* 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” 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, 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 not interact 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 (less than 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 4th CDC telebriefing 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 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.
If you and your doctor disobey FDA dictates both of you will be harmed. Your doctor will be fined. He may lose his practice and be imprisoned. You risk danger too. Try to import treatments of which the FDA disapproves and you too could be jailed. Resist this and you will suffer violence. You may even be killed.
Is this a service? Is it moral?
We say no. We uphold something called the Zero Aggression Principle (ZAP) . . . The State must not threaten or initiate violence against people. Violence must be defensive only.
Initiating violence is inherently criminal. We want to end FDA criminality. The letter to Congress for our FDA campaign shows how . . .
Make the FDA advisory, not mandatory. This easy change would civilize the FDA. It would place the FDA on the same basis as Underwriters Laboratory. If drug companies, doctors, and patients value the FDA’s seal of approval then the FDA will prosper, just like Underwriters Laboratory does.
This is a non-criminal, consumer controlled approach to providing governmental services. It points the way to the future . . .
* We must Deny Consent for state criminality.
* We must force The State to obey the Zero Aggression Principle.
* We must demote the political state in favor of consumer controlled government.
If you agree, please send Congress a letter saying so. You can borrow from the personal comments I included in my letter to Congress . . .
The drug Metformin is a perfect example of why the FDA must lose its power to coerce. Metformin treats diabetes and metabolic syndrome. It also appears to have youth preserving powers. But . .
The FDA denied this drug to Americans until 1994, even though it was approved for use in Europe as long ago as 1958!
That’s 36 years of unneeded suffering and death caused by the FDA’s violence based monopoly.
This is why I consider the mandatory FDA to be a criminal organization. I deny my consent to this criminality. Fix it. Make the FDA voluntary.