Leaked Avandia paper didn’t fall victim to the Ingelfinger Rule after all
By now, you will have no doubt read about the study published online in JAMA earlier this week showing that people taking Avandia (rosiglitazone) had a higher rate of stroke, heart failure, and death than those taking pioglitazone (Actos). (The study, like the one I blogged about yesterday, was published while I was on vacation.)
An earlier version of this manuscript, leaked to Ed Silverman’s Pharmalot blog, was the subject of an Embargo Watch post two weeks ago. In my last post, I wondered whether the Ingelfinger Rule — read this for background — applies if the author didn’t seek any attention himself. Apparently not, according to a story on the new study by heartwire:
A JAMA spokesperson provided heartwire with a statement saying that the journal believed Graham’s paper had been leaked to the media without his knowledge or consent. “In that case, the JAMA editors do not consider Dr Graham to have violated JAMA policy regarding prepublication release of information. More important, unlike the leaked paper, the study by Graham et al being published by JAMA has been peer reviewed, evaluated by content and biostatistical experts, and appropriately revised, just as is the custom for all published JAMA research papers.”
According to heartwire:
Graham explained that he has no idea who leaked his email and manuscript, but he believes it was a calculated attempt by someone at the FDA to prompt the journal to reject it, based on submission policies that restrict consideration of papers to those that have not been published previously in print or electronic format or shared with the media (outside of media activities associated with meeting presentations).
“In my view, and in the view of JAMA for sure, this was an attempt by people at the FDA to block the publication [of this data],” Graham said. “The idea was that JAMA would invoke the Ingelfinger rule, and the paper wouldn’t get published, and it wouldn’t have ‘credibility.’ ”
When he found out about the leak, Graham says he called a JAMA deputy editor immediately and explained that he thought it was “an act of sabotage.”
The JAMA editors, he continued, “were very reassuring and basically at the end of the day said that this is a poison pill and we aren’t going to swallow it. We know it’s an important study, and if this is the length the FDA is going to to stop it, it must even be more important than we recognized.”
Apparently, poison pills are no better than sliced bread. In my last post, I noted what JAMA editor in chief Catherine DeAngelis told New York Times medical correspondent Lawrence Altman in 2000 in a story on JAMA‘s tightening of the Ingelfinger Rule:
Many scientists who submit manuscripts believe ”they are on to something that is the most important thing since sliced bread, and they want it out there,” Dr. DeAngelis said.
”Fine,” she added, ”put it out there, but don’t submit it to JAMA.”
Regardless of the culinary metaphor, I think JAMA made the right calls here. This is an important paper that will inform a July 13-14 hearing at the FDA. The journal didn’t let the Ingelfinger Rule stand in the way of publishing it, and they got peer review done quickly, so that a vetted version of the originally leaked manuscript could become public within weeks. That makes it more difficult for Avandia defenders to dismiss the study outright.
Read the rest of the heartwire post, and other coverage, to see if the paper changed substantially from submission to publication. It was released along with an updated meta-analysis by Steven Nissen and Kathy Wolski, whose original meta-analysis had sparked an earlier FDA review.
Another embargo twist: There’s some evidence that several outlets ran their stories about an hour before the 10 a.m. Eastern embargo on Monday. I wasn’t tracking things then, however, since I was on vacation, so I’ve put in a message to the JAMA/Archives press office and will wait before saying anything definitive.
Update, 11:00 a.m. Eastern, 7/1/10: JAMA tells me that some outlets did in fact post their stories before Monday’s embargo, but that “human and electronic error” were at work. As I mentioned, the breaks were by less than an hour.