Metro

CDC investigator says fungal meningitis outbreak rivaled Ebola epidemic

FRAMINGHAM, MA - OCTOBER 05: The New England Compounding Center is shown here on October 5, 2012 in Framingham, Massachusetts. The pharmacy is currently being investigated for producing a contaminated steroid shot that included the meningitis fungus that has killed at least five people. (Photo by Jared Wickerham/Getty Images)
Jared Wickerham/Getty Images/File
The New England Compounding Center in Framingham in 2012.

A lead investigator for the Centers for Disease Control and Prevention told a federal jury Tuesday that the initial days of a deadly fungal meningitis outbreak in 2012 created a public health scare that would rival the Ebola epidemic in Africa.

Doctors could not determine how a fungus had attacked patients, how to test for it, or how to treat it.

“This was really a public health tragedy,” Dr. Benjamin Park told jurors in the first federal criminal trial related to a meningitis outbreak that killed more than 60 people from at least seven states.

Advertisement

The Ebola epidemic affected more people, but the meningitis outbreak, which was eventually connected to a fungus-contaminated drug prepared by the New England Compounding Center in Framingham, “was here, in our country, and it was entirely preventable.”

Get Fast Forward in your inbox:
Forget yesterday's news. Get what you need today in this early-morning email.
Thank you for signing up! Sign up for more newsletters here

Park was the first witness called in the criminal trial of Barry J. Cadden, the former president and head pharmacist at the New England Compounding Center, known as NECC.

Cadden faces more than 90 charges including racketeering and causing the deaths of at least 25 people, and he could be sentenced to life in prison if convicted.

Prosecutors say he ran NECC like a criminal enterprise: He and other employees allegedly skirted industry standards to maximize profits, and they produced drugs in unsanitary conditions, knowing the health risks. Authorities allege the employees distributed drugs they knew or should have known did not meet industry standards or posed health risks, including a contaminated steroid that caused the meningitis outbreak.

While Park did not speak about Cadden’s direct involvement in the outbreak, he outlined for jurors how investigators in September 2012 traced the health crisis to a specific steroid that was produced at NECC, and eventually to a fungus that had contaminated three batches of steroids manufactured at the pharmacy from May to August 2012.

Advertisement

In September 2012, Tennessee health officials reported seven cases of sickened patients, then a case was reported in North Carolina. As more cases were identified nationwide, investigators searched for commonalities. At the onset, the death rate was at 50 percent.

By Oct. 4, 2012, the CDC issued a health alert after investigators with the Food and Drug Administration reported that they had found visible mold in an unopened vial of the NECC-manufactured steroid methylprednisolone acetate. The mold was so significant it was visible and did not need to be cultured for testing, Park testified.

Ultimately, the CDC attributed 64 deaths to the outbreak, and roughly 700 others were seriously sickened. Some people suffered from meningitis, while others got spinal infections. Some had both. Park told jurors that many patients who survived still have not recovered fully, and many suffered relapses.

Park said authorities were able to reduce the death rate to 5 percent or less after learning the cause of the infections.

“The core thing we were focusing on was whether there was contamination, whether anyone was getting sick from that contamination,” he said. “We were trying to come up with how to treat these patients. We didn’t have any experience.”

Advertisement

While cross-examining Park, an attorney for Cadden tried to show that contamination can happen by mistake and that the different batches of steroids could have been contaminated in ways unrelated to NECC. But Park disagreed, saying the fungus that was detected among all of the cases identified by the CDC came from the same contamination at the Framingham center.

Prosecutors indicted 14 people in 2014, but Cadden and supervisory pharmacist Glenn Chin are the only ones accused of causing deaths. Cadden is the first to go to trial.

While acknowledging the severity of the contamination and outbreak, lawyers for Cadden have argued that he cannot be held criminally responsible for the mistakes of an entire company, and they argue that there is no evidence that he was responsible for any deaths. The lawyers argued that Cadden took steps to hire companies to clean the pharmacy and conduct environmental testing, and he lashed out at them when they did not meet expectations.

Frank Lombardo, a special agent with the FDA who was involved in his agency’s investigation and who took part in searches of the pharmacy building in Framingham in October 2012, is slated to testify Wednesday.

Milton Valencia can be reached at Milton.Valencia@globe.com. Follow him on Twitter @MiltonValencia