So there's an outbreak of meningitis?
Yeah. Two hundred and five cases reported so far. And 15 people have died.
Whoa. Since when?
The first case was reported on September 18 in Tennessee.
And it's still spreading?
No. It was never spreading. It came from a pretty sizable batch of contaminated steroid medication. Over 17,000 doses shipped to 76 medical clinics in 24 states.
What do you mean by 'contaminated steroid medication'?
There's a drug called methylprednisolone acetate—a steroid—that doctors sometimes inject into their patients' necks and backs to ease pain. Millions of Americans get these injections, and it's usually fine, because drug treatments are usually formulated in perfectly sterile Clean Rooms. This batch was apparently made in a not-so-Clean Room.
Jesus. So 17,000 people could get meningitis?
Not all of the doses got used. There were about 4,000 left when the CDC got wise to the contamination. So about 13,000 people could have been exposed, but it's possible that some of the doses weren't contaminated, and not everyone who was exposed will get sick.
Yeah. It's pretty serious.
But it's not contagious?
It is not.
Didn't I have to get a meningitis vaccine before starting my freshman year of college?
Right. So, there are different forms of the disease. Any time someone's meninges—these thin layers of tissue that surround your brain and spinal cord, sort of like protective shrink-wrap for your central nervous system—any time those get infected and start swelling up with inflammation, doctors call it meningitis. But there are several different bugs that can cause the infection— bacteria, fungi, parasites, and viruses. You got vaccinated against the bacterium meningococcus, which likes to live in mucus, and spreads when one person's saliva ends up in another person's body. Thus the college vaccine rule. Ah, college.
And the current outbreak?
Aspergillus and Exserohilum. Fungi.
Fungi that don't spread?
They don't have to--they're already everywhere. Exserohilum is a common mold that grows in soil and on plants, and Aspergillus, another common mold, is probably growing somewhere in my kitchen, and possibly in my shower, right now.
Look, all I'm saying is, it's very common, because it's good at living in the same environment that we live in. We breathe it into our lungs on a daily basis.
But we don't all have fungal meningitis.
Correct. That's because these molds are great at colonizing our defenseless bread and houseplants, but pathetic when it comes to invading our bodies. In order to set up shop on your meninges, aspergillus and exserohilum would have to multiply in your mucous, get into your bloodstream somehow, survive the trip through your very well-defended bloodstream, and then squeeze past the immune fortress that separates your brain and spinal cord from the rest of your body. That last step, getting past what doctors call the 'blood-brain barrier', is nearly impossible for most pathogens. Meningococcus—the saliva-loving campus bug-- has a few tricks up its membrane that allow it to achieve all of that, but unless your immune system is really hurting, like if you have another really serious infection going on, these common molds don't have a prayer.
Then why is the contaminated medicine causing meningitis?
Remember how I said this medicine was for back and neck pain?
Well, that's how. Aspergillus didn't have to fight its way past anyone's immune system. Doctors injected it directly into their spinal column, right under the meninges. Can't ask for a better invitation than that.
Wow. Is there anything doctors can do for these people?
Yeah. If they catch it early, they can treat people with heavy doses of antifungal medication. But it's dicey. You're dealing with something that can cause brain injury really fast. And it's not what doctors are looking for when they encounter a case of meningitis.
So the drug manufacturer screwed up enormously.
Welllll… it's not really a 'drug manufacturer' in the way you're thinking. It's a compounding pharmacy.
A compounding pharmacy. A company that mixes stuff together to make small batches of medicine. Like in the old movies, where the pharmacist has all those rows of jars on his shelves, and he combines different stuff to make everyone's medicine.
But no one has a pharmacist like that anymore. All I've ever seen my pharmacist do is stand in an elevated corner of Walgreen's and count pills.
Mine also glares at me.
So why do compounding pharmacists still exist?
Because the drug manufacturing companies don't make all the medications that people need. If a drug isn't making money, for example, the big companies may stop making and selling it. Compounding pharmacies can whip up those discontinued drugs or other specialized treatments on a small scale. These pharmacies are pretty rare but most big cities have at least one.
Then how did this compounding pharmacy end up shipping over 15,000 doses of this steroid stuff to multiple U.S. states?
Maybe because none of the drug companies were making this steroid treatment anymore?
Actually, they were. The same drug is available under several brand names.
I'm confused. Are these compounding pharmacies just like mini drug manufacturers?
No. They're supposed to just be sort of filling this small role. They don't invent drugs or even synthesize stuff from scratch, and they aren't giant corporations. And they don't have to answer to the FDA.
What do you mean, 'they don't have to answer to the FDA'?
Well, drug manufacturers have to be licensed by the FDA. And the FDA is very meticulous and anal and annoying about stuff, so they do all kinds of ongoing quality control, and the drug manufacturers have to spend a boatload of money just complying. But compounding pharmacies are regulated by state rules. Which vary.
So why would a clinic in Tennessee buy drugs from a compounding pharmacy in Massachusetts if they don't know what they're going to get, when they could just buy the brand name stuff instead?
In this case, it appears that the pharmacy was able to make the treatment for cheaper—not surprising given that they don't have to worry about FDA compliance—and the clinics were happy to buy it for cheaper. Most clinics aren't exactly rich these days.
But how does a doctor in Tennessee know that the drug she's getting from a compounding pharmacy in Massachusetts is not contaminated?
At this point, it's safe to say she doesn't.
Is that going to change now that people are getting deadly injections?
Hard to say. On the one hand, all of the rules about drug safety that have been made so far have followed on the heels of a mistake like this. For example, the FDA didn't exist until a bunch of kids died from contaminated vaccines. And after that, researchers could test new medicine on people without having to show it was safe first. Then one drug company decided to make a drinkable version of this treatment for strep throat, but the company used something similar to antifreeze, and 107 people died. So the rules changed again. On the other hand, there have been plenty of incidents over the past decade that haven't resulted in any changes: a diabetes drug called Rezulin that caused toxic liver failure in some people, and an arthritis drug called Vioxx that was linked to heart attacks and strokes. There was a bill in Congress that would have required drug companies to do follow-up studies after their drugs hit the market--so they could catch problems with medications like Vioxx and Rezulin much earlier--but it didn't end up getting pushed through to law. But this fungal meningitis outbreak is different. It's a lot less murky. People are dying and the reason why isn't that complicated.
hello, so who is asking and who is answering?
Wow. That was really obnoxious to read. When I read an article like this, I generally just want the facts fast. I certainly don't want to have to sift through a long, sarcastic Q & A session to find the important information.
I enjoyed it.
I believe one name is Whoa and the other name is Jesus.
Later there was a name change to Wonderful, Yea and then Wow. Still later, one identifies himself as confused, but forgot to capitalize the first letter in his name; perhaps a typo.
I liked this piece too. I may not have read the whole article otherwise. Thanks.
Funny how nice the fungus looks ... almost like a child's drawing of a flower.
Robin Hood: Men in Gitis
I read that Aspergillus was only identified in one of the cases, while Exserohilum was identified in at least 12. It complicates things, sure, that it is a less common fungus, at least less commonly associated with pathogenicity.
Oh, and most systemwide antifungal treatments are pretty toxic to humans. I thought that might make its way in this somewhat snarky article.
As human societ maturity, I wish we had never even considered or tried to venture out to space or the stars. I wish we always just focus on the current everyday lives of our selves on Earth. Imagine where we be now if created a NASA for human medical science and social problems. WoWzers!
Imagine how many people in just one year suffered medically or was harmed in some way and could of been prevented has the government focus their money not on a rocket to space, but on the real problems of today!
I find the Q&A style of this article much easier to follow than the meandering essay style typically used in news reporting. Having to answer specific questions keeps the writing tight and on point. It also seems to have helped the author probe more deeply into the subject than assembling a collections of scattered facts into paragraphs would have done. Please write more articles in this style!
You are correct, chsy83. Please see the correction above, and thanks for reading!
I wondered what happened to Donald Rumsfeld. Glad to see he landed a job somewhere.
I think a class-action suit is in order here. If only as a message to other mom&pop operations. Are pharmcies required to have insurance for this kind of cases?