Understanding through Discussion


Welcome! You are not logged in. [ Login ]
EvC Forum active members: 80 (8960 total)
20 online now:
PaulK (1 member, 19 visitors)
Newest Member: Mikee
Post Volume: Total: 869,215 Year: 963/23,288 Month: 963/1,851 Week: 86/321 Day: 1/47 Hour: 0/0


Thread  Details

Email This Thread
Newer Topic | Older Topic
  
Author Topic:   Safety and Effectiveness of Herbs and Pharmaceuticals
Taqless
Member (Idle past 4295 days)
Posts: 285
From: AZ
Joined: 12-18-2003


Message 9 of 209 (446047)
01-04-2008 6:58 PM
Reply to: Message 7 by Percy
01-04-2008 2:30 PM


I'll try the opposing position
Hi Percy,
First, Novella's "any chemical or combination of chemicals that has biological activity within the body above and beyond their purely nutritional value." would imply that all chemicals have a nutritional value....I do not think this is true, or I'll grant it might be a semantic issue.

"Herbs...are typically marketed based upon tradition and anecdote with insufficient scientific evidence for safety or efficacy."

1) I find the first part of the statement funny in that tradition and anecdotes are how medicine and pharmacy as professions came to be. In fact, simply because the FDA comes along and stamps an approval on a drug does not make our "tradition" of drug prescription better. Imo, some of the language used by Novella, such as "tradition" and "anecdotes" appears to be used to conjure up ideas of less civilized times....like shamans, etc.

2) Safety and efficacy of drugs introduced by pharmaceutical companies are determined by administering the drug to a group of people and seeing what happens. This has already been done for the naturalist (arguably minus the control population) and is somehow seen as non-scientific because for some herbs it was done LONG before the FDA was in existence?

Given the above considerations I see no need to add herbal remedies to the FDA's jurisdiction.

disclaimer: I have not read Novella's blog.


Probable impossibilities are to be preferred to improbable possibilities.-Aristotle

This message is a reply to:
 Message 7 by Percy, posted 01-04-2008 2:30 PM Percy has responded

Replies to this message:
 Message 10 by Percy, posted 01-04-2008 7:35 PM Taqless has responded
 Message 16 by Granny Magda, posted 01-05-2008 6:41 PM Taqless has responded

  
Taqless
Member (Idle past 4295 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 acknowledged this reply

  
Taqless
Member (Idle past 4295 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 responded

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

  
Taqless
Member (Idle past 4295 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 responded

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

  
Taqless
Member (Idle past 4295 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 responded

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

  
Taqless
Member (Idle past 4295 days)
Posts: 285
From: AZ
Joined: 12-18-2003


Message 36 of 209 (447275)
01-08-2008 5:36 PM
Reply to: Message 27 by Granny Magda
01-07-2008 9:18 PM


Re: I'll try the opposing position
Granny Magda writes:

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.

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.

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.

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.

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.

I understand and agree.

It is my contention that they are the only appropriate tool in investigating such issues.

I agree that it is a great tool even before an issue exists. 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. I do think that such information exists given the parameters I mention in the first paragraph of this response. 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.

With regard to your hypothetical compound, I think that we are both in agreement that it should be tested before release.

I’m sure you realize that the interaction/scenario I proposed is hypothetical, BUT the phenomenon is not.

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.

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).

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…………….

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…………..?

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.

Remember safe and effective does not mean
1) No serious side effects
2) No drug interactions.

Have a great evening.


This message is a reply to:
 Message 27 by Granny Magda, posted 01-07-2008 9:18 PM Granny Magda has responded

Replies to this message:
 Message 42 by Granny Magda, posted 01-08-2008 10:05 PM Taqless has responded

  
Taqless
Member (Idle past 4295 days)
Posts: 285
From: AZ
Joined: 12-18-2003


Message 37 of 209 (447278)
01-08-2008 5:49 PM
Reply to: Message 29 by molbiogirl
01-07-2008 10:30 PM


Re: Anecdotal "evidence"
Whew!
I thought you might use the stronger position of Bigfoot!

I have not read about or seen chicken soup bringing about beneficial results for those who suffer from leprosy.

Context can be everything.


This message is a reply to:
 Message 29 by molbiogirl, posted 01-07-2008 10:30 PM molbiogirl has not yet responded

  
Taqless
Member (Idle past 4295 days)
Posts: 285
From: AZ
Joined: 12-18-2003


Message 69 of 209 (449775)
01-18-2008 10:45 PM
Reply to: Message 42 by Granny Magda
01-08-2008 10:05 PM


Re: I'll try the opposing position
Hi Granny,
Delayed, but.......

Granny Magda writes:

That TCM is guided by scientific inquiry is open to debate.


My position does not include the expanded statements you make regarding “mystical elements” which I guess are part of TCM. In the context I outlined involving herbal drugs I contend that while scientific inquiry 1000s of years ago among the Chinese did not mirror our current process that in no way means that it did not meet the basic definition of scientific inquiry: “Full inquiry involves asking a simple question, completing an investigation, answering the question, and presenting the results to others.”
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.

This is speculative and OT.
We all know of examples of traditions that are false.

So that I’m clear on this, are you suggesting that our current system of scientific inquiry is “tradition” as well? If not, then please explain .
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.

This is a topic all of its own.
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.

I agree, the Chinese “are not idiots”. However, inerrancy is not the point…as I think you yourself have pointed out .
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.

Agreed, but maybe this suggests that regulating those who dispense herbs might help the general public?
So is it still your contention that anecdotal evidence is the equal of clinical trials?

I think that to ask this question the assumptions are:
1) The Chinese did not use ANY form of scientific inquiry, and
2) The Chinese did not have an organized manner to document their findings
and either assumption is problematic.

Granny Magda writes:


Devil's claw
For musculo-skeletal pain, such as backache. May increase stomach acid and should be avoided by people with ulcers

Taqless writes:

Sounds like a warning for ibuprofen.


Valerian
For insomnia. High doses may cause a drug "hangover" effect
Taqless writes:

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.

My comparisons were strictly meant to highlight the fact that a couple of herbs from your list of herbs with “serious side effects” matched a couple of FDA approved drugs that had similar “serious side effects”. Therefore, weakening the position that regulation and clinical trials somehow resolves these aspects of drugs. That was all.

When discussing whether or not drugs, herbal or otherwise, should be regulated one has to leave side effects, interactions, and even effectiveness out as supporting evidence on either side of the issue. Although these are valid concerns, they are not somehow resolved by regulation:
- Approved/Herbal drugs both have side effects
- Approved/Herbal drugs both have interactions, and
- Approved/Herbal drugs both have varying degrees of effectiveness across a diverse population.

Therefore, one is left with whether or not the drug is “proven” and I agree that this is facilitated through scientific inquiry. So, whether or not a drug has been proven seems to be what we are addressing, and this might be slightly OT according to what Percy originally intended. Regardless, my better defined position would be that herbs established and used for 1000s of years in Chinese Medicine do not require regulation as long as they are used in the manner documented. However, as I've stated before if the drug is being used in a different manner (tea vs. pill, with another medication, etc.) it would need to be scientifically re-tested in the "new environment" using the methods currently accepted.


This message is a reply to:
 Message 42 by Granny Magda, posted 01-08-2008 10:05 PM Granny Magda has responded

Replies to this message:
 Message 70 by Percy, posted 01-19-2008 9:49 AM Taqless has not yet responded
 Message 72 by Granny Magda, posted 01-19-2008 1:15 PM Taqless has not yet responded

  
Newer Topic | Older Topic
Jump to:


Copyright 2001-2018 by EvC Forum, All Rights Reserved

™ Version 4.0 Beta
Innovative software from Qwixotic © 2020