fetaldex.org

the AJOB connections

 

This page provides information about the curious roles the American Journal of Bioethics (AJOB) has played in the fetal dex story.


In 2010, AJOB published an article attacking our letters of concern to the feds:

This 2010 AJOB article labeled us “unethical” and “transgressive” for raising our concerns to the feds. In the paper, the lead author, Laurence McCullough only mentioned his affiliation with Baylor College of Medicine. He did not disclose in the paper that he also works for Weill-Cornell and for a Bioethics Program that is funded by the Mount Sinai School of Medicine, the two institutions directly implicated in our letters of concern.

Readers of the paper also probably would not have known that the second author, Frank Chervenak works in and for the administration of Weill-Cornell by heading the program (Maternal-Fetal Medicine) where we think many of the “treatments” with prenatal dexamethasone for CAH probably happened. We also discovered evidence of Dr. Chervenak’s association with Dr. New and her grants through a FOIA request. Read more about that here.

AJOB’s editors were unmoved when we informed them of these undisclosed conflicts.


In 2010, while the FDA’s Robert “Skip” nelson was conducting the FDA investigation, Dr. Nelson was also accepting a leadership position from AJOB:

We didn’t figure this out until well after the fact, but during the period of time Robert “Skip” Nelson was in charge of the FDA investigation in response to our letters of concern, he was also accepting an editorship-in-chief from AJOB for a new subsidiary journal, AJOB Primary Research (AJOB-PR).

The AJOB site says AJOB-PR was launched in February 2010. The first issue, showing a publication date of May 10, 2010, shows Alexander Kon as the starting editor. The first editorial from Nelson, inaugurating his editorship, shows up in the last 2010 issue, which ordinarily would be prepared several months in advance of actual publication date. So, somewhere between the launch of the journal in February 2010 and November of 2010, Nelson accepted an AJOB leadership position.

Our letters of concern went to the FDA in early February 2010, and Nelson responded in September 2010. Thus, this would seem to put Nelson’s taking of the AJOB-PR editorship-in-chief coincident with the same period as his investigation was ongoing, and during the same period AJOB was being used to attack those of us who had called for the investigation Nelson was running. Communication with Nelson confirms this timing.

Among the members of Nelson’s new editorial board at AJOB-PR: Laurence McCullough of Mount Sinai, Cornell, and Baylor. But he only lists his Baylor affiliation.


How much did the federal response rely on FDA/AJOB’s Nelson?

The FOIAs seem to indicate that maybe it was Nelson who suggested the OHRP rely chiefly on his report. (Jerry Menikoff, head of OHRP, to Skip Nelson, Kristina Borror, and Michael Carome, dated September 1, 2010: “And thanks again for coming up with the plan for using the FDA memo.”) In any case, the OHRP did rely chiefly on the memo from Nelson, effectively putting much of the burden of the federal findings about prenatal dexamethasone for CAH on Nelson. (See OHRP letter here.)


Coincidental timing of the AJOB and federal responses?

So, was it a coincidence that the McCullough, Chevernak, et al. paper was ultimately published by AJOB on virtually the same day in September 2010 that the feds released Nelson’s and the OHRP’s responses to our letters of concern? Maybe. But there was someone who lived in both houses -- AJOB’s and the feds’ -- at that point.


Then, later in 2010, AJOB published a “vindication” by Maria New that relied chiefly on Nelson’s FDA memo, with no mention that Nelson is embedded in the AJOB leadership:

A few month’s after the federal response, AJOB’s editors published an article by Maria New in which she suggested that not only had she been vindicated by the feds, but that the intervention also had been.

The article consists chiefly of a long quote from Nelson’s FDA memo.

Yet in conjunction with this article, AJOB did not disclose that Nelson was also employed as a member of the AJOB editorial leadership. How could a reader know this from the article?

The title of New’s article suggested, erroneously, that the intervention itself had been vindicated: “Vindication of Prenatal Diagnosis and Treatment of Congenital Adrenal Hyperplasia with Low-Dose Dexamethasone.”

The text of her article claimed, “The recent reports by the Office of Human Research Protections and the FDA therefore make crystal clear that my research on prenatal treatment of CAH is and always has been both legally and ethically proper at every level.”

If Nelson has asked AJOB to correct these misrepresentations, either in his role as the FDA official quoted or in his role as a member of the AJOB leadership, we are unaware of his request.


This isn’t a unique case with AJOB:

For background history on the ethical track record of AJOB, you can read these reports in Nature, Science, Scientific American, and Reporting on Health. To learn why one prominent doctor-ethicist asked this year about AJOB’s senior editors, “What are these people smoking?”, see this post.