Physicians, Hospitals and Gender Dysphoria in Minors- Fundamental Disputes

By James C. Sherlock

What about the doctors in this controversy?  What about hospital and state oversight?  What do laws and regulations require and on what are they silent?

We’ll look.

The dispute among physicians on the treatment of gender dysphoria in minors is primarily an ethical one.  They agree on the diagnosis and some of the medical effects of hormone treatments.  They agree:

  • that gender dysphoria (GD) in childhood describes a psychological condition in which children experience a marked incongruence between their experienced gender and the gender associated with their biological sex;
  • that with the onset of puberty, the emotional turmoil can be significant and needs to be dealt with. (They disagree on how to deal with it);
  • that puberty blockers stop puberty;
  • that puberty blockers cause emotional distress and some increasingly concerning side effects, but achieve the physical results sought;
  • that once a child has puberty blocked, he or she is very likely to proceed to cross-gender hormones;
  • that cross-gender hormones also “work” in a medical sense, meaning they cause the physical changes sought by the physician, and at some level sterilize the patient;
  • that, once transitioned with cross-gender hormones, the minor will be dependent upon them for the rest of his or her life to maintain the gender reassignment; and
  • that there are no scientific clinical studies that have tracked the health of transitioned minors as they have grown into adults.  What little is available are surveys, not clinical follow-ups.

They agree that transitioned persons as a group go on to have very difficult lives. We have the data on that, just not on their health outcomes from the transition treatments.

They also agree that action or inaction and the types of action chosen involve moral judgments. But they disagree on what is moral here.

The progressive view is that these interventions are life-saving and gender-choice-affirming.  Those who oppose the interventions consider them unethical and dangerous experiments on minors unequipped to make such decisions. Some also consider them immoral.

The ethical debates among physicians start early in the process with different interpretations of “first, do no harm.”

In Virginia in 2020, Governor Northam and the General Assembly put a thumb on the scale.

Virginia Law.  We will examine those debates here in the context of Virginia law.

Virginia law passed in 2020 threatens the licenses of physicians and psychologists accused of “conversion therapy,” defined as counseling of a minor that does not provide “acceptance, support, and understanding of a person” or does not facilitate “a person’s coping, social support, and identity exploration and development.”

So psychiatrists and psychologists can treat gender dysphoric minors but they dare not be accused of not being accepting.

Virginia law also sets strict judicial oversight for those who perform surgical sterilization of minors.   It is silent on medical sterilization.

Lack of medical evidence does not stop the zealots.  The American College of Pediatricians (ACPeds) has stated that:

a review of the current literature suggests that this protocol is founded upon an unscientific gender ideology (and) lacks an evidence base.

We are concerned about the current trend to quickly diagnose and affirm young people as transgender, often setting them down a path toward medical transition.

For that and other anti-progressive sins, the Southern Poverty Law Center (SPLC), confirming the ACPeds statement about unscientific gender ideology, has designated the American College of Pediatricians a hate group.

Yet the Endocrine Society agrees with the lack of an evidence base.  However, it is not only unconcerned, but finds hormone treatments in minors “compelling”:

We recognize that there may be compelling reasons to initiate sex hormone treatment prior to the age of 16 years in some adolescents with GD/gender incongruence, even though there are minimal published studies of gender-affirming hormone treatments administered before age 13.5 to 14 years.

In 2018, the American Academy of Pediatrics reported

There are few studies in this field and they have all been observational.

Low-quality evidence suggests that hormonal treatments for transgender adolescents can achieve their intended physical effects, but evidence regarding their psychosocial and cognitive impact are generally lacking. Future research to address these knowledge gaps and improve understanding of the long-term effects of these treatments is required.

Even the Endocrine Society admits that:

further studies are needed to determine strategies for fertility preservation and to investigate long-term outcomes of early medical intervention, including pubertal suppression, gender-affirming hormones and gender-affirming surgeries for transgender/gender incongruent youth.

But certain endocrinologists continue to go full speed ahead.  And their hospitals do not stop them.

Shell game.  There is a game being played with these children’s lives.

Use of puberty blockers and cross-gender hormones for gender dysphoria is off-label, meaning such use has not been approved by the FDA.  So the treatments are by definition experimental.

But they have not been subject to clinical trials, and won’t be.

UVa Children’s, for example, is conducting pediatric clinical trials examining hormone effects on minors.  But a trial to examine the effects of hormones used in puberty suppression and cross-sex transitions is not among them.  

There is a good reason: such a trial would be too dangerous.

There are significant known risks (sterilization, stunted bone growth and mental disturbance) and unknown risks, including the impact of puberty blockers on psychosexual and gender maturation, cancer occurrence and other long term effects.

If an institutional review board (IRB) did examine such a trial application, it would not be able to approve it under federal regulations because of those risks.  

So no clinical trial applications are made.  Apparently never have been.  That is one reason why there is no evidence base.

That dangerous game has institutional consent, and the practice needs to be brought to a halt by the Department of Health that has oversight of those institutions.

But this is not about UVa exclusively.    Carilion Clinic in Roanoke offers hormone therapy for gender dysphoria in minors. So does Children’s Hospital of Richmond at VCU.  And Children’s Hospital of the Kings Daughters in Norfolk, where Governor Northam was employed as a pediatric neurologist.  They have provided too little oversight of their clinics that offer hormone treatments for gender dysphoria.

Such hospitals by their own standards and those of the federal government should have at least done follow-up clinical studies to track the long-term health of the hundreds of patients they have subjected to the off-label hormone treatments.

The Endocrine Society recommends such follow-ups twice yearly. But apparently Virginia institutions either have not done them, or at least have not reported the results to the medical community.

Clearly the “intended physical effects” of the treatment have been achieved.  The rest of the effects have escaped their interest.

Institutional assessment of risk. Let’s assume for the sake of discussion that hormone treatment of minors for gender dysphoria presents the prospect of direct benefit. 

21 CFR 50.52 (clinical investigations involving greater than minimal risk but presenting the prospect of direct benefit to individual subjects) requires that:

Any clinical investigation within the scope described in §§ 50.1 and 56.101 of this chapter in which more than minimal risk to children is presented by an intervention or procedure that holds out the prospect of direct benefit for the individual subject, or by a monitoring procedure that is likely to contribute to the subject’s well-being, may involve children as subjects only if the IRB finds that:(a) The risk is justified by the anticipated benefit to the subjects;(b) The relation of the anticipated benefit to the risk is at least as favorable to the subjects as that presented by available alternative approaches; and (c) Adequate provisions are made for soliciting the assent of the children and permission of their parents or guardians as set forth in § 50.55.

In other words, children cannot participate until a facility’s IRB conducts a risk assessment, and in this case the short-term risks are significant and long term risks are unknown.  

There will be no clinical trials of the use of these hormones in gender dysphoric children.

Puberty blocker risk.  Endocrinologists who offer puberty blockers to gender dysphoric minors in early stages of puberty advertise them as a risk-free pause.”  They simply cannot know that.

I quote a July 2022 letter to NHS England from Dr. Dr Hilary Cass, Chair, Independent Review of Gender Identity Services for Children and Young People of Britain’s National Health Service :

As already highlighted in my interim report, the most significant knowledge gaps are in relation to treatment with puberty blockers, and the lack of clarity about whether the rationale for prescription is as an initial part of a transition pathway or as a ‘pause’ to allow more time for decision making. For those who will go on to have a stable binary trans identity, the ability to pass in later life is paramount, and many will decide that the trade-offs of medical treatment are a price that is fully justified by the ability to live confidently and comfortably in their identified gender.
The widely understood challenge is in determining when a point of certainty about gender identity is reached in an adolescent who is in a state of developmental maturation, identity development and flux.
It is the latter option regarding a ‘pause’ for decision making about which we have the least information. The rationale for use of puberty blockers at Tanner Stage 2 of development was based on data that demonstrated that children, particularly birth-registered boys who had early gender incongruence, were unlikely to desist once they reached early puberty; this rationale does not necessarily apply to later-presenting young people, including the predominant referral group of birth-registered girls. 
We do not fully understand the role of adolescent sex hormones in driving the development of both sexuality and gender identity through the early teen years, so by extension we cannot be sure about the impact of stopping these hormone surges on psychosexual and gender maturation. We therefore have no way of knowing whether, rather than buying time to make a decision, puberty blockers may disrupt that decision-making process. [Emphasis added.]

That assessment directly questions the safety of the use of puberty blockers for the treatment of gender dysphoria.  

Cross-gender hormones.  There is similarly no scientific evidence for the long-term effects of cross gender hormones in minors.

Bottom line.  This is a legal and ethical disaster that must stop.

A relatively few pediatric endocrinologists in Virginia continue to provide hormone treatments to minors diagnosed with gender dysphoria without apparent interest in adverse effects.

It is an institutional issue in Virginia.  The hormone treatments of minors for gender dysphoria are happening in Virginia children’s hospitals.

I recommended to the Virginia Department of Health (VDH) that it respond to Dr. Cass’ concerns and those of the Endocrine Society and American Academy of Pediatrics about unknown long term effects, as well as the known life-changing effects of these hormones in minors, by stopping these experiments pending better information on their adverse impacts.   

In response, the VDH claimed lack of jurisdiction and referred me to the Department of Health Professions.  There may be work for Health Professions to do, but it is also an institutional issue.

As for VDH jurisdiction, the CMS State Operations ManualAppendix A – Survey Protocol, Regulations and Interpretive Guidelines for Hospitals that VDH uses in its inspections of hospitals includes inspection for compliance with both:

42 C.F.R. § 482.25 Condition of Participation: Pharmaceutical Services. Information relating to drug interactions and information of drug therapy, side effects, toxicology, dosage, indications for use, and routes of administration must be available to the professional staff.

42 C.F.R. § 482.21 Condition of participation: Quality assessment and performance improvement program.  The hospital must develop, implement, and maintain an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement program.

I contend that the inspection team cannot find compliance with those two federal regulations in inspection of hospitals providing hormone therapy to gender dysphoric minors.

  1. 42 C.F.R. § 482.25 –
    1. The side effects and toxicology effects of the off-label use of those drugs are not known; and
    2. their indications for use do not include treatment of gender dysphoria in minors.
  2. 42 C.F.R. § 482.21 –
    1. there are no long-term data available; and
    2. therefore there can be no evidence of a data-driven quality improvement program for those procedures unless there are long-term clinical follow-ups of which there is no public record.

Finally, the requirements of 21 CFR 50.52 are clear, have not been met and cannot be at present because the long term risks are unknown.

The proponents of these experiments have:

  • neither put them forward for approval as clinical trials;
  • nor have the endocrinologists reported on long term effects with clinical follow-up studies that their own professional society recommends.

That shows either fear of or unconcern with long-term patient outcomes and in itself is sufficient evidence with which to stop this practice.

I further urge that the Youngkin administration put forward legislation to treat chemical sterilization of minors with hormones with the same judicial oversight that Virginia law treats surgical sterilization of minors.  There can be no logical argument against that change.

Finally, I recommend change or repeal of the anti-conversion therapy law.  It was written as a plain, unveiled threat.

It will be exploited sooner rather than later by activists to teach a psychiatrist or psychologist just doing their job a lesson about fighting the progressive world view.  I note that the same people who wrote and signed it recoil in horror when other states threaten loss of license for abortions outside the limits of state law.

Clinicians must be free to address the emotional turmoil of those patients without threat of loss of license.