Dan Savage wrote on the SLOG web-site…
Doctor Treating Pregnant Women With Experimental Drug To Prevent Lesbianism
Posted by Dan Savage on Wed, Jun 30, 2010
That's not fair, as Hanna Rosin at Slate will shortly point out. Pediatric endocrinologist Maria New—of the Mount Sinai School of Medicine and Florida International University—isn't just trying to prevent lesbianism by treating pregnant women with an experimental hormone. She's also trying to prevent the births of girls who display an "abnormal" disinterest in babies, don't want to play with girls' toys or become mothers, and whose "career preferences" are deemed too "masculine." Unbelievable:
The treatment of pregnant women with the hormone dexamethasone is discussed at length in a Time article which also raised the question of bioethics…
A Prenatal Treatment Raises Questions of Medical EthicsA little background on research, back in the 1930’s a study was done on blacks who had syphilis without their knowledge. The study was to determine the long-term effects of syphilis. Over the years, they were never told that they had syphilis and when penicillin was developed to fight syphilis, they were never given penicillin and as result, many died of the disease. When the study was discovered, there was a tremendous outcry and a commission was convened to study was to prevent that from happening again. The commission issued the Belmont Report and from the report, federal regulations were written. These regulation apply to all federally funded research and they establish ethical guidelines for using human subjects. The research that we are doing, required that we take the on-line NIH ethics training and go before an IRB for approval of the survey.
Time
By Catherine Elton
Jun. 18, 2010
When Marisa Langford found out she was pregnant again, she called Dr. Maria New, a total stranger, before calling her own mother. New, a prominent pediatric endocrinologist and researcher at Mount Sinai Medical Center in New York City, is one of the world's foremost experts in congenital adrenal hyperplasia, or CAH, a group of inherited disorders of the adrenal gland.
Langford and her husband learned they were silent carriers of the genetic variation that causes CAH when their son was diagnosed with the condition after birth. Their son — like the 1 in 16,000 babies born with CAH each year in the U.S. — faces a lifetime of taking powerful steroid medications to compensate for his faulty adrenal glands. When Langford contacted New about her second pregnancy, New, who was not Langford's regular doctor, called a local pediatric endocrinologist. That doctor prescribed Langford a commonly used medication for CAH. "Dr. New told me I had to start taking dexamethasone immediately," says Langford, 30, who lives in Tampa. "We felt very confident in someone of her stature and that what she was telling us was the right thing to do."
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Langford says also that neither New nor her prescribing physician mentioned that prenatal dexamethasone treatment is an off-label use of the drug (an application for which it was not specifically approved by the government) or that the medical community is sharply divided over whether dexamethasone should be used during pregnancy at all.
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It is these very benefits [preventing tomboyish behavior], however, that lead some researchers to question what, exactly, doctors are treating — and whether it needs to be treated at all. 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 — in two recent presentations on CAH at medical conferences, New offered medical outcome data on prenatal dex alongside data on typical gender behavior. "Maybe this gives clinicians the idea that the treatment goal is normalizing behavior. To say you want a girl to be less masculine is not a reasonable goal of clinical care," says David E. Sandberg, a University of Michigan pediatric psychologist who treats and conducts research on children with CAH.
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It [off label drug use] also enables doctors to do human research without gaining proper approval. All participants in human medical research are, by law, entitled to the protective oversight of an institutional review board (IRB), a committee that safeguards the interests of research volunteers and ensures they have been fully informed about the potential risks and benefits of an experimental treatment. If doctors are simply treating a patient with an off-label drug, they are not required to obtain written informed consent from patients. But if doctors give treatment with the intent to gain knowledge, they are technically doing research, which must receive IRB approval.
The question is, was Dr. New’s research federally funded? And did she collect data from her patients? I do know that she wrote at least two papers on CAH and those studies were federally funded. Alice Dreger, Ellen K. Feder, Anne Tamar-Mattis, in a discussion on a bioethics forum about the treatment of CAH with dexamethasone write,
Two weeks ago, Time magazine reported on our ongoing efforts to protect the rights of pregnant women offered dexamethasone, a risky Class C steroid aimed at female fetuses that may have a form of congenital adrenal hyperplasia (CAH). It appears many women and children exposed to dexamethasone through this off-label use are not being enrolled in controlled clinical trials with IRB oversight, in spite of a persistent consensus among experts that this is the only way this treatment should be happening.
We have learned that, this August, the Journal of Clinical Endocrinology & Metabolism will publish an expert consensus again stating this use of prenatal dexamethasone should only happen via IRB-approved clinical trials through research centers large enough to obtain meaningful data. An announcement of the consensus came at the Endocrine Society’s meeting in San Diego last week (and an earlier version is available here).
This consensus has been endorsed by the American Academy of Pediatrics, the Lawson Wilkins Pediatric Endocrine Society, the European Society for Paediatric Endocrinology, the European Society of Endocrinology, the Society of Pediatric Urology, the Androgen Excess and PCOS Society, and the CARES Foundation. It was reached after review of the existing literature and consultation with researchers indicated significant cause for concern, including the fact that most of the children treated prenatally have been absent from follow-up studies.
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They specifically point to reasons to believe that it is prenatal androgens that have an impact on the development of sexual orientation. The authors write, "Most women were heterosexual, but the rates of bisexual and homosexual orientation were increased above controls . . . and correlated with the degree of prenatal androgenization.”
They go on to suggest that the work might offer some insight into the influence of prenatal hormones on the development of sexual orientation in general. “That this may apply also to sexual orientation in at least a subgroup of women is suggested by the fact that earlier research has repeatedly shown that about one-third of homosexual women have (modestly) increased levels of androgens.” They “conclude that the findings support a sexual-differentiation perspective involving prenatal androgens on the development of sexual orientation.”
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While everyone has been busy watching geneticists at the frontier of the brave new world, none of us seem to have noticed what some pediatricians are up to. Perhaps it is because so many people are fascinated by the idea of a “gay gene” that prenatal “lesbian hormones” have slipped past public scrutiny. In any case, we think Nimkarn and New’s “paradigm for prenatal diagnosis and treatment” suggests a reason why activists for gay and lesbian rights should be wary of believing that claims for the innateness of homosexuality will lead to liberation. Evidence that homosexual orientation is inborn could, instead, very well lead to new means of pathologization and prevention, as it seems to be in the case we’ve been tracking.
Needless to say, we do not think it reasonable or just to use medicine to try to prevent homosexual and bisexual orientations. Nor do we think it reasonable to use medicine to prevent uppity women, like the sort who might raise just these kinds of alarms. Consider that our declaration of our conflict of interest.
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