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Mass. Launches Criminal Probe of Firm Linked to Meningitis Outbreak: Report
Date:10/25/2012

By Steven Reinberg and Margaret Steele
HealthDay Reporters

WEDNESDAY, Oct. 24 (HealthDay News) -- Massachusetts officials said Tuesday that they have launched a criminal investigation into the specialty pharmacy at the center of the fungal meningitis outbreak that has now sickened 317 people in 17 states and killed 24.

State inspectors said they found unsanitary conditions that included black specks of fungus in steroids made at the New England Compounding Center, CBS News reported.

And state regulators have voted to permanently revoke the pharmacy's license, the Worcester Business Journal reported Wednesday.

The inspectors' preliminary investigation also revealed that the company distributed drugs before the return of tests to check for sterility. They added that the company functioned as a drug manufacturer, producing drugs for broad use, rather than filling individual prescriptions for individual doctors, in violation of its state license, CBS News reported.

The network also said the inspectors found dirty floor mats, a leaky boiler, inadequate sterilization of medications and improper testing of laboratory equipment.

The company said it was cooperating with investigators, CBS said.

According to published reports, state records showed that the New England Compounding Center was plagued by problems as far back as 2006.

Those records, obtained by the Associated Press under a public documents request, showed there was evidence of inadequate contamination control and no written standard operating procedures for using equipment, among other problems, at the facility.

Those problems were corrected that year, the AP reported.

The New England Compounding Center is what's known as a compounding pharmacy. These pharmacies combine, mix or alter ingredients to create specific drugs to meet the specific needs of individual patients, according to the U.S. Food and Drug Administration. Such customized drugs are frequently required to fill special needs, such as a smaller dose, or the removal of an ingredient that might trigger an allergy in a patient.

As of Wednesday, U.S. health officials reported that cases linked to the fungal meningitis outbreak have risen to 317, with 24 deaths. The latest count found deaths and infections spread across 17 states, according to the U.S. Centers for Disease Control and Prevention.

Meningitis is a potentially fatal inflammation of the lining surrounding the brain and spinal cord.

Federal health officials said last week that fungus found in steroid injections produced by the company matched the fungus linked to the meningitis outbreak. The officials said they'd confirmed the presence of the fungus, Exserohilum rostratum, in unopened vials of a steroid produced by the New England Compounding Center.

The vial came from one of three lots recalled by the company last month, officials from the CDC and the FDA said.

The steroid, methylprednisolone acetate, is injected into patients for back and joint pain. The company has since shut down operations and stopped distributing its products, health officials said.

The CDC and state health departments estimate that roughly 14,000 patients may have gotten steroid injections from the three lots, and nearly 97 percent of them have been contacted for medical follow-up.

All of the fungal meningitis patients identified so far were thought to be injected with methylprednisolone acetate from the Massachusetts pharmacy, according to the CDC.

Five of the 317 cases involve what the CDC calls "peripheral joint infection," meaning an infection in a knee, hip, shoulder or elbow. These joint infections aren't considered as dangerous as injections near the spine for back pain that have been linked to the potentially fatal meningitis infections.

The FDA said it was advising all health care professionals to follow up with any patients who were given any injectable drug from or produced by the New England Compounding Center. These drugs include medications used in eye surgery, and a heart solution purchased from or produced by the company after May 21.

The CDC on Wednesday had the following state-by-state breakdown of cases: Florida: 19 cases, including 3 deaths; Georgia, 1 case; Idaho, 1 case; Illinois, 1 case; Indiana: 41 cases, including 3 deaths; Maryland: 17 cases, including 1 death; Michigan: 73 cases, including 5 deaths; Minnesota: 7 cases; New Hampshire: 10 cases; New Jersey: 18 cases; New York: 1 case; North Carolina: 2 cases, including 1 death; Ohio: 11 cases; Pennsylvania: 1 case; Tennessee: 70 cases, including 9 deaths; Texas: 1 case; Virginia: 43 cases, including 2 deaths.

Health officials said they expect to see more cases of the rare type of meningitis, which is not contagious, because symptoms can take a month or more to appear.

Infected patients have developed a range of symptoms approximately one to four weeks following their injection. People who have had a steroid injection since July, and have any of the following symptoms, should talk to their doctor as soon as possible: worsening headache, fever, sensitivity to light, stiff neck, new weakness or numbness in any part of your body or slurred speech, the CDC said.

Infected patients must receive intravenous drugs in a hospital.

Compounding pharmacies aren't subject to the same FDA oversight as regular drug manufacturers are, and some members of Congress now say the meningitis outbreak highlights the need for more regulatory control.

More information

The U.S. National Library of Medicine has more about injections for back pain.

SOURCES: Oct. 24, 2012, updated statistics, U.S. Centers for Disease Control and Prevention; Oct. 18, 2012, news release, U.S. Centers for Disease Control and Prevention, and U.S. Food and Drug Administration; CBS News; Associated Press; Worcester Business Journal


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