Creating Waves of Awareness
According to information provided by DCGI during the hearing, 288 persons died due to clinical drug trials in 2008, 637 in 2009, 668 in 2010 and 438 in 2011. India has become a global hub for clinical drug trials on human subjects, reportedly worth $400 million USD and growing by over 30% per year. Commercial interests have started dominating the drug trial scene in which the financial bottom-line can override ethical and human rights concerns. A number of factors are responsible for the current increase in drug trials conducted in India. These include the low cost of experiments, almost 60% less than comparable trials in Europe or the US, and access to a large pool of illiterate and relatively less educated patients with a wide variety of diseases. Trials became easier after the 2005 amendment of the Drugs and Cosmetics Act of 1940 permitting concurrent trials. These factors and the absence of specific laws to protect patients have lead to widespread corruption in clinical drug trials.
Rampant corruption has been alleged from the highest policy level down to local institutions and some so called elite practitioners. The regulatory mechanism is steered from the drug controller’s office at the center with little involvement and control at the local levels. Bioequivalence trials offer participants large payments in violation of existing ethical guidelines inducing poor people to risk their lives. At present, sound and ethical clinical trials depends mostly on personal integrity and honesty of the investigator concerned. While corruption is so widespread, there are no specific laws to prosecute illegal or unethical activities.
Pharmaceutical companies and their hired corrupted unethical doctors always suppress the Adverse effects or Side effects of drugs and supplements for the sake of lucrative high commissions.
Omega 3 is not covered in Homeopathic Pharmacopoeia of U.S.A., France, Britain, Germany or India. Flaxseed plant or Linum usitatissimum in lower potencies or mother tincture is used in inflammation of the urinary passages, cystitis, strangury, etc. (Homeopathic Materia Medica - William Boericke). Some pharma houses are aggressively marketing their Omega 3 Capsules through their homeopathic medicine dealers and retailers with misleading catalogues or publications which apperantly claim it as Homeopathic.
Other Names of Omega 3:
Aceite de Pescado, Acides Gras Oméga-3, Acides Gras Oméga 3, Acides Gras Oméga 3 Sous Forme Ester Éthylique, Acides Gras N-3, Acides Gras Polyinsaturés N-3, Acides Gras W3, ACPI, EPA/DHA Ethyl Ester, Ester Éthylique de l’AEP/ADH, N-3 Fatty Acids, N3-polyunsaturated Fatty Acids, Omega 3, Oméga 3, Omega-3, Oméga-3, Omega-3 Fatty Acid Ethyl Ester, Omega-3 Fatty Acids, Omega 3 Fatty Acids, Omega-3 Triglycerides, PUFA, W-3 Fatty Acids
Omega 3 Supplements
Omega 3 fatty acids are naturally occurring substances in foods previously thought by researchers to reduce inflammation and help a number of health conditions ranging from cardiovascular problems to memory and cognitive function. Many foods contain omega-3 fatty acids. These include cold water fish and plant sources such as flax and flaxseed oil. However, to get the maximum benefit from these fatty acids, many people take supplements. Supplements contain an abundance of omega 3 fatty acids, but taking large doses, over and above what nature designed the human body to handle at one time, can cause many adverse problems and side effects. Although the pharma houses hide this information from patients and print on the packages that ‘there is no known side effects of Omega 3’ some unethical homeopathic doctors who compromised their conscience for the sake of money also suppress such information and aggressively prescribe Omega 3 Capsules to the patients undergoing homeopathic treatment.
Flax seed oil is marketed as nutritional supplement as it is a plant source of Omega 3 fatty acids. It is necessary to learn the flax seed oil side effects since promoters hype the benefits and suppress the side effects, even blindly print on the packaging ' there are currently no known side effects' in order to boost the sales.
“The important message for consumers is that they don't have to take mega-doses of omega-3 to have some impact. It might not take a whole lot to have a significant clinical impact,”
Martha Belury, an associate professor of human nutrition, endocrinology, diabetes & metabolism at Ohio State, in a research study on 'Omega 3 fatty acids affect Risk of Depression, Inflammation'
Ref: Research News, Ohio State University, Columbus, Ohio, USA
Major Side effects of Flax Seed Oil
Blood clotting is affected by consuming flax seed oil, specifically when taken in higher amounts. In case of any cuts, it takes long time to clot. It also causes other symptoms of bleeding like black tools, blood in the vomit, and stool. This is one of the flax seed oil side effects that become worrisome to people who take blood thinning pills like Heparin and Coumadin. Those who are under such medications should consult doctor before taking flax seed oil.
Unsafe in Pregnancy
Flax seed oil is considered unsafe for pregnant women as it enhances the risk of premature birth. This is because phyto-estrogen in flax seed oil promotes menstruation, so premature birth is more likely to happen in second or third trimester. This is considered one of the highly unsafe flax seed oil side effects
Anti inflammatory effect
It is known that Omega 3 fatty acid has the ability to prevent chronic inflammation on the arteries that enhances plaque formation and damages the vessel walls. However as per the study revealed by “American Journal of Clinical Nutrition” flax seed oil is not very effective to treat inflammatory conditions. Few more studies conducted shows that in many cases flax seed oil can enhance the inflammation.
Quite a number of people have reported to suffer from diarrhea, nausea, increased stomach movements, belching, internal stomach gases and so on when they take omega 3 fatty acids. The stomach problems are more pronounced to people who are using Omega three fatty acids from sources that are not pure. These side effects of omega 3 fatty acids are common in people who use omega 3 fatty acids from flaxseed.
The second side effect of omega 3 fatty acids is allergic reactions. Some people develop Allergic reactions especially skin rashes, hives, even, trouble breathing. This side effect of omega 3 fatty acids is more as a result of the source other and quality other than chemical composition of omega 3 fatty acids.
Increase in the level of bad cholesterol
Another very strange side effect of omega 3 fatty acids that has been noted is the increase in the level of bad cholesterol, commonly referred as to LDH. This is ironical since omega 3 fatty acids are known to reduce the levels of this type of cholesterol.
People who suffer from bleeding disorders are discouraged from using excess omega 3 fatty acids. This is another side effects of omega 3 fatty acids that cannot be underscored. Omega 3 is known to cause blood thinning and if anyone who has blood thinning disorder uses omega 3 oil, the case will worsen. Too much omega 3 can cause clotting problems. Symptoms include easy bruising or bleeding.
This is a much more serious, albeit rare, side effect. Symptoms of gastrointestinal bleeding include black and tarry stools, red spots or streaks in the stools, stomach pain or vomiting blood. Seek medical attention if you experience any of these side effects and are taking large doses of omega 3 supplements.
Bleeding in the brain can cause a stroke. Signs are severe headaches, double vision, slurred speech and numbness, tingling or difficult coordinating one side of the body such as one arm or leg. Seek immediate and prompt medical attention if any of these symptoms occur. The sooner you get treatment, the better in the case of potential strokes.
High Blood Sugar(Hyperglycemia)
Some diabetics taking omega 3 supplements report they have more trouble controlling their blood sugar levels. If you have diabetes, tell your health care provider about any supplements you're taking and monitor blood sugar levels carefully. If the omega 3 supplements are affecting your blood sugar, your doctor may need to adjust your insulin dose or take you off of the supplements.
Long term side effects
Finally, people who are under some medications on long term basis are likely to have some more serious side effects of omega 3 fatty acids if they used this product. It is therefore advisable to seek for medical attention before you use omega 3 fatty acids. This will help reduce the omega 3 side effects that may arise.
Ref: Side Effects of Omega 3 By Jeanne Grunert
Prostate Cancer in Men and Breast Cancer in Women are the other flax seed oil side effects that are suppressed to boost sale
•The high consumption of ALA or alpha linoleic acid present in flaxseed oil enhances the chances of developing macular generation.
•It increases the risk of prostate cancer in men and breast cancer in women.
•Cooking flax seed oil can lead to adverse effects. So always use it cold or at room temperature. It is advisable to use it cold on smoothies, shakes and salads
•One of the well known side effects of flax seed is diarrhea. When 30g or more can cause severe diarrhea.
It is necessary look into flax seed oil side effects when you plan to use the natural supplement.
Can Omega 3 Cause Insomnia?
Yes ,Omega 3 Fatty Acids Can Cause Insomnia.
Poor Nights Sleep Caused By Insomnia?
Are you getting side effects like insomnia by taking omega-3?
Which omega 3 fatty acid may be causing your insomnia side effect?
There are 11 common types of omega-3's, some come from vegetables, seeds and oils, whilst others come from cold water oily fish with high fatty acid content.
ALA is the most common fatty acid consumed from vegetable and seed oils. Most of us get enough of it from our regular diet, but you can overdo it by eating and using too many foods rich in ALA like flaxseed
or linseed oil.
ALA, DHA and EPA Omega-3 fatty acids affect your brain in different ways. Each brain and nerve cell is composed mainly of DHA fats, so too much of Omega 3fatty acid may cause insomnia and negatively affect optimal brain health and function.
You might be experiencing a fatty acid imbalance caused by a high omega 6 to omega 3 ratio.
1.Transient insomnia is caused because of another condition like stress and will usually last for less than a week.
2.Acute insomnia is where you have difficulty dropping off to sleep and maintaining it, resulting in poor quality sleep that isn’t restful or recuperative.
3.Chronic insomnia can be on-going and is likely to be caused by another condition like high stress levels or an over active mind.
If you suspect taking omega-3 supplements is contributing to your insomnia stop taking them immediately. Maintaining your health is your number 1 priority. Remember to never risk or abuse your body by unethical unnecessary prescriptions by corrupt Homeopathic physicians for any supplement or drug.
Omega 3 during pregnancy does not protect against excessive Adipose tissue development : Recent Research findings
Is obesity in infants “programmed” in the womb? Previously, researchers assumed that consumption of “bad” fats during pregnancy contribute to excessive infant adipose tissue growth and that “good” Omega 3 fatty acids prevent expansive adipose tissue development. An intervention study run by the Technische Universität München (TUM) showed no evidence to support this “perinatal programming” theory. Expectant mothers increased their intake of Omega 3 fatty acids with fish oil capsules and fish-based meals during pregnancy and breastfeeding. This intervention diet did not have any discernable effect on the fat mass of the offspring. At 12 months, the babies were as rotund or slim as the children in the control group.
Omega 3 fatty acids don't prevent expansive adipose tissue development. Obesity has become a global epidemic with more and more younger children affected by the overweight trend. According to the Robert Koch Institute, 15 percent of children aged between 3 and 17 are overweight. With serious consequences – childhood obesity is a risk factor for type 2 diabetes and also increases the chances of developing coronary heart disease or cancer in adult life. Nutritional experts are therefore keen to find effective prevention methods. “Efforts to control weight gain and obesity should target the earliest possible stages of development,” says Professor Hauner, Head of the Else Kröner-Fresenius Centre for Nutritional Medicine at TUM.
To achieve that, Prof. Hauner decided to research early adipose tissue growth. In their INFAT study, Hauner and his colleagues, explored how the composition of fatty acids in the mother’s diet during pregnancy and lactation affected the offspring. The team hypothesized that decreasing this ratio in the mother’s diet was a promising way of preventing infant obesity. Cell culture and mouse studies had shown that arachidonic acid – an Omega 6 fatty acid – resulted in increased adipogenesis and growth of fat mass in offspring. Experiments with Omega 3 fatty acids, however, revealed a curbing effect on adipose tissue growth among mice offspring.
The results of the INFAT study challenge the validity of this “lean” perinatal programming theory. Hauner and his researchers closely observed and monitored 208 expectant mothers from the start of their pregnancies. One group increased its intake of Omega 3 fatty acids by taking omega 3 capsules and reducing meat-based meals during pregnancy and breastfeeding. The control group maintained its usual diet and refrained from taking fish oil capsules. In both groups, skinfold thickness (SFT) measurements were used to estimate infant adipose tissue growth at regular intervals up until the age of 12 months. For the first time in infants of this age, ultrasound was also used to measure the fat layer at defined sites over the abdomen. The results show no difference in infant adipose tissue growth between the two groups. This study thus refutes the perinatal programming theory. The INFAT study thus revealed no evidence to support the effectiveness of fish oil capsules during pregnancy as a way to control excessive weight gain in infants.
So how seriously can we take claims that food supplements increase intelligence, protect against allergies and help avoid obesity? “Many of the claims associated with food supplements should be treated with caution,” continues Hauner. “Prenatal development is a complex process that cannot be reduced to a simple correlation between nutrient intake and fat mass growth. There are a number of additional, environmental factors and mechanisms that influence body weight – for instance in daycare or at school.” Hence the INFAT study will continue to monitor the children at regular intervals until they reach the age of five. The team now plans to explore other assumptions surrounding the beneficial properties of Omega 3 fatty acids – in relation, for example, to protection against asthma or neurodermatitis. INFAT is the first prospective, dietary intervention study to provide a rich data set to explore these assumptions.
The INFAT study (The impact of nutritional fatty acids during pregnancy and lactation on early human adipose tissue development) is sponsored by the German Ministry of Education and Research (through the competence network on obesity), the European Union (EARNEST consortium), the Danone Research Center, the Else Kröner-Fresenius Trust and the Unilever Foundation.
Overdosed on omega-3 fatty acid ? seek immediate medical attention
Symptoms of an Omega-3 Overdose
An omega-3 overdose is likely to cause any of the usual omega-3 side effects, but perhaps more severely. In particular, stomach upset can be expected. In serious cases, an overdose could increase the risk of bleeding, including dangerous internal bleeding, such as gastrointestinal bleeding or bleeding in the brain. Symptoms of such bleeding may include:
Easy bruising or bleeding in the brain
Black, tarry stools; bright red blood in the stool; or vomiting of blood (signs of gastrointestinal bleeding)
Signs of a hemorrhagic stroke (bleeding in the brain), such as vision or speech changes, weakness or numbness in an arm or leg, or a severe headache.
Treatment for an Omega-3 Overdose:
There is no definite treatment for an omega-3 fatty acid overdose.
Therefore, treatment (if necessary) will involve supportive care, which consists of treating the symptoms that occur as a result of the overdose. For instance, if an overdose caused bleeding, then supportive treatment would include medications or procedures to stop the bleeding.
It is important that you seek prompt medical attention if you believe that you may have overdosed on omega-3 fatty acids.
Due to lack of Survillence on Homeopathy products by Homeopathy Department, Ayush, Govt. of India, and State level authorities, sub-standard and potentially harmful non-homeopathic products are being marketed with ‘safe’ homeopathic label. It’s the high time that the concerned authorities should step foreword for the sake of innocent consumers who easily fall prey to such misleading advertisements of pharma houses or fall prey to some corrupt Homeopathic Doctors who have sold their conscience to the pharma houses for lucrative high commissions.
About the Author
Prof Dr Debasish Kundu is a Visiting Professor of Khulna Homeopathic Medical College & Hospital, Khulna, Bangladesh (Recognized by Ministry of Health, Peoples Republic of Bangladesh), he has authored several best selling books on Natural Medicines, Homeopathy and Community Medicine like Aids, he is associated with several peer reviewed journals as member of Editorial Board, incl. European Journal of Food Research & Review (EJFRR), Sciencedomain international,U.K. ,Journal of Medicinal Plants Research, Academic Journals, Lagos, etc.
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