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Low-value approvals and high prices might incentivize ineffective drug development

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From Nature Reviews Clinical Oncology

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An Addendum to this article was published on 12 November 2018

Drug regulators’ acceptance of any statistically significant improvement shown in a single randomized trial and lofty drug prices has created a situation where it is now, hypothetically, profitable for a company to run a clinical trials portfolio of chemically inert compounds. While the current cancer drug pipeline is certainly superior to inert drugs, we must rethink market incentives to encourage transformational drug development.

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Fig. 1: Break- even point at which a null trials agenda would turn a profit based on one or two nominally significant randomized trials.

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Authors and Affiliations

  1. Division of Hematology Oncology, Knight Cancer Institute, Oregon Health & Science University, Portland, OR, USA

    Vinay Prasad

  2. Department of Public Health and Preventive Medicine, Oregon Health & Science University, Portland, OR, USA

    Vinay Prasad

  3. Center for Health Care Ethics, Oregon Health & Science University, Portland, OR, USA

    Vinay Prasad

  4. Executive Director and CEO of the Institute of Health Economics, Edmonton, Canada

    Christopher McCabe

  5. Myeloma Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA

    Sham Mailankody

Authors
  1. Vinay Prasad
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  2. Christopher McCabe
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  3. Sham Mailankody
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Corresponding author

Correspondence to Sham Mailankody.

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The authors declare no competing interests.

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Prasad, V., McCabe, C. & Mailankody, S. Low-value approvals and high prices might incentivize ineffective drug development. Nat Rev Clin Oncol 15, 399–400 (2018). https://doi.org/10.1038/s41571-018-0030-2

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