Economic Larceny by Food Supplements

Economic Larceny by Food Supplements

Vignette

A 50-year-old male patient with a body weight of 91 kg consulted me one morning with a long-standing cough which I diagnosed as bronchitis. It was preceded by a short period of a flu, which is known as a viral infection, but all the symptoms had disappeared except the hacking, phlegm-producing cough. Bronchitis is an irritating disease that may last for weeks or months, often hard to cure, even much more difficult than the more serious pneumonia (infection of the lung tissue). While community acquired pneumonia is easily cured by antibiotics, bronchitis is difficult to manage and reacts best with rest and anti-asthma drugs, while antibiotics don’t work. This patient, however, was given - by his doctor - 1 unneeded antibiotic and 7 food supplements, costing him Rp 1.4 million.


The free trading of these dietary supplements was initially triggered by the US FDA: the Dietary Supplement, Health and Education (DSHE) Act of 1994. This law makes it easy to market dietary supplements, because no data on safety and efficacy are needed. This means that no basic studies or clinical trials are required. Soon, all nations have silently applied this rule in their respective countries. Many governments and professionals have questioned this controversial Act and The New England Journal of Medicine has in recent years published several critical papers on the subject. In about 2004 the European Parliament has once voted 26 against 1 to require hard data on a supplements marketing status, but was silently abolished the next year. Professor John S. Dowden from Australia wrote an editorial in the Australian Prescriber last year entitled “ A century of concern about complementary medicines”. From the UK are warnings about how toxic popular food supplements can be, especially when overused or large doses were taken. In 1994, the year of the DSHE, it was reported that the estimated 600 dietary supplement manufacturers in the United States produce approximately 4,000 products, with total annual sales reaching at least $4,000,000,000. Nowadays, that figure is estimated at $ trillion and Nutrilite, the top vitamin, sells at a record $3.1 billion. For Indonesia, herbal medicines is said to be sold Rp 1.5 trillion (?), while the figure for dietary supplements, that include herbal medicines, is unknown. An Internet Drug Store News reported,”Despite controversy over credibility, dietary supplement sales surge, it is the only category in the front end of a drug store that generates as much controversy as it generates sales”.

The main issue is that while drugs undergo rigorous evaluation of efficacy and safety data before marketing, these supplements were allowed – up till now - on the market without the necessary scrutiny. It was only limited by the label (indication) it may claim, no disease claim was allowed, only health claims was agreed. But, health and disease is often difficult to differentiate, and soon we witness all types of diseases, like diabetes, cancer, tuberculosis, etc to become indications of use - of course, lacking evidence. This leaves the beholder to be attracted by its flashy advertisements. It is also contradictory to current requirements of medication that practice Evidence Based Medicine, a strategy that should be followed by the entire medical profession (including nurses, clinical laboratories) and hospitals. The use of any drug must be supported by clinical evidence of its efficacy and safety (‘labelled use’). Without the double blind controlled clinical trial one may not claim efficacy, because any lay opinion of efficacy of a medicine may in fact be riding on the powerful placebo effect. This effect may be seen in a very large percentage of users, for some diseases (like an antibiotic for flu) it might be some 90 % or even more. Many medical practitioners are also unaware that supplements are no drugs and are devoid of any evidence of clinical trials that proves efficacy – and safety. Many supplements have adverse reactions too, and combined with polypharmacy (using more drugs than is really needed) practice are causing interactions between molecules in the body, causing unknown and problematic body reactions, not to be excluded, cancers. The rage of consumption of anti-oxidants, for instance, has been signaled to be a trigger of cancer. Anti-oxidants are good for preserving food, especially cake, but no positive proof (evidence) is there for preserving human health needs, notably in overuse. An array of different brands and shape of bottles filled with oxygenated water is also just replacing the wine-list in European restaurants and hotels. By the way, they sell at some EU 10 – 20.00 a bottle.

Food supplements are eating up household money into useless health cravings, often aided by doctors’ prescriptions. The Act caters for business rather than health. Imagine that, perhaps now, at least 20-30% of the world society is using or trading supplements, further stimulated by multi-level-marketing, a business that is non-functional and nothing is gained in terms of economics that would be lasting. It is created by today’s style of business: short term gains by such events like holiday sales, slashed discounted prices, of things that we really wouldn’t need or use. We may, perhaps, have the largest number of malls (relatively) in greater Jakarta, and yet it is still building more. Economically the whole nation may suffer from a backlash of real growth, and may therefore lack innovation for a positive change. Malls are also providing the place to spend that kind of money; they even become the playground of children and adults, causing transmission of airway diseases.

As the name suggests, DSHE stipulates that the Act includes education (of the public). This would fall on the US FDA shoulders, and indeed a large budget is accompanying this activity – although not enough to be efficacious. Adequate information leaflets are to be inserted in each packet and the internet and other media contributes ample warnings and caveats on supplements. In developing countries, however, no impartial information is provided by governments, while deceiving health advertisements in all media is rampant. While some supplements are producing beneficial results in selected users, very often, devious marketing tactics are attracting sick people more than the efficacious drugs available, overthrowing therapeutic systems. This had all begun with the advent of the “crazy open free market economy” that had started with Ronald Reagan, the once charismatic president of the US. Deregulation, which was followed by the world, had created a (predicted) greed, dishonesty and unethical conduct of immense nature. The serious question to be asked is whether this phenomenon, together with all the scam of unethical health practices, may lead to a further downward spiral of poverty and poor health in disordered countries.

Iwan Darmansjah, MD