FOXNews.com: FDA finds pharmacy failed to maintain 'clean rooms' as cases rise in meningitis outbreak

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FDA finds pharmacy failed to maintain 'clean rooms' as cases rise in meningitis outbreak Oct 26th 2012, 18:43 Health officials and doctors have tracked down most of the 14,000 people potentially at risk for fungal meningitis, blamed for the deaths of 25 people and sickening 338 — but the outbreak is still posing challenges. In addition to the new numbers released by the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration released a copy of the FDA Form 483 Friday, which was issued to the New England Compounding Center (NECC). In the report, the agency confirmed contaminated products and listed a number of observations in reference to one of the compounding pharmacies 'clean rooms.' The investigation revealed problems with the NECC's ability to maintain the clean room – an "enclosed space designed and maintained to have a controlled environment with low levels of airborne particles and surface contamination." Health officials say the black mold creeping into the spines of hundreds of people who got tainted shots for back pain marks uncharted medical territory. Never before has this particular fungus been found to cause meningitis. It's incredibly hard to diagnose, and to kill - requiring at least three months of a treatment that can cause hallucinations. There's no good way to predict survival, when it's safe to stop treating, or exactly how to monitor those who fear the fungus may be festering silently in their bodies. "I don't think there is a precedent for this kind of thing," said Dr. Arjun Srinivasan of the CDC. "This is definitely new territory for us," he said. The fungus' brown-black color signals an armor that - along with being injected near the spine - helped this mold sneak past the immune defenses of otherwise healthy people, said Dr. Arturo Casadevall, a fungal disease specialist at New York's Albert Einstein College of Medicine. "What we're dealing with here is fundamentally different" from a typical fungal infection, he said. "This is a bug that most of us don't know much about." But the doctors and scientists are learning fast, piecing together clues that promise some hope. Doctors are beginning to detail in medical journals the first deaths in this outbreak, and the grim autopsy findings make clear that treating early is crucial, before the fungus becomes entrenched. In one case, a woman died in Maryland after the fungus pierced blood vessels in her brain, leading to severe damage. Click here to read JAMA's 'A Compounding Problem.' People getting treated earlier "seem to be doing OK," with fewer of the strokes that characterized the outbreak's beginning, said Dr. Carol Kauffman of the University of Michigan. She has advised the CDC and co-authored advice in the New England Journal of Medicine on how to handle the complex medication used in treatment. People who got contaminated steroid shots made by a Massachusetts pharmacy have been told to be on guard for months for meningitis symptoms. But the CDC said Wednesday that the biggest risk for getting sick seems to be within 42 days of receiving one of the implicated back injections. With the tainted shots recalled in late September, that means the period of greatest risk is nearing an end. And it should help doctors bombarded with calls from the worried determine who most needs a spinal tap to look for the very earliest signs of infection. Still, public health officials recall a 2002 meningitis cluster linked to steroid injections contaminated with a different fungus; one of those victims got sick 152 days after the shot. Fungal infections don't get a lot of attention, but they afflict millions around the world, said David Perlin of the University of Medicine and Dentistry of New Jersey, who is studying better ways to diagnose them. Most are skin infections like athlete's foot, but fungi also can cause pneumonia, sinusitis and other problems. While the more common bacterial and viral forms of meningitis tend to strike quickly with obvious symptoms, fungal meningitis grows very slowly and is hard to diagnose. Few antifungal drugs are absorbed into the central nervous system, limiting treatment options. Plus, human cells and fungal cells have a lot of similarities, making it hard to attack the fungus without side effects, Kauffman explained. The main culprit in this outbreak is a black mold called Exserohilum rostratum, common in dirt and grasses. Only 33 human infections previously had been reported, mostly eye or skin infections in people with weak immune systems, Casadevall said. The Associated Press contributed to this report.

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