It is REPORTED HERE that "The actual paradigm of medical care has not changed much in spite of all of our technological advances. Physicians have been extensively trained and have held steadfast in the belief that presenting symptoms are entities unto themselves. These symptom complexes have been treated as if they have a life of their own, separate and apart from the innocent bystander host, the person with the medical problem. We have divided the human body into a jigsaw puzzle of component parts. We've taken the jigsaw puzzle apart and assigned a specialist to address each one of these pieces of the whole, losing sight of the fact that everything is part of the whole, and everything we do as physicians to each little part affects the whole person. This has fostered the current allopathic paradigm of 'symptom care' in lieu of the more important issue of "health care."

"In order to establish a system that is truly focused on health care, we need to expose some "myths" that will allow us to unlock the door to creating a more efficient and successful healthcare delivery system." In the coming weeks we will look at these myths.

"Myth # 6 - The double blind - placebo controlled study guarantees safety and efficacy in drug therapy.

At this point in the history of mankind, we have been conditioned to abhor symptoms of any kind. Headaches, sneezing, coughing, colds, allergies, pain, infections, hypertension, etc., are no longer tolerated as a part of the process of living. Rather than look into the mechanisms that may be causing these symptoms, we are reaching for the medicine that will suppress them. In so doing, we may feel better, but we now have no motive to look at causes and correct for the issues that may be impairing our health, thus increasing our "need" for more medications over time."

"Well, what about these drugs? How do they make it to the market for public consumption? The answer is the "gold standard" double blind, placebo controlled study. Without this approach, there can be no FDA approval and hence, no way to market a drug. So let's look at this approval process more closely."

"It is imperative that a drug be tested for two main issues in clinical trials, the first being safety and the second, efficacy. Of course we want to know that if a drug proves to control the symptoms it is being designed to control, it can it do it safely, (e.g., with a minimum of "tolerable" side effects)."

"We then want to be able to establish that it is the drug that is working and not the 'mind over matter' phenomenon. To ensure this, the drug is given to half of the test subjects and a placebo is given to the other half, who believe that they are actually being given the medication. Both groups are also instructed to refrain from taking other medications so that a "synergy" effect does not confuse the results. It would be harder to know if side effects and/or efficacy are being affected by these other meds so they are eliminated from the trials. The expectation is that there should be a great discrepancy between the medicated group and the control group (placebo) in the relief of symptoms being reported. This establishes the drug's efficacy."

"All through the clinical trials, all side effects are being reported and catalogued. The side effects are rated as to severity and frequency. The FDA will then look at this 'safety' profile and decide whether or not the drug is safe enough to be approved for marketing."

"So let's assume that a drug has passed the stringent testing requirements and is now FDA approved. Soon, the drug will begin to be prescribed by an ever-increasing number of doctors who believe that new is better. Now, this is where the bigger, broader issues become revealed. Firstly, we mentioned that the medicated group in the study takes the test drug in isolation of other drugs. That is not what happens in real life. As soon as the drug hits the market, it is going to be mixed with lots of other prescription and over the counter medicines, as well as herbal and homeopathic medicines. We now begin to see drug interactions that will cause previously unreported side effects, some of them severe and some of them causing deaths. It is actually after the marketing of the drug that the public becomes the "test subjects" for drug interactions. The Department of Health will quickly respond by informing doctors of these "new" side effects, but it is too late for some people."

"In addition, as the public use of the drug increases, there is now a much larger population of people using the drug and the statistics begin to change. What may have been reported to occur in 2 percent of the original test group may now be seen to be occurring in 6 percent of a broader population. Additionally, new side effects, not previously reported in clinical trials, become apparent. This is because there are so many variables in human physiology that results are often skewed by small populations of people who live in and around the same geographic location."

"So, in fact, this double blind placebo controlled study does not guarantee safety or efficacy because the test leaves far too many questions unanswered."

"The focus on optimization of health not only depends on a working knowledge of genetics, but a deeper understanding of cause and effect through a working knowledge of epigenetics. Integrative medicine (the practice of conventional and holistic medicine) seeks to relate cause and effect in the treatment and prevention of illness by addressing the causative factors in the patient's diet, lifestyle and environment. When the medical profession embraces the duality of symptom care and the optimization of health by addressing epigenetic influences on gene expression, we will begin to see a decrease in morbidity and an overall improvement in quality of life."