The Dex Diaries Part 6: The AJOB Cluster

In the last Dex Diary, Ellen Feder wrote movingly about the experience of just doing what your OB tells you to do. Here I write about the most difficult part of the dex work — the part for which I will forever be grateful to Ellen.

Every time I’ve contemplated writing this entry for the Dex Diaries, I’ve had a particular movie scene suddenly flash into my mind. It’s the scene from Groundhog Day where Bill Murray has decided he can’t take living the same day over and over again, and so he might as well try killing himself. And, he decides, quite rationally, he might as well try to take the groundhog Punxsutawney Phil with him.

So he grabs a pick-up truck and he props Phil on his lap to be holding the steering wheel. Then Murray aims the truck so that, when it starts, it will drive right off a cliff. Just before he hits the gas, Murray says to Phil, in a preternaturally calm voice, “Don’t drive angry.”

I finally realized why that scene — at least that scene as I remember it — keeps coming to me. Throughout the dex ordeal, the American Journal of Bioethics (AJOB) was my Groundhog Day. Day after day, I’d wake up to another round of the AJOB gang coming after me and mine, trying to shut us up and shut us down. Like Murray’s character in the movie, I’d try to explain to people outside of Bioethics what we were experiencing, but I’d sound like a complete nutcase. Surely the American Journal of Bioethics could not be as unethical as I was describing!

And then there’s the fact that, on one September day in 2010 — because I didn’t know what the AJOB gang had really pulled off, and I thought I had gotten somehow just gotten dex all wrong — I nearly drove off a cliff.

I’m glad I didn’t. Now — now that I can see what really happened — it all feels a little bit comic. Apparently it’s become comic enough that, when I think of writing about what happened with AJOB and dex, my brain casts Bill Murray.

Woody Allen was right: tragedy plus time equals comedy.

Except I’m still angry.

So I’ve explained all this online at fetaldex.org before, so I’m not going to go into excruciating detail. I’m just going to lay out as briefly as I can what they did.

First, in May 2010, AJOB put out the target article calling us “unethical” and “transgressive” for alerting the feds, and asking them to investigate what had happened at the medical schools of Cornell and Mount Sinai. They didn’t mention then what we figured out later: the lead author of the article attacking us, Laurence B. McCullough, worked for the medical schools of Cornell and Mount Sinai, and never disclosed it in conjunction with the article. When we found out, we made sure the AJOB editors knew it, if they hadn’t already. Still they didn’t disclose it.

The AJOB editors also never revealed, even though we showed them proof, that the second author of the article, Frank A. Chervenak, had been a consultant on New’s grant.

The AJOB editors never thought it worth mentioning that, while they were publishing the McCullough, Chervenak, et al. article attacking those of us who called for an FDA investigation, that AJOB had moved to give an editorship-in-chief to the physician “ethicist” charged with running that FDA investigation, Robert “Skip” Nelson.

Although FOIAs show us that somebody gave the OHRP the AJOB target article manuscript, we can’t find any evidence that the OHRP was told or knew that the FDA’s Nelson had growing ties to that journal.

So what? Well, let’s pause and review what this means. If you were at the OHRP, how would you have known that this article strongly attacking those who called for the investigation was actually written primarily by someone who worked for the two institutions you were being asked to investigate? How would you know that the second author had worked closely with the researcher being investigated? How would you know that the “peer-reviewed” journal where this article had been accepted as a “peer-reviewed” target article was offering an editorship to the guy running the FDA parallel to yours at the OHRP?

Did Jerry Menikoff, head of the OHRP, know about Nelson working for AJOB as well as the FDA when, on September 1, 2010, Menikoff offered “thanks” in an email to Nelson and two others “for coming up with the plan for using the FDA memo” as the basis of the OHRP report? I’m thinking probably not. (And yes, just to be clear, that is a quote from an email by Menikoff to Nelson, Kristina Borror, and Michael Carome, dated September 1, 2010. We got it via FOIA.)

So, was it a coincidence that on virtually the same day the federal response was released from the OHRP and the FDA — with the OHRP largely relying on Nelson’s FDA memo — AJOB officially published the target article (previously released in manuscript form)? Or was the fact that the FDA investigator was also working for AJOB a way for AJOB to time it just so perfectly, so that McCullough and the then-head of AJOB, Glenn McGee, could together do a dance on our graves and draw attention to AJOB?

(And yes, that was the day I almost drove off the cliff. Because I didn’t know then what I know now.)

But wait, there’s more. In December 2010, AJOB publishes an article by Maria New entitled “Vindication of Prenatal Diagnosis and Treatment of Congenital Adrenal Hyperplasia with Low-Dose Dexamethasone.” And what does she quote as proof of the alleged “vindication” of her and the intervention? Nelson’s FDA memo.

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Do you really need to ask if they disclosed, in that article, that the FDA’s Nelson was also part of the AJOB editorial leadership, something a person finding the article via pubmed would probably never figure out? (No, they didn’t disclose it.)

Yesterday, yet another editor of AJOB resigned — this time, the wife of Glenn McGee, who himself resigned earlier this year. Why did Summer Johnson McGee resign? Her letter to the editorial board didn’t really say. But she did remark, “Whether it is me, the field, or the journal that has changed, I know that I no longer want to lead our field’s most cited journal.”

Gee, could it be that AJOB has lately actually been held to account for its failure to disclose conflicts of interest? Is the field just becoming too ethical for the McGees? Or was it the Senate investigation that made Summer Johnson McGee finally cut and run?

Alice, don’t drive angry.

Whatever. Even though we’ll probably never get us a Senate investigation, today Ellen Feder and I are submitting a new request to AJOB’s now-McGee-free editorial board.

We are asking that AJOB: (1) add a disclosure to the target article that McCullough worked for Cornell; (2) add a disclosure to the target article that McCullough worked for Mount Sinai; (3) add a disclosure to the target article that Chervenak was a consultant on New’s grant; (4) add a disclosure to New’s “vindication” article that Nelson was offered and accepted an editorial leadership position with AJOB at the time he was conducting the FDA investigation that resulted in the memo New uses as her “vindication”; (5) add a disclosure to New’s “vindication” article that the FDA’s Nelson was a member of AJOB’s editorial team when New’s paper was published; (6) clarify, contrary to the title of New’s article, that the use of prenatal dexamethasone for CAH has not been “vindicated,” and that it remains an off-label use which Dr. New herself recognizes “should continue to be considered experimental and should only be used within the context of a formal IRB-approved clinical trial.”

The topic of the next Dex Diary will depend on what happens after this one goes live. With the AJOB gang, you just never know.

UPDATE: The AJOB editors refused to make any disclosures or run any corrections. The full correspondence is reproduced here.