A response to Mount Sinai:
[If you want the background to why I wrote and posted this, read my book Galileo's Middle Finger.]
Slate’s Amanda Schaffer has a sharp new article out on the paper I just published with Ellen Feder, PhD, and Anne Tamar-Mattis, JD. In response to our indictment of what’s happened at Mount Sinai School of Medicine (MSSM), spokesperson Ian Michaels of MSSM has issued a formal statement. Here’s what I just wrote to Mr. Michaels.
August 15, 2012
Dear Mr. Michaels,
As you respond to our report, you might want to know the following:
The FDA official who ran the investigation into prenatal dex in 2010 was simultaneously accepting an AJOB editorship-in-chief. He did not disclose this in his FDA memo, nor did Dr. New disclose this dual role in her own 2010 AJOB article where she quoted the FDA memo as having "vindicated" her and the intervention. [Read more about the AJOB connections here.]
In 2004, MSSM's IRB head, Dr. Jeffrey Silverstein, assured the NIH that Dr. New had MSSM IRB approval for a study of "Prenatal Diagnosis and Treatment." We attach Dr. Silverstein's letter. [Silverstein to NIH 2004 on New IRB approval.pdf] We understand MSSM has represented Dr. New's research on prenatal dex at MSSM as only involving retrospective studies, but Dr. Silverstein's letter suggests otherwise, as it refers to prenatal diagnosis as well as treatment. The accompanying grant materials support this reading.
Further, in 2006, Dr. New reported "galloping ahead" at MSSM with prenatal diagnosis and treatment of CAH with dexamethasone as part of her NIH research progress report, even revealing the number of fetuses exposed at MSSM. We can send you that, if you like, including the pages where she reports on outcomes of infants' genitals following "DEX-treated pregnancies."
You may now understand why we say, in our report, "If these fetuses were not regarded as research subjects locally in terms of having IRB protections, they appear to have at least been counted as research subjects federally."
Finally, the 1996 FDA IND waiver letter does not refer to the intervention we're talking about. In case you haven't seen the waiver, I attach it. As you can see, it refers to treating pregnant women who themselves had CAH, not to trying to alter fetal development for fetuses who might have CAH. We would appreciate if you would represent this letter accurately in the future.
Alice Dreger, PhD, Professor of Clinical Medical Humanities and Bioethics
Feinberg School of Medicine, Northwestern University