The FDA is Not an Example of Government Success.

[Sam Stone]

Whenever threads about Libertarianism pop up, liberals usually cite the FDA as an example of why government is needed, why the market fails, and claim that if the FDA didn't exist, drugs would be much less safe and on average more people per year would die from drug-related problems than die now under the FDA's regulatory regime.

I happen to think this is an example of exactly the kind of wrong-headed thinking that pervades most arguments about the value of government programs. Namely, once a program is enacted it's no longer possible to see what would have happened if it didn't exist. Successes of the program are trumpeted by politicians and government supporters, and failures ignored. The opportunity costs of regulation are never discussed, nor the economic costs of the regulation itself - since it's absorbed by the market it doesn't appear on government balance sheets and is thus ignored.

So, given all that, I think it's worthwhile to look a little closer at the FDA and try to determine if it really deserves its status as poster boy for the goodness of government.

I'll start with some history of the various regulations that created the modern FDA, then talk about what the FDA actually does today, then level some criticisms against it.

History of the FDA
The first regulatory act controlling food and drugs was the Pure Food and Drug Act of 1906. This act came about because of public hysteria over food quality after the publication of Upton Sinclair's "The Jungle". Before this act was passed, you could buy and sell any drugs on the free market, and you didn't need a doctor's prescription. There was no public outcry for regulation until this alarmist book was published. This first regulation did little except provide criminal penalties for mislabeling foods and adulterating the content of foods and drugs. Note that there was no testing for safety or efficacy by the government - just tests to make sure that the food or drug was what you said it was.

In 1912, the act was amended again, this time to add criminal charges against false claims of efficacy.

The act remained unchanged until 1937, when a bad form of a sulfa drug was put on the market, resulting in the deaths of 107 children. The fact that this happened to children added to the public outcry, and the Roosevelt Administration was in the height of its regulatory expansion, so the Food, Drug, and Cosmetic act of 1937 was passed. This was the first time that new drugs actually had to be subject to regulatory approval before they could be sold. But the regulatory process was very light - producers had to submit a form with testimonials from doctors and documentation of tests that were done to prove the product safe. Regulatory approval was automatic after 60 days unless the FDA spotted a problem with the documentation.

There was also an 'exemption' clause for labeling requirements, ostensibly to allow manufacturers some flexibility in labeling, which the FDA abused to create a new category of drugs that could only be labeled as safe if they were prescribed by a doctor. This gave the FDA the power to prohibit certain drugs from being sold at all unless they were prescribed by a doctor - a power that was not the intent of the legislation.

By the start of the 1960's, the average time for regulatory approval of a new drug was still only about half a year. But this resulted in the FDA's big success, still touted today - the delay of the entry of Thalidomide into the U.S. market prevented it from being in widespread use before the discovery of infant birth defects from the drug. Therefore, the FDA did prevent thousands of birth defects.

As a result of this success, the government pushed for a massive expansion of the FDA's powers. In 1962, the FDA's power expanded to regulate manufacturing processes, to require pre-clearance of every human trial, to pre-approve all advertising and labels for drugs, and, in the biggest change, to require testing and certification for efficacy, and not just safety. This last change is primarily responsible for the huge increase in regulatory costs and delays. A big spike in overall development times for new drugs occured after 1962 - before 1962, the average development time of a drug was four to six years. By 1990, it had increased to 16 years - most of that time spent in FDA-controlled certification trials and testing.

After 1962, the number of new drugs entering the market began to decrease, as would be expected from economic theory. A radical increase in the costs of drug certification made many forms of drug research unprofitable, and manufacturers made more efforts to market drugs that could be sold to a mass audience, since the regulatory burden was a fixed cost that didn't change whether you sold a thousand bills or a hundred billion.

The key thing to note here is how these regulations came to be - it wasn't a slow, incremental process of fine-tuning and adding and removing regulations as market conditions changed or gaps in current regulation were found. The regulations were fairly static throughout most of the 20th century, punctuated by major new regulatory 'bursts' after high-profile events temporarily gave government political capital to use to expand its power. The odds that the regulations crafted in this kind of environment are anywhere close to optimal are vanishingly small. As are the odds that an act designed to regulate a highly technical field in 1962 is in any way appropriate to the R&D and markets in play in 2008. There have been minor changes in FDA regulations over the years, but the essential form and function of the agency has been defined by three incidents spread over 60 years.

Here's a cite for this information: George Mason Law Review

[Capt. Ridley's Shooting Party]

Originally Posted by Sam Stone

Whenever threads about Libertarianism pop up, liberals usually cite the FDA as an example of why government is needed, why the market fails, and claim that if the FDA didn't exist, drugs would be much less safe and on average more people per year would die from drug-related problems than die now under the FDA's regulatory regime.

Yet you yourself provide evidence that this isn't some irrational complex on the part of "liberals" (I'm not a liberal, I still want drug regulationary bodies), in citing a drug, sold on the open market, that managed to kill 107 children! Isn't this prima facie evidence of the market failure alluded to by "liberals"?

Further, do you think it's wise to allow consumers to buy drugs, where there's a high risk of the development of resistive strains of bacteria developing, without stringent controls on their usage, like antibiotics, at will?

[Iacob_Matthew]

I'm a little slow, so let me see if I'm reading your argument correctly:

"The FDA isn't an example of success, because its power have been expanded by leaps and bounds at punctuated intervals rather than slowly creeping up over time. It also makes designing drugs in the US wildly more expensive & time consuming, because they regulate judiciously."

While true, I think most folk would respond by saying "So what?" to the first part, and "that's exactly what they should be doing" to the second. Am I missing something?

[IdahoMauleMan]

Originally Posted by Sam Stone

Whenever threads about Libertarianism pop up, liberals usually cite the FDA as an example of why government is needed, why the market fails, and claim that if the FDA didn't exist, drugs would be much less safe and on average more people per year would die from drug-related problems than die now under the FDA's regulatory regime.

I happen to think this is an example of exactly the kind of wrong-headed thinking that pervades most arguments about the value of government programs. Namely, once a program is enacted it's no longer possible to see what would have happened if it didn't exist. Successes of the program are trumpeted by politicians and government supporters, and failures ignored. The opportunity costs of regulation are never discussed, nor the economic costs of the regulation itself - since it's absorbed by the market it doesn't appear on government balance sheets and is thus ignored.

So, given all that, I think it's worthwhile to look a little closer at the FDA and try to determine if it really deserves its status as poster boy for the goodness of government.

I'll start with some history of the various regulations that created the modern FDA, then talk about what the FDA actually does today, then level some criticisms against it.

History of the FDA
The first regulatory act controlling food and drugs was the Pure Food and Drug Act of 1906. This act came about because of public hysteria over food quality after the publication of Upton Sinclair's "The Jungle". Before this act was passed, you could buy and sell any drugs on the free market, and you didn't need a doctor's prescription. There was no public outcry for regulation until this alarmist book was published. This first regulation did little except provide criminal penalties for mislabeling foods and adulterating the content of foods and drugs. Note that there was no testing for safety or efficacy by the government - just tests to make sure that the food or drug was what you said it was.

In 1912, the act was amended again, this time to add criminal charges against false claims of efficacy.

The act remained unchanged until 1937, when a bad form of a sulfa drug was put on the market, resulting in the deaths of 107 children. The fact that this happened to children added to the public outcry, and the Roosevelt Administration was in the height of its regulatory expansion, so the Food, Drug, and Cosmetic act of 1937 was passed. This was the first time that new drugs actually had to be subject to regulatory approval before they could be sold. But the regulatory process was very light - producers had to submit a form with testimonials from doctors and documentation of tests that were done to prove the product safe. Regulatory approval was automatic after 60 days unless the FDA spotted a problem with the documentation.

There was also an 'exemption' clause for labeling requirements, ostensibly to allow manufacturers some flexibility in labeling, which the FDA abused to create a new category of drugs that could only be labeled as safe if they were prescribed by a doctor. This gave the FDA the power to prohibit certain drugs from being sold at all unless they were prescribed by a doctor - a power that was not the intent of the legislation.

By the start of the 1960's, the average time for regulatory approval of a new drug was still only about half a year. But this resulted in the FDA's big success, still touted today - the delay of the entry of Thalidomide into the U.S. market prevented it from being in widespread use before the discovery of infant birth defects from the drug. Therefore, the FDA did prevent thousands of birth defects.

As a result of this success, the government pushed for a massive expansion of the FDA's powers. In 1962, the FDA's power expanded to regulate manufacturing processes, to require pre-clearance of every human trial, to pre-approve all advertising and labels for drugs, and, in the biggest change, to require testing and certification for efficacy, and not just safety. This last change is primarily responsible for the huge increase in regulatory costs and delays. A big spike in overall development times for new drugs occured after 1962 - before 1962, the average development time of a drug was four to six years. By 1990, it had increased to 16 years - most of that time spent in FDA-controlled certification trials and testing.

After 1962, the number of new drugs entering the market began to decrease, as would be expected from economic theory. A radical increase in the costs of drug certification made many forms of drug research unprofitable, and manufacturers made more efforts to market drugs that could be sold to a mass audience, since the regulatory burden was a fixed cost that didn't change whether you sold a thousand bills or a hundred billion.

The key thing to note here is how these regulations came to be - it wasn't a slow, incremental process of fine-tuning and adding and removing regulations as market conditions changed or gaps in current regulation were found. The regulations were fairly static throughout most of the 20th century, punctuated by major new regulatory 'bursts' after high-profile events temporarily gave government political capital to use to expand its power. The odds that the regulations crafted in this kind of environment are anywhere close to optimal are vanishingly small. As are the odds that an act designed to regulate a highly technical field in 1962 is in any way appropriate to the R&D and markets in play in 2008. There have been minor changes in FDA regulations over the years, but the essential form and function of the agency has been defined by three incidents spread over 60 years.

Here's a cite for this information: George Mason Law Review

Nice summary Sam. And thanks for starting the new thread.

I'm a little worn out from the 'Libertarian/fringe' thread, so if you don't mind, I'll post a background null hypothesis for readers to consider as they go through this. And then lurk for a while.

Does anyone on this Board object to:

1. Having the freedom to select the FDA as the approver of their drugs, exactly as they do today, and

2. Leaving themselves the option to consider something else if they want to

In other words, safeguarding the option to do something else if they choose to do so. That's all. It doesn't mean eliminating the choice of having the FDA certify their drugs. It does mean taking back the option of choice, which doesn't exist at the present moment.

If someone does object, I would appreciate it if they could explain why.

Extra bonus points for posters who explain why having the 2 options above would affect **their personal decision** to buy drugs.

Thanks again.

[haymarketmartyr]

Yes Idaho - I would object to that.

We happen to live in a society where there is a collective assumption for the welfare of others who take upon stupid risks and lose. Quite frankly, I do not want to have my tax dollars going to pay for some 20 year old, or 30, 40 or whatever year old, who is now disabled for the rest of their life because they wanted the freedom to make their own choice - and they got badly burnt by it.

Its one thing to pay for a returning veteran who served his country and is disabled and needs support. As it is, we do not do enough for those folks. I do not want to add a whole new category to the list of societal dependents.

[Capt. Ridley's Shooting Party]

Originally Posted by IdahoMauleMan

In other words, safeguarding the option to do something else if they choose to do so. That's all. It doesn't mean eliminating the choice of having the FDA certify their drugs. It does mean taking back the option of choice, which doesn't exist at the present moment.

Why beat around the bush? What you're proposing is the reintroduction of uncertified drugs into the marketplace. Having multiple sources of certification, with no oversight, is as bad as having none: you know nothing about drugs, I know nothing about drugs, neither do the vast majority of people, who are completely incapable of assessing the merits of multiple types of drug certification.

The free market is incapable of stopping bad drugs from entering the market, as the OP by Sam Stone shows. Drug sales are one area where problems need to be stopped before being released to the market, not waiting for hundreds to die then performing a recall.

[Digital Stimulus]

Originally Posted by IdahoMauleMan

Does anyone on this Board object to:

1. Having the freedom to select the FDA as the approver of their drugs, exactly as they do today, and

2. Leaving themselves the option to consider something else if they want to

In other words, safeguarding the option to do something else if they choose to do so.

I'll object, but not as you desire. Rather, I object to what I see as your (mis)leading and false options. The choices are not as you say, rather they're:

1. Having the freedom to select a drug produced by a manufacturer that chooses the FDA as the approver of their drugs, and

2. Allowing manufacturers to choose a different approver of their drugs (or none at all) if they want to.

In other words, an individual selecting a drug has no freedom of choice in the matter -- that freedom is solely the manufacturer's.

Note that my point is not to argue your advocacy for removing the FDA. Rather, it's simply to put it on a proper footing, agreeing on premises and all that. Do you agree with my modifications?

[Chronos]

We don't need to look at the history of the FDA to make the comparison. We just need to look at the multitude of drugs which, woefully, are not subject to FDA oversight. So-called "herbal supplements" currently do compete in a free market. The "supplement" companies could, if they chose, establish some independent non-governmental regulatory agency to certify the safety and effectiveness of their products. They don't, and the result is that many poisons get marketed to the public without anyone knowing until the death toll starts piling up.

[Der Trihs]

Originally Posted by haymarketmartyr

Yes Idaho - I would object to that.

We happen to live in a society where there is a collective assumption for the welfare of others who take upon stupid risks and lose. Quite frankly, I do not want to have my tax dollars going to pay for some 20 year old, or 30, 40 or whatever year old, who is now disabled for the rest of their life because they wanted the freedom to make their own choice - and they got badly burnt by it.

The libertarian "solution" would be to let the people who take risks and lose rot. Regardless of the fact that it's the libertarians insisting that they take that risk. And libertarians seldom seem to acknowledge the existence of bad luck or forces beyond your control; anything bad happens to you, it's your fault.

[DrCube]

Originally Posted by Digital Stimulus

I'll object, but not as you desire. Rather, I object to what I see as your (mis)leading and false options. The choices are not as you say, rather they're:

1. Having the freedom to select a drug produced by a manufacturer that chooses the FDA as the approver of their drugs, and

2. Allowing manufacturers to choose a different approver of their drugs (or none at all) if they want to.

In other words, an individual selecting a drug has no freedom of choice in the matter -- that freedom is solely the manufacturer's.

Note that my point is not to argue your advocacy for removing the FDA. Rather, it's simply to put it on a proper footing, agreeing on premises and all that. Do you agree with my modifications?

I don't see what is so misleading about IMM's choices:

1) Buy drugs that say "FDA Approved". Or,

2) Buy drugs that don't.

Sounds straightforward to me.

Here's a question:

If the FDA is so awesome at saving us from ourselves, why are our store shelves so full of liquor and tobacco? Thalidomide is mother's milk compared to that shit. Sounds like a "regulatory failure" to me, sorely in need of a little free market correction.

How many people are fooled by the illusion of safety? "Cigarettes can't be that bad! Why bother being an informed consumer when the FDA wouldn't dare let me buy cigarettes if they weren't good for me?"

[Sam Stone]

Problems caused by the FDA

Here's what's wrong with the FDA, and why:

It Delays Necessary Drugs from the Marketplace

Good drugs help people. They save lives or improve our quality of living. The longer you keep the good ones off the market, the more people are harmed by lack of access. In many cases, people die.

There is plenty of evidence that the FDA causes excessive delays in drug certification, and that this has killed tens of thousands of people and caused uncountable others to spend years with less quality than they otherwise might have had. One way to do this is to compare the time-to-market of drugs in the U.S. compared to drugs developed in other countries. For example, drugs in Europe are often available for years before they clear FDA testing in the U.S..

A prime example of this was the availability of beta blockers in Europe for years before they were available in the U.S. Beta Blockers save thousands of lives per year from the prevention of secondary heart attacks in coronary patients. The FDA did not approve the first beta blocker in the U.S. for ten years after it was available in Europe, and other beta blockers that worked better in some patients were blocked much longer. Some estimates put the cost in lives of the FDA's risk aversion over beta blockers in the tens of thousands of people.

The FDA has introduced some reforms to speed the process up, but only when the politics of the situation pushed them into it. The FDA fast-tracked some AIDS drugs like AZT for this reason, but other, less 'sexy' drugs do not get the same consideration.

Now, you might argue that the FDA is actually better than Europe's system, because the additional lag time results in safer drugs. One way to test this is to look at recall rates of drugs that pass FDA approval and compare them with the recall rates of drugs developed in other countries which do not have an FDA. And in fact, there's no statistical difference in recall rates - about 3% of FDA-approved drugs that enter the market are recalled, which is roughly the same amount of drugs recalled in Europe and other non-FDA markets.

Another way to determine if FDA approval in terms of efficacy works well or not is to compare on-label vs off-label uses. When the FDA approves a drug for efficacy, it only does so for the stated purpose of the drug. That use is the 'on-label' use of the drug. But once the drug is available, doctors are free to prescribe it for any use they see fit. This calls into question the need to test for efficacy in the first place, but it also gives us data points, because we can compare on label uses to off-label uses and see if there are any problems that can be attributed to lack of FDA efficacy testing.

What has been found is that an entire market-based certification system has built up for off-label uses of drugs. This study, which surveyed 500 doctors, is quite illuminating. Almost all of them prescribe drugs for off-label uses. The majority of them said that the FDA should not demand efficacy testing for off-label drugs, but agreed with efficacy testing for the primary use. This makes little sense, because some of these doctors wrote as many as 40% of their prescriptions for off-label uses. Why would they be willing to do that without efficacy testing, yet still demand it for one other use? I believe it is because of the native tendency of many people to see existing regulations as good and necessary, because the regulations have crowded out alternatives or they have simply grown up believing in them and have never questioned them. But when asked about an unregulated market, people can see the mechanisms that already exist and are therefore skeptical of more regulation.


Many off-label prescriptions for drugs are for treatments completely unrelated to the on-label use. For example, the only FDA-approved use for Thalidomide is in the treatment of leprosy, but 99% of the prescriptions for Thalidomide are for completely unrelated uses.

The widespread off-label use of drugs is also interesting, because it provides an argument for those who say that FDA testing is necessary because otherwise people would not get the information they need about drugs and widespread abuses would occur. In fact, in this case, the FDA actually prevents information from spreading, because it prohibits the marketing of drugs for off-label uses, it prohibits labeling of drugs for purposes of off-label use (even prohibiting things like recommended dosages). And yet, it appears that off-label use is not abused, is supported by the vast majority of doctors (94% of those surveyed), and is about as safely prescribed as on-label uses. How can that be?

The answer is as free-market supporters have been claiming - remove the FDA from the loop, and the market will provide mechanisms for evaluation, and tort law will prevent abuse. In fact, such a mechanism has been created. Standard reference works have been created by the AMA and other organizations: AMA Drug Evaluations, American Hospital Formulary Service Drug Information, and U.S. Pharmacopoeia Drug Indications. These standard references aggregate peer-reviewed research and doctor's findings from around the world and give recommendations and critical information about drugs to doctors. Doctors rely on these trusted intermediaries, plus their own research and literature reviews, and patients trust their doctors. The various certifying boards keep the doctors in line, and malpractice lawyers hunt down those who abuse the system.

The result is that a fairly large percentage of drug prescriptions are actually done under the regulatory framework of the pre-1962 FDA, where safety was tested but not efficacy. Comparisons of that unregulated subset of prescriptions to on-label uses show that off-label uses are just as safe, just as efficacious, and generally make it into use years earlier than FDA drugs.

All of those leads me to conclude that the FDA should have its efficacy requirements removed altogether. This would drastically shorten regulatory trials, lower the costs of drug development and therefore the costs of drugs overall, and make the entire system more flexible in that the uses of drugs could be better tailored to the needs of individuals rather than fitting into the one-size-fits-all FDA approval approach.

[Sam Stone]

This is what I get for taking so long to compose these messages: The message above and subsequent ones will answer your questions.

Originally Posted by Capt. Ridley's Shooting Party

Why beat around the bush? What you're proposing is the reintroduction of uncertified drugs into the marketplace. Having multiple sources of certification, with no oversight, is as bad as having none: you know nothing about drugs, I know nothing about drugs, neither do the vast majority of people, who are completely incapable of assessing the merits of multiple types of drug certification.

But as I pointed out above, off-label uses of drugs essentially creates an entire sub-field of medicine where there is no FDA efficacy testing whatsoever, and yet it seems to be working very well, and the vast majority of doctors are strongly opposed to extending FDA regulation into off-label uses. Even the American Medical Association is opposed. So why is efficacy testing so important for the one use originally proposed, but unnecessary for all others? Some drugs are not even used at all for their primary purpose, but almost exclusively prescribed for uses which the FDA has never even commented on.

The free market is incapable of stopping bad drugs from entering the market, as the OP by Sam Stone shows. Drug sales are one area where problems need to be stopped before being released to the market, not waiting for hundreds to die then performing a recall.

The post I made also shows that the recall rate is no different in countries which don't have an FDA, and which have a history of getting drugs to market quicker. How do you reconcile that?

Originally Posted by Iacob_Matthew

I'm a little slow, so let me see if I'm reading your argument correctly:

"The FDA isn't an example of success, because its power have been expanded by leaps and bounds at punctuated intervals rather than slowly creeping up over time. It also makes designing drugs in the US wildly more expensive & time consuming, because they regulate judiciously."

While true, I think most folk would respond by saying "So what?" to the first part, and "that's exactly what they should be doing" to the second. Am I missing something?

The 'so what?' can easily be answered by those who will die of cancer because a promising drug, showing good results in Europe, is withheld from them because of the FDA. It could have been answered by the tens of thousands of people who died from secondary heart attacks because the FDA wouldn't let them have beta-blockers which were widely available elsewhere in the world.

[scabpicker]

Originally Posted by DrCube

If the FDA is so awesome at saving us from ourselves, why are our store shelves so full of liquor and tobacco? Thalidomide is mother's milk compared to that shit. Sounds like a "regulatory failure" to me, sorely in need of a little free market correction.

How many people are fooled by the illusion of safety? "Cigarettes can't be that bad! Why bother being an informed consumer when the FDA wouldn't dare let me buy cigarettes if they weren't good for me?"

Pretty poor comparison. No one is claiming any medical benefits for alcohol or tobacco these days, and the Mfrs. of same had no problem making them in the past. IIRC the government made them stop making these claims in the 60's-70's. If the FDA had authority over cigarettes, you'd have some sort of leg to stand on. As it is, you don't. Sorry, this is really an argument against the marketplace regulating itself.

[Lamar Mundane]

Originally Posted by Sam Stone

Problems caused by the FDA

Here's what's wrong with the FDA, and why:

It Delays Necessary Drugs from the Marketplace

So do doctors with their iron-fisted control of the prescription pad. Shouldn't we just let the drug manufacturers sell the drugs directly to the consumer? Doctors delay the delivery of and add to the expense of drugs. Fair enough?

[Todderbob]

Originally Posted by Lamar Mundane

So do doctors with their iron-fisted control of the prescription pad. Shouldn't we just let the drug manufacturers sell the drugs directly to the consumer? Doctors delay the delivery of and add to the expense of drugs. Fair enough?

I can go to a different doctor.

Can I go to a different FDA?

[IdahoMauleMan]

Originally Posted by Digital Stimulus

I'll object, but not as you desire. Rather, I object to what I see as your (mis)leading and false options. The choices are not as you say, rather they're:

1. Having the freedom to select a drug produced by a manufacturer that chooses the FDA as the approver of their drugs, and

2. Allowing manufacturers to choose a different approver of their drugs (or none at all) if they want to.

In other words, an individual selecting a drug has no freedom of choice in the matter -- that freedom is solely the manufacturer's.

Note that my point is not to argue your advocacy for removing the FDA. Rather, it's simply to put it on a proper footing, agreeing on premises and all that. Do you agree with my modifications?

I do. You may proceed.

[Sam Stone]

Next Problem - Distortion of Incentives against some drugs and in favor of others

Have you noticed that drug manufacturers are increasingly researching 'lifestyle' drugs such as Cialis, Propecia, and Viagra? Why do you think that is?

The answer is that the regulatory burden imposed by the FAA is a fixed cost. Imposing a fixed cost skews the profitability of drugs. If a drug can sell 2 billion units and costs $200 million to put through, the cost per pill is 10 cents. But if the drug can only sell 100,000 pills, the cost of regulation is $2,000 per pill. The result is that pharmaceutical companies have been dropping research into drugs for conditions that only affect a small proportion of the population, in favor of drugs they can sell to everyone. This is a terrible unintended consequence, because the drugs that would only be sold in small quantities would tend to be for very serious conditions like rare cancers. The FDA is now trying to create a fast-track certification for these drugs, but let me point out again the inconsistency here - if they fast-track certification for this drug, it's now available for off-label use, which could be for uses across the wider population. So if that's acceptable, how do you justify much more stringent certification for other drugs just because their on-label use hits a larger percentage of people?

Next Problem - Reduction in New Drugs Overall

Since the introduction of the 1962 amendments to the Pure Food and Drug Act, the number of firms researching drugs, and the number of new drugs entering the market, has declined. The problem is getting worse. In an age where technology is providing increased choice and new products to people in every other industry, the number of new drug releases has been decreasing steadily. Only 16 new drugs were approved in 2007, and 18 in 2008.

Problem: The FDA raises drug costs
People die if they can't afford the drugs they need. The high cost of drug certification is the primary reason why drugs are as expensive as they are - especially those drugs that apply to small parts of the population. A drug manufacturer has a fixed time window to earn back an investment in a drug before the patent expires and generics eat away at all the profits. This time window, multiplied by the number of people who can be expected to buy the drug, gives a pretty well known overall lifetime sales target for a drug. If a manufacturer has to spend 12 years and $200 million certifying a drug, and then has a fixed window to recoup that money, then those drugs are going to be very expensive. This eliminates many possibly beneficial drugs from even being considered for trials, but for the ones that do make it through, it drives their cost way up. This limits access, increases insurance costs, and is a major factor in the high cost of health care in the U.S.

The result of all this is that it seems to me the clear path forward would be to launch a regulatory review of the FDA with an eye towards eliminating the 'efficacy' requirement for on-label use, and for eliminating the restrictions on labeling and information regarding off-label uses.

If the U.S. made just this one change, it would bring all uses of the drugs into line with 'off-label' use, which has already shown itself to be safe and effective. It could cut years and tens of millions of dollars from the certification process, and dramatically lower the cost of drugs. It would also help push research back in a direction towards drugs needed for critical health problems affecting smaller subsets of the population and aware from 'lifestyle' drugs.

I have no problem with the FDA acting in an informational capacity, and I could accept it requiring safety testing, although I don't think it's necessary. But the efficacy requirement is damaging and on balance kills more people than it saves and is destructive to the health care industry. It should be dropped.

[IdahoMauleMan]

Originally Posted by haymarketmartyr

Yes Idaho - I would object to that.

We happen to live in a society where there is a collective assumption for the welfare of others who take upon stupid risks and lose. Quite frankly, I do not want to have my tax dollars going to pay for some 20 year old, or 30, 40 or whatever year old, who is now disabled for the rest of their life because they wanted the freedom to make their own choice - and they got badly burnt by it.

Its one thing to pay for a returning veteran who served his country and is disabled and needs support. As it is, we do not do enough for those folks. I do not want to add a whole new category to the list of societal dependents.

Rats. You didn't earn the extra bonus points. You immediately jumped to 'welfare of others'.

[IdahoMauleMan]

Originally Posted by scabpicker

Pretty poor comparison. No one is claiming any medical benefits for alcohol or tobacco these days, and the Mfrs. of same had no problem making them in the past. IIRC the government made them stop making these claims in the 60's-70's. If the FDA had authority over cigarettes, you'd have some sort of leg to stand on. As it is, you don't. Sorry, this is really an argument against the marketplace regulating itself.

I'm not sure I buy your argument.

So what if medicines 'claim' something, and cigarettes and tobacco don't? Anybody is free to claim anything they want. Those late-night TV penis-length enhancers that are the stuff of cocktail-party jokes because of their claims. Nobody believes them.

If cigarettes claimed that they were healthy for you, and made you relax, would it really matter? If the little WARNING labels were taken off cigarettes altogether, or made bigger, would it really matter?

A product can claim anything it wants. There's probably some grey area here in terms of laws protecting consumers from fraud and such. And as Sam Stone pointed out, many drugs today are used for off-label use anyway.

[haymarketmartyr]

Idaho - I do not think my answer was in the welfare of others. I would say its the opposite - I just do not want to pay for others stupid mistakes. Thats in my own self interest.

[Capt. Ridley's Shooting Party]

There is plenty of evidence that the FDA causes excessive delays in drug certification, and that this has killed tens of thousands of people and caused uncountable others to spend years with less quality than they otherwise might have had. One way to do this is to compare the time-to-market of drugs in the U.S. compared to drugs developed in other countries. For example, drugs in Europe are often available for years before they clear FDA testing in the U.S..

How is this any sort of evidence for your thesis? Are you under the impression that drugs in Europe are untested? If not, then surely you agree that the only thing the above passage implies is that there's a problem with the specific American implementation of drug certification, not with the idea in general.

The post I made also shows that the recall rate is no different in countries which don't have an FDA, and which have a history of getting drugs to market quicker. How do you reconcile that?

I reconcile it by recognizing that America and Europe are the world's two largest consumer market---any drug developed anywhere in the world is going to be sent for FDA/EHEA/MHRA etc. approval at some point. In effect, those countries without the equivalent of the FDA/EHEA/MHRA etc. are leeching off those who do.

It would also help if you could pinpoint a specific group of countries that we're talking about, as America, Canada and the Eurozone all have FDA equivalents, with India in the process of setting one up, due to rampant abuse. Where exactly are we talking about here? Deepest Africa?

Oh, and the idea of comparing recall rates in countries with the equivalent of no FDA is moronic. Do you honestly believe that a country that doesn't test drugs before market is going to give a shit if a few people die from faulty medicine, or even keep a reliable track of such things?

[Capt. Ridley's Shooting Party]

Originally Posted by IdahoMauleMan

A product can claim anything it wants. There's probably some grey area here in terms of laws protecting consumers from fraud and such. And as Sam Stone pointed out, many drugs today are used for off-label use anyway.

They're used for off-label use after going through testing showing that they aren't completely deadly. You know, so they won't kill 107 kids, or something like that.

[Capt. Ridley's Shooting Party]

Let's inject some facts into the debate about off-label use. Here, directly from the horse's mouth, the UK's General Medical Council's Code of Good Practice in Prescribing Medicines:

19. You may prescribe medicines for purposes for which they are not licensed. Although there are a number of circumstances in which this may arise, it is likely to occur most frequently in prescribing for children. Currently pharmaceutical companies do not usually test their medicines on children and as a consequence, cannot apply to license their medicines for use in the treatment of children. The use of medicines that have been licensed for adults, but not for children, is often necessary in paediatric practice.

20. When prescribing a medicine for use outside the terms of its licence you must:
1. Be satisfied that it would better serve the patient's needs than an appropriately licensed alternative
2. Be satisfied that there is a sufficient evidence base and/or experience of using the medicine to demonstrate its safety and efficacy. The manufacturer's information may be of limited help in which case the necessary information must be sought from other sources
3. Take responsibility for prescribing the medicine and for overseeing the patient's care, monitoring and any follow up treatment, or arrange for another doctor to do so (see also paragraphs 25-27 on prescribing for hospital outpatients)
4. Make a clear, accurate and legible record of all medicines prescribed and, where you are not following common practice, your reasons for prescribing the medicine.

So, off-label use is most common when prescribing drugs, tested on adults and fully-licensed, for children with the same condition. Further, to even prescribe off-label, it is required that the use is consistent with existing medical practice, and that the medic uses his or her best judgment as a trained medical professional.

[Sam Stone]

Originally Posted by Capt. Ridley's Shooting Party

How is this any sort of evidence for your thesis? Are you under the impression that drugs in Europe are untested? If not, then surely you agree that the only thing the above passage implies is that there's a problem with the specific American implementation of drug certification, not with the idea in general.

Exactly right. My point was that the FDA is hurting people because it is too risk averse. My point is also that there is a fundamental contradiction in requiring very expensive and time-consuming efficacy testing for one single use, and then once the drug is released allowing it to be used for anything at all. If 'off-label' use isn't a problem, why require efficacy testing at all?

I reconcile it by recognizing that America and Europe are the world's two largest consumer market---any drug developed anywhere in the world is going to be sent for FDA/EHEA/MHRA etc. approval at some point. In effect, those countries without the equivalent of the FDA/EHEA/MHRA etc. are leeching off those who do.

This makes no sense at all. The point is that Europe's regulatory regime is less stringent than the FDA's, resulting in drugs getting to market on average about 3 years sooner. Despite that, there is no greater incidence of drug recalls in Europe, and no greater incidence of drug disasters among approved drugs. This would also suggest that the FDA is too risk-averse, and that this is hurting people.

It would also help if you could pinpoint a specific group of countries that we're talking about, as America, Canada and the Eurozone all have FDA equivalents, with India in the process of setting one up, due to rampant abuse. Where exactly are we talking about here? Deepest Africa?

Clearly they do NOT have FDA equivalents, since they get drugs to market 2-3 years sooner than the FDA does. you're creating straw men.

Oh, and the idea of comparing recall rates in countries with the equivalent of no FDA is moronic. Do you honestly believe that a country that doesn't test drugs before market is going to give a shit if a few people die from faulty medicine, or even keep a reliable track of such things?

You are engaging in a fallacy here by setting up a dichotomy that does not exist to argue against something I never said. I did not compare recall rates between Botswana and the U.S. - I compared them between the U.S. and the EU, both of which are regulated markets. My point was that it appears that the FDA needs to deregulate to some degree - specifically, by eliminating efficacy requirements.

The larger point I'm making is that many people on the left always seem to accept that regulations are good, that more regulations are better, and will rarely accept that government regulation has gone too far and is doing more harm than good.

You've repeatedly brought up the deaths of 107 children as a fact that disproves my thesis. But I also pointed out that delays to market due to over-regulation by the FDA have killed tens of thousands of people, and you just ignore that. No one doubts that the FDA has prevented deaths by keeping dangerous drugs from the market. But we could prevent even more by simply not allowing any drug use at all. Do you think that's a good idea? If not, why would you automatically assume that the very rigid and expensive FDA approval process is a good thing, merely because we can point to 107 children who were saved by it?

And by the way, under the reform I'm proposing, those kids would still have been saved, because I'm simply talking about getting rid of efficacy testing, and not safety testing.

The other point I'm making is that off-label use disproves the notion that, absent the FDA, there would be chaos in the drug market. Off-label use is pretty much unregulated. Drugs can be used for purposes not even remotely related to the original illness, and used in people such as children who were never part of the initial clinical trials, including safety trials. They can be given to pregnant women, even if the drug was never certified for such use or tested on pregnant women. Basically, the entire onus to maintain safety and use these drugs appropriately is on the practitioners and their various standards and certifying bodies. And yet, there is no apparent safety problem in this part of the industry, and doctors and the AMA overwhelmingly support the continued unregulated use of drugs for off-label purposes.

This suggests to me that such a system could work even if the FDA did not exist at all, but especially if the FDA reduced its role to basic safety testing of the drugs.

[IdahoMauleMan]

Originally Posted by haymarketmartyr

Idaho - I do not think my answer was in the welfare of others. I would say its the opposite - I just do not want to pay for others stupid mistakes. Thats in my own self interest.

Fair enough. Let me run with that for awhile.

I would make a quick passing note, however, that some people (including me, if I was in a different mood) would immediately retort that you are on The Road To Serfdom. That is, your argument that the government needs to get involved in testing is because the government is already involved in healthcare.

Or stated in other terms, because the government is involved it must get even more involved.

But I'll let that pass for now. Let's dive into the self-interested part of your argument and attempt to throw some numbers around.

I'm going to temporarily accept your argument that the public will bear the full costs of the deaths caused by drugs that are not tested, and were chosen by unwitting customers.

Let's begin.

There are costs associated with the FDA. They are

C1. The direct costs associated with it's existence
C2. The costs required by companies to comply with its laws
C3. The costs of preventable deaths (and maybe more importantly, the 'cost of suffering') from drugs it doesn't allow to market, or doesn't allow to market fast enough

I think C1 is about $2 billion per year, if my memory is correct. C2 is much, much bigger....probably an order-of-magnitude bigger. I'm not sure how much. I have no idea what C3 is, because it isn't measured. It's the important box that so many people miss....Box 3 of the 2x2 matrix of

1. FDA Approved/Will Save You
2. FDA Approved/Will Kill You
3. Disapproved/Will Save You
4. Disapproved/Will Kill You

Most people just focus on Boxes 1 and 4. Box 1 is what the drug companies want. Box 4 is the thalidomide example. The FDA is extremely risk-averse and shoots for Box 2 to be as close to zero as possible.

But Box 3 is a very important box. That's the box that the free market could open up to those who wish to choose it.

I would argue that C3 is at least as big as C2. Maybe bigger. Adding all three costs together C1 + C2 + C3 is probably many $10s of billions of dollars per year. That's just an order of magnitude guesstimate. Please poke holes in my hypothesis if you would like to do so.

The self-interested costs you are trying to avoid are the costs of people getting sick and dying. Fair enough.

But data on sick and dying people from suspect drugs spreads very rapidly. Especially in today's wired society. It strikes me as highly unlikely that many 100s, much less 1,000s, of people would start dying from certain drugs before we would all know about it in short order.

It's a self-correcting mechanism. Sam cited 107 deaths from a certain drug many decades ago, when information traveled much slower. That strikes me as a high-end benchmark. Can you imagine 107 children dying from suspect drugs in the 2009 and not having it on CNN almost immediately? How long did it take to hear about that Chinese toothpaste thing? That news spread like wildfire.

You would have to believe that people would be dropping dead all over the place, in huge numbers, and that customers would plow ahead and continue to buy suspect drugs to start running up hospital bills that even approach the C1 + C2 + C3 costs outlined above. We're talking $10s of billions of dollars here.

To be fair, I haven't subtracted off the costs of the new, free market testing from the C1 + C2 + C3 amount. That is, the costs to the consumer from the new entrants into the testing space that replace some of the FDA functions. But they are almost certain to be <= C1, and <=C2, otherwise the drug companies wouldn't use them. Even after making that correction you're still stuck with an order of magnitude in the $10s of billions that 'the cost of dying' has to match in order for it to be a poor cost-benefit tradeoff.

Please suggest modifications to my analysis as you see fit.

[Sam Stone]

Originally Posted by Capt. Ridley's Shooting Party

Let's inject some facts into the debate about off-label use. Here, directly from the horse's mouth, the UK's General Medical Council's Code of Good Practice in Prescribing Medicines:



So, off-label use is most common when prescribing drugs, tested on adults and fully-licensed, for children with the same condition. Further, to even prescribe off-label, it is required that the use is consistent with existing medical practice, and that the medic uses his or her best judgment as a trained medical professional.

And who ever said anything to the contrary? And while pediatric use is a very common form of off-label use of drugs, there are plenty of others. Those doctors surveyed reported that up to 40% of the prescriptions they write are for off-label uses.

In addition, doctors routinely prescribe over the counter medications in uses for which they were never originally certified. In some cases, the FDA has actually killed people by preventing information about these uses to be spread. For example, the FDA disallowed the advertisement of Aspirin for use as a heart attack preventative, despite plenty of clinical evidence that for some people, an aspirin a day could significantly reduce the risk of heart attack.

From here:

On December 8 [2003], the FDA's Cardiovascular and Renal Drugs Advisory Panel voted not to support using aspirin for the primary prevention of heart attacks. The petition to approve aspirin for reducing the risk of heart attack in moderate-risk patients (those whose 10-year risk for heart attack is 10% or greater) was brought to the panel by the Bayer Corporation.
...
The FDA panel was merely being scientifically "pure" in making this vote. One of the panel members noted that what was needed is a seven-year trial enrolling 15,000 patients in the moderate-risk group, and until such data was available FDA should not give its stamp of approval.

But while agreeing with this opinion, another panel member further noted that aspirin's overall benefits have been so well-documented that it would probably be unethical (and certainly unfeasible) to actually perform such a trial.

It is worth mentioning that during the open hearing before this panel, the American College of Cardiology, the American Diabetes Association, the American Heart Association, and the US Preventative Services Task Force supported the use of aspirin in moderate-risk individuals. Further, several panel members who voted against the petition remarked that they themselves take aspirin every day, and recommend that their patients do the same. The panel seems convinced that aspirin should be used - they just didn't have the statistical evidence sufficient to allow a labeling change in this particular subset.

The bottom line: All this vote means is that the Bayer company will not be able to promote aspirin for moderate-patients in their advertising. Doctors will continue recommending aspirin (even some of those in the FDA panel that voted in the negative) for patients who have a moderate risk of heart attack.

That's your FDA in action. Against the advice of several major medical associations, and presented with clinical evidence as to the efficacy of the medicine, and even while acknowledging that the safety of Aspirin had been well established and the board members took it themselves for exactly the purpose they were ruling on, they still declined the petition to allow information to be disseminated to the public.

Their ruling stated that the only way they could make this allowance would be after a 7.5 year trial involving 15,000 people, which even they agreed would be unethical and not feasible to carry out. So, by the FDA's own admission, the Bayer company was permanently barred from telling people about a life-saving benefit of their product.

Does that make any sense to you?

[Capt. Ridley's Shooting Party]

Originally Posted by Sam Stone

Exactly right. My point was that the FDA is hurting people because it is too risk averse. My point is also that there is a fundamental contradiction in requiring very expensive and time-consuming efficacy testing for one single use, and then once the drug is released allowing it to be used for anything at all. If 'off-label' use isn't a problem, why require efficacy testing at all?

As already pointed out, there is no contradiction with off-label use.

This makes no sense at all. The point is that Europe's regulatory regime is less stringent than the FDA's, resulting in drugs getting to market on average about 3 years sooner. Despite that, there is no greater incidence of drug recalls in Europe, and no greater incidence of drug disasters among approved drugs. This would also suggest that the FDA is too risk-averse, and that this is hurting people.

Nice try. Drugs getting to market three years sooner isn't necessarily indicative of different standards of testing. For example, the FDA may be unable to cope with a backlog of drug testing applications. How about you produce some evidence that e.g. the MHRA is less stringent than the FDA?

Clearly they do NOT have FDA equivalents, since they get drugs to market 2-3 years sooner than the FDA does. you're creating straw men.

What are you talking about?

You are engaging in a fallacy here by setting up a dichotomy that does not exist to argue against something I never said. I did not compare recall rates between Botswana and the U.S. - I compared them between the U.S. and the EU, both of which are regulated markets. My point was that it appears that the FDA needs to deregulate to some degree - specifically, by eliminating efficacy requirements.

Again, what are you talking about? The MHRA performs safety and efficacy testing, just like the FDA.

The larger point I'm making is that many people on the left always seem to accept that regulations are good, that more regulations are better, and will rarely accept that government regulation has gone too far and is doing more harm than good.

This isn't a left-vs-right issue. I'm a conservative and I still think your ideas are stupid.

You've repeatedly brought up the deaths of 107 children as a fact that disproves my thesis. But I also pointed out that delays to market due to over-regulation by the FDA have killed tens of thousands of people, and you just ignore that.

I've ignored it because it's something you've pulled out your ass. How about I pull something out of mine? Stringent FDA testing has saved millions more people than have died from drug-licensing delays. There, we both can do it.

If not, why would you automatically assume that the very rigid and expensive FDA approval process is a good thing, merely because we can point to 107 children who were saved by it?

Because nobody with a brain believes that those 107 were the only victims.

The other point I'm making is that off-label use disproves the notion that, absent the FDA, there would be chaos in the drug market.

This is pretty much given, as your OP demonstrates.

Off-label use is pretty much unregulated. Drugs can be used for purposes not even remotely related to the original illness, and used in people such as children who were never part of the initial clinical trials, including safety trials.

No it isn't unregulated, at all. Off-label use is covered by the GMC's Code of Conduct, and as a result any misuse is grounds for striking off the medical register---it isn't like a physician can prescribe a random drug for a random illness. Further, only a fifth of drug prescriptions are off-label, and the majority of them are prescribing licensed drugs to children where only the dosage is changed.

[Tamerlane]

Without getting involved in the nitty-gritty of this drug debate, I would like to add that FDA stands for Food and Drug Administration and they do considerably more than just approve pharmaceuticals.

I had a roommate at one time, an FDA employee, who worked entirely on issues of food quality, including the monitoring of imports, federal labeling laws ( partially obfuscated by political interference, especially from Orrin Hatch re: herbal supplements ), as well as inspection of domestic food production facilities ( a duty shared with, but not identical to that done by the USDA ) and the tracking of contamination outbreaks ( i.e. as with the melamine disaster a little while back ). From my exposure I'd say that focusing only on the drug side of the FDA's mandate in determining it's usefulness is only covering half ( or less ) of the argument.

[Deeg]

Originally Posted by Sam Stone

Next Problem - Reduction in New Drugs Overall

Since the introduction of the 1962 amendments to the Pure Food and Drug Act, the number of firms researching drugs, and the number of new drugs entering the market, has declined. The problem is getting worse. In an age where technology is providing increased choice and new products to people in every other industry, the number of new drug releases has been decreasing steadily. Only 16 new drugs were approved in 2007, and 18 in 2008.

Wouldn't we expect the same result if the FDA was perfectly performing its function? Requiring FDA approval means that quack pharmaceuticals might as well close up shop. Drugs that have no benefit do not enter the market.

[Voyager]

I'm a bit confused. If Sam is saying that the FDA is not the best regulatory agency the world has ever seen, or even not as good as in Europe, I have no argument. I've seen criticisms of it for both doing too much and too little. We only know how many lives it could have saved before it started (and no doubt many more not recorded or dying from more subtle drug effects), not how many it has saved by preventing dangerous drugs on the market.

As for efficacy, once you grant the need for the FDA for safety, how do you consider the case where a person taking a useless drug dies from not taking a useful one. Could a useless drug that is on the market block the development of a useful one, for market reasons? Now, studies have shown that expensive placebos seem to work better than cheap ones, so there is some benefit to useless drugs being on the market, but might safe but useless drugs crowd out safe and useful, if more expensive, ones?

I'm all for off-label use, given the kind of guidelines they have in England, since I think these are used when there is no proven on-label remedy, safety has been proven, and there is no false claim of efficacy.

[Todderbob]

I should be ultimately responsible for what I do and do not put into my body.

If I want to put a ton of opiates into my body, to get me hopped up 24/7, why shouldn't I be allowed to?

I can understand the need to regulate Antibiotics, as there's a level of public safety (resistant diseases) involved, but what good reason is there to prevent me from doping myself up? I won't drive drive when hopped up, operate heavy machinery, etc.

If I can be trusted to drink booze, why can't I be trusted to pop pills?

[IdahoMauleMan]

Originally Posted by Trocisp

I should be ultimately responsible for what I do and do not put into my body.

If I want to put a ton of opiates into my body, to get me hopped up 24/7, why shouldn't I be allowed to?

I can understand the need to regulate Antibiotics, as there's a level of public safety (resistant diseases) involved, but what good reason is there to prevent me from doping myself up? I won't drive drive when hopped up, operate heavy machinery, etc.

If I can be trusted to drink booze, why can't I be trusted to pop pills?

You're being far too rational, and showing a willingness to be accountable for your own decisions. Neither seems to be in particularly abundant supply when it comes to this particular debate.

[Honesty]

Originally Posted by Sam Stone

If 'off-label' use isn't a problem, why require efficacy testing at all?

Off-label use of drugs probably isn't considered a big deal because the individuals prescribing these drugs are well-versed with the pharmacology. Let me give you an example. I have (or had) pseudofolliculitis barbae which is relatively common in African-American men who shave frequently. I've been to doctors since I was 18 for this problem. Dermatologists have prescribed all sorts of drugs ranging from antibacterial creams to laser hair removal on the beard area.

I met with a spritely, young Dermatologist who prescribed the drug accutane which is intended for people with severe acne. She rattled the reasons why she felt it would help me. Well, not only did the drug clear up my face but it suppressed further occurences. I've been off the drug for two months and I look 4 years younger (of course, I'm only 27).

I am grateful that doctors, like my dermatologists, can examine the mode-of-action of drugs and prescribe them based on the patient's needs.

In any case, I don't think the FDA was intended to micromanage the dispension of drugs by doctors, just to ensure the medicine is safe for consumption by the public.

[kaylasdad99]

Is this thread really about whether the FDA is an example of Government success? Or is it about the imperfections of the FDA, and a debate over whether "the left" wishes to exacerbate those imperfections?

It's been pointed out that the FDA is not as efficient/effective as European phamaceutical regulatory agencies. Are these superior bodies not government agencies? If they are, would it be unfair to point to them as examples of Government success?

[Todderbob]

Originally Posted by IdahoMauleMan

You're being far too rational, and showing a willingness to be accountable for your own decisions. Neither seems to be in particularly abundant supply when it comes to this particular debate.

Don't misunderstand... I fully support the FDA.

I just don't want to be bound by their bullshit decisions.

[IdahoMauleMan]

Originally Posted by kaylasdad99

Is this thread really about whether the FDA is an example of Government success? Or is it about the imperfections of the FDA, and a debate over whether "the left" wishes to exacerbate those imperfections?

It's been pointed out that the FDA is not as efficient/effective as European phamaceutical regulatory agencies. Are these superior bodies not government agencies? If they are, would it be unfair to point to them as examples of Government success?

That's a really good question.

I don't want to speak for Sam, but I think it was an attempt to narrow down the argument a bit from the 'Libertarian/fringe' thread, which started to take off around post #132.

Personally, I'm not interested in defining a measuring stick of 'successful' for one particular government body or the other. I'm interested in debating why free markets, and free choices by individuals, can choose to incorporate or not incorporate the outputs from those agencies at their personal discretion.

[haymarketmartyr]

Trocisp
its pretty simple
1- when you do these things to your own body, I do not want to be around to see the damage you could cause to other people

2- even if you never harm anyone, and only harm yourself, I do not want my tax dollars paying for care for you for the rest of your life when you do something stupid and need expensive medical care or support for the next fifty years.

Your claim that you won't do anything bad while on pills is pure crap. Sorry to be blunt - but it is.

[Todderbob]

Originally Posted by haymarketmartyr

its pretty simple

Okay, haymarketmartyr, explain it to me real nice and simple, like.

Originally Posted by haymarketmartyr

1- when you do these things to your own body, I do not want to be around to see the damage you could cause to other people

I didn't say you had to be around it. Did I?

I should be perfectly allowed to ingest whatever I want, in the privacy of my own home. Without fear of government reprisals. I'm a(n) (relatively) intelligent adult, I know the risks.

Originally Posted by haymarketmartyr

2- even if you never harm anyone, and only harm yourself, I do not want my tax dollars paying for care for you for the rest of your life when you do something stupid and need expensive medical care or support for the next fifty years.

Because people who drink never do anything stupid?

Should we ban booze? People get in wrecks, or get Alcohol poisoning and go into vegetative states all of the time.

There is no evidence that recreational usage of Pills, by adults, leads to more injuries than recreational alcoohol usage.

Originally Posted by haymarketmartyr

Your claim that you won't do anything bad while on pills is pure crap. Sorry to be blunt - but it is.

Prove it.

[Deeg]

Originally Posted by Trocisp

If I want to put a ton of opiates into my body, to get me hopped up 24/7, why shouldn't I be allowed to?

For me, the reason is because there is a cost to society when people are hopped up 24/7. For example, increased crime and problems with drug addled babies. The cost of being hopped up is debatable (and thus its legal standing) but the principle is this: if something has a detrimental effect on society at large then it is (IMO) open for potential regulation.

The amount of regulation should be apportioned to the cost. Cigarettes have a relatively low cost so you are allowed to pump your body full of nicotine 24/7 (as long as you don't do it near me.) To take an extreme example, the potential cost of privately-owned nuclear weapons is astronomical and so they are regulated with a complete ban. Opiates are somewhere in the middle.

The FDA is an attempt to manage the cost of food and drugs to society. It doesn't do everything right, of course (I believe it over-rates the dangers of pot) but that doesn't mean it doesn't work.

[Todderbob]

Originally Posted by Deeg

For me, the reason is because there is a cost to society when people are hopped up 24/7. For example, increased crime and problems with drug addled babies. The cost of being hopped up is debatable (and thus its legal standing) but the principle is this: if something has a detrimental effect on society at large then it is (IMO) open for potential regulation.

Alcohol.

Why the difference in regulation?

Originally Posted by Deeg

The amount of regulation should be apportioned to the cost. Cigarettes have a relatively low cost so you are allowed to pump your body full of nicotine 24/7 (as long as you don't do it near me.) To take an extreme example, the potential cost of privately-owned nuclear weapons is astronomical and so they are regulated with a complete ban. Opiates are somewhere in the middle.

The FDA is an attempt to manage the cost of food and drugs to society. It doesn't do everything right, of course (I believe it over-rates the dangers of pot) but that doesn't mean it doesn't work.

The free market dictates that if I can afford to purchase opiates, I must be doing my job properly.

If you're worried about drug-babies, make it illegal to consume Opiates or alcohol while pregnant. Don't force me, a man who cannot get pregnant, to suffer because an entirely different sub-group of people (pregnant women) may put another entirely different group of people (fetus') in danger.


It's like banning ski masks in Idaho because they like to use them for robberies in Georgia.

[Guinastasia]

Originally Posted by Tamerlane

Without getting involved in the nitty-gritty of this drug debate, I would like to add that FDA stands for Food and Drug Administration and they do considerably more than just approve pharmaceuticals.

I had a roommate at one time, an FDA employee, who worked entirely on issues of food quality, including the monitoring of imports, federal labeling laws ( partially obfuscated by political interference, especially from Orrin Hatch re: herbal supplements ), as well as inspection of domestic food production facilities ( a duty shared with, but not identical to that done by the USDA ) and the tracking of contamination outbreaks ( i.e. as with the melamine disaster a little while back ). From my exposure I'd say that focusing only on the drug side of the FDA's mandate in determining it's usefulness is only covering half ( or less ) of the argument.

So do you have any information on that? Such as on the FDA's monitoring of food products and the like?


As someone again, dependent on drugs to control a debiliating condition (epilepsy), trust me, I'm grateful for FDA testing and approval.

[furt]

As someone who has been reliant on a medication since 1980, only to have the FDA change the way the mediation was adminstered, resulting in an effective doubling of the price and making the medication significantly more expensive than it is in other countries, trust me, I think the FDA sucks.

[Cervaise]

Sam, the alternative you are proposing is how medicine is handled in the Third World. My girlfriend is Iranian, and has described to me, from experience in her home country, the common sight of the corner pharmacy where anyone can buy pretty much any medicine one wishes, from antibiotics to narcotics, with no prescription and no oversight, either state (no equivalent of the FDA in Iran) or private (no need for a doctor's prescription). The pills are usually not sealed (in bottle or blister pack or whatever) and are not guaranteed in any way; they might be surplus from an aid group, they might be properly purchased on the open market, they might be expired, they might be sugar pills for all anyone knows. Buyer beware; let word of mouth identify the shady operations; the consumer must educate himself about what to acquire, and what to take.

So I want you to tell me, with a straight face, that you would prefer to live with the superior Iranian approach to health care.

Go 'head. I'm waiting.

[Guinastasia]

That's another issue I forgot, Cervaise-antibiotic abuse. More and more, we have to worry about strains of infections that become resistant to antibiotics because people don't use them properly. And if the FDA and doctors had no control over them-once again, you're not only affecting yourself.

[Sam Stone]

Originally Posted by Voyager

I'm a bit confused. If Sam is saying that the FDA is not the best regulatory agency the world has ever seen, or even not as good as in Europe, I have no argument. I've seen criticisms of it for both doing too much and too little. We only know how many lives it could have saved before it started (and no doubt many more not recorded or dying from more subtle drug effects), not how many it has saved by preventing dangerous drugs on the market.

I'm saying not only that it's not as good as it could be, but that in its current form it is probably on balance doing more harm than good. The negative effects of slowing drug introductions, increasing the cost of a vital product to the health of all, preventing information flow, and distorting the market away from critical drugs is, on balance, worse than having no FDA at all.

For example, Streptokinase is a drug that helps break down clots in heart attack patients. Data on its use since it was approved has shown that it reduces mortality rates in in-hospital heart attack patients by 18%. That's roughly 11,000 patients a year whose lives are saved by this drug. The FDA kept Streptokinase off the market for two years after it was widely available in other parts of the world. How many people died as a result?

As for efficacy, once you grant the need for the FDA for safety, how do you consider the case where a person taking a useless drug dies from not taking a useful one.

Easy. You simply recognize that there's a vast difference between a drug that kills you, and one that just doesn't work for its intended purpose. People try things all the time that don't work for their ailments. Why should the FDA impose such a huge regulatory burden just to prevent that for one particular use? As I pointed out, off-label uses do not get certified for efficacy, and we seem to be doing just fine with them. Why not simply extend that to all uses?

Could a useless drug that is on the market block the development of a useful one, for market reasons? Now, studies have shown that expensive placebos seem to work better than cheap ones, so there is some benefit to useless drugs being on the market, but might safe but useless drugs crowd out safe and useful, if more expensive, ones?

This smacks of an argument you just made up on the spot. Couldn't you say the same thing for any alternative medicine? Couldn't you say the same for any off-label drug prescription? I just don't think this is a compelling argument at all.

I'm all for off-label use, given the kind of guidelines they have in England, since I think these are used when there is no proven on-label remedy, safety has been proven, and there is no false claim of efficacy.

So you want to actually tighten the rules for off-label use of drugs in the United States? Because the rules you just mentioned are more stringent than the rules in play in the U.S. What possible good would that do?

[gonzomax]

Originally Posted by furt

As someone who has been reliant on a medication since 1980, only to have the FDA change the way the mediation was adminstered, resulting in an effective doubling of the price and making the medication significantly more expensive than it is in other countries, trust me, I think the FDA sucks.

The FDA is an arm of the Pharm industry.When its bosses quit they get big time jobs in the industry. They take care of each other very well. Money corrupts and the kind of money that exists in Pharm is too much to stay clean.

[Sam Stone]

Originally Posted by Cervaise

Sam, the alternative you are proposing is how medicine is handled in the Third World. My girlfriend is Iranian, and has described to me, from experience in her home country, the common sight of the corner pharmacy where anyone can buy pretty much any medicine one wishes, from antibiotics to narcotics, with no prescription and no oversight, either state (no equivalent of the FDA in Iran) or private (no need for a doctor's prescription). The pills are usually not sealed (in bottle or blister pack or whatever) and are not guaranteed in any way; they might be surplus from an aid group, they might be properly purchased on the open market, they might be expired, they might be sugar pills for all anyone knows. Buyer beware; let word of mouth identify the shady operations; the consumer must educate himself about what to acquire, and what to take.

So I want you to tell me, with a straight face, that you would prefer to live with the superior Iranian approach to health care.

Go 'head. I'm waiting.

You know, I'm starting to suspect that it's just impossible to get a serious debate on this issue, along with most issues around government regulation.

AT WHAT POINT is what I proposed anything remotely similar to the way drugs are handled in Iran? How do you get from, "Leave the FDA as it is, but simply remove the efficacy requirement for drug testing", to selling unknown, unlabeled bottles of pills on streetcorners?

And even if I did recommend a complete deregulation of all drugs, how do you know the system would devolve down into the way Iranians handle drugs? There are lots of things the free market does better in first-world countries than in backwater nations with oppressive theocratic governments and large black markets.

Originally Posted by haymarketmartyr

1- when you do these things to your own body, I do not want to be around to see the damage you could cause to other people

2- even if you never harm anyone, and only harm yourself, I do not want my tax dollars paying for care for you for the rest of your life when you do something stupid and need expensive medical care or support for the next fifty years.

Gotcha. So I take it then that you are in favor of banning skiing? After all, if you break your leg skiing, society has to pick up the tab.

Alcohol kills more people than almost all illegal drugs do. I take it you are in favor of bringing back prohibition?

How about extreme sports? They result in a lot of emergency room visits, and sometimes lifetime paralysis that society has to support at huge expense. Should we ban all extreme sports?

AIDS was a systemic threat to society, and cost the government billions of dollars per year. AIDS is primarily spread through anal sex. Do you support sodomy laws?

One of the biggest factors in increased health care cost is obesity. Should there be a fat tax? How about regulating junk food? Mandatory exercise requirements for citizens?

I'm just trying to get a sense of where you think you would draw the line, given your stated principle that the state has a right to regulate any behavior that has societal costs. The truth is, almost everything we do has some impact on the world around us. If I were working right now instead of typing on the SDMB, I would be earning more income, and paying more tax. So by your logic, society is paying for me to sit here and type this, and therefore has a right to decide whether or not I should be allowed to continue.

[Sam Stone]

Originally Posted by gonzomax

The FDA is an arm of the Pharm industry.When its bosses quit they get big time jobs in the industry. They take care of each other very well. Money corrupts and the kind of money that exists in Pharm is too much to stay clean.

This is a very good point. One of the other drawbacks of regulation is regulatory capture, in which the regulated industries eventually learn to manipulate the regulations to their benefit. A good example of this is in food regulation. The Brazilian cane sugar tariff costs Americans billions of dollars, and also forces them to downgrade the quality of some of their foods and drinks by using inferior corn syrup (try a Coke from the pre-tariff days). This tariff is ostensibly to protect consumers, but in fact is the result of heavy lobbying by large agri-businesses like Monsanto and Archer-Daniels-Midland. The dairy industry is full of regulations put in place not to protect the customer, but to protect the businesses affected by the regulations from competition. The Department of Education is supposed to be looking after the interests of students, but instead has become a wholly-owned subsidiary of the teacher's unions. There are building code that have been put into place not for safety reasons, but to protect the jobs of plumbers and electricians. And so it goes.

[kaylasdad99]

Originally Posted by Sam Stone

You know, I'm starting to suspect that it's just impossible to get a serious debate on this issue, along with most issues around government regulation.

AT WHAT POINT is what I proposed anything remotely similar to the way drugs are handled in Iran? How do you get from, "Leave the FDA as it is, but simply remove the efficacy requirement for drug testing", to selling unknown, unlabeled bottles of pills on streetcorners?

It appears to be demanded by the title of the thread, a blanket assertion that the FDA is not an example of Government success.

"Even compared to nothing at all?" would seem to be a valid challenge to that assertion.

I don't know what the solution is. You COULD petition a mod to rewrite the thread title for you, but given how the thread has progressed so far, that wouldn't be fair to those who have posted as though the title of the thread accurately reflected the issue you're interested in debating. Or you could ask that the thread be closed, and you could post the thread you want to debate with a title that DOES accurately reflect it. Or you could just abandon this one without requesting that it be closed, and start a new one anyway.

[kaylasdad99]

Come to think of it, why are you so interested? Isn't there enough creeping socialism in Canada for you to rail against?