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It is my understanding that, under Objectivism, it is the government's responsibility to protect its citizens and that this includes law enforcement and military. However, I posit that this includes regulating the food and drug industries as well, as well as most industries related to public health and safety. I argue that the average consumer does not have the tools needed to determine the safety and quality of these particular products on their own, and that private regulatory agencies would lack the authority to enforce standards. So my question is this: do you agree or disagree with the regulation of the food and drug industries? Why?

Ex. A person purchases a drug from a pharmaceutical company and its use results in their death. In the absence of the FDA (or similar regulatory agency) how is this mitigated or prevented?

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What "authority" would a private regulator need? They can simply refuse to put their stamp of approval on a product, and the consumer can refuse to buy a product that lacks that stamp of approval.

More generally, what makes a politician better at making decisions for a person than the person himself?

As for your example: that would be handled by the courts. If fraud was committed by the drug company, that company can be sued for damages and prohibited from further fraud.

Edited by brian0918
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"But what about the *masses*?! They can't be exposed to [private unregulated product]! People are stupid, and someone must do their thinking *for* them! If only *I* had ultimate power, I could make the whole system work perfectly!"

That is the mentality you have to resist and fight.

Edited by brian0918
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It is my understanding that, under Objectivism, it is the government's responsibility to protect its citizens and that this includes law enforcement and military.

...

Ex. A person purchases a drug from a pharmaceutical company and its use results in their death. In the absence of the FDA (or similar regulatory agency) how is this mitigated or prevented?

That's a little inaccurate. It is better to say the government's responsibility is to protect its citizen's rights, not protecting citizens from their own actions or mistakes.

If an individual does not have the tools to determine safety and quality, it is probably not in their interest to buy the product. It would make sense to have inspection companies which do have the proper tools, so don't think the government is the only way to verify a product's condition. It could work just like the FDA, except the point is that no company is *forced* to comply with those standards. The standards do not need to (and should not) be legally enforced. Some people honestly don't mind a little more risk than others.

Edited by Eiuol
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It is my understanding that, under Objectivism, it is the government's responsibility to protect its citizens and that this includes law enforcement and military. However, I posit that this includes regulating the food and drug industries as well, as well as most industries related to public health and safety. I argue that the average consumer does not have the tools needed to determine the safety and quality of these particular products on their own, and that private regulatory agencies would lack the authority to enforce standards. So my question is this: do you agree or disagree with the regulation of the food and drug industries? Why?

Ex. A person purchases a drug from a pharmaceutical company and its use results in their death. In the absence of the FDA (or similar regulatory agency) how is this mitigated or prevented?

Disagree. The government does not exist to protect its citizens from making bad choices, it exists to protect their individual rights, that is, to protect them from force and fraud. Since free trade is not an initiation of force, the government has no right to regulate it.

The notion that the average consumer does not have the tools to make decisions, therefore the FDA is needed and private certification is not is also based on false assumptions. This is based on the view that the consumer is an idiot who cannot make decisions for himself, so some government official, selected by the same idiots are needed to approve which goods he should be allowed to purchase or not. This assumes the FDA is in fact not staffed with people from the same social pool that says the federal government already has the necessary resources to regulate food and drugs but rather with wizards that posses special magical powers that the rest of us don’t and can somehow determine the “goodness” of foods and drugs for human consumption. It assumes the FDA doesn’t even need humans to determine the human effects of foods and drugs, it just knows and has the power to force its divinely revealed knowlege on the rest of us idiots for our own good.

Of course this is false, the FDA has only the resources that they take from the private sector in the way of taxes, debt, inflation, manpower and scientific research. Furthermore, it conducts clinical trials on humans who volunteer to participate. Basically, that means that the FDA gets volunteers to try new foods and drugs and then they sit back and watch what happens. If the volunteers have bad side effects, like their heads turn purple, their hair falls out, they are maimed, sickened or die, then the FDA disseminates this information to the public and the food or drug is not approved for sale in the U.S. and so people have no choice: they cannot buy it even if they wanted to.

So, in summation, the government's job is to protect rights, not to regulate people's affairs. This means it requires market participants to sell their products openly, honestly, without deception. So if a company sells a product as in your example, and it causes harm to the purchaser under false pretenses, the government can bring any criminal fraud charges which may apply against the shyster, and/or the purchaser and his legal representation can sue for damages in a civil case.

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The proper recourse is through the courts: when a person willfully causes you harm, they are obliged to compensate you for that harm. This does not require any regulatory agency.

Something I have problem understanding is that, with cases such as this, it always seems like, well, wait 'till it's too late. Wait 'till someone gets hurt or dies. Now, the FDA might MAKE sure that a company isn't doing harm to any of its customers. If there was no agency to do that, a company might harm their customers (for whatever reason, let's say it is cheaper not to run the tests on this potentially harmful substance) whether they know they will cause harm or not. They might just think they can get away with it. Well, people start dying and only then does a company get held responsible (sued, go to jail, whatever). Wait 'till it's too late.

Another example is global warming (can we just say it is real for the sake of an example? I am sorry if I am ignorant to the fact that it is totally outside of reality). The only, rational, reason we should demand (as customers) better 'environmental' standards of companies (the only reason companies should change) is self-interest, i.e., we want to breathe the air around us. It seems like no one would change until it is too late though.

I am not suggesting any government agency to impede on free trade, but am wondering how a free market would handle this.

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Something I have problem understanding is that, with cases such as this, it always seems like, well, wait 'till it's too late. Wait 'till someone gets hurt or dies. Now, the FDA might MAKE sure that a company isn't doing harm to any of its customers. If there was no agency to do that, a company might harm their customers

Far more people die from domestic violence than corporate negligence. And yet, daily visits from a cop supervising family interactions would horrify people. That's because they themselves would be subjected to the kind of harassment innocent business owners are faced with every day, from the government in the name of "prevention".

Until the day advocates for government control of the business environment agree to a similar control of the far more statistically deadly environment in their own homes, I'll dismiss their position as blissful ignorance. (be it the type of ignorance that causes them to approve of and support the persecution of a minority, the same way ignorant Nazis supported the persecution of minorities they thought were causing them harm) After that day, I will rightfully call them out on being Orwellian villains, just as Nazis turned into such villains after they witnessed the consequences of their ideology. Most Nazis, of course, eventually gave up their ideology, once they lost the war. I don't know if most hardened socialists will have the chance to learn and save their souls.

Edited by Jake_Ellison
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Something I have problem understanding is that, with cases such as this, it always seems like, well, wait 'till it's too late. Wait 'till someone gets hurt or dies. Now, the FDA might MAKE sure that a company isn't doing harm to any of its customers. If there was no agency to do that, a company might harm their customers (for whatever reason, let's say it is cheaper not to run the tests on this potentially harmful substance) whether they know they will cause harm or not. They might just think they can get away with it. Well, people start dying and only then does a company get held responsible (sued, go to jail, whatever). Wait 'till it's too late.

This ideology comes from a basic misunderstanding about the operation of free will and the application of justice to a being with volitional consciousness, i.e., man. People have free will and can (and must) choose to be good or bad. It is NOT just to penalize people on the basis that they MIGHT be or do evil because ALL people have the POTENTIAL to be evil. You cannot prevent accidents or even downright intentionally evil acts. History has shown over and over that attempts to do this inevitably result in the destruction of the good while the evil proliferate and gain control over the corrupt machinery that is supposed to preventing that evil to begin with.

If you want examples: it is MUCH cheaper to bribe an official than to comply with a regulation--and those who choose to bribe rather than comply benefit from decreased costs that let them run their would-be competitors off the market. It is MUCH cheaper to form a "partnership" with the gov't where you agree to accept a MODERATE squeeze on your company in return for your competitors being COMPLETELY squeezed off the market. It is MUCH cheaper to LIE about your compliance and throw a few hundred thousand dollars at lawyers to keep the regulatory agencies off your back than to actually go through the byzantine process of compliance. All these behaviors and more become de rigeur, just part of the business culture, under a regulatory gov't.

The only way for people to deal justly with one another is to leave them free to CHOOSE whether they will be evil or good and then deal with the consequences (and the people) as they deserve. This fact is often argued with by people who then claim that other people, given the opportunity, will always choose to be evil, but this isn't the case. Just LOOK at how very many individuals and companies STRIVE to comply with the ever-increasing load of gov't and private regulations even though it harms them and makes them less competitive. People WANT to be good and will even jump through incredible torturous hoops--inflicting harm ON THEMSELVES--in order to comply with a morality that they cannot possibly comply with 100%. Imagine what these people would be accomplishing if they were left free to operate under a morality that requires no self-harm.

Once you understand the enormous power of human good that has been stifled and destroyed under the crushing burden inflicted by this "prevention" morality/mentality, you will never fear the incidental accidents that might come along as an incidental result of the vanishingly small minority who MIGHT choose to be evil under such a system. You don't live in terror of lightning strikes or being kicked to death by a rogue donkey, do you? Yet those things COULD happen to you. It's just not worth your time to *worry* about them, much less establish a gov't agency to follow you around with a lightning rod and donkey repellent.

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Jake_Ellison - I agree that what the government and FDA does now is horrible harassment. It sucks and I would never want to suggest that. Did I miss something else?

JMeganSnow - I love what you said about this being a benevolent universe. And I agree that we should not live to avoid fear. You pointed out the things that DO happen under a regulatory government. And I was just pointing out what I thought would be the flow of things in a free market. Wasn't trying to point some little thing that COULD go wrong. According to you though, this is just something that people could choose to do. Like someone could still choose to kill someone in a free market.

I can imagine, in a free market, lots of defective (harmful) products being sold. AND at the ignorance of the seller. Not just some evil person trying to make a buck at the cost of others. But in the case of the ignorant, he might not go through all of the necessary precautions that today's FDA might make him (there are DEFINITELY a lot of unnecessary ones today, but besides the point). Even if he isn't a trusted seller (because he doesn't have a reputation with his customers), some people, I am sure, would still purchase his product.

Am I not understanding something else? Or is this just the way it would be and the crapy products and sellers would eventually vanish? But in that case, not before some people were harmed.

Do you just have to understand before dealing with someone, that they could harm you?

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Do you just have to understand before dealing with someone, that they could harm you?

Well, yes, but this is true of every human being on the planet in every aspect of life. And people DO understand it and (mostly) deal with it appropriately. The fact that so many of us survive to adulthood is an indication that we're not a horde of gullible idiots who go around climbing in pedophiles' vans or eating our Halloween candy before checking it first. When we're young, yes, we do have to be protected by our parents to an extent. But once we're adults, it's up to us to protect ourselves. The government is not your mom, even if you HAVE somehow managed to reach adulthood without ever learning anything.

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Something I have problem understanding is that, with cases such as this, it always seems like, well, wait 'till it's too late. Wait 'till someone gets hurt or dies.
If a company willfully sells a poison product, they are liable for very substantial damages. And therefore companies do not distribute poison products (outside of China). So there is no need for any prior restraint. Moreover, what the FDA does is well beyond preventing lawsuits in advance: they hold products to a ridiculous standard of proof that no harm could be imagined.

UL and their type of business provides the kind of service that most consumers do need; if you want to gamble on an untested product to save some money, that's your right. So there is no need for the FDA, and it is certainly morally wrong to take that choice away from people.

Another example is global warming (can we just say it is real for the sake of an example?
No, we really can't. Perhaps you could switch to something like the Easter Bunny, which is more believable as a hypothetical. Seriously, what exactly is it you're trying to accomplish with the "global warming" hypothetical? I know the question is "how do we do this", but do what?
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A person purchases a drug from a pharmaceutical company and its use results in their death. In the absence of the FDA (or similar regulatory agency) how is this mitigated or prevented?

Under Objectivism, there will be no FDA as a strong arm of The Government.

To your example -- if a person purchases a drug (perhaps by prescription, perhaps not) and its use results in that person's death, a few more bits of information need to be known before your question can be answered reasonably. Since it is a hypothetical, I will try to draw in more bits of information with as much reality as possible:

The drug is prescribed by a doctor. The patient asks the doctor about side-effects. Can I die from this medication? he asks. The doctor says that in rare cases. the drug has led to death, and gives the patient the pages of information about side effects that the drug manufacturer made available. It looks like the drug is not indicated for folks with high blood pressure or problems with circulation or compromised lung function. The patient has neither of these three conditions, but notes that the information shows several deaths. How did they test this drug? he asks the doctor.

Well, this company is completely unregulated, of course, but they do publish research. Let's look online. Here . . . is all the testing that the company did. It is not that easy to interpret, but it has been through the industry standard of three stage testing: animal testing, preliminary human testing, and double-blind controlled testing. That means that this drug has probably been tested by the most stringent standards around. There is a possibility with any drug of unforeseen consequences, but of any drug on the market for your condition, this is the best. The choice is in your hands.

The person takes the drug and dies, and the cause of death was, in reality, a reaction to the drug. The police investigate all suspicious deaths, of course, but in this case, they don't suspect murder or manslaughter or anything untoward. The wife and family are convinced that the death was a direct result of the drug. They hire a lawyer.

Of course, anyone could fill in the rest of the bits of information, and sway the answers to your example in any direction.

-- That there could be a mysterious fatal drug reaction was contained in the information provided by the manufacturer.

-- That there could be a fatal reaction as experienced in our example was know to the manufacturer, but not included in the information.

-- That there were definite contra-indications contained in the information that corresponded to the patient's state of health.

Any and all of these qualifiers could be true. But the truth would not be known in the absence of an investigation. The police don't have a mandate to investigate, as there is nothing in the statutes for them to find a crime, we see -- it's a consumer affair. If a harm has actually befallen our consumer that can be clearly and rationally laid at the feet of the manufacturer's product, his survivors can take their complaint to court.

Will the court hear a case about a suspected fatal drug reaction? Certainly they would now. Wrongful death. Would a company be protected from wrongful death suits? I don't see why . . . if there was actual harm that the company did.

Give a couple of outcomes to a lengthy wrongful death suit, shall I?

-- the company was found to have not actually followed the procedures of its own policies on safety testing and drug warning information. Fraud.

-- the company was found to have fully informed the consumer and followed the strictest industry standards. That's business. Sorry, dumbass.

-- the doctor did not read page fifty six of the company handout. Uh oh, hope doctor has malpractice insurance.

-- the company actually did a rush to market and hadn't rationally vetted its product. So what. Buyer beware. Case closed. Next.

+++++++++++++++++++++++++++

-- perhaps the best way to approach your global query is to figure out what the FDA does that still would need to be done, rationally, in a world without an FDA. That's big job!

If you posit that a govenment remit includes regulating the food and drug industries and most industries related to public health and safety, you won't find a lot of support among the objectivish. If you believe that the average consumer (of items under FDA oversight) does not have the tools needed to determine the safety and quality of these particular products on their own, you would be right (in my humble opinion).

That said, how would safety and quality be assured in particular products under Objectivism? Nobody knows. As I noted, the raft of actions, processes and procedures, tests and certifications might include some very rational items that should be performed in the absence of an FDA. Perhaps testing would be performed by an independent, industry-funded body. Perhaps safety inspections would be part of a guild-type contract. Maybe drugs would not get an industry 'kiss of approval' until they satisfied some criteria that could be independently assessed.

I am with you if you believe that the part of government which concerns itself with public health needs some kind of enforcement. That policing the shared byways of the world requires preventive and regulatory methods (as with traffic laws, pure food laws), there is now a welter of guide posts that say "this way, not that way" and "test fully for purity, safety and efficacy before marketing. Tell the whole truth about your product."

Some of these are fully rational, even moral precepts, some are finicky and seemingly crazy (registering autos, insuring autos, not parking in a load zone, not selling pure honey that actually contains botulism). Some are, shall we say -- in the Objectivist sense -- wrong, unethical.

Should there then be a law/regulation on the loading zone, the botulism, or can we kind of clear up the whole mess of regulation and law with one sweep of the broom?

If we can sweep it all away except for the pure rational core, what is left? If it makes sense to an Objectivist to have a No Parking In Load Zone sign subjecting every single motor vehicle operator to the exact same sanction, with an enforcement mechanism in place to ensure compliance, should there be a similar sign on the marketing byway that says Do Not Adulterate Foodstuffs?

Should there be a traffic policemen on the street? Should there be a traffic policemen who can stop traffic in dangerous drugs? Can a policeman enforce the rules and fine your ass?

Some would say no.

A substantial portion of the FDA regulation might stem from a common-sense need: scientific testing of claims, prevention of adulterated and/or otherwise tainted products being sold to consumers. In a perfect world, no producer of a drug would want to put anything on the market that had not been thoroughly vetted to the highest rational standards. Do we need something like an FDA to be manage the welter of products that can poison or otherwise harm people? Is an individual well-served by a regime (even entirely industry-ran) that commits those in the market to rational standards of testing, labeling, warning, etc, that is accountable?

If yes, and the regime is privately-managed, what is the recourse for the crazed drivers of the drug world -- what about the manufacturers who obey no traffic precepts, no matter how moral and just? Do they get ticketed? By whom . . . ?

I say yes. I would go further and say that such concepts as "public health" are a legitimate interest of government. What kind of government is a separate question -- whether traffic is regulated by a non-state actor, whether the production of drugs is governed by industry standards that are enforced within the industry (a levy on each producer to pay for the inspection and vetting of its agreed-upon standards). Some transactions are governed by trust. "Here's your car. Off you go. Be safe and responsible. Don't kill anybody. Good luck."

It could be argued that government per se (meaning an administration, management, oversight, publicly accessible and accountable) -- a governing body or bodies to coordinate the most rational processes and practices -- can be established without being part of the state. In some cases (fire protection, disaster response, emergency mobilization, health and safety practices, drinking water, and a few other items) I am not at all certain that a modern industrial society can prosper without management by an independent, rational set of principles and procedures.

I don't believe that a laissez-faire works on the roads, nor in our rivers, our skies, and not in the marketing of drugs powerful enough to kill me.

But then, I am not an Objectivist.

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It is MUCH cheaper to LIE about your compliance and throw a few hundred thousand dollars at lawyers to keep the regulatory agencies off your back than to actually go through the byzantine process of compliance.

This statement is incorrect, given the real world example of Zyprexa. Lilly lied, and paid the big price.

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This statement is incorrect, given the real world example of Zyprexa. Lilly lied, and paid the big price.

Um, yeah, because Zyprexa is off the market now and Eli Lilly is out of business. OH, wait, they aren't. Zyprexa sales as of 2007: $37 billion. Judgment: $1.42 billion. Hmm.

With the FDA, sometimes you lose the litigation roulette and have to pay out that round. But it keeps going and most of the "big" drug companies are in some sort of partnership with the gov't where they GET money for all sorts of stuff that the gov't "approves" of. I'm not seeing where this has some sort of huge deterrent effect.

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Something I have problem understanding is that, with cases such as this, it always seems like, well, wait 'till it's too late. Wait 'till someone gets hurt or dies. Now, the FDA might MAKE sure that a company isn't doing harm to any of its customers.

You put the emphasis on the wrong word. The appropriate word to emphasize would be "might." One could argue whether the FDA actually "might" make sure a company isn't doing any harm. But the history of the FDA is replete with approved food and drugs that went on to kill, or harm, tens of thousands of people.

Furthermore, David Odden's reply holds an interesting aside:

And therefore companies do not distribute poison products (outside of China).

If regulation were the answer to protecting people, then how does the most heavily regulated market on the planet put out proportionately more dangerous products than all relatively free markets combined?

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...if you want to gamble on an untested product to save some money, that's your right. So there is no need for the FDA, and it is certainly morally wrong to take that choice away from people.

No, we really can't. Perhaps you could switch to something like the Easter Bunny, which is more believable as a hypothetical. Seriously, what exactly is it you're trying to accomplish with the "global warming" hypothetical? I know the question is "how do we do this", but do what?

Ok, I must say thank you. I think there might still be some confusion on both sides (definitely on mine), but I found the answer I was looking for. Pretty simple

You can buy anything you want, or not buy anything you don't want. It is your right to buy something that might not be tested (wouldn't that require the seller to forewarn their customers though?), and if they say it is tested, well, that is fraud. Ok.

About global warming. I also stated that I am sorry if it is outside reality. I guess it is, so I apologize.

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In world without FDA, I can imagine private companies that would specalize in helping citizens in demostrating harm by conducting clinical trials.

Let's call one of these companies "D-FENSE", with headquarters in, say, Palo Alto California.

D-FENSE would carefully review the cases and clinical charts of 500 complaining citizens. D-FENSE would conclude that there is enough evidence as to take the risk to run a large clinical trial, or meta-analysis, or any other study scientifically sound to demostrate harm.

After three years, D-FENSE would had gathered the data, and proved that Big Pharma's drug was the culprit.

The judge would then fine Big Pharma with millions of dollars to be paid to the 500 citizens. These would in turn pay D-FENSE, which would not only fully cover the huge cost of the research, but even get substantial profit.

Under this scenario, Big Pharma would better start doing things right, knowing that very talented people would be joining D-FENSE and other similar companies, with growing expertise in breaking the bones of ill-designed drug development programs.

I can even imagine a competition between Big Pharma and D-FENSE in getting the best brains in drug development to their boards.

Edited by Hotu Matua
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For this case, assume the FDA was eliminated tomorrow. I could see, almost immediately, several new groups would emerge to do its job better. I always think of Consumer Reports when this question is asked. Major pharmaceutical companies would want a trusted stamp of approval to put on their drugs. They make enough money from legit drugs that they would want to protect the public's trust in their drug safety. Of course patients and doctors would have to make their own decisions and not accept things as blindly as they often do now. But if your doctor says the drug is the best for your condition and it has the seal of approval from both an industry funded non-profit testing agency and a for-profit commercial testing agency (both agencies with established testing procedures) I'd feel more comfortable taking that drug then I would now. (with an FDA full of red tape and with often subjective motives)

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Actually, several groups that do the job better ALREADY exist. When I worked at the tissue bank here in Dayton, we didn't worry much about the FDA inspections because they just wanted to make sure we were filling in our paperwork (we were)--heck, they couldn't even be bothered to put on scrubs and go back to inspect the clean rooms. But we were also inspected regularly (and voluntarily) by the AATB (American Association of Tissue Banks) and the ISO commission and we almost always had to fix a few things after they went through. All the processing technicians, procurement technicians, and the supervisors/managers went out and VOLUNTARILY got AATB certified. The company even offered you a premium if you did it and PAID the $500 fee for you to take the test.

Why go through all this business? Because being able to put the "AATB certified" stamp on your staff and your products makes a big difference in where/how/when you can sell your products. And this was in a relatively UNCOMPETITIVE industry: there are SIX, count them, SIX tissue banks in the United States and their areas of operation don't overlap very much--each one is very nearly a monopoly in their area.

Something to think about.

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how would you apply this concept to the supplement industry.

The way it *is* being applied. You can go all over the place and get tons of information about supplements, which ones are good, which ones are not so good, etc. People who really need supplements usually go to their doctor for recommendations and try out a number of things until they get the effect they want. (You should read Diana Hsieh's blog entries about her experience with hypothyroidism and the steps she's taken to combat it.)

Is it true that a lot of people don't seem to value their health and well-being enough to be really proactive in evaluating supplements et al? Are a lot of people apparently looking for a quick fix? Perhaps. But installing a government nanny isn't going to change this situation--in fact, it generally makes it worse because there's even less incentive for people to exercise their judgment when the gov't is supposedly doing it for them.

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JMeganSnow replies to my disagreement that it is much cheaper to lie than to comply with FDA requirements.

JMegan had suggested by way of an example that it is "MUCH cheaper to LIE about your compliance and throw a few hundred thousand dollars at lawyers to keep the regulatory agencies off your back than to actually go through the byzantine process of compliance."

I wrote that Eli Lilly lied, and paid the big price.

Um, yeah, because Zyprexa is off the market now and Eli Lilly is out of business. OH, wait, they aren't. Zyprexa sales as of 2007: $37 billion. Judgment: $1.42 billion. Hmm.

My disagreement was that it was not cheaper for Lilly to lie than to comply. In any case, JMegan's totals are wrong. Lilly's lies to the FDA cost them much more than that 1.42 billion criminal fine. There was a separate settlement of 1.2 billion, as well as continuing legal fees and suits, including suits from Lilly's insurance companies who charge fraud, seeking $6.8 billion in damages. BNet reports that Lilly 'burned through' 6% of its revenues since 2006 on payouts for its Zyprexa follies. Lilly hasn't finished paying out on this file.

BNet notes a figure of $3,914,400 and counting. That's a big price for lying, to my eyes.

If JMegan might assert that 4 billion dollars is cheaper than compliance, I just don't see the reasoning.

Edited by William Scott Scherk
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