The age of the magic pill is over–and nobody knows this better than U.S. pharmaceutical giant Merck & Co., Inc. The recent US$253-million settlement awarded by a Texas jury to the family of a man who died after taking the company's blockbuster Vioxx painkiller has created a massive headache for the Whitehouse Station, N.J.-based firm. Merck plans to appeal. Meanwhile, thousands of other lawsuits have been filed in Canada and the U.S.
Sales of the entire Cox-2 inhibitor family of drugs (of which Vioxx is a member) are down, and Canadian retail pharmacies such as Shoppers Drug Mart and Pharma Plus recorded a 26.3% drop in Vioxx prescriptions in 2004 compared to a year earlier. But there is some good news. Industry experts say the Vioxx ruling could help to force government agencies and pharmaceutical companies to inject millions more into long-term drug safety studies, after their products have hit store shelves. It's a new concept, known as post-marketing evaluation, and it involves clinical research that looks at the long-term effects of medications used to treat chronic conditions such as high blood pressure.
“This is a new area of surveillance that the Cox-2 inhibitor problem has sparked interest in,” says Joseph D'Cruz, a professor at the University of Toronto's Rotman School of Management who specializes in health-care strategy. “The idea that the so-called miracle drugs don't have associated negative side effects has to be dispelled.” Although there is no legislation in Canada or the U.S. that mandates compliance with these long-term safety studies, D'Cruz believes a renewed interest in patient safety could change that. And with support from Health Canada to sponsor long-term research by organizations such as the Toronto-based Institute for Clinical Evaluative Sciences, patients and drug companies would benefit equally. These studies may not do much for Merck's current headache, but they will certainly help to lessen the pain in the future.