Guest Post: Retraction Reveals Downfall of Company Where Ron Waksman Consulted

Editor’s Note: CardioBrief is pleased to publish this guest post by Adam Marcus and Ivan Oransky. A different version of this story appeared on their blog, Retraction Watch, which has been called “required reading for anyone interested in scientific journalism or the issue of accuracy” by the Columbia Journalism Review.

Spirocor is an Israeli company that until last year was developing a new point-of-care test for coronary artery disease. The firm’s advisors and consultants included Ron Waksman, the prominent Washington, D.C. cardiologist, who was a co-PI on what was going to be a major study to demonstrate the utility of the test, called respiratory status response, or RSR.

Waksman has published at least one paper and one abstract on RSR, but it’s a third article that tells the full story. The American Journal of the Medical Sciences (AJSM), not exactly a top-drawer cardiology title, has retracted a May 2010 paper by Waksman’s Israeli collaborators (and a few other authors, although not Waksman himself) about the test.

The notice speaks for itself, but what it has to say can make the head spin:

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.

The letter is so confusing that even the editor, David Ploth, said he had trouble parsing the language. All we can really say about the notice is that something very bad happened in the wake of the publication of this paper, something so bad that the results are no longer valid. The problem was severe enough to topple the development of the drug, halt the critical comparative trial and, quite possibly, destroy the company, which doesn’t seem to have a pulse on the web anymore (an email to the chief operating officer has not yet raised a reply)

Waksman’s role in all of this is uncertain. But again, some elements are  clear, including the fact that he is editor-in-chief of Cardiovascular Revascularization Medicine, which in its January-March issue published an article about RSR. The first author of that paper: Ron Waksman.

So far, Cardiovascular Revascularization Medicine hasn’t retracted the paper. We have attempted to contact Waksman but haven¹t succeeded yet.

Guest post by Adam Marcus and Ivan Oransky of Retraction Watch. Here’s more on this case.

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