When we spoke last week to Lilly about its anti-counterfeiting investments, its security experts told us it collaborates “very closely” with regulatory bodies and even its own competitors. Now Pfizer has also disclosed to in-Pharmatechnologist.com its co-operation with rivals to combat what it calls a “multibillion-dollar transnational organised crime.”
Pfizer informs other companies if it unearths fakes of their drugs, its deputy chief of global security, Matthew Bassiur, told us, adding pharma giants regularly get together to share knowledge in forums such as the Pharmaceutical Security Institute.
A third way companies work together is through joint operations and shared costs, added Derek Walmsley, Lilly’s global product security manager. “Or we’ll run one operation and they’ll run the next one.”
“It’s not just Lilly fighting this fight,” he said. “We’re not competitive when it comes to counterfeit issues.”
Lilly’s expert said liaison between companies is improving year-on-year. Purse-tightening may be a factor in the increased partnerships: “We’re trying to spread what we can in the current economic climate. And the regulators are glad to have the companies work together – they appreciate the evidence we can bring to them.”
Fake abortion and cancer pills
The consensus among the pharma industry is that drug counterfeiting is escalating in volume and beyond the usual pharmaceutical suspects, anti-anxiety and sexual enhancement medicines.
A recent investigation by the National Association of Boards of Pharmacy which examined 10,400 websites selling prescription drugs to US patients found nearly 97% operated outside the law, by supplying medicine without a prescription or selling non-FDA-approved and controlled drugs.
“It used to be the erectile dysfunction drugs that were most heavily counterfeited,” Pfizer’s security expert told us. “Now it’s the life-sustaining drugs, the oncology drugs.”
The move into life-saving medicines has been a money-maker for counterfeiters who already owned pill presses and have no attendant costs for R&D, advertising, or safety. “It’s a free-for-all,” said Bassiur.
This includes Cytotec (misoprostol), manufactured by Pfizer to treat ulcers, which is heavily counterfeited in Latin America where it is used off-label for illicit abortions in places where terminations are illegal or hard to obtain. “If it’s popular and needed, counterfeiters will do it.”
Bassiur predicted the next focus of counterfeiting will be expensive specialty care drugs, made for extremely small patient populations with rare diseases.
Printer ink and rat poison
“We find counterfeit meds are being manufactured in the most deplorable facilities. We’re talking bacteria on the walls, dirt being tracked in – places you wouldn’t walk into.”
Bassiur told us counterfeiting premises vary, and can be inside homes, warehouses and large garages, as long as there is space for pill presses, chemicals and packaging machines.
Pfizer’s analysis of the ingredients in seized pills has found heavy metals, arsenic, phosphoric acid, brick dust, floor wax, leaded paint, and rat poison.
“For Viagra they use printer ink to get the nice blue colour,” Bassiur told us.
For erectile dysfunction medicines, he continued, counterfeiters will include the active pharmaceutical ingredient (API), “because the customer is expecting immediate results.”
But in the case of a cancer or cholesterol medicine, there may be no API and no therapeutic value in the drug.
“In terms of active ingredients, we see too little, too much or none at all.”