"Eric J. Topol", M.D., is an American cardiology/cardiologist, genetics/geneticist, and researcher. Much of Topol's career was spent at the Cleveland Clinic, where he served as chairman of cardiovascular medicine and founded the Cleveland Clinic Lerner College of Medicine. Topol was one of the first researchers to question the cardiovascular safety of rofecoxib (Vioxx), culminating in the drug's ultimate withdrawal from the market. Topol's advocacy on the subject led to what the New York Times described as an "unusually public dispute" with the Cleveland Clinic's leadership over ties between the academic institution and the pharmaceutical industry, ultimately leading to Topol's departure from the Clinic after his academic position was abolished.

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This is such a big and important medical technology, and there's not a systematic attempt in getting these devices interrogated if a patient dies.

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My view is that we're not ready for that.

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There has been a series of blatant problems, ... This is the worst situation we've faced in decades at the FDA.

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The FDA did nothing to assure that the proper trials were conducted, but at the same time allowed mass-marketing campaigns with hundred of millions of dollars supporting direct-to-consumer advertising.

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There has been a series of blatant problems. This is the worst situation we've faced in decades at the FDA.

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The [drug-approval] system was tested in ways it was never tested before. In an era of mass marketing, where data may show uncertainty and where the FDA has no real authority to take action, this class of drugs was set up to fail.

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They actually were harmed. This was a trial to determine the boundaries of benefit, and it did. You don't use this drug for patients without coronary artery disease.

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