Comment | Published:

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

Nature Reviews Clinical Oncologyvolume 15pages399400 (2018) | Download Citation

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.

Access optionsAccess options

Rent or Buy article

Get time limited or full article access on ReadCube.

from$8.99

All prices are NET prices.

References

  1. 1.

    Tang, J., Shalabi, A. & Hubbard-Lucey, V. M. Comprehensive analysis of the clinical immuno-oncology landscape. Ann. Oncol. 29, 84–91 (2018).

  2. 2.

    Fojo, T., Mailankody, S. & Lo, A. Unintended consequences of expensive cancer therapeutics-the pursuit of marginal indications and a me-too mentality that stifles innovation and creativity: the John Conley Lecture. JAMA Otolaryngol. Head Neck Surg. 140, 1225–1236 (2014).

  3. 3.

    Gyawali, B. & Prasad, V. Drugs that lack single-agent activity: are they worth pursuing in combination? Nat. Rev. Clin. Oncol. 14, 193 (2017).

  4. 4.

    Carlisle, B. et al. Benefit, risk, and outcomes in drug development: a systematic review of sunitinib. J. Natl Cancer Inst. 108, djv292 (2016).

  5. 5.

    Zhu, A. X. et al. Effect of everolimus on survival in advanced hepatocellular carcinoma after failure of sorafenib: the EVOLVE-1 randomized clinical trial. JAMA 312, 57–67 (2014).

  6. 6.

    Chan, A. et al. Neratinib after trastuzumab-based adjuvant therapy in patients with HER2-positive breast cancer (ExteNET): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 17, 367–377 (2016).

  7. 7.

    Gyawali, B. & Ando, Y. Adjuvant sunitinib for high-risk-resected renal cell carcinoma: a meta-analysis of ASSURE and S-TRAC trials. Ann. Oncol. 28, 898–899 (2017).

  8. 8.

    Prasad, V. & Mailankody, S. Research and development spending to bring a single cancer drug to market and revenues after approval. JAMA Intern. Med. 177, 1569–1575 (2017).

  9. 9.

    Sertkaya, A. et al. Key cost drivers of pharmaceutical clinical trials in the United States. Clin. Trials 13, 117–126 (2016).

  10. 10.

    Basch, E. Toward a patient-centered value framework in oncology. JAMA 315, 2073–2074 (2016).

Download references

Author information

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. Search for Vinay Prasad in:

  2. Search for Christopher McCabe in:

  3. Search for Sham Mailankody in:

Competing interests

The authors declare no competing interests.

Corresponding author

Correspondence to Sham Mailankody.

About this article

Publication history

Published

DOI

https://doi.org/10.1038/s41571-018-0030-2

Newsletter Get the most important science stories of the day, free in your inbox. Sign up for Nature Briefing