Why High Drug Pricing Is A Problem for Research Ethics

Spencer Phillips Hey1,2
1Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School, Boston, USA
2Harvard Center for Bioethics, Harvard Medical School, Boston, USA

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Appelbaum, P.S., L.H. Roth, C.W. Lidz, P. Benson, and W. Winslade. 1987. False hopes and best data: Consent to research and the therapeutic misconception. Hastings Center Report 17(2): 20–24.

Bach, P.B., S.A. Giralt, and L.B. Saltz. 2017. FDA approval of tisagenlecleucel: Promise and complexities of a $475,000 cancer drug. JAMA 318(19): 1861–1862.

Clarke, T., and N. Grover. 2016. Bowing to pressure, FDA approves Sarepta’s Duchenne drug. Reuters, September 19. https://www.reuters.com/article/us-sarepta-fda/bowing-to-pressure-fda-approves-sareptas-duchenne-drug-idUSKCN11P1HK. Accessed August 20, 2019.

Committee on Finance United States Senate. 2015. The price of Sovaldi and its impact on the U.S. health care system. Washington D.C.: U.S. Government Publishing Office.

Dowling, J.J. 2016. Eteplirsen therapy for Duchenne muscular dystrophy: Skipping to the front of the line. Nature Reviews Neurology 12(12): 675–676.

Güth, W., R. Schmittberger, and B. Schwarze. 1982. An experimental analysis of ultimatum bargaining. Journal of Economic Behavior & Organization 3(4): 367–388.

Iuga, A.O., and M.J. McGuire. 2014. Adherence and health care costs. Risk Management and Healthcare Policy (7): 35–44.

Kesselheim, A.S., J. Avorn, and A. Sarpatwari. 2016. The high cost of prescription drugs in the United States: Origins and prospects for reform. JAMA 316(8): 858–871.

Kimmelman, J. 2007. The therapeutic misconception at 25: Treatment, research, and confusion. Hastings Center Report 37(6): 36–42.

Locock, L., and L. Smith, 2011. Personal benefit, or benefiting others? Deciding whether to take part in clinical trials. Clinical trials 8(1): 85–93.

Manton, K.J., C.S. Gauld, K.M. White, P.M. Griffin, and S.L. Elliott. 2019. Qualitative study investigating the underlying motivations of healthy participants in phase I clinical trials. BMJ Open 9(1): p.e024224.

National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, Bethesda, Md. 1978. The Belmont report: Ethical principles and guidelines for the protection of human subjects of research. Superintendent of Documents.

Oosterbeek, H., R. Sloof, and G. Van De Kuilen. 2004. Cultural differences in ultimatum game experiments: Evidence from a meta-analysis. Experimental Economics 7(2): 171–188.

Prasad, V., K. De Jesús, and S. Mailankody. 2017. The high price of anticancer drugs: Origins, implications, barriers, solutions. Nature Reviews Clinical Oncology 14(6): 381.

Senior, M. 2014. Sovaldi makes blockbuster history, ignites drug pricing unrest. Nature Biotechnology 32(6): 501–503.

Silverman, E. 2016. Sarepta to charge $300K for Duchenne drug. “We tried to be reasonable,” CEO says. Stat News, September 19. https://www.statnews.com/pharmalot/2016/09/19/sarepta-duchenne-drug-prices/. Accessed August 20, 2019.

Thomas, K. 2017. Insurers battle families over costly drug for fatal disease. New York Times, June 22. https://www.nytimes.com/2017/06/22/health/duchenne-muscular-dystrophy-drug-exondys-51.html. Accessed August 20, 2019.

World Medical Association 2013. Declaration of Helsinki—Ethical principles for medical research involving human subjects. https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/. Accessed August 21, 2019.