Julio Palmaz Really Doesn’t Want You To Read This Story

—Raising questions about a trial provokes a ‘cease-and-desist’ letter.

The world  stent pioneer Julio Palmaz really doesn’t want you to read this post. After I raised questions about a recent paper involving Palmaz I received a “cease-and-desist” letter from his lawyer.

Here is the background to this story:

Last year I wrote a brief post reporting the news that Palmaz Scientific had declared bankruptcy. The company had been founded by Julio Palmaz, who was a co-inventor of the first coronary stent. After publishing that story I received information that led me to ask additional questions about the company and an unpublished study involving an experimental Palmaz Scientific design for a new stent. Results of the study had been presented by Juan Granada at the TCT meeting in 2015. Granada is an interventional cardiologist at Columbia University and a leading investigator at the Cardiovascular Research Foundation (CRF). (Coincidentally, he was just today named the President and CEO of the CRF.) The CRF, for those unfamiliar with cardiology, is the highly influential interventional cardiology foundation associated with Columbia University. The annual TCT meeting is by far the largest and most important interventional cardiology gathering each year.

Recently the study that Granada presented at TCT in 2015 was published in Open Heart. Granada was the senior author of the paper, which was entitled “Biological effect of microengineered grooved stents on strut healing: a randomised OCT-based comparative study in humans.”  The co-authors included researchers from Colombia (the country), where the study was apparently performed, cardiologists from the CRF, one scientist from the large device company Abbott Vascular, and Julio Palmaz himself.

Here are questions I have raised about this study:

–The ClinicalTrials.Gov site states that the trial tested the “Palmaz Mach-5 Grooved Bare Metal Coronary Stent System Versus the Palmaz Bare Metal Coronary Stent System.” But the Open Heart paper reports that all the stents in the study were “commercially available Multi-Link Vision stents” manufactured by Abbott Vascular. For half of the stents the microengineered stent grooves were “applied on the luminal surface of the stents by Palmaz Scientific.” There was no mention of Abbott’s involvement in the study in Granada’s TCT presentation or on ClinicalTrials.Gov.

–There are important questions regarding conflict of interest. The ClinicalTrials.Gov site reports that the trial was sponsored by Palmaz Scientific. There is no mention of sponsorship or financial support in either the 2015 TCT presentation or the Open Heart paper. The Open Heart paper reports that the authors declared “no competing interests.” It is impossible to imagine that this study was performed without any financial support. The CMS Open Payments website does not list any payments to Granada from Palmaz or Abbott (except for a $100 payment from Abbott) between 2013 and 2016. It is also abundantly clear that both Julio Palmaz and the Abbott author have irreducible conflicts.

There is an additional, mysterious, and potentially disturbing conflict of interest question that also needs to be addressed. Because Palmaz Scientific declared bankruptcy it was forced to disclose its financial transactions. The documents in the bankruptcy case do not show any record of payment to the CRF or the CRF authors. On the other hand, the documents show that, as I reported last year, while Palmaz Scientific was on the road to bankruptcy it invested more than $443,000 in Triventures, a venture capital company co-founded by Martin Leon. Leon is also the Founder and Chairman Emeritus of CRF, and he is undoubtedly the most influential interventional cardiologist in the world. What if any role did Triventures play in this saga? Why would a company in dire financial straits invest so much money in a VC fund?

–Finally, I am also concerned that there may still be important information missing about the trial. Records from Invima, the Colombian regulatory agency, indicate that one patient in the trial died as a result of pancreatitis. It seems unlikely that this was related to the stent but shouldn’t this information have been reported in the Open Heart paper?

–In fact, we need a full accounting of the trial and all the patients who participated in this research. The Open Heart paper reports on 37 patients, out of a total of 40 who were randomized. The paper states that 3 patients were excluded from the analysis because OCT was poor quality. But the entry for the trial on ClinicalTrials.Gov states that 48 patients were randomized. Further, the ClinicalTrials.Gov site lists the study start date as September 2013 and the completion date as June 2015. Yet the trial was registered on ClinicalTrials.Gov nearly a year after the study was completed, on April 27, 2016– and only after I contacted the authors raising questions about the trial.

There may be entirely innocent explanations for all these discrepancies, but I received no response from Granada, Leon, and other interested parties when I first raised these issues last year, and I have received no response (except for the “cease-and-desist” letter) to my new questions sent to Granada. Let me be clear: I am eager to publish any response from any of the interested parties.

One final very important point: it shouldn’t be necessary to say this but asking hard questions about a clinical trial and a scientific paper should not result in a threatening letter from a lawyer.  As a journalist I enjoy very powerful first amendment rights, but in fact anyone should be able to raise questions without being subject to lawsuits or the threat or lawsuits.

Pascal Meier, the editor-in-chief of Open Heart, sent the following statement:

“As editor-in-chief of the journal that published this paper, Open Heart, I very much welcome criticism about any research articles we publish , and this is also the case concerning the points raised about this paper. I regard post-publication review as an integral part of scientific publishing. In my view, the ideal platform is a “’letter to the editor’, published with a response by the authors, because it is directly linked to the published article and can be immediately seen by the any reader. In this case, there are certainly several points that I would like the authors to clarify.”

Related reading:

• On Road To Bankruptcy A Stent Company Invested in Marty Leon’s VC Fund
• Stent Pioneer’s Company In Bankruptcy And Under Investigation