The report claims that the physicians are using dexamethasone to prevent female babies with a propensity toward lesbianism, bisexuality, tomboyism and intersexuality from being born.

The paper's authors are Alice Dreger, professor of clinical medical humanities and bioethics at Northwestern University Feinberg School of Medicine; Ellen Feder, associate professor of philosophy and religion at American University and Anne Tamar-Mattis, founder and executive director of Advocates for Informed Choice.

CAH is, according to the paper "an endocrinological condition that can cause virilization which is more commonly known as the development of masculine traits in female fetuses." Dexamethasone is, according to the National Institutes of Health National Library of Medicine website, "a corticosteroid, similar to a natural hormone produced by your adrenal glands. It often is used to replace this chemical when your body does not make enough of it."

In the report—which used extensive Freedom of Information Act (FOIA) findings—they assert that "this intervention has been aimed at preventing development of ambiguous genitalia, the urogenital sinus, tomboyism, and lesbianism and intentionally engineering the development of fetuses for sex normalization purposes in CAH-affected female fetuses." According to the American Urological Association Foundation website, a urogenital sinus is "a defect present at birth in which the vagina and urethra open into a common channel, rather than separately."

Since the drug is administered to pregnant women as soon as a pregnancy is confirmed some women, according to the report, are given the drug before a CAH diagnosis or the sex of the baby is determined. If a fetus is diagnosed as a CAH-affected female, dexamethasone continues to be administered throughout the pregnancy, however, if the fetus is shown to be male or not CAH-affected the drug ceased to be given to the patient "because the intention is only to alter the course of development in CAH-affected females."

Tamar-Mattis notes that "prenatal dexamethasone does not cure CAH, and does not treat the underlying endocrine dysfunction. It is only intended to prevent the development of atypical genitals and 'behavioral masculinization'. There is no substitute prenatal treatment, but it is not clear that 'treatment' is justified. A small number of girls born with CAH will require surgery for physiological reasons, and prenatal dexamethasone may prevent some of these cases. But most cases of atypical genitals are simply cosmetic, and there is no evidence that atypical genitals cause harm (although most doctors would do surgery on these cases as well). Lesbianism and tomboyish behavior, of course, are not medical issues. Attempts to prevent these characteristics through prenatal use of risky medication are clearly unethical."

The researchers assert in their report that there are numerous ethical problems surrounding this treatment 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)—(which was given to pregnant women in the 1970s and is now banned because it was shown to cause cancer and fertility problems), and the use of medicine and public monies to attempt prevention of benign behavioral sex variations."

The most prominent promoter of dexamethasone for CAH-affected fetuses is Dr. Maria New of Mount Sinai School of Medicine in New York City. New is a pediatric endocrinologist, professor of pediatrics, endocrinology—adrenal steroid disorder, professor of genetics and genomic sciences and member of the National Academy of Sciences. In her work, according to the report, "she had already publicly taken credit for having 'treated' more than 600 pregnant women with dexamethasone in an attempt to prevent virilization in CAH-affected female fetuses."

During the researchers FOIA request process they uncovered the fact that the U.S. National Institutes of Health (NIH) "funded New to see whether prenatal dexamethasone 'works' to make more CAH-affected girls straight and interested in having babies." New's 1996 grant application states that "the spectrum of behavioral effects of CAH ranges from mild or marked tomboyish behavior of childhood to increased adolescent/adult bisexuality and lesbianism; through full male identification with request for sex reassignment surgery and legal gender change in adolescence or adulthood. In addition, genital abnormalities and often multiple corrective surgeries needed affect social interaction, self image, romantic and sexual life, and fertility. As a consequence, many of these patients, and the majority of women with the salt-losing variant—of CAH, appear to remain childless and single. Preventive prenatal dexamethasone exposure is expected to improve this situation."

New's NIH grant application specifically promised to try to determine "the success of dexamethasone in suppressing behavioral masculinization." According to the findings of the report the researchers determined that there is an absence of Institutional Review Board "oversight for prenatal dexamethasone administration for CAH at Mount Sinai, where New began working in June 2004."

When 32 academicians raised concerns with the U.S. Food and Drug Administration (FDA) and the Office of Human Research Protections (OHRP) they were told in September 2010 that "they could find nothing worth pursuing further. The OHRP decided that the abuse had not occurred since New is not usually the doctor who signs the prescription for prenatal dexamethasone therefore the patients didn't need this kind of protection. The FDA explained that regulations allow a clinician to promote an off-label use—even an experimental use intended to alter fetal development—as 'safe and effective' so long as the clinician doe not simultaneously work for the drug maker or count as an FDA approved investigator of the drug."

Upon further investigation, Dreger, Feder and Tamar-Mattis said that "the material generated by the government's own investigations—along with further scholarly inquiry on our part—appear to actually confirm the concerns we expressed at the outset; suggesting a major failure of the layered systems designed to protect subjects of research, especially pregnant women and their fetuses." They have expressed disappointment in the government agencies that are charged with looking out for the welfare of patients through the oversight and the informed consent processes.

Tamar-Mattis told Windy City Times that the researchers "have also objected to the fact that mothers taking the drug, often on the advice of New's clinic, were apparently not fully informed of the risks and that while they were on the drugs they would be studied to see if it was harmful. New has repeatedly stated publicly that the drug is 'safe and effective' although this claim has not been adequately tested and some studies have shown harm."

When reached for comment, New did not respond to queries about the report or her research practices.

To read the entire report, visit www.springerlink.com/content/m1523l7615744552.