Demythologizing the high costs of pharmaceutical research

BioSocieties

Volumn 6, Issue 1, 2011, Pages 34-50

  Light, Donald W ^a,b   Warburton, Rebecca ^c  

^a STANFORD UNIVERSITY   (United States)

^b UNIVERSITY OF MEDICINE AND DENTISTRY OF NEW JERSEY   (United States)

^c UNIVERSITY OF VICTORIA   (Canada)

Author keywords

AMC (Advance Market Commitment); costs; myths; neglected diseases; pharmaceutical research

Indexed keywords

EID: 84860390112     PISSN: 17458552     EISSN: 17458560     Source Type: Journal    
DOI: 10.1057/biosoc.2010.40     Document Type: Article

References (56)

1. Adamini, S., Maarse, H., Versluis, E. and Light, D.W. (2009) Policy making on data exclusivity in the European Union: From industrial interests to legal realities. Journal of Health Politics, Policy and Law 34: 979-1010.
2. Andrews, E.L. (2005) Hitting the tax-break jackpot. The New York Times, 1 February: C1-C2.
3. Angell, M. (2004) The Truth About the Drug Companies: How They Deceive Us and What to Do About It. New York: Random House.
4. Barton, J. and Emanuel, E. (2005) The patent-based pharmaceutical development process: Rationale, problems, and potential reforms. Journal of American Medical Association 294: 2075-2082. (Pubitemid 41539941)
5. Berenson, A. (2005) Tax break gives huge benefits to drugmakers. New York Times, 8 May.
6. Boston Consulting Group. (2001) A Revolution in R&D. Boston, MA: Boston Consulting Group.
7. Butler, D. (2010) Cash crisis looms for vaccine drive. Nature 464: 338.
8. Canadian Coordinating Office for Health Technology Assessment. (1997) Guidelines for Economic Evaluation of Pharmaceuticals, 2nd Edition. Ottawa, Canada: Canadian Coordinating Office for Health Technology Assessment.
9. Carpenter, D., Zucker, E.J. and Avorn, J. (2008) Drug-review deadlines and safety problems. New England Journal of Medicine 358: 1354-1361, (1359: 1396-1398). (Pubitemid 351468412)
10. DiMasi, J.A., Hansen, R.W. and Grabowski, H. (2003a) The price of innovation: New estimates of drug development costs. Journal of Health Economics 22: 151-185. (Pubitemid 36279392)
11. DiMasi, J.A., Hansen, R.W. and Grabowski, H.G. (2003b) The price of innovation: New estimates of drug development costs, Appendix B, pp. 1-6. Tufts University (unpublished).
12. DiMasi, J.A., Hansen, R.W., Grabowski, H.G. and Lasagna, L. (1991) Cost of innovation in the pharmaceutical industry. Journal of Health Economics 10: 107-142.
13. EFPIA. (2010) The Pharmaceutical Industry in Figures. Brussels, Belgium: European Federation of Pharmaceutical Industries and Associations.
14. Engelberg, A.B. (1982) Patent term extension: An overreaching solution to a nonexistent problem. Health Affairs 1(2): 34-45.
15. European Commission for Competition. (28 November 2008) Pharmaceutical Sector Inquiry-Preliminary Report. Brussels, Belgium: European Commission for Competition.
16. Farlow, A. (2005) Accelerating the innovation of vaccines. Innovation Strategy Today 1(2): 66-202.
17. Fisher, J.A. (2009) Medical Research for Hire: the Political Economy of Pharmaceutical Clinical Trials. New Brunswick, NJ: Rutgers University Press.
18. Frew, S.E., Kettler, H.E. and Singer, P.A. (2008) The Indian and Chinese health biotechnology industries: Potential champions of global health? Health Affairs 27(4): 1029-1041.
19. General Accounting Office. (2003) Technology Transfer: NIH-Private Sector Partnership in the Development of Taxol, (No. GAO-03-829). Washington DC: General Accounting Office.
20. Goozner, M. (2004) The $800 Million Pill: The Truth Behind the Cost of New Drugs. Berkeley, CA: University of California Press.
21. Grabowski, H. (ed.) 1976) Drug Regulation and Innovation: Empirical Evidence and Policy Options. Washington DC: American Enterprise Institute.
22. Grabowski, H.G. (1978) Drug Regulation and Innovation. Washington DC: American Enterprise Institute for Public Policy Research.
23. Hansen, R.W. (1979) The pharmaceutical development process: Estimates of current development costs and times and the effects of regulatory changes. In: R.I. Chien (ed.) Issues in Pharmaceutical Economics. Lexington, MA: Lexington Books, pp. 151-187.
24. Harris, G. (2001) Health costs of developing new medicine swelled to $802 million, research study reports. Wall Street Journal; http://www.globalaging.org/health/world/costnewmedicines.htm, accessed November 2010.
25. Keyhani, S., Diener-West, M. and Powe, N. (2006) Are development times for pharmaceuticals increasing or decreasing? Health Affairs 25(2): 461-468. (Pubitemid 43529555)
26. Kremer, M. and Glennerster, R. (2004) Strong Medicine: Creating Incentives for Pharmaceutical Research on Neglected Diseases. Princeton, NJ: Princeton University Press.
27. Le Fanu, J. (1999) The Rise and Fall of Modern Medicine. New York: Carroll & Graf Publishers.
28. Light, D.W. (2006) Basic research funds to discover important new drugs: Who contributes how much? In: M.A. Burke (ed.) Monitoring the Financial Flows for Health Research 2005: Behind the Global Numbers. Geneva, Switzerland: Global Forum for Health Research, pp. 27-43.
29. Light, D.W. (2007) Is G8 putting profits before the world's poorest children? The Lancet 370: 297-298. (Pubitemid 47096844)
30. Light, D.W. (2009) Advanced Market Commitments: Current Realities and Alternate Approaches. Amsterdam, the Netherlands: HAI Europe/Medico International Publication.
31. Light, D.W. (ed.) (2010) The Risk of Prescription Drugs. New York: Columbia University Press.
32. Light, D.W. and Lexchin, J. (2005) Foreign free riders and the high price of US medicines. BMJ 331: 958-960. (Pubitemid 41510858)
33. Light, D.W., Andrus, J. and Warburton, R. (2009) Estimated costs of research and development of rotavirus vaccines. Vaccine 27: 6627-6633.
34. Love, J. (2003) Evidence Regarding Research and Development Investments in Innovative and Non-Innovative Medicines. Washington DC: Consumer Project on Technology.
35. McGoey, L. (2009) Pharmaceutical controversies and the performative value of uncertainty. Science as Culture 18: 151-164.
36. Mitsuya, H., Winhold, K., Yarchoan, R., Bolognesi, D. and Broder, S. (1989) Credit government scientists with developing anti-AIDS drugs (letter). New York Times.
37. Moran, M. (2005) A breakthrough in R&D for neglected diseases: New ways to get the drugs we need. PLoS. Medicine 2(9): e302.
38. Moran, M. et al (2007) The Malaria Product Pipeline: Planning for the Future. Sydney, Australia: The George Institute for International Health.
39. Morgan, S.G. et al (2005) 'Breakthrough' drugs and growth in expenditure on prescription drugs in Canada. BMJ 331: 815-816. (Pubitemid 41442361)
40. National Institute for Health Care Management. (2000) Prescription Drugs and Intellectual Property Protection. Washington DC: National Institute for Health Care Management.
41. National Science Foundation. (2003) Research and Development in Industry: 2000. Arlington, VA: National Science Foundation, Division of Science Resources Statistics.
42. Olson, M.K. (2004) Are novel drugs more risky for patients than less novel drugs? Journal of Health Economics 23: 1135-1158. (Pubitemid 39535588)
43. Patented Medicine Prices Review Board. (2002) A Comparison of Pharmaceutical Research and Development Spending, (No. PMPRB Study Series S-0217). Ottawa, Canada: PMPRB.
44. Pharmaceutical R&D Policy Project. (2005) The New Landscape of Neglected Disease Drug Development. London: The Wellcome Trust and London School of Economics and Political Science.
45. Pharmaceutical Research and Manufacturers of America. (2002) Pharmaceutical Industry Profile 2002. Washington DC: Pharmaceutical Research and Manufacturers of America. PhRMA. (2009)
46. Pharmaceutical Industry Profile 2009. Washington DC: Pharmaceutical Research and Manufacturers of America.
47. Plahte, J. (2005) Tiered pricing of vaccines: A win-win-win situation, not a subsidy. The Lancet Infectious Diseases 5(1): 58-63. (Pubitemid 40037629)
48. Public Citizen. (2001) Rx R&D Myths: The Case Against the Drug Industry's R&D 'Scare Card'. Washington DC: Public Citizen.
49. Russell, K.B., Gold, M.R., Siegel, J.E., Daniels, N. and Weinstein, M.C. (1996) The role of cost-effectiveness analysis in health and medicine: Panel on cost-effectivess in health and medicine. Journal of American Medical Association 276: 1172-1177. (Pubitemid 26329746)
50. Tax Policy Center. (2002) Marginal rates of the Federal Corporation Income Tax, 1942-2002. Washington DC: Tax Policy Center.
51. United States Office of Management and Budget. (2003) Guidelines and Discount Rates for Benefit-Cost Analysis of Federal Programs. Washington DC: United States Office of Management and Budget.
52. US Food and Drug Administration. (2004) NDAs Approved in Calendar Years1990-2003 by Therapeutic Potential and Chemical Types. Washington DC: U.S. Food and Drug Administration.
53. US Office of Technology Assessment. (1993) Pharmaceutical R&D: Costs, Risks and Rewards, (No. NTIS #PB93-163376). Washington DC: Office of Technology Assessment.
54. Wardell, W.M. and Lasagna, L. (eds.) (1975) Regulation and Drug Development. Washington DC: American Enterprise Institute
55. Waxman, H., Durbin, R.J. and Kennedy, E.M. (2006) New GAO Analysis of Drug Development Refutes Industry Myths. Washington DC: U.S. Congress.
56. Weinstein, M.C., Siegel, J.E., Gold, M.R., Kamlet, M.S. and Russell, L.B. (1996) Recommendations of the panel on cost-effectiveness in health and medicine. Journal of American Medical Association 276: 1253-1258. (Pubitemid 26337709)