|Patient Care vs. Corporate
By REED ABELSON and ANDREW POLLACK
Published: January 25, 2005
http://www.nytimes.com/2005/01/25/business/25cleveland.html?th (must register to view original article)
CLEVELAND - Like many prominent researchers at the nation's major medical centers, Eric J. Topol, the chief academic officer of the Cleveland Clinic Foundation, has over the years had consulting and financial ties with numerous drug and medical device companies.
Dr. Topol, an outspoken cardiologist who frequently opines on the medical issues of the day, has done work for drug companies like Eli Lilly, the Medicines Company and a partnership of Bristol-Myers Squibb and Sanofi-Aventis.
Recently, however, as he has come under the spotlight for potential conflicts of interest, he said in a letter to one company that he had decided to end most of his relationships to "maintain my academic credibility."
The decision follows a report in December by Fortune magazine that Dr. Topol, a leading critic of the painkiller Vioxx, was a paid consultant to a hedge fund that had made money betting that shares of Merck, Vioxx's maker, would fall. Dr. Topol severed his ties with that firm, though he said he had no knowledge of the firm's investment position.
His voluntary move to end most of his corporate ties comes as drug makers find themselves under greater scrutiny for their relationships to researchers. At the same time, medical centers are trying to deal with doctors who are increasingly entangled with companies whose primary goal is to make money, not necessarily to deliver the most appropriate care.
The Cleveland Clinic, one of the most entrepreneurial and prestigious medical institutions in the country, for one, is struggling to revamp rules intended to ensure that corporate connections do not lead to bias in patient care or academic research. But it is far from willing to sever all ties.
The clinic, a nonprofit health system with nearly $4 billion a year in revenue, has in recent years become the epitome of Medicine Inc., where doctors and researchers are encouraged to develop new drugs, devices and medical treatments.
It is hardly alone in confronting these ethical questions. But the aggressive and freewheeling capitalist spirit that has taken it to the top of the medical profession has also made conflicts of interest more visible than at many other institutions.
Many of Dr. Topol's colleagues on this sprawling 130-acre campus are starting companies and serving as consultants and board members. In some cases, they may use their patients in clinical trials to test new treatments in which they have a financial stake.
"All of these financial arrangements with industry yield various kinds of conflicts," said Dr. Jerome P. Kassirer, a former editor in chief for The New England Journal of Medicine, who recently wrote a book, "On the Take" (Oxford, 2004), about the undue influence of business on medicine.
To address those concerns, the Cleveland Clinic says it is overhauling its ethics policies, and will present them to the board for approval, perhaps within weeks.
"We want to protect data from money," said Guy M. Chisolm III, a cell biologist who is spearheading the effort. "Money has no role to play in validating and directing data."
But getting consensus on solutions is no easy matter, Dr. Chisolm said. "We've grappled with them, we've debated them."
Delos M. Cosgrove, for one, who took over as the clinic's chief executive last October, says he does not believe that across-the-board restrictions are desirable. "What we want to do is encourage innovation," Dr. Cosgrove said. "There are always going to be conflicts in the world."
The clinic, even in its new policies, will not prohibit financial relationships that give rise to conflicts. Most medical centers refuse to take this step because they rely on money from private industry, and they argue that any prohibition on outside business ventures would cause the best researchers to flee to institutions that allow them to profit more from their inventions.
A few academic centers go as far as preventing researchers from studying a drug or a device from a company in which they have any financial interest. Harvard Medical School, for example, does not allow its researchers to receive significant compensation from serving as consultants or holding equity in private companies if they are studying anything related to those companies.
But like most institutions, the Cleveland Clinic is trying to avoid outright bans by asking researchers to disclose their ties and trying to minimize the effect of the conflicts.
Dr. Mildred K. Cho, a medical ethicist at Stanford University, however, argues that managing conflicts, especially when the institution is itself involved, is "unlikely to be very effective, given all the pressures that are pushing in one direction."
Situated in a dismal area of Cleveland, the clinic, which was founded by four doctors in 1921, essentially operates as a gigantic group medical practice. It takes immense pride in its delivery of cutting-edge medicine, having pioneered angiography and coronary bypass surgery.
Under the direction of its former chief executive, Floyd D. Loop, also a cardiac surgeon, the clinic amassed more than a dozen hospitals and focused its attention on one of the most profitable areas of medicine - cardiac care. Within the last few years, it has started both a medical school and a venture capital fund called the Foundation Medical Partners, which invests in companies founded both on campus and outside.
Though it sits in a gritty urban center, the medical center fairly gleams with freshness and wealth. Its paying customers - patients with insurance - are able to help finance the clinic's constant expansion and renovation. "Our facilities are second to none," boasted Michael O'Boyle, the system's chief financial officer.
The institution is now pouring some $500 million - $300 million of which is expected to come from charitable donations - into a new heart center, intended to showcase the latest in cardiac care and to treat the tens of thousands of heart patients who visit the clinic each year. The expansion comes on the heels of the construction of a new stem-cell research center.
All of this display of financial resources has drawn criticism among some in the community that the Cleveland Clinic has provided very little charity care to patients without insurance. It is among a group of hospitals being sued by plaintiffs' lawyers across the country contending that the hospitals violated their obligation as charities by overcharging people without insurance. Some community leaders have mounted legal challenges to the clinic's moves to exempt certain operations from local taxes.
The clinic argues that it does its fair share and that any profit goes into areas like research and education. "We have no shareholders, we have no market capitalization," said Mr. O'Boyle. "What we make we re-invest." The clinic also says the lawsuit is without merit.
Yet the clinic is unabashed in its push to capitalize on the medical expertise of its 1,400 doctors to increase its revenue to finance research. In 2003, the clinic says it filed for more patents per research dollar than the Mayo Clinic, Johns Hopkins Medical Center or Massachusetts General Hospital, the Harvard-affiliated Boston hospital.
"I think they're a lot more entrepreneurial than many of the others," said Martin D. Arrick, an analyst with Standard & Poor's, who follows the debt of tax-exempt hospitals. He praises the Cleveland Clinic for investing in those areas where it excels. "They've followed a strategy of making their core asset shine, and you can see that."
Dr. Cosgrove is particularly familiar with the interplay between industry and medicine.
He personally holds nearly 20 patents and developed a new catheter that reduced the number of strokes in patients undergoing heart surgery. He also sits on the board of medical device companies like AtriCure and Novare Surgical Systems and serves as a general partner in the venture fund started by the Cleveland Clinic.
The venture fund is independent of the clinic, though the clinic has provided about a third of its financing to date. The fund makes its own investment decisions, but the clinic is a special limited partner that receives a share of the profits in return for access to the doctors' expertise. Dr. Cosgrove says he does not plan to sever his outside relationships anytime soon unless the clinic's board determines that these relationships are inappropriate.
"I spent 30 years developing relationships with industry," he said. "I was an inventor and an entrepreneur and asked to be a venture capitalist by the institution."
Similar ties abound at the clinic. For example, the venture capital fund has invested in CardioMEMS, a device company in Atlanta started by a clinic doctor. The clinic recently started patient studies of an implantable sensor made by CardioMEMS used in surgery to repair an aortic aneurysm. Dr. Topol also served as a consultant to CardioMEMS.
AtriCure, a small Cincinnati company making an atrial fibrillation device, has also received financing from the venture fund. At the same time, the clinic is conducting a clinical trial of a new AtriCure treatment and the clinic's atrial fibrillation center often uses AtriCure products.
The clinic has also invested in Novare Surgical Systems. The first use in the United States of Novare's device, an alternative to traditional methods of surgical clamping in beating-heart bypass surgery, was at the clinic.
Dr. Cosgrove said these kinds of relationships have all been scrutinized by the board, and that he plays no role in any decisions involving the use of devices from these companies.
"There's a difference between being conflicted and the appearance of conflicts," Dr. Cosgrove said. But managing the appearance of conflicts, as Dr. Topol learned after Fortune magazine revealed his involvement with the hedge fund, can be difficult.
"I think there's a real problem in academics today," Dr. Topol said. "There's a very close-knit relationship with industry, and it's too close when any individual can derive a profit from that relationship."
Indeed, Dr. Kassirer said it was often quite difficult to discern the subtle factors that affected decisions about patient care. Research has suggested that doctors who invent a medical device tend to use that device even where there are better alternatives available.
"It has an influence on what you do," he said.
The Cleveland Clinic says it is currently reviewing some of the potential conflicts related to its own investments. Under the clinic's current rules, situations that create the potential for conflict of interest for an individual doctor must be approved by a special committee. The proposed policies - which would also apply to the clinic's own financial relationships - would lower the amount of the financial benefit that would set off a review to $10,000 from $25,000, with increased involvement by the clinic's Institutional Review Board, which oversees research involving patients.
When there are institutional conflicts, including conflicts involving clinic executives, the clinic plans to propose a separate review process that would include members of the clinic's board.
In recent months, the clinic has had its statisticians or outside specialists review data independently when a study involves a researcher with a potential conflict of interest.
Dr. Chisolm acknowledges that these strategies are works in progress. The question raised by ethicists like Dr. Kassirer and Dr. Cho is whether it can be done effectively, if at all.
"The ideal of handling these conflicts of interest," Dr. Kassirer said, "is not to have them at all."
Reed Abelson reported from Cleveland for this article and Andrew Pollack from Los Angeles.