The FDA is Not an Example of Government Success.

And if I have a hunk of land, I get to control how you use your car - in other words, I don’t have to let you drive it on my property.
We might disagree about fair use, but the issue was patents, not copyright, and that case is pretty clear.

Via all your recurrent woolly generalizations about how dreadful you think the FDA is overall, and how overly dependent people are on government regulation in general, and yadda yadda freedom yadda yadda invisible hand yadda blah markets yadda blah yadda blah.

If you would just stick to a focused, fact-based argument in favor of the specific position “Leave the FDA as it is, but simply remove the efficacy requirement for drug testing”, you might get a focused, fact-based debate on the subject.

Leave the generic fuzzy libertarian anti-government propaganda out of your posts for a change, and maybe you’ll get fewer respondents attempting to debate the generic fuzzy libertarian anti-government propaganda instead of the specific claims you’re making about FDA drug efficacy requirements.

You are comparing using one form of tangible property to infringe another’s tangible property rights. I was talking about using intangible property rights to infringe another’s tangible property right. Your post is a non-sequitir. It is counter to the libertarian notion of tangible property rights to support a patent regime.

No where in my post did I mention copyright, although copyright is a subset of intangible property rights. I specifically used an example related to patents. You are the one bringing up copyrights. Please go back and reread my post.

I said back pain from overdoing it, not from an injury which is a totally different thing.

If you have actually injured yourself, how do you know whether or not it is bad enough to require something more than painkillers unless you go to the doctor?

No. Prescribed drugs are taken to cure or mitigate some disease or illness. Alcohol is taken to get a buzz and then later if the drinker is addicted, and cigarettes are smoked first to look cool and then because the smoker is addicted. There is no useful reason for alcohol or cigarettes.

Doesn’t make them the same thing.

It would be nice if there was some place in the world where we are not penalized for the irresponsible few, but unfortunately that isn’t how the world works. Which is why we as taxpayers are required to pay for those who get hooked on cigarettes, alcohol and both sorts of drugs.

Why should I have to pay even more for my drugs than I do now, in order to pay for those irresponsible folks? Better that they cannot easily get their hands on Vicodin.

Still no takers on this, I see.

Because those of us who know our bodies, and recognize that the vast majority of injuries are superficial and that the body is very much a self correcting organism are willing to take that risk.

Not every bruised knee, over extended limb, etc requires medical intervention.

No they’re not. Prescribed drugs are used to treat an disease, illness or injury.

And because it doesn’t have any medical proprties it should be treated less stringently?

If two things are roughly equal in danger, but one has a potential medical benefit, the one with medical benefit should be illegal and the one without should be legal? That’s illogical.

I didn’t say it did. But you can purchase both.

Some countries, England, I think, actually benefit from their smokers. I remember reading an article that said smokers contribute 120% of their cost to the national health fund.

There’s no reason that perscriptions wouldn’t exempt you from that tax. After all, it is a recreational drug tax.

Earlier Sam suggested that one reason the FDA shouldn’t be involved in approving drugs based on efficacy was connected to the current high rate of off-label prescribing for conditions. The claim was made that there are many drugs given in situations for which efficacy has not been demonstrated and no real problems result, so why not do away with this regulatory burden entirely?

But off-labed use does pose hazards, most acute when serious side effects are possible (as for example with some psychotropic medications) and little to no evidence of efficacy exists. Lack of effectiveness for off-label uses is common:

*The study authors - David Radley (Dartmouth Medical School), Stan Finkelstein (MIT Sloan School of Management) and Randall Stafford (Stanford Prevention Research Center) - classified 73% of the off-label mentions as having “little or no scientific support,” based on Thomson Micromedex’ DRUGDEX compendium.

In the context of all prescribing, the results indicate that 15% of estimated uses “lacked scientific evidence of therapeutic efficacy,” the authors conclude."*

Knowledgeable observers (not including the “free market uber alles” contingent) see off-label use as posing considerable problems requiring more study and regulation, not less.

I take it you are referring to adults, not to children who’d be excluded from the choice to use proven safe and effective therapies. Or do you believe in parents having the option, say to use essiac tea on their kids’ cancer to the exclusion of life-saving drugs?
Even if you’re referring to adults only, I do not believe in unfettered access to any drug someone might want, no matter how useless or dangerous it is. Apart from general concerns about exploitation of the misguided and ignorant through sale of these products, I don’t want to pay for the end result of using them - i.e.- unnecessary mortality and morbidity. Somehow I doubt that the “health freedom advocates” would be willing to put up sizable bonds to cover the cost of treating them after they poison themselves or their conditions deteriorate on nonefficacious/dangerous drugs.

Thanks for the post.

Of course I’m not referring to children under the supervision of adults. But that’s a topic for another post altogether…how to make decisions for those who are not lucid, capable consenting adults. The FDA argument is irrelevant to that.

And thanks in advance for not referring to your reasoning as something akin to ‘looking out for society’.

But I’ll say it again, and also volunteer to dive deeply into a discussion of the economics of medical costs for those who make poor choices. They are absolutely trivial compared to the cost of regulation and a government-imposed monopoly. 2 orders of magnitude, at least. That means 2 zeroes difference on each side of the equation.

The argument that the government needs to get involved, as a legally enforced monopoly, in the regulation of drugs because otherwise the medical costs will be far greater than the costs of regulation cannot possibly be true.

For example, death by use of tainted drugs is what risk managers call ‘High Severity Bad Events’. That means they become very obvious, very quickly. Even more so in today’s wired society. They prompt a self-correcting mechanism whereby people change their choices, manufacturers change their product, testers revisit their methods, etc. very quickly.

I threw out some numbers above in post #25 to calculate the costs of regulation. I’ve spent a few minutes on the Internet trying to find a global estimate of FDA regulation by somebody, anybody…left-wing think tank, Cato Institute…anybody, to benchmark it against. Haven’t found anything yet. If you find something, please post it.

But my scribbling, back-of-the-envelope estimate was

C1 = $2 billion
C2 = $10-99 billion (my order-of-magnitude guesstimate)
C3 = $10-99 billion (ditto)

for a total of C1 + C2 + C3 = $22 - 200 billion. Netted against new costs of testing.

Now that’s wide range, to be sure. But at first blush it seems to be in the ballpark. Even if you bake in some conservatism to work against my argument as much as possible, total costs of regulation of C1 + C2 + C3 = $10 billion per year seems to be a very, very reasonable estimate.

What’s the cost of one person dying from poor drugs, on average? $10,000? $100,000? Let’s pick $100,000 per person dying from poor quality drugs. Again, to work against my argument as much as possible.

That means 100,000 people need to drop dead, each year, from lack of proper testing in either the public or private sector to even match the costs of regulation. Even with my conservative estimate on the cost-of-regulation side. If my costs are off by an order-of-magnitude on the low side, the number of people that need to die gets bumped up accordingly…to 1,000,000 per year. Ditto if the ‘cost per death’ drops.

There is no way that could ever possibly happen in our modern, developed society. It defies plausibility. It also assumes that people and companies would continue to plow ahead, year after year, making choices that fly in the face of that data.

Could you give an explicit example of the problem that you see? Patents are meant to stop the development of an infringing product. If that product cannot be sold, after development, that happens because it is the only remedy available given that we cannot monitor all R&D for infringement - nor should we. I brought up copyright because I’ve seen a lot more debate about inherent issues in the protection of IP through copyright than through patents. I’m also not interested in problems with the current implementation of the patent system. But what are inherent problems, especially with regard to drugs?

This was my patent argument. The choice lies with the drug company, not the consumer. Because of patent protection, a consumer wishing access to a new drug whose make chose not to go the FDA route has no choice of FDA approval.

In a later post, you tried to give some numbers. I think $1 million cost of death is way on the low side, even just considering the value of expected earnings. Also, your analysis basically assumes that problems will be detected quickly. If people dropped over dead after taking a bad drug, testing would be much faster and much cheaper. Testing today is also designed to detect long term side effects and health risks, such as a 10% greater chance of dying of a heart attack in ten years. Without careful testing, and well designed experiments that can pick up these effects, you can get a drug in wide use before anyone finds out about the risk. So your benefits of testing are way on the low side.
There is another issue. You might think that drug makers would randomly choose FDA or non-FDA paths. However, a maker with a more risky drug, for which there is a possibility of FDA rejection (how would that work?) would tend to go the non-FDA route, increasing the risk.

People might get around the problem by looking to Europe for approval, but that doesn’t make your method more logical, since European approval only works if drug companies cannot sell there without testing. Do you really want to abdicate drug safety rules to them?

Bottom line, since there aren’t a lot of drugs available for certain ailments until patents expire, the consumer is not going to have the choices you are assuming.

I think you might be misunderstanding the point I was making. I’m not arguing whether patents are good or bad, or whether anyone should support them. I am merely pointing out that libertarians have a specific philosophy regarding property rights, and patents run counter to that philosophy.

Hmm, I thought just the opposite. I’m not aware that libertarians thought that the government protecting property rights was not a legitimate function. We’ll have to let them weigh in on this, though.

You keep trying to treat intangible and tangible property rights as the same thing, when as I’ve already pointed out, they are entirely different creatures.

Not all libertarians believe this.
Libertarian doesn’t necessarily mean anarchist, or anything close to anarchist. It could just be the emphasis on person rights and personal responsibilty over group rights and group responsibilities.

Excuse me? WTF?

Would you be so kind as to show me the error of my thinking? Or, at least confirm/deny your agreement with me?

Reading the thread does not magically make the words “The title is not what this thread is about” appear in the OP.

I’m having a difficult time understanding why this hijack is being permitted to completely cast aside any meaning that the thread title has.