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

Nature Reviews. Clinical Oncology
Tim K MackeyBryan A Liang

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, multistakeho...Continue Reading

References

Nov 12, 2002·Chest·Barbara G Bigby, Timothy D Bigby
Aug 21, 2003·JAMA : the Journal of the American Medical Association·Robert F Forman
Sep 24, 2008·Annals of Oncology : Official Journal of the European Society for Medical Oncology·A JirilloM Giacobbo
Jun 13, 2009·Postgraduate Medical Journal·C S GautamG L Singal
Jan 26, 2010·The Journal of Arthroplasty·Richard H WhitePatrick S Romano
Feb 2, 2010·Trends in Pharmacological Sciences·Paul N NewtonFacundo M Fernández
Mar 30, 2010·Journal of Pain & Palliative Care Pharmacotherapy· U S Food And Drug Administration
Jul 24, 2010·Pharmacoepidemiology and Drug Safety·Grazia OrizioUmberto Gelatti
Apr 6, 2011·The Lancet Oncology
Jun 24, 2011·Journal of Pharmaceutical Sciences·Tim K Mackey, Bryan A Liang
Nov 2, 2011·The New England Journal of Medicine·Mandy L Gatesman, Thomas J Smith
Nov 19, 2011·Vaccine·Bryan A Liang, Tim K Mackey
Jan 11, 2012·CMAJ : Canadian Medical Association Journal = Journal De L'Association Medicale Canadienne·Cal Woodward
Jan 25, 2012·Journal of the National Cancer Institute·Eric T Rosenthal
Jan 27, 2012·The New England Journal of Medicine·Alberto J Montero, Charles Vogel
Feb 11, 2012·Journal of Medical Internet Research·Bryan A Liang, Tim K Mackey
May 29, 2012·The Lancet Infectious Diseases·Gaurvika M L NayyarJames Herrington
Jul 25, 2012·Nature Reviews. Urology·Bryan A Liang, Tim K Mackey
Oct 19, 2012·Journal of Oncology Practice·Zaina P QureshiCharles Lee Bennett
Oct 24, 2012·BMC International Health and Human Rights·Tim K Mackey, Bryan A Liang
Nov 15, 2012·BMJ : British Medical Journal·Amir AttaranMartin McKee
Mar 2, 2013·Journal of Oncology Practice·Tim K Mackey, Bryan A Liang
Mar 7, 2013·JAMA : the Journal of the American Medical Association·Bridget M Kuehn
Apr 13, 2013·JAMA : the Journal of the American Medical Association·Lawrence O GostinPatrick W Kelley
May 4, 2013·Scientia pharmaceutica·Dipika BansalPramil Tiwari
Jul 31, 2013·Journal of Medical Internet Research·Tim K MackeySteffanie A Strathdee
Sep 5, 2013·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Dawn L HershmanAlfred I Neugut
Oct 10, 2013·Indian Journal of Ophthalmology·Gerardo Garcia-AguirreHugo Quiroz-Mercado
Dec 27, 2013·The New England Journal of Medicine·Kevin Outterson
Feb 19, 2014·The Lancet Oncology·Ronan J Kelly, Thomas J Smith
Sep 27, 2014·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Keith B HoffmanColin B Erdman

❮ Previous
Next ❯

Citations

Mar 16, 2016·Stem Cells International·Elena CodriciCristiana Tanase
Mar 6, 2016·Mayo Clinic Proceedings·Amir AttaranReed Beall
May 17, 2015·Cancer Letters·Yi-Fang PingXiu-Wu Bian
Apr 22, 2015·Daru : Journal of Faculty of Pharmacy, Tehran University of Medical Sciences·Simin Dashti-Khavidaki, Mohammad Abdollahi
Jun 12, 2016·American Journal of Ophthalmology·Michael W StewartUsha Chakravarthy
Mar 30, 2017·Expert Opinion on Drug Safety·Tim K Mackey, Gaurvika Nayyar
Oct 19, 2019·Sudebno-meditsinskaia ekspertiza·N V MesonzhnikS A Appolonova
Apr 10, 2021·Journal of Pharmaceutical and Biomedical Analysis·Helen Sant'Ana Dos Santos RibeiroJan Schripsema
Apr 27, 2021·Health Informatics Journal·Mueen UddinSamer Ellahham
May 1, 2021·International Journal of Environmental Research and Public Health·Damian ŚwieczkowskiMiłosz Jaguszewski

❮ Previous
Next ❯

Related Concepts

Trending Feeds

COVID-19

Coronaviruses encompass a large family of viruses that cause the common cold as well as more serious diseases, such as the ongoing outbreak of coronavirus disease 2019 (COVID-19; formally known as 2019-nCoV). Coronaviruses can spread from animals to humans; symptoms include fever, cough, shortness of breath, and breathing difficulties; in more severe cases, infection can lead to death. This feed covers recent research on COVID-19.

Blastomycosis

Blastomycosis fungal infections spread through inhaling Blastomyces dermatitidis spores. Discover the latest research on blastomycosis fungal infections here.

Nuclear Pore Complex in ALS/FTD

Alterations in nucleocytoplasmic transport, controlled by the nuclear pore complex, may be involved in the pathomechanism underlying multiple neurodegenerative diseases including Amyotrophic Lateral Sclerosis and Frontotemporal Dementia. Here is the latest research on the nuclear pore complex in ALS and FTD.

Applications of Molecular Barcoding

The concept of molecular barcoding is that each original DNA or RNA molecule is attached to a unique sequence barcode. Sequence reads having different barcodes represent different original molecules, while sequence reads having the same barcode are results of PCR duplication from one original molecule. Discover the latest research on molecular barcoding here.

Chronic Fatigue Syndrome

Chronic fatigue syndrome is a disease characterized by unexplained disabling fatigue; the pathology of which is incompletely understood. Discover the latest research on chronic fatigue syndrome here.

Evolution of Pluripotency

Pluripotency refers to the ability of a cell to develop into three primary germ cell layers of the embryo. This feed focuses on the mechanisms that underlie the evolution of pluripotency. Here is the latest research.

Position Effect Variegation

Position Effect Variagation occurs when a gene is inactivated due to its positioning near heterochromatic regions within a chromosome. Discover the latest research on Position Effect Variagation here.

STING Receptor Agonists

Stimulator of IFN genes (STING) are a group of transmembrane proteins that are involved in the induction of type I interferon that is important in the innate immune response. The stimulation of STING has been an active area of research in the treatment of cancer and infectious diseases. Here is the latest research on STING receptor agonists.

Microbicide

Microbicides are products that can be applied to vaginal or rectal mucosal surfaces with the goal of preventing, or at least significantly reducing, the transmission of sexually transmitted infections. Here is the latest research on microbicides.