Modern medical practice operates on the principle of informed consent. Physicians have an ethical responsibility to explain the risks and benefits of any treatment that may have serious side effects, and explain any alternatives to the treatment, to ensure that the patient understands and consents to the path chosen. Informed consent flows directly from respect for the dignity and authority of the patient.

In many or most cases, the consent discussion is straightforward. A particular surgical procedure may be more effective than the nonsurgical alternative but will create its own risks. A particular drug may work better than another but may generate uncomfortable side effects. Although the ultimate decision always rests with the patient, the physician’s responsibility is to ensure the patient has a full picture of what may come.

The picture becomes substantially more complex when the patient suffers from gender dysphoria and if the contemplated medical intervention is so-called gender-affirming treatment (GAT). GAT could involve administering drugs called GnRH agonists to block normal puberty; administering cross-sex hormones to diminish the appearance of the biological sex and create the appearance of the desired gender; and surgically removing sex-specific body parts and perhaps fashioning imitations of others.

Because this area of medicine is so new and indeed experimental, medical providers disagree about appropriate interventions and certainly about the paradigm for obtaining informed consent from patients (or from the parents of minor patients). The consequences of GAT extend far beyond physical outcomes. They encompass mental health, family relationships, intimate relationships, and overall ability to function in society over the long term.

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Too many GAT practitioners either do not recognize this reality or consider themselves bound to inform the patient only about physical consequences, and only those related to their particular area of practice. Endocrinologists will describe the effects of hormone treatments, surgeons will discuss how the body will look and function after the surgery, and so on. But any informed-consent model that focuses only on such physical outcomes will fail to address the full humanity and well-being of the patient.

Thoughtful analysis of these thorny issues comes from Dr. Stephen B. Levine of the Center for Marital and Sexual Health at Case Western Reserve University School of Medicine. Relying on his extensive experience treating patients with gender dysphoria, Levine wades into the medical/psychological/political morass that transgender treatment has become. His two academic papers, “Informed Consent for Transgendered Patients” and “Ethical Concerns About Emerging Treatment Paradigms for Gender Dysphoria,” are must reads for professionals and policymakers in this area.

Levine illuminates the folly of assuming that every gender-dysphoric individual must be automatically affirmed in his desire to live as the opposite sex and be offered GAT upon demand. Doing so, he argues, ignores the breadth of issues that come into play, and ultimately violates the physician’s ancient oath, “First, do no harm.” Further, doing so without laying out the full range of medical, psychological, and social consequences of undergoing GAT violates the physician’s ethical obligation to obtain truly informed consent.

In these articles, Levine traces the history of the transgender phenomenon: “Within about thirty years, body/gender incongruence has gone from being viewed as a rare psychiatric disorder, to a serious medical condition (for legal and insurance reasons), . . . to an increasingly common normal variation of gender identity development that, only when patients request, requires medical assistance.”

This normalization of gender dysphoria (GD) has been driven less by scientific research into the causes and treatment of the condition and more by political advocacy focused on the civil rights of a sexual minority. A prominent influence has been the World Professional Association for Transgender Health (WPATH). Contrary to its name, WPATH is not a medical organization: while many of its members are medical or mental-health professionals, there is no such requirement for membership. WPATH is thus unduly influenced by political activists whose agenda is much broader than (and perhaps even in opposition to) the welfare of individual patients. Nevertheless, WPATH’s “Standards of Care” are highly influential in treating sufferers of GD.

As Levine relates, WPATH’s 2011 revision of the Standards of Care introduced a new model governing informed consent for such patients: “patients know best what they need to be happy, generally meaning that patient autonomy is the singular ethical consideration for informed consent.” This new model decreed that even children and adolescents should be trusted to decide what sex they are and should have their wishes honored. WPATH thus de-emphasized the role of the mental-health professional in determining whether and when a patient should be offered GAT, because, as Levine explains, the new model maintains “that there is nothing pathological about any state of gender expression.”

The WPATH model is duplicated in one offered by an advocacy group called Informed Consent for Access to Trans Health (ICATH). Decreeing that “[psychotherapy] is an option, not a requirement, for accessing gender confirming health care,” ICATH embraces the patient-is-always-right paradigm: “Transgender, intersex, and gender-non-conforming people are not required to attend therapy to receive [GAT]. No one should have to go to therapy to prove their true gender, or to get permission to change their bodies.”

According to Levine, the WPATH/ICATH model blends an entirely medical explanation for transgenderism (diagnosing GD as the wrong body rather than a confused mind and “curing” it with GAT) and a political view that focuses on minority rights (patients, even minor patients, are entitled to any treatment that helps them fulfill any gender expression they wish). Under the “rights” paradigm, Levine says, “anyone who hesitates in supporting transition and SRS is a dinosaur committed to an outgrown inherently discriminatory understanding of trans persons and needs to be defeated in court or in the public arena.”

Levine contrasts the WPATH/ICATH approach with what he labels the Developmental Paradigm, which treats gender dysphoria as resulting from the interaction of changing biological, social, psychological, and cultural forces. The Developmental Paradigm recognizes that for these patients, gender identity can be fluid, evolving from youth to old age, and that reliable research shows that the vast majority of trans-identifying children will become comfortable with their sex if allowed to progress through normal puberty and not treated with cross-sex hormones or surgery.

Although Levine believes some patients may reasonably be offered hormones and surgery after psychotherapy (a view with which other psychiatrists disagree), he advocates the Developmental Paradigm to focus on “what can be done to help the patient in the cultural setting of the patient’s life.” This requires psychotherapy to achieve “clarification of the forces that shape the individual’s distress, current needs, and behavior . . . to help the person face past dilemmas and recognize the underlying conflicts that are being avoided through transitioning.” Central to this paradigm is the “do no harm” principle: avoid rushing into any treatment that may not help and in fact may harm the patient.

The bottom line is that what was not long ago recognized as a mental disorder has now been pushed by professional and political activists into the realm of the perfectly normal, and indeed an entitlement. But as Levine notes, “[d]eclaring trans identity as a healthy choice does not make it so.”

A central impediment to ethical certainty in administering GAT to dysphoric patients is that treatment protocols have barreled ahead without scientific evidence about their safety and efficacy. “It seems that even with the reassurance and recommendations from a mental health professional,” Levine writes, “ethical unease cannot be entirely erased because treatment guidelines have preceded the answers to vital relevant questions.”

These questions revolve around much more than the physical effects of the intervention. From a psychological standpoint, what will the patient’s life look like in five, ten, or twenty years? What dynamics will characterize relationships with family members and with old and new friends? Will marriage and intimacy be a realistic goal?

The presence of these considerations makes GAT unique among all medical treatments. No other procedures implicate such a broad range of issues, many of which may not surface until years or even decades after the initial intervention. The question is not whether GAT will transform the patient into someone who can pass for a member of the opposite sex, nor even whether this transformation can take place with tolerable physical complications. Rather, the ultimate question is a holistic one: What kind of life will this patient have?

Viewed in this light, Levine argues, every physician along the GAT chain bears an ethical obligation to broaden the focus beyond his own limited area of immediate responsibility and to consider all the ramifications. A problem with persuading GAT providers to do this, Levine observes, is that hormone-prescribers and surgeons may be insulated from the long-term effects of their work:

Their convictions are reinforced by the fact that they usually work with individuals at the beginning phases of their transitions. These are hope-dominated times followed by the giddy delight of having transitioned socially, hormonally, or surgically. It is a forward-looking process supported by cross-sectional studies showing improvements in patients’ lives. . . .

These physicians may never see what happens after the glow wears off. As Levine notes, “[t]he duration of these improvements remains an unanswered question.”

The clinicians who are more likely to see the long-term fallout are mental-health professionals. But those professionals operate in what has become a hyper-politicized environment that pressures them to affirm everything and question nothing. They thus face a dilemma:

Do we deny our clinical perceptions by assuming that either we must be seeing a highly selective group of limited or impaired individuals or we must be unconsciously transphobic? Or, do we assume that when it comes to aspirational policy statements, it is more important to protect trans people’s civil rights than to accurately reflect their developmental struggles?

Mental-health professionals also wrestle with the unwillingness of many dysphoric patients to consider anything other than immediate GAT. Patients who present for therapy likely have been influenced by the radical culture of transgender activism and thus know and demand exactly what they want—and what they want is not intensive psychotherapy under the Developmental Model. When so many physicians and other professionals are willing to provide GAT on demand, why settle for a clinician who counsels caution, delay, and the hard work of therapy?

For such a patient, the best a psychotherapist can do may be to provide fully “informed” consent. Moreover, Levine argues, all GAT practitioners have an obligation to do so as well—to offer each patient a broad array of considerations that almost certainly have never occurred to the patient or his family.

Levine identifies four key questions that should be asked of any patient to determine how realistic the patient is being:

  1. What benefits do you expect that the consolidation of this identity, gender transition, hormones, or surgery will provide?
  2. What do you understand of the social, educational, vocational, and psychological risks of this identity consolidation and gender role transition?
  3. What do you understand about the common and rare short- and long-term risks of hormone and surgical interventions?
  4. What have you considered the nature of your life will be in ten to twenty years?

Levine then outlines ten detailed questions that any medical professional should consider to determine his own knowledge of the relevant science in treating GD. These questions address assessment of long-term risks and benefits associated with physical, psychological, and social consequences of GAT. Included in these questions is an examination of scientific studies and the practitioner’s own clinical experience.

“It is apparent,” Levine warns, “that the more these questions are refined, the more limited knowledge becomes.” Given multiple studies about medical risks, premature mortality from both medical and psychiatric conditions, and psychiatric pathologies such as substance abuse and depression—studies frequently minimized or ignored by GAT practitioners—Levine concludes that too often “informed consent is based on a great deal of patient and professional hope about the future.”

To counteract this dangerous tendency, Levine argues that a full explanation of the risks and benefits of GAT should be part of any protocol in dealing with gender-dysphoric patients. This explanation should encompass all risks, not just those related to one particular step implemented by a particular practitioner. And he contends that, while the mental-health professional would seem best able to assess the patient’s psychological state, “no physician [in the GAT chain] is exempt from making this determination.”

What risks are practitioners ethically obligated to explain? And if they do so, have they achieved fully informed consent? In tomorrow’s essay I will discuss these issues.