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In meningitis scare, charges firm misled US regulators

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By Tim Ghianni

NASHVILLE, Tennessee, Oct 11 (Reuters) - The deadlymeningitis outbreak that has claimed a dozen lives is promptingcalls for increased oversight of the nation's custom-madepharmaceutical industry, amid charges that the company at thecenter of the scare may have misled U.S. regulators.

On Wednesday, Idaho became the 11th state to report a caseof the rare illness, which has been linked to tainted steroidsproduced by a specialty pharmacy in Massachusetts.

The U.S. Food and Drug Administration, whose role in theoutbreak has come under criticism, said it was planning anafternoon media briefing on Thursday.

In all, 138 people have contracted meningitis as a result ofthe now-recalled drugs, according to the latest tally from theU.S. Centers of Disease Control and officials in 11 states wherethe outbreak has spread. The case in Idaho is the firstdiscovered in the western United States.

Lawmakers have come under pressure to close what critics seeas a loophole in oversight that left the New England CompoundingCompany (NECC), the Massachusetts pharmacy linked to the taintedsteroids, largely exempt from federal regulation.

The FDA regulates only the ingredients and their suppliers,not the little-known corner of the drug world known as"compounding," which is subject to a patchwork of stateoversight.

State and federal officials are now investigating NECC,which distributed thousands of vials of a contaminated steroidmade at a shabby brick complex next to a waste and recyclingoperation in a western suburb of Boston.

The pharmacies are owned by Gregory Conigliaro, an engineer,and his brother-in-law, Barry Cadden, a pharmacist who was incharge of pharmacy operations at NECC. The waste and recyclingfacility is another of Conigliaro's business interests.

Compounding pharmacies such as NECC are permitted to makemedications based on specific prescriptions for individualpatients.

State and federal regulators are investigating why NECCshipped thousands of vials of preservative-freemethylprednisolone acetate steroid to healthcare facilities inmultiple states.

"It does seem like the agencies, both at the state and thefederal level, may have been misled by some of the informationwe were given," Massachusetts Governor Deval Patrick toldreporters on Wednesday.

The number of cases has grown rapidly as healthpractitioners contacted about 13,000 people who receivedinjections from a potentially tainted supply of steroidmedication shipped to 23 states.

In five states - Tennessee, Michigan, Maryland, Virginia,and Florida - the outbreak has claimed lives, with the latestvictim a 70-year-old man in Florida.

Thousands of people received the injections to relieve backpain and other complaints and are at risk of infection.

Meningitis is an infection of the membranes covering thebrain and spinal cord. Symptoms include headache, fever andnausea. Fungal meningitis, unlike viral and bacterialmeningitis, is not contagious.

(Writing by James B. Kelleher; Editing By Greg McCune; Deskingby Vicki Allen)

Keywords: USA HEALTH/MENINGITIS