Meningitis Outbreak | featured news

A grand jury is investigating the compounding pharmacy at the heart of a deadly meningitis outbreak, the Boston Globe reported on Saturday.

The U.S. Food and Drug Administration took 684 days to issue a warning letter after uncovering serious issues at the pharmacy at the center of the deadly U.S. meningitis outbreak, newly released documents showed.

Pharmacy compounding has come under a spotlight in recent months, after a center produced pain medicine contaminated with fungus that caused a national meningitis outbreak.

It was just an e-mail about a single case of illness, but a gut instinct developed through years of disease detective work made Dr. Marion Kainer sense a bigger danger. Kainer, the director of health care-associated infections for the Tennessee Department of Health, started investigating the day she got that e-mail and hasn't stopped since. She camped out in her office for three weeks, leading a team of state workers as they traced the source of what would become a national outbreak of fungal meningitis.

Vilinda York lies in her Florida hospital bed, facing a dry-erase board that lists in green marker her name, her four doctors and a smiley face. Also on the board is this: "Anticipated date of discharge: NOT YET DETERMINED."

Executives at the Boston-area pharmacy whose steroid shots have been linked to a deadly U.S. meningitis outbreak have been sued in a bid to freeze their personal assets, while the death toll in the scandal rose to 21, with 268 cases of infection reported.

...These recent quality lapses at big drug companies show that contamination and shoddy practices extend well beyond the loosely regulated compounding pharmacies that have attracted attention because of their link to an outbreak of meningitis... [S]everal industry observers and former plant employees said that the recent quality issues were troubling and that manufacturers had been reluctant to fix problems because stopping production was simply too costly in a business where profits were driven by volume.

The House of Representatives on Friday widened its investigation into the deadly meningitis outbreak to include the role health regulators played in monitoring the pharmacy that produced steroid treatments suspected of causing the crisis.

Two more people have died from fungal meningitis linked to steroid injections, bringing the total to 14 deaths since the outbreak began last month, the U.S. Centers for Disease Control said on Thursday.