Content Sections
KEY POINTS
- ANH-Intl leaks a letter from a UK academic, Professor Elizabeth Williamson, to the UK Health Minister
- In it, the academic complains that the UK medicines agency isn't cracking down on botanical food supplements. She appears to take the position of the large phytopharmaceutical companies who have got licenses and want competition from food supplements removed
- In taking this position, Professor Williamson has misrepresented the scope, intent and implications of the Directive and appears to have aimed to deliberately mislead the Health Minister
- Along with her letter, ANH-Intl posts its replies to Professor Williamson and the Health Minister, pointing out important misconceptions and areas of misinformation in her letter
- We urge all our followers to share this story far and wide!
The temperature is again rising on the herbal debate, at least in the UK. Call us ANH-Leaks if you like, but we have posted today on our website a letter sent by a UK academic to the Secretary of State for Health, Andrew Lansley MP. In the letter, Professor Elizabeth Williamson, a pharmacist from Reading University, UK, has a major blow-off about the European Union’s (EU’s) Traditional Herbal Medicinal Products Directive (THMPD). According to her, the THMPD is not effectively getting rid of herbal food supplements, which continue to compete against products that have been licensed under the EU Directive’s registration scheme.
In our view, Professor Williamson dresses up her complaint to make it look like there is some kind of impending threat to public health if all these dangerous food supplements are left on the market. On this point, the facts simply don’t stack up. Herbal food supplements in general are considerably safer than conventional foods. It’s quite apparent that the actual thrust of the letter concerns what the author perceives as unfair competition. It’s almost as if the very companies that have been successful in getting licenses, in particular the German phytopharmaceutical companies, have orchestrated the complaint because things haven’t quite gone to plan.
In her letter, Professor Williamson suggests that the UK government authority on medicines, the Medicines and Healthcare products Regulatory Agency (MHRA), has gone soft on herbal food supplements and won’t necessarily be forcing them off the market. The reason? They are apparently worried about recent European Court of Justice (ECJ) judgments on herbs. Well, isn’t that a turn-up for the books? Is the MHRA actually concerned that it will have to answer for its decisions to the judges at the ECJ, once our judicial review takes the issue to Luxembourg?
Going transparent
We’ve not only leaked Professor Williamson’s letter to the UK Secretary of State for Health on our website. We have also posted two further responses from ourselves, one sent to Professor Williamson herself, the other to the Secretary of State for Health. Here they are:
- Download Professor Williamson’s original letter to the Andrew Lansley MP
- Download Dr Robert Verkerk’s response to Professor Williamson
- Download Dr Robert Verkerk and Adam Smith’s clarification to Andrew Lansley MP
Academic cries wolf
We were so concerned by the content of Professor Williamson’s letter that we felt we had no option but to respond publicly both to the Professor and to the Minister. We believe that Professor Williamson has enormously misrepresented the scope and intentions of the THMPD legislation, and its implications for the UK herbal products sector. In doing so, she has inexplicably adopted the position taken by the largest phytopharmaceutical companies, who have gained a big commercial advantage over their competitors by registering many of their products under the THMPD, in the hope — it seems — that the competition from botanical food supplements will be removed.
It is a great surprise to us that Professor Williamson has acted in this manner. With over 30 years’ experience, she has written and edited books on herbal medicine, Ayurvedic herbs and alternative and complementary medicine. Given such a wealth of knowledge, it seems out of character that Professor Williamson has so misrepresented the THMPD, its scope and implications, as well as the accompanying case law from the ECJ.
Mistaking solutions for problems
Whereas Professor Williamson portrays the ECJ as being part of the problem, it has in fact been trying to clarify the incredibly confused food/medicine borderline. The Professor makes no bones about the fact that she thinks all herbal products should be regarded as medicines, and that’s why she has a problem with the ECJ. The Court has ruled in several separate cases that all properties of an herb or herbal product, including the dosage of active constituents, must be considered before it can be declared a medicine. This allows herbs that may have specific medicinal uses to be sold as food supplements when active ingredients are present in lower amounts, as they often are in many complex polyherbal products that are typical of the great Asian traditions, such as Ayurveda and traditional Chinese medicine (TCM). Rather than criticising these rulings, Professor Williams should be applauding them, especially Case C-27/08 involving the Ayurvedic anti-inflammatory herb, Boswellia serrata.
Heading off a deceitful campaign
In the face of an ongoing campaign by certain phytopharmaceutical companies to portray herbal food supplements as a danger to public health and in need of yet more regulation – including questions in both Houses of the UK Parliament – Professor Williamson’s intervention was at risk of wielding a dangerous level of influence. Accordingly, we felt compelled to do something about this, exposing what might have otherwise been kept behind closed doors.
We strongly believe that an open debate on these important issues is sorely needed, and hope that today’s open letters will kick-start that process.
Professor Williamson, Mr Lansley: we eagerly await your replies.
To our readers and followers, we also look forward to you sharing this information with your own contact groups. We’re also very keen to receive your comments below, as well comments and shares on our Facebook profile.
Comments
your voice counts
Jo
18 November 2011 at 10:26 pm
Fascinating! How on earth did you find out about the letter? I bet Mr Lansly didn't send it to you!
Hans Find Andersen http://www.findovia.dk
19 November 2011 at 1:03 am
We probably need a serious revolt like the Arabic spring to reclaim our right to produce and market all sorts of healthy herbs and similar health remedies. The suppression from the medicine industry and the like is best characterized as violence, and the best reaction to this might well be civil inobidience, rather than brutal warfare.
How long can we tolerate being terrorized by all this authoritarian madness?
We have a right to live our lives as we please as long as we do not harm anybody. All this supervision, control and law-making is sick and adds to the global crisis caused by not respecting nature and live in accordance with it.
This note only addresses one corner of the global crisis, but it reflects the necessity of respecting freedom and our own subjective respontibility for creating healthy living and all aspects involved in this.
Science is great but the misuse of it is criminal. As long as we let ourselves be manipulated by economical powers rather than ecological sanity we loose the game.
It is not up to me to come up with any form of concrete action. I merely intend to provoke you to change you attitude to trust your own cut feeling and act accordingly. It is all you choice.
alison
19 November 2011 at 11:04 pm
Well done! Look forward to seeing more of ANH-Leaks! Must have taken courage but the times they are a'changing and the Truth is busting out all over - just like Spring in that famous musical. these greedy cowards' time is up and not before time. We've all had more than enough of their nonsense.
Tania
21 November 2011 at 1:44 pm
Fantastic work Rob & Co. Txxx
Dinah Everett Snyder
22 November 2011 at 6:09 pm
The simple truth is rather an inconvenient one for industry: herbal supplements are not only NOT dangerous but vital to peoples wellbeing. Most especially in the face of the adulterations and annihilation of most foods in our foodchain, due to GMO's and the ever expanding list of additives which nature never intended nor created ! Regulating our supplements and botanicals is but ONE step from the control that pharmaceuticals emjoy, along with immense profits, at the expense of people everywhere. The simple truth is that people do NOT die from supplement use but they DO die from the use of " controlled/ regulated" pharmaceuticals....daily!
VARS system has recorded ONE death by supplement in the last decade.....while recording millions of deaths by government/ FDA sanctioned DRUGS in the same time span. I rest my case.
WAKE UP AND PARTICIPATE people ! Push back against any and all moves to encroach on your rights to unfettered access to supplements before the EU and Codex takes that right away, forever. Botanicals can and do heal cancer, altzheimers, immune dysfunction, relieve and in some cases reverse autism, boost the immune and make you LESS vulnerable to infection to begin with, protect the heart, brain and major organs. Food no longer does any of this. In fact, eating commercially available food will set you back, and then some ! Hence the move by pharma and business to control " novel delivery systems", to control all sustenance! YES on supplements, NO to any and all suggestions from FDA, CDC and Codex. The rogue militia for Big Money, Big Pharma and Big Ag ! WE are not " the little people" , no indeed, WE are "The People"....
Dinah Everett Snyder
www.dinaheverettsnyder.org
[email protected]
Doran
22 November 2011 at 6:10 pm
I seem to remember we used to have a little thing called common law rights and that good old queenie swore on oath to protect the traditional customs and practice of us common oiks. That should, of course also protect the rights of our asian fellow citizens to continue the use of their traditional medicine.
As I don't ever recollect being asked to vote to join the EU, I am increasingly loath to part with my taxes to shore up an unelected body that allows me no effective right of representation and seeks to deny me the right as an adult to be responsible for my own health.
Have you spoken to the common law rights lot at thebcgroup.org.uk ?
I can drink soda or alcohol all day long, smoke tobacco, sniff aerosols and glue, access chlorine bleach and drain cleaner, eat any amount of take away and cheap supermarket junk and self medicate on pain pills, gaviscon and laxatives at will.
The good old EU even allows farm animals to be fed GMO foods, so I can wreck my internal organs and compromise my health, even faster from the comfort of my armchair. All of these things are known to be toxic and many are lethal at easily imbibed or ingested quantities.
If I can choose to top myself on gin and paracetamol (valium would be even better) it's a nonsense to insist that access to herbal remedies be denied me for my own protection.
I have every intention of quietly defying as much of this idiocy as I can, down to making/growing my own supplements. There are a whole lot of herbs that can be bought on the open market, even now. Even restricted herbs can still be bought legally as "botanical samples".
Perhaps every health site and every practitioner in the land should be openly posting "traditional" recipes for chronic complaints to every client, purely in the interests of "historic research and information" of course.
Perhaps we need a fighting fund to support a company with little left to lose, to continue as before until legally challenged, and then pursue a legal case to test this EU gobbledegook all the way to the court of human rights.
Perhaps, if the EU wants to be seen to protect our health, we should insist that it apply it's concern impartially and outlaw the sale of tobacco and alcohol immediately.
Anonymous
23 November 2011 at 12:04 pm
THMPD enacted in 2004 has TO DATE not produced a community list to confirm (in their opinion!) which plants are medicinal and which aren't. This had lead to different member states having contradictive lists (so much for the harmony of the legislation ad free trade across EU borders). In Greece Echinacea is a food supplement, in Italy senna is permitted in supplements, Belgium allows cascara etc etc. Perhaps "therapeutic" doses should be medicinal and "supplemental" doses classed as food. Although many of the approved THRs are rediculously low dose (and full of talc, shellac etc) compared to the supplements my friends and I have been taking safely for years! NB: I am far healthier than any friends who rely solely on drugs to treat symptoms - I try to look for the root cause.
It is the medicine that should include warnings not the food/supplement/herbal product. If the contraceptive pill says do not take st johns wort with this medicine there is no risk, if warfarin says do not take with ginkgo there is no risk.
There are NO multi (5+ ingredient) herb combinations registered in the UK, yet multi herb products have been used in the UK & EU for hundreds of years perfectly safely. In German a 10+ ingredient product has been approved!
To say the supplements industry is "notoriously unregulated" is rediculous. Responsible UK manufacturers have for years adhered to GMP (or equivalent food standards such as BRC), bought ingredients which comply with EU/USP monographs and have long history of use - they shouldn't have to pay thousands of £ to continue to do so (costs which are then passed on to us consumers). Trading Standards (not the MRHA) should ensure products are safe by randomly sampling them and checking label claims for nutrients/components are accurate.
michael g collins
28 November 2011 at 12:22 pm
whos paying these academics.big pharma? dont try to defend natural health,ask them about about vioux drug that killed or maimed 10030.000 americans.and they are worried about vit c. what a joke.they are all part of the mafia.protecting there own industry and they dont care who they kill doing it.legalised murder i call it.roll on the revolutions.the problem is the whole world has been brainwashed by the medical system.even here in new zealand a man got bird flue and his sons had to get top auckland lawyer to force the hospitals to supply him with intervenous vit c he was unconsious,4 days to live but survide and is well.the big pharmac co s are criminals running a sickness industry.they have blood on there hands and should be had up for war crimes against the people.they internet will set you free.they should remember the french revolution,heads will roll.mike collins
Anonymous
30 November 2011 at 3:16 pm
How sad that our world has come to this. We are controlled from every angle. The good medicine that our earth provides for us in our natural environment is being slowly but surely taken away from us. Why should these large phamaceutical companies have so much say... particularly when their only aim is to make money with little care to what damage the drugs they prduce does to our body.
Supermarkets, tobacco and drug companies should all be challenged and lets stack up the figures of the damage of what these 3 industries have done to public health!
Jack Bonehead
06 December 2011 at 1:36 pm
Interesting to see that you already commented on 17 November on a letter that was sent one day later on 18 November ?????
That's proactive ?!
Anonymous
13 December 2011 at 12:19 am
We need our herbs and food supplements as our food supply is so manipulated it does not contain all the necessary vitamins and minerals. We need these for our health. The people who stay away from doctors most of their lives are the ones enhancing nutrition by using herbal products and food supplements. Please let us keep the choice of taking vitamins, minerals, herbs and safe remedies such as homeopathic ones. We can make unhealthy choices why should we not be allowed to make healthy ones as well?
squodgy
28 January 2012 at 6:56 pm
Further to your comments regarding Professor Elizabeth Williamson, I recently wrote to this extremely professional lady asking for clarification of her comments, and it seems the points she was making have been completely misconstrued by whoever wrote the transcript in a pathetic attempt to gain an emotive response.
Her stance is quite clear, stating that she has no wish to stop people buying herbal medicines either; her only concern is that herbal products which are not foods (and never have been), and which people buy because they are unwell in some way, should be of proven quality and not passed off as food supplements for the following reasons:
Food supplements are not required to prove that they are of good quality, nor to put warnings on the label, nor contain patient information leaflets giving advice, and this is where problems can happen, for instance if a person is on a medicine which can be made ineffective when taken alongside a herbal medicine. This is not speculation, it has happened many times.
Her other consideration is that if very low doses of medicinal herbs are used in herbal products, that medicine won’t be effective, and this will not help the reputation of herbal medicines at all.
I thank her for the clarification, which is quite logical and reasonable and seemingly parallel to the views of we laypeople with regard to labelling GMO’s.
Because of the "twisting" of her obviously inoffensive letter, she has been wrongly criticised, and this is a blatent example of how the alternative press, in irresponsible hands can prove itself as gutterworthy as the mainstream media.
Get a grip!
ANH Admin
31 January 2012 at 5:16 pm
Dear ‘Squodgy’, many thanks for your comment.
We must congratulate you on your proactive attitude in contacting Prof Williamson yourself. However, the response you received from her, and your attitude to that response, is for us indicative of the problem we are facing. On the surface, her position appears to be a common-sense one; but when you examine the actual terms of the relevant medicines and food legislation, alongside the huge diversity of products that have been used with considerable benefit for many years by consumers, it turns out that things are not nearly as clear-cut as Prof Williamson makes out.
We’re not sure what you mean by, “It seems the points she was making have been completely misconstrued by whoever wrote the transcript in a pathetic attempt to gain an emotive response.” She wrote a letter to the Secretary of State for Health, and we, or rather Dr Verkerk, simply answered that letter, putting the issue at the same time into the public domain so it could be more widely considered. Dr Verkerk pulled out key points made by Prof Williamson that were inconsistent with known facts, and he explained his reasoning. Nothing Prof Williamson has said to you or anyone else since, nor anything said by the British Herbal Medical Association’s Herbal Quality Campaign, changes the fact that there are significant factual errors in what has been claimed.
We urge you to read Dr Verkerk’s letter to Prof Williamson [http://anhinternational.org/files/111117_Verkerk_response_to_Elizabeth_Williamson_on_THMPD_final.pdf] and compare it with what she said in her original letter [http://anhinternational.org/files/111104_Letter_to_Secr_of_State_for_Health_Elizabeth_Williamson.pdf]. Our main points of contention with the Professor are as follows:
1) Contrary to what Prof Williamson said, the herbal Directive is not applicable to patients. It is very specifically for manufactured herbal medicines, designed for symptomatic treatment of mild, self-limiting conditions. So it is not accurate for her to state that the DIrective attempts to ensure that patients have access to high-quality herbal medicines. We believe that the lack of a practitioner-specific regulatory scheme for herbal medicines is a huge flaw in the current system [http://anhinternational.org/files/100831-ANH-Benefyt-THMPD-position-paper.pdf].
2) Prof Williamson expresses concern that some companies may not be complying with the Directive, thereby risking public safety. However, the Directive is not mandatory and there are multiple other, legal, routes by which manufacturers can bring herbal products to the UK market. One of these is the food supplement route.
You also state in your comment that herbal products have never been foods. Whole herbs themselves are, in fact, a form of food: they are complex mixtures of thousands of chemical ingredients, as are foods. To quote Dr Verkerk’s letter: “There are a very wide range of foods that have physiological or even therapeutic effects on the body...Would you argue, for example, that cinnamon, turmeric, ginger and broccoli sprouts should only be sold as medicines, given that they are all used in certain instances for medicinal purposes? Surely not, bearing in mind their widespread use as foods or food ingredients.”
Finally, it is very important to note that foods, and food supplements, must be safe before they can be marketed. In fact, food supplements are much safer than foods at normal exposure levels!
3) Safety concerns have rarely been linked to food supplements, and where they have, it is usually because the manufacturers haven’t followed traditional preparation methods or the products have been spiked or contaminated with pharmaceuticals. Either way, food supplement law as it stands is sufficient to remove such products from the shelves.
4) Reclassifying certain herbal medicines as food supplements is not “passing off”, as you term it. It is usually a perfectly legal mechanism to keep safe and effective products on the market. Herbal food supplements, unlike herbal medicines, cannot carry a therapeutic indication and neither do they need to include patient safety information. In addition, the dose of herbal active ingredients in food supplement versions of herbal products, such as St John’s wort, that are known to interact with conventional medicines, is reduced compared with the medicinal versions.
A significant problem with the herbal Directive is that only a very narrow type of product is eligible for registration [http://anhinternational.org/news/european-medicines-agency-reports-on-progress-of-eu-herbal-directive]. They are overwhelmingly single-herb products, made as highly purified extracts stabilised in an artificial base containing synthetic polymers and other additives – not the type of product many herbalists consider herbal medicines, and, somewhat ironically, not the type of product that Prof Williamson has championed in the past! Yes, many herbal food supplements are lower-dose products than their medicinal equivalents, but there are plenty of good-quality, highly effective products out there. Another plus point for herbal food supplements is that many are multi-herb products, which allows them to take advantage of synergistic effects that can often compensate for the low doses of individual herbs. This is something that Ayurveda and traditional Chinese medicine (TCM) – neither of which are catered for at all by the herbal Directive [http://anhinternational.org/news/european-medicines-agency-reports-on-progress-of-eu-herbal-directive] – particularly specialise in.
5) The European Court of Justice (ECJ), far from complicating matters, has attempted to clarify them. As alluded to in the above examples, the borderline of what constitutes a food and what constitutes a medicine is a complex issue. To quote Dr Verkerk’s letter again, “[The ECJ] has deemed that a medicinal determination can be made only when a product is weighed up in its totality, including the dosage of active ingredients (posology), their consequent likely pharmacological actions and the presentation of the product...In the absence of this kind of clarification, the abounding legal uncertainty causes some to assume that all herbal products used for healthcare purposes should be deemed as medicines.” Although Prof Williamson, and possibly yourself, appear to be in this category, the ECJ does not agree – and neither do we.
6) The only people who will benefit from a clampdown on herbal food supplements are the big players in the herbal industry – the ones who could afford the huge sums of money necessary to jump through all the herbal Directive’s many hoops.
7) The ECJ is not questioning the legality of the Directive. We intend to do that, by bringing judicial review proceedings [http://anhinternational.org/node/3113].
In response to your strongly worded condemnation of our article, the facts clearly show that it is Prof Williamson who has misrepresented the aims and scope of current legislation. What is more worrying is that, if she gets her way, it is only the ‘big boys’ of the herbal products sector who will benefit, at the expense of the more innovative, smaller players. There is absolutely no parallel between a campaign for labelling of GMOs – something that we whole-heartedly support [http://anhinternational.org/campaigns/say-no-to-gm] – and Prof Williamson’s position.
If your correspondence with Prof Williamson continues, perhaps you would ask her to answer the specific points raised by Dr Verkerk in response to her original letter to the Secretary of State for Health? Regardless of how ‘common sense’ her concerns appear to be, they display an ignorance of the actual situation, and a seeming desire to create a monopoly in the herbal products sector for large companies selling a very limited range of herbal products. Not to mention removal from the market of a broad swathe of herbal medicines and products that Prof Williamson has spent most of her career studying and defending.
squodgy
29 January 2012 at 12:39 am
I note my response to this article and its specific reference to Professor Williams has not been posted and suspect it does not comply with the trashing policy of the editor.
stan
13 March 2012 at 12:29 pm
your malice shows your true intent
Your voice counts
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