Abonnement à la biblothèque: Guest
Ethics in Biology, Engineering and Medicine: An International Journal

ISSN Imprimer: 2151-805X

ISSN En ligne: 2151-8068

SJR: 0.123

Affordable Access to Cancer Drugs and Other Lifesaving Medicines in the United States

Volume 9, Numéro 1, 2018, pp. 99-115
DOI: 10.1615/EthicsBiologyEngMed.2019032845
Get accessGet access

RÉSUMÉ

The current trajectory of astronomical price increases for cancer drugs and other lifesaving medicines in the United States is mind-boggling and has created enormous anxiety for many cancer patients and society in general. Most cancer drugs typically cost > $100,000/yr. Recently, a group of cancer researchers and physicians vigorously questioned the ethics of such exorbitant drug prices that are out of reach for most buyers/patients. Cancer patients may be forced to forgo or cut back on other vital needs and medicines to pay for cancer drugs. The free-market approach that is currently emphasized and practiced in the US has obviously failed to effectively address the out-of-control rising trend of cancer drug costs and those of other lifesaving drugs. Striking a delicate balance between promoting innovation and public interest is imperative in the current debate. Broad-based approaches for strategies to effectively deal with the ethical issue of affordable access to cancer drugs and other lifesaving medicines in the US has been argued to be a solution. Such strategies would consist of reducing aggressive and costly advertising and marketing practices; implementing value-based reimbursement and pricing, quality-adjusted life-years, and incremental cost-effectiveness ratio; and using national evidence-based guidelines, flexible price controls, and compulsory licensing for cancer drugs and other lifesaving medicines, especially in a monopolized market environment. Also argued to be viable solutions are legislative proposals such as Medicare negotiating drug prices with pharmaceutical companies, prescription drug importation from Canada, prohibition of anticompetitive payoff agreements to keep more affordable generic equivalents off the market, and allowing consumers to access cost-saving generics. In addition, providing for a research and development allowance of ~ 20%, as in the United Kingdom for each pharmaceutical firm, is argued as a solution to foster greater innovation.

RÉFÉRENCES
  1. CMS.gov. National Health Expenditure Projections 2011-2020 [homepage on the Internet]. [cited 2018 Feb 24]. Available from: https://pnhp.org/news/national-health-expenditures-in-2011-and-2020/.

  2. Kantarjian HM, Fojo T, Mathisen M, Zwelling LA. Cancer drugs in the United States: Justum Pretium-the just price. J Clin Oncol. 2013;31(28):3600-4.

  3. Himmelstein DU, Thorne D, Warren E, Woolhandler S. Medical bankruptcy in the United States, 2007: Results of a national study. Am J Med. 2009;122(8):741-6.

  4. Bunnell C. Integrating value assessment into discussions about the price of cancer drugs. Mayo Clin Proc. 2012;87(10):932-4.

  5. Light DW, Kantarjian H. Market spiral pricing of cancer drugs. Cancer. 2013;119(22):3900-2.

  6. Household Income in the United States [Internet]; [updated 2014 Jan 28; cited 2018 Feb 24]. Available from: http://en.wikipedia.org/wiki/Household_income_in_the_United_States.

  7. Kantarjian H. Experts in chronic myelogenous leukemia: The price of drugs for chronic myeloid leukemia (CML) is a reflection of unsustainable prices of cancer drugs: From the perspective of large group of CML experts. Blood. 2013;121(22):4439-42.

  8. Kantarjian H, Steensma D, Sanjuan JR, Elshaug A, Light D. High cancer drug prices in the United States: Reasons and proposed solutions. J Oncol Prac. 2014;10(4):e208-11.

  9. Hillner BE, Smith TJ. Efficacy does not necessarily translate to cost effectiveness: A case study in the challenges associated with 21st-century cancer drug pricing. J Clin Oncol. 2009;27(13):2111-3.

  10. Siddiqui M, Rajkumar SV. The high cost of cancer drugs and what we can do about it. Mayo Clin Proc. 2012;87(10):935-43.

  11. Kantarjian H, Rajkumar SV. Why are cancer drugs so expensive in the United States, and what are the solutions? Mayo Clin Proc. 2015;90(4):500-4.

  12. Light DW, Lexchin J. Foreign free riders and the high price of US medicines. BMJ. 2005;331(7522): 958-60.

  13. Merck GW. Wikipedia website [Internet]. [cited 2018 Mar 4]. Available from: http://en.wikipedia.org/wiki/George_W._Merck.

  14. Martin D. Rashi Fein, economist who urged Medicare, dies at 88. Obituary [Internet]. The New York Times website; 2014 [cited 2018 Mar 5]. Available from: https://www.nytimes.com/2014/09/14/us/ rashi-fein-economist-who-urged-medicare-dies-at-88.html.

  15. Light DW, Lexchin J. Pharmaceutical R&D: What do we get for all that money? BMJ. 2012;345:e4348.

  16. Light DW, Warburton RN. Demythologizing the high cost of pharmaceutical research. Biosocieties. 2001;6(1):1-17.

  17. Angell M. The truth about the drug companies: How they deceive us and what to do about it. New York: Random House Trade Paperbacks; 2004. p. 12.

  18. Stiglitz J. The price of inequality. New York: W.W. Norton; 2012. p. 45.

  19. Scherer FM. The F.T.C., Oligopoly, and shared monopoly [Internet]. Faculty Research Working Paper Series. Harvard Kennedy School; 2013. Available from: https://research.hks.harvard.edu/publications/ getFile.aspx?Id=978.

  20. Vernaz N, Haller G, Girardin F, Huttner B, Combescure C, Dayer P, Muscionico D, Salomon JL, Bonnabry P. Patented drug extension strategies on healthcare spending: A cost-evaluation analysis. PLOS Med. 2013;10(6):e1001460.

  21. Wyatt E. Justices to take up generic drug case. New York: The New York Times; 2012 Dec 8. p. B1.

  22. Obi EC. Post-trial access to drugs in developing nations: Global health justice. Cham, Switzerland: Springer; 2017. p. 104.

  23. Medecins Sans Frontieres. Access to medicines at risk across the globe: What to watch out for in free trade agreements with the United States. Geneva, Switzerland: MSF; 2004. Available from: https:// www.msfaccess.org/access-medicines-risk-across-globe.

  24. Forman L. Trading health for profit: The impact of bilateral and regional free trade agreements on domestic intellectual property rules on pharmaceuticals. Cohen JC, Illingworth P, Schuklenk U, editors. The Power of pills: Social, ethical and legal issues in drug development, marketing and pricing. London: Pluto Press; 2006. p. 192.

  25. Das K, Petigara T, Anderson G. Price negotiations for drugs in the U.S. Health Policy Monitor; 2007. Available from: www.hpm.org/survey/us/b9/3.

  26. Rome E. Big pharma CEOs rake in $1.57 billion in pay [Internet]. Huff Post Business. 2017 Dec 6 [cited 2018 Mar 12]. Available from: www.huffingtonpost.com/ethan-rome/big-pharma-ceo- pay_b_3236641.html.

  27. Yakowicz W. Top 10 most profitable industries of 2014. Inc.com website [Internet]. [cited 2018 Mar 12]. Available from: http://www.inc.com/ss/will-yakowicz/10-best-in-dustries-on-2014-inc-5000. html.

  28. Baker D. The savings from an efficient Medicare prescription drug plan. Center for Economic and Policy Research website [Internet]. [cited 2018 Mar 12]. Available from: http://www.cepr.net/docu- ments/efficient_medicare_2006_01.pdf.

  29. Frank L, Basch E, Selby J. Patient-Centered Outcomes Research Institute. The PCORI perspective on patient-centered outcomes research. JAMA. 2014;312(15):1513-4.

  30. US Food and Drug Administration [homepage on the Internet]. For industry: Importations of drugs [cited 2018 Mar 13]. Available from: http://www.fda.gov/Forindustry/importProgram/ucm173751. htm.

  31. Potter W. Opinion: Big pharma's stranglehold on Washington. Center for Public Integrity website [Internet]. [cited 2018 Mar 13]. Available from: http://www.publicintegrity.org/2013/02/11/12175/ opinion-big-pharmas-stranglehold-washington.

  32. Center for Responsive Politics. Lobbying spending database pharmaceuticals/health products, 2012. OpenSecret.org website [Internet]. [cited 2018 Mar 16]. Available from: http://www.opensecrets.org/ lobby/indusclient.php?id=H04&year=2012.

  33. Light DW. Spiraling prices for cancer and specialty drugs. Edmond J. Safra Center for Ethics website [Internet]. [cited 2018 Mar 16]. Available from: http://ethics.havard.edu/blog/spiraling-prices.

  34. Conti RM, Rosenthal MB. Pharmaceutical policy reform: Balancing affordability with incentives for innovation. New Engl J Med. 2016;374(8):703-6.

  35. Chin WW A delicate balance: Pharmaceutical innovation and access. New Engl J Med. 2015;373(19): 1799-801.

  36. Frank R, Ginsburg PB. Pharmaceutical industry profits and research and development, 2017. Health Affairs website [Internet], [cited 2018 Mar 18]. Available from: https://www.brookings .edu/blog/usc-brookings-schaeffer-on-health-policy/2017/11/17/pharmaceutical-industry-profits-and-research-and-development/.

  37. Cremieux PY, Jarvinen D, Long G, Merrigan. Pharmaceutical spending and health outcomes. Sloan FA, Hsieh CR. Pharmaceutical innovation: Incentives, competition and cost-benefit analysis in international perspective. Cambridge: Cambridge University Press; 2007. pp. 226-41.

  38. Otterson K. Pharmaceutical arbitrage: Balancing access and innovation in international prescription drug markets. Yale J Health Policy Law Ethics. 2005:5(1):193-292.

  39. World Intellectual Property Organization [Internet]. Public Health and Patents. [cited 2018 Mar 18]. Available from: http://www.wipo.int/patent-law/en/developments/publichealth.html.

  40. Strongin RJ. Hatch-Waxman, generics, and patents: Balancing prescription drug innovation, competition, and affordability [Internet]. National Health Policy Forum Background Paper. 2002 [cited 2018 Mar 18]. Available from: file:///C:/Users/evaobi/Documents/Hatch-Waxman,%20Generics,%20 and%20Patents%20-%20Balancing%20Prescription%20Drug%20Innovation,%20Competition,%20 and%20Affordability.pdf.

  41. Engelberg AB, Kesselheim AS, Avorn J. Balancing innovation, access, and profits: Market exclusivity for biologics. New Engl J Med. 2009;361(20):1917-9.

  42. Digital Access to Scholarship at Harvard [Internet]. Prescription drug pricing: How much is too much? [cited 2018 Mar 21]. Available from: file:///C:/Users/evaobi/Documents/Prescription%20drug%20 pricing%20-%20how%20much%20is%20too%20much.pdf.

  43. Brody B. Ethical issues in drug testing, approval, and pricing: The clot-dissolving drugs. New York: Oxford Press; 1995. p. 235.

  44. Greider K. The big fix: How the pharmaceutical industry rips off American consumers. New York: Public Affairs; 2003. p. 64.

  45. Lawrence HJ. The high cost of prescription drugs: The price of success. Yale J Health Pol Law Ethics. 2004;4(1):165-72.

  46. Cegedim Strategic Data [Internet]. 2012 U.S. Pharmaceutical company promotion spending. 2013 [cited 2018 Mar 23]. Available from: http://www.skainfo.com/health_care_market_reports/2012_promotional_.pdf.

  47. Johar K. An insider's perspective: Defense of the pharmaceutical industry's marketing practices. Albany Law Rev. 2013;76(1):308.

  48. Donohue JM, Cevasco M, Rosenthal MB. A decade of direct-to-consumer advertising of prescription drugs. New Engl J Med. 2007;357(7):673-81.

  49. PEW Charitable Trusts [Internet]. Persuading the prescribers: Pharmaceutical industry marketing and its influence on physicians and patients. 2013 [cited 2018 Mar 24]. Available from: http://www. pewtrusts.org/en/research-and-analysis/fact-sheets/2013/11/11/persuading-the-prescribers-pharma-ceutical-industry-marketing-and-its-influence-on-physicians-and-patients.

  50. Peyrot M, Alperstein NM, Doren DV, Poli LG. Direct-to-consumer ads can influence behavior: Advertising increases consumer knowledge and prescription drug requests. Market Health Serv. 1998;18(22):26-32.

  51. Bell RA, Kravitz RL, Wilkes MS. Direct-to-consumer prescription drug advertising and the public. J Gen Int Med. 1999;14(11):651-7.

  52. Kravitz RL, Epstein RM, Feldman MD, Franz CE, Azari R, Wilkes MS, Hinton L, Franks P. Influence of patients' requests for direct-to-consumer advertised antidepressants: A randomized controlled trial. JAMA. 2005;293(16):1995-2002.

  53. Rockoff JD. Drugs reps soften their sales pitches [Internet]. Wall Street Journal website [Internet]. 2012 [cited 2018 Mar 24]. Available from: http://online.wsj.com/news/articles/SB1000142405297020 4331304577142763014776148.

  54. Peay MY, Peay ER. The role of commercial sources in the adoption of a new drug. Soc Sci Med. 1988;23(12):1183-9.

  55. Chew LD, O'Young TS, Hazlet TK, Bradley KA, Maynard C, Lessler D. A Physician survey of the effect of drug sample availability on physicians' behavior. J Gen Int Med. 2000;15(7):478-83.

  56. Pharmaceutical Research and Manufacturers of America (PhRMA) [Internet]. PhRMA adopts new marketing code. 2002 [cited 2018 Mar 25]. Available from: http://www.phrma.org/mediaroom/press/ releases/19.04.2002.390.cfm.

  57. Lawrence HJ. The high cost of prescription drugs: The price of success. Yale J Health Pol Law Ethics. 2004;4(1):165-72.

  58. Goodman A. Value-based approaches to the rising costs of cancer drugs [Internet]. 2017 [cited 2018 Mar 25]. Available from: http://www.ascopost.com/issues/march-10-2017/value-based-approaches-to -the-rising-costs-of-cancer-drugs/.

  59. Sassi F. Calculating QALYs, comparing QALY and DALY calculations. Health Policy Plan. 2006; 21(5):402-8.

  60. Kaplan RM, Anderson JP. A general healthy policy model: Update and application. Health Serv Res. 1998;23(2):203-35.

  61. Erickson P, Wilson R, Shannon I. Years of healthy life. Healthy People 2000 Stat Notes. US Dept Health and Huma Serv. 1995;Apr(7):1-15.

  62. World Trade Organization [Internet]. Doha declaration on the TRIPS Agreement and Public Health. 2001 [cited 2018 Apr 8]. Available from: https://www.wto.org/english/thewto_e/minist_e/min01_e/ mindecl_trips_e.htm.

  63. Baker D. The savings from an efficient Medicare prescription drug plan [Internet]. 2006 [cited 2018 Apr 8]. Available from: http://cepr.net/documents/efficient_medicare_2006_01.pdf.

  64. Leonard K. Pelosi releases long-awaited plan to have government negotiate drug prices [Internet]. Washington Examiner. 2019 Sep 19 [cited 2019 Oct 24]. Available from: https://www.washington-examiner.com/policy/healthcare/pelosi-releases-long-awaited-plan-to-have-government-negotiate-drug-prices.

  65. DeLorenzo T. US House of Representatives committee approves prescription drug bill [Internet]. Jurist; 2019 Oct 18 [cited 2019 Oct24]. Available from: https://www.jurist.org/news/2019/10/us-house-of-representatives-committee-approves-prescription-drug-bill/.

  66. Sanders B. Fighting to lower prescription drug prices [Internet]. [cited 2018 Apr 8]. Available from: https://berniesanders.com/issues/fighting-to-lower-prescription-drug-prices/.

  67. Grassley C. Klobuchar, Grassley introduce bipartisan legislation to crack down on anticompetitive pay-for-delay pharmaceutical deals [Internet]. 2017 [cited 2018 Apr 8]. Available from: https:// www.grassley.senate.gov/news/news-releases/klobuchar-grassley-introduce-bipartisan-legislation-crack-down-anti-competitive.

Dernier numéro

Heroics at the End of Life in Pediatric Cardiac Intensive Care: The Role of the Intensivist in Supporting Ethical Decisions around Innovative Surgical Interventions Mithya Lewis-Newby, Emily Berkman, Douglas S. Diekema, Jonna D. Clark Transplantation for Older Patients with Hematologic Malignancies in 2021: Uncertainty and Ethics in Decision-Making H. Joachim Deeg Exploring the Hippocratic Oath: A Critical Look at Medicine's Oldest Surviving Guide to Medical Ethics D. John Doyle All Sore Eyes and Beasts: Spiritual Care Providers' Role in End-of-Life Existential Distress Debra Josephson Abrams, David B. Brecher, Douglas W. Lane The Ethics of Technology Development and Technology Use David W. Chambers Ethical Challenges of Artificial Intelligence in Health Care: A Narrative Review Aaron T. Hui, Shawn S. Ahn, Carolyn T. Lye, Jun Deng The Goods of Health Care Wade L. Robison The Ethics of Observing Low-Risk Thyroid Cancer Betty Y. Chen, Brendan C. Stack A Sampling of Engineering Ethics Conundrums Intended for Classroom Discussion D. John Doyle Toward a Better Understanding of Risk-Taking in Medical Decision Making David S. Dinhofer, Shweta Agarwal Ethical Issues Involving the Development of COVID-19 Vaccines: Role of Vaccine Development, Clinical Trials, and Speed of Peer Review in Dissuading Public Vaccine Hesitancy Leisha M. A. Martin, Gregory W. Buck Autonomy and Addictive Design Stephen Scales Ethical Implications with the Utilization of Artificial Intelligence in Dentistry Neekita Saudagar, Rafia Jabeen, Pallavi Sharma, Sean Mong, Ram M. Vaderhobli Meeting Report: 9th International Conference on Ethics in Biology, Engineering, and Medicine Subrata Saha, Pamela Saha Index, Volume 12, 2021
Portail numérique Bibliothèque numérique eBooks Revues Références et comptes rendus Collections Prix et politiques d'abonnement Begell House Contactez-nous Language English 中文 Русский Português German French Spain