Read on to see what the Ecologist has to say about the EU Directives.....
Date Published: 22/05/2003 Author: The Ecologist
If you are one of the many millions of people who rely on vitamins and supplements to maintain their health and conquer illness, it's time for you to get active. The Ecologist explains why.
From vitamin C to echinacea, zinc tablets to St John's Wort – more and more people are taking vitamins and supplements. In part this trend reflects a growing interest in natural alternatives, but for many people it is a conscious effort to avoid being beholden to the multinational pharmaceutical industry and its ‘cure-all' drugs – drugs that reap billions for the corporations and cost us our health.
Unfortunately, this trend has not gone unnoticed by the pharmaceuticals, which for the last few years have been quietly buying up vitamin manufacturers all over the world. By 1998, the drugs firms controlled 70 per cent of the market. So if you buy vitamins or minerals today, the chances are that your money is going right back to the very companies you are trying to avoid.
And worse still is that the remaining 30 per cent – the independent, innovative sector – of the vitamin market is under threat too. On 12 March 2002, the European Commission approved a directive, which if unchallenged will result in the elimination of all competition to the drug giants.
EU standardisation The main reason given for this new piece of EU legislation is seemingly straightforward and relatively innocent. The market for vitamins and minerals is not the same in every country in Europe. In France and Germany, for instance, no products containing more than the recommended daily allowance (RDA) of a substance may be sold without a pharmaceutical licence. The UK and the Netherlands, by contrast, do not restrict vitamin contents and are allowed to export vitamins and supplements throughout Europe without restrictions.
In its desire for a neat and tidy European superstate, Brussels has decided to remedy this inequality. Hence the passing of the Food Supplements Directive, which seeks to standardise laws governing vitamin supplements across the whole of Europe. For the corporate supplement manufacturers, and the drug companies that own them, this is a major triumph. And the way it has been achieved, a piece of textbook corporate deception.
One such lobbyist is the US Council for Responsible Nutrition (CRN). Made up of 120 dietary supplements companies, this ‘vitamin trade association' is dominated by pharmaceutical companies like Bayer and Wyeth. These corporations pay anything from $4,000 to $125,000 per year for the CRN to lobby on their behalf.
But the biggest of all the industry's lobbyists is the International Alliance of Dietary Food Supplement Associations (IADSA), which represents 8500 companies and their 39 trade associations across 6 continents. The IADSA's chairman is Randy Dennin, who also happens to be a senior manager of Capsugel, now owned by Pfizer – the largest pharmaceutical company in the world.
‘They look so responsible that it's hard to pick holes in them, but they are controlled opposition groups. They torpedo the opposition,' says Frank Wiewal, one of the founders of People Against Cancer, which has lobbied against attempts to regulate dietary supplements in the US. By ‘controlled opposition groups', Wiewal refers to organisations that go through the motions of defending a position or party while actually helping the interests of the opposition. He confirms: ‘The drug companies are buying up the vitamin companies. It's all about big fish eating the little fish.'
The real effects of the European Commission's new directive are obvious. It will allow the drug giants to sell low-dose, low-efficacy products across Europe without having to reformulate them so as to comply with the requirements of individual countries. This means that products can be produced in bulk quantities at a cheaper cost and with greater profits. The 30 per cent of the vitamins industry that represents small manufacturers will simply not be able to compete.
The ‘positive list' The Food Supplements Directive centres on the use of a ‘positive list' of permitted ingredients. Incredibly conservative, it lists only the oldest, most well-known vitamins and minerals for which RDAs have been established. Of these vitamins and minerals, the only ones to be approved by the EU's list are the cheapest forms – the ones that can be produced in great bulk. This is all good news for the giant drug companies. The only form of vitamin E on the list is the alpha tocopherol variant; none of the more readily absorbed, or bioavailable, mixed forms are included. Yet all vitamins and minerals come in a huge variety of formulations, both synthetic and natural, all of which the body absorbs to different degrees. Generally speaking, the synthetic forms have lower bioavailability.
Many other supplements, such as boron, sulphur and vanadium, may be banned outright. In total, the directive could lead to the banning of some 300 popular supplements that are currently on the British market. But intent on banning many naturally derived minerals, the European Commission has been less scrupulous about the ingredients that will be allowed in the supplement manufacturing process. The positive list includes a number of highly toxic substances, such as sodium fluoride – the toxic form of inorganic fluoride, which has been used as a rat poison – and sodium hydroxide – another name for caustic soda.
Another worrying section of the directive concerns the criteria for determining permitted levels of nutrients. These levels haven't been set yet, but many of the discussions demonstrate that the EU is likely to adopt extremely low upper limits — one to three times the RDA. For many supplements, this new ceiling could represent levels that are some 20 times lower than those currently sold in the UK.
Suppressing innovation Any vitamin that is not on the positive list will be cleared off the shelves by August 2005 – unless the company marketing it applies for a licence. Such licences are so prohibitively expensive (the industry estimates that costs will typically be between £80,000 and £250,000 per ingredient) that it will be beyond the reach of all but the very largest vitamin firms.
The net effect of all this will be to kill future innovation. ‘The positive list locks us into the state of nutrition we had in the 1950s forever,' says Dr Robert Verkerk, the executive director of the Alliance for Natural Health – a European alliance that is working to minimise the directive's impact. Verkerk adds: ‘The development of any new vitamin products will be beyond the economic reach of any company besides the large pharmaceuticals; and the only way they will go ahead with bioavailable nutrients is after they've tampered with them and are able to patent them.'
The directive is also likely to cripple Europe's health food shops, as most of these businesses make their greatest margins on supplements and need a wide range of them to survive. According to Ralph Pike, director of the National Association of Health Stores in England, up to a third of British health food retailers could go out of business if this directive is implemented in its current form.
Challenging the science A number of groups challenge the science behind the directive, saying it ignores the breakthrough work in nutritional medicine, which uses high doses of vitamins to prevent and treat disease. British doctors including Patrick Kingsley, Damien Downing and the nearly 300 other members of the British Society for Allergy, Environmental and Nutritional Medicine routinely use high-dose supplements to treat everything from asthma to cancer. As Downing, the editor of The Journal of Nutritional and Environmental Medicine, says: ‘There are several thousand valid scientific papers every year that demonstrate the importance and value of nutritional supplements to treat and prevent a wide range of diseases.' And Kingsley, who is world renowned for his successful treatment of multiple sclerosis and cancer, says that considerable scientific evidence proves RDA is not only inadequate for the average person; it is totally inadequate when they are unwell. ‘The more unwell they are,' Kingsley says, ‘the more of these nutrients they need to correct their unwell metabolism.' (See box below)
Because food is far less nutritious than it was 50 years ago, vitamins are now a virtual necessity – even for the healthy. The use of intensive farming, pesticides and fertilisers that lack many important minerals means that soil and the food grown in it are virtually depleted of most essential minerals (see box below).
Even healthy people can benefit from supplements, particularly when they are older. Kingsley says: ‘Studies in the US show that when so-called fit and healthy older people are given considerable doses of supplements they are healthier in every regard.' The Journal of American Medical Association has gone even further, advising all US doctors to prescribe them as necessary for human health. Ignoring all this, the Food Supplements Directive has made it illegal for any supplement manufacturer to say on its packaging that it is impossible to get all necessary nutrients from food.
Eliminating the competition The EU is busy dismantling other forms of alternative medicine, too. The Traditional Herbal Medicinal Products Directive, which has undergone a first reading, seeks to force herbal medicines and possibly even substances like flower essences into regulatory procedures similar to those governing the pharmaceutical industry. Once again, many products could be effectively banned or – because the companies that produce them would not be able to afford the costly regulatory process – removed from the shelves. Most repugnant of all, however, animal testing could become a mandatory part of the process of testing these products.
Particularly at risk are blends of herbs with vitamins and minerals. The UK's Medicines Control Agency (MCA) argues that if the herbal ingredient of these products is at therapeutic levels then they should be classed as medicines requiring a full licence. The MCA has already removed a number of them from British health food stores' shelves. Vitamin manufacturers Solgar and Biocare have both been asked to remove or reformulate products, even though the directive has not even gone into law.
The first stages have also been completed on amendments to the European Pharmaceuticals Directive. And, although this amendment started life as a simple exercise in ‘tidying up' drugs legislation, the pharmaceutical industry has used it as an excuse to create a far more elastic definition of a medicinal product.
If accepted as currently worded, the Pharmaceuticals Directive could allow regulators of medicines to insist that many food supplements are, legally, medicines; these products would need to be licensed as such – even if they are covered by other EU directives covering food products. Theoretically, Britain's MCA could end up regulating alternative medicines like homeopathy and aromatherapy. The Pharmaceuticals Directive would have supremacy over other European laws, and all manner of natural remedies could be classed as drugs subject to licensing, regulation and potential prohibition.
Falling in line With a few exceptions, most supplement manufacturers – their eyes firmly on the euro signs of a Europe-wide market – have fallen quite easily into line. According to Ralph Pike, 80 per cent of the members of Britain's Health Food Manufacturers' Association are set to abandon any principle about high-dose supplements and have thrown their support behind the new directives.
Christopher Whitehouse, an adviser to Holland and Barrett and the pharmaceutically-dominated CRN, recently gave a talk with the defeatist title ‘Living with the Directive'. His clear message was ‘seek to influence, but expect to comply' – a succinct way of saying ‘it's a done deal'.
Besides the manufacturers, many alternative medicine professional associations either don't understand how their field is being dismantled or they have cowered into submission. The herbal societies, in the main, support the herbal legislation because they believe it will prevent many herbals from being sold in shops and it will force consumers to seek out the professionals. Many homeopathic organisations don't see what any of this has to do with them.
Last chance They soon will. The pharmaceutical industry is the most profitable in the world. In 2000, the top 20 drug firms had a combined sale of £135 billion. In 2001, at a time when the average Fortune 500 company saw profits plummet by 53 per cent, the drug companies saw theirs soar by 33 per cent. With these directives, they are eliminating their biggest competition: preventive medicine. ‘The simple fact is that the pharmaceuticals don't want people to get healthy,' says Lynne McTaggart, editor of What Doctors Don't Tell You. ‘Degenerative disease is the single biggest money-spinner of all time.'
Once they have been agreed by the European Commission, all these directives must be adopted by all member states. As trade directives, there is, in theory, no possibility of individual members opting out of them – an option that is available with other categories of directives such as taxation.
However, the Food Supplements Directive will not be ratified by the British Parliament until July, and companies will not be forced to comply until June 2005. Theoretically, there is still time for Parliament to influence legislation that clearly isn't the will of either British business or British consumers. Similar legislation in the US was defeated by a massive grassroots campaign. Currently, some 20 million Britons use some form of nutritional or natural medicine. London's International March for Health Freedom on 15 June (see box below) represents an opportunity for these people's voices to be heard.
What's wrong with the Recommended Daily allowance?
The Recommended Daily Allowances (RDAs) were formulated more than 50 years ago to boost British people's health. Although there are some small differences between the RDAs of the UK and other countries, they are all similar.
RDAs are derived from two sets of numbers: the quantity of nutrient required to maintain metabolic balance over time; and the quantity required to prevent the development of a deficiency disease – ie, a disease caused by a lack of a particular vitamin.
There are several problems with using a single yardstick for all individuals throughout Europe: o Different cultural groups have different needs. It's impossible to compare the nutritional needs of people living in the Mediterranean with those living in northern Finland. The latter may, for example, have vastly higher needs for vitamin D supplements.
o Vitamin requirements vary according to the individual, depending on, for instance, height, weight, metabolism and absorption, genetics, state of health and specific health problems. Someone with multiple sclerosis would have a very high need for vitamin B12, whereas someone with heart disease or cancer would have a very high need for vitamin C.
o Eating habits can also affect vitamin absorption. Smoking, caffeine and alcohol all have an effect on nutritional needs. Drugs such as diuretics or even the Pill can also cause nutrient loss.
o People are biochemically individual. Dr Damien Downing, editor of The Journal for Nutritional and Environmental Medicine, unearthed one study showing that the requirement for vitamin C among a set of guinea pigs varied by as much as 2,000 per cent. Human beings could have an even wider variation. o Nutrients in daily diets also vary enormously. You cannot compare the diet of the average British child with their counterpart in rural Italy or Greece. The latter are much more likely to live on a diet of fresh, unprocessed food.
o Preventing deficiency is not the same as preventing disease. Overwhelming scientific evidence demonstrates that high doses of a variety of supplements can prevent or treat disease. Many studies of vitamin C have shown that high doses can prolong life in cancer patients. When people are ill, their requirements for certain nutrients can rocket to hundreds or thousands of times the RDA. Cancer patients may require up to 20 grammes of vitamin C per day.
Why are supplements important? 20th century industrial agriculture has created a food supply that is far less nutritious than it once was. Intensive farming, battery conditions for livestock and widespread processing have depleted food of many vital nutrients.
o In 1940 the UK's Medical Research Council produced a report entitled The Chemical Composition of Food. In 1991 it repeated its study. It examined 28 raw and 44 cooked vegetables, 17 fruits and 10 types of meat, poultry and game. The results showed: all vegetables had lost up to 75 per cent of nutrients such as magnesium; meats had about half their minerals; and fruits had lost about two-thirds. The authors concluded that you would have to eat 10 tomatoes in 1991 to obtain the same copper that one tomato would have yielded in 1940, and three oranges to get the same iron as 50 years ago.
o Comparing nutrient values in US Department of Agriculture handbooks with those of 25 years ago, US nutritionist Alex Jack found that vitamins have also dramatically declined in fruits and vegetables.
o Current fertiliser methods, which seed the soil with just a few minerals (ie – sodium, phosphorus and potassium), have drastically altered the ratios between minerals that naturally occur in food. In 1940, there was a two-to-one ratio between phosphorus and calcium; now it is one-to-one. Swedes, for instance, now contain 110 per cent of the phosphorus they once did. Because there are critical ratios of certain minerals in human physiology, these new ratios could have profound effects on our body's chemistry.
Join the International March for Health Freedom The International March For Health Freedom takes place in London on Sunday, 15 June. The march is being organised by the Health Freedom Movement (HFM), a non-profit organisation representing all consumers of natural medicines, and which is spearheaded by the consumer organisation What Doctors Don't Tell You..
The march will send a message to Parliament that we don't intend to allow the directives to be enacted in their current form. All British participants on the march should gather in the North Carriage of Hyde Park near Speaker's Corner at 11am. At 12 noon the march will set out for Trafalgar Square, where speakers will address the demonstrators.
It is vital that you, and everyone you know who cares about health freedom, march with us on 15 June. See the HFM website (www.healthfreedommovement.com) for details.
Find out your MP's position on the EU directives. They will have to vote to ratify the Food Supplements Directive in late July. You still have time to tell him that you won't support him if he votes in favour of it. Also write to manufacturers, telling them that you intend to boycott harmonised products.