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Suggested Citation:"References." Institute of Medicine. 2014. Conflict of Interest and Medical Innovation: Ensuring Integrity While Facilitating Innovation in Medical Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18723.
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Page 49
Suggested Citation:"References." Institute of Medicine. 2014. Conflict of Interest and Medical Innovation: Ensuring Integrity While Facilitating Innovation in Medical Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18723.
×
Page 50
Suggested Citation:"References." Institute of Medicine. 2014. Conflict of Interest and Medical Innovation: Ensuring Integrity While Facilitating Innovation in Medical Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18723.
×
Page 51
Suggested Citation:"References." Institute of Medicine. 2014. Conflict of Interest and Medical Innovation: Ensuring Integrity While Facilitating Innovation in Medical Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18723.
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Page 52

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References Attenello, F. J., D. Mukherjee, G. Datoo, M. J. McGirt, E. Bohan, J. D. Weingart, A. Olivi, A. Quinones-Hinojosa, and H. Brem. 2008. Use of Gliadel (BCNU) wafer in the surgical treatment of malignant glioma: A 10- year institutional experience. Annals of Surgical Oncololgy 15(10):2887– 2893. Barinaga, M. 1999. Genentech, UC Settle Suit for $200 Million. Science 286(5445):1655. Brennan, T. A., D. J. Rothman, L. Blank, D. Blumenthal, S. C. Chimonas, J. J. Cohen, J. Goldman, J. P. Kassirer, H. Kimball, J. Naughton, and N. Smelser. 2006. Health industry practices that create conflicts of interest: A policy proposal for academic medical centers. Journal of the American Medical Association 295(4):429–433. Chaichana, K. L., P. Zadnik, J. D. Weingart, A. Olivi, G. L. Gallia, J. Blakeley, M. Lim, H. Brem, and A. Quinones-Hinojosa. 2013. Multiple resections for patients with glioblastoma: Prolonging survival. Journal of Neurosurgery 118(4):812–820. DiMasi, J. A., R. W. Hansen, and H. G. Grabowski. 2003. The price of innovation: New estimates of drug development costs. Journal of Health Economics 22(2):151–185. DOJ (U.S. Department of Justice). 2008. Merck to pay more than $650 million to resolve claims of fraudulent price reporting and kickbacks. Press release, February 7. Washington, DC: DOJ. http://www.usdoj.gov/opa/pr/2008/February/ 08_civ_094.html (accessed December 10, 2013). HHS (Department of Health and Human Services). 2011. Responsibility of applicants for promoting objectivity in research for which Public Health Service funding is sought and responsible prospective contractors; final rule. Federal Register 76(165):53255–53293. IOM (Institute of Medicine). 2008. Resident duty hours: Enhancing sleep, supervision, and safety. Washington, DC: The National Academies Press. 49

50 COI AND MEDICAL INNOVATION IOM. 2009. Conflict of interest in medical research, education, and practice. Washington, DC: The National Academies Press. IOM. 2013. Sharing clinical research data: Workshop summary. Washington, DC: The National Academies Press. IOM. 2014. Improving the efficiency and effectiveness of genomic science translation: Workshop summary. Washington, DC: The National Academies Press. Krumholz, H. M., J. S. Ross, C. P. Gross, E. J. Emanuel, B. Hodshon, J. D. Ritchie, J. B. Low, and R. Lehman. 2013. A historic moment for open science: The Yale University Open Data Access Project and Medtronic. Annals of Internal Medicine 158(12):910–911. Lichter, A. S., and R. McKinney. 2012. Toward a harmonized and centralized conflict of interest disclosure: Progress from an IOM initiative. Journal of the American Medical Association 308(20):2093–2094. Lichter, A., R. McKinney, T. Anderson, E. Breese, N. Brennan, D. Butler, E. Campbell, S. Chimonas, G. Chisolm, C. Clark, M. Corn, A. Coukell, D. Dean, S. Eringhaus, P. Fontanarosa, M. Frankel, R. Hutchinson, T. Jost, N. Kahn, C. Laine, M. LaLonde, L. Lynn, P. McCormick, P. Miller, H. Pierce, J. Hartzler Warner, P. Weber, D. Zuk, A. C. Berger, and I. Von Kohorn. 2012. Harmonizing reporting on potential conflicts of interest: A common disclosure process for health care and life sciences, Discussion Paper, Institute of Medicine, Washington, DC. http://www.iom.edu/COIperspective (accessed December 9, 2013). Lockhart, A. C., M. S. Brose, E. S. Kim, D. H. Johnson, J. M. Peppercorn, D. L. Michels, C. D. Storm, L. M. Schuchter, and W. K. Rathmell. 2013. Physician and stakeholder perceptions of conflict of interest policies in oncology. Journal of Clinical Oncology 31(13):1677–1682. Ornstein, C., and T. Weber. 2011. Heart society’s tip sheets fail to mention risks. ProPublica. http://projects.propublica.org/docdollars (accessed December 9, 2013). Ornstein, C., T. Weber, and D. Nguyen. 2010. Docs on pharma payroll have blemished records, limited credentials. ProPublica. http://projects.propublica.org/docdollars (accessed December 9, 2013). Palmer, R. 2010. Avandia update: Trial suspended, panelists conflicted, mechanism discovered. Spoon Full of Medicine: A blog from Nature Medicine. http://blogs.nature.com/spoonful/2010/07/avandia_update_trial_ suspended.html (accessed December 10, 2013). Paul, S. M., D. S. Mytelka, C. T. Dunwiddie, C. C. Persinger, B. H. Munos, S. R. Lindborg, and A. L. Schacht. 2010. How to improve R&D productivity: The pharmaceutical industry’s grand challenge. Nature Reviews Drug Discovery 9(3):203–214. Rosenthal, M. B., and M. M. Mello. 2013. Sunlight as disinfectant—new rules on disclosure of industry payments to physicians. New England Journal of Medicine 368(22):2052–2054.

REFERENCES 51 Thomas, K., and M. Schmidt. 2012. Glaxo agrees to pay $3 billion in fraud settlement. New York Times, July 3. http://www.nytimes.com/2012/07/03/ business/glaxosmithkline-agrees-to-pay-3-billion-in-fraud-settlement.html?page wanted=1&_r=2&nl=todaysheadlines&emc=edit_th_20120703& (accessed December 10, 2013). Zinner, D. E., C. M. DesRoches, S. J. Bristol, B. Clarridge, and E. G. Campbell. 2010. Tightening conflict-of-interest policies: The impact of 2005 ethics rules at the NIH. Academic Medicine 85(11):1685–1691.

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Scientific advances such as the sequencing of the human genome have created great promise for improving human health by providing a greater understanding of disease biology and enabling the development of new drugs, diagnostics, and preventive services. However, the translation of research advances into clinical applications has so far been slower than anticipated. This is due in part to the complexity of the underlying biology as well as the cost and time it takes to develop a product. Pharmaceutical companies are adapting their business models to this new reality for product development by placing increasing emphasis on leveraging alliances, joint development efforts, early-phase research partnerships, and public-private partnerships. These collaborative efforts make it possible to identify new drug targets, enhance the understanding of the underlying basis of disease, discover novel indications for the use of already approved products, and develop biomarkers for disease outcomes or directed drug use. While the potential benefits of collaboration are significant, the fact that the relationships among development partners are often financial means that it is vital to ensure trust by identifying, disclosing, and managing any potential sources of conflict that could create bias in the research being performed together.

Conflict of Interest and Medical Innovation is the summary of a workshop convened by the Institute of Medicine Roundtable on Translating Genomic-Based Research for Health in June 2013 to explore the appropriate balance between identifying and managing conflicts of interest and advancing medical innovation. A wide range of stakeholders, including government officials, pharmaceutical company representatives, academic administrators and researchers, health care providers, medical ethicists, patient advocates, and consumers, were invited to present their perspectives and participate in discussions during the workshop. This report focuses on current conflict of interest policies and their effect on medical innovation in an effort to identify best practices and potential solutions for facilitating innovation while still ensuring scientific integrity and public trust.

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