How a famed hospital invests in device it uses
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CLEVELAND -- Since 2001, more than 1,200 patients at the prestigious Cleveland Clinic have had an operation aimed at correcting atrial fibrillation, a form of heart fluttering.
Doctors commonly call it the "AtriCure procedure," after the maker of the equipment used in the surgery, a company called AtriCure Inc. In medical journals and at conferences, the Cleveland Clinic and its doctors have been leading advocates of the AtriCure procedure.
The Clinic's relationship with AtriCure, however, goes deeper. A venture-capital partnership that the Clinic helped found and invested in owns about 4.1 percent of AtriCure's stock, valued at about $7 million. The Clinic's chief executive, heart surgeon Delos "Toby" Cosgrove, sat on AtriCure's board of directors until March. He also invested personally in the fund and was one of the general partners managing it until, according to a Clinic spokeswoman, he cut his ties to the fund at the end of October.
In addition, Dr. Cosgrove will be entitled to royalties for a medical device he developed that AtriCure plans to begin selling next year. Marc Gillinov, another Clinic surgeon who performs the AtriCure procedure, is a paid consultant to the company, as is another doctor who recently left the Clinic.
The Clinic didn't disclose these ties to AtriCure to the patients on whom it performed the AtriCure procedure. The venture fund the Clinic helped found has also invested in two other medical companies conducting clinical trials at the Clinic.
All this last spring came to the attention of the hospital's conflict-of-interests committee, where famed cardiologist Eric Topol and blood specialist Alan Lichtin were among those who questioned the ties to AtriCure, according to people familiar with the situation. Dr. Cosgrove last week told Dr. Topol he was losing his top post at the Clinic's medical school, a change that will take Dr. Topol off the conflict-of-interests committee and the Clinic board of governors. Dr. Topol also is an outspoken critic of Vioxx, the withdrawn Merck & Co. drug, and testified at a trial against Merck.
The Clinic ascribed Dr. Topol's loss of his medical-school position -- as provost and chief academic officer -- to an administrative reorganization. Asked whether it was related to his criticism of Vioxx or of the Clinic's ties to AtriCure, the Clinic spokeswoman said no. Dr. Topol had a conflicts issue of his own last year when an investment fund to which he was a paid adviser bet against Merck's stock. He resigned that post.
The Cleveland Clinic's board of trustees, meeting today, is expected to discuss the change in Dr. Topol's status, which needs its approval. Meanwhile, at the behest of the conflicts committee, the Clinic this spring redid a consent form for atrial-fibrillation patients taking part in clinical trials, and it imposed a limit on the consulting fees doctors could earn.
The Cleveland Clinic is a huge and prominent establishment with 30,000 employees and $3.8 billion in revenue last year. Besides its main 155-acre complex, it owns eight other hospitals in the area, two more in Florida and three hotels. Its cardiac center, routinely ranked No. 1 by U.S. News and World Report magazine, is building a new $400 million complex in the city.
In an interview, Dr. Cosgrove said the Clinic favors the AtriCure procedure because it works and is safe, not because of any financial considerations. Clinic doctors and others have reported that nearly 90 percent of patients have normal heart rhythms six months after the procedure. Long-term data are sketchy.
The Food and Drug Administration has three times rejected AtriCure's application to have its system approved for cardiac use, most recently earlier this year. Doctors may legally do the procedure anyway because the equipment is approved for "soft tissue" surgery. Though that category doesn't include the heart, they may use it on the heart in what's known as "off-label" usage. AtriCure says that all current use of its equipment is off-label.
Four patients are known to have died shortly after having the AtriCure procedure, at hospitals other than Cleveland Clinic. AtriCure didn't notify the FDA -- which requires companies to tell it of any "adverse consequences" related to their products -- because it says it didn't believe its equipment was to blame. Dr. Cosgrove said he wasn't aware of the patient deaths.
First Published December 12, 2005 12:00 am
