The director of The Food and Drug Administration’s Office of Criminal Investigations (FDA-OCI) warns consumers about counterfeit medication.
George Karavetsos, the director of FDA-OCI, discussed patient risks from counterfeit medication in a recent episode of the daytime TV show, “The Doctors,” and shared a short film called FDA Supplement Truth that illustrates the dangers posed by many, seemingly innocent dietary supplements.
Director Karavetsos shared the disturbing story of how counterfeit cancer medication ended up being used to treat an unsuspecting cancer patient in Arizona:
“This had to do with a counterfeit cancer drug, a chemotherapy drug, that was also coming through the International Mail Facility that you saw on the segment. It was counterfeit Avastin, which is an IV chemotherapy drug to treat cancer. Through our investigation we learned that a woman going in for her regular treatment for her cancer went in on this day…going into a clinic in Arizona. This was her regularly scheduled monthly treatment of chemotherapy. She sat down in her chair, they put the IV in, supposedly she was receiving Avastin, the drug that was going to treat her cancer. She didn’t receive Avastin that day. What was being pumped into her veins was tap water. Not only was it tap water, but it was tap water in which mold and fungus had grown.”
In May last year, PSM Board member Jim Dahl interviewed Director Karavetsos about the FDA-OCI’s evolving role in fighting counterfeit pharmaceuticals. Director Karavetsos said, “Identifying and dismantling fake online pharmacy websites is a top investigative priority for FDA-OCI. Criminals that inject counterfeit drugs into the global supply chain do so with such callous disregard for human life that it truly shocks the conscience.”
According to Dan Solis, the Director of Import Operations FDA, Los Angeles District, “The average American consumer is probably not aware of the amount of unknown ingredient that we’re finding in these tainted supplements.”
The FDA routinely sends out warnings about banned pharmaceuticals and other toxic ingredients that are found in so-called herbal supplements. When discussing the wild growth of questionable dietary supplements, Director Karavetsos explained that the FDA is “focused on the worst of the worst, the modern day snake-oil salesmen that are just going and targeting the most vulnerable in our society.”
Show host Dr. Travis Stork asked him what the FDA can do to prevent dangerous dietary supplements from reaching market. Karavetsos explained that the FDA does not have the authority to approve dietary supplements prior to consumer sales. “Unlike prescription drugs, [dietary supplements] are not screened pre-market, so they FDA can only take action after they have hit the market, whether they’re dangerous prescription drugs, new dietary ingredients, or they’re making false and misleading claims.”