Understanding Corporate Responsibility: Culture and Complicity

Abstract

Kipnis's fictional account of the televised treatment of Elaine Robbins clearly shows the surgeon's negligence (Kipnis 2011). The problems with Anodyne's support for the telesurgery breakfast are harder to discern, but show up clearly when we take into consideration how surgical evidence is generated, evaluated, and used by surgeons. Current evidentiary practices in surgery have two major weaknesses, related to the epistemic culture of surgery and to practices of knowledge transmission. We argue that this is a systemic problem, which companies such as Anodyne both contribute to and benefit from. Thus, while we agree with Kipnis's claim that Anodyne is complicit in creating “conditions of danger,” we believe that Anodyne's contributory roles extend beyond creating moral hazards for susceptible surgeons and harms for individual patients. The Epistemic Culture of Surgery By the epistemic culture of surgery, we mean the traditions and practices surrounding the generation, transmission, and uptake of new knowledge in surgery. The traditional research-totreatment pathway starts with a series of clinical trials to test the safety and efficacy of a new drug or device. Such research results are communicated to practitioners via publications in reputable peer-reviewed journals, and used by regulatory bodies such as the U.S. Food and Drug Administration in decisions about whether to approve use of the novel treatment. For several reasons this ideal pathway does not function well in surgery. First, surgery lacks a strong foundation in the kind of evidence that characterizes evidence-based medicine (EBM). The best evidence requires results generated by rigorous research such as randomized controlled trials (RCTs), or syntheses of such trials in systematic reviews. Mounting RCTs in surgery is more difficult than RCTs involving drugs. Not only do surgeons provide interventions that are inherently more open to variation than a relatively straightforward prescribing regime, but outcomes may be affected by a range of factors including operating theatres, team composition, postoperative care, and so forth. There are further reasons for surgery's weak evidence base arising from methodological and ethical issues unique to surgical research: difficulties with control groups or blinding; justifying the harms intrinsic to sham surgery in surgical RCTs; and problems of equipoise. Equipoise requires that the investigator be genuinely uncertain as to the merits of two candidate treatments, but is difficult to achieve because the typical orientation of surgeons “characterized by confidence and decisiveness” fits poorly with admitting uncertainty about treatment options (Miller and Brody 2003, 554). The literature reflects these difficulties: Only 3.4%