Cadden boasted of control over federal regulators
Many “pain docs” that deal with implanted pumps uses these compounding pharmacies for the medications that they put in those pumps… because there is only one FDA approved opiate approved for use in those implanted pumps INFUMORPH (Morphine).. but because they can add a Lidocaine type product – which provides little/no pain relief to the pt – they can legally justify having the medication for their pumps compounded… Not to mention that they can purchase those compounded medications for 10% -25% of the cost of the commercially available product. Also, Medtronics – the company that makes most of the implanted pumps – has tested the stability of the commercial product at SIX MONTHS – and typically the compounding pharmacy will only stand behind their stability for 30-60 days… allowing the pain doc to be able to charge for refilling pumps for frequently than would otherwise be necessary using the commercially available product. Medications that are infused into the spinal fluid has not only have to be STERILE …but.. must be PRESERVATIVE FREE… thus the potential issues of stability. And how do I know all of this.. because my wife has had an implanted pain pump for TEN YEARS and I walked her out of the first pain clinic because they REFUSED to even discuss using INFUMORPH in the pump they were planning on implanting in her… Even though they knew I was a Pharmacist… I was told that it was a “liability issue” and a “BIG BOY ISSUE” and that I didn’t understand… that they used a compounding pharmacy some 700-800 miles away and that there was no discussion to options about what they used in the pump. After the New England Compound Center horror story… the FDA inspected 28 such compounding pharmacies and all but ONE got a NON-COMPLIANCE LETTER .. including the one that this pain clinic used. So much for me NOT UNDERSTANDING 🙂
BOSTON – 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 this week 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 place 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 when complaints came 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. He added, “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 concerns 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.
Connolly 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,” and that the company would get shut down.
NECC shuttered its doors for good in October of 2012, just a month after the deadly outbreak became public.
Filed under: General Problems
Medicare fraud is rampant.you have to be really stupid or really greedy to get caght
Dean Willis of Alabama Pain Center bilked Medicare and Blue Cross our of a fortune with his compounding pharmacy that he owned (along with a Sleep Center, Outpatient Addiction, Counseling Center, and Family practice at his peak). Regulators sent after him for this, but could care less about all the ESI’S he forced people to receive I’d they didn’t have a pump. He would require patients show up for injections in withdrawal because he claimed he found pain generators better that way. Underated pts were instructed to pray. He often even skipped local anesthetics. Patients were withdrawing, in pain, and of course they moved. Incidence of arachnoiditis has largely been hidden but I can name OVER a dozen confirmed cases.
OMG that’s horrific!