Health supplements: R.I.P.

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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.