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OBSERVER ARTICLE QUOTES ANH- DETAILS GLOBAL PLIGHT OF VITAMIN CONSUMERS

 

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FSD

 

IAHF List: The following article from the UK's Observer Magazine provides an

excellent wake up call to anyone you may know who doesn't realize the supplement

industry is under global attack.

 

Please mass forward it, and urge everyone to donate to the Alliance for Natural

Health via http://www.alliance-natural-health.org for the second half of their

legal campaign to overturn the EU FSD.

 

The article quotes David Hinde from ANH. Far too many Americans, especially, are

oblivious to the dire need for consumers world wide to support ANH's legal and

lobbying efforts. Anyone who needs help " connecting the dots " so as to

understand why ANH's effort in England is so important to Americans, (and

vitamin consumers world wide) should read Greg Ciola's interview with me in The

Health Crusader Magazine at

http://www.thehealthcrusader.com/pgs/article-0104-ban.shtml

 

 

http://observer.guardian.co.uk/magazine/story/0,11913,1157031,00.html

 

Nil by mouth

 

For thousands of Britons battling the debilitating effects of cancer,

depression, even eczema, diet is crucial. They view the vitamins and minerals

they take as vital in their fight against sickness. So why does the EU want to

cut off their supply? Rose Shepherd makes the case for rescuing remedies

 

Sunday February 29, 2004

The Observer

 

In the 21st century we live under siege. There are concerns about pesticides,

herbicides, antibiotics, GM, mobile phones, microwaves, amalgam fillings,

falling sperm counts, mad cows, MMR - even milk. Farmed salmon is a Trojan horse

for carcinogens. Obesity and diabetes are on the march. There is a mass of

documentation on all this. So what is the European Commission's big idea? 'Let's

clamp down on vitamins and minerals.'

It would be funny if it weren't so tragic. While the EU has been busy drafting

legislation, we seem to have been sleepwalking into a situation where chemists

and health stores will be purged of hundreds of nutritional supplements.

 

I'm sorry, maybe you are alert to this already. Maybe you have written to your

MEP, marched with the Health Freedom Movement, joined the Alliance for Natural

Health or Consumers for Health Choice. Tens of thousands of people have been

railing against this infringement of their rights, this insult to their

intelligence and, not least, this threat to their health. The psychotherapist,

writer and long-time cancer survivor Beata Bishop, author of A Time to Heal

speaks for many when she says, 'I feel passionately angry about this.' I myself

have been surprised, though, by how many others seem neither to know nor to care

about any of what is afoot - and, still more, by the complaisance of some

commentators.

 

What is at issue is couched in soothing terms in three EU directives. First, the

Food Supplements Directive (FSD), under the guise of harmonisation, creates a

restricted list of vitamins and minerals, effectively a 'positive list' of

allowable nutrients. EU member states will be mandated to market these

'harmonised' supplements, facilitating trade.

 

However, from August 2005, nutrients not on the list will be banned. This may be

good news for states in which the sales and dosages of supplements have hitherto

been severely restricted, but it's bad news for the UK, where our regulators

have long regarded food supplements as foods, not medicines. We face losing some

270 nutrient supplements, including 40 trace elements, most forms of the more

bioavailable organic minerals, and most food-state vitamins. And it doesn't end

with vitamins and minerals. By 2007, if not before, the directive requires the

European Commission to put forward proposals for a similar list, to apply to all

nutrient supplements.

 

Nor does it stop at nutrients. The Traditional Herbal Medicinal Products

Directive (THMPD), now working its way through the EU machine, promises to

provide for a 'simplified pharmaceutical registration' for 'herbal medicines' -

but only for substances that have been in safe use for 30 years, 15 of them

within the EU, singly or in the same combinations. Thus, medicinal herbs in

centuries-long use outside the community cannot benefit from the fast-track

licence procedure.

 

The THMPD is a part of the existing Pharmaceuticals Directive, currently being

amended to widen the scope of drug classification. According to the amendment,

anything that 'restores, corrects or modifies physiological function' in the

body will be deemed a drug. The directive will have power to take precedence

over both the FSD and THMPD, even though they may all be applicable to the same

natural food supplement.

 

Public safety is cited as the motivating force behind these directives. Their

combined effect, however, could be to drive out, degrade or drive underground

many of the herbs and nutrients to which some people swear they owe their

health. For the 40.9 per cent of us who use supplements to boost nutrition, this

is no trivial matter, while to those using herbs and supplements to manage

chronic pain or life-threatening disease, it must seem like sabotage. Sceptics

dismiss such individuals' experience as 'anecdotal', but when you are your own

anecdote, it's hard not to be convinced.

 

Beata Bishop's book - now, sadly, out of print - is a testament to the value of

a nutrient-rich diet, boosted by supplements. As she wrote in 1985: 'I should

have died of malignant melanoma... around June 1981. When my secondary cancer

was diagnosed in late 1980, I was suffering from diabetes, incipient

osteoarthritis, frequent knockout migraines and dental abscesses.' Today, she is

free of these and attributes her recovery to Gerson Therapy, the radical regime

under which the body is detoxified and activated with ionised minerals and

organic fruit and vegetables, whereupon, it is hoped, the natural healing

process kicks in. I don't want to be glib or simplistic about cancer. I know it

comes in many guises and has multiple causes. Having lost two grandparents, my

father and my partner to it, I am in mortal terror of it. Like most people,

irrationally, I fear it more than I do the cardiovascular disease that took my

other two grandparents and my mother. I should find it hard to refuse

the slash-and-burn approaches to it. But when I try to think of it as being,

like heart disease, a degenerative process, I see the wisdom of Gerson.

 

'I have been described as disgustingly healthy,' Beata Bishop tells me, 'but

when I was very, very ill, without those supplements I wouldn't have got well. I

believe it's totally wrong to interfere in people's attempts to maintain their

health. I'm willing to fight at the barricades if it comes to that, because if

it ain't broke, don't fix it.'

 

Or, you might say, if it ain't broke, don't break it. Despite occasional scare

stories, the risk of death from food supplements is less than that of being

struck by lightning, and significantly less than that of dying of penicillin

allergy. Should the EU plans prevail, however, consumers may in future have to

resort to the internet, to order products from unregulated sources, with no

guarantee of quality or authenticity. It sounds fanciful, but observers are

predicting a black market. After next August, if someone sidles up to you and

asks if you want to buy some 'E', think mixed tocopherols and tocotrienols,

since almost the whole spectrum of naturally occurring vitamin E is off the

positive list.

 

'In my opinion,' says OM columnist Dr John Briffa, 'the proposal to restrict

public access to nutritional supplements represents one giant retrograde step

for the health of the nation. There is good evidence that the nutritional

content of our diet has declined substantially over the past few decades. At the

same time, studies exist that show that long-term nutrient supplementation has

the potential to prevent a range of conditions, including heart disease,

cataracts and certain forms of cancer.'

 

'We, as a nation, have a huge problem in looking after our people,' says Sue

Croft, a director of Consumers for Health Choice, 'and those of us who take the

trouble to keep ourselves well should be encouraged. Yet the very tools we need

to do so are being taken away from us by Brussels, and our government is

standing by and doing nothing.'

 

'It's disgraceful,' agrees shadow health minister Earl Howe. 'Traditionally, in

this country, we've adopted a safety-based approach to licensing products for

sale. There's never been any suggestion that our vetting procedures are

inadequate in that respect. To have a harmonisation measure foisted upon us for

no good reason is a very retrograde step indeed, and consumers will suffer.'

 

And so we will, one way or another. Consider HRT, associated with an increased

breast cancer risk. For this and other reasons, women are turning, in

preference, to alternative remedies, at the very time when these remedies seem

threatened with extinction. 'The mineral boron is very useful,' says Dr Marilyn

Glenville, a specialist in women's health and prolific author. 'There are good

clinical trials on its effect on bone health. If you get a good multivitamin

that's designed around the menopause, boron will be in there.' But boron is off

the positive list, guilty until proved innocent, under European Napoleonic law.

 

Boron could even now be reprieved. The European Food Safety Authority, a

faceless organ of the European Commission, will consider dossiers submitted on

banned nutrients. With a deadline of 12 July 2005, however, and with compiling

costs of anything from £80,000 to £250,000 per substance, the race will be to

the swift and to the rich. Some big manufacturers are working on dossiers. But

with no guarantee they will be accepted and no possibility of a patent on the

nutrients they champion, there can be scant incentive to do so. Hence, a kind of

nutritional dumbing down is underway, with manufacturers reformulating products.

 

So much for boron. How about the herbal supplements black cohosh and dong quai?

Both can be effective against hot flushes, but their future looks uncertain

under the THMPD and amended Pharmaceuticals Directive.

 

The THMPD is, in some ways, the most Eurocentric directive. In his 1997 King's

Fund lecture on integrated healthcare, the Prince of Wales said: 'No knowledge,

experience or wisdom from different traditions should be overlooked in efforts

to help the suffering.' This directive could scarcely be less in that spirit. We

plunder the world's larder, the world's table, yet set our face against the

herbal medical traditions on which two-thirds of the world relies, when they

could have much to give us.

 

Witness Carctol. At the inaugural conference of the British Society of

Integrated Medicine last November, Dr Rosy Daniel introduced four cancer

patients, all doing well on a dairy-free, vegetarian diet and this Ayurvedic

preparation. 'We have a traditional remedy that has been brought from India,'

says Daniel, founder of Health Creation, which offers holistic healthcare stuff

and support. 'But because three of the eight herbs in Carctol are classed as

medicine, they are prohibited from putting out any information about it, as this

is construed as advertising.'

 

The law is spacious enough to allow doctors to prescribe an unlicensed medicine

if they believe it may be effective. Patients have to be told that the medicine

is unlicensed, and to sign a consent form. What doctors cannot tell patients is

what they think the stuff will do, since this would be to make a medicinal

claim. Importers Cankut Herbs are similarly constrained. 'It's a bizarre

paradox, isn't it,' says Daniel, 'that when something actually does work, and

has some medical activities, nobody can talk about it?'

 

Well, Gillian Gill, at least, can talk. When she was diagnosed with an

inoperable ovarian tumour, she was offered radiotherapy but, having made her own

risk-benefit assessment, declined. A combination of meditation, Reiki healing

and a non-dairy, vegetarian diet effected some improvement. Then, when progress

stalled, with some trepidation she went on Carctol. 'It was,' she recalls, 'like

a splint to my brain. Suddenly the panics, the awful thoughts and feelings

didn't come any more, and there was no looking back. With each six months I had

more energy. I feel fitter now than I did before I had cancer. Eighteen months

ago my oncologist gave me the best present I could have. She said, " Gillian, I'm

seeing something I've never seen before. " My tumour had been so big they said

they'd never seen anything like it. Now it's about the size of an orange, and it

seems to have transformed into a cyst with fluid.'

 

In the course of her recovery, Gill wrote and published a book, Where's the

Meat? Acid-free Vegetarian Dishes. It is available from Health Creation and

costs £6. Hospital dieticians still tell cancer patients to combat cachexia, or

wasting, with high-calorie cakes, pork pies and burgers. However, pioneers of

integrated medicine, such as Dr Julian Kenyon at the Dove Clinic, near

Winchester, propose a wholefood regime free of meat, dairy products and sugar,

designed to push the acid/alkaline balance of the body towards an alkaline

environment, in which, they say, tumours cannot thrive.

 

Derek Ritchie is a Dove Clinic patient. He has mesothelioma, an asbestos-related

cancer of the lung lining. It is slow-growing, but the prognosis was depressing:

two years at best. Yet six-and-a-half years later, here he is, about to fly to

Spain, sustained by a regime that has included high-dose vitamins, herbal

remedies and food supplements. He admits he's 'lost a bit of weight and one

thing and another', but says, 'Quality of life is not bad. And all I know is, if

I hadn't been taking these things from the very beginning, I wouldn't be here.'

 

Kenyon prescribes the remedies that he favours, always with an eye to quality

and emerging research, on an informed consent basis. 'I am aware of impending

legislation,' he says, 'and I am making every effort to comply completely with

all regulatory issues.' But such remedies will disappear if their manufacturers

go to the wall once the shop shelves are stripped.

 

How can such ostensibly benign and well-intentioned legislation be so onerous?

To understand, look first at which products are berthed in the safe harbour of

the FSD positive list, and which cast adrift. The positive list overwhelmingly

excludes natural, organic substances, which, say campaigners, are the most

innovative and most readily absorbed.

 

But, then, the list has not, as you'd imagine, been drawn up on the basis of

scrupulous research into the safety and efficacy of available supplements. The

permitted substances are those listed under the Directive on Foods for

Particular Nutritional Use (Parnuts) which determines what may be added for

nutritional purposes to adult dietetic foods. The list is literally one they

made earlier, and is inappropriate to the consideration of food supplementation.

Critics point to the fact that it sanctions the use of sodium and potassium

hydroxides, powerful caustic agents that no one would want to supplement ('If

swallowed,' runs the safety advice for the former, 'drink plenty of water and

call for immediate medical help.')

 

At the same time, highly valuable nutrients are absent. Take selenium, a mineral

in which the British diet is known to be deficient. Inorganic selenite and

selenate are on the list, but two organic forms, selenomethionine and selenium

yeast, are not. This despite the fact that selenomethionine (the primary form,

in foods such as Brazil nuts) and selenium yeast are safer and more

bioavailable.

 

'With cancer,' says Ralph Pike, director of the National Association of Health

Stores (NAHS), 'selenium is the most important mineral. There is a big company

in the process of compiling a dossier on selenium yeast. It's cost them far in

excess of £250,000. They've just completed a two-year rat study. People will

find it abhorrent that the only way that selenium yeast can stay on the market

is by killing untold rats. They've actually told us animal studies are not

necessary. This is one of the myths surrounding the directive. Every time you

talk to the Commission, they say " absolutely not necessary " , but if you're going

to show how selenium yeast goes through the body and where it ends up in

tissues, you've got to start doing histology, and autopsies, and tissue

samples.'

 

'The science simply does not add up,' says David Hinde, legal director of the

Alliance for Natural Health. The Alliance has mounted one of two separate legal

challenges to the FSD (alongside the NAHS and the Health Food Manufacturers'

Association), which were heard in the high court on 31 January, when Mr Justice

Richards was persuaded that both had 'an arguable case' and agreed that both

should be referred to the European Court as soon as possible.

 

'At the heart of the challenge is, first, the contention that the alleged legal

basis for the directive under Article 95 is invalid under EU law,' Hinde

continues. 'The European Union doesn't have the right to legislate just any old

way. It's subject to very strict rules. Then there is the principle of

subsidiarity. That means that decisions should always be taken as close to the

rock-face as possible, so if a member state is capable of regulating its own

food supplements, they shouldn't be regulated by the EU unless there is a very

good reason.'

 

In court, the government was put in the invidious position of defending the

directive proposed by the European Commission in Brussels. When asked why there

was this prohibition, says Hinde, 'They were reduced to saying, " Well, because

of safety. " That's a bit like saying we are incapable of regulating our

supplements as food in this country, even though we've done so for many years.'

 

The judge, most helpfully, wants to push things along. It normally takes 18

months to two years to get a decision, but the ANH is hopeful we'll get one

before the ban is set to come in on 1 August 2005.

 

Hinde is not just a professional but a personal advocate of supplementation,

having made the engagingly boyish mental leap from internal combustion engine to

human organism. 'I was your typical male. I'd whack a Lean Cuisine in the

microwave, take some salad, and think I was doing a good job for myself.' He

then discovered that if he put clean, high-octane petrol in his car it went

better, and he saw the light. 'I started taking supplements, and couldn't

believe the increase in energy. I thought, " These things work! " Then I began to

look into this whole area, and discovered the fundamental thesis that is missing

from our health paradigm is the link between micro-nutrition deficiency and

illness. Your body is remarkably resilient. If you're missing key nutrients, it

gets by, but eventually things begin to go wrong.'

 

That was the way Dr Max Gerson's thoughts were running in the 1920s, in a far

less toxic world. And it is how Dr Robert Verkerk's thoughts are running now.

Previously a research fellow at Imperial College, Dr Robert Verkerk left to set

up the ANH. Researching sustainable agriculture, he had seen how impoverished

our soil, and hence our food supply, was becoming. 'There are few drugs that can

demonstrate the cancer-defying properties of natural substances,' he says. 'Why

on earth is the EU wanting to ban them? How many leading cancer research

institutes, still besotted by chemical and radiation treatments, have put

together the poor nutrition, plus poor lifestyle, plus toxic chemical puzzle?'

 

'Let food be thy medicine,' said Hippocrates, yet precious few of the doctors

who have sworn the Hippocratic oath, or one of its revisionist versions, have

embraced this tenet. In his Editor's Choice column in the BMJ of 24 January,

Richard Smith wrote: 'Although many patients are convinced of the importance of

food in both causing and relieving their problems, many doctors' knowledge of

nutrition is rudimentary. Most feel much more comfortable with drugs than foods,

and the " food as medicine " philosophy of Hippocrates has been largely

neglected.' Smith goes on to make the 'unadventurous prediction' that we will be

hearing much more about the science, medicine and politics of food, and

concludes, 'Hippocrates would be pleased.' Not with the FSD, he wouldn't.

 

The idea of setting safe maximum limits on supplements is also highly

questionable. In many EU countries, they are limited to three times the

recommended daily amount, and this could be imposed across the board. But, with

RDAs, you need to think bog standard, not gold standard.

 

'I call them the Ridiculous Dietary Arbitraries,' says Patrick Holford, founder

of the Institute for Optimum Nutrition (ION), and author of The Optimum

Nutrition Bible. 'The RDA is not a scientifically robust score for a nutrient.

It's the level that prevents overt deficiency, and if you take the case of

vitamin C, it started at 30mg, then went to 45mg, then 60mg, while in America

it's 85mg. Now, 30mg does prevent scurvy, but scientists on the panels who

decide RDAs are gradually thinking that more might be better. We [the ION] work

from what is arguably the most scientific position, which is to ask, " What is

the optimal intake of a nutrient? " What level of, say, vitamin C confers maximum

protection against infections? And we know that it is around 1,000mg.'

 

The official EU classification of a drug, meanwhile, throws up some priceless

anomalies. There are two parts to the definition of a drug. One is the

'presentation' limb, that anything that claims to treat, prevent or cure a

disease is a medicine. 'So, if you say, " An apple a day keeps the doctor away, "

and you're selling the apple,' says Holford, 'you've just contravened the

Medicines Act.' The other is the so-called 'function' test: ie, if something

'restores, corrects or modifies physical function' in the body, it can be

classified as a drug (that apple, again). Does this mean that, to reverse the

logic, if anything remains on the positive list and is not reclassified as a

medicine, we can assume it does not restore, correct or modify physical

function? If so, who is going to rush out to buy supplements that can claim, at

best, to have no effect?

 

This is not to say that there are no concerns about the use of herbs and

supplements, and in particular about how they interact with prescription drugs.

Dong quai, feverfew, St John's wort and ginkgo, for instance, are

contraindicated with warfarin. But, then, so is cranberry juice.

 

Warfarin is the sodium salt form of rat poison. Cranberry juice is rich in

antioxidants and potent against cystitis. Anyone on warfarin should be advised

to avoid it, but it would be a strange inversion of reality to say that

cranberry juice is dangerous.

 

In the matter of St John's wort, if we apply the same risk-benefit criteria as

are used in the licensing of medicines, we may well find in favour of an

antidepressant herb that has far fewer side effects than its chemical

counterparts.

 

In February 1992, the consumer research body Social Audit reported, on the basis

of four studies between 1981 and 1988, that more than 10,000 hospital beds are

taken up at any one time by people suffering adverse reactions (ADR) to

prescription drugs. While the side effects of drugs is a recognised problem, it

is one with which we are prepared to live, much as we are prepared to live with

the car, for all the hazards it poses.

 

While we know that cars kill, however, we are less conscious that drugs are a

major cause of mortality in the Western world. In May 1998, The Journal of the

American Medical Association reported that 'each year, prescription drugs injure

approximately 1.5m people so severely that they require hospitalisation, and

100,000 die.' That puts the health concerns over herbs into perspective. Not

that we want a free-for-all. There are some horrible products out there, but if

you use a legislative purse-seine net to trap the fishiest ones, you inevitably

get a huge and unacceptable by-catch.

 

'Herbs are powerful,' acknowledges actress Jenny Seagrove, a stalwart of

Consumers for Health Choice, 'which is why they work when used properly, and why

they can cause problems when used incorrectly. However, they're not as powerful

as the synthetic versions, which are prescription drugs. I believe there should

be some kind of regulation, but not the kind they're suggesting. I think they

should have spot checks of every manufacturer's products each year, and people

who sell herbs should have to do some kind of training. Products should be

labelled with health warnings, then people could make educated choices.'

 

Not the least depressing aspect of this whole debate is the orgy of vivisection

it could unleash. Animal rights campaigners, who point out that ADRs are rife in

medicines that have passed animal tests, must be feeling nauseated at this

point.

 

The Alliance for Natural Health at least has the green light to make its case to

the European Court. 'The doors are closing,' says Robert Verkerk, 'but our

recent court success tells us that the EU may have overstretched its powers. We

believe that bringing this case to the European Court of Justice might elicit

the paradigm shift needed by our healthcare system, currently splitting at the

sides.'

 

The fight doesn't end there. Today Europe, tomorrow the world. Similarities have

been noted between the EU's Food Supplements Directive and the Codex

Alimentarius Draft Guidelines for Vitamin and Mineral Supplements. Codex is

about harmonisation on a global scale. US health freedom campaigners are

watching nervously, mindful that the US will have one vote, compared with the

expanded EU's 25-strong block vote. If the legal challenges succeed, it will

pose a potent obstacle to the plan to impose Codex worldwide. If they fail...

Well, ultimately you have to ask yourself, cui bono?

 

This is what the Americans term a wake-up call. I prefer the English word

'alarm'. Be alarmed. Be very alarmed.

 

· Alliance for Natural Health 01252 371 275; Consumers for Health Choice 020

7222 4182; Health Creation helpline 0845 009 3366

 

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