vitamins & minerals: Why does the EU want to cut off their supply

[Guest guest]

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 <http://www.observer.co.uk>

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

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 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 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 , 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 ,

'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 n

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.

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 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 s 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 Verkerk's thoughts are

running now. Previously a research fellow at Imperial College, Dr

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, 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.' 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 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 '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 '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 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

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 <http://www.healthcreation.co.uk> helpline 0

http://www.healthcreation.co.uk

*

[Comment: For the families who are the primary stockholders in

pharmaceutical companies, the more wellness in a population, the lower

the families' income from pharmaceutical profits. Too many politicians

and high-level bureaucrats have loyalty turned away from citizenry.]

*

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