Criteria for Standard Versus Experimental Therapy

Prologue: Deciding when an innovative new therapy has moved from experimental to standard treatment is an issue with which insurers, providers, and public policymakers all struggle. Here Stanley Reiser takes on this subject out of a “growing concern I had that in clinical and policy discourse there was a constant ambiguity and confusion expressed about the nature of standard and experimental practice. I felt it was important to clarify the distinctions, and the actions to take from those distinctions” such as reimbursement and clinical use, he explained. In this paper Reiser sets forth some criteria to define and separate standard from experimental therapies. Along the way, he reveals that the conventional wisdom that innovations move lineally forward from experimental to standard therapy and then decline as they are replaced by new innovations is not entirely accurate. Instead, innovations more often move to and fro between the categories; as new uses are discovered for standard therapies, they become experimental once again. Reiser suggests an analogy for this movement: “Therapies are like trains: They exist in an oscillating motion, shuttling back and forth between standard and experimental stations, and sometimes taking a crossover track to pause at a place in between them. ” To define this in between place, Reiser offers the term “crossover therapy.” Reiser is the Griff T. Ross Professor of Humanities and Technology in Health Care at the University of Texas-Houston Health Science Center. He received his medical degree from State University of New York, as well as a doctorate in the history of science and a master of public administration degree from Harvard University. He has authored and edited numerous books, including Medicine and the Reign of Technology and, most recently, The Ethical Dimensions of the Biological Sciences. He also serves as coeditor of the International Journal of Technology Assessment in Health Care. Abstract: This paper demarcates the boundaries between experimental and standard therapy and the influence of this division on policy, payment, and practice. It proposes a new-category, crossover therapy, to deal with the many therapies that fall in between. It establishes four criteria to separate these categories: (1) the populations and conditions for which use is helpful; (2) the expected outcomes of care; (3) the skill, personnel, and site requirements and the economic, ethical, and legal understandings essential for use; and (4) the level of knowledge needed to certify that prospective users can apply it well. The paper then explores the use of experimental therapy in desperate situations and of standard therapies in new areas and gives policy recommendations to facilitate these actions.