Consumer Affair
Natural Substance Knock Offs in the FDA Pipeline Could be Dangerous
By American Association for Health Freedom
Sep 6, 2008 - 6:51:50 PM

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Some of the natural substances taken through the FDA approval process don't appear to be dangerous. For example, Omacor, the FDA approved fish oil, is only a problem because it is so expensive compared to regular fish oil. All of us who pay Medicare taxes are bearing this cost since Medicare won't reimburse any other fish oil.

But, unlike Omacor, there are other natural substances coming through the FDA approval process that could be positively dangerous.

Pipex Therapeutics is seeking approval for something called Trimesta. This is just a knock off of natural estriol, the very same substance that the FDA has just effectively banned. These two events -- the drug company Pipex seeking approval for its version of bio-identical estriol and the FDA banning versions of the same estriol compounded by pharmacies -- are probably closely related.

You will recall that the drug company Wyeth (not Pipex) used a "Citizens Petition" to ask the FDA to ban estriol, a key ingredient in bio-identical hormone treatments for menopause. That is because Wyeth had seen the sales of its synthetic womens' hormones plummet after they were shown to be unsafe.

It is quite possible that the FDA granted Wyeth's petition not primarily to help Wyeth but rather to reward Pipex for bringing a bio-identical estriol through the approval process. Pipex's Trimesta is supposed to be for treating multiple sclerosis (MS). But the FDA knows that doctors can prescribe it for other conditions after approval. The bottom line: pay up to the FDA. If you do, the Agency will try to reward you with monopoly control of the market.

There is another important issue here. Trimesta may be natural estriol, but it may not be a safe version of natural estriol. Famed natural physician and bio-identical hormone pioneer Jonathan Wright MD pointed this out in his newsletter (Health and Healing, February 2007). The potential problem is that Trimesta is a taken by mouth. Dr. Wright believes that this hormone should not be taken orally, only transdermally (through the skin). Taking it by mouth can lead to trouble.

As Dr. Wright has said: "...When the inevitable findings of excessive endometrial cancer are ultimately disclosed, you can bet the blame will fall on the bio-identical hormone itself -- and not on the oral route of administration, which is known to be more risky."

Will the FDA catch this before Trimesta's approval? Don't count on it. The FDA has already approved Prestara, another drug company version of a natural hormone, in this case DHEA. This DHEA is taken at an oral dose of 200 mg daily -- much too high for women, as Dr. Wright has also pointed out. Even doses of 50 mg in women may cause facial hair and other undesirable side effects.

Why would the FDA approve 200 mg of DHEA for women administered orally? And for that matter why do we need a drug company version of DHEA? It's sold in every drug store as well as every natural health store at low cost.

But that's just it. The drug companies would like to replace low cost DHEA with sky-high-priced drug company DHEA. This version of DHEA is reimbursable by Medicare -- even if it is dangerous.

Meanwhile we have seen bills in Congress to ban DHEA. What is the rationale for these bills? Supposedly concern about athletes’ use of synthetic steroids. But DHEA has nothing to do with synthetic steroids. 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.

Have you signed our ReformFDA.org petition? If not, please do so now.

This newsletter is copyrighted material (copyright by American Association for Health Freedom, 2008) but we hope you will forward, copy, or reprint it without prior authorization. Just remember to note the source and date -- American Association for Health Freedom, September 2, 2008.