Tuesday, January 31, 2017
NECC Drugs Tested up to 5,000 Per Cent Potent
By Walter F. Roche Jr.
BOSTON, Mass. Drugs produced by the company blamed for a nationwide fungal meningitis outbreak contained ingredients that tested up to 5,019 per cent stronger than they were supposed to while other products contained not even a trace of a mandated ingredient.
That was the testimony today by Tommy Means, the quality control manager for Analytic Research Laboratories (ARL), in a hearing in U.S. District Court in the murder trial of Barry Cadden the one time president of the drug company, the New England Compounding Center.
Means told jurors that Oklahoma based ARL, which had been doing testing for NECC for over a decade, was asked by an investigator for the U.S. Food and Drug Administration to produce records of its NECC tests during the investigation of the outbreak.
Cadden is on trial on charges of racketeering and 25 counts of second degree murder. He was one of 14 owners and employees of the now defunct NECC blamed for the outbreak, which first surfaced in Tennessee. NECC steroids contaminated with fungus sickened 778 patients, killing 76 of them.
Under questioning by Assistant U.S. Attorney Amanda Strachan, Means went through a list of aberrant test results including an antibiotic solution that ARL found contained 5,019 percent of the level of bacitracin that was prescribed.
While Means called that drug "superpotent," he cited other tests with the opposite result. A drug that was supposed to contain famotidine and dexamethasone contained not a trace of famotidine.
A drug that was supposed to contain clindamycin and gentamicin had subpotent amounts of both ingredients, Means testified.
An eye drug lacked the required dose of lidocaine.
But a syringe containing a drug called Mannitol, contained 169.1 per cent of the prescribed dose.
Means was not asked what effect the errant dosages might have had on patients, but he was grilled by Michelle Peirce, one of Cadden's lawyers about ARL's own record.
Citing an FDA inspection report prompted by the outbreak, Peirce asked Means about the FDA finding that ARL had not been collecting adequate samples of the drugs the company had been testing.
Means acknowledged that ARL changed its order forms following the FDA inspection. Peirce also produced internal ARL records showing that a consultant had raised concerns about the number of samples being tested from any given drug lot.
Means said the revised order form was meant to make it clear that the number of samples were supposed to comply with an industry standard.
Twice during the cross examination, U.S. District Judge Richard G. Stearns told Peirce to end her line of questioning.
"That's the last word on that subject," Stearns said following a series of questions on sterility testing.