Thursday, February 10, 2011

It's Happened Again--Journal Reviewer Leaks Manuscript to Firm

About a year ago, I discussed the Avandia debacle ( including the outrageous behavior of a journal reviewer, Dr. Steven N. Haffner, then of University of Texas-San Antonio, who leaked a manuscript he had been sent for review by the New England Journal of Medicine to his handlers, the drug company. This of course was in violation of the explicit confidentiality agreement that all journal reviewers are subject to, and without which the peer review process for scientific journals could not happen. I was later pleased to report ( that it seemed that Dr. Haffner, unlike most academic physician wrongdoers, had actually suffered some negative career consequences for his actions.

There is a new poster child for academic malfeasance, if an ABC News report is to be believed:

Here's what ABC News's investigvation has shown-- a few years ago, a group at the University of Texas-Southwestern in Dallas headed by Dr. Sharon Nations, a neurologist/neurophysiologist, submitted a manuscript to the journal Neurology reporting on several patients with nerve damage apparently due to high zinc level in the body, and the culprit appeared to be the denture cream, Fixodent, manufactured by Procter & Gamble. Now, to prove cause and effect you need something more than a report of four patients' cases, but it is common that the first way that a serious and yet rare side effect of a medicine comes to light is through just such a case report. So this article seems to have been fully valid and worthy of publication, as the danger of zinc toxicity from that source had not previously been reported. (The four patients, apparently, had been heavy users of Fixodent.)

Neurology sent the paper for review to a dentist, Kenneth Shay, not otherwise identified by ABC, but who Google informs us appears to be an adjunct professor at University of Michigan and a big wheel at the VA Hospital there. (Assuming this is the right Shay; many apologies if it's the wrong person.) Dr.Shay lambasted the study, said it was basically garbage, and managed virtually single handedly to hold up publication for a couple of years and to force the authors considerably to tone down what they said. Unbeknownst to the journal editors (apparently), Shay was a paid consultant to Procter & Gamble, and he also at least once leaked the manuscript to P&G. There was no question of his simply being ignorant of the rules; in an e-mail to P&G, he said, "Please be circumspect because, as a reviewer, I'm not supposed to be passing an unpublished manuscript around."

OK, again assuming the accuracy of charges, there are two very big things wrong with this picture: a conflicted reviewer agreeing to review a manuscript in the first place; and a reviewer violating the confidentiality agreement and sharing the manuscript with anyone, let alone a commercially interested firm. We have to assume the editors at Neurology knew none of this; if somehow they did know then the wrong is greatly multiplied.

Now, let's talk reform. What should happen here? First, U-Mich should investigate and if the charges are substantiated, Shay should be out the door, period. No excuses.

Second, how about this as a statement of adherence to professional ethics? All commercial firms engaged with health-related products should agree to a compact. If any of them is sent a confidential manuscript under review by a misguided paid consultant like Shay or Haffner, the agreement would call for the firm immediately to notify the journal editors.

ADDENDUM 2/11/11: The editors of Neurology have now stated to their subscribers that they had no report of any conflicts of interest in Dr. Shay's case, view his behavior as "egregious misconduct," and have asked the American Academy of Neurology's (the journal's publisher organization) general counsel for options in dealing with the case. However, the editors also differ with the claim that Dr. Shay's review held up publication for two years, stating that the delay arose from the authors' taking that much time to prepare and submit revisions:

1 comment:

Anonymous said...

These "people" are literally without shame. We live in a "post superego" world. Anything goes as long as there is profit to be had. And screw anyone else. Including our patients.