How to Regulate Pediatric Gender Medicine
Pursuing bans on drugs and surgeries may not be the most pragmatic approach—lawmakers hoping to reverse the medicalization of youth should instead consider these eight avenues.
As medical authorities in Sweden, Finland, and the U.K. have moved away from the use of puberty blockers, cross-sex hormones, and surgery as a first-line treatment for gender dysphoria in minors, the United States has become increasingly isolated as a purveyor of “gender-affirming care.” The Biden administration, medical groups like the American Academy of Pediatrics (AAP), progressive political organizations like the American Civil Liberties Union, and high-profile activists have joined forces to disseminate misinformation on the issue. Evidence supporting the use of the controversial protocol for youths is, at best, extremely weak, yet its advocates continue to overstate its benefits, conceal its risks, and thwart meaningful discussion of its alternatives.
Some states have responded to these challenges by passing legislation banning the use of drugs and surgeries to treat gender-dysphoric minors. We understand the motivation behind these efforts and believe there is a reasonable scientific basis to support them. But we doubt that, at least in the present moment, they are the most pragmatic way to regulate this area of medical practice. If nothing else, these bans run the risk of being invalidated in court, where judges misled by medical groups bestow upon gender-affirming care the glow of civil and constitutional “rights.”
Regulation of pediatric gender medicine should respect parents’ rights, secure medical professionals’ ability to dispense evidence-based care for their patients, push back against the misleading characterization of the scientific evidence, and protect youths against unwarranted and harmful medicalization. To that end, we present eight policy proposals for political leaders to consider in anticipation of the next legislative session.
Medical-board decisions. Ideally, state medical boards would lead the way in setting the standards for clinical practice. Unfortunately, large swathes of the medical establishment exhibit clear signs of ideological capture on this issue, making distrust by state authorities of their own medical boards understandable. Nevertheless, the recent example of Florida—whose medical boards conducted hearings, reviewed expert testimony on both sides, and issued professional judgment on clinical standards—illustrates that rigorous, evidence-based review is possible.
Because groups like the World Professional Association for Transgender Health (WPATH) and AAP have promulgated “best practices” on the basis of very poor evidence (on gender as well as on other issues), it is imperative that state health authorities follow the lead of European countries and conduct, or in their proceedings rely on, systematic reviews of the evidence (SR). Florida relied on an overview of SR. A properly done SR analyzes the entire body of the evidence surrounding the costs and benefits of using puberty blockers and cross-sex hormones to treat youth gender dysphoria. As such, SRs counteract the tendency, on display in statements like the AAP’s 2018 endorsement of gender-affirming care, to draw conclusions from cherry-picked studies, many of them having unreliable methodologies and poor controls, and to omit relevant studies whose conclusions are politically inconvenient. The SR yields a far more accurate and unbiased assessment of what is currently known and unknown about medical interventions, and if done properly, its results are reproducible by anyone using the same methodology.
Due to the expensive and time-consuming nature of SRs, several states might wish to conduct them as a coalition. As with multistate amicus curiae filings, one state health department might take the lead in conducting the review, or several departments might jointly steer the effort as co-partners.
Aside from injecting professional expertise into the process of regulating pediatric gender medicine, having medical boards lead the way would bring four distinct advantages. First and probably most important, an SR-based professional judgment, especially if done by several states, would grant reformers a powerful tool to push back against Democratic officials’ and the medical establishment’s unfounded assertions about the appropriateness of “gender affirmation” for minors.
Second, such a judgment would also very likely carry weight in litigation, where non-expert judges have been reluctant to second-guess the consensus view of ideologically motivated medical groups. At present, with most major medical organizations lining up behind plaintiffs who challenge state bans, judges perceive these contests as one between Republican politicians and the medical community. This perception arises mainly because activists have managed to clog medical journals with subpar articles, conceal non-findings behind paywalls, prevent the publication of criticism, capture institutions like the AAP, and intimidate dissenters into silence. The result is a manufactured appearance of broad consensus.
Third, medical-board hearings are an opportunity to get practitioners and advocates of gender-affirming care to explain their views in a public setting and on the record, something they have been reluctant to do. As the precedent of Florida demonstrates, the world of “gender-affirming” health care is awash with incompetence, dishonesty, and most commonly, confirmation bias. Public hearings are a good, and perhaps the only, way to expose these problems.
Finally, medical board hearings are an opportunity for parents of gender-distressed minors to learn, in an adversarial setting, the arguments and counterarguments in the debate over pediatric gender medicine. A century of consistent Supreme Court precedents holds that parents have a fundamental constitutional right to direct the care, custody, and control of their children. Because parents are (or should be) the ultimate authority in making decisions about their children’s health, it is crucial that they be exposed to the full range of medical opinion on this topic.
Informed consent. States that prefer European-style restrictions over outright bans should have strict requirements for informed consent. To provide truly informed consent on behalf of their children, parents should fully understand the unvarnished facts about the risks, lasting consequences, potential benefits, and viable alternatives to these medical interventions. Far too often, parents are presented with a Hobson’s choice: proceed with drugs or have their child commit suicide. They are fed the false narrative that puberty blockers have been proven safe and effective, and that their use prevents suicide.
State law can correct the problem of misinformed consent by mandating that parents receive unbiased and trustworthy disclosures as a condition of informed consent. For example, state law can require that parents be informed what exactly “reversible” means in the context of puberty blockers. When used for central precocious puberty, puberty blockers delay abnormally timed puberty in order to ensure that it occurs at a developmentally appropriate stage. In that narrowly defined way, their puberty-blocking effects are reversible. When used for gender dysphoria, however, the goal—or, at any rate, the effect in over 95 percent of cases—of these drugs is to prevent the body from going through puberty. Even in the rare circumstances where puberty blockers are discontinued and not followed-up by cross-sex hormones, their effect is a lag in a teenager’s psychosocial development, which may have serious and lasting consequences that are unlikely to be reversible.
Another and related risk is iatrogenesis (meaning an intervention that is itself the cause of illness): the fact that minors who are put on puberty blockers almost always go on to receive cross-sex hormones may well be because of the effects of puberty blockers themselves rather than the ability of doctors to avoid false positives when identifying candidates for these drugs. Thus, the common claim that puberty blockers merely buy patients a “window of time” in which to decide on next steps is at best an exaggeration, and at worst a distortion of clinical realities.
The concept of informed consent is certainly not without problems. Complex information can sometimes overwhelm the comprehension of the average parent. Yet it is nonetheless necessary for parents seeking to exercise their constitutional rights.
Well-designed state laws can, moreover, ameliorate some of these problems. For example, long-established laws have addressed situations where complex information risks underinformed decision-making, notably in the context of financial disclosures and lending. The 1968 federal Truth in Lending Act (known sometimes as Regulation Z), for example, protects consumers against unfair and inaccurate credit practices. Truth-in-Lending Disclosure Statements provide consumers seeking mortgages and credit cards with standardized explanations of loan terms in simple English.
This same approach can be applied to pharmacological or surgical options for gender dysphoria. A “Truth in Medicine Act” (TIMA) would require parental disclosures that include, among other things, up-to-date rates of persistence and desistance in youth gender dysphoria, suicide rates (as distinct from suicidal thoughts and self-harming behaviors, or “suicidality”), the exact meaning as well as the risks and prospects of “reversibility,” the lack of evidence supporting the superiority of medical intervention to psychotherapy, facts about regulations adopted by other countries (including Sweden, Finland, and the U.K.) and the systematic reviews on which these policies are based, and providers’ economic interests. Like truth-in-lending disclosures, TIMA legislation can require that this information be disclosed through a standardized, easy-to-read format that uses basic English.
Because so much of this unvarnished information is likely to be new to parents—it may be the first time that they ever hear about the significant risks associated with pediatric gender medicine—states can require a disclosure period of several months, in which mental health experts work with families to guarantee full understanding of what they are being asked to agree to. The famous Dutch protocol, for example, called for a months-long evaluation process in the context of which patients’ expectations were lowered and—in theory, at least—the risks and uncertainties of drugs were made clear. Short of managing clinical care at this level of detail, states can mandate a post-disclosure waiting period before medical providers proceed with a hormonal or surgical course of action. This would give parents enough time to read and internalize the information provided, discuss alternatives in light of risks as a family, and ask questions of medical and mental-health professionals.
Medical malpractice suits. Tort law has long served as a vehicle for achieving public policy changes through private litigation. However, two barriers to pediatric gender-malpractice claims currently exist. The first is that the statute of limitations is far too short—generally on the order of two years—for those who experience regret about the medicine and procedures they received to file a malpractice claim. According to some studies, regret typically emerges ten years after completion of medical transition. Owing to the impact of “gender-affirming care” on a person’s fertility and future reproductive prospects, and the fact that most teenagers can scarcely understand what it could mean to their overall quality of life to sacrifice these prospects, statutes of limitations for gender-related claims should be extended to ten years after reaching legal adulthood. Alternatively, legislation can allow for malpractice suits within four years of the time of discovery by the injured party of both the injury and the causal relationship between the treatment and the injury.
The other barrier to successful malpractice suits results from the generalist background of American judges as well as their busy schedules. In assessing whether a doctor has violated the standard of care, judges are likely to defer to the opinion of such groups as the American Medical Association (AMA) and the AAP, especially when these groups line up in concert against plaintiffs.
Because state law defines the standard of care, legislation can refine this standard for pediatric gender dysphoria, which would obviate the need for judges to defer to politicized medical institutions. Preferably, this would happen after state medical boards reviewed the evidence, heard testimony, and clarified best practices. An appropriate standard of care in gender dysphoric-related malpractice suits could include international standards and practices, which have changed dramatically in the past few years to caution against the administration of puberty blockers, cross-sex hormones, and surgery.
State law can also assign jurisdiction for medical malpractice claims to specialized health courts, similar to bankruptcy and family law courts. This would allow judges with special expertise in medical issues to assess the standard of care or their application in particular cases without deference to the opinions of captured groups like the AAP. Legal reformer Philip K. Howard has, for example, long called for health courts to limit the potential for overwhelming malpractice liability to drive excessive health-care costs and the practice of “defensive medicine.” Under Howard’s plan, administrative judges trained in the law and medicine would be advised by experts and would “make decisions and write opinions on standards of care.”
The risks of adversarial legalism—using litigation to achieve policy change—should not be discounted. Unlike legislation or bureaucratic regulation, litigation typically involves high (and sometimes prohibitive) transaction costs, favors the well-funded and well-organized irrespective of the merits of their claims, involves lengthy procedures, and can, due to the decentralization of the American judiciary, produce haphazardness in the administration of justice. Manhattan Institute scholars from Jim Copland to Peter Huber have for decades warned about the overuse of malpractice and class-action litigation as a means of achieving political change outside of the political system. Still, the structure of American federalism and the many veto points it produces in the policy process make bureaucratic and legislative regulation less likely than judicial, especially in certain states.
The stick of malpractice suits may be complemented by the carrot of legal safe harbors for providers who follow a stringent-but-reasonable set of requirements. Again, this assumes that states are willing to follow the European model and allow pediatric transition in extreme cases, and in the context of controlled clinical studies. Safe harbor requirements can include, in addition to robust informed-consent provisions, a multidisciplinary assessment of the child, including with a psychotherapist, and an extended period of psychotherapy and “watchful waiting” (as opposed to automatic social transition) prior to the administration of any puberty blocker. During this time, parents can carefully assess, in light of the potential progress made through psychotherapy, whether to proceed with drugs. If past studies are indicative, chances are good that most children will come to terms with their bodies by adolescence and find medicalized “transition” unnecessary. This, however, assumes no placebo-effect-inducing social environment in which parents and their children are not relentlessly told that only drugs and surgeries will resolve their problems. Doctors forced to abide by a period of watchful waiting coupled with psychotherapy may be less likely to mislead parents with the unsubstantiated “transition or suicide” narrative, leading in turn to a more cautious and rational weighing of risks versus benefits.
Ideally, the potential to receive a shield from liability would encourage malpractice insurers and their underwritten doctors to go out of their way to comply with the conditions of the safe harbor. In contrast, without a safe harbor, providers face little incentive to comply with the appropriate standards of care beyond the bare minimum they can legally get away with. Counterintuitively, using safe harbors may make actual cases of malpractice less likely.
Medicaid funding. Though Medicaid is a federal program, each state has wide latitude to determine which procedures and treatments it will cover under the program. States may impose “non-quantitative treatments limits,” which can include denial of coverage for experimental treatments, or a refusal to pay for high-cost therapies until it can be demonstrated that lower-cost treatments are not effective. They also have significant leeway to formulate tests to determine what treatments would be covered as “medically necessary.”
It bears mention that advocacy organizations like WPATH make claims about “medical necessity” primarily because of the insurance implications of this term. It is because they have universal public health insurance that medical boards in Europe conducted systematic reviews of evidence and found “gender-affirming” interventions to be medically unnecessary.
Currently, at least ten states deny Medicaid coverage for hormones and surgeries to those diagnosed with gender dysphoria. In Florida, for example, state administrative law requires that covered health services be consistent with “generally accepted professional medical standards” (GAPMS) and not “experimental or investigational.” In making this determination, the state’s Agency for Health Care Administration is guided by multiple factors listed in the Florida administrative code, which include evidence-based clinical practice guidelines. In June, the state made news when the health agency denied Medicaid coverage for puberty blockers, cross-sex hormones, and gender-related surgeries. In an accompanying report, the agency explained, “Considering the weak evidence supporting the use of puberty suppression, cross-sex hormones, and surgical procedures when compared to the stronger research demonstrating the permanent effects they cause, these treatments do not conform to GAPMS and are experimental and investigational.”
Drug registries. The excessive opioid prescription problem of the last decade bears some resemblance to the phenomenon of pediatric gender medicine. Both medical ventures were launched on the basis of a small body of weak studies that were adopted by the medical community. Both utilized patients’ subjective self-assessment—pain in the case of opioids, “gender identity” in the case of pediatric gender medicine—to evaluate the “need” for treatment. Both include high risk of iatrogenesis.
During the first years of the opioid epidemic, patients seeking to obtain ever greater quantities of the powerful painkillers would “doctor shop,” or visit multiple providers to obtain several prescriptions—without the prescribers’ knowledge of the other visits. The lack of a centralized information system containing patients’ pharmacological histories allowed this practice to continue. In response, state lawmakers adopted innovative prescription drug monitoring programs (PDMPs) to track the administration of controlled substances in the state, including opioids. PDMP legislation creates a digital registry that contains patients’ prescribing histories, allowing doctors to know whether they have already received an opioid prescription.
As a best practice, some states require the provider to check the PDMP prior to prescribing a controlled substance. Pharmacists must also enter the prescription into the PDMP before dispensing a controlled substance. State health department officials then track the quantity and location of opioid distribution, granting them greater insights into where they should focus interventions. Large health systems currently contract with companies like EPIC and CERNER to maintain patient medical records and streamline billing. These or other companies could be encouraged or required to develop “decision support tools” (currently in use for painkiller prescriptions) that would require hormone-prescribing doctors to acknowledge that they have read informational materials on puberty blockers and cross-sex hormones and considered less invasive alternatives (i.e., psychotherapy).
PDMPs can similarly be used to track the administration of puberty blockers and cross-sex hormones. Testosterone is already classified as a controlled substance and is therefore already tracked by state PDMPs. State law can simply add puberty blockers and estrogen to the list of drugs that pharmacists must enter into the PDMP. Doing so would both deter endocrinologists from excessive prescription of these drugs and allow for better collection of data on the frequency of these interventions.
Restrict pediatric interventions to research settings. As “gender-affirming care” remains an experimental protocol, with no high-quality studies to evaluate its benefits or risks, any decision to allow it to continue should do so only within the context of an IRB-approved research protocol. This is what Sweden, Finland, the U.K., and Florida’s Board of Osteopathic Medicine have decided to do.
Eligibility to participate in such a study would be based on the Dutch protocol’s criteria, strictly defined and enhanced in light of the recommendations above. Candidates would need a diagnosis of early-onset (prepubertal) gender dysphoria that intensifies in adolescence (though states should protect against overdiagnosis as a way to leave open the option for adolescent interventions). Candidates should have no history of social transition before puberty in order to minimize the chance of iatrogenesis. They should have no serious psychological counterindications, and if they do these should be dealt with first through psychotherapy. Parental support for the medical transition and informed consent (utilizing TIMA) should also be required. Finally, participation in these trials should happen in a context that is reasonably free of distortive, placebo-enhancing messaging about the “life-saving” and “medically necessary” nature of synthetic hormones.
Lawmakers should recognize that the Dutch study, from which the Dutch protocol derives, though considered the gold standard of pediatric gender medicine research, nevertheless suffers from significant flaws and problems of generalizability. The retreat from the affirmative model to the Dutch model is an improvement, to be sure, but further retrenchment might be necessary as more information about the long-term results of the original Dutch study comes to light.
Research on patients receiving hormones should include long-term follow-up (a minimum of ten years seems reasonable) and be as well-controlled as is ethically possible for confounding factors. Investigators should have an affirmative duty to do, within reason, whatever is necessary to increase patient follow-up. This includes reaching out by phone, email as well as snail mail, physical visitations, and offering strong monetary incentives. High dropout rates, typical of research on gender dysphoria, allow activists and researchers themselves to spin the findings of studies from which very little can reliably be deduced.
In light of past experience, the language used in these studies should not reflect the sensitivities of activists or even of the subjects. Instead, it should reflect clear, objective, and well-supported scientific concepts. Sex is not “assigned at birth.” Misleading terms like “retransition,” which have been used to describe regret and a decision to stop medical transition, should be avoided. The term “suicidality” should be clearly defined and distinguished from “suicide.”
The chief purpose of Institutional Review Boards is to protect patients and ensure that research is done in an ethical manner. It is vitally important that IRBs not fall capture to activists promoting an ideological agenda. To that end, states could mandate, as a condition for pediatric interventions, that IRBs approve only research that, among other things, adheres to the requirements of informed consent and data collection mentioned above. They could ensure that appointment to an IRB board be based solely on professional background and expertise, not arbitrary identity characteristics or ideological commitments.
Drug-company liability. Using lawsuits to hold pharmaceutical companies financial accountable for harms inflicted by their products is a powerful tool of medical regulation. That said, two considerations bear mentioning. First, the use of puberty-blocking drugs like Lupron, which is produced by AbbVie, is technically off-label and non-FDA approved. In general, doctors should be able to prescribe drugs off-label, even and especially to minors (who typically cannot participate in clinical trials). Second, strict liability for drug manufacturers can often do more harm than good, for instance by stymieing innovation.
In American tort law, the “learned intermediary doctrine” (LID) attempts to strike a balance between allowing harmed patients to receive their just due and ensuring drug companies are not discouraged from developing and launching new drugs. LID does this by shielding manufacturers from legal liability, provided that prescribing doctors have adequate notice of a drug’s risks, which is typically disclosed by the manufacturer for on-label uses. Where possible and within the bounds of FDA regulations, states could impose an affirmative duty on drug companies to warn doctors about ongoing off-label risks and uncertainties of puberty blockers and cross-sex hormones as an eligibility condition for LID.
For example, state law could require that drug companies share the findings of state-backed systematic reviews of the evidence with doctors and other learned intermediaries, which would also provide LID protection—in effect, a disclosure regime that serves as a safe harbor. Given that such systematic reviews would be rigorous assessments of peer-reviewed medical literature, not funded in any way by pharmaceutical companies, they would likely pass muster under FDA guidance limiting the sharing of off-label drug use with prescribers.
Such a requirement need not be limited to pediatric gender medicine, either. Where a state has undergone the extensive effort to conduct or participate in a systematic review of an off-label use, requiring drug manufacturers to share its findings might save lives—and would certainly foster an atmosphere of greater informational openness. (That result comports with past research by Manhattan Institute scholars.) Drug companies might even encourage states to conduct these reviews, given that they could become shields against prospective liability.
School policy. Any effort to regulate pediatric gender medicine would be incomplete without addressing one of the root causes of youth gender medicalization: schools. Public and private schools nationwide have introduced gender theory in K-12 classrooms, often without parents’ knowledge or consent, on the supposition that it merely fosters respect and inclusion. Though often well-intentioned, there is good reason to believe that teaching pseudoscientific concepts to children and teenagers causes identity discordance and leads to iatrogenic social gender transition. The U.K.’s National Health Service recently released draft guidance strongly discouraging social transition in children and recommending it in adolescents only on the basis of a gender dysphoria diagnosis and only with informed consent—typically a requirement reserved for medical treatment.
In addition, schools have begun to adopt—officially or quietly—“gender transition” and “gender support” plans, which specify, often in great detail, precisely how school personnel are expected to “affirm” children and adolescents in their stated “gender identity.” Some of these plans, including the model policy published in a handbook coauthored by (among others) the ACLU, Human Rights Campaign, and the National Education Association, make parental notification conditional upon the consent of the student.
States can take a number of corrective steps to ensure that good intentions do not further cement a school-to-clinic pipeline. First, states can codify parental rights to be informed of and consent to their child’s social transition at school. The Supreme Court’s substantive due process jurisprudence extends to parental rights. Contrary to what some activists have claimed, the Family Educational Rights and Privacy Act, interpreted in light of Court decisions, requires that schools not withhold medically relevant information about students from their parents or legal guardians. States should clarify that social transition constitutes a mental-health intervention that requires the explicit consent of parents, whose right to make medical decisions regarding their children can be limited only in the most extreme circumstances. If school officials sincerely believe that a student is at risk of serious physical or emotional abuse (as opposed to mere parental questioning or refusal to go along with their newly avowed gender), then they should contact state child welfare services.
Second, curriculum transparency is a commonsensical and broadly appealing way of facilitating parental knowledge and engagement in their child’s education. Last December, for example, scholars at the Manhattan Institute produced a policy document containing model legislative language that would require schools to post on their websites a list of all curricular materials and activities used to instruct children and train teachers. If parents can quickly and easily see that kids are being exposed to instructional materials that they find concerning or inappropriate, they might seek to discuss the matter with teachers, and, if necessary, remove their child from the school. States might consider making any teaching of sex, sexuality, or gender to students conditional upon those students’ parents opting into the instruction. This reduces the chance that parents will learn of inappropriate instruction only after the fact.
State lawmakers rightly concerned about pediatric gender medicine need not resort to bans. Responsible, effective regulations can uphold parents’ rights, protect gender-distressed kids from overmedicalization, and better ensure that the medical profession does no harm.
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