The last year, June 1992 through September 1993, has seen a great deal of ferment with respect to access to and financing of health care in the United States. The elections of 1992 portend dramatic changes in the American health care system, and vigorous debate regarding both expansion of access to health care and transformation of the health care financing system is taking place at the federal and the state levels. In fact, however, the time period covered here produced remarkably (...) few changes in the law, particularly at the federal level. The one piece of Medicare and Medicaid legislation passed by Congress in the fall of 1992, H.R. 11, was vetoed by President Bush immediately after the election. The Omnibus Budget Reconciliation Act of 1993 contained a host of minor adjustments to the Medicare and the Medicaid programs, but only the Medicaid asset transfer provisions and extensions to the self-referral provisions of the fraud and abuse laws, discussed below, are of import to us. (shrink)

Advances in medicine depend not only on the generation of information but also on its dissemination. Clinically relevant data must be transmitted to the practitioners who will use it. Health care professionals in North America are aware of their ethical and legal obligations to inform patients adequately concerning interventions and treatments so that they may make informed choices about medical care. This obligation has been well described and defined by the courts and in the literature of medicine, ethics, and law. (...) But do investigators and others who are responsible for disseminating information have any obligation to divulge adequately the results of clinical trials to practitioners so that the latter might offer the choice of appropriate care to their patients? Can incomplete disclosure of trial outcomes result in harm to patients? If this is the case, what possible avenues are available to avoid such harm? (shrink)

Advances in medicine depend not only on the generation of information but also on its dissemination. Clinically relevant data must be transmitted to the practitioners who will use it. Health care professionals in North America are aware of their ethical and legal obligations to inform patients adequately concerning interventions and treatments so that they may make informed choices about medical care. This obligation has been well described and defined by the courts and in the literature of medicine, ethics, and law. (...) But do investigators and others who are responsible for disseminating information have any obligation to divulge adequately the results of clinical trials to practitioners so that the latter might offer the choice of appropriate care to their patients? Can incomplete disclosure of trial outcomes result in harm to patients? If this is the case, what possible avenues are available to avoid such harm? (shrink)