A new paper just published in the Journal of Bioethical Inquiry uses extensive Freedom of Information Act findings to detail troubling off-label prescription in the US on pregnant women to intentionally engineer the development of their fetuses for sex normalization purposes.
The pregnant women targeted are at risk for having a child born with the condition congenital adrenal hyperplasia (CAH), which can result in female fetuses being born with intersex or more male-typical genitals and brains. Women genetically identified as being at risk are given dexamethasone, a synthetic steroid, off-label starting as early as week five of the first trimester to try to “normalize” the development of those fetuses, which are female and CAH-affected. Because the drug must be administered before doctors can know if the fetus is female or CAH-affected, only one in eight of those exposed are the target type of fetus.
The off-label intervention does not prevent CAH; it aims only at sex normalization. Like Diethylstilbestrol (DES) -- which is now known to have caused major fertility problems and fatal cancers among those exposed in utero -- dexamethasone is a synthetic steroid. Dexamethasone is known -- and in this case intended -- to cross the placental barrier and change fetal development. Experts estimate the glucocorticoid dose reaching the fetus is 60 to 100 times what the body would normally experience.
What are the ethical problems with this? Authors Alice Dreger, of Northwestern University Feinberg School of Medicine, Ellen Feder, of American University, and Anne Tamar-Mattis, of Advocates for Informed Choice have drawn up a long list. These include: high risk treatment even though nearly 90% of the foetuses exposed cannot benefit; informing women that the treatment is safe when there is no scientific evidence; and evidence from Sweden that there are serious risks.
But Dreger and her co-authors also have bigger fish to fry. They suggest that there has been “a major failure of the layered systems designed to protect subjects of research, especially pregnant women and their fetuses” -- not just with Dexamethasone.
“Yet rather than suggesting that the case of prenatal dexamethasone for CAH should be understood as one of the “big” stories of the history of medicine (like DES), we are suggesting something more disturbing: that this case appears to be representative of problems endemic in modern medicine, problems that threaten the health, lives, and rights of patients who continue to become unwitting subjects of (problematic) medical experimentation. Because so many systems of protection appear to have failed these women and children, we fear that prenatal dexamethasone for CAH is a canary in the modern medical mine.”
Apparently complaints to the Office of Human Research Protections (OHRP) have dropped steeply in the past few years. This, the authors suggest, raises questions about the agency’s commitment to oversight and investigation. ~ Northwestern University press release, Aug 2