The case count continues to climb as people contract a rare form of meningitis that produces strokelike symptoms. As of this posting, 14 patients have died and 156 others have fallen ill across 11 states. The U.S. Centers for Disease Control and Prevention (CDC) and Food and Drug Administration (FDA) have traced the unusual outbreak to three lots of steroid medication injected into the spine to treat pain.

Meningitis is an infection of the membranes surrounding the spinal cord and brain. It can be caused by a number of infectious agents. Viral meningitis is relatively benign, and those infected may recover without specific therapy. Bacterial meningitis—particularly meningococcal meningitis—can be acute and severe but is treatable if diagnosed early. The current outbreak is fungal meningitis, a rare form because fungi do not usually infect individuals with a healthy immune system. Unlike viral and bacterial meningitis, fungal meningitis is not contagious—and it is treatable if detected early.

The tainted drug is preservative-free methylprednisolone acetate contaminated with different fungus species. The CDC has identified two kinds of fungi in the meningitis patients: Aspergillus, commonly found in moldy leaves, and Exserohilum, which is involved in wood rot. Epidural steroid injections—a procedure to relieve back pain—likely delivered the fungus adjacent to membranes surrounding the spinal cord, according to the ongoing investigation. The meningitis symptoms can take weeks or even months to develop.

The contaminated lots came from the New England Compounding Center beginning May 21. The center, which voluntarily recalled all its products last week, is a so-called compounding pharmacy: it creates tailored formulations of medications by packaging different doses or changing a medicine from solid to liquid, for example. Compounding facilities do not fall under the same regulatory categories as larger pharmaceutical companies.

To learn more about the outbreak, Scientific American spoke with William Schaffner, an infectious diseases specialist and chair of the Department of Preventive Medicine at Vanderbilt University School of Medicine. He describes what we know about fungal meningitis, how it is being treated and how the unfolding investigation may subject compounding facilities to closer scrutiny.

[An edited transcript of the interview follows.]

How many people are at risk in this outbreak?
The investigation indicates that there were over 17,000 vials of this potentially contaminated medication produced. There may be some variability from vial to vial within each batch. It has been estimated that something like 13,000 people were exposed to this medication; some of it hadn't been used yet by the time the alert went out, and some people received more than one dose. That's very large. If there is a silver lining in this dark cloud, it's that the proportion of people who received this medication who are actually getting sick is rather low. It looks to be less than 5 percent.

What are the symptoms?
The symptoms are insidious. They begin slowly and not very dramatically: fever and chills, headache and a stiff neck from the inflammation. People lose their appetite, feel ill, can be nauseated and can vomit. But there's something else that's subtle: It seems these fungi have the capacity to invade little blood vessels in and around the brain, cause bleeding and produce symptoms that mimic a stroke—difficulty speaking, loss of balance and trouble walking. Those symptoms can occur even without fever, so physicians have to learn that patients who present with stroke symptoms may actually be part of this.

6 Comments

1. 1. dbtinc 09:01 AM 10/12/12

   This lack of regulatory oversight is another outrage being foisted on the public. A compounding pharmacy is intended to compound a prescription by a physician for a drug not normally commercially available. It is NOT what NECC is or does - tens of thousands of pre-filled syringes is not a local operation. Where is FDA and why haven't the regulations been updated to allow FDA oversight into these compounders? Just curious - would Willy Robme and his boy wonder be in favor of more regulations in this instance?

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2. 2. tharter in reply to dbtinc 11:56 AM 10/12/12

   The regulations WERE updated in the early 90's. The courts invalidated the law due to some kind of issue with restrictions on advertising.

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3. 3. jgrosay 06:33 PM 10/12/12

   The fungal meningitis outbreak is a sad event, but we must remember that: 1) Plague epidemics killeth more than 70 million persons in the Middle Ages. 2) A drug vial's filling line contaminated by the previous use of Vincristine produced around a hundred irreversible palsy cases in China. 3) Every place outside south Europe and to a lesser extent, the towns in North America and Canada are places with a serious risk of contracting dangerous infectious diseases and other environmental dangers. 4) I visited the italian town of Trieste, formerly the only sea access of the Austro-Hungarian empire in 1978, before a short trip to the then still existing Yugoslavia, Tito was alive, and the Yugoslavian bank notes were written in 4 alphabets: latin, greek, slavic and arab, just to realize that the very beautiful town of Trieste looked as having lost its soul, and that the prices for eating a fish dish in a restaurant were too high for my budget. Today, the more amazing new you can get from local Trieste TV is about an old woman in a bus beating with her umbrella another old woman during a conflict for a seat. As Bob Dylan said: "The times they are a'changin'". "Forging the great century, many have passed". -Caco Senante. Salut +

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4. 4. Bob32 11:54 PM 10/17/12

   It is likely that this product was supposed to have been a sterile fill in contrast to post fill sterilization. This remains a fairly risky procedure requiring rigid sterile room discipline as well as post fill sterility testing. Small startup manufacturers and the state authorities may not be sufficiently experienced to produce or monitor production of these products. Since the product was distributed nationwide there should be federal regulation by the FDA of these products.

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5. 5. postfuture 09:04 AM 10/21/12

   The primary causes of fungal infections directly related to antibiotics and steroids. When antibiotics remove bacteria, including beneficial, it cleans up the territory for the rise of fungi and yeast, and steroids weaken a body immune defense. The lab probably get over sterilized against bacteria, but fungi is much more dangerous and more difficult to destroy, they produce spores that almost impossible to destroy. We need to stop mindless production and overuse of cleaning products, antibiotics, steroids, as well as other dangerous drugs that destroy natural defenses and the environment etc., etc., etc. We destroy natural balance and it turns against us.

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6. 6. mastic 05:10 AM 10/31/12

   I suppose it is a mix between contaminated medications, bad administration procedure and immune deficiency.
   www.fistic.net

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