Column by Carrie Burdzinski.
Exclusive to STR
* Compounding pharmacies: heroes or outlaws? – NBC News
* Compounding pharmacies highlight need for government to regulate business – Forbes
* Meningitis outbreak sheds light on compounding drugs and lack of regulation – Fox
News
These alarming headlines refer to the deadly fungal meningitis outbreak allegedly traced to contaminated prescription injections used to treat back pain. Not surprisingly, the media is ignoring pertinent facts of the case while scaring the public into believing that greater FDA regulation is necessary to protect us from small-scale pharmacists who “concoct [5]” poisonous toxins. Yet the demands for regulation are unwarranted, based on fearful emotion rather than facts. Upon inspecting the statements from both the CDC and FDA, one discovers a startling series of glaring omissions and cover-ups. First, there may not be an outbreak of fungal meningitis. Second, the alleged cases of fungal meningitis have not been conclusively linked to the implicated pharmacy, which, thanks to fear-mongering, is now permanently out of business.
No evidence of an outbreak
“Meningitis” refers to inflammation of the meninges, the protective membranes surrounding the brain and spinal cord. Meningitis may result from microbial infections (bacteria, viruses, fungi, or eukaryotic parasites), or from non-infectious immunodeficiency related to cancer and anti-inflammatory medicines. The condition is serious and can be life-threatening due to the proximity between the meninges and the central nervous system.
Since late September, 200 cases of illness and 15 deaths spanning 13 states have been attributed to methylprednisolone acetate, a steroidal injection packaged by New England Compounding Center. An additional 13,000 people are claimed to be at risk of exposure. Accordingly, regulators recalled and confiscated all 1,200 products from this facility and shut down the company for investigation.
The first reported case of fungal meningitis was detected in a patient in Tennessee, whose cerebrospinal fluid (CSF) tested positive for Aspergillus fumigatus mold 46 days after receiving a steroid injection. Shortly thereafter, when eight other patients displayed meningitis-like symptoms, the media began reporting a fungal meningitis “outbreak.”
But according to the CDC’s own Morbidity and Mortality Weekly Report [6], the investigation “had identified an additional eight patients with clinically diagnosed, culture-negative meningitis: seven in Tennessee and one in North Carolina.” Culture-negative means that microorganisms were not detected in the patient samples; the patients were not conclusively infected with mold! But at this point the meningitis scare had taken off, and the powers-that-be needed an alternative means of proving that the outbreak was real. To assign the diagnosis, “Clinical meningitis was defined as having one or more symptoms (e.g., headache, fever, stiff neck, or photophobia)and CSF pleocytosis (more than five white blood cells per µL, adjusting for presence of red blood cells), regardless of CSF protein and glucose levels.”
Remarkably, the patients’ CSF lab results were assessed using reference ranges in opposition to the government’s own diagnostic criteria for fungal meningitis.
First, fungal meningitis presents with a marked increase in lymphocytes, the type of white blood cells involved in our adaptive (memory) immune response. In contrast, bacterial meningitis presents with a marked increase in neutrophils, the type of white blood cells involved in phagocytosis, or the consumption and destruction of bacteria as part of the innate immune response. Strikingly, neutrophils do [7]not interact [7] with Aspergillus, the mold implicated in the outbreak. The patients sampled in the alleged outbreak showed increased neutrophils, not lymphocytes, nearly excluding the diagnosis of fungal meningitis.
Second, the CSF of true fungal meningitis patients shows a decrease in glucose levels (<40 mg/dL). In contrast, the patients sampled in the alleged outbreak display glucose levels ranging up to 121 mg/dL. As glucose levels in CSF are less than 2/3 of the concentration present in blood, these patients are extremely diabetic and are thus at high risk for various health ailments, including the primary symptoms used to clinically assess meningitis: headaches, stroke, and neuropathy.
Third, according to the same CDC report, “As of October 10, evidence of a fungal infection had been found in 26 (37%) patients by culture, histopathology, or polymerase chain reaction. The fungal species had been identified in 14 patients; Exserohilum spp. was identified in 13, and Aspergillus fumigatus was identified in one patient.” Only 1/3 of the cases are conclusively related to a fungal infection, and now two unrelated species are identified as the cause.
Finally, the CDC is unsure whether this “outbreak” represents a greater number of patients than usual. The October 4 [8]th CDC telebriefing [8] states:
JESSICA BLISS [reporter]: You mentioned that fungal meningitis is quite rare. I wondered if you could quantify that at all if you could give us an idea the past incidents in the United States on a year-by-year basis for fungal meningitis.
BENJAMIN PARK [CDC]: Fungal meningitis is not a reportable condition so we don't know how often it occurs.
The CDC acknowledges [9] that the fungal species implicated in infection are abundant in soil—“particularly in the Midwest near the Ohio and Mississippi Rivers.” (Note that Tennessee and Michigan have the greatest number of cases supposedly resulting from the medicine contamination.) The CDC also states, “You may also get fungal meningitis after taking medications that weaken your immune system. Examples of these medications include steroids (such as prednisone)…”
Although every illness should be treated with caution, there is currently little evidence that fungal meningitis is a public health crisis. Rather, it is primarily affecting Midwestern elderly diabetic patients taking immunosuppressants—the very population who is at risk from fungal spores naturally present in our environment.
No evidence against the compounder
Imagine a typical salad mix prepared in a grocery store: the grocer mixes lettuce from Farmer A with spinach from Farmer B and tomatoes from Farmer C, and packages them with an in-house label. If it is later discovered that the salad mix is contaminated, the FDA not only investigates the grocer but also Farmers A, B, and C to isolate the original source of the contaminant. But this is not the case when it comes to contamination involving a compounding pharmacy. The compounder is named as the source of infection, without implicating his Big Pharma suppliers.
A compounding pharmacy mixes, dilutes, or repackages brand-name medicines for patients requiring unique doses or formulations. For example, a compounder may dilute a dose for a child, or mix an active compound with a non-toxic base for patients who are allergic to the dyes used in brand-name pills. In the case of the steroid injections, New England Compounding Center mixed methylprednisolone acetate powder with a preservative-free solution for patients who react negatively to the preservatives in Medrol (manufactured by Pfizer).
In the October 4 [8]th CDC telebriefing [8], several news reporters attempted to discover whether the alleged contamination was introduced by NECC during the mixing process, or whether the contamination occurred earlier in the supply chain:
STEVE OSUNSAMI [reporter]: You said--you said that--that you--that--when you investigated the New England plant, that you found contaminants in--I got the sense other things were contaminated. I’m wondering did you find contamination in different compounds, different medicines that were being made in New England?
ILISA BERNSTEIN [FDA]: I’m going to refer to New England District Director on that.
MUTAHAR SHAMSI [FDA]: Hi. Not at this point. It was unopened vials that we saw, foreign material that was not consistent with the finished product.
STEVE OSUNSAMI: But what medicine was it?
MUTAHAR SHAMSI: Investigation is still ongoing so, again, I don't have much more than that.
Concludes the New York Times op-ed Out of Control Compounding of Drugs [10], “The steroid was almost certainly contaminated by a fungus, although final laboratory results are not yet in.” For the Times, this is reason enough to shut down all compounding pharmacies.
Become immune to misinformation
By the CDC’s own admission, fungal infection has not been identified in many of the patients alleged to be ill with fungal meningitis. By the CDC’s own admission, no unsanitary conditions were identified at the New England Compounding Center, and none of their 1,200 other products are contaminated, which they likely would be if fungal spores were present in the facility. By the CDC’s own admission, the original steroid supplier to NECC has not been investigated. Attributing sporadic cases of an unidentified illness in elderly patients to fungal contamination at a compounding pharmacy is mysterious at best, and disingenuous at worst. I refer you to the opening headlines for some possible motivations for making this correlation.
It is possible that the unfortunate illnesses are caused by fungal meningitis and that a contaminated lot from the compounder is indeed to blame. But let us acquire all the relevant facts before making a judgment, instead of blindly believing that Big Pharma and the FDA are needed in order to keep us safe.
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