The FDA Does More Harm Than Good

[kevinquinnyo]

"...estimates the loss of life from [FDA] delay alone to be in the hundreds of thousands (not to mention millions of patients who endured unnecessary morbidity). "


http://www.fdareview.org/harm.shtml

It seems we would be better off without the FDA at all.

[elbe]

Are you still hung up on imaginary dreams of a super free market?

[kevinquinnyo]

Are you still hung up on imaginary dreams of a super free market?

Why don't you just read the study, it's not that jargonized or dense actually.

Then make up your mind. And aren't you the guy who was talking about Marx and how socialism begets more freedom?

Who's really the dogmatic one here?

[Professor Yaffle]

Ambulance delays probably cost some lives too. Maybe we would be better off not having them at all...

:rolleyes:

[kevinquinnyo]

[QUOTE]Ambulance delays probably cost some lives too. Maybe we would be better off not having them at all...
[QUOTE]

Good grief. Really? Is that really your response to this?

More harm than good is actually in the title of the thread, it doesn't say "The FDA does a certain amount of harm, but the benefits exceed the harm.

It says "More Harm Than Good."

[elbe]

Why don't you just read the study, it's not that jargonized or dense actually.

Then make up your mind. And aren't you the guy who was talking about Marx and how socialism begets more freedom?

Who's really the dogmatic one here?

I really don't remember saying that, I remember arguing that libertarianism just fails and you need a properly regulated market. The FDA is an important regulatory agency, perhaps it isn't perfect, but it's far better than nothing. Would you rather we have homeopath's selling water as a cure for cancer?

[kevinquinnyo]

I really don't remember saying that, I remember arguing that libertarianism just fails and you need a properly regulated market. The FDA is an important regulatory agency, perhaps it isn't perfect, but it's far better than nothing. Would you rather we have homeopath's selling water as a cure for cancer?

Elbe,

Read the title of the thread.

It says "The FDA Does More Harm Than Good."

The study backs this up. Certainly you are entitled to an opinion, but you must present some sort of evidence to the contrary. If you have a problem with the way these economists did their analysis, or gathered the data, then speak up.

But right now, you're just asserting that you believe federal regulation is better than not.

I understand it's counterintuitive, but you can't support something because it feels right, or seems right. This is people's lives we're talking about.

[elbe]

Additional testing often enhances safety and effectiveness, but requiring a lot of testing has at least two negative effects. First, it delays the arrival of superior drugs. During the delay, some people who would have lived end up dying. Second, additional testing requirements raise the costs of bringing a new drug to market; hence, many drugs that would have been developed are not, and all the people who would have been helped, even saved, are not.

See, here's your problem. Those are problems, yes, but they aren't directly harming anyone, but are instead, essentially, extending the period where there just isn't a drug available (like before the drug was created at all). You want to argue for reform, that's fine, but completely abolishing it could cause direct harm by unregulated sales of "drugs" that can cause more harm than good.

[kevinquinnyo]

See, here's your problem. Those are problems, yes, but they aren't directly harming anyone, but are instead, essentially, extending the period where there just isn't a drug available (like before the drug was created at all). You want to argue for reform, that's fine, but completely abolishing it could cause direct harm by unregulated sales of "drugs" that can cause more harm than good.

Nope. Read the entire section of the study entitled "Theory of Harm."

[kevinquinnyo]

I welcome any criticism of the way the economists analyzed the data. There's always a bit of art that has to go into complicated regression analysis problems with a lot of unknowns, but I think the evidence is compelling.

[elbe]

I'm only skimming because I'm in the middle of cooking dinner, but is there something in there that isn't about delays or unapproved drugs?

ETA: I think the actual intent of the article, as I read it, makes some good points - that we should probably consider some reform of how FDA approves drugs and what it approves, but I fail to see, at all, how it supports your claim that "
It seems we would be better off without the FDA at all. "

[shadron]

http://www.fdareview.org/harm.shtml

It seems we would be better off without the FDA at all.

You're only saying that because you didn't live in the USA before the FDA, when you couldn't trust your drugs not to contain sweepings from a factory floor, or your cookies not to contain flys, or your soda pop not to contain ethylene glycol.There was a time in the US when this was a possibility. Why don't you read up on what caused the nation to build such an entity before you decide what's good or bad from a single article?

[KoihimeNakamura]

Espically since the writers are in fact libertarians and write a libertarian journal. It's not a far leap to auto conclude they MIGHT be pushing that.

(that said..)

Three bodies of evidence indicate that the costs of FDA requirements exceed the benefits. In other words, three bodies of evidence suggest that the FDA kills and harms, on net. First, we compare pre-1962 drug approval times and rates of drug introduction with post-1962 approval times and rates of introduction. Second, we compare drug availability and safety in the United States with the same in other countries. Third, we compare the relatively unregulated market of off-label (http://www.fdareview.org/harm.shtml#on-label) drug uses in the United States with the on-label market. In the final section, before turning to reform options (http://www.fdareview.org/reform.shtml), we also discuss the evidence showing that the costs of FDA advertising restrictions exceed the benefits.

1. He argues since the FDA rejects more drugs now after the amendments that it has killed more people. This is an.. weird argument.

2. The argument is : Europe approves drugs faster than the US and has the same amount of postmarket withdrawals. It doesn't address what types of drugs are withdrawn (a very.. interesting omission)

This point has merit, but to be properly evaluated, it should really compare apples to apples instead of an aggregate.

3.


By their actions, doctors tell us that they believe in off-label prescribing. Getting the FDA to approve a new use for an old drug requires an expensive and lengthy process. In many cases, the costs to the sponsor of the required testing exceed the benefits of approval. It is clear that if the FDA prohibited off-label prescribing, current practices would have to change significantly. No one would be foolish enough to suggest that the FDA prohibit off-label prescribing.

But there is a logical inconsistency in allowing off-label prescribing and requiring proof of efficacy for the drug’s initial use (Tabarrok 2000 (http://www.fdareview.org/references.shtml#tabarrok00)). Logical consistency would require us either (1) to oppose off-label prescribing and favor initial proof of efficacy, or (2) to favor off-label prescribing and oppose initial proof of efficacy. Experience recommends the second option. Efficacy requirements should be dropped altogether!


So.. since doctors use medicines for *nonintended purposes*, it's good. And..


Okay, at this point I'm not amused as these aren't good arguments.

Final ETA: I refuse to even touch the advertisment argument angle. It's just nonsensical when you think that the FDA has good reason to want them to not advertise something *under testing*

[oggiesnr]

You want drugs cut with chalk (or strychnine)? You want snake oil? Fine, it's an open market if you want to get rid of the FDA.

Drugs are essentially poison. Some do good, a lot of trial drugs fail because they either don't work or they kill people. Yes the FDA hurdles are high but do you want confidence in what your doctor prescribes or not?

The US model of healthcare probably kills a hell of a lot more than any delays by the FDA.

Steve

[kevinquinnyo]

You're only saying that because you didn't live in the USA before the FDA, when you couldn't trust your drugs not to contain sweepings from a factory floor, or your cookies not to contain flys, or your soda pop not to contain ethylene glycol.There was a time in the US when this was a possibility. Why don't you read up on what caused the nation to build such an entity before you decide what's good or bad from a single article?

Nope. Again, let's examine the title of the thread. "MORE HARM THAN GOOD"

This is very important, because what you've done is list some things that could injure and/or kill people.

More harm than good means, by definition, that less people would be injured or harmed Without the FDA.

Do you understand? The most important thing is people's lives, not your incorrect perception of danger, or fear. Tally up the amount of dead people, and whichever method has less dead is the better method. Period.

And why do you assume I haven't read up on the history of the FDA?

[kevinquinnyo]

You want drugs cut with chalk (or strychnine)? You want snake oil? Fine, it's an open market if you want to get rid of the FDA.

Drugs are essentially poison. Some do good, a lot of trial drugs fail because they either don't work or they kill people. Yes the FDA hurdles are high but do you want confidence in what your doctor prescribes or not?

The US model of healthcare probably kills a hell of a lot more than any delays by the FDA.

Steve

Steve you ignore economics (science) in favor of feel-good policy.

[Yoink]

Your article does not make the argument that you think it makes. It makes an argument that the FDA should approve new drugs more quickly--it offers no argument at all that the US would be better off if the FDA were entirely abolished. It doesn't even enter into that question.

If you want a discussion of the advantages and disadvantages of an expedited drug approval system, you probably shouldn't try to get it going by titling the thread "The FDA Does More Harm Than Good" and offering not a single lick of evidence to support your claim.

[themusicteacher]

Steve you ignore economics (science) in favor of feel-good policy.

Economics are far from a hard science so don't even go there.

[kevinquinnyo]

First of all, if you look at the SAEE, most people would consider most economists to be very libertarian.



1. He argues since the FDA rejects more drugs now after the amendments that it has killed more people. This is an.. weird argument.


So, you think it's weird, or wrong? They have the pre 1962 data and the post 1962 data. They know how many people died of bad or ineffective drugs pre 1962. The number of victims (107) of Elixir Sulfanilamide tragedy and of all other drug tragedies prior to 1962 is very small compared to the death toll of the post-1962 FDA.

I guess I don't understand what your counter argument is.



2. The argument is : Europe approves drugs faster than the US and has the same amount of postmarket withdrawals. It doesn't address what types of drugs are withdrawn (a very.. interesting omission)


Tell me what's interesting about it, I guess I don't see what you're driving at, exactly. They are saying that the postmarket withdrawl was around 3% for European countries as well as the United States. If the FDA lag was effective in its scrutiny of new drugs, you would expect the postmarket withdrawl rate to be much different here. Do you think the market for drugs there is different than in the U.S., because of some overlooked cultural difference? Explain.


This point has merit, but to be properly evaluated, it should really compare apples to apples instead of an aggregate.


How's this for apples to apples:

Deaths owing to drug lag have been numbered in the hundreds of thousands. Wardell (1978a) estimated that practolol, a drug in the beta-blocking family, could save ten thousand lives a year if allowed in the United States. Although the FDA allowed a first beta-blocker, propranolol, in 1968, three years after that drug had been available in Europe, it waited until 1978 to allow the use of propranolol for the treatment of hypertension and angina pectoris, its most important indications. Despite clinical evidence as early as 1974, only in 1981 did the FDA allow a second beta-blocker, timolol, for prevention of a second heart attack. The agency’s withholding of beta-blockers was alone responsible for probably tens of thousands of deaths (on this general issue see Gieringer 1985; Kazman 1990).
So.. since doctors use medicines for *nonintended purposes*, it's good. And..



Okay, at this point I'm not amused as these aren't good arguments.

Final ETA: I refuse to even touch the advertisment argument angle. It's just nonsensical when you think that the FDA has good reason to want them to not advertise something *under testing*

Are you kidding me?

...the banning of advertising of aspirin for first heart attack prevention, may be the single most harmful regulatory policy currently pursued by any agency of the U.S. government

Tens of thousands could have been saved if that hadn't been restricted.

[elbe]

So... you believe it is far better to have no protection than to be over protected? Weird.

[kevinquinnyo]

Your article does not make the argument that you think it makes. It makes an argument that the FDA should approve new drugs more quickly--it offers no argument at all that the US would be better off if the FDA were entirely abolished. It doesn't even enter into that question.

If you want a discussion of the advantages and disadvantages of an expedited drug approval system, you probably shouldn't try to get it going by titling the thread "The FDA Does More Harm Than Good" and offering not a single lick of evidence to support your claim.

Three bodies of evidence indicate that the costs of FDA requirements exceed the benefits. In other words, three bodies of evidence suggest that the FDA kills and harms, on net.

Any questions?

[kevinquinnyo]

So... you believe it is far better to have no protection than to be over protected? Weird.

Inside of your closed socialist mind, you cannot imagine 'consumer protection' exists without the use of government regulation. I don't understand why you can't see past that.

Really, really think about this. Read the article. It has pre 1962 data and post 1962 data. Before '62 the market was relatively free of government restriction.

[kevinquinnyo]

So... you believe it is far better to have no protection than to be over protected? Weird.

And further, "over-protected?"

What? This very point that I'm making is that the "over-protection" killed hundreds of thousands of people. Is that what you call protection?

Let me ask you this. Would you rather have one seatbelt while you drive or so many seatbelts wrapped around you that you suffocate?

[Yoink]

Three bodies of evidence indicate that the costs of FDA requirements exceed the benefits. In other words, three bodies of evidence suggest that the FDA kills and harms, on net.

Any questions?

Yes: have you read the article you link to? It does not provide any evidence to support that claim. None. Nada. Zip. Zilch. Zero.

It doesn't address, for example, food safety at all. It compares outcomes to nations that approve prescription medication more rapidly than the US but it does not compare outcomes to nations (because there really are no comparable nations where this is true) where medication is completely unregulated.

It is not, in fact, an argument for abolishing the FDA. It is an argument for a revision of the way in which the FDA goes about approving new pharmaceutical products.

That is a subject one could have an interesting discussion about. You, apparently, want to quote a sentence or two from the preamble to the article and then shriek very loudly.

[kevinquinnyo]

Yes: have you read the article you link to? It does not provide any evidence to support that claim. None. Nada. Zip. Zilch. Zero.

It doesn't address, for example, food safety at all. It compares outcomes to nations that approve prescription medication more rapidly than the US but it does not compare outcomes to nations (because there really are no comparable nations where this is true) where medication is completely unregulated.

It is not, in fact, an argument for abolishing the FDA. It is an argument for a revision of the way in which the FDA goes about approving new pharmaceutical products.

That is a subject one could have an interesting discussion about. You, apparently, want to quote a sentence or two from the preamble to the article and then shriek very loudly.

First of all, the claim that you say there is no evidence to support is pulled straight from the article itself. That was a copy/paste from within the article.

It is true that this article is about the Drug side of the FDA. I guess to be clear, specifically, with respect to this article, the conclusion to be drawn is that everything that the FDA has done that has been good with regard to drug regulation, is outweighed by bad. The lives it has saved are much smaller than the lives lost because of the FDA.

[elbe]

Inside of your closed socialist mind, you cannot imagine 'consumer protection' exists without the use of government regulation. I don't understand why you can't see past that.

Seriously, is there something wrong with your comprehension? I have not advocated anything socialist here, and if you don't understand that then you don't even know what socialism is.

Really, really think about this. Read the article. It has pre 1962 data and post 1962 data. Before '62 the market was relatively free of government restriction.

The article does not support your desire to do away with the FDA, just to reform it's practices.

And further, "over-protected?"

What? This very point that I'm making is that the "over-protection" killed hundreds of thousands of people. Is that what you call protection?

Let me ask you this. Would you rather have one seatbelt while you drive or so many seatbelts wrapped around you that you suffocate?

And what about all those cancer patients dying without a cure! Damn the medical industry not curing them all!

The FDA delays their drug approvals for testing that some people, such as the authors of the articles, think is too long and unnecessary. If you remove the regulation how will you prevent all those scam artists from selling placebos, or even harmful drugs, as "cures"?

[kevinquinnyo]

You're right that I must consider Food regulation as well..

But really, has the FDA saved hundreds of thousands of people by regulating food, to make up for it's failures on the drug side?

If it has, then I suppose I'm way out of line. I doubt it, but I would certainly like to know now.

[Yoink]

First of all, the claim that you say there is no evidence to support is pulled straight from the article itself. That was a copy/paste from within the article.

A "claim" is not "evidence." There is no evidence to support the claim you quoted in that article.

It is true that this article is about the Drug side of the FDA. I guess to be clear, specifically, with respect to this article, the conclusion to be drawn is that everything that the FDA has done that has been good with regard to drug regulation, is outweighed by bad. The lives it has saved are much smaller than the lives lost because of the FDA.

Again, the article makes no comparison between the US system and some other first world system in which none of the offices performed by the FDA with regard to pharmaceutical products is performed. It therefore offers NO EVIDENCE AT ALL that the US would be better off if the pharmaceutical industry was left entirely unregulated by the FDA.

Please, if you wish to keep making this absurd and childish claim, cut and paste some relevant portion of the article that is not merely about different approaches to drug regulation but about the difference between some regulation and no regulation at all.

You will find that you cannot do this, because that is not what the article you have linked is about. It is about modifying the way the FDA approaches drug regulation, not about doing away with the FDA altogether.

[MysteryMammal]

Interesting bit of conjecture, let me see if I can follow your logic in this real-life anology:

My car doesn't run the way I want it to. Rather than replacing the battery that acts up like you wouldn't believe, I should just blow the damn thing up.

Is that close to the mark at all? I'm really trying to understand the leap from what the article supports to the idea we should just blow the whole thing to hell. The article seems to support loosening advertising restrictions, streamlining testing, etc. not demolishing the organization tasked with keeping us safe from potentially harmful products.

[kevinquinnyo]

Seriously, is there something wrong with your comprehension? I have not advocated anything socialist here, and if you don't understand that then you don't even know what socialism is.


I guess I was thinking of someone else.. apologies, although I thought you were the one who said that you think the level of freedom in countries with larger governments is higher, etc. I may be wrong.



And what about all those cancer patients dying without a cure! Damn the medical industry not curing them all!

The FDA delays their drug approvals for testing that some people, such as the authors of the articles, think is too long and unnecessary. If you remove the regulation how will you prevent all those scam artists from selling placebos, or even harmful drugs, as "cures"?


Elbe,

The amount of people that would die from unregulated drugs, such as cancer scams and snake oil salesmen is LOWER then the amount killed from the FDA drug lag, etc.

That IS the point. This is like the third time I've said this.

[Yoink]

Interesting bit of conjecture, let me see if I can follow your logic in this real-life anology:

My car doesn't run the way I want it to. Rather than replacing the battery that acts up like you wouldn't believe, I should just blow the damn thing up.

Is that close to the mark at all? I'm really trying to understand the leap from what the article supports to the idea we should just blow the whole thing to hell. The article seems to support loosening advertising restrictions, streamlining testing, etc. not demolishing the organization tasked with keeping us safe from potentially harmful products.

He didn't actually read the article. He read the opening paragraph, masturbated furiously for a while, then--spent--started this thread.

[kevinquinnyo]

Interesting bit of conjecture, let me see if I can follow your logic in this real-life anology:

My car doesn't run the way I want it to. Rather than replacing the battery that acts up like you wouldn't believe, I should just blow the damn thing up.

Is that close to the mark at all? I'm really trying to understand the leap from what the article supports to the idea we should just blow the whole thing to hell. The article seems to support loosening advertising restrictions, streamlining testing, etc. not demolishing the organization tasked with keeping us safe from potentially harmful products.

Yoink, this is addressed to you as well regarding your last post:


That's sort of a burn the village to save it thing, I don't think you understand.

The Drug Lag and other regulations of the FDA result in more people dead than no regulation at all.

The way in which the article explains this is through examining the pre 1962 data and comparing it to the post 1962 data.

Because we don't have a time machine to do an infallible experiment, the researchers have estimated the amount of new drugs that would have been created as well as directly comparing the amount of deaths in the U.S. to the lives saved in Europe where the drug lag is significantly shorter.

[Yoink]

The amount of people that would die from unregulated drugs, such as cancer scams and snake oil salesmen is LOWER then the amount killed from the FDA drug lag, etc.

That IS the point. This is like the third time I've said this.

This argument is not supported by the article you linked to. And I don't mean "they fail to adequately support their argument"--I meant that this isn't the argument that the authors of the article intend to make. They do not compare the US system to systems in which any old poison can be sold as a wonder cure for cancer.

Seriously, would you just go and actually read the damn article you linked to and then come back and apologize for wasting our time.

[Yoink]

Yoink, this is addressed to you as well regarding your last post:


That's sort of a burn the village to save it thing, I don't think you understand.

The Drug Lag and other regulations of the FDA result in more people dead than no regulation at all.

The way in which the article explains this is through examining the pre 1962 data and comparing it to the post 1962 data.

Because we don't have a time machine to do an infallible experiment, the researchers have estimated the amount of new drugs that would have been created as well as directly comparing the amount of deaths in the U.S. to the lives saved in Europe where the drug lag is significantly shorter.

The FDA was not established in 1962. The article makes that quite clear. It is not, therefore, comparing "pre-FDA" and "post-FDA" America.

READ. THE. ARTICLE.

[elbe]

I guess I was thinking of someone else.. apologies, although I thought you were the one who said that you think the level of freedom in countries with larger governments is higher, etc. I may be wrong.

Evidence suggests that countries with larger governments have happier, freer people. Large government != socialism. But that was an argument for another thread.

Elbe,

The amount of people that would die from unregulated drugs, such as cancer scams and snake oil salesmen is LOWER then the amount killed from the FDA drug lag, etc.

That IS the point. This is like the third time I've said this.

No matter how much you argue it, the FDA does not directly kill anyone. It, at most, just expands the time where that drug doesn't, effectively, exist. Fake drugs can either directly kill (or complicate) a person or just rip them off.

It is a very common argument, and a valid one, that the FDA should change how it approves drugs, including opening up public use of some unapproved drugs (that have gone through basic safety checks) with written patient consent. But you just jumped beyond the conclusion of the article you present to support your existing position and claim we should just abolish the FDA.

[kevinquinnyo]

He didn't actually read the article. He read the opening paragraph, masturbated furiously for a while, then--spent--started this thread.

Yoink, I read the entire thing.

I'm drawing a very obvious conclusion that if the deaths caused are higher than an unregulated market (pre 1962 was relatively unregulated), then the FDA has been counter productive to saving lives.

And I'll admit that I'm ignoring the food aspect. I'll also admit that the article doesn't specifically say that the FDA itself should be abolished, but it does say that the FDA kills and harms on net.

If you're against people dying needlessly then you should be against the FDA.

[elbe]

This argument is not supported by the article you linked to. And I don't mean "they fail to adequately support their argument"--I meant that this isn't the argument that the authors of the article intend to make. They do not compare the US system to systems in which any old poison can be sold as a wonder cure for cancer.

Seriously, would you just go and actually read the damn article you linked to and then come back and apologize for wasting our time.

To echo Yoink: The site itself supports FDA reform (http://www.fdareview.org/reform.shtml), I can't find anything about abolishing it.

[Yoink]

Yoink, I read the entire thing.

I'm drawing a very obvious conclusion that if the deaths caused are higher than an unregulated market (pre 1962 was relatively unregulated), then the FDA has been counter productive to saving lives.

And I'll admit that I'm ignoring the food aspect. I'll also admit that the article doesn't specifically say that the FDA itself should be abolished, but it does say that the FDA kills and harms on net.

If you're against people dying needlessly then you should be against the FDA.

The article offers some evidence to support its fairly modest claim that the FDA's regime of regulation is too strict. As I say, there is an interesting argument to be had about whether the FDA drug approval regime is too burdensome and too slow.

You, however, have either utterly misunderstood or have utterly mischaracterized the linked article. In comparing the pre-1962 FDA with the post-1962 FDA it is comparing two different schemes of regulation; it is not comparing a regulated system with an unregulated system. It is not, therefore, offering any evidence at all for your claim that the complete abolition of the FDA would save lives.

You have no evidence of any kind to support your position. If you think you have such evidence somewhere other than in the article you linked to (and which you clearly cannot comprehend) please bring it forward.

[kevinquinnyo]

Evidence suggests that countries with larger governments have happier, freer people. Large government != socialism. But that was an argument for another thread.


Different thread yes, but I disagreed then and I still do. I'd like to see this evidence.



No matter how much you argue it, the FDA does not directly kill anyone. It, at most, just expands the time where that drug doesn't, effectively, exist. Fake drugs can either directly kill (or complicate) a person or just rip them off.


Well, it's just semantics, but I would call it involuntary manslaughter at the very least.

If you were bitten by a snake, I also wouldn't be directly killing you by not giving you the antidote in my hand.

[elbe]

If you were bitten by a snake, I also wouldn't be directly killing you by not giving you the antidote in my hand.

I think we both know that the FDA is refusing to give the "antidote" because they haven't proven, to their standard, that it does what it claimed to do and won't exacerbate the problems. Changes should probably be made to the system, and that's what the site suggests.

Would you find it better if someone gave you a homeopathic snake bite remedy, instead of an actual antidote, and no one was there to stop them?

[Yoink]

By the way, kevinquinnyo, while you're desperately trying to find even a shred of supporting evidence for your absurd proposition, why don't you do a little light reading on the case that spurred the creation of the FDA in 1938 (yes, 1938--24 years before 1962): the famous Elixir Sulfanilamide (http://en.wikipedia.org/wiki/Elixir_Sulfanilamide)story.

When you've read up on that, please come back here and tell us all why it should be legal for companies to sell deadly poison (quite literally) as medicine, and why it would save lives if we allowed that.

[kevinquinnyo]

The article offers some evidence to support its fairly modest claim that the FDA's regime of regulation is too strict. As I say, there is an interesting argument to be had about whether the FDA drug approval regime is too burdensome and too slow.

You, however, have either utterly misunderstood or have utterly mischaracterized the linked article. In comparing the pre-1962 FDA with the post-1962 FDA it is comparing two different schemes of regulation; it is not comparing a regulated system with an unregulated system. It is not, therefore, offering any evidence at all for your claim that the complete abolition of the FDA would save lives.

You have no evidence of any kind to support your position. If you think you have such evidence somewhere other than in the article you linked to (and which you clearly cannot comprehend) please bring it forward.

First of all your anger and cattiness is making me uncomfortable. Just act normal, please.

From the article:

When we look back to the pre-1962 period, do we find anything like this tragedy? The historical record—decades of a relatively free market up to 1962—shows that voluntary institutions, the tort system, and the pre-1962 FDA succeeded in keeping unsafe drugs to a low level. The Elixir Sulfanilamide tragedy, in which 107 people died, was the worst of those decades. Every life lost is important, but the grisly comparison is necessary. The number of victims of Elixir Sulfanilamide tragedy and of all other drug tragedies prior to 1962 is very small compared to the death toll of the post-1962 FDA.

The important word here is "relatively." (relatively free markets prior to '62.)

But the article, to be clear expresses that they wish to see tort law and nongovernmental parties be the motor of certification.

I suppose the one thing lacking is a list of the drugs that were banned by the FDA, and the amount of people that would have died from those. But there is no way to know that.

The only way they were to approximate this was to look at the off-label usage of drugs, which are unregulated and subject to the scrutiny of independent research, medical doctors, etc.

[kevinquinnyo]

I think we both know that the FDA is refusing to give the "antidote" because they haven't proven, to their standard, that it does what it claimed to do and won't exacerbate the problems. Changes should probably be made to the system, and that's what the site suggests.

Would you find it better if someone gave you a homeopathic snake bite remedy, instead of an actual antidote, and no one was there to stop them?


If I were, instead of an individual, 10,000 individuals, and 500 of me were given homeopathic remedy, and the other 9500 were given a real remedy, then yes.

The alternative would be that everything (scam and legitimate) is banned until all 10,000 are dead.

Elbe, this isn't hard. Cost/benefit analysis.

[kevinquinnyo]

By the way, kevinquinnyo, while you're desperately trying to find even a shred of supporting evidence for your absurd proposition, why don't you do a little light reading on the case that spurred the creation of the FDA in 1938 (yes, 1938--24 years before 1962): the famous Elixir Sulfanilamide (http://en.wikipedia.org/wiki/Elixir_Sulfanilamide)story.

When you've read up on that, please come back here and tell us all why it should be legal for companies to sell deadly poison (quite literally) as medicine, and why it would save lives if we allowed that.


I don't need to read it, I know the story, it caused flipper babies right?

So what?

Compare that to Hundreds of thousands dead. (FDA drug lag and etc)

That was the worst tragedy before 1962. The worst one.

[kevinquinnyo]

I thought that drug also caused fetal problems for pregnant women...

So it killed 107, and then the guy killed himself.

I'm not trying to devalue individual human beings lives, but 108 dead is relatively insignificant.

[Yoink]

I don't need to read it, I know the story, it caused flipper babies right?

So what?

Compare that to Hundreds of thousands dead. (FDA drug lag and etc)

That was the worst tragedy before 1962. The worst one.

You're thinking of Thalidomide (http://en.wikipedia.org/wiki/Thalidomide); a tragedy that happened long after the institution of the FDA. The Thalidomide tragedy (which you jokingly dismiss as being about "flipper babies") had barely any effect in the US because the FDA did not approve the drug. Nonetheless, the worldwide disaster that was avoided in the US because of the FDA did prompt some of the tightening of the FDA drug approval laws in 1962 to which your article refers.

And no, the elixir sulfanilamide case isn't "the worst one" from before the FDA--it is just one we happen to know quite a lot about and which spurred Congress to pass the legislation. If you want to look into another well-known case you could look at the so called "Jake Leg (http://en.wikipedia.org/wiki/Jamaican_ginger)" epidemic.

You don't actually know anything at all about this issue, do you?

Yes, flagrant ignorance marshaled in support of dangerous social policies does make me angry.

[kevinquinnyo]

You're thinking of Thalidomide (http://en.wikipedia.org/wiki/Thalidomide); a tragedy that happened long after the institution of the FDA. The Thalidomide tragedy (which you jokingly dismiss as being about "flipper babies") had barely any effect in the US because the FDA did not approve the drug. Nonetheless, the worldwide disaster that was avoided in the US because of the FDA did prompt some of the tightening of the FDA drug approval laws in 1962 to which your article refers.

And no, the elixir sulfanilamide case isn't "the worst one" from before the FDA--it is just one we happen to know quite a lot about and which spurred Congress to pass the legislation. If you want to look into another well-known case you could look at the so called "Jake Leg (http://en.wikipedia.org/wiki/Jamaican_ginger)" epidemic.

You don't actually know anything at all about this issue, do you?

Yes, flagrant ignorance marshaled in support of dangerous social policies does make me angry.

Yoink.

The amount of deaths from these drug company mistakes, although heartbreaking, AGAIN, utterly pale in comparison to the passive murder by the FDA through its regulation.

You can list as many tiny tragedies that you want, and list every gruesome detail that these mistaken medical treatments had on humans, but it will never even come close to the hundreds of thousands that have died as a result of the FDA.

This is the problem. The FDA is never in a good position. They are attacked as harshly as the medical companies that make the mistake if a bad drug gets through, but they are never questioned for preventing a medicine that could save just as many or even thousands of times the amount of people than the last mistake killed. They are overly cautious by public demand.

And: Stop being creepy and passive aggressive on the internet. Just act normal. No more ad hominem nonsense. It's unbelievably irritating.

[Darat]

Elbe,

Read the title of the thread.

It says "The FDA Does More Harm Than Good."

The study backs this up. Certainly you are entitled to an opinion, but you must present some sort of evidence to the contrary. If you have a problem with the way these economists did their analysis, or gathered the data, then speak up.

But right now, you're just asserting that you believe federal regulation is better than not.

I understand it's counterintuitive, but you can't support something because it feels right, or seems right. This is people's lives we're talking about.

That is not a study, it is simply an opinion piece.

[KoihimeNakamura]

First of all, if you look at the SAEE, most people would consider most economists to be very libertarian.

Appeal to bandwagon - I don't even think this is relevant to the argument, just somkething I was noted. (i.e, I wasn't making it as an argument, sorry for not making that clear)



So, you think it's weird, or wrong? They have the pre 1962 data and the post 1962 data. They know how many people died of bad or ineffective drugs pre 1962. The number of victims (107) of Elixir Sulfanilamide tragedy and of all other drug tragedies prior to 1962 is very small compared to the death toll of the post-1962 FDA.

I guess I don't understand what your counter argument is.


You're not factoring in what would have happened had the drugs been approved. It factors in what it wants to, ignores the flipside: how many people would have been harmed by approving bad drugs.

Tell me what's interesting about it, I guess I don't see what you're driving at, exactly. They are saying that the postmarket withdrawl was around 3% for European countries as well as the United States. If the FDA lag was effective in its scrutiny of new drugs, you would expect the postmarket withdrawl rate to be much different here. Do you think the market for drugs there is different than in the U.S., because of some overlooked cultural difference? Explain.

What kinds of drugs were withdrawn? Were they both the same type? Or was one, say, a blood medication and other aspirin more? It's too incomplete to conclude on that alone.



How's this for apples to apples:

Deaths owing to drug lag have been numbered in the hundreds of thousands. Wardell (1978a) estimated that practolol, a drug in the beta-blocking family, could save ten thousand lives a year if allowed in the United States. Although the FDA allowed a first beta-blocker, propranolol, in 1968, three years after that drug had been available in Europe, it waited until 1978 to allow the use of propranolol for the treatment of hypertension and angina pectoris, its most important indications. Despite clinical evidence as early as 1974, only in 1981 did the FDA allow a second beta-blocker, timolol, for prevention of a second heart attack. The agency’s withholding of beta-blockers was alone responsible for probably tens of thousands of deaths (on this general issue see Gieringer 1985; Kazman 1990).

Yes, we have an ancedote. I need /data/.






Are you kidding me?

...the banning of advertising of aspirin for first heart attack prevention, may be the single most harmful regulatory policy currently pursued by any agency of the U.S. government

Tens of thousands could have been saved if that hadn't been restricted.

Yes, requoting the paper isn't getting you anywhere. And yes, you can point to individual issues. Again, not looking at the whole of why banning unproven claims is a good idea.

[MysteryMammal]

The amount of people that would die from unregulated drugs, such as cancer scams and snake oil salesmen is LOWER then the amount killed from the FDA drug lag, etc.

That IS the point. This is like the third time I've said this.

Interesting position. Can I see some evidence to back up this assertion? I didn't see it in the original article.

[Darat]

The article mentions the % of drug withdrawals since the 1962 point but it neglects to mention that without the FDA those drugs would have gone onto the market anyway, therefore removing the FDA would not reduce that number.

[MysteryMammal]

The amount of deaths from these drug company mistakes, although heartbreaking, AGAIN, utterly pale in comparison to the passive murder by the FDA through its regulation.


Interesting. When drug companies push a drug that causes deaths it is a mistake. When a regulatory agency requires proper testing and documentation of efficacy, side effects and all that good stuff, it's MURDER!!!

Please continue. I don't get nearly enough of my recommended daily allowance of hyperbole from Glenn Beck clips.

[DC]

oh cool a Milton Friedman fanatic.

Some police officers are corrupt, fat and slow, demotivated and not really serving the public.
do you think we are better off without police? or should we take care to pick out the bad apples and improve the police service?

[paximperium]

The amount of deaths from these drug company mistakes, although heartbreaking, AGAIN, utterly pale in comparison to the passive murder by the FDA through its regulation. I am very interested in hearing about the evidence of this claim.

You can list as many tiny tragedies that you want, and list every gruesome detail that these mistaken medical treatments had on humans, but it will never even come close to the hundreds of thousands that have died as a result of the FDA. Except for this being your fantasy, yeah sure.

This is the problem. The FDA is never in a good position. They are attacked as harshly as the medical companies that make the mistake if a bad drug gets through, but they are never questioned for preventing a medicine that could save just as many or even thousands of times the amount of people than the last mistake killed. They are overly cautious by public demand. You haven't heard about the Fast-Tracking Process that the FDA instituted years ago do you? You don't know a thing about the several cases or appeal and hearings that FDA hear each year for drug delays by patient's do you?

And: Stop being creepy and passive aggressive on the internet. Just act normal. No more ad hominem nonsense. It's unbelievably irritating.
Sorry Kevin, you are projecting your inadequacies onto others in a very lame attempt at an Ad Hominem, now THAT is creepy as to how it applies to you.

[kevinquinnyo]

The article mentions the % of drug withdrawals since the 1962 point but it neglects to mention that without the FDA those drugs would have gone onto the market anyway, therefore removing the FDA would not reduce that number.

Of course not. That's the point. The amount of withdrawls would likely be the same.

The interesting part was that when compared to European countries who have a much shorter drug lag/approval scrutiny, the percentage was identical.

[paximperium]

Of course not. That's the point. The amount of withdrawls would likely be the same.

The interesting part was that when compared to European countries who have a much shorter drug lag/approval scrutiny, the percentage was identical.
Great point. Therefore we should increase funding to the FDA and streamline the rules so that we can catch up to European countries.

What a great idea.

[Darat]

Of course not. That's the point. The amount of withdrawls would likely be the same.

...snip...

According to the opinions expressed in the article that is not very likely, if you follow the logic of the argument of that article there would be more withdrawals.

Or rather more bad drugs would get to market since without the FDA "withdrawal" would mean something quite different i.e. a company would weigh up whether it could make more money selling a bad drug than it would have to pay out to suppress the information that it is a bad drug or pay any future compensation claims. And we know this is exactly the calculating that companies actually do in those circumstances e.g. the tobacco industry from the 30s to the 90s.



The interesting part was that when compared to European countries who have a much shorter drug lag/approval scrutiny, the percentage was identical.

And where is the evidence to support such a claim?

[paximperium]

And where is the evidence to support such a claim?
This is actually true. FDA approval times is about 450 days vs. 400 days for EU drug approval...at least it was about 4 years ago when I did Clinical Research and did some contract work with pharma.

[kevinquinnyo]

According to the opinions expressed in the article that is not very likely, if you follow the logic of the argument of that article there would be more withdrawals.

Or rather more bad drugs would get to market since without the FDA "withdrawal" would mean something quite different i.e. a company would weigh up whether it could make more money selling a bad drug than it would have to pay out to suppress the information that it is a bad drug or pay any future compensation claims. And we know this is exactly the calculating that companies actually do in those circumstances e.g. the tobacco industry from the 30s to the 90s.


The point that the authors were making with regards to the withdrawal rate was that you would expect for Europe to have more withdrawals because of quicker approval periods. The evidence indicates the withdrawal rate was almost identical in several European countries as the United States at about 3%.

And as far as your second point, I won't argue that companies won't make that rather disgusting cost benefit analysis. I know that they do and have.

The problem, again, is that the amount of lives lost due to the FDA's regulation outweighs that perhaps necessary evil in an outright tally of lives lost.

They also compare the unregulated off-label usage of drugs to on label usages, and we find that the market itself regulates these off label usages through research, peer review, U.S. Pharmacopoeia, AMA, etc, etc.


And where is the evidence to support such a claim?

See above. 3%. It's in the article, there are references to the study.

[Fishstick]

Different thread yes, but I disagreed then and I still do. I'd like to see this evidence.




Well, it's just semantics, but I would call it involuntary manslaughter at the very least.

If you were bitten by a snake, I also wouldn't be directly killing you by not giving you the antidote in my hand.
And thanks to the FDA you would know what to expect from the antidote down to common side effects, and not have to trust that whoever manufactured in it didn't just bottle up saline with food colouring.

[paximperium]

The point that the authors were making with regards to the withdrawal rate was that you would expect for Europe to have more withdrawals because of quicker approval periods. The evidence indicates the withdrawal rate was almost identical in several European countries as the United States at about 3%.

And as far as your second point, I won't argue that companies won't make that rather disgusting cost benefit analysis. I know that they do and have.

The problem, again, is that the amount of lives lost due to the FDA's regulation outweighs that perhaps necessary evil in an outright tally of lives lost.

They also compare the unregulated off-label usage of drugs to on label usages, and we find that the market itself regulates these off label usages through research, peer review, U.S. Pharmacopoeia, AMA, etc, etc.




See above. 3%. It's in the article, there are references to the study.
Thanks for continuing to argue for the expansion and increased funding for the FDA.

[kevinquinnyo]

Interesting. When drug companies push a drug that causes deaths it is a mistake. When a regulatory agency requires proper testing and documentation of efficacy, side effects and all that good stuff, it's MURDER!!!

Please continue. I don't get nearly enough of my recommended daily allowance of hyperbole from Glenn Beck clips.

I would say that both are mistakes, and both are murder, albeit passive murder, or involuntary manslaughter?

Either way, the difference is in thousand fold, so it is important.

[kevinquinnyo]

And thanks to the FDA you would know what to expect from the antidote down to common side effects, and not have to trust that whoever manufactured in it didn't just bottle up saline with food colouring.

Or a private regulatory agency, perhaps one of several independent organizations that are much harder to sway with incentive.

But even still, my point is specifically that the utility is higher without the FDA, period.

[paximperium]

Or a private regulatory agency, perhaps one of several independent organizations that are much harder to sway with incentive. Ahhh, the Libertarian fantasy of "self-regulation".

But even still, my point is specifically that the utility is higher without the FDA, period.
No. Period.

[paximperium]

I would say that both are mistakes, and both are murder, albeit passive murder, or involuntary manslaughter?

Either way, the difference is in thousand fold, so it is important.
No, the difference is markedly different. One is based on negligent research and another is based on cautious research.

[kevinquinnyo]

Thanks for continuing to argue for the expansion and increased funding for the FDA.

The more the FDA's powers and funding are expanded, the more people will die unnecessarily from a lack of life saving chemicals.

[paximperium]

The more the FDA's powers and funding are expanded, the more people will die unnecessarily from a lack of life saving chemicals.
Not according to your article or your argument.

[kevinquinnyo]

No, the difference is markedly different. One is based on negligent research and another is based on cautious research.

It's precisely the catiousness that is at fault.

It doesn't matter the type of research done. It also doesn't matter if I use a butter knife and you use a gun, whoever kills more people is more of a threat to society.

[kevinquinnyo]

Not according to your article or your argument.

I don't think you read it then. Because that's precisely and explicitly what it says.

[paximperium]

It's precisely the catiousness that is at fault.

It doesn't matter the type of research done. It also doesn't matter if I use a butter knife and you use a gun, whoever kills more people is more of a threat to society.
No. The difference is between a man who dies in a car crash because of a badly made airbag Vs. the ambulance not arriving in time due to lack of resources. Your analogy continues to fail.

[paximperium]

I don't think you read it then. Because that's precisely and explicitly what it says.
No. They set forth a case of drug delays and the cost/benefit analysis of these delays and then decided to compare the Drug Approval Process to Europe which ALSO has a drug regulation system that is as stringent but is more efficient.

Didn't you argue that Europe has a fast and efficient drug regulation system? Guess what, you are correct, the EU is faster because they have a more streamlined drug approval process and better funding therefore we should follow the EU's example and increase funding and expansion of the FDA.

[MysteryMammal]

It's precisely the catiousness that is at fault.

It doesn't matter the type of research done. It also doesn't matter if I use a butter knife and you use a gun, whoever kills more people is more of a threat to society.

I'm still waiting on the evidence that more people are killed by "drug lag" than would be killed if we were to end all regulation.

Yes, it doesn't matter if you use a gun or a knife to kill me. But what does matter to me is if I die because a drug manufacturer did not take necessary precautions (for example: drug testing to determine efficacy and side effects) or if I die because a drug has not yet been determined to be safe.

Then again, if I needed a drug that was in testing, why the hell am I not a subject in the drug trials?

[kevinquinnyo]

No. They set forth a case of drug delays and the cost/benefit analysis of these delays and then decided to compare the Drug Approval Process to Europe which ALSO has a drug regulation system that is as stringent but is more efficient.

Didn't you argue that Europe has a fast and efficient drug regulation system? Guess what, you are correct, the EU is faster because they have a more streamlined drug approval process and better funding therefore we should follow the EU's example and increase funding and expansion of the FDA.

No, no, no, no.

I can't explain this again, ask someone else here to explain the European comparison data. You interpreted it in a way that allows you to justify central regulation. No where does it say that the European regulations are more "efficient." It just says they don't take as long to approve drugs.

Read it again.

[SezMe]

kevinquinnyo, why do you refuse to address the point several posters have made that your opinion piece argues for FDA reform, not elimination? Please speak directly to that point - and don't repeat yourself in the process.

[Travis]

I'm still waiting on the evidence that more people are killed by "drug lag" than would be killed if we were to end all regulation.

This is what I would like to know as well. I would be very interested in how any such numbers are reached seeing as how we have the FDA so any number about lives saved by letting all drugs go to the market would be entirely speculative.

In fact the only way one could know such a thing is to somehow travel to an alternate universe where the FDA was never created and then see how many people died from bad drugs and how many lives were saved by fast tracking good ones. Then come back to our reality with the data.

Was this entire line of thought just some excuse to get us to try and make Sliders real?

[paximperium]

It just says they don't take as long to approve drugs. Therefore using YOUR argument, the EU system saves more lives. In conclusion, we should emulate the EU system and expand the FDA and increase funding.

Read it again.
Perhaps YOU should.

BTW: I've read more about this than your silly little opinion piece. This is a hot topic of discussion in the Pharma research field and many if not all researchers would laugh at your face if you told them we didn't need the FDA. The debate it how to streamline the FDA and how to decrease the time for drugs to be approved and yet keep patient's safe. People are working on this issue. Unlike you, people who are not blinded by dogma, actually have ethics and care about patient safety and are not willing to compromise the safety and lives of patient's purely for dogma.

[paximperium]

Was this entire line of thought just some excuse to get us to try and make Sliders real?More like it is some excuse to push a Libertarian anti-FDA agenda.

[kevinquinnyo]

kevinquinnyo, why do you refuse to address the point several posters have made that your opinion piece argues for FDA reform, not elimination? Please speak directly to that point - and don't repeat yourself in the process.




If you read the proposed reform, and the "Sensible Alternative," it calls for deregulation and no mandatory approval from the FDA. It basically calls for allowing the FDA to function as a certifier, not a mandatory approver, similar to Underwriter's Labratory for electronics.

It goes on to discuss all of the ways in which products are regulated without the use of a central government and how it is more effective and less subject to harmful incentive.

They also talk about the reputation machine and how it is an effective means of market regulation.

It's not even subtle.

[kevinquinnyo]

More like it is some excuse to push a Libertarian anti-FDA agenda.

The only agenda I have is educating you guys about this important issue and trying to rid you of your anti-market bias.


This is what I would like to know as well. I would be very interested in how any such numbers are reached seeing as how we have the FDA so any number about lives saved by letting all drugs go to the market would be entirely speculative.

In fact the only way one could know such a thing is to somehow travel to an alternate universe where the FDA was never created and then see how many people died from bad drugs and how many lives were saved by fast tracking good ones. Then come back to our reality with the data.

Was this entire line of thought just some excuse to get us to try and make Sliders real?


That's correct. The only way to do a truly infallible experiment would be to set up a second Earth and change only the variables you desire, such as elimination of the FDA.

Most sociological or economic experiments do not have that luxury. They have to resort to regression analysis, inference, and comparisons of similar events in other parts of the world, or time periods.

[paximperium]

If you read the proposed reform, and the "Sensible Alternative," it calls for deregulation and no mandatory approval from the FDA. It basically calls for allowing the FDA to function as a certifier, not a mandatory approver, similar to Underwriter's Labratory for electronics.

It goes on to discuss all of the ways in which products are regulated without the use of a central government and how it is more effective and less subject to harmful incentive.

They also talk about the reputation machine and how it is an effective means of market regulation.

It's not even subtle.Yes indeed, it is just delusional; just like all the various "self-regulation" nonsense that Libertarians love to push.

[paximperium]

The only agenda I have is educating you guys about this important issue and trying to rid you of your anti-market bias. You are educating people here? What a joke. Sorry pal, but what people here are advocating is not "anti-market", it is consumer rights and patient safety.

[DC]

The only agenda I have is educating you guys

LOL

[kevinquinnyo]

Therefore using YOUR argument, the EU system saves more lives. In conclusion, we should emulate the EU system and expand the FDA and increase funding.

The European systems do save more lives, by not taking too long to approve drugs. Not because they have more funding, which they don't.



Perhaps YOU should.

BTW: I've read more about this than your silly little opinion piece. This is a hot topic of discussion in the Pharma research field and many if not all researchers would laugh at your face if you told them we didn't need the FDA. The debate it how to streamline the FDA and how to decrease the time for drugs to be approved and yet keep patient's safe. People are working on this issue. Unlike you, people who are not blinded by dogma, actually have ethics and care about patient safety and are not willing to compromise the safety and lives of patient's purely for dogma.

You didn't understand the 3% thing at all, and then you completely fabricated the "equally stringent, yet more efficient" thing.

It's not dogma, it's "what saves more lives?/what's the better way to do this"

I don't care if the solution is for a unicorn to piss on a leprechaun, if it makes less people die, then it's a better way to do it.

[MysteryMammal]

I will try this one last time:

Where is the evidence to support your position that "drug lag" costs more human lives than would be lost due to having no regulations in place.

[DC]

The European systems do save more lives, by not taking too long to approve drugs. Not because they have more funding, which they don't.



You didn't understand the 3% thing at all, and then you completely fabricated the "equally stringent, yet more efficient" thing.

It's not dogma, it's "what saves more lives?/what's the better way to do this"

I don't care if the solution is for a unicorn to piss on a leprechaun, if it makes less people die, then it's a better way to do it.

why dont you present a real study and evidence for your theory?

[kevinquinnyo]

I will try this one last time:

Where is the evidence to support your position that "drug lag" costs more human lives than would be lost due to having no regulations in place.

I answered this question above. It's not possible for me to prove that. But it is possible to draw conclusions from the evidence that point to that.

The only thing that would logically prevent that from being true is if there were some diminishing returns on a lack of regulation at some point headed towards zero, that isn't immediately evident.

Why don't you prove that the FDA is necessary on any level?

[paximperium]

The European systems do save more lives, by not taking too long to approve drugs. Not because they have more funding, which they don't.
2007 Budget: European Medicines Agency(EMEA): EUR47million
2008 Budget: Center for Drug Evaluation and Research(CDER): USD42million
You are wrong as usual.


You didn't understand the 3% thing at all, and then you completely fabricated the "equally stringent, yet more efficient" thing. So the EU has a faster drug approval process and similar drug withdrawal numbers. In what way is that "less stringent" or "less efficient"?

[kevinquinnyo]

You are educating people here? What a joke. Sorry pal, but what people here are advocating is not "anti-market", it is consumer rights and patient safety.

I am apparently not educating anyone here. That much is right.

[paximperium]

Why don't you prove that the FDA is necessary on any level?
The Story of the Laws Behind the Labels, Wallace F. Janssen, FDA Historian

http://www.fda.gov/AboutFDA/WhatWeDo/History/Overviews/ucm056044.htm

[Darat]

The point that the authors were making with regards to the withdrawal rate was that you would expect for Europe to have more withdrawals because of quicker approval periods.

...snip...

Personally I don't see why you would think that since it is, to my mind, an obviously a complex issue and so I doubt any one metric on its own is significant.

That aside....



The evidence indicates the withdrawal rate was almost identical in several European countries as the United States at about 3%.

...snip...

..... according the article it is 4% in the UK i.e. higher which is what apparently you and the authors would expect because of the quicker approval times....

What you seem to be doing (and the article's author/s) is to cherry pick your statistics.



And as far as your second point, I won't argue that companies won't make that rather disgusting cost benefit analysis. I know that they do and have.

...snip...

So do you argue that the current FDA doesn't stop that type of behaviour?




The problem, again, is that the amount of lives lost due to the FDA's regulation outweighs that perhaps necessary evil in an outright tally of lives lost.

...snip...

Which of course is still yet to be shown to be an accurate claim.

[paximperium]

I am apparently not educating anyone here. That much is right.
Most definitely. When you are woefully ignorant about the topic you're attempting to teach, that tends to happen.

[paximperium]

..... according the article it is 4% in the UK i.e. higher which is what apparently you and the authors would expect because of the quicker approval times....

What you seem to be doing (and the article's author/s) is to cherry pick your statistics.
True, but I remember during in a more intelligent debate between the FDA regulators and industry in 2006, the differences between 3% and 4% was brought up and found to be within the margin or statistical noise so it's not that valid a point. The FDA did agree to speed up and streamline their process.

The primary issue affecting the FDA is not due to lack of oversight or proper safety but due to red tape and just being overwhelmed by the workload. Their budget has had little increase within the last decade while the number of drugs needing approval has increased.

[Darat]

...snip...

Yes, it doesn't matter if you use a gun or a knife to kill me. But what does matter to me is if I die because a drug manufacturer did not take necessary precautions (for example: drug testing to determine efficacy and side effects) or if I die because a drug has not yet been determined to be safe.

...snip...

Or of course the pharmaceutical company actively hides the data that shows that there are significant risks for one of their drugs, which we know they will do if they are not tightly regulated..

Or in kevinquinnyo's libertarian case - they could just come to an arrangement with the "private regulatory" inspectors, which of course would not be a criminal matter, just a matter of two private organisations making business decisions.

[Darat]

This is actually true. FDA approval times is about 450 days vs. 400 days for EU drug approval...at least it was about 4 years ago when I did Clinical Research and did some contract work with pharma.

Not doubting you but I would still like to see some external data that supports this and any research into why one system is apparently quite a bit quicker than another.

[kevinquinnyo]

2007 Budget: European Medicines Agency(EMEA): EUR47million
2008 Budget: Center for Drug Evaluation and Research(CDER): USD42million
You are wrong as usual.

So the EU has a faster drug approval process and similar drug withdrawal numbers. In what way is that "less stringent" or "less efficient"?

2 things.

1) The time period that the data was collected for the 3% withdrawal rate was not 2008.

2) Where did you get that figure. It just sounds wrong right off the bat. Wikipedia says that the annual budget for the CDER is closer to 290 million dollars.

?

[kevinquinnyo]

Or of course the pharmaceutical company actively hides the data that shows that there are significant risks for one of their drugs, which we know they will do if they are not tightly regulated..

Or in kevinquinnyo's libertarian case - they could just come to an arrangement with the "private regulatory" inspectors, which of course would not be a criminal matter, just a matter of two private organisations making business decisions.

Yes, and could you provide proof of this conspiracy theory collusion that you seem so positive will happen more with a private company?

Why do you think that anyone could get away with that kind of thing more than a few times?

And why do you think the government isn't more prone to dirty incentives?

Show me an example of an existing successful private watchdog group, knower company, or private certifier who accepted a bribe from another corporation, and still has a shred of reputation.

[Darat]

No, no, no, no.

I can't explain this again, ask someone else here to explain the European comparison data. You interpreted it in a way that allows you to justify central regulation. No where does it say that the European regulations are more "efficient." It just says they don't take as long to approve drugs.

Read it again.

Isn't one of your major points that you want to reduce the "drug lag"? If so then why does it matter how that is done (as long as it is done effectively)?

What your article shows (if we take it at face value) is that there are better systems than the FDA which reduce the "drug lag". Why are you not in favour of a system, that according to the article not only can but does reduce the "drug lag"?

[Darat]

True, but I remember during in a more intelligent debate between the FDA regulators and industry in 2006, the differences between 3% and 4% was brought up and found to be within the margin or statistical noise so it's not that valid a point. The FDA did agree to speed up and streamline their process.

...snip...

That's fair enough.



The primary issue affecting the FDA is not due to lack of oversight or proper safety but due to red tape and just being overwhelmed by the workload. Their budget has had little increase within the last decade while the number of drugs needing approval has increased.


Number of drugs needing approval has increased - but how can that be the case - the FDA has reduced the number of drugs.... ;)

[kevinquinnyo]

Isn't one of your major points that you want to reduce the "drug lag"? If so then why does it matter how that is done (as long as it is done effectively)?

What your article shows (if we take it at face value) is that there are better systems than the FDA which reduce the "drug lag". Why are you not in favour of a system, that according to the article not only can but does reduce the "drug lag"?


Because first of all, even though the drug lag is significantly shorter in Europe, people are still dying while the drugs are sitting on their desk.

And more importantly, the article isn't just about drug lag. It also compares the unregulated off-label usage of drugs to the on-label usage as a forecast tool on how a totally deregulated drug market can function, as well as the deaths caused by bans on advertisement of drugs by the FDA.

[Darat]

Yes, and could you provide proof of this conspiracy theory collusion that you seem so positive will happen more with a private company?

...snip..

I've already mentioned the tobacco companies, here is another one that I know a little bit about as I'm still trying to get some money back from them: http://on line.wsj.com/article/SB124748655379832447.html




Why do you think that anyone could get away with that kind of thing more than a few times?

...snip...

Why should it take a "few times"?


And why do you think the government isn't more prone to dirty incentives?

...snip...

Different incentives, different pressures.

[Leif Roar]

This is actually true. FDA approval times is about 450 days vs. 400 days for EU drug approval...at least it was about 4 years ago when I did Clinical Research and did some contract work with pharma.

Out of curiosity, do you happen to known (or have a personal opinion) as to why? I can see three possible explanations for this, that EU approval is less stringent than the FDA's, that the EU approval process is more efficent than FDA's or that it's an artifact of which order the approvals are usually sought in. (Assuming that having gotten one approval, getting the second approval will tend to go smoothly.)

[DC]

Because first of all, even though the drug lag is significantly shorter in Europe, people are still dying while the drugs are sitting on their desk.

And more importantly, the article isn't just about drug lag. It also compares the unregulated off-label usage of drugs to the on-label usage as a forecast tool on how a totally deregulated drug market can function, as well as the deaths caused by bans on advertisement of drugs by the FDA.

how many would die if a product enters the market that isnt save?

[MysteryMammal]

I answered this question above. It's not possible for me to prove that. But it is possible to draw conclusions from the evidence that point to that.

The only thing that would logically prevent that from being true is if there were some diminishing returns on a lack of regulation at some point headed towards zero, that isn't immediately evident.

Why don't you prove that the FDA is necessary on any level?

A picture is worth a thousand words:

http://tencure.com/images/more_natural_cures_book_kevin_trudeau_98o9.jpg

I've never read his first "Natural Cures" book, but I did read this one. Got a copy for free from a friend and had a good laugh.... until I did some searching on the intermess and saw that some people read it as a medical book (as opposed to the humour book I thought it was) and had some serious health related consequences from going off their meds and following his advice.

While the FDA has never come down on Mr. Trudeau (at least from what I've gleaned from the interwebs), the FTC has pimp-slapped him more times than... well, let's just say that regulatory agency has their hands full with him.

http://en.wikipedia.org/wiki/Homeopathy

Fun fact: Homeopathy doesn't work. Still, each year many people make claims regarding their homeopathic products and their efficacy to treat diseases.

http://en.wikipedia.org/wiki/Vioxx

What is enlightening about this link is the "VIGOR study" part. To sum it up: Patients treated with Vioxx were at a four fold risk of heart attack versus patients treated with naproxen. Merck then claimed an implausible and unsubstantiated defense of their drug: naproxen protects the heart.

Without regulation Kevin Trudeau would be free to actually say what he wants to: his products and advice cure cancer, HIV, halitosis AND male pattern baldness (and likely that he is Jesus); homeopaths would sling their wares alongside real medicine; and drug companies would be keeping doctors and patients in the dark regarding harmful side effects of their wares.

But, perhaps, in an unregulated free market people will all suddenly grow consciences and human life and honesty would be valued more than money.

[Darat]

Because first of all, even though the drug lag is significantly shorter in Europe, people are still dying while the drugs are sitting on their desk.

...snip...

Yes they are but you can make that statement for any system that includes testing for safety so it is rather a meaningless objection. (Unless you are for a system that says no testing for safety should take place?)

So again I'll ask you, why are you not supporting a system that we know would achieve what you claim to want i.e. reduce the drug lag?

[Darat]

...snip... (Assuming that having gotten one approval, getting the second approval will tend to go smoothly.)

I was wondering about this last one - perhaps the EU authority accepts some trials that have already been run as part of the FDA process?

[kevinquinnyo]

The withdrawal % is the same because the regulation isn't effective.

How hard is that to understand?



Darat, see my post where I already answered your question. If it was a choice between the European or the US system, of course I would choose the European.

But those aren't our only choices.

This is maddening to try to debate in here. You all not only have anti-market bias, but a bordering on religious adherence to the effectiveness of government to regulate, despite evidence to the contrary. Of course you don't see that... you are convinced that I'm the nut.

[kevinquinnyo]

Yes they are but you can make that statement for any system that includes testing for safety so it is rather a meaningless objection. (Unless you are for a system that says no testing for safety should take place?)

So again I'll ask you, why are you not supporting a system that we know would achieve what you claim to want i.e. reduce the drug lag?


And just to be clear, let me say this again. Actually, I'll just copy/paste my post that you snipped the top off of.

kevinquinnyo
Because first of all, even though the drug lag is significantly shorter in Europe, people are still dying while the drugs are sitting on their desk.

And more importantly, the article isn't just about drug lag. It also compares the unregulated off-label usage of drugs to the on-label usage as a forecast tool on how a totally deregulated drug market can function, as well as the deaths caused by bans on advertisement of drugs by the FDA.

[kevinquinnyo]

...

But, perhaps, in an unregulated free market people will all suddenly grow consciences and human life and honesty would be valued more than money.

Yeah we all hate that guy.

People will not change. That's the point. People do self-regulate. We're part of that process right now. Many book stores refuse to sell books they find innapropriate, groups petition to have them boycotted, or worse, tort action can ruin them.

What has the FTC done to this guy to stop him from exploiting uneducated and sick people?

He's still here.

[Darat]

The withdrawal % is the same because the regulation isn't effective.

How hard is that to understand?

...snip...

I was quite surprised to read the withdrawal rate is so low - I think it shows that the current regulatory systems are very effective.



Darat, see my post where I already answered your question. If it was a choice between the European or the US system, of course I would choose the European.

But those aren't our only choices.

...snip...

True but don't you think it is better to use a system that you know will reduce a problem than adopt a system that we do not know will reduce the problem?



This is maddening to try to debate in here. You all not only have anti-market bias, but a bordering on religious adherence to the effectiveness of government to regulate, despite evidence to the contrary. Of course you don't see that... you are convinced that I'm the nut.

Not at all - I don't care one iota how something is achieved as long as it is effective, which of course does not just mean looking at the costs of a particular solution (and of course in line with my ethical beliefs). If self-regulation works we should use that, if government regulation works we should use that.

What you are coming up against is simply that you are not putting forward a good argument backed with evidence for why I should consider that your proposed "self-regulation" system would be more effective than what we currently have. It has nothing to do with the fact that what we currently have is a government backed system.

[elbe]

I was giving it some thought when I couldn't get back to sleep (take that as you will) and you know what? Kevin is totally and completely right! Every minute the FDA takes to approve a drug is costing lives! But we can't stop there.

Drug companies do testing to find the side effects of their drugs. But dammit, people are dying, release them earlier!

Drug companies test to see if drugs will actually do more damage to a patient, like kill them. But dammit, people are dying!

Drug companies have to test to see if the drugs even do what they think they'll do. But dammit, people are dying!

So the answer is clear, any drug ever produced should be immediately released for public consumption with whatever the manufacturer thinks it will do because any, any delay will cause untold death. The blood is on your hands, drug companies!

[Darat]

And just to be clear, let me say this again. Actually, I'll just copy/paste my post that you snipped the top off of.


Yes they are but you can make that statement for any system that includes testing for safety so it is rather a meaningless objection. (Unless you are for a system that says no testing for safety should take place?)

So again I'll ask you, why are you not supporting a system that we know would achieve what you claim to want i.e. reduce the drug lag?

[kevinquinnyo]

Most definitely. When you are woefully ignorant about the topic you're attempting to teach, that tends to happen.

What is the correct figure for the CDER Budget? I got $290 million per year for the U.S. You said 40 something million? That's over 8 times more..

[Darat]

Yeah we all hate that guy.

People will not change. That's the point. People do self-regulate. We're part of that process right now.

...snip...

That is correct, and one of the ways we self-regulate is to create regulatory bodies such as the FDA.

[DC]

Yeah we all hate that guy.

People will not change. That's the point. People do self-regulate. We're part of that process right now. Many book stores refuse to sell books they find innapropriate, groups petition to have them boycotted, or worse, tort action can ruin them.

What has the FTC done to this guy to stop him from exploiting uneducated and sick people?

He's still here.

Do you have the slightest idea how much work it would be for you to find out if a drug is save without the FDA?
you would propably alerady fail to get together the proper informatino you need to come to a meaningfull conclusion.

especially when i look at the tiny little bit of information you want to use to argue against the FDA.

and still you havent brought up any evidence that would support your conclusion.

[kevinquinnyo]

Yes they are but you can make that statement for any system that includes testing for safety so it is rather a meaningless objection. (Unless you are for a system that says no testing for safety should take place?)

So again I'll ask you, why are you not supporting a system that we know would achieve what you claim to want i.e. reduce the drug lag?

DARAT,

Dude. I'm about done with you now.

Read the rest of what I wrote and stop wasting my time with this nonsense. Read what I wrote. Drug lag is not the only concern I have.

I just posted that TWICE now in response to the same question. I'm not gonna do it again.

GO Back And READ it.

[Darat]

DARAT,

Dude. I'm about done with you now.

Read the rest of what I wrote and stop wasting my time with this nonsense. Read what I wrote. Drug lag is not the only concern I have.

I just posted that TWICE now in response to the same question. I'm not gonna do it again.

GO Back And READ it.

Yet one of the claims yo keep making in this thread is that "drug lag" is "killing people". There are systems that according to your article reduce that lag and therefore according to your argument would mean less people are killed.

Why do you not support such a system?

[kevinquinnyo]

Do you have the slightest idea how much work it would be for you to find out if a drug is save without the FDA?
you would propably alerady fail to get together the proper informatino you need to come to a meaningfull conclusion.

especially when i look at the tiny little bit of information you want to use to argue against the FDA.

and still you havent brought up any evidence that would support your conclusion.

There is no way I could do it. Of course I couldn't do it. I never said I could.

Who do you think works for the FDA? Robots? Superhumans? Martians? They're human beings. There are already nongovernmental private watchdog groups for testing drugs.

Stop villifying the private sector and looking at government as holy.

[MysteryMammal]

This is maddening to try to debate in here. You all not only have anti-market bias, but a bordering on religious adherence to the effectiveness of government to regulate, despite evidence to the contrary. Of course you don't see that... you are convinced that I'm the nut.

Trust me, it's no picnic from this end either. You refuse to offer support to your argument, instead proffering conjecture and speculation as evidence. Yet you keep calling us "anti-market" because we demand evidence.

Protip: Insinuating that people who disagree with you are nuts is not a good way to make friends. Don't you want to be my friend? I don't think you're nuts, I just think you're an idealist... just like me.

[Leif Roar]

The withdrawal % is the same because the regulation isn't effective.

How hard is that to understand?

Very, as there is no logical progression from the initial statement to your conclusion.

The FDA drug regulation consists of two parts: a set of standards that available drugs are meant to meet and a process to ensure that drugs actually do meet those standards. The percentage of withdrawn drugs only speak to the accuracy of this second part, the process, and barely that as all it gives you is the false positive to all positives ratio. It says nothing about the effectiveness of it, because to determine a measure of effectiveness you have to also take into account the total number of drugs submitted to the process . A process that always denies approval will give you 0% withdrawn drugs, but is clearly neither effective nor accurate.


You would also need to take into account the number of true negatives (drugs that does not meet the standards and that were not approved) and the number of false negatives (drugs that do meet the standards but were not approved because of an error in the process.) And if you really want to measure the accuracy of the process you also need to take into account that the drug companies are "reading for the test": they do not submit all their potential drugs they have researched, only those that they believe will be approved.

[DC]

There is no way I could do it. Of course I couldn't do it. I never said I could.

Who do you think works for the FDA? Robots? Superhumans? Martians? They're human beings. There are already nongovernmental private watchdog groups for testing drugs.

Stop villifying the private sector and looking at government as holy.

the government is not Holy, it is something you have to watch very closely and carefully, and very very often you need to correct them.
the government are the people we as " we the people" hired to work for us.
on a government i can take direct influence in a company not.

a governmnet body is ideal to do something like the FDA.

[kevinquinnyo]

yet one of the claims yo keep making in this thread is that "drug lag" is "killing people". There are systems that according to your article reduce that lag and therefore according to your argument would mean less people are killed.

Why do you not support such a system?


darat
read this right here:
kevinquinnyo
darat, see my post where i already answered your question. If it was a choice between the european or the us system, of course i would choose the european.

But those aren't our only choices.

...

[Darat]

There is no way I could do it. Of course I couldn't do it. I never said I could.

Who do you think works for the FDA? Robots? Superhumans? Martians? They're human beings. There are already nongovernmental private watchdog groups for testing drugs.

Stop villifying the private sector and looking at government as holy.

Perhaps you should stop vilifying the government regulatory bodies and looking at the private sector as holy?

I hope that by my turn around of your comment above you realise that your comment is not actually making any point relevant to your argument?

If you want people to change something it is really beholden on you to explain why your change would be for the better, that is what you have failed to do so far. I have to admit that I am getting the impression that your objection to the FDA is an idealogical one, not a pragmatic one. If that is the case then it would be better if you just told me that so I can better understand your arguments.

[Darat]

darat
read this right here:

Yet one of the claims yo keep making in this thread is that "drug lag" is "killing people". There are systems that according to your article reduce that lag and therefore according to your argument would mean less people are killed.

Why do you not support such a system?

[DC]

what would secure that private FDA like controll bodys will work better than the Banks private ratings companys?

[elbe]

Stop villifying the private sector and looking at government as holy.

The only person doing any vilifying here is you. Unless you've forgotten, the drug companies are private sector and I haven't seen anyone claim that they should be taken over by the "holy" government.

Let me ask you this, hypothetically, if it was demonstrated that government regulation of drugs is safer and more efficient than private regulation, would you support it? Or would you follow your reactionary anti-government bias all the way into the ground?

[kevinquinnyo]

I was giving it some thought when I couldn't get back to sleep (take that as you will) and you know what? Kevin is totally and completely right! Every minute the FDA takes to approve a drug is costing lives! But we can't stop there.

Drug companies do testing to find the side effects of their drugs. But dammit, people are dying, release them earlier!

Drug companies test to see if drugs will actually do more damage to a patient, like kill them. But dammit, people are dying!

Drug companies have to test to see if the drugs even do what they think they'll do. But dammit, people are dying!

So the answer is clear, any drug ever produced should be immediately released for public consumption with whatever the manufacturer thinks it will do because any, any delay will cause untold death. The blood is on your hands, drug companies!

Yeah why don't you go back to sleep

[kevinquinnyo]

Yet one of the claims yo keep making in this thread is that "drug lag" is "killing people". There are systems that according to your article reduce that lag and therefore according to your argument would mean less people are killed.

Why do you not support such a system?

I told you if those were the only 2 choices I would. I wonder if even after the big text you didnt read that...

[Aepervius]

By the way, kevinquinnyo, while you're desperately trying to find even a shred of supporting evidence for your absurd proposition, why don't you do a little light reading on the case that spurred the creation of the FDA in 1938 (yes, 1938--24 years before 1962): the famous Elixir Sulfanilamide (http://en.wikipedia.org/wiki/Elixir_Sulfanilamide)story.

When you've read up on that, please come back here and tell us all why it should be legal for companies to sell deadly poison (quite literally) as medicine, and why it would save lives if we allowed that.

Just a nitpick , one can trace the origin to 1906 with the FDA name coming in 1930.

A 1911 Supreme Court decision ruled that the 1906 act did not apply to false claims of therapeutic efficacy,[22] in response to which a 1912 amendment added "false and fraudulent" claims of "curative or therapeutic effect" to the Act's definition of "misbranded." However, these powers continued to be narrowly defined by the courts, which set high standards for proof of fraudulent intent.[20] In 1927, the Bureau of Chemistry's regulatory powers were reorganized under a new USDA body, the Food, Drug, and Insecticide organization. This name was shortened to the Food and Drug Administration (FDA) three years later.[23]

[DC]

I told you if those were the only 2 choices I would. I wonder if even after the big text you didnt read that...

what choices would you offer?

[elbe]

I told you if those were the only 2 choices I would. I wonder if even after the big text you didnt read that...

I would hate to speak for Darat, but I think the point is that wouldn't it be better, if we were to change systems, to adopt a system we already know works (to reduce lag time and still provide drug safety) than to adopt an unproven system?

[kevinquinnyo]

The only person doing any vilifying here is you. Unless you've forgotten, the drug companies are private sector and I haven't seen anyone claim that they should be taken over by the "holy" government.

Let me ask you this, hypothetically, if it was demonstrated that government regulation of drugs is safer and more efficient than private regulation, would you support it? Or would you follow your reactionary anti-government bias all the way into the ground?

Elbe,

As you should know, I sit on the fence on issues where governmental top-down market interference can actually be more efficient.

In the case of a public goods problem or largescale adverse selection rarities in insurance markets, and even possibly patent laws, I accept government interference can be more effective.

But this is an aside, because even those market failures I look at with a skeptical eye.

If there were a study just like the one I presented that said the exact opposite, then of course I would accept it. But there isn't.

[elbe]

Yeah why don't you go back to sleep

Where did I go wrong in my conclusion?

[Darat]

I told you if those were the only 2 choices I would. I wonder if even after the big text you didnt read that...

And as I said:

True but don't you think it is better to use a system that you know will reduce a problem than adopt a system that we do not know will reduce the problem?

[kevinquinnyo]

I would hate to speak for Darat, but I think the point is that wouldn't it be better, if we were to change systems, to adopt a system we already know works (to reduce lag time and still provide drug safety) than to adopt an unproven system?

yeah why try anything that might save lives and make the world better, that would be dumb

[elbe]

yeah why try anything that might save lives and make the world better, that would be dumb

So you would go with the proven system and forgo the system that we don't know if it would even accomplish that simple goal?

[kevinquinnyo]

And as I said:

True but don't you think it is better to use a system that you know will reduce a problem than adopt a system that we do not know will reduce the problem?

That's like saying we shouldn't try to build an electric car because we know that hybrid cars are better than all gas cars.

It's weird logic, Darat.

[Darat]

yeah why try anything that] might[/HILITE] save lives and make the world better, that would be dumb

According to your article there is already a system that does "save lives and make the world better".

Why would we not want to adopt that system?

[Leif Roar]

That's like saying we shouldn't try to build an electric car because we know that hybrid cars are better than all gas cars.

It's weird logic, Darat.

True. On the other hand, your line of reasoning seems to be that "since American cars are less safe than European cars we should all walk."

[elbe]

That's like saying we shouldn't try to build an electric car because we know that hybrid cars are better than all gas cars.

It's weird logic, Darat.

That's not a very good analogy at all, Kevin.

[kevinquinnyo]

So you would go with the proven system and forgo the system that we don't know if it would even accomplish that simple goal?

It's absolutely bizarre that in an article that outright proves the FDA on net, kills and harms in mass, you guys find a silver lining for the European system and claim that is the solution.

It's just weird.

[kevinquinnyo]

That's not a very good analogy at all, Kevin.

Why isn't it?


FDA = all gasoline
European = hybrid
Deregulation = all electric

[Darat]

That's like saying we shouldn't try to build an electric car because we know that hybrid cars are better than all gas cars.

It's weird logic, Darat.

Your anaology does not fit your argument. To make it fit your argument it would have to be more akin to saying "we will now stop using hybrid cars and use electric cars, even if we don't know if electric cars can replace hybrid cars".

[elbe]

It's absolutely bizarre that in an article that outright proves the FDA on net, kills and harms in mass, you guys find a silver lining for the European system and claim that is the solution.

It's just weird.

I think we're trying to follow your logic here. If the FDA kills more people through drug lag, then the best solution (and still be safe) is to reduce the drug lag. The Euro system has been held as an example, in this very thread, that you can have a shorter drug lag and still be as safe. Therefore, wouldn't the Euro system be a better system to adopt?

Removing the FDA completely has not been shown to both reduce drug lag and be as safe, but that's the solution you've reached.

[kevinquinnyo]

Your anaology does not fit your argument. To make it fit your argument it would have to be more akin to saying "we will now stop using hybrid cars and use electric cars, even if we don't know if electric cars can replace hybrid cars".

Nope. Not at all. Because I didn't ever say that I wouldn't rather have any amount of deregulation or less drug lag than none.

In fact, I said that if I had to choose between the U.S. or European I would take the European.

That was that thing that you kept not reading or overlooking, or ignoring, remember?

[elbe]

Why isn't it?


FDA = all gasoline
European = hybrid
Deregulation = all electric

I like Leif Roar (http://forums.randi.org/showpost.php?p=5037991&postcount=138)'s analogy, but Darat (http://forums.randi.org/showpost.php?p=5037997&postcount=142)'s is more accurate to your argument.

[Darat]

Why isn't it?


FDA = all gasoline
European = hybrid
Deregulation = all electric

Again to fit your argument:

FDA = all gasoline
European = hybrid
Deregulation = all electric even though they do not currently exist and we do not know if they will be effective if they are ever developed

Your problem is that you have not, at least yet, shown that the "electric" option would work as effectively as the "all gasoline" or the "hybrid".

So far in this thread, and the same is true for the article, you have not provided evidence that your proposed alternative would be more effective than current systems. To date it appears that you simply have faith that your solution would be more effective, simply because it isn't "government".

[Belz...]

It says "The FDA Does More Harm Than Good."

The study backs this up.

Studies usually back numbers, not opinions.

[kevinquinnyo]

I think we're trying to follow your logic here. If the FDA kills more people through drug lag, then the best solution (and still be safe) is to reduce the drug lag. The Euro system has been held as an example, in this very thread, that you can have a shorter drug lag and still be as safe. Therefore, wouldn't the Euro system be a better system to adopt?

Removing the FDA completely has not been shown to both reduce drug lag and be as safe, but that's the solution you've reached.

ALMOST! But not quite.

Again. Drug lag is not the only important thing. There are other regulatory factors that cause deaths and inefficiency, cited in the article, besides drug lag alone.

Would it make you happy if I said, "Okay, we solved it! We found through this article that drug lag is slightly shorter in Europe, so let's go party, no need to think about it ever again, problem solved, the end?"

[Leif Roar]

Why isn't it?


FDA = all gasoline
European = hybrid
Deregulation = all electric

Considering all the inherent problems of all electric cars, and that they're nonetheless presented as a panacea, it's probably a better allegory than you realise. Although the European system would be "more efficent gasoline cars" rather than hybrids.

[kevinquinnyo]

Again to fit your argument:

FDA = all gasoline
European = hybrid
Deregulation = all electric even though they do not currently exist and we do not know if they will be effective if they are ever developed

Your problem is that you have not, at least yet, shown that the "electric" option would work as effectively as the "all gasoline" or the "hybrid".

So far in this thread, and the same is true for the article, you have not provided evidence that your proposed alternative would be more effective than current systems. To date it appears that you simply have faith that your solution would be more effective, simply because it isn't "government".


What I have done is show that deregulation of the drug market correlates to less death and suffering.

What you haven't done is PROVE that there is at some point a diminishing return on the amount of lives saved as we approach ZERO regulation.

There may be, but it is not evident. Do you understand my point?

[elbe]

ALMOST! But not quite.

Again. Drug lag is not the only important thing. There are other regulatory factors that cause deaths and inefficiency, cited in the article, besides drug lag alone.

Would it make you happy if I said, "Okay, we solved it! We found through this article that drug lag is slightly shorter in Europe, so let's go party, no need to think about it ever again, problem solved, the end?"

And aren't those all, at worst, signs of problems that should be fixed? The article does not support the conclusion of doing away with the entire drug regulation system like you are proposing.

As far as I can tell, you think because a government agency has problems, (and what doesn't) that it should automatically be completely abolished without any consideration to actually addressing the problems. You are remarkable short sighted.

[Belz...]

Nope. Again, let's examine the title of the thread. "MORE HARM THAN GOOD"

You seem to be obsessed with that title.

[kevinquinnyo]

You seem to be obsessed with that title.

ok

[Leif Roar]

What I have done is show that deregulation of the drug market correlates to less death and suffering.

You have done nothing of the kind. What you fail to realise is that drugs in EU is just as strongly regulated as in the USA (I actually believe it's slightly tighter). They're just quicker about checking if a drug adheres to the regulations or not.

[kevinquinnyo]

And aren't those all, at worst, signs of problems that should be fixed? The article does not support the conclusion of doing away with the entire drug regulation system like you are proposing.

As far as I can tell, you think because a government agency has problems, (and what doesn't) that it should automatically be completely abolished without any consideration to actually addressing the problems. You are remarkable short sighted.

No, it's the other way around. The burden of proof is on you to tell me why there is a diminishing return on loss of life as we approach zero regulation on a scale of full regulation to none whatsoever.

[Belz...]

You're right that I must consider Food regulation as well..

But really, has the FDA saved hundreds of thousands of people by regulating food, to make up for it's failures on the drug side?

Huh ? How in the blue hell do you come to that conclusion ?

[kevinquinnyo]

You have done nothing of the kind. What you fail to realise is that drugs in EU is just as strongly regulated as in the USA (I actually believe it's slightly tighter). They're just quicker about checking if a drug adheres to the regulations or not.


That is a statement that requires some evidence to back it up. You believe it's slightly tighter?

[kevinquinnyo]

Huh ? How in the blue hell do you come to that conclusion ?

It's not a conclusion

[Belz...]

Well, it's just semantics, but I would call it involuntary manslaughter at the very least.

:rolleyes:

[Belz...]

It's not a conclusion

You said:

"But really, has the FDA saved hundreds of thousands of people by regulating food, to make up for it's failures on the drug side?"

So it's a question. A question based on your understanding that one is making up for the other, which you conjured up from thin air.

[kevinquinnyo]

Yeah people needlessly dying :rolleyes::rolleyes: i know right? LOLZ

[DC]

kevinquinnyo

how well did the non government ratings companies performe in their credit ratings?
Do you want to ridk the same with your Drugs regulation?

[kevinquinnyo]

You said:

"But really, has the FDA saved hundreds of thousands of people by regulating food, to make up for it's failures on the drug side?"

So it's a question. A question based on your understanding that one is making up for the other, which you conjured up from thin air.

No I didn't conjure up a damn thing from thin air.

[Darat]

Nope. Not at all. Because I didn't ever say that I wouldn't rather have any amount of deregulation or less drug lag than none.

In fact, I said that if I had to choose between the U.S. or European I would take the European.

That was that thing that you kept not reading or overlooking, or ignoring, remember?

Lets take this away from specifics so you can perhaps gain a better understanding of why you are meeting apparent "resistance" in this thread, so stripping the FDA out of this:

You:

We have a problem, X

Our current system at least contributes to X

The EU has a system that reduces X

I have a solution that I believe will reduce X.

Us:


OK - so can you provide evidence as to why your solution will reduce X?

You:

No

Us:

So why not go with what we know works to reduce X?

[kevinquinnyo]

kevinquinnyo

how well did the non government ratings companies performe in their credit ratings?
Do you want to ridk the same with your Drugs regulation?


Examine the entire history of Moody's, or S&P or any of the hundreds of ratings agencies, speculative stock magazines, newsletters, online blogs, etc, etc.

The ratings agencies sell an opinion, trust them or don't, it's up to you. The housing market was a giant systemic bubble that left a trail of destruction. No one was really immune, but I'll tell you who got a lot more reputation after that - the people and companies who did manage to accurately predict it.

Did the FCC put up a single warning? Did any government agency publicly warn the public not to invest in CDOs and MBS andbuy houses above their means? No, in fact Greenspan encouraged it.

So let's not even have that discussion

[elbe]

No, it's the other way around. The burden of proof is on you to tell me why there is a diminishing return on loss of life as we approach zero regulation on a scale of full regulation to none whatsoever.

So the X number of people dying through over regulation scales with the amount of regulation, then zero regulation will result in zero people dying through over regulation.

And where do the increased number of deaths due to under regulation come in? You know, where someone tries to sell rat poison as a cure for cancer. Someone will try it, you know.

[kevinquinnyo]

Lets take this away from specifics so you can perhaps gain a better understanding of why you are meeting apparent "resistance" in this thread, so stripping the FDA out of this:

You:

We have a problem, X

Our current system at least contributes to X

The EU has a system that reduces X

I have a solution that I believe will reduce X.

Us:


OK - so can you provide evidence as to why your solution will reduce X?

You:

No

Us:

So why not go with what we know works to reduce X?



Okay, you're right. Let's lobby to make the FDA more like the European Union because of the single statistic you felt like reading out of the article that shows less drug lag. Let's ignore all other factors and just be intellectually lazy and call it a day.

[kevinquinnyo]

So the X number of people dying through over regulation scales with the amount of regulation, then zero regulation will result in zero people dying through over regulation.

And where do the increased number of deaths due to under regulation come in? You know, where someone tries to sell rat poison as a cure for cancer. Someone will try it, you know.


sigh. This is really frustrating man.

I just can't seem to get through to you. I don't think you even understood what I meant.

What I'm saying is that as we hypothetically approach zero regulation of drug markets, in order for you to be correct in that we need the FDA, which you have at least tacitly implied that you believe, then there would have to be a diminishing return at a certain point on the scale towards deregulation outright.

So if you think that the amount of people selling rat poison as cancer drug will at some point go up dramatically, outweighing the benefits of deregulation, you have to explain why you think that.

[leftysergeant]

I welcome any criticism of the way the economists analyzed the data. There's always a bit of art that has to go into complicated regression analysis problems with a lot of unknowns, but I think the evidence is compelling.

Sakrament noch Mal! I have barely begun to skim this thread and I find that you are going to back up your arguments with the work of a scientific prostitute from some right-wing stink tank.

He's an ECCONOMIST?

What the hell qualifies him to address the safety of drugs?

Who cares how much money some corporate fat cat does not get in his golden parachute if he sells us crap that kills people?

I sure don't. I actually prefer that he leave his employment penniless and scorned and forbidden ever to work in the industry again.

All I see is a bunch of right wingers snivelling about lost profits.

They don't matter to civilized people any more.

[DC]

Examine the entire history of Moody's, or S&P or any of the hundreds of ratings agencies, speculative stock magazines, newsletters, online blogs, etc, etc.

The ratings agencies sell an opinion, trust them or don't, it's up to you. The housing market was a giant systemic bubble that left a trail of destruction. No one was really immune, but I'll tell you who got a lot more reputation after that - the people and companies who did manage to accurately predict it.

Did the FCC put up a single warning? Did any government agency publicly warn the public not to invest in CDOs and MBS andbuy houses above their means? No, in fact Greenspan encouraged it.

So let's not even have that discussion

and you want the same with Drug regulations?
you would give those drugs to your kids?

[kevinquinnyo]

pointless aside:

rat poison is actually used as treatment for certain medical conditions in humans

[Leif Roar]

That is a statement that requires some evidence to back it up. You believe it's slightly tighter?

Yes, it's my lay-man's impression of a large and complicated area. That's besides the point, though, since for your argument to have merit you will have to show that the EU drug market is less stringently regulated than its US counterpart, something which you have not even attempted to do.

[elbe]

So if you think that the amount of people selling rat poison as cancer drug will at some point go up dramatically, outweighing the benefits of deregulation, you have to explain why you think that.

Perhaps because we know that there are lots, and lots of people who really want to sell benefit-less, or even harmful products as medical cures. Things that are currently being, somewhat, regulated with our current systems - even though there are ways to get around them, at least for the placebo "cures". It's an ongoing fight (http://www.quackwatch.com/), and if we made it easier for them to make their claims that they cure anything from the common cold to aids then they would. As it is there are people who stop taking medically sound treatments for alt-med and just end up dying sooner and poorer.

Medicine is, I believe, an easy target for scam artists. When people are dying they really, really want an easy, fast cure - no matter the cost.

[ddt]

ALMOST! But not quite.

Again. Drug lag is not the only important thing. There are other regulatory factors that cause deaths and inefficiency, cited in the article, besides drug lag alone.

Would it make you happy if I said, "Okay, we solved it! We found through this article that drug lag is slightly shorter in Europe, so let's go party, no need to think about it ever again, problem solved, the end?"

I don't think anyone is arguing that the FDA should just adopt the European procedures, and then rest on its laurels. It's always worthwhile to look at ways to speed up the approval process, without compromising the safety of the process. That holds as much for the FDA as for the EMEA as for other regulatory agencies around the world.

I have the idea though that you, kevin, are avoiding to take a clear stand on the issue. So what is your proposal to do about it?
1) speed up the FDA approval process, e.g. by taking on board lessons from the EMEA process, or by better funding, or whatever measures are found beneficial to that end.
2) abolish the FDA entirely.
3) abolish the mandatory nature of FDA approval, but require labelling of the FDA status on the drugs sold.
4) abolish the mandatory nature of FDA approval, no labelling requirement.

If you have another alternative, please state it clearly and unambiguously.

I can definitely see an evolutionary advantage in (3), if the labelling also requires to state "safe for libertarians only". :rolleyes:

[kevinquinnyo]

and you want the same with Drug regulations?
you would give those drugs to your kids?

Yes. I don't fear markets. Markets are just people, millions of minds competing and interacting. And in the case of a ratings agency or Knower company, reputation is king.

[Darat]

Okay, you're right. Let's lobby to make the FDA more like the European Union because of the single statistic you felt like reading out of the article that shows less drug lag. Let's ignore all other factors and just be intellectually lazy and call it a day.

It is you that has stated many times in this thread that the FDA with its long "drug lag" is killing a lot of people; according to the article you use to support that claim there is already a system which results in less people being killed.

Yet for apparently no reason, bar an idealogical one, you do not want to consider that system and instead want to introduce a system you have thought up, that you cannot support either with strong arguments nor by evidence.

Do you really expect people to adopt a system just because you have faith that it would reduce the problem you think exists with the current system?

[kevinquinnyo]

I don't think anyone is arguing that the FDA should just adopt the European procedures, and then rest on its laurels. It's always worthwhile to look at ways to speed up the approval process, without compromising the safety of the process. That holds as much for the FDA as for the EMEA as for other regulatory agencies around the world.

I have the idea though that you, kevin, are avoiding to take a clear stand on the issue. So what is your proposal to do about it?
1) speed up the FDA approval process, e.g. by taking on board lessons from the EMEA process, or by better funding, or whatever measures are found beneficial to that end.
2) abolish the FDA entirely.
3) abolish the mandatory nature of FDA approval, but require labelling of the FDA status on the drugs sold.
4) abolish the mandatory nature of FDA approval, no labelling requirement.

If you have another alternative, please state it clearly and unambiguously.

I can definitely see an evolutionary advantage in (3), if the labelling also requires to state "safe for libertarians only". :rolleyes:

I don't know, but I would like to see at the very least, the FDA compete openly with private firms for a certification as opposed to a mandatory approval, so #4.

[leftysergeant]

And why do you assume I haven't read up on the history of the FDA?

Maybe it has something to do with your making assertions that seem to originate in the wrong part of your torso.

You know why the approval process was changed in the 1960s?

Thalidamide. Don't tell me it is better to take a chance. I was there to see some of what happens when government works the way you want it. It sucks.

[leftysergeant]

I don't know, but I would like to see at the very least, the FDA compete openly with private firms for a certification as opposed to a mandatory approval, so #4.

Another idea out of the wrong part of your torso.

You cannot privatize the protection of our right to life just because a bunch of snivelling entrepreneurs do not like having to live like adults.

You have no right to sell a dangerous product. End of discussion.

[Leif Roar]

Yes. I don't fear markets. Markets are just people, millions of minds competing and interacting. And in the case of a ratings agency or Knower company, reputation is king.

Yes, let's not forget that markets and the "wisdom of the crowds" have done a great job in getting rid of bogus treatments such as acupuncture, homeopathy, chiropractice and detoxifying footh-baths.

[ddt]

Maybe it has something to do with your making assertions that seem to originate in the wrong part of your torso.

You know why the approval process was changed in the 1960s?

Thalidamide. Don't tell me it is better to take a chance. I was there to see some of what happens when government works the way you want it. It sucks.

Also known under its brand name "Softenon". God I wish pharma companies would stop making up several different names for the same product - and especially selling them under different names on both sides of the Atlantic. (sorry for the rant).

[kevinquinnyo]

It is you that has stated many times in this thread that the FDA with its long "drug lag" is killing a lot of people; according to the article you use to support that claim there is already a system which results in less people being killed.

Yet for apparently no reason, bar an idealogical one, you do not want to consider that system and instead want to introduce a system you have thought up, that you cannot support either with strong arguments nor by evidence.

Do you really expect people to adopt a system just because you have faith that it would reduce the problem you think exists with the current system?

Darat, buddy, listen.

I don't think that you read the article, and you didn't read any of my responses to this question. And you keep repeating yourself, and I just keep repeating myself. We need to figure out how to communicate, but I don't think you're trying very hard.

So, here's the issue. Deaths are caused by the FDA in several ways. One of them is the drug lag, BUT there are also other very serious issues at stake that I have already listed several times for you, but here they are again:

Drug Lag
Restriction of advertising
On-Label Vs. Off-Label as proof of concept of unregulated market stability

[DC]

Yes. I don't fear markets. Markets are just people, millions of minds competing and interacting. And in the case of a ratings agency or Knower company, reputation is king.

well most people dont, and thats a good thing.
reputation is King, if people would actually inform themself and care. but that isnt the case, thats why a Friedmann free market cannot work.

people are more fixated on the price rather than quality. Nor do they inform themself about the companys they buy their stuff from.

[Darat]

...snip...

So if you think that the amount of people selling rat poison as cancer drug will at some point go up dramatically, outweighing the benefits of deregulation, you have to explain why you think that.

Because that is why we ended up with regulation in the first place!

[kevinquinnyo]

Yes, let's not forget that markets and the "wisdom of the crowds" have done a great job in getting rid of bogus treatments such as acupuncture, homeopathy, chiropractice and detoxifying footh-baths.

Well I like to think the JREF and organizations like it make a dent. What you don't realize is that Skeptic magazine is a private regulator.

What has the government done to stop it? I mean like you said, it's all still around...

[oggiesnr]

I have re-read the article and would suggest that the sting (and it's true purpose) is in the last section. What the authors are arguing is that the FDA shuld allow more advertising of drugs (including the off-label uses) and does so under the emotive "Ignorance is Death" headline. The rest is opinion made to look like science (references etc all in place) and any inconvenient truth is glossed over. It also ignores the fact that as the USA is the major market for many new drugs FDA approval is usually sought there first as this speeds up other approvals down the line.

As far as Kevin's quip "Steve you ignore economics (science) in favor of feel-good policy. " is concerned I don't. I do however reject "bad" pseudo science in favour of real scientific evidence.

Steve

Steve

[kevinquinnyo]

well most people dont, and thats a good thing.
reputation is King, if people would actually inform themself and care. but that isnt the case, thats why a Friedmann free market cannot work.

people are more fixated on the price rather than quality. Nor do they inform themself about the companys they buy their stuff from.

I disagree. Take Good Housekeeping Institute, or Underwriter's Labratory. They stamp electronics products that they approve of. That's a private company. Me and you don't have time to do that, but we trust UL, and more importantly, Radio Shack and Wal*Mart Trust them.

Or take Sears, Sears is really just an aggregator of products that they put their name on, they do the diligence for you, and you respect the Sears or Craftsman name.

(Sears is kind of a dying company, but that's for other reasons and another thread)

[kevinquinnyo]

I have re-read the article and would suggest that the sting (and it's true purpose) is in the last section. What the authors are arguing is that the FDA shuld allow more advertising of drugs (including the off-label uses) and does so under the emotive "Ignorance is Death" headline. The rest is opinion made to look like science (references etc all in place) and any inconvenient truth is glossed over. It also ignores the fact that as the USA is the major market for many new drugs FDA approval is usually sought there first as this speeds up other approvals down the line.

As far as Kevin's quip "Steve you ignore economics (science) in favor of feel-good policy. " is concerned I don't. I do however reject "bad" pseudo science in favour of real scientific evidence.

Steve

Steve

So you are saying that you think they made up the data, and the list of known, verifiable research on the sources section on the sidebar is fabricated so that they can push their drug marketing agenda?

That's a conspiracy theory my friend

[Darat]

Darat, buddy, listen.

I don't think that you read the article, and you didn't read any of my responses to this question. And you keep repeating yourself, and I just keep repeating myself. We need to figure out how to communicate, but I don't think you're trying very hard.

So, here's the issue. Deaths are caused by the FDA in several ways. One of them is the drug lag, BUT there are also other very serious issues at stake that I have already listed several times for you, but here they are again:

Drug Lag
Restriction of advertising
On-Label Vs. Off-Label as proof of concept of unregulated market stability

It is very simple:


You and the article have claimed that drug lag kills people.

There is a system which according to you and the article reduces the number of killings.

Therefore (according to your argument) adopting that system and not addressing any other problems would mean less people would be killed.


You do not wish to adopt such a system because it is against your ideology, which means that you value your ideology over a pragmatic change that, according to you, would reduce the number of people being, (again according to you), 'unnecessarily' killed by the FDA.

[kevinquinnyo]

Another idea out of the wrong part of your torso.

You cannot privatize the protection of our right to life just because a bunch of snivelling entrepreneurs do not like having to live like adults.

You have no right to sell a dangerous product. End of discussion.

End of Discussion. Willful ignorance. Don't bother learning anything that doesn't fit your preconceived beat-poet gonzo hippie ultra liberal worldview.

[ddt]

I don't know, but I would like to see at the very least, the FDA compete openly with private firms for a certification as opposed to a mandatory approval, so #4.

So you chose #4, to recap, FDA approval optional, no labelling requirement of FDA status. And you advocate private certification firms. Who is going to bankroll a certification firm - needs quite a bit of money to do that. So what we'll get is the Merck Drug Agency (MDA), the Pfizer Drug Agency (PDA), the Glaxo Drug Agency (GDA), and so on. Of course they'll have different names to deceive the public, but in fact, they'll only be marketing shills for the respective companies. To maintain a veneer of "objectivity", the various pharma companies will "certify" each others' products in branches where they don't have a competing product anyway. Nobody will bother with FDA approval anymore. Doctors and patients alike have lost all sight on which drugs are really safe and which not.

The pharma companies will sell snake oil and snake poison, and people will die from various of their products. No brand can be trusted over the others, as they'll all do it. But, after 10,000 deaths from some snake poison, the "invisible hand" will pull the snake poison product from the market. That's how it works in Libertopia. But at least, we're FREE! :jaw-dropp

[kevinquinnyo]

It is very simple:


You and the article have claimed that drug lag kills people.

There is a system which according to you and the article reduces the number of killings.

Therefore (according to your argument) adopting that system and not addressing any other problems would mean less people would be killed.


You do not wish to adopt such a system because it is against your ideology, which means that you value your ideology over a pragmatic change that, according to you, would reduce the number of people being, (again according to you), 'unnecessarily' killed by the FDA.


You don't want to deregulate because of your socialist ideology.

And the thing is Darat, to repeat it for I'm sure at least the 3rd time, if I had to choose between simply adopting exactly the European lag times as the one variable to change over the existing U.S. system, I would take it in a heartbeat.

[Darat]

You don't want to deregulate because of your socialist ideology.

...snip...

But I'm not a socialist so that is rather a strange thing to claim.



And the thing is Darat, to repeat it for I'm sure at least the 3rd time, if I had to choose between simply adopting exactly the European lag times as the one variable to change over the existing U.S. system, I would take it in a heartbeat.

So why not do so?

[kevinquinnyo]

So you chose #4, to recap, FDA approval optional, no labelling requirement of FDA status. And you advocate private certification firms. Who is going to bankroll a certification firm - needs quite a bit of money to do that. So what we'll get is the Merck Drug Agency (MDA), the Pfizer Drug Agency (PDA), the Glaxo Drug Agency (GDA), and so on. Of course they'll have different names to deceive the public, but in fact, they'll only be marketing shills for the respective companies. To maintain a veneer of "objectivity", the various pharma companies will "certify" each others' products in branches where they don't have a competing product anyway. Nobody will bother with FDA approval anymore. Doctors and patients alike have lost all sight on which drugs are really safe and which not.

The pharma companies will sell snake oil and snake poison, and people will die from various of their products. No brand can be trusted over the others, as they'll all do it. But, after 10,000 deaths from some snake poison, the "invisible hand" will pull the snake poison product from the market. That's how it works in Libertopia. But at least, we're FREE! :jaw-dropp

Absolute nonsense. If that kind of conspiracy were possible, there would have to be no independent journalists investigating, for one thing, and no watchdogs agencies that watch over the watchdogs, which you ignore, and worst of all, there isn't proof of that kind of collusion and conspiracy among the existing and trusted private watchdog companies.

[kevinquinnyo]

But I'm not a socialist so that is rather a strange thing to claim.


No one has a problem labeling me. You are certainly on the far left of center.




So why not do so?

I won't answer this again. I'm done talking to you, you're just asking the same thing over and over and I've satisfactorily answered it several times.

[fls]

Since we already have an unregulated drug market available for comparison, it seems like it would make more sense to compare regulated drugs to that market. Off-label use isn't really comparable. In order for a drug to be available for off-label use, it must have already passed tests which show it has some other use. And off-label use is tightly controlled by people with expertise. That is, it still often requires a prescription in order to obtain access to the drug which means that valid and reliable evidence has been made available to guide its off-label use.

The presence of the FDA and other regulatory agencies forces the pharmaceutical companies to substantially contribute to a body of knowledge which people with expertise can access in order to provide evidence-based advice. The question is, would that same (or similar) body of knowledge be formed if the process was voluntary. And the indications are that it would not. The body of information that satisfies the lay-person is miniscule in comparison. And if you no longer need to satisfy a knowledgeable gate-keeper, why wouldn't you simply provide the minimum amount to support your marketing?

Also, unsafe drugs will be left on the market, rather than withdrawn. If Vioxx were a 'dietary supplement', it would still be on the market, as the evidence would be insufficient to have it withdrawn or for there to be a substantial threat from litigation.

Linda

[Darat]

Absolute nonsense. If that kind of conspiracy were possible, there would have to be no independent journalists investigating, for one thing, and no watchdogs agencies that watch over the watchdogs, which you ignore, and worst of all, there isn't proof of that kind of collusion and conspiracy among the existing and trusted private watchdog companies.

Which independent watchdog told me that Virgin Atlantic was ripping me off?

Which independent watchdog told my mother that cigarettes were in fact harmful to health, not beneficial as the cigarette manufacturers told her Doctor and advertised?

Which independent watchdog told my grandmother that the local diary was adulterating their milk with chalk and dirty water?

[Darat]

No one has a problem labeling me. You are certainly on the far left of center.

...snip...

Haven't you stated that you are a libertarian and have argued for the ideology of libertarianism?

Even if I was "on the far left of center" how would that equate with being a socialist or proposing a socialist ideology?




I won't answer this again. I'm done talking to you, you're just asking the same thing over and over and I've satisfactorily answered it several times.

To date you have not answered it.

[leftysergeant]

End of Discussion. Willful ignorance. Don't bother learning anything that doesn't fit your preconceived beat-poet gonzo hippie ultra liberal worldview.

You are defending willfull ignorance, not I. We have an FDA specificly because people with a profit motive cannot be trusted to act like adults.

The fact of the matter is that the freer the market becomes, the more outrageously the entrepreneurs screw us.

That is, in fact, why our ecconomy is circling the toilet bowl right now.

[MysteryMammal]

No one has a problem labeling me. You are certainly on the far left of center.


I may have missed the name calling directed at you. But seriously, are you using the "Everyone else is doing it!" defense? Has this debate gotten to that point?

And is someone seriously "left of center" just because they don't agree with absolute deregulation of any and all industry?

[DC]

I disagree. Take Good Housekeeping Institute, or Underwriter's Labratory. They stamp electronics products that they approve of. That's a private company. Me and you don't have time to do that, but we trust UL, and more importantly, Radio Shack and Wal*Mart Trust them.

Or take Sears, Sears is really just an aggregator of products that they put their name on, they do the diligence for you, and you respect the Sears or Craftsman name.

(Sears is kind of a dying company, but that's for other reasons and another thread)

i come from Switzerland, we dont have UL. you do not even need a CE label.
but many people do trust on the German Stiftung Warentest for example, they are actually founded by the German Government in 1962/64.
also the Public TV SFDRS does alot testing but is also not private, but public.

[leftysergeant]

Absolute nonsense. If that kind of conspiracy were possible, there would have to be no independent journalists investigating, for one thing,

Uncle Rupert is working on that. The news has been cancelled so that he may bring you the vile racist remarks of Glenn Beck and the passive-agressive insanity of Bill OReilly and the brain farts of a fat deaf pill-popping eunuch in Florida and a schizophrenic botanist who sampled too many of the cerimonial drugs on his expeditions to the rain forests.

and no watchdogs agencies that watch over the watchdogs, which you ignore, and worst of all, there isn't proof of that kind of collusion and conspiracy among the existing and trusted private watchdog companies.

Bull flops. The Shrub and his predecessors slipped the watchdogs a Mickey and a bunch of people died of arthritis medication that kind of made their hearts go BOOM and quit.

[Darat]

...snip...

And is someone seriously "left of center" just because they don't agree with absolute deregulation of any and all industry?

Well as I said earlier in the thread - I don't care who, how or what "regulates" anything, as long as it is effective at doing what it is meant to do.

Indeed I struggle very hard to understand anyone who doesn't share that approach, why would you not want to adopt the most pragmatic and/or effective system?

As I've tried to show kevinquinnyo several times my issue is that he has not supported his solution, all he has done is, to paraphrase, say "I have faith that my solution would be more effective and therefore will not even consider an approach, that according to my arguments we know will reduce deaths because it is not in line with my ideology."

That will never persuade me on an issue such as should government regulation of pharmaceuticals be removed.

[kevinquinnyo]

Uncle Rupert is working on that. The news has been cancelled so that he may bring you the vile racist remarks of Glenn Beck and the passive-agressive insanity of Bill OReilly and the brain farts of a fat deaf pill-popping eunuch in Florida and a schizophrenic botanist who sampled too many of the cerimonial drugs on his expeditions to the rain forests.



Bull flops. The Shrub and his predecessors slipped the watchdogs a Mickey and a bunch of people died of arthris medication that kind of made their hearts go BOOM and quit.

Lefty, You get an A++ :) for creativity!!! Great Job!

Unfortunately this isn't a 3rd grade creative writing class, it's an economics discussion.

[Darat]

Lefty, You get an A++ :) for creativity!!! Great Job!

Unfortunately this isn't a 3rd grade creative writing class, it's an economics discussion.

No it isn't - it is a public health and protection discussion!

[leftysergeant]

So if you think that the amount of people selling rat poison as cancer drug will at some point go up dramatically, outweighing the benefits of deregulation, you have to explain why you think that.

Historically, any time market controls are lifted, the entrepreneurs go wild selling us crap that only thet can see is crap.

A few years back, some total jerk of a Senator from Texas sold people on the idea that the safe-guards that FDR set on the bankiong industry were keeping people from making money, and the safeguards got removed.

I am not going to let someone do to our medication what an idiot Republican did to our banking system without getting into a few people's faces for even suggesting de-regulation.

[leftysergeant]

Lefty, You get an A++ :) for creativity!!! Great Job!

Unfortunately this isn't a 3rd grade creative writing class, it's an economics discussion.

Flunked history, did you? Nothing creative about what I wrote. Statements of facts. The entrepreneurs are buying the press out from under us so there is greater opportunity for collusion by supressing news that embarrasses the entrepreneurial class.

[MysteryMammal]

Uncle Rupert is working on that. The news has been cancelled so that he may bring you the vile racist remarks of Glenn Beck and the passive-agressive insanity of Bill OReilly

I do not understand why you feel the need to assail two of the greatest comedians of our time in such a hateful way.

[kevinquinnyo]

Since we already have an unregulated drug market available for comparison, it seems like it would make more sense to compare regulated drugs to that market. Off-label use isn't really comparable. In order for a drug to be available for off-label use, it must have already passed tests which show it has some other use. And off-label use is tightly controlled by people with expertise. That is, it still often requires a prescription in order to obtain access to the drug which means that valid and reliable evidence has been made available to guide its off-label use.

The presence of the FDA and other regulatory agencies forces the pharmaceutical companies to substantially contribute to a body of knowledge which people with expertise can access in order to provide evidence-based advice. The question is, would that same (or similar) body of knowledge be formed if the process was voluntary. And the indications are that it would not. The body of information that satisfies the lay-person is miniscule in comparison. And if you no longer need to satisfy a knowledgeable gate-keeper, why wouldn't you simply provide the minimum amount to support your marketing?

Also, unsafe drugs will be left on the market, rather than withdrawn. If Vioxx were a 'dietary supplement', it would still be on the market, as the evidence would be insufficient to have it withdrawn or for there to be a substantial threat from litigation.

Linda


Thanks for the sensible reply.

Here's where I disagree with you. First, just because a drug has an FDA approved on label usage, doesn't make it's off label usage not just as arbitrary as an entirely new drug would be. But I'll give you the benefit, because if it is FDA approved we assume it isn't outright harmful to a human body.

More important though, is the market means by which the testing and research for the alternative off label usage is derived.

Secondly, as far as your Vioxx and your Extenze, and your homeopathy at Whole Foods kind of stuff, to a certain extent this stuff will always be around, but one of the reasons people buy it and stores stock it, is because it's not banned by the FDA. So there is this mentality that everything is okay, because the FDA has everything under control. The reality is, they can't possibly keep an eye out for every drug that comes into the market, even if they were comprised of the smartest and best trained people in the world. I don't doubt that some of them are exceedingly good at their jobs. But they can't be everywhere at once.

I think the mentality of well it's okay cause dad didn't say not to only exists in heavily regulated markets. People do trust reviews, and guides, and fashion shows, and consumer reports, and kelly blue book, and UL, and Penn and Teller, and Skeptic Magazine to do their diligence for them, and do some on their own.

Also, just for the record, deregulation in part or in full of the FDA does not by any means equal ending bans on certain substances. That's an entirely different subject.

[DC]

Lefty, You get an A++ :) for creativity!!! Great Job!

Unfortunately this isn't a 3rd grade creative writing class, it's an economics discussion.

ECONOMIC????
i thought of it as Security or Health, but not Economics

[kevinquinnyo]

No it isn't - it is a public health and protection discussion!

That's kind of true , I wonder if it should be moved

[ddt]

Absolute nonsense. If that kind of conspiracy were possible, there would have to be no independent journalists investigating, for one thing, and no watchdogs agencies that watch over the watchdogs, which you ignore, and worst of all, there isn't proof of that kind of collusion and conspiracy among the existing and trusted private watchdog companies.

Food, toys, consumer electronics etc. are already tested for their safety by government agencies. What consumer reports typically do is to line up all available kitchen machines, for example, and test which gives the best value for money, and split that out over various parameters, say, the number of widgets it comes with, the ease to clean it, you name it. Do you expect them to make a similar line-up for cancer drugs? :eye-poppi

Pax has given the numbers how much the FDA and the EMEA cost. That's only a tip of the iceberg of the money, as the FDA mainly checks if the tests that the pharma companies perform themselves are sufficient. The approval process of a single drug is expensive and it requires specialized expertise. It's uncomparable with testing the safety of a kitchen machine. No-one will bankroll an organization that is going to rigorously test drugs. Without the mandatory parameters set by the FDA, the drug companies will do much more lenient testing, and your independent certification organization will have to do the whole process for itself.

Oh, and apropos "quis custodiet ipsos custodes" - we, the people, can watch the FDA because it's a government organization and its actions are open to public scrutiny. Can you say that of a non-government organization?

But thanks for playing, and thanks for outing yourself as a libertarian. That makes discussion so much easier.

[kevinquinnyo]

Flunked history, did you? Nothing creative about what I wrote. Statements of facts. The entrepreneurs are buying the press out from under us so there is greater opportunity for collusion by supressing news that embarrasses the entrepreneurial class.

I just want to take a minute to examine this statement.

You really think that conflict of sponsors with media companies is a cause of collusion and information suppressing worse than lobbying politicians?

[kevinquinnyo]

Food, toys, consumer electronics etc. are already tested for their safety by government agencies. What consumer reports typically do is to line up all available kitchen machines, for example, and test which gives the best value for money, and split that out over various parameters, say, the number of widgets it comes with, the ease to clean it, you name it. Do you expect them to make a similar line-up for cancer drugs? :eye-poppi

Pax has given the numbers how much the FDA and the EMEA cost. That's only a tip of the iceberg of the money, as the FDA mainly checks if the tests that the pharma companies perform themselves are sufficient. The approval process of a single drug is expensive and it requires specialized expertise. It's uncomparable with testing the safety of a kitchen machine. No-one will bankroll an organization that is going to rigorously test drugs. Without the mandatory parameters set by the FDA, the drug companies will do much more lenient testing, and your independent certification organization will have to do the whole process for itself.

Oh, and apropos "quis custodiet ipsos custodes" - we, the people, can watch the FDA because it's a government organization and its actions are open to public scrutiny. Can you say that of a non-government organization?

But thanks for playing, and thanks for outing yourself as a libertarian. That makes discussion so much easier.

Play this out though. Why would drug companies fear thousands of independent testing laboratories LESS than one government agency? I know I would fear the private labs much more.

Think about the incentives. The labs will make money by being regarded as the best, because their logo will be stamped on only the best, safest, most effective drugs. Competition among competing firms would produce better safer drugs.

[elbe]

But thanks for playing, and thanks for outing yourself as a libertarian. That makes discussion so much easier.

He appears to lean more to AnCap than just a small government libertarianism. It's hard to argue against an extremist's ideology.

[joobz]

Play this out though. Why would drug companies fear thousands of independent testing laboratories LESS than one government agency? I know I would fear the private labs much more. Interesting.
1.) In your model, who's paying the labs?


Think about the incentives. The labs will make money by being regarded as the best, because their logo will be stamped on only the best, safest, most effective drugs. Competition among competing firms would produce better safer drugs.
Again. Whose paying those labs?

[leftysergeant]

I just want to take a minute to examine this statement.

You really think that conflict of sponsors with media companies is a cause of collusion and information suppressing worse than lobbying politicians?


Actually, sponsors do shape what goes on the news.

Do you think Boeing, Exxon and Archer Daniels Midland are putting commercials on the rightwing shows to sell their product? It wouldn't be to remind the ownership of the stations who really owns the stations, would it?

Well, of course it is about intimidation. Notice that Uncle Rupert didn't give that lunatic Beck a time out until corporate sponsors got scared and started pulling ads.

Freedom of the press is only guaranteed to those who own a printing press.

[kevinquinnyo]

He appears to lean more to AnCap than just a small government libertarianism. It's hard to argue against an extremist's ideology.

I lean toward whatever system (or non system if it may be) that has the least waste, the least suffering, and the most freedom.

I don't think that's extreme at all.

[elbe]

I lean toward whatever system (or non system if it may be) that has the least waste, the least suffering, and the most freedom.

I don't think that's extreme at all.

Yet you randomly calling posters "socialists" just makes you sound like an ideologue.

[kevinquinnyo]

Actually, sponsors do shape what goes on the news.

Do you think Boeing, Exxon and Archer Daniels Midland are putting commercials on the rightwing shows to sell their product? It wouldn't be to remind the ownership of the stations who really owns the stations, would it?

Well, of course it is about intimidation. Notice that Uncle Rupert didn't give that lunatic Beck a time out until corporate sponsors got scared and started pulling ads.

Freedom of the press is only guaranteed to those who own a printing press.

Sure, no I'm not denying it, but that's why you can listen or view anything you want. You don't have to watch FOX News, or MSNBC, or CNN, you can get your news wherever you want.

I think the problem of information being warped for profit is the fault of special interest groups more than anything.

[kevinquinnyo]

Yet you randomly calling posters "socialists" just makes you sound like an ideologue.

I honestly thought he was. I think in the "Disproportionate Socialism in the Forums" thread or something like that, he was arguing in favor of it.

[ddt]

He appears to lean more to AnCap than just a small government libertarianism. It's hard to argue against an extremist's ideology.

Sorry for applying the wrong label. I meant the extreme "no government" type.

[ddt]

Play this out though. Why would drug companies fear thousands of independent testing laboratories LESS than one government agency? I know I would fear the private labs much more.

Think about the incentives. The labs will make money by being regarded as the best, because their logo will be stamped on only the best, safest, most effective drugs. Competition among competing firms would produce better safer drugs.

Oh, I'm sure in Libertopia THOUSANDS OF LABS will rise up out of nowhere, and pharma companies will be all too glad to give their $20,000/QALY cancer drugs for free to these labs for elaborate testing out of the kindness of their hearts.

Meanwhile, I rather reason about the real world.

[Leif Roar]

Play this out though. Why would drug companies fear thousands of independent testing laboratories LESS than one government agency?

Because that one government agency has the power to say "No." All a testing laboratory would be able to say would be "Not with us." Worst case scenario, you put on some home-made logo that looks like it's for some obscure testing laboratory and run an agressive marketing campaign. Sure, your sales might be a little less than if you'd gotten the FancyLab logo, but hey -- at least you're getting something back, and you didn't even have to run those expensive clinical trials. Besides, you can always relaunch it again in a few years time under a new name.

[Leif Roar]

Well I like to think the JREF and organizations like it make a dent.

Not much of one.

What you don't realize is that Skeptic magazine is a private regulator.

Oh, I understand that. I also understand that as a "private regulator" the Skeptic magazine is an abysmal failure as the products it reviews badly remains popular and certainly doesn't appear to be leaving the marketplace.

What has the government done to stop it? I mean like you said, it's all still around...

The government(s) haven't stopped it because they haven't bothered. They've put in place some limits to what claims can be made for such treatments to prevent them being used in lieu of medical treatment, and they've put in place some guards to make sure the practices are not actively harmeful (sterilising acupuncture needles and so on.) Beyond that, if two grown-up people want to stick needles into each other ... well, it's silly, but it's not really the government's business.

That's all really besides the point, though, which is this: If an unregulated market worked as you believe, with the cream rising to the top and the crap quickly falling out of the market and disappearing, then all these inefficent, worthless treatments would have disappeared a long time ago and nobody would be interested in purchasing them. As that hasn't happened, an unregulated market can not work as you want to believe it would.

[kevinquinnyo]

Oh, I'm sure in Libertopia THOUSANDS OF LABS will rise up out of nowhere, and pharma companies will be all too glad to give their $20,000/QALY cancer drugs for free to these labs for elaborate testing out of the kindness of their hearts.

Meanwhile, I rather reason about the real world.

I'm really bored with the Libertopia thing. It's a real straw man, because no one says less government or no government would be a utopia. I know I don't.

[DC]

I'm really bored with the Libertopia thing. It's a real straw man, because no one says less government or no government would be a utopia. I know I don't.

but you want less government in one of the most important field. you would like to see profit driven institutions doing the FDA's job.

most people dont belive it can work, nor did anyone ever present evidence that would indicate that it could work.

[technoextreme]

First of all, if you look at the SAEE, most people would consider most economists to be very libertarian.



So, you think it's weird, or wrong? They have the pre 1962 data and the post 1962 data. They know how many people died of bad or ineffective drugs pre 1962. The number of victims (107) of Elixir Sulfanilamide tragedy and of all other drug tragedies prior to 1962 is very small compared to the death toll of the post-1962 FDA.
That is absolutely 100% wrong. Pre 1962 you could drink, wear, eat and RADIUM.

[joobz]

I'm really bored with the Libertopia thing. It's a real straw man, because no one says less government or no government would be a utopia. I know I don't.
Then start by explaining where these private independant test labs are to obtain funding from.

[The Man]

Thanks for the sensible reply.

Here's where I disagree with you. First, just because a drug has an FDA approved on label usage, doesn't make it's off label usage not just as arbitrary as an entirely new drug would be. But I'll give you the benefit, because if it is FDA approved we assume it isn't outright harmful to a human body.

Who is this “we” you claim ‘assumes’ that? So you are claiming that prescribing a drug which has undergone testing, clinical trials and on label use, establishing to some degree risks, side effects, possible adverse interactions and counter indications is somehow “just as arbitrary as an entirely new drug would be”?


More important though, is the market means by which the testing and research for the alternative off label usage is derived.

What is “the market means by which the testing and research for the alternative off label usage is derived” are you referring to?


Secondly, as far as your Vioxx and your Extenze, and your homeopathy at Whole Foods kind of stuff, to a certain extent this stuff will always be around, but one of the reasons people buy it and stores stock it, is because it's not banned by the FDA. So there is this mentality that everything is okay, because the FDA has everything under control. The reality is, they can't possibly keep an eye out for every drug that comes into the market, even if they were comprised of the smartest and best trained people in the world. I don't doubt that some of them are exceedingly good at their jobs. But they can't be everywhere at once.

So your solution to problems due to lack of oversight in areas where the FDA lacks regulatory authority is to reduce its oversight and regulatory authority?

Please provide some evidence of your claim that “because it's not banned by the FDA” “there is this mentality that everything is okay”.


I think the mentality of well it's okay cause dad didn't say not to only exists in heavily regulated markets. People do trust reviews, and guides, and fashion shows, and consumer reports, and kelly blue book, and UL, and Penn and Teller, and Skeptic Magazine to do their diligence for them, and do some on their own.

No the ‘mentality’ of actually regulating things exists because they are, well, actually regulated, and guess what those regulations can be changed as deemed necessary. Abandoning regulation for “reviews, and guides” akin to “fashion shows, and consumer reports, and kelly blue book, and UL, and Penn and Teller, and Skeptic Magazine to do their diligence for them” can not replace the level of control and reliability inherent from actual regulation.


Also, just for the record, deregulation in part or in full of the FDA does not by any means equal ending bans on certain substances. That's an entirely different subject.

Also “just for the record” I inject a TNF inhibitor every week. In doing so I undertake considerable potential risks (even with FDA regulations) that I am fully aware of. At no time does the existence of FDA regulations make me feel complacent about those potential risks and believe me if those injections were not absolutely required, I would not undertake such risks. However without such regulations or if I had to rely on your “reviews, and guides” akin to “fashion shows, and consumer reports, and kelly blue book, and UL, and Penn and Teller, and Skeptic Magazine to do their diligence for them”, the increase in potential risks could seriously outweigh potential benefits. If I buy a bad toaster or car, big deal, but with something I must inject I could not give a flying handshake what “consumer reports, and kelly blue book, and UL, and Penn and Teller, and Skeptic Magazine” have to say. One bad dose could kill me and who would write up my bad "review" then, “consumer reports”? Please tell us how many deaths might it take in your imagined plan for the “kelly blue book” rating of a drug or manufacturer to go from “excellent” to just “good”? Unlike you, I will require stringent and enforceable controls on manufacturing and quality control as well as tractability and documentation of compliance, not just ‘ratings’ or "reviews, and guides". When you require such regulations yourself for your own continued functioning or survival and understand the increased risks you are trying to force others to endure, then perhaps you may gain a more realistic perspective on this issue.

[Darat]

I honestly thought he was. I think in the "Disproportionate Socialism in the Forums" thread or something like that, he was arguing in favor of it.


Ahem...

I definitely have a left leaning bias to my political views, but in what I will support (as solutions) to social issues I am a pragmatist. I am interested in what works rather than what ideology it is supposed to reflect.

[ddt]

I'm really bored with the Libertopia thing. It's a real straw man, because no one says less government or no government would be a utopia. I know I don't.

Lying for Libertopia. Oh, that's a fresh breeze from Lying for Jezus.
Here's you saying that less government (in this case) is better and works wonderfully:

I don't know, but I would like to see at the very least, the FDA compete openly with private firms for a certification as opposed to a mandatory approval, so #4.

Absolute nonsense. If that kind of conspiracy were possible, there would have to be no independent journalists investigating, for one thing, and no watchdogs agencies that watch over the watchdogs, which you ignore, and worst of all, there isn't proof of that kind of collusion and conspiracy among the existing and trusted private watchdog companies.

[oggiesnr]

So you are saying that you think they made up the data, and the list of known, verifiable research on the sources section on the sidebar is fabricated so that they can push their drug marketing agenda?

That's a conspiracy theory my friend

No, I'm saying they are cherry picking some facts that support their desired outcome and ignoring the ones that aren't helpful.

Steve

[Travis]

Drug X is created and is sent off to Pharmacy Ratings Unlimited who study it and determine it does nothing for any condition and melts peoples eyeballs. So now Drug X is sent to Drug Investigators who also note it's eyeball melting tendency but think it might help with arthritis. So now it gets sent to Pharma Notions who do not think it helps with arthritis but don't find the eyeball melting, instead they find it just blinds people. So now it goes off to Drug & Herb Contractors Incorporated who also think it might help with arthritis but don't see any eyeball melting, or total blindness, but note pronounced blurry vision and projectile vomiting. They send a note back to Drug X's creators noting they'll omit the vomiting discovery for an additional "fee" and are swiftly rewarded.

Two weeks later Drug X is on store shelves advertising itself as a miracle cure for arthritis with a "Drug & Herb Contractors Incorporated approved" label proudly affixed to the front and a caution about potential vision problems in little tiny print on the back.


Does anyone seriously think that's a better system?

[Yoink]

No, I'm saying they are cherry picking some facts that support their desired outcome and ignoring the ones that aren't helpful.

Steve

Is there a single Libertarian in the world who doesn't do this? Why is that Libertarians are ALL so completely incapable of honestly assessing both costs and benefits of their proposals? It's as if they were all 11 years old and had suddenly had a really brilliant idea: if Mum and Dad stopped wasting all that money on paying the rent, we could afford to go to Disneyland EVERY WEEK!!!

Kevinquinnyo: here is the problem with your analysis. Try to keep up.

Yes, it is self-evidently true that, under the current regulatory system, when a life-saving drug is developed some people will die who would otherwise have survived had that drug been made available earlier. This is your "hey, look at all the money Mum and Dad are wasting on rent" moment.

Now...here's why that fact is nowhere near as interesting as you think it is. Let us do away with the FDA (as you suggest). O.K., now there's no regulatory framework at all. Utopia, right? Everyone gets the life-saving medicine as soon as it is developed, right?

No. Wrong. What incentive does a company have to sink millions and millions of dollars into developing that life-saving medicine now, Kevinquinnyo? With barriers to the market removed, the obvious way to make money is to flood the market with sugar-pills that claim to cure everything that ails you (which is exactly what the pre-FDA market was like, of course; people drank a thousand different kinds of "elixir" to treat their various ailments; most of them weren't particularly harmful--they were just useless). Even if I'm an honest CEO who really, truly wants to help people, how do I make enough money to keep the company afloat? Sure, my drug really is useful--but how do I get it to customers when they have no reason to believe my claims over the claims of rivals pushing sugar-pills? So how many untold hundreds of thousands of people will die because they take a useless medication rather than a medication that actually does something for them? How many untold hundreds of thousands more will die because actually useful medications are simply never developed?

Now--do those deaths figure in your calculations at all? No. You didn't even think about them. You're too wide-eyed at the prospect of Disneyland EVERY WEEK!!!! to be able to see that paying the rent actually serves a purpose.

Now, let me imagine a couple of probable responses to this point. First off there's your laughable idea of private drug-testing companies. If you're the CEO of Sugar-Pill Inc, what's the first thing you're going to set up? That's right, a private drug-testing company. Can you guess what it's going to say about your sugar-pills?Secondly, there's the usual free-market nonsense about the "market deciding." You imagine that people will see that sugar-pills don't work and that the miracle drug does work, so they'll flock to the miracle drug. Market forces prevail and freedom and goodness triumph! Disneyland EVERY WEEK!!!

The problem with this particular fairy-story is that we know for a fact that it doesn't work. It's incredibly difficult in most cases to find out what works and what doesn't work in medicine. Why do drug companies complain about the FDA? Because it costs millions and millions of dollars to do the testing they require. Nobody would do that testing if it weren't required by law (well, nobody but government-funded university researchers--but I assume you would defund them as well). It's incredibly expensive, and often enough you discover that your drug--that looked great in animal tests, looked great in small group tests etc. etc.--is a complete dud in the large scale double-blind tests.

Without the FDA to require that kind of testing, why would anybody do it? Sugar-Pill Inc will plaster the airwaves with ads touting the extraordinary lab results of their new wonder medicine; they'll pay doctors to use the medicine and pay doctors to endorse it in their ads; they'll find thousands of people who took their medicine and got well (why? because with most diseases even the people taking the sugar pill get better eventually), who will talk tearily about how the Sugar Pill transformed their lives. If Real Medicine Inc says "well, I don't care what Sugar Pill Inc does, we're going to do large scale testing" they'll go bankrupt in a year.

And, yes, under that scenario millions and millions of people will die or suffer unnecessary pain and illness that they would otherwise have been spared. And the worst thing of all is that most people wouldn't even know it. They'd think that they were receiving the best medical care--just as the people who swore by "Dr. Brown's Purple Elixir" or "Smith's Patent Medicine" in the Libertopia of the 1890s had no idea that these had no medicinal value whatsoever.

[Belz...]

Or a private regulatory agency, perhaps one of several independent organizations that are much harder to sway with incentive.

Ah, yes. Healthy if you've got the means.

[Belz...]

No, no, no, no.

I can't explain this again, ask someone else here to explain the European comparison data.

Honestly, I think you're just trying to market your own opinion, here. The article has nothing to do with it, but you're using a single "the FDA isn't perfect" as a catalyst for your "remove the FDA" nonsense.

[David Wong]

Honestly, I think you're just trying to market your own opinion, here. The article has nothing to do with it, but you're using a single "the FDA isn't perfect" as a catalyst for your "remove the FDA" nonsense.

Actually, can anyone find an article from ANY source that makes an argument that drugs would be safer without the FDA?

Even from a kook source? I don't think even fringe AnCap types push that argument too hard. It's just too blatantly silly.

[Travis]

Actually, can anyone find an article from ANY source that makes an argument that drugs would be safer without the FDA?

Even from a kook source? I don't think even fringe AnCap types push that argument too hard. It's just too blatantly silly.

I think kevinquinnyo is the only one to have made the leap to "no FDA=good!"

[Yoink]

Actually, can anyone find an article from ANY source that makes an argument that drugs would be safer without the FDA?

Even from a kook source? I don't think even fringe AnCap types push that argument too hard. It's just too blatantly silly.

Oh yes (http://www.lewrockwell.com/grichar/grichar17.html). There's no limit to the lunacy of the Libertarian fringe.

[ddt]

Actually, can anyone find an article from ANY source that makes an argument that drugs would be safer without the FDA?

Even from a kook source? I don't think even fringe AnCap types push that argument too hard. It's just too blatantly silly.

No links, but I've seen the argument pushed before on forums by AnCap types.

[lomiller]

And in the case of a ratings agency or Knower company, reputation is king.

Reputation is primarily a function of marketing, not effectiveness since ineffectiveness can be hidden or obfuscated through marketing.


It’s also worth looking at the companies that currently make such recommendations. Almost unanimously, they recommended against getting medical treatment in countries like Mexico that don’t have the same type of regulation. IOW, you can expect the companies that are actually earnest about being effective to simply recommend not getting medical treatment in the US because of the risk of unsafe drugs.

[fls]

Thanks for the sensible reply.

Here's where I disagree with you. First, just because a drug has an FDA approved on label usage, doesn't make it's off label usage not just as arbitrary as an entirely new drug would be.

The difference is in what kind of information will be used to support the drug's use. If it's simply a new drug, without the need for FDA approval, the information supporting its use will be anecdotal (cheap and easy to obtain) plus a few animal physiology studies (also cheap and easy to obtain). This is more than sufficient for direct marketing to the consumer. It doesn't matter than none of that information is sufficient to determine safety and efficacy. Compare that to off-label use which is likely to be based on (at the very least) compelling case series, but more likely, some small trials or secondary end-points for large trials, because a doctor usually won't prescribe it without that information. There is no comparison as to the reliability and validity of information, but the average consumer will not know this. Regardless of whether their own doctor, Skeptical Inquirer or Consumer Reports says otherwise, they will use the drug. After all, pure sugar pills are already a billion dollar industry despite ongoing condemnation by those very groups.

But I'll give you the benefit, because if it is FDA approved we assume it isn't outright harmful to a human body.

More important though, is the market means by which the testing and research for the alternative off label usage is derived.

I agree that is very important. Which is why the 'testing and research' will focus on those highly unreliable methods which the average consumer finds persuasive because now it is the consumer who is your target, rather than the knowledgeable physician.

Secondly, as far as your Vioxx and your Extenze, and your homeopathy at Whole Foods kind of stuff, to a certain extent this stuff will always be around, but one of the reasons people buy it and stores stock it, is because it's not banned by the FDA. So there is this mentality that everything is okay, because the FDA has everything under control. The reality is, they can't possibly keep an eye out for every drug that comes into the market, even if they were comprised of the smartest and best trained people in the world. I don't doubt that some of them are exceedingly good at their jobs. But they can't be everywhere at once.

Exactly. And by taking away their ability to even discover that Vioxx is harmful, the market will be filled with these drugs. It seems like this would easily dwarf the small number of deaths from the lag of new drug approval. Realistically almost no new drugs are life-saving or more life-saving than those that are already available. And those few that are are made available for those people who need them before they are approved, through the process of clinical trials designed to gather safety and effectiveness data outside of formal DBRPCT's. It is in drug companies' best interests to make drugs available before they can be sold in order to generate recognition, good-will, a head start on marketing, etc.

I think the mentality of well it's okay cause dad didn't say not to only exists in heavily regulated markets. People do trust reviews, and guides, and fashion shows, and consumer reports, and kelly blue book, and UL, and Penn and Teller, and Skeptic Magazine to do their diligence for them, and do some on their own.

I'm sorry, but that is patently false, since those sources universally condemn stuff like homeopathy and yet homeopathy (which is the opposite of heavily regulated) is a billion dollar industry.

Also, just for the record, deregulation in part or in full of the FDA does not by any means equal ending bans on certain substances. That's an entirely different subject.

How would we discover which substances to ban?

Linda

[DC]

Actually, can anyone find an article from ANY source that makes an argument that drugs would be safer without the FDA?

Even from a kook source? I don't think even fringe AnCap types push that argument too hard. It's just too blatantly silly.

dZL25NSLhEA
hYjE45a4pBk

[Yoink]

How would we discover which substances to ban?

Linda

The ghost of Milton Friedman would appear to True Believers and reveal them.

[Chaos]

No links, but I've seen the argument pushed before on forums by AnCap types.

Shanek used to make that argument. He probably still does, for that matter.


Drug X is created and is sent off to Pharmacy Ratings Unlimited who study it and determine it does nothing for any condition and melts peoples eyeballs. So now Drug X is sent to Drug Investigators who also note it's eyeball melting tendency but think it might help with arthritis. So now it gets sent to Pharma Notions who do not think it helps with arthritis but don't find the eyeball melting, instead they find it just blinds people. So now it goes off to Drug & Herb Contractors Incorporated who also think it might help with arthritis but don't see any eyeball melting, or total blindness, but note pronounced blurry vision and projectile vomiting. They send a note back to Drug X's creators noting they'll omit the vomiting discovery for an additional "fee" and are swiftly rewarded.

Two weeks later Drug X is on store shelves advertising itself as a miracle cure for arthritis with a "Drug & Herb Contractors Incorporated approved" label proudly affixed to the front and a caution about potential vision problems in little tiny print on the back.


Does anyone seriously think that's a better system?

The producers of Drug X certainly do. Drug & Herb Contractors Incorporated should be pretty happy with it, too.

[blutoski]

Why isn't this under 'politics'?

[technoextreme]

Is there a single Libertarian in the world who doesn't do this? Why is that Libertarians are ALL so completely incapable of honestly assessing both costs and benefits of their proposals? It's as if they were all 11 years old and had suddenly had a really brilliant idea: if Mum and Dad stopped wasting all that money on paying the rent, we could afford to go to Disneyland EVERY WEEK!!!

The sad fact is that people like Ron Paul think like that:
`(2) EXEMPTIONS FROM REGULATION AS ADVERTISING- No content of any publication shall be considered advertising regulable under this Act unless the content is intended by the seller of a product to promote the sale of that product and the content includes (A) the name of the product offered for sale; (B) an express offer to sell the named product; and (C) a purchase price for the product. No content excerpted in whole or part from a peer-reviewed scientific publication shall be considered advertising regulable under this Act.

[kevinquinnyo]

David Wong,

The link in the OP endorses limiting the FDA to the level of a certification akin to private ratings companies.

edit: http://www.fdareview.org/voluntary_assurance.shtml

[oggiesnr]

David Wong,

The link in the OP endorses limiting the FDA to the level of a certification akin to private ratings companies.

edit: http://www.fdareview.org/voluntary_assurance.shtml


Of course it endorses it, it's part of the same organisation! Same agendas, same delusions.

Steve