Special Agent Burke shared cases such as grandmother Betty Hunter’s run-in with counterfeit cancer medication.
Special Agent Daniel Burke, Senior Operations Manager in Charge of Cybercrime Investigations for the Office of Criminal Investigations at the U. S. Food and Drug Administration acted as moderator for Interchange 2014’s panel concerning the impacts that fake online pharmacies have on patient safety. During his opening presentation he shared stories from his investigations.
In his opening presentation for Panel 3: The Impacts of Fake Online Pharmacies on Patient Safety, Special Agent Burke explained the dangers consumers face when shopping for medication online and just how little control FDA has over quality and purity when a medication is manufactured and sold outside the secure U.S. drug supply chain.
FDA’s investigations into unlicensed online pharmacies have found medications that are“sub or super-potent, are counterfeit drugs with no active ingredient, drugs that are tainted with poisons such as lead or arsenic, drugs contaminated with mold, substitute drugs, drugs that are not yet controlled but have addictive qualities, drugs that are new and untested, but sold anyway, cold-chain drugs that are not stored or transported [properly], and stolen drugs.”
Special Agent Burke warned patients that “many of these supposed Canadian online pharmacies rarely distribute drugs from Canada, but hide behind a global distribution network, making it appear that the drugs are sourced from say, the European supply chain, but are often sourced elsewhere.” While the danger of such drugs to consumers is palpable, yet consumers have little-to-no recourse if the drugs they buy from fake online pharmacies do not work or make them sick.
Special Agent Burke also shared cases such as grandmother Betty Hunter’s run-in with counterfeit Avastin: “Betty was a lung cancer patient. In May 2011, Ms. Hunter went to 4-Winds Hematology and Oncology in Chandler, Arizona for an infusion of Avastin, a drug she had taken previously. Soon after the infusion began, Ms. Hunter became nauseous and feverish. The nurse reported in her chart ‘Patient complaining of feeling very jittery, shaking and appeared red in the face. Doctor notified and infusion stopped. Patient given Benadryl.”
Special Agent Burke described the subsequent investigation of 4-Winds Hematology and Oncology which found that they had counterfeit Turkish-labeled Altuzan in their medication stores. The drugs had been sold to 4-Winds using blast-fax advertising from Richards Pharma, a British medication wholesaler.
According to the Wall Street Journal, Betty Hunter died 3 months later, in August 2011, of end-stage lung cancer.