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Thursday 21 August 2014

US authorities raid pharmacy linked to meningitis outbreak that killed 16

Toni Clarke and Svea Herbst-Bayliss

Published 17/10/2012 | 09:07

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FEDERAL agents have raided the Massachusetts pharmacy linked to a widespread meningitis outbreak that has killed 16 people and sickened more than 200 others.

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Agents from the US Food and Drug Administration searched the New England Compounding Center, or NECC, in the Boston suburb of Framingham, with officers from the local police department providing support..

The raid took place as calls came for an even wider probe into whether the once obscure pharmacy may have broken federal laws dealing with controlled substances, and as additional meningitis cases were announced.

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," said Paul Cirel, of the firm Collora LLP in Boston.

The entrance to NECC's headquarters - a squat, nondescript brown brick building - was cordoned off with yellow "caution" tape.

An officer with the Framingham motorcycle unit guarded the front door. Lights were on inside, and a number of people, including uniformed agents, were seen moving around inside the facility into the night.

The FDA's criminal unit, the Office of Criminal Investigations, is a team of agents with specialised knowledge and training to investigate violations of food and drug laws. It pursues about 1,200 criminal cases each year.

The raid came as a leading US lawmaker called for an investigation of whether the compounding pharmacy violated federal laws covering potentially addictive drugs.

The US meningitis outbreak is widening. A 16th death was announced yesterday, a patient from southwest Virginia.

Overall, there are 231 confirmed meningitis cases, according to the tally from the US Centers for Disease Control and Prevention, an increase of 19 on the day.

"We will see more patients reporting in ill and we'll have to treat many more," said Dr William Schaffner, an infectious diseases expert at the Vanderbilt University Medical Center in Nashville, Tennessee.

The FDA on Monday widened its investigation of the cause of the fungal meningitis outbreak to other drugs made by NECC.

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.

Besides the meningitis cases, two additional patients have a different type of fungal infection from injections in their joints (as opposed to back injections).

Massachusetts Democratic Representative Edward Markey, a senior member of the committee that oversees business, called on the Justice Department to investigate whether NECC violated federal laws designed to stem illegal activity in controlled drugs.

The company already faces multiple investigations by the FDA and several states, but Markey's request could launch an even more serious probe involving the Drug Enforcement Administration, which oversees sales of potentially addictive, or "controlled" drugs.

The FDA said on Monday it was looking into two other drugs made by NECC.

The agency said it had received reports of a patient with possible meningitis who received an injection of a different steroid from the one found to have caused the deaths. It said on Tuesday that one transplant patient was infected with a fungus after receiving a drug used in open heart surgery made by NECC. The FDA originally said two such patients were infected.

Another patient identified by the FDA received an injection of the steroid triamcinolone, also supplied by NECC.

FDA official Janet Woodcock stressed that the two additional products had not been linked to confirmed infections. She asked doctors to contact patients injected since May to make sure they had no signs of infection.

NECC said in a statement that it was reviewing the new information from the FDA.

The FDA has been inspecting the NECC facilities. Woodcock said that based on the condition of the plant and other factors, "we really can't assure the sterility of these products."

The legal threat to NECC also mounted as more victims of meningitis filed lawsuits, including two filed by Michigan residents this week.

All but eight of the 23 states that received suspect medications from the Massachusetts specialist pharmacy have reported at least one case of fungal meningitis.

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

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.

In compounding, pharmacies prepare specific doses of approved medications, based on guidance from a doctor, to meet an individual patient's need.

A Reuters investigation found that NECC solicited bulk orders from physicians and failed to require proof of individual patient prescriptions as required under state regulations, emails to a customer showed.

State pharmacy regulators have said that NECC violated its license in Massachusetts by not requiring patient prescriptions before shipping products.

The states reporting cases of meningitis are Tennessee, Michigan, Pennsylvania, New Hampshire, Illinois, Indiana, Minnesota, New Jersey, Texas, Idaho, Maryland, North Carolina, Virginia, Ohio and Florida.

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