After counterfeit Avastin®--what have we learned and what can be done?
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.
Department of Anesthesiology and Division of Global Public Health, School of Medicine, University of California, San Diego (UCSD), 8950 Villa La Jolla Drive, Suite A204, La Jolla, CA 92037, USA.
Tim K
TK
Mackey
Joint Doctoral Program in Global Public Health, Division of Global Health, School of Medicine, UCSD, 9500 Gilman Drive, La Jolla, CA 92093, USA; Graduate School of Public Health, San Diego State University, 5500 Campanile Drive, San Diego, CA 92182, USA.
Raphael
R
Cuomo
Joint Masters Degree Program in Health Policy and Law, Division of Medical Education, School of Medicine, UCSD, 9500 Gilman Drive, La Jolla, CA 92093, USA; California Western School of Law, 225 Cedar Street, San Diego, CA 92101, USA.
Camille
C
Guerra
Global Health Policy Institute, University of California, San Diego (UCSD), 8950 Villa La Jolla Drive, Suite A204, La Jolla, CA 92037, USA.
Bryan A
BA
Liang
D020533:Angiogenesis Inhibitors / Q000600:supply & distribution*; D000068258:Bevacizumab; D058110:Counterfeit Drugs / Q000600:supply & distribution*; D003415:Crime / Q000331:legislation & jurisprudence / Q000706:statistics & numerical data; D004335:Drug and Narcotic Control / Q000331:legislation & jurisprudence*; D006801:Humans; D061214:Patient Safety / Q000331:legislation & jurisprudence / Q000592:standards; D014481:United States
D020533:Angiogenesis Inhibitors; D058110:Counterfeit Drugs; D000068258:Bevacizumab