UCLA internist Ben Ansell says his patients -- many of them executives who are voracious consumers of news -- have always asked a lot of questions about the safety of medications he proposes. But in the wake of headline-grabbing drug withdrawals like the FDA's decisions on Vioxx and Bextra, those questions escalate. "It does definitely heighten their concern -- particularly for new drugs and particularly for drugs in the same class" as those cited for safety concerns, he said.
Susan Schwartz McDonald, chief executive of National Analysts, says patients and their physicians have grown more attuned to the risks of pharmaceuticals over time, fueled by greater public access to medical information on the Internet and more extensive media coverage of developments in medical research. But Merck's withdrawal of Vioxx last September and the FDA's recent decision to ask for the withdrawal of Bextra were watershed events, she added.
Since it was approved by the FDA in 1999, 84 million people worldwide have taken Vioxx, and an additional 7 million have taken Bextra since it was approved in 2002. Vioxx "had almost become a household term," McDonald said. "It really reached into every household." When its safety was questioned, she added, the resulting shaken confidence was a national phenomenon.