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Subscribe to RSSInvestigators at the Massachusetts pharmacy linked to the meningitis outbreak say they found visible fungus, standing water and other unsanitary conditions at the facility.
By Jay Lindsay, Associated Press
Water from a leaking boiler collected just outside a room that was supposed to be sterile. Floor mats used by technicians were filled with dirt and debris. Drugs were shipped out before the company even confirmed they were sterile.
State officials said Tuesday that they found these and other problems at the New England Compounding Center during a preliminary investigation into the company, linked to a deadly outbreak of meningitis.
The probe can't yet conclusively prove what caused the outbreak, a top health official said. In the meantime, Massachusetts Gov. Deval Patrick said he wants to tighten oversight at similar companies, including with surprise inspections — the first of which happened Tuesday.
The state has also moved to permanently revoke the pharmacy's operating license, as well as the licenses of its top three pharmacists.
"Those whose laboratory practices caused this outbreak should never practice pharmacy or manufacture in Massachusetts again," Patrick said.
The outbreak of fungal disease including meningitis, an inflammation of the lining of the brain and spinal cord, has sickened 308 people, including 23 who have died, in 17 states. The outbreak has been traced back to a steroid made by the NECC and given mainly for back pain. Compounding pharmacies like NECC custom-mix solutions in doses or forms generally not commercially available.
The federal government is conducting a criminal investigation.
The state said Tuesday that its preliminary investigation, which began last month after the company was first suspected in the growing outbreak, found batches of drugs ready for general distribution but not labeled for specific patients.
Its state license permits the company to fill out only specific prescriptions for specific patients, and distributing drugs in batches like a manufacturer would violate that, said Dr. Madeleine Biondolillo, director of the state Department of Public Health's Bureau of Healthcare Safety.
But company attorney Paul Cirel said it's "hard to imagine" state regulators weren't previously aware of the scale of its operations because they've worked so closely together. The state Board of Registration in Pharmacy has always had complete access to the facility, and board members were there as recently as last summer, he said.
"NECC's transparency in dealing with the board since inception in 1998 demonstrates its good-faith intention to operate in compliance with the requirements of its license," Cirel said.
Besides possible state license violations, Biondolillo said the inspections also revealed "several health and safety deficiencies" at the NECC facility in Framingham, just west of Boston.
Three lots of steroids produced by the company are suspected in the outbreak, and the company shipped orders from those lots 13 times before receiving the results of its own tests to confirm those lots were sterile, Biondolillo said. Some medication was shipped as long as 11 days before the company received test results, she said.
Biondolillo also detailed signs of flawed sterilization procedures, including black specks of fungus in sealed vials of the steroids, which were returned to the company during a recall.
Investigators found the company didn't sterilize its products long enough and didn't adequately test whether its sterilization equipment was working, she said.
In addition, mats on which people wiped their shoes to remove contamination before entering a sterile environment were "visibly dirty and soiled with assorted debris," she said. And a leaking boiler adjacent to a pharmacy clean room left an unsanitary pool of water around it and the adjacent walls, she said.
As the investigation continues, Patrick's moves to increase oversight at the state's 25 compounding pharmacies have started.
The first of the unannounced inspections, to take place at least annually, was done on Tuesday, health department spokesman Alec Loftus said. He wouldn't give the inspected facility's name and said the results are being reviewed.
Patrick also said compounding pharmacies will now be required to file annual compliance reports that could help regulators determine if they are acting as manufacturers.
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Revoke their license??? How about Manslaughter charges...
Well let's not get too hasty and implement any of those job killing regulations. Best to kill people instead of jobs or profit. That's the American way.
Scott Brown gladly accepted campaign donations from this company!
Who owns this company? Why did they allow those dangerous conditions to exist? Instead of taking down the rich owner(s), they will probably go after the pill counters or some other lowlife that has no control or oversight over the sanitary conditions of this company. Either an absentee owner or another incompetent Desai have been raking in the immense drug profits and are responsible but probably will never come up for charges. They will just have the company pay a fine and go out and start another drug company. Who owns this company? Why are the owner(s) names not published so that the public can avoid dealing with them again?
lmao...don't hold your breath...they are human enough to donate to their favorite candidate but not to stand trial for their crimes...
Why is it that people have to die before Government gets involved? There should have been government oversight on all of these companies with unannouced visits.
In my area County Health runs continous checks on restaurants and labs etc. and issues citations ffor violations and if bad enough shut them down.
"Those whose laboratory practices caused this outbreak should never practice pharmacy or manufacture in Massachusetts again,"
Then they can move to Georgia, Alabama or any of the other "Red" states where jobs and business profits are Number 1 concerns.
According to the Massachusetts Board of Pharmacy website, the NECC (pharmacy) has "voluntarily" surrendered their licenses.
My company manufactured this drug in 5ml multiple dose vials in 40 and 80mg strengths in the 1980's and early 90's. The Arizona board of Pharmacy was incompetent at best. However since we were classified as a MANUFACTURER we were under the auspices of the FDA and routinely underwent CGMP inspections. We shipped 10's of thousands of units and never had a STERILITY issue. That said, the laws were overturned in the mid 90's gutting the FDA and transferring these inspection activities to the State Pharmacy Boards. Thus the fragmentation of inspection activities. There is something very wrong with this scenario. Blame the Republicans for this. Why isn't the Obama Campaign is not Jumping on this?
Don't worry. They will manage to escape criminal charges and may escape Civil Suits also.
Why? Pressure from Politicians and Big Pharmacy Companies.
If you want to see more dead Americans, vote GOP often. They say companies like this will police themselves.
Well if a company is in non-compliance of regulations- did the GOP write bad regulations ? Why don't you take a look at how well government agencies operate. You can write all the laws and regulations you want but if the rules are not enforced, they are useless. The MMS let Exxon write their own reports. Was that the fault of those who wrote the regulations ? Remember the deep water oil catastrophe ?
All this regulation crap is just un-Republican. Oops, I mean un-American, or do I? Vote GOP and get death panels of Zombie Capitalists. Sarah had the right words but applied them to the wrong activity. Did you see Alan Greenspan's face when he admitted to congress that he was wrong for 3 decades about the bankers regulating themselves? And congress still hasn't allowed regulation of derivatives. The next fiscal collapse may leave a pile of starved bodies. Until the GOP is run out of town by the voters (don't hold your breath) we will see more of this and other schemes to take people's money and leave them hurting or dead.
So glad that Romnesia and the Party of No want to get rid of all regulation!
Heck of a job, Party of No.
Torpedo, could you please repeat your message LOUD & CLEAR for all to hear??????? People constantly want to blame the FDA for everything, even though their numbers and powers have been gutted. Please, please, please, repeat this message over and over until people come to their senses. We need all the safety regulations and inspections possible so things like this do not happen. Thank you.
I agree with you M-3356206...GOP(Nazi) party bites the big one and their little ankle biters(Tea Party) included!!! The Nazi...I mean the GOP ever since Nixion on up have screwed America! I voted Yesterday(early voting)...EVERYONE please get OUT AND VOTE!!!! We dont need a Crazy&Crazier in the White House!
For Profit Drug industry fail....
We don't want to gubmit interference!
Ih ave two things to say. 1 is that the gobmit creates regulation to try and prevent cases such as this. And 2, Sam's Spring Ale is so far my favorite.
1. What is the Gobmit? Will there be a tv series about them/it? 2. Sam's Octoberfest is my personal favorite and worth the wait each year.
LOL who the hec took offense and collapsed my post?
Yes I have a 12 of Octoberfest now. delishous. But that Spring Ale really done dit it for me. Maybe it was the whether. LOL
I know. Why collapse our posts, NBC?
Its not them. Anyone here who doesn't agree with a post can click on the !. Silly idea to give people that power. Its someone posting here.
I smell a giant Suit of Law
... withdrawn
Just wondering how we would have found out about or even stopped these guys from producing their falty product without any government regulations.
I get shots in my knees on a regular basis and think they are safe - sad for everyone who got so sick from the callous disregard for safety.
KeenInsight-TFNJ-Zeivah
First, there are two types of regulations in place. Each state has its own regulations. Then Congress has passed some regulations as well. The greatest obstacle is that there is no uniform national blanket laws and one major significant one, but a patchwork of laws. in 2002, the Supreme Court struck down a case which would have listed compounding pharmacies as the same regulations as manufacturers. Since they were not, the FDA was stripped of most of its powers to force these companies to clean up their act. So what was left were mostly the states regulations.So the FDA filed warning, did inspections and had a complicated path to getting companies to comply.
In addition the FDA was constantly being sued by lawyers represented by these pharmacies, while in 2003 and 2007 Congress failed to pass bills which would have given the FDA the power to go after these companies by listing as manufacturers, but lobbyists fought long and hard and defeated these bills. Meanwhile other problems with products caused similar deaths, blindness and deaths to animals. It will take these deaths, I suspect, before the laws are finally passed to regulate these companies. All too late for those who have died and are suffering from the poor management.
Hmmm...........2003 to 2007. Who was president then, I forget? Maybe regulation would have hurt these businesses..............don't want that "interference"...........until people die and then it is Obama's fault he didn't do anything about it
Windancersong. Excellent post! The Media has not gone far enough in investigating the root cause and the issues facing the FDA in today's regulatory climate. Comon MSNBC give me a call and I tell you chapter and verse how this product should be made and the regulations under which this product was manufactured. I still have the Master Formula Cards and the Validation Protocols for this product!
MSNBC is not MSNBC any longer. Microsoft got smart...they are no longer affiliated with this right wing, kissing the president's ass network
I would think the state or town should have had some type of regulations or cleanliness standards to uphold, just as they would a restaurant. Perhaps there was confusion over what agency or whose domain would handle this type of a business.
The owners were clearly in over their heads and now they should be made to pay and pay dearly.
Strange. This should have been front page news..and yet, I found obscurely placed on the page. Meanwhile, no name mentioned of the culprits...must be foreign run or owned. When it comes to this country, we should be handling our own affairs, particularly health related. One day we all will realize that we are not on the same page and dont speak the same language, when it comes to priorities.
Since you regulary get shots for your joints, please check and re-check to be sure you are given a safe steroid. Ask as many questions as you can while you're at the pain clinic.
They have been investigating the steroids sent out by NECC and some of those include shots for knees and shoulders.
They are also checking into some of the serum NECC has sent out that is used during heart surgeries and also optical shots.
Is this a coporation? If corporations are people, and they cause death out of laziness. Why aren't they charged with murder? If I'm driving down the road and forget to pay attention to the road because I have more important things to do, and I kill you, I will get in trouble.
The owners and anybody associated with the manufacture of the drugs should be charged with experimenting on humans. That is the charge placed against previous company executives who disregarded federal drug and medical device laws.
It sounds like the state is already in the process of killing the corporation.
I don't think that's good enough. I think the company (and by extension those in charge) should have to pay people or their insurance companies every damned dime extra for their healthcare costs. Unfortunately you can't put a price on a life that is lost, but the courts try and it is usually not a small sum. In other words, unless the company shuts its doors due to the amount of cash going out the door and unless those in charge become so poor that they are cast into the "47%" there really is no justice.
Seriously?! I do this kind of thing EVERY DAY and I don't get mold in the things I sterilize. And I'm just doing research that is not intended for humans or animals! I mean really, it isn't at all hard to do. I could teach anybody to do it in less than 10 minutes. And it isn't expensive.
If it's autoclaved, it costs some water and a few kWh. In other words, a few cents!
If it's processed by ethylene oxide (EtO) the cost is the gas. EtO costs about $1,600 per TON. So again, a few cents.
If it's sterilized by gamma irradiation, that's a few kWh, or a few cents.
There is no excuse. NONE. These systems are automatic. Push a button and go do something else. It's not like you're paying somebody to watch the sterilizer.
I know exactly what these murderers were thinking. "Reduce the sterilization time by half, then we can sterilize twice as much, crank out more product, and make more money." 100% pure greed. That's not how it works. That's like cooking chicken to 82.5 F (half the recommended temp of 165 F) and saying "good enough, now I can cook twice as much chicken."
You can't cook chicken at 82.5 F, nor 165 F. Perhaps you meant Celsius. But a better analog would be cooking it at regular temperature for only half the time.
I cook my chicken at 350
"Corporations are people, my friend".................but sometimes they are not if it would hurt profits!!!!
Z, Pragmatoic meant to cook the chicken to 165 deg., not at. Most probably a typo.
With a modicum of common sense, you can understand w/out having to make rude comments. Geez.
Yes, that's correct. You can put chicken at 350 F for 2 minutes, the internal temperature won't increase that much. Food safety is all about the internal temperature of the meat and whether it is high enough to kill pathogens. 165 F is high enough for most chicken pathogens to be killed.
Food works differently from injections too. "Most pathogens" is okay for food, because it's all about what species survive and how many of them survive. When you're injecting something, it has to be "all pathogens" and it has to be every single one. This particular mold is very slow growing, which is why people may not exhibit ymptoms for many weeks, then suddenly they fall ill. It could be just a single spore that enters the blood stream. It takes a while, but it grows and when it grows enough, it causes trouble.
Here you go guys. Corporate non-interference at it's best. Wasn't it Ron Paul telling us we don't need "unecessary" government oversight?
But it wasn't the government oversight that was the issue here. It was people within the corporation who willfully disregarded those regulations. This isn't any different than somebody selling crack cocaine on the corner, except for the suits and ties to fool customers.
The state Board of Registration in Pharmacy has always had complete access to the facility, and board members were there as recently as last summer, he said.
"NECC's transparency in dealing with the board since inception in 1998 demonstrates its good-faith intention to operate in compliance with the requirements of its license," Cirel said.
Well, so much for "good faith transparency" if no one is REALLY looking...
I think it's an issue. They didn't do their job. If the company knew they were constantly under the gun, they'd do the right thing or have been shut down earlier, before drugs could become contaminated. Unsanitary practices are easy to catch. Unsanitary conditions are easy to spot. Any gaps in record keeping (which includes everything from drug handling and testing to facility maintenance) raises red flags.
And they should be held personally responsible.
Bruce Stern - grow up and stop trying to turn every discussion into something political. Find something constructive to do with your time. BTW, the correct spelling is "unnecessary".
Pragmatic-3918582,
I completely agree with you on both counts. I should have clarified my statement regarding oversight - I intended to say "federal government oversight". In this case the party responsible for oversight was the state of Massachusetts, who dropped the ball with inspections.
I still place the blame with the people within the corporation who were not in compliance with federal drug laws since they were operating as a manufacturer and failed to register as a manufacturer with the FDA. Ultimately, the government can't provide oversight of a corporation if the company doesn't comply with the laws and register. Otherwise, the FDA would have to investigate every company, like John Deere, to see if they are manufacturing a controlled drug or device.
The pharmacy must have broken the law with regards to FDA regulations once they shipped over state lines. I wonder what other states have this lack of regulation allowing pharmacies to become unregistered drug manufacturers.
Just another reason I almost always refuse medicines prescribed by a doctor until all non-invasive, non-drug options have been explored.
That sounds like an early death.
Please elaborate as to how exploring options that aren't designed to make pharmaceutical companies rich leads to an early death?
Most medicines today are simply quick fixes for people who neglect their own physical health. I for one believe that being proactive about health can lead to less problems, which leads to less need for doctor prescribed medications, plain and simple.
NeroMaj1,
Speaking from an FDA regulated company, you are right on target. Unless it is an emergency, never go into surgery, use an invasive device or take a new drug until you have investigated every alternative - including doing nothing.
Sometimes the cure is worse than the disease...
Lists of potential side effects don't even include possible incorrect formulation or production in unsanitary conditions. You're right armurray...the cure may well be worse than the ailment.
NeroMaj1, I totally agree. We must take responsibility for our own health and do our best to avoid medical problems. When they do arise, it is important to avoid medications and surgery unless absolutely necessary. For your own good, find a physician who feels the same, not one who holds the prescription pad in one hand and pen in the other. I have finally found just the right physician for me, listens carefully, recommends exercise, dietary modification, quit smoking, reduce alcohol intake, etc. If these fail, then and only then, does the prescription pad come into play. She then tries the simplest, least costly drugs. Of course, in a life-threatening situation, this would be completely different. But, perhaps using these measures, the life-threatening situation can be delayed or avoided.
As I do agree sometimes government regulations seem to be excessive, but it is times like this where you can fully understand why the regulations are there.
This will happen more and more if we remove regulations from business as Romney wants.
But this isn't a case of too few regulations. It is a case where a company didn't follow existing regulations and seems willfully disregarded them.
armurray, it's a case of having regulations but not having enough staff inspectors to make sure people are following them. Inspectors are government employees, and according to GOP dogma, can't do anything right and should be fired because the free market will self regulate (and cutting taxes on the rich will trickle down growth, and you can increase defense spending and lower taxes and the national debt at the same time).
So much for states rights...clearly the states are not up to the task of properly regulating and inspecting this type of business.
wryobsever, You are exactly right! When ever a politican spews "states rights", I think of the old adage "united we stand, divided we fall" and this is just one example of what can happen.
How dare they attack these job creators!!! We are over-regulated and the free market will make sure nothing like that ever happens again!!!
Of course such minor problems do not apply to banking and financial industry, right?
The Republican con men and the retards who trust them should be repeatedly injected with crap made by that pharmacy!
I think we all knew that this would be the case and the out come. We have a GREED driven society and the only thing that matters is how much gold you have in your pockets. We have no regulations for banks, wall street and medicine / medical. This company totally out stepped it’s State license and had been getting away with it for years. Greed killed these people and the ones that actually live through this horror will never, ever be the same person they were. After the fact, it will go to the court system, because that is the way we regulate things in America. We let the court system determine the regulations; well that will never give these people their lives back or make them whole again. When a society has no morals, values, ethics or empathy and it is solely based on greed, then we need to regulate these people. We live in a Country that will not properly regulate the manufacturing of medicine but will happily tell you what size soda pop you can buy at 7-11; pretty damn screwed up. My deepest sympathy to all the people this travesty has affected.
The survivors of the people who died from spinal meningitis caused by this contaminated steroid should sue the pants off the state of Massachusetts!
And Mitt Romney. No I don't have a logical reason to tie him to this, just thought it would make fun news.
I do. The NECC was in trouble with state regulators in 2002. Mitt Romney became governor of MA in 2002. He didn't follow up.
Hey, I love it when I accidentally create a smart post. LOL
Hmm, I have a feeling someone here doesn't like me and is collapsing my posts, yet too much a coward to come out and say so.
TFNJ, stay on-topic or it will lead to suspensions in the future.
We need more government oversight. You cannot simply trust corporate greed machines to protect the public's safety. How many more real-world examples do we need? Lord knows it's happened plenty of times.
... from Capitalism 1A
Corporations will regulate themselves.
Oversimplification...Capitalism in an extreme form might suggest no regulation is necessary, but no one I've heard of would suggest that solution. A combination of local, state, federal and professional society regulations usually work best.
RT, the regulations only work if there are enough inspectors to catch the cheaters and enough political will to throw them in jail.
In idealistic capitalism everybody plays by a mutually agreed upon set of rules. Like, say, a contract. Their own interests are preserved. Regulations are not needed because everybody agrees on the rules and plays by them.
In reality, people are greedy and will bend or break rules to promote their own self interest.
Think of regulations as being a part of the contract with a society. You can do business here, but you must abide by these rules.
Great, it's the company's defense that the government should have done more to monitor them. Wow. And, all these businesses are lobbying for less intervention. Who knows what americans are really consuming on a day to day basis.
Wow! In Italy they convicted seven scientists for failing to predict and warn the populace about an earthquake, they would probably draw and quarter the folks at NECC. In several states there is a precedence for filing criminal charges in what other states would categorize as Civil Tort. In Colorado, negligence is not enough, maleficence with negligence is necessary to meet the requirements for criminal charges. In Florida, manslaughter charges have been filed against both the Physician and the Safety Director of a Hyperbaric unit after a fire killed two. The NECC folks will need civil and criminal attorneys before this is over.
This is murder in my book. Someone(s) better be put away for a long time.
Wouldn't be surprised if that didn't happen.
We reap what Bush sowed... fewer regulations, less enforcement penalities, lax oversight, etc. means more profit for the drug companies that will police themselves... YEAH, RIGHT!!!
We need another debate so Romney and/or Ryan can be asked if they think this is another example of over-regulation that kills jobs.
Im sorry but as long as a company or physician gives you well warning of the dangers involved they should not be held liable. Its really the govt fault for giving a false assumption of saftey when it comes to domestic made pharms.
So you think in the drug discloser it said, “that you could die from a rare fungal meningitis because the manufactures are greedy, dirty pigs”. Could you show all of us that line?
David Severy,
I would agree with you if the drugs in question were approved by the FDA, like the way drugs in Europe and Canada are exempt from lawsuits if approved. That isn't currently the law, and wouldn't protect manufacturers if they manufacture incorrectly.
However, since these drugs were never approved or regulated by FDA, there should be no chance of liability protection even if following European or Canadian legal standards.
What? Quote: "Im sorry but as long as a company or physician gives you well warning of the dangers involved they should not be held liable. Its really the govt fault for giving a false assumption of saftey when it comes to domestic made pharms."[SIC]
Your kidding right? I was given these shots for my chronic pain, and never was I given ANY warning about the dangers... Thank Goodness I declined after 3 months worth of these shots, for what they cost me it was not worth it, i was paying cash.. over $400.00 a visit.. and that was cheaper than what they billed insurance companies for the same procedure because i paid cash.
David did you ever get these? you should try having some experience in these matters before you speak.On the contrary they say nothing because they do not want you to know what can happen, they just want money.. I know people who say they have gotten 3 times as many shots as they where supposed to, because they had good insurance.. and got billed $800.00 for what i paid $400.00 cash for. Its like a production line at these places, you are lucky to see a Real doctor on your visit, its done by assistants . one time, my leg went numb, and they where like.. oops, sorry your arm was supposed to go numb not your leg, let me try again.. that was my last visit by the way. I am lucky I stopped going, it turns out some of the stuff was shipped to my area. anyway do us all a favor and try to have some sense before posting B.S.
Are you serious??!?!?! They shouldn't be held liable for giving people medication filled with mold?!?!?!
We all understand the "normal" risks associated with any medical treatment. When I get these shots (and I just had one on Monday), I am provided a list of possible side effects, and I have to sign a paper saying I understand the risks. But nowhere on this list does it mention dying of fungal meningitis due to mold being in the vial of medication because the place that made it was filthy. But you're saying that's just something I should have to accept?
People are jumping all over you for a reason. A danger with a drug is usually a side effect. For example, a side effect of the anti-fungal medication these folks have to take is liver and kidney failure.
That is totally different from the improper handling and manufacture of a drug. The physician can't know whether the drug was handled in a clean manner, because they didn't oversee every step of the production process from bulk ingredients to final vial. That's what regulatory bodies (are supposed to) do, so the physician can concentrate on being a doctor of medicine and not an inspector of manufacturing. They can't account for the stuff that isn't supposed to be there.
What a world! The lawyer for the company blames the regulators for not regulating them enough.
This lawyer should have his head shoved in a vat of molten s**t..................Give me a friggin break with the same guy who would likely say we have too many regulations on pharmacy companies...........This lawyer should go to hell way before his scheduled time.
The state regulators need to be nailed to the wall also!
I wonder how much graft has changed hands, between the inspectors and the "Company" since 1998?
I really hope the state gets taken to court also!
Sic the DEA Diversion unit on these guys.
You can thank the FDA and the Supreme Court for these deaths.
Please explain what you are talking about. The FDA doesn't regulate compound manufacturers. I think you're late to the party and know little of the facts.
These plants should be completely closed down....oh wait, maybe Obama will use an executive order and let them stay open because of his Obama care.
Your comment is not worth the dignity of a reply........you are one sick person