There's a new way of free market competition in the good ole US of A. If you can't beat your competition with a superior product, buy out the government. That's exactly how Big Pharma plays the game. Case in point? Hormones.

Last year, the corporation Wyeth, sent a "citizen's petition" to the FDA. Huh? A corporation sending a "citizen's" petition? Yes, because in the eyes of our corporate owned government, corporations are U.S. citizens. And what did this petition "request"? That the FDA remove bio-identical hormones from distribution by compounding pharmacies.

Why did Wyeth take this step and why now? Wyeth is the maker of the infamous Premarin, also known as pregnant horse estrogen. Wyeth pushed hormone replacement therapy for decades without any backing of safety and benefit.

When the data about the dangers of HRT came out, Premarin took a near fatal hit. Wyeth suffered great financial losses. Many women, realizing that Premarin is horse estrogen turned to bio-identical hormones instead. Bio-identical hormones are hormones structurally identical to what the human ovary makes.

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Since the human body makes these hormones, Wyeth can't patent them. And since they're not patentable, there's no incentive to sell them - or study them. So, no research was done on the safety of your own hormones.

Well the FDA acted on "citizen Wyeth's" petition. The agency recently issued an edict forbidding compounding pharmacies from promoting bio-identical hormones, including the safest of the estrogens - estriol. Women have used estriol for decades. It's a component of popular hormone cocktails, such as Triest and Biest. And it's approved in Europe, where it has widespread use.

Even the FDA says estriol doesn't cause adverse events or other health and safety issues.

In fact, the government agency admits that safety concerns didn't play a role in its decision to try to remove estriol from the market.

Now after the FDA received good "citizen" Wyeth's petition, the draconian agency also received some 77,000 messages regarding the threat. The paltry few supporting Wyeth were from organizations that stood to profit from Wyeth's success. Seems that the FDA considers Wyeth' s profits more important than the needs of tens or hundreds of thousands of women - and truth.

Now I want to temper and "balance" this report. The FDA's action was a warning letter only. It went to seven compounding pharmacies forbidding them from making unsubstantiated claims regarding bio-identical hormones and estriol. Unlike what you may have heard about this action, the FDA did not, I repeat, did not ban bio-identical hormones. Any physician can still prescribe a specific bio-identical formulation for you. I'm still prescribing them. In fact, I did so just today. It may surprise you that I don't oppose the FDA going after unsubstantiated claims.

There's little scientific controversy that hormones identical to our own are safer than plastic synthetic versions. But you need to know that just because the hormone you get is "bio-identical" doesn't mean that it's safe for you. Many women have too much self-produced estrogen and get cancer as a result. That estrogen is also "bio-identical." So everything must be done in harmony with your personal needs. Too much of any good thing might not be so good.

Even though I support going after unsubstantiated claims, the FDA must use its power justly. Wyeth is commanding the FDA to punish the same action Wyeth itself committed for decades. Wyeth pushed its horse hormones without any proof of safety. As a result tens of thousands of women got cancer. Now they are crying "wolf" on bio-identicals. This isn't anything new. Big Pharma regularly publishes fraudulent studies, and makes claims that would put vitamin makers out of business. But the FDA rarely does anything about it when Big Pharma is the culprit. That has to stop!

Your congressional leaders need to hear from you on this. They have to put a stop to this government/big-business collusion. You are the one that will get hurt.


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