This week, cardiologists are attending the Transcatheter Cardiovascular Therapeutics (TCT) meeting. And an online news organization covering the sessions, MedPage, reports interventional cardiologists are trying to sort out conflicting claims about stents. Peer-reviewed journals and regulatory agencies have been posting reports of significantly higher complication rates for the devices.

Now the website says: “Stent makers Boston Scientific and [Johnson & Johnson unit] Cordis Corporation opened their clinical trial databases to so-called independent analyses, which found no increase in death or acute myocardial infarction for the stents, but did confirm a small late stent thrombosis risk.”

The two medical device companies have given their trial data to ostensibly neutral physicians with no known conflicts of interest. One of the issues is simply defining stent thrombosis. With new definitions, it seems, reports of the complication vanish. The device companies appear to want to preempt criticism at an upcoming FDA session on the topic in December. Beyond that, usage of drug-coated stents has fallen dramatically in the wake of safety concerns that the manufacturers are scrambling to address.

For the industry as a whole, the development is fascinating. How much clinical trial data can be shared? When? To which experts? Generic concepts of corporate data transparency are filtering through to the pharmaceutical and medical device industries. The legacy of ClinicalTrials.gov, New York Attorney General Eliot Spitzer and the Vioxx saga, for better or worse, is that companies can be forced to provide safety data during litigation or the threat of litigation. The strategy at Boston Scientific and JNJ now seems to be to share some trial data selectively with opinion leaders. The goal may not be to nudge the regulatory process or peer-reviewed publication in a particular direction. It may simply be to prevent any company’s critics in academia from having a “gotcha” moment in a courtroom later.

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