Have Any Double Blind Tests Been Conducted?
A double blind test is a test where both the researcher and the test subject are unaware of who is taking the real treatment (e.g. a new medicine) or the placebo (the dummy treatment). Controlled tests have been carried out in which a group was treated with ELEOTIN® and others were treated with non-treatment. Even though doctors seem to place a large emphasis on double blind testing, it is not necessarily crucial when it comes to ELEOTIN®. Here's why:
Scientists believe that a placebo would not create a noticeable effect on a diabetic subject. The human subjects tested all had a history of severe diabetes. No placebo would be able to reduce and control their blood glucose levels in the manner that ELEOTIN® did. Insisting on using a placebo knowing that it could endanger the test subjects was a difficult thing to do.
There is a statistical reason why a test with a placebo is irrelevant so far as testing ELEOTIN® is concerned. Placebo controlled experiments are important when there is a statistical problem called “multi-colinearity between explanatory variables.” Multi-colinearity happens where there are 2 or more variables that explain or are responsible for an event and those variables statistically cancel each other out. Since these variables work in the same way (they are co-linear), they statistically cancel each other out. In that case, if you run a statistical inference test, you will get an erroneous conclusion that none of those variables are important or contributing to the event, while those variables are important.
This means that statistically you must conduct placebo treatments until you discover the true contributing variables. But that is not the case with ELEOTIN®; the major variables that affect blood glucose levels are not really co-linear. For glucose control, the multi-colinearity is not prevalent among the major explanatory variables. In this case, double blind tests do not provide additional information and are quite redundant. In other words, present research results are statistically powerful enough to make concrete inferences on the safety and effectiveness of ELEOTIN®. What a double blind clinical test does is not much more. However, clinical trials with double blind tests are being considered by distributors of some countries.
You can find more information on the problems with a double blind test with respect to ELEOTIN® by searching the internet or more specifically visitting the science section of www.eleotin.ca .
Has ELEOTIN® Been Approved By The FDA As A Drug Product?
ELEOTIN® is not a drug, so we do not have FDA approval for it as a drug.
ELEOTIN® is a food or dietary supplement product and has been cleared for sale as a food/dietary supplement in the U.S. by the FDA.
There are a few reasons why ELEOTIN® has not attempted to obtain drug status with the FDA. One reason is due to the excessive time and financial resources. Applying for drug status takes at least $800 million and about 8 years to complete on average. And this still does not guarantee that there will be success. Also, this additional cost would be added to the cost of purchasing ELEOTIN® for the customer. It would force the price of ELEOTIN® to rise.
The most important reason is that for ELEOTIN®, this is almost impossible under the current system. Here is a simplified version of why: to create a drug that would be approved by the FDA, a pharmaceutical company must first isolate 1 or 2 active ingredients . Since ELEOTIN® is made up of not just 1, but many herbs, isolating 1 active ingredient may be almost impossible.
There are an infinite number of combinations of chemical variations that happen during the brewing and digestion process. There is a strong possibility that it may never be possible to isolate the single active ingredient in ELEOTIN®. Also, even if it were possible to single out the active ingredient, there is a high possibility that these active ingredients would be considered too toxic. Scientists feel almost certain that those few ingredients when isolated and singled out would be toxic when used in large quantities. Singling out active ingredients runs directly counter to the basic approach of ELEOTIN®, which emphasizes “gentleness and mildness.” Remember Bülgi's principle that we discussed earlier. This is the complete and balanced approach.
This may not be a perfect analogy, but often the absurdity of trying to isolate the single active ingredient of ELEOTIN® is compared to that of trying to figure out the single active ingredient of spaghetti. Even if it were possible to single out the active ingredient of spaghetti, it is quite sure that the active ingredients are toxic, not like the healthy tasty spaghetti your mother cooks.
In fact, this point is well known by the people of the FDA. They suggested that the packages of ELEOTIN® be marked clearly as “dietary supplement.” The practical differences between dietary supplement and drug are:
• You can buy dietary supplements without a doctor's prescription, while you need a doctor's prescription to buy pharmaceutical drugs.
• Medical insurance covers drug cost, while dietary supplements are not normally covered.
Has ELEOTIN® Been Approved By Regulatory Bodies In Other Countries?
ELEOTIN® is sold in several other countries besides the U.S. and Canada so regulatory approvals have been received for a food/dietary supplement product in those countries. For example:
• Ingredient Approval
ELEOTIN®'s ingredients or herbs have been reviewed and approved in Korea, Japan, China, Taiwan and a few other countries. All the ingredients are recorded in many countries' pharmacopeias and food codes.
• Health Food Approval
Approval related to the distribution of ELEOTIN® as a health food and the seal of safety have been acquired in Korea. In Taiwan, it was possible to obtain health food approval through which medicinal claims could be made. In still a few more countries, it was possible to obtain health food status. Usually it is more difficult for a product to be cleared as a food than to be cleared as a drug. The safety standards are higher for food, as foods are supposed to be consumed on a regular basis and are expected to be taken by many different people without a doctor monitoring. Even though a product is highly toxic, as long as its medicinal benefits outweigh its toxicity, then it can be approved as a drug. Not so for foods. Having acquired the status of a food is a better sign for safety.
• Drug Approval
There appears to be a few changes in regulatory environments in a few countries recently. Consequently, obtaining the Canadian and Chinese approval equivalent to the U.S. FDA drug approval is in the process.
How Come My Doctor Hasn't Heard Of ELEOTIN®?
It usually takes a long time for doctors to know about a new product. Considering that ELEOTIN® was introduced in March of 1998, and that Eastwood Bio-Medical Canada Inc. (EBMR) was a tiny company, ELEOTIN® is very well known for such a short period of time. Also, nothing can be further from the truth than saying “ELEOTIN® is not a well known product.” According to a survey, almost 100% of Korean endocrinologists know about ELEOTIN® or have at least heard of it. About 70% of Korean diabetics know about or have at least heard of it. Diabetes associations of a couple of countries officially issued special review newsletters. You can read these newsletters and reviews at the EBMR website at www.eleotin.ca.
Of course, when compared to a drug like, say, Viagra, it is a relatively unknown product. It is known that Viagra marketers spent billions of dollars to promote Viagra. ELEOTIN® obtained its reputation with virtually no marketing or PR budgets. No money was spent to “push” or “promote” ELEOTIN® to doctors. One statistic states that the average medical doctor in the U.S. receives, in one form or another, the support of pharmaceutical companies of up to $15,000 a year. Doctors are human too. Their opinions can be influenced by their supporters and sponsors.
In my own investigation, I found that Eastwood Bio-Medical Canada Inc. never did and never will give any financial support to medical doctors. Therefore, you can trust that when your doctor recommends ELEOTIN®, that it is purely due to their conviction in the benefits of ELEOTIN® for you, and not for their personal financial reasons. Of course, a doctor can be a distributor of ELEOTIN®, but in that case, it is required that he should clearly tell the patient that he is a distributor.
Doctors usually find out about ELEOTIN® through one of their patients. The patient will usually approach his doctor either before he starts with ELEOTIN® or after the effects of ELEOTIN® have started and the patient wants to discuss lowering his drug dosage.
Also, there are many doctors and researchers who volunteered their opinions and reviews of ELEOTIN® in highly respected professional journals and books. If you search on the internet, you will find many professional opinions of medical doctors and world leading researchers. You can also find these reviews at the EMBR website.
ELEOTIN® has also received its fair share of the media. It has been reported on many TV shows and newspapers. With virtually no advertisement, except for a simple news release, almost 5,000 units were sold during the first 8 months of introduction. It will take time for everybody to know about ELEOTIN®, but in time they will. The average life span of an herbal diabetes product is 6 months. They usually make huge unsubstantiated claims and disappear. Some medical doctors were under the impression that ELEOTIN® was another one of those products. But after many years of ever growing sales and ever accumulating evidence, the attitudes of doctors has changed substantially.
Why Should I Recommend Any Herbal Product?
Most western doctors used to be quite skeptical about herbal products. But in general, this skeptical attitude of western doctors is rapidly changing. In Europe and Asia, many doctors with conventional western medical training are using these kinds of herbal remedies. There, herbal medicine is not “complimentary.” It is already a part of the mainstream. In North America, more and more doctors are also exploring herbal products with an open mind.
ELEOTIN® being developed and tested at a traditional western university in North America is positive proof that western educated scientists and doctors are willing to openly explore all possible treatments as long as they are safe and effective. If doctors review our product and the scientific research conducted with an open mind, then the worst reaction they may have is, “I will wait until more evidence is available.” That can be accepted. Now, there are over 40,000 users due to the studies after studies of experts highly respected in their fields who are providing the evidence that confirms the effectiveness of ELEOTIN®. There is more than enough to convince.