Going Dutch
The small study that launched a big experiment in gender change
The gist
Tens of thousands of teenagers around the world are undergoing medicalised gender change on the strength of one questionable Dutch study with only 70 patients, the internationally renowned psychiatrist Professor Riittakerttu Kaltiala has warned.
“70 patients as a model for treatment for tens of thousands of patients — I find that really lousy,” Professor Kaltiala told a Florida Board of Medicine committee, which met last Friday to consider a new, more cautious standard of care for treating minors with gender dysphoria.
At the hearing there was a stark contrast between the concerns of Professor Kaltiala — a Finnish clinician and researcher with a global reputation — and the reassurances from American physicians defending what they call “gender-affirming care”.
Professor Kaltiala’s wry comment to the medical board was: “You may be wondering why I seem to have a different evidence [base] from the American speakers.”
She said the shared international evidence did indeed show that hormonal and surgical interventions achieved the limited aim of modifying secondary sex characteristics — giving a female facial hair, for example, or removing breasts.
“But almost all the other claims of their effectiveness [such as reducing dysphoria or boosting mental health] are based on questionable studies,” she said.
In many of today’s teenage patients, pre-existing mental disorders seemed more important than the dysphoria, and made it impossible to conclude there was a stable opposite-sex identity that would justify life-altering medical interventions.
“So, I consider it is of utmost importance that severe psychiatric disorders first be treated into remission [before any thought of medicalised gender change],” Professor Kaltiala said.
Finland, an early adopter of youth gender medicine, became in 2020 the first country to shift to caution, after disappointing clinical results and its own research suggested that the Dutch protocol did not work with recent patients.
Sweden was next to end medicalised gender change as a first-line treatment for minors, and the independent Cass review is steering England in a similar, more cautious direction.
The interim Cass report issued in February was noteworthy for its “subtlety and nuances,” according to Florida medical board member Dr David Diamond.
“And it’s remarkable how humble they are in their admission of how little we know [particularly about puberty blockers],” he said.
Dr Diamond asked gender-affirming physicians at Friday’s meeting how they explained the contrast between Europe’s conservative turn and the more permissive treatment approach of the United States.
“Before legal interference a year ago, the U.S. was not out of step with practice in other countries,” said paediatrician and endocrinologist Dr Meredithe McNamara from Yale Medical School.
“No other country in the world has prohibited the provision of gender-affirming care, despite the picture painted by some.”
Some Republican-run states in America have moved to prohibit medicalised gender change for minors. In litigation to block such prohibition in Alabama, Stonewall U.K. and other trans rights lobbies filed a brief in August.
Dr McNamara recommended this “amicus brief” to Florida’s medical board as an “accurate account” of the situation in Europe, saying she did not “see any substantive differences in other countries [compared to the U.S.].”
The brief fails to acknowledge that Finland and Sweden have stopped routine medicalised gender change for minors. It reflects very little of the concerns raised by the Cass review in the U.K.
It does not mention July’s announcement that the world’s largest youth gender clinic, the London-based Tavistock service, is to be shut down following advice from the eminent paediatrician Dr Hilary Cass, who heads the independent review.
And the Stonewall brief predates October’s draft plan for post-Tavistock gender services in England, which emphasises that an opposite-sex identity “may be a transient phase” and puts exploratory psychotherapy ahead of gender-affirming medicalisation, confining puberty blockers to formal research.
In Finland, Sweden, England (and Florida itself), bias-resistant systematic reviews of the international scientific literature have concluded that medicalised gender change for minors rests on a weak and uncertain evidence base.
The European embrace of a psychotherapy-first approach represents a rejection of the the gender-affirming treatment guideline of the World Professional Association for Transgender Health (WPATH), the supposed international benchmark.
Dr Aron Janssen, a child and adolescent psychiatrist and gender-affirming clinician at Lurie Children’s Hospital of Chicago, told the Florida medical board that the guidelines issued by WPATH were “based upon the best available science and expert professional consensus after careful and robust discussion, review and comment.”
He said WPATH’s guideline was recognised “as the prevailing standard of care by the major professional associations of medical and mental health providers in the U.S.”
The launch of the latest version of that guideline, known as SOC 8, was “a mess”, according to The Economist magazine.
SOC 8 had lowered the minimum ages for treatment — 14 for opposite-sex hormones, 15 for removal of breasts, 17 for testicles — but an abrupt “correction” eliminated all age minimums amid confusion and competing explanations.
A new SOC 8 chapter on adolescent care, noting “a sharp increase” in teenagers seeking gender treatment, claimed that a systematic review was “not possible” because of the sparse medical literature.
SOC 8 also devotes a fresh chapter to “eunuchs”, saying that “castration” may be “medically necessary gender-affirming care” for adults. However, this advice is offered for adult patients only.
“Due to the lack of research into the treatment of children who may identify as eunuchs, we refrain from making specific suggestions,” SOC 8 says.
At Friday’s five-hour meeting, the committee of Florida’s medical board voted to draft a rule that would prohibit future use of hormonal and surgical interventions with minors unless this is done in a formal research setting.
The issue is scheduled to go before the full medical board on November 4.
Update: On November 4, Florida’s Board of Medicine voted to prohibit future use of hormonal and surgical gender change interventions with minors.
The detail
Dutch researchers pioneered the use of puberty blockers as the first step in paediatric medical transition, with key publications in 2011 and 2014. Blockers were followed by opposite-sex hormones at age 16 and surgery at 18.
Professor Kaltiala told the Florida medical board that the positive outcomes claimed by the Dutch were open to question because the comparison group for the study was not in fact comparable.
Other countries adopted these Dutch interventions but began to use them at lower ages and with a different group of patients affected by psychiatric disorders, autism, emerging same-sex attraction and family dysfunction.
“Now we are treating a totally different patient mix,” Professor Kaltiala said.
She pointed out that the Dutch had mostly worked with early-onset gender dysphoria among psychiatrically stable biological males, whereas today’s gender clinic caseloads are dominated by troubled female patients with adolescent-onset dysphoria.
“There is no literature [about] the natural course of adolescent-onset gender dysphoria, there is no evidence [about] the treatment options for this [kind of] patient,” she said.
Research following in the footsteps of the Dutch had been “even worse” in quality.
“They only have a handful of patients, the follow-up time is up to one or two years only, [they have not] been able to demonstrate an improvement of mental health or functional abilities,” she said.
She was also critical of the failure of researchers to document patients not included in a study, making it impossible to judge how representative the treatment group and its outcomes might be.
“So the evidence is lousy in general, and [in particular for] mental health and adolescent development,” Professor Kaltiala said, adding that this fell below the standards expected today of evidence-based medicine.
Amid an international surge in atypical adolescent-onset dysphoria and a flip in the sex ratio of patients, a leading authority from the Amsterdam clinic, Dr Thomas Steensma, has protested that other countries have been “blindly adopting” the Dutch model to transition minors without doing their own research.
In August, the Tavistock scandal reached the home of the Dutch protocol when the medically trained Health Minister for the Netherlands, Dr Ernst Kuipers, was presented with eight questions in parliament.
These included —
How does the medical pathway of the Tavistock clinic compare to the care provided in Dutch clinics for children and adolescents with gender dysphoria?
Do Dutch clinics also work on the basis of the principle of gender affirmation, as in the Tavistock clinic?
Have Dutch clinics seen a remarkable increase in the number of applications from children and teenagers with gender dysphoria, such as at the Tavistock clinic where there was an increase of up to 5,000 per cent?
The questions on notice were put by Dutch MP Dr Nicki Pouw-Verweij, a physician and member of the party JA21, and by independent MP Pieter Omtzigt.
On Friday, Yale University’s Dr McNamara told Florida’s medical board that solid observational studies supporting youth gender medicine were being wrongly dismissed as “low quality” in systematic reviews of the literature.
“The misuse of technical language [used to grade the quality of evidence] is confusing to non-experts,” she said.
“Low-quality evidence is a technical designation rather than terminology that should be viewed in lay terms.
“Low-quality evidence does indeed inform strong recommendations for clinical practice.
“For instance, the Endocrine Society’s guidelines on obesity recommend that children consume fruits and vegetables rather than sweetened beverages such as juice — this is based on ‘low-quality’ evidence, but it’s been adopted widely.”
In October 2019, Yale University enjoyed widespread media coverage for a study, published in the Journal of American Psychiatry, that claimed a breakthrough in proving the enduring mental health benefits of gender surgery.
In a field plagued by poor data sets and short-term studies, this research made use of Sweden’s unusually comprehensive medical records.
The Yale School of Medicine issued a media statement quoting the one of the paper’s authors, Dr John Pachankis, who declared: “No longer can we say that we lack high-quality evidence of the benefits of providing gender-affirming surgeries to transgender individuals who seek them”. (Emphasis added.)
A little less than a year later, the journal had to publish an extraordinary correction and letters from a dozen psychiatrists, clinicians and researchers in four countries identifying multiple flaws in the 2019 U.S.-Swedish paper, with the conclusion that in fact the data showed no improvement in mental health after surgery.
Misleading coverage of the study remains uncorrected online, while Yale’s media statement has disappeared from the medical school’s webpage.
Assessment assessed
Professor Kaltiala told the Florida medical board that in Finland exploratory psychotherapy was now the first-line treatment for youth gender dysphoria.
This followed the conclusion by the public sector organisation the Council for Choices in Health Care (COHERE) that, “In light of available evidence, gender reassignment of minors is an experimental practice.”
Primary care and local health gave first priority to dealing with any psychiatric disorders and developmental problems of patients, as well as interventions tailored to those with autism spectrum disorder.
The 2020 COHERE advice says: “In adolescents, psychiatric disorders and developmental difficulties may predispose a young person to the onset of gender dysphoria. These young people should receive treatment for their mental and behavioural health issues, and their mental health must be stable prior to the determination of their gender identity.”
Professor Kaltiala said: “Very seldom would we see patients where you could think that the mental health co-morbidities would only be secondary [to gender dysphoria]”.
If after first-line treatment minors were to be considered for hormonal interventions, they would be referred for assessment by nationally centralised multi-disciplinary teams. (Unlike the U.S., Finland does not allow gender surgery on minors.)
“These assessments comprise multiple meetings over a period of 6-12 months — in practice it’s more close to 12 months, very rarely we can do it in 6 months,” Dr Kaltiala said.
Among the considerations would be whether or not the adolescent had the psychological strength and resilience to go through medical transition.
The Amsterdam clinic responsible for the Dutch protocol of paediatric transition also conducted assessments over a period of months, and excluded patients with severe psychiatric issues.
On Friday, physicians associated with U.S. gender clinics assured the Florida medical board that patients were thoroughly assessed by multi-disciplinary teams and received individualised care.
Reuters published a special news report last month about the surge in U.S. gender medicine for minors, and assessed the assessment process.
“In interviews with Reuters, doctors and other staff at 18 gender clinics across the [U.S.] described their processes for evaluating patients. None described anything like the months-long assessments [that the Dutch clinicians] adopted in their research,” the report said.
“At most of the clinics, a team of professionals — typically a social worker, a psychologist and a doctor specialising in adolescent medicine or endocrinology — initially meets with the parents and child for two hours or more to get to know the family, their medical history and their goals for treatment.
“They also discuss the benefits and risks of treatment options.
“Seven of the clinics said that if they don’t see any red flags and the child and parents are in agreement, they are comfortable prescribing puberty blockers or hormones based on the first visit, depending on the age of the child.”
Cis-contagion
Asked about the rapid spread of gender clinics catering to ever more teenagers, Yale University’s Dr McNamara told the Florida medical board this had been “blown out of proportion.”
“If you look at the absolute numbers, it’s not exponential by any means,” she said.
“The data do not back up the social contagion claim [that trans identity and dysphoria spread online and through peer groups].
“This a predominantly, overwhelmingly cis-gendered [or non-trans] society and young people are far more exposed to cisgender social norms [so that] social contagion would work in the reverse.”
In October, Reuters estimated that diagnoses of gender dysphoria among 6-17 year-olds in the U.S. increased from 15,172 to 42,167. This is likely to be an underestimate because it is limited to insurance claims.
Major city hospitals in affluent countries around the developed world have been reporting sharp increases in teenage dysphoria patients since the mid-2010s.
Data, what data?
Oxford University sociologist Dr Michael Biggs told the Florida medical board that he began to read the scientific literature on gender medicine after students had urged him “to educate myself on transgender children”.
“I was surprised by the poor quality of published research and very disturbed by the absence of data — there are huge gaps in that literature,” he said.
In 2011-14 England’s Tavistock gender clinic attempted the first replication of the famous Dutch study, lowering the minimum age for puberty blockers from 16 to 12.
Discovering in 2018 that full results from this “early intervention” study were still unpublished, Dr Biggs led a campaign for their release.
His belief was that “because the results of puberty suppression were not positive, [the Tavistock clinic] decided not to publish them.”
The English High Court — hearing litigation against the Tavistock brought by detransitioner Keira Bell in October 2020 — also wanted to know why it was taking researchers so long to make the data public.
The results appeared immediately after the court verdict in Bell’s favour in December 2020, and they showed no improvement in the psychological functioning of the patients. The only attempt to replicate the Dutch study had failed.
All but one child in the Tavistock study started on puberty blockers went on to potentially lifelong opposite-sex hormones, a trajectory already suggested by Dutch data and one at odds with gender-affirming promotion of blockers as a low-stakes, no-regrets option.
Dr Biggs said the U.S. had seen a handful of longitudinal studies since the Tavistock research but they were “worse in quality.”
“Instead of replicating the methods pioneered by the Dutch, and repeated by the British, each [U.S.] research team used a different set of psychological measures,” he said
“They have tiny [patient] samples, they have high rates of attrition [meaning missing data for these patients], which is never explained and they use dubious statistical measures.”
The Chicago gender clinician Dr Janssen told the medical board that a start had been made on research that would remedy the lack of data to guide treatment of today’s adolescent-onset patients, citing a longitudinal study funded by the U.S. National Institutes of Health.
However, like the Tavistock early intervention study and Australia’s Trans20 longitudinal research, this NIH project is limited to gender-affirming interventions and lacks a comparison group offered an alternative treatment. This will undermine any firm conclusion about what it was that produced the outcomes.
“Watchful waiting” — now an alternative to the gender-affirming model but once the orthodox approach — is included as an option in October’s draft plans for post-Tavistock gender services issued by England’s National Health Service.
GCN sought comment from the Amsterdam clinic.
As if low quality evidence to tell you apples are better or worse than sugary drinks is comparable to low quality evidence saying a minor should be sterilized or have their breasts cut off. Good one Yale!
Thank you for the great informative article!!!
The Melbourne’s Royal Children’s Hospital (RCH) Gender service website includes the statement:
“Puberty blockers suppress the development of secondary sex characteristics and are used for adolescents in the early stages of pubertal development. As they are reversible in their effects, should an adolescent wish to stop taking them at any time, their biological puberty will resume”.
In addition the RCH website states that:
“It provides care that is consistent with the Australian Standards of Care and Treatment Guidelines for Trans and Gender Diverse Children and Adolescents (Version 1.3, 2020)”.
Those treatment guidelines include the statement:
“The long term impact of puberty suppression on bone mineralisation is currently unknown.”
Presumably that implies that puberty suppression could impact negatively on bone mineralisation. If that were the case then the effects of puberty blockers would not be reversable.
That aside, cited below recent changes in NHS website in relation to the ‘reversibility’ of gender blockers:
“GONE is the claim that puberty blockers are considered to be fully reversible:
The effects of treatment with GnRH analogues are considered to be fully reversible, so treatment can usually be stopped at any time after a discussion between you, your child and your MDT.
NEW is the admission that long-term effects are unknown:
Little is known about the long-term side effects of hormone or puberty blockers in children with gender dysphoria. Although the Gender Identity Development Service (GIDS) advises this is a physically reversible treatment if stopped, it is not known what the psychological effects may be.
It’s also not known whether hormone blockers affect the development of the teenage brain or children’s bones. Side effects may also include hot flushes, fatigue and mood alterations”.
It seems that the evidence of the long-term effects of puberty blockers have morphed from ‘reversable’ to ‘unknown’ and who is qualified to state that the next move might not be to ‘irreversible’?
Time will tell!