E-mail updates
Follow on Twitter
Subscribe to RSS
Centers for Disease Control and Prevention
The two molds that have caused meningitis in 203 people and killed 15 of them. Left is Aspergillus; on the right is Exserohilum
More than 200 people in 14 states have either died or shown symptoms in an outbreak of rare fungal meningitis linked to contaminated pain injections, federal health officials said Sunday. Fifteen people have died.
The Centers for Disease Control and Prevention said 203 people had meningitis, while two had infections in their joints.
The CDC has also published its first case report of the outbreak, which began when a Tennessee doctor diagnosed a patient with fungal meningitis on Sept. 18, nearly six weeks after getting a steroid injection for back pain.
The CDC says 26 of the patients have a confirmed fungal infection, and all but one are infected with a type of black mold called Exserohilum. It’s never been known to cause meningitis before, although it’s common in the environment and can cause sinus and eye infections. One patient has Aspergillus, another fungus that occasionally can cause meningitis if injected into the spine, as well as other infections.
Both grow slowly and don’t cause the classic symptoms of meningitis. “Early in this outbreak, many patients with meningitis had only a few mild symptoms,” the CDC and state health offficials say in their report.
Worse, treatment can last months and requires infusions of two strong antifungal drugs, the CDC says. Right now, no one knows how long patients will have to be treated, and the drugs themselves can cause severe side effects such as kidney damage. As many as 14,000 patients may have been given the tainted steroids.
“Early identification and treatment of patients with fungal infections might reduce the risk for serious complications, such as stroke or death,” CDC says.
Meningitis is an inflammation of the spinal cord or the membrane surrounding the brain. It's extremely serious when caused by bacteria; viruses can also cause meningitis. Fungi and parasites cause it more rarely. Most of the patients in this outbreak have complained of headaches.
"FDA urges patients who believe they received an injection or other product compounded by NECC to remain vigilant for the signs and symptoms of infection, including meningitis. The signs and symptoms of meningitis include fever, headache, stiff neck, nausea and vomiting, photophobia (sensitivity to light) and altered mental status," the Food and Drug Administration said in a statement.
State and federal health officials are trying to find out how and why a Massachusetts pharmacy, the New England Compounding Center, managed to distribute so many vials of the steroid, called methylprednisolone. It can be injected into the spine or joints such as the knee or ankle to treat pain.
Massachusetts state health authorities say it appears NECC broke regulations in distributing the high volume of drugs. All of the cases so far have been linked to three affected batches of the steroid, although all of NECC’s products have been recalled.
A sister company, Ameridose, is also being investigated. "Based on the business relationship between NECC and Ameridose, FDA and the Massachusetts Board of Pharmacy launched a joint inspection at the Ameridose facility in Westborough, Massachusetts on October 10, 2012," the FDA said in a statement.
"As part of our efforts to protect the public health, FDA is investigating whether certain aspects of compounding practices and facility conditions observed at NECC may be present at the Ameridose facility. FDA will review whether Ameridose has procedures and facilities necessary to safely produce and provide sterile drug products. At this time, there is no known contamination of products produced by Ameridose."
Related stories:
- Regulators say they had no clear power to stop outbreak
- Compounding pharmacies - heroes or outlaws?
- One man worries after getting tainted injection
Leave a Comment:
Having the FDA check all the medications going out to be used by injections, and otherwise, is the best thing for this country to do for it's people. Anything else now will suspect.
Some people will, of course, blame "socialism" for this outbreak, accusing the government (rightly so in this case) of failing to do an adequate job monitoring the drug supplies. But just imagine how it would be if there were no oversight, if the free market were allowed "to take care of itself." All drug manufacture would be outsourced to China, and half of the drugs imported look like the real thing but would actually be placebos.
Frankly, I think that the infrastructure of the United States is decaying fast, like that of the former Soviet Union. That's what happens when we spend so much money on wars and other shady enterprises overseas while neglecting our own nation's internal affairs. If Romney wins the White House, well... we ain't seen nothin' yet!
Wait until Romney cuts 24% from the federal budget (the estimated impact of Romney's tax plan by the Tax Policy Institute).
And then there's no CDC, no FDA the next time this happens.
Is that really what we want for the richest nation on earth?
. . . . Yes Mr Romney Less Regulation is What We Need . ..
In:
Drug Companies
Health Care
Wall Street
Banks with predatory lending pactices
Rich corporations that buy votes in Washington
Monopolistic Corporations.
Credit Card Companies
THAT WILL SOLVE ALL OUR COUNTRIES ILLS ! ! !
@Julkie, what a stupid comment. Republicans don't want excess regulation and government, but if you really believe that they want no regulation and government, you are very mistaken. Pathetic.
WHY would the FDA give a license to a pharmacy owner who is a trash recyclers and allow him to open it in the same building as his trash business and then wonder how cross contamination could have happened...
it's like opening fast food restaurant next to operating room and then complain when a french fries ends up in the patient...
A little common sense these days goes along way....when I have to show ID and sign a DEA register book to get (1) box of cold medicine
Kevin - Then why did they repeal Glass-Steagall?
(Repealed by Graham (R) - Leach (R) - Bliley (R), prompted by lots of lobbying money from Citibank)
Canada still has the restrictions on banking that Glass-Steagall created - which is why their economy and banking system is in better shape than ours.
. . . Thats Obvious . . .
Because the Big Banks Wanted to Play Casino with our Bank Deposits.
. IF they Hit 2 Six's . . Tons of profits for them & their share holder who bought the votes change the law
. If they Hit snake eyes No moral Hazard. Taxpayers pickup the bill. (hell id like a deal like that)
Senator Scott Brown "has agreed to donate ~$10K in funds received from his campaign to charity" after he wrote a letter of recommendation to loosen pharmacy regulations even further than they are now.
See Boston Globe article
HERE
If what Senator Scott Brown did by writing this letter was "aboveboard, legal and ethical", why did he feel compelled to take the action of donating these funds to charity?
Nothing happens by chance. Make your own conclusions.
When the smoke clears, the medical profession WILL BE at the top of the social hierarchy. This WILL BE so under socialism or capitalism or another other -ism.
Example: In the fall of 1981, the parent company of Tylenol controlled some 37% of the pain-reliever market, thus the free enterprise (market) system was working at its peak effectiveness (with this example). What happened in 1982?
Read my lips: Some people will not allow the free-enterprise system to work (recall the New Deal) - it's time and money. Extrapolate. Extrapolate.
@Julkie, because Glass-Steagall has WHAT to do with getting rid of the CDC and FDA??? Oh, right, NOTHING. Another pathetically WEAK, and pointless argument.
The point is that companies WILL NOT "do the right thing" without regulation. Banks or pharmacies.
Your lack of ability to make the connection (and take responsibility of the outcomes) is exactly what worries me about the GOP.
And what you originally said was that Romney would cut the budget (I hope he does), and get rid of the CDC and FDA, which is just stupid hyperbole. I like how you morph your comments to justify your original premise, which was totally bogus.
I also can't believe how many Democrats blindly gave you thumbs up. No wonder our country is bankrupt with (lack of) thinking like that.
Kevin,
The FDA used to regulate organizations like this. The law was struck down by the SCOTUS because of an advertising ban in 2002. No law has replaced it. The GOP has been in charge for the majority of that time. Have they made any effort at all to replace it? Nope. Neither have the Democrats, so they aren't blameless.
But just you watch. After an incident like this, the GOP will call for the FDA's budget to be cut.
The problem with this country is not precisely what you describe. It's that on both sides party comes first and country is second. Advancing an ideology is more important than solving issues. The GOP ideology is less government in all aspects. They won't let the FDA have the powers it had in the 90's.
Kevin, they themselves said their goal was to make government small enough you could drown it in a bathtub.
Removing "excess" regulations is just their code-speak for having NO regulations.
They also are wondering why a compounding pharmacy is sending out so much medicine.. Even the hospitals and clinics are looking for ways to cut the cost of Phamacuticals... So we are getting more from alternative places.. This is what will continue to happen because Big Pharmacy is so out of control.
Joy, pharma makes up about 6-8% of Health Care Spending. Out of control costs that hospitals deal with are med tech, accounting for upwards of 50% - that's right, half - of our health care dollars. You blame GSK, I blame GE. At least approved medications have demonstrated clinical utility, more often than not the expensive med tech diagnostics are CYA screenings where no other alternative exists.
Someone will go out of business.Hahahhaahha
I'm assuming this virus is just in the states and not in Europe, Asia or anywhere else?
It's unlikely that this compounding pharmacy was shipping out of the country. That's why only Americans are getting the contaminated shots.
Thank the GOP for exempting compounding pharmacies from FDA oversight.
"Actions have consequences", and when there's no regulation, profit margin always wins.
Compounding pharmacies need stricter FDA oversight
This is a GREAT example of the basic flaw in Romney's pipe dream of putting control (and financial responsibility) for all regulatory oversight in the hands of the states.
Big corporations are much more savvy and financially capable than state regulators - it's a classic "David and Goliath" battle, and we, the consumers, will be the ones paying the price.
It's a fungus, not a virus.
This is EXACTLY why we need more NOT less funding for things like the CDC and FDA.
And for peanut butter, chickens, eggs, beef, animal feed, milk, spinich, cantalope, orange juice, salsa, seafood, Foods and Drugs.
With the type of outbreak such as this tragic one, with over 14 thousand patients receiving these compounded doses, it certainly makes you wonder if something like this could be used as a terrorist tool...
How do you know it was not a test run!
Sloppy, greedy profit vultures with sloppy cheap working conditions and not enough employees to do quality work in pressured time range ARE terrorists and they are from the deregulated Capitalist for Profit Private Corporations. The biggest group running America.
Can you imagine the fear, the outright fear of those who got these injections - wondering -watching for any change in their metabolism? They should be monitored every day.
RE: MRS.BURBANK. I am one of those people.IT IS INSANE. Here we the people are trusting these pharmacies and doctors and for what? To now sit a wait hopelessly for some symptoms to kick in. This is bull if you ask me. They should be sued. wHAT ABOUT THE VICTIMS WHO HAVE ALREADY LOST THERE LIVES. FOR A SIMPLE BACK INJECTION. GO FOR A BACK INJECTION TO HELP WITH PAIN AND END UP DEAD.ARE YOU SERIOUS. THEY BETTER HOPE IM FINE. IM SUPPOSE TO GO GET MORE THE 15TH MONDAY. THEY THINK IM GOING I DONT THINK SOOOOO.......
And this is EXACTLY what drives up health care costs. 14 deaths from 14,000 injections. That is 0.1% of the patients affected. Sad, yes. Preventable, debatable. The point is, daily monitoring of the remaining 13,986 patients is a reactionary, expensive proposal. It is not in the interest of public health nor in the best interest of the regulatory agency to waste those resources. However, this is what the average American knee-jerk reaction would have us do. Logistically impossible and down right cost prohibitive.
Let's not pass safeguards for the public,let's just pass obamacare-2700 pages of unread crap designed to screw the middle class and seniors.
Since Obama does not seem to be interested in senior citizens, Obamacare might help get rid of some of us. Anyone past 70 is not on his preferred list. Without needed medicine some of the seniors would not live as long. I guess he forgot he will someday be over 70; but, then again with his millions of bucks he would have no problem getting his medication.
Gerri-367148,
You are so right!! LOL!!!
How can you honestly say the president does not care for seniors? His plans have eliminated the donut hole for citizens and if Romney/Ryan get elected seniors will pay more for their care. Face it, anyone in Congress or high political office has great health care and benefit packages - don't single out the president or just Democrats. Remember it was Romney who said people should take care of health care by getting insurance when they are young (you know, he means when they are healthy). Well, not all young people are healthy and as we grow older our medical needs/care increases - just aging alone. Romney has no plan for those with pre-existing conditions. In other words, if he wins, within his plan we will all have to find and pay for insurance and the older you get the harder that will be and more likely than not be refused because of pre-existing conditions. Of course, his overall plan is for those without insurance to go to their local emergency room - like he told college students to borrow money from their parents to go to college. All I can see is that Romney/Ryan will not be there for anyone, especially the elderly, the poor and those who cannot help their social-economic conditions.
And Romneys plan is identical to Obamas, so either way we are screwed... Plus lets not forget that Romney wants to give Wall Street our Social Security and give us a voucher for healthcare. Who do you think is going to suffer?
WOW just this morning i read 15 now its 200?? Hey msnbc are you sure its not 20? LOL
Pffft...why don't you try reading the article? The only thing funny here is your stupid comment! lol
It is 200 infected; 15 have died.
The FDA does not regulate pharmacies; pharmacies are regulated by the individual State Board of Pharmacy in each state.
Thanks to a Supreme Court judgement from 2002. It wasn't always that way. In the 90's they were FDA regulated.
But facilities such as this compounding pharmacy are also operating outside their licenses and their intended purpose. Their intended purpose is individual doses made to order. This facility was churning out thousands and thousands of doses of the same medication, making them like little drug companies without all that messy FDA oversight. Not all compounding pharmacies do this, but many do.
My Dad was a pilot in WWII and he said the workers that folded parachutes would occasionally be taken up to jump from an airplane with a parachute selected at random from the stack they produced. I think the CEO's of these drug companies should be injected with their own product from time to time. You can bet things would be cleaner than they are now.
If it was a cleanliness problem, you're right. But some steroids can make you sick if you take them for a problem that you do not have. Medicine is an educated opinion (by a highly trained physician) -- and not exact science. I had just gotten over cellulitis (approx. 3 to 4 weeks before) when I had a spot appear on my leg. The doctor naturally assumed it was cellulitis and prescribed medicine for it. Obviously, it was not cellulitis, and I was very sick -- diarrhea and vomiting profusely. I definitely had a reaction to the drug. Even the doctor said that. I had taken the same medication when I had cellulitis and the cellulitis went away. Probably a bug bite or something of that nature. It would be hard to get a CEO to be a guinea pig when medicine is involved.
What you do is a little something called quality control. Because compounding pharmacies are supposed to be making individual doses made to order, QC is a bit harder to do on such a small scale. But when compounding pharmacies are in essence producing batches like a drug company, QC ought to be required. Take some samples and test them!
People, wake up here! Why are hospitals, clinics, and pharmacies going to compound pharmacies for drugs in the first place? Hasn't been in the news recently, but haven't you all heard of the drug shortages? President Obama supposedly signed legislation to help with the situation. Let me tell you, I'm a pharmacist in a hospital and we have seen NO relief in shortages! Drug shortages are the worst in the past few years then ever before! We struggle just to provide lidocaine for pete's sake! Not sure where you all are coming with Romney in all this. He hasn't been in power the last 4 yrs. Drug shortages is a very serious problem and no one has been talking about this at all during this whole meningitis outbreak.
Where are the drugs going? Overseas? the highest bidder?
One of my kids was in a children's hospital when she was an infant. They have their own compounding pharmacy on site and are licensed by the state. My kid avoided surgery and quite possibly owes her life to the meds that were made up fresh just for her each week for several months. The doctor prescribed an off-spec use of an adult med that solved her medical issues, the adult meds had to be made into a suspension at the proper dose for a baby, as a pediatric version of the drug did not exist. Compounding pharmacies do have their place, the big drug companies are not going to make up one pill at a time for one person, even if it is a life-saving procedure.
Why are they blaming Romney? Typical liberal reaction - when something goes wrong, it must be the Republicans' fault!
Romney is not being blamed. But people like me are more than willing to point out that what he is proposing is not going to solve problems such as this and will, indeed, make them worse.
Yes drug shortages are a problem. If you are truly a hospital PharmD, you would know that methylpredisolone is NOT in short supply...you can get it in basically every dosage form, both brand and generic.
IMHO blah blah blah .. blah blea blo blah.
That's the smartest thing you've ever said.
I know a lot of people who have been helped by these shots. Sad to see something so helpful now is causing deaths and/or serious health problems.
I also know how companies skirt the FDA all the time. It is ridiculous to even consider weakening the FDA. In fact, they need far MORE resources and regulation. I know this was compounded domestically but perhaps the underlying drugs came from overseas.
Imported meds, and even ones mfr domestically, are a major problem. Generics help many people who otherwise can't afford prescriptions but they seem to be getting worse and worse. I sat there in the doctor's office this week going over where we could cut back and use generics but it was scary to hear from him what he knows. He has no skin in the game and is a good family friend also so this was his unbiased opinion.
Someone needs to go to jail.
I agree but...
If Romney wins, all the victims will go to jail, dead or alive.
Compounding companies will get gold medals for meritorious service to the nation.
And theri CEOs will get multi million dollar bonuses.
Boy, you are reaching. This has nothing to do with Romney. You're just afraid if he wins, you'll have to get a job.
He is reaching but so are you, savant99. Romney's proposals for fewer regulations won't prevent an incident such as this from happening again. And it is a classic case of why federal intervention is needed. Tennessee, where most of the folks who got sick are from, doesn't have the resources to send inspectors to all 49 states where drugs may be bought from. (Might be a legally gray area too.) And Tennessee can't exactly dictate to Massachusetts what their drug laws ought to be. The best Tennessee can do is wait for an incident such as this and then prohibit compounding pharmacies from Massachusetts from shipping their goods to Tennessee.
Hmmm, and the regulations we have did a great job preventing this, didn't they? Unbeknownst to the simpletons who blindly follow partisan politics, this is not simply about MORE or LESS regulation. This is about creative EFFECTIVE regulation.
I live in TN, and you are right, infrastructure here is strapped. But the root cause is not lack of federal intervention. It is the policy that TN has voted into place. Did you know we have no state income tax? Do you know that the majority of TN citizens like it that way? Great on pay day. Bad when you hit that pothole in the road. Additional federal oversight will magically fix decades of poor decision making. Additional federal oversight will only stretch current budgets more thin, monitoring compliance of companies that didn't comply in the first place. Brilliant plan only if you have your party's blinders on. Bad plan if you think independently.
There are no serious regulations for compounding companies.
They just open up bulk shipments and repackage them in the moldy atmospheres of their factories.
So medicines plus mold equals meningitis and people die.
THIS is a perfect example why the private sector needs to be regulated by a responsible entity like the FDA.
The FDA isn't a responsible entity.. they take money from Companies as a bribe to get the newest drug appoved and sent out to market.. Read up about it.
population control!!!
Simple baking soda cures fungus, as well as cancer. Used in other countries with success.
Baking soda cures cancer, huh?
Maybe on your home world, the planet Bizarro, but not here on Earth.
Yeah, everybody knows its Windex that cures cancer....
End sarcasm
And Bullsh*t grows hair on a bald man... or bald woman.
Yopu know very well why this "outbreak" Happened........... All those illiegals coming over the board that hasn't any medical shots, that's why.
Again, this is another case of companies who said they can verify their operation themselves. Because getting the most profit of every product safety of the people who use the medicine become secondary and forgotten. Corporations cannot do this operation themselves and needs Federal oversight and inspections. We see this in industry after industry jeopardizing the safety of American consumers. People die from this failure of having safety of the product safe. Wake up to the Republican falsehoods over deregulation.
This compounding pharmacy was not under FDA oversight. This is what the GOP wants for our country. Less regulation and more wreck and ruin. I had no idea what treating these unfortunate people involved. Months of treatment with anti-fungals. This company should be forced to close. I read that in the past there was another case of this fungal meningitis from this same pharmacy. God be with these affected people.
I know from experience, my brother took medication for fungal infections of his nails - very strong drugs that could cause serious damage to the liver, kidneys, possibly other organs. All of this is very frightening.
We have two large hospital groups in the area I live and immediately our media and newspapers said patients in our area did not receive drugs from this or any other compounding pharmacy. Why must these drugs be manufactured in this way or why are the patients in our area receiving different forms of medications? Is this procedure similar to when chemo nurses mix drugs for cancer patients?
Why is it so hard to find all those folks who received the injection and then get them treated and tested....beat this thing to the punch...as the article says if caught early perhaps they can prevent worse outcomes....
Where are they purchasing the anti-fungal drugs?
For #23 CHINA????
Maybe these people who are getting these shots needs to be tested to see if they are carrying the gene that causes meningitis to start with. I have a friend who takes these shots through VA. He hasn't had one since way back, but will have to have them as part of his treatment of his ailment.
Just another example of the greatest country in the world! It's amazing our government officials can accomplish anything. What with their inflated salaries and ballooning benefits, it's wonder they have anytime at all to perform their jobs. Both government administrators and company CEO's are raping America blind! I'm going to vomit the next time I hear a politician claim what a great country this is. They either think we are all stupid or patriotically gullible. Here's another example of some government organization fixing a problem after the cat is out of the bag. There's suppose to prevent this sort of thing from happening. What do you think they get the big bucks for?