In his campaign for governor, Kentucky’s Republican candidate has couched gender-affirming health care for transgender youth as “experimental,” “unproven” and “mutilation.”
Kentucky GOP Attorney General Daniel Cameron and his running mate, state Sen. Robby Mills, R-Henderson, have made defense of recent anti-trans policies passed by the state Legislature a central theme in their gubernatorial bid to “restore Kentucky’s values.”
Cameron’s position is clear: He has vowed to protect these values by defending a law that bans trans girls from playing girls’ sports, and another banning gender-affirming health care and restricting school teaching on gender and sexuality.
To contrast these policies with the stance of Democratic Gov. Andy Beshear, who vetoed both bills, Cameron characterizes the governor as wanting to “protect transgender surgeries for kids” — the so-called “experimental” health care.
“Puberty blockers are unproven and harmful to adolescents and removal of healthy body tissue is a radical and unsafe process for gender-confused minors,” Mills tweeted in August. This is a mischaracterization of gender-affirming medical care, which can but does not always include puberty blockers, hormone therapy and, even rarer, gender-reassignment surgery.
This type of care, provided only with permission from a trans patient’s parent or guardian, is endorsed as the standard of care by major U.S. medical associations, including the American Academy of Pediatrics, the American Medical Association and the American Psychological Association.
But Mills’ and Cameron’s definition of “experimental” and “unproven” are less clear, though court filings from the attorney general in a case challenging the constitutionality of Kentucky’s gender-affirming care ban provide some insight.
What is gender-affirming medical care?
Any sort of health care affirming an individual’s gender identity.
Gender dysphoria, the clinical name for being transgender, is when a person experiences conflict between the sex they were assigned at birth and the gender they most emotionally and intellectually identify with.
Examples of this type of care range from a health care provider using a person’s correct name and pronouns, to offering counseling services that validate and affirm their individual experience. In some scenarios, doctors provide guidance on and write prescriptions for certain medications, such as testosterone and estrogen, to better align a person’s internal and physical gender expression.
But at its most fundamental level, gender-affirming care is “affirming someone’s innate sense of their gender,” said Dr. Keisa Fallin-Bennett, co-founder of the Transform Health Services at University of Kentucky HealthCare.
Launched less than a decade ago with the goal of improving health equities for an underserved and marginalized population, Transform is designed to be a safe health care space for LGBTQ+ patients of all ages seeking all forms of health care.
The Transform clinic sees patients from across the state, as it’s one of only two clinics in Kentucky offering this type of care. The other is UofL Health’s endocrinology clinic.
What kind of treatment can trans kids access?
Though there are exceptions, medical intervention is often reserved for older trans adolescents and adult patients, and it’s the recommended standard of care to wait until an individual has turned 18 to undergo gender-reassignment surgery, according to the American Medical Association.
Parent or guardian involvement and permission is a requisite when anyone under 18 is prescribed medication or surgery, and the same standard is the case for gender-affirming care. Like with any other type of medical care, decisions on how to meet the needs of trans patients and their families are tailored to each patient.
“I start by asking about their journey of discernment around their gender not fitting their body completely,” Fallin-Bennett told the Herald-Leader earlier this year. “With adolescents, when their parent is in the room, I ask the teen’s permission to also get the story from their parents.”
It’s not a decision a minor or their family has reached on a whim. Most trans teens Fallin-Bennett sees, for instance, have an established relationship with a mental health therapist by the time they see a Transform provider for the first time.
“For many, they have been working on this and researching, even the younger ones, for at least a year by the time they get to us,” she said.
Though Fallin-Bennett and her colleagues are currently barred by state law from dispensing this medication, the clinic has roughly 40 underage trans patients on its roster, she said.
How many trans kids are there in Kentucky?
While talk of policies to regulate trans kids’ access to medical care dominated the state legislature’s regular session earlier this year and Cameron has made it a focal point in his bid for governor, this population is a known minority, though accurate demographic data is lacking.
A 2022 Pew Research Center survey estimated that only 1.6% of adults in the U.S. over 30 are trans, as are 5% of young adults.
In Kentucky, trans teens make up an estimated 0.7% of Kentucky’s 13-17 population (roughly 2,000 teens), according to a 2022 study from the Williams Institute analyzing Centers for Disease Control and Prevention data.
‘Experimental’ vs. ‘Off-label’
Cameron, in his capacity as the state’s top law enforcement office, has defended the constitutionality of Kentucky’s recent gender-affirming health care ban in court. In the process, he has inaccurately represented what that type of health care entails.
More specifically, his office has equated the use of “off-label” medication in gender-affirming health settings for kids and teens with such care being experimental and untested.
In July, once the statewide health care ban became enforceable, the plaintiffs in the lawsuit — seven trans teenagers and their families claiming the ban is unconstitutional — asked for a judge to block the law from being enforced. That request was denied.
But before it was denied, Cameron asked the court to let him impose the ban, because it protected children from such “experimental” care. Some of of his cited reasons for describing that care as experimental is its “off-label usage” of certain hormone therapies and puberty blockers, particularly in pediatric settings for trans kids.
“The plaintiffs argue that the treatments prohibited by SB 150 are not new and experimental (and) counter that, in general, the off-label use of prescription drugs is widespread,” Cameron wrote in a July 21 filing. “The plaintiffs, however, cannot dispute that the FDA ‘is not prepared to put its credibility and careful testing protocols behind the use’ of puberty blockers and hormones to treat gender dysphoria in minors.”
Cameron’s definition of off-label is misleading, as is his characterization of such care as being experimental, which implies gender-affirming health care, even for teens, is somehow untested in clinical settings, according to people interviewed for this story.
An off-label drug is one that’s prescribed to a population of patients different from the very specific population the drug received FDA approval to treat. Such a scenario is highly common and not at all considered “experimental,” said Craig Martin, professor and associate dean of the University of Kentucky’s College of Pharmacy.
“The term ‘off-label’ gets conflated with ‘experimental’ when the two really don’t mean the same thing,” he said.
The need for this differentiation has surfaced in other court cases around the country challenging similar statewide trans youth health care bans. In a ruling on Wednesday temporarily blocking Montana’s gender-affirming care ban, a judge explained that the medications banned under Montana’s law “remain the accepted standard of care, even when utilized in an “off-label” way. Accordingly, the American Academy of Pediatrics has stated that the off-label use of medication is neither experimentation, nor research.’”
In their response to Cameron’s claim, lawyers for the American Civil Liberties Union of Kentucky and the National Center for Lesbian Rights said Cameron was wrongly conflating “off-label” with “experimental.”
“Medical care for transgender adolescents is guided by a well-established standard of care. More than two decades of research shows they are safe and effective in alleviating gender dysphoria and helping transgender adolescents lead healthy, productive lives,” attorneys for the plaintiffs wrote.
“Cameron attempts to disregard this medical evidence because the banned treatments are not yet FDA approved to treat transgender minors. This argument proves too much,” they wrote. “Most medications prescribed for minors involve off-label use, which is not code for either experimental or improper, and does not signify that the FDA is unwilling ‘to put its credibility and careful testing protocols behind this.’”
Typically in the stringent and costly drug-approval process, the narrower the patient population participating in a clinical trial, the cleaner the data, and the more likely the drug is to receive a green light from the FDA for formal approval. But once a drug crosses that hurdle, it’s well within a licensed provider’s ability to prescribe the medication to patients beyond the just the group it was expressly approved for, as long as there’s published evidence showing its effectiveness, Martin said.
Aspirin, a medicine cabinet staple, is probably the most common example of widespread off-label usage, he explained. On the package labeling in every bottle, it makes clear: aspirin is FDA approved to help prevent heart disease in adults. “But it didn’t go so far as to label it as preventing heart disease in diabetic patients, who are among the highest risk for cardiac events,” he said.
Even though it is the “standard of care to give a diabetic patient who is at risk for heart disease an aspirin every day,” Martin said, “The use of that medication is officially off-label.”
Fallin-Bennett said use of medication in this way is very common. “I think that’s what people don’t understand: they’re probably taking a medication right now that’s off-label.”
Nationwide, up to 20% of all prescriptions are off-label, according to the American Medical Association. That share is much higher in pediatric populations. One study from the Oklahoma College of Medicine estimated 38% of all pediatric prescriptions are off-label.
This is the result of more adults than kids participating in clinical trials with pharmaceutical companies seeking FDA approval, Martin said.
Though the goal is to ultimately enroll more kids in clinical trials, the lack of kids in these trials isn’t necessarily indicative of a medication’s risk, he added. It’s just a hard population to wrangle for a trial that may last months.
In the meantime, though the prescription of puberty blockers — a reversible medication — is a technically off-label medication for trans teens, that reality does not mean it’s “experimental,” Martin said.
The terms “off-label” and “experimental” are often “used as a boogeyman,” he said. “But it’s not illegal, it does not mean it’s unapproved, it’s not wrong or amoral, and it’s not bad medicine.”
In Kentucky’s lawsuit, which is currently before the U.S. Sixth Circuit Court of Appeals, biomedical ethics and public health scholars filed a brief in support of the trans plaintiffs. The argument: Kentucky’s health care ban “reflects a fundamental misunderstanding of how scientific knowledge and medical standards are generated.”