Workers Cite Concerns at Firms Tied to Meningitis

The following is an excerpt from an article in:


The New York Times
Saturday, October 13, 2012

Workers Cite Concerns at Firms Tied to Meningitis

By SABRINA TAVERNISE and ANDREW POLLACK

BOSTON — One pharmacist said she quit because she was worried that unqualified people were helping prepare dangerous narcotics for use by hospitals. A quality control technician said he tried to stop the production line when he noticed that some labels were missing, but was overruled by management. A salesman said he and his colleagues were brought into the sterile lab to help out with packaging and labeling during rush orders, something they were not trained for.

They all used to work at Ameridose, a drug manufacturing company with many of the same owners as the New England Compounding Center, the pharmacy at the center of a national investigation into a meningitis outbreak now in 12 states.

State and federal health officials say they have no reason to believe that Ameridose sent out contaminated products, and have not recalled any. But regulators asked the company on Wednesday to suspend production to allow them to conduct an on-site investigation, because their inquiry “includes concerns for quality and safety across the corporate entity,” the Massachusetts Department of Public Health said.

Paul Cirel, a lawyer representing Ameridose, declined to discuss the statements made by the former employees. “What some anonymous, maybe disgruntled, ex-employees say to you that is not said to us by the F.D.A. or any regulator, I just can’t go there right now,” he said. “If it becomes a claim that a regulator puts to us, then we will address it.”

Mr. Cirel, of Boston-based Collora L.L.P., added that the suspension was voluntary and would be in place until Oct. 22.

In all, eight former employees were interviewed, three from New England Compounding and five from Ameridose. Three of those former workers said the companies were run with good attention to safety.

Thomas DiAdamo, who was a salesman for New England Compounding for about two years, said, “When I heard about this I was shocked, because they were meticulous about safety.”

He said Barry Cadden, New England Compounding’s chief pharmacist, who is also a shareholder in Ameridose and who lost his pharmacist license this week, told him, “ ‘We do not make mistakes.’ Something must have happened that was out of his control.”

For more, visit www.nytimes.com.