Leonard has observed one other intriguing characteristic of E. rostratum in his lab: The fungus can grow from a single spore to a lawn of freshly spore-crowned fungal filaments on a piece of dried leaf in two days flat—faster and more abundantly than any other related species he studied. "This is a fungus very well-adapted to colonizing senescent or dead leaf tissue once conditions are right," Leonard says. "So that would be another reason E. rostratum would be a likely candidate for showing up in a messy lab."
But if the fungus is primarily tropical and subtropical, what was it doing in a place like New England?
In the summer the fungus can probably find ideal growing conditions in places in the northern U.S., Leonard explains, or it may be spread northward by winds. The spores have a static electricity–based ejection system designed to launch them into the air with ease. And plentiful lawn clippings provide an ideal place for the fungus to grow.
Roberts says the group of fungi pigmented with melanin (which includes E. rostratum)—the same molecule that darkens and protects human skin—seem to be generating more human infections for reasons he does not understand. E. rostratum, in addition to causing soft-tissue infections, has also rarely provoked sinus or eye infections, primarily in immunocompromised patients.
Although the identity of the fungus surprised him, Roberts was not surprised by its ability to capitalize on its situation once inside a patient. After the fungus was injected along with the drug into the epidural space—the space between the dura mater, which encloses the spinal fluid and spinal cord, and the inside walls of the vertebrae—the fungus's filaments were able to penetrate the dura mater, enter the spinal fluid and travel straight to the brain, an environment where the immune system has a very difficult time eliminating or even just controlling infection. "Spinal fluid is a great culture medium—one of the best," he says. "The nutrients are there, and the temperature is certainly right."
Those who suffered the worst infections, he speculates, were probably those in whom the needle accidentally penetrated the dura mater, thereby shortening the fungus’s deadly path into the spinal fluid. Then, in some fatal cases, the fungal filaments began to grow in the brain, attracting platelets and white and red blood cells to aggregate around the filaments and form a mass that could block a blood vessel and initiate a stroke. Strokes were not implicated in all the fatalities, however, so the mechanism(s) in those other deaths remains unclear.
The fungus's confinement to just three lots of the drug also remains unexplained. If the facility's water or air supplies in general were contaminated, one would expect all lots to be affected. Perhaps something blew in from a nearby recycling center or some other source on one or a few days and not on others, Roberts speculated.
Another pathway could be the drug itself: Although the water used for making up the final doses was allegedly sterile, the steroid drug ingredient was not. "Using nonsterile components [for injection] in somebody's spine?" Roberts says. "My goodness, that's terrible."
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Add CommentYour last paragraph is a zinger !
Reply | Report Abuse | Link to thisI'm sure that starting with natural products like the diosgenin from Mexican yams presents problems as far as obtaining complete sterility goes, but, really, are you sure the law allows using a non-sterile drug, in compounding an injectable finished product. That just seems so wrong. Why even bother using clean water?
Pasteur must be turning over in his grave.
Does anyone know a NIH source that shows what the rules allow? And if injectables are allowed to be non-sterile (can we say filthy?) what about oral blood pressure meds or antibiotics, or the thousands of other meds in pills or caps not to be injected.
How filthy are they allowed to be?
And how do we define non-sterile/filthy?
I have read they use that specific fungus , rostratum , in drug production to ramp up the production ?
Reply | Report Abuse | Link to thisIs E. rostratum killed in our digestive process-- or do we have to reconsider the hamburger-joints’ wilted lettuce with a more cautious eye? Is it an inhalable problem? Are hay-rides to be re-cataloged as extreme sports? Is picnicking in the park risky behavior?
Reply | Report Abuse | Link to thisironjustice: No, "they" don't. Please leave and take your anti-pharmaceutical conspiracy hypotheses with you.
Reply | Report Abuse | Link to thisR.d nyc: I would say that being careful of what you eat at hamburger joints is always a good idea. As for the other two...I don't think so, but maybe.
doug_pdq -- I think that the problem in this investigation was that compounding pharmacies are not regulated the same way as the rest of the pharmaceutical industry, and then this particular pharmacy was not even meeting minimum standards. It was especially filthy and careless with safety.
Reply | Report Abuse | Link to thisSee the following articles for more details on that angle
http://www.nytimes.com/2012/10/07/us/scant-drug-maker-oversight-in-meningitis-outbreak.html
and
http://www.nytimes.com/2012/10/27/health/fda-finds-unsanitary-conditions-at-new-england-compounding-center.html
R.d nyc -- This fungus is almost certainly harmless to people with healthy immune systems provided it is not injected into their spines. Of the few known human infections prior to this outbreak, most occurred in people with compromised immune systems or who had structural defects in their nose (a birth defect or a broken nose) that made it easier for the fungus to cause allergic sinusitis. Infections with this fungus of either variety are very rare. This is not a fungus most healthy people will ever need to worry about.
Bueno, parece ser que los hongos y aquéllos seres vivos que no son ni plantas ni animales tienen mucho que enseñar: "los colmillos"
Reply | Report Abuse | Link to thisIf you sterilize the final product, i don't see what difference it makes if the ingredients are sterile? When you mix up culture media the various ingredients are not sterile, but you do need to autoclave the media before stuff starts growing and producing unwanted products and changes to the media.
Reply | Report Abuse | Link to thisThanks Jennifer. The two NYTimes articles are informative particularly with respect to how vague the rules are and how easily they are circumvented or ignored. And greed, as usual, seems to have been a consideration. And no excuse for trying to save $3 a shot on a med they were reimbursed $300/shot for.
Reply | Report Abuse | Link to this@MikenStL : And thanks for pointing out that the autoclaving should be done last. I looked at the structure of methylprednisolone and it didn't appear to me to have any super heat sensitive functionalities, although I'm no expert on steroids. So I'm still amazed they sent out a non-sterile injectable, now maybe even more since a simple trip through a 'pressure cooker' would likely have prevented all this and wouldn't have cost hardly anything.
I have been following this news item for some time, and I remember reading elsewhere that drug preparations meant for injection into the spinal cord do not have preservatives. I was reminded of the case of an Indian minister (late Mr Murasoli Maran; see, for example: http://www.rediff.com/money/2002/sep/25maran.htm; September 25, 2002) who died after his mitral valve "prosthesis" got infected with a fungus. Even at that time I was wondering how the implant could have got the fungus, and what fungus it was.
Reply | Report Abuse | Link to this"In 1952, D.H. Peterson and H.C. Murray of Upjohn developed a process that used Rhizopus mold to oxidize progesterone into a compound that was readily converted to cortisone."
Reply | Report Abuse | Link to thisI suppose one mold is the same as another when it comes to drug production.