Heat, Humidity Out of Control at NECC

By Walter F. Roche Jr.

Boston-One government microbiologist said she couldn't believe what she was hearing when the environmental quality supervisor at a drug compounding firm told her that the air conditioning was turned off at night in a clean room where sterile drugs were being prepared.
Another witness, also a microbiologist from the U.S.Food and Drug Administration, said he had never before seen the level of contamination as he did in the drugs he tested from the same Massachusetts company.
The testimony came as the presiding judge told prosecutors to wrap up their case by the end of the week...or else. The developments came in the trial of six former employees of the New England Compounding Center, the now defunct company blamed in the deaths of 76 patients.
Stearns stated he was setting deadlines and limiting testimony "in the interest of bringing this trial to a conclusion."
He issued an order to prosecutors to provide him by the end of the day with a list of their final witnesses and why their testimony is "essential."
The trial, which began in mid-October, is the third phase in prosecutions stemming from the 2012 fungal meningitis outbreak caused by steroids loaded with deadly fungi that were injected into hundreds of unsuspecting patients. All six now on trial were employees of the New England Compounding Center. They face charges ranging from racketeering and conspiracy to mail fraud.
Much of Monday's testimony came from a government investigator who described and read from a series of internal emails implicating many of the defendants, including NECC's former vice president and part owner Gregory Conigliaro.
Jason Kravetz of the Inspector General's office in the U.S. Department of Veterans Affairs read from one email in which Conigliaro expressed concerns that some of the company practices "could come back to haunt us."
In other emails to and from Conigliaro, he and company President Barry Cadden strategized about ways to use differing state laws mandating individual prescriptions to utilize loopholes and maximize profits.
Cadden already is serving a nine-year jail term following his conviction on racketeering and mail fraud charges.
FDA microbiologist Almaris Alonso-Claudio said she was shocked when NECC's quality control chief told her that the company turned off the air conditioning at night in the clean room where sterile drugs were prepared.
Under questioning she verified NECC records showing temperatures soared at night at the Framingham, Mass. facility.
Stating that she was appalled when she learned about that and other practices at NECC, she said,"I couldn't believe what I was hearing." She said that both the temperature and humidity "were out of control."
Philip Istafanos, the second FDA witness, said that in decades of work he had never seen the level of contamination that showed up in the vials of methylprednisolone acetate from NECC that he tested in the Fall of 2012.
He said those and other NECC drugs he tested showed contamination with fungi and yeast, an unusual finding.
"I have never seen that before," he said when questioned about the findings on one NECC drug that had a black filament within the vial.
He said mold like that found at NECC was particularly troubling because it can be difficult if not impossible to eradicate. It was, he said, "a very huge problem."
Under cross examination defense attorneys made note of the fact that of 41 environmental samples collected at NECC and tested only 11 came back with bacterial or fungal contamination and not all of those were actually in the clean room, but found in adjacent areas.
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