Two alarming trends have surfaced in the pharmaceutical industry these past two decades. The first is a surge in ethics violations. Despite journalists, researchers, bloggers, and lately lawmakers who have been working to shame the industry into self-reform, the pace at which new scandals are born appears, if anything, to be accelerating.2 There is wrongdoing in every stage of drug development and promotion. The list includes cam- paigns to “ghost manage” the conduct of basic science, to rig clinical trials, to run trials in poor countries where ethical oversight is weak, to market medical conditions far beyond their natural incidence (“condition branding,” as the marketers term it), to sway public health criteria for the threshold of disease risk, and to lure some of the nation’s most respected doctors into risky off-label pro-motion schemes. All of these problems can be traced back to marketing-inspired ruses.
The second, less apparent trend is a decline in new drug applications marking breakthrough discoveries. In the words of a 2006 Government Accountability Office report to Congress, “Innovation in the pharmaceutical industry has become stagnant.”4 Merrill Goozner, head of the Center for Science in the Public Interest, explains, “Three out of every four drug applications involve drugs that either replicated the action of medicines already on the market or were new formulations that at best added minor conveniences for patients and doctors.”5