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Subscribe to RSSMore contamination has been confirmed in additional vials of drugs produced by the Massachusetts compounding pharmacy blamed for the ongoing outbreak of fungal infections that have sickened hundreds and led to 36 deaths.
But federal health officials said there’s no evidence to date that the new drugs have sparked any additional outbreaks of fungal meningitis or other illnesses.
New laboratory results show bacteria and fungi present in unopened vials of three drugs different from the injection epidural steroids produced by the New England Compounding Center of Framingham, Mass., and already implicated in 541 infections, federal health officials said in a health alert released late Monday.
The contaminants include a dozen types of Bacillus bacteria and fungi species including two types of Aspergillus, plus Cladosporium and Penicillum. Some of those organisms, including Aspergillus fumigatus, are known to cause human disease, the Centers for Disease Control and Prevention said.
The federal Food and Drug Administration had previously found several types of Bacillus bacteria in two additional drugs made by NECC. The three drugs confirmed to be contaminated include injection betamethasone, a steroid to treat inflammation; triamcinolone, which treats severe itching; and cardioplegia solution, which is used in heart surgery, the CDC said.
Some patients have reported illnesses after receiving the drugs, the CDC said. Some patients have even developed inflammation of the central nervous system membranes after receiving the drugs.
However, health officials said they have received no laboratory-confirmed reports of bacterial or fungal meningitis, spinal or para-spinal infections caused by those products. The original infections were linked to tainted methylprednisolone acetate injections.
“Data do not, at this time, support evidence of an outbreak of infections linked to usage of non-methylprednisolone NECC products,” the agency said.
Because there’s a chance the tainted drugs could cause illness, CDC officials urged doctors and other health care providers to be alert for signs of fungal infection in patients who received the additional medications.
About 14,000 people received the tainted epidural steroids, which have been linked to infections in patients in 19 states. About two-thirds of new infections still being reported are not fungal meningitis, but rather abscesses, a condition called arachnoiditis and other infections.
Inspections at the now-shuttered NECC manufacturing site found evidence of environmental contamination -- including mold and other problems -- dating back to January.
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- Some infections thwart treatment in fungal meningitis outbreak
- FDA to Congress: Fungal meningitis outbreak could happen again
- Fungal meningitis victim hopes Congress hears: 'It's torturous'
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With these latest findings, on top of the previous deaths and illnesses, no doubt Congress will finally pass laws allowing the FDA to place regulations on the 7,000 compounding pharmacies requiring them follow the same strict conditions as drug manufacturing companies must adhere to.
Too late for all those who have suffered the consequences from the 2002 Supreme Court's decision which stripped the FDA of most of its power to do so previously. While Congress failed to give the FDA any power in 2003 or 2007.Just awful that such a company would every work under terrible site/
Remember when Mitt Romney said regulation was expensive and "job killing"?
He was Governor of Massachusetts at the time state regulators first found problems with this pharmacy. But he decided it was "too costly" to hold them accountable.
How much did this company's lack of regulation end up costing? How many people have been killed?
The GOP motto should "Penny wise, pound foolish".
Actually this company started getting investigated for all sorts of problems when it first started up in 1998. Then later similar issues crept up again2002. Then dragging into 2003 when Mitt Romney was Governor finally resolving in 2006. The wheels of justice do turn slowly don't they?
The information was turned over to the court. It was put on probation for three years, censured, required to be inspected multiple times and have improvements made at the facility with followups to verifying such had been made.
The following link is the Senate Committee report which covers what happened. As you know Mitt Romney left office 4 Jan 2007. It is normally not the position of the Governor to keep track of every department and what cases they get in the state. Especially concerning every business.
It is also clearly not his position he would have agreed to let this business go on creating an inferior product that could harm or kill people. We can go back and look at what the Supreme Court decided, which stripped the FDA of its ability to pass regulations forcing these companies to comply, same as manufacturing. Not the Democrats nor Republicans. Obviously not everyone can be stuffed in the same box and labeled.Who picks one example and says the whole group is therefore represented in politics?
Then again, in 2003 or 2007, neither party managed to come together and agree to pass the laws necessary to give it either. Not one man, in all fairness.Things are seldom that black or white, no matter how much we would love to make them so.
http://www.help.senate.gov/imo/media/doc/11_15_12%20HELP%20Staff%20Report%20on%20Meningitis%20Outbreak.pdf
Look up the re-count for Ohio in 2004: there were polling places that had more Bush votes than registered voters, and when the real numbers of registered voters was compared to the results, Kerry won, which means that President Kerry should have appointed different Supreme Court Justices. Those SC Justices that Bush appointed were very partisan Republicans, against any kind of safety regulations. This is the way of kings: absolute power corrupts absolutely.
Are you kidding me? Republican's will never let anyone pass more laws to regulate anything! We need to send a message to Congress, if you can't make us a nation that protects its population we don't want you working for us. Don't we give them enough money for what little they do? Why would they want to do more?
Imagine all of the products being produced overseas and shipped Stateside that have been found to be Contaminated or pose other Safety Risks!!! Also imagine all of the Medicines, produced here, that are Expired, or Banned from Sale here, etc. that are shipped overseas for re-sale, especially in Developing Countries and the 3rd World!!!!!
We need stricter Regulations that apply equally to all products whether from here or foreign in nature.
This is not a case of a "foolish" corporation, but murder incorporated. Where are the criminal indictments? Is corporate serial killing allowed because of the tobacco industry? Maybe they didn't notice the visible mold in their labs; it is their job to more than notice, but to look for problems before they occur. Certainly regulation is needed, but criminal indictments might be a deterrent also. And where are the criminal indictments against any corporate leadership in any company that knowingly puts poisonous additives, or neglects safety inspections for food or drugs, or cleaning, or any major neglect that is obvious even to the naked eye? This was not some kind of hidden problem in that building. There is no statute of limitations on murder, so we could wait dozens of years, and those executives could still go to jail for life.
It is just a Republican/Libertarian thing.
“Data do not, at this time, support evidence of an outbreak of infections linked to usage of non-methylprednisolone NECC products,” the agency said.
Because there’s a chance the tainted drugs could cause illness, CDC officials urged doctors and other health care providers to be alert for signs of fungal infection in patients who received the additional medications.
About 14,000 people received the tainted epidural steroids, which have been linked to infections in patients in 19 states. About two-thirds of new infections still being reported are not fungal meningitis, but rather abscesses, a condition called arachnoiditis and """"other infections"""".
Inspections at the now-shuttered NECC manufacturing site found evidence of environmental contamination -- including mold and other problems -- dating back to January."
This is just TOTALLY absurd to say the least!!!!!! My mother died May 11, 2011 a day after being diagnosed with spinal meningitis. She had Cancer and not long to live anyway, but the infectious disease Dr. whom dad and I spoke with (the day before mom's passing) looked at my father and I like we were crazy, for being so concerned and said "oh, don't worry, with the antibiotics she will be much better tommorow".
WTF, I'm a nurse and I
think(KNOW) our health care system is run by greedy @!$%#s who care little about patient /family care & Pharmaceutical Companies with no one to answer to so why bother doing things the right way when they can save a buck? When all this garbage started spilling out about about the meningitis and the tainted meds, I recall thinking "can I get mom's records? and what if ?)...it's not as if a light bulb went off saying "hey lawsuit $$$$"...I just wondered and do now more than ever. I was going to lose my mother regardless, but how many of these other folks lost their loved ones with the belief they were coming home soon and all for greed and carelessness. :(What RealAmerica1st said doesn't surprise me in the least, Romney is not only a Republicon...but a freaking LDS Cult member who along with his RICH, OLD , GREEDY, WHITE-MALE Bishops & GOP members ...CARE ONLY ABOUT THEIR OWN WALLETS...SCREW US LITTLE FOLKS PERIOD-END OF DISCUSSION!!!! Sad that so many meat-heads in America actually voted for this dimwit and never even researched his TRUE background of an absolutely STRANGE (to say the very least...so-called religion).
Thank goodness you people didn't "BLINDLY" lead us into a far worse mess than you could've ever imagined!!!
JACF-1410977:
You do know that whacky Harry Reid, that old white-man who leads the Senate, also belongs to that "so-called religion"!!!
JJ-
You do realize that he is a gay dem who is not really a mormon right? Do you know how many NOMOS there are out there who are dying to share the "TRUTH" of the "CULT"? All I ask is that people google Joseph Smith- the "CON MAN" from NY who had a "VISION" in the 1800's and in so little time the "MORMON EMPIRE" was born. ;) I'm not a nut, and never was a mormon, but I have studied the religion.
Mitt Romney was governor of Mass. when this compounding pharmacy started distributing tainted drugs. Romney said it would cost too much for 'his' state to hold them to the laws. Imagine how many Americans would die under a Romney regime with thinking like that.
Sue the State for negligence.
I find it incredible that the FBI is not involved. Using the current reasoning of leaving this investigation up to the FDA, why wasn't the investigation of 9/11 left up to the FAA?
Just another reason not to accept the ideology of the Ultra-Right-Wing Republican Libertarians. This wing has the goal of removing ALL Regulatory Agencies, etc. within the Federal Government and within the States.
What needs to be done, and must be done, is to repeal any obstructionist Laws against the Regulation of Corporations. Please, also, note that many other Corporations must be Regulated, both at the Federal Level, and at the State Level. Included is Banking, Mortgage Houses, Oil, etc.
Full Speed Ahead, and D*mn the Corporations and the Republican/Libertarians!!!!
PS: Apply, not only huge FINES, but Criminal and Civil Prosecutions against all violators.
You mean these drugs weren't from China?