Wednesday, February 1, 2017

NECC Fungus Bloomed in Petri Dish

By Walter F. Roche Jr.

BOSTON, Mass. When a microbiologist saw the blooming fungus from a sample steroid from the New England Compounding Center she was so surprised she took out her camera and took a picture of it.
Eleven separate fungi were blooming on her petri dish.
Tiffany Hyde from the Analytic Research Laboratories recounted the discovery of the fungus from an NECC steroid in testimony today in the murder trial of Barry J. Cadden, the former president and part owner of NECC.
Cadden is the first to go on trial on charges stemming from the 2012 fungal meningitis outbreak which state and federal regulators say was caused by fungus loaded methylprednisolone acetate shipped by NECC to health providers in 20 states.
First detected in Tennessee, the outbreak sickened 778 patients, killing 76 of them.
"It's very uncommon to see a growth like this," Hyde testified, as her 2012 picture was displayed on monitors in the courtroom.
 Her report described "a large cotton like ball covered covered in product... white filamentous raised fungal colonies with with blackish green center."
ARL, based in Oklahoma was the company NECC hired to test its steroids and other drugs produced at its Framingham, Mass. headquarters.
Under questioning by prosecutors, Hyde acknowledged that her company had sent reports to NECC attesting to the sterility of its methylprednisolone acetate. But that was before the outbreak became public and NECC for the first time asked for fungal testing to be done.
Though it has not been mentioned in the ongoing trial, court records show ARL agreed to pay $6.1 million into a fund for victims of the outbreak. Dozens of victims sued ARL charging that the company had certified that the NECC steroids were sterile though they were later found to be riddled with fungus.
Hyde was questioned about a series of tests performed by ARL that showed other NECC drugs were not sterile.
They included a potassium chloride solution and an antibiotic solution, polymyxin-bacitracin.
Hyde said that when she notified NECC of one of those results she was told not to perform any further tests because NECC would discard the entire lot.
In a two-hour afternoon session, Michele Peirce, one of Cadden's lawyers, repeatedly challenged another ARL employee, Jimmy Means, about entries on a list he had compiled of drug tests ARL had performed to check on the potency of NECC drugs. He said the list included cases in which the drugs were found to be too potent or too weak.
Peirce questioned the testing methods used by ARL and cited several instances in which ARL issued conflicting test results on drug samples from the same lot.
Following the testimony U.S. District Judge Richard G. Stearns said he had questions about whether 27 of the items should be included on the list and presented to the jury. He asked for briefs from both sides on the issue.

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