There’s a highly unusual situation brewing at the Archives of Internal Medicine. At 3:48 Eastern time on Monday, 12 minutes before the embargo lifted on the June 28 issue of the Archives of Internal Medicine, the following message went out from its press office:
The editorial office of the Archives of Internal Medicine has made the decision not to publish, “Stress Reduction in the Secondary Prevention of Cardiovascular Disease: A Randomized Controlled Trial of Transcendental Meditation and Health Education in African Americans,” by Schneider et al, and the accompanying Commentary by Mehta and Bairey Merz that was to post Online First at 3 PM central time today.
The decision is to allow time for review and statistical analysis of additional data not included in the original paper that the authors provided less than 24 hours before posting. We apologize for the short notice, but hope you will understand and not run your stories on this study today.
We asked Archives of Internal Medicine editor Rita Redberg when the paper might be published:
I can’t say at this time, as we are awaiting a revised version that contains additional data which must be reviewed and analyzed.
We also asked Redberg how the study got through peer review without those data, if they were necessary for publication:
The study was peer reviewed, as are all Archives articles, and in general peer review works well as long as all data are provided as required by Instructions to Authors. We thought we had all the data when the manuscript underwent peer review, but it turned out there was additional data to be considered.
We also asked Redberg why it would have been necessary to send in new data less than 24 hours before the study was published, and she referred us to the authors. Schneider responded this morning to say that he and the other authors will release a statement later today “on this process and how it was handled.” [See update at end.]
Without knowing anything about the new data, it’s hard to say what will eventually happen to this paper, of course. The closest thing we’ve seen at Retraction Watch is the sort of academic purgatory where papers land when they’re published online but then withdrawn before running in print. This paper, however, wasn’t published in any form, unless you count an embargoed manuscript, which we wouldn’t. And there was another similar situation at this year’s American Society of Clinical Oncology meeting, in which a journal asked a researcher not to participate in a press conference because the work was to be published at a later date.
Having reported on papers in the Archives for years, we know Redberg has exceptionally high standards, and we can imagine that this was a difficult decision. Whatever questions can be raised about postponing a paper so close to its scheduled embargo, we figure, were less than those that would have been raised about the lack of necessary data in the paper itself. Larry Husten, at CardioBrief, has more on some of the potential problems with the study. As Husten writes:
It should be noted that the study was funded by the NHLBI. In addition, the same study was presented at the AHA Scientific Sessions in 2009. The first author, Robert Schneider, is the Dean of the College of Maharishi Consciousness Based Health Care at Maharishi University of Management and Director of the Institute for Natural Medicine and Prevention, which is funded by the NIH’s National Center for Complementary and Alternative Medicine. “Schneider is a specialist in clinical hypertension and has published extensively, including papers in the American Journal of Cardiology, Stroke, and Hypertension.
Husten later updated his post with information from the National Center for Complementary and Alternative Medicine, which said it “does not currently fund research at Maharishi University of Management; we last provided grant funding to the institution in FY 2004.” Husten had obtained the information about funding from Schneider’s bio page at Maharishi, which is apparently out of date (and remains so at the time we’re publishing this post).
We found out about this story, along with everyone else on the JAMA/Archives press list, on Monday afternoon Eastern, of course, but were waiting to publish until it was officially published, because we don’t want there to be any question about breaking an embargo. We checked with JAMA/Archives spokesperson Jann Ingmire, however, who told us yesterday we were free to post:
This is such an unusual situation that we are not considering any of those stories to be embargo breaks.
We are contacting the few (mostly international) media outlets who have posted stories only about the study and asking them to remove the articles from their websites because they are referencing a paper that was not published. We don’t want inaccurate information for the public or to be attributed to the Archives of Internal Medicine.
For those journalists writing about the situation as a whole, it’s not really an embargo break. We made our own news yesterday by pulling the study from publication at the last minute. It was a very tough decision, but we believe the right one given the questions about the additional data’s possible impact on the paper about to be published yesterday.
Update, 2 p.m. Eastern, 6/29/11: Schneider sent us this comment:
This is a clarification of the status of our paper entitled, “Stress Reduction in the Secondary Prevention of Cardiovascular Disease: A Randomized Controlled Trial of Transcendental Meditation and Health Education,” which was due to be published this week in the Archives of Internal Medicine.
During the week prior to publication, the authors received additional requests for further clarification and data analyses from external reviewers. This trial was complex in design and the authors are carefully considering and working to incorporate the additional input. The authors wish to point out that the paper was carefully reviewed by both internal and external experts at all points along the way. After a series of deliberations, the journal and authors agreed to revise the paper to include the supplemental information and resubmit to the journal for editorial review. It should be emphasized that at each stage of the publication process, the paper underwent the normal procedures of peer review and followed the guidelines for publication in leading medical journals. The authors remain committed to publishing the highest quality scientific report.
Given that this study required nine years to conduct, the authors are pleased to take the additional time needed to review all relevant input and make revisions as necessary.
Cross-posted from Embargo Watch.