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Medical Innovation Then and Now: Perspectives of Innovators Responsible for Transformative Drugs

Published online by Cambridge University Press:  01 January 2021

Shuai Xu  and
Aaron S. Kesselheim
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Extract

The discovery and development of new therapeutics has always been central to improving health worldwide. However, there is ongoing concern regarding the current state of medical innovation. Output from the pharmaceutical industry has been criticized for not being “transformative,” that is, offering substantial improvements in patient outcomes over existing therapeutics. While the cost of drug development continues to rise, breakthrough therapies remain elusive and one half of Phase 3 studies fail. Venture capital, a traditional source of funding for new breakthrough biomedical innovations, has decreased investment by 30% in the biotechnology and medical device sectors from 2007 to 2013. Stakeholders question whether the new drugs approved each year by the FDA —many criticized as marginal improvements over existing therapies — justify the enormous investment.

Type
Independent
Information
Journal of Law, Medicine & Ethics , Volume 42 , Issue 4 , Winter 2014 , pp. 564 - 575
Copyright
Copyright © American Society of Law, Medicine and Ethics 2014

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References

FDA, “Innovation or Stagnation: Challenge and Opportunity on the Critical Path to New Medical Products,” in Services DoHaH, ed. Washington, D.C., 2004, available at <http://www.fda.gov/downloads/ScienceResearch/SpecialTopics/CriticalPathInitiative/CriticalPathOpportunitiesReports/ucm113411.pdf>(last visited December 5, 2014)>Left to their own devices: “Medtronic and the Woes of America's Medical-Technology Industry,” The Economist, September 11, 2011, available at <http://www.economist.com/node/21528644>(last visited December 5, 2014).(last+visited+December+5,+2014)>Left+to+their+own+devices:+“Medtronic+and+the+Woes+of+America's+Medical-Technology+Industry,”+The+Economist,+September+11,+2011,+available+at+(last+visited+December+5,+2014).>Google Scholar
Avorn, J. Kesselheim, A., “The NIH Translational Research Center Might Trade Public Risk for Private Reward,” Nature Medicine 17, no. 10(2011): 1176.CrossRefGoogle Scholar
Munos, B. H. Chin, W. W., “How to Revive Breakthrough Innovation in the Pharmaceutical Industry,” Science Translational Medicine 3, no. 89(2011): 9cm16.CrossRefGoogle Scholar
Arrowsmith, J., “Trial Watch: Phase II Failures: 2008–2010,” Nature Reviews Drug Discovery 10, no. 5(May 2011): 328–329.CrossRefGoogle Scholar
PricewaterhouseCoopers, MoneyTree Report, Vol 2013, available at <http://www.pwcmoneytree.com/HistoricTrends/>..>Google Scholar
Juliano, R., “Pharmaceutical Innovation and Public Policy: The Case for a New Strategy for Drug Discovery and Development,” Science and Public Policy 40, no. 3(2013): 393–405.Paul, S. M. Mytelka, D. S. Dunwiddie, C. T.et al, “How to Improve R&D Productivity: The Pharmaceutical Industry's Grand Challenge,” Nature Reviews Drug Discovery 9, no. 3(2010): 203–214.CrossRefGoogle Scholar
Chabner, B. A. Roberts, T. G.Jr., “Timeline: Chemotherapy and the War on Cancer,” Nature Reviews Cancer 5, no. 1(2005): 65–72.Google Scholar
Cutler, D. M. McClellan, M., “Is Technological Change in Medicine Worth It?” Health Affairs (Millwood) 20, no. 5(2001): 11–29.Google Scholar
Clardy, J. Fischbach, M. A. Walsh, C. T., “New Antibiotics from Bacterial Natural Products,” Nature Biotechnology 24, no. 12(2006): 1541–1550.CrossRefGoogle Scholar
Hanna, K. E. Manning, F. J. Bouxsein, P. Pope, A., Innovation and Invention in Medical Devices: Workshop Summary, Institute of Medicine (Washington, D.C.: National Academies Press, 2001).Krucoff, M. W. Brindis, R. G. Hodgson, P. K. Mack, M. J. Holmes, D. R.Jr., “Medical Device Innovation: Prospective Solutions for an Ecosystem in Crisis: Adding a Professional Society Perspective,” JACC: Cardiovascular Interventions 5, no. 7(2012): 790–796.Ubl, S. J., “The Medical Device Excise Tax – Before It Begins?” New England Journal of Medicine 369, no. 10(2013): 984.Google Scholar
Staff, C., “Internal Memorandum: Ten Bills to Fix FDA's Medical Device Regulation: Saving American Jobs and Saving American Patients,” Commerce HoRCoEa, Washington, D.C., 2011.Google Scholar
Sherman, R. E. Li, J. Shapley, S. Robb, M. Woodcock, J., “Expediting Drug Development: The FDA's New ‘Breakthrough Therapy’ Designation,” New England Journal of Medicine 369, no. 20(2013): 1877–1880.CrossRefGoogle Scholar
See Kesselheim and Avorn, supra note 3.Google Scholar
Drucker, P. F., “The Discipline of Innovation,” Harvard Business Review 63, no. 3(1985): 67–72.Google Scholar
Kesselheim, A. S. Avorn, J., “The Most Transformative Drugs of the past 25 Years: A Survey of Physicians,” Nature Reviews Drug Discovery 12, no. 6(2013): 425–431.CrossRefGoogle Scholar
Constas, M. A., “Qualitative Analysis as a Public Event: The Documentation of Category Development Procedures,” American Educational Research Journal 29, no. 2(1992): 253–266.CrossRefGoogle Scholar
Bradley, E. H. Holmboe, E. S. Mattera, J. A. Roumanis, S. A. Radford, M. J. Krumholz, H. M., “A Qualitative Study of Increasing Beta-Blocker Use after Myocardial Infarction: Why Do Some Hospitals Succeed?” JAMA 285, no. 20(2001): 2604–2611.CrossRefGoogle Scholar
Willms, D. G. Best, J. A. Taylor, D. W.et al, “A Systematic Approach for Using Qualitative Methods in Primary Prevention Research,” Medical Anthropology Quarterly 4, no. 4(1990): 391–409.CrossRefGoogle Scholar
Drucker, P. F., “The Discipline of Innovation,” Harvard Business Review 63, no. 3(1985): 67–72.Google Scholar
Schmookler, J., Invention and Economic Growth (Cambridge, MA: Harvard University Press, 1966).CrossRefGoogle Scholar
Shane, S. Venkataraman, S., “The Promise of Entrepreneurship as a Field of Research,” Academy of Management Review 25, no. 1(2000): 217–226.Sarason, Y. Dean, T. Dillard, J. R., “Entrepreneurship as the Nexus of Individual and Opportunity: A Structuration View,” Journal of Business Venturing 21, no. 3(2006): 286–305.Google Scholar
Eichler, H. G. Bloechl-Daum, B. Brasseur, D.et al, “The Risks of Risk Aversion in Drug Regulation,” Nature Reviews Drug Discovery 12, no. 12(2013): 907–916.Kesselheim, A. S. Xu, S. Avorn, J., “Clinicians' Contributions to the Development of Coronary Artery Stents: A Qualitative Study of Transformative Device Innovation,” PloS One 9, no. 2(2014): e88664.CrossRefGoogle Scholar
Tralau-Stewart, C. J. Wyatt, C. A. Kleyn, D. E. Ayad, A., “Drug Discovery: New Models for Industry-Academic Partnerships,” Drug Discovery Today 14, nos. 1–2(2009): 95–101.Melese, T. Lin, S. M. Chang, J. L. Cohen, N. H., “Open Innovation Networks between Academia and Industry: An Imperative for Breakthrough Therapies,” Nature Medicine 15, no. 5(2009): 502–50.CrossRefGoogle Scholar
Swinney, D. C. Anthony, J., “How Were New Medicines Discovered?” Nature Reviews Drug Discovery 10, no. 7(2011): 507–519.CrossRefGoogle Scholar
Agarwal, P. Searls, D. B., “Can Literature Analysis Identify Innovation Drivers in Drug Discovery?” Nature Reviews Drug Discovery 8, no. 11(2009): 865–878.CrossRefGoogle Scholar
Zinner, D. E. Bolcic-Jankovic, D. Clarridge, B. Blumenthal, D. Campbell, E. G., “Participation of Academic Scientists in Relationships with Industry,” Health Affairs (Millwood) 28, no. 6(2009): 1814–1825.CrossRefGoogle Scholar
Feldman, M. Desrochers, P., “Truth for Its Own Sake: Academic Culture and Technology Transfer at Johns Hopkins University,” Minerva 42, no. 2(2004): 105–126.Jong, S., “How Organizational Structures in Science Shape Spin-Off Firms: The Biochemistry Departments of Berkeley, Stanford, and UCSF and the Birth of the Biotech Industry,” Industrial and Corporate Change 115, no. 2(2006): 251–283.CrossRefGoogle Scholar
See Melese, et al, supra note 23.Google Scholar
Blumenthal, D. Campbell, E. G. Causino, N. Louis, K. S., “Participation of Life-Science Faculty in Research Relationships with Industry,” New England Journal of Medicine 335, no. 23(1996): 1734–1739.CrossRefGoogle Scholar
Bok, D. C., Beyond the Ivory Tower: Social Responsibilities of the Modern University (Cambridge, MA: Harvard University Press, 1982).Google Scholar
Krimsky, S., Science in the Private Interest: Has the Lure of Profits Corrupted Biomedical Research? (Lanham, Maryland: Rowman & Littlefiel, 2003).Google Scholar
Azoulay, P. Ding, W. Stuart, T., The Impact of Academic Patenting on the Rate, Quality and Direction of (Public) Research Output,” Journal of Industrial Economics 57, no. 4(2009): 637–676.CrossRefGoogle Scholar
Grimaldi, R. Kenney, M. Siegel, D. S. Wright, M., “30 Years after Bayh-Dole: Reassessing Academic Entrepreneurship,” Research Policy 40, no. 8(2011): 1045–1057.Kenney, M. Patton, D., “Reconsidering the Bayh-Dole Act and the Current University Invention Ownership Model,” Research Policy 38, no. 9(2009): 1407–1422.CrossRefGoogle Scholar
Swamidass, P. M. Vulasa, V., “Why University Inventions Rarely Produce Income? Bottlenecks in University Technology Transfer,” Journal of Technology Transfer 34, no. 4(2009): 343–363.CrossRefGoogle Scholar
See Kenney, Patton, , supra note 33.Google Scholar
Innes, C., “Best Practices in Transforming Research into Innovation: Creative Approaches to the Bayh-Dole Act,” U.S. House of Representatives, Committee on Science, Space, and Technology, Subcommittee on Technology and Innovation, 2012.Google Scholar
Xu, S. Avorn, J. Kesselheim, A. S., “Origins of Medical Innovation: The Case of Coronary Artery Stents,” Circulation: Cardiovascular Quality and Outcomes 5, no. 6(2012): 743–749.Google Scholar
Scannell, J. W. Blanckley, A. Boldon, H. Warrington, B., “Diagnosing the Decline in Pharmaceutical R&D Efficiency,” Nature Reviews Drug Discovery 11, no. 3(2012): 191–200.CrossRefGoogle Scholar
Fernandez, J. M. Stein, R. M. Lo, A. W., “Commercializing Biomedical Research through Securitization Techniques,” Nature Biotechnology 30, no. 10(2012): 964–975.CrossRefGoogle Scholar
See Munos, Chin, , supra note 3.Google Scholar
Paulsen, E. Altmire, J., “New Tax Will Hurt Medical Device Innovation,” The Hill's Congress Blog vol. 2013, 2012.Google Scholar
Bloom, J. Torreele, E., “Should Patents on Pharmaceuticals Be Extended to Encourage Innovation?” Wall Street Journal, January 23, 2012.Google Scholar
See Staff, supra note 11.Google Scholar
Ebersole, T. J. Guthrie, M. C. Goldstein, J. A., “Patent Pools and Standard Setting in Diagnostic Genetics,” Nature Biotechnology 23, no. 8(2005): 937–938.Hunter, J. Stephens, S., “Is Open Innovation the Way Forward for Big Pharma?" Nature Reviews Drug Discovery 9, no. 2(2010): 87–88.CrossRefGoogle Scholar