The Cleveland Clinic ranks among the best-known hospitals in the nation, joining institutions like Johns Hopkins Hospital and the Mayo Clinic among healthcare's aristocracy.
But the elite institution is now struggling with ethical issues that have triggered an uncomfortable self-examination over potential conflicts in its business practices and the cozy relationships that exist between top officials, physicians and the high-tech vendors that sell products to the clinic.
Toby Cosgrove, the hospital's chief executive officer, asked for an independent review of conflict-of-interest policies just days after news reports in mid-December 2005 detailed his role as a board member of a medical-device company that the clinic helped found through a venture-capital partnership. The clinic reportedly owns about $7 million worth of stock in AtriCure, whose products are used by clinic doctors to correct atrial fibrillation. Cosgrove, a well-known cardiac surgeon, invested in the venture-capital fund and served as a general partner until he cut his ties about two months ago.
The well-publicized controversy at the famous hospital could trigger soul-searching at other institutions grappling with this potentially volatile mixture of private industry, academic research, patient care and profits.
For example, revelations of Cleveland Clinic's arrangements with vendors led to a critical reappraisal of the 3-year-old conflict-of-interest policy at the Johns Hopkins University School of Medicine in Baltimore, said Julie Gottlieb, assistant dean for policy coordination.
"I think many institutions are evaluating what policies and procedures they have in place to capture and manage or eliminate conflicts of interest," Gottlieb said. "This (situation with the clinic) is a very high-profile case. It's a strong reminder to all of us in this business that we need to make sure we have robust policies."
To some, the case is a another example of the blurred ethical lines in an industry where drug companies lavish gifts on doctors to prescribe their costly medicines and peer-reviewed medical studies are conducted by researchers with ties to drug companies. Just last week, the Journal of Thoracic and Cardiovascular Surgery announced a new policy that will bar authors who fail to disclose financial ties to industry. The tough new guidelines stemmed from the failure of two authors, including Cleveland Clinic heart surgeon Mark Gillinov, to disclose their financial ties to AtriCure in a September 2005 article that cast the company in a positive light.
Meanwhile, it has become more routine for doctors and healthcare executives to sit on the boards of directors of for-profit vendors that do business with their institutions, a situation that can generate at least the perception of a conflict of interest. In February 2005, the National Institutes of Health unveiled a strict policy prohibiting all employees from taking drug-company money in the aftermath of news reports that raised questions about those relationships.
"There's kind of a tsunami of trouble out there for healthcare in terms of these kinds of conflicts," said Arthur Caplan, director of the Center for Bioethics at the University of Pennsylvania. "The situation with the Cleveland Clinic may be a big wave, but it's just one of many. It definitely gives the clinic a black eye. I think they're going to have some work to do to rebuild their reputation."
Like Gottlieb, Caplan said he thinks the harsh media attention focused on the Cleveland Clinic sends a "strong message" to other institutions that "you'd better re-examine policies and stances on conflicts of interest." While he suggests that the industry "doesn't know or have an agreement on how to manage conflicts of interest," he said the simple formula boils down to two key principles: "One: Where there are conflicts, disclose them; and, two: Don't study what you own."
"I think the biggest lesson from the Cleveland Clinic situation is that no institution -- even our best -- has figured out a way to manage conflicts of interest. It's almost time, I think, to have a national retreat to look at this subject, because it's out of hand and destroying the moral standing of healthcare."
Gottlieb, of Johns Hopkins, blamed a "combination of factors" leading to the ethics quandaries, pointing specifically to the omnipresent pharmaceutical industry and its increasingly close ties to academia and medical research studies. "What makes the Cleveland Clinic unique is their investment in a venture capital firm, and their CEO's investment," Gottlieb said. "It makes that set of relationships that much more complicated and troubling."
Malachi Mixon, a Cleveland businessman who is chairman of the hospital's board of trustees, said it's almost impossible for a big hospital like the clinic not to have some type of relationships between executives, doctors and the medical industry.
"For some reason, the press has decided that conflict of interest is evil," Mixon said. "We believe that conflicts of interest create a potential for wrongdoing. But you must have a strong policy and adequate safeguards. If you're an organization like the Cleveland Clinic, we want our doctors to work with industry, including drug companies, device companies, entrepreneurs and others to develop and advance medicine."
Mixon himself came under scrutiny in the wake of the revelations about Cosgrove because of his potential conflicts as CEO of Invacare, a healthcare supply company in the Cleveland area that conducts about $200,000 per year in business with the clinic. He said the figure represents a tiny fraction of a business with annual revenue of $1.5 billion. He said the clinic couldn't fill the board with qualified individuals without accepting the fact that some will have business ties to the hospital. Indeed, three other individuals have direct ties with both Invacare and the clinic. The Invacare board also includes Bernadine Healy, a physician and the former head of the American Red Cross who is married to Floyd Loop, Cosgrove's predecessor as the clinic's top official.
Last year, Loop, who retired in 2004 after 15 years as the clinic's CEO, was named to the board of Cleveland-based Noteworthy Medical Systems. The private firm declined to disclose board members' compensation. In another recent example of this trend, Paula Johnson, a cardiologist who is an associate professor at Harvard Medical School and the founder of the Center for Cardiovascular Disease in Women at Brigham and Women's Hospital in Boston, was named to the board of West Pharmaceutical Services. The company pays its board members a retainer of $20,000, along with other compensation.