The Vioxx story: would it have ended differently in the European Union?

I. INTRODUCTION The rise and fall of the pain-killer Vioxx is one of the most remarkable marketing stories in pharmaceutical history. A true riches to rags tale, its events unfolded with lightning speed in an industry defined by lethargy. On May 20, 1999, the Merck Company secured FDA approval of Vioxx for the management of acute pain in adults and for relief of the signs and symptoms of osteoarthritis.2 From that date through August 2004, 105 million Vioxx prescriptions were filled in the US3 and an undetermined number were filled outside the US.4 In 2003 alone, Merck's worldwide Vioxx sales totaled $2.5 billion.5 The fall happened even more quickly than the rise. In March 2000, Merck published a study raising the specter of cardiovascular problems associated with taking Vioxx.6 In November 2000, The New England Journal of Medicine published a study raising similar concerns.7 In February 2001, an FDA advisory panel became sufficiently concerned about the association of Vioxx and cardiovascular events that it advised the FDA to require a label warning about the possible link.8 Merck continued, however, with an aggressive marketing campaign to physicians that minimized any link between Vioxx and cardiovascular events.9 Then, in September of 2001, the FDA warned Merck to cease misleading physicians and in April 2002 ordered Merck to add label warning about cardiovascular risk.10 Finally, on September 30, 2004, Merck withdrew Vioxx from the market in the U.S. and over 80 other countries as concerns about the risks of using Vioxx mounted.11 Of course, Merck suffered economic fallout over the withdrawal of Vioxx. Merck's stock has plunged by thirty percent since the withdrawal12 and it recently announced that it was closing five manufacturing plants and laying off approximately seven thousand workers-eleven percent of its workforce.13 Moreover, in the midst of this woeful news, Merck's CEO announced that he will step down.14 There is litigation fallout, too. To date, Vioxx patients and their survivors have filed more than 6,000 lawsuits against Merck.15 That number is growing exponentially and is expected to swell to more than ten thousand.16 So far, the scorecard is inconclusive. Merck and the plaintiffs each have a victory and a third case ended in a mistrial.17 While estimates on eventual total liability vary wildly from $12 billion to $50 billion, no one doubts that Merck's losses will be substantial.19 The mis-tried case may hold the key to the resolution of future litigation. The judge in the case ordered a re-trial.20 On retrial, a new piece of evidence will likely find its way to the jury. The New England Journal of Medicine recently re-examined a manuscript it published in 2000.21 The Journal concluded that the Merckemployed authors of the article edited the manuscript to delete data revealing heart attacks in three of the study participants.22 One of the authors served as Merck's lead scientific witness in the first three trials.23 On retrial of the third case and in all subsequent cases, analysts expect plaintiffs' lawyers to use the Journal's revelation to cross-examine that witness and to cast doubt on the company's credibility.24 This tale certainly has the ingredients to brand it as a distinctly US phenomenon. It features a pharmaceutical industry with extraordinary political influence over a solitary regulatory agency, US-style marketing to physicians and patients, and an unpredictable litigation system. But, could this story have also unfolded in the European Union? Can the regulated influence the regulators in the EU in the same way that Merck has been able to influence the FDA in the US? Could a once decentralized pharmaceutical regulatory system that is moving toward centralization have spawned a similar outcome? Are EU regulators sufficiently strong enough to resist financial and political influences? Is a regulatory process that is a compromise between multi-national and national power more or less subject to the process corruption that may have occurred in the Vioxx story? …