Editor's note: This guest post by Dalmeet Singh Chawla is reprinted with the permission of , where it was originally published in a slightly different form.
The Journal of the American College of Cardiology (JACC) has retracted a recently published paper that questioned the effectiveness of a treatment for irregular heartbeat. The lead author, well-known electrophysiologist , the study's last and corresponding author and Executive Medical Director of Texas Cardiac Arrhythmia at Austin, took to social media to express his frustration over the retraction of the , which showed electrical rotors were less effective at fixing nonparoxysmal AF than other treatments. On Twitter, Natale implied industry played a role in its demise.
However, according to the retraction notice, the paper was felled by problems with randomization; Natale has that some patients were removed from the analysis after one center included them incorrectly.
Here's the for ":"
"This article has been retracted at the request of the JACC Editor-in-Chief, its Editorial Board, and the JACC Ethics Board for the following reasons:
"In the title and multiple times in the article, the study is referred to as a "randomized trial" but deviation from a random allocation of subjects to treatments across sites and the imbalance introduced by a non-random "randomization error" were not disclosed in the manuscript.
"Registration with ClinicalTrials.gov was not completed before patient enrollment began."
The used rotors from a company called Topera, which was acquired by the firm in 2014.
Natale told us he believes the company played a role in retracting the paper, and expressed his views on Twitter:
yes very sad. Another victory of the industry and their conflicted accolades
— Andrea Natale, MD (@andreanatalemd)
A JACC spokesperson confirmed that one letter was sent by an industry representative, but did not name the firm.
Natale noted that the authors excluded nine patients from one of the treatment sites to match the journal's inclusion criteria, but argued that isn't enough to fell a study:
yes very sad. Another victory of the industry and their conflicted accolades
— Andrea Natale, MD (@andreanatalemd)
The other issue in the notice -- that the study enrolled patients before it was registered -- was raised by people who sent letters to the journal, Natale told us.
A spokesperson from the American College of Cardiology, which publishes JACC confirmed that the journal had in fact received three letters about the study that expressed "very similar concerns," one of which was from an industry representative.
Patient enrollment started in April, 2014, and the trial was registered in December, 2014.
Natale -- who left the Cleveland Clinic in 2007 after , following allegations he performed unauthorized procedures -- stands by the scientific findings of the paper, tweeting:
regardless of this conflicted decision mark my words. Rotor ablation does nothing
— Andrea Natale, MD (@andreanatalemd)
The JACC spokesperson, however, said that they can "no longer speak to the validity of the findings."
The study has ; in response, co-author .
At the time of the study's publication, JACC also released an accompanying audio summary by its editor-in-chief, but has now also removed that. The JACC spokesperson added: "When the paper was retracted, the accompanying features of the manuscript were also removed because they are no longer relevant."
Natale told Retraction Watch he plans to resubmit a revised version of the now-retracted study to another journal.
Natale initially reported the findings at a Heart Rhythm Society meeting in May. At that time, he told 51˶: "I don't think it's the end of this technology, but certainly it is a study that does raise some question about the validity of this approach."
Hat tip:
Disclosures
Ivan Oransky, MD, Global Editorial Director, 51˶ is a co-founder and editor of Retraction Watch.