U.S. Meningitis Death Toll Reaches 25

The U.S. death toll from a meningitis outbreak tied to contaminated steroid injections reached 25 on Friday following another death in Tennessee, the state where the problem was first discovered, the Centers for Disease Control and Prevention said.

The U.S. Food and Drug Administration said on Friday it found "greenish black foreign matter" and other contaminants in the injectable steroid, the drug at the heart of the deadly outbreak, produced by the New England Compounding Center of Massachusetts.

In its daily update on the meningitis emergency, the CDC said the latest fatality brings the number of deaths to 10 in Tennessee, the most of any state.

Michigan has reported five deaths, Florida and Indiana three each, Virginia two, and Maryland and North Carolina one each.

Eight more cases of meningitis were reported on Friday, bringing the national total to 331 cases. There were another seven cases of infections after a steroid was injected in a joint such as a knee, hip, shoulder or elbow.

The new cases reported by the CDC on Friday were in Maryland, Michigan, Minnesota, New Hampshire and Tennessee. Cases have been discovered in 18 of the 23 states that received shipments of the suspect steroid.

COMPLAINTS FROM 1999

Meanwhile, the New England center now faces multiple investigations. Interviews with former NECC employees and its customers, and a review of internal documents and newly-released state records, paint a picture of a company whose rapid growth was marred almost since its inception by breaches of regulations governing compounding practices. They also show how regulators failed to punish the company despite repeated violations of the rules.

As far back as 1999, barely a year after NECC was formed, the Massachusetts Board of Registration in Pharmacy responded to a complaint from a pharmacist alleging that Barry J. Cadden, chief pharmacist and co-owner of NECC, had improperly provided a healthcare provider with prescription blanks. The Board voted to issue an informal, non-disciplinary reprimand.

In 2004 the Board voted again to issue an informal reprimand after it received complaints from pharmacists in Iowa, Wisconsin, Texas and South Dakota alleging that Cadden and NECC were improperly soliciting out-of-state business, in some cases using prescription ordering forms that had not been approved by the Board.

And in 2006, the company reached a settlement with the Board sparing it from a public reprimand and other measures despite evidence that the company had again violated rules governing the proper use of prescriptions, according to public documents.

NECC has stopped operating and faces an array of federal and state investigations, not to mention the prospect of civil suits for liability. Its owners could face criminal charges.

The FDA is also under pressure, with some members of Congress calling for greater regulation of compounding pharmacies.

The U.S. Food and Drug Administration said on Friday it found "greenish black foreign matter" and other contaminants in the injectable steroid, the drug at the heart of the deadly outbreak, produced by the New England Compounding Center of Massachusetts.

In its daily update on the meningitis emergency, the CDC said the latest fatality brings the number of deaths to 10 in Tennessee, the most of any state.

Michigan has reported five deaths, Florida and Indiana three each, Virginia two, and Maryland and North Carolina one each.

Eight more cases of meningitis were reported on Friday, bringing the national total to 331 cases. There were another seven cases of infections after a steroid was injected in a joint such as a knee, hip, shoulder or elbow.

The new cases reported by the CDC on Friday were in Maryland, Michigan, Minnesota, New Hampshire and Tennessee. Cases have been discovered in 18 of the 23 states that received shipments of the suspect steroid.

COMPLAINTS FROM 1999

Meanwhile, the New England center now faces multiple investigations. Interviews with former NECC employees and its customers, and a review of internal documents and newly-released state records, paint a picture of a company whose rapid growth was marred almost since its inception by breaches of regulations governing compounding practices. They also show how regulators failed to punish the company despite repeated violations of the rules.

As far back as 1999, barely a year after NECC was formed, the Massachusetts Board of Registration in Pharmacy responded to a complaint from a pharmacist alleging that Barry J. Cadden, chief pharmacist and co-owner of NECC, had improperly provided a healthcare provider with prescription blanks. The Board voted to issue an informal, non-disciplinary reprimand.

In 2004 the Board voted again to issue an informal reprimand after it received complaints from pharmacists in Iowa, Wisconsin, Texas and South Dakota alleging that Cadden and NECC were improperly soliciting out-of-state business, in some cases using prescription ordering forms that had not been approved by the Board.

And in 2006, the company reached a settlement with the Board sparing it from a public reprimand and other measures despite evidence that the company had again violated rules governing the proper use of prescriptions, according to public documents.

NECC has stopped operating and faces an array of federal and state investigations, not to mention the prospect of civil suits for liability. Its owners could face criminal charges.

The FDA is also under pressure, with some members of Congress calling for greater regulation of compounding pharmacies.


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