By SABRINA TAVERNISE and ANDREW POLLACK
Published: October 12, 2012
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.
Elise Amendola/Associated Press
An employee at Ameridose, a drug manufacturer in Westborough,
Mass., near Boston.
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. To read full story click here
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