Dietary supplements: the free market vs. the FDA

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shanek
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Dietary supplements: the free market vs. the FDA

Post by shanek » Mon Jun 21, 2004 12:45 am

So, these new "much-needed" FDA regulations on dietary supplements that go into effect this year will finally enable consumers to choose which dietary supplements are safe and effective, something they were completely unable to do up until now.

Right?

Well, no, and no. Consumers have always been able to tell whether or not a particular product is safe simply by looking for voluntary free-market standards that have been applied to these products, such as the US Pharmacopeia's Dietary Supplement Verification Program (via the USP Verified seal), which tests for the presence of substances known to be hamful and also audits the factories to make sure no contaminants are added, and the Good Housekeeping Seal of Approval, which for almost 100 years has gained respect in reviewing and testing both the safety and efficacy of a wide range of products, from foods and medical remedies to toys and electronic devices. Consumers have always had the ability to determine what supplements are safe simply by looking for products that bear either or both of these certifications. And there are many other examples.

But now, I guess, the FDA will go beyond that, requiring standards for safety and efficacy that neither the DSVP or Good Housekeeping can propide? Uh, no again. ALL the new regulations will do is make sure that no known contaminants are in the supplement--it doesn't even go as far as what the DSVP does!

(And heaven forbid they should actually allow product makers to make claims about their products that are known for a scientific fact are true, such as the benefits of folic acid in preventing birth defects or the positive effects of alcohol on the heart.)

And yet, if the FDA's track record persists, what this will result in is yet more harm being done to the consumer. To try and prevent the 20 or so deaths per year (almost five times as many people die every year from being struck by lightning, BTW) from occuring from a future ephedra, they will relegate thousands of babies to be born with birth defects, or to not even make it to birth at all. They will allow far more people to continue to be seriously injured or die of heart attacks than would have been killed by unsafe dietary products. They will do this by keeping products off the market unless their own tests (which aren't even for safety of the base ingredient anyway) are applied their own way, which drive up the price and may even force many manufacturers out of business. They will do this by continuing prevent people from finding out about many of the health benefits of these supplements other than by their own diligent research, since manufacturers will still be prohibiting from advertising these benefits no matter how good the science behind their claim is.

And perhaps worst of all, they will take away your ability to be able to choose products that have been scientifically proven to work. They will take away your right to decide for yourself what to put in your own body, based on whatever criteria you choose, and what level of safety you think is sufficient.

What the government really should be doing is restoring product liability to the field of dietary supplements, which was effectively limited by the DSHEA by ultimately making it much more expensive to persue, and to allow the work of standards bodies such as the USP to continue to work as they have. They should also acknowledge companies concerned about their customers' health and their brand name integrity that act on new information, such as the numerous brands containing ephedra that were voluntarily yanked from the market by the manufacturer as the troubles with the supplement began to emerge.

And they certainly shouldn't implement regulations that won't even solve the problems that prompted them to act in the first place.
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Post by Doctor X » Mon Jun 21, 2004 1:29 am

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Post by Earthborn » Mon Jun 21, 2004 5:23 am

Consumers have always had the ability to determine what supplements are safe simply by looking for products that bear either or both of these certifications.
They may have had the ability to find out, but how many of them knew what to look for? How many actually took the effort to find out, instead of simply assuming that it 'wouldn't be on the market if it wasn't safe' ?
ALL the new regulations will do is make sure that no known contaminants are in the supplement--it doesn't even go as far as what the DSVP does!
I think you would also complain if they went further.
And heaven forbid they should actually allow product makers to make claims about their products that are known for a scientific fact are true, such as the benefits of folic acid
Do you have any evidence that the makers wouldn't be allowed to make that claim? Or is it just an assumption?
the positive effects of alcohol on the heart.
Any positive effect on the heart caused by alcohol is not a scientific fact. What is a scientific fact is that there is a correlation between mild use alcoholic beverages and heart failure. No one knows exactly what causes it.

One explanation is that people who are able to use alcohol moderately are also better able to use other dangers moderately, for example foods that have a provable effect on the heart.

Even if we assume that it is because of the use of alcoholic drinks, it does not mean it is caused by the alcohol itself. The effect on the heart is assumed to be caused by antioxidants in red wine. That's assuming there is any effect at all. Very few researchers have claimed that it is the alcohol itself that must be responsible.

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they will relegate thousands of babies to be born with birth defects, or to not even make it to birth at all.
Are you saying that they are going to ban folic acid? I find that hard to believe.
They will do this by continuing prevent people from finding out about many of the health benefits of these supplements other than by their own diligent research, since manufacturers will still be prohibiting from advertising these benefits no matter how good the science behind their claim is.
I don't know what kind of ads you read for dietary supplements, but they don't seem too informative to me. If independent researchers are still able to publish any health benefits from dietary supplements, I don't really need the manipulative junk manufacturers usually present.

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Post by Tez » Mon Jun 21, 2004 7:26 am

I agree that government regulation is unlikely to be that useful Shane. I certainly could use independent (and probably better) sources of information. However, let me expand on something Earthborn said: Unfortunately, and therein lies the rub, I cannot do it for every little thing I have to buy in life which may be harmful to me. I simply have better things to do.

Now, ideally, market forces driven by the percentage of consumers who do carry out that research, will ensure that only good products end up on the shelves. But I'd dearly love to see a tight game-theoretic analysis of what the threshold percentage is, and how it conforms with typical behaviour of humans, before I actually believe such a supposition. I presume Libertarians have done some research along these lines. I can see reasonably clearly how to do such an analysis (there will need to be some "maximal lag time" and a "maximal diffusion distance" that you do not mind an unscrupulous product being out in the population for, and that may concern some folks, thoguh not me really) .

Another option, and a quite reasonable one at that, is for me to pay someone I trust to do all my research for me....

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Post by MRC_Hans » Mon Jun 21, 2004 8:20 am

It is always funny to read Shanek's rants about the FDA. I'm sure it is possible, maybe even easy, to find instances where the FDA has goofed, but that is not the point. The point of a thing like the FDA is to stop chalatans and quacks to sell snake-oil to unsuspecting users, while claiming fabulous effects.

The purpose of the FDA is also to keep a much-needed rein on big international pharmaceutic and food companies that would otherwise do anything for profit.

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Post by shanek » Mon Jun 21, 2004 1:32 pm

Earthborn wrote:They may have had the ability to find out, but how many of them knew what to look for?
Surely that's a matter of education, isn't it? Besides, this is still a big problem with the FDA's restrictions on advertisements. They can't claim that a product is "proven safe and effective" unless it's the FDA that did the testing, no matter how prodigious the examining body. They can put the seal on their product, they can even mention it in their advertisements, but they can't actually tell you what it means. This is insanity.
Do you have any evidence that the makers wouldn't be allowed to make that claim?
Because IT ACTUALLY HAPPENED. When the makers of folic acid tried to make that SCIENTIFICALLY PROVEN claim about birth defects, the FDA shut them down. Why? Because the tests, as valid as they were scientifically, weren't FDA approved. What's insane about this is that the FDA and the Department of Health and Human Services directly recommended folic acid in 1996 as an additive to normal foods such as bread to help prevent birth defects. But the makers of folic acid supplements can't advertise it.
Are you saying that they are going to ban folic acid?
No, they just prevent the makers of folic acid supplements from advertising its benefits in preventing birth defects. How are people gong to know to take folic acid to produce birth defects if the companies can't advertise that effect? Like you said above, should we just depend on them to do the research themselves?
I don't know what kind of ads you read for dietary supplements, but they don't seem too informative to me. If independent researchers are still able to publish any health benefits from dietary supplements, I don't really need the manipulative junk manufacturers usually present.
:roll: So, in one sentence, you say, "How many actually took the effort to find out, instead of simply assuming that it 'wouldn't be on the market if it wasn't safe'" but in the next you say it's fine to have independent researchers publishing the effects, even though that would require people to "take the effort to find out."

THEY CAN'T MAKE ANY CLAIM THAT ISN'T FDA APPROVED. And in order for it to be FDA approved, they have to spend hundreds of millions of dollars doing FDA-approved tests, no matter how much valid scientific data is out there already. Since these supplements aren't patentable, there's no way they can make the money back. It's the same effect that caused AIDS patients in this country to (on the advice of their doctors) go to the black market to get DDI for their treatment, a known safe and effective treatment throughout the world, instead of the FDA-approved DDC, which was toxic and much more dangerous.
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Post by shanek » Mon Jun 21, 2004 1:35 pm

Tez wrote:I agree that government regulation is unlikely to be that useful Shane. I certainly could use independent (and probably better) sources of information. However, let me expand on something Earthborn said: Unfortunately, and therein lies the rub, I cannot do it for every little thing I have to buy in life which may be harmful to me. I simply have better things to do.
You shouldn't have to. The companies should be able to advertise that, say, the DSVP tested the product as safe. All you'd need to look for is that little seal. Again, I have to point out electrical devices: do you spend hours researching whether or not an electrical device is safe? Or is that little UL label enough for you?

It shouldn't be necessary for the consumer to do ANY research. Unfortunately, the FDA is leaving us with little choice in the matter.
Another option, and a quite reasonable one at that, is for me to pay someone I trust to do all my research for me....
Or for the company to do it...pay someone like UL or the USP. Or for Good Housekeeping or Consumer Reports to do it on their own. You aren't helpless here...at least, until the government steps in and regulates it.
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Post by shanek » Mon Jun 21, 2004 1:36 pm

MRC_Hans wrote:It is always funny to read Shanek's rants about the FDA. I'm sure it is possible, maybe even easy, to find instances where the FDA has goofed, but that is not the point. The point of a thing like the FDA is to stop chalatans and quacks to sell snake-oil to unsuspecting users, while claiming fabulous effects.
Even the most conservative estimates put the death toll from FDA regulations at tens of thousands a year. The body bags are piling up. Are you HONESTLY saying that there would be many, many more from unregulated medicine? I'd love to see evidence for that.
There is an old android saying. In binary it reads: 01001001001001110110110100100000011011100110111101110100001
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Post by MRC_Hans » Mon Jun 21, 2004 1:52 pm

shanek wrote:
MRC_Hans wrote:It is always funny to read Shanek's rants about the FDA. I'm sure it is possible, maybe even easy, to find instances where the FDA has goofed, but that is not the point. The point of a thing like the FDA is to stop chalatans and quacks to sell snake-oil to unsuspecting users, while claiming fabulous effects.
Even the most conservative estimates put the death toll from FDA regulations at tens of thousands a year. The body bags are piling up. Are you HONESTLY saying that there would be many, many more from unregulated medicine? I'd love to see evidence for that.
Obviously nobody can give you evidence for what would have happened, had the world been different, and you know that. But you might provide evidence for your piling body bags.

As for the effects of lack of regulations, just one word: Thalidomide.

In an earlier post ,you said:
Surely that's a matter of education, isn't it? Besides, this is still a big problem with the FDA's restrictions on advertisements. They can't claim that a product is "proven safe and effective" unless it's the FDA that did the testing, no matter how prodigious the examining body. They can put the seal on their product, they can even mention it in their advertisements, but they can't actually tell you what it means. This is insanity.
The FDA does not conduct any testing at all. They audit the testing and quality systems of the producers. They are simply enforcing the laws made by your government.

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Post by shanek » Mon Jun 21, 2004 2:09 pm

MRC_Hans wrote:Obviously nobody can give you evidence for what would have happened, had the world been different, and you know that. But you might provide evidence for your piling body bags.
Well, there's the estimates of Robert Goldberg, senior research fellow at Brandeis University. There's the estimates of former pharmaceutical research scientist Mary J. Ruwart.

But do it yourself: look at the deaths caused by medicines, or that would be caused by medicines that were blocked by the FDA (simple: just look at their track record in Europe, where most of them are commonly available). Then compare them to the deaths of people suffering from fatal illnesses, and look at the portion that would have been saved by the drugs. I'm pretty sure you'll find the former to be in the dozens, while the latter is in the thousands.
As for the effects of lack of regulations, just one word: Thalidomide.
Blah blah blah. I've refuted the Thalidomide nonsense so much it's ridiculous. HOW ON EARTH do the regulations on EFFICACY, which are the regulations that Thalodomide prompted (safety regulations were already in place), necessary to prevent another Thalidomide?

What they did was CAUSE A NEW THALIDOMIDE by preventing makers of folic acid from advertising its benefits. It took them ten years to recognize reality itself--while 2500 children a year were born with spina bifida, which is completely preventable by folic acid. Who knows how many more were aborted?

BTW, pop quiz: Of the hundreds of drugs that have been recalled over the FDA's existance, how many of them were recalled by the FDA itself, as opposed to the manufacturer? The answer to that question may surprise you...
The FDA does not conduct any testing at all. They audit the testing and quality systems of the producers.
No, they manage the entire testing procedure. Even if the testing has already been done, and even if it had been done exactly the way the FDA would have wanted, none of that is good enough; it must be tested AGAIN. And so it can take ten or more years and up to a billion dollars to get a drug on the market in the US. That is completely ridiculous.
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Post by Earthborn » Mon Jun 21, 2004 2:42 pm

They can put the seal on their product, they can even mention it in their advertisements, but they can't actually tell you what it means.
How many people actually know all the seals and approval marks, and how many people can judge how trustworthy they are? That's researching these things means. Of course they are not going to be able to do actual clinical trials themselves, or read the medical journals. What is important is whether they will be able to recognize the seals of approval.

Unfortunately there are lots of companies who know that people are attracted by seals of approval, but at the same time don't know them all. So they love to put their own silly made up seals on them to make the product look prestigeous. 'Approved', 'Dolphin Friendly', 'All Natural', 'Dermatologically tested'... You know what I mean.
How are people gong to know to take folic acid to produce birth defects if the companies can't advertise that effect?
You don't get all your information solely from advertising do you? Doctors can recommend it, pharmacists too. An article in a women's magazine or a radio interview with a doctor who explains it, can educate a lot of people.

The point is, these companies are not in the business of educating people. If they can advertise their product with such claims, it will only encourage people to buy the expensive pills instead of the cheaper ones that do the exact same thing. Doctors should just prescribe pregnant women some generic folic acid tablets and that should prevent all the birth defects that could be prevented with it.
you say it's fine to have independent researchers publishing the effects
Yes. Independent researchers should be able to publish their results, doctors and pharmacists should be able to prescribe stuff when needed or recommend when desired. Just cheap stuff that works just as well as the expensive products. No advertising by any particular manufacturer as that would only encourage over use and the use of more expensive products.
All you'd need to look for is that little seal.
That will just result in a lot of seals that nobody recognizes.
The companies should be able to advertise that, say, the DSVP tested the product as safe.
They shouldn't have to. If a product isn't safe, they shouldn't be allowed to sell it.
Even the most conservative estimates put the death toll from FDA regulations at tens of thousands a year. The body bags are piling up.
Nice one sided emotional language. You are forgetting one thing: the people who die every year because the FDA approved a drug too quickly. The FDA needs to balance between both problems: any direction whether towards regulation or away from it, will cost lives.
Are you HONESTLY saying that there would be many, many more from unregulated medicine? I'd love to see evidence for that.
Here is a nice PBS documentary that claims the exact opposite of what you are saying: that the FDA is too much in the pocket of drug companies and often approves drugs too quickly.

I also recommend the article Defending the FDA
But you discover that really what's happened to the FDA is they have this public health mission, but they're under constant pressure to be as friendly toward free-enterprise as they can. They're really pushed very hard all the time in that direction -- to give in to the companies, to shorten the process, to be efficient. All this constant pressure. So if you're going to regulate, this is the absolute most conservative way you can do it.
And, of course, the companies are always pressing to have these things put out faster. And the people who are worried about the large number of drug side effects and the hazards of modern treatments are always pushing to be more careful. They say, "There are all these drugs out there already. Why do we have to have one more? Can't we be a little more careful?" So nobody is happy. There's no way of putting science into policy, into real life, without having a lot of unhappy people. So they have the dirty job.
So here they are in the '90s, far along this line, doing high-end science, being very careful about the studies -- these are the best companies I'm talking about -- and all of a sudden somebody comes along and says, "Don't you remember? You didn't want to have regulations a few years ago." And the companies said, "Well, now, wait a minute. If we pull off the regulation and all of a sudden we're not testing publicly, and these products are not being certified as safe, where are we?" And in private they were quite plain about it. They thought they had got themselves into a very bad bind because they had been supporting the Republican Party and the conservatives more than they had the Democrats. And then this legislation came along which would have really desperately hurt them.

You mean it would hurt their credibility?

Yeah. The credibility of the drugs comes from the existence of the FDA, the existence of deep scientific testing, the real stamp of approval, saying, "This is actually quite safe. And this does actually work." That's something that they earned over the previous 40 years, which they were now about to lose if the FDA goes away or gets weakened. And they knew that perfectly well, because now they have a lot of scientists and doctors on their staff.

Or how about an article about how cheaper more effective drugs aren't sold because drug companies like to make more money with more expensive ones?

There is a whole lot more about this then 'the FDA is bad and abolishing it will make everything better.'

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Post by Geni » Mon Jun 21, 2004 4:29 pm

shanek wrote: THEY CAN'T MAKE ANY CLAIM THAT ISN'T FDA APPROVED. And in order for it to be FDA approved, they have to spend hundreds of millions of dollars doing FDA-approved tests,
Did the dollar fall even further over the last few days? Source for this claim?

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Post by shanek » Mon Jun 21, 2004 6:51 pm

Earthborn wrote:How many people actually know all the seals and approval marks, and how many people can judge how trustworthy they are? That's researching these things means. Of course they are not going to be able to do actual clinical trials themselves, or read the medical journals. What is important is whether they will be able to recognize the seals of approval.
Do I YET AGAIN have to point you to the success of UL doing exactly this?
You don't get all your information solely from advertising do you?
But you said above that it's hard for people to do researching on their own! Again, make up your mind!

We need regulations because people can't be expected to research everything. But we don't need to let companies advertise the safety of their products because people can do the research if they want. How screwed up is that!!!
The point is, these companies are not in the business of educating people.
Yes, they are, at least as far as the advantages of their product are concerned.
If they can advertise their product with such claims, it will only encourage people to buy the expensive pills instead of the cheaper ones that do the exact same thing.
Oh, for crying out loud, talk about reaching... :rolleyes: I guess no one buys generic drugs, huh, or knows they're exactly the same as their brand name counterparts?
Doctors should just prescribe pregnant women some generic folic acid tablets and that should prevent all the birth defects that could be prevented with it.
The problem is, doctors can only do that once they get pregnant. Otherwise, they won't know to. And by that point, it's too late to prevent many of the defects. But a woman trying to get pregnant should be able to supplement on her own, and so makers of folic acid supplements should be able to advertise its advantages to her.

You have NO EXCUSE. This is ANTI-FREEDOM, it is HARMFUL, and it is WRONG.
That will just result in a lot of seals that nobody recognizes.
Like UL? And "nobody recognizes" the little seals, but they can do all this research in magazines etc. on their own? Geez...could you at least have a LITTLE consistency here?
Nice one sided emotional language. You are forgetting one thing: the people who die every year because the FDA approved a drug too quickly.
No, I'm not. The estimates account for that.
Are you HONESTLY saying that there would be many, many more from unregulated medicine? I'd love to see evidence for that.
Here is a nice PBS documentary that claims the exact opposite of what you are saying: that the FDA is too much in the pocket of drug companies and often approves drugs too quickly.
Uh, no, it isn't. Read the site. It basically says the FDA requirements are inefficient--and they are. Seriously, TWELVE YEARS is "too quickly"? Yeah, the FDA is charged with doing a job, and it's screwing it up; sounds like a Libertarian argument to me!
I also recommend the article Defending the FDA
Why? He's taking the insane position that the regulations aren't working, so what we need is MORE regulations! But that didn't work with other areas of health care, with welfare, with campaign finance reform, or any other area of government.
Yeah. The credibility of the drugs comes from the existence of the FDA,
Which, according to your own source, isn't doing its job. So it's a false credibility. Whereas independent standards bodies and brand name reputations rise and fall on actual credibility--a system that ACTUALLY WORKS.
"This is actually quite safe. And this does actually work."
Except when it isn't, and except when it doesn't.
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Post by MRC_Hans » Mon Jun 21, 2004 7:15 pm

shanek wrote:
MRC_Hans wrote:Obviously nobody can give you evidence for what would have happened, had the world been different, and you know that. But you might provide evidence for your piling body bags.
Well, there's the estimates of Robert Goldberg, senior research fellow at Brandeis University. There's the estimates of former pharmaceutical research scientist Mary J. Ruwart.

Would that be a certain "Rube Goldberg"? ;)

But do it yourself: look at the deaths caused by medicines, or that would be caused by medicines that were blocked by the FDA (simple: just look at their track record in Europe, where most of them are commonly available). Then compare them to the deaths of people suffering from fatal illnesses, and look at the portion that would have been saved by the drugs. I'm pretty sure you'll find the former to be in the dozens, while the latter is in the thousands.

Ahh, another "would have". I'm afraid "would have" don't count as evidence :roll:

As for the effects of lack of regulations, just one word: Thalidomide.


Blah blah blah. I've refuted the Thalidomide nonsense so much it's ridiculous. HOW ON EARTH do the regulations on EFFICACY, which are the regulations that Thalodomide prompted (safety regulations were already in place), necessary to prevent another Thalidomide?

There is now regulations, enforced in the US by the FDA, which forces producers to report every adverse event to the authorities.

What they did was CAUSE A NEW THALIDOMIDE by preventing makers of folic acid from advertising its benefits. It took them ten years to recognize reality itself--while 2500 children a year were born with spina bifida, which is completely preventable by folic acid. Who knows how many more were aborted?

I don't know about that subject, but .. you don't sound too credible right now. Looks like another would have.

BTW, pop quiz: Of the hundreds of drugs that have been recalled over the FDA's existance, how many of them were recalled by the FDA itself, as opposed to the manufacturer? The answer to that question may surprise you...

I would expect that close to 100% were recalled by the manufacturer. That's the way things work. Having the FDA recall your stuff is more or les suicide. But without the FDA, most of the recalls wouldn't have happened.

The FDA does not conduct any testing at all. They audit the testing and quality systems of the producers.


No, they manage the entire testing procedure. Even if the testing has already been done, and even if it had been done exactly the way the FDA would have wanted, none of that is good enough; it must be tested AGAIN.

Nonsense.

And so it can take ten or more years and up to a billion dollars to get a drug on the market in the US. That is completely ridiculous.

Nonsense


Excuse me, but I work in the pharmaceutical industry. Working with the FDA is part of my job. We don't love them, but, all in all they make sende to us all.

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Post by EvilYeti » Mon Jun 21, 2004 9:34 pm

Tez wrote: Now, ideally, market forces driven by the percentage of consumers who do carry out that research, will ensure that only good products end up on the shelves. But I'd dearly love to see a tight game-theoretic analysis of what the threshold percentage is, and how it conforms with typical behaviour of humans, before I actually believe such a supposition. I presume Libertarians have done some research along these lines. I can see reasonably clearly how to do such an analysis (there will need to be some "maximal lag time" and a "maximal diffusion distance" that you do not mind an unscrupulous product being out in the population for, and that may concern some folks, thoguh not me really) .
I would love to see something like this as well, but I'm not sure that game theory is well enough equipped to deal with real-world problems. The main issue being, in my opinion, is that free-markets are predicated on the concept of full disclosure. Consider the following, for example:

Bill, who has an ear infection, buys some medicine from Bob, the pharmacist, on the recommendation of Doug, his doctor. Sounds like a typical free market transaction, right?

But what if it turns out that Doug isn't really a doctor, Bob isn't really a pharmacist and the "medicine" is just morphine and alcohol? And that Bill pays for it with counterfeit currency? Or doesn't even really have an ear infection in the first place and is just a junkie? What could we possibly learn about the efficiany and safety of morphine and alcohol as a treatment for ear infections from such transactions?

And here in America, all the government regulations are really doing is enforcing full disclosure. You actually have to be a licensed doctor to practice medicine. You have to be a licensed pharmascist to dispense medicine. The medicines doctors are allowed to prescribe have to pass a rigorous approval process, they have to be demonstrated to be effective and the pharmacist is required by law to sell you the pure drug at the dosage prescribed. And the consumer is required by law to pay for it with real money.

Free markets DEPEND on regulation, they cannot exist without it.

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Post by Earthborn » Tue Jun 22, 2004 12:01 am

We need regulations because people can't be expected to research everything. But we don't need to let companies advertise the safety of their products because people can do the research if they want.
No, I am saying that experts who are independent of the drug companies (or even if they are dependent as long as they don't advertise a particular brand) should reach out to the public to inform them. Instead of expecting people to do the research on their own, or making people learn what a gazillion seals of approval mean, they should be taught which medications work so people can get them.
Yes, they are, at least as far as the advantages of their product are concerned.
A manufacturer is not an unbiased party: it wants to sell its products. So it is likely that it will exaggerate the advantages of its product to sell more. This will encourage patients to ask for a particular brand instead of the best product.
I guess no one buys generic drugs, huh, or knows they're exactly the same as their brand name counterparts?
If they are exactly the same as their brand name counterparts there is no reason why anyone should buy those brand name counterparts, and there is also no reason why those brand name counterparts are sold at all.
And by that point, it's too late to prevent many of the defects. But a woman trying to get pregnant should be able to supplement on her own, and so makers of folic acid supplements should be able to advertise its advantages to her.
That's why the medical community should reach out to the public to inform them. It is not the job of a manufacturer who has an interest that people by a particular brand. It is the job of independent experts.
No, I'm not. The estimates account for that.
You still haven't presented those estimates. You haven't presented how those estimates were made, or even mentioned a non-ideological source.
Uh, no, it isn't. Read the site. It basically says the FDA requirements are inefficient--and they are.
I assume you haven't seen the documentary.
Yeah, the FDA is charged with doing a job, and it's screwing it up; sounds like a Libertarian argument to me!
It sounds like a libertarian argument to me too, when you are misreading it. Watch the program if you have such difficulty reading the text.
He's taking the insane position that the regulations aren't working, so what we need is MORE regulations!
If you actually read what he said, you would know that he is an expert, and he does not demand more regulations. What he does is try to explain why it is hard balancing between ideologues who demand less regulation (even to the point where they go further than the pharmaceutical industry) and those ideologues who demand more regulation. And he's saying that the FDA doesn't do a half-bad job of balancing between the two.
Which, according to your own source, isn't doing its job.
According to my own source, it isn't working because the drug industry has too much influence on the process. This is because free market ideologues have made it too dependent on drug industry money and less dependent on government money.
Whereas independent standards bodies and brand name reputations rise and fall on actual credibility--a system that ACTUALLY WORKS.
If you read the article about hypertension drugs (under Spin Doctors) you would know that many expensive drugs have a high brand name reputation they don't deserve, because in most cases they are not nearly as good than cheap generic diuretics. But because the brand name products are widely advertised, people use them more often.

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shanek
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Post by shanek » Tue Jun 22, 2004 3:09 am

Earthborn wrote:No, I am saying that experts who are independent of the drug companies (or even if they are dependent as long as they don't advertise a particular brand) should reach out to the public to inform them. Instead of expecting people to do the research on their own, or making people learn what a gazillion seals of approval mean, they should be taught which medications work so people can get them.
Except that a seal of approval has proven to be a very effective means for doing exactly that.

There's your perception, and then there's reality.
A manufacturer is not an unbiased party: it wants to sell its products. So it is likely that it will exaggerate the advantages of its product to sell more. This will encourage patients to ask for a particular brand instead of the best product.
And why not, as long as their claims are truthful?
If they are exactly the same as their brand name counterparts there is no reason why anyone should buy those brand name counterparts, and there is also no reason why those brand name counterparts are sold at all.
Nice. Now answer the question.
That's why the medical community should reach out to the public to inform them.
And where are they going to get the money to do this from? The manufacturer can do this because they'll make the money back in extra profits. How can the "medical community" (whatever that is) afford to do so without taking much-needed money from elsewhere?
You still haven't presented those estimates.
I gave references to them. Robert Goldberg of Brandeis University. Dr. Mary J. Ruwart, author of Healing Our World. Many, many others. They've all found the same thing. And yes, they account for the lives saved. It's not even anywhere close.
You haven't presented how those estimates were made, or even mentioned a non-ideological source.
While granting that Dr. Ruwart is not exactly ashamed of being a Libertarian, how is Goldberg "ideological"? Besides, that's just attacking the source again. You're just playing "my source can beat up your source."
I assume you haven't seen the documentary.
No, I've only gone on what YOU submitted.
It sounds like a libertarian argument to me too, when you are misreading it. Watch the program if you have such difficulty reading the text.
Well, as the video doesn't appear to be on the site anywhere, how about you enlighten me?
If you actually read what he said, you would know that he is an expert,
Argument by authority.
and he does not demand more regulations.
Yes, he does. He demands them to make stop the FDA from "heavily favoring the industry" (a laughable claim).
And he's saying that the FDA doesn't do a half-bad job of balancing between the two.
That doesn't mean that the result of that balance is the most effective system. Besides, free markets have proven to be much, much better at striking exactly this kind of balance--and in the most efficient and effective way.
According to my own source, it isn't working because the drug industry has too much influence on the process.
Which is a laugh. The FDA effectively cripples the drug industry.
This is because free market ideologues have made it too dependent on drug industry money and less dependent on government money.
Amazing how UL, being 100% dependent on "electrical industry" money, doesn't seem to have this problem...
If you read the article about hypertension drugs (under Spin Doctors)
Yeah...when you have a source that makes the statement, "It was the kind of study that only a government agency could organize," when in fact the free market has organized many studies set up just like that, it really doesn't do much for its credibility.
you would know that many expensive drugs have a high brand name reputation they don't deserve, because in most cases they are not nearly as good than cheap generic diuretics. But because the brand name products are widely advertised, people use them more often.
And they're widely advertised because the manufacturers have to make back the almost $1 billion the FDA made them spend bringing it to market. And the ten years or more it can take to go through the FDA brueaucracy means that they don't have that much time to make that money back before the patent expires.

Now, I'll give you a counterexample, straight from Dr. Ruwart's experience at Upjohn, from her speech at the LPNC Convention this year:

She herself holds a patent for prostaglandin to fight liver disease (among many others as well). At the time, there was no cure at all, and prostaglandin was very promising. This was a very important drug and she was personally assured by the FDA examiner that they would do everything possible to help bring this remarkable drug to the market. However, proving efficacy was almost impossible even conceptually since no one had ever cured liver disease before and there was no real parameter to use in order to get the right statistical significance; they would have to do several studies to tell them how to do the studies! And even then, there was no guarantee they would find a method that would yield the proper statistical significance and they would have to start all over again. Meanwhile, the patent clock is ticking. Essentially, the FDA regulations made it impossible to do all of the studies necessary to bring the drug to market and still make money off of it. To this day, it is unknown whether or not prostaglandin works for liver disease, and probably never will.

I'll see if I can get ahold of a recording of her speech and host it so y'all can hear it. She covers that, her estimate of the numbr of lives lost due to FDA regulations, and so much more. It's a great speech.
There is an old android saying. In binary it reads: 01001001001001110110110100100000011011100110111101110100001
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Post by Earthborn » Tue Jun 22, 2004 5:07 am

Well, as the video doesn't appear to be on the site anywhere, how about you enlighten me?
Oh, dear... I suggest you have your eyes checked, and I don't mean that in a bad way.

The first link I gave you has on it very big letters saying 'Watch The Full Program Online'. How else am I supposed to know what the documentary is like? It's PBS, so if it isn't online, there is no way for me to watch it.

I'll make it easy for you: this is where you would end up if you click the big letters.
Argument by authority.
Of course he is an authority on the subject, so it is not a fallacy.
Yes, he does. He demands them to make stop the FDA from "heavily favoring the industry" (a laughable claim).
A laughable claim perhaps. Strangely enough, as you will see in the documentary, there are more people who work there or have worked there who get that impression. I take their opinion more seriously than yours.
Besides, free markets have proven to be much, much better at striking exactly this kind of balance--and in the most efficient and effective way.
Says you. For some reason however, the countries with the most effective healthcare systems are also the ones with the least free markets. According the Grandfather Healthcare Report anyway.
Which is a laugh. The FDA effectively cripples the drug industry.
If that is true, it makes me wonder why the drug industry doesn't feel that way at all.
Yeah...when you have a source that makes the statement, "It was the kind of study that only a government agency could organize," when in fact the free market has organized many studies set up just like that, it really doesn't do much for its credibility.
Please give an example of such a study. One is enough to disprove that only the government can organise such a thing.
She herself holds a patent for prostaglandin to fight liver disease (among many others as well).
Does the 'she' in this sentence refer to Mary Ruwart herself, or is it a quote? And which prostaglandin exactly? There are many! Some of them are in fact on the market.
It's a great speech.
I'm sure it is, but you should know by now that I'm not interested in the speaches of politicians, but instead prefer some independent evidence.

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Post by MRC_Hans » Tue Jun 22, 2004 8:26 am

This embedded quoting facility is as much a curse as a blessing, so here we go in the old-fashioned way:

Except that a seal of approval has proven to be a very effective means for doing exactly that.

There's your perception, and then there's reality.

Seals of approval may work for utensils and such, where the danger is limited, but it is not enough for pharmaceuticals. It is not just a question of whether a drug works, but also of right drug in the right dose for the right disease.


And why not, as long as their claims are truthful?

Unfortunately, the claims of the manufacturers are not trutful.

And where are they going to get the money to do this from? The manufacturer can do this because they'll make the money back in extra profits. How can the "medical community" (whatever that is) afford to do so without taking much-needed money from elsewhere?

I agree that the manufacturers should pay for the tests (is't that what you were just protesting against??), but there must be an independent entity that ensures that they conduct the tests properly and report them in a thruthful way.

Yes, he does. He demands them to make stop the FDA from "heavily favoring the industry" (a laughable claim).

The FDA is actually favoring the industry, but not in the way you probably think ;).

That doesn't mean that the result of that balance is the most effective system. Besides, free markets have proven to be much, much better at striking exactly this kind of balance--and in the most efficient and effective way.

This is a very naive notion.

Which is a laugh. The FDA effectively cripples the drug industry.

Absolutely not. The drug industry loves the FDA, because it provides a very effective barrier to cheap suppliers from low-wage areas. And it makes it extremely profitable to market drugs.

The claim of anything crippling the drug industry is ridiculous in itself, since the industry is obviously not crippled, quite the opposite; it is one of the most profitable industries in existence.


Amazing how UL, being 100% dependent on "electrical industry" money, doesn't seem to have this problem...

There is absolutely no comparison between the simple, essentially unenforced requirements of the eletrical industry, and the complex issues in the pharmaceutical industry. All it requires to get an UL stamp is that you declare that you follow some simple rules. There in no control, no requirements for quality control, no nothing. It is an entirely complaint-driven system. Meaning that as long as nobody files a complaint, you can essentially do as you please.

And they're widely advertised because the manufacturers have to make back the almost $1 billion the FDA made them spend bringing it to market. And the ten years or more it can take to go through the FDA brueaucracy means that they don't have that much time to make that money back before the patent expires.

This is nonsense. It does take about ten years to get a drug to the market, but that has nothing to do with FDA bureaucracy, the FDA part is only a few months. The ten years is what it takes to comply with the LAWS that regulate the industry.

The FDA is just a law enforcement agency, you make not like the laws, but it is ridiculous to blame the policemen for it.



She herself holds a patent for prostaglandin to fight liver disease (among many others as well). At the time, there was no cure at all, and prostaglandin was very promising. This was a very important drug and she was personally assured by the FDA examiner that they would do everything possible to help bring this remarkable drug to the market. However, proving efficacy was almost impossible even conceptually since no one had ever cured liver disease before and there was no real parameter to use in order to get the right statistical significance; they would have to do several studies to tell them how to do the studies! And even then, there was no guarantee they would find a method that would yield the proper statistical significance and they would have to start all over again. Meanwhile, the patent clock is ticking. Essentially, the FDA regulations made it impossible to do all of the studies necessary to bring the drug to market and still make money off of it. To this day, it is unknown whether or not prostaglandin works for liver disease, and probably never will.

There is something very fishy about this account. You say that there is this currently incurable disease and there is this new drug that has a fantastic effect. Why exactly is it a problem to show that experimentally? That should be a breeze to do.

Excuse me, but this reminds me of the homeopaths: "We are sure it works, but we just cannot test it because, yada, yada, yada."


I'll see if I can get ahold of a recording of her speech and host it so y'all can hear it. She covers that, her estimate of the numbr of lives lost due to FDA regulations, and so much more. It's a great speech.

It may be a great speech, but is it credible?

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Post by shanek » Tue Jun 22, 2004 5:53 pm

Earthborn wrote:Oh, dear... I suggest you have your eyes checked, and I don't mean that in a bad way.

The first link I gave you has on it very big letters saying 'Watch The Full Program Online'. How else am I supposed to know what the documentary is like? It's PBS, so if it isn't online, there is no way for me to watch it.

I'll make it easy for you: this is where you would end up if you click the big letters.
It must not like Mozilla or Linux, 'cause I'm not getting a thing.
Of course he is an authority on the subject, so it is not a fallacy.
It is when it's your only rebuttal to other authorities on the subject.
Strangely enough, as you will see in the documentary, there are more people who work there or have worked there who get that impression. I take their opinion more seriously than yours.
I'd really like to know how a system that delays introduction of their product 10-12 years or more, and can add about $1 billion to the costs of going to market, can be considered to be "favoring" the industry.
Says you.
Says the evidence.
For some reason however, the countries with the most effective healthcare systems are also the ones with the least free markets. According the Grandfather Healthcare Report anyway.
Bogus statistics. They don't take into account things like, accidental death due to the fact that so many people in the US drive cars, more than any other country, so we have more deaths due to traffic accidents that drop the total; we have a lot of smokers, etc. There are many factors outside of quality of health care that could explain this that aren't accounted for there.
If that is true, it makes me wonder why the drug industry doesn't feel that way at all.
Everyone I've talked to who works in the industry feels that way. Maybe the politically-connected ones don't...
Please give an example of such a study.
Oh, come on! What the fark do you think Good Housekeeping, Consumer Reports, and those kinds of magazines DO???? ALL THE TIME!!!
One is enough to disprove that only the government can organise such a thing.
I've got more than that. I've got magazines full of 'em.
Does the 'she' in this sentence refer to Mary Ruwart herself, or is it a quote?
Yes.
And which prostaglandin exactly?
Not sure.
I'm sure it is, but you should know by now that I'm not interested in the speaches of politicians,
She's not a politician. She worked in pharmaceutical research for something like 35 years. She's an expert in the field.
There is an old android saying. In binary it reads: 01001001001001110110110100100000011011100110111101110100001
00000011101110110010101100001011100100110100101101110011001
1100100000011100000110000101101110011101000111001100100001. Makes you think, huh?