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Saturday, July 05, 2008

How the FDA favors Big Pharma

Drugs first and all others beware.

This must be the FDA mantra in its fervor to keep you from knowing about just how beneficial vitamins and minerals are for your health.

Even the alarm sounded over neuropathy as a side effect of B6 is countered by taking complete B complex as an adjuntive nutrient. So that argument fails muster.

Read more about just how the FDA indicts itself.
The hand of Pharma
US citizens have your say! Are you willing to sit on the sidelines?
Natural health has been under increasingly heavy pressure from regulators, despite little or no evidence that natural health products cause any significant harm. By all accounts, natural health products are the safest products we put in our mouths—being safer than foods, and much safer than licensed pharmaceutical drugs.

The pharmaceutical industry is itself under pressure. It is struggling to develop new patented products that work, and consumers are increasingly opting to find other ways of managing their health—many naturally.

Two recent cases have emerged that have shown the hand of Pharma. If you still believe that there is some semblance of a democracy left—and if you are a US citizen—please read on. If you are not a US citizen but you know others who are—and you know they care about managing their health naturally—also read on.

Medicure Pharma’s attempt to ban the natural, bioactive form of vitamin B6
On 30 November 2007, Medicure Pharma submitted a citizen’s petition to FDA that asserts that all dietary supplements containing pyridoxal 5’-phosphate (“P5P supplements”) are adulterated under FDC Act § 402(f). Despite the fact that P5P is the bioactive—and natural—form of vitamin B6, Medicure want to see the product banned from sale by the US dietary supplement industry because its marketing of P5P-containing supplements undermines the company’s incentive to continue developing its drug product (MC-1).

Dr Robert Verkerk, ANH’s executive & scientific director, says, “This is an astonishing development that shows just how easily pharma companies are willing to show their hand. Well I’m sorry, natural got there first! You can’t just decide to have a natural form of a product banned because it interferes with your drug patents. We’ve found two patents secured by Medicure for P5P to be used in cases of heart disease. It seems they’ve come to the same realization as millions around the world—vitamins and other natural products can be used to help protect you from chronic diseases, including heart disease.”

Medicure Pharma has in excess of $21 million to protect today, says Datamonitor, but sales for its label use, to reduce reperfusion injury from inflammation following heart bypass grafts, is set to hit nearly $89 million by 2012

To read an abstract of a recently published clinical trial on MC-1, published in the Journal of the American Medical Assocation, click here. The trial shows that MC-1 had no benefit in reducing deaths or heart attacks in mid to high risk patients undergoing heart bypass surgery. Perhaps Medicure should have been looking at using the natural bioactive form of B6, along with food forms of folate and B12, to help reduce the risk of heart disease in the first place. A recent, large scale Japanese study, published in the Journal of the American College of Nutrition (2008 Feb;27(1): 127-36), which included 468,472 years of follow-up, concluded "Dietary intake of vitamin B6 was associated with a reduced risk of coronary heart disease among middle-aged non-multivitamin supplement users. Dietary folate and vitamin B12 were also suggested to be protective factors for coronary heart disease."

And if you'd really like to know just how helpful B6 is for health just peruse the data in this abstract -

For a few cents a tablet or capsule you can improve your health immensely. And do not overlook the benefit of B vitamin sources in foods. You'll find the same in our new product, RK BioDrops.

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