TRENDS & PERSPECTIVES
This past summer, a Shanghai court fined a Chinese businessman 400,000 yuan ($53,000) and sentenced him to 3½ years in prison for producing fake versions of the OneTouch brand of diabetes testing supplies, a product of LifeScan Inc. (Milpitas, CA), a Johnson and Johnson company.
LifeScan announced in October 2006 that it discovered counterfeiters were distributing the imitation test strips. Complaints about faulty results last year in September led to the discovery. These test strips, which are used to help monitor blood sugar levels of people with diabetes, produced erratic results according to LifeScan, and as a result, testers could give themselves life-threatening amounts of insulin. No known cases of injury or death were associated with the use of these counterfeit products, though certainly both were possible.
According to U.S. federal court documents, about 1 million counterfeit OneTouch test strips had been distributed throughout Canada, Greece, India, Pakistan, the Philippines, Saudi Arabia, Turkey, and in at least 35 U.S. states. In China, Su Zhiyong (alias Henry Fu) sold the strips through Halson Pharmaceuticals, a company with an Internet site, according to Bloomberg and USA Today, which pointed to a nonexistent physical address in Shanghai. Internet sites are increasingly common ways for counterfeiters to front covert operations.
Although specific data about the scope of counterfeiting relating to medical devices are unavailable, counterfeit medical devices, which have also included intraaortic pumps, stethoscopes, and sphygmomanometers, and increased counterfeiting sophistication have elevated the problem to a major public health concern.
While FDA has placed global notices warning about counterfeit tests on its Web site, those inside the organization are staying tight-lipped. According to Karen Riley in FDA’s Office of Public Affairs, the agency is unwilling to provide interviews “on matters about China, because of ongoing negotiations with that country.”
“Counterfeiting is something we take very seriously,” says Dave Detmers, director, communications, at LifeScan. “While obviously we can only pursue civil suits and we do, we cooperate fully and support criminal investigations. We are certainly cooperating with the Chinese government and we are very grateful for their diligent effort on this.”
In fact, with the recent landslide in product recalls of goods manufactured in China for everything ranging from leukemia drugs to Barbie dolls, consumers are wisely taking a step back. The Chinese government is well aware of the effects of consumer perceptions on trade relations between the United States and China.
At a news briefing in August in response to the backlash against Chinese products, Kuang Weilin, deputy consul general, Consulate General of the People’s Republic of China in New York, said, “the [Chinese] government is really serious, and you will see concrete results by the end of this year.” For example, regulators will block food without a safety label from export.
While there are no known incidences of injury or death resulting from the counterfeit blood glucose tests, the possibility has medical device and pharmaceutical manufacturers on their toes.
According to Aniruddha Railkar, PhD, an anticounterfeiting expert, companies are taking steps to combat counterfeit medical products. Railkar says that “educating the customer about counterfeiting and incorporating multiple levels of anticounterfeiting measures into the drug or device” are key strategies, adding that collaborations between pharmaceutical companies, wholesalers, distributors, doctors, pharmacies, governmental agencies, and global organizations such as WHO can effectively solve these problems. Collaborations such as IMPACT help to ensure accountability, since taking swift and dramatic action makes counterfeiting less attractive.
“We are not aware of and we do not believe that there are any counterfeit products currently for sale in the United States,” Detmers emphasizes. As a safety measure, LifeScan continues to conduct ongoing surveillance audits of product on pharmacy shelves. “We haven’t encountered any counterfeit products for several months. However, we will keep the notices posted, as these products could still be in medicine cabinets,” Detmers says.
Prevention is important, Detmers says. Just like at the U.S. Mint where they continually alter processes to prevent counterfeiting, companies must remain dynamic and incorporate product features that consumers can distinguish easily, but which manufacturers can regularly change. “We want to make counterfeiting as unprofitable, undesirable, and risky as possible,” says Detmers.
“The degree of risk and consequence is very great,” Detmers concludes. “It takes it to a whole new level when you are talking about healthcare products.”
