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After counterfeit AvastinĀ®--what have we learned and what can be done?

Authors :
Mackey TK
Cuomo R
Guerra C
Liang BA
Source :
Nature reviews. Clinical oncology [Nat Rev Clin Oncol] 2015 May; Vol. 12 (5), pp. 302-8. Date of Electronic Publication: 2015 Mar 03.
Publication Year :
2015

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.

Details

Language :
English
ISSN :
1759-4782
Volume :
12
Issue :
5
Database :
MEDLINE
Journal :
Nature reviews. Clinical oncology
Publication Type :
Academic Journal
Accession number :
25734637
Full Text :
https://doi.org/10.1038/nrclinonc.2015.35