Perspectives on the failure of pharmaceutical and medical device industries to fully protect public health interests.

This discussion raises a fundamental, yet simple, public health issue--failure by the pharmaceutical and device industries to institute proper informed consent and full disclosure of critical medical information to patients (through their physicians) and recognize the autonomous right of patients to participate in important medical decisions that may affect their well-being, including the risk of death or injury. In this discussion, 2 recent affairs with high public visibility were analyzed as models illustrating these issues involving Merck and Co. (Whitehouse Station, New Jersey; for Vioxx) and Guidant Corp. (Indianapolis, Indiana; for implantable defibrillators). These scenarios proved to be remarkably similar with regard to their themes and parallel pathways and the pitfalls they illustrate. In conclusion, the focus of this review emphasizes the lessons learned and the changes already underway that will promote improved communication between industry and the physician community (and their patients) so that ultimately patient trust in the medical establishment can be restored and maintained and the errors of the past not repeated.