March 16, 2006

Physician, Divest Thyself:
Lessons from the Cleveland Clinic

Peter Levin and I penned the editorial in the current issue of AJOB on an issue that attracts more readers to this blog than most others: continuing controversy concerning Cleveland Clinic cardiovascular docs Eric Topol and Toby Cosgrove. Here's our take:
Cleveland Clinic is among the world’s elite healthcare institutions, and is a major initiator of improvements in cardiac care. It also is one of the last healthcare institutions in the country still under the complete control of physicians. The Clinic’s CEO, cardiac surgeon Dr. Delos “Toby” Cosgrove, answers to no academic officer or faculty senate. The Cleveland Clinic stands for physician independence, and that is what is in jeopardy. Patients expect physicians to make judgments on treatment solely based on their needs and wishes, not on the economic interests of the physician.

One such conflict of interest arose when Dr. Eric Topol, Chairman of the Clinic’s Department of Cardiovascular Medicine, long the top-ranked cardiovascular group in the nation, came under fire in Fortune magazine in late 2004 (McLean 2004). The issue was Vioxx, a COX-2 inhibitor and part of a class of selective non-steroidal antiinflammatory drugs (NSAIDs) used in the treatment of arthritis, pain and migraine. Vioxx had long been a subject of Dr. Topol’s scrutiny. In 2001, for example, he published a paper in the Journal of the American Medical Association (JAMA) warning of potential health dangers associated with use of COX-2 inhibitors, and calling on Merck to do a long-term study to investigate whether Vioxx increased cardiovascular risks (Mukherjee et al. 2001). He also asked the FDA to demand specially designed safety studies of Vioxx. These studies never happened.

However, the Fortune article erroneously suggested that Dr. Topol might have shared his views on Vioxx in his subsequent role during 2004 as a medical advisor to Great Point Partners LLC, a hedge fund that, by definition, frequently sells shares on the belief that they will lose value, with the aim of buying them back more cheaply later. In the fund’s newsletter to its investors after the Vioxx withdrawal, the hedge fund claimed it had made money by shorting Merck–the price of Merck stock dropped 37% in a matter of days following the September 30th announcement of the drug’s withdrawal.

But this had nothing to do with Dr. Topol, who had no investment or interest in the fund, and had not discussed Vioxx or Merck with the fund.. Nevertheless, in the unexpected heat of the media spotlight he acknowledged the dangers of even appearing to be a clinician-cum-sentinel for stock brokers. Topol then did something extraordinary: he turned his error into a research project, demonstrating in another JAMA study that more than 75,000 clinicians and researchers consult for hedge funds, stock analysts and venture capitalists (Topol and Blumenthal 2005). He also suggested new strategies to avoid these conflicts.

In December 2005, Dr. Topol gave videotaped testimony in the case of Irvin/Plunkett v. Merck, taking the stand to discuss his study of Vioxx and other COX-2 inhibitors. That videotape deposition is now sealed, but TheWall Street Journal obtained a transcript and published portions in which Dr. Topol “accused Merck of scientific misconduct, misrepresenting facts and endangering patients, and said Merck’s former chief executive complained to a top Cleveland Clinic official about Dr. Topol’s activities” (Tesoriero 2005).

Just days after his testimony, the Cleveland Plain Dealer and many other papers carried a shocking story: Dr. Topol’s key leadership roles at the Clinic were eliminated by Cosgrove, who offered no substantive comment either on Dr. Topol’s testimony or on the reasons for his demotion.

Then, on December 12, 2005, The Wall Street Journal reported that under Dr. Cosgrove’s leadership, the Clinic had failed to disclose to patients that it held a substantial interest in the company that makes equipment used in a procedure called “AtriCure,” a new treatment for atrial fibrillation (Armstrong 2005). More significant, Cosgrove did not disclose to Clinic patients that he himself was a general partner managing the company and an investor in it, and thus stood to benefit personally from AtriCure, as well as from another device the company is developing: the “Cosgrove clip.”

It is always important to be clear with patients about conflicts of interest. In the case of AtriCure, long-term studies have not yet been completed on either the safety or the efficacy of this controversial treatment. The Journal found that the company had failed to notify the U.S. Food and Drug Administration (FDA) that four patients died shortly after undergoing the AtriCure procedure. The FDA has refused to approve the procedure for cardiac use, though clinicians may use it “off-label.”

The general assumption is that patients should be able to trust that their physician will lay out all of the complicated facts about innovative therapies in an open and unbiased way. As co-author of a key article evaluating the procedure, Dr. Cosgrove failed to disclose any conflict of interest, including his own and the Cleveland Clinic’s financial ties to AtriCure. Physicians cannot hide from their patients any financial or even a purely research interest they may have in a particular therapy.

It was also reported in the Wall Street Journal that AtriCure was discussed by the Cleveland Clinic’s conflictof- interest committee at the insistence of, among others, Dr. Topol. Dr. Cosgrove again denied any conflict of interest, and claimed that AtriCure Inc. did not make him aware of any deaths associated with the procedure. But Dr. Cosgrove took another important action: along with other leadership positions, he stripped Eric Topol of his seat on that very same conflict-of-interest committee. To whom could Topol then turn with his concerns? As the Journal revealed in yet another story about the matter, of the 87 members of the Cleveland Clinic’s Board of Trustees more than half do business with the Clinic in some way (Armstrong and Stecklow 2005).

The appearance that practicing physicians have major conflicts of interest is deleterious for any American hospital, but the Cleveland Clinic should be held to an even higher standard. The Clinic represents the idea that physicians can police themselves by holding fast to the ethics and leadership roles that stem from the autonomy and skill of the physician. The physicians at the tiller of the Cleveland Clinic steer not only one of the top programs in cardiovascular care in the world, but also one of the last great symbols of physician dominance in healthcare.

We, as a society, do not ask venture capitalists to take an oath to abstain from being harmful to others’ businesses. Not so with physicians. One of the key ethics of the physicians’ guild, affirmed in more than a dozen codes of ethics, is that doctors should not profit from the drugs or devices that they develop for use on their own patients. The Hippocratic Oath states, “I will follow that system . . . which, I consider for the benefit of my patients, and abstain from whatever is deleterious and mischievous.” Physicians can be physicians or venture capitalists. They should not be both.

[revised 3/30/6]

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