Fetal Cosmetology
Human Bodies

Hilde Lindemann, Ellen K. Feder, and Alice Dreger

, 02/08/2010

Fetal Cosmetology

(Human Bodies) Permanent link

There’s a common misperception that, now that the Johns Hopkins psychologist John Money is gone, so are all the ethical problems with the way people with genital anomalies are treated. Not so.

You may recall that Money lied about the life of his patient David Reimer (known as “John/Joan”), who as a baby had been sex-changed on Money’s recommendation following a circumcision accident in which a physician burned off most of Reimer’s penis. Despite David’s actual later reversion to a male gender identity, Money used a false version of Reimer’s story to convince clinicians that children with atypical sex could be made into “acceptable” versions of girls or boys if you just did surgery early, did hormone treatments as necessary, and avoided having the patients understand much beyond the party line about their genders.

These days, we’ve got a lot of questions about what’s been going on with the use of prenatal dexamethasone to try to prevent children from being born with atypical genitalia.

Some clinicians prescribe this steroid off-label for pregnant women suspected of carrying a 46,XX (female) fetus with 21-hydroxylase deficiency, a form of congenital adrenal hyperplasia (CAH). Such girls make extra androgens, and in the womb this may cause their genitalia to form more like something in between female and male. The goal of the prenatal “dex” treatment is to prevent that virilization.

CAH is a serious medical condition that needs to be treated throughout the affected person’s life. Prenatal dex, however, does nothing to prevent or treat the CAH. Instead, it is used to try to engineer normal-looking genitalia. The justification for offering this drug is that fully functional but atypical genitalia represent a psychosocial problem requiring normalizing cosmetic surgeries in childhood. Yet there is actually very little evidence that a girl is at risk for increased psychosocial harm if she has atypical genitalia and is allowed to grow up with her genitals intact. In spite of this and a major consensus among physicians in 2006 calling for fewer cosmetic surgeries on atypical genitalia, many surgeons still hasten to put such girls under the knife.

More than a few prominent clinicians have serious reservations about prenatal dex, and have had them for years. There is evidence from animal studies that prenatal dex treatment leads to neurotoxicity – brain cell death. Studies of children exposed to prenatal dexamethasone in utero also indicate plenty of reason for concern. Evidence from human studies indicates an increased risk to the children of problems with working memory, speech processing, and anxiety.

Because the steroid is given before the sex of the fetus can be known, and because only some of the fetuses will have CAH, 87.5 percent of the pregnant women started on dexamethasone for this use are not even carrying an affected child. (In fact, half of the fetuses started on the treatment will be males.) They will not receive the treatment past the point at which their fetuses’ sex and CAH-status are accurately diagnosed; nonetheless, for a period of fetal development (including, obviously, brain development), almost 90 percent of those fetuses are being given a steroid that might harm them and can do them no good whatsoever.

Dex is a nontrivial hardship for the mother, too, as Monica Casper reported in her analysis of the treatment: “Pregnant women treated with dexamethasone report excessive weight gain, mood fluctuations, striae or streaking of the skin, acne, and edema. The American Academy of Pediatrics describes maternal side effects as ‘serious and long-lasting’.”

Given these questions about the risk-to-benefit ratio, Walter Miller, distinguished professor of pediatrics and chief of endocrinology of University of California, San Francisco, has concluded that “this experimental treatment is not warranted and should not be pursued, even in prospective clinical trials.”

Proponents of prenatal dex, however, seem to promote this off-label treatment as safe and effective – indeed even necessary – to “at risk” women. Much of the promotion has occurred via the CARES Foundation, the leading support group for parents of children with CAH. In 2003, an article appearing in the CARES newsletter written by a representative of Weill Medical School of Cornell declared, “The benefits [of prenatal dex] to families of classically affected girls cannot be underestimated. We hope that the availability of this treatment will be shared with all families.” The representative of Weill-Cornell further claimed to the CARES membership that prenatal dex had shown “no adverse developmental consequences” (in spite of a study out of Cornell Medical College a few years earlier showing adverse developmental consequences) and concluded that prenatal dex “appears to be safe for mother and child.”

Dr. Maria New, formerly of Weill-Cornell and now of Mount Sinai School of Medicine and Florida International University, continues to be the leading proponent for giving prenatal dex to women at risk for CAH. New says she has treated over 600 such pregnant women. Since this is an off-label use, it may be technically classified as a “clinical innovation” undertaken by a physician rather than a clinical trial undertaken by a researcher. But New and her colleagues have been obtaining grants for and publishing follow-up studies of these women and children.

Despite our best efforts, we cannot determine whether prenatal dex has been administered in the U.S. as part of clinical trials for preventing virilization. If it has, at least we could be assured the pregnant women exposed to this have had IRBs overseeing the projects and we could assume good science will come out of the experiments performed on them. It would be good to know a lot more about what’s happened to these mothers and their babies.

But if prenatal dex has been pursued in clinical trials, we have to say we can’t imagine what on earth the IRBs were thinking in approving them. This looks to us like just the sort of ethically problematic experiment IRBs were designed to prevent, since there is no clear medical benefit and there may be substantial risks including to unaffected women and children. To us, and to many of our colleagues, this sure looks like another case of doctors assuring parents, when their children are at risk for sex atypicality, that they don’t need to worry their pretty little heads about the science and the safety issues. Just let the doctor take care of it all.


Posted by Susan Gilbert at 02/08/2010 04:39:54 PM | 

I had to take decadron to decrease edema in my head, from recurrance of brain tumor. I took it for 4months I came off of the drug slowly. My hands shook so bad and I could'nt hardley walk up stairs and I'am still having difficulty with that.Extreme mood swings,crying,no sleep even taking anxiety pills did'nt help.Oh well hope that my legs and feet and muscle get back to normal again. It did however relieve my swelling in the brain.
Posted by: jarichon@gmail.com ( Email | Visit ) at 11/24/2010 3:52 AM

One time I read in NYT that some dr (Miller) believes that prenatal dex is being used to alleviate "parental anxiety," rather than the child's condition. Other doctors and researchers have criticized New for introducing gender behavior into the medical prognosis
When I finish read the article i thought that sometimes we don't have strict rules to obey
Yea.Ethic dilema isn't easy
Best Regard
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