Word: merck
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Dates: during 2000-2009
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...wasn't just big news when Merck announced last week that it was pulling Vioxx off the market; it was a bombshell that rocked financial markets and set doctors' phones ringing. A few days earlier, an independent panel had concluded that taking the drug for more than 18 months doubled the risk of suffering a heart attack or stroke. Merck had a choice: it could beef up its warning labels, or it could bite the bullet and pull its blockbuster off the market. Given the legal risks of selling a drug known to cause heart problems, Merck probably...
...reaction on Wall Street was swift and brutal. Merck's chief executive Ray Gilmartin announced that the company's 2004 earnings could shrink as much as 20%. Its stock promptly lost $28 billion of its market value, temporarily dragging the Dow Jones industrial average down with it. The timing could not have been worse for Merck, whose sales last year grew a paltry 5%, compared with 23% in 2000, and whose big anticholesterol drug Zocor will lose patent protection in 2006, with nothing to replace it. Some analysts wondered whether the company was ripe for a merger--an idea Merck...
...Celebrex has been studied the longest; some patients in three ongoing Celebrex trials have been followed for several years without any signs of cardiovascular effects. Bextra, also from Pfizer, hasn't been tested as long, but so far the data look good. Two more COX-2 inhibitors, Arcoxia (from Merck) and Prexige (from Novartis), are awaiting FDA approval. "Obviously, we now have to look more carefully at the other members of the class," says Dr. Steven Nissen, a cardiologist at the Cleveland Clinic who voiced his concerns about Vioxx several years...
...that compared Vioxx with naproxen (the active ingredient in Aleve) showed that Vioxx cut gastrointestinal problems in half but increased the risk of heart attack from 0.1% to 0.4%. Those results were ambiguous, though. Was Vioxx causing the heart attacks, or was naproxen protecting the heart? Few experts fault Merck for continuing to market Vioxx on the basis of that study alone...
...evidence didn't stop there. Subsequent studies based on reviews of large numbers of clinical records continued to show troubling indications. The final straw was a piece of research that Merck conducted. It was a particularly careful study--a randomized, double-blind trial of 2,600 patients, comparing Vioxx with a placebo--designed to determine whether Vioxx might prevent the formation of polyps in the colon. The study was scheduled to last three years, but two weeks ago, the panel of doctors and statisticians that was monitoring the trial's safety data informed Merck that the evidence of cardiovascular problems...