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The Chickens Came Home to Roost… Tom Curb, R.Ph.
(Almost four years ago, I recommended to all funded prescription benefit plan Sponsors that prescribing protocols be established for certain drugs, including Vioxx and Celebrex, and that these "COX-2" drugs be MAC’d against naproxen – an inexpensive generic NSAID that was just as effective for pain relief, but did not have the implications of increased heart attack and stroke associated with Vioxx. Because of member demand generated by direct-to-consumer advertising and manufacturer pressure on physicians, unfortunately only one benefit plan complied. Although the expensive COX-2 drugs were aggressively promoted as causing fewer GI problems than "blood-thinning" aspirin (the historic NSAID), upon exposure of Vioxx’s clotting problems, a representative for Vioxx’s manufacturer, Merck, flippantly retorted, "Let patients take an aspirin with their Vioxx." Now, as Granny said, "the chickens have come home to roost".) From "Good Riddance to a Bad Drug" – by Eric J. Topol: "After three years of denying that its arthritis drug Vioxx could induce heart attacks and strokes, this week Merck bowed to reality: It withdrew Vioxx from the market. The impact of this decision is far-reaching, and not only because tens of millions of people have tried Vioxx - it also highlights the absence of Food and Drug Administration (FDA) oversight of the pharmaceutical industry…" In 2001, Topal helped publish a paper demonstrating the significant heart attack risk of Vioxx and reporting that, compared to naproxen, a commonly used over-the-counter anti-inflammatory drug with similar benefits, Vioxx has a five times greater heart attack risk. In response to this study and others demonstrating Vioxx's dangers, Merck claimed that the studies were "flawed." Now, Merck finally has acknowledged the truth - that 3.5% of patients taking Vioxx suffer heart attacks or strokes as against 1.9 percent taking a placebo – almost double the rate. Topal emphasizes two important issues: First, the risk of heart attack or stroke may be greatly underestimated - the number of patients who may have sustained heart attack or stroke as a result of using the COX-2 drugs could be tens of thousands. Second, and what may be more alarming, is that despite studies showing the magnitude of the public health problem, for several years Merck did nothing to investigate, revealing a conflict between the interests of the public and the interests of a company with a blockbuster drug that had sales of $2.5 billion in 2003. While Merck was spending at least $100 million a year for direct-to-consumer Vioxx advertising, the company's employees and their consultants published papers challenging the studies that exposed Vioxx's cardiovascular risks. Topal says, "The FDA could have forced Merck to do the appropriate research studies, but instead it was a bystander. As the Vioxx debacle shows, we have a long way to go in this country to get on track with prescription medications. Most important, we need a stronger regulatory agency* (than FDA) to compel pharmaceutical companies to do the proper studies and force these companies to stop direct-to-consumer advertising unless a drug has major benefits for patients… Our two most common deadly diseases (heart attacks and strokes) should not be caused by a drug." *Despite the findings of a belated study led by David Graham, associate director for science in the FDA drug center's office of drug safety and Drug Administration safety, projecting that the widespread use of Vioxx may have led to more than 27,000 heart attacks and sudden cardiac deaths , Steven Galson, the acting director of the FDA's drug center, said "…it is too early to say" whether the agency agrees with the findings of the authors - the FDA’s own experts.
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