The former business manager for a now-defunct cancer treatment center was sentenced in federal court to three years of probation for his part in purchasing misbranded chemotherapy medications.
Michael Dean Combs, 32, Piney Flats, pleaded guilty in the case in September to receiving interstate commerce, which was the misbranded medication. He was also assessed a $4,000 fine.
In a sentencing memorandum filed in U.S District Court in Greeneville, Combs’ attorney, Cliff Corker, stated his client ordered the misbranded drugs at the direction of the clinic’s owner, Dr. William Kincaid.
In the document, Corker also said the medications turned over to FDA officials were tested and all had the active ingredients to treat cancer.
Corker and Kincaid’s attorneys have argued all along that the drugs were never said to be ineffective, they were just not purchased through and FDA-approved pharmacy.
The misbranded drugs were purchased by McLeod Cancer and Blood Center in Johnson City between September 2007 and early 2008 and August 2009 until February 2012. Those medications were identified by federal prosecutors as Abraxane, Alimta, Avastin, Eloxatin, Gemzar, Herceptin, Rituxan/Mabthera, Taxotere and Zometa.
“We pled to a fairly minor misdemeanor offense,” Corker said after Combs pleaded guilty in September. “It means the label on the product itself was not consistent with the federal government standard. Nobody has accused them receiving or using fake drugs. Michael Combs did not plead guilty to receiving a fake drug. He pleaded guilty to receiving a real drug that was mislabeled.”
According to the federal case against Combs, detailed in a 13-page plea agreement, McLeod Cancer Center purchased several prescription medications, including chemotherapy drugs, from a Canadian company, QSP, and those drugs were obtained by QSP from a foreign manufacturer.
The Food and Drug Administration does not allow doctors to distribute or prescribe unapproved medications to patients in the U.S.
McLeod first started buying medications from QSP in 2007, but when nurses at the center raised concerns in late 2007 and early 2008 the clinic stopped ordering from QSP. But in August 2009, Combs and Kincaid met with a QSP representative and again began ordering the unapproved drugs from the company.
Kincaid told Combs to have the drugs shipped to a storage business Kincaid owns in Johnson City. From there, the medications were taken to Combs’ office at the clinic and then mingled into FDA-approved drugs in the clinic’s drug storage area.
Kincaid also pleaded guilty to the same charge in the case, but he has not been sentenced.