issue: informed consent


A major concern we’ve had with the use of prenatal dexamethasone for CAH is whether the pregnant women given it consented to the treatment after being informed of the status of the treatment and informed of what is known and not known about the risks.

In other words, did they give fully informed consent? We hope so, but we are afraid they did not.

When Dr. Maria New was asked by Dr. Eric Vilain of UCLA at a conference in Miami, in January 2010, what kind of informed consent she was obtaining from the pregnant women to whom she is recommending this treatment (one would like to know, what exactly is she telling these women about the necessity, risk, harm, and benefits, and is she explaining that this is experimental and off-label?), she refused to answer Dr. Vilain’s question, indicating she thought his question about informed consent was out of line. We do not believe questions about informed consent are ever out of line.

According to corroborated reports, Dr. New did assure attendees in Miami that, as a mother, she would never harm other mothers and children, and she assured her audience that this treatment was not accidentally making treated boys gay, an outcome she seemed to imply would be a strike against using the treatment.

What were the women given this drug while pregnant told?

Were these pregnant women informed that this was an off-label (not FDA-approved) use of a category C pregnancy drug that had already been shown in animal studies to cause harm to fetuses, and had not been shown to be safe in humans? (It probably should be listed as a category D drug.)

Were these women informed that again and again specialist clinicians said this use was experimental and should only be conducted (if at all) in formal clinical trials with the approval of Institutional Review Boards (ethics committees) to make sure the mothers’ rights were protected? Were they told the major pediatric societies that had weighed in on this--including the American Academy of Pediatrics (AAP), the Lawson Wilson Pediatric Endocrine Society (LWPES), and the European Society for Pediatric Endocrinology (ESPE)--had said this drug use should be treated as experimental, with all the necessary precautions experimentation requires, and never changed their positions on that? (They actually reiterated the positions recently.)

AAP, 2001: “the Academy Committee unanimously agrees that prenatal glucocorticoid therapy for CAH should be confined to centers doing controlled prospective, long-term studies. The memory of the tragedies associated with prenatal use of DES (diethylstilbestrol) and thalidomide demands no less.”

LWPES/ESPE, 2002: “We believe that this specialized and demanding therapy should be undertaken by designated teams using nationally or multinationally approved protocols, subject to institutional review boards or ethics committees in recognized centers. Written informed consent must be obtained after the balanced review of the risks and benefits of treatment. Families and clinicians should be obliged to undertake prospective follow-up of prenatally treated children whether they have CAH or not.”

Were these women told that, while Dr. New was advertising this treatment against the consensuses of all the relevant medical societies as “safe for mother and child,” she was seeking grants to study whether the children already treated in the womb had, in fact, been harmed by this treatment? In other words, did they know that Dr. New herself was telling them it was “safe for mother and child” even while she was still doing follow-up research to see whether prenatal dex actually harms children exposed to it in the womb?

Or were these women (and their trusting and trusted ob/gyns and endocrinologists) simply sold the claim by Dr. New that it has been “found safe for mother and child”? And were they sold this claim through the CARES Foundation, an organization that perhaps allowed itself to be used as a vehicle for this kind of experimentation? (Mysteriously, in spite of lots of pushing from lots of angles, CARES still has not told parents at their website about the renewed major medical consensus that prenatal dex for CAH should be treated as experimental. Yet their own medical and scientific advisory board members authored this latest consensus. Is CARES more worried about offending Dr. New with this news than protecting families with CAH? We hope not.)

We still have not seen any evidence that the six hundred or more pregnant women “treated” “personally” by Dr. New and her associates were informed in a way that protected their rights. Reporting in Time magazine by Catherine Elton suggests that these women were, in fact, not informed. Weill-Cornell, where most of these treatments appear to have occurred, has produced no evidence that informed consent occurred. If there was informed consent, why won’t New and Weill-Cornell produce the evidence?

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(Written by Alice Dreger; copyright Alice Dreger, 2010)