Workers Cite Concerns at Firms Tied to Meningitis

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."

Most former employees declined to speak for attribution because they did not want to be implicated in the current case. Some said they had signed legal agreements not to speak about the company. All left before the current outbreak, which the authorities have traced to thousands of contaminated vials of a steroid made by the New England Compounding Center. All of its products have been recalled, including the steroid, methylprednisolone acetate, that is the source of the current trouble.

New England Compounding declined to comment on specific accusations, saying in a statement that its "intent has always been to operate in compliance with our licenses in the states where we do business, and we have made our best efforts to be in compliance with all governing laws and regulations."

The investigation into New England Compounding and its associated companies is happening as the number of deaths climbed to 14 in the meningitis outbreak linked to its tainted medicine. Health officials estimate that 14,000 patients across the country might have been exposed to the drug, and announced this week that they had contacted about 12,000 of them.

The sheer magnitude of the potential exposure has drawn attention to the large-scale compounding pharmacies, many of which have become mini-drug companies, overstepping the bounds of traditional pharmacy activity and taking advantage of a legal no-man's land between state and federal authorities. Lawmakers and federal regulators called this week for stronger rules.

"It is really unfortunate that it takes a crisis to bring this kind of change, but that is often the case," said Deborah Autor, a Food and Drug Administration deputy commissioner. Ameridose has F.D.A. approval as a manufacturer, but it also produces compounded drugs, the Massachusetts health department said. It has emphasized that it a separate entity from New England Compounding.

Six former employees, five from Ameridose and one from New England Compounding, described a corporate culture that encouraged shortcuts, even when that meant compromising safety. The former Ameridose pharmacist said she was concerned about a pilot project in which quality control workers, rather than trained pharmacists, did preliminary checks to make sure the correct drugs were present and the pumps were set correctly before filling intravenous bags.

Sabrina Tavernise reported from Boston and Andrew Pollack from Los Angeles. Sheelagh McNeill contributed research from New York.

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