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Regulators virtually powerless to stem flow of counterfeit drugs

Filed March 13th, 2012 Joshua Sophy

Health regulators in the U.S. and around the world are admitting they’re nearly powerless to stop a seemingly growing supply of counterfeit prescription drugs available to needy patients.

Though the World Health Organization believes only 1 percent of the counterfeit drugs available in the developed world are counterfeit, the under-developed world’s prescription drug market is saturated with up to 10 percent counterfeit drugs.

According to a report from MSNBC.com, the recent outbreak of counterfeit Avastin that’s reached the global market has shed light on a major deficiency in the regulatory processes over prescription drugs. The fake Avastin was found in the U.S. and tests on the counterfeit medication revealed it contained a number of chemicals but no traces of the drug.

MSNBC reports the process to get counterfeit drugs on the market can stem from “one shady distributor.” In the case of the fake Avastin – which hasn’t been linked to any injuries just yet – it took a circuitous route to that U.S. oncology center.

“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,” according to that MSNBC report. The director of the FDA’s Office of New Drugs admitted it’s “so easy to be fooled” by the counterfeit drugs.

Several years ago, counterfeit heparin led to numerous unexpected patient deaths and life-threatening side effects. It was determined the Active Ingredient was derived from a counterfeit source and then sent to Baxter to be finished and prepared as heparin.

New WHO laws to possibly get some control over the flow of counterfeit drugs on the market are not supposed to take effect until after 2014.

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