Membranes protect the brain and spinal column from harmful particles that might be circulating in the blood. How does the fungus get past the blood–brain barrier?
The fungi were inoculated adjacent to this barrier but it is still a bit of a mystery how they were able to translocate from outside the membranes into and beyond the membranes.

There are a couple of theories. One is that the fungi begin to multiply in a secluded space, then they kind of eat their way through the membranes. Another hypothesis is: Could the inoculation have nicked the membrane and provided a microscopic mode of access? Practitioners who perform these procedures say this happens very rarely, but it remains to be seen.

People who die of the infection will receive postmortem examinations—autopsies. Careful study will help us understand what happened in this circumstance and how to prevent this from happening in the future.

What treatment options are available?
There are two major drugs, called amphotericin B and voriconazole. Both of those drugs are effective if we get in early. They are given intravenously initially, and then we hope we can transition to oral variations. They have substantial side effects, and we have to walk a kind of tightrope to treat the patient without damaging the kidneys or the liver.

This is all new territory for all of us, so we will learn as we go how completely we can treat these patients and how quickly or slowly it takes them to get better. We know that it is much slower than the treatment of bacterial meningitis.

Could you get fungal meningitis from an injection in locations other than adjacent to the spinal cord—the knee or shoulder, for example?
We know that some of these steroid vials were injected into the knees and shoulders and other joints for people who had painful inflammation in those joints. We anticipate that in the course of this outbreak we will discover people who developed infections in those joints. But those infections would not then cause meningitis.

How could the fungus have contaminated the medication?
All pharmaceutical manufacturers should adhere to good manufacturing practices and guidelines. We don't know what went wrong, but certainly some of those practices were likely not adhered to and that opened the door for contamination. We'll have to wait and see what the investigation tells us.

Are epidural steroid injections safe from other facilities?
Yes. Steroid preparations from other manufacturers are safe, and they can continue to be used. If you received an injection from one of those, you need not worry.

Do you think this outbreak should prompt a change in how compounding facilities are overseen?
I think these compounding pharmacies have fallen into a gap within our regulatory framework. I daresay we will see congressional hearings that address that. My own thought is that the Food and Drug Administration needs to be given explicit authority, and it needs to be given the appropriate resources so it can do the job. I think the whole role of these compounding facilities in our society and our medical care system will come under close examination.

How much longer will this outbreak last? When do we know it has run its course?
Sadly, we will see more cases. The incubation interval—the interval between the exposure, the inoculation and the onset of symptoms—can be quite prolonged. We initially thought it might extend as long as a month. But just recently it has been suggested that it can go beyond that—two months, maybe even three months. As the outbreak evolves and we gather new information, we'll get a better idea, but for the next several weeks we will continue to see, unfortunately, new patients identified and needing therapy.

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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