FDA Ignored Early Warning

By Walter F. Roche Jr.

One year before a deadly fungal meningitis outbreak first emerged in Tennessee, a former salesman for the company that caused the outbreak went to the Stoneham, Mass. office of the U.S. Food and Drug Administration with a warning.
The salesman, in that meeting and in subsequent communications, had a simple message: If the FDA did not step in people were going to die.
The dire prediction turned out to be frighteningly true. Nearly 800 patients were sickened and 76 died in the outbreak caused by contaminated spinal steroids injected into unsuspecting patients.
The FDA visitor was Daniel Carney, a former salesman for Medical Sales Management, the sales arm of the New England Compounding Center, the now defunct company that shipped thousands of vials of a spinal steroid contaminated with deadly fungi.
Carney said he went to the FDA office in the Fall of 2011 to express his concerns about the practices of NECC and a sister company Ameridose.
The agency did not respond to requests for comment on its dealings with Carney, citing the ongoing criminal trial. It issued a statement expressing its continuing concerns with compounding pharmacies and expressed regret at the lives lost in the 2012 outbreak.
Carney had been employed until the summer of 2011 by Medical Sales Management, which served as the sales arm for both NECC and Ameridose.
The role of MSM and its sales force has come into focus during the ongoing trial of six former employees of NECC, who are charged with racketeering and mail fraud.
In recent testimony, Rose Mann, a former pharmacy buyer at a Los Angeles hospital testified about Carney's visit to her facility and the subsequent purchase of NECC products.
Robert Ronzio, who headed NECC's sales efforts, has entered a guilty plea to conspiracy charges as part of a plea agreement with federal prosecutors and has testified at prior trials of NECC's former president Barry J. Cadden and its supervising pharmacist Glenn Chin. Both are now serving federal prison sentences.
Carney said he clashed frequently with Ronzio, especially when he expressed concerns to his boss about the safety and quality of the company's products.
Carney said he visited the FDA in both 2011 and 2012, but he never heard from the agency again until a day in December of 2012 when FDA agents showed up at his home with guns drawn. That was the same day federal agents arrested Cadden and other NECC employees who had been indicted by a federal grand jury. Carney was not arrested and was never charged.
He said that in one of his meetings with the FDA he was told he was going to be issued an official designation as a confidential informant.
Carney said he first contacted the FDA by phone in September of 2011 and subsequently a meeting was scheduled for Oct. 20 at the agency's Stoneham office. There he met with some of the agency officials including Stacey Degarmo who would later turn up as prosecution witnesses in the on going criminal trials.
At the meeting he said he expressed his concerns that patients were going to be hurt by the poor practices at NECC
He said a subsequent meeting was held at the FDA's Wakefield office.
The list of concerns Carney said he raised at the meetings reads like an outline of the ongoing criminal trials.
NECC was not properly testing the drugs for sterility; NECC was actually acting as a drug manufacturer, not a pharmacy; quality assurance reports were being falsified; beyond use dates for drugs were being ignored or altered; NECC was producing drugs it was not authorized to sell; fake names were being used on prescriptions.
"I pleaded with the inspectors to do something," he said
Carney said the message he got from the FDA officials he met was that he should hire a lawyer and file a whistleblower suit so he could make a lot of money.
He said he reiterated to one of the agents that his concern was not money but that patients might be hurt.
He said he and his wife, a registered nurse who attended the session with him, were disgusted when they left the FDA office.
Even then, however, he followed up by sending anonymous complaints to the Inspector General for the U.S. Department of Human Services, all to no apparent avail.
That only added to his outrage when armed agents showed up at his door in October of 2012.
He said he yelled to the agents that they should have listened to him. One of them yelled back, "Why didn't you come back to us."
He said his young daughter was terrified and he told her to go hide in the bathtub.
"If only the FDA had listened," Carney said. "I just want the victims to know somebody cared."