Fake Avastin® Pulls the Curtain Back on Internet Pharmacies
By Lew Kontnik, Director, Brand Protection, Amgen
The Avastin® scandal has placed the shadowy world of Internet pharmacies and global diversion on center stage for patients, doctors and the public to see. And the reviews are not good.
Recent reporting by CBS, the Wall Street Journal and several sources have dug into how at least 64 vials of fake Avastin, containing starch and acetone, but no active ingredients, wound up being sold to 19 oncology practices in the United States. What they are finding is a theater of illusions, with potentially life-threatening consequences, perpetrated by the so-called Internet Pharmacy industry.
While the drama can appear very complicated, the basic facts are straight forward: a company that specializes in buying foreign medicines and selling them illegally into the United States was itself duped into buying (or intentionally bought) fake foreign medicine. Then, with its usual disregard for US laws prohibiting the sale of unapproved foreign medicines, it sold the fakes to US doctors for use with their cancer patients.
When authorities identified that the supposedly foreign medicine was counterfeit, the grim reality of the drama became clear: cancer patients may have been infused with a worthless combination of household chemicals, rather than the life-saving medicine created by Genentech. Since the February 14, 2012 revelation by the US FDA (FDA Notice), the story has continued to unwind and has stimulated a Grand Jury investigation, calls in Congress for tighter regulation and stiffer penalties, and revealing interviews by the main actors on national television.
The actors tell the story. It begins in Egypt where Milad Kamal Ayad, a small time trader for a shadowy company (SAWA), bought 167 units of fake Turkish Avastin from a Syrian contact, Mohamed Fakkas el-Beid. The handwritten contract for sale was sealed with el-Beid’s finger print, because he is illiterate. Ayad made the purchase on behalf of Swiss-based trading company Hadicon AG. Hadicon told Reuters that they had sourced product from SAWA previously, but no such company existed at the address Hadicon provided. (Reuters Egypt)
Hadicon sold the fake Turkish Avastin to the Danish drug wholesaler, CareMed ApS. While CareMed maintains that it did not know the product was counterfeit, the two owners of CareMed had their wholesalers license revoked in 2007 because Danish authorities determined they were importing medicines without authorization. (Danish Comment)
And, CareMed sold 41 vials of the product to British pharmaceutical wholesaler River East Supplies Ltd. River East is owned by Tom Haughton. Haughton, who lives in Barbados, also apparently owns a number of other pharmaceutical trading companies, including Quality Specialty Products (QSP) and Montana Health Care Solutions, who sold the fake Turkish Avastin to the 19 oncologists identified by FDA in individual letters on February 14, 2012 (FDA Dr Letters). Houghton talked to CBS News on March 21, in an awkward exchange where he alternately maintained that his companies had followed “strict protocols” and that he did not know what the laws were in his principle marketplace, the United States. (Houghton Interview).
The final set of actors to consider in this drama is the 19 oncologists who purchased the fake Turkish product. As the pictures of fake product and the genuine US Avastin demonstrate, there is no way that a physician could confuse one packaging with the other. In other words, the doctors knew they were buying foreign, unapproved products—indeed the Montana Health Care order form specifically describes the product it offers as “international alternatives” and “European alternatives” to US approved medicines. (Montana Form).
The curtain was pulled back on this tainted distribution system through the discovery that what the actors had assumed/hoped was Turkish Avastin was not. The entire chain was caught in their devious attempts to skirt the law and patient safety by the fact that some other criminal had taken advantage of the unreliable chain to introduce counterfeit Turkish product into the system. Thirty six of the 41 vials remain unaccounted for.
Logically, there are calls from several quarters for investigations, prosecutions and stronger controls. These demands are appropriate. There is at least one other action that is warranted as well: Doctors and their practice staff need to understand the safety and legal risks presented by buying on the Internet and trying to evade the law that prohibits the importation of foreign unapproved medicines. Some practices have already begun to communicate about their commitment to safe purchasing, and others should listen and learn to help put an end to this charade. (MD Anderson )
Available to download: Click here to access a special presentation with further visuals and details.