Fake Avastin shows very little protects drug supply

As drug counterfeiters step up their sales of bogus medicines, global health regulators have few protections in place to prevent them from reaching patients, and new laws aimed at addressing the problem could be years away. Scrutiny of the supply chain has grown since fake versions of Roche's multibillion-dollar cancer drug Avastin turned up at U.S. oncology practices late last year, sparking an international investigation that so far stretches from southern California back to Turkey with a stopover in a Cairo suburb. Drug manufacturers, distributors, pharmaceutical security experts and regulators interviewed by Reuters identified vulnerabilities all along the supply chain and called for comprehensive measures to protect patients and punish perpetrators. The World Health Organization (WHO) estimates that less than 1 percent of medicines available in the developed world are likely to be counterfeit. Globally, however, the figure is around 10 percent, while in some developing countries as much as a third of medicines are estimated to be bogus. Problems include the lack of a system to track medications as they change hands, loose regulation that allows potential counterfeits to enter the system and a willingness by legitimate distributors and medical practices to look the other way even when medicines appear to come from a questionable source. "Right now you have a situation where one shady wholesaler can introduce something and that can then pass through multiple actors in the system," said Allen Coukell, director of medical programs at the Pew Health Group who co-authored a report on counterfeit medicines. "Once they've gone outside the legitimate supply chain they can't be sure they're protecting patients." Europe beginning in 2016 will require a unique identifier on all medicine packages. The United States has no national system for tracking drugs, but a California law requiring serial numbers goes into effect in 2015, and the FDA and U.S. legislators have called for universal tracking systems to combat counterfeiting.The fake Avastin contained a variety of chemicals but none of the life-extending medicine. It has so far been traced back to Turkey via an illiterate Syrian businessman who procured it for an Egyptian firm, parties involved in the transactions told Reuters. Story: Fake Avastin contained chemicals, no drug "The business about counterfeit Avastin really demonstrates how easy it is to be fooled," said Sandra Kweder, deputy director of the FDA's Office of New Drugs. "Often these outfits, they're in business one day and out the next." WHO said newer technologies are helping counterfeiters produce and sell more convincing fakes.