Safety and Effectiveness of Herbs and Pharmaceuticals

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

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? 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 populationImo, 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.

Hi Granny, 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.

Hello Granny, 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. 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. 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. Hopefully the same way you select your physician because as you point out there are a lot of quacks out there licensed or not. You mean after it was approved, so that means the initial clinical trials did not identify "any" problems. ".......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-

Hello molbiogirl, 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.

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. 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. I understand and agree. 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. I’m sure you realize that the interaction/scenario I proposed is hypothetical, BUT the phenomenon is not. 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). As many drugs, so . . . . . . Of course it isn’t. Once again, as with many other drugs, so . . . . ..? Sounds like a warning for ibuprofen. 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.

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.

Hi Granny,
Delayed, but....... 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.” This is speculative and OT. 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 . This is a topic all of its own. I agree, the Chinese “are not idiots”. However, inerrancy is not the point . as I think you yourself have pointed out . Agreed, but maybe this suggests that regulating those who dispense herbs might help the general public? 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. 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.