CDC Raced to Find Quick Outbreak Test

By Walter F. Roche Jr.

BOSTON- With the death toll mounting and quick treatment essential,  a federal health official said her agency had to come up with a new and speedier test to determine what was causing patients to contract fungal meningitis.
Mary Brandt, head of the myotic diseases branch of the U.S. Centers for Disease Control and Prevention, testified Monday in the racketeering and second degree murder trial of pharmacist Glenn Chin. The charges stem from a two-year probe of the 2012 fungal meningitis outbreak which first surfaced in Tennessee.
Under questioning by Assistant U.S. Attorney George Varghese, Brandt went through a list of victims, starting with Thomas Rybinski of Smyrna, who became the so-called index or lead case.
Brandt said that the existing tests either took too long or were not precise enough to quickly identify the fungus causing the outbreak.
She said without rapid diagnosis victims would be showing up at emergency rooms with the staffers having no idea of the real cause or the best treatment.
"Strokes would kill patients before the cause would be realized," she said.
The test developed, called Real Time PCR, enabled a quicker identification of the fungus contained in specimens of tissue and liquid extracted from victims being delivered to CDC's Atlanta laboratories.
Brandt said her unit also tested and matched vials of the suspect steroid, methylprednisolone acetate, gathered from Chin's employer, the New England Compounding Center and health facilities around the country.
Stating that it was critical to precisely identify the fungus, Brandt said the results showed that the predominant fungus turned out to be exserohilum rostratum, while tests on specimens from Rybinski contained a different fungus, aspergillus fumigatus.
She testified that subsequent tests on other NECC products showed a variety of different fungi and bacteria.
"It's very unusual to see such a diverse group of organisms," she said.
Brandt said the CDC had little to no experience with treatment of the dominant fungus so they quickly assembled a panel of experts to come up with treatment plans.
"We stopped all work in the bureau for three months," she said, referring to multiple teams set up to address the crisis. "Everybody had a job."
She said some 1,000 specimens were tested including spinal fluid and brain and spinal tissue extracted from victims.
She said the fungus appeared as long strands "which are very difficult to capture." The analysis was made more difficult because some of the patients were already being treated with anti-fungal medications which destroyed some of the evidence.
She said the new Real Time PCR test improved
from 10 per cent to 50 per cent the number of cases being correctly diagnosed.
Other victims cited in Brandt's testimony included Diana Reed and Marie Hester of Nashville along with victims from Indiana and Michigan. Chin, whose initials appeared on the vials put in evidence, has been charged with second degree murder in 25 of those deaths.
 Under cross examination by Chin's lawyer, Stephen Weymouth, Brandt acknowledged that there were NECC vials, 41 in fact, that contained no evidence of fungus. Weymouth challenged the prosecution's contention that a lot of steroids produced in May were contaminated.
Weymouth also noted that the new "Real Time" test has not received formal approval from the U.S. Food and Drug Administration.
But another prosecution witness, Dr. Sudha Chaturvedi, said tests done under her supervision at the New York State Health Department showed at least one NECC vial from the May lot was contaminated with the suspect fungus. Calling the results "devastating," she said tests on other NECC steroids showed they were heavily contaminated with another fungus.
Contact: wfrochejr999@gmail.com