Company linked to meningitis scare besieged as deaths rise

CHICAGO Sat Oct 13, 2012 6:58pm EDT

1 of 4. A security guard looks out from the front doors of pharmaceutical compounding company New England Compounding Center (NECC), a producer of the steroid methylprednisolone acetate, in Framingham, Massachusetts October 8, 2012.

Credit: Reuters/Jessica Rinaldi

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CHICAGO (Reuters) - The company that produced contaminated medications linked to an unprecedented fungal meningitis outbreak faced mounting scrutiny on Saturday over whether it illegally sold drugs to medical facilities, as the death toll from the disease grew to 15.

The Centers for Disease Control and Prevention (CDC) said another person died from meningitis, the second death in Indiana. The number of cases of the disease reported reached 201 in 14 states, according to the CDC and state officials.

Illinois reported its first case of meningitis from a steroid injection and New Hampshire officials reported that state's first four confirmed cases from the outbreak, which showed no signs of abating.

Tennessee is the worst affected state with six deaths and 52 cases followed by Michigan with three deaths and 41 cases, including one case of an infection that has not been confirmed as meningitis.

As federal and state authorities scrambled to contain the outbreak, investigators were trying to determine how the medication produced by New England Compounding Center was contaminated and whether its sprawling drug supply business complied with licensing laws.

A series of emails between the company and a clinic in Mississippi reviewed by Reuters show that NECC sold drugs without requiring physicians to supply individual patient prescriptions. The customer confirmed that NECC supplied the clinic with drugs without patient names or prescriptions, which are required by a number of states including Massachusetts, where the company is based.

The emails also indicate that NECC referred business to a sister company, Ameridose LLC, despite a statement by Ameridose earlier this week that the two operated separately.

NECC has recalled the suspect product, surrendered its license to operate in Massachusetts and suspended operations. Ameridose also has temporarily suspended operations.

"NECC's intent has always been to operate in compliance with our licenses in the states where we do business," the company said in a statement.

FEDERAL CRITICISM

The U.S. Food and Drug Administration is investigating NECC and there have been calls from some in Congress for a criminal investigation of the company.

"FDA considers this to be one of our top priorities and we are dedicating many resources to this investigation," the agency said in a statement late on Friday.

Federal regulators have come under criticism for failing to prevent the outbreak by closely regulating drug compounding companies such as NECC, which prepare medications for clinics and doctors largely outside federal oversight. The FDA has said the law does not give it adequate authority to do so, leaving regulation largely to the states.

"This outbreak began at a compounding pharmacy and the Food and Drug Administration has very limited authority over what these facilities produce," said a spokesman for the Health and Human Services Department in Washington. "We urge Congress to give FDA the authority it needs to ensure these kinds of outbreaks do not happen again."

NECC faces mounting threats from states as well. Several states are investigating the company and at least two - Michigan and Massachusetts - have said the company violated their regulations, according to a Reuters survey.

Some 14,000 patients received the suspect steroid medications, which were shipped to 76 facilities in 23 states as long ago as May.

Meningitis is an infection of the membranes covering the brain and spinal cord. Symptoms include headache, fever and nausea. Fungal meningitis is a rare form and is not contagious.

Cases of meningitis have been reported in Tennessee, Michigan, Florida, Idaho, Illinois, Indiana, Maryland, Minnesota, New Jersey, North Carolina, Ohio, Texas, Virginia and New Hampshire.

(Additional reporting by David Bailey, Toni Clarke, Aaron Pressman, Andrea Shalal-Esa and Ros Krasny; Editing by Bill Trott)

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Comments (6)
EthicsIntl wrote:
Are we sure this is happening here in the USA and not on China ?

Oct 13, 2012 12:04pm EDT  --  Report as abuse
sleeperdvr wrote:
Why hasn’t discussion linked the expanding need for Compounding Pharmarcies to the FDA crackdown on generic pharmaceuticals, layers of new regulation, and resultant critical shortages of hundreds of regularly used drugs. Look at the trade off, the FDA indirectly has made by allowing these Compounding Pharmacies to temporarily fill in for the shortages. Is it really worth it? Was quality assurance and manufacturing really so bad that nationwide drug shortages quadrupled in numbers in the past three or so years?

Oct 13, 2012 12:06pm EDT  --  Report as abuse
tyg wrote:
sleeper, the FDA does not seem to be involved in letting compounding pharmacies do anything to fill shortages. the courts took away some of FDA’s authority over compounded drugs and congress has done nothing to restore. we rely on the FDA to determine quality assurance and compliance with manufacturing, cheap manufacturing, cheap ingredients, cutting corners, and lots of middle men, large contracts for unapproved drugs, sometimes means more risk. compounding is even worse than cheap manufacturing because it is not supposed to be manufacturing. as ethicsintl alludes, this can happen anywhere when there is no regulation of willie nillie drug sourcing and selling. the multitude of “generic” manufacturers with problems may be the result of no national price controls where the brand name drugs are so expensive and the cost to review them is tied to the survival of the agency that regulates the end product that the public is left with no option but to take chances. the FDA has to do more to protect the public from compounding pharmacies and find the valve that would reduce the sourcing and marketing of drugs when firms start working outside of their states. local health boards and boards of pharmacies may need to limit pharmacy licenses to instate pharmacies and when the resources are limited request assistance from the federal agencies that have a vested interest in the health of that community.

Oct 13, 2012 7:44pm EDT  --  Report as abuse
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