#poor evidence

https://journals.lww.com/prsgo/fulltext/2021/11000/letter_to_the_editor__regret_after.29.aspx

https://academic.oup.com/jcem/article-abstract/107/9/e3937/6572526?login=false

https://www.sciencedirect.com/science/article/abs/pii/S1054139X22007194

https://www.mdpi.com/2227-9032/10/1/121

https://link.springer.com/article/10.1007/s10508-021-02163-w

https://www.bmj.com/content/380/bmj.p382

https://www.bmj.com/content/380/bmj.p382

https://www.reuters.com/investigates/special-report/usa-transyouth-outcomes/

https://link.springer.com/article/10.1007/s11930-023-00358-x

By: Max Stephens and Alex Barton

Published: Jun 9, 2023

By: Michael Searles

Published: Apr 10, 2024

Children who think they are transgender should not be rushed into treatment they may regret, a landmark report has concluded.

The report by paediatric consultant Dr Hilary Cass has made 32 recommendations, including: calling for the “unhurried” care of those under 25 who think they may be transgender; an end to the prescribing of powerful hormone drugs to under-18s; and early help for primary school children who want to socially transition.

The Telegraph has summarised the report’s key findings:

Doctors must be extremely cautious about giving any trans drugs to under-18s

Last month, the NHS banned the prescribing of puberty blockers outside of clinical trials. However, Dr Cass has gone further and said children who think they are transgender should not be given any hormone drugs at all until at least 18.

The former president of the Royal College of Paediatrics and Child Health said there was no evidence the drugs “buy time to think” or “reduce suicide risk”.

While the drugs can suppress puberty, research commissioned by the review and carried out by the University of York found the drugs have no effect on the person’s body satisfaction or their experience of gender dysphoria – where the person feels they are a different gender to the sex they were born – despite this being the reason they had been prescribed.

[ Dr Hilary Cass said there was no evidence hormone drugs 'buy time to think' or 'reduce suicide risk' ]

Dr Cass stated there was “concern that [puberty blockers] may change the trajectory of psychosexual and gender identity development” with most patients going on to take cross-sex hormones as a result.

She said the NHS should exert “extreme caution” in giving out cross-sex hormones to under-18s as the research carried out by her review concludes there is “a lack of high-quality research” on their effectiveness. She said their use should be incorporated into the puberty blocker trial.

Dr Cass said all children and teenagers should be given time “to keep options open during this development window” and that this would allow time to diagnose and treat other conditions while preserving fertility.

She said doctors must be able to “refer to the longer-term benefits and risks” of treatment options but this was “not currently available” for children experiencing gender incongruence or dysphoria. A systematic review by the University of York of more than 1,000 children who had been treated by the Tavistock, found that 7.4 per cent of under-16s given puberty blockers stopped their treatment.

It found that the younger children started treatment, the more likely they were to continue on to cross-sex hormones, which means the drugs “are not buying time to think”.

It had also been suggested that the drugs could improve body image and psychological wellbeing – however, the review found “no changes in gender dysphoria or body satisfaction were demonstrated.”

Young children should have therapy before they are allowed to socially transition

Families should be able to see a medical professional such as a child psychologist or paediatrician as quickly as possible if a primary school child wants to socially transition, the report recommends.

Dr Cass states that while “exploration is a normal process” in teenagers, children who are yet to go through puberty will have been affected by “parental attitudes and beliefs”.

She states the importance of “avoiding premature decisions” and seeking help early on to understand the child’s behaviour and assess whether they are experiencing any mental health issues or distress.

Research conducted for the review found that prepubescent children who socially transition – which means a child being treated as their preferred gender, including using their chosen pronouns and name, and allowing them to use the facilities such as lavatories and changing rooms of their choice – were more likely to undergo medical treatment later.

She suggests that a “partial rather than full transition can be a way of ensuring flexibility and keeping options open until the developmental trajectory becomes clearer”.

“There should be a distinction for the approach taken to pre- and post-pubertal children,” she said. “This is of particular importance in relation to social transition, which may not be thought of as an intervention or treatment because it is something that generally happens at home, online or in school and not within health services.”

The report finds that “social transition in childhood may change the trajectory of gender identity development for children with early gender incongruence”.

The younger children are when they present with “gender incongruence” the more likely they are to move on from that phase, it says.

“The current evidence base suggests that children who present with gender incongruence at a young age are most likely to desist before puberty, although for a small number the incongruence will persist.”

It recommends a clinical professional such as a mental health specialist “should help families to recognise normal developmental variation in gender role behaviour and expression”.

Parents fear being labelled transphobic

Dr Cass said her review heard concerns from many parents about their child being socially transitioned and affirmed in their expressed gender without parental involvement.

Such cases often involved an adolescent who had “come out” at school while expressing concern about how their parents might react. “Some parents felt ‘forced’ to affirm their child’s assumed identity or risk being painted as transphobic and/or unsupportive,” the report said.

In a small number of cases, there were concerns that parents were “consciously or unconsciously” influencing their child’s gender expression, it said.

“It is very important that the child/young person’s voice is heard and that perceptions of gender identity represent the child/young person’s sense of self,” it said.

Under-25s must not be rushed into changing gender

Under-25s should not be rushed into changing gender, but should receive “unhurried, holistic, therapeutic support”, Dr Cass concluded. She said “life-changing” decisions must be properly considered in adulthood, noting that brain maturation continues into the mid-20s.

The report found that “clinicians are unable to determine with any certainty which children and young people will go on to have an enduring trans identity”. Young adults aged 17 to 25 who want to change gender should be seen by “a follow-through service” rather than sent straight to an adult clinic, the report concludes.

The NHS has been accused of fast-tracking thousands of teenagers to adult clinics, because they would not be seen before their 17th birthday, and prescribing them cross-sex hormones.

Dr Cass said these people were still at a “vulnerable stage in their journey” and that regional centres offering gender services for children, as well as mental health assessments and support, should care for those aged up to 25 or link up with such services.

The consultant paediatrician said it was not possible to “know the ‘sweet spot’ when someone becomes settled in their sense of self” but that decisions should not be rushed before an individual becomes a mature adult at about 25.

“When making life-changing decisions, what is the correct balance between keeping options as flexible and open as possible as you move into adulthood, and responding to how you feel right now?” she wrote in the report’s foreword.

The report said far more consideration should be given to reaching a point of maturity before taking a decision.

“It used to be thought that brain maturation finished in adolescence, but it is now understood that this remodelling continues into the mid-20s as different parts become more interconnected and specialised,” the report notes.

“Changes in the limbic area, which is ‘present-orientated’ and concerned with risk taking and sensation seeking, begin with puberty; this part of the brain becomes super sensitised, drives emotional volatility, pleasure and novelty seeking, and also makes adolescents more sensitive to social rejection, as well as vulnerable to addiction and a range of mental health problems,” the review continues.

“The ‘future orientated’ prefrontal cortex matures later, with development continuing into an individual’s 20s, and … is concerned with executive functions such as complex decision making, rational judgement, inhibition of impulsivity, planning and prioritisation,” it states.

Trauma is prevalent among trans children

Childhood trauma, neglect and abuse feature heavily in the cohort of patients seeking gender changes, the report shows.

It cites a systematic review that found that in some services, as many as two thirds of those referred had suffered some kind of neglect or abuse, with high levels of parental mental illness, substance abuse and exposure to domestic violence. The research found about half of cases had suffered from maternal mental illness or substance abuse while almost 40 per cent had experienced paternal mental illness or substance abuse.

An early study of UK cases referred to gender services found one quarter of children had spent some time in care. More than four in 10 cases had experienced living with only one parent, with almost as many having experience of family mental health problems.

The report shows that rates of mental ill-health have risen among children and young people, especially girls and young women.

This comes in parallel with the rising numbers seeking help from NHS gender clinics, where the biggest rise has been among those registered as female at birth, seeking help in adolescence to change gender.

Within this group, there are higher levels of neurodiversity and mental health issues, it says, calling for a “holistic” appraisal of the young patient, not solely in terms of their gender-related distress.

“Children/young people referred to NHS gender services must receive a holistic assessment of their needs to inform an individualised care plan. This should include screening for neurodevelopmental conditions, including autism spectrum disorder, and a mental health assessment,” it states.

People who change gender may regret it

The report advises children expressing a desire to change gender are given time to think before being rushed into a decision they may regret.

It suggests that too many decisions about changing gender have been rushed, with too little consideration given that children might regret their actions in later life.

A survey included in the findings found “the history of the child/young person’s gender journey was rarely examined closely for signs of difficulty, regret or wishes to alter any aspect of their gender trajectory.”

Evidence considered by the Cass review included talking to those who have transitioned to the opposite sex and those who have detransitioned back. It found that “whilst some young people may feel an urgency to transition, young adults looking back at their younger selves would often advise slowing down”.

It continued: “For some, the best outcome will be transition, whereas others may resolve their distress in other ways. Some may transition and then de/retransition and/or experience regret. The NHS needs to care for all those seeking support.”

Data on the number of adults who have detransitioned are scarce, but the report said the number was “increasing”. A 2021 study found that 70 per cent of people detransitioning had another condition in the first place, while 23 per cent were actually gay, lesbian or bisexual.

By: Azeem Ibrahim

Published: Aug 23, 2023

We cannot allow activists masquerading as experts to have the final word any longer. An open letter sent to the Wall Street Journal last month came and went without the public attention it sorely deserved.

Signed by 21 leading experts on paediatric gender medicine from nine countries, they wrote to take issue with the US Endocrine Society’s statement that so-called ‘gender-affirming’ care is best for minors presenting with gender dysphoria.

Gender-affirming care is code for the belief that hormones and surgery is the best and primary treatment for gender dysphoria since it purportedly “reduces the risk of suicide”.

The experts minced no words – the belief is “not supported by evidence”. Rather than cherry-pick studies which fit the narrative, the experts used far deeper meta-studies which found evidence of mental health benefits to be of “low or very low certainty”.

The risks for minors of puberty blockers and surgeries, including permanent sterility, regret, and lifelong dependence on repeat surgeries and medication are very real. Furthermore, the experts wrote that the claim that gender transition reduces suicides is contradicted by every systematic review. Even the Endocrine Society’s review found no reliable evidence that hormonal transition prevents suicide, yet they have no qualms promoting it.

This is something that every parent across Scotland, deep in their hearts, knew already to be true. That surgery and hormones are unlikely to resolve the underlying mental unwellness that troubles their children.

We live in a world where gender distress has increased in prevalence by several thousand percent in the last two decades – but to question the longevity of these feelings or to describe them in the context of mental health is denounced as transphobic and as provoking suicide. Parents face ultimatums about the suicide of their children despite their being no good reason to believe that puberty blockers will help them.

As Dr Paul McHugh noted all those years ago, “when children who reported transgender feelings were tracked without medical or surgical treatment at Vanderbilt University and London's Portman Clinic, 70%-80% of them spontaneously lost those feelings.”

In the vast majority of cases, the best approach is to love your children and take no medical intervention. Yet, according to The Telegraph, figures show that 98 per cent of children who were given puberty blockers went on to be given cross-sex hormones.

Blockers are dangerous and irreversible in their own right, but they also 'lock-in' children to even more devastating outcomes when they would likely have recovered from the dysphoria without intervention – if only doctors had let them. It is not reality that is causing most of these young people to commit suicide, is it collaborating with a mental disorder with body and mind-altering drugs.

Doctors are supposed to advise treatment on the basis of evidence and fully inform their patients. The Tavistock Clinic scandal shows that even the most (formerly) prestigious institutions were letting children down.

In court, the Government’s Gender Identity Service (GIDS) couldn’t even provide data on the outcomes and consequences of puberty blockers on the minors who were given them. Even if the children were old enough to consent, the consent wouldn’t have been informed.

In order to skirt around questions of consent, we are told convenient myths. Puberty blockers are described as a “physically reversible treatment if stopped” by GIDS. This is an improvement, as until 2020 the claim had been that “treatment with GnRH analogues are considered to be fully reversible”, but it is still scandalously misleading to my mind.

The new definition tacitly concedes that the puberty blockers are not and have never been psychologically reversible – they had been promoted as harmless despite little research having gone into finding out whether this was the case. It also allows the words “if stopped” to do an inordinate amount of linguistic legwork.

The fact that the GnRH drugs shut down large parts of the hypothalamus – the hormonal structure of the brain that regulates our perception of the world around us – should have given clinicians pause for thought before allowing them into the developing brains of children. Indeed, these same GnRH analogues are used for chemical castration. But ideology comes first and children come second.

In many cases, the children affected are girls – now around 75% of them – and many also suffer from autism and other issues which are known to affect socialisation. There are strong correlations between such mental disorders and gender dysphoria.

Parents who attempt to remove vulnerable children from suggestive environments, offer a counter-message, or even attempt to make children more comfortable in their natural sex in the meantime are condemned as transphobic. So are those who insist that minors are not capable of consenting to use chemicals which impact their future so profoundly.

In Canada, a father has been jailed for opposing his child’s gender transition. He insisted that his child, who was 13 at the time, was still a ‘she’ – an utterance which is (quite literally) considered criminal violence in Canada.

He refused consent for her to be given puberty blockers. Dragged through the courts, fined thousands, and imprisoned, the father was unable to stop his child being given not just puberty blockers, but cross-sex hormones, causing them to go through puberty with testosterone and changing his child’s life forever.

In Scotland, children as young as nine have been prescribed puberty blockers. Despite activists' best efforts, minors who want surgery and cross-sex hormones in the UK must wait until the frail old age of 17. This is still a child, but it could be so much worse.

The World Professional Association for Transgender Health’s (WPATH) insist that children as young as nine years old can be given cross-sex hormones. Their ‘guidelines’ also permit mastectomies, implants and prosthetic genitals once these children have been on hormones for 12 months, with no mental health assessment.

Tragically, after 12 months, the risk of cancers, infertility and negative psychoactive effects are already high. It is barbaric to do this to children. Doctors who endorse this course of action should not be trusted. In fact, only a third of WPATH’s ethics committee are medical doctors. As with the Endocrine Society, we cannot allow activists masquerading as experts to have the final word any longer. We need our ethics to be based on compassion and understanding rather than politics.

Paul McHugh's seminal 2014 essay should still serve as a critical point of reference on the use of puberty blockers. McHugh, a distinguished former psychiatrist-in-chief at Johns Hopkins Hospital (an institution which was an early pioneer of such surgeries), wrote candidly at a time before the transgender issue became the cultural powder keg it is today.

McHugh identified three subgroups of transgender people who might be given surgery or medication. The first is the opportunist, such as Isla Bryson, who have obvious motives to change sex. The second group are internally and externally suggestible, similarly to anorexia nervosa patients, who are convinced that a physical surgery will fix their psycho-social problems. The third group are often prepubescent children who, in the process of naturally exploring how they fit into the world, begin to imitate behaviours of the opposite sex.

By: Leor Sapir

Published: Jun 28, 2023

A growing number of countries, including some of the most progressive in Europe, are rejecting the U.S. “gender-affirming” model of care for transgender-identified youth. These countries have adopted a far more restrictive and cautious approach, one that prioritizes psychotherapy and reserves hormonal interventions for extreme cases.  

In stark contrast to groups like the American Academy of Pediatrics (AAP), which urges clinicians to “affirm” their patient’s identity irrespective of circumstance and regards alternatives to an affirm-early/affirm-only approach “conversion therapy,” European health authorities are recommending exploratory therapy to discern why teens are rejecting their bodies and whether less invasive treatments may help.  

If implemented in American clinics, the European approach would effectively deny puberty blockers and cross-sex hormones to most adolescents who are receiving these drugs today. Unlike in the U.S., in Europe surgeries are generally off the table before adulthood.  

Why are more countries turning their backs on what American medical associations, most Democrats and the American Civil Liberties Union call “medically necessary” and “life-saving” care? The answer is that Europeans are following principles of evidence-based medicine (EBM), while Americans are not.

A bedrock principle of EBM is that medical recommendations should be grounded in the best available research. EBM recognizes a hierarchy of information. The expert opinion of doctors, for example, even when based on extensive clinical experience, furnishes the lowest quality — meaning, least reliable — information. Slightly higher on the information pyramid are observational studies. Systematic reviews of evidence, meanwhile, furnish the highest quality evidence. They follow a rigorously developed, reproducible methodology. They do not cherry-pick studies with convenient results, but instead consider all the available research.  

Most importantly, systematic reviews don’t merely summarize the conclusions of available studies on a question of interest. Instead, they assess the strengths and weaknesses of these studies to determine the reliability of their findings. To do this, systematic reviews typically use the GRADE system (Grading of Recommendations, Assessment, Development and Evaluations) and rank the quality of evidence as “high,” “moderate,” “low” or “very low.”  

Systematic reviews by EBM experts in Scandinavia and the United Kingdom have concluded that there are serious gaps in the evidence base for sex modification in minors. The U.K. systematic reviews found the available research to be of “very low” quality — meaning that there is very low certainty that an observed effect, like reduced suicidality, is due to the intervention, and therefore the studies’ claimed results are unlikely to represent the truth.  

Importantly, even the famous Dutch study that is said to be the “gold standard” of research in this area received a rating of “very low” due to serious methodological problems. Sweden’s National Board of Health and Welfare has said that the risks of treating gender dysphoric minors with hormonal interventions “currently outweigh the possible benefits.”  

Last year, Florida’s health authorities commissioned what is known as an “umbrella review,” or a systematic overview of systematic reviews, from independent experts at McMaster University, home of EBM. Unsurprisingly, that overview came to the same conclusion: There is no reliable evidence that youth transition improves mental health outcomes.  

Because U.S. medical groups don’t always use EBM, their conclusions can be based on studies whose fatal flaws are overlooked or ignored. Consider, as an example, a study done at Seattle Children’s Hospital and published last year. The study’s authors reported that use of puberty blockers and cross-sex hormones was associated with 60 percent lower odds of depression and 73 percent lower odds of suicidality. Leading mainstream publications, including Scientific American and Psychology Today, celebrated the findings. More recently, major U.S. medical associations cited the study in federal court proceedings.  

But a careful look at the study’s data shows that the kids who received hormonal interventions did no better by the end of the study than at the beginning. The researchers’ claim about improvement was based on the fact that the kids in the control group, who received psychotherapy but not hormones, got worse relative to the hormone group. But even this isn’t accurate, as 80 percent of the control group dropped out by the end of the study, and a likely reason for this dramatic loss to follow-up is that many or perhaps all of the non-hormone-treated kids improved without “gender-affirming” drugs. It’s quite possible that if the researchers had followed up with all the participants, we’d see this study become Exhibit A in the case against pediatric sex changes.

Similar problems exist in studies purporting to show a rate of transition regret of less than 1 percent. The true rate of regret is not known and won’t be known for years to come. The claim that gender dysphoric teens are at high risk of suicide if not given access to “gender-affirming” drugs and surgeries is likewise baseless and irresponsible. In February, Finland’s top expert in gender medicine emphasized this point to the country’s liberal newspaper of record.

The American Academy of Pediatrics’ main statement on gender medicine, authored by a single doctor while still in his residency, is not a systematic review. The author himself has conceded as much. A later published peer-reviewed fact check found the AAP statement to be a textbook example of cherry-picking and mischaracterization of evidence.

The World Professional Association of Transgender Health (WPATH) says in its latest “standards of care” that a systematic review of evidence is “not possible.” Instead, WPATH used a “narrative review,” which has a high risk of bias according to EBM because it doesn’t utilize a reproducible methodology. England has broken from WPATH, and the director of Belgium’s Center for Evidence-Based Medicine has said he would “toss them [WPATH’s guidelines] in the bin.” In the U.S., WPATH’s standards are widely accepted as authoritative.

The U.S. Endocrine Society has relied on two systematic reviews in developing its own guideline. But these reviews were not for mental health benefits, and in any case the Endocrine Society ranks the quality of evidence behind its own recommendations as “low” or “very low.”

All other U.S. medical groups cite these three sources when assuring the public about “gender-affirming care,” thus creating an illusion of consensus around “settled science.”  

Earlier this year, an investigative report in the prestigious British Medical Journal concluded that although pediatric gender medicine in the U.S. is “consensus-based,” it is not “evidence-based.” Gordon Guyatt, distinguished professor in the Department of Health Research Methods, Evidence, and Impact at McMaster University, Ontario, and one of the founders of EBM, recently called American guidelines for managing youth gender dysphoria “untrustworthy.” 

Consensus can be produced by misguided empathy, ideological capture or political pressures. Consensus can also be manufactured. The new president of the American Medical Association (AMA) has said there should be “no debate” when it comes to offering kids “gender-affirming” drugs and surgeries.  

Yale School of Medicine’s Dr. Meredithe McNamara calls the questioning of the evidence behind pediatric sex changes “science denialism.” Her protest is ironic. Science is a process of ongoing inquiry and debate, not a set of predetermined conclusions. Science depends on skepticism, especially about sensitive subjects. True science denialism means restricting rational, evidence-based debate — exactly what McNamara and the AMA’s new president want to do.

Their calls are bearing fruit. Just this month, gender activists successfully pressured a medical journal to retract a paper whose conclusions they found inconvenient. The ongoing campaign to suppress scientific debate allows a pseudo-consensus to emerge around “gender-affirming care.”

Put simply, pediatric gender medicine in the U.S. is out of control. Medicalization of gender diversity in children is a fast-growing industry that shows no signs of self-correction. Doctors and therapists who practice “affirmative” medicine consistently demonstrate ignorance about EBM principles and deceive the public about the grim realities behind the euphemism “gender-affirming care.”  

A Reuters investigation last year interviewed providers at 18 pediatric gender clinics and found that none were doing comprehensive mental health assessments and differential diagnosis. Those who promote and practice “gender-affirming care” themselves tell us that their approach is child-led. “Gatekeeping” of medical transition, they insist, is pointless, even “dehumanizing.”

The author of the AAP’s position paper on gender medicine has said that a “child’s sense of reality” is the “navigational beacon to orient treatment around.” The director of the gender clinic at Boston Children’s Hospital has admitted that they give out puberty blockers “like candy.” Even the founding psychologist of that clinic has warned that kids are being inappropriately “rushed toward the medical model.”

Why the U.S. has become an outlier on pediatric transgender medicine is a complicated question, but at least part of the answer is that European welfare states have centralized health bureaucracies and public health insurance. Before medicines can be approved for state funding, their evidence base needs to be evaluated. The American health care system is more vulnerable to profit motives, activist doctors and political pressures. Medical associations claim to advocate for patient health but can have other motives as well.

The situation is so dire that when pediatric gender medicine experts in other countries want to defend their practices before a skeptical public, they sometimes say that at least they are not as bad as the Americans. That is one kind of American exceptionalism we can do without.

==

[A] “child’s sense of reality” is the “navigational beacon to orient treatment around.”

Holy shit.

How can you claim that it's "settled science" and "consensus," and then leave everything up to the most immature, most depressed, most anxious, least experienced person in the room?

By: Jesse Singal

Published: Apr 18, 2023

Do people with severe depression have a right to accurate information about antidepressants? I suspect most people would answer “yes”. There is a general understanding that individuals who suffer from medical conditions are in a vulnerable position, making them susceptible to misinformation. There is also increased awareness of the influence that the profit motive can have on how medical research is funded, undertaken and communicated to the public.

But for some reason, this basic principle doesn’t seem to apply to the hyper-politicised subject of gender medicine. On one side, Republican states are attempting to ban youth gender medicine — and, in some cases, to dial back access to adult gender medicine. On the other, liberals maintain that there is solid evidence for these treatments, and that only an ignorant person could suggest otherwise.

Whether or not you agree with the GOP’s stance (I do not), the latter view is simply false. The trajectory of youth gender medicine in nations with nationalised healthcare systems has been relatively straightforward: these countries keep conducting careful reviews of the evidence for puberty blockers and hormones, and they keep finding that there is very little such evidence to speak of. That was the conclusion in Sweden, Finland, the UK, and, most recently, Norway. As a recent headline in The Economist had it: “The evidence to support medicalised gender transitions in adolescents is worryingly weak.”

Yet despite this evidentiary crisis in Europe, and despite multiple scandals vividly demonstrating the downside of administering these treatments in a careless way, liberal institutions in the US have only become more enthusiastic about them. In recent years, everyone from Jon Stewart and John Oliver to reporters and pundits at the New York Times, The Washington Post and NPR have exaggerated the evidence for these interventions.

The logic seems to be that if activists, doctors and journalists repeat “The evidence is great!” enough times, regardless of whether the evidence actually is great, the controversy will go away — as though the state of Arkansas could be shamed into reversing its policy on trans youth because Jon Stewart made fun of them. Meanwhile, as I can tell you from experience, if you openly question these treatments or highlight just how little we know about them, you’re going to have a bad time.

But look a little closer, and it swiftly becomes clear that the evidence for both adult and youth gender medicine is frequently drawn from alarmingly low-quality studies. Almost invariably, when you examine the latest study to go viral, there’s much less there than meets the eye — whether because of serious overhyping and questionable statistical choices on the part of the researchers, outright missing data, flawed survey instruments, more missing data, or just generally beyond-broken methods.

Since any individual study or group of studies can suffer from these issues, serious researchers know that you can’t just take a few that point in the right direction and herald them as evidence. Rather, you need to sum up the available evidence while also accounting for its quality. This is what European countries have done, and they have all come to roughly the same conclusion: the evidence supporting these treatments isn’t there.

But even at the level of sweeping summaries, America’s conclusions are often distorted. A prime example came in a recent New York Times column by Marci Bowers, a leading gender surgeon and the president of the World Professional Association for Transgender Health (WPATH). Bowers paints a very rosy picture of the evidence base:

“Decades of medical experience and research since has found that when patients are treated for gender dysphoria, their self-esteem grows and their stress, anxiety, substance use and suicidality decrease. In 2018, Cornell University’s Center for the Study of Inequality released a comprehensive literature review finding that gender transition, including hormones and surgery, ‘improves the well-being of transgender people’. Nathaniel Frank, the project’s director, said that ‘a consensus like this is rare in social science’. “The Cornell review also found that regret… became even less common as surgical quality and social support improved. All procedures in medicine and surgery inspire some percentage of regret. But a study published in 2021 found that fewer than 1% of those who have received gender-affirming surgery say they regret their decision to do so… A separate analysis of a survey of more than 27,000 transgender and gender-diverse adults found that the vast majority of those who detransition from medical affirming treatment said they did so because of external factors (such as family pressure, financial reasons or a loss of access to care), not because they had been misdiagnosed or their gender identities had changed.”

Here we have a leading expert (Bowers) citing a leading institution (Cornell) and relating astonishing claims (what medical procedure has a 1% regret rate?). The case appears to be closed — until you actually click the links and read Bowers’s sources. (Bowers and WPATH did not return emailed interview requests.)

Let’s start with Cornell’s data. According to a summary at its “What We Know Project“:

“We conducted a systematic literature review of all peer-reviewed articles published in English between 1991 and June 2017 that assess the effect of gender transition on transgender well-being. We identified 55 studies that consist of primary research on this topic, of which 51 (93%) found that gender transition improves the overall well-being of transgender people, while 4 (7%) report mixed or null findings. We found no studies concluding that gender transition causes overall harm.”

If you are familiar with systematic literature reviews, you will find the above unusual. Researchers don’t generally ask whether a procedure works or not in such a vague a manner, then tally up the results. To usefully gauge the level of evidence, a review has to carefully define its research questions, and factor in the potential biases of the existing studies. The Cornell project does none of this.

I emailed Gordon Guyatt, one of the godfathers of the so-called evidence-based medicine movement, to ask him whether he thought the Cornell project qualified as a systematic literature review. His response was: “It meets criteria for a profoundly flawed systematic review!” When we later spoke, he explained why he didn’t trust it. “Presumably, they are trying to make a causal connection between what the patients received and their outcomes,” he said. “That is not possible unless one has a comparator.” In other words, if you’re only tracking people who received a treatment, and don’t compare their outcomes to another group not receiving the treatment, you simply can’t learn that much. Guyatt offers the example of someone taking hormones and saying afterwards that they feel better. “That does not mean that the hormones have anything to do with your feeling good.” 

This is a very basic, very well-understood problem in both medical and social-scientific research. If all you have is before-and-after measurements of how someone who received a treatment changed over time, there are all sorts of potential confounds, from the placebo effect to regression towards the mean to the possibility that receiving the treatment coincided with some other salutary intervention, such as therapy, that wasn’t accounted for.

Because the Cornell team made no effort to even evaluate the risk of bias in the individual studies it evaluated, the final product tells us very little. It’s roughly analogous to coming upon a pile of coins and trying to determine its worth simply by counting how many coins there are, rather than sorting the pile by denomination. When I raised this with Nathaniel Frank, the head of the Cornell project, he said via email that “we don’t publish traditional systematic reviews”, but rather web summaries of important research questions. So the first words of its overview might confuse readers: “We conducted a systematic literature review.” 

If Bowers had wanted to cite a carefully conducted, peer-reviewed systematic review of the gender medicine literature, she actually had one at her fingertips: her own organisation, WPATH, funded one a few years ago. The results, published in the Journal of the Endocrine Society in 2021, revealed that there is almost no high-quality evidence in this field of medicine. After they summarised every study they could find that met certain quality criteria, and applied Cochrane guidelines to evaluate their quality, the authors could find only low-strength evidence to support the idea that hormones improve quality of life, depression, and anxiety for trans people. Low means, here, that the authors “have limited confidence that the estimate of effect lies close to the true effect for this outcome. The body of evidence has major or numerous deficiencies (or both).” Meanwhile, there wasn’t enough evidence to render any verdict on the quality of the evidence supporting the idea that hormones reduce the risk of death by suicide, which is an exceptionally common claim.

Oddly, though, the authors of this systematic review conclude by writing that the benefits of these treatments “make hormone therapy an essential component of care that promotes the health and well-being of transgender people”. That claim completely clashes with their substantive findings about the quality of the evidence. So, when Bowers cited the Cornell project, she was citing a review that is of very limited evidentiary value — while also ignoring a much more professionally conducted, and much more pessimistic, though strangely concluded, review that her own organisation paid for.

But what about the study which, she claims, “found that fewer than 1% of those who have received gender-affirming surgery say they regret their decision to do so”? Here’s where things get downright weird.

The study in question, published in 2021 in the journal Plastic and Reconstructive Surgery Global Open, has dozens of errors that its nine authors and editors have refused to correct. Indeed, it appears to have been executed and published to such an unprofessional standard that one might ask why it hasn’t been retracted entirely. 

Before we get into all that, though, it’s worth pointing out that even if it had been competently conducted, the review could not have provided us with a reliable estimate of the regret rate following gender-affirming surgery: the studies it meta-analyses are just too weak. Many of those included did not actually contact people who had undergone surgery to ask them if they regretted it; rather, the authors searched medical records for mentions of regret and/or for other evidence of surgical reversals. Yet this method is inevitably going to underestimate the number of regretters, because plenty of people regret a procedure without going through the trouble of either reversing it or informing the doctor who performed it. In one study of detransitioners — albeit one focusing on a fairly small and non-random online sample — three quarters of them said they did not inform their clinicians that they had detransitioned.

The studies included in this review also failed to follow up with a very large number of patients. The meta-analysis had a total sample size of about 5,600; the largest study, with a sample size of 2,627 — so a little under half the entire sample — had a loss-to-follow-up rate of 36%. If you’re losing track of a third of your patients, you obviously don’t really know how they’re doing and can’t make any strong claims about their regret rates. And yet, the authors don’t mention the loss-to-follow-up issue anywhere in their paper. No version of this meta-analysis, then, was likely to provide a reliable estimate of the regret rate for gender-affirming surgery.

Even so, the version that was published was particularly disastrous. Independent researcher J.L. Cederblom summed it up: “What are these numbers? These are all wrong… And these weren’t even simple one-off errors — instead different tables disagreed with each other. The metaphor that comes to mind is drunk driving.”

To take one example, the authors initially reported that the aforementioned largest paper in their meta-analysis had a sample size of 4,863. But they misread it — the true figure was actually only 2,627. They also misstated other aspects of that report, such as how regret was investigated (they said it was via questionnaire but it was via medical records search) and the age of the sample (they said it included some juveniles, but it did not).

Not all the errors were significant, but they were remarkably numerous. And because of the abundance of issues, the paper attracted the attention of other researchers. “In light of these numerous issues affecting study quality and data analysis, [the authors’] conclusion that ‘our study has shown a very low percentage of regret in TGNB population after GAS’ is, in our opinion, unsupported and potentially inaccurate,” wrote two critics, Pablo Expósito-Campos and Roberto D’Angelo, in a letter to the editor that the journal subsequently published. In her own letter, the researcher Susan Bewley highlighted what appears to be an absence of vital information about the authors’ method of putting together the meta-analysis. 

The authors and the editors decided to simply not correct any of this. They did publish an erratum, in which they republished seven tables that still contained errors, while maintaining that all those errors had no impact on the paper’s takeaway findings. But the paper itself remains published, in its original form, complete with those 2,200 ghost-patients inflating the sample size.

Bewley and Cederblom have continued to ask the journal to reveal the process that led to the paper getting published, and to address why so many of the errors remain uncorrected. In an email in January to Bewley, Aaron Weinstein, its editorial director, claimed that because critical letters to the editor had been published, and because the corrected data was reanalysed by a statistical expert, “the Publisher and the ASPS [American Society of Plastic Surgeons] feel that PRS Global Open has done due diligence on this article and this case is closed”. He also claimed, curiously, that he had no power to force the authors to address the many serious remaining questions raised by the paper’s critics, saying “there is no precedent for an editorial office to do so”. Neither Weinstein nor the paper’s corresponding author, Oscar Manrique, responded to my emailed requests for comments.

Finally, there is Bowers’s claim that “a separate analysis of a survey of more than 27,000 transgender and gender-diverse adults found that the vast majority of those who detransition from medical affirming treatment said they did so because of external factors”. This is technically true, but is also rather misleading because the survey in question — the 2015 United States Transgender Survey (which has profound sampling issues) — was of currently transgender people. It says so in the first sentence of the executive summary. Research based on this survey obviously can’t provide us with any reliable information about why people detransition, because it is not a survey of detransitioners. If you want to know how often people detransition, you need to follow large groups of trans people over time and check in to see if they still identify that way later on — and we don’t have high-quality research on that front.

It’s also worth bearing in mind that the vast majority of studies being discussed here concern adults, while the legislative discussion mostly centres on adolescents. The most recent version of WPATH’s Standards of Care is very open about the lack of evidence when it comes to the latter: “Despite the slowly growing body of evidence supporting the effectiveness of early medical intervention, the number of studies is still low, and there are few outcome studies that follow youth into adulthood. Therefore, a systematic review regarding outcomes of treatment in adolescents is not possible.” Again, WPATH is Bowers’s own organisation — surely she is familiar with its output?

Despite the backbreaking errors of that nine-authored paper, the severe limitations of the Cornell review, and the near-utter-irrelevance of the United States Transgender Survey, all three are chronically trotted out as evidence that we know transgender medicine is profoundly helpful, or that detransition or regret are rare — or both. It’s frustrating enough that these lacklustre arguments are constantly made on social media, where all too many people get their scientific information. But what’s worse is that many journalists have perpetuated this sad state of affairs. A cursory Google search will reveal that these three works have been treated as solid evidence by the Associated Press, Slate, Slate again, The Daily Beast, Scientific American and other outlets. The NYT, meanwhile, further publicised Cornell’s half-baked systematic review by giving Nathaniel Frank a whole column to tout its misleading findings back in 2018.

Why does such low-quality work slip through? The answer is straightforward: because it appears, if you don’t read it too closely, or if you are unfamiliar with the basic concepts of evidence-based medicine, to support the liberal view that these treatments are wonderful and shouldn’t be questioned, let alone banned. That’s enough for most people, who are less concerned with whether what they are sharing is accurate than whether it can help with ongoing, high-stakes political fights. 

But you’re not being a good ally to trans people if you disseminate shoddy evidence about medicine they might seek. Whatever happens in the red states seeking to ban these treatments, transgender people need to make difficult healthcare choices, many of which can be ruinously expensive. And yet, if you call for the same standards to be applied to gender medicine that are applied to antidepressants, you’ll likely be told you don’t care about trans people.

By: Roy Eappen and Ian Kingsbury

Published: Jun 28, 2023

A federal court last week struck down an Arkansas law banning the provision of sex-change procedures—off-label “puberty blockers,” opposite-sex hormones and surgery—to minors. In the June 20 ruling, Judge James M. Moody Jr. repeatedly cited the Endocrine Society, the professional organization of physicians who specialize in hormones. He wrote that the society has “published widely-accepted clinical practice guidelines for the treatment of gender dysphoria” that “were developed by experts in the field” and “are recognized as best practices.”

In truth, over the past decade transgender activists have co-opted the Endocrine Society and other professional organizations to promote such treatments for adolescents and even young children. Their guidelines are based on flimsy evidence, giving the appearance that invasive and irreversible treatments are beneficial for young patients despite a growing body of evidence to the contrary. The guidelines have been used by lawmakers in states such as California and New York to endanger children—and now by judges to block state efforts at protecting youngsters.

A few days before Judge Moody’s ruling, we attended the annual meeting of the Endocrine Society, of which one of us (Dr. Eappen) is a member. We found that endocrinologists are aware of the society’s failings and rue its elevation of transgender activism over medical expertise and patient needs.

The Endocrine Society endorsed medical “transition” for young people in 2017. It published the “clinical practice guidelines” for the “treatment of gender-dysphoric/gender-incongruent persons” that Judge Moody cited. At the time, there was little good research on this issue, and the Endocrine Society admitted the guidelines were largely based on evidence of “low” or “very low” quality. The society nonetheless recommended that some children receive a “hormone regimen that will suppress the body’s sex hormone secretion, determined at birth and manifested at puberty.”

At this year’s meeting, we had frank and fruitful discussions with endocrinologists who provide hormonal treatments to kids with gender dysphoria, as well as some who don’t. Without exception, they acknowledged that the society’s evidence base for pediatric gender transition is weak, at best. Yet while they’re aware of the guidelines’ shortcomings, they’re afraid to voice their concerns. The society’s full-throated endorsement of gender-affirming care implied condemnation of anyone who holds differing views. Medical professionals are being cowed into silence and coerced into providing treatments they know are dangerous to children.

Perhaps the most telling interactions were with European endocrinologists, who were there to discuss the latest research and treatments in the specialty. Those we spoke with expressed surprise that the U.S. hasn’t banned, or at least severely restricted, such treatments for adolescents and children.

England, Sweden and Finland have all taken this path, and Norway is likely to follow. Belgium, France, Ireland and Italy are also raising concerns. These countries are following the science, which shows that the claimed benefits of hormonal intervention for young people fail to outweigh the risks.

Most disturbing, endocrinologists on all sides of this debate told us that practitioners aren’t complying with the precautions set forth in the society’s guidelines. Despite the document’s call for careful mental-health screening and its acknowledgment that most cases of childhood gender dysphoria naturally resolve during puberty, endocrinologists recognize that some of their peers are rushing young patients to irreversible hormonal treatments. Every endocrinologist we spoke with supports doing more to ensure that these guardrails are enforced, and many favor erecting new ones.

Judge Moody’s ruling cites the Endocrine Society’s guidelines in a lengthy section titled “Findings of Fact,” which is essentially a recitation of transgender ideology. A trial judge’s findings of fact are all but unreviewable on appeal. By allowing ideologues to hijack their organization, endocrinologists are making themselves complicit in a scientifically baseless movement that inflicts serious harm on children’s physical and mental health.

Dr. Eappen is a practicing endocrinologist in Montreal and a senior fellow at Do No Harm. Mr. Kingsbury is Do No Harm’s research director.

[ Via: https://archive.is/TPpis ]

Published: Jul 9, 203

Stephen Hammes’s response (Letters, July 5) to our op-ed (“The Endocrine Society’s Dangerous Transgender Politicization,” June 29) proves our point: The Endocrine Society is ignoring the dangers that sex-change treatments pose to children.

Dr. Hammes, president of the Endocrine Society, leaves out that the society’s pro-sex-change guidelines are based on “low” or “very low” quality evidence. He says nothing about the growing number of progressive European countries that are abandoning America’s model of gender-affirming care following systematic reviews of the evidence.

Dr. Hammes says that “2,000 studies published since 1975” support gender-affirming care. Yet many of these studies show negative results or nonresults, while all suffer from methodological problems like selection bias or a lack of proper control groups. These failings make it impossible to say whether drugs and surgeries were superior to less invasive alternatives like psychotherapy or even placebos. All but two dozen studies involved adults who transitioned as adults, not children, meaning more than 1,900 of the studies Dr. Hammes cites have no bearing on this issue. The layman may be impressed by the large number, but evidence-based medicine is concerned with the quality and reliability of research, not its quantity.

If Dr. Hammes is so confident in the Endocrine Society’s guidelines, he should have no problem launching a systematic review of all risks and benefits of hormonal interventions. It is more than warranted, six years after the guidelines were released. Until then, states have no choice but to pass laws to protect children from well-intended but harmful practices.

Roy Eappen, M.D., and Ian Kingsbury, Ph.D. Do No Harm Montreal and Marblehead, Mass.

[ Via: https://archive.is/2wUMl ]

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