Meningitis probe continues to widen

Fungus detected in unopened vials of preservative-free steroid linked to meningitis

FRAMINGHAM, Mass. | October 19, 2012

U.S. health officials confirmed Thursday the fungus Exserohilum rostratum was detected in unopened vials of a preservative-free steroid linked to meningitis.

"This laboratory confirmation further links steroid injections -- methylprednisolone acetate -- from the three lots from the New England Compounding Center to the multistate outbreak of fungal meningitis and joint infections," the CDC website said. "Testing on the other two implicated lots of methylprednisolone acetate and other NECC injectable medications continues.

"Fungal meningitis -- confirmed in 47 patients -- is not contagious and the CDC confirmed Exserohilum rostratum in clinical specimens for all but two of these patients. Of the other two patients, one has been found to be infected with Aspergillus fumigatus and one with Cladosporium. These fungi are common in the environment but rarely cause meningitis."

The CDC said the fungal meningitis was linked to 20 deaths and 257 illnesses.

Federal investigators also acknowledged they are investigating the Massachusetts pharmacy linked to 19 meningitis deaths.

Carmen M. Ortiz, U.S. attorney for the District of Massachusetts, said in a statement: "I can confirm that this office and our law enforcement partners are investigating allegations concerning the NECC. I think that it is entirely premature to suggest what the results of the investigation will be."

Investigators, including from the Drug Enforcement Agency and the Food and Drug Administration, raided the NECC's Framingham, Mass., offices Tuesday. They gave no details about what they found or what type of case they may pursue against the compounding company.

Officials believe the outbreak was caused by the steroid methylprednisolone acetate contaminated with a fungus. The drug, used in spinal injections for back and neck pain, was produced by the NECC, which shipped more than 17,000 vials of it to 23 states.

Meningitis, an inflammation of the protective membranes covering the brain and spinal cord, can damage blood vessels in the brain and cause devastating strokes. The incubation period for fungal meningitis can run longer than a month.

Ortiz's statement came on the heels of U.S. Rep. Edward Markey, D-Mass., calling on the Department of Justice to investigate the NECC for possible controlled substance violations.

In a letter to U.S. Attorney General Eric Holder, Markey asked the agency to investigate the compounding pharmacy to see if the NECC violated federal law and was subject to enforcement action beyond any violations it might be subject to at the state level.

"Drug Enforcement Administration regulations state retail pharmacies that compound or sell controlled substances must be registered with the agency and are only permitted to sell compounds containing controlled substances directly to patients in response to a patient-specific prescription unless the pharmacy is registered with the DEA as a manufacturer/supplier," Markey said in a statement.

The DEA told Markey's office the NECC was not registered with the DEA as a manufacturer/supplier, and media reports indicated the center appeared to have been distributing compound drugs that were not associated with a patient-specific prescription to healthcare facilities, Markey said.

"This is a matter that I believe requires further investigation by the DEA to ensure that this facility, already believed to have broken Massachusetts state law, has not also skirted federal law related to controlled substances," Markey wrote in the letter.

"The types of medications being compounded by the New England Compounding Center included controlled substances such as cocaine, morphine and ketamine and require the highest level of federal oversight," Markey said in separate comments.

There have been no reports of further product contamination except for the contaminated steroids from the NECC, but the pharmacy announced Oct. 6 it was voluntarily recalling all products currently in circulation that were compounded at and distributed from its facility in Framingham.

"This action is being taken out of an abundance of caution due to the potential risk of contamination, and in cooperation with an investigation being conducted by the U.S. Food and Drug Administration, the Centers for Disease Control and Prevention and the Massachusetts Board of Registration in Pharmacy," the NECC said.

A congressional report completed in June said a contributing factor to the injectable drug shortage was a provision of the Medicare Modernization Act of 2003 -- Medicare Part D -- that dramatically reduced the prices paid by Medicare for many generic injectable medications, particularly older generics. This resulted in a growing market concentration with fewer drug manufacturers producing injectable medications and treatments.

The congressional report found FDA regulatory activity effectively shut down 30 percent of the total manufacturing capacity at four of America's largest producers of generic injectable medications: Bedford Laboratories, Hospira Pharmaceuticals, Sandoz Pharmaceuticals and Teva Pharmaceuticals.

In 2009, when Margaret Hamburg became FDA commissioner, she stepped up drug manufacturer inspections and enforcement. Inspectors found weevils floating in vials of heparin, morphine cartridges with twice the labeled dose, human hair and fungal growth in vials, rusty tools, mold in production areas and a barrel of urine, The New York Times reported.

Between 2009 and 2010 the number of warning letters sent by the agency increased 42 percent, and between 2010 and 2011 the number of warning letters sent by the FDA increased an additional 156 percent. In many cases, warning letters resulted in companies agreeing to take manufacturing offline to address FDA concerns, the congressional report said.

As a result of the enforcement, several of the drug manufacturers said they invested hundreds of millions to upgrade facilities -- some dating to the 1970s -- or built new plants. Teva said it spent $375 million for improvements and reopened its factory in Irvine, Calif., but has not yet resumed full production, the Times said.

Regulators and drug manufacturers noted most sterile injectables such as chemotherapy drugs and anti-seizure drugs sold in the United States were safe and of high quality, The Times said.

Two other drugs made by NECC have also been linked to the outbreak, the FDA said. They are triamcinolone, another steroid used in spinal injections, and cardioplegia, used in open-heart surgery.

The U.S. Department of Health and Social Services' Section of Epidemiology Wednesday urged six Alaska healthcare providers to contact more than 840 patients for possible infection in the growing deadly outbreak. No cases have so far been identified in Alaska, KTUU-TV, Anchorage, reported.

2012 United Press International, Inc. All Rights Reserved.

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