There Will Be Blood and Money
And a lawsuit. And many, many questions about the relationship between a local hospital and the world’s largest medical device company.
As a teaching hospital affiliated with Tufts Medical School, Lahey has always been proud of the research it’s done, but in recent years it has invested ever greater time and resources in conducting clinical trials. The number of studies undertaken by the cardiology department alone has tripled over the past five years. The benefits of hosting so many trials are numerous: They attract high-profile doctors who want to be leaders in their fields, and, in turn, patients who want the best treatment they can find. They also tend to bolster a facility’s standing in the medical world — today, Lahey has one of the most highly rated cardiology departments in the country.
By the summer of 2009, the talk among cardiologists nationwide was about the upcoming trials for an exciting new device: an artificial heart valve called CoreValve. Because it could be threaded into place through a patient’s artery, a process far less invasive than traditional open-heart surgery, CoreValve was expected to be a blockbuster device (especially after it showed promising results in European tests). Medtronic foresaw a multibillion-dollar market for the valve — which is why it bought the company that developed the technology for $700 million in early 2009.
Piemonte knew that CoreValve could help countless patients, and that they would flock to the hospitals that had the most experience with the device. Like other ambitious cardiologists across the country, he also knew that Medtronic would be selecting just a few dozen hospitals to participate in U.S. trials.
WHILE CATH LABS were buzzing over Medtronic’s upcoming trials for CoreValve, Gossman had apparently begun to harbor concerns about the company’s Endeavor stent. Gossman had used Endeavor after it was first released, but eventually moved away from it after reading several studies that seemed to suggest the device’s restenosis rate was higher than that of other brands (other studies tout the value of the Medtronic stent). Though restenosis is rarely life-threatening, patients who get it often have to go back to the hospital for additional surgery. Gossman was hardly the only cardiologist to make such a decision: After initially claiming 20 percent of the market, Endeavor’s share had fallen to roughly half that.
Despite the growing pile of literature detailing Endeavor’s problems, Gossman couldn’t help but notice that some Lahey doctors still seemed intent on using the device. He began to wonder why that was — and whether the answer had something to do with the hospital’s interest in landing a CoreValve trial.
On August 27, 2009, Gossman walked into a presentation for Lahey cardiologists and department fellows. The subject of the talk was clinical research at Lahey, including the role of the hospital’s institutional review board, which vets the ethics of prospective projects. Gossman took a seat across the room from Piemonte.