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Bioethics Forum Essay

Pediatric Gender Care: Absence of Evidence Is Not Absence of Efficacy

In “The Cure for Politicized Pediatric Gender Care,” Moti Gorin argues that a U.S.-based systematic review, conducted by a trusted major medical organization such as the National Institutes of Health or the National Academy of Medicine, is needed to develop consistent standards for pediatric gender care. While the intent behind his call is well-intended, it is based on a flawed premise, and the reasoning for recommending such a review is unclear.

Systematic reviews derive information from published, peer-reviewed literature and, sometimes, grey literature—information developed outside of traditional academic or commercial publishing channels. The results from systematic reviews rely on the information contained in available manuscripts, white papers, conference abstracts, theses, and dissertations. However, simply because these materials can be found and may be in a published format does not mean they contain quality data. Thus, results drawn from systematic reviews are only as valid as the original sources from which they were drawn.

While there are have been hundreds if not thousands of published articles on the health disparities associated with youth experiencing gender dysphoria, from poor mental health outcomes and societal violence to suicide, the majority of this literature is from observational or cross-sectional studies. Most of these studies were conducted in academic medical center gender clinics among people with financial means who had access to quality care. Few studies have examined outcomes or experiences among people in rural areas or with limited means. Thus, in addition to lacking methodological rigor, the available data are not representative of the population. In other words, there is at best limited, poor-quality data from which to draw conclusions from systematic reviews.

As far as we are aware there have been no randomized controlled trials in pediatric gender care. The pool of available data is very limited. Thus, meta-analyses or systematic reviews are not likely to prove fruitful.

Is it reasonable, therefore, to request funding for more original studies? In fact, it may be unethical to suggest that randomized, placebo-controlled trials be conducted. The feelings of unresolved dysphoria, social stigma, and unacceptance are well known to be associated with the negative psychological effects of being transgender, and the literature abounds with reports of high rates of depression, anxiety, and suicidality among trans youth compared to their cisgender peers. Policies and legislation that restrict or forbid access to gender-affirming care have been shown to have life-threatening consequences. Thus, it could be morally dubious to allow one group access to puberty suppression and another group only psychological care. Although randomized trials are the gold standard of scientific research, designed to show causality, it may not be possible to launch such studies given the plight of potential subjects.

As Gorin notes, several professional societies have provided guidelines suggesting puberty suppression and gender-affirming hormones are standard of care. Yet the policy landscape for pediatric gender care is rapidly shifting to restrictions and penalties. Consider, then, the challenges of a parent of a dysphoric child: medical intervention now or suicide later? While we do not know the long-term effects of puberty blockers on cardiac and bone health, and there are likely some potential harms, we do know that dysphoric youth who cannot receive medical and psychological intervention often take their own lives. Poor-quality evidence from systematic reviews of the limited data available will not add much evidence on the efficacy of care. While evidence is greatly desirable, it may not be possible to create the studies that would generate it without harming those intended to benefit.

Another claim by Gorin needs clarification. We agree that “[a]ll patients deserve evidence-based care, and all physicians deserve to practice medicine with the help of authoritative clinical practice guidelines.” However, we don’t see how a systematic review, even by a trusted source such as NIH or the National Academy of Medicine, would help achieve that goal in pediatric gender care in the U.S., much less resolve the inconsistencies in pediatric gender treatment around the globe that Gorin rightfully laments.

We wish Gorin had explained more fully how evidence-based medicine, including consistent clinical practice guidelines, could blunt, much less cure, politicization of gender care for children. The raft of anti-care laws spreading through this country suggest that reason and evidence are not sufficient for the task.

Gwendolyn P. Quinn, PhD, is the Livia Wan Endowed Chair and Professor in the Department of Obstetrics and Gynecology at New York University Grossman School of Medicine. Lisa Kearns, MS, MA, is a senior researcher in the Division of Medical Ethics, at NYU Grossman School of Medicine. Arthur Caplan, PhD, is the founding head of the Division of Medical Ethics at NYU Grossman School of Medicine. He is a Hastings Center fellow and a member of The Hastings Center’s advisory council.

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  1. Dr. Quinn, Kearns, & Caplan,
    I greatly appreciated your response to Dr. Gorin’s “The Cure for Politicized Pediatric Gender Care.” While the call to have more evidence-based medicine to inform best practices is paramount to positive patient outcomes and longevity of practice, your insight to systematic review is extremely relevant. These studies take years to come to fruition, firstly due to the fact primary studies must precede systematic reviews and that the ethics therein are many. Transgender youth are at a severely increased risk to attempt and complete suicide compared to their cis-gendered counterparts (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7317390/.) What we are seeing occurring in the trans community is very real and happening daily. Placing further restrictions that could limit these individuals access to care would be an additional burden placed in this community.
    While Gorin states that evidence-based care is necessary to ensure “patients aren’t exposed to medically unnecessary risks,” I would challenge this notion. How are these “medically unnecessary risks” any more pressing than the suicide risks this population already faces? It is in fact because of this new standard of care (i.e. gender-affirming care, puberty blockers, etc.) we have seen a drastic drop in trans suicide rates (https://www.eurekalert.org/news-releases/930195.) This is also due to increase access to these services that were otherwise not available or inaccessible by many in rural or underserved communities.
    Gorin states there has been a “dramatic rise in gender dysphoria diagnoses,” and while this is true I would like to point out acceptance of the LGBTQIA+ population has also had a dramatic rise over the past few years (https://news.gallup.com/poll/1651/Gay-Lesbian-Rights.aspx.) Can we say for certain why this rise is? No. But what we are seeing is an increase in visibility of a community that has been largely othered. This is being seen and modeled to younger generations and to send additional messages that decisions about their bodies will be determined by a panel of medical professionals will undo much progress made.
    We need to meet the needs presented by this population now. Gender clinics are under “significant stress,” but while this community continues to face barriers and challenges accessing necessary care, the response to these needs should not immediately be additional obstacles. Funneling time, resources, and attention back to the major medical institutes is simply another way to further politicize gender care.
    Brandon Saenz, RN, Psychiatric Mental Health Doctoral NP Candidate

  2. Thank you for this exploration of a vital concern for scientific and ethical inquiry.

    You do not, however, discuss – likely because it is not your immediate concern responding to the earlier piece – current chaos with informed consent in pediatric gender care. THIS MUST BE DISCUSSED.

    In my comments replying to the earlier piece I identify features of that chaos:

    – entry of online-only or online-mostly gender care groups that do not – and perhaps, structurally can not – maintain the highest standards for informed consent
    – other gender care groups that do not maintain these highest standards and that appear, rather, to skirt the standards intentionally
    – pressures to produce revenue from gender care
    – social media and other cultural ‘influencers’ using gender dysphoria for various ideologically-driven purposes, revenue-producing purposes
    – authoritative groups – e.g. WPATH – that appear to discuss gender care in ideologically-driven frameworks (that are not explicitly disclosed, with limitations and biases announced, as is required by scientific, professional ethical and moral integrity)
    – failed appreciation for legal and moral duties in loco parentis

    Writers of both pieces – and others – are asked – URGENTLY – to produce a third piece responding to the chaos with informed consent in pediatric gender care.

    Respectfully,

    PS: our Virginia research on transgender health and well being – among landmarks of early quantitative and qualitative research – purposefully included a rural cohort. So, we must take seriously your comment that rural cohorts are rarely included. THAT is true.
    What else is true? : dear readers, and others, if YOUR university, research center or group, foundation-funded work, IS NOT purposefully including rural cohorts YOU are participating in the great social in-justice of rural health disparities and inequities. Using the lack of rural cohorts in research to make a point – without ensuring more rural research – is disingenuous, ain’t it?

  3. Let me see if I understand this article:
    Point 1: A broad review of evidence regarding pediatric gender medicine isn’t going to do any good because so many of the studies are low-quality, not representative of diverse patients, not RCT’s, mostly observational, etc.

    Point 2: But we know, for SURE, that this stuff works! and if trans kids don’t get hormones and surgeries and puberty blockers they’re going to die.

    In New York State, a minor can’t even consent to get a tattoo. But we shouldn’t do a systematic review of evidence about cutting the healthy breasts off teen girls or giving boys medicines that may forever impair their growth, sexual function, or bone density, because somehow we just know it works, despite admitting that the vast majority of studies are low quality. Even the putative suicide reduction studies are often based on online surveys, and may not account for other mental health interventions that the kids are receiving at the same time as gender medicine.

    To me, Caplan, et al, have just proven Gorin’s point: that since many of the studies are low-quality we need to review them before giving kids powerful drugs and surgeries. In what other area of medicine would this be remotely controversial, were it not for the fact that gender medicine is politicized, as shown by this very article?

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