An independent audit of the famed Cleveland Clinic on 8 February revealed that the clinic and its scientists have not been attentive enough to financial conflicts of interest. The finding is prompting the clinic to change the way its scientists report and manage conflicts.

The clinic has in the past few months found itself the subject of intense media attention—and not the kind to which it is accustomed. Investigative newspaper reports revealed in December that several clinic officials have had questionable financial ties with makers of medical devices and drugs tested on the clinic's patients. Those reports prompted the clinic to launch the audit.

“The clinic has reached a point of imbalance between innovation and transparency,” the auditors wrote in their preliminary report.

Managing financial conflicts is a challenge for any research institution, but even more so for one with as much of a business slant as the Cleveland Clinic.

“The way I think of the clinic is that it's like a zebra,” says Arthur Caplan of the University of Pennsylvania's Center for Bioethics. “Half of it is a business, half of it is an academic health center. These two creatures don't always fit so nicely together. They make a funny-looking animal.”

The Cleveland Clinic is the most entrepreneurial, most aggressively business-oriented hospital of any I know. Arthur Caplan, University of Pennsylvania

With a cardiac center that is perennially ranked as the best in the US, the nonprofit Cleveland Clinic Foundation generates $3.8 billion in annual revenues and employs 30,000. The institute boasts a 15,000-square-foot 'innovation center' to help its researchers develop and commercialize products—and that mission begins at the top. Chief executive officer Delos Cosgrove, a cardiac surgeon, is the owner of 20 patents.

Much of the recent focus on the clinic has centered on Cosgrove. An internal committee in early 2005 began questioning whether he had undisclosed conflicts of interest. The audit concluded that neither Cosgrove nor any other clinic officer has shown a “lack of integrity,” says clinic spokeswoman Eileen Sheil.

In 2001, Cosgrove had helped launch a venture capital fund, dubbed Foundation Medical Partners (FMP), which would draw on the clinic's expertise to identify promising new drug and device companies. The clinic invested $25 million in FMP and is entitled to receive 38% of its profits. Cosgrove served as one of FMP's three managing general partners.

FMP invested in several firms whose products the clinic's doctors tested on their patients, although they did not disclose these relationships to the patients. In one instance, Cincinnati-based AtriCure developed a device that the clinic's doctors used to correct irregular heart rhythm in nearly 1,250 individuals.

FMP owned about 4.1% of AtriCure's stock and Cosgrove sat on the company's board of directors until March 2005. He told The Wall Street Journal that he stepped down to avoid the perception of a conflict, and that he had been considering doing so before the committee began questioning the arrangement. He has also vacated his role as general partner of FMP.

The Wall Street Journal's report on Cosgrove's ties to AtriCure appeared on 12 December. The same day, the clinic's trustees stripped its cardiology chief, Eric Topol, of his posts as chief academic officer and medical school provost, along with his seats on the conflict-of-interest committee and board of governors.

Topol had helped wage a long and noisy campaign against the now-withdrawn painkiller Vioxx and its manufacturer, Merck. He severed his own ties to industry after a report in December 2004 revealed that he had been advising a hedge fund that profited from a decline in the value of Merck's stock. Clinic officials say Topol's demotion was a streamlining move, but Topol has complained that it was payback for his criticism of Merck. The clinic announced on 9 February that Topol was leaving his post to join the faculty at Case Western Reserve University.

The Clinic's difficulties with conflicts of interest, ethicists say, stems from a dynamic that is troubling but far from unique. More than one-half of US academic medical centers lack policies that mandate the disclosure of conflicts of interest to clinical-trial participants, according to a study published in February (Acad. Med. 81, 113–118; 2006).

“I wouldn't be surprised if, quietly, other systems like the clinic aren't asking themselves, 'What can we do so that we don't get caught like the clinic did?'” says John Kastor, professor of medicine at the University of Maryland.

Kastor, who last year wrote a book about the clinic, says the clinic's organizational structure resembles that of a large corporation more than the lumbering bureaucracy of most universities, and its entrepreneurial ethos is integral to its mission. In any case, few expect that the events will permanently tarnish the clinic's reputation.

“The Cleveland Clinic is the most entrepreneurial, most aggressively business-oriented hospital of any I know, but to be frank, that's why most people travel tens and hundreds of thousands of miles to get there,” says Caplan. “This isn't a place where people jump up and start screaming because their doctor has equity interest in a company.”

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