Allegations against a Johnson City cancer center and the doctor who runs it have a bigger bite after the center’s business manager pleaded guilty in federal court Wednesday to purchasing “misbranded drugs” unapproved for use in the United States, according to a press release from federal prosecutors.
Michael Dean Combs, 32, Piney Flats, pleaded guilty to receiving interstate commerce, which was the misbranded medication. He faces up to a year in prison and a $100,000 fine, and a possible five-year probation term.
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.
There is no indication in the press release or plea agreement that the drugs were fake or didn’t have cancer-fighting properties in them.
“We pled to a fairly minor misdemeanor offense,” Combs’ attorney, Cliff Corker, said. “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 receiving a fake drug. He pleaded guilty to receiving a real drug that was mislabeled,” Corker said.
According to documents filed in U.S. District Court in Greeneville, Combs worked at McLeod Cancer Center, which is owned by Dr. William Kincaid. He is the defendant in a federal civil suit filed by a former patient’s husband after his wife died.
That civil suit claims Kincaid provided fake cancer drugs to the woman while she was a patient there. Kincaid has adamantly denied using unapproved cancer medications.
The case hasn’t made much progress, and the attorney who filed it recently said he would withdraw it and refile as a medical malpractice suit. It is unclear how Combs’ plea will affect the lawsuit, or any that may follow.
Bristol attorney Wendel Jackson filed the lawsuit earlier this year. Attorneys for McCleod have asked a federal judge to impose sanctions on Jackson for filing a frivolous lawsuit.
Judge Ronnie Greer has taken the motion under advisement after hearing testimony in the case, but has not ruled yet.
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.
An FDA spokesman said the case is proof the government will not allow misbranded drugs in the U.S.
“Americans must have confidence that prescription drugs introduced into and distributed throughout the United States are genuine, FDA-approved products. Further, the public must be able to trust medical professionals who administer those medications,” said Special Agent in Charge David Bourne of criminal investigations in the Miami field office.
“The FDA will aggressively pursue all those who seek to profit from causing the importation and distribution of misbranded foreign drugs.”
The investigation into McLeod Cancer Center is continuing and federal prosecutors anticipate more charges in the case. As part of Combs’ plea, he has agreed to cooperate with authorities in the investigation.
Combs will be sentenced April 1 in Greeneville.