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| Sunday, 6 March 2005 |
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Features |  |
| News Business Features Editorial
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Unseen risks of 'quick fixes'
The 'Sunday Observer' learns that dietary supplements banned in USA and EU countries, due to proven health risks, are also being sold in super markets in the country. P. Madarasinghe, Food and Drug Inspector of the Drug Regulatory Authority (DRA) of the Ministry of Health, says that over 100 dietary supplements with claims of reducing fat, controlling weight and cholesterol, maintaining healthy joints, keeping the blood vessels clean and several other similar claims are being sold in local super markets. by Shanika Sriyananda They fill supermarket shelves and offer quick fixes to any and all problems ranging from uncontrollable weight gain to hair loss, acne, wrinkles, dark skin, haemorrhoids, osteoporosis to about anything, even pro-longing life. Available over the counters, they ease the hassle of waiting in long queues for a doctor's appointment, are often cheaper than prescription drugs and always promise instant results. Call them 'quick fixes', 'wonder drugs', 'miracle cures' or whatever, the medical authorities have still not been able to categorise them as drugs or food. Going by the term 'Dietary Supplements', more and more people are now being attracted to colourful advertisements of these wonder drugs, with, popular figures vouching for many of these products with "money back" guarantees. In an era, where the local health authorities and even experts around the world are 'wondering' about the efficacy and safety of these 'supplements' and are still formulating guidelines to separate these fixes from drugs and food items, a warning note is being sound by local experts, urging consumers to be cautious about 'Dietary Supplements'. "THINK TWICE BEFORE YOU ORDER THESE STUFF", warn the experts who caution about possible health hazards as these products need much more research before their efficacy and safety can be determined. According to experts, those who try to order these over the counter run the risk, that is as 'dangerous' as self medication drugs. According to Madarasinghe, these drugs cannot be registered in Sri Lanka, either under the Cosmetics, Devices and Drugs Act or the Food Act. As there is no law or Custom restrictions on these wonder drugs, there is nothing to deter importers from bringing in large quantities of these drugs easily. The Ministry of Health appointed a committee in 2002 to keep tab on these items in a bid to implement new guidelines on their registration. The committee, under the Director General of Health Services has come up with recommendations, suggestions and definitions to the dietary supplements and has already prepared a report on the legal aspect of registering these items with the DRA. "The Committee also recommended a procedure to differentiate dietary supplements from drugs and to implement a registration procedure, the committee recommended that a procedure based on the 'Recommended Daily Allowance (RDA) Schedule be followed to decide whether a product is a medicine or not and identify products, which must be registered by the DRA as drugs and to register products containing RDA or less as foods. The products with therapeutic claims and with content exceeding RDA limits as drugs", Director DRA Dr. B.F.S. Samaranayake said. Although, some of the dietary supplements are advertised in Sri Lanka, it is illegal in most of the countries, unless the product is registered as a medicine. Under these restrictions, printing wordings such as 'this product prevents heart disease' or this product lowers blood pressure' on a label is an offence. According to Madarasinghe, there is no restriction on the import of these items and anyone can easily get clearance from the Customs Department. "There may be nutritional value in these supplements but their direct or indirect health hazards are still unclear. There is no particular authority for these items and no research on dietary supplements has ever been conducted here. This phenomena is a world wide threat", he said. "This needs a thorough study. Some ingredients in these supplements have true medicinal value, but it is doubtful whether the manufacturer uses the required amount of the particular ingredient to get the real benefit", he added. According to Madarasinghe, strict action should be taken to control these drugs from reaching the country and their registration under the DRA, especially since there is a high demand for weight reducing supplements among the people. Consumers should be well informed about rackets and the unseen risks of using these quick fixes, which need clear scientific proof to claim their efficiency, especially pills and syrups, without proper medical guidance. The profit minded businessmen may influence and mislead consumers with attractive advertisements using popular figures to say how to enhance brain power, to reduce weight or how to boost sports performances. But, the consumer has the right and the choice. As Dr. Chandrani Piyasena, Head of the Nutrition Unit of the Medical Research Institute advises, a greater responsibility lies with the consumer. " Any product with attractive claims should not be bought unless your doctor has recommended it. Consumers should be more intelligent with the latest technology", said Dr. Piyasena. **** What is dietary supplement A product (other than tobacco) that is intended to supplement the diet which bears or contains one or more of the following dietary ingredients : a vitamin, a mineral, a herb or other botanical products, an amino acid, a dietary substance for use by man to supplement the diet by increasing the total daily intake, or a concentrate, metabolite, constituent, extract or combinations of these ingredients. It is intended for ingestion in pill, capsule, tablet or liquid form, is not represented for use as a conventional food or as the sole item of a meal or diet and is labelled as a dietary supplement. Source: The USA 'Dietary Supplement Health Education Act of 1994' Beware of these commonly used dietary supplements in Sri Lanka. * Beepollen: * Evening primrose oil : * Vitamin E: * Aloe Vera: * Ginseng: * Selenium: Source : 'Dietary Supplements' by Pamela Mason Controlling dietary supplements Head Nutrition Unit of the Medical Research Institute Dr. Chandrani Piyasena said that stringent control of dietary supplements was needed and the committee formulating a system of control would look into the scientific evidences of each and every item that is imported. " If the importer claims that the product is good for diabetics, he has to submit scientific evidences to prove it prior to the importation, to get approval", she said. According to her, dietary supplements would be essential for patients, who are critically ill for a period of time or even after serious surgery. " Dietary supplements plus the normal diet would help them to recover fast", she said. Dr. Piyasena advised consumers not to take dietary supplements without the guidance of a medical officer, since laymen are not aware of the real medicinal value or the ingredient in the product. " Think especially think about the safety", she cautioned. She also warned against taking sliming tablets. " Becoming slim is not an easy and instant task. Slimming by swallowing tablets is a risk", she cautioned. " A balanced diet with exercise will slim you naturally. Say no to fatty ... sugary...and processed foods. Select your diet carefully and properly. Do exercise for 15 minutes a day to reduce extra fat. Add lots of vegetables and fruits to each of your meal", she said. She also recommended that those seeking to lose weight and lead a healthy life should avoid processed foods like rolls, patties, pastries and all instant foods which contain high amount of oil. " Earlier we advised people to eat bread. But today, rice is better than bread, because the content of 'undigestible carbohydrate' known as fibre is high in rice than bread", she added. ****************** CRP and heart disease by Dr. D. P. Atukorale Following the publication of an article in a recent Sunday journal, there are some misconceptions in the minds of the readers that the test called C - Reactive Protein (CRP) is specific for diagnosis of heart attacks and strokes. CRP is a test that measures the concentration of a protein in serum that indicates acute inflammation. Inflammation by the way is a defensive reaction of the body's tissues to invasion by pathogenic micro-organisms such as bacteria and viruses or in the presence of foreign body or any other injury. CRP is a special type of protein produced by the liver that is present during episodes of acute inflammation. While CRP is not a specific test for heart disease and stroke, it gives a general indication of acute inflammation in the body. Normally there is no CRP in the blood serum of normal healthy people, although there may be very low levels of High Sensitive CRP (hsCRP) in normal people. Abnormal levels of CRP occur in a number of diseases such as (a) Rheumatoid Arthritis (b) Rheumatic Fever (c) Cancer e.g. colorectal cancer (d) Tuberculosis (TB) (e) Pneumococcal Pneumonia (f) Myocardial Infarction (heart attacks) (g) Strokes (brain attacks) (h) System Lupus Erythematosis (SLE) (i) Peripheral Vascular Disease (e.g. intermittent claudication) (j) Certain normal people who may develop hypertension later (k) During last half of pregnancy (l) With the use of contraceptives CRP, heart disease and strokes As mentioned earlier, inflammation is the process by which body responds to injury. In atherosclerosis (process by which fatty deposits build up in the inner lining of arteries) there is believed to be low grade inflammation and the possible infective bacterial include Chlamydia pneumonia, Helicobacter pylori and viruses such as herpes simplex virus and cytomegalovirus. It has been suggested that testing CRP in the blood may be a new way to assess risk for cardiovascular diseases such as heart disease and strokes, but as mentioned earlier, it is not a specific test for heart attacks and strokes. A large number of research studies done in the recent past show that CRP can predict cardiovascular events in people who have high levels of CRP or hsCRP. Normal range of high sensitive CRP If the hsCRP is lower than 1mg/per litre, a person has a low risk of developing a heart attack or a stroke. If hsCRP level is between 1 and 3 mg per litre, a person has an average risk of developing a heart attack or a stroke. So if a patient has an unusually high serum level of hsCRP, that person should undergo a check-up to exclude risk factors for cardiovascular disease. If a person with high CRP has no risk of Coronary Heart Disease or strokes such as hypertension, hyperlipidaemia, smoking and diabetes, the physician should exclude other diseases such as arthritis, TB, Cancer or SLE. Estimation of CRP in patients on statin therapy Majority of physicians prescribe statins such as lovastatins, simvastatin and atorvastatin to patients with elevated L.D.L. (bad) cholesterol when they find it difficult to control the cholesterol levels by low saturated and low cholesterol diet and exercise. Side effects of statin - therapy are rare. During the last 25 years of my experience I have come across a very few patients (less than 10) who developed serious side effects out of thousands of patients I have treated with statins. Once statins were withdrawn, the side effects subsided, in all the patients. Statins are a group of wonder drugs and there is scientific evidence to show that those on statins have a low incidents of cancer and other chronic diseases. Use of statins for heart attacks There is scientific evidence to show that use of statins results in decrease in the level of CRP in these patients with unstable angina and major heart attacks. Other very useful blood test done in patients with acute coronary syndrome and heart attacks is Troponin T or Troponin I. If the CRP levels are low and if Troponin T or Troponin I are repeatedly negative, such patients can be observed in an intermediate coronary care unit or in a medical ward even if ECG is abnormal. If CRP or hs CRP is high, the test should be repeated after statin therapy with a view to assess the prognosis of these heart patients. CRP and hypertension Recent research suggests that people with elevated hs CRP levels are at a higher risk of developing hypertension and this suggests that hypertension is an inflammatory disease (Howard et al, JAMA, 2003, 290, 2945 - 2967). High CRP levels and coronary risk factors Recent research suggests that elevated CRP levels are also found in people with other coronary risk factors such as smokings obesity and lack of exercise, whereas athletic individuals tend to have lower levels of hsCRP levels. Thus there appears to be an association between CRP level of person and future development of heart disease. This is true even in normal healthy people with normal blood cholesterol levels. Therefore all physicians should include this very useful blood test (hs CRP) in the assessment of the cardiovascular risk of their patients. At present, both CRP and high sensitive CRP (hsCRP) can be performed in a number of recognized private labs. As far as I am aware there are no facilities to carry out above test in the Sri Lankan government hospitals at present. ************** The 'power' of coffee! A cup of coffee can give you a jolt to get your day going. But over time, you are likely to find that it takes more to get the same kick start as your body builds up a tolerance to your usual daily amount ( a phenomenon that occurs with most addictive substances). So you have to be careful about how many cups you build up to. Though coffee has a surprising number of benefits - from reviving up your metabolism to enhancing mental acuity - you can get too much of a good thing. So called caffeine intoxication is a condition that brings about anxiety, nervousness and tremors, says Dr. Roland Griffiths, Professor of behaviourial biology at Johns Hopkins school of Medicine, Baltimore. The average person can consume between 250 to 500 mg of caffeine a day without ill effects. An average cup delivers 100 mg. Though annoying, caffeine in toxication is not life threatening. The only thing you can do is wait it out. It can take upto six hours for the effect of caffeine to wear off. Courtesy - Ladies Home Journal.
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