Useful Articles - Health and Fitness

If you have lost your joie de vivre, then there is every chance that you are deficient in the essential fatty acids required for regulating mood and for efficient functioning of the brain. It is now well documented that insufficient Omega 3 fatty acids in the

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

diet not only leads to an increased risk of developing physical health problems like heart disease and atherosclerosis, but also to mood and learning related disorders.

Studies show that people who are suffering from depression, bipolar disorder, ADHD, ADD, po

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

tnatal depression, PMS, dyslexia and many other mood and learning related disorders have low levels of the essential Omega 3 fatty acids in their blood. High levels of the equally essential but over abundant Omega 6 fatty acids have also been found. This imbala

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

ce can turn out to be extremely debilitating for some, or it could simply mean low moods, an inability to concentrate and focus, irritability and a general feeling of malaise for others.

Over the past 70 years or so, we have dramatically increased our consumpt

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

on of Omega 6 and all but annihilated our intake of Omega 3 and the staggering reality is that very few of us are actually getting the amount of Omega 3 we need. Fish oil contains the Omega 3 fatty acids Eicosapentaenoic acid (EPA) and Docosahexaenoic acid (DH

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

A), both of which are vital for healthy brain development and function. Putting physical health problems aside, those of us who have low blood levels of Omega 3 are more likely to adopt a negative outlook on life, to behave impulsively and to feel depressed acc

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

rding to researchers at the University of Pittsburgh.

It stands to reason that if we increase our intake of Omega 3 fatty acids in the form of fish oil, then we might be able to improve mood and reduce, eliminate or even prevent many of the symptoms associated

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

with a lack of these fatty acids. And this is exactly what researchers have found.

What the research says…

• According to a study led by Lawrence Whalley, a mental health professor at Aberdeen University, fish oil appears to help the brain to work faster, it

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

increases IQ scores and slows down the ageing process by reducing inflammation.

• The Durham trials led by Dr Madeleine Portwood have consistently shown that fish oil with a high EPA content improves behaviour, concentration and learning resulting in better gr

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

ades at school. • Adelaide University, who also used high EPA fish oil, claimed it to be an effective treatment for ADHD.

• Research led by Dr Andrew Stoll looked at the effect of Omega 3 fatty acids on Bipolar disorder and found that fish oil reduced the seve

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

ity of the symptoms.

• Hibbeln et al found a direct link between lower fish consumption and the risk of developing postnatal depression and that research spanned 22 countries.

• An Italian study by Fontani et al concluded that Omega 3 supplementation improves

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

complex cortical processing with improvements in mood and a reduction in anger, anxiety and depression

These examples represent only a fraction of the studies conducted but they demonstrate just how effective fish oil can be in positively influencing mood and

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

ental functioning.

But one of the biggest studies to date on the effect of Omega 3 fatty acids on depression was conducted by Malcolm Peet at Sheffield University who found that ethyl-EPA, a highly concentrated and purified form of the Omega 3 fatty acid EPA,

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

dramatically reduced depression. He, along with a growing number of others, now believe that EPA is the fatty acid primarily responsible for the profound effect on mood and brain functioning and not DHA as once was thought.

EPA versus DHA

Although we need bo

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

h EPA and DHA equally, as Ralph Holman, an expert on fatty acids once said "DHA is structure and EPA is function". We need DHA for the proper development of the brain during pregnancy and through the first few years of life, but the rest of the time we need EP

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

for the brain to function efficiently. Some research has also indicated that the presence of DHA might actually interfere with the beneficial properties of EPA making it somewhat less effective than fish oil with a very high EPA content.

How EPA works

No one

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

yet knows exactly how EPA works, but it is believed to reduce inflammation, thin the blood, increase serotonin levels, and improve blood flow to the brain leading to greater inter-connectivity in the neural networks. EPA and other fatty acids we consume compet

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

e with each other to be converted into eicosanoids. These hormone-like compounds will either be pro-inflammatory or anti-inflammatory depending on the type of fatty acid that dominated at the time, for example, Omega 3 or Omega 6.

As EPA is constantly being us

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

d up as it were, we need to replenish our supplies in order to inhibit overproduction of pro-inflammatory eicosanoids, which is known to put us at greater risk of depression and other health problems. Conclusion

Fish oil may not be a panacea for mental health

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

problems, but there is little doubt that supplementing with fish oil high in EPA has the ability to improve mental functioning and to make a profound difference to the symptoms associated with mood related conditions like depression.

Copyright 2006 David McEvo

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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