Re: Regulation again!!

[Guest guest]

Hi,

A brief comment:

As far as I have been able to ascertain, poisoning by aristolochic acids

occurs for two main reasons:

1. There are some mixtures that actually purport to include

Aristolochicia herb for it's physiological actions (!!!)

2. There are some uncontrolled materials that include the herb, either

by mistake or because of fraudulent adulteration.

Either way, people's lives have been repeatedly put at risk.

Other lower grade adverse effects also occur from time to time, mainly

by mistake.

But all this is because herbalists are not required to obtain materials

that are made under the manufacturers code of practice.

With some companies going to the trouble and overhead costs of a MIA and

others not, most herbs are bought from the cheaper unaudited companies.

Therefore there is no true traceability of most herbs in the market, so

who knows what they are getting?

That's simple enough, but more complicated is the recent emergence of

one or two companies which do not have cGMP but pretend to (even on one

website I have seen). Not only is this dishonest but it makes the case

for regulation almost incontrovertible.

The government discussion papers say plainly that a regulated profession

would have to give guarantees about the standard of material it is

using. That would rid the profession of sub-standard, adulterated and

dried materials containing unacceptable microbial loads (which is a very

common problem indeed, affecting up to 25% Chinese herbs on the market

in some cases we have seen). Professionally speaking, a no-brainer, you

might think but you would then be surprised to hear that most

practitioners still mainly buy on cost rather than quality

considerations.

Btw, cGMP does not in any way detract from vitality. It just means that

things are done to a standard agreed and accepted by manufacturing

experts across the world. That has to include independent licensing of

the manufacturers who supply herbalists.

Chenery

Rutland Biodynamics Ltd

>

>

> Hello everyone

>

> One of the responses regarding regulation was posted to me by one of

> my colleagues on the independant herbalist forum. For those that read

> the Herbal thymes,and the letter from Philip & and

> Mr McIntyres response ,he wondered if you would care to read it.

> He is not on this forum so I thought I would post it for all to see.

> You may agree with him, you may not, but its nice that we have a

> choice about what we think in the UK. By the way, anyone can join the

> independant herbalist forum if you happen to subscribe to the ideas

> and ideals that it embraces of their Declaration of Intent.

>

> Best wishes to you all, happy easter, not too many eggs!!

>

> Jacqui

>

> Here is the response from Mr Sandy

>

> " I have given some thought to the statements made by Mr McIntyre on

> the subject of the questionable benefits of Statutory Regulation and

> the alleged disaster that would occur if it were not to be

> implemented. The following comments are intended to form a rebuttal to

> the comments made by Mr McIntyre as a response to the article by

> Philip and published in the Herbal Times, as well as

> to the further comments published by Mr McIntyre in the pre-formatted

> letter that was sent to members of NIHM for their endorsement.

>

> The latest erroneous claim that he appears to be making concerns the

> recent unfortunate problems that arose with the patient taking

> traditional Chinese medicine that contained aristolochic acids that

> were not supposed to be in it. He is currently putting forward the

> idea that its Statutory Regulation were in place, this would not have

> happened. Unfortunately he totally fails to substantiate the reasoning

> behind this claim.

>

> If THMPD were fully in place and functioning in the way that is

> intended, this strategy might have been averted. Statutory regulation

> does not in any way affect the licensing of herbal products by the

> MHRA. Statutory regulation would concern the regulation of the

> therapist by the HPC, which the last time I checked was a different

> QUANGO.

>

> Mr McIntyre and those of his persuasion have put forward the idea that

> Statutory Regulation would give the therapist the ability to continue

> to access and prescribe unlicensed manufactured herbal products. This

> of course is not strictly true. To achieve this benefit, herbalists

> would not only have to become statutorily regulated, they would also

> have to qualify as been authorised health professionals. Even this

> would not prove sufficient, as a derogation also had to be put in

> place to allow the authorised health professional to access

> unlicensed, and therefore illegal, herbal products. It was precisely

> such a product that caused the problem. It follows on from this line

> of argument that strategy regulated practitioners were only become

> further elevated to the appropriate level of professional status, but

> the appropriate legal instrument was also brought into force, this

> situation could again arise where an unlicensed toxic preparation

> could be unwittingly unleashed upon an unwary patient.

>

> As the European Union has allegedly set about forcing the introduction

> of THMPD to prevent such an occurrence, there seems little logic to

> the argument that is in the interest of public safety to concoct a

> regime to defeat its purpose. If all the appropriate challenges were

> overcome to initiate the nightmare scenario that Mr McIntyre proposes,

> the only beneficiaries would be the manufacturers of unlicensed herbal

> products, and would have been safety expects of legalising their

> products. This clearly would demonstrate that the financial health of

> the manufacturing companies was being put before the health and safety

> of the public. Exactly how many more scandals does the population of

> the planet need to experience before they wake up to the inherent

> danger associated with this immoral philosophy?

>

> Mr McIntyre has expressed his concern of the amount of trouble the

> MHRA might be put to, were they to be confronted with the requirement

> to generate a licensing scheme for herbal medicine. The MHRA already

> have THMPD, which relates to herbal medicine products. As the

> government has set itself the task of finding the appropriate level of

> regulation for herbal medicine proportionate to any risk that it might

> represent, the subject of the convenience of the MHRA is completely

> irrelevant.

>

> Mr McIntyre and those of his persuasion have repeatedly put forward

> that the standards of practitioner excellence could not be maintained

> without the introduction Statutory Regulation. Here again the

> rationale of this argument has yet to be explained. The current

> standards of excellence have been created without is the enforcement

> of Statutory Regulation, and it is therefore be logical put forward an

> argument that the continuation of the current arrangements would lead

> to a different outcome. If he is maintaining that non-statutorily

> regulated practitioners are automatically dangerous and incompetent,

> then perhaps he should retire from the profession in the interest of

> public safety. I have yet to hear a convincing argument against this

> line of logic.

>

> Mr McIntyre and those of his persuasion had been highly vociferous on

> the subject of evidence of efficacy in relation to herbal medicine.

> The RCHM was highly on this subject in its response to the public

> consultation. They complain that it is unfair and unjust that

> empirical knowledge and experience is not adequately taken into

> consideration, with a preference for evidence of efficacy being

> primarily based on blind drug trials. This is one point upon which I

> am agreement with him. The problem, from his point of view, is that in

> taking this stance, he also confirming that the appropriate evidence

> of efficacy for herbal medicine cannot be met to satisfy the criteria

> of the HPC. Mr McIntyre and those of his persuasion have consistently

> contradicted themselves on this particular subject. Even the House of

> Lords Select Committee on Science and Technology stated that

> Acupuncture and Herbal Medicine only had an " incomplete evidence

> base " , as quoted in the EHTPA briefing paper and associated

> documentation dated 7.5.2008 to Mr Ben Bradshaw Minister of State for

> Health Services, and posted on the EHTPA website. This statement and

> its quotation by Mr McIntyre constituted a direct admission that the

> criterion of evidence of efficacy had not actually been met.

>

> Mr McIntyre has put forward that those signing the petition against

> statutory regulation of herbal medicine are not herbalists. Apart from

> the blatant untruth of this statement, it also raises another problem

> for his arguments. Mr McIntyre and those of his persuasion have been

> very keen to mislead the public for the purpose of gaining its support

> for Statutory Regulation. It therefore appears that, in their world

> view, members of the public (also happen to be your patients) are only

> entitled to have a valid opinion when it can occurs with their own. If

> dissenting voices are to be ignored, he is advocating a de facto

> totalitarian regime.

>

> Mr McIntyre has often quoted the house of Lord's Select Committee on

> Science and Technology's report which stated that the inherent risk

> posed by herbal medicine " is the risk of omission of conventional

> medical treatment " . This argument is more than somewhat paradoxical

> when put alongside the BMJ evidence centre report (also frequently

> quoted by Mr McIntyre), which states:-

>

> " Of around 2500 [commonly used NHS] treatments covered 13% are rated

> as beneficial, 23% likely to be beneficial, 8% as trade off between

> benefits and harms, 6% unlikely to be beneficial, 4% likely to be

> ineffective or harmful, and 46%, the largest proportion, as unknown

> effectiveness. "

>

> The relevance here is that these dangerous and ineffective treatments

> have been variously approved by the MHRA and NICE (the National

> Institute of Clinical Excellence). This situation almost beggars

> belief, but was adequately explained in the House of Commons Select

> Committee Report on the Influence of the Pharmaceutical Industry,

> which explained in great detail the incestuous relationship between

> the pharmaceutical companies and the regulatory body which was

> supposed to stand as a watchdog over their products and activities.

> This same report categorically stated that the MHRA was antipathetic

> to the interests of herbal medicine is practitioners and their

> patients. We therefore have a situation where Mr McIntyre is

> supporting an argument that the democratic freedom of choice of the

> population should be curtailed in favour of a form of treatment

> officially characterised as the best unreliable and dangerous.

> It is of course also notable that the concept of the introduction of

> regulation in a attempt to control and regulate the democratic freedom

> of choice of the population, is a direct contradiction of the

> requirements laid down by the European Treaty to preserve and protect

> diversity. From this it becomes manifestly clear that the proposal to

> statutory regulate herbal medicine is contrary to its interests both

> now and in the future. Those advocating this process can at best be

> seen as offering a policy of appeasement to a regime already exposed

> as corrupt and incompetent. Such a policy of betrayal is unlikely to

> protect the current and future interests of herbal medicine and may

> eventually lead to its eventual elimination altogether.

>

> As it has been demonstrated above, those arguments that have been put

> forward as allegedly supporting Statutory Regulation, upon

> consideration can be shown to demonstrate that such a regime is not

> the appropriate way forward. The counter logic employed by Mr McIntyre

> and those of his persuasion might seem to indicate that they are

> either actively conspiring with the pharmaceutical companies against

> herbal medicine, or political refugees from " Alice Through the

> Looking Glass " fleeing the threat of decapitation by order of the

> Queen of Hearts. Were she to have been given similarly unsound advice,

> a Royal response of this nature might be seen as being no more than

> reasonable. "

>

>

>

>

>

--

Chenery

Rutland Biodynamics Ltd.