EU: Health supplements: R.I.P.

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http://www.guardian.co.uk/weekend/story/0,3605,790733,00.html

 

Health supplements: R.I.P.

 

Millions of Britons take herbal vitamin and mineral supplements, either as

a preventative measure or to treat specific ailments. But we may not be

able to for much longer

 

Joanna Blythman

Saturday September 14, 2002

The Guardian

 

You feel shivery, your back aches, the glands in your throat resemble

golfballs; it's only a matter of time until your nose starts streaming.

What do you do? You could visit your doctor's surgery and brave a waiting

room full of people who are in as bad a state as you, or worse, and wait

patiently for a five-minute consultation with your pressured GP - only to

be told that it's probably viral and you should go home to bed, or be given

antibiotics that you most likely don't need. Alternatively, you used to be

able to head for your local healthfood shop where, at no cost to the

creaking, over-burdened NHS, you could get free, and often lengthy, advice

from a helpful member of staff who would recommend an affordable

combination of vitamin C, echinacea and zinc, a safe, over-the-counter

supplement found to be effective by millions of users.

If you're one of those who find such remedies useful, however, you'd better

start stockpiling now. A raft of EU legislation looks set to nip the

natural medicine market in the bud: soon, that popular vitamin C, echinacea

and zinc combination may not be allowed on the shelves. A shadow looms

large over the alternative health sector. Estimates of the impact of this

new legislation vary, but hundreds of vitamin and mineral supplements could

be banned outright, while an as yet incalculable number of common herbal

remedies will disappear unless consumers challenge it. The National

Association of Health Food Stores claims that as many as three-quarters of

its members could go out of business. The writing is on the wall for small

British supplement companies, which will be forced to reformulate entire

ranges and invest massively in applying for new product licences.

 

It's a scenario that is hard to take in. In recent years, so many more

consumers have been turning to the health store in preference to the

doctor's surgery that it had begun to seem a permanent fixture in modern

life. Though there may still be the odd simple soul who believes that

eating a clove of garlic can cure cancer, all sorts of perfectly sensible

people who want to take greater personal responsibility for their health

are finding solutions, or partial ones, at least, in natural remedies.

Arthritis sufferers tired of conventional anti-inflammatory drugs that

upset the stomach are looking to alternatives such as glucosamine sulphate

and chondroitin. People prone to anxiety are choosing kava kava over

Valium. Those who feel depressed are going for St John's wort in preference

to conventional anti-depressants such as Prozac. Menopausal women are

seeing black cohosh as an attractive alternative to hormone replacement

therapy. The hungover take high doses of vitamins B and C (eg, in the

popular Berocca tablets). This surge is reflected in the media.

Conventional " doctor knows best " columns have been eclipsed by alternative

practitioners with a proactive attitude to health and a range of natural,

nonpharmaceutical suggestions for the treatment of everything from cold

sores to migraine.

 

All this interest is despite the fact that evidence of how - and, indeed,

if - these remedies work is open to interpretation and incomplete. Some

supplements are relatively well researched - two major epidemiological

studies have shown that vitamin E supplements, for example, can reduce the

incidence of heart disease by about 40%, while a substantial body of

research suggests that antioxidant vitamins protect against certain diseases.

 

For other more obscure supplements, however, relatively little conventional

medical research has been carried out, so evidence of efficacy relies more

heavily on traditional usage. Much of the scientific work into rhodiola

rosa, for example - a herb that is thought to make the body more resistant

to stress - has been carried out in Russia, and a lot more research is

needed to confirm the benefits that are claimed for it. Even so, it seems

that growing sections of the public can live with this sort of uncertainty.

More people are voting with their feet and concluding that alternative

remedies work as well, or even better, than conventional drugs, with fewer,

if any, side effects. But that option could be taken away altogether if the

new EU legislation goes ahead unchecked.

 

The attack comes from four different pieces of legislation, one of which is

already in force, another approved in principle. All are couched in the now

familiar EU language of consumer safety and free trade. Currently, the UK,

the Netherlands and Ireland have a far more permissive attitude towards

supplements than other member states, and make available a wider range of

higher-dose remedies. This approach is in line with those in the US,

Australia, New Zealand and Canada. But those days are numbered. The idea

behind the new regulations is that, irrespective of whether you are a

healthy Cretan, living on fish, multiple fruit and vegetables and

monounsaturated olive oil, or a typically sun-starved Brit, existing on

nutritionally impoverished processed food, you should have the same range

and strength of supplements at your disposal.

 

Attack number one comes in the form of the Food Supplements Directive,

which will set maximum levels for vitamins and minerals. Currently,

consumers in the UK can buy high-strength vitamins in dosages that are way

above what's known as the recommended daily allowance (RDA). Far from being

a formula for good health, however, the RDA is simply the minimum dose you

need to prevent nutritional deficiency. RDAs were developed during the

second world war, to ensure that soldiers did not get sick. Now, modern

research into the positive health properties of vitamins and minerals is

focused on safe upper levels, or " suggested optimal nutrient allowances "

(SONAs), much larger doses that actively promote health, rather than simply

prevent disease. The difference between the two is vast. The RDA for

vitamin B5, for example, is just 6mg, but consumers in the UK can currently

buy it in 550mg doses; and arthritis sufferers take it in doses as high as

1g-2g, and find it efficacious. Meanwhile, in most other European

countries, a much more restrictive range of vitamin and minerals, based on

the RDA, is available. A likely EU consensus might set limits at only two

or three times the RDA, representing a liberalisation for most European

countries, but decimating the choice available to the British consumer.

 

This " framework " directive has already been approved in principle by MEPs,

most of whom were effectively voting as if writing a blank cheque; now that

the full implications of the directive are emerging, however, many of those

same MEPS are reported to be " flabbergasted " . The all-important detail -

the setting of new upper limits and an agreed " positive list " of nutrients

- will be decided next spring. So far, some 300 popular nutrient forms from

which thousands of supplements are derived are not listed. " This will wipe

the most popular and effective higher-dose vitamins and minerals off the

shelves, " says Sue Croft of Consumers For Health Choice, the group that

successfully campaigned between 1997 and 1998 against the proposed ban on

higher-dose vitamin B6. " Millions of people will have their choices

restricted or taken away. "

 

The second attack takes the form of the Traditional Herbal Medicinal

Products Directive, which says that herbal remedies can only be licensed if

they can be shown to be safe and produced to high standards. That sounds

reasonable enough - until you learn that herbal remedies will be licensed

in the same way as drugs. A company making garlic capsules, for example,

will have to go through many of the same regulatory hoops as a company

producing a new pharmaceutical drug. Estimates for the cost of getting

these herbal licences vary from £10,000 to several million pounds a

product. This would almost certainly deter all but the largest companies

from producing remedies such as St John's wort, kava kava, gingko biloba,

red clover, rhodiola, evening primrose oil and ginger. There is no prospect

of several manufacturers pooling resources to get an ingredient licensed,

because each company's formulation will be treated as individual.

 

Furthermore, to get a licence, a specific product must have been on the

market for 30 years, 15 of which must have been in Europe. The effects of

that time bar are dramatic. Black cohosh, for example, an oestrogenic herb

traditionally used by native Americans, has demonstrated results superior

to hormone replacement therapy in the treatment of menopausal symptoms,

with women who take the herb reporting fewer adverse events, even than

those taking a placebo.

 

But black cohosh has only been available here for around five years, so,

like any product introduced since 1973 - in other words, the most

cutting-edge herbal products - it will become illegal. As yet unknown

herbal remedies might never even see the light of day in Europe. " This is

highly restrictive and racist, " says Patrick Holford, founder of the

Institute for Optimum Nutrition. " It could wipe out hundreds of really

useful herbs, not on the basis of consumer protection or science, but on

the basis of geography - herbs that have been used safely for hundreds of

years in the Americas, Africa, India and China. " In addition, any

combination of herbal and vitamin/mineral products that natural medicine

practitioners believe work better in synergy than apart, such as vitamin B6

with evening primrose oil, will be banned.

 

There's a third prong to the attack, in the form of the Novel Foods

Directive, which is already in force. This was originally designed to

control genetically modified foods and new, so-called " functional " foods,

such as fish oil-enriched bread, but is now being applied to absolutely

everything that is sold under food law. Any food product (which includes

supplements) that was not on the EU market before May 15 1997 can only be

granted approval after submission of a dossier containing huge amounts of

technical and safety data. So far, a herbal sweetener and an immune

system-boosting tonic have already been forced off the shelves as a result,

and next in the line of fire is MSM, an increasingly popular organic

sulphur that has been found to be effective in the treatment of joint

problems. What makes these developments even more worrying is that there is

no appeals process under this directive.

 

The final attack seems on the surface to be an innocuous tidying-up of the

EU Medicines Directive. But, in fact, it will mean that anything with a

physiological action can be reclassified as a medicine - and under EU

definitions, that means that any product sold in a health store, even

herbal tea, could be deemed to be medicines, while items such as coffee and

grapefruit juice (which also have proven physiological effects, but which

are sold in food shops), will not be affected. So much for Hippocrates, who

said, " Let food be your medicine. " The new EU laws will say that a product

must be either one or the other.

 

The authority in the UK charged with drawing this line is the Medicines

Control Agency (MCA), yet it has a direct interest in classifying

supplements as medicines - it earns 95% of its budget from licensing the

latter. MCA committees are filled with doctors whose experience lies in

conventional medicine. Many of them are either employees of pharmaceutical

companies or are beholden to them for research grants. By contrast, the New

Zealand government recently decided that its equivalent of the MCA is not

qualified to consider natural reme-dies, while in Australia the Traditional

Medicines Evaluation Committee made up of natural medicine practitioners,

suppliers and scientists and applies different criteria to supplements than

those it applies to conventional drugs.

 

Faced with this onslaught of hos-tile legislation, the UK natural health

industry is smarting at what it sees as the breathtaking injustice of it

all. A key principle of natural medicine is the Hippocratic requirement

primum no nocere , or " first, do no harm " . At the moment, supplements are

sold under food law, which means they have to be as safe as a loaf of

bread. The MCA already has the power to remove from the market any

supplement it considers to be dangerous. Conventional pharmaceutical drugs,

on the other hand, are sold on a costs versus benefits basis, the thinking

being that the beneficial effects of the drug should be balanced against

its risks. Side effects are simply an accepted part of the pharmaceutical

package.

 

" There has never been a death due to vitamin and minerals in the UK, " says

Holford, " but thousands have been caused by conventional drugs. The risks

are completely different. " Or, as John McKee, who runs Hanover Health Foods

in Edinburgh, puts it: " You can go to any petrol station and buy enough

paracetamol to kill yourself. It's very hard to commit suicide in a

healthfood store. "

 

Yet EU commissioner David Byrne insists that the aim of the legislation is

to " assure consumers that these products are safe and that doses available

are not excessive and potentially dangerous " . This echoes the long-running

demonisation by the orthodox medical establishment of natural health

practitioners as a bunch of cranks and charlatans, hawking useless and

potentially deadly products to a gullible public.

 

If you believed recent headlines, then fears over kava kava, the

traditional Polynesian remedy for anxiety, seem to lend weight to that

viewpoint. " Shyness remedy ruins your liver! " screamed the London free

paper Metro last December, and throughout the media reports appeared that

kava kava had been linked to 30 cases of liver failure and death in

Germany. The MCA put pressure on health stores not to stock it, and it was

promptly voluntarily withdrawn; it has been off the shelves ever since.

Kava kava's future is now in the hands of the MCA and the Food Standards

Agency (which has gone as far as issuing it with a health hazard warning),

and a proposed permanent ban is out for consultation. The MCA claims that

there is " significant existing evidence of hepatoxicity " .

 

But delving into the details of those so-called casualties, the case

against kava kava is deeply unconvincing. Most of the victims were already

taking pharmaceutical drugs known to be toxic to the liver, and many were

elderly heavy drinkers who had already abused their livers. " The vast

majority of these cases involved hepatoxic drugs or alcohol, " says Holford.

" Of the remaining nine, five have spurious relevance to a safety assessment

of kava kava for one reason or another, and four do not provide enough data

to know if it was kava kava causing the problem. " Holford, along with Dr

Hyla Cass, associate professor at the University of California's school of

medicine, has carried out a detailed review, which is consistent with the

longest running study of kava kava to date, reported in 1997 in the journal

Pharmacopsychiatry, which concluded that, " in contrast to both

benzodiazepines and antidepressants, kava kava possesses an excellent

side-effect profile " .

 

" The MCA's double standards are abhorrent, " says Holford. " A large number

of published safety and toxicity studies clearly indicate that kava kava is

far safer than conventional pharmaceutical anti-anxiety and antidepressant

prescription drugs. "

 

The MCA's cautious approach to kava kava contrasts with its attitude to the

commonly prescribed family of drugs called Selective Serotonin Reuptake

Inhibitors (SSRIs), of which Prozac is the best-known example. These have

been blamed for suicides, murders and even mass murders in the US, and are

the subject of ongoing litigation. In the UK, however, the MCA has resisted

putting a warning on them. " The MCA liaises with pharmaceutical companies

to decide what warnings might be appropriate, " says Dr David Healy of the

North Wales department of psychological medicine, who has been petitioning

the MCA to issue some form of general warning. The drug firms, however,

argue that patients on SSRIs are already high suicide risks, and that the

warnings that accompany the medication are sufficient. " These are big

players with tremendous incentives to defend their product, " says Healy.

" Small companies fighting off restrictions on herbs are at a disadvantage.

They are small, they don't have exclusive ownership of the herbs, so they

have less reason to do so, and they don't bite back. "

 

Speculation is rife in the natural medicine world about the extent to which

pharmaceutical interests are orchestrating legislation. Back in 1987, the

Campaign Against Health Fraud (Healthwatch) waged an aggressive public

campaign against natural remedies, financed initially by medical insurance

and drug companies. Similar campaigns were waged in the US and Canada. And

in the 1990s, there was a series of well-publicised attacks on food

supplements. Now, there's a persistent rumour that PR agencies working for

drug firms are spinning stories to the media, casting doubt on the safety

and efficacy of natural alternatives.

 

Drug companies have a proven track record in trying to legislate the

natural health business out of existence. In 1996, for example, the

Ecologist magazine revealed that, when the Codex Alimentarius (the World

Trade Organisation body that sets international standards for drugs, food,

supplements, etc) met, the German delegation put forward a proposal,

sponsored by three German pharmaceutical firms, that no herb, vitamin or

mineral should be sold for preventive or therapeutic reasons, and that

supplements should be reclassified as drugs. The proposal was agreed, but

protests halted its implementation.

 

That same lobby now seems to be powering EU legislation. According to the

UK department of health, the impetus for the Traditional and Herbal

Medicinal Products Directive came from the European commission's

pharmaceutical committee. " No one is saying that the natural health

industry does not need regulation, " says Holford. " It has grown from a

small niche to a major market sector. But this legislation is draconian. UK

consumers now have experience of many years of safe and effective usage.

They don't want supplements forced off the shelves or available only in

ludicrously low doses. "

 

And if consumers can no longer buy that helpful supplement in the health

store, they may simply source them from unregulated internet suppliers. It

might lead, say, to a new variant on the clothes shopping trip to New York:

UK consumers who can afford it might go on supplements trips to stock up on

remedies that are freely available in the US, but banned or unavailable here.

 

Surprisingly, in the 1980s the policy of the US Food and Drugs

Administration was to reclassify supplements as medicines. This even led to

a farcical situation in which armed FDA officers would raid clinics looking

for illegal caches of vitamins. But public protest forced a change, and

since 1994 the US has had a statute that guarantees both free availability

of supplements and information about how they work. Similarly, in Canada,

doctors in the 1990s were being struck off for prescribing vitamins and the

government reclassified hundreds of herbal remedies as medicines. Following

public outcry, however, they were all later declassified.

 

In the UK, when the government tried to withdraw higher-dose vitamin B6, it

met with a similar reaction. Many MPs were staggered by the sheer volume of

well-informed mail, and B6 was saved - at least until now. And the natural

health sector hopes that it can play the same card again, with the same

results: " There is still time to force changes to this ruinous

legislation, " says Croft.

 

To that end, healthfood stores are tooling up with Save Our Supplements

petitions and leaflets, while celebrities such as Elton John, Cliff Richard

and Paul McCartney have weighed in with support. The ranks of regular

health store users are being mobilised. As consumers begin to realise the

extent of the attack on natural remedies, the hope is that they will simply

not stand for it. And heaven help any politicians who try to come between

articulate OAPs and their glucosamine sulphate or angry hormonal women

deprived of vitamin B6 and evening primrose oil

 

Consumers For Health Choice can be contacted by email at

enquiries (www.healthchoice.org.uk).