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Science, pharmacoeconomics and ethics in drug R&D: a sustainable future scenario?

Abstract

The costs associated with the development of new drugs have increased dramatically in recent years, and fewer truly innovative drugs are making their way to the market. The reversal of this trend has therefore become an urgent priority for the pharmaceutical industry. What are the factors that contribute to these costs, and to what extent can they be effectively controlled? Does the solution lie in new technologies? How is the industry dealing with these problems? And what are the ethical implications of these trends?

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Figure 1: The risks of drug R&D.
Figure 2: Average capitalized costs for new drug R&D during the past 25 years.
Figure 3: Trends in drug R&D.

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References

  1. Geiling, E. M. K. & Cannon, P. R. Pathologic effects of elixir of sulphanilamide (diethylene glycol) poisoning. J. Am. Med. Assoc. 111, 919–926 (1938).

    Article  CAS  Google Scholar 

  2. Temple, R. in Principles of Pharmacology (ed. Munson, P. L.) 1643–1663 (Chapman A. Hall, New York, 1995).

    Google Scholar 

  3. Federal Food, Drug and Cosmetic Act. As amended. Code of Federal Regulations, Title 21, Publication n. 667340 (US Government Printing Office, Washington DC, 1963).

  4. Tishler, M. The role of industry in national science policy. The people's welfare: health and medicine. Persp. Biol. Med. 13, 528–535 (1970).

    Article  CAS  Google Scholar 

  5. Berkowitz, B. A. & Katzung, B. G. Basic and Clinical Pharmacology 9th edn (ed. Katzung, B. G.) 67–74 (Lange Medical/McGraw–Hill, New York, 2004).

    Google Scholar 

  6. Pritchard, J. F. et al. Making better drugs: decision gates in non-clinical drug development. Nature Rev. Drug Discov. 2, 542–553 (2003)

    Article  CAS  Google Scholar 

  7. DiMasi, J. A., Hansen, R. W., Grabowski, H. G. & Lasagna, L. Research and development costs for new drugs by therapeutic category: a study of the U. S. pharmaceutical industry. PharmacoEconomics 7, 152–169 (1995).

    Article  CAS  Google Scholar 

  8. DiMasi, J. A. Success rates for new drugs entering clinical testing in the United States. Clin. Pharmacol. Ther. 58, 1–14 (1995).

    Article  CAS  Google Scholar 

  9. Monzo, A. & Mehta, D. Are single-dose toxicology studies in animals adequate to support single doses of a new drug in humans? Clin. Pharmacol. Ther. 59, 258–264 (1996).

    Article  Google Scholar 

  10. Polastro, E. T. Managing primary development for competitive edge. Scrip Magazine, 33–34 (November 1995).

  11. Editorial. 18 new blockbusters by 2008, with $ 24 billion sales forecast. PharmacoMarket Letter 29, 24–25 (July 1, 2002).

  12. DiMasi, J. A. Risks in new drug development: approval success rates for investigational drugs. Clin. Pharmacol. 69, 297–307 (2001).

    CAS  Google Scholar 

  13. DiMasi, J. A., Hansen, R. W. & Grabowski, H. G. The price of innovation: new estimates of drug development costs. J. Health Econ. 22, 151–185 (2003).

    Article  Google Scholar 

  14. Styliani, E. R. & D costs are staggering. Pharmacobusiness 48 (January/February 2002).

  15. Greaves, P., Williams, A. & Eve, M. First dose of potential new medicines to humans: how animals help. Nature Rev. Drug Discov. 3, 226–236 (2004).

    Article  CAS  Google Scholar 

  16. Claude, J. R. Les études de sécurité des produits en dévelopment dans l'industrie pharmaceutique. Ann. Pharm. Fr. 59, 324–330 (2001).

    CAS  PubMed  Google Scholar 

  17. Regan, T. Defending Animal Rights (University of Illinois Press, 2001).

    Google Scholar 

  18. Roberts, I., Kwan, I., Evans, P. & Haig, S. Does animal experimentation inform human healthcare? Observations from a systematic review of international animal experiments on fluid resuscitation. BMJ 324, 474–476 (2002).

    Article  Google Scholar 

  19. Paton, W. Man and mouse — animals in medical research 44 (Oxford Med. Press, 1984).

    Google Scholar 

  20. Ellen Frankel, P. Jeffrey, P. Why Animal Experimentation Matters: the Use of Animals in Medical Research (Transactions Publishers, 2001).

    Google Scholar 

  21. Shaw, W. H. Cost and benefits of inflicting pain. Nature 414, 396–397 (2001).

    Article  CAS  Google Scholar 

  22. Wickelgren, I. Animal studies raise hopes for spinal cord repair. Science 297, 178–181 (2002).

    Article  CAS  Google Scholar 

  23. Nies, A. S. in Goodman and Gilman's The Pharmacological Basis of Therapeutics 10th edn (eds. Hardman, J. G. & Limbird, L. E) 45–66 (McGraw Hill, New York, 2001).

    Google Scholar 

  24. Reichert, J. M. Trends in development and approval for the new therapeutics in the United States. Nature Rev. Drug Discov. 2, 695–702 (2003).

    Article  CAS  Google Scholar 

  25. DiMasi, J. New drug development in the United States from 1963 to 1999. Clin. Pharmacol. Ther. 69, 286–296 (2001).

    Article  CAS  Google Scholar 

  26. Mitka, M. Accelerated approval scrutinized. Confirmatory Phase 4 studies or new drug languish. J. Am. Med. Assoc. 289, 3227–3229 (2003).

    Article  Google Scholar 

  27. Goldstein, A., Aronow, L. & Kalman, S. M. Principles of Drug Action. The Basis of Pharmacology 2nd edn 815 (J. Wiley a. Sons, Chichester, 1974).

    Google Scholar 

  28. Lewis, I. A. Post marketing surveillance. how many patients? Trends Pharmacol. Sci. 2, 93–94 (1971).

    Article  Google Scholar 

  29. Freeman, J. in Drug Safety: A Shared Responsibility, International Drug Surveillance Department Glaxo Group Res. Ltd. 13–26 (Churchill Livingstone, Edinburgh 1991).

    Google Scholar 

  30. Generali, J. A. Drug withdrawals in the US: 1980 to 2001. Drug facts and comparison news 43–45 (Facts and Comparisons, a Wolters Kluwer Company, St. Louis, 2001).

  31. McQuaid, K. R. in Basic and Clinical Pharmacology (ed. Katzung, B. G.) 1049 (Lange Medical/McGraw Hill, New York, 2004).

    Google Scholar 

  32. Farmer, J. A. Learning from the cerivastatin experience. Lancet 358, 1383–1384 (2001).

    Article  CAS  Google Scholar 

  33. Katzung, B. G. in Basic and Clinical Pharmacology 9th edn (ed. Katzung, B. G.) 267 (Lange Medical/McGraw Hill, New York, 2004).

    Google Scholar 

  34. Elliott, W. I. Nefazodone under attack once again. Pharmacol. Watch, May 2003, 2 (Thomson American Health Consultants, Atlanta 2003).

  35. Edwards, I. R. Withdrawing drugs: nefazodone, the start of the latest saga. Lancet 361, 1240 (2003).

    Article  Google Scholar 

  36. Editorial. R. & D. revolution remains just around the corner. Scrip Magazine February, 72–73 (2002).

  37. Watters, J. W. & McLeod, H. L. Using genome-wide mapping in the mouse to identify genes that influence drug response. Trends Pharmacol. Sci. 24, 55–58 (2003).

    Article  CAS  Google Scholar 

  38. Evans, W. E. & McLeod, H. L. Pharmacogenomics — drug disposition, drug target, and side effects. N. Engl. J. Med. 348, 538–549 (2003).

    Article  CAS  Google Scholar 

  39. Weinshilboum, R. Inheritance and drug response. N. Engl. J. Med. 348, 529–537 (2003).

    Article  Google Scholar 

  40. Weinstein, J. N. Pharmacogenomics — teaching old drugs new tricks. N. Engl. J. Med. 9, 1408–1409 (2000).

    Article  Google Scholar 

  41. Roses, A. D. Genome-based pharmacogenetics and the pharmaceutical industry. Nature Rev. Drug Discov. 1, 541–549 (2002).

    Article  CAS  Google Scholar 

  42. 2002 Workshop on Pharmacogenetics/Pharmacogenomics in drug development and regulatory decision-making. Chairpersons: L. Lesko, R. A Salerno. www.fda.gov/CDER/Calendar/MEETING/PHARMA52002/default.htm

  43. Phillips, K. A., Veenstra, D. L., Oren, E., Lee, J. K. & Sadee, W. Potential role of pharmacogenomics in reducing adverse drug reactions. J. Am. Med. Assoc. 286, 2270–2279 (2001).

    Article  CAS  Google Scholar 

  44. Holmes, E. Methodological approach in metabonomics. Tox. Lett. 144 (Suppl. 1), S4 (2003).

    Article  Google Scholar 

  45. Thompson, D. C. Methodological approaches in proteomics. Tox. Lett. 144 (Suppl. 1), S4 (2003).

    Article  Google Scholar 

  46. Editorial. Genomics may increase costs of NCE development says Lehman Bros. PharmaMarkeletter 28, 24–25, February 2001.

  47. Lord, P. G. Progress in applying genomics in drug development. Tox. Lett. 144 (Suppl. 1), S4 (2003).

    Article  Google Scholar 

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ABCB1

ADRB2

ERBB2

UGT1

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Gilbert syndrome

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Preziosi, P. Science, pharmacoeconomics and ethics in drug R&D: a sustainable future scenario?. Nat Rev Drug Discov 3, 521–526 (2004). https://doi.org/10.1038/nrd1418

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