Drug Counterfeiters Gear up to Meet Growing Demand

May 01, 2006 at 02:46 pm by steve

Government probes have been helping to shine a harsh light on the growing global traffic in counterfeit drugs. One group of federal investigators inspecting doses of what was being sold as the cancer drug Procrit® found that patients were getting non-sterile tap water. In another case, agents found that drugs marked as Zyprexa® – a powerful medication used to treat schizophrenia – were actually aspirin. And more recently, United States Customs agents have been garnering headlines for their work seizing fake batches of Tamiflu® at the country's borders. With the price of branded drugs rising at a double-digit pace every year, regulators and the pharma industry have grown increasingly sensitive to the proliferating signs that counterfeiting operations have been growing by leaps and bounds. According to the World Health Organization, about 10 percent of all pharmaceuticals on the market today are counterfeit, representing a market worth tens of billions of dollars. Estimates on the counterfeit trade in the United States are lower, but the FDA nevertheless estimates that counterfeits are used to fill 35 million prescriptions each year. "I think that it is safe to say that the U.S. market is an attractive market for counterfeiters," says Tom Kubik, the executive director of the Pharmaceutical Security Institute, which includes the security chiefs of 14 major pharma companies. "There are a couple of reasons: because of the volume of pharmaceuticals available and because of the existence of higher priced drugs in the marketplace." But counterfeiting, he adds, covers the full range of drugs in the market, including plenty of generic drugs and over-the-counter treatments as well. "They're not just looking for a price advantage," adds Kubik, "but a large market so they can avoid detection, places where it is not well regulated." And in many cases, he says, counterfeit drugs are being added to round out shipments of medications that are being illegally diverted from other countries into the United States, where they can fetch a higher price. Top selling counterfeits include genitourinary therapeutics followed by anti-infectives and drugs for the central nervous systems. With the growing number of reports circulating about shortages of Tamiflu to combat a possible bird flu pandemic, signs are rife that counterfeiters have been adding the antiviral to the list. "In an area where there's some demand for a drug, there's a potential for counterfeiting. We found counterfeiting in virtually every therapeutic category," adds Kubik. "The counterfeiting operation doesn't specialize. An illegal counterfeiter will make a variety of drugs." And they will do it in a variety of ways. Drug traffickers may brand a placebo as a drug, but they're also just as likely to make the drug with a dangerously high concentration of an active ingredient, or with too little to have a therapeutic effect. In all cases, the counterfeit poses a direct threat to the health of a patient. There are a variety of measures being taken to rein in the trafficking of counterfeit drugs. After creating the FDA Counterfeit Drug Task Force in 2003, the agency beefed up its investigative muscle, launching more than 20 probes a year into counterfeiting operations. The FDA has also been expanding access to the Counterfeit Alert Network. The Partnership for Safe Medicines, a coalition of physicians, pharmacists and drug companies, has linked up with the FDA to broadcast e-mail alerts on counterfeit drugs. "Counterfeiters have grown more sophisticated, so we have to use the power of the Internet to fight back," says Marv Shepherd, PhD, director of the Center for Pharmacoeconomic Studies at the College of Pharmacy, University of Texas-Austin. "This is just the beginning," adds Shepherd. "The more partners we find, the more we can expand this system across the globe." The rest of the globe may need the help even more than Americans. The FDA estimates that upwards of half of all the drugs in China are counterfeit, while less developed countries like Argentina, Mexico and Colombia are seeing counterfeit rates as high as 40 percent. Some of those fake drugs are also ending up back inside United States borders. Officials here say that Mexican border towns are heavily populated with pharmacies that stock their shelves with fake drugs. In one investigation south of the border, officials uncovered quantities of fake Zocor® … and all of it was destined for Americans seeking cheaper meds in Mexico.

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Apr 23, 2024 at 10:42 am by kbarrettalley

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