Tests Results On Deadly Drug Never Produced

By Walter F. Roche Jr.

Boston, Mass.-The medical director at a Nashville, Tenn. clinic testified today that officials of the company blamed for a deadly fungal meningitis outbreak never answered his question about whether spinal steroids shipped to his clinic had been tested for fungus.
Dr. John Culclasure said he asked the question of the New England Compounding Center because he had just learned that one of his patients had been diagnosed with fungal meningitis. That patient, who subsequently died, had been injected with methylprednisolone acetate obtained from NECC.
Culclasure's testimony in U.S. District Court came in the second day of the federal criminal trial of six former employees of NECC, the company blamed for the deadly 2012 outbreak. They face charges 18 ranging from racketeering to mail fraud.
Also testifying for federal prosecutors was a former salesman for NECC, Kenneth Boneau who told jurors that there were "multiple errors" in drug production at the firm in the months leading up to the 2012 outbreak as the company attempted to deal with a surge of orders.
"There was an uptick as far as the amount of complaints," he testified, adding that the errors included the mislabeling of drugs.
Culclasure, who still serves as medical director at the St. Thomas Outpatient Neurosurgical Center, said he was standing by the phone when another clinic employee called NECC with questions. The call was made on Sept. 21, 2012, just as word of the outbreak was emerging. Eventually 13 of Culclasure's patients, including the one whose case triggered the alarm, would die among the 103 of his patients who were sickened.
The physician said when the clinic employee asked NECC about tests for fungal contamination the NECC official said they would have to get back to him.
They never did.
Culclasure said the clinic not only contacted NECC but other suppliers because the victims could have been infected from the needle used for the injection, a dye used to aim the needle or even a numbing agent.
He said that the other suppliers, like NECC, reported no reports of patient problems.
Cuclasure said that early the next week, Debra Schamberg, a clinic employee, told him that an NECC salesman, Mario Giamei Jr., had called to tell her that NECC could not be the source of any problem because of its state-of-the art production facilities. He said Giamei also invited him to visit NECC to see the facilities for himself. He never did.
Though not brought out in the day's testimony, federal investigators would conclude that 76 patients in more than 20 states died from fungus laden NECC steroids. They were among 778 who were sickened.
Boneau, who was an employee of NECC's sales arm, Medical Sales Management, was led through a series of exhibits showing the materials distributed to NECC's customers.
The brochures, he acknowledged, included claims that NECC met or exceeded all federal and industry standards.
"We told them we were doing more than the FDA (U.S. Food and Drug Administration)required," Boneau testified.
He said it was only later that he learned NECC wasn't testing all of it products before shipping them out and some products weren't tested at all.
He said clients were assured NECC not only complied with but exceeded industry standard set by the U.S. Pharmacopeia, a nonprofit.
The former salesman was questioned extensively about NECC's enforcement of a Massachusetts legal requirement that all customers provide patient specific prescriptions for each dose of drugs ordered.
He said he discovered that some health providers had gone for years with out complying.
When customers complained, he said NECC would allow them to "backfill" patient names.
He said under that system customers could get an initial order without patient names and then use the names of the old patients for subsequent orders.
He said working as an NECC was "slave driving for the most part" especially toward the end when the company was rapidly growing its sales volume. He said salesman would spend three weeks on the road and then spend a week in the office.
"Most people got fired," Boneau said.