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Hilary's Desk

Part One: When common becomes lethal.

Hilary Butler - Monday, October 15, 2012

Since May 2012, the CDC has been investigating a meningitis outbreak, seemingly caused by contamination by Aspergillus and Exserohilum spores in injectable steroids and other drugs made at a compounding pharmacy, …a point that’s being emphasised by risk management departments worldwide.

More on that later. There are some serious issues at stake here, the first being why common, can become lethal.

Let’s talk hypothetical basics:

“Okay everyone. Line up. I want to swab your skin, and your throats. … Great…. Off you go now, and I’ll come back later with the results.”


Guess what.

Those throat swabs would show a RAFT of bacteria, normally thought of as big killers. Things like Staph Aureus, or the dreaded MRSA. Pneumococcus, neisseriae – both of which can cause invasive disease. You might even find clostridium of many types in the throat, since it’s known that quite a high percentage of people carry it in their guts normally. There might also be fungi, and a raft of rhinoviruses, adenoviruses, whooping cough bacteria and… goodness knows what else… as well. Normal people probably inhale millions of Aspergillus and Exserohilum spores into their lungs, and often introduce these fungi into their broken skin. It’s called, “life”!

Those skin swabs usually show diphtheroids, streptococcus types, and staphylococcus, all of which can cause problems particularly necrotising fasciitis which is on the rise in New Zealand. It’s notable to me that necrotising fasciitis is far more common amongst people prescribed “pain medication” or “non-steroidal anti-inflammatories” (same difference). Why might that be? Because pain medication markedly slows down the part of the immune system which deals with bacteria in the system, and gives the bacteria a survival advantage.

We are literally riddled with all sorts of things which just because you can’t see them, you assume they aren’t there. As one website puts it:

“Our skin is home to about a trillion microscopic organisms like bacteria and fungi. Together, these creatures and their genetic material—their genomes—make up the microbiome of human skin.”

Your tummy button alone, is a veritable mine of more than 1,400 different species.

To get a good handle on what they are starting to find on, and in your body, read this 

If some of these bacteria somehow get into your system, and if your immune system, for whatever reason, can’t cope – you can be in serious trouble. Why and how, might that happen?

Part of the answer to that problem is the WAY the medical profession treats both infection AND pain.

Far too often, if a doctor sees a pain problem, their “go-to” method of stopping the person feeling the pain is to drug it. In my opinion, that’s something that has to stop. This article stated that millions of steroid joint injections are given yearly for pain, because it’s “bread and butter” orthopaedics.

If the problem is seen to be bacterial, viral or fungi, the system recommends the napalm it, nuke it, poison it, or kill it approach. This systemic napalm approach, especially for non-life threatening events, is a practice that needs to be rethought.

But back to the Meningitis outbreak

In May this year, the FDA notified the public that they were investigating an outbreak of meningitis amongst people who received spinal injections of a steroid called methylprednisolone acetate produced and distributed by New England Compounding Center (NECC) in Framingham, Massachusetts. 

As of Tuesday, the toll from the fungal meningitis outbreak stood at 15 dead and 231 people infected, some of whom have had strokes as a result.  The fungi involved are very common - "ubiquitous" is the word used to describe it. The one causing the most infections, is called Exserohilum rostratum which is a common mold  that grows on my lawn, in my garden soil and on my plants. The other is Aspergillus, which loves to contaminate starchy foods like bread and potatoes, but also happily grows in or on plants and trees. Both fungus species are in most people’s houses and they don’t know it; we eat it, and it could come up as a finding on skin swabs, or throat swabs.

BUT under normal circumstance, these two fungus species ONLY cause infections in immunosuppressed people, people who are on cancer treatments, whose body flora has been utterly trashed by the treatment….or …. like clostridicum difficile, in people napalm-bombed with antibiotics indiscriminately.

When a dose of steroids is injected, it’s designed to suppress inflammation. If you inject a sterile steroid dose into the spinal lesion, and introduce some fungal spores into the skin abrasion, that’s still not a big deal, no serious consequences. But when they are injected together, then a culture media for the fungi to grow unchecked is created at the site of injection, and then the fungus literally explodes into the body from there, so this contamination in a STEROID, because of what a steroid does, is a big deal.

Most of the infections from the spinally injected steroids have so far been Exserohilum rostratum, causing meningitis, strokes and other conditions. 

One medical website describes some Exserohilum presentations as mycotic keratitis, an inflammation of the cornea, the transparent membrane that covers the colored part of the eye (iris) and pupil of the eye, subcutaneous phaeohyphomycosis (usually under the skin cysts or abscesses, but can be elsewhere) , endocarditis (inflammation of the inside chambers of the heart and the valves), osteomyelitis (bone infection) and sinusitis in both normal and immunosuppressed patients, but they are USUALLY only in immunosuppressed patients. Icky pictures can be seen here

Why don’t normal people get these fungal infections?

Because there are a raft of things we eat, funguses, listeria etc, which any normal immune system just flicks off, deals with, and passes by. A normal immune system works. A steroid suppressed immune system doesn’t work the same.

However, the problems aren’t just limited to spinal injections. Steroid injections into joints are also causing problems. Again, the steroid is suppressing the immune system at the site of the injection – after all, that’s what the steroid is designed to do. Shut up the immune system therefore, stop the pain.

"Fungal infections in a joint can be extremely difficult to treat and can be quite devastating," said Dr. Sanjeev Suratwala, a spinal reconstructive surgeon at Glen Cove Hospital in Glen Cove, N.Y. "Typically, these patients need several months of antibiotics and are prone to relapses, and may even require surgical treatment."…

Suratwala said that while the waiting period for meningitis in the spine or brain has been about one to four weeks, joint infections can take longer to appear. "Fungal infections can be masked, so it may take a longer time to present itself," he said.

Damage control experts have said that… “The outbreak has led to calls for tighter regulation of the loosely controlled pharmaceutical compounding industry. Critics said drug manufacturers have found a way to sidestep costly and strict oversight by classifying themselves as pharmacies, which are given freer rein to mix drug compounds for patients.”

There is a hitch here though.  Compounding pharmacists normally make drugs that the big companies won't.  This problem however, isn’t unique

.“Just last year, there were at least three apparently similar incidents: At least 33 patients suffered fungal eye infections traced to products made by a compounding pharmacy in Ocala, Fla.; at least a dozen Florida patients were blinded or damaged in an outbreak linked to a compounder in Hollywood, Fla.; and the deaths of nine Alabama patients were attributed to tainted intravenous nutritional supplement provided by a compounder in Birmingham.

"These events have been happening once or twice a year for the last 15 years," Kastango said. "We wouldn't tolerate this if a plane crashed once or twice a year. But in health care, we've grown desensitized to these kinds of problems."



.........That’s not the only thing the medical system has become desensitized to.

To be continued.. Part Two

General information

Q6. What led FDA to take this action? http://www.fda.gov/Drugs/DrugSafety/ucm322735.htm   

A6: As a result of FDA, CDC, and state health departments’ ongoing investigation of contamination at the New England Compounding Center’s (NECC) Framingham, Massachusetts facility, we have learned that two patients may have infections associated with other possibly contaminated NECC products. While the investigation of these patients is ongoing, and there may be other explanations for their infections, out of an abundance of caution, we are issuing new guidance for providers to contact their patients for whom they administered an injectable product, including an ophthalmic drug that is injectable or used in conjunction with eye surgery, or a cardioplegic solution purchased from or produced by NECC after May 21, 2012.

With regard to the two patients who are being evaluated, we can provide the following information. One patient, identified through active surveillance, is under investigation for possible meningitis potentially associated with epidural injection of an additional NECC product, triamcinolone acetonide. Triamcinolone acetonide is a type of steroid injectable product made by NECC. FDA-approved triamcinolone acetonide is approved for intra-articular (within a joint) or soft tissue injection. The cases of meningitis identified to date have all been associated with methylprednisolone acetate, another similar steroid injectable product.

In addition, one heart transplant patient with Aspergillus fumigatus infection who was administered NECC cardioplegic solution during surgery hase been reported. Investigation of these patients is ongoing, and, there may be other explanations for their Aspergillus infection. Cardioplegic solution is used to induce cardiac muscle paralysis during open heart surgery to prevent injury to the heart.

At this time, no patients are under investigation in connection with any NECC-produced ophthalmic drug that is injectable or used in conjunction with eye surgery, but FDA believes this class of products could present potentially similar risks of infection because of concerns about sterility.

Pdf of 1,200  potentially contaminated products = http://www.fda.gov/downloads/Safety/Recalls/UCM322970.pdf   
 
URL http://edition.cnn.com/2012/10/15/health/meningitis-outbreak-duplicate-2/index.html?hpt=hp_t3  

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