BY KEN LITTLE
The lead U.S. Food and Drug Administration investigator in the drug misbranding case of Dr. Anindya Sen and his wife, Patricia Posey Sen, took the stand Friday in the Sens' U.S. District Court trial.
Robert West, a special agent with the FDA's Office of Criminal Investigations, testified that he became aware in March 2012 that some area cancer treatment clinics might be purchasing foreign drugs that are not FDA-approved, and administering them to patients.
West told prosecuting Assistant U.S Attorney M. Neil Smith that Patricia Sen contacted him by telephone after he stopped at the East Tennessee Hematology, Oncology and Internal Medicine clinic in Johnson City operated by Dr. Sen, who also has a clinic in Greeneville. Patricia Sen is office manager.
West asked if the practice used any unapproved drugs or "foreign-labeled drugs."
He said the purpose of his visit was to determine if the practice used drugs purchased from a warehouse in Illinois where drugs were shipped from a supplier in the United Kingdom.
"She said no," West testified. "She denied that the practice was using foreign drugs or foreign-labeled drugs."
On April 7, 2012, West testified that he obtained a subpoena for "communications" and drugs from the Sen practice in Greeneville.
West testified that several days eralier, he was at the Meiko America warehouse in Wood Dale, Ill., looking for proof of shipments to a clinic in Johnson City.
At the warehouse, he became aware of alleged shipments from Meiko America to the Sen clinic that were ordered at a Canadian company called Clinical Care.
West testified he called Patricia Sen on April 5, and asked her if she was doing business with Clinical Care. Sen denied it, West said.
"We determined that was a lie based on records we found in Meiko America," he testified.
The FDA agent went to the Greeneville clinic with an invoice found at Meiko America and again asked her if the practice was using foreign drugs.
Patricia Sen denied purchasing or using cancer or blood disease treatment drugs not approved by the FDA, West said.
On April 12, 2012, the practice "surrendered some of the foreign-labeled drugs that they had purchased from Clinical Care," West said.
The FDA lab took photographs which were submitted as evidence by Smith at trial Friday which showed packaging and lot numbers.
Some of the drugs had labeling and information in German and other languages, West said. The brands included Aloxi, Bonviva, Neutrogen and Venofer, which West said was "distributed in Turkey" and had foreign characters written on it.
Prosecution testimony by West will continue Monday as the trial goes into a second week.
Earlier Friday, Sen clinic employees and relatives of clinic patients offered other prosecution testimony.
CHARGES AGAINST SENS
Anindya Sen, 65, is charged with 29 misdemeanor violations of causing the introduction into interstate commerce of misbranded drugs. Patricia Sen is charged with 29 felony violations of the same statute.
The government has also charged Patricia Sen with 44 counts of engaging in a scheme to defraud health care benefit programs, seven counts of receiving merchandise imported contrary to law, in addition to two counts of making a false material statement to West.
Anindya Sen and Patricia Sen have maintained their innocence since the first indictment in the case was made public in June.
Brandi McAmis started working in 2008 as a medical lab technician at the Greeneville clinic. McAmis testified about a sign posted in the office that said, "We do not use non FDA-approved drugs in the office."
She said the sign was put up in the Greeneville practice in 2009, the years the government alleges the practice began purchasing unapproved drugs. McAmis testified that Patricia Sen is responsible for ordering drugs for the practice.
Several relatives of patients at Sen's practice also took the stand.
The government alleges the practice substituted a foreign unapproved drug with the brand name Altuzan for an approved cancer treatment drug called Avastin.
Smith asked witness Ronald K. Burrell if his mother, who was treated at the Sen practice, was asked by anyone if "she would agree" to take the drug in place of Avastin.
Burrell replied he didn't know what drugs his mother took.
He told Smith she was sent home without treatment "four, maybe six times" because the practice did not have in stock the chemotherpy drugs she used.