In the drug market, a new drug is patented. A patient wishing to use this new drug has no choice at all, except to not use it, and use something less effective (at least according to the claims of the manufacturer.) Do you wish to eliminate the patent system for drugs? If not, how does the free market work in this monopoly situation?
Now THAT’s a good question.
Although it has absolutely nothing to do with the FDA, or testing for safety and efficacy. It has to do with protection of property rights, in this case intellectual property rights, which any red-white-and-blue blooded libertarian will most surely be interested in.
Why don’t we hold off on that one for a little while, and finish this thread?
I would comment in passing that having mandated FDA testing actually works against where (I think) you are going with this argument. By driving up costs and time for drug testing, current law creates incentives for pharma companies to have armies of patent lawyers, and increased prices to consumers, in order to recoup the investment they have made in drug research in the window of time available to them under patent protection.
No worries. If it didn’t come across, I don’t think there was intent to confuse on your part. You just hit a nerve and I reacted.
If you go back, my original objection was not about power, but choice, specifically a consumer’s choice of approval agency. As I’ve said, this bothered me because you tend to use personal choice as an end point to your arguments. (Actually, “end point” is not quite right…more like a beginning point, a foundational tenet.) But without options from which to choose, there is no choice. And I don’t see how or why the choice you posited will become available…at least, I don’t see it well enough to accept it as a given. Rather, what I see is that the choice of approval agency rests solely with the manufacturer.
But I’ve said all that already, and you can go back to my previous posts if you think that’s necessary. On to new things, expanding on what I’ve said…due to the fact that things are never quite so clear-cut and simple. For instance, I agree with you that there’s no (theoretical) reason that, once a drug is on the market, a 3rd party cannot perform it’s own tests. But that qualification (once on the market) is important – the drug has to be available before a 3rd party has access; until then, the manufacturer (and only the manufacturer) has control of the testing procedures. (Unless, of course, some regulation is in place that requires a given level of testing prior to availability.)
Expanding on that a bit, since Sam Stone has taken issue: as I said before, I have no idea why a manufacturer would perform more than the least stringent tests they could (none, if that’s possible). I’m baffled by the mere suggestion that either you or Sam Stone don’t agree with that – isn’t that a key critique of the FDA? That the required level of testing is onerous, expensive, and delays drug release? And please note that when I say “least stringent tests they could”, I’m not saying a pharmaceutical company is inherently evil, nor that any given drug will be harmful, nor even that a manufacturer will not perform some level of testing – please don’t bother with insulting and inane claims of strawmen and “evil drug cartels”. Rather, it’s simple economic reality that a (financially) responsible company will look at its testing regime through the lens of a cost/benefit analysis. Need I say more about this?
So, prior to a drug’s availability on the market, I have no idea how and why it would be tested by a 3rd party. Thus, a consumer has no options concerning approval agencies, and thus no choice in the matter. It’s disingenuous and wrong to imply or state otherwise – which was my original objection.
With that said, there’s still the post-release to consider. With a drug on the market, data starts coming in on its effects (and effectiveness). 3rd party agencies can gather that data and/or run their own trials. Let’s tackle proactive testing first: it’s not clear to me why an agency would undertake testing on its own – they’re subject to the same economic considerations as the manufacturer. Unless and until such an agency can recoup its financial outlay, it’d be fiscally irresponsible to run a testing program. Perhaps such an agency could be hired – by whom? A collective of consumers, a philanthropy, or a competitor (of either the manufacturer or another testing agency) are all possible, I guess. But again, I’m not seeing where a consumer’s choice of agency really comes about in any common, substantial way…certainly not to the point where I can accept it as the given you claim it to be.
Now consider the passive case of data gathering. First, a certain level of market penetration/sales has to be reached to determine meaningful results. Gathering, processing, analyzing, and publishing those results is costly (although certainly less costly than other methods of obtaining data). Assume a Consumer Reports type of agency here, or the AMA, or whatever else – sure, that would not only be feasible, but quite valuable. But consider: this is a passive process that requires people to serve as proverbial guinea pigs. Consumer choice is reserved for those who can and are willing to wait; early adopters, again, have no choice (of testing agency). And this is where, it seems to me, many objections crop up. Namely – is it responsible to accept “people as guinea pigs” as a plank in our social structure? I’m not going near that one; just pointing it out.
And there are other wrinkles to consider. I’m glad that Voyager brought up patents, as that was in the forefront of my thoughts…I just didn’t think it was the time to bring it up (why obfuscate the basic questions even more?). There’s also non-disclosure agreements, where a testing agency is only allowed to release its results if approved by the manufacturer. Naturally, that only occurs if the results are positive (from what I gather, this is quite a common practice), so the consumer remains uninformed.
Then there’s the possibility of an Underwriter’s Laboratory type agency. I’m very curious about that, to the point that I went to their website to try to figure out a bit about how UL is structured and/or relied upon. What I gather is that they’re an independent agency to which manufacturers submit their products; it’s not clear to me that such an agency is different from anything I’ve already touched upon. One question that wasn’t answered (but was mentioned by BrightNShiny) is whether the government requires, by law, products to be UL certified. If so, we’re just swapping agencies; while it may be relatively better or worse by whatever yardstick you choose, it doesn’t change the fundamental arguments. But I digress; doubtless, there are plenty of other wrinkles I’m missing.
About the only choice that I see generally reserved for the consumer is the choice to take the drug or not. I’m pretty sure that that’s what you want to hear me say – that a consumer has the right to choose/refuse medication and so has the ultimate power in whether a drug is successful or not. Sure, I’ll grant that. If you can build it into some argumentative edifice that shows me the error of my thinking, I’ll cheerfully and gratefully accept it. But that wasn’t my objection, and it carries with volumes of other discussion for which I’m unprepared.
And finally, to contribute, albeit minimally, to the OP: Is the FDA a “government success”? I don’t know, but I think that it has done more good overall than harm. Should it be restructured or relax its control? Again, I don’t know…but I tend to think Sam Stone makes a good case that there is most certainly room for improvement.
cite for your apparent claim drunk people aren’t way more likely to do something stupid?
I’ve been around people hopped up on alcohol and pills (both illegally, and legally, in regards to both).
And in my experience – purely anecdotal – Alcohol makes people do much dumber things.
However, I didn’t really want to bring that up in this thread. :smack:
from Sam Stone
to myself
I do not draw the line. That is done by elected representatives of the people acting together in the public interest.
Where is my stated principle that you refer to above?
Ahh so different substances have different effects. Some of which can include, shall we say, judgmentally impaired behavior. So you very well could do something very stupid and long term damaging on the wrong substance. The problem is people’s stupid choices hurt other people. We don’t live in the woods 8 miles apart. Also people aren’t 100% informed. That’s why we have doctors so you don’t have to spend 7 years in medical school to self medicate. I’d much rather ignorance was unpleasant at worst and fought at worst, then fatal.
I’m not against recreational drug use. I’d personally never do it, but I think people should have the right. I also think they should have the right to know what a substance does and that it’s reasonably safe.
To wit weed after a stringent trial for safety and drug interactions = sure; meth = fuck no.
I rather suspect we agree on patents. Even if the patent system is not implemented well at the moment, they are important. I’m not one of those who believes that creators should be encouraged to give away their intellectual property for the fun of it.
The cost of developing a drug far outweighs the cost of testing it, so I suspect that the army of patent lawyers would still be there. In fact, there is probably no such army, since many companies hire outside counsel to fight a patent suit. The patent attorneys I worked with spent full time filing patents and dealing with the response of the patent office, back when they patent office actually looked at prior art.
However, my point was really about the contradiction between the free market which you assume and the non-free market (properly) created by the patent system.
You’re serious? You’ve provided a series of anecdotes and episodes. In the hundred year history of the FDA, you fill up a few paragraphs? And you want to be taken seriously? And “A.Customer” and the book itself, to which I was referring, provide a view of the evidence at large. Nobody seriously wants to eliminate the FDA except you. Respectfully, you’re nuts.
They are for some, teenagers mostly from what I hear. My Vicodin is worth quite a bit “on the street” from the offers I’ve had.
(Why would you have to spend hundreds of dollars to go to the doctor? Are you uninsured?)
For one thing, if you have back pain that lasts for any significant length of time, you should go to the doctor to find out why your back hurts - different causes have different treatments. Simply masking the pain with opiates might lead to further damage. OTOH, if you have back pain just because you overdid it last weekend, you don’t need anything more than Motrin.
Vicodin is an addictive drug, some say highly so. It can have some interesting and troublesome side effects, and can interact with other drugs. You will eventually get used to it’s effect and have to start taking more. This is true of almost every pain killer that doesn’t have an OTC counterpart. Despite the fact that I have been taking schedule II & III drugs all of my adult life, I would not take any of them without a doctors supervision, and I do know a bit more about them than the average weekend warrior. House aside, Vicodin is not something that should be taken casually.
That said, I agree that the FDA needs some looking at. My husband creates durable medical devices and gets them to market, and the amount of useless FDA red tape his company has to pay to get past is ridiculous. I don’t know about the drug end of it, but since the time to market is much shorter for durable medical than drugs, the FDA is probably throwing up even more worthless expensive roadblocks there.
Actually, Pills are more often abused by ‘soccer moms’ than teens. They’re out of the price range of most teens, and teens have more fun on Marijuana anyway.
Irrelevant, the actual cost of going to the doctor is hundreds of dollars, regardless of whether you pay it yourself or your insurance company does.
The cost is there, you either pay for it in cash, up front, or in premium increases as a group.
You know this because you’re inside of my body?
Cigarettes are addictive. So is Alcohol, depending on who you ask.
Yet they’re perfectly legal.
Yes, definitely.
I am not necessarily saying that people should be allowed to take whatever drugs they want, whenever they want. But what we do need to do is examine our laws, and make them consistent - that’s first and foremost.
But we also need to consider that people don’t want or need to be babied for the most part, and if someone is willing to take a risk in order to possibly ease their pain, cure their cancer, etc., as long as they’re well educated on the issue, it’s no ones place to them that they may not do so.
I certainly don’t have the authority to go to my neighbors house and tell him he cannot smoke marijuana, nor do I want it. I don’t see how me, and you, and Joey from down the road get the authority to do so.
And I don’t mean to apply this to everything in government, but what someone does in the privacy of their own home – without harming others – this should certainly apply.
Sam’s response to problems associated with the FDA is to strip the agency of its major responsibilities with regard to introduction of new drugs and (presumably) recall of drugs proven to pose risks that do not justify their usage.
I do not see how returning to the Wild West days of patent medicines (during which the “free market” permitted things like opium-containing drugs used to quiet fussy children and many other dangerous concoctions) will solve current problems.
Those problems also include introduction of new drugs which improve only incrementally on older, relatively cheap versions, and which through intensive marketing on TV and in publications (through relaxed regulation) have markedly driven up the cost of health care.
It is of course fashionable in right-wing circles to bash the FDA. A prominent example is Senator Orrin Hatch, who bears major responsibility for DSHEA, legislation under which the FDA has virtually no power to regulate “dietary supplements”, which are essentially drugs in everything but name (but without adequate safety or efficacy testing), and include not only ephedra but such things as comfrey (which when taken internally is capable of causing severe liver damage) and bloodroot salves (used by the credulous to burn off skin bumps and tumors under the delusion that this highly caustic material spares normal skin. Horrifying disfigurement (and spread and metastasis of tumors from incomplete removal) has resulted from the unregulated use of this product, available on the Internet. Lots of other ineffective and outright quack remedies (such as essiac tea, promoted as a cancer cure) either harm users directly or indirectly, by delaying adequate treatment. Due to the wonders of the free market, though, Senator Hatch has garnered lots of campaign contributions from the supplement industry (and a well-paid job for his son). No connection to his legislative efforts, of course.
Ron Paul is another right-wing anti-FDA (and anti-FTC) ideologue who’s a hero of the “health freedom” (i.e. “freedom to sell whatever I want”) brigade. Ron Paul is against government-mandated vaccinations, too. I’m curious, Sam are you also of the opinion that the “free market” should decide whether we and our kids are protected from preventable communicable diseases?
Sorry, but I prefer a more effective (and in some instances, more empowered) FDA to a gutted agency and the mercies of the “free market”, which has given us our current surging economy thanks to the wonderful state of the mortgage loan industry under Bush deregulation.
By the way, Sam told us that thalidomide is only approved by the FDA to treat leprosy. In fact, under a fasttrack approval this drug has now been OKd by the FDA to use in treating multiple myeloma.
This is a pretty interesting debate, but why is it getting side tracked on to drugs and prohibition? Surely there are far more laws forbidding ecstasy, heroin, cocaine etc. in the USA then just the regulations passed by the FDA?
So I don’t think its fair to attribute US Drug policy (which I’m not a fan of) to the FDA which is the subject of discussion. Although it is an area where I agree, a more liberal (Non-US meaning) attitude is probably needed.
Nope, in the US it’s pretty much all the Controlled Substances Act (on a federal level), which gave the Federal Government agencies (Departments of Justice/Health and Human Services, which contain the DEA and FDA respectively) power to ‘classify’ drugs.
Wow… I did not know that. So could whatever board of executives in charge of the FDA unilaterally legalise marijuana at the federal level? If so I’ve got some friends lobbying the wrong people!
I believe it’s possible, however I’m not sure on exactly how re-scheduling works.
For marijuana reform, it’ll take an act of congress. I’m almost positive of it.
Huh. Haven’t been approached by any soccer moms, but then I probably don’t know any!
You said why should you have to spend it. Plus, even my specialists don’t cost hundreds of dollars for an office visit!
I know this as someone that has more than a passing aquaintance with pain killers. People who think they need Vicodin for muscle strain are why those sorts of drugs are prescription only.
So?
If you mean consistent between drugs, cigarettes and alcohol, they can’t be. Apples and oranges.
These days we cannot even educated them on the dangers of smoking and you think they should have carte blanche WRT drugs?
You just said we don’t…
I would agree if the taxpayer didn’t have to pay for the results.
Luck you, they’re mean when they need their fix! :eek:
Chalk it up to a poorly constructed euphemism.
As someone who’s had more than a passing aquatience with Pain killers and a variety of injuries, sometimes it does take something more powerful than an OTC to take the edge off some of them.
And not all of them require doctors or hospital visits for anything other than pain killing.
Between drugs of equal or lesser danger, yes they can be.
And I can buy both apples and oranges in my local grocery store.
We don’t deny the dangers of smoking, yet it’s still legal.
I’m not suggesting we deny the dangers of these other drugs, I’m just suggesting that responsible, intelligent adults not be penalized for the irresponsible ones any more than they are in relation to alcohol.
Then implement a “Drug Tax,” the same way they have them on Cigarettes. Have it go toward funding Drug Rehabilitation programs for addicts, and drug aversion programs for kids.
What on earth are you talking about? Intellectual property rights aren’t like tangible property right. When I have rights to a tangible piece of property (such as land or a car), I get to control how that property is used. However, intellectual property rights give me the right to control how other people use their own tangible property.
If you own all the parts to make a widget and I own the patent for the widget, I can prevent you from making and selling a widget. I will be able to use the “coercive” power of the state to prevent you from using your own physical property as you see fit. A patent regime is completely opposite to how a libertarian is supposed to view property rights.
What is the purpose of this type of argument: “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.”
Why are you giving out discourses about the better nature of businessmen and scientists in a thread presumably about regulatory economics? If you are going to continue to make these type of arguments, then I am going to continue to read that as an ignoring of economic efficiency problems.
If a defective product comes out of a regulated industry, then that seems to me to be an argument to revise the regulations, not to wholesale abandon them.
See what you did here? You left out a whole bunch of stuff in your calculation. Not only do regulatory bodies “stop some defective products from reaching the market,” they also can reduce information assymetry problems, externality problems and underinsurance problems. You can’t exactly accuse me of arguing with straw men, when you yourself fail to account for these things in your own cost-benefit analysis.
Why would you assume that drugs would trickle in? What is the basis for this, particularly in a market prone to misinformation problem? Did we have a “trickling” in of drugs prior to the FDA, or did we have a bunch of snake-oil salesmen peddling everything under the sun? In an area prone to information assymetry problems, producers may be incentivized to put out injurious and misleading products on the market.
So?
No. In a purely free-market system, some people would choose to do introduce drugs this way, and some people would choose to dump whatever they can on the market for as long as they can get away with it.
Your system doesn’t produce this as a better way, it produces this as one of several alternate ways. Your way isn’t bad, but I’m concerned about the alternate ways, which can be very damaging. Unless…
You are proposing that manufacturers be required to introduce drugs only in the manner you describe. Which is interesting, but puts us right back at using a regulatory regime for drug sales, and what you are proposing is a few rule changes at the FDA, which again, is a less-broad topic then the way you are arguing in this thread.