Content area
Full text
ABSTRACT. There are serious problems with the way in which pharmaceutical research is currently practiced, many of which can be traced to the influence of commercial interests on research. One of the most significant is inadequate dis- sent, or organized skepticism. In order to ameliorate this problem, I develop a proposal that I call the "Adversarial Proceedings for the Evaluation of Pharma- ceuticals," to be instituted within a regulatory agency such as the Food and Drug Administration for the evaluation of controversial new drugs and controversial drugs already in the market. This proposal is an organizational one based upon the "science court" proposal by Arthur Kantrowitz in the 1960s and 1970s. The primary benefit of this system is its ability to institutionalize dissent, thereby ensuring that one set of interests does not dominate all others.
Many observers now acknowledge that there are serious prob- lems with the way in which pharmaceutical research is cur- rently practiced. These problems include the suppression of undesirable results, bias in the design of studies and in the interpretation of results, and neglect of diseases that afflict the poor in developing countries. These problems can be traced at least in part to the influence of commercial interests on research. In what follows, I will discuss some of the main deficiencies of current pharmaceutical research, and I will argue that an important one is inadequate dissent. As many have argued, rigorous scientific research requires dissent, or what Robert Merton called "organized skepticism" (1942). Yet it is increasingly the case that some forms of dissent in pharmaceutical research are either absent or unheard, due to the predominance of one set of interests (i.e., commercial) over others. In order to ameliorate this problem, I develop a proposal that I call the "Adversarial Proceedings for the Evaluation of Pharmaceuticals" (APEP), to be instituted within a regulatory agency such as the Food and Drug Administration (FDA) for the evaluation of controversial new drugs and controversial drugs already in the market. This proposal is an organizational one based upon the "science court" proposal by Arthur Kantrowitz in the 1960s and 1970s. The primary benefit of this system is its ability to institutionalize dissent, thereby ensuring that one set of interests does not dominate all others.