At Interchange 2013, we heard from Christopher Weaver of the Wall Street Journal about the role black market drug wholesalers played in the distribution of counterfeit Avastin. Dr. Marv Shepherd also described the tactics shady drug wholesalers use to sell their wares to hospitals. Since then there have been several prosecutions against black market drug wholesalers. At Interchange 2014, we’ll discuss the latest tactics used by drug wholesalers who compromise the secure drug supply chain.
At Interchange 2013, two speakers in particular talked about the role black market drug distributors play in introducing counterfeit medications into medical offices. Christopher Weaver of the Wall Street Journal (WSJ) spoke about counterfeit Avastin and the role Canada Drugs played in distributing the fake cancer drugs to medical offices. As he explained why they began to look at the story, “What really drove our interest, as opposed to things like Viagra, (is that) this is a drug patients had no role in acquiring.”
Mr. Weaver described how his research into the story led him to the fake online pharmacy giant, Canada Drugs; “Small named distributors were acquired by Canada Drugs ahead of the Avastin case. Canada Drugs appeared to be moving into B-to-B sales.”
He also posed the real question that patients face when trying to protect themselves from counterfeit drugs at the doctor’s office: “how do you ask your doctor “where do you buy your Avastin?’ How does a patient ask that?”
PSM’s Dr. Marv Shepherd presented research-in-progress, Grey Market Vendor Activities and Drug Shortages in Texas Acute Care Hospitals that he is doing in South Texas. Dr. Shepherd’s preliminary findings showed that most hospitals are regularly contacted by non-FDA sanctioned drug wholesalers offering either to sell hospitals drugs currently listed in shortage, or offering to purchase drugs in shortage. Dr. Shepherd found that of 125 hospital pharmacy directors who replied to his study, over 85% have been contacted by black market vendors offering to sell drugs in short supply. Close to 25% of respondents reported being asked to sell drugs they had in their stores.Many of the pharmacy directors reported repeated phone calls from vendors trying to talk them into making purchases or selling off drugs in their stores.
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In the last year, indictments and convictions have been handed down to at least three different black market pharmaceutical wholesalers in the United States. Gallant Pharma International was a drug wholesale business that operated wholly outside the supervision of the FDA. According to the Department of Justice (DOJ), Gallant Pharma posed as a Canadian prescription drug wholesaler offering low-cost Canadian prescription drugs for sale to medical offices and hospitals in the U.S. In actual fact, Gallant Pharma was located in Virginia, and sold drugs that had been imported from places like India and Turkey, that were in no way approved for use in the United States. To date, 12 people who worked for Gallant Pharma have been convicted of drug misbranding charges, reports the DEA.
Montana Healthcare Solutions was a prescription drug wholesaler that had connections to Canada Drugs, according to Christopher Weaver’s report in the Wall Street Journal. Owner Paul Bottomley pleaded guilty to supplying counterfeit cancer medication to doctors and medical offices in the United States, reports the Department of Justice. Bottomley received a 5 year suspended sentence, and was required to forfeit $6 million in assets, according to NBC News.
In February 2013, the FDA reported that yet another black market drug wholesaler, Medical Device King, was implicated in a third incident of counterfeit cancer medication. It is currently unknown how many doctors throughout the United States may have been affected by the actions of this black market wholesaler, but the FDA warns that it “cannot ensure the safety and efficacy of any product that has not undergone the rigorous scientific review that is part of FDA’s approval process. To protect patient health, health care professionals should use only FDA-approved medicines.”
By S. Imber