welcome to fetaldex.org
Purpose: This website seeks to raise ethical concerns about the prenatal use of dexamethasone (a Class C steroid) when it is given to pregnant women to attempt to prevent female fetuses from developing genitals that are atypical, and when it is given by clinicians to also prevent females from being psychologically “masculnized,” i.e., tomboyish, more aggressive than average girls, and ultimately lesbian of bisexual in sexual orientation.
An excellent plain-language introduction to this topic is provided via this article at Time magazine.
Our primary concern is that women given this drug may have been experimented upon without their knowledge and without human research protections. It appears that some researchers, notably Dr. Maria New’s team, may have treated and still be treating pregnant women with prenatal dex, off-label and outside any clinical trials or human subjects research protections, even while they are concerned enough to be studying the mothers and children after the birth. In other words, it appears these clinician-researchers consider the off-label use of this drug questionable enough to get grants to study its long-term safety, yet not questionable enough to manage as formal clinical trials during pregnancy when they are actively putting the mothers and their children at risk.
This is not our only concern. You can read about our concerns one-by-one by going to our “issues page.
What the medical community as a whole says: Contrary to Dr. New’s advertising of this treatment as “safe for mother and child,” the medical community has repeatedly come to the consensus that this use of prenatal dex remains risky enough that it should only be attempted within IRB-approved clinical trials. That consensus has recently been reiterated, indeed even more strongly. Yet, as we have documented, it appears hundreds if not many thousands of women have been subjected to this experimental use without giving informed consent to experimentation. This may still be going on today, although it appears that, since we started our efforts, most clinicians now know about the experimental nature of this treatment.
The worries about prenatal dex for CAH: According to a recent article in Endo Daily reporting on the Task Force that produced the latest consensus to label prenatal dex experimental, dexamethasone “crosses the placental barrier and may affect the fetal hypothalamic-pituitary-adrenal axis. Prenatal use of the drug is associated [with] low birth weight, central nervous system effects, cleft palate, liver enlargement, a decrease in fetal beta cells and other negative outcomes in animals. The human literature suggests that prenatal dexamethasone carries a 1.7 odds ratio for orofacial clefts and decreases birth weight by about 0.5 kg.”
The Endo Daily article continues: “The task force [reviewing the evidence about the risks and benefits of prenatal dex for CAH] was hampered by the lack of high-quality data. Of 1,083 studies originally identified [by the task force], only four met the quality criteria agreed upon by the sponsoring groups. [...] Side effects included stillbirth (odds ratio 1.27), malformation (odds ratio 1.51), maternal edema (odds ratio 1.83) and maternal striae (odds ratio 1.62). Outcome data on prenatal treatment are suspect. Most are derived from questionnaires, not from physical examination of the offspring. And because dexamethasone prenatal treatment is relatively new, no offspring have yet reached middle age where many problems can be expected to present.”
Which fetuses are targeted: Prenatal dexamethasone is recommended by some physicians to pregnant women who are believed to be “at risk” for having a female fetus with 21-Hydroxylase Deficiency Congenital Adrenal Hyperplasia (CAH). In CAH, the adrenal glands produce abnormally high levels of androgens, which are sometimes called “masculinizing” hormones. This form of CAH can result in a girl being born with genitals that look in-between the male and female types (e.g., she may have a large clitoris) and with a confluence of her urethra and vagina (a urogenital sinus). Studies have also indicated that these girls’ brains are “masculinized” in the womb, meaning that, on average, they are also more likely than other girls to be tomboyish and to grow up to be lesbian in sexual orientation.
The goals of the prenatal dexamethasone treatment: Importantly, CAH is a serious endocrine disease (a hormone imbalance) which prenatal dexamethasone does absolutely nothing to cure. A child with CAH who was treated with prenatal dexamethasone is still born with CAH and must have lifelong endocrine management to be safe. So why is prenatal dexamethasone used? Most clinicians who administer it are seeking to prevent ambiguous genitalia. Read more about that here. Some clinicians appear to also administer it in the hopes of preventing lesbianism and gender nonconformity. Read about that here.
Actions have we taken to follow up on our concerns: You can read the various letters of concern and formal complaints at our correspondence page. That page also shows responses to letters of concern and complaints. You can read findings of our FOIA requests at our FOIA page. (We are still awaiting results of 4 additional FOIA requests.) At the page on disseminating the truth about standards of care, you can read about what we’ve done to try to make sure health care professionals know the status of prenatal dex for CAH.
We hope we are wrong about experimentation on hundreds if not thousands of pregnant women without their knowledge. But we started making noise and formal complaints about this in February of 2010, and still no one has shown us proof that we are wrong, nor has the major institution involved, Weill Medical College at Cornell University, told us to shut up, as we would expect them to if we were wrong.
If you want to learn more, I recommend you go to the FAQ page or the issues page.