FDA Witness Says
BY KEN LITTLE
Current and former employees of the oncology and blood clinics operated by Dr. Anindya Sen and his wife, Patricia Posey Sen, testified Thursday that some packaging and labeling on drugs received at the practice were in foreign languages.
Prosecution testimony continued during the third day of the Sens' U.S. District Court trial in Greeneville.
Witnesses included a doctor working for the U.S. Food and Drug Administration (FDA) who reviewed labels and packaging from some drugs administered at the Sen medical practice.
In response to questions by Assistant U.S. Attorney M. Neil Smith, registered nurse Barbara Henegar reviewed billing forms from East Tennessee Hematology Oncology and Internal Medicine, which operates practices in Greeneville and Johnson City.
Some foreign-made cancer treatment drugs were billed under the name of their U.S. equivalent, such as Altuzan, which the government alleges the practice substituted for Avastin, a drug approved for use by the U.S. Food and Drug Administration.
Altuzan is approved for use in Turkey but not in the U.S. Avastin, manufactured in Switzerland by Roche, is FDA-approved.
The Greeneville clinic administered Altuzan and other misbranded drugs to its patients between 2009 and 2012, the government alleges.
Other unapproved foreign-made drugs the government claims were misbranded and administered to patients include Bonviva, MabThera, Neupogen and Venofer.
Henegar testified about a clinic employee's learning about a recall of Altuzan in February 2012. Lot numbers at the clinic were checked to see if the stock of the intravenous drug at the clinic was included. It was, she said.
At Patricia Sen's direction, the drugs were mailed back to the provider, said Henegar, who no longer works at the practice.
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.
Patricia Sen is also charged with 44 counts of engaging in a scheme to defraud health care benefit programs and seven counts of receiving merchandise imported contrary to law, in addition to two counts of making a false material statement to an FDA special agent.
Sen and his wife maintain their innocence and chose to go to trial.
Under cross-examination by Patricia Sen lawyer Daniel Warlick, Henegar testified that, in her capacity as a nurse, she would never knowingly administer any medication that would harm clients of the clinic.
Warlick later asked the same question of several other nurses who worked for or remain employed by Sen, and received the same response.
NO EVIDENCE OF HARM
Defense lawyers have said there is no evidence that any patients of the practice were harmed by the unapproved drugs. Many FDA-approved drugs in common use in the U.S. are manufactured in other countries, trial testimony has shown.
While an objection raised by defense lawyers about questioning the safety of unapproved drugs administered to patients was argued, trial Judge J. Ronnie Greer spelled out what the case was not about.
"Whether these drugs are safe or not is not something the government has to prove," he said.
Henegar also testified that when Altuzan was administered to cancer patients, she didn't believe she was doing anything wrong.
Henegar said she trusted the other nurses working at the practice, along with Dr. Sen.
Torri Emmette, another registered nurse who administered intravenous drugs to cancer patients while working at the Greeneville clinic in 2011 and 2012, agreed with Smith that some of the drug packaging at the clinic was "in a language other than English."
Amy Fillers, a registered nurse who worked part-time at Sen's office, told Special Assistant U.S. Attorney Ben Cunningham that she also noticed what he termed "foreign language on drugs."
"I remember making the statement 'We're going to have to call (Patricia Sen) to see what to do,'" Fillers testified.
Under cross-examination by Edward M. Yarbrough, lead defense lawyer for Anindya Sen, Fillers said that she didn't understand what the term "foreign drugs" meant in the context of the case.
"Most drugs are manufactured outside the United States and that's not unusual?" Yarbrough asked.
"Yes," Fillers said.
Registered nurse Kristy Cutshaw started working at the practice in March 2009 and remains employed there.
She told Smith that, prior to April 2009, a U.S. company called Oncology Supply supplied drugs to the practice.
Some drugs were ordered from other companies after that, she said.
"I just remember seeing a packaging slip inside the box and being unable to read it," she said.
Drugs were automatically ordered when needed in the computerized system in use at the practice before a Canadian company called Clinical Care was used.
After the system was discontinued with some drugs, Cutshaw testified, "we made up our own list" at the practice.
There were delays in receiving the drugs on several occasions, she testified.
Order forms for drugs from Clinical Care were filled out using the names of their American equivalent, Cutshaw said.
On cross-examination, Warlick asked if Patricia Sen personally instructed Cutshaw how to fill out drug order forms.
"No," she testified.
Amy Cobble, a registered nurse who worked at the practice between 2007 and 2009, testified that Patricia Sen told her in 2009 that "certain drug companies had drugs on sale and we could get them for a certain time on a discount."
Cobble said that, to the best of her knowledge, Patricia Sen ordered the drugs.
She told Smith she noticed nothing out of the ordinary about drugs being shipped from Clinical Care.
Earlier Thursday, Dr. Charles E. Lee testified as an expert witness for the prosecution.
Lee is a medical officer with the FDA's Division of New Drugs and Labeling Compliance and Center for Drug Evaluation and Research.
He testified Thursday after trial Judge J. Ronnie Greer overruled defense objections Wednesday over the focus of his testimony: the packaging and labeling of drugs received by the Sen practice.
Smith showed Lee photographs of various labels and other packaging materials for drugs the government maintains were in use at the clinic.
The jury also viewed the photographs.
The labeling on many drugs ordered by the practice "did not have required content and labeling," Lee testified.
The drugs reviewed by Lee had "no FDA-approved application" in the U.S. Many had use instructions and package inserts in languages other than English, he testified.
Some of the labels and packaging were taken from Sen's office, while others were photographs of drugs obtained from other sources that the government said were used at the clinic.
Under cross-examination by Yarbrough, Lee said that he did not examine the "actual contents" and was not aware of which photographs were from Sen's office and which were provided to him from other government sources before trial.
The foreign equivalents of some U.S. drugs used by the Sen practice between 2009 and 2012 "are not the same product," Lee said in response to a question by Yarbrough on cross-examination about what made them illegal in this country.
The active ingredients, inactive ingredients, labeling, packaging and trade names all differ, Lee testified.
While the drugs may be approved in other countries, "We've got a higher standard," Lee said. "Standards that will make a drug safe and effective for its intended use."
Lee acknowledged to Yarbrough that "a significant amount" of drugs used in the U.S. are manufactured in other countries.
Lee told Yarbrough he did not examine Sen patient records as part of his analysis. He said some of the unapproved drugs from other countries have the same brand name as their American equivalent.
"So a nurse or an employee opening a crate would see the same name?" Yarbrough asked.
"It's what's in the box. It's what's in the vial. It's what's in the language," Lee said. "The active ingredients in the foreign products are the same as the active ingredients in the U.S. products."
Lee's area of medical expertise is not in oncology, he told Warlick on cross-examination.
Prosecution testimony in the trial continues today.