The recent counterfeit Avastin debacle highlights the issue with weak drug protections. The international investigation spanned from California, to Turkey, to Egypt. Avastin is a cancer medication manufactured by Roche.
Many are concerned that as drug counterfeiters fine-tune their practices, global health regulators are ill-prepared to prevent fake drugs from reaching patients, said Reuters, noting that the law has not caught up and is not expected to for years to come.
We previously wrote that, according to Roche’s Genentech, the fake Avastin does not contain the key ingredient in Avastin, which is prescribed for the treatment of colon, lung, kidney, and brain cancers.
Reuters interviewed a number of drug makers and distributors, pharmaceutical security experts, and regulators and discovered a number of weaknesses along the supply chain and is now urging for more complete processes to protect patients and punish those involved in the manufacture and distribution of bogus drugs. According to the World Health Organization (WHO), a little under one percent of drugs available in developed countries are probably fake; internationally, the figure is about 10%, said Reuters, although in some developing countries that figure can be as high as 33%.
Reuters said some problems it detected included a lack of a tracking system to determine when drugs change hands, loose regulations, and a willingness on the part of legitimate distributors and medical offices to ignore medicines that appear to come from possibly fraudulent sources. “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,” he added.
Starting in 2016, Europe will be mandating a unique identifier on medicine packaging, said Reuters, which noted that there is no national system in place to track drugs in the U.S., although California does have a law coming into effect in 2015 that will mandate drug serial numbering. The U.S. Food and Drug Administration and U.S. legislators have asked for universal tracking systems, said Reuters. “The business about counterfeit Avastin really demonstrates how easy it is to be fooled,” Sandra Kweder, deputy director of the FDA’s Office of New Drugs, told Reuters. “Often these outfits, they’re in business one day and out the next.”
“Nowadays, access to all sorts of copying technology and printing technology for labels is much, much easier than it used to be,” said Lembit Rago, coordinator for quality and safety of medicines at WHO in Geneva, wrote Reuters. “Online pharmacies add another layer to the picture by concealing where the stuff comes from,” Rago added.
In the case of the Avastin fraud, the bogus medication was sold in the U.S. by Montana Healthcare Solutions and Tennessee-based Volunteer Distribution, which are under investigation by the FDA, said Reuters. The FDA said 19 oncology practices 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, an FDA official.
A source at one of the practices said the Montana Healthcare sales rep was “a good con man…. He had a legitimate business license and he had a legitimate distributor’s license, or it seemed he did,” said the source, wrote Reuters, which noted that the source was speaking on the condition of anonymity because he/she did not have permission to speak to the media.
The source at one of the practices said it bought drugs from Montana Healthcare’s list of U.S. products, not from its “lower-priced European alternatives,” which included Avastin under its Turkish brand name, said Reuters. The source did acknowledge that the presence of these drugs should have alerted the practice that Montana Healthcare was breaking U.S. laws.