The FDA is effectually banning something safe and helpful to some people for no good god damn reason. This is exactly the thing people should rail against the government for. That's what the fuck I'm talking about. You apparently enjoy government dick up your ass.
The FDA is effectually banning something safe and helpful to some people for no good god damn reason. This is exactly the thing people should rail against the government for. That's what the fuck I'm talking about. You apparently enjoy government dick up your ass.
Hayabusa Rider
Admin Emeritus & Elite Member
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One of the great freedoms of the internet is that without any knowledge of the subject you are able to be critical of those that do. The feeling of freedom that comes with ignorance must be heady stuff indeed.
Oh, get real. This company should be made to meet the same onus of proof as other companies. If the drug isn't patentable, and the market is saturated, as you say, a simple bio-equivalence study wil do. It's the same procedure every generic company has to go through today.
Quit your anti-establishment whining.
Look, I go on the information before me just like everyone else. If there is an error in the articles feel free to point it out. Otherwise, with all due respect, STFU on my supposed ignorance.
What's up with you being so anti-healthcare reform then coming to the government's defense when they take someone's medicine away? I'll make you a deal, we can talk about my ignorance if we talk about your logical inconsistancy.
Hayabusa Rider
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It must be my turn to have a bad day.
The problem in a nutshell is this:
Hypothroidism (the only reason that one would take any of this stuff) requires medication. There is no other way to manage the disease. Contrary to what is out on websites, I and others have seen more trouble regulating metabolism with it than L-thyroxine. Part of that is that the amount of hormone needed is minute, with some people responding adequately to as little as tens of micrograms. Typically, we are talking 100 mcg or less for treatment. Many of the sites refer to dessicated thyroid as being superior because it's "natural". Well that means nothing of itself. You can find some foxglove, make an extract and drink it. If you have CHF, or "dropsy" as it was once known, you can certainly improve the condition. It's certainly cheap. The problem is that it can kill you. Why? Not because of anything in it, but plants (and thryoid) contain different amounts of active ingredient not directly related to weight. In many cases this would make little difference, but there is something known as the therapeutic index. Like digitalis and the other cardiac glycosides, thyroid has a narrow index, which means there isn't a great deal of difference between the amount that helps and the amount that kills. This is serious stuff, and while deaths are indeed rare, there is variation from lot to lot which can cause metabolism to be high sometimes and low the next. The feedback mechanism which controls this is highly sensitive, but that doesn't exist because someone is chomping down pills rather than having it released as appropriate. It's the very devil to get right, and with thyroid it's like playing whack a mole.
Now there are problems with treating thryoid, and some of the sites refer to them. One of the more serious is that we measure the active metabolites and determine how much to dose based on that. For the majority of patients, this works, but there is a significant population which doesn't correlate. That creates problems because to get relief of symptoms one sometimes has to increase to the extreme upper end of dosing, and it doesn't take much more to kill a person.
One thought is that there may be a receptor problem which makes a person resistant to thyroid hormones in a way that's analogous to type II diabetes, and no one is particularly pleased with this medical reality. That isn't something that thyroid "cures". It's a real problem and much needs to be done, however that's unrelated to L-thyroxine in and of itself.
Another thing is that a claim is made that this is an attempt to force people to take a more expensive patented medication, when in fact thyroid is more expensive and has been off patent for many years.
So there is a "conspiracy" to take a "less expensive" "harmless" drug off the market in order to force people to take a "patented" "dangerous" "more expensive" one.
It doesn't hold up.
Besides you are forgetting that the FDA has some latitude in what it does, but Congress is the driving force here. There is something known as DESI (look it up) which has been a pain in the neck to deal with. If anything the FDA has been dragging it's heels on a lot of things, and yes I do agree that they haven't everything right.
That said, it's best to be critical of things which are rather than inventing a crisis and sticking it to them based on that.
.
The problem in a nutshell is this:
Hypothroidism (the only reason that one would take any of this stuff) requires medication. There is no other way to manage the disease. Contrary to what is out on websites, I and others have seen more trouble regulating metabolism with it than L-thyroxine. Part of that is that the amount of hormone needed is minute, with some people responding adequately to as little as tens of micrograms. Typically, we are talking 100 mcg or less for treatment. Many of the sites refer to dessicated thyroid as being superior because it's "natural". Well that means nothing of itself. You can find some foxglove, make an extract and drink it. If you have CHF, or "dropsy" as it was once known, you can certainly improve the condition. It's certainly cheap. The problem is that it can kill you. Why? Not because of anything in it, but plants (and thryoid) contain different amounts of active ingredient not directly related to weight. In many cases this would make little difference, but there is something known as the therapeutic index. Like digitalis and the other cardiac glycosides, thyroid has a narrow index, which means there isn't a great deal of difference between the amount that helps and the amount that kills. This is serious stuff, and while deaths are indeed rare, there is variation from lot to lot which can cause metabolism to be high sometimes and low the next. The feedback mechanism which controls this is highly sensitive, but that doesn't exist because someone is chomping down pills rather than having it released as appropriate. It's the very devil to get right, and with thyroid it's like playing whack a mole.
Now there are problems with treating thryoid, and some of the sites refer to them. One of the more serious is that we measure the active metabolites and determine how much to dose based on that. For the majority of patients, this works, but there is a significant population which doesn't correlate. That creates problems because to get relief of symptoms one sometimes has to increase to the extreme upper end of dosing, and it doesn't take much more to kill a person.
One thought is that there may be a receptor problem which makes a person resistant to thyroid hormones in a way that's analogous to type II diabetes, and no one is particularly pleased with this medical reality. That isn't something that thyroid "cures". It's a real problem and much needs to be done, however that's unrelated to L-thyroxine in and of itself.
Another thing is that a claim is made that this is an attempt to force people to take a more expensive patented medication, when in fact thyroid is more expensive and has been off patent for many years.
So there is a "conspiracy" to take a "less expensive" "harmless" drug off the market in order to force people to take a "patented" "dangerous" "more expensive" one.
It doesn't hold up.
Besides you are forgetting that the FDA has some latitude in what it does, but Congress is the driving force here. There is something known as DESI (look it up) which has been a pain in the neck to deal with. If anything the FDA has been dragging it's heels on a lot of things, and yes I do agree that they haven't everything right.
That said, it's best to be critical of things which are rather than inventing a crisis and sticking it to them based on that.
.
As Hyabusa points out, the differential between what they are moving and what's currently on the market is minute. My wife pays something like $20/mo for the *ACTUAL* Synthroid (she doesn't like the fillers in the generic). Generic is about $10/mo, if not less.
As Hyabusa says, the amounts taken are *VERY* minute. When she first went onto the pill she was taking 40mcg. Now she's taking 130mcg, mainly to keep her T-levels low, preventing future growth of cancer. The pills she takes can be measured in millimeters.
Furthermore, as Hyabusa said, the actual problem with people who suffer severe hypothyroidism isn't the thyroid hormones themselves, but the imbalance created elsewhere. Despite having a higher dosage of Synthroid, she still has had huge problems with her metabolism, most of which have been fixed now.
The "natural" occuring levels that are supposedly missing from Synthroid, and others, can be created in the body in other hormonal organs, not just the Thyroid. Her levels are just fine.
Again, you're making a huge deal out of NOTHING. The drug companies will gain NOTHING from this. You need to get off your ignorant high-horse.
I'm not going to pretend to know the ins and outs of Thyroid treatments. As impressive as that all is, it's irrelevant to the issue at hand. The issue is that the government is taking away medicine from people who feel it's the best option for them. Period. Bottom line. That's it. Everything else is extraneous. People should be the ultimate authorities on what goes into their own bodies. Not government. Not insurance companies. And not even doctors. And the people previously making that decision for themselves are now being denied. Not because of any new safety concerns. Not because of new efficacy concerns. Apparently just because the FDA says so. Also irrelevant is the expense of the drugs in question. The FDA is directing funds away from one set of companies and towards another. But of course, government would never take action just to pad the pockets of a company. That's just crazy talk. Did you even go to my second link? There is more information than just from the first article. And much more if you follow the links from there. Plus a lot of comments from people who must have some reason to be going to thyroid.about.com. And none of them seem to have such a passive attitude to this news. Seems to be a big deal to them. Maybe they should just know better.
You just ignored the entire mandate of the FDA. Go read some Upton Sinclair and get back to us when when you're done. After that, maybe you can educate yourself on a cause before you take up its cross. Bottom line is that you have no fucking idea what you're talking about.
Meaning you just can't be bothered to lookup the real reason. Posters have explained to you that name brand marketed drugs are often preferred over generics in spite of their increased cost because of the stability of the drug - particularly for this indication. Drug stability is one of dozens of facets of pharmacueticals that the FDA regulates. Armour Thyroid has known cardiac side-effects, which due to the T3 levels it contains, making drug stability an issue. A quick search of the FDA's website turns up numerous instances where there have been stability issues with Armour Thyroid. This has been an ongoing issue. Outside of the advocacy groups you've linked to, I can find little other information. The FDA has likely ordered Forest Laboratories, the makers of Armour Thyroid, to stop production, get their their shit together, and meet the drug stability requirements - and they've likely done it quietly to save them embarassment and falling stock prices.
Your about.com artcle blasts MedCo over an alleged conspiracy against 'natural dissecated thyroid' (quotes because it comes from pigs) in favor of MedCo's own synthetic version, and yet Forest - the company who produces Armour, also produces Levothroid, which is a synthetic thyroid, itself. This theory you have about 'Big Pharma' being in bed with the FDA over something as petty as a thyroid treatment is asinine.
Hayabusa Rider
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What you don't seem to understand is that the vast majority of people are completely unqualified to know what's best for them. If you disagree, ask some thalidomide kids.
You'll probably not like the analogy, but it's like giving 8 year old kids loaded weapons and telling them not to shoot.
Do they teach courses in arrogance in whatever medical field you are in? Everything doctors learn in med school is "out there" now for anyone interested enough to look for it. No doctor is motivated as much as a patient to make themselves well. Anyone can learn more than any doctor about what specifically is wrong with them. I rather take a chance at shooting myself than have some doctor that doesn't really care about me or practice anything beyond what Pharma tells him to do it for me.
Hayabusa Rider
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I said you wouldn't like it. Frankly I don't mind if someone wants to chomp down on whatever. Be my guest. Just don't ask me to be sorry because they thought the internet replaces education. Sure you can find anything on the web, and that's a problem. No context. But again go for it. My particular issue is that someone with a monitor, keyboard and a mouse figures they can make these kinds of decisions for their kids. The argument is probably that since they are yours you can do anything you like with them. That's where I would have a problem.
Well thank god we have the FDA looking out for us and our kids:
http://www.youtube.com/watch?v=dBnniua6-oM
All those educated doctor types too. Great job! :thumbsup:
Hayabusa Rider
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I'm not going to bother to click on the link for the moment. I assume it's some condemnation of the FDA which may or may not be justified? Close?
In any case there is much about the FDA (and most government agencies) which needs to be addressed. In this case I can see their point (from a medical perspective that is). Looking for me to say what a good job government does? I think they suck at healthcare and that's my objection to politician run medicine.
YMMV.
In any case there is much about the FDA (and most government agencies) which needs to be addressed. In this case I can see their point (from a medical perspective that is). Looking for me to say what a good job government does? I think they suck at healthcare and that's my objection to politician run medicine.
YMMV.
Watch it and you tell me if warrants condemnation of a whole bunch of people for the last 30 years or not. It makes the whole establishment look either stupid or criminal. Not the people I want deciding what goes or not goes into my body for reasons very clear in the vid.
Wow, nuts...
This is like when they banned ephedrine for killing people and then on the very first page of the detailed report admitted they had no proof linking it to any to any deaths--but hey I'm the only one I know who read the actual report instead of just the press release...no one will both here...good luck. (don't/didn't ever use that product but come on, if you are going to ban it because it's a precursor to making meth just friggin say so.)
This is like when they banned ephedrine for killing people and then on the very first page of the detailed report admitted they had no proof linking it to any to any deaths--but hey I'm the only one I know who read the actual report instead of just the press release...no one will both here...good luck. (don't/didn't ever use that product but come on, if you are going to ban it because it's a precursor to making meth just friggin say so.)
halik
Lifer
- Oct 10, 2000
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But why be rational, when you can put forth some sensationalist headlines and hyberboles?
I'm glad FDA is regulating all those herbal BS products, next step penis enlargement pills.
If you want to bitch about FDA, do it because they sway to political pressure like no other (OTC morning-after pills anyone?), rather than corporate pressure.
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