Some of the natural substances taken through the FDA approval process don't appear to be dangerous. Omacor, the FDA approved fish oil, is only a problem because it is so expensive compared to regular fish oil -- although taxpayers bear the brunt of this price difference, because Medicare won't reimburse any other fish oil.

However, there are other natural substances coming through the FDA approval process that are even more troubling. Pipex Therapeutics is seeking approval for Trimesta, a knock-off of natural estriol -- a substance that the FDA has just effectively banned.

But Trimesta may not be a safe version of natural estriol. Trimesta is a taken by mouth, which is known to be a greater risk factor for endometrial cancer than taking the hormones transdermally (through the skin).

And the FDA has already approved Prestara, another drug company version of a natural hormone, in this case DHEA. Prestara is taken at an oral dose of 200 mg daily, which is much too high for women; even doses of 50 mg in women may cause facial hair and other undesirable side effects.

Meanwhile, there are now bills in Congress calling for a ban DHEA. Supposedly the concern is about athletes’ use of synthetic steroids. But contrary to false claims, no one can make synthetic steroids out of DHEA. The real reason to ban natural DHEA is to knock out the competition for expensive knock-off drugs.

Original Article: Beware: Natural Substance Knock-Offs in FDA Pipeline are Dangerous

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