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June 21st, 2009
FDA: Fostering a False Sense of Security
Nothing wraps death in a shroud of legitimacy like the government. Official pronouncements, fiat mandates, and governmental stamps of approval all convince a trusting (gullible?) citizenry that the subject of the government’s gaze is indeed what they say it is—nothing more, nothing less. Never is this seen in a more striking light than with the Food and Drug Administration.
The previous mention of death is not simply a casual word thrown out to elicit a reaction. Rather, it is the epitome of the industry in which the FDA exists. Whether refusing to allow the sale and distribution of life-saving products by imposing stringent regulatory burdens, or approving a product that ends up causing harm or death, there is no substantial difference.
The establishment of a regulatory agency over the nation’s food and drug supply does just one thing, and it does it extremely well: a false sense of security grows like a rotten fungus in a petri dish of authoritarian agar. Whether its actions are those of omission (denying helpful products) or commission (authorizing hurtful products), the very existence of the FDA lulls people into a state of stupified complacency. Instead of doing their own due diligence and research, the overwhelming majority of people simply concern themselves with whether or not the FDA says a certain product is okay to use.
The FDA’s own track record hardly lends support to the claim that they are adequate arbiters of the nation’s food and drug use. Already this year there have been 707 products recalled from the market. In a marketplace of millions of items, this number is surely a small and perhaps insignificant statistic. However, the fact that already-approved products are later being recalled clearly illustrates that the aura of credibility created by the FDA’s approval secures an easier and wider demand on supply that there otherwise may have been. Simply put, the false trust created by FDA approval quells any concerns that might prevent somebody from trying whatever the doctor prescribes.
And it’s not just the masses that are being duped. The President of the American Medical Association, Ron Davis, has said that “I think most doctors, maybe all doctors, assume that if a medication is on the market, it has been approved by the FDA, it must be safe and effective.” This quote appeared in response to a story regarding a gaping loophole in the FDA’s approval process which has allowed an untold number of products from being prescribed and purchased by people who assumed that the product had met the FDA’s onerous requirements. Much like questionable diet programs that exaggerate promised results and use celebrity likenesses to instill credibility, these products were able to masquerade in the open market as FDA-approved items, when the opposite was true. Here the FDA’s mere existence was used to indirectly sanction a product.
This government-created distortion of reality is not unique to food and drugs, though in few other places does it cause so much unnecessary suffering. Just over one century ago, Americans could (and did!) decided for themselves which drugs to take and what food to ingest. Free from the vacuum of governmental authorizations regarding the safety of a product, individuals were required to shoulder the investigative burden and determine for themselves what products they would consume and what medicine they would ingest. After all, it’s in the manufacturer’s best interest to make a healthy and helpful product; killing the customer is generally understood to be bad for business.
Further, a closer inspection of the actual approval process yields numerous additional examples of incompetence. The submitted applications, usually averaging around 100,000 pages, contain (among other things) studies that allegedly ensure the efficacy and safety of the product in question. The FDA does not do any of their own testing, and therefore they rely upon the accuracy, integrity, and thoroughness of the manufacturer’s submitted studies. Relying upon the manufacturer’s assurances of safety is, of course, the furthest thing from oversight and trustworthy approval that possibly exists. Little wonder, then, that such an agency has found it necessary to retain a PR firm to help improve its image.
None of these arguments suggest that manufacturers should not be held accountable for the quality of their products. The opposite is true—fraud, harmful products, false advertising, and all other related business practices should be dealt with accordingly. But the presence of the FDA distorts the decision making process by supposedly adding legitimacy to a product that would otherwise have to stand on its own merit. Lending its government-backed approval, the FDA creates an assumption in the mind of the patient or consumer, and thus perpetually promotes a false sense of security regarding the safety of the products it endorses.
This blanket of security is perhaps no more visible than when the subject of herbal remedies and dietary supplements is introduced. Not being classified as drugs, these products fall outside of the FDA’s jurisdiction, and thus are left to compete on the open market for the consumer’s attention and money. But having already been sidelined by the FDA’s reality distortion field, many manufacturers of supplements and herbs make wild claims and exaggerated promises about what their product can do, ostensibly in an effort to attract the attention of a consumer market that gravitates towards governmental legitimacy. Left to compete freely on the open market with other drugs and products (in absence of the FDA), the product would have to demonstrate its ability to do what is claimed. Pushed to the fringe by the FDA and the millions of people who look with skepticism towards any product not rubber-stamped by the government, these products must start their campaign at a significant disadvantage. This is, of course, not an excuse for deceptive advertising and outlandish claims. But much like an unpopular kid at school might further amplify his weirdness in a bid to get some attention from the popular crowd, supplements and similar products find themselves using whatever method possible to catch the consumer’s eye.
Government is masterful at misdirection, misallocation, and misinformation. While these actions may be the result of well-intentioned individuals, when taken in the aggregate these interferences into the marketplace alter the consumer-producer relationship and bestow advantages to big business interests. Setting a high (and depending on the manufacturer, impossible) bar with long clinical trials, costly research, and regulatory hula hoops, the Food and Drug Administration favors those who can meet its demands and pushes to the fringe (both literally and in the minds of trusting Americans) any product that cannot.
The onus of investigation regarding a product’s history and efficacy belongs not on the shoulders of federal bureaucrats, but on those of each would-be consumer.
22 Responses to “FDA: Fostering a False Sense of Security”
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You forgot those who bribe FDA officials to get the approval that they want.
You’re quite right about the legal burden. I myself know of a natural product that has been developed that’s quite effective as a anti-viral, anti-bacterial, as well as a preservative, which has cost hundreds of thousands of dollars *to test* to meet the FDA guidelines so that claims can be made without being sued. To my knowledge it’s not out on the market yet – they’re still testing. The sad thing is that if all possible applications of this product were to be tested it would cost millions more.
Not everyone who has a good idea has the monetary means to spend millions on a product to produce. Since these tests can be faked with little verification from the FDA, once again only the people who are trying to be honest are the ones who get screwed. Laws have little effect on those who do what they can to get around them.
I agree. I do feel as though the FDA gives a significant advantage to large pharmaceutical companies and disadvantages to smaller manufacturers. Also, it is far from immune to political pressures (as is illustrated by the stories surrounding the FDA approval of Aspartame, which have been recently been removed from Wikipedia and replaced with a more government friendly version of the story).
This is only one of the 1,001 reasons I tend to avoid doctors and hospitals. But most of the 1,001 problems, I tend to blame on things that can ultimately be traced back to the government meddling in the free market and individual lives.
(Yes, that’s the libertarian in me).
Connor, have you read “The Jungle,” by Upton Sinclair? What about “Unsafe at Any Speed,” by the now famous Ralph Nader
I think your faith in consumers to make good decisions is a bit misplaced.
In reality consumers rarely have the time and patience to do due dilligence. They can easily be swayed or blinded by marketing. They can even be persuade to buy an unsafe product, in spite of the most damning of evidence.
After all, it’s in the manufacturer’s best interest to make a healthy and helpful product; killing the customer is generally understood to be bad for business.
I find this to be an extremely naive statement. It is merely in a company’s best interest to make money, and to have consumers buy it’s products. If making a product safer interferes with a company’s profits, or it’s ability to sell it’s products, then in general they will do everything they can to resist doing so.
Good examples of this are Lead paint, tobacco, car seat belts (and the automotive industry in general), alcohol, asbestos, the mining industry, pesticides, the list goes on and on.
Relying upon the manufacturer’s assurances of safety is, of course, the furthest thing from oversight and trustworthy approval that possibly exists.
I think this would be even MORE true, not less, if the FDA didn’t exist. (I don’t care if I’m taking this out of context……)
None of these arguments suggest that manufacturers should not be held accountable for the quality of their products. The opposite is true—fraud, harmful products, false advertising, and all other related business practices should be dealt with accordingly.
How? And by whom? Consumers? False advertising is notoriously difficult to prove in court. I mean, just look at the history or tobacco lawsuits. In the the absence of laws and regulation to effect, courts can accomplish little. Removing regulations effectively forces the consumer to operate under the assumption that all products are safe and effective until proven otherwise.
Caveat emptor may be OK for certain kinds of products, but at what point do the risks become too much?
Not being classified as drugs, these products fall outside of the FDA’s jurisdiction,
…….Even though many if not most make drug-like marketing claims.
I’m sure you’re familiar with the whole debacle over ephedra, this should be evidence enough that in the absence of regulation, companies can and will sell unsafe products to an unsuspecting public. Are you saying that people ultimately have themselves to blame for getting sick from bad products? Not quite, I think. (Note: we have Utah’s own Senator Orrin Hatch to thank for this nice little technicality, which has effectively earned him millions.)
Government is masterful at misdirection, misallocation, and misinformation.
Private industry is even better at it.
Left to compete freely on the open market with other drugs and products (in absence of the FDA), the product would have to demonstrate its ability to do what is claimed.
How so? Where lies the legal burden of proof? On the consumer again? How would that happen? Would a drug be put on the market, and then if people started to get sick and die, then legal action would be taken at length? Or not? You’ll forgive me if I don’t exactly have funds for clinical research at my disposal, nor for a long protracted tort lawsuit.
I agree that the FDA approval process is arcane, costly, and inefficient. I also agree that it it’s a huge disincentive to drug development, (for all but the biggest drug companies, that is.) But this in itself does not excuse a blanket buyer-beware policy, not when many lives would be at stake.
Instead, I think the FDA should update and streamline it’s approval process. Though, not in the sense of relaxing standards, but in requiring less documentation and less legal-rigmarole. I think they should require peer-reviewed, third party testing. I think they should also close a number of legal loopholes, some of which you’ve mentioned. The latter would be relatively easy.
I think that laxities and inefficiencies at the FDA are mostly a reflection of a lack of manpower, funds, and more importantly, public attention. In this instance I’d argue that tax dollars are relatively well spent, since unlike military spending, the FDA actually DOES save lives.
I should have known that Zicam wouldn’t pass the smell test! 😉
You know, after reading this article and thinking of the problems inherent in government endorsement of marriage/education curriculum/select businessmen and the like, it’s pretty clear that the involvement of an organization seen as infallible (government) in most regulation and policy results in these types of problems – endorsement of something that may not be beneficial, implicit rejection of things not endorsed that may be beneficial, and a sort of governmental celebrity status wherein the authority to hock products rests in some sort of ultimate authority that is far from impartial.
Connor, have you read “The Jungle,” by Upton Sinclair? What about “Unsafe at Any Speed,” by the now famous Ralph Nader
I have read neither.
I think your faith in consumers to make good decisions is a bit misplaced.
I have far more faith in an individual’s sovereign right to make informed (to the extent possible) decisions than I do the results of delegating that authority collectively to the government.
In reality consumers rarely have the time and patience to do due dilligence.
Agreed. But this need can itself be an opportunity for (non-governmental) organizations to provide authoritative, well-vetted, non-partisan reviews, tests, and information regarding a type of product. Independent research groups could easily fill this role and be free from the regulatory burdens and political tap dancing that government introduces.
They can easily be swayed or blinded by marketing.
And the government doesn’t do its own “marketing”? Can anybody say “War in Iraq”?
They can even be persuade to buy an unsafe product, in spite of the most damning of evidence.
This argument seems to support my argument more than it opposes it. Read the link I included in the article to see just what I mean (one of many examples).
Particulars aside, I think that an individual’s right to decide for himself should remain paramount. Having the government refuse to allow me to try out a product that I may think be helpful to me is asinine. Can people be duped and persuaded into trying products that will harm them? Absolutely. Did you see that link regarding 2009’s 707 (and counting) recalled products?
It is merely in a company’s best interest to make money, and to have consumers buy it’s products.
And if a product kills somebody, then fewer consumers will buy its products. While there may be sinister motives here and there, market forces will always work in the end. Products that help and heal people will continue to gain market share, while products that have less than rosy results will fail.
How? And by whom?
Through the courts, by those who have been defrauded or injured in some way.
In the the absence of laws and regulation to effect, courts can accomplish little.
I don’t think that this is a strong argument for heavy-handed food and drug regulations. Grownups should be allowed to live their lives as they please. We’re enticed by all sorts of advertising, and so to claim that a nanny state should be created to prevent people from making bad decisions is not only a dangerous pretext for authoritarian government as an embraced way of life, but a overly simplistic method of dealing with what is perceived to be a harmful product. Education and persuasion will always win out over regulation and restriction. After all, black markets thrive on government-controlled markets.
Removing regulations effectively forces the consumer to operate under the assumption that all products are safe and effective until proven otherwise.
I disagree. The absence of regulation would, I believe, lead an individual to do their own homework before testing something out. If they choose to assume otherwise, than that’s their own problem, isn’t it? But on the whole, I think far more people would research a product and its alternatives if they weren’t limited in their options.
Caveat emptor may be OK for certain kinds of products, but at what point do the risks become too much?
Too much to do what? Institute laws prohibiting certain products outright? I oppose the FDA for the same reason I oppose seatbelt laws—people own their own bodies and should not have their agency limited by imposed restrictions of little import to society as a whole.
Even though many if not most make drug-like marketing claims.
Anybody who judges a book by its cover, as it were, will likely quickly learn a good lesson about doing the due diligence I have mentioned. Accepting these claims at face value is a person’s personal option regarding the choices they will make about what to use and consume. What good are we doing if we try to prevent people from making bad decisions?
I’m sure you’re familiar with the whole debacle over ephedra, this should be evidence enough that in the absence of regulation, companies can and will sell unsafe products to an unsuspecting public.
One might make the argument for education. In the absence of a federally-reviewed school curriculum, school teachers can and will teach incorrect and misleading information to an unsuspecting classroom. At some point we have to allow people to make their own decisions, fight back through due process when necessary, and move on and learn from their mistakes.
Are you saying that people ultimately have themselves to blame for getting sick from bad products? Not quite, I think.
Yes, actually, I am. If somebody chooses to ingest something, then they’re left to suffer the consequences, whether positive or negative.
Private industry is even better at it.
This is simply human nature. But government wears a mantle of authority that private industry cannot, and thus more easily foists their folly on the rest of us.
How so? Where lies the legal burden of proof? On the consumer again? How would that happen? Would a drug be put on the market, and then if people started to get sick and die, then legal action would be taken at length? Or not? You’ll forgive me if I don’t exactly have funds for clinical research at my disposal, nor for a long protracted tort lawsuit.
Then only consume products that have reliably and repeatedly demonstrated positive outcomes in those who have used it. Nobody is forcing you to ingest what others are offering. If a company makes a specific claim and you can prove otherwise, then you have recourse to sue them if you so desire. But I cannot and will not support a federal agency that aims to police every food and drug product that sits on our nation’s shelves. Not only is it (you guessed it) un-Constitutional, but it’s untenable. As pointed out in the article, the sheer number of recalled products demonstrates this.
…since unlike military spending, the FDA actually DOES save lives.
If you ignore the deaths caused by the existence of the FDA, then it’s quite easy (and convenient) to make this claim. But evidence overwhelming suggests that the distortion created by FDA approval (explicit or otherwise) contributes to a great deal of suffering and death in this country.
Thanks for the response, Connor.
But evidence overwhelming suggests that the distortion created by FDA approval (explicit or otherwise) contributes to a great deal of suffering and death in this country.
Which evidence? (just to clarify.) I don’t think the evidence is that clear. The sheer number of recalls, by itself, indicates that there are a lot of products. But in fairness I’ll retract my previous statement about the FDA saving lives, since I guess it’s a matter of opinion. (Note: the link you gave in your last comment is a poorly written propaganda piece. You could have done better than that.)
This is simply human nature. But government wears a mantle of authority that private industry cannot, and thus more easily foists their folly on the rest of us.
Wait a minute though; isn’t it a bit inconsistent, to extol the virtue of personal consumer choice, but then accuse consumers of being hoodwinked by the government’s “mantle of authority”? Lies, damn lies, or statistics?
OK, I guess there is a difference in that it’s easy to sue a drug manufacturer, but difficult to sue the FDA for approving a drug. That’s not a question of restriction of choice, but an issue of the unjust exercise of power.
But I cannot and will not support a federal agency that aims to policy every food and drug product that sits on our nation’s shelves.
Well, they don’t really, do they…….they regulate companies more by fear than by force. Their real function is to protect companies from lawsuits when they follow the rules.
It would seem your real problem is with the products the FDA DOESN’T let through. Would it be more just if they let products ship that they hadn’t approved, but added a warning label that said “ingest at your own risk, not ours”? E.g. tobacco.
I agree that the approval process
This discussion seems to be a variation on the more general idea that the principle catalyst of socioeconomic problems is, in fact, government interference. This is something I don’t feel is universally, or even generally true. I think I’ve accused you of hasty generalization in this respect before……I.D.K.
Another part of your argument is the idea that the individual’s right to choose is a “moral imperative”, and the moral hazard of countermanding this outweighs any specific good that may be done.
I think this is a bit idealistic, and I’d like to invoke social contract theory.
OK, the idea of social contract is that individuals in a society cede certain personal rights to the government, in exchange for the government protecting other ones. Which rights are overruled and which are defended is based on a heuristic examination of the state of society in the presence or absence of such restrictions. (philosophy 2010)
Therefore, I think there is a fair moral argument for the existence of the FDA, or something similar, in light of all the insane, irresponsible stuff that was going on in the 19’th and early 20’th century. Don’t act as if the issue is morally one-sided. In my mind it’s not a large moral problem, it’s a practical problem and moreso a legal one.
I apologize if this is a bit poorly strung together.
let me clarify that there is no love lost between me and the FDA. They’re another great example of the fact that power corrupts, and that the best laid plans often go awry.
While you, Connor, find arbitrary interference by the government to be unacceptable, I find the condition I believe would result from the absence of the FDA and the laws it enforces, to be similarly unacceptable.
Which evidence?
This article contains a story that perfectly describes what I’m talking about.
Wait a minute though; isn’t it a bit inconsistent, to extol the virtue of personal consumer choice, but then accuse consumers of being hoodwinked by the government’s “mantle of authority”? Lies, damn lies, or statistics?
The only virtue I’m an extolling is that of individual agency—the liberty to freely choose what one desires. Consumers can be lied to both by government and private industry, though only one carries an implicit recognition of authority. But what I aim for is informed decisions, regardless of what the people choose, and what influenced them. The FDA restricts information and access to resources, which is the opposite of what I think should happen in a country that respects individual liberty.
It would seem your real problem is with the products the FDA DOESN’T let through.
My problem is not with the products at all, really. My main problem is the way in which this government agency alters the decision making process—both by restricting access to products that one may desire to use, and by giving its stamp of approval to products which in many cases do a great deal of harm. The free flow of goods and access to both information and resources demands that we eliminate the corroded bottleneck in the middle.
Would it be more just if they let products ship that they hadn’t approved, but added a warning label that said “ingest at your own risk, not ours”?
I don’t think that the government should even be in the approval business for food and drugs to begin with. Neither should they be in the advisory business or warning people to “ingest at your own risk”. I don’t elect people to tell me what to have for dinner, or warn me that eating too many Nutty Bars is bad for my health.
I think this is a bit idealistic, and I’d like to invoke social contract theory.
We have a social contract. It’s called the Constitution. And nowhere in that document did we give consent to an entity like the FDA.
Connor,
I’m having trouble sticking to a libertarian view on one issue in particular. There are many drugs that are categorized as a “date rape drug”. This includes something as simple as alcohol. But it also includes other drugs which are much more powerful.
Some in particular serve no other function than to render someone unconcious, with amnesiac effects later on. They do not provide a “buzz” like alcohol or other drugs. They do not provide any medicinal purpose. They are too unpredictable to be used professionally as an anesthetic.
While we can make the case that even alcohol can be used to perform the heinous act, it is the surreptitious nature of these drugs that concerns me. Based on all we know, the only known legitimate purpose of such a drug would be to render someone unconcious without regard for that person’s safety (too many side-effects).
It is so extreme that the mere posession of the drug would mean that you really have no other intent than to rape someone.
Without getting into the Minority Report paradox, can you really say that such things should not be illegal?
Without getting into the Minority Report paradox, can you really say that such things should not be illegal?
I have made no such claim, but only have stated my opposition to the FDA having any say in the matter. If a drug is going to be outright banned in the country (or state or municipality), then I believe that it should be so done by the legislative branch. The people, through their elected representatives, should have the ultimate say in what they will or will not tolerate.
I have made no such claim
Connor,
You make two central arguments in the article and subsequent posts:
1) The FDA doesn’t do the job people believe they are supposed to do.
2) Consumers should have access to all drugs and make their own decisions on what drugs to buy.
The conclusion I tend to make here is that you believe all drugs should be legal because the government doesn’t to a good job of regulating drugs in the first place. I mostly agree with this. But like I said, I’m having difficulty with this one issue.
You allude to the legitimacy of legislation through appropriate representation vs. a bureaucrat making a decision without will of the people. I can see this argument. But we have the freedom principles that this fails to satisfy.
A free system cannot stop someone on “intent”. You must be stopped based on what you have already done. A free system cannot stop a mutual agreement (the initial purchase of a drug). Or are you arguing that a free system can?
FDA is also going after Cheerios…. because on their box it says it can lower blood pressure. Now the FDA says its a drug and THEY will regulate it?
Now the FDA says its a drug and THEY will regulate it?
Good example. They already regulate it, in the sense that they have to write down a list of all the ingredients, plus the often taken for granted- “nutrition facts.”
I think this is really just a petty squabble between the FDA and General Mills. There are quite a number of “dietary supplements” which make bolder claims than cheerios, but they carry the fine print disclaimer on the side:”FDA has not evaluated these statements,” which Cheerios doesn’t. General mills doesn’t want to add the disclaimer because they think it’ll hurt sales- by association, they don’t want to have to market it as a “supplement.” So the FDA says, fine, we’ll just say it’s a bona-fide drug, then.
Interesting topic. The problem is that there are so many products out there and no time to research all of them. Plus, people, at least people like me, don’t know enough about medicine/chemistry/biology to know what drug is best for them. Who wants to take a drug based on word of mouth from a friend or family member or try a new drug hoping for the best?
In other words, we definitely need some organization(s) to test drugs and inform people about their level of safety and effectiveness. As you mentioned above, rather than the FDA, private organizations could “certify” drugs so that consumers know they are okay to use, kind of like all sorts of organizations rate all sorts of products for consumers already.
If the FDA has any role at all, then perhaps it could be a certifier of certifiers. The FDA could have certain requirements that if met would make a certifying organization a government-recognized certifier. Then consumers can choose which certifying organization they want to trust, whether government-approved or not, rather than everyone relying on the FDA. Or perhaps this role for the FDA could be the transition from all FDA to no FDA.
JHP,
I’ve contemplated this same conundrum myself many times. I’ve finally figured out what liberty-minded solution can fix this:
Community.
Not Communism, community. De Tocqueville’s little platoons network with other platoons to provide enough experts in all fields. It is the finding of the correct experts that you trust that makes your platoon function properly.
Such structures would require some minimum size to encompass significant numbers of experts in the multiplicity of fields a typical community deems necessary. There would also need to be enough flexibility to overlap fields as required.
This isn’t a complete thought yet, but this would work a whole lot better than a Federally mandated FDA certification.
You also have to keep in mind that the existing medical industry (particularly big pharma) would never have existed without Medicare. The research money for most expensive medecines we have today would never have been available without a basically unlimited supply of money from Medicare. Even private insurance companies would be too stingy.
Doctors used to be of fairly modest means. The most successful ones were on par with the most successful of any business endeavor. And they didn’t just treat an illness, they usually were able to cure things.
True that our scenario has provided us with many advances in medicine that have saved many lives that were otherwise left to die. But looking at the big picture, I wonder if saving those lives was worth the loss in liberty we had as well as the cost to society by having a more expensive medical industry.
First create a problem. Then offer an option that purports to solve the problem at the cost of some liberty.
Bye bye, Tylenol.
A friend pointed me to this article detailing an analysis of deaths caused by marijuana vs. the FDA. Care to guess which won (or lost, depending on how you look at it)?
The FDA is pure tyranny:
Almost seems like they’re arguing a pretty abstract point, getting into private rights and the theoretical justification for their organization’s existence rather than just going after issues of public health or information.
On a related note, I can barely parse my writing from a year ago. I hope I don’t read like that to everybody else.
Oh, the Fraud and Drug Administration really is one big lie. So many people die needlessly every year from their “approved” drugs while their are plenty of safe natural cures on the market.