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Fungal Meningitis Safe From Burdensome Regulation
Our Regulations, Our Selves: If we could take de-regulation and inject it directly into our spines, this is what it might look like.
At least eight people have died so far, 105 have been sickened, and thousands more have been exposed to fungal meningitis as a result of being injected with tainted steroids. The disease leads to swelling of the brain and central nervous system, can last for months, and can kill patients with weaker immune systems or patients who are exposed to large doses. The steroids were mixed in a mass-producing compounding pharmacy, New England Compounding Center Inc., in Framingham, Mass., which essentially does what your local pharmacist does, mixing up medicine, except on a massive scale.
Outrageously, this industry is not regulated by the Food and Drug Administration, thanks to heavy lobbying and long legal battles to keep it that way. Instead, it is regulated in only 17 states, which use quality-control guidelines set by the industry itself. This tainted batch of steroids is only the latest in a series of such incidents involving compounding pharmacies, Reuters notes, with infections of meningitis, Hepatitis C and other diseases occurring "repeatedly in the last decade." The Wall Street Journal notes that the FDA, having failed in Congress and in court to win oversight of the industry, has been helplessly warning for years of the dangers of compounding pharmacies, citing "devastating repercussions" from these drugs, including "three patients dying of infections from a drug used to paralyze the heart during surgery and two patients at a veterans hospital who were blinded by a compounded product used in cataract surgery."
The FDA is still fighting in court to win oversight of the industry, and Reuters notes the battle may eventually get to the Supreme Court. That is cold comfort: The Supreme Court is where Justice Sandra Day O'Connor wrote an opinion in 2002 closing one avenue for regulation of this industry to the FDA, the WSJ writes. It is doubtful that the Roberts Court will be much more sympathetic to the FDA's pleas. This is a court that may be the most corporate-friendly, anti-regulation court in history. It is the court of Citizens United, a court in which the Chamber of Commerce had a perfect 7-0 record in the latest term -- the first undefeated term for business interests at the high court since 1991, according to the Constitutional Accountability Center.
So every time you go to a hospital and get injected with one of these compounded drugs, you will likely continue to get a shot of de-regulation right into your blood stream or central nervous system, your heart or your eyeball. Best of luck.
http://www.huffingtonpost.com/2012/10/08/seven-and-a-half-things-you-need-to-know_n_1949504.html
At least eight people have died so far, 105 have been sickened, and thousands more have been exposed to fungal meningitis as a result of being injected with tainted steroids. The disease leads to swelling of the brain and central nervous system, can last for months, and can kill patients with weaker immune systems or patients who are exposed to large doses. The steroids were mixed in a mass-producing compounding pharmacy, New England Compounding Center Inc., in Framingham, Mass., which essentially does what your local pharmacist does, mixing up medicine, except on a massive scale.
Outrageously, this industry is not regulated by the Food and Drug Administration, thanks to heavy lobbying and long legal battles to keep it that way. Instead, it is regulated in only 17 states, which use quality-control guidelines set by the industry itself. This tainted batch of steroids is only the latest in a series of such incidents involving compounding pharmacies, Reuters notes, with infections of meningitis, Hepatitis C and other diseases occurring "repeatedly in the last decade." The Wall Street Journal notes that the FDA, having failed in Congress and in court to win oversight of the industry, has been helplessly warning for years of the dangers of compounding pharmacies, citing "devastating repercussions" from these drugs, including "three patients dying of infections from a drug used to paralyze the heart during surgery and two patients at a veterans hospital who were blinded by a compounded product used in cataract surgery."
The FDA is still fighting in court to win oversight of the industry, and Reuters notes the battle may eventually get to the Supreme Court. That is cold comfort: The Supreme Court is where Justice Sandra Day O'Connor wrote an opinion in 2002 closing one avenue for regulation of this industry to the FDA, the WSJ writes. It is doubtful that the Roberts Court will be much more sympathetic to the FDA's pleas. This is a court that may be the most corporate-friendly, anti-regulation court in history. It is the court of Citizens United, a court in which the Chamber of Commerce had a perfect 7-0 record in the latest term -- the first undefeated term for business interests at the high court since 1991, according to the Constitutional Accountability Center.
So every time you go to a hospital and get injected with one of these compounded drugs, you will likely continue to get a shot of de-regulation right into your blood stream or central nervous system, your heart or your eyeball. Best of luck.
http://www.huffingtonpost.com/2012/10/08/seven-and-a-half-things-you-need-to-know_n_1949504.html
Yes and the conditions of the lab were bad. There was black mold on the ground. Apparently someone tried to go in later and clean it up with bleach, but too late.
I definitely will be doing that, right now I have a kid on my lap and one screaming to play games on the computer. LOL, its easier to give in! Nite all
Listen to the NPR link that Dsert posted when you have some down time. It is really informative.
I certainly wouldn't blame the Governor over this but in my opinion it is a good example of how we need Federal regulations to protect the public from this sort of thing. If it is to be regulated by the State then the standards and regulations need to safeguard that this never happens again.
I certainly wouldn't blame the Governor over this but in my opinion it is a good example of how we need Federal regulations to protect the public from this sort of thing. If it is to be regulated by the State then the standards and regulations need to safeguard that this never happens again.
I heard they stopped putting some kind of preservative in the shots and that's what caused the problem.
All I know is people are dying and someone better be held accountable! Its getting a might ridiculous. Every single week its something that is killing people or making them . Usually contaminated food. Im glad I refused those injections in MY back.
My husband heard that on the radio earlier today.
Yep, Gov Romney voted against regulating that pharmacy.
Yep, Gov Romney voted against regulating that pharmacy.
Did I hear correctly that there may be political implications here in terms of accountability?
Someone mentioned that Governor Romney had the opportunity to regulate that very pharmacy in 2002 and decided against it due to some intense lobbying on their behalf?
I don't have a written text, so it was hard to remember the details.
Interesting...
Someone mentioned that Governor Romney had the opportunity to regulate that very pharmacy in 2002 and decided against it due to some intense lobbying on their behalf?
I don't have a written text, so it was hard to remember the details.
Interesting...
I haven't heard about people dying from vitamins or supplements
They are dying from de-regulation of the pharmacy industry.
They are dying from de-regulation of the pharmacy industry.
Two dozen dead and still counting. Thanks for the link, I will check it out now.
http://www.npr.org/rss/podcast/podcast_detail.php?siteId=7454969
Ths was covered in an excellent manner on Talk of the Nation this afternoon.
Don't let the fact that it's broadcast on NPR scare you. Neal Conan is very evenhanded, well respected, and almost all his guests - Liberal and Conservative - seem genuinely pleased with his questions and the quality of the call-in responses. What Talk Radio should be.
The concept of copounding pharmacies was supposed to be individualized Rxs - not mass shipments unregulated by the FDA. Whether you believe enforcement of current regulations or additional regulations is the answer, we have two dozen people dead because there are some things that the federal gvernment does way better than individual states. 'States Rights' is the lamest buzz phrase since George Wallace used it to block kids from going to school. And yes, there are some things States can do better. Quality control of pharmaceuticals doesn't seem to be one of them.
Ths was covered in an excellent manner on Talk of the Nation this afternoon.
Don't let the fact that it's broadcast on NPR scare you. Neal Conan is very evenhanded, well respected, and almost all his guests - Liberal and Conservative - seem genuinely pleased with his questions and the quality of the call-in responses. What Talk Radio should be.
The concept of copounding pharmacies was supposed to be individualized Rxs - not mass shipments unregulated by the FDA. Whether you believe enforcement of current regulations or additional regulations is the answer, we have two dozen people dead because there are some things that the federal gvernment does way better than individual states. 'States Rights' is the lamest buzz phrase since George Wallace used it to block kids from going to school. And yes, there are some things States can do better. Quality control of pharmaceuticals doesn't seem to be one of them.
How do we go about making the companies accountable without thr regulations?
So every time you go to a hospital and get injected with one of these compounded drugs, you will likely continue to get a shot of de-regulation right into your blood stream or central nervous system, your heart or your eyeball. Best of luck.
LOL...that's amusing. NO drama there at all.
It's not the regulation that's the problem, it's the compliance. Almost every single story reminiscent of something like this is going to include a company with a background of noncompliance...not following the rigid standards.
We don't need more regulation, we need enforcement and for companies to be freaking accountable.
LOL...that's amusing. NO drama there at all.
It's not the regulation that's the problem, it's the compliance. Almost every single story reminiscent of something like this is going to include a company with a background of noncompliance...not following the rigid standards.
We don't need more regulation, we need enforcement and for companies to be freaking accountable.
Hoping they regulate the Vitamin industry and holistic/alternative medicine industry as well.
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