Are the ethics of studying the sports performance of 12-year-olds on puberty blockers changing?

Wrong in the UK and other European countries should be wrong everywhere, but sadly, it's not

Given that the Supreme Court is hearing arguments about a Tennessee law banning “gender affirming care,” and given that Dr. Johanna Olson-Kennedy, one of the country’s leading proponents and practitioners of medicalizing gender distressed minors, is being sued by a detransitioner for medical negligence, it’s time to revisit an article I wrote about a study that’s going on right now involving the performance of young athletes who are undergoing “gender affirming care.”

Adding to the drumbeat of medical scandal, the UK just banned puberty blockers indefinitely for children under 18, joining Finland, Sweden, Denmark, and France in restricting their use. But while European countries are pulling back on unevidenced interventions for minors, Dr. Kathryn Ackerman’s response, like the medical zeitgeist in the U.S., is to “get them younger,” to “see what happens” when puberty blockers are started on even younger patients, age 12 to be exact.

Ackerman’s study of young “trans” athletes looks at how early suppression of puberty and administration of cross-sex hormones affects sports performance as compared to adolescents not going through treatment.

“That is the million dollar question,” Ackerman said. “I think if we start people at a younger age with treatment, we don’t know how much of an effect that’s going to have on performance compared to someone who transitions at the age of 35.”

In that quote was from 2023 (watch both of the clips of Ackerman talking about this study here), Ackerman was pretty excited about monitoring the effects of pathologizing 12-year-olds’ bodies, but said more than she meant to when she said she didn’t know how much of an effect treating kids at a younger age would have on performance. In fact, neither she nor anyone else fully understands puberty blockers’ effect on fertility, on cognition, on bone health, on virtually every biological process. But what little solid evidence they do have is not pretty. She was admitting her subjects’ “treatment” was completely experimental. But to reiterate and be perfectly clear, she’s just there to watch what happens. She’s not directing the treatment or prescribing the meds. And that’s an important ass-covering distinction.

Ackerman’s willingness to participate, however passively, in an uncontrolled experiment on children is made even more repellent by her motivations. Given that she’s a strong supporter of inclusion of trans-identified males in female sports, it appears she is hoping that early medicalization will eliminate male advantage, and thus circumvent some sports policies that ban males who have been through any part of puberty. There are already examples, volleyball player Blair Hamilton being the most recent and visible, of trans-identified males who took puberty blockers and cross-sex hormones very young as a way of competing in women’s sports by deception. That Ackerman’s research may provide a perverse incentive to medicalize children at ever younger ages adds to its seeming ethical bankruptcy.

Which brings up Institutional Review Boards (IRB). IRBs are responsible for protecting the rights and welfare of human research participants. Between the Supreme Court case, Olson-Kennedy’s high profile medical negligence suit, and the UK ban on puberty blockers that found them a “scandal” and an “unacceptable safety risk,” wouldn’t IRBs’ views on studies involving puberty blockers in minors be changing?

According to the Office for Human Research Protections, every institution that conducts research using human subjects typically has its own IRB to

“review research studies to ensure that they comply with applicable regulations, meet commonly accepted ethical standards, follow institutional policies, and adequately protect research participants. IRB reviews help to ensure that research participants are protected from research-related risks and treated ethically, a necessary prerequisite for maintaining the public’s trust in the research enterprise and allowing science to advance for the common good.”

IRB committees are made up of at least five members, at least one of whom has scientific expertise, one of whom has expertise in nonscientific areas, and one not affiliated with the research institution. Aside from the community members, IRB members are usually scientists and experts on research ethics. Every study involving human participants must gain IRB approval before it begins, and is reviewed annually throughout its course. The IRB may require modifications to the protocol, or it may deny approval.

As an aside, the Office for Human Research Protections, and IRBs, fall under the federal Department of Health and Human Services where trans-identified male Rachel Levine is the assistant secretary for health. Levine pressured WPATH to remove any minimum age for gender surgery for minors from their guidelines because it might fuel political opposition to cutting healthy body parts off children. Levine leading the way with that brand of ethics does throw doubt on what standard IRBs are using for “ethical treatment,” subjects’ welfare, and “maintaining the public’s trust in the research enterprise.”

Ackerman’s study is taking place at four institutions—Boston Children’s Hospital, Oregon Health & Sciences University, Colorado Children’s Hospital, and Stanford Medicine Children’s Health—centers that conveniently house pediatric gender clinics from which she will recruit participants. She mentioned receiving IRB approval from each center.

Ethics, and IRB approval, I discovered, are not as straightforward as it might seem. I spoke to a pediatrician and a bioethicist who have a great deal of expertise in IRBs and studies of pediatric exercise science, both of who first spoke freely but later asked not to be named or quoted, and backpedaled fast and hard from anything on the record.

I learned that IRB approval is a risk/reward ratio with much less risk allowed in vulnerable populations like minors, and greater requirement for benefit.

That Ackerman is merely studying the effects of hormone treatment kids would be getting anyway is crucial. She is testing children’s performance and following them for a period of time. It’s less risky, and less invasive than if she was prescribing and directing their medical treatment.

IRBs apparently do not look at Supreme Court cases or what happened in the UK. They evaluate the submission they received. Which, in this case, just involved putting kids through fitness tests, Dexa scans, and lab tests. Nothing to see here.

From what I learned, it would take more than Supreme Court cases, high profile lawsuits, and other countries banning puberty blockers to sway IRB approval in this country. It would require a federal ban on puberty blockers.

There are really three issues going on here. One, is giving children puberty blockers medically appropriate? Two, is the study methodology sound to answer the research question involving the effects of puberty blockers? And three, is the study ethical under applicable federal research regulations? In considering issue #3, it is important that the study protocol does not involve giving the puberty blockers; it only involves studying the effects of a medical intervention that was already in progress. As to #1, the medical intervention is legal and not outside the mainstream of current clinical practice. As to #2, if a study does not present more than minimal risk (as the IRBs presumably decided in this case), then an IRB generally will not base its decision on whether it considers the study methodology to be the best approach to answer a research question. Therefore, an IRB could well conclude that the study is ethical even though the fact that some experts would question the wisdom of one or both of the first two steps.

While cracks may be appearing in support for puberty blockers and cross-sex hormones for minors in this country, the U.S. is a ways behind the UK and European countries.

A more feasible and conclusive way to shut down at least one incentive for medicalizing gender distressed children is for sports organizations like World Athletics and World Aquatics to restrict the female category to those born female. Leaving a loophole for males who haven’t experienced puberty is antithetical to the goal of a female category. By closing the loophole, Dr. Ackerman’s million dollar question of what happens to 12-year-olds’ sports performance when their endocrine systems are completely shattered suddenly looks like a bad deal.