Religion is a Mental Illness

U.S. Study on Puberty Blockers Goes Unpublished Because of Politics, …

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The leader of the long-running study said that the drugs did not improve mental health in children with gender distress and that the finding might be weaponized by opponents of the care.

An influential doctor and advocate of adolescent gender treatments said she had not published a long-awaited study of puberty-blocking drugs because of the charged American political environment.

The doctor, Johanna Olson-Kennedy, began the study in 2015 as part of a broader, multimillion-dollar federal project on transgender youth. She and colleagues recruited 95 children from across the country and gave them puberty blockers, which stave off the permanent physical changes — like breasts or a deepening voice — that could exacerbate their gender distress, known as dysphoria.

The researchers followed the children for two years to see if the treatments improved their mental health. An older Dutch study had found that puberty blockers improved well-being, results that inspired clinics around the world to regularly prescribe the medications as part of what is now called gender-affirming care.

But the American trial did not find a similar trend, Dr. Olson-Kennedy said in a wide-ranging interview. Puberty blockers did not lead to mental health improvements, she said, most likely because the children were already doing well when the study began.

“They’re in really good shape when they come in, and they’re in really good shape after two years,” said Dr. Olson-Kennedy, who runs the country’s largest youth gender clinic at the Children’s Hospital of Los Angeles.

That conclusion seemed to contradict an earlier description of the group, in which Dr. Olson-Kennedy and her colleagues noted that one quarter of the adolescents were depressed or suicidal before treatment.

In the nine years since the study was funded by the National Institutes of Health, and as medical care for this small group of adolescents became a searing issue in American politics, Dr. Olson-Kennedy’s team has not published the data. Asked why, she said the findings might fuel the kind of political attacks that have led to bans of the youth gender treatments in more than 20 states, one of which will soon be considered by the Supreme Court.

“I do not want our work to be weaponized,” she said. “It has to be exactly on point, clear and concise. And that takes time.”

She said that she intends to publish the data, but that the team had also been delayed because the N.I.H. had cut some of the project’s funding. She attributed that cut, too, to politics, which the N.I.H. denied. (The broader project has received $9.7 million in government support to date.)

Dr. Olson-Kennedy is one of the country’s most vocal advocates of adolescent gender treatments and has served as an expert witness in many legal challenges to the state bans. She said she was concerned the study’s results could be used in court to argue that “we shouldn’t use blockers because it doesn’t impact them,” referring to transgender adolescents.

Other researchers, however, were alarmed by the idea of delaying results that would have immediate implications for families around the world.

“I understand the fear about it being weaponized, but it’s really important to get the science out there,” said Amy Tishelman, a clinical and research psychologist at Boston College who was one of the study’s original researchers.

Dr. Tishelman also noted that, even if the drugs did not lead to psychological improvements, they may have prevented some of the children from getting worse. “No change isn’t necessarily a negative finding — there could be a preventative aspect to it,” she said. “We just don’t know without more investigation.”

In the 1990s and 2000s, doctors in the Netherlands began studying a small group of children who had experienced intense gender dysphoria since early childhood. For most of these children, the negative feelings dissipated by puberty. For others, puberty made them feel worse.

For those who struggled, the researchers began prescribing puberty blockers, which had long been used to treat children whose puberty began unusually early. The Dutch scientists reasoned that by preventing the permanent changes of puberty, transgender adolescents would fare better psychologically and fit in more comfortably in society as adults.

In 2011, the researchers reported on the first 70 children who were treated with the so-called Dutch Protocol. The children were thoroughly assessed to make sure that they had persistent dysphoria and supportive parents and that they did not have serious psychiatric conditions that might interfere with treatment.

These patients showed some psychological improvements after puberty blockers: fewer depressive symptoms, as well as significant declines in behavioral and emotional problems. All the patients chose to continue their gender transitions by taking testosterone or estrogen.

The findings were highly influential even before they were published, and clinics around the world opened to treat transgender adolescents with puberty blockers and hormones.

England’s youth gender clinic in 2011 tried to replicate the Dutch results with a study of 44 children. But at a conference five years later, the British researchers reported that puberty blockers had not changed volunteers’ well-being, including rates of self-harm. Those results were not made public until 2020, years after puberty blockers had become the standard treatment for children with gender dysphoria in England.

In 2020, Dr. Olson-Kennedy’s group described the initial psychological profile of the children enrolled in the U.S. study of puberty blockers, whose average age was 11. Before receiving the drugs, around one quarter of the group reported depression symptoms and significant anxiety, and one quarter reported ever having thoughts of suicide. Eight percent reported a past suicide attempt.

In a progress report submitted to the N.I.H. at that time, Dr. Olson-Kennedy outlined her hypothesis of how the children would fare after two years on puberty blockers: that they would show “decreased symptoms of depression, anxiety, trauma symptoms, self-injury, and suicidality, and increased body esteem and quality of life over time.”

That hypothesis does not seem to have borne out. “They have good mental health on average,” Dr. Olson-Kennedy said in the interview with The New York Times. “They’re not in any concerning ranges, either at the beginning or after two years.” She reiterated this idea several times.

When asked in follow-up emails to clarify how the children could have good initial mental health when her preliminary findings had showed one quarter of them struggling, Dr. Olson-Kennedy said that, in the interview, she was referring to data averages and that she was still analyzing the full data set.

Dr. Hilary Cass, a pediatrician who this year published an extensive review of youth gender services in England, said that the delays from the American and British research groups had led the public to believe that puberty blockers improved mental health, even though scant evidence backed up that conclusion.

“It’s really important we get results out there so we understand whether it’s helpful or not, and for whom,” Dr. Cass said.

Her report found weak evidence for puberty blockers and noted some risks, including lags in bone growth and fertility loss in some patients. It prompted the National Health Service in England to stop prescribing the drugs outside of a new clinical trial, following similar pullbacks in several other European countries.

An N.I.H. spokesman said that while the agency generally encourages the publication of data supported by its grants, researchers decide how and when to do so.

Dr. Olson-Kennedy’s collaborators have also not yet published data they collected on how puberty blockers affected the adolescents’ bone development.

But many other papers have been published from the wider N.I.H. project, including a 2023 study of older transgender and nonbinary adolescents who took estrogen or testosterone to aide their gender transition. After two years on hormones, the volunteers showed improvements in life and body satisfaction, and patients taking testosterone showed declines in depression and anxiety. (Two of the 315 patients died by suicide, a rate much higher than the general population.)

Dr. Olson-Kennedy noted that doctors’ clinical experience was often undervalued in discussions of research. She has prescribed puberty blockers and hormonal treatments to transgender children and adolescents for 17 years, she said, and has observed how profoundly beneficial they can be.

Although the N.I.H. studies are large, she said, “these are minuscule compared to the amount of people that we’ve taken care of.”

"I do not want our work to be weaponized."

Conclusions Intercessory prayer itself had no effect on complication-free recovery from CABG, but certainty of receiving intercessory prayer was associated with a higher incidence of complications.

Biden Officials Pushed to Remove Age Limits for Trans Surgery, Documents Show

Newly released emails from an influential group issuing transgender medical guidelines indicate that U.S. health officials lobbied to remove

nytimes.com

Newly released emails from an influential group issuing transgender medical guidelines indicate that U.S. health officials lobbied to remove age minimums for surgery in minors because of concerns over political fallout.

Health officials in the Biden administration pressed an international group of medical experts to remove age limits for adolescent surgeries from guidelines for care of transgender minors, according to newly unsealed court documents.

Age minimums, officials feared, could fuel growing political opposition to such treatments.

Email excerpts from members of the World Professional Association for Transgender Health recount how staff for Adm. Rachel Levine, assistant secretary for health at the Department of Health and Human Services and herself a transgender woman, urged them to drop the proposed limits from the group’s guidelines and apparently succeeded.

If and when teenagers should be allowed to undergo transgender treatments and surgeries has become a raging debate within the political world. Opponents say teenagers are too young to make such decisions, but supporters including an array of medical experts posit that young people with gender dysphoria face depression and worsening distress if their issues go unaddressed.

In the United States, setting age limits was controversial from the start.

The draft guidelines, released in late 2021, recommended lowering the age minimums to 14 for hormonal treatments, 15 for mastectomies, 16 for breast augmentation or facial surgeries, and 17 for genital surgeries or hysterectomies.

The proposed age limits were eliminated in the final guidelines outlining standards of care, spurring concerns within the international group and with outside experts as to why the age proposals had vanished.

The email excerpts released this week shed light on possible reasons for those guideline changes, and highlight Admiral Levine’s role as a top point person on transgender issues in the Biden administration. The excerpts are legal filings in a federal lawsuit challenging Alabama’s ban on gender-affirming care.

One excerpt from an unnamed member of the WPATH guideline development group recalled a conversation with Sarah Boateng, then serving as Admiral Levine’s chief of staff: “She is confident, based on the rhetoric she is hearing in D.C., and from what we have already seen, that these specific listings of ages, under 18, will result in devastating legislation for trans care. She wonders if the specific ages can be taken out.”

Another email stated that Admiral Levine “was very concerned that having ages (mainly for surgery) will affect access to care for trans youth and maybe adults, too. Apparently the situation in the U.S.A. is terrible and she and the Biden administration worried that having ages in the document will make matters worse. She asked us to remove them.”

The excerpts were filed by James Cantor, a psychologist and longstanding critic of gender treatments for minors, who used them as evidence that the international advisory group, referred to as WPATH, was making decisions based on politics, not science, in developing the guidelines.

The emails were part of a report he submitted in support of Alabama’s ban on transgender medical care for minors. No emails from Admiral Levine’s staff were released. Plaintiffs are seeking to bar Dr. Cantor from giving testimony in the case, claiming that he lacks expertise and that his opinions are irrelevant.

Admiral Levine and the Department of Health and Human Services did not respond to requests for comment, citing pending litigation.

Dr. Cantor said he filed the report to expose the contents of the group’s internal emails obtained by subpoena in the case, most of which remain under seal because of a protective order. “What’s being told to the public is totally different from WPATH’s discussions in private,” he said.

Dr. Marci Bowers, a gynecologic and reconstructive surgeon and the president of WPATH, rejected that claim. “It wasn’t political, the politics were already evident,” said Dr. Bowers. “WPATH doesn’t look at politics when making a decision.”

In other emails released this week, some WPATH members voiced their disagreement with the proposed changes. “If our concern is with legislation (which I don’t think it should be — we should be basing this on science and expert consensus if we’re being ethical) wouldn’t including the ages be helpful?” one member wrote. “I need someone to explain to me how taking out the ages will help in the fight against the conservative anti-trans agenda.”

The international expert group ultimately removed the age minimums in its eighth edition of the standards of care, released in September 2022. The guidelines reflected the first update in a decade and were the first version of the standards to include a dedicated chapter on medical treatment of transgender adolescents.

The field of gender transition care for adolescents is relatively new and evidence on long-term outcomes is scarce. Most transgender adolescents who receive medical interventions in the United States are prescribed puberty blocking drugs or hormones, not surgeries.

But as the number of young people seeking such treatments has soared, prominent clinicians worldwide have disagreed on issues such as the ideal timing and criteria for the medical interventions. Several countries in Europe, including Sweden and Britain, have recently placed new restrictions on gender medications for adolescents after reviews of the scientific evidence. In those countries’ health systems, surgeries are only available to patients 18 and older.

The email documents were released by the U.S. District Court for the Middle District of Alabama, in a challenge to the Alabama ban brought by civil rights groups including the National Center for Lesbian Rights and the Southern Poverty Law Center on behalf of five transgender adolescents and their families.

Transgender rights groups have turned to the courts to block laws, like Alabama’s, that have been approved in more than 20 Republican-controlled states since 2021, but the courts have been split in their rulings.

On Monday, the Supreme Court announced that it would hear a challenge to Tennessee’s ban on youth gender medicine, which makes it a felony for doctors to provide any gender-related treatment to minors, including puberty blockers, hormones and surgeries. The petition, filed by the Department of Justice, cited the WPATH guidelines among its primary “evidence-based practice guidelines for the treatment of gender dysphoria.”

Additional emails cited in the new court filings suggest that the American Academy of Pediatrics also warned WPATH that it would not endorse the group’s recommendations if the guidelines set the new age minimums.

In a statement on Tuesday, Mark Del Monte, chief executive of the American Academy of Pediatrics, pointed out that the medical group, which represents 67,000 U.S. pediatricians, had not endorsed the international guidelines because it already had its own in place.

He said the academy had sought to change the age limits in the guidelines because the group’s policies did not recommend restrictions based on age for surgeries.

Last summer, the pediatrics academy reaffirmed its own guidelines, issued in 2018, but said that it was commissioning an external review of the evidence for the first time.

The numbers for all gender-related medical interventions for adolescents have been steadily rising as more young people seek such care. A Reuters analysis of insurance data estimated that 4,200 American adolescents started estrogen or testosterone therapy in 2021, more than double the number from four years earlier. Surgeries are more rare, and the vast majority are mastectomies. or top surgeries. In 2021, Reuters estimated that 282 teenagers underwent top surgery that was paid for by insurance.

Gender-related surgeries for minors have been a focal point for some politicians. Gov. Ron DeSantis, Republican of Florida, has argued that surgeons should be sued for “disfiguring” children. In Texas, where parents of transgender children have been investigated for child abuse, Gov. Greg Abbott, a Republican, has called genital surgeries in adolescents “genital mutilation.”

The final WPATH guidelines state that distress about breast development in particular has been associated in transgender teenagers with higher rates of depression, anxiety and distress.

“While the long-term effects of gender-affirming treatments initiated in adolescence are not fully known, the potential negative health consequences of delaying treatment should also be considered,” the guidelines state.

“Gender-affirming surgery is valued highly by those who need these services — lifesaving in many cases,” Dr. Bowers said.

Hilary Cass Says U.S. Doctors Are ‘Out of Date’ on Youth Gender Medicine

Dr. Hilary Cass published a landmark report that led to restrictions on youth gender care in Britain. U.S. health groups said it did not cha

nytimes.com

After 30 years as one of England’s top pediatricians, Dr. Hilary Cass was hoping to begin her retirement by learning to play the saxophone.

Instead, she took on a project that would throw her into an international fire: reviewing England’s treatment guidelines for the rapidly rising number of children with gender distress, known as dysphoria.

At the time, in 2020, England’s sole youth gender clinic was in disarray. The waiting list had swelled, leaving many young patients waiting years for an appointment. Staff members who said they felt pressure to approve children for puberty-blocking drugs had filed whistle-blower complaints that had spilled into public view. And a former patient had sued the clinic, claiming that she had transitioned as a teenager “after a series of superficial conversations with social workers.”

The National Health Service asked Dr. Cass, who had never treated children with gender dysphoria but had served as the president of the Royal College of Pediatrics and Child Health, to independently evaluate how the agency should proceed.

Over the next four years, Dr. Cass commissioned systematic reviews of scientific studies on youth gender treatments and international guidelines of care. She also met with young patients and their families, transgender adults, people who had detransitioned, advocacy groups and clinicians.

Her final report, published last month, concluded that the evidence supporting the use of puberty-blocking drugs and other hormonal medications in adolescents was “remarkably weak.” On her recommendation, the N.H.S. will no longer prescribe puberty blockers outside of clinical trials. Dr. Cass also recommended that testosterone and estrogen, which allow young people to develop the physical characteristics of the opposite sex, be prescribed with “extreme caution.”

Dr. Cass’s findings are in line with several European countries that have limited the treatments after scientific reviews. But in America, where nearly two dozen states have banned the care outright, medical groups have endorsed the treatments as evidence-based and necessary.

The American Academy of Pediatrics declined to comment on Dr. Cass’s specific findings, and condemned the state bans. “Politicians have inserted themselves into the exam room, which is dangerous for both physicians and for families,” Dr. Ben Hoffman, the organization’s president, said.

The Endocrine Society told The New York Times that Dr. Cass’s review “does not contain any new research” that would contradict its guidelines. The federal health department did not respond to requests for comment.

Dr. Cass spoke to The Times about her report and the response from the United States. This conversation has been edited and condensed for clarity.

What are your top takeaways from the report?

The most important concern for me is just how poor the evidence base is in this area. Some people have questioned, “Did we set a higher bar for this group of young people?” We absolutely didn’t. The real problem is that the evidence is very weak compared to many other areas of pediatric practice.

The second big takeaway for me is that we have to stop just seeing these young people through the lens of their gender and see them as whole people, and address the much broader range of challenges that they have, sometimes with their mental health, sometimes with undiagnosed neurodiversity. It’s really about helping them to thrive, not just saying “How do we address the gender?” in isolation.

You found that the quality of evidence in this space is “remarkably weak.” Can you explain what that means?

The assessment of studies looks at things like, do they follow up for long enough? Do they lose a lot of patients during the follow-up period? Do they have good comparison groups? All of those assessments are really objective. The reason the studies are weak is because they failed on one or more of those areas.

The most common criticism directed at your review is that it was in some way rigged because of the lack of randomized controlled trials, which compare two treatments or a treatment and a placebo, in this field. That, from the get-go, you knew you would find that there was low-quality evidence.

People were worried that we threw out anything that wasn’t a randomized controlled trial, which is the gold standard for study design. We didn’t, actually.

There weren’t any randomized controlled trials, but we still included about 58 percent of the studies that were identified, the ones that were high quality or moderate quality. The kinds of studies that aren’t R.C.T.s can give us some really good information, but they have to be well-conducted. The weakness was many were very poorly conducted.

There’s something I would like to say about the perception that this was rigged, as you say. We were really clear that this review was not about defining what trans means, negating anybody’s experiences or rolling back health care.

There are young people who absolutely benefit from a medical pathway, and we need to make sure that those young people have access — under a research protocol, because we need to improve the research — but not assume that that’s the right pathway for everyone.

Another criticism is that this field is being held to a higher standard than others, or being exceptionalized in some way. There are other areas of medicine, particularly in pediatrics, where doctors practice without high-quality evidence.

The University of York, which is kind of the home of systematic reviews, one of the key organizations that does them in this country, found that evidence in this field was strikingly lower than other areas — even in pediatrics.

I can’t think of any other situation where we give life-altering treatments and don’t have enough understanding about what’s happening to those young people in adulthood. I’ve spoken to young adults who are clearly thriving — a medical pathway has been the right thing for them. I’ve also spoken to young adults where it was the wrong decision, where they have regret, where they’ve detransitioned. The critical issue is trying to work out how we can best predict who’s going to thrive and who’s not going to do well.

In your report, you are also concerned about the rapid increase in numbers of teens who have sought out gender care over the last 10 years, most of whom were female at birth. I often hear two different explanations. On the one hand, there’s a positive story about social acceptance: that there have always been this many trans people, and kids today just feel freer to express who they are. The other story is a more fearful one: that this is a ‘contagion’ driven in large part by social media. How do you think about it?

There’s always two views because it’s never a simple answer. And probably elements of both of those things apply.

It doesn’t really make sense to have such a dramatic increase in numbers that has been exponential. This has happened in a really narrow time frame across the world. Social acceptance just doesn’t happen that way, so dramatically. So that doesn’t make sense as the full answer.

But equally, those who say this is just social contagion are also not taking account of how complex and nuanced this is.

Young people growing up now have a much more flexible view about gender — they’re not locked into gender stereotypes in the way my generation was. And that flexibility and fluidity are potentially beneficial because they break down barriers, combat misogyny, and so on. It only becomes a challenge if we’re medicalizing it, giving an irreversible treatment, for what might be just a normal range of gender expression.

What has the response to your report been like in Britain?

Both of our main parties have been supportive of the report, which has been great.

We have had a longstanding relationship with support and advocacy groups in the U.K. That’s not to say that they necessarily agree with all that we say. There’s much that they are less happy about. But we have had an open dialogue with them and have tried to address their questions throughout.

I think there is an appreciation that we are not about closing down health care for children. But there is fearfulness — about health care being shut down, and also about the report being weaponized to suggest that trans people don’t exist. And that’s really disappointing to me that that happens, because that’s absolutely not what we’re saying.

I’ve reached out to major medical groups in the United States about your findings. The American Academy of Pediatrics declined to comment on your report, citing its own research review that is underway. It said that its guidance, which it reaffirmed last year, was “grounded in evidence and science.”

The Endocrine Society said “we stand firm in our support of gender-affirming care,” which is “needed and often lifesaving.”

I think for a lot of people, this is kind of dizzying. We have medical groups in the United States and Britain looking at the same facts, the same scientific literature, and coming to very different conclusions. What do you make of those responses?

When I was president of the Royal College of Pediatrics and Child Health, we did some great work with the A.A.P. They are an organization that I have enormous respect for. But I respectfully disagree with them on holding on to a position that is now demonstrated to be out of date by multiple systematic reviews.

It wouldn’t be too much of a problem if people were saying “This is clinical consensus and we’re not sure.” But what some organizations are doing is doubling down on saying the evidence is good. And I think that’s where you’re misleading the public. You need to be honest about the strength of the evidence and say what you’re going to do to improve it.

I suspect that the A.A.P., which is an organization that does massive good for children worldwide, and I see as a fairly left-leaning organization, is fearful of making any moves that might jeopardize trans health care right now. And I wonder whether, if they weren’t feeling under such political duress, they would be able to be more nuanced, to say that multiple truths exist in this space — that there are children who are going to need medical treatment, and that there are other children who are going to resolve their distress in different ways.

Have you heard from the A.A.P. since your report was published?

They haven’t contacted us directly — no.

Have you heard from any other U.S. health bodies, like the Department of Health and Human Services, for example?

No.

Have you heard from any U.S. lawmakers?

No. Not at all.

Pediatricians in the United States are in an incredibly tough position because of the political situation here. It affects what doctors feel comfortable saying publicly. Your report is now part of that evidence that they may fear will be weaponized. What would you say to American pediatricians about how to move forward?

Do what you’ve been trained to do. So that means that you approach any one of these young people as you would any other adolescent, taking a proper history, doing a proper assessment and maintaining a curiosity about what’s driving their distress. It may be about diagnosing autism, it may be about treating depression, it might be about treating an eating disorder.

What really worries me is that people just think: This is somebody who is trans, and the medical pathway is the right thing for them. They get put on a medical pathway, and then the problems that they think were going to be solved just don’t go away. And it’s because there’s this overshadowing of all the other problems.

So, yes, you can put someone on a medical pathway, but if at the end of it they can’t get out of their bedroom, they don’t have relationships, they’re not in school or ultimately in work, you haven’t done the right thing by them. So it really is about treating them as a whole person, taking a holistic approach, managing all of those things and not assuming they’ve all come about as a result of the gender distress.

I think some people get frustrated about the conclusion being, well, what these kids need is more holistic care and mental health support, when that system doesn’t exist. What do you say to that?

We’re failing these kids and we’re failing other kids in terms of the amount of mental health support we have available. That is a huge problem — not just for gender-questioning young people. And I think that’s partly a reflection of the fact that the system’s been caught out by a growth of demand that is completely outstripping the ability to provide it.

We don’t have a nationalized health care system here in the United States. We have a sprawling and fragmented system. Some people have reached the conclusion that, because of the realities of the American health care system, the only way forward is through political bans. What do you make of that argument?

Medicine should never be politically driven. It should be driven by evidence and ethics and shared decision-making with patients and listening to patients’ voices. Once it becomes politicized, then that’s seriously concerning, as you know well from the abortion situation in the United States.

So, what can I say, except that I’m glad that the U.K. system doesn’t work in the same way.

When asked after this interview about Dr. Cass’s comments, Dr. Hoffman, the A.A.P.’s president, said that the group had carefully reviewed her report and “added it to the evidence base undergoing a systematic review.” He also said that “Any suggestion the American Academy of Pediatrics is misleading families is false.”