Wednesday, October 17, 2012

Meningitis Outbreak Grows; NECC Communication Shrinks

New England Compounding Center has yet to reach rock bottom. It seems the worse things get, the worse they keep getting. You may remember NECC as the medicine compounder believed responsible for an outbreak of fungal meningitis, which at last count had infected 231in 15 states and killed 16. Nearly 14,000 people nationwide are at risk of infection because they received injections from suspect steroid medications shipped to 76 facilities in 23 states.

Now federal agents, Congress, civil trial lawyers, and the Department of Justice have deepened the crisis for the Massachusetts company.

Agents from the U.S. Food and Drug Administration Tuesday searched NECC's facility in Framingham. Officers from the local police department provided support.

"A lawyer for NECC said the raid was unnecessary and that 'asking would have produced the same result. It is difficult to understand the purpose of this search, since we have been clear that (NECC) would provide, and has provided, anything requested. We've been clear that warrants weren't needed,' Paul Cirel, of the firm Collora LLP in Boston, said in a statement." (http://www.reuters.com/article/2012/10/17/usa-health-meningitis-idUSL1E8LG9LW20121017)

State pharmacy regulators have said that NECC violated its license in Massachusetts by not requiring patient prescriptions before shipping products. The outbreak has raised questions about how the pharmaceuticals industry operates. NECC engaged in a practice called drug compounding that is not regulated by the FDA, which generally oversees drug manufacturers. NECC's crisis mounted as more victims of meningitis filed lawsuits, including two by Michigan residents this week.

Rep. Edward Markey (D-Mass), in a letter to the Department of Justice, wrote, "This is a matter that I believe requires further investigation by the (Drug Enforcement Administration) to ensure that this facility, already believed to have broken Massachusetts state law, has not also skirted federal law related to controlled substances."

"Massachusetts authorities have alleged that the NECC went beyond its authorization as a compounding pharmacy to mix or alter drugs for patient-specific prescriptions. 'What they were doing instead is making big batches and selling out of state as a manufacturer would,' Gov. Deval Patrick (D-Mass) told reporters last week. In a statement from the DOJ, U.S. Attorney Carmen Ortiz of the District of Massachusetts wrote, 'I can confirm that this office and our law enforcement partners are investigating allegations concerning the New England Compounding Center.'"
(http://www.blogger.com/blogger.g?blogID=1573781346072455735#editor/target=post;postID=2283842915196016660)

The FDA also is investigating whether other NECC medications, including treatments used during heart and eye surgery, may have been contaminated and caused a different fungal meningitis infection in at least two more patients.

This is a full-blown crisis that might bring an end to NECC, large fines, costly civil suit payouts, and jailtime for some managers. How would you respond if NECC hired you as its communications consultant? Has this ship sunken too deeply to salvage? These aren't just rhetorical questions. Please share your comments and ideas below.

Just don't suggest NECC stay the course. The company reacted to the raid through its attorney, as quoted above. NECC unplugged its website for several days until October 6, when it replaced its website with a statement about the recall. The site has never been updated. It claims the recall came "out of an abundance of caution due to the potential risk of contamination.... While there is no indication at this time of any contamination in other NECC products, this recall is being taken as a precautionary measure." (http://www.neccrx.com/)

"Precautionary?" There are 231 victims and counting. Sixteen are dead. NECC at the very least should be expressing its sympathy and regrets. It needs to be aiding the most seriously infected victims -- primarily the very young and the very old -- to show it cares and wants to make things right. Organizations that remain out of sight during a crisis risk appearing guilty and drawing more civil suits. Openness may not save the company at this point, but I don't see what it would hurt.

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