Expert: NECC Failed to Meet Testing, Sterility Standards

By Walter F. Roche Jr.

BOSTON, Mass. A pharmaceutical expert witness says the New England Compounding Center failed repeatedly in multiple categories to meet standards for the production of sterile drugs, thus putting patients at grave risk.
Eric S. Kastango, a pharmacist who was hired by federal prosecutors to assist in the investigation of the 2012 fungal meningitis outbreak, said, "The testing was not being done. Every time a lot was done, each and everyone should have been tested."
He said that when drugs that are not sterile are injected into the body they can cause "devastating harm and death can occur."
Kastango was one of two new witnesses to testify today in the racketeering and second degree murder trial of Barry J. Cadden, the one time president and part owner of the now defunct NECC.
The outbreak sickened 778 patients. Seventy eight died.
The 15 jurors also heard from the head of the California drug company that sold NECC a chemical used in a cancer treatment drug. He said the chemical purchased by NECC in 2005 expired in 2007 even though NECC used it and shipped it to healthcare providers in 2012.
Thomas N. Tyner, vice president of Spectrum Chemical, said his company had never authorized an extension in the expiration date for methotrexate, the chemical purchased by NECC.
He said there was only one option in 2012, "Throw it out."
Kastango, who was on the witness stand for most of the session, said he was hired by prosecutors at a rate of $225 an hour and billed for 100 hours in his efforts to investigate NECC and the outbreak. He said he was being paid $350 an hour for his court testimony.
Under questioning by Assistant U.S. Attorney George Varghese, Kastango said he had visited NECC's Framingham heaquarters, examined company records, interviewed NECC employees and reviewed transcripts of the NECC grand jury.
From everything from autoclaving to sterility testing to maintaining sanitary conditions to temperature and humidity control, Kastango said NECC failed to meet the industry standards for the compounding of sterile drugs.
"They did not use validated procedures," he said.
On autoclaving Kastango said the industry standard set by the nonprofit U.S. Pharmacopeia called for
placing the drug in the autoclave for 20 to 60 minutes at 121 degrees.
But NECC was only auto-claving for 15 minutes or as low as 12 minutes, and that included no so-called ramp up time, the five minutes needed for the autoclave to reach the desired temperature.
"There was no evidence they did any testing to make sure it was properly auto-claved," he said, adding that the company also failed to use bio-indicators, another testing method to ensure sterilization.
He was also critical of NECC's practice of auto-claving drugs, like the spinal steroid blamed for the outbreak, in bulk. He said NECC stored the bulk material in beakers, leaving the opportunity for later contamination.
Kastango said NECC's sterility testing was not done consistently or correctly and when they did send out drugs for outside testing, they sent an insufficient amount. Instead of the single vial sent to an Oklahoma firm, NECC should have sent four or 20 depending on the size of the lot.
As for the use of outdated ingredients by NECC, Kastango quipped, "When in doubt, throw it out."
Varghese showed jurors and Kastango an email Cadden sent to an NECC employee regarding a testing procedure.
"What you are seeing is what we are not currently doing but should be doing," Cadden wrote. "We are not covering these things all the time in the current testing method."
Asked to comment on the email, Kastango said, "Cadden knew they weren't doing the testing correctly."
Kastango said NECC failed to comply with a number of other elements in the industry standard including a written procedure for notifying physicians and patients in the event an adverse test result came back on a drug already shipped.
He said they were using alcohol to wipe down the clean room even though it was not effective for combating fungus.
He said NECC in some categories was actually doing more testing than was recommended in industry standards, but when tests showed action levels had been exceeded, "They basically ignored that for weeks on end."
Under cross examination by Cadden's attorney Bruce Singal, showed materials from a training session Kastango hmself had conducted that included a recommendation to autoclave drugs from only 12 to 30 minutes.
Showing more of those materials, Singal asked if co-defendant Glenn Chin and not Barry Cadden, was responsible for determining clean room standards such as the length of time for auto-claving sterile drugs. Cross examination continues Wednesday.