In 2010, AIC filed complaints with the federal Office of Human Research Protection (OHRP) and the FDA regarding research conducted on the prenatal use of dexamethasone to prevent atypical genitals and “masculinized behavior” in girls born with Congenital Adrenal Hyperplasia (CAH). We received notice from the OHRP and the FDA that they have investigated, and it seems they will take no further action.
It is important to ask questions when research is being done on vulnerable human subjects. As an organization advocating on behalf of children with intersex conditions or DSD, AIC has a special responsibility to keep raising questions now. We want to know that research and treatment involving these children meets the legal and ethical standards applied to everyone else.
What do the findings mean?
The OHRP and FDA findings state that 3 studies conducted by Dr. Maria New at Weill Cornell Medical College and one at Mt. Sinai School of Medicine into the effects of prenatal dexamethasone were conducted with the approval of the universities’ Institutional Review Boards (IRBs, or ethics boards), and that the subjects gave informed consent. However, they don’t answer the central questions that AIC and others have been asking all along:
Why did the IRBs decide that use of prenatal dexamethasone was justified?
- How did the IRBs justify the risk of harm to the fetus, given the fact that atypical genitals have not been shown to be harmful?
- How did they determine that it was worth exposing the 7 out of 8 unaffected pregnancies to the risks of prenatal dexamethasone, when they did not stand to benefit in any way from the treatment?
- Did they consider reduction of “tomboyish” behaviors or lesbianism to be a potential benefit of treatment that would justify exposing mothers and fetuses to potential harm?
- Or did the IRBs only approve the follow-up studies, without ever considering the ethics of giving dexamethasone to pregnant women in the first place?
What were the pregnant women who were given dexamethasone told?
- Were they told of the significant safety concerns raised by many in the scientific community?
- Were they told that dexamethasone is not approved by the FDA for this use?
- Were they told that dexamethasone is “safe and effective” even as the doctors making this claim were planning to study their future children to see if the drug was indeed safe?
- Was the “written informed consent” given before they took the drug, or did they just consent to participate in a follow-up study after the fact?
Are Dr. New and her institutions continuing to tell women that dexamethasone is “safe and effective” even after 5 leading medical societies came out with a consensus statement that it should not be considered routine care and should not be given outside of clinical studies?
What is AIC’s position?
AIC believes that children with intersex conditions or DSD – and women who may be pregnant with such children – are vulnerable populations. We know that the doctors involved with this research believe they are helping children with intersex conditions or DSD. However, good intentions and strong convictions have led to too many tragedies in human subjects research – and treatment of intersex conditions and DSD has a special place in this history.
We believe that parents and pregnant women have a right to complete information when they are making medical decisions or when they or their children are targeted for research. However, many women have told us that they took dexamethasone and were not told of the risks or unknowns of the treatment. They say they were just told that it was normal care for women who might have a child with CAH. They deserved more accurate and complete information – and if they did not get it and their children were harmed, they may still have legal claims.
We also believe that the public has a right to answers. After funding Dr. New’s studies for decades, the government has told us that everything is all right (although they fail to mention that the Weill Cornell IRB that approved the studies through 2004 was sanctioned by the government for serious deficiencies.) But they haven’t answered our questions.
We have also asked Weill Cornell and Mount Sinai to answer the same questions. In fact, we asked them first, but they refused to respond. We had to file federal complaints just to find out whether their IRBs had approved anything, and whether the women had signed any kind of consent form. We know that they have conducted internal investigations. However, they have failed to provide answers so far.
What can we do?
AIC will continue to press Weill Cornell and Mount Sinai for answers, and we are investigating other legal options. Meanwhile, there is a lot you can to do help.
• If you are concerned that your rights or your child’s rights may have been violated, contact AIC.
• If you are a lawyer or law student, contact AIC to volunteer!