Back in September of 2007 the physician-owners of the McLeod Cancer and Blood Center in Johnson City Tennessee, received a marketing banner from a Canadian distributor called Quality Specialty Products (QSP). The advertisement announced that QSP, located in Winnipeg, Canada, was able to provide clinics with impressive discounts on a veritable litany of costly prescription medications:
Avastin – with a $400 per vial discount
Rituximab – for far less than the FDA-approved doses
Doctor William Kincaid, and part owner Doctor Charles Famoyin decided business manager Michael Combs should start ordering their cancer meds from QSP, and so they did. Within three months, staff nurses McLeod noticed that the chemotherapy drugs from QSP were not labeled in English. The nurses voiced their concerns that the drugs were not approved for use in the United States.
As a result of staff complaints, the doctors told them they would no longer use the QSP medications, and they did stop for several months. But Kincaid once again began buying drugs from the company. To hide what he was doing from the nurses, Kincaid directed business manager Combs to have the drugs shipped to a storage facility across town. Combs and other staff members then took the drugs to the clinic, where they were mixed in with legitimate medications. McLeod Cancer center also continued to receive FDA-approved drugs, which were shipped directly to the cancer center. This arrangement with QSP continued until February 2012.
At that time, the FDA had issued its first set of warnings that physicians and clinics which may have purchased a fake version of Avastin 400 mg/16 mL, containing cornstarch, salt, acetone and other chemicals, but none of the drug’s active ingredient bevacizumab. The FDA had also sent letters to medical centers throughout the nation that had purchased unapproved medicines, possibly including fake Avastin, from QSP, which was also known as Montana Healthcare Solutions. McLeod Cancer was on the list of recipients. According to court documents, records from McLeod Cancer show that QSP shipped a variety of non–FDA-approved drugs to Doctor Kincaid’s storage facility, including a rituximab knock-off called MabThera. Although MabThera contained the active ingredient in rituximab, it had been manufactured by F. Hoffman-LaRoche Ltd. in Switzerland, not Genentech in the United States and was not approved for sale in the United States. To reach America the drug traveled via a complex supply chain, which began in India and passed through the United Kingdom on its way to a QSP shipping facility in Chicago.
On Dec. 11, 2012, Kincaid pleaded guilty to receiving misbranded prescription drugs in interstate commerce, with the intent to defraud or mislead the state’s Medicaid program and others. During the time McLeod Cancer was doing business with QSP, it had purchased more than $2,000,000 in unapproved drugs and billed Medicare along with other programs for more than $2,500,000.
More than a year after the FDA issued its first caution about QSP, the agency continues to investigate the spread of fake Avastin. As of November 2012, the FDA has sent 150 letters warning medical practices in the United States that their supply may be tainted with fake Avastin or a counterfeit version of Altuzan. Altuzan is the brand name Avastin is sold under in Turkey, and is not approved for sale in the United States. On Feb. 5, 2013, the FDA alerted U.S. medical practices that it had uncovered two batches of counterfeit Altuzan, at least one of which contained no active ingredients. “Avastin has opened our eyes to the problem of poor drug control, and the U.S.’s increasing vulnerability to counterfeit drugs,” said. But marketing fake drugs is not a new problem. “Counterfeit medicines are as old as the hills,” said Mark Davison, CEO of Blue Sphere Health Ltd., in Cambridge, England, a company working to combat the production and spread of counterfeit drugs.
“Counterfeiting drugs is not back-street crime anymore with a few guys in workshops turning out a couple thousand pills and making a few bucks on the side,” said Davison. “This trade has predominantly organized crime, and looks very much like traditional networks of prostitution and illegal drug trafficking. We’re seeing some really sophisticated worldwide supply chains of illicit drugs.” prescriptions written every year in the United States, so even a tiny percentage has a great effect.”
In 2008, investigators identified fake versions of Baxter’s anticoagulant heparin, which contained a substituted contaminant, over-sulfated chondroitin sulfate, resulting in at least 149 deaths in the United States. In some cases, patients receive a drug that is not FDA-approved (as with MabThera). In other instances, a fake drug may have no active ingredients (as with Avastin) or may contain the active ingredient, but in lesser amounts (e.g., the Casodex case). Also, on occasion, a drug may have 100% of the active ingredient, but storage, transport and other considerations make use unsafe. and communication in the Office of Drug Security, Integrity, and Recalls at the FDA’s Center for Drug Evaluation and Research, agreed. “Consumers in the U.S. can be confident about what they’re getting at their local pharmacy.” But, even if the chances of receiving a fake drug are one in a million, when it happens to you, it’s 100%, said Bryan Liang, MD, vice president of the Partnership for Safe Medicines and the director of the San Diego Center for Patient Safety at the University of California, San Diego School of Medicine.
“Population information is important but never forget you’re treating the individual patient,” he said. “When my wife had breast cancer, if I knew my colleague had infused her with chemotherapy and had not checked the viability of the medication or was simply interested in making higher profits, it would have ruined her chances. To be cheated like this is a crime against humanity, and it should be treated as such.”
(We thank investigative medical reporter Victoria Stern for her work in this case)