Ridiculous cost of clinical trials hinder new bug repellant

[Justforfun000]

This isn't a crusade against traditional medicine. It's a rejection of USELESS medicine (and potentially dangerous etc) which is why testing is important. Nobody really gives a FUCK if it's an ancient chinese solution to athlete's foot or whatever - only RESULTS matter. You know what happens to 'alternative' therapies when they're proven to work?

THEY'RE NOT ALTERNATIVE ANYMORE. They're actual, factual, testable and reliable therapies.

Championing 'alternative' medicine appears to be a tribal crusade here, dividing medicine into regular medicine and alternative, secret-of-the-ancients medicine you have to have an open mind to use. In reality, there are useful therapies, and useless therapies, and that's it. Testing is needed to determine the safety and efficiacy of a therapy.

I don't disagree with a single thing you've said there. And not a single word is in opposition to any of my main points. The only reason "alternative" is used is for simplicities sake because it's not CONVENTIONAL yet.

[Knife]

Cite people you quote so it is easier to respond.

I didn't address it because it's irrelevant. In reference to most herbs they are generally recognized to be safe in reasonable quantities,

You've never quantified this, and this is the nexus of your problem. Safe reasonable quantities for what? You can treat one ailment with 'safe reasonable quantities' on a drug and still cause other effects. Ever heard of 'side effects'?

and potentially effective at treating or preventing some ailments. So what's your point? Look, either show a really good reason why I should treat all herbal products like they're deadly nightshade or sugar pills, take your pick, or stop exaggerating. They either work or they don't. They are either harmful in some way, to an individual, or they aren't.

Er...the scientific method. The same fucking thing we've been discussing. To test every single fucking drug to see what it does to all systems in you body, not just the ailment you are treating it with. A drug that cures diarrhea may cause fucking cancer. Testing it to see if it cures diarrhea doesn't see if it causes cancer. To test all the contingencies, costs fucking money. You've lost sight of the actual question in your crusade to be right.

That alone should make you pause.

[Simon_Jester]

Where the fuck are you getting that I said it was reasonable? Are you having reading comprehension issues today? I said it didn't have anything to do with this thread, which is entirely different from saying it's reasonable. Turns out there's a difference between identifying things that are common in foods that might have some health benefits and using an "herbal remedy" being marketed entirely on its own as an alternative to regular medicine?

Not the way hypothetical Alzheimer's-me would be using it, there isn't. I'm talking about, for all practical purposes, taking medicinal turmeric in hopes that those studies indicating that it fights Alzheimer's are valid. The stuff might not be advertised as a medicine, but I'd still be using it as a medicine.

In a situation like that, I don't have the inclination to worry about low-probability side effects, and I don't have the time to wait for the FDA to do a study on an entire generation of people fed turmeric to wait for the side effects to kick in. By the time they publish their study results in 10 or 15 years and really NAIL the side effects, I'll be so senile I can't remember anything that happened in the last fifty years.

Plenty of food additives have turned out to have nasty side effects and been banned because they couldn't be proven safe; look at what happened to Red #2 or cyclamates. I'd be taking my chances with the side effects of turmeric (and there might very well be some) in hopes of gaining a few months against the Alzheimer's.

Am I making a foolish or wrong choice because I'm making this decision without the full weight of the medical establishment's research and testing assets behind me? Because that's where this thread seems to be going.
__________

So what's more important to you? An unlimited amount of choice, or the assurance that the drugs you're taking aren't going to wind up making you sterile in ten years?

If I considered Garlic or Ginseng a drug, you might have a point. i don't.

Until those expensive studies show they cause a disease worse than the thing you are trying to cure.

If plants commonly used as spices had major side effects, wouldn't we have noticed? I mean, it would be kind of hard to miss the entire nation of Greece dropping dead of garlic overdose or something like that.

When we're looking at something that we just invented, there's a very good chance that it'll make people swell up and die, because it's pretty much just a random new chemical. If you pick a random chemical out of the (very large) space of possible chemical compounds, most of them are either useless or actively poisonous to humans. Since we select drugs from the ones that aren't useless (the ones most likely to affect the body) a fair number of poisons will have to be screened out of the drug creation process (like thalidomide).

But if it's something people have been sticking in their mouths for the hell of it for thousands of years, giving you a large population to do statistical studies on, you already have a fair amount of data to go on. It may have side effects, but they've got to be subtle enough not to have a major demographic impact. In which case a sane person might decide "what the hell, I might as well take my chances with it, since it doesn't seem to be killing them."

And yeah, maybe it won't work. Sometimes people try things that don't work. As long as they don't cling to stuff that doesn't work at the expense of things that do work (AIDS patients taking "immune supplement herbal remedies" and not taking their retrovirals or something dumb like that), it's not the end of the world.

[General Zod]

I don't disagree with a single thing you've said there. And not a single word is in opposition to any of my main points. The only reason "alternative" is used is for simplicities sake because it's not CONVENTIONAL yet.

If it's conventional then that means it works as advertised. The only reason people use "alternative" is because it doesn't have the same stigma with most people as "hokum".

[Justforfun000]

JFF a single anecdote proves nothing. You have no way of demonstrating whether or not what you gave her did actually change her results. You're confusing causation with correlation, here. She improved after she went off the medication prescribed to her, but was it a result of a placebo benefit of this alternative stuff, a result of being taken off the medications (she could have been having a negative reaction to one or all of them), or was it actually this stuff giving her benefits? You can't answer that. There's a reason why studies are done on drugs in the first place, which you seem to consistently not understand.

I know it's not enough to PROVE it, but who are you or anyone here to say that it isn't RIGHT for her to use this because it seems to be? Lets be realistic. The chances are pretty goddamn good that it's directly beneficial and doing exactly what the bioprospecting has seen as having a particular effect on the liver that's protective. Yes we need majopr studies ultimately to get all the nuts and bolts worked out and prove absolutely how effective, how often for most people, and possibly any contraindications or adverse effects. But the point is, that it's GENERALLY KNOWN to be a safe herb and it's demonstrating what is either a very coincidental response or a very real effect. So again, are you or anyone else here suggesting she should not have the right to use it? That's what it ultimately boils down to. I don't care whether you think it's stupid or not. People take gambles on things that look good early. Life is risk. If you wait for everything to be proven, you'd never use anything new.

EDIT: I also wanted to mention that "herbal supplements" have been shown to have real effects and then been refined and manufactured. Aspirin is an excellent example of an incredibly ubiquitous drug that has its root in natural settings. There's a whole host of drugs similar to Aspirin in that regard, so there isn't some massive conspiracy against herbs in the medical world, it's just that quite a few of these "supplements" have been shown to have no real effect on patients.

And this supports my point ultimately. Of course some herbs have been shown to be without merit. They have fallen by the wayside in the main. There's a reason why some have remained popular. They seem to work.

[Stark]

So you're outraged testing is so slow/expensive or whatever for something you declare already works, and then turn around and say you agree only tested stuff is real medicine? HILARIOUS. This is the exact attitude I referred to in my original post. You're a self-educated, self-proclaimed medical authority and you just don't fucking get that that isn't how science or the real world works.

I know it's not enough to PROVE it, but who are you or anyone here to say that it isn't RIGHT for her to use this because it seems to be? Lets be realistic.

What the fuck. That you defend this attitude is appalling. PS, you just said you agree only tested, proven benefits are relevant when you 'agreed' with me. Are you a liar, a hypocrite, or an idiot?

[General Zod]

Not the way hypothetical Alzheimer's-me would be using it, there isn't. I'm talking about, for all practical purposes, taking medicinal turmeric in hopes that those studies indicating that it fights Alzheimer's are valid. The stuff might not be advertised as a medicine, but I'd still be using it as a medicine.

There's a reason people who self medicate are made fun of. Unless you're a doctor then you aren't going to properly understand all the effects involved or necessarily all of the consequences of doing so. Unless you're in the position where you can't get any real medical advice whatsoever, it's generally a bad idea.

Am I making a foolish or wrong choice because I'm making this decision without the full weight of the medical establishment's research and testing assets behind me? Because that's where this thread seems to be going.

The only reason it seems to be going that way is because you're trying to derail it.

[Knife]

I know it's not enough to PROVE it, but who are you or anyone here to say that it isn't RIGHT for her to use this because it seems to be?

It isn't right because you are peddling a placebo for a cure. If it wasn't a 'traditional medicine' you would cry foul. It is her right to take it, but it is also her right to know what the fuck she is taking. Hence, testing.

If she is hurting and nothing proved to help her works, and she likes shit that doesn't help but doesn't make things worse, and she understands that, go a fucking head. But if some douche sells her snake oil and she thinks it will help when it doesn't, it IS WRONG. That is why we test shit and why it is expensive.

Lets be realistic.

You are not.

The chances are pretty goddamn good that it's directly beneficial and doing exactly what the bioprospecting has seen as having a particular effect on the liver that's protective. Yes we need majopr studies ultimately to get all the nuts and bolts worked out and prove absolutely how effective, how often for most people, and possibly any contraindications or adverse effects. But the point is, that it's GENERALLY KNOWN to be a safe herb and it's demonstrating what is either a very coincidental response or a very real effect. So again, are you or anyone else here suggesting she should not have the right to use it? That's what it ultimately boils down to. I don't care whether you think it's stupid or not. People take gambles on things that look good early. Life is risk. If you wait for everything to be proven, you'd never use anything new.

How may people ate PhenPhen before the FDA stopped it from being sold? How many ate it after?

[Knife]

This whole section of thread is a perfect example of an appeal to emotion, with a side trip to appeal of tradition.

[Stark]

I love how he DECLARES 'the chances are pretty goddamn good that it's directly beneficial'. Turns out without proper testing results that's a totally ridiculous thing to say?

If I eat a camel dick and my girlfriends tits seem to get better, OBVIOUSLY the camel dick was directly beneficial. What do you mean sample size one? What do you mean correlation/causation? OBVIOUSLY IT WORKS! If you ate one and nothing happened, there was obviously some special circumstance that stopped it working. It's GENERALLY KNOWN to be safe, so there couldn't be anything worth testing safetywise. What's that? Relatively common compounds can adversely affect some individuals? Who cares, it's GENERALLY KNOWN to be safe, that's good enough, cancel the safety battery! It's obviously directly beneficial!

As I said, this is EXACTLY the attitude in the OP I took issue with. He's stunned that something that 'obviously works' and is 'obviously safe' still requires years of expensive testing... because he HONESTLY DOESN'T UNDERSTAND WHY IT'S NECESSARY. Look at the way he talks about inherited, 'common sense', intuitive and group attitudes! What do you mean there's no scientific validity there?!

And he wonders why people think alterative medicine people are kooks.

[Erik von Nein]

I know it's not enough to PROVE it, but who are you or anyone here to say that it isn't RIGHT for her to use this because it seems to be?

*Sigh* Calm down, there. I said you don't know what's causing the shift, because at the same time you put her on this other stuff you took her off the rest, as well as made plenty of assurances that it would help. Now, there's a lot going on there that you can't, for certain, say it was the drugs you put her on, and not a combination of other factors, which is why her example is useless for evidence that they work. This isn't a matter of right or wrong, it's a matter of evidence, and, quite frankly, your evidence stinks.

Lets be realistic. The chances are pretty goddamn good that it's directly beneficial and doing exactly what the bioprospecting has seen as having a particular effect on the liver that's protective.

No, they probably aren't "goddamn good." They could be promising, if the studies that were conducted were properly done, but so far it's a "there is a possibility it could help." Nothing very conclusive.

Yes we need majopr studies ultimately to get all the nuts and bolts worked out and prove absolutely how effective, how often for most people, and possibly any contraindications or adverse effects. But the point is, that it's GENERALLY KNOWN to be a safe herb and it's demonstrating what is either a very coincidental response or a very real effect.

So, your argument is testing is necessary, but not necessary for people to take the drug, because it's already "generally known" to be effective. Well, there's some vague references to "studies" showing that it could be. I wonder who funded these studies, what their criteria is and how they conducted them? Do you have these studies? Who is it "generally known" to? Because your claims are sounding as reasonable as homeopathic claims, including the personal anecdotes.

So again, are you or anyone else here suggesting she should not have the right to use it? That's what it ultimately boils down to. I don't care whether you think it's stupid or not. People take gambles on things that look good early. Life is risk. If you wait for everything to be proven, you'd never use anything new.

I never said she couldn't use it. She can drown herself in homeopathic remedies for all it matters. That's not the debate at hand and you're going completely off the rails from what my point was, which is that your anecdote is not representative of any kind of real effect.

And this supports my point ultimately. Of course some herbs have been shown to be without merit. They have fallen by the wayside in the main. There's a reason why some have remained popular. They seem to work.

"Seem to" and "actually" are not the same thing. As far as your statement about herbs falling by the wayside, to what are you referring? All the herbs that have been tested that have no effects on people but are still used, like ginka biloba? This article apparently says otherwise.

In any event, hyperventilating about how we're trying to say it's not right for your relative to take herbs for conditions is such a huge red herring it's insane. What we're saying is it's not right for you to spout off about how these herbs DO work for these conditions without any real testing and for you to advocate their use. The whole tangent about your relative is just about your level of evidence being insufficient for any conclusion. Tossing in an anecdote is only useful if you then provide further evidence that it actually is useful.

[Broomstick]

Why is there any NEED for the costs to be so astronomical?

Have you ever heard those ads on the radio where they offer you thousands of dollars to come in for a weekend and participate in a medical study? Now think about the fact that you probably want a large number of participants, plus a control group, all of which is being paid four figures per head. All of this will need to be documented by highly paid personnel, supervised by highly qualified (and even better paid) personnel, run by a company which has to do all kinds of certification work and paperwork, etc. And you aren't going to run just one study: you have to run studies on safety, studies on effectiveness, probably for different population types and conditions, etc.

One of the reasons for the high costs of medical studies is the fact that most people are rather reluctant to participate in one, and must be bribed with considerable sums of money to do it. Would you participate in a medical study of a hitherto untested experimental drug? How much money would it take? I wouldn't do it. What if I have some horrible reaction and get fucked up for life?

Ever hear of Hibiclens? Many, many years ago I was a participant in the process of getting it approved - I have extremely sensitive skin and they wanted to test it on sensitive skin to see if it was safe or if there was a reaction. I was paid $110 to wash my face with it twice a day for several weeks (I don't even remember how long it was any more). If they have 10 people participate in that trial it's $1,100. If it's a 100 then it's 11,000. That is just one step in the process. There were additional tests before that one on people, and more on other people afterward, on animals before that, record keeping, materials to buy, follow up... the costs add up very quickly. From the title I thought it would be a complaint about millions or tens of millions of dollars. Hundreds of thousands to bring a new product to market is a significant amount of money but actually pretty common.

It's not just a matter of whether or not skin cells will react to the chemical (though that isn't a bad test) - anything you put on your skin will eventually get on your hands, and anything you get on your hands will eventually get on your food and utensils and into your mouth. It might react chemically with other common topical chemicals like soap and cosmetics. That's why testing has to occur part of the time in the real world with real people and not just in a laboratory.

[Darth Wong]

Justforfun is saying some stupid things, but let's keep in mind that the way drugs are currently approved, the system does discriminate against anything which can't be patented. Without patentability, no company has the incentive to spend the money necessary to get approval and bring the product to market. Companies are tasked with doing their own testing (let's ignore the conspicuous conflict of interest in this concept for now), so any company which forked over a million dollars to win approval for some non-patentable therapy would simply end up losing a million dollars while its competitors could freely market and sell the same product once it's approved.

There are problems with the way the whole drug approval process works. And there is some considerable ambiguity in the system as well, where we draw the line between "herb", "drug", and "food". Suppose someone eats a lot of broccoli because he has been told that it's good for his health and reduces his risk of heart disease and certain types of cancer. Is that a dietary choice? Or is it primitive unregulated self-medication based on untested quack therapies which have not been approved by the FDA?

[Stark]

As you say, that's a financial issue with a lack of profit motive (without the certain profit of a patent). I imagine that's why there are products patented that are simply a complicated way of delivering some unpatentable active ingredient to get around this - but of course there is no security investment-wise because anyone else can use the same active ingredients.

I'm not even sure independent testing organisations woudl resolve it, since they'd probably want to be funded by sales of the tested object somehow (even indirectly through special taxes etc) which still leaves a discouragement to development.

[Justforfun000]

All right, I've cooled down and re-read the thread a bit and I'll concede a little bit of a minor point that seems to be much more harped on then I guess what I am really trying to get at.

I understand and agree things should be eventually and estensively tested so that we can have the best evidence possible of efficacy and also address any side effects, adverse reactions, allergies, etc. This is a given for any new drug and is VERY necessary before they can be promoted. And eventually, all herbals should be as extensively tested.

All I am trying to say is that herbs have always been in a bit of a grey category because in the main, they are relatively non-toxic IN COMPARISON with pharmaceuticals. Thats besides the point that they sometimes prove beneficial, and many times for exactly what they have been used for over the centuries. That's a simple statement of fact and it's also the reason why the United States has the DSHEA act. I's not a point of view that I myself thought up and am promoting, it's simply agreeing with the same people who lobbyed for that separate category. In a lot of your minds, I guess that means I simply have a lot of idiots for company, but oh well.

In any event, I am not saying examples of individual people absolutely prove an individual herb as effective. But to THAT person, if it demonstrably affects their biochemistry for he better, it's good enough! That is why I'm saying that I think it's perfectly sensible to choose to take certain herbs that A) Have a long history of general safety, B) Have a reputation of being useful for certain conditions, C) Have some promising clinical studies indicating that yes they actually DO seem to be having a beneficial effect and more studies need to be done...

Taking ALL of those into account along with individual people who other then just "feel good", but actually show significant medical benefit that if it appears out of the blue while taking something new, and lasts longer than the placebo effect would and is CONSISTENT, then it's a perfectly logical and hopeful chioce to take the supplement.

I've probably gone off these main points when I've gotten flustered, but for Christ's sake...instead of giving me the benefit of the doubt that I have any knowledge whatsoever of human anatomy, medical science and continually having people strawman my points to ridiculous extremes is hardly helping me focus without getting me pissed off and derailed. You guys are like vultures sometimes. You just attack and attack without a break. It just gets so hostile and contrary that you feel it's not to truly reach an understanding or get to the truth, it's all about showing the other person up if they don't agree with you.

Anyway, if the above doesn't clarify my main point enough, or if you still just disagree then I'm giving up because I truly believe I'm right enough in what I'm professing. There's a certain amount of collective evidence that in my opinion is worth basing a reasonable expectation of benefit from certain herbs.

[Simon_Jester]

Not the way hypothetical Alzheimer's-me would be using it, there isn't. I'm talking about, for all practical purposes, taking medicinal turmeric in hopes that those studies indicating that it fights Alzheimer's are valid. The stuff might not be advertised as a medicine, but I'd still be using it as a medicine.

There's a reason people who self medicate are made fun of. Unless you're a doctor then you aren't going to properly understand all the effects involved or necessarily all of the consequences of doing so. Unless you're in the position where you can't get any real medical advice whatsoever, it's generally a bad idea.

So what happens if I go to said doctor and ask "Hey, doctor, what about these studies indicating that turmeric fights Alzheimer's?

I'm not trying to be willfully obtuse about this, nor am I proposing that people with terminal illnesses be willfully obtuse. But I think you guys are overlooking an important aspect of the issue here. There are a lot of diseases where we honestly haven't built up a comprehensive pharmacopeia of carefully tested pharmaceuticals that can readily suppress all the problems. The search space of possible chemicals is large, and the time and resources available to search it are limited. There are a lot of experimental drugs for which testing is still underway, and there's a lot of naturally occurring stuff that nobody's gotten around to spending a decade and half a billion dollars analyzing.

Ignoring that stuff on the kneejerk assumption that it's all crap, even the stuff that HAS passed multiple double-blind tests, isn't reasonable.
________

Am I making a foolish or wrong choice because I'm making this decision without the full weight of the medical establishment's research and testing assets behind me? Because that's where this thread seems to be going.

The only reason it seems to be going that way is because you're trying to derail it.

I disagree. You guys were bawling out JFF over this idea of trying to use herbal stuff the FDA hasn't bothered to nail down yet before I even showed up, and the tone of the bawling didn't change until very recently.

I know what I'm talking about*, and I'm pretty sure I know what JFF is talking about, and I'm pretty damn sure we're talking about the same thing. So I question the logic of calling it a derail

*I mean that literally, not metaphorically. Not "I am an expert biochemist," but "I know what the subject of my own statements is."
________

There are problems with the way the whole drug approval process works. And there is some considerable ambiguity in the system as well, where we draw the line between "herb", "drug", and "food". Suppose someone eats a lot of broccoli because he has been told that it's good for his health and reduces his risk of heart disease and certain types of cancer. Is that a dietary choice? Or is it primitive unregulated self-medication based on untested quack therapies which have not been approved by the FDA?

Exactly.

Broccoli having some positive effects is fairly well documented, too. And it's been demonstrated to contain substances with positive effects by serious professionals; this isn't in the same class as eating powdered rhinoceros horn as a cure for impotence. But it's not something your doctor will necessarily prescribe specifically to lower your risk of heart disease, even if it's quite likely to have that effect.

[Stark]

The distinction between 'medical treatment for a specific ailment' and 'healty diet' is an interesting one - as someone said in another thread, all health issues are playing the odds, so a healthy diet just improves your odds and any step of a relevant illness. Doctors prescribe in diets when there are specific things needed to be avoided etc, but the idea that there's nothing to treat beforehand is where nutrionists found their niche.

[General Zod]

Ignoring that stuff on the kneejerk assumption that it's all crap, even the stuff that HAS passed multiple double-blind tests, isn't reasonable.

Oh bullshit. If something comes with the effective warning that its side effects are not fully documented? Then ignoring it in favor of something that's been thoroughly studied is perfectly reasonable. One has greater evidence supporting its efficacy than the other. This isn't rocket science here.

I disagree. You guys were bawling out JFF over this idea of trying to use herbal stuff the FDA hasn't bothered to nail down yet before I even showed up, and the tone of the bawling didn't change until very recently.

Turns out we mock people for making stupid claims on here? Shocking, I know.

I know what I'm talking about*, and I'm pretty sure I know what JFF is talking about, and I'm pretty damn sure we're talking about the same thing. So I question the logic of calling it a derail

You brought up an example that was unrelated to what was being discussed and that attacked points nobody was making, that's a derail by any reasonable definition.

[Justforfun000]

Justforfun is saying some stupid things, but let's keep in mind that the way drugs are currently approved, the system does discriminate against anything which can't be patented. Without patentability, no company has the incentive to spend the money necessary to get approval and bring the product to market. Companies are tasked with doing their own testing (let's ignore the conspicuous conflict of interest in this concept for now), so any company which forked over a million dollars to win approval for some non-patentable therapy would simply end up losing a million dollars while its competitors could freely market and sell the same product once it's approved.

There are problems with the way the whole drug approval process works. And there is some considerable ambiguity in the system as well, where we draw the line between "herb", "drug", and "food".

Suppose someone eats a lot of broccoli because he has been told that it's good for his health and reduces his risk of heart disease and certain types of cancer. Is that a dietary choice? Or is it primitive unregulated self-medication based on untested quack therapies which have not been approved by the FDA?

And thank you Mike. At least a couple of points were at least acknowledged as reasonable. Everyone else arguing with me wouldn't concede one whit of anything I said, Just continually attacking whatever I was unclear or weak on in their mind.

your last paragraph is a great example of how blurred the lines are between some things we label "foods" and "herbs". For example, Artichoke leaf is arguably a food, but it's also an herb and it's one of the ingredients in AOR's original Liver Health formula.

As they justify it's inclusion:
Artichoke Leaf is another important addition to Ortho•Liver because it stimulates the production of bile which helps to clear bilirubin and to eliminate cholesterol.

And if you do even a quick search, you can find a good study to back up exactly what they are saying. But again, if I just listened to the nay sayers here, I'd have to consider all of this "worthless" and not have the sense to make such a decision as to take this. Godz, it could be so HARMFUL.

This argument against me got way off the rails. I'm not pushing alternative medicine OVER orthodox, and I completely believe in the scientific method. There is just a serious bias here from many against anyone accepting preliminary evidence regarding medical things like herbs, but the arguments boil down to harm vs benefit ratio and as I've already stated and is a known fact, many herbs are similar if not as above, identical to food and the issue of toxicity and the safety profile concerning the substance is in a completely different ball game from the get go as a rule. Why anyone is being so stubborn to not accept these simple facts is beyond me. And before some asshole snips this and tries to strawman me again, I said quite clearly "MANY" herbs. Not all, not every, and not always.

Here. Look at the study supporting the efficacy of this new "drug":

Artichoke Leaf Extract Lowers Cholesterol

ScienceDaily (July 7, 2008) — Researchers at the University of Reading have found that an over-the-counter Artichoke Leaf Extract (ALE) from the globe artichoke plant can lower cholesterol in otherwise healthy individuals with moderately raised levels. Cardiovascular diseases are the chief causes of death in the UK, and are associated with raised circulating levels of total cholesterol in the plasma.

Once plasma cholesterol reaches a certain level, drugs such as statins are often prescribed to help reduce it. Intervention before concentrations reaches these levels may help reduce the risk of developing cardiovascular diseases without the need for drugs. This new piece of research has shown that otherwise healthy people with moderately raised plasma cholesterol may be able to lower their levels by taking this herbal supplement.

During the trial, 75 volunteers were given 1280mg (4 capsules) of an ALE, or matched placebo, each day for 12 weeks. ALE consumption resulted in a modest but favourable statistically significant reduction in total plasma cholesterol after the intervention period.

For over 10 years, the relationship between dietary intakes of antioxidant nutrients and a reduced risk of cardiovascular diseases has been recognised and investigated. Antioxidant nutrients include ‘non-essential’ phytochemicals (e.g. flavonoids) as well as ‘essential’ nutrients (e.g. vitamins C, E). Several plant-rich sources of flavonoids, such as fruits and vegetables, tea, red wine, cocoa and olive oil, have been associated with lower risk of cardiovascular diseases, although the exact mechanisms for their protective effects is still not clear. Research has shown that ALEs are rich in various flavonoids.

Globe artichokes have been used traditionally in Europe to improve digestive and urinary tract health. Artichoke leaf extracts (ALEs) are currently used in Germany and Switzerland as a remedy for indigestion, and are available in the UK as over-the-counter food supplements. Various studies have provided an evidence base for their use in conditions such as dyspepsia and irritable bowel syndrome.

Dr Rafe Bundy said “Reducing cholesterol levels can reduce the risk of developing cardiovascular disease. Our research investigated whether ALE could be beneficial to otherwise healthy people who had raised levels of cholesterol but were not yet at a stage where they needed standard medical intervention. ALE may provide another option which people could try over and above a healthy diet in order to help lower plasma cholesterol.”

Journal reference:

1. Bundy R., et al. Artichoke leaf extract (Cynara scolymus) reduces plasma cholesterol in otherwise healthy hypercholesterolemic adults: a randomised double-blind placebo controlled trial. Phytomedicine, DOI: 10.1016/j.phymed.2008.03.001

Adapted from materials provided by University of Reading.

[Darth Wong]

Oh bullshit. If something comes with the effective warning that its side effects are not fully documented? Then ignoring it in favor of something that's been thoroughly studied is perfectly reasonable.

Is there any dietary regime which has been clinically tested as if it were a drug, and then approved by the FDA as a therapy for heart disease? If not, then does this mean we should ignore dietary regimens in favour of Lipitor?

[Justforfun000]

Oh bullshit. If something comes with the effective warning that its side effects are not fully documented? Then ignoring it in favor of something that's been thoroughly studied is perfectly reasonable. One has greater evidence supporting its efficacy than the other. This isn't rocket science here.

Zod, you just Strawmanned him the same way you've been doing to me. Where the hell did he say anything about choosing an alternative type of medicine OVER an orthodox? And you're also again insinuating that it's identical in consideration as if it was a competing investigational drug. Why is it so hard to get through to some people here how different some herbs and foods can be? You know, it's not very likely DSHEA whould have passed if it wasn't based on this common sense as a starting point. Same reason we have similar laws here in Canada. Are you suggesting all our governments are complete anti-science idiots?

[General Zod]

Oh bullshit. If something comes with the effective warning that its side effects are not fully documented? Then ignoring it in favor of something that's been thoroughly studied is perfectly reasonable.

Is there any dietary regime which is approved by the FDA as a therapy for heart disease? If not, then does this mean we should ignore dietary regimens in favour of Lipitor?

I was referring more to drugs and other supposed herbal remedies than necessarily something like dietary regimes. A number of studies have shown diets with foods high in Omega 3 fatty acids help with lowering risk of heart disease, though.

[Darth Wong]

A number of studies have shown diets with foods high in Omega 3 fatty acids help with lowering risk of heart disease, though.

So? There are a number of studies about herbs too, but you're ignoring all of those because they aren't FDA approved. By that logic, all of this Omega-3 stuff is just whoo-whoo anti-science quackery too.

The whole point I'm making is that the drug approval process was specifically designed for commercial pharmaceutical products. It does not apply well to other areas. They should really try to devise some method of educating the public about the benefits and risks of some of these alternative therapies, but then we run into an uncomfortable fact: most of our health information comes from entities with some kind of commercial link. The whole apparatus is not really set up to do this sort of thing.

[Stark]

PS JFF, pointing out systemic flaws in testing (financial, etc) doesn't mean someone is agreeing with your ridiculous 'obviously it's safe' 'damn likely it works' statements. Stop thinking tribally; Mike isn't on 'your side of the fence' because he's 'anti-testing'; he's simply raising relevant issues to the discussion.

He'll be on your side when he sticks his fingers in his ears and says 'I know it works waaaah'.

I'm curious about the relative standards of the work of nutritionists (with regard to dietary research) and that of drugmakers, since they're both part of the 'health industry'. Is the distinction (at least in the US) due to the FDA being set up to stop 'snake oil' etc, rather than actually being a 'test and regulate health claims' body?

EDIT - BAH instaposted.

[Justforfun000]

Just for the hell of it, since it's one of the main formulas I've been referencing in my debate, here is a combination of herbs and substances that have a great deal of collective research that is very suggestive of benefit. It's the same line my mother has been taking for years.

The liver is the largest gland and the most important detoxification organ in the body. More than 500 functions have been attributed to the liver. These functions include the production of bile and the secretion of glucose, proteins, vitamins and fats. The liver also stores energy in the form of glycogen and decomposes red blood cells and unwanted proteins. These important functions explain why the liver has two distinct blood supplies, one to bring oxygen to the liver; the other (called the hepatic portal system) to bring nutrients and molecules absorbed from the gastrointestinal tract to the liver for processing and detoxification.

Liver disorders are a major health problem in North America. While most of the severe liver disorders are related to alcohol consumption, viral hepatitis and hemochromatosis, most of us should be taking better care of our liver because when we overindulge, our liver suffers...
Prevalence of Chronic Liver Disease
• Cirrhosis of the Liver: 400,000 people in the USA 1976-80 (NIH, 1994).
• Alcoholic liver disease: More than 2 million Americans (NIAAA).
• Alcohol is the cause of 44.7% of all death due to liver disease.
• Chronic Hepatitis C: Almost 4 million Americans have antibodies indicating infection or prior exposure (NIDDK).
• Chronic Hepatitis B: 750,000 people in the United States (NIAID).
• Autoimmune Hepatitis: 1,156 people in the USA in 1996.
• Hemochromatosis: more than 1 million Americans (CDC); 5 per 1000 in Caucasians (NIDDK).
• Primary biliary cirrhosis: 9,232 people in the USA in 1996.
• Sarcoidosis: 20 per 100,000 overall; 5 in 100,000 caucasians; 40 out of 100,000 African Americans; Scandinavia 64 out of 100,000 people
• Liver cancer: 16,600 annual cases (SEER 2002 estimate)
• Sarcoidosis: 20 per 100,000 in the city, less in the country.

Ten to fifteen percent of North Americans drink excessively and five percent of us have a genetic disorder known as Gilbert's syndrome which causes abnormal bilirubin metabolism. It should come as no surprise that roughly six percent of healthy people have abnormal liver function. The liver produces or processes most of the nutrients and compounds used by the body; it deserves to be looked after.

The effects of alcohol on the liver:
• Most liver disorders are linked to ethanol, hepatitis C and hemochromatosis.
• In cases of hemochromatosis, vitamin C should be avoided because it increases iron absorption.
• Chronic ethanol administration alters methionine metabolism in the liver, which increases SAH levels. Elevations of SAH levels in the liver are linked to hepatotoxicity and apoptosis and increases homocysteine levels in plasma. Methylating agents counteract this pathological change.
• Ethanol induces oxidative stress and leads to the depletion of antioxidants. Ethanol also alters the fluidity of the cellular membrane of hepatocytes.
• Ethanol increases inflammation through the release of inflammatory cytokines.
• Heavy alcohol consumption often leads to a condition known as fatty liver. This increases the potential for oxidative stress which leads to further inflammation and fibrosis.

Ortho•LiverTM was formulated to support optimal liver function. The ingredients found in Ortho•Liver have collectively been shown in studies to protect the liver from toxins, stimulate liver regeneration, inhibit lipid peroxidation, enhance levels of glutathione and induce cytochrome P450.

Milk Thistle Extract - Milk thistle has been used as a traditional remedy for over 2000 years. Milk thistle protects the liver against toxins and has been used successfully to treat chronic liver diseases. More recent trials have also suggested that milk thistle has anticancer, antidiabetic, and cardioprotective effects.

Schizandra - Ortho•Liver also contains Schizandra, an East Asian berry used in Traditional Chinese Medicine. Recent research suggests that Schizandra increases the production of an important antioxidant known as glutathione. The benefits of Schizandra also include the induction of detoxification pathways and the possible prevention of liver cancer as recently shown in animal trials.

N-Acetyl-Cysteine - NAC is a precursor to glutathione, one of the most important antioxidants of the body. Glutathione is a protein made from 3 amino acids and its synthesis is limited by the availability of cysteine. NAC protects the liver against free radicals and toxins and is now used to prevent liver injury associated with acetaminophen poisoning which is the number one cause of calls to poison centers in the US.

Phyllanthus niuri (PN) - PN is a perennial herb common in hot central and southern areas of the Indian Subcontinent. One of the most impressive applications of PN is in the treatment of certain viruses, particularly hepatitis B. Hepatitis B is a virus that affects the liver, causing inflammation and jaundice, possibly leading to liver cirrhosis, cancer, or even death. The effect of phyllanthus for the treatment of infective hepatitis has been studied clinically in 160 patients suffering from jaundice. Of the 160 cases, 101 were completely cured while there were 59 dropouts. PN has also been documented to protect the liver from damage by a variety of chemical liver toxins and oxidative stress.

Sulforaphane glucosinolate (SGS) is a naturally occurring isiothiocyanate found in the brassica family of vegetables, such as broccoli. Sulforaphane has been shown to stimulate the natural defenses of the body to prevent or ameliorate chronic disease. It is a natural anti-oxidant and a potent inducer of phase II liver detoxification enzymes. These effects give sulforaphane not only potent hepatoprotective properties, but also anti-carcinogenic properties.

If you are looking for a complete liver formula that will support liver function and detoxification while promoting liver regeneration, look no further - Ortho•Liver is based on the latest research trials and contains ingredients shown to prevent liver injury and support normal liver function.


References
Manov I, Hirsh M, Iancu TC. Acetaminophen hepatotoxicity and mechanisms of its protection by N-acetylcysteine: a study of Hep3B cells. Exp Toxicol Pathol. 2002 Feb;53(6):489-500.

Thong-Ngam D, Samuhasaneeto S, Kulaputana O, Klaikeaw N. N-acetylcysteine attenuates oxidative stress and liver pathology in rats with non-alcoholic steatohepatitis. World J Gastroenterol. 2007 Oct 14;13(38):5127-32.

Nagai H, Yakuo I, Aoki M, Teshima K, Ono Y, Sengoku T, Shimazawa T, Aburada M, Koda A. The effect of gomisin A on immunologic liver injury in mice. Planta Med. 1989 Feb;55(1):13-7.
Chiu PY, Mak DH, Poon MK, Ko KM. In vivo antioxidant action of a lignan-enriched extract of Schisandra fruit and an anthraquinone-containing extract of Polygonum root in comparison with schisandrin B and emodin. Planta Med. 2002 Nov;68(11):951-6.

Patt CH, Yoo HY, Dibadj K, Flynn J, Thuluvath PJ. Prevalence of transaminase abnormalities in asymptomatic, healthy subjects participating in an executive health-screening program. Dig Dis Sci. 2003 Apr;48(4):797-801.
Mehrotra R, Rawat S, Kulshreshtha DK, Patnaik GK, Dhawan BN. "In vitro studies on the effect of certain natural products against hepatitis B virus." Indian J Med Res 1990 Apr; 92: 133-8.

Bagalkotkar G, Sagineedu SR, Saad MS, Stanslas J. "Phytochemicals from Phyllanthis niuri Linn. And their pharmacological properties: a review." Journal of Pharmacy and Pharmacology 2006; 58: 1559-70.

Thornalley, PJ. Isothiocyanates: mechanism of cancer chemopreventative action. Anti-Cancer drugs. 2002;13;331-338.

Yoxal V, Kentish P. Coldham N, Kuhnert N, Sauer MJ, Ioannides C. Modulation of hepatic cytochromes P450 and phase II enzymes by dietary doses of sulforaphane in rats: Implications for its chemopreventive activity. Int J Cancer. 2005; 117(3): 356-362.
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