‘Contaminated, deficient, deadly drugs’

Five more people have been convicted on federal charges relating to the deadly 2012 fungal meningitis case in the United States

US Attorney Andrew E. Lelling’s office has released a statement outlining the convictions, which followed the contamination of preservative-free methylprednisolone acetate injections which were sent to patients across the US.

The outbreak was the largest public health crisis ever caused by a pharmaceutical drug.

In 2012, 753 patients in 20 states were diagnosed with a fungal infection after receiving the injections.

Of those 753 patients, the US Centers for Disease Control and Prevention reported that 64 patients in nine states died.

The government has since identified a total of 793 patients throughout the country harmed by the New England Compounding Center’s contaminated MPA. More than 100 patients have now died.

Following the new convictions, a total of 11 former owners, executives, and employees of NECC, in Framingham, Massachusetts, have now been convicted of federal criminal charges. 

“These defendants were professionals who acted recklessly to the extreme detriment of public health,” said Mr Lelling.

“Over the course of years, the defendants callously disregarded patient health by cutting corners and prioritising profits over safety. And they got away with it by defrauding federal and state regulators.

“The result was contaminated, deficient, deadly drugs that never should have been made or distributed.”

Those convicted include:

  • Former NECC clean room pharmacist Gene Svirskiy, who supervised NECC’s production of high-risk heart medications, and was convicted of racketeering, racketeering conspiracy, 10 counts of mail fraud, and two counts of introduction of adulterated drugs into interstate commerce with intent to defraud or mislead;
  • NECC clean room pharmacist Christopher Leary, who was convicted of three counts of mail fraud, one count of introduction of adulterated drugs into interstate commerce with intent to defraud or mislead, and two counts of introduction of misbranded drugs into interstate commerce;
  • Alla Stepanets, an NECC verification pharmacist who was convicted of six counts of introduction of misbranded drugs into interstate commerce;
  • Greg Conigliaro, a former owner of NECC, who was convicted of conspiracy to defraud the United States; and
  • Former NECC director of operations Sharon Carter, who was convicted of conspiracy to defraud the United States.

Another former clean room pharmacist was acquitted of the charges against him.

The statement from Mr Lelling’s office highlighted that as well as making and selling the contaminated MPA, NECC pharmacists including Mr Svirskiy and Mr Leary “knowingly made and sold numerous drugs in a similar unsafe manner and in insanitary conditions”.

“The unsafe manner included, among other things, the pharmacists’ failure to properly sterilize NECC’s drugs, failure to properly test NECC’s drugs for sterility, and failure to wait for test results before sending the drugs to customers.

“They also approved the use of expired drug ingredients, and the mislabeling of those drugs in order to deceive customers.

“The insanitary conditions included, among other things, NECC’s lack of proper cleaning and NECC’s failure to take any action when its own environmental monitoring repeatedly detected mold and bacteria within NECC’s clean rooms throughout 2012.”

At the February 2018 sentencing of Glenn Chin, the supervisory pharmacist at the NECC, the court heard that one public health official described the NECC as a “fungal zoo”.

As well as producing drugs in unsatisfactory conditions, the NECC “repeatedly” took steps to hide what it was doing from the FDA by claiming to be a pharmacy dispensing medicines for valid scripts.

Instead, it “routinely dispensed drugs in bulk without valid prescriptions,” Mr Lelling’s office said.

One of the newly convicted pharmacists, Alla Stepanets, approved shipments of drugs for patients with names including “Wonder Woman,” “Fat Albert,” “Bud Weiser,” “Bill Clinton” and “Donald Trump”.

FDA Commissioner Scott Gottlieb warned that the FDA continues to see “significant risk” associated with some compounded medicines, as well as companies which produce and ship them in bulk “without any regard for product quality and patient safety”.

“We’re increasing our oversight in this space to crack down on activity that puts patients at risk,” said Dr Gottlieb.

“At the same time, we’re continuing to advance new policies to help responsible firms that are seeking to stay in compliance with quality standards find efficient ways to meet those requirements.”

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