Tuesday, September 19, 2017

First Suspicion in Outbreak Focused on Nashville

By Walter F. Roche Jr.

Boston, Mass. -- A top federal health official testified today that he first thought that the cause of a growing and deadly outbreak would be found in the Nashville clinic where the first case of fungal meningitis was reported.
Dr. Benjamin Park, testifying as the lead witness in the racketeering and second degree murder trial of Glenn Chin, said that while he first suspected the outbreak was limited to the Saint Thomas Outpatient Neurosurgical Center in Nashville, Tenn. he soon learned the outbreak traced back to the Massachusetts drug compounding firm that shipped contaminated steroids to clinics in 23 states, including Tennessee.
Park testified after Assistant U.S. Attorney George Varghese told jurors it was Chin who was responsible for sending out contaminated drugs that killed the 25 patients in seven states.
Citing the case of Kentucky Judge Eddie Lovelace, who was injected at the Nashville clinic, Varghese said it was Chin who certified that the vials of methylprednisolone acetate were sterile.
Instead, he said, they were contaminated with deadly fungi that traveled to Lovelace's brain eating blood vessels and causing a massive stroke.
Chin's legal team made an immediate call for a mistrial because he said Varghese had given jutors misinformation about the standards required of the New England Compounding Center, which employed Chin as a supervisory pharmacist.
U.S. District Judge Richard G. Stearns denied the mistrial motion but then clarified for jurors the source of the standards NECC was expected to meet.
Stephen Weymouth, Chin's lawyer said in his opening statement that prosecutors were attempting to portray Chin as "a horrible villain" who was responsible for the outbreak.
Citing statements by prosecutors in the recent trial of codefendant Barry J. Cadden, Weymouth noted that they called NECC "Cadden's baby" and that they repeatedly claimed that everything that happened at the now defunct Framingham, Mass. company happened because Cadden ordered it.
Cadden was convicted of racketeering and mail fraud charges but cleared of the same 25 second degree murder charges now facing Chin. Cadden was given a nine year prison sentence.
Park, an official of the U.S. Centers for Disease Control and Prevention who also testified in the Cadden trial, said the first word of a possible outbreak came from Dr. Marion Kainer of the Tennessee Health Department. In a call in early September of 2012, Kainer told the CDC a patient had died after being injected with a spinal steroid at the Nashville clinic.
As additional cases were reported, Park said he became more and more concerned. He said the strokes were in an unusual area at the center of the brain.
He said there were a lot of common denominators in the initial cases which caused him to think something was going wrong at the Nashville clinic. He said that feeling was reinforced after a conference call with Cadden and another NECC officer who told the CDC there had been no other complaints from NECC customers.
A turning point came when a new case was reported at a North Carolina clinic on Sept. 26. That clinic also had purchased steroids from NECC and the victim suffered the same unusual stroke.
"This told us it was outside the (Nashville) clinic," Park said.
While relieved they had found the source, Park said he also learned that some 14,000 doses of suspect steroids already had been injected in patients in 23 states.
"I was quite scared," Park said.
On cross examination by Weymouth, Park was challenged on his comparison of the meningitis outbreak with an ebola epidemic that killed thousands of victims.
Weymouth also presented records showing thousands of vials of NECC drugs were shipped and injected in patients without any evidence of injury. He also raised questions about the lack of evidence that one of the three lots of suspect steroids actually harmed anyone.
In his opening statement Weymouth said the second degree murder charges were unjustified.
"It's not murder," he said, adding "he (Chin) did make mistakes for sure."
Instead he said that despite the intensive federal investigation, the exact fungus contained in the steroids was never found at NECC.
"No one could determine exactly what happened in that clean room," he said.
In his opening statement Varghese showed jurors an email from Cadden to Chin in which he reported a "fungal bloom" had been detected in the clean room. That was just one day before one of the suspect lots was prepared.
Nonetheless, Varghese said, NECC failed to inform federal investigators about that finding when the investigation was underway.
And the prosecutor said there were multiple other problems with NECC drugs including some contaminated with bacteria and others made with outdated components.
He cited an email from Chin to Cadden in which he described one component of a juvenile cancer drug this way.
"When I say old, I mean old," Chin wrote.
"They used it anyway," Varghese concluded.




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