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Red Yeast Rice (as USDA certified organic Monascus purpureus)........1200mg
Coenzyme Q10 (as 100% natural source ubiquinone)........40mg
Vitamin E (as d-alpha tocopherol)......4IU
Moreover there were some patent issues levied by big pharma through the FDA in that an active ingredient in the fermented version was the same as their drug version and therefore in some way “owned” by them in a proprietary manner. Naturalists have argued that this is as crazy as someone having a patent on vitamin C and therefore claiming that you can’t sell oranges. One case in particular pitted the FDA against a product called Cholestin. At first the FDA lost, and then won on appeal. As this regulatory drama continues to play out, the bottom line hidden truth and dirty little secret that that some don’t want you to know is that fermented red yeast rice is actually the parent natural compound of the synthetic pharmaceutical cholesterol drug Mevacor™, also known as lovastatin. The difference is that it’s a natural substance that has absolutely been proven in published scientific studies to effectively lower cholesterol.
Much to the chagrin of the pharmaceutical industry, the latest conventional wisdom reflects the fact that red yeast rice is finally being accepted as perhaps being better for a certain number of their patients. Philadelphia cardiologists David Becker, M.D., and Ram Gordon, M.D., published the findings of their most recent study, "Red Yeast Rice for Dyslipidemia in Statin-Intolerant Patients," in the June 16, 2009 issue of Annals of Internal Medicine.
So where does that leave us? The Dietary Supplement Health and Education Act (DSHEA), companies are permitted to sell some forms of red yeast rice as dietary supplements, but it’s not allowed to be said that these forms or any particular formula has been shown to reduce cholesterol, protect the heart, and/or prevent stroke as good if not better than the so-called “statin drugs”.
So what can be said about ORGANOSTAT 023? Well, unlike other formulas you will ever see, the blend in ORGANOSTAT 023 from Peak Wellness Biopharma only uses USDA Certified Organic Red Yeast Rice (Monascus purpureus) strictly and only grown in the USA. It is our belief that excess processing in compounding, even when a substance is a natural dietary supplement, can inactivate some of the natural occurring substances and alkaloids. But again, it must be clearly stated that this form of red yeast rice is in no way a substitute for any drug, nor does it contain any drug. While the red yeast rice in ORGANOSTAT 023 is unique in its own way, we are not allowed to say that it lowers cholesterol either by itself or in comparison to any drug. The FDA simply won’t allow it. Furthering this point, it cannot be said that ORGANOSTAT 023 will treat any disease state, and this must be made clear.
What we can say is that we’ve gone to great length to source red yeast rice of the absolute highest quality, non-chemically manipulated, carefully screened for dangerous citrinins, 100% USDA certified organic, and made right here in the USA.
Coenzyme Q10 (CoQ10) is also known as ubiquinone. It is naturally produced by the human body and a critical cofactor necessary for numerous processes in the body at the cellular level. HMG-CoA reductase inhibitors, whether drugs or natural substances, can interfere with the body’s ability to produce CoQ10.
As a result of this depletion, side effects may include myalgias (muscle pain), myopathies, rhabdomyolysis, kidney dysfunction, gastrointestinal distress, liver problems, and progression of cataracts, among other ailments. These untoward effects are all thought by some experts to be brought on as a direct consequence of CoQ10 depletion from taking HMG-CoA reductase inhibitors.
As such, combining organic red yeast rice with CoQ10 is a logical measure. Furthermore, CoQ10 on its own is a remarkable active ingredient supporting heart and overall health. According to the world famous Mayo Clinic, “CoQ10 levels are reported to decrease with age and to be low in patients with some chronic diseases such as heart conditions”. But just to be fair, according to Mayo, an absolute consensus has yet to reached, as they believe that there is not enough scientific evidence to recommend for or against the use of CoQ10.
In line with the Mayo Clinic, the American College of Cardiology issued an expert consensus in 2005 concluding that CoQ10 in cardiovascular disease has not been clearly established. However according to the University of Maryland Medical Center, researchers believe that there is a benefit of CoQ10 in the prevention and treatment of heart disease. According to these same researchers, this beneficial effect is due in part to the ability of CoQ10 to improve energy production in cells and inhibit the formation of blood clots. They point to a pivotal clinical study that found people who received daily CoQ10 supplements within 3 days of suffering a heart attack were less likely to have another heart attack or even chest pain. Add to that, these same patients proved less likely to die of heart disease than others that did not take CoQ10. While a consensus has not been reached and the debate continues, studies continue to pile up supporting the utility of CoQ10 for
heart health.
In terms of what we can say about ORGANOSTAT 023, we looked for the highest quality Coenzyme Q10 and found it in the form of 100% natural source ubiquinone as a perfect complement to the organically sourced red yeast rice in the formula. The CoQ10 in ORGANOSTAT 023 uses a patented delivery system that has been shown to significantly increase absorption and bioavailability.
Vitamin E (as d-alpha tocopherol) serves as a small but important part of the formula. While the HIH acknowledges that there is evidence that vitamin E may prevent or delay heart disease, they also feel that further research is needed to determine whether supplemental vitamin E has any protective value for younger, healthier people at no obvious risk of CHD. One thing they do confirm for us is that the alpha tocopherol form of vitamin E is the only form that is recognized to meet human requirements. Ample research supports this conclusion.
As a result the purpose of having this precise form of vitamin E in the ORGANOSTAT 023 formula is for synergy cofactor catalysis. The idea is to make everything else work even better.
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