Friday, February 24, 2017

More NECC Drugs Found Contaminated

By Walter F. Roche Jr.

BOSTON, Mass. - A parade of microbiologists from the U.S. Food and Drug Administration detailed today how they found contaminants in a variety of drugs produced by the now defunct New England Compounding Center.
Testifying in U.S. District Court the scientists from New York, Denver and San Francisco described in brief detail how they tested the drugs, some collected at NECC's Framingham offices along with others from Tennessee, Florida and West Virginia.
The drugs found contaminated included the spinal steroid blamed for dozens of death, but also other drugs not previously identified such as triamcinolone, betamethasone and cardioplegia.
At the Saint Thomas Outpatient Neurosurgical Center in Nashville, Tenn. 78 vials of methylprednisolone acetate were collected.
Haydee Romero from FDA's New York office, said 28 of the vials contained yeast, while 20 had two different kinds of mold.
NECC vials found at the Specialty Surgery Center in Crossville, Tenn. also were contaminated.
Romero also tested 25 vials that were collected directly at NECC. All 25 were contaminated with yeast or mold.
The testimony came in the case of NECC's one time president and part owner, Barry J. Cadden. He has entered not guilty pleas to charges of racketeering and second degree murder. The murder charges stem from the death of 25 of some 78 patients who died after being injected with fungus ridden steroids from NECC.
In other testimony Stacey Degamo, an FDA investigator, testified that while they found several varieties of fungus when they inspected NECC in October of 2012, they did not find either of the two specific fungi, aspergillus fumigatus and exserohilum rostratum found in victims of the 2012 outbreak.
Other microbiologists to testify under questioning from Assistant John Claud, a U.S. Justice Department attorney, included Patricia Stanke from FDA's Denver office. She said one of 10 vials of betamethasone she tested had a bluish mold, which turned dark grey with aging.
Henry Lau from FDA's San Francisco office said he also tested betamethasone produced by NECC. Five vials were found to have bacteria, which he said could be "very harmful."
He also tested triaminclone and three vials showed the presence of bacteria, bacillus lentus.
A third drug he said he tested was cardioplegea, a drug used to stop the heart from beating during surgery. He said three vials contained bacteria.
On cross examination Lau said that he became aware that some of the drugs collected from NECC went missing, but he said he didn't know whether they were ever found.
The vials that turned out to be tainted came from health facilities in Florida, West Virginia and Kentucky

No comments:

Post a Comment