The Glade 4.0

So the individual himself has to review the three tractor trailers full of documentation? Of course he's not going to do that. Without the FDA, he's going to pay some other company to do this for him.

He already pays the FDA.

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"It's real, grew up in trife life, the times of white lines
The hype vice, murderous nighttimes and knife fights invite crimes" - Nasir Jones

Let’s disregard the medical, pharmaceutical and research training needed to understand even a simple drug application.

The amount of products out there claiming to help a certain condition is overwhelming. At least with government approval you know the drug you’re taking is made in a safe environment, to a high standard and will not cause side affects not listed on the product information.

Who would you hold responsible if someone dies from taking a medicine?

That was sort of the point, he's going to end up paying someone anyway.

And thus your contention that he has to pay the company isn't very relevant.

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"It's real, grew up in trife life, the times of white lines
The hype vice, murderous nighttimes and knife fights invite crimes" - Nasir Jones

Claims made: With government approval you know it was made in a safe environment , to a high standard, and will not cause side effects not listed.
None of that is known. It is assumed and so individual responsibility is surrendered. There are many drugs that passed FDA testing requirements that had unlisted side effects and or where ineffective.

One would hold the maker responsible - just as one does now. Why do you assume without the FDA somehow product responsibility goes out the window? The two are not related activities of government. Indeed they are the actions of two different branches.

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"...but there exists also in the human heart a depraved taste for equality, which impels the weak to attempt to lower the powerful to their own level and reduces men to prefer equality in slavery to inequality with freedom." - De Tocqueville

I'd like to point out that technically FDA drug trials are paid for by the pharmaceutical companies via user fees which many people feel is a conflict of interest.

http://www.cspinet.org/integrity/watch/200703052.html#2



http://www.thefiscaltimes.com/Articles/ ... aspx#page1

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This is sort of a nit-pick, but I don't think there would be much interaction between the systems themselves. Businesses selling or producing goods in multiple states would need to meet the requirements of each of them in order to stay in those markets, of course. As I said, there is a valid efficiency concern. However, bear in mind that dealing with varying conditions across multiple markets is fact of life for anyone that does business in multiple locales. This is not an insurmountable obstacle to entrepreneurship. Businesses already frequently opt to vary their product lines, prices, advertising, and so on across different markets. Meeting different regulatory demands is really not all that different from meeting different market demands.

Some businesses might address this by simply producing their goods according to the most stringent of the regulatory systems. Others may choose to abandon markets whose regulations they don't care to meet. This is part of the feedback system that I believe would help shape and balance the states' policies. Ex. "Hm, if we set this particular standard too high, businesses pull out of our state". With a federally regulated system, you don't this kind of feedback because no one is willing to bail out of the entire U.S. market.


Of course food and drugs are not people. Education isn't person, either. Likewise, high school algebra and chemistry curricula are substantially similar everywhere -- arguably more similar to one another than are the different varieties of potatoes. That isn't the point. The point is that these are all things produced, transacted, and consumed by people, and different people are going to have different ideas about how to best do those things and balance those operations.

For instance, looser regulations may lower the cost of production and the time-to-market for drugs. This is benefit to the consumer, but it has to be weighed against the potential health risk of inadequately researched drugs, and so on. Risk vs. reward is a very basic economic tension. The constituents of some states may have different tolerances for risk or for cost than others, and would be better served by a different balance of regulations. For instance, states with higher poverty rates might choose to lean more towards the lower cost side of the equation than more affluent states. Even within a state, there may not be a single balance across all products. Perhaps states like Kentucky and Virginia with (comparatively) very high lung, throat, and mouth cancer rates would want to be a more permissive with respect with chemotherapy drugs that are targeted to these cancers, but be more conservative with other drugs. Perhaps states with high obesity and heart disease rates would want to adopt tighter regulation of things like trans fat, and so on. The list of potential differences is too myriad to enumerate, really. Which brings me to this:

As I said before, the general answer to this is by betting able to take advantage of varying local conditions. This isn't necessarily restricted to economic efficiency, although that's probably part of it. It's also about how efficiently the system can meet the variegated and constantly shifting desires (like the examples above) of the people it ostensibly serves. A one-size-fits-all system is generally less efficient at accomplishing this. Simply put: which is more efficient at meeting people's demand for cereal: a "market" in which there is exactly and only one variety sold at one price, or a market in which there are many varieties with many different price-points? Unless your population is remarkably homogeneous, the answer is obvious. A diversity of regulatory system could be more efficient than a federal system for the same reasons that diverse markets tend to be more efficient over all than monopolies/monopsonies, even thought the latter clearly has less cost in terms of duplicated effort, and so on.


I need to clarify a few things:

First, when I said "substantially similar", what I meant was "similar enough as to be reasonably interoperable". I doubt that the state-level approach would ever settle into something as monolithic as what we have now via federal regulation. There is a balancing act between the benefits of diversity and the benefits of similarity. I believe that by breaking up the "monopoly" of federal regulation, the system would strike a more natural equilibrium between these two factors, which is to say "substantially similar" as opposed to "completely uniform".

Secondly, I suppose I should really say that homogeneity isn't necessarily bad. The problem is actually monopoly. Forced homogeneity is just the mechanism through which the harm is done. If multiple agents settle into a homogeneous state on their volition, there's nothing anymore "wrong" with this than any other state.

Having said that, even supposing that the many states did converge on a more-or-less uniform state, this is still crucially different than a uniform state produced by federal level regulation in a couple ways:

One, the state-level system is free to break that uniform state at any time. Unless you believe that the production of food and drugs and the people that use them are all completely static entities (bearing in mind that the regulation thereof encompasses many political, moral, and economic concerns), it is inevitable that there will be changing conditions over time. Even the field of agriculture (which some might assume is low tech and plodding) experiences change -- sometimes rapidly. In recent years, we've seen the introduction of genetically modified crops, for instance.

This brings me to the other major difference: when new conditions like this arise, it isn't clear how we should proceed. Different states are likely to take different regulatory approaches, and this is good thing for everyone. By actually trying different approaches simultaneously, we gain empirical evidence of how well these various policies actually work relative to one another. My speculation is that, like in most other human affairs, people tend to gravitate to those things that work well, rather than the things that don't. While this might mean that the initial "perturbations" eventually dissipate, the process itself is important. What it produces may ultimately have the trait of homogeneity in common with a system produced by federal-level regulation, it would not yield the same final state.

Or, in any case, would be exceedingly unlikely to IMHO. Given a homogeneous final state produced by a "top-down", centralized planning process and a homogeneous final state produced by a multi-agent system with at least some degree of competitive forces, I'll choose the latter any day. While neither result may be ideal, I have more faith that such a process will produce a more ideal result than any central planning process.

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Sail forth! steer for the deep waters only!
Reckless, O soul, exploring, I with thee, and thou with me;
For we are bound where mariner has not yet dared to go,
And we will risk the ship, ourselves and all.

By acclamation, Stathol shall forthwith be referred to as "Don Stathol de la Claro".

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The problem with a state based standard is this. Large populous states could basically get to dictate the standards without the nation having having input or farmers would have to not do business in the largest markets.

Let's say (for example) new York state bans transfats. All margarine has to be transfat free or miss out or the new York markets. Thus a ban on transfats in NY could led to a defacto ban without input of the 49 states. Yes Kraft or whoever could produce two versions of their product, but that would increase the burden on the company which is passed onto the consumer in the form of higher prices.

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I prefer to think of them as "Fighting evil in another dimension"

I still don't see why the Fed needs to get involved, even if every single thing you said was true. Seems like some strong conjecture to me. New York putting a ban on trans fats is no different than California having higher standards for vehicle emissions. A modified product for a different market.

This is not true. Kraft already has multiple products that they're selling. The only burden is to produce a trans fat free variety. That cost of production likely will get passed on to the consumer, but that's no different than Kraft introducing an instant Gouda cheese to complement their other products. They do that all the time, and nobody complains about R&D costs being pushed on to the consumer. Instead, people try the product. If they like it and the product does well in test markets, Kraft adds it to their regular product line. If the product bombs, it goes away.

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Buckle your pants or they might fall down.

This may be true with respect to foods, but drugs are generally far more complex to produce, and we cannot necessarily expect that it will be possible to produce a different version of a drug to meet California's nanny-state standards, which might then put the drug outside the realm of economic feasibility, especially if other populated states with similar political bents, such as Illinois and New York were to follow suit. In this way, the most populated (which, with certain exceptions also tend to be the most liberal and the most apt to impose regulatory burdens) states would be able to dictate what the standards would be to the other states - except that unlike now, where each state gets at least 2 senate and 1house vote on what's being dictated, they would get zero. Sure, a drug manufacturer could decide to move out of those states and not sell in them, but with the biggest markets in the country unavailable that would impact the economic viability of certain drugs.

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"Hysterical children shrieking about right-wing anything need to go sit in the corner and be quiet while the adults are talking."

Again, this seems to sum up the entire issue. Clearly, there is a difference between "completely uniform" and substantially similar. However, this all seems to come back to the same basic problem: All these benefits seem to come down to a simple belief that things would be better, because of a belief that less Federal involvement and greater state-level regulation is just going to be better for reasons that largely pertain to what I'll call, for the sake of brevity, "granularity"; that is, that each state could tailor regulations to local needs.

The problem is that every one of these benefits seems to be qualified with "possibly" or "it could result in.." or "I believe..." or something like that. Nothing is terribly convincing as a counterpoint to the arguments raised regarding the overall efficiency of the system. Of course, the system as it exists is far from perfect, but it is also very far from the spurious claims of "security theater"; the fact is that people very very rarely have to worry about purchasing tainted food, whent hey do purchase food they can (contrary to what was asserted earlier) take such steps as verifying the expiration date or physically inspecting the food or its packaging for tampering or spoilage and in conjunction with existing regulations, people's food is generally safe, and it is not as if food is in short supply in this country either. With respect to drugs, there is certainly ample room for improvement in terms of the lengthy testing process, but by the same token we do not encounter situations like The Fugitive on a regular basis where a harmful drug is being passed off as safe.

The passage I quoted above illustrates this problem of assumption perfectly; there is assumed to be some sweet spot that will result in greater efficiency (in general, not just economic, although I would say that greater economic efficiency is the most important sort in making drugs economically viable and affordable to the population, and thus drives efficiency in other areas anyhow) in which the states' regulatory decisions are similar enough that it is not impossible to do business in California if you are based in Delaware, but where there is still sufficient difference that they are not completely uniform, and by that I mean that "substantially similar" does not mean "Cosmetic differences that allow advocates to claim state systems are different, while being so similar that for any practical purpose they are homogenous".

Even assuming that this "sweet spot" exists, we have no way of knowing how "wide" it is or whether the states will manage, in the aggregate, to actually hit it. I am not particularly confident that state government will be any more capable in that regard than the Federal; some might be but others won't and even if they are the incompetence of their fellows in other states might defeat their best efforts. It helps Kentucky little to have low standards for cancer drugs to get them to its population quicker if the drugs are manufactured in a state with such high regulatory burdens on their manufacture that they defeat the purpose of Kentucky's effort in the first place.
It is not so much a matter of the Federal government being some wonderful blessing of food and drug administrative bliss as that the arguments in favor of changing horses are so mediocre. Nothing truly convincing has been said. Granted, as you pointed out the only way to know for sure is to try, but this is not some game where we can revert to a save if things end up worse. Some practical advantage that can be demonstrated to have a high likelihood of actually appearing needs to be shown, and not simply because smaller government/libertarian ideology says it should appear.
Unless such an argument can be made, or unless the performance of the FDA worsens substantially, there’s no strong reason for a switch. There are far better candidates in terms of Federal agencies to receive the axe, such as the DOE, the ATF, or any number of other agencies with indiscernible purposes. In regards to the FDA, I simply see excessive credulity for the idea because Ron Paul endorses it and because it serves the wider purpose of “small government”, not because it has real advantages pertaining to food and drugs.

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"Hysterical children shrieking about right-wing anything need to go sit in the corner and be quiet while the adults are talking."

It is assumption made on the side of the consumer. Any drug advertising is always done with a “Use only as directed, … “. Registration with the FDA does not mean approval (even though that is the most common word used). It, in no way, suggests that personal responsibility should be surrendered, and any surrendering done is done on both an assumption and lack of education on this matter.

I would like to see any examples you may have where a prescription drug, which passed FDA approval (not an ANDA application) have later been found ineffective.

Unlisted side effects are common, as a 10k people clinical trial is not as effective as world wide distribution, especially in areas of vaccinations. This is often references in the Product Information as “Some side effects may include”… This language is used to ensure the consumer understands not everything is listed.



The thing about medicines is that there is often a single legal manufacturer and a single legal sponsor. The legal manufacturer is often responsible for the final release of a product, even though the ingredients could be made by different manufacturers. As the case, the cost of setting up a legal manufacturer/legal sponsor is minimal compared with the amount of profit often made on a drug. The risk on the other hand, of mass distribution is huge.

In a perfect world, those that are responsible should do the right thing, and are shot if they don’t. However in the real world, even if those responsible are shot, you could have heaps of dead people along with that 1 person responsible. Due to the vast amount profit associated with drugs, the incentive of less regulation would create more manufacturers of drugs who are out there to make a quick buck. Would you dare to be the first person to try an un-approved drug without reading through all the clinical, medical and pharmaceutical papers associated with it?

Without a yard stick to measure new drugs, and with only self regulation in mind, you’ll end up with less to no RnD for non-life threatening medications as no one would dare to be the guinea pig of new drugs.

The intention may be to not surrender individual responsibility but that is always the effect. People are conditioned to implicitly trust the government so if they say X is Y then it is Y and no need to look up any information.
Here is one the drugs found to be ineffective:

http://io9.com/5860856/fda-declares-blo ... they-right

Here is an article detailing known ineffective drugs being allowed by the FDA:
http://www.correntewire.com/fda_allows_ ... n_changing

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"...but there exists also in the human heart a depraved taste for equality, which impels the weak to attempt to lower the powerful to their own level and reduces men to prefer equality in slavery to inequality with freedom." - De Tocqueville

Avastin wasn't found to be ineffective... it even says so in your own link. It was found that the risk out weight the benefit of the drug, which is why the FDA wants to remove its use for metastasized breast cancer ONLY. It is still available for other cancers…

Your second link doesn’t actually mention a specific drug, rather over arching statement criticizing the lack of follow up on effectiveness. You should be aware that if a product is ineffective, and reported by a consumer, the product would undergo a recall and re-assessment. I see no benefit in actively perusing drug effectiveness, especially considering there is no requirement for a registered product to be actively marketed in the US or even sold as a product. The consumer complaint channel is a much more cost effective way of monitoring such things.

There is however a statement I find interesting in your second link.



The majority of drugs are designed to either take away the unpleasant side effects of diseases or restrict/control the growth of diseases (exception being Anti-biotics). Drugs are never designed with the extension of a patient’s life in mind, although that is sometimes a side effect. That statement shows the extent of the writer’s ignorance on the subject of medicines.