Why is it necessary for you, or other libertarians, to have to rephrase my words, reframe my arguement, change it around, before you can reply to it?
I live in the real world. I cannot speak for you but that is where I reside. Nothing in it is perfect because of the human condition and human nature. Nothing having to do with the behavior of people is perfect.
The idea that a certain law or program is wrong because there exists a different law of program which is less than perfect is the worst sort of strawman. It is meaningless in the real world.
Of course, these type of debates do not take place in the real world - at least the one I live in. They take place in the same rarified atmosphere of the college sophmore all night bull session where a bunch of intellectually curious 19 year olds hopped up on too much coffee and Red Bull debating all the burning issues of ethics, morality and philosophy.
Its intellectual masturbation and is meaningless to anyone beyond the intellectually overconfident participants. The vast majority of people move on to bigger and better things. Unless you are libertarian.
You are free to wager anything you want on anything you want. Thats fine with me. But if that is some sort of evidence you are offering, please provide some statistics or research to support that point. Otherwise, its just your opinion founded on nothing more than you wanting to further your previous opinion with made up stuff without foundation.
If that is what you read - your clearly did not read it thoroughly. Yes, I criticized the libertarian tact of redefining the opposing arguement so that it better fits into their own way of dealing with things. Yes, this sort of thing pisses me off to no end and in never ends. When the arguer twists and perverts the original point of someone else, it is right and proper to point that out and attack the arguer. Look up the proper use of ad hominen attacks on sights discussing Logical Fallacies and you will see it is entirely proper in that case.
But I did speak to your points, and if you go back and read you will see it clearly.
I didn’t alter your argument, nor is mine a Libertarian Tact.
It’s a simple statement. If two things are equal, they should be treated equally. That’s not libertarian, that’s Equalitarian… or something to that effect.
I believe that two things which pose equal risks, should be treated equally. That has nothing to do with libertarianism.
Care to provide a cite for these herbal “poisons” killing people, and a comparison to the number of FDA approved drug related deaths each year? Approval does not indicate safety at all. Safety has taken a back seat to efficacy, financially and temporally. Showing that something’s relatively safe takes little time; showing that it works is much harder and more expensive.
I don’t mind safety regulations, I have a huge problem with efficacy ones. I think the placebo effect is a *good thing, not a bad thing, and as long as something isn’t causing harm, it should be available for a free person to use to try to heal. Furthermore, I think that there is an acceptable rate of life loss in exchange for freedom and better health for more people, although that’s not a popular opinion these days. I’m not sure where I’d put that line, but it would be somewhere higher than the two lives lost to the misuse of ephedra and lower than the tens of thousands of lives lost to obesity related illnesses.
Did you miss the recent downfall of Enzyte? The huge class action lawsuit against Airborne? They were both taken down for making false health claims in their ads, not because of anything dangerous in the formulations themselves.
No, it can’t, not even close. As a result, people writing labels and ads for supplements have to be ridiculously verbose and poetic, instead of stating clearly and succinctly what a product is (might be, could be) good for.
I did not say you were attempting to obfuscate the issue (which would imply intent), I said your presented choice does obfuscate the issues (whether you meant it or not). A large part of arguing regulation is establishing both its extent and from whence the power of enforcement derives. Hence why it matters whether the consumer or the manufacturer wields power and to what degree.
I’d appreciate it if you would not guess my intentions, especially because of your repeated insistence of others’ strawmen and irrationality…it just makes you look like a hypocritical dick. You already agreed to the modified choices I presented, and I said:
If you agree – and you did – that consumers have no freedom of choice in selecting a testing agency (much less whether the drugs are tested at all), then you do not get to build an argument on “If consumers demand tested drugs…”; these statements are contradictory. If, on the other hand, you think that consumers do have that freedom of choice, then I wonder (1) why you agreed to my modifications and (2) why and how that choice would ever become manifest (i.e., why a manufacturer would ever submit drugs for testing in the first place, much less duplicate the process using different agencies).
What it comes down to is that you like to trumpet individual choice as a philosophical foundation. Which is fine (and one that I agree with as a general principle), but which does have a prerequisite: unless options exist in actuality, there is no choice. Thus goes your foundation, a victim of the theory/practice divide, because I am not convinced that without (forced) regulation in place the choice between tested/untested drugs will be available, much less the one you posit of multiple agencies performing testing.
Although I should note that I’m also not convinced that weighing the costs/benefits will lead me to conclude that requiring such a choice is necessarily the best situation – there is that off-label drug use comparison to consider.
So again, I’m not proceeding anywhere at this point, just trying to get clear on your argumentive foundations and mulling things over.
You’re serious? After all this discussion, and the cites I provided documenting the problems with the FDA, you simply state that we’re better off with it, and your cite is an anonymous review of a book at Amazon? I mean, who could disagree with the sterling credentials of “A. Customer”?
Before the 1962 Amendments, the average time to market for a new drug was 3-5 years - time spent by the manufacturer undergoing their own, voluntary testing.
Honestly, I think many people who argue that the market can’t take care of these issues really don’t have the foggiest notion of the forces inherent in the market. Why would a drug maker spend 3-5 years testing a product if they don’t have to? For the same reason software companies spend months or years doing quality assurance and beta testing of their products before releasing them into the wild - they have reputations to uphold, they run the risk of lawsuits if they don’t do due diligence, and believe it or not, the people involved in drug manufacture are not generally evil monsters like hollywood portrays, but serious scientists and businessmen who have no desire to kill or hurt people. And even if they did, self-interest forces them to test their products thoroughly if they don’t want to be bankrupted by lawsuits or have their reputations destroyed.
I’m involved in a software product right now where we decided to ‘reset’ the project and scrap two year’s worth of work (about 5 million dollars in effort) because, in we engineers’ opinions, the quality just wasn’t up to snuff. No government regulator told us to do that, and nothing was stopping us from just shipping what we had - other than the knowledge that we’d probably all be fired if we knowingly shipped something that buggy to our customers. Why would we be fired? Because our company has spent decades building a reputation for quality, and would be mighty pissed if a development team took and shortcut and trashed that hard-won reputation.
We also spend a lot of effort each year on our processes, making sure that we’re tacking quality and our standards are high. Then we voluntarily pay huge money to a private company to come in and audit us, so we don’t fool ourselves. We do this to earn ISO 9001 certification, which again has nothing to do with government.
The choice is not ‘FDA vs drugs not being tested’, it’s whether or not in this case the forces that drive quality in the market would be preferable to the FDA as it exsts today.
Right back at you. Perhaps you should try taking a look at concepts such as information assymetry problems, externalities, and behavioral economics before you start lecturing people. Oh, wait, you’re familiar with these concepts, yet you show up in thread after thread acting as if you’ve never heard of them.
It is a fact, period, that companies do put out products which are dangerous and deadly to consumers. That has simply happened repeatedly throughout the US’s history, and any cursory reading of the history of tort law in the United States will tell you this is true. And this has happened at times of minimal government regulation.
Now, if you were actually trying to figure out how to prevent such products from injuring people, you would start by asking why, given such apparent market incentives to avoid injuring your customers, do companies nonetheless push injurious products into the marketplace. And if you were really serious about this issue, you might try to come up with a way to structure a market so that incentives point towards safe, effective products. But you don’t ever try to do this. Instead, you always seem to imply that any market will automatically assure these things, even though historically, that hasn’t happened.
This is just crap economics here. Each market is incentivized differently, and various individuals within a company have their own set of incentives. Simply because one company in one particular market chooses to behave a certain way, that’s no reason to believe other markets, which have their own incentives, necessarily will behave a similar way. Again, the question is, why do companies routinely put out injurious products, even knowing that they are harming their customer base? Why do consumers purchase products that are injurious? Both things do routinely happen, and simply pointing at one particular company’s exemplary behavior does nothing to answer these questions.
ISO 9001 is a QM protocol. Large, publicly traded companies have incentives to have a structured way to manage their manufacturing process. Why would you assume that those incentives are the same for product safety or for smaller companies generally?
You routinely try and conflate “quality” with product safety in these threads. They are not the same things, and you’re continued insistence on doing this strikes me as poor form. Almost nobody in the US advocates for the government to set quality (in an aesthetic sense) standards. What they want are minimum safety standards.
One more thing. After the nonsense about Underwriters Labs that routinely gets thrown around in these threads, I’ve learned not to take claims like this at face value. Saying that ISO 9001 has nothing to do with the government is misleading at best. Thirty seconds of googling reveals that Canada has something called the Standards Council of Canada which accredits standards bodies and coordinates activities between them. This is mixed approach to regulation, and for the area of QM, the government has very limited involvement, but to claim that the government has absolutely nothing to do with ISO 9001 is simply factually untrue.
And even then, that’s not always a given. Cytotec, an ulcer-reducing medication, is used off-label to induce labor in pregnant women. The problem is that this drug has not been tested for this purpose, and its use in this fashion has led to the deaths of women and of babies, and has led to uterine ruptures and hysterectomies which have put women’s lives at risk and compromised or destroyed their future fertility. In the 1990s alone, the deaths of roughly 100 neonates can be traced directly to the use of Cytotec to induce their mother’s labors.
In August, 2001, the manufacturer put out a bulletin saying “do not use this drug to induce labor.” The FDA followed this with a safety advisory which is the legal limit of what they can do to limit off-label use. The package of Cytotec was redesigned and now prominently features the silhouette of a pregnant woman with a big red circle slash, the international “no” sign, on every box. I personally saw that labeling when Cytotec was used to induce labor in my cousin in February of 2008. It’s still being used for this purpose. There are women right at this minute sitting in hospitals with Cytotec pills in their vaginas, waiting to have their babies.
So no, we can’t say that off-label use is safe because the drugs are safe. The drugs are safe (maybe) for what they were researched and developed for. That doesn’t always extend to the ways that doctors might try to make use of them.
I’ll readily concede that I didn’t think to append the phrase “by an independent entity”, although I don’t think it was necessary. After all, my objection was to IdahoMauleMan’s assumption that the consumer would have not only have a plethora of drug certifications from which to choose, but would have the power to direct/control who did the testing. He’d like to rest his argument on the principle of individual choice, but hand-waves it into existence (IMO). Not much of an argument to be had if we don’t agree on the premises. (Why, yes…let’s talk about irrationality, shall we?)
I’d also note that I said “the default position of every drug manufacturer would be to not have their products tested”. Clearly, if a manufacturer does some sort of cost/benefit analysis and believes that testing – whether internal or by an independent agency – is worth it, they’ll do it…although to what degree is another matter.
But it’s also notable that you bring up software for comparison. Your company does rigorous testing and is willing to scrap two years of work. That’s fantastic, and I have no doubt that such dedication to quality has resulted in a robust and well-architected system. However, surely you’ll concede that that’s not the norm in software, won’t you? In fact, given my own software developer credentials, I’d hazard a guess that the percentage of packages that are subjected to such rigorous testing is vanishingly small. Why? Because the product only has to be good enough to make a profit. $DEITY help us if drugs are subject to the same lack of regulation as software.
I’d appreciate it if you would direct your attention to BrightNShiny’s retorts, who has said more than I could have and better than I would have.
Nor did I say otherwise, assuming the above is directed specifically at me. If so, go back and re-read the rest of my post you quoted.
Perhaps you should extract the three main posts meant to kick off the thread into a new one. I’m of the opinion that this one got off to a bad start (due to the gaps between the three) and that it might be worth another shot.
But that isn’t the point that’s being made here – Sam conceded that the FDA has done some good in the OP.
The question at hand is whether or not the FDA does more harm than good ON BALANCE. Yes, you take into consideration the bad things the FDA keeps from happening; but you must also make into consideration the GOOD things they keep from happening.
ISTM that is the crux of his whole argument, and I have not seen anyone here seriously dispute that. He’s named specific drugs that the FDA has kept off the market, arguing that that resulted in tens of thousands of deaths.
If anyone disputes the specifics of those cases, please do so. I have no clue myself. If people want to concede that the FDA is too risk-averse but that it nonetheless is good, please do so. But Sam’s claiming tens of thousands of dead bodies, and everyone is whistling past.
And there’s another important aspect-not all drugs work the same for everyone. I tried taking one anti-convulsant, and it worked, but I still had seizures. My doctor tried weening me off of it to put me on another. When I was on both, fine. THEN, as I was off the other-I was back to having seizures every week. So now I’m on both, and so far, so good. (It’s only been a month though, crosses fingers)
So it wouldn’t be the consumer making the choice-would it not be their doctor doing so? Or are we eliminating prescriptions all together?
I was tackling the general economic arguments made by Sam, not the specific ones on particular functions of the FDA.
On balance where? Efficacy testing? Safety testing? If we want to be really proper economists about this, then we’d have to add up the values of all these people deaths and the values of all the people whose lives were saved and compare them, but that’s a difficult thing to do and involves a lot of guesswork.
If this is the sole objection to the FDA, then we can simply look at the FDA’s experimental drug regulations and testing protocols and see if they can be revised to allow specific drugs on the market for terminal situations. The FDA already does this, but, like anything else, there’s probably room for improvement. However, that’s a far less-broad debate than “the FDA is not an example of government success.”
That’s fine. I’m sorry. I wasn’t trying to ignite some argument. I was trying to guess what you were getting at, and instead of ping-ponging back and forth to clear up what the other party was saying, I created a bit of a strawman so I could move forward. If that’s not what you were saying that I’m happy to retract it.
But I’m still confused. Your language above still seems to doubt that consumers, or the ‘demand-pull’ side of the equation, have any power in these matters in a large, developed and free market. Am I misinterpreting that?
Prohibition was tried. It failed in part because so many people needed their booze that banning it was impractical. If opiates had the same sort of support they would be legal, too; not because of some libertarian ideal but because of pragmatism.
If the sum total of society was its economy then I might agree with you. IMO it’s not.
If the only cost of opiates was the birth of drub-babies then I would agree with your solution. But this is getting bogged down into a debate on what (if any) the detrimental cost of opiates are. The main debate should be:
Are there any scenarios where the incentives created by the free market are at odds with what we consider to be a “good” society?
If yes, then is an organization like the FDA the best way to regulate it?
For me the answer to #1 is an unqualified yes. The answer to #2 is more murky.
How many times do I have to say that the market isn’t perfect and there will certainly be shoddy and defective products sold, before people stop attacking that particular straw man? I never claimed the market did not have problems, or that there would never be defective products sold. Hell, there are plenty of them sold now, both government regulated and unregulated.
Yes they have. And they will continue to do so. Many of those defective and deadly products have come out of very highly regulated industries. The question not not can we get rid of a flawed government regulatory body and have utopia, but whether the regulatory body on balance does more harm than good. This means weighing the cost of drug delays, the opportunity cost of increased regulatory burdens, the reduction in investment, and the distortion of the market caused by the regulatory body, against the undisputed fact that such regulatory bodies do stop some defective products from reaching the market.
But there are a lot of unintended consequences of government regulation we haven’t even discussed yet. For example, the moral hazard of putting people in the habit of delegating the responsibility for their safety to the government. When the FDA certifies a drug, it often goes into immediate widespread use. This raises the stakes if the FDA makes an error. In a less controlled system, where different people would accept differing amounts of risk, drugs would trickle into the system (I’m talking about prescription drugs here).
In the the FDA regulated market, the profile of a new drug introduction looks like this: It goes into very limited human trials. Then it goes into a wider trial but still a tiny fraction of the population. Then the FDA stamps its approval, and suddenly use of the drug jumps by an order of magnitude or more.
In a free market system, the profile would look more like a linear expansion, from early trials, to wider trials, to gradual end user use by the patients with the highest risk tolerance, and then as data collected over time more and more people would use it.
That might be a better way to introduce a new drug in the first place.