On its own, aspergillus is a common fungus, the product of damp and moldy conditions, that normally doesn't threaten the healthy immune systems of humans. The same can be said of exserohilum, a fungus normally associated with grasses, plants or corn blight and rarely seen in human infections
That is until the recent national outbreak of fungal meningitis that has led to 14 deaths and more than 185 cases in 12 states as of Friday. Federal investigators suspect that an untold number of vials of a commonly injected pain relief steroid were tainted by exserohilum and aspergillus during the pharmaceutical compounding process at a now-closed firm in Framingham, Mass.
Unlike typical forms of serious bacterial or viral meningitis that can be contagious and affects the brain and nervous system, this outbreak is not contagious but is dangerous because fungi could have been directly injected into the lining near the spinal cord.
"Aspergillus is a ubiquitous environmental germ and it can cause infections," said Dr. David Itkin, a specialist in infectious diseases and the staff epidemiologist at Portsmouth Regional Hospital. "But these (fungi) are generally benign to healthy immune systems."
He said this is a rare form of meningitis and especially dangerous because the contaminating fungus was injected directly into the patients' bodies.
"In terms something on this scale," he said, "I do believe this is unprecedented."
The outbreak has also left health officials scrambling to keep up with developments. On Thursday, the CDC said the incubation period for symptoms could range from one to three months. Because the fungi are difficult to grow in lab analyses, the CDC has advised doctors that if a patient who got the injection starts to develop meningitis symptoms, he or she should be treated, even if testing is negative for the fungus.
Symptoms of meningitis, which is an inflammation of the lining of the brain and spinal cord, include severe headache, nausea, dizziness, fever and stroke-like sensations. The CDC said many of the cases have been mild, some patients have experienced no harm and some people had strokes. Itkin said those with non-epidural injections are at risk of a potential serious infection in the injected area but not of fungal meningitis itself.
The CDC estimates that as many as 14,000 people in 23 states received epidural (near the spine) and non-epidural (joint) injections. There have been three contaminated batches identified by the CDC and they are concerned most about patients who received epidural injections between May 21 and Sept. 26 when a recall was ordered. PainCare LLC, which gave injections of the steroid at locations in Newington, Somersworth and Merrimack, has contacted, informed and offered follow up tests to 215 patients believed to be most at risk. A handful of patients who are exhibiting meningitis symptoms are being treated and watched carefully.
Federal health officials warned that patients will need to keep watch for symptoms of the deadly infection for months.
"We know that we are not out of the woods yet," said Dr. J. Todd Weber of the CDC as the death toll reached 14 on Thursday.
Though investigators do not know exactly how the batches of the steroid Methylprednisolone Acetate became contaminated with the two fungus germs, Itkin said the contamination at New England Compounding Center in Framingham showed a serious breakdown of quality control. The company has halted operations, surrendered its license and recalled all of its products.
"We don't know how this fungus was introduced during the preparation stages for making the product," he said. "Generally, these processes are tightly regulated in controlled environments."
Investigators do not know if all or just some of the vials were contaminated, or how many doses were administered for back pain or for other reasons. The CDC said its fungal disease laboratory has confirmed the presence of exserohilum in 10 people with meningitis and aspergillus in one person with meningitis among the reported cases. Tennessee has reported the most cases with 49 and the most deaths at six through Thursday.
Itkin said contamination of this type can include more than one fungus. In a television report last week, CNN showed that a recycling and waste dump was located directly behind the NECC building.
"If things aren't sterile, there are a lot of steps along the way where things can be contaminated," he said.
As an example, he said whenever a hospital has a construction project, health workers are very careful about the dust and environmental molds that are stirred up during the process, which can impact delicate procedures such as transplants.
In addition to safe sanitary concerns, the growing NECC case reflects a possible regulatory black hole. As a pharmaceutical compounding company it did not fall under federal oversight and was supposedly overseen by a state pharmacy licensing agency. Regulators are not called in until a problem arises. In 2006, the Federal Drug Administration sent the company a warning letter about potential unsafe sterile conditions but the FDA had no enforcement capability.
Dr. Madeleine Biondolillo of the Massachusetts Department of Public Health said it appears the company violated state law governing those pharmacies and went beyond its license to produce medication for patient-specific prescriptions.
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