We would like to think that the medications we take are safe -- protected by government standards from containing harmful ingredients. Unfortunately, that simply is not true these days. Manufacturers of counterfeit drugs are managing to stay a step ahead of the regulators, both in the United States and in other countries. The situation is likely to get worse before it gets better.
A Reuters article discussed this problem in detail recently. Here are excerpts:
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."
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.
WHO said newer technologies are helping counterfeiters produce and sell more convincing fakes.
The drugs were sold in the United States by Montana Healthcare Solutions and Tennessee-based Volunteer Distribution, which are under FDA investigation. The agency named 19 oncology practices that might have purchased counterfeit Avastin.
"The counterfeiters are so good at what they do, and they're so good at making a product that looks real, it's easy for someone to say, 'well, I didn't know, it looked right,'" said Ilisa Bernstein, another FDA official. She added that in some cases they are helped by "willful blindness" on the part of customers.