on cancer patients with fake medications in our series, Rogues Gallery.
US Department of Justice convicts two in cases tying counterfeit cancer drugs
to Canadian pharmacy business.
On November 15th, Dr. William Kincaid, of Johnson City, TN, was convicted for knowingly purchasing non-FDA approved injectable cancer medications from Quality Specialty Products (QSP). Dr. Kincaid accepted a plea deal with the federal government in exchange for assisting them with their ongoing investigation. Previously, Dr. Kincaid’s business manager, Michael Dean Combs pled guilty in the same case on September 19th, reports
Dr. Kincaid and his business manager confessed to purchasing $2 million in
misbranded cancer drugs, reports Knox News. Dr. Kincaid was charged with a felony count
of introducing misbranded drugs into interstate commerce with the intent to defraud patients and the state’s Medicaid program. Dr. Kincaid pleaded guilty and admitted that his clinic purchased unapproved, discounted versions of Rituxan, a cancer treatment, which were not approved for use in the US, reports the Wall Street Journal.
In March of 2012, the FDA announced that they had sent a warning letter to McLeod Cancer and Blood Center, notifying them that “your medical practice has purchased medications from Quality Specialty Products (QSP), a foreign supplier that may also be known as Montana Health Care Solutions. Many of the products sold and distributed through this supplier have not been approved by the FDA.”
The letter goes on to warn, “FDA has information indicating that QSP has used distributors in the United States to distribute unapproved products, which may include a counterfeit product.”
Dr. Kincaid admitted in his plea agreement, that he and the other doctors in his practice made the initial decision to order chemotherapy and other injectable cancer drugs from QSP in late 2007. “The drugs provided by QSP to McLeod Cancer were drugs from foreign sources that were not inspected and approved by the FDA,” stated the agreement.
The nurses in the practice noticed the misbranded drugs and brought them to the doctors’ attention.
“In late 2007 and early 2008, nurses at McLeod Cancer observed that packaging for chemotherapy drugs which were being obtained by McLeod Cancer from QSP bore labeling in foreign languages, establishing that the drugs were not approved for use in the United States. After the nurses raised their concerns with Drs. Kincaid, Lamb and Famoyin and with Combs, the decision was made to stop ordering drugs from QSP,” according to the text of Kincaid’s plea agreement.
However, in August 2009 Dr. Kincaid and Combs went back to the misbranded cancer drug distributor in 2008 without the nurses’ knowledge.
The plea agreement states, “To prevent the nurses from learning that McLeod Cancer was again purchasing unapproved foreign drugs, Dr, Kincaid directed Combs to have the drugs shipped to a storage business in Johnson City which Dr. Kincaid owned in part. The drugs, after having been received at the storage business, were transported by Combs and others to Combs’ office at McLeod Cancer and then placed by a pharmacy technician into the clinic’s drug storage and control system where the misbranded drugs were mingled with FDA-approved drugs from legitimate sources. FDA-approved drugs obtained from legitimate U.S. drug manufacturers and distributors were still shipped directly to McLeod Cancer and not to the storage business.”
Quality Specialty Products (QSP) and Montana Healthcare Solutions (MHS) first came to the attention of Federal authorities in February 2012, when the FDA first reported its involvement in the distribution of a counterfeit version of the cancer treatment, Avastin. Ongoing investigations reported in the Wall Street Journal and CBC News have identified a Canadian online pharmacy, Canada Drugs, as the owner of QSP. QSP “later did business jointly” with MHS, reports the Combs plea agreement.
After an initial period of purchasing misbranded unapproved foreign drugs from QSP and MHS from September 2007 to early 2008, McLeod Cancer then continued to obtain them for more than two years from August 2009, to February 2012, states the Kincaid plea agreement.
Local Johnson City, TN news station, CBS 11, interviewed patients that sought treatment at McLeod Cancer and Blood Center. They reported a loss of trust in the physician, and expressed concern about their own well being if they had been given the unapproved drugs.
Said Sheila Gray, one of the patients interviewed, “Was all that treatment for nothing? Was the chemotherapy for nothing and is it going to come back? Is the cancer going to come back, that’s my concern … and I would like to know did I get some of those drugs? I think I deserve to know that.”
Tom Kubic, President and CEO of the Pharmaceutical Security Institute, advises patients to routinely ask to see medications prior to treatment in order to become familiar with them, and to speak up if the packaging or material seems to be new or unfamiliar.
Dr. Kincaid could face up to three years in prison upon sentencing, if his plea is accepted by the court. He admitted earning $500,000 by billing insurers for the discounted misbranded foreign medications, reports The Wall Street Journal.
By S. Imber