THE IMPORTANCE OF CLINICAL EVALUATION


Natural Products

Clinical trials and studies are rarely found in natural or nutritional products. This is primarily due to the fact that these natural occurring compounds already exist in nature and there is nothing new or novel to patent. Due to this, companies will not incur this massive expense to run trials as they do not have the exclusivity protection of a patent, in which to recoup their investment. This has unforeseen consequences as certain important criteria are therefore never determined.
1. Is the product toxic
2. Does it work
3. Does it interact with other compounds.

Qina has clinical trials that prove all the above and more.

Problems facing Natural Products

There are some major problems with natural or nutritional products and that is the lack of clinical data supporting efficacy, toxicology, interaction and processing quality.

As natural and nutritional medicines cannot be patented, manufacturers may patent the extraction process or use terms like "proprietary blend" to hide the exact composition of the ingredients to protect their formulation. This unfortunately opens this market to all forms of abuse with many product duplications and pricing discrepancies, depending on whether the marketer is basing their product on quality or pricing.

Efficacy or does it work.

There are daily allowance guidelines for vitamins and minerals that were detailed back in the 1930's and to date have changed very little. Many believe that the criteria in determining these maximum allowable quantities was to circumvent a healthy adult male from developing Rickets. Another report states that these daily allowance guidelines were set so low in order to perpetuate disease thereby ensuring the growth of the pharmaceutical industry and providing a constant flow of patients into an ever increasing pool of doctors.

We know that good nutrition from food can help prevent many diseases, but can these natural occurring components generate the same result after being processed. Vitamin C for example has undergone 17 chemical changes from its original form to ascorbic acid.
Calcium plays a major role in bone density. But does calcium supplementation offer an effective alternative. Marketers embarked on a major advertising drive to prevent Osteoporosis by supplementing with calcium. The two misleading facts here are that osteoporosis is not as big a problem that has been portrayed and only affects 3-4% of people in their old age. Secondly there are so many forms of calcium, most of which have never been proven to penetrate into the cell in order to affect change. So what you have is high levels of calcium floating in the blood stream that will eventually develop into calcification of the joints.

Toxicity

This is more apparent when taken in high doses. A misunderstanding is the thinking that because a substance is natural, it is safe without side effect... this is untrue. High dose medication especially herbal products can, and do lead to liver toxicity. A newly discovered ingredient in weight loss products saw a flood of patients arriving at Canadian hospitals ....

Interaction

Heart patients on Warfrin to thin their blood, should avoid taking White Willow bark extract which is the natural form of aspirin which also thins the blood. Insufficient studies have been done on the interaction of natural medicines and drug interactions.

Processing

This area is where there is great concern in the quality of the product or extract. Aloe Vera is a product that is open to abuse. Firstly there is the terminology "aloe vera" which is derived from the plant Aloe Barbadensis Miller. Products use the the picture of the plant and state it contains aloe, but is not aloe vera. Concentrations come in 1:1 up to 200:1 and one never knows the exact content the product contains. And perhaps the most important is the processing of the leaves. One never knows if the particular processing method used was able to keep all the original symbiotic elements intact. If a manufacturer runs short of stock and has to use a different supplier, the reality is that the product has now changed, as the quality and bio availability from a different source has not been checked. The efficacy of plants is dependant on many factors. Where they were grown, when they are picked, from which part of the plant. How were they transported and stored and how they were processed.

In conclusion

Qina has satisfied all the criteria to ensure a safe and effective product proven by clinical and scientific studies

 

Pharmaceutical Drugs

Pharmaceuticals on the other hand or synthetic compounds which do not occur naturally. For these a patent is available and clinical studies are imperative due to safety and efficacy concerns.
To explore all the variables and designs of all the clinical studies and trials available is a huge undertaking, and the depth and scope of them is a subject in themselves. The first step starts with a pre clinical laboratory study, to determine efficacy and pharmacokinetics (what the body does to the drug). 90% of drug trials fail this stage. If successful they move onto animal studies usually in rats or mice. The failure rate at this stage is also very high. And finally they move onto human trials. This is where the highest failure rate is and is also the most costly.

Due to these high costs, which can run into millions of dollars, the drug manufacturer is assured of a patent protecting them for the next 20 years. When the patent runs out the drug can be made by other companies, and is called a generic. If manufactured in the original manner the only difference between a generic and the original is the brand name.

All pharmaceutical drugs have adverse side effects, primarily because these synthetics are not supposed to be in our system. This has become more evident of late. In the USA the 4th leading killer is "Adverse Drug Reaction", in other words, the medicine is killing the patient. However the doctor patient trust factor remains firmly intact.

Interestingly enough in the last 13 years only 6% of new drugs coming onto the market are novel and new, the other 94% are reformulation's of the older drug. This in no way means that the revised version is better, in fact in many cases they have added side effects, but the drug companies want to ensure market share and continue making unrealistic profits. At the end of the day drug companies are not owned by loving caring people, they are owned by investors and shareholders who demand improved profits. If they do not perform, their investment will shift elsewhere.

 

The war between natural and pharmaceutical products

Kava Kava was taken off the market due to one person showing signs of liver toxicity. On close examination he was taking 10 times the daily dose, but this did not affect the resulting world wide ban. When one takes a look which product Kava Kava was in competition to, it's Prozac, no guess who was behind that.

Another excellent naturally occurring compound called Policosinol, which is derived from sugar cane. It competes with a statin drug called Lipitor which posted profits of $16.8 Billion in 2006. All of a sudden a new study is done showing that Policosinal does not work, and this information is posted to every medical practitioner world wide. Now most doctors have absolutely no understanding of natural medicines, so when you as the patient, ask if it is safe to take, he will reply "you're wasting your money." This is based on the information he receives from peer reviewed medical journals. What was never told to the doctor is that the original trials undertaken used sugar cane as their source and the new debunked trial source was from Yams or beeswax. The end result is that the damage has been done.

This type if disinformation campaign is evident whenever a natural medicine competes with a profit making pharmaceutical drug.

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