Deregulation Creates a New Disease

The Boston Globe reports that more violations of safe practice are emerging in the pharmacy that manufactured a contaminated drug injected into hundreds of unsuspecting patients…

By Liz Kowalczyk, Globe Staff

Federal regulators said Thursday they found bacterial contamination in two more drugs produced by the Framingham compounding pharmacy that made the injectable steroids blamed for the national meningitis outbreak.

The additional New England Compounding Center products are preservative-free betamethasone, a steroid used to ease back pain, and cardioplegia solution, a medication used in heart surgery.

The US Food and Drug Administration and the Centers for Disease Control and Prevention identified bacteria in three separate lots of betamethasone and in a single lot of cardioplegia solution. They did not say how many doses were in each lot.

A fungus previously found in another steroid the company makes, preservative-free methylprednisolone acetate, is believed to have infected 386 patients with fungal meningitis and joint infections and killed 28. The fungus has been found in two of the three lots of the drug implicated in the outbreak, and testing of the third lot is ongoing.

Talk about locking the barn door after the horse has been stolen. High tech invasive medicine and anti-regulation politics have teamed up to create a disease not found in nature…

The black mold creeping into the spines of hundreds of Americans who got the tainted shots marks uncharted territory for doctors, because this particular fungus has never been found to cause meningitis. The main culprit is a fungus called Exserohilum rostratum, which is commonly found in dirt and grasses. Only 33 human infections with Exserohilum rostratum have previously had been reported, and they are mostly eye or skin infections in people with weak immune systems, said Dr. Arturo Casadevall, a fungal disease specialist at New York’s Albert Einstein College of Medicine.

Governor Deval Patrick is taking action now, former Governor Mitt Romney hired a ‘sketchy’ firm to investigate the pharmacy with no success in dealing with the problem. I’d say ‘better late than never’ but it’s too late for the trusting innocent people who should have been protected from this avoidable tragedy.

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