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Author Topic:   Safety and Effectiveness of Herbs and Pharmaceuticals
Granny Magda
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Posts: 2462
From: UK
Joined: 11-12-2007
Member Rating: 4.0


Message 4 of 209 (445750)
01-03-2008 7:13 PM
Reply to: Message 1 by Percy
01-02-2008 3:45 PM


Hi Percy,
Hi Percy,
This issue is one that regularly has me spitting blood. "Natural" has become a synonym for good and it is a particular shibboleth of the alternative medicine crowd, but its influence is becoming increasingly widespread. "Natural" has become the advertiser's favourite buzz-word.
Highly processed breakfast cereals are described as "natural", just because they have a few freeze-dried strawberries thrown in. In my experience, wild strawberries are quite a bit smaller than the ones in the cereal packet, and they don't come freeze-dried.
It is in the field of "alternative medicine" however, where this fallacy is most prevalent and most dangerous. People see natural remedies as being innately safer, better and well, just friendlier, but this is just not true. A prime example is that of aspirin. The salicylic acid upon which aspirin is based, has been used for centuries, in the form of willow bark, a natural source of the chemical. The problem is, that if you take enough nice, eco-friendly, hippy-dippy, natural willow bark, the acid will cause gastrointestinal upsets, and strip out half the lining of your stomach. With that nasty old pharmaceutical aspirin however, this effect is greatly reduced, plus it comes in a handy pill form, instead of some disgusting tea-bark brew.
I've even heard people decide what recreational drugs to take based on this kind of thinking. I once overheard someone at a party saying that he disapproved of LSD, but liked magic mushrooms, because "they're natural". He was immediately rounded upon by another party-goer and myself, both lecturing him on the flaws in this idea. Neither substance can really be considered "safe", and nasty synthetic LSD doesn't present you with the very real risk of mistakenly eating a poisonous (but natural) mushroom of some other species.
Natural=good is idiotic rubbish. Hemlock, herpes and haemophilia are all natural, and I would argue that they are all bad (I know, I like to court controversy). Cameras, computers and cakes are all artificial, and yet I think that they are all quite good.
Remember, laughter is the best medicine. Unless you've got syphilis, in which case it's penicillin.

Mutate and Survive

This message is a reply to:
 Message 1 by Percy, posted 01-02-2008 3:45 PM Percy has seen this message but not replied

  
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

  
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

  
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

  
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

  
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

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


Message 33 of 209 (447188)
01-08-2008 1:17 PM
Reply to: Message 32 by purpledawn
01-08-2008 7:02 AM


Re: Abuse
Hi Dawn,
purpledawn writes:
The point of the comparison was the rise of black markets. That is a situation the government would not want to create.
I can see it now. Shady characters hanging around on street corners, whispering "Hey kid, wanna buy some gingko?". Seriously, ephedra is part of a very small group of drugs that can be used recreationally. That is where the black market is. I can't see purely therapeutic herbs being a big thing on any black market. Even if it did become a concern, better that the majority of herb vendors act under regulation, than none of them.
I read the article on ephedra that you linked to, and it does indeed seem to suggest that most of the case of toxicity were to do excessive doses, possibly apart from this one;
quote:
The first case had not significantly exceeded the normal daily therapeutic dose, although the duration is not mentioned.
I'm still not sure what point you are trying to make here. Ephedra was a disaster when left unregulated. Prescribed by proper doctors, it might be a better bet. Actually, this article makes obvious the fallacy of people thinking that a "natural" drug must be safe.
quote:
In fact, much product marketing and packaging leads many consumers to believe that because an ephedrine product contains only the botanical source of the drug, it is safe.
purpledawn writes:
Granny writes:
The caveat is that none of this means that any given tradition is correct about their herbal medicines.
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.
"None of this what?" - I mean to say that the many success stories of herbal medicine offer us no guarantees that that the next herb to come under consideration will prove useful, or that the traditions associated with its use are correct.
"Correct in what way?" - Correct in that the traditional claims of efficacy/safety match what happens in reality, eg. if tradition X says that herb Y cures malady Z, is this claim true? It could well be wrong, and it is for this reason that traditional herbal know-how can't be completely relied upon. It is worth listening to, since the tradition may be correct, but that is only a starting point. Believing that traditional wisdom is reliable enough for use in medicine strikes me as shockingly naive.
You then go on to talk about herbal mixtures, rightly saying that the effects of mixtures of many herbs are more difficult to test than single herbs. 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. I linked to this article before, but I link it again because it deals specifically with the dangers of using these mixtures. Interaction between drugs, is a problem for all kinds of medicine and I'm afraid that it all requires testing.
purpledawn writes:
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.
You call them whatever you like. I think that understanding that herbs are drugs is an essential point if we are to promote understanding of what herbal medicine is and how it should be approached. If that requires my typing the word pharmaceutical a few times, then fine. The characterisation of herbs as drugs was right there in the OP.
purpledawn writes:
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.
But who decides what is correct or incorrect. If my doctor treats me with a herb, and he uses it a way that a traditional Chinese herbal practitioner would describe as "incorrect", yet I am cured of my illness, does that really make it incorrect? Is it misuse? I don't think so. I don't care whether someone thinks a treatment is "misuse", all I care about is outcome.
purpledawn writes:
Does it heal what? The symptom or the underlying problem? Or both?
Either. Both. Whatever. Quite clearly, it depends on what you are trying to achieve. You are splitting hairs.

Mutate and Survive

This message is a reply to:
 Message 32 by purpledawn, posted 01-08-2008 7:02 AM purpledawn has replied

Replies to this message:
 Message 34 by purpledawn, posted 01-08-2008 2:55 PM Granny Magda has replied

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


Message 35 of 209 (447266)
01-08-2008 5:08 PM
Reply to: Message 34 by purpledawn
01-08-2008 2:55 PM


Re: Abuse
Ah, I see...
purpledawn writes:
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.
Yes and no. Preventing deliberate abuse is not one of the aims of trials, nor should it be. Quite obviously, no amount of testing is going to stop idiots from overdosing on a drug, taking it the wrong way, etc. One of the main aims of testing however (and this is something that you've already mentioned), is working out what the best dose actually is. Only when this is established can people use the drug in an informed way, thus guarding them against unknowing or accidental misuse.
No testing = no knowledge of safe dose = no definition of proper use = guaranteed misuse.
Proper testing = improved knowledge of safe dose = improved definition of of proper use = misuse minimised.
You can apply similar logic to other aspects of drug performance, eg. tolerability, efficacy, price.
purpledawn writes:
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.
Wrong. Proper trials, carried out prior to the drugs release, might have picked up these concerns a lot sooner, and lent more weight to health warnings for use and might actually have saved some lives. If people knew that herbal drugs were taken seriously enough that they required thorough testing before release, then they might be less susceptible to the "natural=safe" fallacy, and more inclined to obey the dosage limits. Lack of testing trivialises herbals and that is dangerous.
I believe the point that Percy was trying to make by reference to the example of ephedra was simply "herbs are drugs, with powerful and even dangerous side effects". This suggests that testing is needed.
purpledawn writes:
So isn't it also necessary to test these mixtures for effectiveness and safety?
A guarded yes. It is clearly impossible to test every conceivable combination of herbs and other drugs. For this reason I think that herbalists should start testing their wares one herb at a time, before charging in like a bull at a gate, and mixing them together in a myriad of personalised cocktails. This kind of thing makes it much harder to detect where any potential side effects are coming from.
It is worth noting that many herbalists claim that mixtures are more effective than single herbs, and especially that personalised mixtures have a special therapeutic power. There is no evidence to back this claim up. Wish thinking, nothing more.
purpledawn writes:
Isn't that what I've been saying, that's where we start?
Agreed then.
purpledawn writes:
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.
I see what you mean. Of course, a novel use for an existing drug requires (you guessed it) more trials, to test the drugs efficacy in the new situation. I believe that drugs are only licensed for a specific use use. New use, new test, new license.

Mutate and Survive

This message is a reply to:
 Message 34 by purpledawn, posted 01-08-2008 2:55 PM purpledawn has not replied

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


Message 42 of 209 (447334)
01-08-2008 10:05 PM
Reply to: Message 36 by Taqless
01-08-2008 5:36 PM


Re: I'll try the opposing position
Taqless writes:
I have to admit that when I consider herbal medicine the Chinese are what comes to mind. Obviously with this specific group of people in mind you get a large population, a certain amount of scientific inquiry, and most important documentation. So, I am taking a very specific opposing position.
OK. We could talk about ayurveda or bach flower remedies if you wanted, but you're right, traditional Chinese medicine (TCM) serves as a good example. That TCM has a long standing history of widespread use is true. That's good. That it has much documentation associated with it is also true, and that's very helpful. These pieces of information are like little flags that should draw our attention to a potential source of useful cures.
That TCM is guided by scientific inquiry is open to debate. There is no doubt that early TCM practitioners were seeking to move away from random tribal superstitions, and towards a standardised system of medical knowledge.The question is "how completely did they succeed?". How much of it really works?
We all know of examples of traditions that are false. When we look around the world we see millions of people labouring under various strange delusional beliefs. How can we be sure that TCM is isn't just another false belief system? Certainly it has some improbable mystical elements, such as chi, the theory that illness is caused by in imbalance between "stagnation" and "catastrophism", and something called "kidney essence" that creates bone marrow and semen. Does any of that sound likely to you? If this is the kind of stuff that TCM espouses, why should we take their assertions regarding their herbal cures at face value? How much is just dogma?
I'm suggesting that TCM contains much that is useful, after all, they are not idiots. The thing is, you don't have to be an idiot to make mistakes. It will thus include much that is in error (dried lizard anyone?). Unless your position is that TCM in inerrant, you surely have to agree with me on this.
With me so far?
Taqless writes:
I would still point out that physician reporting is useful in separating the crap from the keepers. Obviously this kind of reporting has proven to be important in FDA approved drugs as well.
Of course. That's why systems of feedback are built into modern medicine, such as the yellow card scheme here in Britain. You won't see those kind of set ups in herbalism. There isn't enough agreement amongst practitioners.
Taqless writes:
If the herbal drug was used in the manner with which it was documented for a long period of time and no issues have been reported I do not see the necessity of requiring re-assessment.
So is it still your contention that anecdotal evidence is the equal of clinical trials?
Taqless writes:
However, if an issue does exist I would agree that it is fair game for regulation. As you point out not every drug helps every person . ..herbal or FDA approved.
I’m sure you realize that the interaction/scenario I proposed is hypothetical, BUT the phenomenon is not.
All agreed.
Taqless writes:
It sounds like you’re suggesting regulation of herbalists will eliminate serious side effects and/or drug interactions(which occurs with many approved drugs already).
I'm suggesting no such thing. Trials will help reduce such risks, by forewarning us of the dangers.
Taqless writes:
Granny writes:
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.
As many drugs, so . . . . . .
Granny writes:
St. John's wort is not the only herb to have serious side effects.
Of course it isn’t. Once again, as with many other drugs, so . . . . ..?
So . . . . . we do trials until we are armed with enough data to allow physicians and patients to make informed choices, based on the very best evidence available. To do otherwise would be unethical.
Taqless writes:
Devil's claw
For musculo-skeletal pain, such as backache. May increase stomach acid and should be avoided by people with ulcers
Sounds like a warning for ibuprofen.
Valerian
For insomnia. High doses may cause a drug "hangover" effect
This is a common side-effect of anti-insomnia drugs.
Precisely why;
a) both herbs and pharmaceuticals should be regarded as drugs.
b) both herbs and pharmaceuticals should be subject to clinical trial.
c) both herbs and pharmaceuticals should be regulated.

Mutate and Survive

This message is a reply to:
 Message 36 by Taqless, posted 01-08-2008 5:36 PM Taqless has replied

Replies to this message:
 Message 69 by Taqless, posted 01-18-2008 10:45 PM Granny Magda has replied

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


Message 51 of 209 (447490)
01-09-2008 2:27 PM
Reply to: Message 48 by Percy
01-09-2008 1:09 PM


Re: Banning Herbals
Percy writes:
The US is very libertarian regarding many aspects of health care. Did you know homeopaths in Arizona can perform surgery?
No, I didn't know that. That is unbelievably shocking. Homoeopathy is total bunkum. I assume that they don't use homoeopathic anaesthetics.

Mutate and Survive

This message is a reply to:
 Message 48 by Percy, posted 01-09-2008 1:09 PM Percy has seen this message but not replied

Replies to this message:
 Message 52 by macaroniandcheese, posted 01-09-2008 2:47 PM Granny Magda has not replied

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


Message 54 of 209 (447681)
01-10-2008 12:27 PM
Reply to: Message 53 by purpledawn
01-09-2008 7:36 PM


Re: Banning Herbals
HI Dawn,
purpledawn writes:
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.
Not at all. there are other ways than to introduce an overnight ban. The usual solution in these situations, where legitimate businesses must change their practices, is to set a date when the legislation comes into force. A date is announced, say, 4 years on, and the suppliers must comply with the new rules by that date, just as is happening right now with EU legislation against keeping battery chickens. Many herbs have already been tested anyway.
I still think that the comparison with prohibition is ridiculous. Prohibition was inspired by pious moralising as much as public health. If the case is made properly, I think that people will understand that legislation is for their own good.
purpledawn writes:
Political leaders have to take into account the impact such a decision would have on society, the economy, and their careers.
Society - People would be better able to make informed decisions about their healthcare. Good science would be promoted. Disasters where people fail to take real medicines in favour of quack cures might be prevented. All sounds pretty good to me.
Economy - There certainly is a lot of money made out of alternative therapies, but that still only represents a very small percentage of the total economy, in US or Europe. The effect would be minimal. Even if there is a negative economic effect, it would be worth it, in order to prevent unethical people making money by exploiting the desperate and gullible. Besides, I can actually envisage a positive effect on the herbalism sector. Plenty of people avoid herbalists, because they know that many of their claims are unproven. If the whole business became evidence based, it would make a much more attractive proposition.
Politicians Careers - I'm assuming that you don't really believe that a politician should back away from worthwhile legislation for the sake of his career. That would be despicable. Slimy self-serving politicians can be a barrier to effective government of all kinds when they become obsessed with covering their arses. The point is to persuade them that regulation is worthwhile, and that as many people support it as oppose it.
purpledawn writes:
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.
So if a problem already exists, there is no point legislating against it? I fail to see any logic in that.
purpledawn writes:
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.
Agreed. There is no point being overly bullish about this issue. Better that it is handled sensitively, especially since most of the people who sell herbs are well meaning. But the business of selling unproven cures to often very ill people, is immoral. It should be stopped, even if that proves problematic.

Mutate and Survive

This message is a reply to:
 Message 53 by purpledawn, posted 01-09-2008 7:36 PM purpledawn has replied

Replies to this message:
 Message 55 by purpledawn, posted 01-10-2008 4:35 PM Granny Magda has replied

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


Message 56 of 209 (447881)
01-11-2008 10:25 AM
Reply to: Message 55 by purpledawn
01-10-2008 4:35 PM


Re: Banning Herbals
purpledawn writes:
This is like playing a game of telephone, but on the computer.
Got to admit, I had to look that one up. We call that game "Chinese whispers" on this side of the pond.
I apologise if I took your comment out of context, but I am a little perplexed as to why, if you support regulation of herbals, you keep stressing potential problems with it.
Just to be clear, I'm not advocating banning herbals, only regulating them. I would only ban herbs that prove to be dangerous, and outlaw the sale of herbs by means of unsubstantiated therapeutic claims.

Mutate and Survive

This message is a reply to:
 Message 55 by purpledawn, posted 01-10-2008 4:35 PM purpledawn has replied

Replies to this message:
 Message 57 by purpledawn, posted 01-11-2008 11:58 AM Granny Magda has not replied

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


Message 61 of 209 (448299)
01-12-2008 10:12 PM
Reply to: Message 60 by subbie
01-12-2008 7:26 PM


Re: Banning Herbals
Hi Subbie,
Caveat emptor indeed, but the fact is that a great many fools have held onto their money, thanks to legislation that forces Big Pharma to prove the efficacy of its wares. The system works. That is proven by the way that quacks have been driven out of pharmaceutical medicine, leaving only the "alternative" market unregulated.
What makes you think that regulation of herbals would play out differently?

Mutate and Survive

This message is a reply to:
 Message 60 by subbie, posted 01-12-2008 7:26 PM subbie has replied

Replies to this message:
 Message 62 by subbie, posted 01-12-2008 11:49 PM Granny Magda has replied

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


Message 68 of 209 (448508)
01-13-2008 8:49 PM
Reply to: Message 62 by subbie
01-12-2008 11:49 PM


Re: Banning Herbals
Hey Subbie,
subbie writes:
So Big Pharma hasn't cheated them out of their money. That also means that they haven't had a chance to learn from a foolish mistake.As a result, they simply lost their money to some other scam.
Sure, unless they're dead, because they had no way of evaluating the various medicines on offer, and they happened to choose the wrong one. How can ordinary people be expected to make life or death decisions without proper studies to provide the information? How are they to judge the worth of an unregulated clinical trial? For that matter, how can doctors make informed decisions if there is no agreed system of regulation to ensure that all medicines actually do what they claim they do. Regulation allows everyone, patients, doctors, researchers and drug companies, to assess the real value (and dangers) of medicines. This has advanced medical science and saved countless lives. Without it we'd all be in the dark.
subbie writes:
Let people buy and use whatever nonsense they want to. What's it to you?
I'm curious. The above comment implies that you would support full decriminalisation and deregulation of recreational drugs, such as crack-cocaine. What do you say to that?
subbie writes:
Why should the government protect them from some frauds but not others?
Exactly my point. Why should people be protected from most forms of fraud, but not from charlatans who peddle snake oil? Selling unproven rubbish as if it were a useful medicine exploits the sick and the desperate. It is an especially despicable form of exploitative fraud.
subbie writes:
So we start to regulate herbals. What's next? Magnet therapy? Aroma therapy? Copper bracelets? Gimmick diets? Cosmetics claims of younger-looking skin?
Yes, that sounds about right, with the possible exception of the diets. Where there is a claim of curative properties, there should be evidence to back up that claim. No evidence, no dice. Furthermore, herbs with genuine active ingredients should only be available from qualified persons, in order to avoid medical complications brought on by improper use.
If wacky alternative therapists want to be taken seriously, they should submit to regulation and clinical trials. Your claims about the necessary bureaucracy seem a little over blown to me. It is the industry that must pay for the testing, not the government. Believe me, they can afford it. In fact, many alternativists do perform trials, but, because they do so in an unregulated environment, many such trials aren't worth the paper they're printed on.

Mutate and Survive

This message is a reply to:
 Message 62 by subbie, posted 01-12-2008 11:49 PM subbie has not replied

  
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