Tuesday, March 7, 2017

Fungus in Victims Matches Fungus in Steroids

By Walter F. Roche Jr.

BOSTON, Mass.- A microbiologist and genetic expert testified today that the DNA of fungus from victims of the 2012 fungal meningitis outbreak matches perfectly the DNA of fungus found in vials of steroids produced by the New England Compounding Center.
"The fungi are exactly the same," said David Engelthaler, director of programs and Operations for TGen, an Arizona-based nonprofit.
Engelthaler was testifying in U.S. District Court in the trial of Barry J. Cadden, who has been charged with racketeering and second degree murder for his role in the deadly 2012 outbreak. Cadden was president and part owner of the New England Compounding Center, the company that shipped the contaminated steroids to health providers in more than 20 states.
The outbreak sickened 778 patients, killing 76 of them.
Engelthaler testified that the 22 samples of fungal DNA came from 19 of the outbreak victims. The matching fungal DNA came from vials of two lots of preservative free methylprednisolone acetate seized by federal agents from NECC's Framingham, Mass. facility.
Though he did not identify the victims from whom the samples were taken, he said the samples included victims from Virginia, Michigan, Tennessee, Maryland and Indiana. The fungal DNA, he said came from the brains and spines or injection sites of victims.
He said he was "highly confident" that the fungi in the victims and the fungi in the vials came from the same source.
"They were essentially all the same," he said, adding that the fungus was identified as exserohilum rostratum. He said the results were the same for samples from victims who contracted fungal meningitis and those that suffered fungal infections at the injection site.
The tested vials came from lots produced by NECC in June and August of 2012 , Engelthaler said. He said both the patient samples and the vial samples came from the U.S. Centers for Disease Control and Prevention, which also did parallel testing.
Engelthaler gave the jury, judge and all others in the courtroom a brief description of his organization's DNA testing and matching methods which he described as the equivalent of an Ancestry.com for pathogens or "a family tree or organisms."
He said his organization has worked with the CDC on similar projects including  the anthrax investigation and a probe of a series of fungal infections in patients who had undergone transplants. The transplant victims all had received organs harvested from the same homeless donor.
Engelthaler's testimony came as prosecutors indicated they were winding down their case against Cadden and expect to complete it later this week.
Also testifying today was a CDC supervisor, David Craft, who reported on the findings on the testing of two other lots of NECC steroids which were contaminated but not with the same exserohilum fungus.
Jo Stewart, former pharmacy director at the Mass Eye and Ear Infirmary, testified about shipments of an eye numbing agent used in cataract surgery that turned out to be subpotent. She reported that anesthesiologists and patients complained and eventually a complaint was filed with the Massachusetts Pharmacy Board.
Stewart acknowledged regular prescription forms were not used to order the drugs, instead an NECC order form was used and no names were provided. She said that was included in an agreement between the facility and NECC.

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