A second Johnson City doctor was charged with purchasing misbranded cancer drugs just days after Dr. William Kincaid was sentenced to 2 years for his role in purchasing & administering questionable cancer medication from non-FDA approved foreign suppliers.
According to the indictment (Download Sen Indictment) released on June 11, 2013 by the U.S. District Court in Greeneville, TN, Dr. Anindya Kumar Sen and his office manager and wife, Patricia Posey Sen, owners of the East Tennessee Cancer and Blood Centers were indicted on 37 charges, including the introduction of misbranded and unapproved drugs into interstate commerce, and Medicaid fraud.
Dr. Sen and his wife operate two clinics in Tennessee, one in Greeneville, and one in Johnson City. This is the second cancer treatment center in Johnson City to be pursued by the Federal government for their dealings with foreign-based drug suppliers (see below). The Johnson City Press reports that as of June 13, both branches of the East Tennessee Cancer and Blood Centers were still open for business.
The indictment alleges that Dr. Sen and his wife began purchasing misbranded and unapproved medication in April 2009, and continued to replace FDA-approved medications with questionable imports until March, 2012. According to the Times News, the Sens are also alleged to have defrauded Medicare and other state-funded programs for approximately $3.2 million dollars.
The Sen’s indictment alleges that they purchased a great variety of expensive cancer treatment drugs from a foreign supplier called Clinical Care. In December 2012, the FDA sent warning letters to 350 U.S. doctors warning them that “Medications obtained from Quality Specialty Products (QSP), A+ Health Supplies, QP Medical, Bridgewater Medical, Clinical Care, or other foreign or unlicensed suppliers may be from unknown sources, may have unknown ingredients, may be counterfeit, or may not have been manufactured, transported or stored under proper conditions as required by U.S. law, regulations, and standards. Such products put patients at risk of exposure to ineffective or dangerous products. In virtually all cases, importing or causing the importation of unapproved prescription medications from foreign sources violates the Federal Food, Drug, and Cosmetic Act and is illegal. FDA has previously warned about unapproved and counterfeit oncology products obtained from some of these same foreign suppliers.”
The first Johnson City doctor indicted for using unapproved cancer medication on patients, Dr. William Kincaid, was sentenced to 2 years in prison June 10th, for knowingly purchasing non-FDA approved injectable cancer medications from Quality Specialty Products (QSP) reports the Department of Justice. Nurses identified the drugs as misbranded due to their questionable packaging however he and his office manager simply hid the source of the drugs from the nurses, according to the FBI.
Kincaid’s sentencing was packed with concerned patients, including Elizabethton resident Dannie Pate, reports WCYB, who worries that his wife died as a result of non-FDA approved cancer medication. Said Pate to WCYB, “She was a patient of Kincaid’s for 84 days. They cannot test the drugs that were given to her. She’s gone.”
The FBI report further described U. S. District Court Judge J. Ronnie Greer’s remarks in handing down Kincaid’s sentence. He said, “it was about greed” and the “motivation was to make more money.” Judge Greer, while acknowledging that it was virtually impossible to find out which of Kincaid’s patients had received the misbranded drugs, the “emotional harm” patients experienced from not knowing if they had received non-FDA approved drugs contributed to the seriousness of Kincaid’s crime.
One the occasion of Kincaid’s conviction, U.S. Attorney William C. Killian remarked, “This conviction sends a message to all medical providers and practitioners that federal criminal penalties await those who distribute misbranded and potentially unsafe drugs, especially those used in cancer treatment. The FDA’s regulatory system is designed to protect patients from substances such as these.”
Dr. Sen and his wife are due back in court on June 27, reports the Johnson City Press.
By S. Imber