Ellen K. Feder

The OHRP and SUPPORT - Another view

A group of physicians, bioethicists, and scholars in allied fields agrees with the Office for Human Research Protections about the informed-consent documents in SUPPORT.

IMPERATIVES OF NORMALITY From “Intersex” to “Disorders of Sex Development”

In May 2006 the U.S. and European endocrinological societies published a consensus statement announcing a significant change in nomenclature. No longer would nineteenth-century variations on the term hermaphrodite, or the more newly introduced term intersex, be used in a medical context to describe “congenital conditions in which development of chromosomal, gonadal, or anatomical sex is atypical”; instead the preferred term henceforth would be disorders of sex development (DSDs). The announcement met with significant controversy, which I here examine in terms of the historical convergence of the treatment of homosexuality and intersex. The contemporary association of homosexuality with intersex risks obscuring genuine medical concerns unique to the treatment of intersex conditions and the consequences for affected individuals. At the same time, we must reckon with the ways that the complex and persistent identification of homosexuality with intersex has shaped the motivations both for the prevailing standard of care that has been so harmful and for the organized resistance to these practices in the intersex movement. Michel Foucault’s understanding of the power of “normalization” can help us make sense of the history of medicalization and its pernicious effects, but in addition can allow those with intersex conditions and their allies to understand the positive possibilities that the change from intersex to DSDs can bring.

Prenatal Dexamethasone for Congenital Adrenal Hyperplasia An Ethics Canary in the Modern Medical Mine

Following extensive examination of published and unpublished materials, we provide a history of the use of dexamethasone in pregnant women at risk of carrying a female fetus affected by congenital adrenal hyperplasia (CAH). This intervention has been aimed at preventing development of ambiguous genitalia, the urogenital sinus, tomboyism, and lesbianism. We map out ethical problems in this history, including: misleading promotion to physicians and CAH-affected families; de facto experimentation without the necessary protections of approved research; troubling parallels to the history of prenatal use of diethylstilbestrol (DES); and the use of medicine and public monies to attempt prevention of benign behavioral sex variations. Critical attention is directed at recent investigations by the U.S. Food and Drug Administration (FDA) and Office of Human Research Protections (OHRP); we argue that the weak and unsupported conclusions of these investigations indicate major gaps in the systems meant to protect subjects of high-risk medical research.

Normalizing Medicine: Between “Intersexuals” and Individuals with “Disorders of Sex Development”

In this paper, I apply Michel Foucault’s analysis of normalization to the 2006 announcement by the US and European Endocrinological Societies that variations on the term “hermaphrodite” and “intersex” would be replaced by the term, “Disorders of Sex Development” or DSD. I argue that the change should be understood as normalizing in a positive sense; rather than fighting for the demedicalization of conditions that have significant consequences for individuals’ health, this change can promote the transformation of the conceptualization of intersex conditions from “disorders like no other” to “disorders like many others.” Understood in these terms, I conclude, medical attention to those with atypical anatomies should be recast from a preoccupation with “normal appearance” to the concern with human flourishing that is the proper object of medical attention.

Misrepresentation of Evidence Favoring Early Normalizing Surgery for Atypical Sex Anatomies

Questions concerning the timing of normalizing surgery in cases of atypical genitalia have been contentious ones, with pediatric specialists (and often parents) preferring early surgery, and critics arguing for deferral of decisions. Early surgery is intended to secure children the benefits of “normal appearance” and has been assumed important for a child’s psychosocial development. There is only anecdotal evidence on the question of the timing of surgery and this evidence has been employed both to support and to challenge the assumption of the benefits of early surgery.

More Rhetoric Than Argument

One of two commentaries on “Normalizing Atypical Genitalia: How a Heated Debate Went Astray,” by Josephine Johnston, from the November-December 2012 issue.

Beyond Good Intentions

Ethical questions in medicine tend to emphasize the intentions of researchers and physicians. Questions concerning harm have more often been addressed in terms of legal culpability. This commentary proposes that normalizing interventions for atypical sex anatomies, both historical and ongoing, be recognized as a kind of medical error, and that attention be focused not simply on prevention, but on repair.

From Principles to Process in Disorders of Sex Development Care

the DSD consensus [2] – that makes possible such good decision-making remains elusive. Further, providers caring for patients with these rare conditions, at least in North America, are not contributing to patient registries that collect the evidence needed for meaningful informed consent. They do not engage qualified psychosocial clinical professionals who can help families manage the ongoing challenges of life outside the hospital. They do not have systems in which parents’ distress, confusion, and need for extensive education are addressed, slowly and deliberately and repetitively enough to achieve true shared decision-making regarding surgeries, hormone treatments, and follow-up care. The authors have opted to ignore the existing DSD ethics literature in an effort to arrive at principles putatively unburdened by previous ethical engagement. They used a dialogue between an ethicist and two clinicians to articulate their proposed principles. We find this strange; it is hard to imagine a surgery article that explicitly ignores the surgical literature. And yet the authors unwittingly suggest a model of how parents might be similarly engaged, slowly and deliberately, in dialogue with a dedicated DSD team member – perhaps a specialized psychologist, genetic counselor, or DSD-knowledgeable clinical ethicist – to arrive organically at a similar understanding of what really matters: the long-term well-being In the article ‘Ethical principles for the management of infants with disorders of sex development’, Gillam, Hewitt, and Warne articulate six principles for the care of children with disorders of sex development (DSD) [1] . These principles strike us as good and reasonable, and indeed those with which many clinicians are already concerned, as is evident from the 2006 consensus of the Lawson Wilkins Pediatric Endocrine Society and the European Society for Paediatric Endocrinology [2] . Indeed, these are essentially the principles on which ethicists and patient advocates have been insisting for years [3, 4] . This article seems largely to be responding to the major DSD debate of a decade ago, namely over genital surgeries in infancy. Many have now recognized that the central challenge in DSD care is not centered on the surgeries per se, but rather finding a way to help families (and healthcare professionals) overcome the shame and anxious secrecy that may shape minds and force hands in ways that ultimately harm all involved. The challenge now is not articulation of principles; the challenge is creating a process for implementation. The authors appear to assume ‘that conditions for good ethical decision-making [...] are already in place’. And yet the environment for shared decision making [5] – the highly integrated, interdisciplinary healthcare team that includes behavioral health services called for in Received: May 31, 2010 Accepted: June 8, 2010 Published online: December 15, 2010 HORMONE RESEARCH IN PÆDIATRICS