Who's Policing the Ethicists?

11 Feb 2012

There’s an old adage about how pyromaniacs become firefighters, criminals become cops, and crazy people become psychiatrists. Let’s talk about ethicists.

When I accidentally fell into the field of medical ethics by virtue of doing patient advocacy from within academia, I was struck by how many bioethicists proper were afraid of being seen as “the ethics police.” I had a sense this anxiety grew out of the notion that if doctors saw us as “the ethics police,” they would restrict our access to their conversations and perhaps even hide from us their “crimes.”

These days I’ve come to believe that the real fear was loss of income. I hate to be that cynical, but the kinds of stuff people in the field get away with are pretty stunning. Take what’s going on right now with one of the most prominent journals in the field, the American Journal of Bioethics (AJOB).

I should first disclose that I’ve had a lousy experience with AJOB—perhaps not coincidentally because of its unethical attitude towards financial disclosure. When in 2010 I organized letters of concern to the FDA and Office of Human Research Protections over a particular fetal intervention, AJOB decided to publish a scatterbrained article attacking me and my colleagues for calling on the Feds as we did. The AJOB slam called me and my co-signers “transgressive” and “unethical.”

As it happens, the lead author of the professional assault calling us unethical, one Laurence McCullough of Baylor College of Medicine, failed to disclose that he works for units of the two institutions implicated in the investigation for which we had asked (Weill-Cornell and Mount Sinai). Alerted to this, the editor of AJOB, Glenn McGee, still didn’t think it required disclosing, because hey, what does it matter that McCullough was moonlighting for the medical schools at the center of the controversy? Apparently, that’s what ethicists do. We write about disclosures of competing interests, we don’t write actual disclosures themselves.

Now McGee, the founding editor of AJOB, is apparently resigning as editor-in-chief of AJOB because he’s decided to take up with a for-profit Texas outfit called CellTex. Interesting political background here: CellTex was founded by the doctor who gave Governor Rick Perry stem cell injections for his back problem. Those injections must have done wonders, because Perry appears to have thanked his doctor and the doctor’s partner (a major campaign donor) by working on giving CellTex a nice little governmental push.

Hold on, it gets weirder: It would appear that CellTex licenses its wares from a Korean company called RNL Bio that has been hawking stem cells for everything from cosmetics to serious diseases. News out of Texas from yesterday indicates that the Texas Medical Board has apparently decided to let CellTex push these stem cell “treatments.” Yes, the Texas Medical Board is apparently giving a go-ahead to an intervention whose safety and efficacy are, to say the least, not established.

You might think that McGee resigning from AJOB while he takes up with industry (in a more obvious fashion than his peers) shows that he has some professional standards. Separate the business from the academic ethics work, right? But it actually isn’t clear whether McGee voluntarily resigned, or whether perhaps the publisher of AJOB, Taylor & Francis, decided that running AJOB as a side business to the hawking of stem cell “treatments” was just a little too embarrassing to tolerate.

Perhaps Taylor & Francis was aware that McGee had, at least a year earlier, been defending RNL Bio in the press after two of their “customers” died following stem cell treatments. After McGee’s sudden departure late last year from the Center for Practical Bioethics—a departure left strangely unmentioned on the Center’s website—he apparently simply took to running AJOB out of a Texas office while working for CellTex. Maybe Taylor & Francis didn’t like that? Who knows. According to colleagues of mine on the editorial board, they had no idea of the move. I suppose it is possible Taylor & Francis also didn’t know, and maybe still doesn’t know. As I write, they still list McGee as editor-in-chief of AJOB and they don’t seem to know he’s not in Kansas anymore.

As for why the Center for Practical Bioethics appears absolutely mum on McGee’s departure, maybe they don’t want to have to admit what Albany admitted to in McGee’s wake?

Wait, it gets better. By which I mean worse. Everybody is assuming that CellTex is going to be drawing the attention of the FDA, no matter how sunny the Texas Medical Board feels about stem cell “treatments.” The FDA was set up specifically to go after snake oil companies, and CellTex smells kind of reptilian.

But does McGee have an “in” with the FDA, given that he bestowed the gift of editorship of an AJOB subsidiary journal, AJOB Primary Research, on a physician-ethicist at the FDA?

And isn’t it also kind of curious that that FDA official, Robert “Skip” Nelson, took the editorship at the same time he took on the FDA job of conducting the investigation we had asked for in our letters of concern? Why “curious”? Well, in his FDA investigation of the fetal intervention issue, Nelson concluded there was nothing of much concern after all, and everyone should look away—while at the same time McGee used AJOB to help undermine our concerns. (Oh, and you’ll never guess who Nelson has on his editorial board—unless you guess Laurence McCullough. Who only lists Baylor as his affiliation.)

And what role did McGee play in the supposed “clearing” of RNL Bio following the two deaths? No one on the outside seems to have figured that out yet, but one always has to wonder about integrity of investigative findings when the ethicists involved are paid by the companies who might be found at fault. You don’t get much of a reputation among these companies as a go-to guy if you tell them something they don’t want to hear.

Leigh Turner of the University of Minnesota has looked at the matter of the inquiry into the deaths. Here is his initial take: “It appears that the review fails to address the most basic questions about RNL Bio conduct. How risky were the stem cells? Given the limited science behind injections, what was the basis for making claims about risks and benefits? How effective were the injections supposed to be at treating long list of diseases? How were risks disclosed to recipients of stem cells? Who disclosed them? What was the science behind giving adult stem cells? What basis for injecting them into humans? Were the injections described as research or treatment? If the former, why were customers paying for them? Was there IRB review? Who did Glenn interview? What made him qualified to conduct the investigation? What basis is there for any of his conclusions and why was the scope of his analysis so narrow?”

Good questions, all. Leigh’s colleague Carl Elliott, also of the University of Minnesota, says of the affair, "If you wanted to whitewash a death from a quack therapy, you could hardly do a better job."

What’s probably most remarkable in the supposed shift of the editorship of AJOB is how long it has taken. Glenn McGee does not exactly hold the confidence of the field, and he has not held it for some time. McGee was denied tenure at the University of Pennsylvania and then was fired from his next position, in Albany, apparently because of ethical transgressions. (Forging three co-authors names on publication forms? Giving himself the title of “chief of the Office of Bioethics for the New York State Department of Health,” when in fact he was just a volunteer? Read all about it in Scientific American.)

So why has McGee been allowed to remain as editor-in-chief of AJOB? Well, because the ethicists on the editorial board have put up with his embarrassing—uh, unethical—behavior. Perhaps they’ve been figuring that if we keep McGee as the standard, we all look pretty darned good.

Not all have put up with McGee, though. After McCullough’s failure to disclose his ties to Weill-Cornell and Mount Sinai in his AJOB attack on us, my colleague Hilde Lindemann of Michigan State University got fed up enough with the charade to resign from the AJOB board. Her letter of resignation said plainly what everybody knew: the board has been used as a backless front by McGee.

So McGee, now the “President of Ethics and Strategic Initiatives” of CellTex, claims he is stepping down as editor-in-chief of AJOB. But is he remaining in control of “the AJOB Family of Journals”—a “family” that would continue to include an FDA official acting in a subsidiary editorial position to CellTex’s McGee? (For a medical ethics journal!)

And why does CellTex’s announcement claim McGee actually stopped being editor of AJOB in November of last year, as if perhaps the AJOB editorship and CellTex job did not overlap? Just two days ago Glenn announced on LinkedIn that he would remain as Editor-in-Chief of AJOB until March 1. But then someone deleted this announcement of his upcoming resignation. (Email me if you want a copy of it; I happen to have saved it.) All so odd.

I should note that I’ve learned much of the CellTex-McGee story via the excellent Twitter feed of Leigh Turner. Leigh notes many curious discrepancies in the claims coming out about McGee’s professional affiliations, and raises particularly important concerns about the fact that McGee has—without any consultation with the editorial board members I’ve talked to—installed his wife and his best friend as his successors. Were McGee’s wife, Summer Johnson McGee, half as qualified as the members of the editorial board, this might make sense. As it is, it looks like a convenient way to continue Glenn McGee’s controlling interest.

Leigh Turner has called upon the members of the editorial board to explain themselves or to resign. Hilde Lindemann has also suggested it is time for the rest of the editorial board to join her in resignation. (You can find the names of the editorial board here. For some reason, McGee doesn’t want you to find it easily at his site.)

Will the members of the AJOB editorial board finally stand up, and in doing so, show that the field is at least capable of policing itself—if not medicine, and if not the companies for whom many do work on the side? Or will they let McGee continue to be the big daddy of the AJOB Family of Journals, with his wife playing mother to “the family’s” oldest child? Only time will tell.

A final note: Glenn McGee has a habit Leigh Turner aptly refers to as “scrubbing the internet.” This means that if you go to the links I’ve provided here, some of them may have changed since I posted this. Read all about the scrubbing going on here.