In February, a group of bioethicists made headlines by accusing Dr. Maria New, a leading pediatric endocrinologist, of experimenting on pregnant women and their fetuses without proper ethical oversight. New had been studying the long-term effects of a drug called dexamethasone, which is used as a prenatal treatment for congenital adrenal hyperplasia (CAH), a disease that causes ambiguous genitalia and birth defects in girls. At the request of the bioethicists, New was investigated by the Office of Human Research Protections at the Department of Health and Human Services, and on Sept. 2, the OHRP announced that the charges were unfounded .
New is the latest pediatrician to be dragged into a controversy over how to treat girls with CAH, the leading cause of ambiguous genitalia in girls. In June, a Cornell surgeon who performs reconstructive surgery on young girls with this condition was declared barbaric . Both are targets of ethicist activists who have decided that the correct treatment for ambiguous genitalia is no treatment, and that society should just come to accept these anatomical variations as part of the normal gender continuum. In an attempt to paint New as an enforcer of rigid gender norms, critics have accused her of attempting to “treat” lesbianism in utero, a charge she dismisses as absurd. She says she has never proposed any such thing.
But as Dr. New has pointed out, dex is the best of a range of bad options. An enlarged clitoris is the least serious effect of CAH. In the most severe cases, the vagina and the urethra merge into a single tube and the labia fuse together. These girls will need extensive, painful, and frequently unsuccessful reconstructive surgery to prevent incontinence, chronic infections, and sexual dysfunction. As New points out, the ideology of her critics blinds them to the medical realities of CAH as a treatable disease, whose worst expression can be avoided.
OHRP found that she got all necessary permissions to study prenatal dex prescribed by other doctors. New’s critics asked why prenatal dex didn’t have to be approved by research ethics committees. The answer is simple: Prenatal dex is not experimental. The treatment has been used since the late ‘70s. Medical students learn from standard textbooks that it is the standard of care. Patients with CAH have to take dex or another steroid for life, so it’s really just a question of how early to start. True, prenatal dex is not FDA-approved for CAH. However, there is nothing unusual or unethical about off-label prescribing. By some estimates, more than 50 percent of all prescriptions are technically off-label. The problem here is economics: Dex is an old drug that already has many indications and CAH is a rare disease, so it’s unlikely that any drug company will ever spend millions to get FDA approval.
Dr. New has followed hundreds of children whose mothers took prenatal dex. Her research shows no long-term developmental or medical adverse effects of prenatal dex in patients with CAH or normal patients who were exposed in utero. Maybe the drug has as-yet-undiscovered side effects. However, we know that affected girls who go untreated in utero are at high risk for severe birth defects that will permanently affect their health and quality of life.
Illustration of lesbian symbol by Telnet for Wikimedia Commons.