Triamazon

4/3/2006 12:00:00 AM by Martin Last, BA (2:1 Hons) MMRS MRS Dip

In the case of herbs, the U.K. position was clearly unsatisfactory in that the existing system did not usually allow adequate communication of product benefits nor did it impose minimum uniform standards of quality for manufacturers, consumers and authorities alike. Change was therefore inevitable and, following years of debate, the Traditional Herbal Medicinal Products Directive (THMPD) has now been created to attempt to redress this situation.
But the new law regarding herbals is complex and, while it has the intention to eventually harmonize the legal position across the E.U., the current position is one where national interpretation of the legislation is the norm.
Status of THMPD
The THMPD was adopted by the E.U. in Spring 2004 and was implemented in the U.K. on Oct. 30, 2005. The immediate implications are minor. No further “medicinal herb” products can be launched without Traditional Herbal Medicinal Products (THMP) registration or marketing authorization (licence), but existing products (sold legally) can remain on the market until the transitional period ends in 2011. The THMPD allows herbal products to be registered as THMP under medicines law. To gain this registration, these products must demonstrate high (pharmaceutical) standards of manufacture and product quality and mild claims can be made for the products.
Herbal products that have been used traditionally in the E.U. for 30 years may be registered with a dossier showing quality data on the product and its ingredients, evidence of its traditional use and a bibliographic review of safety. Approval of such a dossier satisfies the medicinal requirements of safety and quality, with efficacy demonstrated by long term use. In this “simplified” registration it is also possible that the evidence of tradition and safety review is not required if the product is already on a central E.U. list or has a central monograph.
This differs from the previous U.K. system, which included four categories of herbal products on sale in the U.K.: those classed as botanicals or herbal food supplements; those under Section 12.2 of the Medicines Act relating to a specific exemption that allows for the sale of certain medicinal herbs provided that no product claims are made; Section 12.1 herbals, another exemption which allows practitioners to supply certain herbal materials to their clients on a one-to-one basis; and, finally, licensed herbal products converted from ‘licences of right’ granted to products on the market in 1968 and for which limited claims are allowed.
When the THMPD is fully implemented in 2011, there will still be four categories but two major changes will occur. The Section 12.2 exemption will lapse, as it is assumed that most current 12.2 products will have by then obtained THMP status. One benefit of the THMPD is herb/nutrient combinations (which do not technically fit under 12.2 legislation) will be allowed if the nutrient is plausible and at a safe level. A further change is that the Section 12.1 system is undergoing review by the U.K. authorities with a view to establish statutory registration of practitioners.
But other options also exist for manufacturers to market herbs separately from the THMPD, with either a further marketing authorization category called “well-established use” or under the category of botanicals (herbal food supplements).Well-established products are relevant to herbal products deemed capable of meeting THMPD’s more stringent criteria—the rewards are potentially stronger claims and possibly higher dosages; however, no herbal product has yet achieved this status in the U.K. The botanicals category is under separate review as an extension of the Food Supplements Directive but the use of herbs in food supplements is likely to be distinctly limited.
In this way, the law establishes a means for companies to decide to which category to apply the marketing of their products. The decision depends, to some extent, on the level of data available or the level of claim which they wish to make.
Problems with THMPD
There are significant differences between the U.K. herbals market and herbals markets in several other E.U. Member States. Many suppliers in the U.K. are SMEs (Small and Medium-sized Enterprises) compared to some other markets, which are dominated by big players. The U.K. also has a long-established network of herbal practitioners who tend to favor the use of multi-herb combination products; other Member States have single herb products that tend to be prescribed by medical doctors. U.K. consumers tend to use predominately multi-component products compared to single herbal products that have much stronger use elsewhere in the E.U. And the U.K. has vibrant ethnic herbal medicine disciplines, particularly the Ayurvedic and Traditional Chinese Medicine (TCM) systems, both of which are heavily reliant on multi-component products. Indeed, it is the multi-component nature of so many U.K. products that is the root cause of many U.K. problems with the E.U. legislation.
The THMPD involves very major new costs for many suppliers that result from bringing herbal products under pharmaceuticalbased medicines legislation. Requirements include expensive analytical testing, product registrations, GMPs (good manufacturing practices), various licences, pharmacovigilance measures and staff training. Even the U.K. authority, the Medicines & Healthcare Product Regulatory Agency (MHRA), estimates the average cost of preparing a single registration application for a simple single-herb product could be approximately £40,000 before taking into account the cost of any GMP upgrades or additional personnel. This cost would, of course, increase significantly for multi-component products. The MHRA has also concluded, “There may well be some rationalisation within the UK market as regards both businesses and products.”
Industry believes the MHRA cost estimates will probably prove conservative largely because the analytical regime required to demonstrate quality and stability is inappropriately and disproportionately onerous for multi-component products. U.K. industry is surprisingly united in arguing that more practical (and lower-cost) analytical test regimes are more appropriate without in any way imperilling product safety.
As things currently stand, the optimistic outlook of a fastgrowing herbals sector supplying high quality, safe and efficacious products is looking rather less likely than one in which company closures are accompanied by a sharp decrease in consumer choice; product development is stifled by high cost barriers and the supposed gains in consumer safety are undermined by a consumer exodus from U.K. retailers to buying from overseas suppliers selling products unregulated according to E.U. law over the Internet.
Because of this, 14 different bodies, including the Health Food Manufacturers Association (HFMA), have joined together over the last five years into the Herbal Forum to further negotiate with the MHRA on THMPD implementation. The result has been a commitment from the MHRA to maximize the simplicity and flexibility of their approach to implementation within the terms of the legislation. However, they themselves are restricted by pan- E.U. Guidelines being ratified by the Herbals Medicinal Products Committee (HMPC) of the E.U. Medicines Agency (EMEA). Therefore, there is still much lobbying at all levels to achieve a practical and satisfactory outcome.
So, although the valid intention is to achieve the goal of E.U. harmonisation of herbal law, many E.U. countries have yet to even address the issues of implementation of the THMPD into their national systems. Even when this is achieved, it is likely that some elements of national interpretation may prevail for many years thereafter.
Martin Last is a leading marketing consultant with over 25 years experience, specializing in the health products and food supplements industry and representing manufacturers and ingredient suppliers around the world. He is also the vice chairman of the U.K. Health Food Manufacturers Association (HFMA).

Intellectual acrobatics

Here is an astonishing medical fact determined by the MHRA
(courtesy of Mr Ian Oulsnam , GCP inspector of the MHRA to the press on 3/6/2006).

“No objective evidence has been provided to suggest an adverse change in risk/benefit ratio of the drug in question (Actonel).
On the contrary, the national scheme for reporting Adverse Reactions
related to medicines, shows a decline in the annual number of Adverse reactions reported for the drug in question.
More specifically, the number of reported fractures related to this drug has averaged one per year since the year of the publication. This is closely similar to the number of fracture reports for its competitor product.”
Mr Ian Oulsnam MHRA to the Press 3/6/2006

One fracture. Now that’s some blistering insight. A GCP inspector for the MHRA might be expected to have some medical insight particularly when when making public comment to the press on behalf of the MHRA.

If Mr Oulsnam had done some reading (or had spoken to his GP) he might have understood the concept of relative risk on therapy, the number of fractures that occur in osteoporosis, and the relevance of yellow card scheme fractures to the rather meaningless question he seems to be asking.

Mr Oulsnam may be excellent at his job serving the MHRA, but that he feels able to make such insightful public medical comments to the press on behalf on the MHRA is interesting. We will keep you posted here on more blistering medical insights from
the MHRA. Mr Oulsnam says that he was somehow involved with the inquiry into the ill fated TGN1412 drug experiment – lawyers acting for the affected volunteers are complaining of a whitewash. It may be equally likely that the MHRA just couldn’t understand why it might be a mistake to give a potentially toxic drug to 6 volunteers simultaneously while ignoring scientific advice.
Public Survey on possible corruption of the MHRA
http://www.network54.com/Votelet/39199
Corporate Killing laws and the MHRA
See discussion
MHRA caught in “flat out deception”
Report by the Alliance for Human Research Protection (AHRP)
Resignation of Richard Brook Chief Executive of mental health charity Mind from the MHRA expert panel
Mr Brook stated
“On Thursday the Agency at last published information advising that many thousands of men and women in this country may have been taking Seroxat at a dose that was unsafe. What they failed to mention – and what I am now making public – is the fact that the regulator had the data on which the basis of this decision was made for well over a decade as part of the original license application.
Either they didn’t understand the full implications of the available medical data at the time or, worse, that data was fully understood and they failed to act. Either way it amounts to extreme negligence and a clear dereliction of the MHRA’s duty to safeguard the well-being of the British public.
Paul Flynn MP “Regulator investigates the regulator”
http://www.paulflynnmp.co.uk/newsdetail.jsp?id=456
Paul Flynn MP (Newport West) said “the report on the dangerous reaction to the drug’s trial is a predictable whitewash. It was an act of lamentable lack of care”

“The MHRA is wholly funded by the pharmaceutical industry and its membership comprises many with pharmaceutical interest as employees and shareholders. We now know that the MHRA failed to consult on a similar monoclonal antibody which had caused severe toxic reactions in patients”.
“We cannot allow the regulators to investigate the regulators” Paul Flynn said.
Shame and more shame on the MHRA
The Seroxat Support Group Website
This group is concerned about asking questions of the MHRA, and is seeking to determine whether the MHRA contributed to scientific deception and hiding of critical clinical data about the bestselling antidepressant, Seroxat. So far they seem to be receiving few answers.
Why are corporate scientific crimes shielded from criminal prosecution?
See http://www.ahrp.org/cms/content/view/192/94/
The TGN1412 disaster: Company Knew of the Catastrophic Risk–so did the MHRA
http://www.ahrp.org/cms/content/view/138/26/
Predictions in 2004 – Deaths in 2006
http://www.ahrp.org/infomail/04/12/06.php
“Across the Atlantic, officials of the Medicines and Healthcare Products Regulatory Authority (MHRA, FDA’s equivalent) are about to make fools of themselves by issuing a clean bill of health to SSRI antidepressants. MHRA officials acknowledge that they have not actually examined the clinical trial data, but are relying on summaries selected and submitted by drug manufacturers (perhaps the Oulsnam’s of this world thought that might be a good idea). Given the documented revelations demonstrating a pattern of deceit by drug manufacturers, it is difficult to fathom what these UK regulators expect to accomplish–other than garnering public contempt.”
Vera Sharav in 2004
How many preventable SSRI induced deaths and human misery was directly related to that MHRA decision? When did the MHRA know?
The MHRA in poetry
Patient groups and doctors are convinced that the MHRA appear have delayed telling the truth, some accuse it of colluding in the hiding of information and in the telling of lies, and most critics claim that it has avoiding the proper answering of questions which might allay these concerns.

HUMAN SACRIFICE (ODE TO THE MHRA)

40 Mgs of Seroxat
to keep me safe from harm.
These drugs are not addictive
say’s the suited man with charm.

They didn’t warn of feelings
that swim inside my head.
feelings of hate, anger and jealousy
and wishing I was dead.

The secrets of Seroxat
hidden from us all.
To line the pockets of the rich men
while those around all fall.

Thank you Mr Executive man
and Pharmaceutical Industry.
Thanks for all those lies & cover – ups
and what you’ve done to me.

Time to spread your wealth out
make ammends to us poor souls
whose lives have been shattered,
whose heads are full of holes.

Goodbye dear Seroxat
Hello withdrawal hell
Who will feel the wrath of me
underneath this angry spell?

Thank God, I’m not the only one
whose head cries out in pain.
While the bastards at GSK
drown in financial gain.

© BOB FIDDAMAN

There was a society of men among us,
bred from their youth in the art of proving,
by word multiplied for the purpose,
that white is black and black is white according to how they are paid
Jonathan Swift

Obfuscation and patient protest
Obfuscating responses to questions about personal financial dealings on behalf of Professor Sir Alasdair Breckenridge
Obfuscating answers about data never properly scrutinised by the MHRA pertaining to suicides in clinical trals
Patients feel the need to write apparently satirical pieces here about the MHRA “You cannot get me… I am untouchable.”

Patient support groups question the MHRA – again and again but receive no response
Specialist drugs trial solicitor criticises MHRA report into failed drugs trial
Specialist drugs trial solicitor Ann Alexander,who represents the two most seriously affected victims of the Northwick Park clinical drug trial condemned the report released today by the Medicines and Healthcare products Regulatory Body (MHRA).