Tuesday, January 10, 2017

CDC Official "Very Scared" by Outbreak

By Walter F. Roche Jr.

A federal health official testified today that he became "very scared" as the 2012 fungal meningitis began to unfold and patients were dying at an alarming rate.
"I remember feeling very scared," Dr. Benjamin Park, a division chief at the U.S. Center for Disease Control and Prevention.
In his second day as the prosecution's first witness, Park laid out a sketch of the rapidly developing outbreak from the time in September when the first alarm was sounded by the Tennessee Health Department.
Park described the events following that initial alarm, including a telephone conversation with
Barry Cadden, the man on trial on charges of racketeering and second degree murder. Cadden was a part owner and president of the New England Compounding Center, the firm blamed for the outbreak.
Park said NECC did provide a list of its customers following the conference call with Cadden and Gregory Conigliaro, another part owner of NECC.
At the time of the call, Park said the spinal steroids from NECC were on the list of possible causes of the outbreak. Other candidates included a numbing agent administered before patients were injected with the methylprednisolone acetate, and a dye used in the procedure.
"We did not rule out other causes," Park said, adding, "We didn't know if it was this single (Nashville) clinic."
He described the unfolding tragedy as "remarkable" including the unusual strokes victims were suffering. He said this strokes were in the middle of the brain were "very uncommon."
"I'll never forget it," he said, "something truly tragic was happening."
Park said he became even more apprehensive after learning that NECC had sent out some 17,000 vials of the spinal steroid from the three suspect lots.
On Oct. 4, Park said, the U.S. Food and Drug Administration reported that they had found fungus in an unopened vial of methylprednisolone acetate.
"There's not supposed to be mold in an unopened vial," Park said, adding "they could actually see the fungus."
"About half the people were dying," Park said. "It was very important for us to act quickly."
He said a press conference was called in early October to send out an alarm, along with health alerts to health professionals. "We were looking at a large amount of deaths."
He said those victims treated quickly had a greater chance of survival and recovery, but doctors were  having difficulty making diagnoses.
He said one of the first steps was to identify all those patients injected with the suspect drugs and then contact them to see if they were displaying any of the symptoms.
Calling it "a massive effort," Park said with the help of state and local health officials they were eventually able to contact 99 percent of the 14,000 potential victims."
Park also was questioned extensively about how federal health officials set the parameters of what cases qualified to be part of the outbreak.
He said the concern was that too narrow a definition would leave out many cases, while too broad a definition would likely include many cases that were not part of the outbreak.
"There was a back and forth," he said of the discussions leading to the official case definition.
"The outbreak was very significant, really a public health tragedy," he said adding that only the recent ebola outbreak was comparable.
Park was questioned extensively by Michelle Peirce, part of Cadden's defense team, about a study he co-authored on the outbreak.
She asked if it was possible that some of the vials were not at all contaminated and, if so, what effect that would have on the study results. She also asked if it was possible that vials from the same suspect lots might have been filled on separate days.
Park said that would be a question for the FDA, which was looking into procedures in the NECC facility.
A second witness called by prosecutors was Frank Lombardo, an FDA special agent who led raids on NECC's Framingham, Mass headquarters in 2012.
Lombardo identified numerous records that he said were found in Cadden's office. Responding to questions from Assistant U.S. Attorney Amanda Strachan, Lombardo said the documents included records relating to subpotent drugs shipped to the Massachusetts Eye and Ear Infirmary. The drugs were supposed to numb the eyes of patients undergoing surgery, such as cataract removal.
He also testified about the NECC office setup, which abutted a recycling business run by Gregory Conigliaro.
He also detailed other records seized including the agenda of an upcoming "barnstorming opportunities" session that was to be held among company officials.

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