<< Previous Section | < Previous Page | Next Page > | Next Section >> Bibliography (page 9 of 13) Moses, H., III, E. Braunwald, et al. (2002). "Collaborating with Industry -- Choices for the Academic Medical Center." N Engl J Med 347(17): 1371-1375.       This is a core paper that defines the issues in the various relationships between industry and academic medical centers. They take a drastic step in outlawing (at Harvard) most conflicts of interest with industry. U. S. G AO (2003). University Research: Most Federal Agencies Need to Better Protect against Financial Conflicts of Interest. G. A. Office.       This extensive study of Federal agencies and universities indicated that at the time of the report protection against conflicts of interest was inadequate. Among Federal agencies only the NIH and NSF had policies requiring review and reporting of conflicts of interest related to research support. Orlowski, J. and L. Wateska (1992). "The effects of pharmaceutical firm enticements on physician prescribing patterns. There's no such thing as a free lunch."Chest 102(1): 270-3.       They examined the impact on physician prescribing patterns of pharmaceutical firms offering all-expenses-paid trips to popular sunbelt vacation sites to attend symposia sponsored by a pharmaceutical company. Drug usage patterns were tracked for 22 months preceding each symposium and for 17 months after each symposium. Ten physicians invited to each symposium were interviewed about the likelihood that such an enticement would affect their prescribing patterns. A significant increase in the prescribing pattern of both drugs occurred following the symposia. These changed prescribing patterns were also significantly different from the national usage patterns of the two drugs by hospitals with more than 500 beds and major medical centers over the same period of time. These alterations in prescribing patterns occurred even though the majority of physicians who attended the symposia believed that such enticements would not alter their prescribing patterns. Patricia, B., D. Jocelyn, et al. (2002). "MEDICINE: Clinical Trials and Industry." Science 297(5590): 2211-. Royal Australasian College of Physicians (2000). Ethical Guidelines in the Relationship Between Physicians and the Pharmaceutical Industry.       The Australians were able to agree on a set of ethical guidelines related to physicians and the pharmaceutical industry. They were opposed to most forms of gifts and proposed a skeptical position. It was not clear the extent to which these guidelines penetrated the profession.. Psaty, B. M., C. D. Furberg, et al. (2004). "Potential for Conflict of Interest in the Evaluation of Suspected Adverse Drug Reactions: Use of Cerivastatin and Risk of Rhabdomyolysis." JAMA 292(21): 2622-2631.       In recent years, US patients have increasingly been the first to receive new medications, some of which are subsequently discovered to have suspected adverse drug reactions (SADRs). As a result, the challenge of early detection has largely shifted to the US postmarketing systems. They sought to review the association between the use of cerivastatin sodium and the risk of rhabdomyolysis in an effort to illustrate the operation and limitations of the current US postmarketing safety-surveillance system. In the published literature, cerivastatin was associated with much larger risks of rhabdomyolysis than other statins. Analyses suggested that compared with atorvastatin calcium, cerivastatin monotherapy substantially increased the risk of rhabdomyolysis. To our knowledge, these findings were not disseminated or published. The company continued to conduct safety studies, some of them inadequately designed to assess the risk of rhabdomyolysis, until cerivastatin was removed from the market in August 2001. They concluded that despite limitations of the available data, the asymmetry between the information available to the company and the information available to patients and physicians seems striking. A subjective element is present in the effort to infer whether or not the occurrence of untoward outcomes in users of a particular drug was actually the consequence of the use of that drug, and, under the current system, a pharmaceutical company's appraisal of SADRs may be influenced by economic considerations. Such an appraisal would best be made by an independent group. They claim US Congress should mandate and provide adequate support for independent reviews and analysis of postmarketing data. << Previous Section | < Previous Page | Next Page > | Next Section >> Chapter 4 Quick Links Conflicts of Interest (COI) Definitions Consequences of a COI Government Intervention Industry Sponsorship Professional Societies Clinical Practice Guidelines Other Initiatives COI in Financial Consulting Cases Bibliography Chapter 4 Download (PDF)