Amended 2014-04-18: see bottom of this post!
I'm sure several readers remember a long series of posts across 2011-12, connected to a series of internal troubles in the management of the American Journal of Bioethics. One of the roots of all that mess was a controversy that eventually led to the resignation of Hilde Lindemann from the AJOB editorial board in protests of its managerial operations, followed by other weighty ones later by, e.g. Udo Schuklenk and John Lantos. Eventually, after much external pressure, following a less than elegantly handled stepping over to private business by then editor-in-chief, Glenn McGee (later to become CEO of the now defunct stem cell banking, cosmetics and therapeutic business RNL Europe), the drop-out of the AJOB operation of both him and his wife Summer Johnson McGee, who had initially been appointed to advance to co-editor with the new EiC appointed to succeed McGee.
The last post with any substance out of this mess was this one, and the entire series is found here.
The affair leading to the resignation of Lindemann connected to a critical scrutiny, and eventual letter to the FDA, signed by a large number of bioethicists, regarding some unresearched, non-evidence based, experimental off-label prenatal drug treatment at the Mount Sinai hospital with regard to congenital adrenal hyperplasia. This led to a long series of complicated controversies involving AJOB, later leading up to the developments summarised above, and one of those concerned the possible conflict of interests of several centrally placed AJOB managerial figures. Among those involved was Robert “Skip” Nelson, now editor-in-chief of the AJOB Empirical Bioethics journal, at the time ethicist linked to the FDA (he still is, as a matter of fact), who sent a letter to the Office for Human Research Protections on the Prenatal Dex case, as it came to be known, clearing the accused doctor of having broken any FDA regulations. Now it is reported that, apparently, Nelson at the same time had close and live ties, to AJOB and the people in the management who were deeply involved in one side of the controversy. That is, it is argued in a recent post by Alice Dreger and Ellen K Feder (who belong clearly to the other side, it must be added), one of the prime expert sources had hidden loyalties and dependencies that remained undisclosed and is now holding a gallant EiC title in the AJOB family of journals.
The whole story and argument is told much better than I ever could by Alice Dreger and Ellen K. Feder themselves at the superb Canadian Impact Ethics blog.
Amendment:
Skip Nelson contacted me personally after posting the first version of this report, and made clear that he finds nothing new in what is described by Dreger and Feder, that no payments to him from AJOB have ever been involved in his service as EiC, that he performs this job as part of his FDA assignment, and that what he claimed in his letter to the OHRP regarding Prenatal Dex remains true (Dreger's and Feder's view on that is set out here). Nelson also told me that he has no plan to respond publicly to Dreger and Feder. This post has been amended in the light of that in a few places above.
In his letter to OHRP, Dr. Nelson claimed Dr. New was given an FDA IND Exemption "for the administration of dexamethasone during pregnancy for the purpose of preventing virilization in females with congenital adrenal hyperplasia." He knows that is not what the IND Exemption letter (which we finally obtained through FOIA) says. He also knows there is no documentation to support his misrepresentation of the IND Exemption letter, because, as he told OHRP, all the related documents were destroyed in a move. So his letter to the OHRP contained a major misrepresentation of the FDA history of this off-label use of a Pregnancy Class C drug, and he knows that.
ReplyDeleteIt is shocking and disturbing that an FDA official would behave in this fashion.
You can read more here: http://fetaldex.org/IND.html