Safety and Effectiveness of Herbs and Pharmaceuticals

Well Lumpy,You haven't actually said anything to debate.

So why do you feel I would take issue with that position?

Lumpy,I try to look at each thread as a new beginning. No mistakes, no misconceptions, etc.I'd appreciate it if you'd let me assume my own position in a thread.
You don't seem to understand me very well concerning this issue. Please keep that in mind should I decide to participate.Thanks

Should I participate, make sure you aren't the one creating the false front.I only have to stay true to the position I present as mine.

The study you provided doesn't really differentiate between adverse reactions due to the misuse or abuse of ephedra and adverse reactions associated with proper use of ephedra.I agree that poor labeling and misconceptions of safety contribute to the misuse and abuse of medicinal products, but misuse and abuse is not confined to non-FDA approved products. EphedrineThe point being that testing for safety and effectiveness only applies to the proper usage of the product. It can't stop people from misusing and abusing the products.When reading about Chinese Medicine and their use of ephedra, the reference to 5000 years of use doesn't seem to be referring to misuse and abuse of the plant. They are talking about the proper usage as practiced by health practioners. Supposedly the proper use of ephedra by health practioners was not banned.I agree that holistic practioners should report adverse effects, which I think the government is working on that. This would help gather data for those grandfathered herbs.

In a perfect world, it would be nice if everything was approved before going to market. Unfortunately when it comes to herbs/botanicals, some of these things have been used medicinally for thousands of years by various cultures. So politically it would be difficult to completely ban something like ephedra, which is used by Chinese Medicine groups in this country. That's one of those balancing acts of trying to keep everyone happy. Many of them were already out before the FDA came to be. I think any new concoction should be subject to approval before marketing and I think labeling and quality are crucial for anything contained.The clinical trials should be looking at whether the product is safe under proper use and whether it is effective under proper use. I think drug tests usually try to see where the limit is on dosage. I don't know for certain.Someone saying that the problems in the study weren't revealed during 5000 years of use in China, is misleading in my opinion. We can't tell what they have encountered and changed over 5000 years Apparently ephedra isn't prescribed by itself. Maybe those reasons should be researched and probably have before the government made a decision.An MD prescribes an FDA approved drug. The warning says do not take with alcohol. If the patient takes the drug with alcohol and has an adverse effect or the drug does not work correctly, that does not change the safety and effectiveness rating of the drug because it was not used properly.If the study was only looking at the results of misuse and abuse, it doesn't really give us a good picture of ephedra when used properly.

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Difficult perhaps, but necessary where there is a proven danger to health. Should tradition be allowed to trump public safety? I think not.

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The United States tried that once with alcohol. Prohibition I don't think our government wants to create a bigger problem than they already have. Now there's money attached to that tradition.

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The abstract provided in Percy's link made no mention of it, only of an analysis of toxic exposures.

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That's why I said the study you (Percy) provided doesn't really differentiate between adverse reactions due to the misuse or abuse of ephedra and adverse reactions associated with proper use of ephedra.

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Can you demonstrate that all (or even a significant portion) of those exposures were the results of misuse?

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No, I can't. The study doesn't give us enough information.

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Anyway, what constitutes proper use, and how are we to tell?

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I would think the proper use would be determined by the culture using it for 5000 years. I would think if one is going to start testing they start there.

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I'm sure that increased attention to traditional herbal remedies will provide us with many very useful medicines, but the only way to measure their usefulness is by clinical trial.

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I think some of the difficulty with clinical trials as used for drugs, is that the herbal remedies, when done correctly, aren't as precise as the drugs.The mixtures supposedly may address more than one issue. When people try to use medicinal herbs the same way we use drugs, that is usually when we have misuse and abuse. Holistic is a different way of looking at healing. So I think a system of testing for effectiveness would need to take that into consideration.Edited by purpledawn, : Changed are to aren't in 5th paragraph.

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Dawn, I appreciate your comparison of banning dangerous herbs with prohibition, but I don't buy it. Alcohol is almost ubiquitous in western society, and whatever its dangers, it is at least of proven efficacy!

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The point of the comparison was the rise of black markets. That is a situation the government would not want to create.

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Herbs with active ingredients should be regarded as drugs, and subject to the same licensing regulations. They should only be prescribed by properly qualified individuals, operating within a regulatory framework.

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I agree there needs to be regulation and I feel that will eventually come around. Change takes time.

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Then why bring up the possibility that negative side effects of ephedra use were a result of misuse?

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The article on Ephedrine I linked to in Message 17

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The caveat is that none of this means that any given tradition is correct about their herbal medicines.

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None of this what? Correct in what way? To understand the accepted proper use so that one can test accordingly, we would go to the health practitioners trained in herbal medicine. They should know how the herb has been used and the expected results.

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Herbs are not as precise as lab-prepared drugs.

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Sorry, typo. That should have said herbal remedies, when done correctly, aren't as precise as the drugs.

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It deals with the whole subject of herbal medicine, not just foxglove, and it is a fantastic read.

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Yes, I read it. The use of foxglove is another example of what I mean when I say mixtures. In the article, Flower for the Heart, we see that when first discovered; foxglove was used in a mixture, not by itself. Just as the use of ephedra in Chinese Medicine is supposedly not given by itself. So if we test herbals are we testing just the active ingredient of the herb or the mixture for a certain ailment. The herb by itself may not have the same outcome as the mixture. Do we test one, both, or all the ingredients and their interactions to truly test how they affect the body?

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Herbs are drugs.

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But for the ease of discussion can we just call them herbs and drugs so that we don't have to type pharmaceutical drug or herbal drug to differentiate? This debate concerns safety and effectiveness not whether herbs are or are not drugs. We've already agreed they need to be tested and I don't have the knowledge or resources to debate molecules.

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The only sensible definition of misuse and abuse is where harm outweighs benefit, or benefit is non-existent.

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Misuse is when one uses something incorrectly. It doesn't matter whether the outcome is beneficial or not.
We just call it a discovery when we misuse something and a benefit is found.

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Does the drug heal(by which I mean "does it perform significantly better than placebo?")?

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Does it heal what? The symptom or the underlying problem? Or both?

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I'm still not sure what point you are trying to make here.

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The point was in Message 17. Having FDA approval doesn't stop people from misusing them and the study did not differentiate as we mentioned before. So to interpret the info from the study as support for having herbs tested, we would need to know whether these were properly used drugs or misused.

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This is a major problem with modern herbalism, where the "holistic" mindset holds that personalised mixtures are more effective than standardised products. This is faith-based wish-thinking, with a total lack of evidential backing.

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So isn't it also necessary to test these mixtures for effectiveness and safety?

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It is worth listening to, since the tradition may be correct, but that is only a starting point.

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Isn't that what I've been saying, that's where we start?

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But who decides what is correct or incorrect.

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If it is FDA approved, then whatever it was approved for is designated as correct. Like I said before, if something is misused and something good happens, it is a discovery. It is still misuse until the standards are changed. A good outcome just wouldn't make the adverse affects list. It doesn't change the meaning of misuse though.

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Quite clearly, it depends on what you are trying to achieve.

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Agreed

No, I haven't said always to anything. I pointed out in Message 21 that politically it would be difficult to ban all medicinal herbs. They didn't ban ephedra from being used by health practitioners. I think it would be like suddenly banning cigarettes. Politicians don't want to be unpopular.

So you're saying that banning herbal medicines across the board until they are throughly tested would have no impact whatsoever on any society or culture within the United States?

Exactly!

If one takes the position that herbal medicines are to be fully tested before marketing; then the implication is that to fulfill this mission, should the decision come down, all herbal medicines would need to be taken off the market until fully tested.Prohibition is only an example of a past decision that didn't go as well as planned. We have no idea what would develop if all herbal medicines were banned until fully tested. (That means that those that pass the test get returned according to prescribed protocols.)Political leaders have to take into account the impact such a decision would have on society, the economy, and their careers.So my point since Message 21 is that saying all herbal drugs should be tested before marketing is rather a mute point since they are already out. We can say anything new should be tested before marketing, but for herbal drugs that are already out; the government will have to devise a plan with the least impact on society and the economy.

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So if a problem already exists, there is no point legislating against it? I fail to see any logic in that.

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This is like playing a game of telephone, but on the computer. How in the world do you come up with that question relative to everything I've said in this thread since Message 17?

Then we are not in disagreement concerning regulation of herbal medicines. Good to know.