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Monday, August 13, 2007

Another FDA Funny

I received a reply of sorts from the FDA along with a visit from the spyputer at FDAs DIMES HQ (ref: Elk Watching People). The reply was not from Dr. Galson to whom I wrote, but was an unsigned so-called response from an unnamed party at the FDA aka 'CDER'. The reply did not answer my query but danced around the issues in typical bureaucratic style.

I understand this because at one time in my career I worked with HHS and the USPHS, as well as the Washington state DSHS. Several years was enough to make clearly understand why integrity is so much a critical philosophy in my life.

If you would like to read a 2004 in depth article regarding statins from two key researchers, please see Dangers of Statin Drugs: What You Haven’t Been Told About Popular Cholesterol-Lowering Medicines


The FDA once again targets natural treatments while avoiding the ever increasing number of problems with their "approved" drugs.

What you don't read here is that RRY is the very statin that is the basis for the pharmaceutical industry's drug.

Statins are associated with rhabdomyolysis which can lead to very serious side effects, kidney failure and death. The statins have been associated with death yet remain on the market.

The statins also lead to cancer and Alzheimer's disease.

There is a prohibition of selling a substance that causes cancer, yet the FDA kow-tows to Big Pharma in deference to patients who can do as well or better with natural approaches to health problems.

And yes, there is a "cholesterol myth" but the FDA doesn't tell you about this either. The agency just waits for another BIG PAYOFF from Big Pharma to push yet another dangerous drug with little or no benefit, except taking your money...

Wonder why only Swanson and Sunburst Biorganics brands are being attacked when there are a number of companies selling RRY? I am waiting for this answer too, just as I wait for a prescribing physician to explain the risks of the statin drugs to their patients.
FDA Warns Against Use of Red Yeast Rice Supplements

ROCKVILLE, Md., Aug. 10 -- The FDA has warned consumers against using three brands of red yeast rice, a product marketed as a natural remedy for high cholesterol, because they may contain lovastatin, the active ingredient in Mevacor.

The products, marketed in stores or on the Web, are Red Yeast Rice and Red Yeast Rice/Policosonal Complex, sold by Swanson Healthcare Products, and manufactured by Nature's Value, and Kabco, respectively; and Cholestrix, sold by Sunburst Biorganics.

FDA investigators conducting routine testing of the supplement detected lovastatin, which was the first statin approved by the FDA. It has been available as a generic drug since 2002.

Steven Galson, M.D., M.P.H., director of FDA's Center for Drug Evaluation and Research, said consumers may be unaware of side effects associated with lovastatin. These include rhabdomyolysis, especially when lovastatin is combined with the antidepressant nefazodone, certain antibiotics, drugs for fungal infections and HIV infections, and other cholesterol-lowering medications.

The FDA recommended that consumers who use any red yeast rice product obtain medical advice if they have muscle pain or other problems that may be associated with the red yeast.

The agency issued warning letters advising Swanson and Sunburst Biorganics to stop promoting and selling the products.

The FDA's warning letters said that the products Red Yeast Rice, Red Yeast Rice/Policosonal Complex, and Cholestrix represent unapproved new drugs that are marketed in violation of the Federal Food, Drug, and Cosmetic Act.

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