The FDA Protects Consumers

The purpose of government is to protect citizens rights. Rights can only be violated by force or fraud. In the case of force, there is the "Terry Stop" a proactive engagement by a law enforcement officer to prevent an armed robbery. The Food and Drug Administration acts to prevent fraud.

FDA researcher blasts manufacturer's tests on diabetes drug
By the CNN Wire Staff

Washington (CNN) -- A prominent Food and Drug Administration researcher sharply criticized a safety study by the manufacturer of the diabetes drug Avandia on Tuesday as an FDA panel weighed whether to yank the drug from the market.

The study, dubbed RECORD by GlaxoSmithKline, came under attack throughout the first of two days of hearings by the 33-member FDA advisory committee.

"You can't trust it, and if we do trust it, we're engaging in the willing suspension of disbelief," said Dr. David Graham, the FDA scientist who first flagged deadly side effects of the painkiller Vioxx.
One of the committee members, Dr. Sanjay Kaul, urged caution "before drawing any definitive conclusions" based on data he called "fragile." That drew a blunt response from Dr. Steven Nissen, the Cleveland Clinic cardiologist who authored the 2007 study and presented an updated, critical assessment of the drug Tuesday.

"Whose fault is that?" Nissen asked. "We have a drug that has been on the market for 11 years. The company had every opportunity to do large-outcome trials, adequately powered and properly run, to answer this question. They didn't do it."

In a study published in June, Graham also found patients on Avandia are more likely to suffer stroke, heart failure or premature death than patients who used another drug. And he said the RECORD study would have been dismissed as "garbage" if it had been used to seek the drug's original approval.

http://www.cnn.com/2010/HEALTH/07/12/fda.avandia/index.html?hpt=T2

Post 1

Tuesday, July 13, 2010 - 6:44pm

Michael:

Whether the FDA, or any other government consumer advocacy department, has some degree of effectiveness isn't the objection. It's the fact that there is no accountability. If they screw up, there's no financial penalty for those who were responsible. Nobody's going to get fired or lose their pension, but if a company such as Consumers Union were monitoring the efficacy of the drug and it screwed up, then the Consumers Union, and their employees would suffer. Subscriptions would dry up and heads would roll.

This is just a normal John Stossel argument. Don't you get it?

Sam

WIJG?

Post 2

Wednesday, July 14, 2010 - 6:24am

Well, yes, Sam, but that applies also to the army, police and courts, does it not? (Are prosecutors or jurors accountable for their errors?) Either we have a government or we do not. I am not arguing against government, but for its proper functions.

We easily roll off the tongue, "army, police, and courts of law" and insist that they be all. But "courts of law" supposes some body or mechanism to make law. We never discuss that, how laws are made.

If you can find a problem with the analogy to the Terry Stop, then that is valid. But to say that the government is not accountable to the citizens is to raise a different question, entirely.

Under the present system, Congress controls the FDA by controlling its budget. Congress also gives "agency" to the department, empowering it to act. Congress has oversight. Were the FDA to act egregiously, you could write to your representative and ask for an investigation. As a citizen, you can always launch your own. There are oversight organizations such as Cato, Hoover, etc.,

As an administration or executive function, the FDA comes under the President who also has some responsibility and control. We could write to him and bring problems to his (office's) attention. In fact, tangentially, this problem of Congress empowering administration to do the work of Congress was the subject of one of Elena Kagan's papers. ("Chevron's Nondelegation Doctrine," by David J. Barron and Elena Kagan, The Supreme Court Review, Vol. 2001 (2001), pp. 201-265.)

I'm just saying, if the police can prevent a robbery by detaining a suspect before he acts, then, by that same theory, the government can act to prevent fraud.

Post 3

Wednesday, July 14, 2010 - 8:18am

Michael:

We easily roll off the tongue, "army, police, and courts of law" and insist that they be all. But "courts of law" supposes some body or mechanism to make law.

Yes, we agree that the only proper function of government is the protection of individual rights but there is a difference between preventing fraud and regulating an industry. If the government law enforcement agency has reason to believe that a fraud is being committed by a drug company then it should prosecute, as in the Terry Stop but that doesn't mean that the government should regulate the way people walk down the street. When they act suspiciously then there is enough evidence to investigate. Legitimate reason for suspicion of fraud by a drug company might be a whistle blower volunteering information. That would also be an occasion to intervene.

The accountability of the government for mishandling a situation is second or third hand at best, whereas a private company suffers directly.

Sam

WIJG?

(Edited by Sam Erica on 7/14, 8:39am)

Post 4

Wednesday, July 14, 2010 - 10:54am

Michael wrote, "I am not arguing against government, but for its proper functions."

A miracle has happened, pigs are flying, and hell is frozen over.... Michael is no longer an anarchist!!!!

Post 5

Wednesday, July 14, 2010 - 11:52am

The FDA has blood on its hands from all the people who have died waiting for safe medicines to wend their way through the expensive testing phase, or died waiting for medicines that never got developed because of those additional costs making them not cost-effective, or died because the costs of complying with the FDA testing drove the costs of the drugs out of their reach.

The FDA is, if not the poster child, at least on the short list of government agencies that need to have all their employees fired, their buildings torn down, and the earth salted over the smoking rubble.

/humorous hyperbole

And the question an anarchist like you should be asking, Michael, is why a monopoly government agency with the power to use force to prevent drugs from getting on the market is better than private rating agencies similar to Underwriter Laboratories combined with lawyers suing drug companies who put unsafe drugs on the market without adequate testing.

Why would an anarchist think that in * this * case top-down command and control would work better than a marketplace, especially given the FDA's abysmal track record?

Post 6

Wednesday, July 14, 2010 - 3:18pm

Sulfanilamide, a drug used to treat streptococcal infections, had been shown to have dramatic curative effects and had been used safely for some time in tablet and powder form. In June 1937, however, a salesman for the S.E. Massengill Co., in Bristol, Tenn., reported a demand in the southern states for the drug in liquid form. The company's chief chemist and pharmacist, Harold Cole Watkins, experimented and found that sulfanilamide would dissolve in diethylene glycol. The company control lab tested the mixture for flavor, appearance, and fragrance and found it satisfactory. Immediately, the company compounded a quantity of the elixir and sent shipments--633 of them--all over the country.

The new formulation had not been tested for toxicity. At the time the food and drugs law did not require that safety studies be done on new drugs. Selling toxic drugs was, undoubtedly, bad for business and could damage a firm's reputation, but it was not illegal.
FDA History here.

Frances Kathleen Oldham Kelsey, Ph.D., M.D., (born 24 July 1914) is a pharmacologist, most famous as the reviewer for the U.S. Food and Drug Administration (FDA) who refused to authorize thalidomide for market because she had concerns about the drug's safety. Her concerns proved to be justified when it was proven that thalidomide caused serious birth defects. Kelsey's career intersected with the passage of laws strengthening the FDA's oversight of pharmaceuticals.
http://en.wikipedia.org/wiki/Frances_Oldham_Kelsey

I posed this problem before. Suppose a police officer on patrol sees a child surrounded by a pack of coyotes. Is the officer obligated to act? A child has fewer rights than an adult and coyotes are not volitional creatures, so they cannot violate rights. I offered the problem to show the limitation of rights-based government.

Here, too, we have the same problem. If no one complains, can any person engage in any act?

Must there exist a whistleblower or a plaintiff for the government to prevent fraud? .... or coercion?...

Can the government never be proactive in the protection of rights?
Are rights -- not well defined, we must admit, after much argumentation here -- the only basis for government action?

Post 7

Wednesday, July 14, 2010 - 3:22pm

Steve and Jim, you both misunderstand me here, and probably always have generally. I am not an "anarchist" who seeks to change the world, destroy governments, convert people to my way of thinking, create a utopia, or whatever else you think you mean by that term.

Time and again I said that as I understand the theory of consistent capitalism, applied to the world we live it, the Randian/conservative construct of constititionally limited government does not apply. The so-called "anarcho-capitalist" model is better at describing and predicting behavior in our globalist society.

Post 8

Wednesday, July 14, 2010 - 6:08pm

Michael,

You make posts that marginalize your credibility. You say you are an Objectivist AND an anarchist.

You lump Rand with conservatism.

You say you don't want to convert people to your way of thinking - but yet you post again and again - so, is it to enjoy the disagreement?
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You write, "... the Randian/conservative construct of constititionally limited government does not apply..." [to the world we live in] Sorry, but that doesn't make sense.
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You go on to write, "The so-called 'anarcho-capitalist' model is better at describing and predicting behavior in our globalist society."

Sorry again, but since capitalism CANNOT even exist under anarchy - making 'anarcho-capitalism' a contradiction in terms - you lose more credibility.

Post 9

Wednesday, July 14, 2010 - 6:14pm

Michael:

Must there exist a whistleblower or a plaintiff for the government to prevent fraud? .... or coercion?...

No. As Jim and I pointed out, agencies such as Consumers Union and Underwriters Labs can monitor the efficacy of their products.

The government is there to prosecute fraud.

Sam

WIJG?

Post 10

Thursday, July 15, 2010 - 3:08am

Sam, we are talking past each other and repeating ourselves.

The question is: Does the government have a responsibility to protect against fraud, just as it does to protect against force? To say that we do not need the government to deal with fraud is to claim that we do not need the government to prevent coercion.

You say that the government can prosecute violators, but how does that begin? If Consumer's Friends were to find a flaw in a product and take the matter to court, the other side would say that Consumer's Friends has no standing in this matter: they were not harmed.

Moreover, from our point of view, Consumer's Friends only reverse engineered the product -- and rather than making a better one themselves, they seek to get the government to prevent this one from coming to market, based on its putative design flaws.

The problem is -- as with the coyotes and the child -- that we have not said that they government exists to prevent force and fraud, only to act after a complaint has been filed. The government does not protect your life, liberty, and property, but only retaliates against those who violate them. So, then, does "limited government" mean that government is "limited to general deterrance"?

Steve, I do not care whether you believe me or not. Based on what I read of your work, for you "credible" means "agreeing with what I already believe."

Here on RoR and other Objectivist forums, I floated my idea of money as a Crusoe Concept. Here and there, I got nothing back except quotations from the same books we all have read. However, on Objectivism Online, the sysop there pointed me to a post of his own along the same lines. It was helpful. I mentioned this also to one of my professors, as I intend to formalize it for a peer reviewed journal. Having worked in a department of central planning before the demise of central planning, he asked me a question I could not answer. He knew something about economics and starting from the premise I suggested, he raised a consequent point I had not considered. That is all I look for in a discussion.

Many of the fruitless exchanges here I was able to build on in my work for classes in criminology and sociology. Having made my point once or twice, recasting the presentation created a better product. Realize that not one of the professors who gave me the A grades resulting in my summa cum laude matriculation would write letters of recommendation for me for graduate school. (That is why I returned to EMU for my master's: I was already enrolled there.) They did not like me for being a conservative. I have held office here as a Republican. But my academic work was above reproach.

It was not at all that I had stunning displays of rhetoric that demolished their progressive liberal communist postmodernist fabian socialist new frontier fascist ideologies, thereby converting them to Objectivism. It was that I did not sound like an idiot who gets his ideas from Glenn Beck.

Finally, as a professional writer, these are my keyboard exercises.

(Edited by Michael E. Marotta on 7/15, 3:35am)

Post 11

Thursday, July 15, 2010 - 9:28am

Michael:

This thread is a debate on whether the government should regulate normal business practices. "Regulate" is the word that you don't want to introduce.
.
The question is: Does the government have a responsibility to protect against fraud, just as it does to protect against force? To say that we do not need the government to deal with fraud is to claim that we do not need the government to prevent coercion.

In our legal system we are presumed innocent until proven guilty. Detailed regulation presumes that we are guilty unless no evidence of fraud is found.

You say that the government can prosecute violators, but how does that begin? If Consumer's Friends were to find a flaw in a product and take the matter to court, the other side would say that Consumer's Friends has no standing in this matter: they were not harmed.

You under estimate the power that "Consumer's Friends," as you call them, can wield. An evaluation by Consumers Union on the Lexus rollover problem caused Toyota, one of the worlds great corporations, to cow tow and address the problem forthwith. Buyers stayed away in droves. If there was evidence of fraud and not just incompetence that was discovered, then the government would have a legitimate reason to investigate and prosecute.

You envision a system as it is now, not how most Objectivist and libertarians think it should be. Think of hundreds, maybe thousands, of for-profit rating agencies all carving out their areas of expertise and trying to get the best reputation for integrity.

Sam

WIJG?

Post 12

Thursday, July 15, 2010 - 2:15pm

Michael wrote in reference to his example of the coyotes and the child, " I offered the problem to show the limitation of rights-based government."

What it shows is the limitation of the anarchist's understanding of a proper government... but what else would we expect.
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I'll get to the coyote later. First, what is the purpose of a proper government? It is make a political environment better suited for human flourishing. It is to minimize the use of force. Rights and objective laws are used to implement the government - they are the objective means but not the end. We need the clear understanding of the rights, and we need the objective laws because otherwise we haven't got an objective limit on government which is what we are attempting to do.

A proper government is best created by creating objective laws that proscribe limits on human behavior in the area of force (and force's deriviatives: fraud and theft). Needless to say, the laws are not serving their purpose if they permit government to exercise more force than it is attempting to eliminate. A kind of Occam's razor for politics.
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--- Purpose presumes a beneficiary ---

"The source of the government�s authority is 'the consent of the governed.' This means that the government is not the ruler, but the servant or agent of the citizens; it means that the government as such has no rights except the rights delegated to it by the citizens for a specific purpose." Rand.

Anarchists will immediately pop up like talking jack-in-the-boxes and say, "Ah Hah! I didn't consent." Showing that they missed the point. The point lies, as it must, in the purpose of the government - that is where its existence is for creating the optimal environment for humans as per man's nature. That is how it serves us. Just as my thermostat is my servant, because its purpose is to create the environment in my house that best suits me. And, it means, as Rand points out, that it must use only those actions that can be rightfully delegated.
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Now, back to the coyote...

What in the world does Michael want for an anwer to his coyote and child question? Is he saying that the policeman can't act because a child doesn't have a full set of rights! Does Michael believe a child doesn't have a right to life? Does Michael think the policeman shouldn't act because the coyotes aren't volitional creatures? Absurd! But that is a typical anarchist attempt to create hypotheticals that obscure the main points which are what is the purpose of government, who does it support and how best is it implemented? Or, in summary, What is the best way to achieve a politically friendly environment for the individuals of a nation?

Does Michael believe that each instance of a concrete possibilitity must be detailed, in advance, and cast into approved policy before it can be acted upon? Should there be policy for dark grey coyotes versus light grey coyotes? For dogs? For poisonous snakes? Sometimes answers are so simple that it is embarressing to need to give them. Michael, the policies guiding the actions of police are to intervene in the prevention of a crime. And criminal statutes will not cover coyote attacks, but in evaluating an out-of-policy action, only idiots would question a policeman that saved a child from coyotes.
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The point is that the proper government is one which does a good job of creating an environment free of initiated force, fraud and theft. That has to be done with objective laws. It is going to need continual adjustments to optimize it and to increase or decrease different aspects in light of changing circumstances and levels of cultural civility. It derives most of its benefits from stability and predictability because those allow the greatest release of human creativity, effort and commercial risk because of the decreased worry about the risks of force/fraud/theft. This is what proper government does - creates the environment. Think about it. We have civil courts sitting idle in some communities on many days, because having them there is part of providing the application of objective law for resolving disputes to prevent people from resorting to the use of force to have their way. They are part of the political environment and because they are there, with the civil statutes and case law, the cultural and economic practices are more free-trade oriented, more human friendly. Why do we keep convicted criminals in prison for a period of time? Protecting people against further acts from the person? Punishment for doing wront? Justice? All of the above but mostly because it creates the best environment for freeing the proper human spirit.

Post 13

Friday, July 16, 2010 - 9:08am

Steve,

I think you nailed the "coyote question" when you referred to the police officer's act of saving the child as one that, while "out of policy," was nevertheless justified.

What I was going to say -- and I think I may have said this before when this question was raised -- is that it is not the police officer's job qua police officer to save the child. But he could very well be "obligated" to do it out of respect for the child's life.

He also doesn't have an obligation as a police officer to save a child trapped in ravine, but he does as a caring human being if the opportunity should arise.

In Michael's anarcho-capitalist system, the same issue would arise for a private police officer hired by someone to protect the person's property. His job is only to protect his client's property, but if he sees a child in danger, he could very well be obligated to help him not as part of his job but out of normal concern for the child's life.

Post 14

Wednesday, July 21, 2010 - 7:49am

William:

His job is only to protect his client's property, but if he sees a child in danger, he could very well be obligated to help him not as part of his job but out of normal concern for the child's life.

...as well as, his rational self-interest. If he wants to live in a world where folks don't insanely ignore children in danger, then he has to take actions to create that world.

As well, as part of his rational self-interest, in pursuit of that same want, recognizing that humans are less likely to do more of what they are merely compelled to do by force, and more likely to do more of that they want to do, he has a rational-self interest in living in a world where such actions are not left to acts of mere compulsion, at the point of a local gun. If our regard of others is that others are basically good, we have no fear of that world. If our regard of others is that others are basically bad, then that fear/regard is our justification for our reaching for a gun and compelling them to implement our worldview for us, on their backs.

In a world in which charity and caring deeds have been outlawed and replaced by compulsion, there will be less charity and good deeds, and more of only what compulsion can pry from the fingers of others, who have been stripped of their ability to provide charity and good deeds, and to feel reward at their efforts to build a decent world.

The fear of group C that group B is not doing enough to help group A is not reason enough to permit group C to point a gun at group B and compel group B to help group A per the whims of group C.

If group C feels that strongly about the issue, they should direct their energy at helping group A to the best of their abilities, without reaching for a gun like an emperor wannabee.

regards,
Fred

Post 15

Wednesday, July 21, 2010 - 5:01pm