Turkish Pharmaceutical Owner Sentenced in Counterfeit Drug Sting

An owner of a Turkish pharmaceutical firm was sentenced by the U.S. District Court for the Eastern District of Missouri to 30 months in prison and a $150,000 fine a year after his January 2014 arrest in Puerto Rico. Sabahaddin Akman of the Istanbul-based Ozay Pharmaceuticals pleaded guilty in August 2014 to smuggling shipments of counterfeit and adulterated cancer drugs which included multiple shipments of Altuzan to U.S. doctors in St. Louis, Missouri.

Altuzan. Altuzan is the Turkish version of the cancer treatment drug Avastin®, which had been approved by the FDA to treat recurrent or late-stage (metastatic) cervical cancer in U.S. patients. Unfortunately, Altuzan has been used as a counterfeit drug for Roche’s injectable cancer medication, also named Altuzan (bevacizumab); however, only Avastin is approved by the FDA for U.S. sale. Use of counterfeit Altuzan has endangered the lives of many U.S. cancer-stricken patients.

Endangerment. According to the Wall Street Journal, some U.S. doctors have purchased cancer drugs not approved for U.S. sale because they are often cheaper than approved brands. The doctors knowingly buy the drugs from wholesalers who are often based overseas and administer them to patients via injection or infusion. The drug labels are often printed in different languages, often Turkish, French, or German, which automatically renders them exempt from FDA-approval. In 2012, 79 medical practices were criminally convicted for these purchases, according to a CBS report.

In fact, in the Akman case, the FDA’s Office of Criminal Investigations (OCI) conducted an investigation of several U.S. physicians who purchased the drug from Akman’s wholesaler, Richard Taylor in 2012. Taylor was a drug wholesaler in the United Kingdom who then shipped the vials to U.S. oncologists. An FDA lab test later confirmed that some of the Altuzan vials seized from the physicians by the OCI contained no active cancer-fighting ingredients. As a result, the FDA issued several public alerts about these events.

Sting. Akman did not act alone. His business partner, Ozkan Semizoglu, was sentenced to 27 months in federal prison on similar charges in October 2014. Both men were lured to Puerto Rico as part of a sting operation and were apprehended through a collaborative OCI-led international investigation that involved Europol, several German government offices, and special agents of the U.S. Department of State’s Diplomatic Security Service who were assigned to the U.S. Embassy’s Regional Security Office in Ankara, Turkey. Ozay Pharmaceuticals was not charged by U.S. prosecutors.

It is hard to discern which party is more to blame: the physicians who purchased the non-FDA-approved Altuzan or the persons who distributed them.