More on SPIROCOR noninvasive heart disease test: Second retraction (in fact the first) says little

Since we first wrote about the travails of Spirocor’s bedside, noninvasive test for coronary artery disease, we’ve been trying, without much success, to find out more information.

But as they say about every dog, our day has come.

As we initially reported, Ron Waksman, a prominent Washington, D.C. cardiologist and editor-in-chief of Cardiovascular and Revascularization Medicine, was first author of one of two papers about the Spirocor technology that were published in 2010. The other, by Shiyovich, et al, was retracted earlier this month by the American Journal of the Medical Sciences, which triggered our interest in this case.

At the time, we couldn’t find any evidence that Waksman’s article had been retracted, and Waksman has not responded to multiple requests for comment. Today we spoke with Kate Coons, the journal’s managing editor, who told us that the authors had sought a retraction for the article, “An innovative noninvasive respiratory stress test indicates significant coronary artery disease,” in December, and that it had posted one on its website on Jan. 6 of this year. It will be in print in an upcoming issue.

The notice is not available on Medline, but it can be found on ScienceDirect:

This article has been retracted: please see Elsevier Policy on Article Withdrawal (http://www.elsevier.com/locate/withdrawalpolicy).

This article has been retracted at the request of the Editor-in-Chief and Authors.

The article contains inaccurate data. It was found that patient data files were matched incorrectly in 33 cases to the corresponding Quantitative Coronary Angiography results; therefore the published data is inaccurate. As such, the manuscript should not be available for citation and apologies are offered to readers of the journal.

Of note: Waksman’s the editor-in-chief. And he’s the first author. He also has been a consultant/adviser to Israel-based Spirocor. He disclosed that in an abstract published in Circulation, but not in this paper. The fact that two of his co-authors are assistant medical director and medical director of the company are in the now-retracted paper.

Unlike the retraction from the AJMS, Spirocor isn’t mentioned anywhere in the notice in Waksman’s own journal. We’ll reprint the AJMS notice for comparison’s sake:

The authors have informed us that the above article by Dr. Shiyovich et al published in The American Journal of the Medical Sciences contains results that were significantly biased. The authors continued investigating the above novel diagnostic test in additional studies in the target population — ambulatory patients referred to evaluate the presence of significant coronary artery disease and found much lower diagnostic efficacy. In cooperation with the developing company (SPIROCOR) the authors meticulously reanalyzed the above study results and found that the results of the new test were matched incorrectly with the gold standard (QCA) in a significant amount of cases, hence the results reported in the published article were significantly biased and not reliable. This incorrect matching is the subject of an ongoing investigation. Retrospectively, the authors believe it was nearly impossible to notice this incorrect matching at the time. Following these findings SPIROCOR is shutting down all clinical studies and activities. Importantly, the new test has not been implemented into clinical use anywhere in the world.

No one wants to say much about this case, at least not to us. E-mails to two company officials have bounced back, and the phone number in Israel seems to be dead. We spoke with Spirocor’s self-described “business” lawyer, Jonathan Minnen, who refused to say whether Spirocor was still a going concern but promised to pass along a message to the company’s CEO, Gavriel Meron. We haven’t yet heard anything.

Spirocor had been conducting a multi-site trial, which was halted in November. We called several of the study centers in the United States, but all cited confidentiality agreements and refused to say what information they’d received from the company regarding the reason for the suspension. We spoke (briefly) to William Weintraub, a Delaware cardiologist and co-principle investigator of the halted study, as well as a member of the editorial board of Cardiovascular and Revascularization Medicine, but he refused to answer any questions and hung up on us.

We did, however, learn that more than one location had enrolled patients in the trial and had notified them that it had been halted. That makes us wonder: Would researchers have started the larger multi-center trial if they’d known about the data problems in the earlier research?

We’d like to believe the answer is no, but no one seems to want to talk about this. Stay tuned.