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Why We Need The FDA

Rouser2

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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.
 
Rouser2 said:
To protect us, of course.
Click to expand...
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....
 
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.
 
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?
 
Zombified said:
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?
Click to expand...

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.
 
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.
 
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.
 
Rouser2 said:
I think everyone should decide that for themselves. Certainly pain killers have some value.
Click to expand...
So you think Merck should not have taken Vioxx off the market, then?
 
Re: Re: Re: Re: Why We Need The FDA

Rouser2 said:
No. Ideally, there should be no FDA at all. Then it could do no mischief. [/B]
Click to expand...

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.
 
Re: Re: Re: Re: Why We Need The FDA

Rouser2 said:
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.
Click to expand...

What would you prefer? blissful ignorance?
 
Rouser2 said:
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.
Click to expand...
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.
 
Re: Re: Re: Re: Why We Need The FDA

Rouser2 said:
No. Ideally, there should be no FDA at all. Then it could do no mischief.
Click to expand...
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.
 
Zombified said:
So you think Merck should not have taken Vioxx off the market, then?
Click to expand...

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.
 
Re: Re: Re: Re: Re: Why We Need The FDA

ktesibios said:
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.
Click to expand...

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.
 
Rouser2 said:
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.
Click to expand...

Then they will just start a new company.
 
Re: Re: Re: Re: Re: Re: Why We Need The FDA

Rouser2 said:
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.
Click to expand...

How?

Give use a good example.
 
Anders said:
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.
Click to expand...

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.
 
Rouser2 said:
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.
Click to expand...

What "private drug screening agencies" existed prior to the creation of the FDA?
 
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