Fake Avastin incident 'could happen again'

The infiltration of counterfeit versions of the cancer drug Avastin into the US market remains poorly understood so similar incidents could occur in future, according to cancer specialists.

Three years after it emerged that fake copies of Roche's Avastin (bevacizumab) had been discovered in medical practices in 2012 - with a fresh incident involving a different counterfeit discovered in 2013 - "the medical, public health and patient communities … lack adequate protection should counterfeit drugs penetrate the US drug-supply chain again," they write in Nature Reviews Clinical Oncology.

Tim Mackey, Raphael Cuomo and Bryan Liang of the University of California, San Diego, and Camille Guerra of California Western School of Law point to a lack of empirical, peer-review data on the topic - particularly with regard to the consequences of the infiltration - as well as a low number of successful prosecutions related to the event.

"Collectively, these limitations mean that the events associated with counterfeit bevacizumab supply are only partially understood," they conclude, adding: "We are no closer to ascertaining basic, but crucial, information, such as how much counterfeit bevacizumab actually entered the US market, or the number of patients exposed and adversely affected."

The case highlights the need for improved surveillance of the supply chain but also a need to improve access to and the affordability of cancer drugs, with evidence emerging that US clinics had been aggressively promoting 60 to 80 per cent discounts on Avastin's price of up to $100,000 a year.

Moreover, they note that implementation of track-and-trace technology via Title II of the Drug Quality and Security Act (DQSA) is nearly a decade away for individual medicine packs and may not  provide complete protection. 

They would like to see additional measures in place such as random risk-based testing of drug quality, enhanced penalties and sanctions for criminal violations of the law, and notification of possible safety risks at the patient level.

"Although domestic-policy responses aimed at improving pharmaceutical security are important first steps, renewed international commitment to combating counterfeit medicines is urgently needed in this era of globalized, but complex and vulnerable, drug-supply chains," they conclude.