Many US endocrinologists are crying foul as a growing number of state lawmakers are attempting to enact legislation that would prohibit, and in some cases criminalize, medical treatment for minors with gender dysphoria.

As of press time, 13 states had introduced such bills, and legislators in two additional states said they were drafting bills. So far, one — in South Dakota — was defeated in a Senate committee, and another, in Florida, was essentially tabled without being enacted.

They all have a common goal of preventing minors from receiving puberty blockers, cross-sex hormones, or gender-affirmation surgery.

"These things are being proposed based on a lot of misinformation," said Stephen Rosenthal, MD, professor of pediatrics at the University of California, San Francisco (UCSF), and a past president of the Pediatric Endocrine Society.

Lawmakers "are not looking at the scientific evidence that supports current clinical practice guidelines," Rosenthal, who treats transgender children, told Medscape Medical News.

And "People just aren't really understanding the harm that regulating this kind of medicine would do," stressed Cassandra Brady, MD, assistant professor of pediatric endocrinology at Vanderbilt University School of Medicine, Memphis, Tennessee.

The bills come at a time when gender identity clinics for minors around the world have seen a significant uptick in cases. And, as widely reported by Medscape Medical News, some clinicians have begun to question whether treatment decisions are outpacing science.

Queries about use of puberty blockers and cross-sex hormones have embroiled the United Kingdom's only publicly funded Gender Identity Development Service (GIDS) in controversy, for example, with five clinicians resigning last year over concerns about overuse of the treatments.

And earlier this month, the UK National Health Service (NHS) announced an independent review of services including the use of puberty blockers and cross-sex hormones in youth with gender dysphoria.

Meanwhile, the topic has ignited debate in Sweden, where a report from the Board of Health and Welfare confirmed a 1500% rise between 2008 and 2018 in gender dysphoria diagnoses among 13- to 17-year-olds born as girls, as detailed by The Guardian.

Indeed, there is some indication of a so-called "rapid-onset gender dysphoria" in born females who say they wish to become males and some clinicians have said this represents a "social" phenomenon.

But guidelines from US clinical organizations — including the American Academy of Pediatrics issued in 2018, the Endocrine Society as reported by Medscape Medical News in 2017, and the US Professional Association for Transgender Health (USPATH) — all support the use of medical treatment in adolescents with gender dysphoria who have received mental health evaluations from appropriately trained professionals.

More Data Needed but Evidence to Intervene Is Compelling

Joshua Safer, MD, FACP, FACE, executive director of the Mount Sinai Center for Transgender Medicine and Surgery, New York City, says the data "even if it's rudimentary, are convincing that there is a biological component to gender identity."

Attempts to manipulate gender identity in people who are born intersex, for example, have uniformly failed, he noted.

Yet it's still not known what causes gender identity — whether it might be a result of a cluster of genes or a bundle in the brain, or some other biological process — said Safer, who treats transgender adults, but not children, and is also a coauthor of the aforementioned Endocrine Society Clinical Practice Guideline on Endocrine Treatment of Gender Dysphoric/Gender Incongruent Persons.

This is an area for future research, he noted.

Nevertheless, "The data for interventions for transgender people...is compelling," he added, noting evidence for improved mental health morbidity among those gender-questioning people who have medical interventions.

"Those data are modest at this point and we need better data, but they do all move in the same direction," he asserted.

Meanwhile, a large group of around 1800 parents of transgender and nonbinary children have called on legislators to withdraw the proposals in an open letter organized by the Human Rights Campaign.

"We know better than anyone what our children need in order to thrive: access to best practice, evidence-based gender-affirming healthcare," the parents write.

"These healthcare decisions must be made on a case-by-case basis, in careful consultation with a medical team, and with the goal of reducing the physical and emotional distress experienced by many transgender children," they continue.

"They should not be made by politicians who think they know better than medical professionals," they add.

The American Academy of Child and Adolescent Psychiatry has also condemned state efforts "to block access to these recognized interventions," it said in a statement.

Proponents of Laws Speak of Harms

Most of the state proposals portray medical interventions as harmful to minors.

Missouri's proposed legislation labels surgical or hormonal treatment for a child under age 18 "abuse or neglect"; a physician or anyone who assists or provides for the child would be charged with a felony.

One of the first bills was introduced in South Dakota in January. House bill 1057 would have charged clinicians providing gender-affirming care in anyone under age 16 with a misdemeanor punishable by up to a year in prison and a $2000 fine.

The bill was defeated in the Senate after the South Dakota State Medical Association and several other physicians, families, and adolescents testified against the proposal, according to the Argus Leader.

The Endocrine Society applauded the failure and noted in a statement that it "supports physicians' ability to provide the best evidence-based treatment to their patients," and that "these decisions should be made by the family and physician, and not dictated by policymakers."

Jack Turban, MD, a resident physician in child and adolescent psychiatry at Massachusetts General Hospital, Boston, who conducted a pivotal study of some 26,000 transgender adults showing that early administration of puberty blockers led to lower odds of lifetime suicidal ideation, also expressed dismay over the bills in an opinion piece for the New York Times.

"The potential benefits of providing gender-affirmative care typically outweigh the minor risks associated with treatment," wrote Turban.

"State legislators need to educate themselves about these young people and their medical care before introducing legislation that will hurt them," he added.

Few States Seem To Have Approached Clinicians for Feedback

In Tennessee, lawmakers have approached some clinicians at Vanderbilt and have appreciated the feedback they've received so far, said Brady.

But that may be an exception. It seems that few medical organizations have been consulted in the crafting of bills in the other states: Colorado, Florida, Idaho, Illinois, Kentucky, Mississippi, Missouri, New Hampshire, Oklahoma, South Carolina, South Dakota, and West Virginia. Lawmakers in Ohio and Utah also are drafting proposals.

Physicians could be charged with a felony in Florida, Idaho, Kentucky, Missouri, and reportedly, in the Ohio proposal under development.

The bills have been introduced at the behest of some conservative groups that doubt the existence of gender dysphoria or who have questions about treatment: the Eagle Forum, the Alliance Defending Freedom, and the Kelsey Coalition.

In a recent tweet clarifying its position on state efforts, the Kelsey Coalition said it "supports all bills that protect children, even those that may provide criminal penalties, because we believe these medical interventions should never be performed on children."

"However, we do not support state bills that are not victim-led or used for political gain," they added.

Existing Knowledge Imperfect but Treatment Indicated for Some

The bills have also garnered support from some endocrinologists who have raised concerns about puberty blockers and other medical treatments for gender dysphoria.

One is Michael K. Laidlaw, MD, a Rocklin, California-based endocrinologist who has not treated transgender people but frequently writes about the subject, most recently calling the use of puberty blockers "a public health emergency."

Laidlaw joined several other clinicians who do not treat transgender people in testifying in favor of the South Dakota bill.

Last year, as previously reported by Medscape Medical News, Laidlaw, along with others, criticized the Endocrine Society's 2017 Clinical Practice Guideline on Treating Dysphoric/Gender-Incongruent Persons in a letter to the Journal of Clinical Endocrinology & Metabolism.

They stated that there is no lab, imaging, or other objective test to diagnose someone as transgender and that "the consequences of this gender-affirmative therapy are not trivial and include potential sterility, sexual dysfunction, thromboembolic and cardiovascular disease, and malignancy."

The consequences of this gender-affirmative therapy are not trivial and include potential sterility, sexual dysfunction, thromboembolic and cardiovascular disease, and malignancy. Laidlaw MK, et al.

Laidlaw told Medscape Medical News at the time that "If we're talking about [transgender] adults [who have gone through puberty of their biological sex] and who can make a decision, if they have been truly notified of the risks and benefits [of cross-sex hormones] and have also had psychological evaluation, and they decide, 'This is still the right course for me,' then I don't have any objection."

But considering the use of cross-sex hormones in children and adolescents is "quite a different story," he contended.

In May 2019, Rosenthal, Safer and colleagues responded to Laidlaw's letter in the same journal, stating that for the right person, puberty blockers and cross-sex hormones are appropriate, and that medications can improve mental health outcomes.

"We agree that research to validate the safety and efficacy of all forms of treatment is desirable," they wrote, noting some of that research is underway.

"However, we believe physicians would fall short in their duty of care if they withheld hormonal treatment of gender dysphoria/incongruence in pubertal youth, when indicated, given the existing state of knowledge, imperfect though it is."

Research to Validate Safety and Efficacy of Transgender Tx Underway

Rosenthal's center at UCSF is one of four in the United States that has been carrying out a National Institutes of Health-funded long-term observational study of the impact of early medical intervention on transgender adolescents.

It will take time to get those results, but in the meantime, clinicians should act on what is known now, said Rosenthal.

"We already have very compelling data to suggest that the benefits [of treatment] outweigh the potential harms," he said.

Rosenthal told Medscape Medical News that Laidlaw has advanced the notion that clinicians who prescribe puberty blockers are forcing those individuals into a transgender outcome.

"We don't push anybody down any path," he said. "The guidelines make these treatments available in a very specific subset of people who are evaluated by skilled mental health professionals," said Rosenthal.

We don't push anybody down any path. Dr Stephen Rosenthal

Both he and Safer acknowledge that puberty blockers do have the potential for some harm. For instance, a frank discussion needs to happen about the likely lack of future fertility, said Rosenthal.

"Everything we do in medicine has a theoretical risk of harm," noted Safer.

However, he said, to deny a puberty blocker to an individual approaching puberty who is distraught about growing breasts — but then to possibly have to surgically remove them later — is in itself doing harm.

"Puberty blockers are exactly the epitome of 'do no harm' in this case," argued Safer.

The medications are reversible, he said, adding that they also give an individual and the family time to think through whether the adolescent is transgender, and, if yes, what they want to do in terms of taking cross-sex hormones in the future or getting other interventions.

Safer acknowledged that this doesn't mean there aren't still some concerns, however.

For instance, once puberty blockers — which have the potential to interfere with bone development — are started, "How much harm are you willing to risk? Maybe a couple of years is okay, but maybe 6 years is not," he said.

"So, we do discuss how quickly...you have to get to your next decision point, whether it be to actually introduce hormones or not to introduce hormones," he explained.

State Proposals Will Have Chilling Effect on Gender-Questioning Kids

Clinicians say that even if the proposals do not become law, just the fact of their existence could have a chilling effect on gender-questioning children, their families, and doctors considering whether to provide treatment.

"They're already in a hard position," Brady said of her patients.

"They're coming here to seek something for a life that they've already not wanted to live and then we have people who are trying to put a real big block on that — I see that obviously affecting their mental health," she observed.

"I can't imagine how their lives would be without this care," Brady said.

With the bills being out there, "two things can happen — one is, it can be very depressing and limiting, but it can also embolden people," Rosenthal told Medscape Medical News.

I can't imagine how their lives would be without this care. Dr Cassandra Brady

"The people behind these things are the same people that have tried to stop our research at the National Institutes of Health (NIH)," he explained.

"These people are going to do everything they can, whether it's to go state by state to try and exhaust us, or go to the NIH and try to get them to pull the plug on our research," said Rosenthal.

Safer believes it's ill-considered to try to legislate any aspect of medicine.

"The pitfalls of trying to legislate these things are myriad," he said.

"Across all of medicine, interventions are very customized. Can you imagine a state legislature trying to legislate the optimal approach in medicines that can and cannot be given to people with diabetes? How crazy that would be," he noted.

Rosenthal has served on an advisory panel for Endo Pharmaceuticals and is a grantee of the NIH. Safer has also served on an advisory panel for Endo Pharmaceuticals. Brady has reported no relevant financial relationships.

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