June 1st, 2011

More Questions Raised About Biotronik’s Relationships with Cardiologists

A story by Barry Meier in the New York Times provides new details about a widening investigation into the suspiciously close relationship of referring cardiologists and implanting electrophysiologists with the upstart heart device manufacturer Biotronik. The story cites examples of exchanges between Biotronik employees and their dealings with the physicians. According to Meier, the company is also the subject of a Justice Department investigation.

In one email, a Biotronik executive writes to his colleagues that in order to sell more pacemakers and defibrillators the company will need to fund unnecessary clinical trials to help physicians “generate income from research fees.” Referring cardiologists, who are called “feeders” in one of the documents, can receive as much as $4,800 for every patient they enroll in a company-financed study, Meier reports.

A lawyer for Biotronik told Meier that the company resisted pressure to fund “unscientific studies” and that all of the studies performed by the company were “scientifically sound.”

One former Biotronik employee provided the Times with numerous documents demonstrating how the company influenced physicians in Tucson, Arizona to dramatically increase their use of Biotronik products. One referring cardiologist told an electrophysiologist that he would not refer patients to him unless he started using Biotronik devices. Another electrophysiologist who accepted referrals from the cardiologist increased his usage of Biotronik products eightfold, reaching $1.1 million in 1 year.

A California electrophysiologist appeared caught between Biotronik and Medtronic. He told a Biotronik employee that his referring cardiologists insisted that he use Medtronic devices. The Biotronik official wrote his colleagues that this physician “candidly stated it is the referring community that must accept Biotronik in order for him to implant with us.”

In a previous article, the Times Barry Meier reported that several electrophysiologists in Las Vegas dramatically increased their usage of Biotronik products after becoming paid Biotronik consultants.

 

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