Cracking the 'false' consensus
Florida mounts the most significant challenge yet to under-age gender transition
Health professionals, activists and journalists are relying on the facade of “eminence-based medicine” to justify medicalised gender change for minors, thereby obscuring from the public the very weak evidence base for these risky, irreversible treatments.
That is the allegation by the American state of Florida, where health authorities have made the first government challenge to the authority of medical societies, particularly the American Academy of Pediatrics (AAP), responsible for transgender youth treatment guidelines and policy statements.
In the most comprehensive scientific critique yet commissioned by a U.S. state government, Florida’s Agency for Health Care Administration has issued a report advising against Medicaid subsidies for paediatric transition, backed by five expert papers on the evidence and ethics of hormonal and surgical treatments for the distress of youth gender dysphoria.
“It is the first state to request a comprehensive, independent review and assessment of the literature with respect to whether sex-affirming care is safe, effective and medically necessary by experts who study methodologies, results and standards — and to place it along with other expert testimonies in the record as the basis of their decision,” said former health care lawyer Jane Wheeler of the group Rethink Identity Medicine Ethics.
“I think it is significant also because the state is overtly challenging the AAP and other medical associations, and called out their support for ‘affirmative care’ as ideological and not evidence-based.”
Amid polarised politics, many U.S. Republican-run states are seeking to restrict “gender-affirming” medical interventions with minors, claiming they are too young to give informed consent, while President Biden’s Democratic federal administration endorses gender medicine as beneficial for youth mental health and has warned the states it will litigate to maintain access to these treatments.
In April, U.S. assistant secretary for health Dr Rachel Levine, a trans woman appointed by the Biden administration, claimed that medical transition of minors had the firm foundation of “evidence-based standards of care”, citing treatment guidelines and policy statements from the AAP, the Endocrine Society and the World Professional Association for Transgender Health.
These documents are often relied on by gender clinicians, activists and journalists when claiming a solid medical consensus for social and medical transition of minors using the “gender-affirming” treatment approach.
But the June 2022 Florida Medicaid report says youth gender medicine — from puberty blocker drugs through to cross-sex hormones and surgery — does not constitute a standard of care, and the evidence is so weak that these treatments are “experimental” and cannot be taken as “safe and effective” for gender dysphoria.
“While clinical organisations like the AAP endorse [these] treatments, none of those organisations relies on high quality evidence,” the report says.
“Their eminence in the medical community alone does not validate their views in the absence of quality, supporting evidence.
“To the contrary, the evidence shows that [these] treatments pose irreversible consequences, exacerbate or fail to alleviate existing mental health conditions, and cause infertility or sterility.”
Florida’s Surgeon-General Dr Joseph A. Ladapo has alerted the Florida Board of Medicine to the Medicaid report, as well as the state’s April 2022 Department of Health guidance against social and medical transition of minors.
“I encourage the Board to review the Agency’s findings [in the Medicaid report] and the Department’s guidance to establish a standard of care for these complex and irreversible procedures,” Dr Ladapo said in his June 2 letter.
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The Florida Medicaid report may be used in test-case litigation to argue that the policies of activist medical societies do not represent a “true consensus” among health professionals, and that the low-evidence treatments of the gender-affirming model are not “medically necessary”, according to Candice Jackson, a former senior lawyer for the federal government now helping the international parents’ group Genspect.
“With a specific report to point to, from a government agency — I think that's going to be used far and wide,” Ms Jackson told GCN.
“I'd be surprised if Florida stands alone as the only [Republican] state that goes ahead and truly dives into this [gender medicine debate] in a realistic and rational and specific way like this.”
Ms Wheeler highlighted the decision of Florida’s DeSantis administration to involve the state’s medical board.
“The Florida Medical Board was asked to assess in light of the [Medicaid] review whether minors in Florida should get ‘affirmative care’,” she told GCN.
“By making this a matter for the medical board and conducting an independent review, the medical issues are front and centre — and not so politicised as are the [other] state bans.
“[President] Biden is about to propagate new regulations requiring providers and insurance to provide and cover ‘medically necessary gender-affirming care’.
“So you can say that Florida is heading them off at the pass — and setting up the court case to challenge such a requirement as ‘arbitrary and capricious’, given Florida’s findings.”
Already in an Arizona case heard by a U.S. federal court of appeals, lawyers for young biological females seeking Medicaid cover for trans mastectomy failed to meet a high standard of proof for the “medically necessary” test.
And like the 15 states which recently filed a brief in defence of Alabama’s law against paediatric transition, the Florida report cites the international trend towards greater caution, with systematic reviews of the medical literature in Sweden, Finland and the United Kingdom confirming the weak evidence base for youth gender medicine.
Dr James M. Cantor, the clinical psychologist and researcher commissioned by Florida to review the medical literature on youth gender dysphoria, told GCN that many trans rights advocacy groups “have been shockingly guilty of cherry-picking evidence, citing only the studies or even just pieces of studies that look supportive”.
“The objective and transparent methods used in [Florida’s project] represent a huge step beyond that, capturing all the relevant evidence.”
Assessing the weak and inconclusive evidence, the Florida report notes that “clinical organisations [such as the AAP] 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.”
“Public healthcare systems throughout the world have … been ending the practice of medical transition of minors, responding to the increasingly recognised risks associated with hormonal interventions and the now clear lack of evidence that medical transition was benefiting most children, as opposed to the mental health counselling accompanying transition.” — Dr James M. Cantor, clinical psychologist, expert report for Florida
“[The 2018 ‘rapid-onset gender dysphoria’ study of researcher Dr Lisa Littman] along with [other studies] 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 utilised to address what is still categorised as a mental health issue.” — Florida Medicaid main report
“Given that the majority of surveyed detransitioners [in Dr Littman’s 2021 paper said] they were comfortable with their biological sex, [her] study indicates that gender dysphoria is not necessarily a lifelong issue. This necessarily raises doubts about whether cross-sex hormones, which cause permanent physical damage, are justified.” — Florida Medicaid main report
“Perhaps the greatest failure of informed consent, and non-disclosure of human experimentation outcomes, is found in the supposedly benign use of puberty blocking agents in minors … [T]he development of the adolescent brain and the maturation of its rational and executive functions does not typically complete until one’s early 20s. — Dr G. Kevin Donovan, ethicist and paediatrician, expert report for Florida
“We do not know if brain development that is halted with puberty blockers can return to full function once puberty is allowed to resume. It is very difficult to imagine ethical controlled clinical trials that could elucidate the effects of delaying puberty until the age of consent.” — Dr Quentin L. Van Meter, paediatric endocrinologist, expert report for Florida
“In the self-identified transgender adolescent, breasts are being removed on the basis of a diagnosis that is made by the patient since there are no tests with known error rates that can be used to predict who will benefit from this disfiguring and irreversible surgery.” — Dr Patrick W. Lappert, plastic surgeon, expert report for Florida
“In a year when Florida officials have already unleashed repeated, mean-spirited attacks on the LGBTQ+ community, this latest move by the DeSantis administration to deny best practice, age-appropriate, medically-necessary health care to transgender people is simply one more purely partisan attack on LGBTQ Floridians.” — Cathryn Oakley, Human Rights Campaign
A review of reviews
Florida’s health agency commissioned a systematic review of the medical literature from Dr Romina Brignardello-Petersen and Dr Wotjek Wiercioch, two McMaster University experts in health research methodology and the synthesis of evidence.
For their report, they took data from 75 systematic reviews of studies on puberty blockers, cross-sex hormones and trans surgery; synthesised the evidence on outcomes; and then graded the quality of that evidence.
They found some “low certainty” and “very low certainty” evidence suggesting improvements in gender dysphoria and other outcomes such as depression after these treatments. For most outcomes, these studies lacked a comparison group of patients not given these treatments, making impossible any firm conclusion about cause and effect.
“Due to the important limitations in the body of evidence, there is great uncertainty about the effects of puberty blockers, cross-sex hormones and surgeries in young people with gender dysphoria,” the reviewers say.
“This evidence alone is not sufficient to support whether using or not using these treatments. We encourage [clinical] decision-makers to be explicit and transparent about which factors play an important role in their decision, and how they are weighted and traded off.”
Florida’s various reports cite official reviews and studies in Sweden, Finland, the U.K. and Australia as vindicating the turn to caution by America’s Republican states.
Finland, June 2020: Finland’s Council for Choices in Health Care removed hormonal and surgical interventions as first-line treatments for minors, insisting that psychiatric issues and other problems be treated first. The council said: “No conclusions can be drawn on the stability of gender identity during the period of disorder caused by a psychiatric illness with symptoms that hamper development”. Finland’s new treatment guideline drew on a systematic review of the evidence, which found that “gender reassignment of minors is an experimental practice”.
Australia, April 2021: A study linked to the Children’s Hospital at Westmead in Sydney reported that dysphoric patients had significantly higher rates of childhood attachment issues and “adverse childhood events” such as trauma. This suggests that mainstream psychological approaches be used rather than irreversible medical interventions, according to Florida’s main June 2022 report.
Australia, September 2021: A new position statement from the Royal Australian and New Zealand College of Psychiatrists stressed the importance of mental health assessment before any decision on medical transition. Florida’s ethics expert report notes this more cautious policy, and quotes its warning — “There is a paucity of quality evidence on the outcomes of those presenting with gender dysphoria. In particular, there is a need for better evidence in relation to outcomes for children and young people”. The new RANZCP policy followed a two-year review of evidence.
Sweden, February 2022: The Swedish National Board of Health and Welfare concluded that “the risks of hormonal interventions for gender dysphoric youth outweigh the potential benefits”. This policy to end routine medical interventions followed a systematic review of the evidence base.
U.K., April 2022: In an interim report, the independent Cass review of gender dysphoria treatment said “gaps in the evidence base” — highlighted by systematic reviews — prevented any “definitive advice” on the safety or effects of puberty blockers and cross-sex hormones for minors.
The science of gender dysphoria
In his expert report for Florida, Dr Cantor reviews the small body of prospective studies — tracking outcomes over time — involving dysphoric youth given puberty blockers or cross-sex hormones, and concludes “there is little evidence that transition improves the mental well-being of children”.
“Despite that mental health issues, including suicidality, are repeatedly required by clinical standards of care to be resolved before transition, threats of suicide are instead oftentimes used as the very justification for labelling transition a ‘medical necessity’,” he says.
He says that what looks like adolescent-onset gender dysphoria might sometimes be the “identity disturbance” of undiagnosed borderline personality disorder (BPD), which calls for dialectical behavioural therapy, not medical transition. He says this condition, together with potentially LGB youth presenting as trans, may explain some of the elevated suicide risk attributed to dysphoric youth.
“Social media increasingly circulate demands for transition accompanied by hyperbolic warnings of suicide should there be delay or obstacle,” Dr Cantor says.
He cites the anecdotal refrain of gender clinicians faced with parents sceptical about medical transition — ‘Would you rather have a live, trans son than a dead daughter?’
“Such threats are treated as the justification for referring to affirming gender transitions as ‘lifesaving’ or ‘medically necessary’,” he says.
“Such claims convey only grossly misleading misrepresentations of the research literature, however, deploying terms for their shock value rather than accuracy, and exploiting common public misperceptions about suicide.
“Indeed, suicide prevention research and public health campaigns repeatedly warn against circulating such exaggerations, due to the risk of copy-cat behaviour they encourage.”
Dr Cantor highlights the modest claims and relatively cautious approach of the Amsterdam clinic which pioneered the use of puberty blockers within what became known as the “Dutch protocol” of gender medicine.
He says the protocol stipulates —
no social transition before age 12 (the “watchful waiting” period)
no puberty blockers before age 12
cross-sex hormones considered only after age 16
resolution of mental health issues before any transition
“The data from this [Amsterdam] clinic simply contain no information about the safety or efficacy of employing these measures at younger ages,” Dr Cantor says.
“Many other clinics and clinicians intrepidly proceeded on the basis of only the perceived positives [of the Dutch protocol], broadened the range of people beyond those represented in the research findings, and removed the protections applied in the procedures that led to those outcomes.”
In February 2021, a leading Dutch clinician, Dr Thomas Steensma called out gender clinics internationally for “blindly adopting” the Dutch protocol treatments without researching their own different patient groups.
“We don’t know whether studies we have done in the past are still applicable to today. Many more children are registering, and also a different type,” Dr Steensma said.
Over the last decade, the patient profile has switched from the classic early childhood dysphoria affecting a minuscule number of boys, to an exponentially growing gender clinic caseload of adolescent girls with multiple mental health disorders, autism and other complex issues.
Dr Cantor says “watchful waiting” had been the standard approach with early childhood dysphoria because of the robust research finding that the majority of these children would grow out of their opposite-sex identification, with many emerging as LGB adults.
“In sum, despite coming from a variety of countries, conducted by a variety of labs, using a variety of methods, all spanning four decades, every study without exception has come to the identical conclusion: among prepubescent children who feel gender dysphoric, the majority cease to want to be the other gender over the course of puberty,” he says. This is known as “desistance”.
“Because only a minority of gender dysphoric children persist in feeling gender dysphoric in the first place, ‘transition-on-demand’ increases the probability of unnecessary transition and unnecessary medical risks.”
Dr Cantor says most medical society recommendations on youth gender dysphoria are more cautious than they are made out to be in today’s “highly politicised context”.
At odds with activist claims, he says most of these official documents note that:
• Desistance of gender dysphoria occurs in the majority of prepubescent children
• Mental health issues need to be assessed as potentially contributing factors and need to be addressed before transition
• Puberty-blocking medication is an experimental, not a routine, treatment
• Social transition is not generally recommended until after puberty
Dr Cantor says the 2017 Endocrine Society guideline, one of the most commonly invoked in favour of paediatric transition, in fact does not endorse an “affirmation-only” treatment approach.
He notes that a 2020 Endocrine Society position statement, created in concert with the Pediatric Endocrine Society, states that the society’s 2017 “recommendations include evidence that treatment of gender dysphoria/gender incongruence is medically necessary and should be covered by insurance.”
However, Dr Cantor says, “the Endocrine Society makes neither statement”.
His strongest rebuke is for the 2018 AAP policy, which he says is “ unique among the major medical associations in being the only one to endorse an affirmation ‘on demand’ policy, including social transition before puberty, without any watchful waiting period.
“Although changes in recommendations can obviously be appropriate in response to new research evidence, the AAP provided none.
“Rather, the research studies the AAP cited in support of its policy simply did not say what the AAP claimed they did. In fact, the references that the AAP cited as the basis of their policy instead outright contradicted that policy, repeatedly endorsing watchful waiting.”
Dr Cantor first published his fact-check of the AAP policy four years ago. The AAP has been asked for comment a number of times but has refused.
Affirming natural puberty
“The major benefit of enduring puberty in a gender dysphoric patient is that it provides a strong likelihood of alignment of his gender identity with his natal sex,” paediatric endocrinologist Quentin L. Van Meter says in his expert report.
“There is no doubt that these patients need compassionate care to get them through their innate pubertal changes.”
Dr Van Meter — whose training at Johns Hopkins Hospital included exposure to the methods of Dr John Money, the pioneer of the disembodied concept of “gender identity” — opposes puberty blockers and challenges the claim that they are fully reversible.
He says this suppression of naturally timed puberty is quite different from using the same drugs to stop “precocious puberty” occurring in girls before age 8 or boys before age 9.
“[With precocious puberty] the end of treatment is carefully timed so that resumption of puberty occurs at the average age for females (10.5 years) and males (11.5 years),” Dr Van Meter says.
“This allows the necessary functions of puberty to prepare the body for reproduction and affects the bones, gonads, and brain, among other body systems.
“On the other hand, blocking puberty at the age of normal puberty [in gender dysphoria cases] prevents the needed accretion of calcium into the skeleton and prevents the maturation of the gonads.
“There is no long-term data that compares bone, gonad, and brain health in pubertal-aged patients who have had puberty interrupted and those who have not.
“Without any verifiable safety data, using the puberty blockers for interrupting normal puberty is not a sanctionable ‘off-label’ use of these drugs and is therefore to be considered uncontrolled, non-consentable experimentation on children.”
In his expert report on ethics, Dr G. Kevin Donovan, a paediatrician and former director for the Center for Clinical Bioethics at Georgetown University School of Medicine, says young people with gender dysphoria have been promised “holistic care” while at the same time, the confused idea of a child “trapped in the wrong body” imposes “a fragmented concept of the self”.
“This approach has been warmly embraced, even insisted upon, by many practitioners while viewed as nonsensical and even ludicrous by many laypersons,” he says.
“In reality, we cannot be trapped in the wrong body; we are our bodies, which are an integral and inseparable part of ourselves. To assert that there is a female self inside a male body (or the reverse), is to fail to achieve a full understanding that we are embodied persons, unified body and mind, if you will. A generation ago, sex and gender were taken to be synonyms for the same phenomena.
“We must ask if [today’s gender-affirming approach] represents a shift towards being trapped in a wrong diagnosis, rather than a child being trapped in a wrong body.”
Dr Donovan diagnoses a “headlong rush in the past decade towards the process of gender affirming care”, which he concludes is an unacknowledged experiment with off-label treatments not approved for gender dysphoria.
“Given this, we must ask ourselves: how can experienced and ethical physicians so mislead others, or be so misled themselves?”