Compact versus contract--industry sponsors' obligations to their research subjects.

Public unease about industry’s influence over clinical research has never been greater. Recent events have elevated concerns about financial ties among investigators, academic medical centers, and industry sponsors,1-4 and disquieting findings have emerged about the legal relationships these entities form to conduct clinical trials.5-8 Tort liti­ gation brought by injured research subjects has accentuated the legal dimensions of clinical re­ search relationships.9-11 These areas of focus converged in Abney v. Amgen, an important case decided in March 2006 by the U.S. Court of Appeals for the Sixth Cir­ cuit.12 The dispute centered on the legal obliga­ tion of an industry sponsor to provide clinical­trial participants with an investigational medication after the termination of a study. The court held that despite a provision in the consent form stat­ ing that subjects could elect to continue taking the study drug for up to 2 years after the trial ended, the sponsor had no obligation to provide the drug. It grounded this conclusion in a deter­ mination that the plaintiffs had not entered into a legal relationship with the sponsor that would bind Amgen to fulfill this promise. The Abney case raises weighty legal issues for academic medical centers and their research fac­ ulty, as well as troublesome ethical questions.13 The case underscores that notwithstanding the advantages of an arms­length relationship be­ tween academic investigators and industry spon­ sors, such an arrangement has undesirable legal consequences.