Skrmetti: Treating a Disease Label, Not a Child

In the highly polarized case of United States v. Skrmetti, the Supreme Court upheld Tennessee’s legislative denial of two types of medical care for gender dysphoria in young people. In so doing, the decision stripped medical decision-making for trans youth from doctors and vested it in the legislature.

To sidestep the plaintiffs’ equal protection argument (that states must treat individuals in similar situations alike), the Court creates a linguistic sleight-of-hand: At the risk of over-simplifying, the Court ruled that the case did not involve sex discrimination because the treatments under scrutiny affects trans boys and girls the same way. Yet, in the context of trans care, this distinction is rather loosey-goosey, as the very purpose of these treatments is to affect sexual expression.

To pretzel out of that conundrum, the Court depicts the treatments involved as condition-dependent, meaning the differences between treating cis and trans children is not because of sex, but rather because of the different medical conditions presented.

Even that conclusion does not lay the legal matter to rest. A rational relationship to a legitimate government purpose is also required to justify otherwise asymmetrical actions. Says Justice Roberts: “Where there exist ‘plausible reasons’ for the relevant government action, our inquiry is at an end.” Here, the Court tepidly relies on “protecting the health of minors” to justify the legislation. Recognizing that there is controversy within the medical community regarding trans care, the Court then concludes this discord is ample predicate for the legislation.

Disease, Class, or Condition Dependent?

Generally, drugs are prescribed to address biological conditions. These conditions are given labels, called “diseases.” Over time, disease names can be changed, sometimes reflecting better understanding of causes, sometimes to respect heightened sensitivities of various populations. Nevertheless, saying a drug treats a “disease” is a practice borne of convenience. Rather, it is the cause, signs, or symptomatology that dictates treatment (here, the choice of drug), not per se the “name” of the disease. Justice Roberts agrees:

“The plaintiffs and the dissent, however, contort the meaning of the term ‘medical treatment.’ … Notably absent from their framing is a key aspect of any medical treatment: the underlying medical concern the treatment is intended to address…”

Justice Roberts, however, disregards his own wisdom. As the decision discloses, both sides of the courts’ ideological divide disregard the science and medicine. Instead exposing their political agendas, they make a juridical power grab, evident by their all-or-nothing agendas, rejecting or embacing both puberty blockers and hormones and treating both modalities as a single conflated class (“trans care”). Rather than assessing these treatment modalities separately, they lump the baby with the bathwater, conflating the different effects, risks, and safety profiles of each type of treatment, whether applied to trans or cis children.

Puberty Blockers and Diagnostic Definition: A Drug by Any Other Name

Disingenuously, but necessary to support their artificial construct, the majority defines puberty blockers as treating different diseases in trans children (gender dysphoria) and cis children (precocious puberty). Examining the Majority’s arguments separately for puberty blockers discloses their perfidity.

Precocious puberty is defined as a condition occurring “when children’s bodies begin to change into adult bodies “too soon.” The “too soon” assessment requires clinical judgment based on the child’s presentation, in comparison to his or her peers.

In actuality, the indications for puberty blockers are the same in cis or trans children: These drugs retard the manifestation of secondary sex characteristics, regardless of gender or sex. The same chemicals (GnRH agonists) are used for the same purpose in boys and girls, cis or trans, in the same way — to retard anatomical maturation and to address psychological concerns. Calling the disease in question either precocious puberty or gender dysphoria does not change the fact that in both cases the drug retards sexual expression — i.e., “blocks puberty.” The only real difference is the diagnostic code on the chart.

Safety, Off-label Use, and the Legislative Practice of Medicine

The Court then claims these drug are used for trans youth “off label,” i.e., not for the purpose for which its safety was tested, arguing that this type of use, while entirely legal, subjects the users to heightened risk.

First, the FDA-approved use was for delaying manifestation of secondary sex characteristics — in both sexes. So, in fact, the drug is being used for the purpose for which it was approved. But even if this were not the case, all FDA-approved drugs must satisfy a basic level of safety established in Phase I of the Clinical trial. This process allows “off-label” usage, while assuring a modicum of patient safety. In these cases, the physician assumes the role of weighing risks and benefits for the particular patient.

Further, puberty blockers present the same risk or safety hazards, e.g., bone density issues, in cis and trans children, and their effects are reversible (as opposed to those of hormones). This means the informed consent obstacle is the same for both cis and trans children and easier to assess.

The majority then claims, without support or citation, that trans youth are exposed to puberty blockers longer than cis children, as cis children stop taking the drug at the “normal” age of puberty, while no similar cut-off applies to trans children. In fact, puberty blockers in cis children likely begins earlier than in trans children, as early as age 6. Nor is a particular age cut-off specified in the FDA approval package, and a typical duration could be six or more years. In trans children, typically prescription would not begin until at least two or three years later, the age of normal puberty, and may last until puberty is complete. In real life, then, the duration of treatment may actually be longer in cis children than trans children.

I Define, Therefore I Win

In short, the denial of medically necessary puberty blockers to trans children may not be on the basis of sex, but it’s not on the basis of condition (which is the same in trans and cis children, male or female) either. Seemingly, the distinction is on the basis of some arbitrarily court-created class: having a diagnosis as “trans.”

And while the Court pointedly notes that the medical community is in discord regarding how to treat trans children, rather than vesting the complex medical decision in the hands of those trained to address medical controversy (the child’s trained and treating physician), the Court vests the decision in the hands of the legislature.

The irony is real. The Court refuses to allow physicians to prescribe puberty blocker drugs off-label because of safety concerns, entrusting this safety-decision to the legislature. Yet, this very same supposedly safety-conscious legislature now allows pharmacists to dispense ivermectin on patient request — as an over the counter drug (OTC), with even less FDA oversight than off-label drugs — and without a doctor’s intervention at all. In some states, legislative fiat allows patients, even children, to take ivermectin for any reason they want, with no direction as to dosage — and without anyone doing a risk-benefit analysis.

It seems at the end of the day, who needs doctors? But do we really want the legislature to make these decisions?