11
   

The government shouldn't regulate ineffective drugs

 
 
Thomas
 
  1  
Reply Sat 14 Jan, 2012 04:09 am
@Setanta,
Setanta wrote:
That assumption is wrong,

Thanks for the correction, Setanta. Joefromchicago, feel free to ignore point #2 of my answer and go directly to #3.
0 Replies
 
Thomas
 
  1  
Reply Sat 14 Jan, 2012 04:29 am
@Thomas,
Thomas wrote:
By contrast, if Patient swallows an ineffective drug, in willful ignorance of its effects, she does not endanger her life, because we're assuming that the drug does nothing.

On second thought, I retract this point. The distinction between safety and effectiveness makes almost no difference to my arguments against regulation. I might as well keep the argument simple by assuming that the drug is always harmful.
0 Replies
 
JPB
 
  1  
Reply Sat 14 Jan, 2012 07:13 am
@Thomas,
Quote:
...the FDA does the research so the 1000 people don't have to. That's the transaction cost it saves. Once the FDA has done the research, the 1000 people only have to go to its webpage, look up its advice, and follow it. (Except for the one who still wants to do her own research.) Alternatively, they could ask their doctor to look up the FDA's advice for them. Either way, it's a negligible transaction cost compared to doing the actual research---having producers run clinical trials, checking the results they submit, and whatnot. The additional transaction cost saved by the mandate is trivial.


Just to clarify this point - the FDA doesn't do research. The FDA reviews research it tells other folks to do in support of a product claim. These folks ALL have an agenda -- they want to sell their product. The FDA can look at a submission and 1) approve the product for sale, 2) request additional information/data (research), 3) give a limited use approval (something less than what the original submission indicated as the intended use, or 4) deny the request. They can also decline to accept the submission if it doesn't meet the specifications of what it's looking for in a base application.

The FDA's charter (they aren't independent - they report to Congress and, yes, politics matters) is to evaluate the safety, potency, purity and efficacy of products that someone wants to sell. They approve products for specified intended uses and can pull the approval of a product post-market if there are indications of adverse effects. They also run on-going inspections of manufacturers to ensure compliance with Good Manufacturing Practices.

I don't think the answer to the OP is in the should/shouldn't category (I know that's what started the discussion), but more in the how much is enough vs how much becomes prohibitively expensive to the marketplace, including the consumer who ultimately has to pay for all this over site.

Good discussion!
Thomas
 
  1  
Reply Sat 14 Jan, 2012 08:30 am
@JPB,
JPB wrote:
Just to clarify this point - the FDA doesn't do research. The FDA reviews research it tells other folks to do in support of a product claim.

Thanks for the clarification.

JPB wrote:
They approve products for specified intended uses and can pull the approval of a product post-market if there are indications of adverse effects.

So let's say I want to ingest a medicament against a certain illness I have, and the FDA disapproves of my using it this way. Whose job is it to stop me---the DEA's?
JPB
 
  2  
Reply Sat 14 Jan, 2012 08:52 am
@Thomas,
They don't involve themselves with consumers unless someone puts cyanide in the Tylenol capsules on the drugstore shelves. They control your access by making something available by prescription only and then they control the circumstances that the prescriptions can be written (there's some flexibility on the part of the physician in prescribing drugs for off-label use). You can use an OTC med for whatever purpose you choose (unless you decide to make meth out of sudafed). Yes, it's probably the DEA who will come after you for selling your vicadin on the open market.

edit --- no one is going to stop you from taking your meds in an unintended manner. Suicide (intentional overdose) is still illegal in many states, but taking your cough syrup to treat your hangnail is totally up to you.
0 Replies
 
RABEL222
 
  2  
Reply Sat 14 Jan, 2012 04:08 pm
I would rather put up with the FDA than take the word of some snake oil salesman about their products.
roger
 
  2  
Reply Sat 14 Jan, 2012 04:24 pm
@RABEL222,
So would I.
0 Replies
 
Thomas
 
  1  
Reply Sat 14 Jan, 2012 04:41 pm
@RABEL222,
That's a false alternative. Nobody in this thread wants to abolish the FDA, or keep you from deferring to its judgments by your own choice.
0 Replies
 
joefromchicago
 
  4  
Reply Sun 15 Jan, 2012 02:05 pm
@Thomas,
Thomas wrote:
Not so. Doctors have to be experts on thousands of conditions. It is inevitable that their expertise in each of them remain somewhat shallow. Patients, by contrast, only have to be experts in the few conditions that actually afflict them. They needn't be superhuman to be more proficient about those few than their doctors are about the thousands.

Thinking of all the non-lawyers who have posed as experts on the law, I smile quietly to myself.

Thomas wrote:
1) I hadn't heard of Laetrile until you started this thread. Since you're bringing it up in your own thread about ineffective drugs, I'll assume it's ineffective but not actively harmful. Please correct me if this assumption is wrong.

It's both, but the biggest problem with Laetrile (and other ineffective "cures") is that patients will take them even though there are effective treatments available.

Thomas wrote:
2) On the above assumption, my answer to your question is "not applicable", because I reject your premise that failing to prevent a death is to cause a death.

You're trapped in a burning building. You could phone for help, but you mistakenly believe that the phone is out of order. I am, consequently, the only one who knows you're there. I assure you that I will go for help, but instead I just stand around doing nothing, and when the fire department arrives, I tell them there's nobody in the building. As a result, you perish in the flames, even though prompt assistance could have saved your life. What is my responsibility for your death?

Thomas wrote:
3) Assuming that I did accept your premise---I don't, but I'm not that interested in discussing it---my answer would be as follows: Patients have the choice to learn, or to delegate their learning to their doctors, or to delegate their doctors' learning to the FDA. If they refuse to do any of this, not even to save their own lives, I am willing to tolerate as many deaths as there are patients like that. It's their lives to play with, not mine. If it's legal for those patients to eat rat poison, it should be legal for them to eat Laetrile. Not everything that's bad for people needs to be illegal.

A perfectly predictable libertarian response. Of course, it assumes that everyone else is willing to tolerate as many deaths as you are, including their own. That is an assumption, however, that I am unwilling to share.

Thomas wrote:
No. With or without the mandate, the FDA does the research so the 1000 people don't have to. That's the transaction cost it saves. Once the FDA has done the research, the 1000 people only have to go to its webpage, look up its advice, and follow it. (Except for the one who still wants to do her own research.) Alternatively, they could ask their doctor to look up the FDA's advice for them. Either way, it's a negligible transaction cost compared to doing the actual research---having producers run clinical trials, checking the results they submit, and whatnot. The additional transaction cost saved by the mandate is trivial.

First you say that you know more about your own medical condition than your doctor, but then you suggest that attaining that level of expertise is simply a matter of reading labels. Either you have an extraordinarily high opinion of your own diagnostic acumen or else a shockingly low opinion of the medical profession. Either way, laws are not made for savants such as yourself, they're made for the average person, for whom warning labels are placed on frozen pizza boxes advising consumers not to eat the cardboard tray therein.
RABEL222
 
  1  
Reply Sun 15 Jan, 2012 04:59 pm
@joefromchicago,
Damn!!! You mean that cheese laced cardboard is unhealthy for me. Who da thunk it.
joefromchicago
 
  1  
Reply Sun 15 Jan, 2012 06:43 pm
@Thomas,
Thomas wrote:
The principle is that the government has a legitimate role in protecting people's life, liberty, and property against force and fraud by others. If Producer advertises his ineffective medicine as effective, he endangers Patient's life with a form of fraud. By contrast, if Patient swallows an ineffective drug, in willful ignorance of its effects, she does not endanger her life, because we're assuming that the drug does nothing. But even if the drug was harmful rather than just ineffective, it would not involve force or fraud, but rather be a voluntary action by Patient. I wouldn't be surprised if you disagreed with this distinction, but I would be surprised if you didn't understand it. This is very conventional classical liberalism.

If the FDA loses the authority to dictate which drugs consumers can and cannot take and is transformed instead into the "recommender-in-chief," then it becomes just one more bunch of guys with an opinion, no different from the proponents of Laetrile who think their drug can cure cancer. Yet for some reason you want taxpayers to fund one opinion over the other.

The FDA says Laetrile is ineffective -- the proponents of Laetrile say it cures cancer. I don't see any reason why one persuader should be favored over another in that scenario. You, however, not only want the FDA's opinion to count more than everyone else's, you want it to have the ability to silence those opinions with which it disagrees. That would make sense if the FDA could ban drugs, but it makes a great deal less sense if all it can do is ban opinions.

Justice Jackson once said of the supreme court that "we're not final because we're right, we're right because we're final." In the same way, the FDA doesn't have final authority over drugs because it's right, it's right because it's the final authority. Take that authority away, and it's just another opinion in a marketplace full of opinions -- in which case the laws of the free market will insure that good information will prevail over bad information, regardless of the source. Doctrinaire libertarians understand that, which is why they think there's no reason for taxpayers to fund an operation like the FDA if all it would be doing is issuing opinions.
joefromchicago
 
  2  
Reply Sun 15 Jan, 2012 10:46 pm
@RABEL222,
RABEL222 wrote:

Damn!!! You mean that cheese laced cardboard is unhealthy for me. Who da thunk it.

Depending on what brand you're buying, that might actually be the pizza.
RABEL222
 
  1  
Reply Mon 16 Jan, 2012 09:37 am
@joefromchicago,
Your right!!
0 Replies
 
Thomas
 
  1  
Reply Mon 16 Jan, 2012 01:44 pm
@joefromchicago,
joefromchicago wrote:
You're trapped in a burning building. You could phone for help, but you mistakenly believe that the phone is out of order. I am, consequently, the only one who knows you're there. I assure you that I will go for help, but instead I just stand around doing nothing, and when the fire department arrives, I tell them there's nobody in the building. As a result, you perish in the flames, even though prompt assistance could have saved your life. What is my responsibility for your death?

You have killed me by actively lying to the fire department. You have not killed me by passively letting me die and lying to me about it. That latter part puts me in the same position as if you hadn't been there in the first place, and you had no duty to have been there in the first place.

Thomas wrote:
First you say that you know more about your own medical condition than your doctor, but then you suggest that attaining that level of expertise is simply a matter of reading labels.

No I don't. You misunderstand what I said. Reading labels is not my way of attaining expertise myself. It's my way of deferring to the expertise of others, as I often do at my own discretion. The same is true of following doctors' orders.
0 Replies
 
Thomas
 
  1  
Reply Mon 16 Jan, 2012 02:05 pm
@joefromchicago,
joefromchicago wrote:
If the FDA loses the authority to dictate which drugs consumers can and cannot take and is transformed instead into the "recommender-in-chief," then it becomes just one more bunch of guys with an opinion, no different from the proponents of Laetrile who think their drug can cure cancer. Yet for some reason you want taxpayers to fund one opinion over the other.

The difference is that the FDA's opinion is well-informed and independent. It is well-informed because it has the budget to get accurate information, and is independent because it's funded by the public and can afford to piss off producers with deep pockets. This rightly gives it much greater authority than other organizations' opinion, with or without the power to enforce it against consumers.

joefromchicago wrote:
Doctrinaire libertarians understand that, which is why they think there's no reason for taxpayers to fund an operation like the FDA if all it would be doing is issuing opinions.

I don't know if Richard Posner's wealth-maximizing variant of Utilitarianism falls under your definition of "doctrinaire libertarians". But if it does, at least some doctrinaire libertarians have a perfectly good reason to support an FDA funded by taxpayer money: The FDA produces independent, high-quality information. Competitive markets alone would underproduce that kind of information, just as they underproduce any public good. At least since Alfred Marshall (1890), Utilitarian strains of classical liberalism have advocated that government correct such market failure.
Thomas
 
  1  
Reply Mon 16 Jan, 2012 02:32 pm
@Thomas,
Thomas wrote:
The difference is that the FDA's opinion is well-informed and independent.

In other words, I want the FDA to be Consumer Reports with a better budget, much as the BBC and Canada's CBC are PBS with a better budget. To be sure, there will be people who would rather bet their lives on the equivalent of FOX News or their favorite Christian TV-evangelist. That's very likely a catastrophic mistake. But it's their mistake to make. And unlike you, I don't think too people gamble as recklessly with their own health as they do with everybody's president. Unlike informed voting, individual health is a private good.
joefromchicago
 
  1  
Reply Mon 16 Jan, 2012 02:45 pm
@Thomas,
Thomas wrote:

You have killed me by actively lying to the fire department.

So if I just sat there and said nothing, then I would bear no responsibility for your death?

Thomas wrote:
No I don't. You misunderstand what I said. Reading labels is not my way of attaining expertise myself. It's my way of deferring to the expertise of others, as I often do at my own discretion. The same is true of following doctors' orders.

I'm not sure I'm following you here. At first you said that you had developed an expertise that surpassed that of your doctor, and now you say that reading labels allows you to rely on the expertise of others. Well, which is it? Are you the expert, or are you just an expert at understanding experts?

Thomas wrote:
The difference is that the FDA's opinion is well-informed and independent. It is well-informed because it has the budget to get accurate information, and is independent because it's funded by the public and can afford to piss off producers with deep pockets. This rightly gives it much greater authority than other organizations' opinion, with or without the power to enforce it against consumers.

Surely you can't be serious.

The FDA is a large organization that has to pay attention to lots of different drugs, whereas the proponents of Laetrile, for instance, are only concerned about one. To use Isaiah Berlin's metaphor, the FDA is the fox that knows many things, while the pro-Laetrile lobby is the hedgehog that knows one big thing. Or, as one recent commentator observed in a related context:

Quote:
Doctors have to be experts on thousands of conditions. It is inevitable that their expertise in each of them remain somewhat shallow. Patients, by contrast, only have to be experts in the few conditions that actually afflict them. They needn't be superhuman to be more proficient about those few than their doctors are about the thousands.

Clearly, then, the FDA doesn't have any kind of advantage over someone who has developed a profound expertise in a very narrow area -- and that level of expertise is attainable by the average citizen. Given that anyone is capable of making an informed decision, there's no reason why taxpayer funds should be expended on one set of opinions to the exclusion of all others. Your whimsical notion that the FDA should be able to silence dissenting opinions, in short, stands in sharp contrast to your defense of hedgehoggery when it comes to your own situation. Like I said before, that's not a principled distinction -- it just depends on whether it's your ox that's getting gored.

Thomas wrote:
I don't know if Richard Posner's wealth-maximizing variant of Utilitarianism falls under your definition of "doctrinaire libertarians".

No, but at least he does less temporizing about his libertarianism than you do.

Thomas wrote:
But if it does, at least some doctrinaire libertarians have a perfectly good reason to support an FDA funded by taxpayer money: The FDA produces independent, high-quality information. Competitive markets alone would underproduce that kind of information, just as they underproduce any public good. At least since Alfred Marshall (1890), Utilitarian strains of classical liberalism have advocated that government correct such market failure.

I'm sure they have developed good reasons for supporting institutions like the FDA. I just can't understand why you would.
joefromchicago
 
  1  
Reply Mon 16 Jan, 2012 03:42 pm
@Thomas,
Thomas wrote:
In other words, I want the FDA to be Consumer Reports with a better budget

We already have an organization that puts out information like Consumer Reports -- it's called Consumer Reports. And the Consumers Union, which publishes Consumer Reports, doesn't receive any taxpayer funding (except indirectly, as a non-profit organization).

If the Consumers Union doesn't have a big enough budget to do what you'd like, maybe that's because it's competing with the FDA. Remove the FDA, and independent outfits like CU or a similar watchdog organization would take its place and provide the same service -- just without citizens being forced to pay for that information if they don't want it. Why wouldn't that be preferable to a recommender-in-chief FDA that issues information and squelches dissenting views while existing on taxpayer subsidies?
Thomas
 
  1  
Reply Mon 16 Jan, 2012 04:26 pm
@joefromchicago,
joefromchicago wrote:
Thomas wrote:
You have killed me by actively lying to the fire department.

So if I just sat there and said nothing, then I would bear no responsibility for your death?

At most, you are liable of some offense much lesser than that of killing me.

joefromchicago wrote:
I'm not sure I'm following you here. At first you said that you had developed an expertise that surpassed that of your doctor, and now you say that reading labels allows you to rely on the expertise of others. Well, which is it? Are you the expert, or are you just an expert at understanding experts?

That varies from case to case. I know more than my doctor about a few diseases. I know less than my doctor (and the FDA) about all the others. Frankly I don't see how that's so hard for you to follow.

joefromchicago wrote:
Surely you can't be serious.

Watch me!

joefromchicago wrote:
I'm sure they have developed good reasons for supporting institutions like the FDA. I just can't understand why you would.

That comes at no surprise to me, because this post and your last few ones leave me with the impression that you misunderstand me on purpose for rhetorical effect. That's fine if you're having fun, but it's eroding my interest in explaining my position.
Thomas
 
  1  
Reply Mon 16 Jan, 2012 04:30 pm
@joefromchicago,
joefromchicago wrote:
If the Consumers Union doesn't have a big enough budget to do what you'd like, maybe that's because it's competing with the FDA. Remove the FDA, and independent outfits like CU or a similar watchdog organization would take its place and provide the same service

No they wouldn't---because truthful and relevant information is a public good, and the marketplace underprovides public goods. I already explained that in my last post, which I know you have read because you already answered it. Further evidence that you misunderstand me on purpose.
0 Replies
 
 

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