Why We Need The FDA

Rouser2 said:
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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So, let's suppose you have Crohn's disease. It's unpleasant and debilitating, and you're often in a lot of pain. What sequence of events would need to occur before you were prepared to try the new drug?

Rolfe.
 
Rolfe said:
So, let's suppose you have Crohn's disease. It's unpleasant and debilitating, and you're often in a lot of pain. What sequence of events would need to occur before you were prepared to try the new drug?

Rolfe.
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Well, I happen to know someone with Crohn's. Like a lot of people. And she takes one drug which she claims really helps. But it's not FDA "approved". If I had the disease, I try it in a New York minute. The illegal drug which helps my friend the most is


POT

(The Smokin' kind)

And incidently, just what agency of coercion (government or other) has the moral right to tell any person what they shall eat, drink, smoke or ingest????
 
Rouser2 said:
For example???????
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Well there are plenty. You can start with the Ford Pinto and explaining why Ford are still at it and have done the same thing at least twice since. Start a new thread if you like, as it is a bit OT.

Then explain how your logic has the tobacco companies still in business, oh and alcohol companies.

And if you follow UK news you can see deregulation and privatisation has had a stunning effect on our water, telecom and train industries. There have been benefits, but safety and forward thinking are not evident amongst them.

Maybe the brown-outs in california? that wasn't a one off now was it?
 
Originally posted by Benguin [/i]


>>Well there are plenty. You can start with the Ford Pinto

What about the Ford Pinto???If you start to answer a question, then answer it.

>>Then explain how your logic has the tobacco companies still in business, oh and alcohol companies.

Tobacco and alcohol companies are still in business because some people like to smoke and drink. Do you have a problem with "freedom"?????

>>And if you follow UK news you can see deregulation and privatisation has had a stunning effect on our water, telecom and train industries. There have been benefits, but safety and forward thinking are not evident amongst them.

Not being familiar with UK deregulation in anything since the Iron Lady, I defer. But I strongly suspect you are mis-representing the situation.

>>Maybe the brown-outs in california? that wasn't a one off now was it?

Brown-outs in California were not caused by free, competitive enterprise but by government regulation.
 
Rouser2 said:
Originally posted by Benguin [/i]


>>Well there are plenty. You can start with the Ford Pinto

What about the Ford Pinto???If you start to answer a question, then answer it.
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Manufactured with a dangerous design flaw that made them lethal in a rear end accident. Ford decided after analysis of recall costs it would be cheaper to pay the letigation for the deaths than organise a recall to rectify a fault with the rear indicator relay and petrol cap. They only changed their approach after a public outcry. They are still in business, and still making dangerous design mistakes.


>>Then explain how your logic has the tobacco companies still in business, oh and alcohol companies.

Tobacco and alcohol companies are still in business because some people like to smoke and drink. Do you have a problem with "freedom"?????
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None whatsoever. People are free to take the drug companies' products. Some have side effects, some have poor efficacy ratios. It's your argument, damn well state it properly !

>>And if you follow UK news you can see deregulation and privatisation has had a stunning effect on our water, telecom and train industries. There have been benefits, but safety and forward thinking are not evident amongst them.

Not being familiar with UK deregulation in anything since the Iron Lady, I defer. But I strongly suspect you are mis-representing the situation.
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You could produce some evidence. The notion that privatisation and deregulation produce, of themselves, efficiency, service and safety improvements is not supported. Produce evidence.


>>Maybe the brown-outs in california? that wasn't a one off now was it?

Brown-outs in California were not caused by free, competitive enterprise but by government regulation.
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How is a drop in energy price beneath market rate not, at least in part, competition related. Again, evidence please.
 
Rouser2 said:
Well, I happen to know someone with Crohn's. Like a lot of people. And she takes one drug which she claims really helps. But it's not FDA "approved". If I had the disease, I try it in a New York minute. The illegal drug which helps my friend the most is

POT

(The Smokin' kind)

And incidently, just what agency of coercion (government or other) has the moral right to tell any person what they shall eat, drink, smoke or ingest????
Click to expand...
Nice diversion, Rouser.

Now, can we get back to the question? I'll phrase it more generally, if you like.

In your unregulated free-for-all society, a new drug is marketed which the manufacturer claims is effective against a painful and debilitating disease you happen to suffer from.

What sequence of events do you require to take place before you will decide to take this drug yourself?

Rolfe.
 
Originally posted by Benguin [/i]

>>Manufactured with a dangerous design flaw that made them lethal in a rear end accident. Ford decided after analysis of recall costs it would be cheaper to pay the letigation for the deaths than organise a recall to rectify a fault with the rear indicator relay and petrol cap. They only changed their approach after a public outcry. They are still in business, and still making dangerous design mistakes.

There is no such a thing as perfect safety in anything. But in fact the Pinto case seems to more of an example of government intrusion than any real design flaw, to wit:

"In a summer 1991 Rutgers Law Review article Gary Schwartz demolishes "the myth of the Pinto case." Actual deaths in Pinto fires have come in at a known 27, not the expected thousand or more. More startling, Schwartz shows that everyone's received ideas about the fabled "smoking gun" memo are false. The actual memo did not pertain to Pintos, or even Ford products, but to American cars in general; it dealt with rollovers, not rear-end collisions; it did not contemplate the matter of tort liability at all, let alone accept it as cheaper than a design change; it assigned a value to human life because federal regulators, for whose eyes it was meant, themselves employed that concept in their deliberations; and the value it used was one that they, the regulators, had set forth in documents.
In retrospect, Schwartz writes, the Pinto's safety record appears to have been very typical of its time and class.
-- "The Most Dangerous Vehicle On the Road"
By Walter Olson
Wall Street Journal, February 9, 1993
http://walterolson.com/articles/gmtrucks.html

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>>Then explain how your logic has the tobacco companies still in business, oh and alcohol companies.

Tobacco and alcohol companies are still in business because some people like to smoke and drink. Do you have a problem with "freedom"?????

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>>None whatsoever. People are free to take the drug companies' products. Some have side effects, some have poor efficacy ratios. It's your argument, damn well state it properly !


I just did. It has to do with freedom, You now claim to be in favor of freedom, but your entire point was to extol the tyranny of regulation.


quote:
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>>And if you follow UK news you can see deregulation and privatisation has had a stunning effect on our water, telecom and train industries. There have been benefits, but safety and forward thinking are not evident amongst them.

Not being familiar with UK deregulation in anything since the Iron Lady, I defer. But I strongly suspect you are mis-representing the situation.

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>>You could produce some evidence.

Oh, but it is you who made the claim of a downside to UK de-regulation. Where is YOUR evidence???

>>The notion that privatisation and deregulation produce, of themselves, efficiency, service and safety improvements is not supported. Produce evidence.


I just did. Add to that the following:

quote:
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>>Maybe the brown-outs in california? that wasn't a one off now was it?

Brown-outs in California were not caused by free, competitive enterprise but by government regulation.
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>>How is a drop in energy price beneath market rate not, at least in part, competition related. Again, evidence please.


California's Troubles Not Caused by Deregulation
by Jerry Taylor and Peter Van Doren

"First, the state forced the electricity companies to sell their power plants to independent investors and become power distributors.
Second, the state assumed total day-to-day control of the utilities' power grid to make sure they couldn't abuse their market power.
Third, the state required new owners of the divested power plants to sell their juice to a state-managed "power pool." The price of that power is set by a daily spot market run by - you guessed it - the state. Electricity companies that wanted to compete for your business had to buy their electricity from this pool, and the price charged them was equal to the highest price received by any electricity generator in the daily state-managed spot market.
Fourth, regardless of what they pay for power in the wholesale market, no company can charge a consumer more than 6.5 cents per kilowatt hour. That price can't change until the company has paid off its share of the bailout the state gave the electricity companies in order to accept this new regulatory scheme.
Now, what kind of "deregulation" imposes rigid government dictates on how industries should organize themselves? What sort of deregulation keeps fixed prices on retail providers? What kind of "deregulation" requires retailers to buy power through a state-run central exchange? And what brand of "deregulation" forbids retailers from buying electricity more than one day ahead? "
http://www.cato.org/dailys/01-17-01.html
 
Rolfe said:
Nice diversion, Rouser.

Now, can we get back to the question? I'll phrase it more generally, if you like.

In your unregulated free-for-all society, a new drug is marketed which the manufacturer claims is effective against a painful and debilitating disease you happen to suffer from.

What sequence of events do you require to take place before you will decide to take this drug yourself?

Rolfe.
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It's an open ended question without taking any account into any variables.That's why a specific example such as POT for Crohn's disease is more instructive. In general, I would believe no one's claims regarding drug cures. As to relief of symptoms, that all depends. In the case of say bone cancer and excruciating pain, the prefered choice would be another illegal drug -- heroine. In a desperate situation, most people will reach out and grab anything. And they have that right.
 
Rouser2 said:
There is no such a thing as perfect safety in anything. But in fact the Pinto case seems to more of an example of government intrusion than any real design flaw, to wit:

"In a summer 1991 Rutgers Law Review article Gary Schwartz demolishes "the myth of the Pinto case." Actual deaths in Pinto fires have come in at a known 27, not the expected thousand or more. More startling, Schwartz shows that everyone's received ideas about the fabled "smoking gun" memo are false. The actual memo did not pertain to Pintos, or even Ford products, but to American cars in general; it dealt with rollovers, not rear-end collisions; it did not contemplate the matter of tort liability at all, let alone accept it as cheaper than a design change; it assigned a value to human life because federal regulators, for whose eyes it was meant, themselves employed that concept in their deliberations; and the value it used was one that they, the regulators, had set forth in documents.
In retrospect, Schwartz writes, the Pinto's safety record appears to have been very typical of its time and class.
-- "The Most Dangerous Vehicle On the Road"
By Walter Olson
Wall Street Journal, February 9, 1993
http://walterolson.com/articles/gmtrucks.html

[/B]
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That refers only to the risk analysis not the design mistake and the sale of a vehicle with that in it. Your regulators are recognising that absolute safety is impossible and stating a method calculating a balance between cost and benefit.

Ford clearly used the regulators benchmark (a minimum requirement) as the basis of their decision. You are trying to suggest in the absence of regulators the methodology used by Ford would have been more to the favour of the customer.

In exactly the same way as your claim that the absence of regulators in pharmaceutics will be more beneficial to customers.

It is your exceptional claim, you back it up with some proper reasoning or data. So far we've seen syllogisms and opinion pieces. Oh, and appeals to ignorance.

The UK mess ups with utilities are very similar to the synopsys you describe with California. In other words, just 'deregulating' isn't helping anyone unless it is done properly, but you need to explain how it can work at all without safeguards?

You need to describe properly what system you propose and how it will be beneficial. You assert companies won't kill people with bad products, or their survival is threatened. That is unsupported and exceptional.
 
Rouser2 said:
It's an open ended question without taking any account into any variables.That's why a specific example such as POT for Crohn's disease is more instructive. In general, I would believe no one's claims regarding drug cures. As to relief of symptoms, that all depends. In the case of say bone cancer and excruciating pain, the prefered choice would be another illegal drug -- heroine. In a desperate situation, most people will reach out and grab anything. And they have that right.
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Rouser, stop wriggling. Never mind the exact disease, I only chose Crohn's at random. Any disease causing significant loss of quality of life.

Are you saying that you would never take a drug, because you would never believe that it did what was claimed? Under no circumstances?

If there are circumstances in which you could see yourself deciding to take a drug in your imaginary unregulated world, could you describe these circumstances? (For another example, what if you developed diabetes?)

Heroine? Fay Wray? Oh, you meant heroin!! Why didn't you say so? Funny, approximately 100% of doctors in this country agree with you, and that is exactly what you'd be prescribed.

Does that make it evil allopathic medicine which you should avoid at all costs?

Rolfe.
 
richardm said:
If they have knowingly sold a faulty product it is because the Government made them do it.
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Originally posted by Rouser2
There is no such a thing as perfect safety in anything. But in fact the Pinto case seems to more of an example of government intrusion than any real design flaw,
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See?

Of course, Government Pinto intrusion notwithstanding, GM were thumped in the courts when a jury found that GM had dangerously positioned the fuel tank in their Malibu car to save costs. They were found guilty because because there was plenty of evidence that GM knew the risks of fuel-fed fires, but calculated that the cost to GM per fuel-fed fatality would be approx. $2.40/automobile. The cost of adequately protecting the fuel tanks would be $8.59 /automobile, making a handy saving of $6.19. Multiply that by the 41 million GM automobiles on the road, and it's a sum worth having.

Sadly for GM, the jury awarded $4.8bn dollars to the woman who sued, which rather spoiled the sums (although that was reduced to $1.2 bn on appeal).

Source: The Corporation.

Of course, it's a mistake to think that it's all big businesses like Ford or GM. There are a good number of people who engage in selling counterfeit goods - music, DVDs, clothing, watches, even food. Invariably, they are substandard. They are not concerned about future development. They're just concerned about making a quick buck. When you consider that there are alreadycounterfeit drugs on the market, doesn't that make you stop to wonder if it's a good idea?
 
Originally posted by Benguin [/i]

>>You need to describe properly what system you propose and how it will be beneficial. You assert companies won't kill people with bad products, or their survival is threatened. That is unsupported and exceptional.


Of course I made no such assertion. That's just another one of your strawman arguments based on hyperbole. There is no utopia, no perfect system. Just as in the question of Trial by Jury. Ford may have gotten a rotten deal via the jury system, but to paraphrase what Winston Churchill said about "democracy," that jury system may be the very worst, but it is better than any other ever devised. In a words, the best way to make people truly accountable is "laisse faire" and let not only the buyer beware, but the producer as well. Most busninessmen know very well, that it very unwise to sell a product that would endanger or even kill off your customers. Make sense??
 
Originally posted by Rolfe [/i]

>>Rouser, stop wriggling. Never mind the exact disease, I only chose Crohn's at random. Any disease causing significant loss of quality of life.
Are you saying that you would never take a drug, because you would never believe that it did what was claimed? Under no circumstances?

No. I would never blindly say never to anything.

>>If there are circumstances in which you could see yourself deciding to take a drug in your imaginary unregulated world, could you describe these circumstances? (For another example, what if you developed diabetes?)

No, I would not. I cannot comprehend a world of a zillion drugs and a zillion maladies to assert any such comprehensive statement.

>>Heroine? Fay Wray? Oh, you meant heroin!! Why didn't you say so? Funny, approximately 100% of doctors in this country agree with you, and that is exactly what you'd be prescribed.

And just what country is that???
 
Originally posted by richardm [/i]


>>Of course, it's a mistake to think that it's all big businesses like Ford or GM. There are a good number of people who engage in selling counterfeit goods - music, DVDs, clothing, watches, even food. Invariably, they are substandard. They are not concerned about future development. They're just concerned about making a quick buck. When you consider that there are alreadycounterfeit drugs on the market, doesn't that make you stop to wonder if it's a good idea?


Uh, uh, uh. -- Do not make the mistake of thinking that unregulated laisse faire means counterfeiting is allowed. Counterfeiting is theft. Theft is immoral and a universally accepted crime. You counterfeit, and justice needs to be served -- both to you and to those whom you have stolen from. But prosecuting people for counterfeiting is very different from government making regulations as to what a person may eat, drink, smoke or ingest.
 
Rouser2 said:
Uh, uh, uh. -- Do not make the mistake of thinking that unregulated laisse faire means counterfeiting is allowed. Counterfeiting is theft. Theft is immoral and a universally accepted crime. You counterfeit, and justice needs to be served -- both to you and to those whom you have stolen from. But prosecuting people for counterfeiting is very different from government making regulations as to what a person may eat, drink, smoke or ingest.
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There are libertarians who do not agree with the idea of government protecting intellectual property rights through the use of patents or copyright. If I recall correctly, I had a brief exchange with Shane K once on this subject.

A "counterfeit" could involve either trademark infringement, patent infringement or both. My expectation is the typical libertarian would be relatively protective of trademark rights, but if the counterfeit infringes only a patent, it's not clear all proponents of laissez faire would have a problem with that.
 
Rouser2 said:
>>If there are circumstances in which you could see yourself deciding to take a drug in your imaginary unregulated world, could you describe these circumstances? (For another example, what if you developed diabetes?)

No, I would not. I cannot comprehend a world of a zillion drugs and a zillion maladies to assert any such comprehensive statement.
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You're still evading. You advocate no regulation, and a free market allowing anyone to market anything they like with any therapeutic claims they like. You don't rule out the possibility that you might decide to take a particular drug in this system. So help us out here. Give us some sort of an example of the circumstances in which you might come to such a decision.
Rouser2 said:
>>Heroine? Fay Wray? Oh, you meant heroin!! Why didn't you say so? Funny, approximately 100% of doctors in this country agree with you, and that is exactly what you'd be prescribed.

And just what country is that???
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You have problems reading, or something? It's right there under my avatar, labelled "location".

Rolfe.
 
Rouser2 said:
Originally posted by Benguin [/i]

>>You need to describe properly what system you propose and how it will be beneficial. You assert companies won't kill people with bad products, or their survival is threatened. That is unsupported and exceptional.


Of course I made no such assertion. That's just another one of your strawman arguments based on hyperbole. There is no utopia, no perfect system. Just as in the question of Trial by Jury. Ford may have gotten a rotten deal via the jury system, but to paraphrase what Winston Churchill said about "democracy," that jury system may be the very worst, but it is better than any other ever devised. In a words, the best way to make people truly accountable is "laisse faire" and let not only the buyer beware, but the producer as well. Most busninessmen know very well, that it very unwise to sell a product that would endanger or even kill off your customers. Make sense??
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Makes sense logically, but it does not applyin practice. Business has a primary responsibility to its share-holders not its customers. Companies know it is sometimes economically better to defend the legal claims post hoc win or loose than not go to market. They take a risk. The public takes a risk, how would you ever distinguish between a rogue and a genuine ethical trader? You'd spend your life doing background research and (in the case of medicines) die while doing it.

That is a pretty naff mangling of Winston Churchill's quote;
"Democracy is the worst form of government, except for all the others that have been tried." Are you proposing something that hasn't been tried or what? another syllogism.

State your claim, then you can claim hyperbole. There is no strawman in what I said as I am merely asking you to describe the system you think will work better than the current one. Unless you are now admitting you don't have anything in mind.

I'd like you to point out how your latest little opinion piece is different from my previous attempt to summarise your unclear position.
 
Rouser2 said:
Originally posted by richardm [/i]


Uh, uh, uh. -- Do not make the mistake of thinking that unregulated laisse faire means counterfeiting is allowed. Counterfeiting is theft. Theft is immoral and a universally accepted crime. You counterfeit, and justice needs to be served -- both to you and to those whom you have stolen from. But prosecuting people for counterfeiting is very different from government making regulations as to what a person may eat, drink, smoke or ingest.
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Explain how we prevent counterfeiting rather than addressing it after the event?
 
Originally posted by Rolfe [/i]

>>You're still evading. You advocate no regulation, and a free market allowing anyone to market anything they like with any therapeutic claims they like.

Not so. False advertising is fraud, get it? FRAUD!.

>>You don't rule out the possibility that you might decide to take a particular drug in this system. So help us out here. Give us some sort of an example of the circumstances in which you might come to such a decision.

I already have. Pot and heroin are two examples.

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Originally posted by Rouser2
>>Heroine? Fay Wray? Oh, you meant heroin!! Why didn't you say so? Funny, approximately 100% of doctors in this country agree with you, and that is exactly what you'd be prescribed.

And just what country is that???
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>>You have problems reading, or something? It's right there under my avatar, labelled "location".


Certainly not in America -- land of the "free".
 
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