Register | Sign In


Understanding through Discussion


EvC Forum active members: 65 (9162 total)
1 online now:
Newest Member: popoi
Post Volume: Total: 915,817 Year: 3,074/9,624 Month: 919/1,588 Week: 102/223 Day: 0/13 Hour: 0/0


Thread  Details

Email This Thread
Newer Topic | Older Topic
  
Author Topic:   Safety and Effectiveness of Herbs and Pharmaceuticals
Granny Magda
Member
Posts: 2462
From: UK
Joined: 11-12-2007
Member Rating: 4.0


Message 16 of 209 (446340)
01-05-2008 6:41 PM
Reply to: Message 9 by Taqless
01-04-2008 6:58 PM


Re: I'll try the opposing position
Hello Tagless,
You say that years of use have demonstrated the safety of herbs, and Percy has answered that point. I would like to mention the effectiveness of herbal remedies.
If a genuine negative effect (like that of ephedra) can go unnoticed, then how much harder must it be to notice when the remedy in fact,does nothing at all? Very tiny effects are hard to spot. They need a large sample group and a controlled study to make them apparent. A treatment (be it herbal or artificial) that does nothing at all is similarly hard to detect, a situation that is complicated by the placebo effect. Anecdotal data (and I assure you, the use of the term "anecdotal" is widespread and neutral in tone) is not sufficient in these cases, only clinical trials, preferably controlled, double-blinded and peer reviewed, with a large sample group.
If a herb is marketed as being a remedy for an illness, then it is only right that it should be effective, by which I mean significantly more effective than placebo. The only way that we can ascertain this is by performing proper trials.
I'm only asking for a bit of parity here. I think that if people want to market a cure, be it herbal or pharmaceutical, then it should be of proven worth. Dishing out a few herbal placebos for headaches may seem harmless, but selling unproven cures to people who are often desperately ill, is deeply unethical.
For a detailed look at the issues surrounding alternative medicine I strongly recommend Dr Ben Goldacre's site Bad Science and the column of the same name in The Guardian (UK).
Also worth a read is "Snake Oil and Other Preoccupations" by John Diamond, which takes "an uncomplimentary look at complementary medicine". The book is made all the more compelling by the fact that Diamond was dying of throat cancer as he wrote it, and yet he never succumbed to the allure of bogus panaceas.

Mutate and Survive

This message is a reply to:
 Message 9 by Taqless, posted 01-04-2008 6:58 PM Taqless has replied

Replies to this message:
 Message 20 by Taqless, posted 01-07-2008 11:34 AM Granny Magda has replied

  
purpledawn
Member (Idle past 3457 days)
Posts: 4453
From: Indiana
Joined: 04-25-2004


Message 17 of 209 (446774)
01-07-2008 7:25 AM
Reply to: Message 10 by Percy
01-04-2008 7:35 PM


Abuse
Personal Opinion: Any product made available to the general public for consumption should be tested and shown safe and effective for its proposed use. Safe meaning that the benefits, when used properly, outweigh the risks. Product labeling should provide all content information and list all benefits and risks associated with the proper use of the product.
Natural does not equal harmless. Organic does not equal harmless. FDA approval does not equal harmless.
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. Ephedrine
The 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.

This message is a reply to:
 Message 10 by Percy, posted 01-04-2008 7:35 PM Percy has seen this message but not replied

Replies to this message:
 Message 18 by Granny Magda, posted 01-07-2008 9:10 AM purpledawn has replied

  
Granny Magda
Member
Posts: 2462
From: UK
Joined: 11-12-2007
Member Rating: 4.0


Message 18 of 209 (446792)
01-07-2008 9:10 AM
Reply to: Message 17 by purpledawn
01-07-2008 7:25 AM


Re: Abuse
Hi Dawn,
Thanks for posting, I just wanted to clarify something. Are you saying that herbal cures (and by extension homoeopathic and other alternative products) should be subject to FDA approval before they are allowed to come to market?
If everything undergoes the same regime of clinical trials, then fine, but I can't see how we are meant to differentiate between "proper use" and "abuse" without clinical trials. I don't think that reports from holistic practitioners are sufficient.

Mutate and Survive

This message is a reply to:
 Message 17 by purpledawn, posted 01-07-2008 7:25 AM purpledawn has replied

Replies to this message:
 Message 21 by purpledawn, posted 01-07-2008 1:13 PM Granny Magda has replied

  
Taqless
Member (Idle past 5914 days)
Posts: 285
From: AZ
Joined: 12-18-2003


Message 19 of 209 (446848)
01-07-2008 11:08 AM
Reply to: Message 10 by Percy
01-04-2008 7:35 PM


Re: I'll try the opposing position
I guess I don't fully understand, aside from Ephedra and I think this is an arguable point in itself, what the basis is for thinking that herbs need to be regulated by the FDA. What is the support? Perhaps I should read through Novella's blog?
Percy writes:
Actually, Novella *is* making the point that an FDA stamp of approval is superior to tradition and anecdotal evidence, because it means the drug has gone through clinical trials that can ferret out a host of effects and relationships.
Not a straight comparison
In most cases R&D companies are not using the herb "as is". More often than not they isolate the active ingredient or create some derivative thereof and combine with many other chemicals that are not from the plant but are necessary for preservation, stabilization, etc. So, yes, it is necessary for companies to provide evidence that the effects are still nominal when isolated and combined in this fashion. This would be and is a legitimate argument for FDA regulation because the state of the herb is being drastically changed from its potentially original documented effects.
Redundancy and Effectiveness
The last I had heard the U.S. currently has the highest placebo affect at 33%....therefore, a sugar pill in the U.S. is pretty effective for some...maybe it should be approved (tongue in cheek). Most of the drugs that have taken a lot of heat lately were not only approved by the FDA, but the "problems" were related to the very fact that there is a huge amount of redundancy found in the human body that not even the scientists in pharmaceutical companies can always catch.....I won't cross over into the impact of genetic backgrounds. Also, I had heard that to get FDA approval there are two main criteria:
1) Does not cause death...at least not up to the time of approval.
2) "Beneficial" for either 5 or 15%...not sure...of the test population
Imo, that does not seem to be much of a guarantee. So, based on this I still hold that requiring the FDA to regulate the use of herbs is not necessary or well-supported.

This message is a reply to:
 Message 10 by Percy, posted 01-04-2008 7:35 PM Percy has seen this message but not replied

  
Taqless
Member (Idle past 5914 days)
Posts: 285
From: AZ
Joined: 12-18-2003


Message 20 of 209 (446859)
01-07-2008 11:34 AM
Reply to: Message 16 by Granny Magda
01-05-2008 6:41 PM


Re: I'll try the opposing position
Hi Granny,
I think that if people want to market a cure, be it herbal or pharmaceutical, then it should be of proven worth.
I agree, but to whom though? Percy points out that 5000 years of Ephedra use in China seemed alright, so what happened here? I think the answer to that is more complicated than we would like to admit. Or, maybe we, as a group, were not using it the way the Chinese used it for 5000 years.
As far as I understand it Percy has posited that herbal remedies be regulated by the FDA. I've presented some arguments that indicate why that might not be necessary.
You mention snake oil and the like, BUT I don't think using examples like this are an accurate representation of highly trained herbalists. Just as the fiasco of Phen-Fen (sp?) should not be an example of physician prescribed medicines approved by the FDA.

This message is a reply to:
 Message 16 by Granny Magda, posted 01-05-2008 6:41 PM Granny Magda has replied

Replies to this message:
 Message 22 by Granny Magda, posted 01-07-2008 1:17 PM Taqless has replied
 Message 26 by molbiogirl, posted 01-07-2008 7:43 PM Taqless has replied

  
purpledawn
Member (Idle past 3457 days)
Posts: 4453
From: Indiana
Joined: 04-25-2004


Message 21 of 209 (446891)
01-07-2008 1:13 PM
Reply to: Message 18 by Granny Magda
01-07-2008 9:10 AM


Re: Abuse
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.

This message is a reply to:
 Message 18 by Granny Magda, posted 01-07-2008 9:10 AM Granny Magda has replied

Replies to this message:
 Message 23 by Granny Magda, posted 01-07-2008 2:11 PM purpledawn has replied

  
Granny Magda
Member
Posts: 2462
From: UK
Joined: 11-12-2007
Member Rating: 4.0


Message 22 of 209 (446894)
01-07-2008 1:17 PM
Reply to: Message 20 by Taqless
01-07-2008 11:34 AM


Re: I'll try the opposing position
Taqless writes:
Granny writes:
I think that if people want to market a cure, be it herbal or pharmaceutical, then it should be of proven worth.
I agree, but to whom though? Percy points out that 5000 years of Ephedra use in China seemed alright, so what happened here? I think the answer to that is more complicated than we would like to admit. Or, maybe we, as a group, were not using it the way the Chinese used it for 5000 years.
Or maybe they simply failed to notice the harmful effect. You highlight an important consideration here. If, as you say, centuries of anecdotal evidence are sufficient proof of safety, then how are we to be sure that we are indeed using the herb in the same way? If we are using a herb in the wrong way (as per your suggestion) those centuries of use are not evidence of safety. You have to be able to compare like with like in making these judgements. This is a central aim of clinical trials.
Taqless writes:
As far as I understand it Percy has posited that herbal remedies be regulated by the FDA. I've presented some arguments that indicate why that might not be necessary.
You say in your reply to Percy that an active ingredient, isolated from its original herbal source and combined with other chemicals, ought to be FDA-approved. Fair enough, but that still gives us no guarantee that the active ingredient is safe when used in its original form. It is important to realise that a drug without any undesirable side effects is a rare thing. If a herb contains "active ingredients" then we must be alert to the risk of that ingredient having more than one effect on the body.
You also describe FDA approval of being "no guarantee" of safety. Of course it isn't. It is a basic minimum level of caution. Even the best clinical trial is not omniscient, but that doesn't make them irrelevant. Drug trials are designed to pick up any problems. Even if they don't spot everything, they still provide us with a basic level of protection from harmful side-effects and a guarantee of some level efficacy, above and beyond placebo.
Taqless writes:
You mention snake oil and the like, BUT I don't think using examples like this are an accurate representation of highly trained herbalists. Just as the fiasco of Phen-Fen (sp?) should not be an example of physician prescribed medicines approved by the FDA.
Well first of all, I didn't cite "snake oil" as an example of anything. It is the title of a book which deals with complementary/alternative medicine and is thus relevant to our topic. If you don't like the title, pull up a ouija board and take it up with the author.
What is a "highly trained herbalist"? I don't know what the situation is in the US, but here in Britain, there is no official qualification that might allow the general public to judge the skill of a herbalist. Without clear and consistent regulation, how are we to tell expert from charlatan?
As for Fen-Phen, it only goes to demonstrate the long-term efficacy of clinical trials and drug regulation. The problem with the drug was missed during initial testing, but once concerns were raised by health professionals, it was a clinical trial that proved the danger existed. As such, Fen-Phen serves as an excellent example of how drug regulation works in the long-term, even when mistakes are made in initial testing.
Consider; if the harmful side effects of a drug like Fen-Phen can slip under the wire, even with clinical trials, how can we expect that a potential problem with a herbal treatment will be noticed, when no such trial is performed?

This message is a reply to:
 Message 20 by Taqless, posted 01-07-2008 11:34 AM Taqless has replied

Replies to this message:
 Message 24 by Taqless, posted 01-07-2008 7:14 PM Granny Magda has replied

  
Granny Magda
Member
Posts: 2462
From: UK
Joined: 11-12-2007
Member Rating: 4.0


Message 23 of 209 (446906)
01-07-2008 2:11 PM
Reply to: Message 21 by purpledawn
01-07-2008 1:13 PM


Re: Abuse
purpledawn writes:
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.
Difficult perhaps, but necessary where there is a proven danger to health. Should tradition be allowed to trump public safety? I think not.
purpledawn writes:
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.
I almost agree. Basically, it's important that trials determine what constitutes proper use.
purpledawn writes:
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.
I don't think that the study did look only at misuse. The abstract provided in Percy's link made no mention of it, only of an analysis of toxic exposures. Can you demonstrate that all (or even a significant portion) of those exposures were the results of misuse? Anyway, what constitutes proper use, and how are we to tell?
It's probably worth stating for the record that I am less concerned about the safety of herbal treatments, and rather more concerned about their efficacy, or lack thereof. Traditional use of a herb does provide very weak evidence of safety, but it is far less useful as evidence of efficacy. 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.

Mutate and Survive

This message is a reply to:
 Message 21 by purpledawn, posted 01-07-2008 1:13 PM purpledawn has replied

Replies to this message:
 Message 25 by purpledawn, posted 01-07-2008 7:18 PM Granny Magda has replied

  
Taqless
Member (Idle past 5914 days)
Posts: 285
From: AZ
Joined: 12-18-2003


Message 24 of 209 (447014)
01-07-2008 7:14 PM
Reply to: Message 22 by Granny Magda
01-07-2008 1:17 PM


Re: I'll try the opposing position
Hello Granny,
Granny Magda writes:
Or maybe they simply failed to notice the harmful effect. You highlight an important consideration here. If, as you say, centuries of anecdotal evidence are sufficient proof of safety, then how are we to be sure that we are indeed using the herb in the same way? If we are using a herb in the wrong way (as per your suggestion) those centuries of use are not evidence of safety. You have to be able to compare like with like in making these judgements. This is a central aim of clinical trials.
1) First of all, years of tradition is probably a more appropriate statement.
2) There is information available regarding many herbs and there is training for this profession (how strict that is here in the U.S. I don't know). On the flip side there are many newcomer plants being collected and tested scientifically and I'm certain if promise is shown for medicinal activity it will eventually go through the FDA process.
b) I'm not following your "compare like to like" statement.
c) The central aim of clinical trials is to make sure of 2 things: 1) no adverse effects that lead to death or serious problems, and 2) that the drug provides beneficial results. As you mention "It is a basic minimum level of caution [for new drugs (added by me)]." and should not be taken to imply some higher level of stringency prior to approval.
Granny Magda writes:
You say in your reply to Percy that an active ingredient, isolated from its original herbal source and combined with other chemicals, ought to be FDA-approved. Fair enough, but that still gives us no guarantee that the active ingredient is safe when used in its original form. It is important to realise that a drug without any undesirable side effects is a rare thing. If a herb contains "active ingredients" then we must be alert to the risk of that ingredient having more than one effect on the body.
You also describe FDA approval of being "no guarantee" of safety. Of course it isn't. It is a basic minimum level of caution. Even the best clinical trial is not omniscient, but that doesn't make them irrelevant. Drug trials are designed to pick up any problems. Even if they don't spot everything, they still provide us with a basic level of protection from harmful side-effects and a guarantee of some level efficacy, above and beyond placebo.
Overall it seems you misinterpreted my statements possibly due to miscommunication. "Omniscient" and "irrelevant" by far exceed anything I remotely suggested.
1) My point about taking a molecule out of context (we'll use Ephedra as an example) is the following:
If, for 5000 years an herb is given as a whole (like leaf/root), administered as a tea or salve, and quite possibly NOT administered for the symptoms that current society was attempting to use Ephedra for the possibility that isolating the active ingredient, modifying the active ingredient, OR combining it with other chemicals that are no more associated with the leaf or root than asphalt can result in a more active molecule (this can and does occur). I'm not suggesting this is what has happened with the whole Ephedra story, but I'm proposing a legitimate scenario.
Granny Magda writes:
Well first of all, I didn't cite "snake oil" as an example of anything. It is the title of a book which deals with complementary/alternative medicine and is thus relevant to our topic. If you don't like the title, pull up a ouija board and take it up with the author.
LOL, that last sentence is a knee slapper?!? I concede I saw the snake oil bit and responded in knee-jerk fashion assuming you were making reference to the group of hacks that used to go around the U.S. selling crap as "home remedies". I guess that is NOT the parallel you were trying to make.
What is a "highly trained herbalist"? I don't know what the situation is in the US, but here in Britain, there is no official qualification that might allow the general public to judge the skill of a herbalist. Without clear and consistent regulation, how are we to tell expert from charlatan?
Hopefully the same way you select your physician because as you point out there are a lot of quacks out there licensed or not.
As for Fen-Phen, it only goes to demonstrate the long-term efficacy of clinical trials and drug regulation.
You mean after it was approved, so that means the initial clinical trials did not identify "any" problems.
Consider; if the harmful side effects of a drug like Fen-Phen can slip under the wire, even with clinical trials, how can we expect that a potential problem with a herbal treatment will be noticed.......?
".......once concerns were raised by health professionals......." -Granny Magda. You have answered your own question.
As the subject begins to slide OT I'll stop here and wish you a great evening-

This message is a reply to:
 Message 22 by Granny Magda, posted 01-07-2008 1:17 PM Granny Magda has replied

Replies to this message:
 Message 27 by Granny Magda, posted 01-07-2008 9:18 PM Taqless has replied

  
purpledawn
Member (Idle past 3457 days)
Posts: 4453
From: Indiana
Joined: 04-25-2004


Message 25 of 209 (447016)
01-07-2008 7:18 PM
Reply to: Message 23 by Granny Magda
01-07-2008 2:11 PM


Re: Abuse
quote:
Difficult perhaps, but necessary where there is a proven danger to health. Should tradition be allowed to trump public safety? I think not.
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.
quote:
The abstract provided in Percy's link made no mention of it, only of an analysis of toxic exposures.
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.
quote:
Can you demonstrate that all (or even a significant portion) of those exposures were the results of misuse?
No, I can't. The study doesn't give us enough information.
quote:
Anyway, what constitutes proper use, and how are we to tell?
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.
quote:
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.
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.

This message is a reply to:
 Message 23 by Granny Magda, posted 01-07-2008 2:11 PM Granny Magda has replied

Replies to this message:
 Message 30 by Granny Magda, posted 01-07-2008 10:49 PM purpledawn has replied
 Message 40 by nator, posted 01-08-2008 7:50 PM purpledawn has replied

  
molbiogirl
Member (Idle past 2642 days)
Posts: 1909
From: MO
Joined: 06-06-2007


Message 26 of 209 (447024)
01-07-2008 7:43 PM
Reply to: Message 20 by Taqless
01-07-2008 11:34 AM


Anecdotal "evidence"
Percy points out that 5000 years of Ephedra use in China seemed alright, so what happened here?
If by "seemed alright" you mean "sufficient data by which one can judge safety/effectiveness", I think you are taking Percy's post out of context.
From Percy's Message 10.
But while many herbs have a long history of use, what they don't have is any history of systematic data gathering in clinical settings. Anecdotal data gathering is almost always absent even the basics of such measures as blood pressure, temperature, blood analysis and weight tracking, just to mention a few. And since there's no data gathering, there's also no data analysis.
But let's run with it.
Centuries of use = safe/effective.
How many centuries count? 1? 3? 50?
After all, we have 2 centuries worth of "evidence" that homeopathy works.
We have a 1/2 century worth of "evidence" that Bigfoot exists.
We have 20 centuries worth of "evidence" that chicken soup is good for a cold (and, according to the Torah, leprosy).
We have at least 20 centuries of "evidence" that ghosts exist.
So. What's the cutoff point?

This message is a reply to:
 Message 20 by Taqless, posted 01-07-2008 11:34 AM Taqless has replied

Replies to this message:
 Message 28 by Taqless, posted 01-07-2008 9:46 PM molbiogirl has replied

  
Granny Magda
Member
Posts: 2462
From: UK
Joined: 11-12-2007
Member Rating: 4.0


Message 27 of 209 (447051)
01-07-2008 9:18 PM
Reply to: Message 24 by Taqless
01-07-2008 7:14 PM


Re: I'll try the opposing position
Taqless, I'll take it a bit at a time;
Taqless writes:
1) First of all, years of tradition is probably a more appropriate statement.
Tradition, anecdote, call it what you like. The point is that traditional use of a herb only gives us some weak evidence of its safety and no more than a hint of evidence of its efficacy. People around the world believe some pretty weird stuff. That some tradition might believe that herb x is a sovereign cure against malady y, when in fact it does nothing, seems pretty reasonable, especially when you compare it to some of the beliefs expressed on this board! Unless you believe that every traditional belief about the safety and efficacy of herbs is correct, we must somehow find a way of telling the useful ones from the crap.
Taqless writes:
I'm not following your "compare like to like" statement.
You say that traditional use means that we have evidence of the safety of a herb. You also say "maybe we, as a group, were not using it the way the Chinese used it for 5000 years".
When I say that we must compare like with like, I am saying that we must be assured that it is safe to use the herb in the way it is used today. If the traditional way of use was different, the "evidence" based on that tradition is not relevant today. So roll on the trials. Speaking of which...
Taqless writes:
The central aim of clinical trials is to make sure of 2 things: 1) no adverse effects that lead to death or serious problems, and 2) that the drug provides beneficial results.
Well, that's pretty much right. The aim is to determine all the effects of the drug, whether side effects or intended ones, adverse or beneficial, major or minor. Most important is to demonstrate that the drug is safe and that it does what you want it to do significantly better than placebo. Other aims might include regulating the dose (as noted above by purpledawn), studying how the drug works or evaluating the drug in combination with other drugs. I think that we can all agree that such trials are an extremely useful tool in aiding our understanding of how all kinds of drug work. It is my contention that they are the only appropriate tool in investigating such issues.
With regard to your hypothetical compound, I think that we are both in agreement that it should be tested before release.
Taqless writes:
Granny writes:
What is a "highly trained herbalist"? I don't know what the situation is in the US, but here in Britain, there is no official qualification that might allow the general public to judge the skill of a herbalist. Without clear and consistent regulation, how are we to tell expert from charlatan?
Hopefully the same way you select your physician because as you point out there are a lot of quacks out there licensed or not.
When I choose my doctor I know that, at a minimum, He or she has undergone extensive education, passed many stringent examinations, been through hundreds of hours of first hand training and experience and that they have been passed as fit to practise by a highly respected and rigorous professional body. I know that if they proved to be corrupt or incompetent, they could be struck off. I know that it is illegal to falsely pose as a licensed medical practitioner. Herbalists offer no such guarantee. Under UK law, I could set up as a herbalist tomorrow. Given that many herbals contain active ingredients capable of causing serious side effects or of interfering with prescription medicines, I think that regulation of herbalists is essential. There are indeed a lot of quacks out there, but the overwhelming majority are alternative practitioners, peddling dodgy cures.
As for Fen-Phen, I really don't know what you are trying to prove. You have demonstrated that clinical trials are not perfect, and that they occasionally miss harmful side effects. So what? There is no such thing as perfection, but the controlled, randomised, double-blinded, peer reviewed clinical trial is the best device available to us at the present time. Imagine how bad things would be were we not armed with this vital tool. imagine it, because this is the exact situation in which herbalists voluntarily place themselves. Herbalists should be falling over themselves in the rush to carry out such trials, and prove the efficacy and safety of their wares, but too few take this opportunity.
Let's be clear; some herbs do work. They provide us with valuable medicines. A prime example is St. John's wort, which has performed well in trials where it has been used as a treatment for depression. That's fantastic, but there is a catch; St.John's wort has also been implicated in inhibiting the action of other medicines, as in this trial. St. John's wort is not the only herb to have serious side effects. Here's a partial list, from this article, taken from The Guardian.
quote:
Kava kava
For anxiety. Banned in Britain because of three deaths and six transplants resulting from liver toxicity
Ginkgo biloba
Leaves of the oldest living tree species - for dementia. Some concern over possible increased risk of brain haemorrhage
Devil's claw
For musculo-skeletal pain, such as backache. May increase stomach acid and should be avoided by people with ulcers
Saw palmetto
For enlarged prostate. Should not be taken with drugs like aspirin or warfarin which increase bleeding, and may interfere with the pill
St John's wort
For depression. Interacts with some conventional drugs, such as immune system suppressants, causing heart transplants to be rejected, and the pill
Valerian
For insomnia. High doses may cause a drug "hangover" effect
These are serious side effects, and the herbs that cause them must be trialled, and only if they are found to be safe and effective, should they be licensed.

Mutate and Survive

This message is a reply to:
 Message 24 by Taqless, posted 01-07-2008 7:14 PM Taqless has replied

Replies to this message:
 Message 36 by Taqless, posted 01-08-2008 5:36 PM Granny Magda has replied

  
Taqless
Member (Idle past 5914 days)
Posts: 285
From: AZ
Joined: 12-18-2003


Message 28 of 209 (447055)
01-07-2008 9:46 PM
Reply to: Message 26 by molbiogirl
01-07-2008 7:43 PM


Re: Anecdotal "evidence"
Hello molbiogirl,
molbiogirl writes:
Centuries of use = safe/effective
When used for the condition indicated by the centuries of use, yes. If used to treat anything outside of what the herb was traditionally used for, or manner in which it was administered, no. Re-assessment would be necessary.

This message is a reply to:
 Message 26 by molbiogirl, posted 01-07-2008 7:43 PM molbiogirl has replied

Replies to this message:
 Message 29 by molbiogirl, posted 01-07-2008 10:30 PM Taqless has replied

  
molbiogirl
Member (Idle past 2642 days)
Posts: 1909
From: MO
Joined: 06-06-2007


Message 29 of 209 (447058)
01-07-2008 10:30 PM
Reply to: Message 28 by Taqless
01-07-2008 9:46 PM


Re: Anecdotal "evidence"
Way to miss the point, Tagless! Congrats.
When used for the condition indicated by the centuries of use, yes.
So. Chicken soup for leprosy, then? This is a treatment that has been advocated for nigh on 20 centuries.

This message is a reply to:
 Message 28 by Taqless, posted 01-07-2008 9:46 PM Taqless has replied

Replies to this message:
 Message 37 by Taqless, posted 01-08-2008 5:49 PM molbiogirl has not replied

  
Granny Magda
Member
Posts: 2462
From: UK
Joined: 11-12-2007
Member Rating: 4.0


Message 30 of 209 (447063)
01-07-2008 10:49 PM
Reply to: Message 25 by purpledawn
01-07-2008 7:18 PM


Re: Abuse
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! There are countless studies into the effects of alcohol and its sale is licensed. Also, it can magically transform into the blood of Jesus! Wow!
I would only be in favour of outright banning a herb if it had proven harmful effects and no proven benefits. 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.
purpledawn writes:
Granny writes:
Can you demonstrate that all (or even a significant portion) of those exposures were the results of misuse?
No, I can't. The study doesn't give us enough information.
Then why bring up the possibility that negative side effects of ephedra use were a result of misuse?
purpledawn writes:
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.
Sure, that's a great starting point. The countless traditions of herbal medicine, created by cultures around the world, are a veritable treasure trove of cures, and as tribal cultures worldwide loose their traditional knowledge, this vital resource is disappearing fast. Ethnobotanists are doing sterling work in trying to record this knowledge and I believe that we should applaud their efforts. The caveat is that none of this means that any given tradition is correct about their herbal medicines. They could be wrong, just like people who believe that sex with a virgin will cure AIDS. Tradition is an important starting point for proper research, but it just isn't reliable enough to take at face value.
purpledawn writes:
I think some of the difficulty with clinical trials as used for drugs, is that the herbal remedies, when done correctly, are as precise as the drugs.
I strongly disagree with this. Herbs are not as precise as lab-prepared drugs. Plants vary by year, by growing medium, by season, by year, by individual and on and on. Most importantly, they vary in the amount of active ingredient they contain, as any pot-head will tell you. This variability makes dose control much more difficult with whole herbs, than with extracts thereof. A case in point is foxglove. Please forgive the long cut and paste, but I simply can't put any better than this;
quote:
Digoxin in foxglove is very good at treating atrial fibrillation, a common kind of irregular heart movement. Unfortunately the dose range is very narrow, so it’s really quite easy to kill your patient. From the moment of its discovery, pharmacologists worked hard to standardise the dose.
They started with standardised preparations of the plant, but this proved dangerously inconsistent, because the quantity of the active component in foxglove was so variable, so new strategies were developed: standardised preparations of each batch of plant were tested in animals first, to work out how potent they were, and so on. Eventually we worked out how to extract the digitalis, and it could be weighed out.
Now people do careful studies of large numbers of patients on digoxin to see which dose is most beneficial, to understand how it works, and careful monitoring of side effects takes place, from individual clinicians writing about their concerns in medical journals all the way up to the yellow card system, where doctors and even patients can send in their concerns to the MHRA, however trivial or unproven they may be.
  —Dr Ben Goldacre
I urge you, no I beg you to read the whole article, which can be found here, at badscience.net. It deals with the whole subject of herbal medicine, not just foxglove, and it is a fantastic read.
purpledawn writes:
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.
The only sensible definition of misuse and abuse is where harm outweighs benefit, or benefit is non-existent. Herbs are drugs. They contain molecules that interact with and affect our bodies (at least, some of them do, others are completely ineffective). That's all a pharmaceutical drug does and that's all a herbal drug does. I assure you, your body does not know the difference between a "herb" and a "drug".
purpledawn writes:
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.
I look at healing in only one way; outcome. Does the drug heal(by which I mean "does it perform significantly better than placebo?")? Does it harm? It probably does both, in which case a bit of a balancing act is required. In any case, there's only one way to be sure and that's a randomised, controlled, etc., etc. You get the idea. Sorry to be boring, but it's the only way.

Mutate and Survive

This message is a reply to:
 Message 25 by purpledawn, posted 01-07-2008 7:18 PM purpledawn has replied

Replies to this message:
 Message 31 by molbiogirl, posted 01-08-2008 12:46 AM Granny Magda has not replied
 Message 32 by purpledawn, posted 01-08-2008 7:02 AM Granny Magda has replied

  
Newer Topic | Older Topic
Jump to:


Copyright 2001-2023 by EvC Forum, All Rights Reserved

™ Version 4.2
Innovative software from Qwixotic © 2024