Re: traditions

[Guest guest]

Sue,

I wholeheartedly agree with your sentiments. I have recently used the same

logic at the MCA- that traditional use safety evidence should only apply to

the traditional preparation. It seems to me that much of the arguments over

the efficacy of herbal medicines in clinical trials are flawed because of

this. In most cases the " herbal " medicine in the trial is in fact a

standardised extract which does not necessarily contain all the components

present in the traditional preparation and those that do occur are in far

greater concentrations than in the plant. This does not equate with using the

traditional preparation and the use of different extracts at different

strengths in different trials only further confuses the issue.

This was part of my argument regarding Kava as all the cases of liver damage

have been associated with the standardised extract and not the whole plant,

decoction, tincture or the traditional extracts used in Oceania.

In fact there is research currently underway in the Arhnemland area of the

Northern Territories which is monitoring people taking the traditional kava

preparation in quantities that give an equivalent dose of 10 to 50 times the

recommended kavalactone dose stated in the German Commission E Monographs of

60-120mg per day (many standardised extracts have a recommended daily dose of

greater than 240mg kavalactones per day) and no evidence of liver damage has

been observed.

Our own research has shown that their are other components in the plant and

the more traditional extracts that may prevent liver damage associated with

the lactone component.

In other words traditional use evidence must only apply to the herb or the

preparation that this evidence is based on and not a totally different

preparation from the plant. Even in the world of pharmaceuticals if a

manufacturer wants to increase the dose of their product they have to prove

that the new dose will have a positive risk/benefit analysis.

I believe that it is vital to the future of herbal medicine that herbalists

are well represented on any governing body for manufacture so the regulations

can safeguard the traditional use and manufacture of herbs. There is

undoubtedly an enormous difference between a herbalist prescribing a blend of

herbs that is designed for the particular needs of a particular patient and a

company deciding it wants to produce a new herbal (or even

phytopharmaceutical) product.

If I may answer some of the criticisms of the Herbal Apothecary by others in

recent correspondence, my company has been audited by retailers,

pharmaceutical companies and we are the only non-pharmaceutical company in

Europe who have been given a category 1 supplier rating by Glaxo Kline.

As far as I am aware no other company of similar size has the appropriate

quality assurance, tracability and quality control systems in place to

achieve this status. This status means that our processes have to be

acceptable to the MCA who may audit us as part of the control of the Glaxo

product license. In case anyone is interested we supply them with BP herbal

products.

Our catalogue clearly describes products grown by organically certified

suppliers as organically grown and NOT " organic " . We also explain the

rationale behind this policy. We are not attempting to dupe the public or

practitioners. We spend approximately 30% of our income on Quality Assurance

and Quality Control. The research work we carry out is aimed at gaining a

better understanding of the biochemical mechanisms involved in herbal

medicine so we can counter allegations that herbs are dangerous as we have

recently done with Kava, where we are still fighting but at least we were

able to provide breathing space until our current research is complete.

The other point I would like to make is that this work is funded entirely by

the Herbal Apothecary. We are not introducing more products on the back of

this work and we are publishing our work to make the results available to

all.

Whitton

Senior Scientist

Herbal Apothecary Ltd

High Street

Syston

Leicester

LE7 1GQ

Tel: 0

Fax: 0116260 2757

Direct Tel: 0

email: awhitton@...

[Guest guest]

Dear , I'm afraid I for one do not find it reassuring to be told you

are approved by Glaxo. Sorry. I prefer a less pharmaceutically based

endorsement of my

suppliers. Allshorn

Re: traditions

> Sue,

[Guest guest]

The only products that HA supply to glaxo are BP herbal products such as

Ipicac. (We are not into pharmaceuticals of any kind)

Although you may not like pharmaceutical companies the fact remains that

their standards of production are very high and their requirements for

GMP strict.

Maybe such a classification from glaxsso should reassure HA's customer's

of its high standards of production rather than disconcert them.

Re: traditions

Dear , I'm afraid I for one do not find it reassuring to be told

you

are approved by Glaxo. Sorry. I prefer a less pharmaceutically based

endorsement of my

suppliers. Allshorn

Re: traditions

> Sue,

List Owner

Graham White, MNIMH

[Guest guest]

,

When at the meetings held at the MCA in London recently to discuss to

proposed changes to the law my impression of the new regulations certainly

differs from yours. I have been informed by Woodfield and

Andersen from the MCA that all companies making herbal products will require

a manufacturing license as well as traditional medicine license for each

product. The only time a license will not be required is for a bespoke

medicine for a practitioner to give directly to one particular patient.

This is why we have spent a considerable amount of time and effort (not to

mention money) showing that herbal medicine is more than just a collection of

chemicals with the one " active " . In order to influence the MCA we have to be

able to talk their language to a certain extent and show them that herbal

preparations are infinitely more complex than pharmaceuticals which only have

the one ingredient surrounded by " inert " packing materials. We have to be

able to show that there are differences between herbs and standardised

extracts in chemical terms which they can understand. Otherwise we will have

many more incidents such as that with Kava where a greatly increased dose of

a very components of the plant has been packaged and sold as though it is the

whole herb.

Part of the campaign we have been making is for them to recognise the

knowledge of herbalists. Please remember not all chemists are bad or

misguided and herbal medicine may well have need of them in the future to

help counter allegations.

Surely if herbal medicine is to become more widespread we need to inform the

public that it is available and where to get it. Most people will get their

first introduction to herbal medicine through an OTC product. Therefore it is

vital to be able to influence the regulators to ensure that OTC herbal

medicines are true herbal medicines and not standardised extracts.

By showing that we can make our products in a traditional way and still

comply with their regulations are we not showing that there is far more to

herbalism than meets the eye?

The figures you quote for the licenses puzzle me as these are more than for

an orthodox medicine license. The traditional license can be obtained by

showing evidence of traditional use within the EU for a period of 30 years

(or 15 years inside the EU and 15 years outside the EU). Safety evidence will

be accepted on the basis of a journal search of published information.

Whitton

Senior Scientist

Herbal Apothecary Ltd

High Street

Syston

Leicester

LE7 1GQ

Tel: 0

Fax: 0116260 2757

Direct Tel: 0

email: awhitton@...

[Guest guest]

,

Once again I think we will have to disagree. Science cannot be un-invented

and like it or not we have to live with it. I have always found that more can

be achieved through open discussion and if we do not attempt to educate

others they will be liable to form their own misguided opinions based on

prejudice and ignorance.

Sorry I can't do anything about the rain.

Whitton

Senior Scientist

Herbal Apothecary Ltd

High Street

Syston

Leicester

LE7 1GQ

Tel: 0

Fax: 0116260 2757

Direct Tel: 0

email: awhitton@...

[Guest guest]

Despite the excellent Band on Sunday morning (serious boogie - where did you

find them, ?), have just stumbled back from a day hosted by the

Pharmaceutical Companies and the Medicine Control Agency at the the Royal

College of Physicians, Londinium on the new Medicines legislation, that is

the Traditional

Medicines Directive (or expensive medicines directive as we might call it)

for Herbal Meds AND thought that readers might like an observation..

Gasp....

In essence, Over the Counter (OTC) medicines, prepacked

and sold in little bottles with indications for useage will become seriously

expensive to produce (one guy was talking up to 200 million Euro for a

licence, er...) and will become the preserve of the Big-time

" Pharmaceutical " Industry and totally erradicates the small timers and of

course what the Chemicaal industry calls the cowboys (sic). However am

relieved to say that your humble

supplier of properly described herbal extracts for the exclusive use of

Formally registered Practitioners who then make up their prescriptions for

patients on a one to one basis under Section 12 will not

change (for the Registered Practitioner, that is who is, needless to say,

to be Self or otherwise regulated by law). However, I thought readers might

be interested to hear that when I proposed that the Pharmaceutical Industry

which is now so very

interested in making the move on the herbal market (- do not be fooled, it

was all dominated by firms like Merck) might gain much by taking qualified

herbalists onto their staff, the reaction was rather as if something immoral

had

been suggested.

The Pharmaceuticals politely recoiled and dismissed the suggestion with the

rebuff that herbalists

would need a re-training in order to understand how to make herbal

medicines. In particular, the Chemists consider it laughable that a mere

herbalist can understand a medicine. In case you think this is a joke, or

cynicism gone mad, educators need to appreciate that this is actually a

serious sociological problem. There is now frequently discussion in the

magazine 'Nature' (see last week under book reveiews) about the need for

science to evolve away from its its iconoclastic roots and academic snobbery

towards a more integrated holistic, or inter-disciplinary approach. No sign

whatsoever of that rearing its attractive head at the MLC at present,

methinks.

Whilst paying occaisonal lip-service to the mystery of herbal synergy, the

whole day was taken up on how to standardise extracts proceedures which can

then be legally enforced. Sad isn't it?

However, we are talking OTC not Section 12 Medicines. A thought - as OTC

herbals become standardised pharmaceutical extracts and don't work/ have

side effects - won't that send more patients to the ever growing number of

proper herbalists who will have the choice to make/use proper herbal

medicines?

SSR wise, in private conversation, the MLC attitude is that Registration is

underway now, they're just kindly giving us time to decide whether we want

to do it ourselves or

have it done by them.

Anyway, off to bed now as we are starting planting tomorrow at 0530. Get

done

before a nice good raining, as we always say.

Love to all,

Re: traditions

>

>

> > Sue,

>

>

>

>

>

> List Owner

>

>

>

> Graham White, MNIMH

>

>

[Guest guest]

" Chenery " wrote to

<ukherbal-list >:

> However, we are talking OTC not Section 12 Medicines. A thought - as OTC

> herbals become standardised pharmaceutical extracts and don't work/ have

> side effects - won't that send more patients to the ever growing number of

> proper herbalists who will have the choice to make/use proper herbal

> medicines?

Sadly, that's VERY unlikely. Instead it's likely to send patients back to their

doctors, who can tell them about the side effects of _their_ meds. Make herbs

dangerous in the minds of the people and they'll turn away from them. Does the

propaganda work? You betcha. The good folks at JAMA know what they're doing, and

nobody but us even suspect that they're not all that honest when it comes to

alternative healthcare.

Anyway, what you're saying is that both practising herbalists and the making of

herbal preparations are close to getting completely outlawed. I'd like to know

if this is a pharmagiant trend, or if it is endorsed by the UK government, or,

even worse, by the EU?

In the US herbal practitioners are, for all practical purposes, outlawed, but

survive in the cracks of the system... as long as they keep a low profile.

In Finland we're tolerated with an amused eye, as long as we keep our hands off

the " pharmacy only " herbs - dangerous ones like Echinacea, Valeriana, Hypericum,

Panax spp., Eleuthero... this pharmaceutical factory only list is one reason why

I go out and teach people how to pick'em in their own backyard, and how to grow

them, if necessary.

I do hope the Finns will go for the German system of alternative healthcare.

That is, you study standard medicine for about a year, which gives you basic

medical knowledge like " don't mess with IDDM " and such. Then, after you've

passed a test, you can hang up a shingle as " Heilpraktiker " (alternative

practitioner) -- of whatever flavor.

The German system ensures that dangerous people can't practise. People like the

" herbalist " in the US who recently (?) killed a kid on insulin by telling her

mother to take her off that dangerous drug and use these here herbs instead.

Anyway, this complete (but misplaced) faith in your own modality is not all that

unusual. A few years ago a lady over here was convicted of manslaugher because

she had told an IDDM person to stop insulin and do these here very effective

Kuhne baths instead...

My take is, this would really be quite enough. I see no need for SSR anywhere.

Just require a minimum of common sense, and basic knowledge of what is

life-threatening. Then you can forget about expensive governmental bodies.

On a sidenote, I teach more than a month of herbal medicine at a local

alternative practitioner school. I automatically fail anybody who actually

answers with a list when asked " what herbs would you give to somebody with

bloody stool / bloody urine / bloody vomit / bloody sputum? " . I just might put

in another question that basically asks " What herbs would you give to an IDDM

who wants to stop his/her insulin? "

Cheers

Henriette

--

hetta@... Henriette Kress Helsinki, Finland

Over 30 MB herbal .html files (FAQs, classic texts, articles, links), plus

pictures, zipped archives, the works, at: http://www.ibiblio.org/herbmed

[Guest guest]

it's likely to send patients back to their

> doctors, who can tell them about the side effects of _their_ meds. Make

herbs

> dangerous in the minds of the people and they'll turn away from them. Does

the

> propaganda work? You betcha. The good folks at JAMA know what they're

doing, and

> nobody but us even suspect that they're not all that honest when it comes

to

> alternative healthcare.

One of the potentially positive areas touched on yesterday was an appeal

from the pharmaceuticos for the MCA to help make GPs more responsive to

herbal medication, (although without the holistic model, I can't see the

point).

> Anyway, what you're saying is that both practising herbalists and the

making of

> herbal preparations are close to getting completely outlawed. I'd like to

know

> if this is a pharmagiant trend, or if it is endorsed by the UK government,

or,

> even worse, by the EU?

I think that has been the case anyway for the last 60 years or so.

It cannot be denied it was obvious yesterday that the pharmacos are

immensely cosy with the legislature, almost embarressingly so ( " I would like

to first of all thank my friends in the civil service; how many lumps, one

or two? blah blah " )

I'm sure the MCA try to do their stated job in a totally even-handed way,

but theyr are only human and will respond to the best argued case. If you

have twenty or thirty million and very sharp minds thrown at a PR job, I

guess it is hard not be overwhelmed. If you get several hundred Professor

status scientists in the Pharamcos to each civil servant, what can you

expect?

However, the pharmacos are both realistic and pragmatic:

The practitioner market is so small as to be of no interest to them.

However, if they do not have it outlawed and allow it to grow, then who

knows, maybe one fine day they will see a use for us. We are not any threat

to them, after all. But don't annoy them ! I must say in terms of

unchallengeable power, it felt eerily like being at lunch with the Borgias

yesterday.

In the meantime, I believe that for us, it is essential that we conserve our

energies and relegate politics back to a side show and off the centre stage.

What Western civilisation desperately needs is enlightened scientific

leadership to free us from these slaveries. All pharmacos are is an economic

response to the ideas of 100 years ago. We now need holistic science to be

developed thorughout our schools and universities, in our homes and

entertainment and only then can we hope it will get into the legislature.

Re: traditions

> " Chenery " wrote to

> <ukherbal-list >:

>

> > However, we are talking OTC not Section 12 Medicines. A thought - as OTC

> > herbals become standardised pharmaceutical extracts and don't work/ have

> > side effects - won't that send more patients to the ever growing number

of

> > proper herbalists who will have the choice to make/use proper herbal

> > medicines?

>

> Sadly, that's VERY unlikely. Instead it's likely to send patients back to

their

> doctors, who can tell them about the side effects of _their_ meds. Make

herbs

> dangerous in the minds of the people and they'll turn away from them. Does

the

> propaganda work? You betcha. The good folks at JAMA know what they're

doing, and

> nobody but us even suspect that they're not all that honest when it comes

to

> alternative healthcare.

>

> Anyway, what you're saying is that both practising herbalists and the

making of

> herbal preparations are close to getting completely outlawed. I'd like to

know

> if this is a pharmagiant trend, or if it is endorsed by the UK government,

or,

> even worse, by the EU?

>

> In the US herbal practitioners are, for all practical purposes, outlawed,

but

> survive in the cracks of the system... as long as they keep a low profile.

>

> In Finland we're tolerated with an amused eye, as long as we keep our

hands off

> the " pharmacy only " herbs - dangerous ones like Echinacea, Valeriana,

Hypericum,

> Panax spp., Eleuthero... this pharmaceutical factory only list is one

reason why

> I go out and teach people how to pick'em in their own backyard, and how to

grow

> them, if necessary.

>

> I do hope the Finns will go for the German system of alternative

healthcare.

> That is, you study standard medicine for about a year, which gives you

basic

> medical knowledge like " don't mess with IDDM " and such. Then, after you've

> passed a test, you can hang up a shingle as " Heilpraktiker " (alternative

> practitioner) -- of whatever flavor.

>

> The German system ensures that dangerous people can't practise. People

like the

> " herbalist " in the US who recently (?) killed a kid on insulin by telling

her

> mother to take her off that dangerous drug and use these here herbs

instead.

> Anyway, this complete (but misplaced) faith in your own modality is not

all that

> unusual. A few years ago a lady over here was convicted of manslaugher

because

> she had told an IDDM person to stop insulin and do these here very

effective

> Kuhne baths instead...

>

> My take is, this would really be quite enough. I see no need for SSR

anywhere.

> Just require a minimum of common sense, and basic knowledge of what is

> life-threatening. Then you can forget about expensive governmental bodies.

>

> On a sidenote, I teach more than a month of herbal medicine at a local

> alternative practitioner school. I automatically fail anybody who actually

> answers with a list when asked " what herbs would you give to somebody with

> bloody stool / bloody urine / bloody vomit / bloody sputum? " . I just

might put

> in another question that basically asks " What herbs would you give to an

IDDM

> who wants to stop his/her insulin? "

>

> Cheers

> Henriette

>

> --

> hetta@... Henriette Kress Helsinki, Finland

> Over 30 MB herbal .html files (FAQs, classic texts, articles, links), plus

> pictures, zipped archives, the works, at: http://www.ibiblio.org/herbmed

>

>

> List Owner

>

>

>

> Graham White, MNIMH

>

>

[Guest guest]

Please remember not all chemists are bad or

> misguided and herbal medicine may well have need of them in the future to

> help counter allegations.

,

I once counted myself amongst them, in a Dept of Biochemistry but my

conclusion 30 years ago was and still is that all chemistry has to offer is

a reduction of life to dead bits. This is sometimes beguiling to a certain

type of mind, but ultimately misleading.

By the way, it can rain now.

Thanks

Re: traditions

> ,

> When at the meetings held at the MCA in London recently to discuss to

> proposed changes to the law my impression of the new regulations certainly

> differs from yours. I have been informed by Woodfield and

> Andersen from the MCA that all companies making herbal products will

require

> a manufacturing license as well as traditional medicine license for each

> product. The only time a license will not be required is for a bespoke

> medicine for a practitioner to give directly to one particular patient.

> This is why we have spent a considerable amount of time and effort (not to

> mention money) showing that herbal medicine is more than just a collection

of

> chemicals with the one " active " . In order to influence the MCA we have to

be

> able to talk their language to a certain extent and show them that herbal

> preparations are infinitely more complex than pharmaceuticals which only

have

> the one ingredient surrounded by " inert " packing materials. We have to be

> able to show that there are differences between herbs and standardised

> extracts in chemical terms which they can understand. Otherwise we will

have

> many more incidents such as that with Kava where a greatly increased dose

of

> a very components of the plant has been packaged and sold as though it is

the

> whole herb.

> Part of the campaign we have been making is for them to recognise the

> knowledge of herbalists. Please remember not all chemists are bad or

> misguided and herbal medicine may well have need of them in the future to

> help counter allegations.

> Surely if herbal medicine is to become more widespread we need to inform

the

> public that it is available and where to get it. Most people will get

their

> first introduction to herbal medicine through an OTC product. Therefore it

is

> vital to be able to influence the regulators to ensure that OTC herbal

> medicines are true herbal medicines and not standardised extracts.

> By showing that we can make our products in a traditional way and still

> comply with their regulations are we not showing that there is far more to

> herbalism than meets the eye?

> The figures you quote for the licenses puzzle me as these are more than

for

> an orthodox medicine license. The traditional license can be obtained by

> showing evidence of traditional use within the EU for a period of 30 years

> (or 15 years inside the EU and 15 years outside the EU). Safety evidence

will

> be accepted on the basis of a journal search of published information.

>

>

> Whitton

> Senior Scientist

> Herbal Apothecary Ltd

> High Street

> Syston

> Leicester

> LE7 1GQ

>

> Tel: 0

> Fax: 0116260 2757

> Direct Tel: 0

> email: awhitton@...

>

>

> List Owner

>

>

>

> Graham White, MNIMH

>

>