Thursday, February 24, 2005

Vioxx and Other Painkillers: More Confusion, Less Relief? Although this article at Wharton's Public Policy and Management web site focuses primarily on Vioxx, its treatment of the pharmaceutical industry and FDA regulation may be of interest to many readers - " According to Wharton management professor Lawrence Hrebiniak, author of a new book entitled Making Strategy Work: Leading Effective Execution and Change, flaws in the culture and business model of the pharmaceutical industry are illustrated by Vioxx and the other Cox-2 inhibitors. Drug companies, he argues, have become overly reliant on the blockbuster model in which huge investments in research are targeted to a drug that could reach massive sales volume and drive profits for the entire organization. The model breaks down when a problem arises, he says. If safety concerns crop up, there is little incentive for executives to pursue [these concerns] since the company has invested so much in developing the drug. ... FDA culture and the structure of the regulatory system are bound to create problems with monitoring drug safety after a product goes on the market, Field notes. That is a critical time for drugs because most are only tested on several thousand people before gaining marketing approval -- not enough to pick up side effects that would occur in one out of 10,000 cases or even less frequently, he suggests. 'There's an institutional culture within the FDA that presents an inherent conflict of interest,' says Field."