Video shows prominent doctors acknowledging, and even challenging, the experimental nature of sex change drugs

(Daily Caller News Foundation) – Internal training footage from the world’s leading transgender medical association revealed several prominent gender doctors acknowledging how little is known about the impact of sex reassignment drugs, complicating the organization’s latest treatment guidelines.

The footage, obtained by the Daily Caller News Foundation through a public records request, shows several faculty members of the World Professional Association for Transgender Health (WPATH) Global Education Institute discussing hormonal treatments for gender dysphoria — and their resulting side effects. 

One physician went as far as to characterize the entire field of hormone therapy as “off-label,” a term that refers to the use of drugs for purposes other than that for which they were approved. Another doctor acknowledged the uncertainty around how hormone treatments affect fertility.

The discussions took place during educational sessions held in September 2022, just after WPATH released its “Standards of Care for the Health of Transgender and Gender Diverse People, Version 8” (SOC 8). Physicians who took part in these closed-door sessions routinely recognized undesirable effects associated with sex change procedures and the unknown dangers of certain sex change drugs.

Nevertheless, those same doctors recommended many sex change procedures and drugs, with one doctor even appealing to “justice” for transgender people as a North Star for treatment.

In an educational session titled “Foundations in Hormonal Treatment: Adults & Adolescents,” Dr. Marshall Dahl, a Canadian endocrinologist and WPATH member, joked with the audience about how the field of gender medicine relies on unapproved treatments.

“Basically, not only are the medications off-label, the whole field’s off-label. But that’s all good,” Dahl said, eliciting laughter from the audience.

Dr. Stanley Goldfarb of Do No Harm, a watchdog organization focused on keeping identity politics out of healthcare and medical schools, reviewed Dahl and other doctors’ statements from the recorded sessions. Goldfarb said that while prescribing medications off-label is not inherently unethical or dangerous, the lack of evidence specifically for supposed off-label treatments for “gender affirming care” is. 

“What is unethical here is the failure to properly diagnose and evaluate the causes of the psychological disturbances in these children, and the rush to treat them with medications whose consequences to the pre-pubertal child are basically unstudied, but likely risk a number of complications, including sterility and abnormal development,” Goldfarb said.

Dahl didn’t respond to the DCNF’s requests for comment. Neither did the University of British Columbia, where Dahl works.

‘No Data For It’

During the conference, prominent WPATH-affiliated doctors Dr. Joshua Safer, Dr. Asa Radix, and Dr. Michael Irwig, who had all been members of the revision committee that oversaw the development of SOC 8, acknowledged several unknowns regarding the impact of cross-sex hormones.

Safer, co-author of both SOC 8 and the Endocrine Society’s guidelines for transgender medical care, gave a presentation titled “Advance Gendering Affirming Hormone Therapy,” which addressed the use testosterone in sex reassignment.

When initiating testosterone, Safer recommended giving high doses that enabled the patient to quickly reach a high testosterone level to masculinize them. But Safer also noted that in preparing his presentation he was unable to locate evidence on the normal ranges of testosterone, saying there was “no data for it.”

“We were looking at some [of] these normal ranges and the point is there no data for it. We’re looking at total testosterone with a lot of binding protein influence and to overthink it, it’s just going torture the patient,” Safer said at the conference. 

SOC 8 strongly recommends regular testing during the initiation of cross-sex hormones due to the potential harms associated with elevated sex hormone levels and provides a target range of serum testosterone levels. It also recommends maintaining sex hormones at a level that promotes bone health, which can be compromised by cross-sex hormone interventions.

An audience member asked Safer to provide the minimum testosterone dose that maintains bone health, but he had no answer. “The question is, a minimum testosterone dose that you have to have circulating for minimal bone health,” said Safer. “And the answer is, great question.”

Safer declined to comment through a Mount Sinai Health System spokeswoman.

‘There’s Still A Lot We Don’t Know’

During a panel discussion titled “Advanced Cases In Gender Affirming Hormone Therapy,” Irwig, who worked on the SOC 8 chapter addressing eunuchs, recommended that male patients receiving cross-sex hormones bank sperm if they’re interested in having a biological child.

“Effects on fertility, there’s going to be a lot of sessions on this, there’s still a lot that we don’t know about this topic,” said Irwig. “So, it is still possible for a lot of trans women to be fertile if they were to come off the regimens but we can’t predict. Now, in actuality, what we tell our patients if you’re if you’re interested in having a biological child, the safest thing to do is just sperm bank. Now, put that away so that in the future if you need it.”

Radix, the president-elect of WPATH and co-chair of the SOC 8 revision committee, dissuaded the audience from using bicalutamide, a prostate cancer drug sometimes given off-label as part of a cross-sex drug regimen for its feminizing effect on men.

“When you’ve had someone die of hepatic necrosis, I guarantee you’re not going to be reaching out for that so quickly again,” said Radix.

“It’s important that we talk to our clients about the lack of evidence before we start throwing medications at them that are potentially incredibly dangerous,” Radix said. “And maybe I’m the only one here that says that, but I really … I had a person die from this and I will not be reaching out for it.”

Bicalutamide, which can cause liver injury and fatal liver failure, is not approved by the Food and Drug Administration (FDA) for the treatment of gender dysphoria, precocious puberty or for use in women and children.

Irwig acknowledged the experimental nature of drugs used in sex reassignment, explaining the need to protect patients from unintended harm.

“There is so much we don’t know,” Irwig said. “Safety and efficiency are the two most important things that we need to evaluate, and then so many of the medications, we just don’t know that. And one of our major goals as physicians and healthcare providers is to do no harm. We really don’t want to do something just because they heard it on the internet and then ‘Oops they died.’ You know, this is really bad and tragic.”

SOC 8 guidelines do not recommend routine use of bicalutamide due to lack of safety data in transgender populations. However, in a question and answer segment, Dahl said the said the risk of serious harm from bicalutamide seemed to be low and clinicians needed to be ready to discuss the possibility of patients using the drug.

“The risks for liver, which are quoted on this slide, if you actually look at the numbers, I was checking again, abnormal normal liver enzyme tests are less than 1%. Serious liver trouble is much, much, like three less thans 1%, so you’re in a 1 to 10,000 range perhaps, so probably has a better safety profile — nobody knows,” Dahl said.

“It’s something you just have to be ready to discuss because it’s out there,” Dahl said. “What I commit to do is try spironolactone — cheap, effective, most people are fine. You don’t like it, then we can talk about some of these alternatives.”

Radix did not respond to requests for comment, and neither did Callen-Lorde, where Radix works. Irwig did not respond to requests for comment, and neither did Beth Israel Deaconess Medical Center, where Irwig works.

‘Kids Have Zero Idea About Fertility’

WPATH’s standards say “gender-affirming interventions are based on decades of clinical experience and research; therefore, they are not considered experimental, cosmetic, or for the mere convenience of a patient. They are safe and effective at reducing gender incongruence and gender dysphoria.”

Puberty blockers fall under the banner of “gender-affirming” treatments. WPATH’s guidelines recommend the use of puberty blockers in children, which are used off-label to induce pubertal suppression, claiming they are “fully reversible.”

However, several doctors presented information during the educational presentations that challenged the idea of puberty blockers being “fully reversible.” Among them was Dr. Scott Leibowitz, a co-lead in the development of the adolescent chapter of WPATH’s SOC 8 and current member of the WPATH Board of Directors.

“I think when we just say, ‘Oh, puberty blockers are just reversible and it’s a very noninvasive treatment,’ I would say it’s more invasive than often times the media makes it out to be or other people,” Leibowitz said during one session.

Dr. Daniel Metzger, a WPATH-certified pediatric endocrinologist who presented on sex reassignment hormone therapy for adolescents, described how the effect of puberty blockers on brain development is unknown.

“Obviously teenagers, their brains are changing. They’re unwiring, they’re rewiring. And if we’ve started one kid unwiring and half rewiring, and then we changed their puberty the other way and we’re unwiring, people have been trying to figure out what this does for kids’ brains,” Metzger said.

When asked about the impact of puberty blockers on fertility, Metzger said it was unknown if girls placed on puberty blockers during the initial stages of puberty would have eggs mature enough for fertility preservation.

“A little bit of what we know is from little girls who get cancer. They try to do whatever they can in a very fast fashion to preserve that girl’s fertility for down the road after she’s cured from her cancer. I don’t think a lot is known about that still, for, say a 10-year-old assigned female. I don’t think we know,” Metzger said.

However, SOC * recommends initiating pubertal suppression during the early stages of puberty.

“Kids have zero idea about their fertility,” Metzger said. “Of course it’s not in the mind of a 13-year-old or 15-year-old or even a 17-year-old because, you know, babies are icky, and you can just go to a store and adopt later on, right?”

Metzger also explained how puberty blockers impede adolescents from developing the calcium stores needed to prevent osteoporosis later in life.

“Normally puberty is the time of putting the calcium into your piggy bank,” Metzger said. “This is how I explain it to families. You’ve got a piggy bank for your calcium and you better get it all in by 25 because at 25 you’re going to live off that piggy bank.”

“The puberty blockers slow that calcium accrual back into the bone quite a bit, back to the prepubertal level. We do know that even if you look at people now age 22, if you’ve done all of this and you’ve gone off and then you go back on the hormones that you want to have, you have not caught up by age 22. Which is about the time you need to fill up your piggy bank. This is a concern that not everybody is getting their piggy bank completely filled up with calcium,” Metzger said.

Metzger did not respond to requests for comment. A spokesperson from BC Children’s Hospital, where Metzger works, declined the DCNF’s interview request. Leibowitz declined to be interviewed through a Nationwide Children’s Hospital spokesperson.

‘Now You Can Finally Have Mental Health Problems’

Statements made at the WPATH conference also seemed to complicate the organization’s own SOC regarding sex change drugs producing positive mental health outcomes among gender dysphoria patients.

Leibowitz, for instance, explained that initiating cross-sex hormones doesn’t always solve the mental health problems of young people, adding that it was important to share this message with parents.

“I always say to my patients now that we’re starting testosterone or estrogen, now you can finally have mental health problems. Right?” said Leibowitz.

“And it’s really important because then parents don’t approach the kids saying ‘How come you’re having mental health problems? We thought that that testosterone was going to be the answer?’” Leibowitz added.

Do No Harm’s Goldfarb said it was “bizarre” to assume a child’s mental health problems and transgender desire are unrelated.

“This idea is particularly bizarre because the justification for gender affirming care has been to improve the mental health of the child and has attributed the mental health problems to the failure to receive so called gender affirming care,” Goldfarb said. “However, it is incumbent upon physicians when encountering a child with mental health disturbances and gender dysphoria to first treat the mental health problems, and then observe the effects on gender dysphoria. This is particularly true as it is clear that the vast majority of children with gender dysphoria, if allowed to enter and complete puberty will be perfectly happy in their biologically, determined sex and gender.”

SOC 8 claims “hormone therapy has been found to positively impact the mental health and quality of life of TGD (transgender and gender diverse) youth and adults who embark on this treatment.” But Gail Knudson, the current co-chair of WPATH’s Global Education Institute, acknowledged in one session that a WPATH-funded meta-analysis released the year before that was used to inform the SOC was significantly limited.

“Does gender affirming hormone therapy decrease anxiety and depression?” asked Knudson. “This was a really interesting meta-analysis that they did, actually for the Standards of Care. And what they found was that when you looked at these different studies, that the strength of significance was low.”

“Because we all know in this audience that, you know people have a better quality of life, depressive symptoms decrease, anxiety decreases,” Knudson said. “But what we’re trying to do for the researchers, is really develop much more robust research protocols so it’s much more measurable.”

SOC 8 cites the the WPATH-funded meta-analysis, called Baker et al., 2021, as evidence that hormone therapy improved mental health — a move that was highlighted in the recently-released Cass Review, a sweeping report on the state of gender dysphoria care and medical practices commissioned by the U.K.’s National Health Service.

The SOC states that “there is strong evidence demonstrating the benefits in quality of life and well-being of gender-affirming treatments, including endocrine and surgical procedures, properly indicated and performed as outlined by the Standards of Care,” citing the Baker study among others.

But the Baker study noted its findings were “limited by high risk of bias in study designs, small sample sizes, and confounding with other interventions” and that they “could not draw any conclusions about death by suicide.”

“Future studies should investigate the psychological benefits of hormone therapy among larger and more diverse groups of transgender people using study designs that more effectively isolate the effects of hormone treatment,” the Baker study noted.

Overall, the Cass Review revealed the poor quality of the evidence supporting sex reassignment in children.

Goldfarb said the absence of conclusive evidence for treatments championed by WPATH was a reason for great caution, especially when treating children.

“Since we know that the majority of children, when allowed to enter puberty and complete puberty will be perfectly happy in their biologically determined sex and gender, and since the vast majority of the practitioners of so-called gender affirming care claim that its greatest benefit is to make these children happy and satisfied with their lives, the absence of evidence of such a benefit makes this treatment totally unjustified,” Goldfarb said.

Knudson did not respond to requests for comment, and neither did the University of British Columbia, where Knudson works.

‘Justice For Trans People’

Dr. Leibowitz openly challenged the need for evidence-based medical care, saying clinicians should not only consider medical evidence when providing interventions to transgender people but should weigh ethical considerations, such as “justice” for transgender people, when prescribing sex reassignment medical treatments to adolescents.

“Regardless of the evidence base, as I said evidence is one part of this, but also there’s an ethical human rights component to treating people. We don’t rely on evidence for every single treatment we do in medicine,” Leibowitz said.

“We have to look at the whole thing. Ethics, human rights, justice for trans people.”

Dr. Goldfarb told the DCNF that medicine should be based on objective evidence rather than personal experience.

“We know from literally thousands of studies of various medical problems that an individual practitioner’s sense of the effectiveness or benefit of a treatment is often terribly biased and can result in the exact opposite of their claims of benefit. This is why medical science requires objective studies to test the validity of treatments rather than an individual physicians, ideologic views, or anecdotal experience,“ said Goldfarb.

WPATH did not respond to requests for comment.