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NECC News: Another Person Dead, More Fungal Meningitis Lawsuits Filed, and Fungus Found in 50 Vials

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With million dollar fungal meningitis outbreak lawsuits now filed in Minnesota, Michigan, Tennessee, Virginia, and Indiana, a former federal prosecutor in Boston is going after NECC owners’ personal assets, Reuters reported Friday morning.

Thus far, 254 people out of a potential 14,000 have been infected with fungal meningitis, and 20 people have died, according to the Chicago Tribune. With New York reporting its first case on Thursday, the tally now spans 16 states.

While epidural steroid patients, their family and friends, and U.S. senators who’ve written to the FDA since October 8 await news of what the agency found in its raid on Tuesday, the FDA has confirmed that fungus Exserohilum rostratum was present in more than 50 unopened vials of methylprednisolone acetate from recalled lot #08102012@51, BUD 2/6/2013.

According to the Tribune, Exserohilum has been linked to most of the fungal meningitis cases in the outbreak. Since the CDC’s website states that Exserohilum is found in soils, plants, and grasses of warm and humid climates, one may wonder how an epidural steroid injection could become contaminated with such a thing.

“[T]he betting money seems to be on dirty conditions, faulty sterilizing equipment, tainted ingredients or sloppiness on the part of employees,” Fox News stated on Wednesday. The site said any number of things could have prevented the contamination, including:

  • Mopping the floors and sterilizing both surfaces and equipment;
  • Making employees wear gloves, gowns, and masks; and
  • Producing drugs in a clean room.

Pharmacist and writer Ernest P. Gates, Jr., suggested on modernmedicine.com that a clutter-free $100,000 clean room decked out with stainless steel surfaces, glass windows, and Pharmacy Compounding Accreditation Board endorsement is “integral” to a compounding pharmacy.

“You are giving patients the ability to watch their prescriptions being filled, gaining their confidence in the cleanliness of the facility, reinforcing their perceptions of the staff's professionalism, and generating more business,” he said.

After all, compounding pharmacists aren’t supposed to mass-produce drugs as NECC was. And, as New Jersey-based consultant Lou Diorio told Fox News, “[I]t is harder to keep everything sterile when working with large amounts.”

As reported yesterday, the FDA has known that NECC was mass-producing drugs since at least December 2006, when it sent the compounding pharmacy a warning letter. In that letter, the agency admonished NECC for opening colorectal cancer drug Avastin and pouring that drug into its own syringes.

“FDA is particularly concerned about the manipulation of sterile products when a sterile container is opened or otherwise entered to conduct manipulations,” the letter stated. “The moment a sterile container is opened and manipulated, a quality standard (sterility) is destroyed.”

What NECC was doing is equivalent to finding out that the chocolate milk you’re drinking was made by Joe Schmo down the street who bought some 2 percent, mixed in chocolate syrup, and sold the concoction under his own name, says Spangenberg attorney Will Eadie.

Since NECC’s epidural steroid was made preservative-free, or without alcohol that would have killed germs, it was even more important to manufacture the drug in a hygienic environment, experts told Fox News.

Related posts:

NECC News: FDA Letter to NECC May Answer Senators' and Consumers' Questions re: Meningitis Outbreak

NECC News: Ohio Clinics from Akron to Zanesville that Received NECC Drugs May-October 2012

NECC News: Fungal Meningitis Lawsuits Filed in Minnesota, Michigan, New Jersey, Tennessee, and Virginia (updated October 17)

NECC News: NECC Cuts Jobs, FDA Investigates More Products

NECC News: Two More Injections Possibly Linked to Fungal Meningitis Outbreak per FDA

House of Representatives Wants to Speak with NECC and Woman Files First Meningitis Lawsuit

NECC Loses Ohio License and 2004 Meningitis Lawsuit Comes to Light

What Epidural Steroid Patients Need to Know about the NECC Fungal Meningitis Outbreak

10 Comments

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    I think that a scoop of cooked rice six times a day would greatly help all fungal meningitis patients, as the rice might absorb the toxin (monocerin) found in Exserohilum, which are involved in the instant problem.
    We have had an abundance of mushrooms here this year and I doubt things were all that different in Framingham.
    The fungus spores could have come in airborne via the air-conditioning ducts. Mushrooms and spores can grow in air-conditioning ducts and ducts with a slope of less than three degrees would provide the moisture they require.
    The intake area around the air-conditioning condenser should be inspected for signs of mushroom growth and spores as the degree of distribution speaks to an aerosol mode.

  2. up arrow

    Dear Mr. Sckolnick:
    That’s actually a very interesting and plausible thought. Thank you for sharing it.

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    Indeed, it is. Thanks very much! I’m sure I’ll be posting about that eight-page document on Monday.

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    Looking at the air conditioning condensing system on the roof is not enough. All of the air-conditioning duct-work has to be inspected. I do not know what evidence of mushrooms, spores and toxins might remain now that the temperatures here in New England have dropped to near or below freezing.

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    Until today I had not seen any stories that mentioned the area around the NECC facility in Framingham, MA. I wonder what else has not been reported in the news.

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    Massachusetts Department of Health released preliminary findings this week from its investigation that began in Sept. People may still be sifting through details. From new cases to deaths to lawsuits to FDA lists…there’s so much to report each day — and that’s just the fungal meningitis news!

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    NECC turned the air-conditioning off at the end of each workday and that enabled any growths (bacteria, viruses, mushrooms and spores) in the duct-work to grow at a much more rapid rate. In the morning the air-conditioning was turned back on and that allowed any bacteria and spores to be blown out airborne across the entire plant.

  8. up arrow

    Thanks for following up, Mr. Sckolnick.
    I can only hope that other compounding pharmacies and drug manufacturers are reading the FDA’s report and cleaning up their own act, so we don’t see a similar situation in the future.

  9. up arrow

    When I became ill from a spice while overseas I started taking Pepto Bismol, two tablet three times a day.
    An American doctor in that country had no better solution.
    The problems remained.
    Back home a few days later my doctor told me to up the dose to three tablets three times day.
    The problem began to disappear a few hours later.