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Old 18th October 2004, 02:47 PM   #1
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Why We Need The FDA

To protect us, of course.


Item:


"Many consumers taking Vioxx have suffered strokes, heart attacks, heart failure, chest pains, blood clots, serious bleeding and even death..."


"The U.S. Food and Drug Administration (FDA) approved Vioxx in 1999 for the treatment of osteoarthritis and the management of acute pain in adults. Vioxx, a Cox-2 inhibitor used most often for patients with osteoarthritis, has been linked by researchers to serious side effects including an increase in the risk of blood clots; severe intestinal damage, including ulcerations and bleeding; heart attacks and strokes. In addition, meningitis was a side effect involved in seven cases of patients taking Vioxx."


"An article published in August 2001 in the Journal of the American Medical Association raised concerns over the negative side effects on cardiovascualar health related to both Vioxx and another cox-2 inhibitor Celebrex. Likewise, a research report by the Institute for Clinical Evaluative Science, published in the May 28, 2004 issue of The Lancet, suggests that arthritis patients taking were 80% more likely to be hospitalized for heart failure. This risk is compared to a 10% risk with ibuprofen or naproxen, two non-steroidal anti-inflammatory drugs. The researchers believe that until more research is done on Vioxx, doctors should use caution in prescribing Vioxx, as well as Celebrex, to patients with heart disease."

http://www.1800theeagle.com/topics/Vioxx

Note: In case of death, contact a lawyer.
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Old 18th October 2004, 03:09 PM   #2
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Define "we".

Rolfe.
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Old 18th October 2004, 03:21 PM   #3
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Re: Why We Need The FDA

Quote:
Originally posted by Rouser2
To protect us, of course.

Well, the FDA did mamaged to protect America from the horrors of Thalidomide. We were not as lucky in Europe. The FDA is doing a very good job should you ask me, but I'm not an athority....so....
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Old 18th October 2004, 03:31 PM   #4
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Re: Re: Why We Need The FDA

Rouser2, Do you think perhaps the approval requirements should be even more strict?

I kind of agree with Anders except I think perhaps they are too strict...but not by much.

Sad fact is that no matter how good the human testing, sometimes stuff happens. The testing is really nothing more than a model of the likely reality...'likely' being the key word.

No model, less complex than reality, is perfect. Strive for a cost/benefit win.
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Old 18th October 2004, 03:58 PM   #5
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Rouser:

Do you believe that no drug should ever be used under any circumstances?

If that is not your position, then there must be some criteria you think a drug should meet before it can be used. What are those criteria?
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Old 18th October 2004, 06:14 PM   #6
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Remember its full name is the FOOD and Drug Administration. One of the reasons for its existence was this:
http://www.online-literature.com/upton_sinclair/jungle/

Here are some of its milestones, good and bad (comments in http://www.acsh.org/publications/pub...pub_detail.asp ):
http://www.fda.gov/opacom/backgrounders/miles.html
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Old 18th October 2004, 06:28 PM   #7
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Quote:
Originally posted by Zombified
Rouser:

Do you believe that no drug should ever be used under any circumstances?

If that is not your position, then there must be some criteria you think a drug should meet before it can be used. What are those criteria?
Keep in mind that you are asking this question of an idiot who believes the moon landing was a hoax and that numerous assassins were in Dealy Plaza, but he can't name any of them. Just thought you'd like to know.
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Old 18th October 2004, 07:38 PM   #8
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Re: Re: Re: Why We Need The FDA

Originally posted by Rob Lister [/i]


>>Rouser2, Do you think perhaps the approval requirements should be even more strict?


No. Ideally, there should be no FDA at all. Then it could do no mischief.
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Old 18th October 2004, 07:40 PM   #9
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Originally posted by Zombified [/i]


>>Do you believe that no drug should ever be used under any circumstances?

I think everyone should decide that for themselves. Certainly pain killers have some value.
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Old 18th October 2004, 08:05 PM   #10
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Quote:
Originally posted by Rouser2
I think everyone should decide that for themselves. Certainly pain killers have some value.
So you think Merck should not have taken Vioxx off the market, then?
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Old 18th October 2004, 08:07 PM   #11
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Re: Re: Re: Re: Why We Need The FDA

Quote:
Originally posted by Rouser2
No. Ideally, there should be no FDA at all. Then it could do no mischief. [/b]
So, we'll be better off by dropping a system in which a drug which has bad side effects which weren't caught in the initial trials can be yanked from the market immediately they become apparent, and in which a drug has to demonstrate efficacy before being approved for sale, and going back to the good old days when anyone could put anything they wanted in a bottle and sell it to anyone at all while making any curative claims they wanted to?

Well, hey, putting morphine in "soothing syrups" did keep those teething babies nice and quiet.
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Old 18th October 2004, 11:02 PM   #12
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Re: Re: Re: Re: Why We Need The FDA

Quote:
Originally posted by Rouser2
Originally posted by Rob Lister [/i]


>>Rouser2, Do you think perhaps the approval requirements should be even more strict?


No. Ideally, there should be no FDA at all. Then it could do no mischief.
What would you prefer? blissful ignorance?
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Old 19th October 2004, 01:51 AM   #13
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Quote:
Originally posted by Rouser2
Originally posted by Zombified [/i]


>>Do you believe that no drug should ever be used under any circumstances?

I think everyone should decide that for themselves. Certainly pain killers have some value.
How on earth would the the average American know about the very very real danagers of Thalidomide without FDA? As usual, I think and you don't.
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Old 19th October 2004, 02:56 AM   #14
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Re: Re: Re: Re: Why We Need The FDA

Quote:
Originally posted by Rouser2
No. Ideally, there should be no FDA at all. Then it could do no mischief.
Oooh, come on chaps, this has the makings of a nice fight!

So, Rouser, you believe that everyone should decide for themselves what drugs to take. Do you believe that anyone should be allowed to make and market anything they like, and make whatever claims for it they like? Complete free-for-all? Without even any provision for products to be withdrawn or banned?

How do you propose that people get the information to be able to make an informed choice? Have you any idea the eye-popping amounts of money that would be made by the completely conscience-free, and the number of people who would die and be maimed under such a system?

Please continue to defend your position, I'm intrigued to see how you propose to do that.

Rolfe.
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Old 19th October 2004, 04:42 AM   #15
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Quote:
Originally posted by Zombified
So you think Merck should not have taken Vioxx off the market, then?
Merck must do what is in its own self interest. Putting that drug on the market in the first place along with all of its false promises is going to damage Merck significantly in its bottom line.
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Old 19th October 2004, 04:45 AM   #16
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Re: Re: Re: Re: Re: Why We Need The FDA

Quote:
Originally posted by ktesibios
So, we'll be better off by dropping a system in which a drug which has bad side effects which weren't caught in the initial trials can be yanked from the market immediately they become apparent, and in which a drug has to demonstrate efficacy before being approved for sale, and going back to the good old days when anyone could put anything they wanted in a bottle and sell it to anyone at all while making any curative claims they wanted to?

Well, hey, putting morphine in "soothing syrups" did keep those teething babies nice and quiet.
The noble goals of a government agency such as FDA can be better achieved in the private sector without giving the non-thiinking, gullible public a false sense of security. Caveat Emptor.
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Old 19th October 2004, 04:48 AM   #17
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Quote:
Originally posted by Rouser2
Merck must do what is in its own self interest. Putting that drug on the market in the first place along with all of its false promises is going to damage Merck significantly in its bottom line.
Then they will just start a new company.
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Old 19th October 2004, 04:49 AM   #18
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Re: Re: Re: Re: Re: Re: Why We Need The FDA

Quote:
Originally posted by Rouser2
The noble goals of a government agency such as FDA can be better achieved in the private sector without giving the non-thiinking, gullible public a false sense of security. Caveat Emptor.
How?

Give use a good example.
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Old 19th October 2004, 04:50 AM   #19
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Quote:
Originally posted by Anders
How on earth would the the average American know about the very very real danagers of Thalidomide without FDA? As usual, I think and you don't.
The very lesson that drugs such as Vioxx and Thalidomide should teach is that drugs are dangerous and have unknown long term adverse effects which no short term testing in animals can predict. Nonetheless, private drug screening agencies would surely take FDA's place for whatever value the public would assign to them, based on reputation of past performance -- a private certifying agency such as Underwriters Lab.
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Old 19th October 2004, 04:56 AM   #20
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Quote:
Originally posted by Rouser2
The very lesson that drugs such as Vioxx and Thalidomide should teach is that drugs are dangerous and have unknown long term adverse effects which no short term testing in animals can predict. Nonetheless, private drug screening agencies would surely take FDA's place for whatever value the public would assign to them, based on reputation of past performance -- a private certifying agency such as Underwriters Lab.
What "private drug screening agencies" existed prior to the creation of the FDA?
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Old 19th October 2004, 04:57 AM   #21
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Re: Re: Re: Re: Re: Why We Need The FDA

Originally posted by Rolfe [/i]

>>So, Rouser, you believe that everyone should decide for themselves what drugs to take. Do you believe that anyone should be allowed to make and market anything they like, and make whatever claims for it they like? Complete free-for-all? Without even any provision for products to be withdrawn or banned?


There will always be people who are too stupid to question the claims of others. That is just what is happening with the poisons marketed today which are called FDA "approved" drugs. Without that approval, the public would have to start to think for themselves.
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Old 19th October 2004, 05:06 AM   #22
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Re: Re: Re: Re: Re: Re: Why We Need The FDA

Quote:
Originally posted by Rouser2
Originally posted by Rolfe [/i]
There will always be people who are too stupid to question the claims of others. That is just what is happening with the poisons marketed today which are called FDA "approved" drugs. Without that approval, the public would have to start to think for themselves.
Does this include Doctors as well? Also, if we're going to get rid of the FDA, shouldn't we get rid of education and licensing requirements for doctors?
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Old 19th October 2004, 05:16 AM   #23
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Quote:
Originally posted by Anders
How on earth would the the average American know about the very very real danagers of Thalidomide without FDA? As usual, I think and you don't.
Certainly not from the FDA which only delayed approval due to red tape.

"...in late 1960 that thalidomide might cause neuropathy in some of its users. Neither of these concerns was fatal for the thalidomide application, but together they were enough to hold up the FDA's approval of thalidomide for a year. Since neither problem had anything to do with birth defects, it was only by the sheerest chance that the red-tape in these matters caused introduction of thalidomide to be delayed in the U.S. until it began to be suggested in late 1961 that thalidomide was a dangerous
drug for pregnant women. In the end, the association between thalidomide and birth defects was discovered in Europe, not America -- and certainly was not discovered by the FDA."
http://w3.aces.uiuc.edu:8001/Liberty...alidomide.Html


Only the European experience of thousands of birth defects made the FDA act. But even snake oil potions such as Thalidomide hardly ever die. The FDA has now approved the drug for treatment of Leprosy.

"FDA Announces Approval of Drug for Hansen's Disease (Leprosy) Side Effect; Imposes Unprecedented Authority to Restrict Distribution"

"On July 16, 1998, FDA approved the use of thalidomide for the treatment of the debilitating and disfiguring lesions associated with erythema nodosum leprosum (ENL), a complication of Hansen’s Disease, commonly known as leprosy."
http://www.fda.gov/cder/news/thalinfo/default.htm
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Old 19th October 2004, 05:20 AM   #24
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Re: Re: Re: Re: Re: Re: Re: Why We Need The FDA

Quote:
Originally posted by Rob Lister

Does this include Doctors as well? Also, if we're going to get rid of the FDA, shouldn't we get rid of education and licensing requirements for doctors?
As far as the government is concerned, yes.
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Old 19th October 2004, 05:21 AM   #25
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Quote:
Originally posted by Rouser2


"On July 16, 1998, FDA approved the use of thalidomide for the treatment of the debilitating and disfiguring lesions associated with erythema nodosum leprosum (ENL), a complication of Hansen’s Disease, commonly known as leprosy."
http://www.fda.gov/cder/news/thalinfo/default.htm
So? We know hat went wrong with Thalidomide. It will not be given to pregnant women anyway and I suspect it will have a very high chiral purity. Btw Thalidomide whould not get through the testing program used today.
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Old 19th October 2004, 05:32 AM   #26
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*is thinking of Upton Sinclair's "the Jungle" which, while not entirely true, is an example of human filth and twisted rationalization.*

Hey, well, if someone wants to market colored sugar water as "genuine honey" and let factory workers lose their fingers to dangerous machinary, or allow anyone and everyone to claim themselves a "healer" and sell their snake oil as freely as they seemed to do before, well, I guess there's always Planet X.
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Old 19th October 2004, 05:47 AM   #27
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Quote:
Originally posted by Suezoled
*is thinking of Upton Sinclair's "the Jungle" which, while not entirely true, is an example of human filth and twisted rationalization.*

Hey, well, if someone wants to market colored sugar water as "genuine honey" and let factory workers lose their fingers to dangerous machinary, or allow anyone and everyone to claim themselves a "healer" and sell their snake oil as freely as they seemed to do before, well, I guess there's always Planet X.
Planet X is alive and well and thriving today under the collective apron of the nanny state.
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Old 19th October 2004, 05:56 AM   #28
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Re: Re: Re: Re: Re: Re: Why We Need The FDA

Quote:
Originally posted by Rouser2

There will always be people who are too stupid to question the claims of others. That is just what is happening with the poisons marketed today which are called FDA "approved" drugs. Without that approval, the public would have to start to think for themselves.
With info from what?

Private companies that can be bribed by producers?

Will they have to pay before getting the info?

Will some products not be examend because there isn't enough of a market for it?

Or will they be examend after a lot of people have died?
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Old 19th October 2004, 06:14 AM   #29
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Re: Re: Re: Re: Re: Re: Re: Why We Need The FDA

Quote:
Originally posted by AWPrime
Or will they be examend after a lot of people have died?
Absent the FDA that is the manner in which they are examined.

Ref: Ephedrine
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Old 19th October 2004, 06:23 AM   #30
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Re: Re: Re: Re: Re: Re: Why We Need The FDA

Quote:
Originally posted by Rouser2
Originally posted by Rolfe [/i]

>>So, Rouser, you believe that everyone should decide for themselves what drugs to take. Do you believe that anyone should be allowed to make and market anything they like, and make whatever claims for it they like? Complete free-for-all? Without even any provision for products to be withdrawn or banned?


There will always be people who are too stupid to question the claims of others. That is just what is happening with the poisons marketed today which are called FDA "approved" drugs. Without that approval, the public would have to start to think for themselves.
Homeopathy is evidence that system doesn't work.
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Old 19th October 2004, 06:37 AM   #31
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This is an argument that's quite regularly seen in the P+CE forum. The position boils down to: No private company would ever produce a dangerous drug, because that would hurt their bottom line, and no company wants to do that.

If they did produce a dangerous drug, two things would happen: 1. a private third party (like the aforementioned Underwriters Laboratory) would alert informed Americans that it was unsafe.
2. The company would go broke and stop selling it.

What happens to the people who take the drug in good faith in the meantime doesn't matter. As Rouser2 says: Caveat Emptor - or, Devil take the hindmost, more like.


(It's okay if they die or something, because then their relatives can sue the company, and help to make it go bust to save other people)
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Old 19th October 2004, 06:42 AM   #32
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Quote:
Originally posted by richardm
If they did produce a dangerous drug, two things would happen: 1. a private third party (like the aforementioned Underwriters Laboratory) would alert informed Americans that it was unsafe.
2. The company would go broke and stop selling it.
The fact the approach is an abject failure in other industries clearly does not trouble him.
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Old 19th October 2004, 07:56 AM   #33
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Quote:
Originally posted by Benguin
The fact the approach is an abject failure in other industries clearly does not trouble him.
You are mistaken. No private company has ever knowingly sold a faulty product. If they have knowingly sold a faulty product it is because the Government made them do it. If they apparently did it off their own bat, then it never happened, and any suggestion that it was unsafe and that they knew about it is a lie. Capice?

NB if they actually ever did sell an unsafe product, then they are out of business now, so it doesn't matter any more. Do not bother finding examples to attempt to disprove this, as it cannot be done. There are no examples. Private industry unfettered by Government has no interest in short-term profits, and will make the best product they can to secure long-term profitability.

Yes. I'll go further, and say that the GP Mafia should be shut down too. People can get all the information they need about drugs from the internet, and there shouldn't be a cartel of people who can say what we can and can't put into our bodies. What are you, some sort of facist ? And vets are even worse, being associated with tree-hugging communist facism.
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Old 19th October 2004, 08:07 AM   #34
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I name Rouser as "argumentum canis chasing tailum"
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Old 19th October 2004, 01:43 PM   #35
Rolfe
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So, in this wonderfully nonregulated Rouser-world, I produce a drug. Let's call it "organic germanium". Sounds lovely, doesn't it? I advertise it as being absolutely sovereign for Crohn's disease, diverticulitis and IBD.

So, who's going to be the first to try it, and would they be wise to do so?

Rolfe.
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Old 19th October 2004, 01:55 PM   #36
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Re: Re: Re: Re: Re: Re: Re: Why We Need The FDA

Originally posted by AWPrime [/i]

>>Re: Re: Re: Re: Re: Re: Why We Need The FDA

quote:
--------------------------------------------------------------------------------
Originally posted by Rouser2

There will always be people who are too stupid to question the claims of others. That is just what is happening with the poisons marketed today which are called FDA "approved" drugs. Without that approval, the public would have to start to think for themselves.
--------------------------------------------------------------------------------

>>With info from what?
Private companies that can be bribed by producers?

With private individuals and agencies with a solid track record of integrity.

>>Will they have to pay before getting the info?

Perhaps those who provide the research, such as paying for a subscription to Consumer Reports.

>>Will some products not be examend because there isn't enough of a market for it?

Of course, so long as the world remains imperfect -- just like a whole lot of products, some which may be beneficial, are not examined by the FDA today, and thus can neither help (nor hurt) anybody.
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Old 19th October 2004, 01:58 PM   #37
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Re: Re: Re: Re: Re: Re: Re: Why We Need The FDA

Quote:
Originally posted by Benguin
Homeopathy is evidence that system doesn't work.
Unlike many potions and elixers which have been approved by the FDA, I don't think anyone has ever been harmed by a homeopathic preparation, unless of course, it included too much of an FDA approved drug.
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Old 19th October 2004, 02:00 PM   #38
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Quote:
Originally posted by Benguin
The fact the approach is an abject failure in other industries clearly does not trouble him.

For example???????
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Old 19th October 2004, 02:04 PM   #39
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Quote:
Originally posted by richardm
You are mistaken. No private company has ever knowingly sold a faulty product. If they have knowingly sold a faulty product it is because the Government made them do it. If they apparently did it off their own bat, then it never happened, and any suggestion that it was unsafe and that they knew about it is a lie. Capice?

NB if they actually ever did sell an unsafe product, then they are out of business now, so it doesn't matter any more. Do not bother finding examples to attempt to disprove this, as it cannot be done. There are no examples. Private industry unfettered by Government has no interest in short-term profits, and will make the best product they can to secure long-term profitability.

Yes. I'll go further, and say that the GP Mafia should be shut down too. People can get all the information they need about drugs from the internet, and there shouldn't be a cartel of people who can say what we can and can't put into our bodies. What are you, some sort of facist ? And vets are even worse, being associated with tree-hugging communist facism.
Sorry Charlie, but there is no such a thing as "communist fascism."
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Old 19th October 2004, 02:06 PM   #40
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Quote:
Originally posted by Rolfe
So, in this wonderfully nonregulated Rouser-world, I produce a drug. Let's call it "organic germanium". Sounds lovely, doesn't it? I advertise it as being absolutely sovereign for Crohn's disease, diverticulitis and IBD.

So, who's going to be the first to try it, and would they be wise to do so?

Rolfe.
The first? Probably the very same people who are now in a state of panic to get their flu shots. Wise? Of course not. But people have a right to be stupid.
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