Thursday, January 19, 2017
Cadden Boasted of Control Over Regulators
By Walter F. Roche Jr.
BOSTON, Mass. The head of a now defunct Framingham, Mass. drug compounding firm boasted to his sales staff that state and federal regulators didn't know what they were doing and he had to educate them so they'd stop bothering him.
That was one of the messages Barry J. Cadden delivered to the sales staff for the New England Compounding Center in a series of taped training sessions in 2011 and 2012.
The tapes were played today in U.S. District Court during Cadden's trial on charges of racketeering and second degree murder. The trial, which is expected to last several months, will end its second week of testimony Friday.
Cadden was the president and part owner of the drug compounding firm that has been blamed for a deadly 2012 fungal meningitis outbreak which sickened 778 patients, killing 76 of them.
The jurors who will decide Cadden's fate also heard from a former pharmacy technician at NECC who described the atmosphere in the company clean or sterile rooms as "a locker room on steroids."
Joseph Connelly testified that despite claims that it tested all of its products before shipping them out
NECC did not do so for most of the time he worked there.
And even when an end testing policy was finally initiated in 2012, Connelly said he was told the very next day to ship out an order without testing.
The Cadden training tape excerpts, which were introduced over the objections of his lawyers, show Cadden giving instructions to sales staffers of an affiliated firm, Medical Sales Management. Dressed in blue scrubs Cadden's sessions included a tutorial on the attempts by state and federal regulators to train scrutiny on his operations.
Stating that the Massachusetts Board of Pharmacy had issued NECC its first license, Cadden told the staffers, who were employed by Medical Sales Management, an affiliated firm, they are the ones who "hold my life in their hands."
"They don't want to deal with us," Cadden said, adding "They don't know what they are looking at. They were coming down here all the time. I had to educate them. Then they got to understand."
He boasted that now when complaints come in from other states, the Massachusetts Pharmacy Board just says, "Go away."
He also boasted of turning back efforts by the U.S. Food and Drug Administration to inspect and regulate NECC.
"The FDA was trying to take over drug compounding," he said, adding that they were calling compounders "the wolf in sheep's clothing."
(The lack of either state or federal oversight of NECC prompted investigations both in Massachusetts and Washington, D.C. Ultimately tighter regulation was imposed in the wake of the deadly outbreak.)
Cadden told the staffers that NECC went way beyond regulatory requirements in the compounding of drugs.
"A lot of what we do is way above the standard," Cadden said, adding that "As far as quality goes, we do it. We're not selling jelly beans. We need to bat one thousand."
He instructed the sales staffers to "drop those names" of NECC's big customers when soliciting new business and to stress to potential hospital customers that buying from NECC would eliminate the risk of something going wrong in in-house operations."
In his testimony Connolly, the pharmacy technician, said it was difficult to raise safety comcerns because any efforts would be rebuffed by his boss Glenn Chin. Chin like Cadden is facing racketeering and second degree murder charges. His trial will be held when Cadden's is completed.
He said when he raised concerns, they went nowhere.
With photos displayed by prosecutors, Connolly described rusted equipment, floor defects covered with plastic and tape, and a wide opening to non-sterile areas, all in the rooms that were supposed to be perfectly sterile.
He said that when spiders, flies and other insects appeared, he and other workers would spray them with alcohol.
Connolly said the air conditioning in the clean room area frequently failed sending temperatures soaring especially in summer months. This despite the fact that the some of the chemicals they were using were temperature sensitive. He said one co-worker had to leave the area because he was getting faint.
He said that when the company's regulatory problems heated up in 2012, they were ordered to stop making drugs and clean up the area because inspectors were coming.
On another occasion he said a worker from a sister company, Ameridose, came into the clean room area with some drugs from that firm.
"You don't see this," Connolly said the Ameridose worker told him.
Connolly said there was a big increase in product being produced at NECC in the Spring of 2012. He said he warned that "Something's going to happen. We're going to get shut down."
NECC shuttered its doors for good in October of 2012, just a month after the deadly outbreak became public.