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PETER LURIE * AND ALLISON ZIEVE * I INTRODUCTION According to the advocates of greater corporate involvement in clinical science, the increasingly entwined relationship between corporations, academia and government is the very definition of a "winwin" situation. Corporations can benefit from the knowledge of scientists in academia or government, and the public benefits from the more rapid movement of beneficial products into commerce. That argument, however, ignores a fundamental clash of cultures. Progress in science is based on the free publication of study results and on the public release of data, allowing scientists to build on the experiences of others. In contrast, the governing ethic in the corporate sector is secrecy--the withholding of any information from which a competitor might benefit. There is perhaps no realm in which these competing viewpoints are presented more starkly than in the area of access to pharmaceutical data at the Food and Drug Administration FDA ; . Those committed to the free exchange of scientific information have long complained about various restrictions on access to these pharmaceutical data and the resultant restrictions on open discourse. Such restrictions include the selective publication of favorable results, 2 gag orders on corporate-funded research, 3 and misleading presentations of data.4 Only in the last several years have these concerns penetrated public consciousness. Two recent examples demonstrate the problems these restrictions create.
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The RAND reviews did not consider patient-based measures of outcome in any level of detail. The SBU review emphasised that most studies looking at patient-based outcomes used freedom from angina and return to work as indicators of health-related quality of life. No studies comparing coronary angioplasty and CABG were reviewed. A total of three studies were identified in which angioplasty and CABG are compared; details of these studies are presented in appendix 7. The BARI trial has supported a quality-of-life assessment and 5-year follow-up data are available Hlatky, et al., 1997 ; . Improvement in functional status, as measured by the Duke Activity Status Index was significantly greater in CABG patients after 1-, 2and 3-year follow-up periods but not after 4 years. There were no significant differences throughout follow-up between the two groups in improvement in emotional health, as measured by the RAND Mental Health Inventory. The other studies shown are all relatively small observational studies.2 On the basis of this limited group of studies, the following points can be made. In only one of the studies Papadantonaki, et al., 1994 ; were statistically significant differences found in health-related quality of life between patients undergoing angioplasty and those having CABG. The study found that angioplasty patients experienced a greater improvement in mood and physical functioning between baseline and 3-weeks post-hospital discharge. However.
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