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Original_Intent
SFN Regular

USA
609 Posts

Posted - 02/15/2007 :  21:54:27   [Permalink]  Show Profile Send Original_Intent a Private Message
quote:
Originally posted by Dave W.

And in a third list, put all the drugs that the pharmceutical companies have started working on, but dropped prior to FDA approval. For every drug approved by the FDA, there will be about 6,000 drugs which didn't get to the pharmacists' shelves because the drug researchers themselves found them to be ineffective and/or dangerous.

And since when is Aspartame a health risk? Or Olestra or Splenda? I'd also like to see the public records of trans fats being "approved" by the FDA. If you're going to claim that something that was never approved by the FDA is dangerous and imply the FDA is at fault, at least try to stick Fen-Phen in the list. Only Vioxx was a good example of what you were trying to show, OI, and even that has its drawbacks as an illustration, since both the FDA and Health Canada have suggested that Vioxx be returned to the market - it's Merck that doesn't want to sell it anymore.

Well, at least you didn't try to blame the FDA for Thalidomide...



The FDA dosen't approve trans-fat? Is it because it is not an additive? (own ignorance). This I have a hrad time with because if this is the case, I could roll bread in dog piss, bake it and sell it? Scarey......

Ditto for Vioxx. As long as people know it can kill you, let them choose. My Father-in-law freaks out about any mention of death. He could be 100 years old, bed-confined for the last 10 of it due to aches, and still not want to shorten his life. My 70 year old neighbor though, was riding her dogs for miles regularly. Can't due it without the Vioxx.

Can one really blame Merck from protecting itself from further lawsuits? I would like to see Merck just let the patent go........

Yeah, Phenphen... nice.....

And I realize that a shitload of money is wasted on drugs that never make it to market which is part of the reason new drugs are so expensive. I haven't put time or energy into deep-thought on what, if anything, can be done about this.

Aspartame to me is a good example of politics entering into the FDA.
Too many questions, too many questions. Wont approe it.

Elect Reagen, new FDA head, Rumsfled at the head of Searle (before it was bought by Monsanto), puff... perfectly safe.

I was just rambbling some "safe" things from the FDA. Didn't think of Fen-Phen or the rotovirus vaccine, which both would have been better examples.

Peace
Joe
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Dave W.
Info Junkie

USA
25973 Posts

Posted - 02/15/2007 :  22:33:11   [Permalink]  Show Profile  Visit Dave W.'s Homepage Send Dave W. a Private Message
quote:
Originally posted by Original_Intent

The FDA dosen't approve trans-fat? Is it because it is not an additive? (own ignorance). This I have a hrad time with because if this is the case, I could roll bread in dog piss, bake it and sell it? Scarey......
Yes, you could, until your local health inspector came along to find out what you're selling. The FDA regulates food labels (requiring trans fat content to be listed), food additives (trans fats aren't an additive), biotech foods and large food processing facilities (to ensure they're clean and safe). The FDA doesn't regulate any of the restaurants, supermarkets or other food "outlets" that are regulated by state and local law. You can sell as much pee-dough as you like from your home, until your local inspector comes along. Good luck getting customers, though, since baking pee would concentrate the stink.
quote:
Ditto for Vioxx. As long as people know it can kill you, let them choose.
How many people have enough medical education to be able to make an informed decision about it? Besides, every substance can kill you, so knowledge that Vioxx can do it is simply redundant.
quote:
Can one really blame Merck from protecting itself from further lawsuits? I would like to see Merck just let the patent go........
Would anyone else make it if Merck could "let the patent go?"
quote:
And I realize that a shitload of money is wasted on drugs that never make it to market which is part of the reason new drugs are so expensive. I haven't put time or energy into deep-thought on what, if anything, can be done about this.
My point wasn't the money "wasted." It was that the industry itself is largely self-policing before the FDA even needs to get involved. No pharma company in its right mind would even think to apply to the FDA for approval to start human trials for a drug that killed 90% of the mice it was tested on.
quote:
Aspartame to me is a good example of politics entering into the FDA.
But that didn't appear to be why you brought it up. Maybe it was. Didn't seem like it.
quote:
I was just rambbling some "safe" things from the FDA. Didn't think of Fen-Phen or the rotovirus vaccine, which both would have been better examples.
No, Fen-Phen is entirely the wrong example, since that combination of drugs was never approved by the FDA for use in overweight patients. The combo was never approved for anything. And quickly (for the government) after the heart data rolled in, the FDA took both drugs off the market, despite the fact that neither one, used alone for its intended purpose, was shown to be dangerous.

- Dave W. (Private Msg, EMail)
Evidently, I rock!
Why not question something for a change?
Visit Dave's Psoriasis Info, too.
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Original_Intent
SFN Regular

USA
609 Posts

Posted - 02/16/2007 :  07:18:59   [Permalink]  Show Profile Send Original_Intent a Private Message
quote:
Originally posted by Dave W.

quote:
Originally posted by Original_Intent

The FDA dosen't approve trans-fat? Is it because it is not an additive? (own ignorance). This I have a hrad time with because if this is the case, I could roll bread in dog piss, bake it and sell it? Scarey......
Yes, you could, until your local health inspector came along to find out what you're selling. The FDA regulates food labels (requiring trans fat content to be listed), food additives (trans fats aren't an additive), biotech foods and large food processing facilities (to ensure they're clean and safe). The FDA doesn't regulate any of the restaurants, supermarkets or other food "outlets" that are regulated by state and local law. You can sell as much pee-dough as you like from your home, until your local inspector comes along. Good luck getting customers, though, since baking pee would concentrate the stink.
quote:

Strike one up for the soverirgnty of the states!

quote:

Ditto for Vioxx. As long as people know it can kill you, let them choose.
How many people have enough medical education to be able to make an informed decision about it? Besides, every substance can kill you, so knowledge that Vioxx can do it is simply redundant.

That is between the Doctor and the patient. If I were the doctor, I would explain it all to them and have a real simple form for them to sign before writing a script....

quote:
quote:

Can one really blame Merck from protecting itself from further lawsuits? I would like to see Merck just let the patent go........
Would anyone else make it if Merck could "let the patent go?"


Who knows.....
quote:
quote:
And I realize that a shitload of money is wasted on drugs that never make it to market which is part of the reason new drugs are so expensive. I haven't put time or energy into deep-thought on what, if anything, can be done about this.[/quote
]My point wasn't the money "wasted." It was that the industry itself is largely self-policing before the FDA even needs to get involved. No pharma company in its right mind would even think to apply to the FDA for approval to start human trials for a drug that killed 90% of the mice it was tested on.

Gtcha.
quote:


quote:
Aspartame to me is a good example of politics entering into the FDA.
But that didn't appear to be why you brought it up. Maybe it was. Didn't seem like it.

Although not clear in the current posts, if you go back you will see where I rale against the politics.

[quote]
[quote]I was just rambbling some "safe" things from the FDA. Didn't think of Fen-Phen or the rotovirus vaccine, which both would have been better examples.
No, Fen-Phen is entirely the wrong example, since that combination of drugs was never approved by the FDA for use in overweight patients. The combo was never approved for anything. And quickly (for the government) after the heart data rolled in, the FDA took both drugs off the market, despite the fact that neither one, used alone for its intended purpose, was shown to be dangerous.


Well, cool then, you gave me a chacne to be wrong... and I took it..... . Strike another up for the FDA. Again, not a bad organization, just to open to the curroption of politics.

I would love to see the FDA and other agencies be removed completely from the political process. Leaders for life, nominated / choosen from the best in the feilds, confirmed through a process of Senate interviews with the help of a random sampling of those "best in fiield."

Peace
Joe
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beskeptigal
SFN Die Hard

USA
3834 Posts

Posted - 02/16/2007 :  14:36:45   [Permalink]  Show Profile Send beskeptigal a Private Message
Bush and company in their dictatorial giddiness took political intervening in government agencies like the FDA to new heights. Let's just hope the next administration and the government oversight activities of the Democratic Congress reverse the trend rather than co-opting the harmful influence for their own gain.


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Dude
SFN Die Hard

USA
6891 Posts

Posted - 02/16/2007 :  21:34:32   [Permalink]  Show Profile Send Dude a Private Message
O.I. said:
quote:
I would love to see the FDA and other agencies be removed completely from the political process. Leaders for life, nominated / choosen from the best in the feilds, confirmed through a process of Senate interviews with the help of a random sampling of those "best in fiield."


Then you'd be calling them "activist" agencies when they did stuff you don't agree with.


Ignorance is preferable to error; and he is less remote from the truth who believes nothing, than he who believes what is wrong.
-- Thomas Jefferson

"god :: the last refuge of a man with no answers and no argument." - G. Carlin

Hope, n.
The handmaiden of desperation; the opiate of despair; the illegible signpost on the road to perdition. ~~ da filth
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Dude
SFN Die Hard

USA
6891 Posts

Posted - 02/16/2007 :  21:50:09   [Permalink]  Show Profile Send Dude a Private Message
O.I. said:
quote:
Actually, the purpose of our government WAS ".... to form a more perfect union, establish justice, insure domestic tranquility, provide for the common defense, promote the general welfare, and secure the blessings of liberty to ourselves and our posterity...."

The purpose was not a huge Federal Government, the Costitution was to protect the states and the citizens of the states by not telling the Federal Government what it couldn't do, but explicitly laying out what it could do.

It has all become so compketely ludicrous.

The courts are the justice arm of it. Justice is to be blind. Majority/minority whichever.....



Get back to me when you have actually read at least one of John Locke's books on government and some of the writings of the people who actually implemented our government. After doing so if you still don't think that one of the major themes is protecting minorities (not racial minorities, but political ones) from the majority, we can have a different discussion about it.

And seriously, the FDA isn't out to get you or scam you. They have a job to do, and their record is pretty good. Imagine the US without the FDA for a minute, think of all the snake oil that would be marketed as cures and remedies, imagine the ammount of disinformation that would exist if all the Kevin Trudeaus(google him) were allowed to market their bullshit freely.


Ignorance is preferable to error; and he is less remote from the truth who believes nothing, than he who believes what is wrong.
-- Thomas Jefferson

"god :: the last refuge of a man with no answers and no argument." - G. Carlin

Hope, n.
The handmaiden of desperation; the opiate of despair; the illegible signpost on the road to perdition. ~~ da filth
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Original_Intent
SFN Regular

USA
609 Posts

Posted - 02/16/2007 :  23:34:34   [Permalink]  Show Profile Send Original_Intent a Private Message
quote:
Originally posted by Dude

O.I. said:
quote:
I would love to see the FDA and other agencies be removed completely from the political process. Leaders for life, nominated / choosen from the best in the feilds, confirmed through a process of Senate interviews with the help of a random sampling of those "best in fiield."


Then you'd be calling them "activist" agencies when they did stuff you don't agree with.





Dude, keep your biases, don't try to project them.

Peace
Joe
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Original_Intent
SFN Regular

USA
609 Posts

Posted - 02/16/2007 :  23:55:29   [Permalink]  Show Profile Send Original_Intent a Private Message
quote:
Originally posted by Dude

O.I. said:
quote:
Actually, the purpose of our government WAS ".... to form a more perfect union, establish justice, insure domestic tranquility, provide for the common defense, promote the general welfare, and secure the blessings of liberty to ourselves and our posterity...."

The purpose was not a huge Federal Government, the Costitution was to protect the states and the citizens of the states by not telling the Federal Government what it couldn't do, but explicitly laying out what it could do.

It has all become so compketely ludicrous.

The courts are the justice arm of it. Justice is to be blind. Majority/minority whichever.....



Get back to me when you have actually read at least one of John Locke's books on government and some of the writings of the people who actually implemented our government. After doing so if you still don't think that one of the major themes is protecting minorities (not racial minorities, but political ones) from the majority, we can have a different discussion about it.



Get back to me when you can either explain yourself better, or not be an asshole when you can't.

The discussion was the courts, not the entire system. My statement was centered on the courts, and you tried to take a major theme and apply it wrongly to the courts themselves. It was not a "major theme" discussion. I gave you the benefit of the doubt on the first snide comment

I have actually read more then my fair share of it, and not just picking and choosing that so many First Amendment, Living Document, people like to do.

Joe


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Dude
SFN Die Hard

USA
6891 Posts

Posted - 02/17/2007 :  08:18:39   [Permalink]  Show Profile Send Dude a Private Message
O.I. said:
quote:
Dude, keep your biases, don't try to project them.



So, you have never called a judge an "activist judge" before? It isn't your crowd that keeps bitching about politically appointed people in life terms who have decision making power?

You'd probably enter into a permanent apoplectic fit if a political appointee was put in charge of stuff like the FDA for a life term, especially if they were appointed by a democrat.


Ignorance is preferable to error; and he is less remote from the truth who believes nothing, than he who believes what is wrong.
-- Thomas Jefferson

"god :: the last refuge of a man with no answers and no argument." - G. Carlin

Hope, n.
The handmaiden of desperation; the opiate of despair; the illegible signpost on the road to perdition. ~~ da filth
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Kil
Evil Skeptic

USA
13457 Posts

Posted - 02/17/2007 :  12:32:01   [Permalink]  Show Profile  Visit Kil's Homepage  Send Kil an AOL message  Send Kil a Yahoo! Message Send Kil a Private Message
quote:
Original_Intent:
Aspartame to me is a good example of politics entering into the FDA.

How so?

Uncertainty may make you uncomfortable. Certainty makes you ridiculous.

Why not question something for a change?

Genetic Literacy Project
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beskeptigal
SFN Die Hard

USA
3834 Posts

Posted - 02/17/2007 :  12:49:08   [Permalink]  Show Profile Send beskeptigal a Private Message
quote:
Originally posted by Dude

...
And seriously, the FDA isn't out to get you or scam you. They have a job to do, and their record is pretty good. Imagine the US without the FDA for a minute, think of all the snake oil that would be marketed as cures and remedies, imagine the ammount of disinformation that would exist if all the Kevin Trudeaus(google him) were allowed to market their bullshit freely.



You think Trudeau didn't market his scam freely?

But as to the FDA, they had not been seriously interfered with, (some interference but not any that the medical community bothered about), from the political world in my medical career until the Bush neocons and their religious base and crony favorisms came into office. The medical community has been alarmed by the political interference in an agency that is supposed to be one of the public watchdogs.

Union of Concerned Scientists on the FDA

Congressional Oversight Committee report on FDA trends since Bush took office.

And one top scientist resigned in protest over political interference in the FDA scientific analysis of Plan B birth control. In other words not only did Bush want the FDA to prohibit Plan B, he wanted the FDA to falsely claim the prohibition was based on medical reasons.


Edited by - beskeptigal on 02/17/2007 12:51:04
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Dave W.
Info Junkie

USA
25973 Posts

Posted - 02/17/2007 :  21:47:02   [Permalink]  Show Profile  Visit Dave W.'s Homepage Send Dave W. a Private Message
quote:
Originally posted by beskeptigal

But as to the FDA, they had not been seriously interfered with, (some interference but not any that the medical community bothered about), from the political world in my medical career until the Bush neocons and their religious base and crony favorisms came into office.
Come on, b'gal... The DSHEA was passed in 1994, and has continued to do damage to anti-quackery efforts for the last 13 years. And the FDA and FTC both have been under-funded for their market-policing mandates since before I was born.

The fact that Congress can mandate that the FDA treat all homeopathic ingredients as drugs, as they did in 1938, means that legislators have always been able to trump science as far as consumer protection goes.

Unfortunately, the lifetime appointments suggested by Original Intent will not and cannot fix this problem, because the lifetime appointees, to do their job, have to implement whatever crazy laws Congress passes. A lifetime position doesn't place one above the law. Even if the head of the FDA had a lifetime appointment in 1994, it would not have been an option for him to say "no" to the DSHEA and demand that all "supplements" get properly tested before any health claims are made about them. Just like the non-lifetime appointee had to, he would have had to bow to Congress' will and implement the mandate.

Also, as we see every time a judicial appointment gets Congress into partisan squabbling, lifetime appointments can be and are made for politicial reasons. A lifetime appointment sometimes means nothing more than having to live with the political consequences for decades instead of years. I was surprised that Original Intent even offered this as a possible solution to the FDA's troubles.

The only total solution - theoretically - is one that completely violates the spirit and intent of the Constitution. Congress would have to pass a law restating the FDA's mandates, giving the FDA funding forever (linked to inflation at least), and then stating, in no uncertain terms, that no future law can effect, redirect or otherwise dictate the regulations created by the FDA, which would have the full power of any law passed by Congress itself. This would only work if the FDA were to hire the most-trustworthy scientists, an ideal so ridiculous I'm about to wet my pants. In reality, an FDA which doesn't have to answer to the people would quickly become the most-corrupt and least-functional part of the government.

The only practical solution is to ensure that one's respresentatives give a damn about ensuring that both the FDA and the FTC are fully funded, and to demand that when approving appointments for these positions, one's representatives pay attention to qualifications more than affiliations.

- Dave W. (Private Msg, EMail)
Evidently, I rock!
Why not question something for a change?
Visit Dave's Psoriasis Info, too.
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Dude
SFN Die Hard

USA
6891 Posts

Posted - 02/17/2007 :  23:31:45   [Permalink]  Show Profile Send Dude a Private Message
quote:
You think Trudeau didn't market his scam freely?



He is unable to sell you a bottle of herbs and tell you it will cure cancer. So, no, he isn't able to market his bullshit freely.


Ignorance is preferable to error; and he is less remote from the truth who believes nothing, than he who believes what is wrong.
-- Thomas Jefferson

"god :: the last refuge of a man with no answers and no argument." - G. Carlin

Hope, n.
The handmaiden of desperation; the opiate of despair; the illegible signpost on the road to perdition. ~~ da filth
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Original_Intent
SFN Regular

USA
609 Posts

Posted - 02/18/2007 :  00:25:26   [Permalink]  Show Profile Send Original_Intent a Private Message
quote:
Originally posted by Dude

O.I. said:
quote:
Dude, keep your biases, don't try to project them.



So, you have never called a judge an "activist judge" before? It isn't your crowd that keeps bitching about politically appointed people in life terms who have decision making power?

You'd probably enter into a permanent apoplectic fit if a political appointee was put in charge of stuff like the FDA for a life term, especially if they were appointed by a democrat.





I know you saw it, 'cause you quoted it, but once again don't project your biases.

Joe
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Original_Intent
SFN Regular

USA
609 Posts

Posted - 02/18/2007 :  00:41:23   [Permalink]  Show Profile Send Original_Intent a Private Message
Hmmm.... Dave, I may heve been grasping at straws...... I have always liked the "appointment for life" idea as a way to get around the politics in certain areas. Sure, it leads to confirmation hearings, which are (should be) a great way of doing things, as it it makes it harder to throw just anyone in. If they are that bad, you can always impeach them. It's too bad they can't conduct themselves better during the procedings.

Peace
Joe

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