Do firms underinvest in long-term research? Evidence from cancer clinical trials

American Economic Review

Volumn 105, Issue 7, 2015, Pages 2044-2085

  Budish, Eric ^a   Roin, Benjamin N ^b   Williams, Heidi ^c,d  

^a UNIVERSITY OF CHICAGO   (United States)

^b MASSACHUSETTS INSTITUTE OF TECHNOLOGY   (United States)

^c MASSACHUSETTS INSTITUTE OF TECHNOLOGY   (United States)

^d NATIONAL BUREAU OF ECONOMIC RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANTINEOPLASTIC AGENT; BIOLOGICAL MARKER;

CHEMOPROPHYLAXIS; CLINICAL TRIAL (TOPIC); ECONOMICS; FINANCIAL MANAGEMENT; HUMAN; INVESTMENT; METHODOLOGY; NEOPLASM; PATENT; PRIVATE SECTOR; PROCEDURES; SOCIOECONOMICS; STATISTICS AND NUMERICAL DATA; SURVIVAL RATE; THEORETICAL MODEL; TIME FACTOR; UNITED STATES;

ANTINEOPLASTIC AGENTS; BIOMARKERS; CHEMOPREVENTION; CLINICAL TRIALS AS TOPIC; FINANCING, GOVERNMENT; HUMANS; INVESTMENTS; MODELS, THEORETICAL; NEOPLASMS; PATENTS AS TOPIC; PRIVATE SECTOR; RESEARCH DESIGN; SURVIVAL RATE; TIME FACTORS; UNITED STATES; VALUE OF LIFE;

EID: 84937611403     PISSN: 00028282     EISSN: 19447981     Source Type: Journal    
DOI: 10.1257/aer.20131176     Document Type: Review

References (85)

1. Abramowicz, Michael. 2007. "The Danger of Underdeveloped Patent Prospects." Cornell Law Review 92 (6): 1065-1121.
2. Acemoglu, Daron, and Joshua Linn. 2004. "Market Size in Innovation: Theory and Evidence from the Pharmaceutical Industry." Quarterly Journal of Economics 119 (3): 1049-90.
3. Adams, Christopher P., and Van V. Brantner. 2006. "Estimating The Cost Of New Drug Development: Is It Really $802 Million?" Health Affairs 25 (2): 420-28.
4. American Society of Clinical Oncology. 2011. Accelerating Progress Against Cancer: ASCO's Blueprint for Transforming Clinical and Translational Cancer Research. Alexandria, VA: American Society of Clinical Oncology.
5. Angrist, Joshua D., and Jörn-Steffen Pischke. 2009. Mostly Harmless Econometrics: An Empiricist's Companion. Princeton: Princeton University Press.
6. Asker, John, Joan Farre-Mensa, and Alexander Ljungqvist. 2015. "Corporate Investment and Stock Market Listing: A Puzzle?" Review of Financial Studies 28 (2): 342-90.
7. Bernstein, Shai. Forthcoming. "Does Going Public Affect Innovation?" Journal of Finance.
8. Bloom, Nicholas, Mark Schankerman, and John Van Reenen. 2013. "Identifying Technology Spillovers and Product Market Rivalry." Econometrica 81 (4): 1347-93.
9. Bronnenberg, Bart J., Jean-Pierre H. Dubé, Matthew Gentzkow, and Jesse M. Shapiro. 2013. "Do Pharmacists Buy Bayer? Sophisticated Shoppers and the Brand Premium." Unpublished.
10. Budish, Eric, Benjamin N. Roin, and Heidi Williams. 2015. "Do Firms Underinvest in Long-Term Research? Evidence from Cancer Clinical Trials: Dataset." American Economic Review. http://dx.doi.org/10.1257/aer.20131176.
11. Cohen, Wesley M., Richard R. Nelson, and John P. Walsh. 2000. "Protecting Their Intellectual Assets: Appropriability Conditions and Why U.S. Manufacturing Firms Patent (or Not)." National Bureau of Economic Research Working Paper 7552.
12. Collins, Francis S. 2012. "Fiscal Year 2013 Budget Request: Testimony before the US House Subcommittee on Labor - HHS - Education Appropriations." Washington, DC: Department of Health and Human Services, National Institutes of Health.
13. Cutler, David M. 2004. Your Money or Your Life: Strong Medicine for America's Healthcare System. New York: Oxford University Press.
14. Cutler, David M., and Srikanth Kadiyala. 2003. "The Return to Biomedical Research: Treatment and Behavioral Effects." In Measuring the Gains from Medical Research: An Economic Approach, edited by Kevin M. Murphy and Robert H. Topel, 110-62. Chicago: University of Chicago Press.
15. de Bono, Johann S., Christopher J. Logothetis, Arturo Molina, Karim Fizazi, Scott North, Luis Chu, Kim N. Chi et al. 2011. "Abiraterone and Increased Survival in Metastatic Prostate Cancer." New England Journal of Medicine 364 (21): 1995-2005.
16. DiMasi, Joseph A., Ronald W. Hansen, and Henry G. Grabowski. 2003. "The Price of Innovation: New Estimates of Drug Development Costs." Journal of Health Economics 22 (2): 151-85.
17. Dubois, Pierre, Fiona Scott Morton, Paul Seabright, and Olivier de Mouzon. Forthcoming. "Market Size and Pharmaceutical Innovation." RAND Journal of Economics.
18. Eisenberg, Rebecca S. 2005. "The Problem of New Uses." Yale Journal of Health Policy, Law, and Ethics 5 (2): 717-40.
19. Farber, Sidney, Louis K. Diamond, Robert D. Mercer, Robert F. Sylvester, Jr., and James A. Wolff. 1948. "Temporary Remissions in Acute Leukemia in Children Produced by Folic Acid Antagonist, 4-Aminopteroyl-Glutamic Acid (Aminopterin)." New England Journal of Medicine 238 (23): 787-93.
20. Finkelstein, Amy. 2004. "Static and Dynamic Effects of Health Policy: Evidence from the Vaccine Industry." Quarterly Journal of Economics 119 (2): 527-64.
21. Fleming, Thomas R. 2005. "Surrogate Endpoints and FDA's Accelerated Approval Process." Health Affairs 24 (1): 67-78.
22. nd ed., edited by Camille Georges Wermuth, 687-95. Amsterdam: Elsevier.
23. Gilbert, Richard, and Carl Shapiro. 1990. "Optimal Patent Length and Breadth." RAND Journal of Economics 21 (1): 106-12.
24. Gompers, Paul A. 1995. "Optimal Investment, Monitoring, and the Staging of Venture Capital." Journal of Finance 50 (5): 1461-89.
25. Grabowski, Henry G., and Margaret Kyle. 2007. "Generic Competition and Market Exclusivity Periods in Pharmaceuticals." Managerial and Decision Economics 28 (4-5): 491-502.
26. Grossman, Gene M., and Edwin L. C. Lai. 2004. "International Protection of Intellectual Property."American Economic Review 94 (5): 1635-53.
27. Hammitt, James K., and Kevin Haninger. 2010. "Valuing Fatal Risks to Children and Adults: Effects of Disease, Latency, and Risk Aversion." Journal of Risk and Uncertainty 40 (1): 57-83.
28. Hemphill, C. Scott, and Bhaven N. Sampat. 2012. "Evergreening, Patent Challenges, and Effective Market Life in Pharmaceuticals." Journal of Health Economics 31 (2): 327-39.
29. Institute of Medicine of the National Academies. 2008. Improving the Quality of Cancer Clinical Trials: Workshop Summary. Washington, DC: National Academies Press.
30. Johnson, John R., Grant Williams, and Richard Pazdur. 2003. "End Points and United States Food and Drug Administration Approval of Oncology Drugs." Journal of Clinical Oncology 21 (7): 1404-11.
31. Jones, Christopher U., Daniel Hunt, David G. McGowan, Mahul B. Amin, Michael P. Chetner, Deborah W. Bruner, Mark H. Leibenhaut et al. 2011. "Radiotherapy and Short-Term Androgen Deprivation for Localized Prostate Cancer." New England Journal of Medicine 365 (2): 107-18.
32. Kaplow, Louis. 1984. "The Patent-Antitrust Intersection: A Reappraisal." Harvard Law Review 97 (8): 1813-92.
33. Klemperer, Paul. 1990. "How Broad Should the Scope of Patent Protection Be?" RAND Journal of Economics 21 (1): 113-30.
34. Korn, David, and Donald R. Stanski. 2005. Drug Development Science: Obstacles and Opportunities for Collaboration Among Academia, Industry and Government. Report of and Invitational Conference Organized by the Association of American Medical Colleges Food and Drug Development Science, at the University of California, San Francisco.
35. Kozauer, Nicholas, and Russell Katz. 2013. "Regulatory Innovation and Drug Development for Early-Stage Alzheimer's Disease." New England Journal of Medicine 368 (13): 1169-71.
36. Kremer, Michael. 1998. "Patent Buyouts: A Mechanism for Encouraging Innovation." Quarterly Journal of Economics 113 (4): 1137-67.
37. Lakdawalla, Darius N., Eric C. Sun, Anupam B. Jena, Carolina M. Reyes, Dana P. Goldman, and Tomas J. Philipson. 2010. "An Economic Evaluation of the War on Cancer." Journal of Health Economics 29 (3): 333-46.
38. Lathia, C. D., D. Amakye, W. Dai, C. Girman, S. Madani, J. Mayne, P. MacCarthy et al. 2009. "The Value, Qualification, and Regulatory Use of Surrogate End Points in Drug Development." Clinical Pharmacology and Therapeutics 86 (1): 32-43.
39. Lee, Lucia H., Christopher L. Wu, Benjamin R. Lee, and Chi-Jen Lee. 2006. "Decision Points in Drug Development." In Clinical Trials of Drugs and Biopharmaceuticals, edited by Chi-Jen Lee, Lucia H. Lee, Christopher L. Wu, Benjamin R. Lee, and Mei-Ling Chen, 77-86. Boca Raton, FL: CRC Press.
40. Lerner, Josh. 2002. "Patent Protection and Innovation Over 150 Years." National Bureau of Economic Research Working Paper 8977.
41. Levin, Richard C., Alvin K. Klevorick, Richard R. Nelson, Sidney G. Winter, Richard Gilbert, and Zvi Griliches. 1987. "Appropriating the Returns from Industrial Research and Development." Brookings Papers on Economic Activity 1987 (3): 783-831.
42. Lichtenberg, Frank R. 2012. "The Effect of Pharmaceutical Innovation on Longevity: Patient-Level Evidence from the 1996-2002 Medical Expenditure Panel Survey and Linked Mortality Public-Use Files." National Bureau of Economic Research Working Paper 18552.
43. Lindgren, Peter, and Bengt Jonsson. 2012. "Cost-Effectiveness of Statins Revisited: Lessons Learned about the Value of Innovation." European Journal of Health Economics 13 (4): 445-50.
44. nd sess., Committee Print 15.
45. Mansfield, Edwin. 1986. "Patents and Innovation: An Empirical Study." Management Science 32 (2): 173-81.
46. Mansfield, Edwin, Mark Schwartz, and Samuel Wagner. 1981. "Imitation Costs and Patents: An Empirical Study." Economic Journal 91 (364): 907-18.
47. Mayer Brown. 2009. Pharma & Biotech: Drug Development: Valuing the Pipeline: A UK Study. London: Mayer Brown.
48. Meyskens, Frank L., Gregory A. Curt, Dean E. Brenner, Gary Gordon, Ronald B. Herberman, Olivera Finn, Gary J. Kelloff, Samir N. Khleif, Caroline C. Sigman, and Eva Szabo. 2011. "Regulatory Approval of Cancer Risk-Reducing (Chemopreventive) Drugs: Moving What We Have Learned into the Clinic." Cancer Prevention Research 4 (3): 311-23.
49. Mossinghoff, Gerald. 1999. "Overview of the Hatch-Waxman Act and Its Impact on the Drug Development Process." Food and Drug Law Journal 54 (2): 187-94.
50. Mukherjee, Siddhartha. 2010. The Emperor of All Maladies: A Biography of Cancer. New York: Scribner.
51. Murphy, Kevin M., and Robert H. Topel. 2006. "The Value of Health and Longevity." Journal of Political Economy 114 (5): 871-904.
52. National Academy of Engineering. 1992. Time Horizons and Technology Investments. Washington, DC: National Academy Press.
53. Neher, Darwin V. 1999. "Staged Financing: An Agency Perspective." Review of Economic Studies 66 (2): 255-74.
54. Nordhaus, William D. 1969. Invention, Growth, and Welfare: A Theoretical Treatment of Technological Change. Cambridge, MA: MIT Press.
55. Nordhaus, William D. 1972. "The Optimum Life on a Patent: Reply." American Economic Review 62 (3): 428-31.
56. Nordhaus, William D. 2004. "Schumpeterian Profits in the American Economy: Theory and Measurement."National Bureau of Economic Research Working Paper 10433.
57. Patrick, Graham L. 2005. An Introduction to Medicinal Chemistry. Oxford: Oxford University Press.
58. Pazdur, Richard. 2000. "Response Rates, Survival, and Chemotherapy Trials." Journal of the National Cancer Institute 92 (19): 1552-53.
59. Philipson, Tomas J., Gary Becker, Dana Goldman, and Kevin M. Murphy. 2010. "Terminal Care and The Value of Life Near Its End." National Bureau of Economic Research Working Paper 15649.
60. Philipson, Tomas J., and Anupam B. Jena. 2006. "Who Benefits from New Medical Technologies? Estimates of Consumer and Producer Surpluses for HIV/AIDS Drugs." Forum for Health Economics and Policy 9 (2). http://dx.doi.org/10.2202/1558-9544.1005.
61. Porter, Michael E. 1992a. "Capital Choices: Changing the Way America Invests in Industry." Journal of Applied Corporate Finance 5 (2): 4-16.
62. Porter, Michael E. 1992b. Capital Choices: Changing the Way America Invests in Industry. Report presented to the Council on Competitiveness and Co-sponsored by the Harvard Business School, Washington, DC.
63. President's Council of Advisors on Science and Technology. 2012. Report to the President on Propelling Innovation in Drug Discovery, Development, and Evaluation. Washington, DC: Executive Office of the President.
64. Psaty, Bruce M., Noel S. Weiss, Curt D. Furberg, Thomas D. Koepsell, David S. Siscovick, Frits R. Rosendaal, Nicholas L. Smith et al. 1999. "Surrogate End Points, Health Outcomes and the Drug-Approval Process for the Treatment of Risk Factors for Cardiovascular Disease." Journal of the American Medical Association 282 (8): 786-90.
65. Ridley, David B., Henry G. Grabowski, and Jeffrey L. Moe. 2006. "Developing Drugs For Developing Countries." Health Affairs 25 (2): 313-24.
66. Roin, Benjamin N. 2010. "Drug Patent Length." https://www.law.stanford.edu/sites/default/files/event/263873/media/slspublic/Benjamin%20Roin%20-%20Drug%20Patent%20Length.pdf.
67. Sakakibara, Mariko, and Lee Branstetter. 2001. "Do Stronger Patents Induce More Innovation? Evidence from the 1988 Japanese Patent Law Reforms." RAND Journal of Economics 32 (1): 77-100.
68. Schankerman, Mark, and Ariel Pakes. 1986. "Estimates of the Value of Patent Rights in European Countries during the Post-1950 Period." Economic Journal 96 (384): 1052-76.
69. Scherer, F. M. 1972. "Nordhaus' Theory of Optimal Patent Life: A Geometric Reinterpretation." American Economic Review 62 (3): 422-27.
70. Schmookler, Jacob. 1966. Invention and Economic Growth. Cambridge, MA: Harvard University Press.
71. Schreiner, Stephen T., and Patrick A. Doody. 2006. "Patent Continuation Applications: How the PTO's Proposed New Rules Undermine an Important Part of the U.S. Patent System with Hundreds of Years of History." Journal of the Patent and Trademark Office Society 88: 556-69.
72. Scotchmer, Suzanne. 1991. "Standing on the Shoulders of Giants: Cumulative Research and the Patent Law." Journal of Economic Perspectives 5 (1): 29-41.
73. Stein, Jeremy C. 1989. "Efficient Capital Markets, Inefficient Firms: A Model of Myopic Corporate Behavior." Quarterly Journal of Economics 104 (4): 655-69.
74. Stein, Jeremy C. 2003. "Agency, Information and Corporate Investment." In Handbook of the Economics of Finance, vol. 1A, edited by George M. Constantinides, Milton Harris, and René M. Stulz, 111-65. Amsterdam: Elsevier B.V.
75. Surveillance, Epidemiology, and End Results (SEER) Program of the National Cancer Institute. 2012. "Surveillance Epidemiology, and End Results (SEER) Program Research Data, 1973-2009." US Department of Health and Human Services, National Institutes of Health. http://seer.cancer.gov (accessed May 6, 2015).
76. nd ed. Hoboken, NJ: Wiley-Interscience.
77. Trusheim, Mark R., and Ernst R. Berndt. 2012. "The Segmentation of Therapeutic Populations in Oncology." Health Management, Policy and Innovation 1 (1): 19-34.
78. US Food and Drug Administration. 2007. Guidance for Industry: Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics. Rockville, MD: US Department of Health and Human Services.
79. Wegner, Harold, and Stephen Maebius. 2001. "The Global Biotech Patent Application." In Biotechnology Law: Biotechnology Patents & Business Strategies in the New Millennium. Intellectual Property Course Handbook, 129-30. New York: Practicing Law Institute.
80. Weisfeldt, Myron L., and Susan J. Zieman. 2007. "Advances In The Prevention And Treatment Of Cardiovascular Disease." Health Affairs 26 (1): 25-37.
81. Weitzman, Martin L. 1998. "Why the Far-Distant Future Should Be Discounted at Its Lowest Possible Rate." Journal of Environmental Economics and Management 36 (3): 201-208.
82. Welch, H. Gilbert, Lisa M. Schwartz, and Steven Woloshin. 2000. "Are Increasing 5-Year Survival Rates Evidence of Success Against Cancer?" Journal of the American Medical Association 283 (22): 2975-78.
83. Weyl, E. Glen, and Jean Tirole. 2012. "Market Power Screens Willingness-to-Pay." Quarterly Journal of Economics 127 (4): 1971-2003.
84. Wroblewski, Michael S., Elizabeth A. Jex, Suzanne Drennon Munck, Christopher J. Garmon, Suzanne T. Michel, Alissa Wantman, and Ossie L. Neal. 2009. Emerging Health Care Issues: Follow-on Biologic Drug Competition. Federal Trade Commission Report. Washington, DC: Federal Trade Commission.
85. Zanders, Edward D. 2011. The Science and Business of Drug Discovery: Demystifying the Jargon. New York: Springer.