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.
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.
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.
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.
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?
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?
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.
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?
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.
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.
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.
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.
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.
Come to think of it, why are you so interested? Isn’t there enough creeping socialism in Canada for you to rail against?
I don’t think the FDA has anything to do with the banning of recreational drugs. IIRC, studies on the real impact of marijuana on health (not much, I think) got deep sixed by the right wing powers that be. If we had a rational system for banning/allowing drugs, and not one based on tradition, things would be much more sane.
I’ve got to disagree. I wouldn’t want to live in a modern country without an FDA. Can it work better? Yes. Can it be corrupted? Yes. But the thesis seems to me to be making the perfect the enemy of the good. We would be much worse off without the FDA.
Here is an amazon book link that argues the opposite much better than I couldhttp://www.amazon.com/Protecting-Americas-Health-Business-Regulation/dp/0807855820/ref=pd_bbs_sr_4?ie=UTF8&s=books&qid=1232270877&sr=8-4
One purchaser wrote:
I think that the primary mission of the FDA with respect to drugs is to oversee the reporting of clinical trials and only allow safe and effective drugs per scientific testing to make it to market. The FDA does a much better job than a void of the “invisible hand” would.
As for food inspection, many outbreaks of food poisoning are limited to the hundreds rather than the hundreds of thousands because of standards, serial numbering and recall standards.
The benefit of the FDA accrues as safe drugs stay on the market. The benefit of the FDA depends strongly on how you value patient safety.
I’ve already said, twice, that this sort of thing is a tradeoff on lives safed/improved. Clearly we don’t want a drug that just worked on rabbits to be widely distributed, and neither do we want a useful drug delayed a decade until they get the probability of no harmful side effects to under .0001%. Where you set the best release time is a technical issue which I suspect neither you nor I are qualified to resolve. Drug companies will push for earlier release, the FDA might want to push for a later one to be positive, and the best number will no doubt be in the middle. I don’t see how any regulatory agency will do this perfectly.
Are we talking about the initial release which may get held up or approval for other uses? I was talking about the former, I already said for the latter that the English model sounded good.
Wait - I thought you were complaining about initial efficacy - then you started talking about off label uses, and now you’re saying that the US is more liberal in allowing off label use than the fairly non-stringent English model. Please try again and distinguish these cases.
As for the other thing, the placebo effect study can be found in Predictably Irrational, chapter 10. And yes, the same thing applies for herbal medicines. It was actually a bit of a joke on the only benefit to expensive medicines that don’t do anything. Efficacy studies in the future should take this into account, if they don’t already. A danger of herbal medicines and kooky cancer cures is that they might delay patients getting treatment that might help, and thus kill them. If someone who has been treated as best as possible and is still terminal wants to use this stuff, that is a different story. I’m fine with them as a last gasp, not as a first gasp.
Trocisp
Stupid decisions - drinking - do not justify other stupid decisions. I do not expect perfection in the world, I do not expect consistency, I do not expect all things to be equal. To point out that people drive drunk means nothing to me regarding drugs. Nothing.
The whole point of mind altering substances is to alter ones mind. Good judgement comes with that. The ability to make good decisions comes with that. The ability to put the brakes on foolish or reckless beahavior comes with that. This is simple. Its not complicated.
If you or anyone else wants to check out the the life hotel in the privacy of your own home, grab the shtogun and fire away. I don’t think government should stop you from blowing your head off.
Its when you do just stupid things like drive under altered mental conditions, then I am happy to join arms with coercive government and take away your liberty to do so. Yeah, I know, you have already told us you won’t do any stupid or reckless things. Fact is bro, I don’t trust you or your judgement when your brain is scrambled or fired or whatever you do to your eggs.
Your rights… sorry… your LIBERTY…(trumpet flourish please) has been weighed against the rights of the larger society. The final score is in and guess what? You lost. Society won. And I like it like that.
And if the FDA is not working up to some expectations, the answer is a bigger and badder FDA… not the opposite.
I would just like to point out that today, aspirin wouldn’t pass the FDA - because they can’t prove how it works, only that it does. I think you would be hard pressed to find anyone that would argue that aspirin is effective. Of course, it does have side-effects, such as possible stomach upset…it would be interesting to see what the labeling would look like if it did manage to get past the FDA today.
Presumably you’re talking about “don’t know how it works” in some sense other than this:
? From here.
It’s not clear to me that I’m proceeding anywhere – rather, I’m mulling things over (particularly the off-label drug comparison). I’ll readily admit that I don’t know enough to intelligently debate the intricacies of the FDA.
However, I recognize that there is a large discrepancy between claiming I am free to choose (the testing agency) and the manufacturer is free to choose. The former implies that any available drug will be tested by some number of agencies (perhaps none), giving one a choice of which agency one trusts to perform evaluations; the latter (correctly) states that the consumer has no direct control over what agency (if any) tests a drug.
This is important because (from the Libertarianism/fringe thread) IdahoMauleMan says things like:
Again, the consumer does not make this choice, and it’s disingenuous to imply (or outrightly state) that the option is there. In fact, since drug testing costs money, I’d expect that the default position of every drug manufacturer would be to not have their products tested. For those drugs that did undergo testing, I’d expect that a manufacturer would choose one (and only one) agency to perform the testing – testing is expensive, and why duplicate the effort?
So, given that, it seems to me that the FDA specifically is removed from IdahoMauleMan’s basic argument; the question is reduced to whether drug manufacturers should have to submit their product for testing at all, which is easier to discuss (and should be in a different thread). With an answer to that, then one might pursue arguments over the FDA’s monopoly, or its specific structure/mission, or the general regulatory structure for drug approval.
But accepting the choices as laid out only obfuscates the issues. And there’s certainly enough of that already, yes?
It wasn’t an attempt to obfuscate the issue. The United States drug manufacturers are at only one point of the value chain from drug production to the American consumer.
I’m going to have to guess where you’re going with this point, and create a bit of a strawman. Please poke holes in it if you want.
I’m going to guess that you will argue that it’s not really the CONSUMER’s choice to select FDA-approved drugs. They don’t really have the power. That it really boils down to the power of the MANUFACTURER. Yes? Is that correct?
OK. Let me take a crack at it.
There are many, many independent labs that exist today that do outsourced work for the drug manufacturers. I threw out one example of by ex-brother-in-law’s company in the ‘Libertarian/fringe’ thread. There are trained people doing work in biotech fields, and other fields, tangentially related to drug manufacture, but are capable of doing the same thing. There is a large installed base of laboratories and equipment all over the USA.
There are the skilled people already existant within the FDA. There are data-gathering and marketing firms who could collect, and collate data on drug efficacy even without testing in laboratories at all. There are other countries who could sell drugs to American consumers through the mail.
In short, there are many 100s or even 1000s of companies, 10,000s of capable and skilled people, and a multitude of choices and productive capacity all over the world standing ready to satisfy consumer demand for tested drugs. Both within the four walls of the manufacturers today, and in the surrounding business ecosystem that supports the drug industry. And there are $100s of billions of dollars at stake from being able to do so and satisfy the consumer demand.
If consumers demand tested drugs, any one of those sources has an incentive to spring into action and satisfy the demand. First off, it’s implausible to suggest that somehow all of the world’s drug manufacturers could interlock in some evil, multi-country and multi-company cartel and refuse testing on their drugs. There’s just too many of them, and it doesn’t make economic sense. Plus, they have 100,000s of employees and major shareholders of their own, with families to protect. I’m sure many of those employees, people on the Board of Directors, and institutional shareholders would also like tested drugs.
Oh, I’m sure there will be a couple of lunatics on this Board who will propose that such an evil cartel would happen immediately, but I hope you can see that it’s patently ridiculous.
But even if the drug companies did try and avoid testing, there are independent 3rd parties who will gladly fill the void. They could buy untested drugs from manufacturers and test the drugs themselves. Then they could sell them to you with their stamp of approval. In fact, that approach might even work better, since I have faith in smaller, more entrepreneurial companies to figure out ways to do things better, faster and cheaper than large behemoths. The FDA could adopt that approach tomorrow if they wanted to do so.
I hope you can see that will the installed base of skills and capital equipment in the United States and elsewhere, and with the overwhelming demand from consumers for tested drugs, it is simply implausible to consider that demand won’t be filled by somebody, somewhere. Even if it’s not the manufacturers.
I like the attempts at serious debate as much as you, my friend.
But I’ll say it again, as I said it umpteen times in the ‘Libertarian/fringe’ thread…you’re dealing with irrationality here. It’s at the core of the responses that are frustrating you.
What you’re saying, since all things are not equal, is that you’re for arbitrary laws. By saying A = B, but A = Okay, and B = Banned, you’re saying… “Arbitrary laws are A-Okay in my book.”
Plenty of people can use recreational drugs, of a variety of sorts, including pills, and be perfectly responsible. Plenty of people treat alcohol in the same way. It’s a very tiny minority who abuse drugs or alcohol.
I would be willing to wager that the same subset of people who drink and drive are the same subset who would pop pills and drive (Reckless, careless people). The issue is, they’re already doing the former. By adding the latter to the equation you’re not increasing the risks to society in general.
It’s not exclusively recreational drugs. Would you call Valium a recreational drug? Vicodin?
If I have back pain, and I want a more powerful than currently OTC pain killer, and I’m aware of the risks, why should I have to spend hundreds of dollars on a doctors visit?