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After counterfeit Avastin®—what have we learned and what can be done?

Abstract

Three years have passed since the FDA announced that it had detected counterfeit versions of the injectable anticancer drug bevacizumab (Avastin®, Genentech, USA) in the US drug-supply chain. Following this discovery, almost 1,000 FDA warning letters were sent to physicians and medical practices in 48 different states and two US territories, as more batches of counterfeit Avastin were uncovered. In response, criminal prosecutions have been pursued against certain distributors and clinicians, and other individuals who trafficked, sold, purchased, and/or administered an unsafe and ineffective treatment while also defrauding the government. Although limited and targeted legal action has been taken, patients potentially affected by this seminal patient safety event have not been appropriately identified. Hence, despite the clear and documented patient-safety and public-health risks posed by the transnational criminal trade in counterfeit medicines, the case study of counterfeit bevacizumab detection in the USA demonstrates the continued lack of information, knowledge, and solutions that would be necessary to protect those who are most affected—the patients. In response, we call for greater investment in multisector, multistakeholder strategies to enhance surveillance for counterfeit medicines and enable improvements in communication of risk information, to better protect patients with cancer.

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Figure 1: Visual depiction of a total of 949 FDA safety notifications that were sent to 932 physicians and/or clinics in 795 zip codes from 2012 to 2013.

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Acknowledgements

T.K.M. is the recipient of an American Cancer Society Institutional Research Grant (70-002) provided through the Moores Cancer Center, University of California, San Diego, CA, USA, that also provided support for R.C. T.K.M. also thanks the Engelberg Center for Health Care Reform at the Brookings Institute for his invitation to the Expert Workshop “Reducing the threat of counterfeit and unapproved drugs in clinical settings” on 19 July 2013.

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T.K.M., R.C. and C.G. researched the data for the article. All authors contributed to discussion of content, to writing the article, and to reviewing and editing the manuscript before submission.

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Correspondence to Tim K. Mackey.

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Competing interests

T.K.M. and B.A.L. are reimbursed for travel to one Partnership for Safe Medicines annual conference each year. T.K.M. is also a non-compensated member of the academic advisory panel of the Alliance for Safe Online Pharmacies. R.C. and C.G. declare no competing interests.

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Mackey, T., Cuomo, R., Guerra, C. et al. After counterfeit Avastin®—what have we learned and what can be done?. Nat Rev Clin Oncol 12, 302–308 (2015). https://doi.org/10.1038/nrclinonc.2015.35

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