficient. Between the permanent effects, off-label use, and consequences to
long-term health, cross-sex hormones are a risky option that does not promise a cure but does
guarantee irreversible changes to both male and female bodies. Additionally, the inadequate studies
serving as the basis for recommendations by clinical associations can lead to providers making poorly
informed decisions for their patients. Research asserting that taking cross-sex hormones improves
mental health is subjective and short-term. More studies that utilize large sample sizes and appropriate

21
methods is required before the medical profession should consider cross-sex hormones as one of
gender dysphoria’s standard treatments.

22
Literature Review: Sex Reassignment Surgery
The final phase of treatment for gender dysphoria is sex reassignment surgery. This method consists of
multiple procedures to alter the appearance of the body to resemble an individual’s desired gender.
Some procedures apply to the genitals (genital procedures) while others affect facial features and vocal
cords (non-genital procedures). While the surgery creates aesthetical aspects, it does not fully transform
someone into the opposite biological sex. Transgender persons who undergo the procedures must
continue taking cross-sex hormones to maintain secondary sexual characteristics. Additionally, all
physical changes are irreversible, and the success rate of a surgery varies depending on the procedure
and the population. For example, surgeries for trans-females have much better results than those for
trans-males. Complications such as post-operative infections can also arise with the urinary tract system.
However, sex reassignment surgery supposedly can provide drastic, if not complete, relief from gender
dysphoria (Endocrine Society, 2017). The following is a list of procedures (both genital and non-genital)
for trans-females and trans-males that create physical features of the desired sex.

Procedures for Trans-Females

 Genital Surgeries: These consist of penectomy (removal of the penis), orchiectomy (removal of
the testicles), vaginoplasty (construction of a neo-vagina), clitoroplasty (construction of a
clitoris), and vulvoplasty (construction of a vulva and labia). To perform, a surgeon begins by
deconstructing the penis and removing the testicles. The penile shaft and glans are repurposed
to serve as a neo-vagina and artificial clitoris (Note: These are not actual female genitalia but
tissue constructed to resemble female anatomy). If the shaft tissue is insufficient, the surgeon
may opt to use a portion of intestine to build a neo-vagina. The scrotum serves as material for
fashioning a vulva and labia. In addition to constructing female genitalia, the surgeon reroutes
the urethra to align with the neo-vagina. Genital surgeries for trans-females result in permanent
sterility (Bizic et al, 2014).
 Chest Surgery: To attain full breasts, trans-females can undergo enlargement. The procedure is
similar to breast augmentation for women where a surgeon places implants underneath breast
tissue. Prior to surgery, trans-females need to take cross-sex hormones for roughly 24 months to
increase breast size to get maximum benefit from the procedure (Endocrine Society, 2017).
 Cosmetic and Voice Surgeries: Designed to create feminine facial features, fat deposits, and
vocal sounds, these procedures are secondary to genital procedures and intended to alter trans-
females’ appearances to better integrate into society as a member of the desired gender
(WPATH, 2012).

Procedures for Trans-Males

 Mastectomy: This is the most performed sex reassignment surgery on trans-males because
cross-sex hormones and chest-binding garments are often insufficient at diminishing breasts. To
remove this secondary sexual characteristic, trans-males can undergo a mastectomy where a
surgeon removes breast tissue subcutaneously (i.e., under the skin) and reconstructs the
nipples to appear masculine. The procedure can result in significant scarring (Monstrey et al,
2011).
 Genital Surgeries: Unlike the procedures for trans-females, genital surgeries for trans-males are
more complex and have lower success rates. Consisting of hysterectomy, oophorectomy

23
 (removal of the ovaries), vaginectomy (removal of the vagina), phalloplasty (construction of a
penis), and scrotoplasty (construction of prosthetic testicles), a team of surgeons must
manufacture a penis using skin from the patient (taken from an appendage) while removing the
vagina and creating an extended urethra. The functionality of the artificial penis can vary based
on how extensive the construction was. Attaining erections requires additional surgery to
implant a prosthesis, and the ability to urinate while standing is often not achieved. Genital
procedures for trans-males result in irreversible sterility (Monstrey et al, 2011).
 Cosmetic Surgeries: Similar to trans-females, these procedures create masculine facial features,
fat deposits, and artificial pectoral muscles. They aid trans-males with socially integrating as
their desired gender. Surgery to deepen voices is also available but rarely performed (WPATH,
2012).

Because sex reassignment surgery is irreversible, the criteria for receiving these procedures is the
strictest of all gender dysphoria treatments. WPATH and the Endocrine Society suggest rigorous reviews
of patient history and prior use of other therapies before approving. Furthermore, the two organizations
recommend that only adults (18 years old) undergo sex reassignment surgery.8 WPATH and the
Endocrine Society also recommend ensuring a strongly documented diagnosis of gender dysphoria,
addressing all medical and mental health issues, and at least 12 months of cross-sex hormones for
genital surgeries. Although the organizations agree on most criteria, they differ on whether hormones
should be taken prior to mastectomies. WPATH asserts that hormones should not be a requirement,
whereas the Endocrine Society advises up to 2 years of cross-sex hormones before undergoing the
procedure (WPATH, 2012; Endocrine Society, 2017). What this indicates is that trans-males might
undergo breast removal without having first pursued all options if their clinician adheres to WPATH’s
guidelines, which can lead to possible regret over irreversible effects.

As with cross-sex hormones, sex reassignment surgery’s irreversible physical changes can potentially
show marked mental health improvements and prevent suicidality in people diagnosed with gender
dysphoria. In April 2022, the chair of the University of Florida’s pediatric endocrinology department, Dr.
Michael Haller, advocated for the benefits of “gender affirming” treatments (WUSF, 2020). However,
the available evidence calls such statements into question. Recent research assessing both cross-sex
hormones and sex reassignment surgery indicate that the effects on “long-term mental health are
largely unknown.” In studies regarding the benefits of surgery, the results have the same weaknesses as
the research for the effectiveness of cross-sex hormones. These include small sample sizes, self-report
surveys, and short evaluation periods, all of which are insufficient to justify recommendations for
irreversible treatments (Bränström et al, 2020).

Two studies conducted in Sweden provide insight on the effectiveness of sex reassignment surgery in
improving the behavioral health of transgender persons. Because Sweden has a nationalized health
system that collects data on all residents, this country can serve as a resource to assess service
utilization and inpatient admissions. Both studies, one by Dhejne et al from 2011 and another by
Bränström et al published in 2020, assessed individuals who had received sex reassignment surgery and
examined outcomes over several decades. Dhejne et al’s findings indicate that sex reassignment

8
Although practice guidelines indicate the minimum age to undergo sex reassignment surgery is 18, available
evidence demonstrates that mastectomies have been performed on adolescent girls as young as 13 who
experience “chest dysphoria” (Olson-Kennedy et al, 2018).

24
procedures do not reduce suicidality. The authors explained that individuals who underwent sex
reassignment surgery were still more likely to attempt or commit suicide than those in the general
population. This study is unique because it monitored the subjects over a long period of time. Dhejne et
al note that the transgender persons tracked for the study did not show an elevated suicide risk until ten
years after surgery (Dhejne et al, 2011). Given that a high proportion of research follows sex
reassignment patients for much shorter timeframes, this evidence indicates that surgery might have
little to no effect in preventing suicides in gender dysphoric individuals over the long run.

In addition to having an increased suicide risk, Dhejne et al discuss how individuals who underwent sex
reassignment procedures also had higher mortality due to cardiovascular disease. The authors do not
list the specific causes but establish the correlation. Given that cross-sex hormones can damage the
heart, the increased risk could be related to the drugs and not the surgery. Furthermore, the study
explains that the tracked population had higher rates of psychiatric inpatient admissions following sex
reassignment. Dhejne et al established this by examining the rates of psychiatric hospitalizations in
these individuals prior to surgery and noted higher utilization in the years following the procedures.
These results are in comparison to the Swedish population at large. While the study contradicts other
research emphasizing improvements in mental health issues, it has its limitations. For example, the
sample size is small. Dhejne et al identified only 324 individuals who had undergone sex reassignment
surgery between 1973 and 2003. In addition, the authors noted that while the tracked population had
increased suicide risks when compared to individuals identifying as their natal sex, the rates could have
been much higher if the procedures were not available (Dhejne et al 2011). What this study postulates is
that sex reassignment surgery does not necessarily serve as a “cure” to the distress resulting from
gender dysphoria and that ongoing behavioral health care may still be required even after a complete
transition.

Bränström et al’s study evaluating the Swedish population used a larger sample (1,018 individuals who
had received sex reassignment surgery) but tracked them for just a ten-year period (2005 to 2015).9
Unlike Dhejne et al, the authors did not track suicides and focused primarily on mood or anxiety disorder
treatment utilization. Their results indicate that transgender persons who had undergone surgery
utilized psychiatric outpatient services at lower rates and were prescribed medications for behavioral
health issues at an annual decrease rate of 8%. Bränström et al also did not limit comparisons to
Sweden’s overall population and factored in transgender persons who take cross-sex hormones but
have not elected to have surgery. Those results still presented a decrease in outpatient mental health
services. However, Bränström et al note that individuals only on cross-sex hormones showed no
significant reduction in that category, which calls into question claims regarding effectiveness of cross-
sex hormones in ameliorating behavioral issues.

The Bränström et al study prompted numerous responses questioning its methodology. The study
lacked a prospective cohort or RCT design, and it did not track all participants for a full ten-year period
(Van Mol et al, 2020). These criticisms resulted in a retraction, asserting that Bränström et al’s
conclusions were “too strong” and that further analysis by the authors revealed that the new “results
demonstrated no advantage of surgery in relation to subsequent mood or anxiety disorder-related

9
Although Bränström et al claim to follow individuals for a ten-year period, peer reviews of the research revealed
that this was not the case, noting the authors had varying periods of tracking, ranging from one to ten years (Van
Mol et al, 2020).

25
health care visits or prescriptions or hospitalizations following suicide attempts in that comparison”
(Kalin, 2020).

There are multiple explanations for why the Bränström et al study reached different results than the
Dhejne et al study. For starters, Bränström et al tracked a larger sample group over a later period (2005
to 2015 as opposed to 1973 to 2003) during which gender dysphoria underwent a dramatic shift in
definition. Also, Dhejne et al did not see elevated suicides until after ten years, raising the question as to
whether sex reassignment surgery has temporary benefits on mental health rather than long-term or
permanent benefits. Like the other Swedish study, Bränström et al’s findings are a correlation and do
not specifically state that the procedures cause reduced psychiatric service utilization (Bränström et al,
2020).

A 2014 study by Hess et al in Germany evaluated satisfaction with sex reassignment procedures by
attempting to survey 254 trans-females on their quality of life, appearance, and functionality as women.
Out of the participants selected, only 119 (47%) returned completed questionnaires, which Hess et al
indicate is problematic because dissatisfied trans-females might not have wanted to provide input. The
results from the collected responses noted that 65.7% of participants reported satisfaction with their
lives following surgery and that 90.2% indicated that the procedures fulfilled their expectations for life
as women. While these results led Hess et al to conclude that sex reassignment surgery generally
benefits individuals with gender dysphoria, the information is limited and raises questions (Hess et al,
2014). Such questions include whether the participants had mental health issues before or after surgery
and did their satisfaction wane over time. Hess et al only sent out one questionnaire and not several to
ascertain consistency over multiple years. Questions like these raise doubts about the validity of the
study. Although Hess et al’s research is just one study, numerous others utilize the same subjective
methods to reach their conclusions (Hruz, 2018).

In his assessment, Patrick Lappert contributes additional insight on the appropriate clinical indications
for mastectomies, noting that removal of breast tissue is necessary following the diagnosis of breast
cancer or as a prophylactic against that disease. He cites that this basis is verifiable through definitive
laboratory testing and imaging, making it an objective diagnosis, whereas gender dysphoria has no such
empirical methods to assess and depends heavily on the patient’s perspective. Also, Lappert notes that
trans-males who make such decisions are doing so on the idea that the procedure will reduce their
dysphoria and suicide risk. However, they are making an irreversible choice based on anticipated
outcomes supported only by weak evidence, and thus cannot provide informed consent (Lappert, 2022).

The literature is inconclusive on whether sex reassignment surgery can improve mental health for
gender dysphoric individuals. Higher quality research is needed to validate this method as an effective
treatment. This includes studies that obtain detailed participant histories (e.g., behavioral diagnoses)
and track participants for longer periods of time. These are necessary to evaluate the full effects of
treatments that cause irreversible physical changes. In addition, sex reassignment procedures can result
in severe complications such as infections in trans-females and urethral blockage in trans-males. Health
issues related to natal sex can also persist. For example, trans-males who undergo mastectomy can still
develop breast cancer and should receive the same recommended screenings (Trum et al, 2015). Until
more definitive evidence becomes available, sex reassignment surgery should not qualify as a standard
treatment for gender dysphoria.

26
Literature Review: Quality of Available Evidence and Bioethical
Questions
Quality of Available Evidence

Clinical organizations that have endorsed puberty suppression, cross-sex hormones, and sex
reassignment surgery frequently state that these treatments have the potential to save lives by
preventing suicide and suicidal ideation. The evidence, however, does not support these conclusions.
James Cantor notes that actual suicides (defined as killing oneself) are low, occur at higher rates for
men, and that interpretations of available research indicate a blurring of numbers between those with
gender dysphoria and homosexuals (Cantor, 2022). Although information exists that contradicts certain
arguments, media outlets continue to report stories emphasizing the “lifesaving” potential of sex
reassignment treatment. A May 2022 story by NBC announced survey results under the headline
“Almost half of LGBTQ youths ‘seriously considered suicide in the past year’” (NBC, 2022). This is a
significant claim that can have a sensational effect on patients and providers alike, but how strong is the
evidence supporting it? Almost all of the data backing this assertion are based on surveys and cross-
studies, which tend to yield low-quality results (Hruz, 2018). In addition, how many gender dysphoric
individuals are seeing stories in the media and not questioning the narrative? Because research on the
effectiveness of treatments is ongoing, a debate persists regarding their use in the adolescent and
young-adult populations, and much of it is due to the low-quality studies serving as evidence.

In their assessment, Romina Brignardello-Petersen and Wojtek Wiercioch examined the quality of 61
articles published between 2020 and 2022 (Note: See Attachment A for the full study). They identified
research on the effectiveness of puberty blockers, cross-sex hormones, and sex reassignment surgery
and assigned a grade (high, moderate, low, or very low) in accordance with the Grading of
Recommendations Assessment, Development, and Evaluation (GRADE) approach. Out of the articles
reviewed, all with a few exceptions received grades of low or very low quality when demonstrating
outcomes regarding improvements in mental health and overall satisfaction with transitioning. For
puberty blockers, Brignardello-Petersen and Wiercioch identified low quality evidence for alleviating
gender dysphoria and very low quality for reducing suicidal ideation. The authors also had nearly
identical findings for cross-sex hormones. However, they noted moderate quality evidence for the
likelihood of cardiovascular side effects. Regarding surgery, Brignardello-Petersen and Wiercioch graded
articles that examined overall satisfaction and complication rates. None of the studies received grades
higher than low quality. These findings led the authors to conclude that “there is great uncertainty
about the effects” of sex reassignment treatments and that the “evidence alone is not sufficient to
support” using such treatments. Among the studies graded was one the U.S. Department of Health and
Human Services cited in its information on “gender affirming” treatments. The authors noted this
research had a “critical risk of bias” and was of low quality (Brignardello-Petersen and Wiercioch, 2022).

For his part, James Cantor provided a review of available literature, which addresses studies on etiology,
desistance, effectiveness of puberty blockers and cross-sex hormones, suicidal behaviors, and clinical
association and international guidelines. Throughout his analysis, Cantor cites weak evidence, poor
methodologies (e.g., retrospective versus prospective studies), and lack of professional endorsements in
research that indicates the benefits of sex reassignment treatment. Additionally, he notes that
improvements in the behavioral health of adolescents who take cross-sex hormones can be attributed
to the counseling they receive concurrently and that suicidality is not likely to result from gender

27
dysphoria but from co-occurring mental disorders. The reasoning behind the third point is based on the
blending of suicide and suicidality, which are two distinct concepts. The former refers specifically to
killing oneself, and the second regards ideation and threats in attempts to receive help. Cantor
specifically notes that actual suicides are highly unlikely among gender dysphoric individuals, particularly
trans-males. His other conclusions indicate that young children who experience gender identity issues
will most likely desist by puberty, that multiple phenomena can cause the condition, and that Western
European health services are not recommending medical intervention for minors. The basis for these
statements is the paucity of high to moderate quality evidence on the effectiveness of sex reassignment
treatments and numerous studies demonstrating desistance (Cantor, 2022).

Despite the need for stronger studies that provide definitive conclusions, many practitioners stand by
the recommendations of the AAP, Endocrine Society, and WPATH. This is evident in a letter submitted to
the Tampa Bay Times, which was a rebuttal to the Florida Department of Health’s (DOH) guidance on
treatment for gender dysphoria (Note: The guidance recommends against using puberty blockers, cross-
sex hormones, or surgery for minors) (DOH, 2022). The authors, led by six professors at the University of
Florida’s College of Medicine, state that recommendations by clinical organizations are based on
“careful deliberation and examination of the evidence by experts.” However, evaluations of these
studies show otherwise. Not only does the available research use cross-sectional methods such as
surveys, but it provides insufficient evidence based on momentary snapshots regarding mental health
benefits. These weak studies are the foundation for the clinical organizations’ guidelines that the
University of Florida professors tout as a gold standard. In addition, the letter’s authors state that DOH’s
guidance is based on a “non-representative sample of small studies and reviews, editorials, opinion
pieces, and commentary” (Tampa Bay Times, 2022). That statement misses the point when it comes to
evidence demonstrating whether treatments with irreversible effects are beneficial because the burden
of proof is on those advocating for this treatment, not on those acknowledging the need for further
research. This raises the question concerning how much academic rigor these professors are applying to
practice guidelines released by clinical organizations and whether they also apply the same level of rigor
to novel treatments for other conditions (e.g., drugs, medical devices).

Another example of a lack of rigor is a 2019 article by Herman et al from the University of California at
Los Angeles (UCLA) that evaluated responses to a 2015 national survey on transgender individuals and
suicide. Unlike other studies, this one utilized a large cohort with 28,000 participants from across the
U.S. responding. However, the researchers used no screening criteria and did not randomly select
individuals. In addition, responses consisted entirely of self-reports with no supporting evidence to even
prove a diagnosis of gender dysphoria. Although Herman et al conclude that the U.S. transgender
population is at higher risk for suicidal behaviors, the authors’ supporting evidence is subjective and
serves as a weak basis. Additionally, the survey results do not establish gender dysphoria as a direct
cause of suicide or suicidal ideation. The questions required participants to respond about their overall
physical and mental health. Out of those that indicated “poor” health, 77.7% reported suicidal thoughts
or attempts during the previous year, whereas just 29.1% of participants in “excellent” health had.
These percentages indicate that causes beyond gender dysphoria could be affecting suicidal behaviors.
Other reasons cited include rejection by family or religious organizations and discrimination. The authors
also acknowledge that their findings are broad, not nationally representative, and should serve as a
basis for pursuing future research (Herman et al, 2019).

28
Yet another example is a study published in 2022 by Olson et al tracks 300 young children that identify
as transgender over a 5-year period, and asserts low probabilities for detransitioning, while supporting
interventions such as puberty blockers. The authors found that children (median age of 8 years) who
identified as a gender that differed from their natal sex were unlikely to desist at a rate of 94% and
conclude that “transgender youth who socially transitioned at early ages” will continue “to identify that
way.” While this appears to contradict earlier studies that demonstrate most young adolescents who
change gender identities return to their “assigned gender at birth,” the authors note differences and
limitations with the results. For example, Olson et al notes that they did not verify whether the
participants met the DSM-V’s diagnostic criteria for gender dysphoria and that the children’s families
supported the decisions to transition. Instead, the authors relied on a child’s chosen pronouns to classify
as transgender. Also, Olson et al acknowledged that roughly 66% of the sample was biologically male.
This is particularly significant considering that the majority of transitioning adolescents in recent years
were natal females. Another issue with the study includes the median age at the end of follow-up (13
years), which is when boys begin puberty. Furthermore, the authors cite that the participants received
strong parental support regarding the transitions, which constitutes positive reinforcement (Olson et al,
2022). Other research demonstrates that such feedback on social transitioning from parents and peers
can prevent desistance following pubertal onset (Zucker, 2019). Despite these limitations, the New York
Times announced the study’s publication under the headline “Few Transgender Children Change Their
Minds After 5 Years” (New York Times, 2022). Such a title can add to the public’s perception that gender
dysphoria requires early medical intervention to address.

Bioethical Questions

The irreversible physical changes and potential side effects of sex reassignment treatment raise
significant ethical questions. These questions concern multiple bioethical principles including patient
autonomy, informed consent, and beneficence. In a 2019 article, Michael Laidlaw, Michelle Cretella, and
Kevin Donovan argue that prescribing puberty blockers or cross-sex hormones on the basis that they will
alleviate psychological symptoms should not be the standard of care for children with gender dysphoria.
Additionally, the three authors assert that such treatments “constitute an unmonitored, experimental
intervention in children without sufficient evidence of efficacy or safety.” The primary ethical question
Laidlaw, Cretella, and Donovan pose is whether pushing physical transitioning, particularly without
parental consent, violates fully informed consent (Laidlaw et al, 2019).

In accordance with principles of bioethics, several factors must be present to obtain informed consent
from a patient. These consist of being able to understand and comprehend the service and potential
risks, receiving complete disclosure from the physician, and voluntarily providing consent. Bioethicists
generally do not afford the ability of giving informed consent to children who lack the competence to
make decisions that pose permanent consequences (Varkey, 2021). Laidlaw, Cretella, and Donovan
reinforce this point regarding sex reassignment treatment when they state that “children and
adolescents have neither the cognitive nor the emotional maturity to comprehend the consequences of
receiving a treatment for which the end result is sterility and organs devoid of sexual function” (Laidlaw
et al, 2019). This further raises the question whether clinicians who make such treatment
recommendations are providing full disclosure about the irreversible effects and truly obtaining
informed consent.

29
Another issue is the conflict between consumerism and the practitioner’s ability to provide appropriate
care. Consumerism refers to patients learning about treatments through media/marketing and
requesting their health care provider to prescribe it, regardless of medical necessity. Considering that
social media is rife with individuals promoting “gender affirmative” drugs and surgeries, children are
making self-assessments based on feelings they may not understand and that can lead to deep regret in
the future (Littman, 2018). This can contribute to patients applying pressure on their doctors to
prescribe medications not proven safe or effective for the condition. Consumerism can also affect
bioethical compliance because it constrains clinicians from using their full “knowledge and skills to
benefit the patient,” which is “tantamount to a form of patient abandonment and therefore is ethically
indefensible” (Varkey, 2021).

In his assessment, G. Kevin Donovan explains the bioethical challenges related to sex reassignment
treatment, emphasizing the lack of informed consent when administering these services. He asserts that
gender dysphoria is largely a self-diagnosis practitioners cannot verify with empirical tests (e.g., labs and
imaging) and that providing such treatments is experimental. Because of the lack of consent and off-
label use of puberty blockers and cross-sex hormones, Donovan raises the question as to how
“experienced and ethical physicians so mislead others or be so misled themselves?” He further
attributes this phenomenon to societal and peer pressures that influence self-diagnosis and confirm
decisions to transition. As a result, these pressures lead to individuals wanting puberty blockers, cross-
sex hormones, and surgery. Donovan goes on to identify several news stories where embracing sex
reassignment treatment is a “cult-like” behavior. To conclude, he links these factors back to the failure
to obtain informed consent from transgender patients and how that violates basic bioethical principles
(Donovan, 2022).

30
Coverage Policies of the U.S. and Western Europe
U.S. Federal Level Coverage Policies

Medicare: In 2016, the Centers for Medicare and Medicaid Services (CMS) published a decision memo
announcing that Medicare Administrative Contractors (MACs) can evaluate sex reassignment surgery
coverage on a “case-by-case” basis. 10 CMS specifically noted that the decision memo is not a National
Coverage Determination and that “no national policy will be put in place for the Medicare program”
(CMS, 2016). This memo was the result of CMS reviewing over 500 studies, reports, and articles to the
validity of the procedures. Following its evaluation, CMS determined that “the quality and strength of
evidence were low due to mostly observational study designs with no comparison groups, subjective
endpoints, potential confounding . . . small sample sizes, lack of validated assessment tools, and
considerable (number of participants in the studies) lost to follow up.” In 2017, CMS reinforced this
position with a policy transmittal that repeated the 2016 memo’s criteria (CMS, 2017).

The basis for Medicare’s decision is that the “clinical evidence is inconclusive” and that “robust” studies
are “needed to ensure that patients achieve improved health outcomes.” In its review of available
literature, CMS sought to answer whether there is “sufficient evidence to conclude that gender
reassignment surgery improves health outcomes for Medicare beneficiaries with gender dysphoria.”
After evaluating 33 studies that met inclusion criteria, CMS’s review concludes that “not enough high-
quality evidence” is available “to determine whether gender reassignment surgery improves health
outcomes for Medicare beneficiaries with gender dysphoria and whether patients most likely to benefit
from these types of surgical intervention can be identified prospectively.” Additionally, out of the 33
studies, just 6 provided “useful information” on the procedures’ effectiveness, revealing that their
authors “assessed quality of life before and after surgery using validated (albeit non-specific)
psychometric studies” that “did not demonstrate clinically significant changes or differences in
psychometric test results” following sex reassignment surgery (CMS, 2016).

U.S. Department of Defense – Tricare: Tricare does not cover sex reassignment surgery, but it will cover
psychological services such as counseling for individuals diagnosed with gender dysphoria and cross-sex
hormones when medically necessary (Tricare, 2022).11

U.S. Department of Veterans Affairs: The U.S. Department of Veterans Affairs (VA) does not cover sex
reassignment surgery, although it will reimburse for cross-sex hormones and pre- and post-operative
care related to transitioning. Because the VA only provides services to veterans of the U.S. armed forces,
it cannot offer sex reassignment treatment to children (VA, 2020).12

10
The Centers for Medicare and Medicaid Services is part of the U.S. Department of Health and Human Services.
Its primary functions are to administer the entire Medicare system and oversee federal compliance of state
Medicaid programs. In addition, CMS sets reimbursement rates and coverage criteria for the Medicare program.
11
Tricare is the insurance program that covers members of the U.S. armed forces and their families. This includes
children of all ages.
12
The U.S. Department of Veterans Affairs oversees the Veterans Health Administration (VHA), which consists of
over 1,000 hospitals, clinics, and long-term care facilities. As the largest health care network in the U.S., the VHA
provides services to veterans of the U.S. armed forces.

31
State-Level Coverage Policies

Florida: In April 2022, DOH issued guidance for the treatment of gender dysphoria, recommending that
minors not receive puberty blockers, cross-sex hormones, or sex reassignment surgery. 13 The
justification offered for recommending against these treatments is that available evidence is low-quality
and that European countries also have similar guidelines. Accordingly, DOH provided the following
guidelines:

 “Social gender transition should not be a treatment option for children or adolescents.”
 “Anyone under 18 should not be prescribed puberty blockers or hormone therapy.”
 “Gender reassignment surgery should not be a treatment option for children or adolescents.”
 “Children and adolescents should be provided social support by peers and family and seek
counseling from a licensed provider.”

In a separate fact sheet released simultaneously with the guidance, DOH further asserts that the
evidence cited by the federal government cannot establish sex reassignment treatment’s ability to
improve mental health (DOH, 2022).

State Medicaid Programs: Because individual states differ in health services offered, Medicaid programs
vary in their coverage of sex reassignment treatments. The following maps identify states that cover sex
reassignment treatments, states that have no policy, and states that do not cover such treatments.

13
Unlike the federal government, the State of Florida delegates responsibilities for Medicaid and health care
services to five separate agencies (Agency for Health Care Administration, Department of Health, Department of
Children and Families, Department of Elder Affairs, and Agency for Persons with Disabilities). Each agency has its
own separate head (secretary or surgeon general), which reports directly to the Executive Office of the Governor.
As Florida’s public health agency, DOH oversees all county health departments, medical professional boards, and
numerous health and welfare programs (e.g., Early Steps and Women, Infants, and Children). Because it oversees
the boards, DOH has authority to release practice guidelines.

32
State Medicaid programs with coverage decisions regarding puberty blockers:

33
State Medicaid programs with coverage decisions regarding cross-sex hormones:

State Medicaid programs with coverage decisions regarding sex reassignment surgery:

34
Western Europe

Scandinavian countries such as Sweden and Finland have released new guidelines on sex reassignment
treatment for children. In 2022, the Swedish National Board of Health stated that “the risks of hormonal
interventions for gender dysphoric youth outweigh the potential benefits.” With the exception of youths
who exhibited “classic” signs of gender identity issues, adolescents who present with the condition will
receive behavioral health services and gender-exploratory therapy (Society for Evidence Based Gender
Medicine, 2022).

In Finland, the Palveluvalikoima issued guidelines in 2020 stating that sex reassignment in minors “is an
experimental practice” and that “no irreversible treatment should be initiated.” The guidelines further
assert that youths diagnosed with gender dysphoria often have co-occurring psychiatric disorders that
must be stabilized prior to prescribing any cross-sex hormones or undergoing sex reassignment surgery
(Palveluvalikoima, 2020).

The United Kingdom (U.K.) is also reassessing the use of irreversible treatments for gender dysphoria
due the long-term effects on mental and physical health. In 2022, an independent interim report
commissioned by the U.K.’s National Health Service (NHS) indicates that additional research and
systematic changes are necessary to ensure the safe treatment of gender dysphoric youths. These
include reinforcing the diagnosis process to assess all areas of physical and behavioral health, additional
training for pediatric endocrinologists, and informing parents about the uncertainties regarding puberty
blockers. The interim report is serving as a benchmark until the research is completed for final
guidelines (The Cass Report, 2022).

Like state Medicaid programs, health systems across Western Europe also vary in their coverage of sex
reassignment treatment.

35
Western European nations’ requirements for cross-sex hormones:

In this context, the age requirement for access to any medical treatment without consent of parents or of
a public authority. This age may range from 16 to 18 years depending on each country's laws.

36
Western European nations’ requirements for sex reassignment surgery:

In this context, the age requirement for access to any medical treatment without consent of parents or of
a public authority. This age may range from 16 to 18 years depending on each country's laws.

37
Works Cited
Almost Half of LGBTQ Youths ‘Seriously Considered’ Suicide in Past Year, Survey Says. NBC News. 4 May
2022.

American Academy of Pediatrics. Policy Statement: Off-Label Use of Drugs in Children. Pediatrics. 2014.
133(3).

American Psychiatric Association. Fifth Edition of the Diagnostic and Statistical Manual of Mental
Disorders. 2013.

American Psychiatric Association. Gender Dysphoria Diagnosis. 2017.

American Psychiatric Association. What Is Depression. 2020.

American Psychological Association. APA Resolution on Gender Identity Change Efforts. 2021.

Baker GM, Guzman-Arocho YD, Bret-Mounet VC, Torous VF, Schnitt SJ, Tobias AM, Bartlett RA, Fein-
Zachary VJ, Collins LC, Wulf GM, Heng YJ. Testosterone Therapy and Breast Histopathological Features in
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Attachments
Attachment A: Secretary for the Florida Agency for Health Care Administration’s Letter
to Deputy Secretary Thomas Wallace. 20 April 2022.

Attachment B: Complete text of Rule 59G-1.035, F.A.C.

Attachment C: Romina Brignardello-Petersen, DDS, MSc, PhD and Wojtek Wiercioch,

MSc, PhD: Effects of Gender Affirming Therapies in People with Gender Dysphoria:
Evaluation of the Best Available Evidence. 16 May 2022.

Attachment D: James Cantor, PhD: Science of Gender Dysphoria and Transsexualism. 17

May 2022.

Attachment E: Quentin Van Meter, MD: Concerns about Affirmation of an Incongruent

Gender in a Child or Adolescent. 17 May 2022.

Attachment F: Patrick Lappert, MD: Surgical Procedures and Gender Dysphoria. 17 May
2022.

Attachment G: G. Kevin Donovan, MD: Medical Experimentation without Informed

Consent: An Ethicist’s View of Transgender Treatment for Children. 16 May 2022.

45