Bioethicists Alice Dreger and Ellen Feder have raised a stir with scathing accusations against two doctors — a pediatric urologist and a pediatric endocrinologist — for what they say are serious violations of human research protocols.
Most of the ire has been directed towards Dix Poppas, a surgeon at Weill Cornell Medical School in New York, who treats young girls with ambiguous genitalia, often as a result of a disorder of the adrenal gland known as congenital adrenal hyperplasia (CAH). Poppas’ technique, which he says preserves a higher degree of nerve function, removes tissue from the shaft of the clitoris in order to reduce it in size. The medical necessity of clitoroplasty has come under scrutiny in the past decade, and many decry it as a form of genital mutilation, but it is still an accepted standard of care.
The other aspect of the controversy has centered around Poppas’ follow-up exam procedure, in which the child’s post-surgery sensitivity is measured by using a vibrator on the thigh, labia and clitoris. Even putting aside the question of the psychological effect on the patient, Dreger says that Poppas’ decision to publish a paper on this new surgical technique was experimental research that, she alleges, was not approved by an institutional review board. (Poppas and the Cornell IRB have not responded to Nature Medicine’s requests for comment.)
In a letter sent to the FDA, HHS and other institutions, Dreger and Feder have also called for an investigation into recent work by Maria New, a pediatric endocrinologist at Mt. Sinai Medical Center in New York, and a former colleague of Poppas’ at Weill Cornell. New has been studying CAH for over 40 years, and she has championed the practice of prenatal administration of dexamethasone, an anti-inflammatory drug, as a possible means of preventing the development of ambiguous genitalia in newborns. Over the last decade, hundreds of pregnant women have been given the drug. In 2008, New registered a follow-up study with the NIH to examine the long-term effects of dexamethasone (which has still not been approved by the FDA for treating CAH) on mothers and children. This, Dreger and Feder’s letter said, made the women who were advised to take dexamethasone unknowing participants in a clinical trial.
“Pregnant women who have been prescribed dexamethasone external to IRB-approved trials may not have provided fully informed consent,” said the letter. “Public descriptions of this drug as safe and effective may have misled some women to believe the use is FDA-approved, when it is not.” Some studies have suggested that prenatal dexamethasone can cause speech and memory problems in the children.
New said that previous IRB reviews of her work at Cornell and Mt. Sinai have found no fault with her methods, and that all of her patients had proper informed consent. Jeffrey Silverstein, head of the Mt. Sinai IRB, says the board has informed the medical school’s dean of the concerns raised by Dreger and Feder, and the IRB is awaiting his reply before proceeding with an investigation.
New told Nature Medicine that her own follow-up study, which has just been submitted for publication, found no instances of birth defects or adverse consequences for both the children and mothers who were treated with prenatal dexamethasone. New added that follow-up studies conducted in France corroborate the safety and efficacy of the treatment. And her work, she says, helps prevent the kind of surgeries that Dreger and Feder are objecting to.
“I can tell you, the parents are very, very happy not to have to subject their child to that procedure,” New says.
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