FDA/EU Regulators and Herb-Drug Interactions

[Guest guest]

Hi All, & Hi Jeffrey

 

I had written that we should argue [with FDA) that most if not all

the " documented " adverse effects of CHMs / Chinese supplements

were because of OTC (non-professionally prescribed) use, and that

the effects in most cases involved INTERACTION with other

(allopathic) drugs in patients with > already compromised LV, KI or

HT function.

 

Jeffrey replied:

> This is where we need to be really careful, if we don't want to

> end up having to get pharmacology degrees / be under the

> supervision of pharmacists / etc. Who holds the keys to herb-drug

> interactions, anyway? Certainly not licensed acupuncturists. I'm

> not so sure anyone does, at least not outside of China and the

> Chinese diaspora.

 

Jeffrey, with respect, I disagree. Yes, much remains unclear on

herb-drug interactions but there are some data (including WWW

data) on that area. For example, one would not use a remedy with

a significant amount of digitalis in a subject already taking digitalis-

type medication.

 

I have argued elsewhere that even air and water (the most vital

essentials for life) can be toxic under certain circumstances. So

can salt and sugar!

 

If so, IMO, ALL herbs and drugs, without exception, are potentially

toxic. It is the DOSE and the OTHER ingredients in a remedy that

decide whether or not toxicity will arise in HEALTHY subjects.

 

The risk of adverse reaction is higher, and the toxic dose lower, in

unhealthy subjects unable to metabolise drugs, active compounds

in herbal ingredients, or their metabolites, or in subjects intolerant

of any of the active agents.

 

For example, I understand that circa 2% (?) of cancer-patients lack

the enzymes to metabolise the agents used in chemotherapy for

cancer. Those unfortunate people have severe side-effects in the

days and weeks after administration of the chemo cocktail. [That is

an area where AP and correctly prescribed herbal formulas might

help greatly! Depending on the chemo used, and on the organs

targeted by its side-effects, AP and herbs to support/protect LV,

KI, HT & SP-ST functions have shown some promise in that area.]

 

Jeffrey, IMO, it is as incumbent on herbalists as on MDs/allopathic

physicians, surgeons and anaesthetists to be aware of possible

drug-herb interactions, and of possible interactions between drugs

OR herbs on a compromised system, especially weakened LV, KI

or HT function.

 

> FDA could destroy us just as effectively with the interaction

> question. We say, " we know what we're doing. " FDA then says, " Okay,

> prove it. " How do we do that? Just as important, how do we afford

> to do it? Jeffrey

 

IMO, the FDA and EU Regulators will destroy us faster if we try to

AVOID the issue! We must face up to it and carefully document

the background health (esp PREVIOUSLY compromised LV, HT

and KI function), and the use of concomitant allopathic and herbal

remedies in any patients that suffer adverse reactions while taking

(or shortly after stopping) herbal remedies.

 

 

Best regards,

 

Email: <

 

WORK : Teagasc Research Management, Sandymount Ave., Dublin 4, Ireland

Mobile: 353-; [in the Republic: 0]

 

HOME : 1 Esker Lawns, Lucan, Dublin, Ireland

Tel : 353-; [in the Republic: 0]

WWW : http://homepage.eircom.net/~progers/searchap.htm

[Guest guest]

Hi All, & Hi Jeffrey

 

I had written that we should argue [with FDA) that most if not all

the " documented " adverse effects of CHMs / Chinese supplements

were because of OTC (non-professionally prescribed) use, and that

the effects in most cases involved INTERACTION with other

(allopathic) drugs in patients with > already compromised LV, KI or

HT function.

 

Jeffrey replied:

> This is where we need to be really careful, if we don't want to

> end up having to get pharmacology degrees / be under the

> supervision of pharmacists / etc. Who holds the keys to herb-drug

> interactions, anyway? Certainly not licensed acupuncturists. I'm

> not so sure anyone does, at least not outside of China and the

> Chinese diaspora.

 

Jeffrey, with respect, I disagree. Yes, much remains unclear on

herb-drug interactions but there are some data (including WWW

data) on that area. For example, one would not use a remedy with

a significant amount of digitalis in a subject already taking digitalis-

type medication.

 

I have argued elsewhere that even air and water (the most vital

essentials for life) can be toxic under certain circumstances. So

can salt and sugar!

 

If so, IMO, ALL herbs and drugs, without exception, are potentially

toxic. It is the DOSE and the OTHER ingredients in a remedy that

decide whether or not toxicity will arise in HEALTHY subjects.

 

The risk of adverse reaction is higher, and the toxic dose lower, in

unhealthy subjects unable to metabolise drugs, active compounds

in herbal ingredients, or their metabolites, or in subjects intolerant

of any of the active agents.

 

For example, I understand that circa 2% (?) of cancer-patients lack

the enzymes to metabolise the agents used in chemotherapy for

cancer. Those unfortunate people have severe side-effects in the

days and weeks after administration of the chemo cocktail. [That is

an area where AP and correctly prescribed herbal formulas might

help greatly! Depending on the chemo used, and on the organs

targeted by its side-effects, AP and herbs to support/protect LV,

KI, HT & SP-ST functions have shown some promise in that area.]

 

Jeffrey, IMO, it is as incumbent on herbalists as on MDs/allopathic

physicians, surgeons and anaesthetists to be aware of possible

drug-herb interactions, and of possible interactions between drugs

OR herbs on a compromised system, especially weakened LV, KI

or HT function.

 

> FDA could destroy us just as effectively with the interaction

> question. We say, " we know what we're doing. " FDA then says, " Okay,

> prove it. " How do we do that? Just as important, how do we afford

> to do it? Jeffrey

 

IMO, the FDA and EU Regulators will destroy us faster if we try to

AVOID the issue! We must face up to it and carefully document

the background health (esp PREVIOUSLY compromised LV, HT

and KI function), and the use of concomitant allopathic and herbal

remedies in any patients that suffer adverse reactions while taking

(or shortly after stopping) herbal remedies.

 

 

Best regards,

 

Email: <

 

WORK : Teagasc Research Management, Sandymount Ave., Dublin 4, Ireland

Mobile: 353-; [in the Republic: 0]

 

HOME : 1 Esker Lawns, Lucan, Dublin, Ireland

Tel : 353-; [in the Republic: 0]

WWW : http://homepage.eircom.net/~progers/searchap.htm

[Guest guest]

I agree with Phil on many points raised here:

 

1. Most of the documented side effects of herbal medicinals due involve

medicinals taken by an individual without advice from a trained herbalist

and quite possibly in combination with other pharmaceuticals or OTC

substances. The myth that because it is an herb it must be safe at all

times simply is not true and the general public needs to be educated about

this. But this does not mean that we will need pharmacy degrees. We are

probably more aware of the potential for herb-herb, herb-drug, and

herb-other substance interaction than most physicians are aware of

drug-drug interactions. Most patients depend upon their pharmacists for

this information - a risky business.

 

2. Everything is toxic at inappropriate dosages. Food substances, herbal

medicinals, pharmaceuticals, air, water, what have you. What we want to

teach our patients is about moderation - nothing too much and nothing too

little - but just appropriate amounts. And we also must remember this when

prescribing medicinals and, as Phil points out, it is incumbent on us to

educate our patients and hopefully the general public on the appropriate

use of chinese medicinals.

 

3. We must show that we are knowledgeable about interactions and we must

document in our charts that we speak to our patients about possible

interactions. If we fail to do this and to present ourselves as the ones

who know and understand this medicine and how it interacts, we will be in

trouble.

 

Thanks Phil.

 

Marnae

 

At 05:19 PM 2/23/2004, you wrote:

>Hi All, & Hi Jeffrey

>

>I had written that we should argue [with FDA) that most if not all

>the " documented " adverse effects of CHMs / Chinese supplements

>were because of OTC (non-professionally prescribed) use, and that

>the effects in most cases involved INTERACTION with other

>(allopathic) drugs in patients with > already compromised LV, KI or

>HT function.

>

>Jeffrey replied:

> > This is where we need to be really careful, if we don't want to

> > end up having to get pharmacology degrees / be under the

> > supervision of pharmacists / etc. Who holds the keys to herb-drug

> > interactions, anyway? Certainly not licensed acupuncturists. I'm

> > not so sure anyone does, at least not outside of China and the

> > Chinese diaspora.

>

>Jeffrey, with respect, I disagree. Yes, much remains unclear on

>herb-drug interactions but there are some data (including WWW

>data) on that area. For example, one would not use a remedy with

>a significant amount of digitalis in a subject already taking digitalis-

>type medication.

>

>I have argued elsewhere that even air and water (the most vital

>essentials for life) can be toxic under certain circumstances. So

>can salt and sugar!

>

>If so, IMO, ALL herbs and drugs, without exception, are potentially

>toxic. It is the DOSE and the OTHER ingredients in a remedy that

>decide whether or not toxicity will arise in HEALTHY subjects.

>

>The risk of adverse reaction is higher, and the toxic dose lower, in

>unhealthy subjects unable to metabolise drugs, active compounds

>in herbal ingredients, or their metabolites, or in subjects intolerant

>of any of the active agents.

>

>For example, I understand that circa 2% (?) of cancer-patients lack

>the enzymes to metabolise the agents used in chemotherapy for

>cancer. Those unfortunate people have severe side-effects in the

>days and weeks after administration of the chemo cocktail. [That is

>an area where AP and correctly prescribed herbal formulas might

>help greatly! Depending on the chemo used, and on the organs

>targeted by its side-effects, AP and herbs to support/protect LV,

>KI, HT & SP-ST functions have shown some promise in that area.]

>

>Jeffrey, IMO, it is as incumbent on herbalists as on MDs/allopathic

>physicians, surgeons and anaesthetists to be aware of possible

>drug-herb interactions, and of possible interactions between drugs

>OR herbs on a compromised system, especially weakened LV, KI

>or HT function.

>

> > FDA could destroy us just as effectively with the interaction

> > question. We say, " we know what we're doing. " FDA then says, " Okay,

> > prove it. " How do we do that? Just as important, how do we afford

> > to do it? Jeffrey

>

>IMO, the FDA and EU Regulators will destroy us faster if we try to

>AVOID the issue! We must face up to it and carefully document

>the background health (esp PREVIOUSLY compromised LV, HT

>and KI function), and the use of concomitant allopathic and herbal

>remedies in any patients that suffer adverse reactions while taking

>(or shortly after stopping) herbal remedies.

>

>

>Best regards,

>

>Email: <

>

>WORK : Teagasc Research Management, Sandymount Ave., Dublin 4, Ireland

>Mobile: 353-; [in the Republic: 0]

>

>HOME : 1 Esker Lawns, Lucan, Dublin, Ireland

>Tel : 353-; [in the Republic: 0]

>WWW : http://homepage.eircom.net/~progers/searchap.htm

>

>

>Chinese Herbal Medicine offers various professional services, including

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