Monday, February 4, 2008

Save Bio-Identical Hormones

Now is the time to act!  Preserve our access to bio-identical hormones and protect the right of the consumer to choose and the practitioner to practice without unwarranted interference by the FDA.
On January 9, 2008, the FDA sent numerous pharmacies, large and small, an order to stop using Estriol, and the term “bio-identical” in their hormone replacement formulas.  This is an unprecedented attack on compounders, patients and physicians because until now NO compounded drug component with a USP monograph has been withdrawn from circulation unless there has been evidence of harm to patients.  Yet that is what the FDA is doing!  If they can do it to Estriol, they can do it to anything they wish to!
The FDA admitted in their press conference that there is no evidence of harm to any patient from the use of Estriol in compounds.  It has been used since 1980, is available throughout the world in numerous prescription compounds approved by other nation’s FDAs, and there is even an investigational new drug application, approved by the FDA, that uses much higher doses of Estriol than is used in any BHRT formula.
What You Can Do

  • Read the timeline and Draw Your Own Conclusion – is the FDA doing Wyeth’s bidding?
  • Contact Congress and the President of the US and let them know that you want the FDA to stop attacking compounding medicine.
  • Personalize your letter.  Tell your story, edit to reflect your points of interest (this is VERY important, please take the extra time!).
  • Spread the word!  We need the loudest voice possible – let your contacts know of this threat, send an email.  Tell people to visit  Download, print, and distribute our flyer (click here) and if you don’t have a printer, let us know how many you need. 
  • Join AAHF so we can continue to lobby on this and other important issues.
  • Make a tax-deductible donation to the Health Freedom Foundation so we can continue educational efforts and fund a lawsuit to block the FDA’s assault on bio-identical hormones.
Tell me more

Dear [ Decision Maker ],

On January 9, 2008, the U.S. Food and Drug Administration sent warning letters to pharmacies to stop providing Estriol in their bio-identical hormone preparations for post-menopausal women and were ordered to stop using the term "bio-identical hormone." 

Countless women currently rely on replacement hormones that are prescribed by their doctors and compounded in local pharmacies.

Estriol is the weakest of the three types of estrogen (the other two are estradiol and estrone) and is derived from a plant source and therefore unpatentable in the US.  Estriol is utilized throughout Europe and other places in the world as a component of prescription drugs, including by some of the manufacturers of FDA "approved" synthetic hormones.  Yet the FDA claims that Estriol is "a new and unapproved drug" and that "the safety and effectiveness of Estriol is unknown."  That is directly contradicted by the fact is has approved an investigational new drug application at UCLA that uses Estriol to treat MS patients at many times the level of Estriol found in bio-identical hormone prescriptions.

Estriol is used in 80% of bio-identical hormone replacement therapy prescriptions and is made by the human body.  Research indicates it is a very protective female hormone.  In a recent press conference, the FDA admitted that no adverse event involving compounded bio-identical Estriol has ever been reported even though doctors and hospitals have to report adverse events.

Research involving 15,000 women funded by the Department of Defense and conducted at Kaiser-Permanente Oakland found that women who produced the most Estriol during their first pregnancy had 58% less breast cancer over the next forty years.  Estriol has had a USP Monograph since 1980.  In the Food and Drug Administration Modernization Act of 1997, Congress acted to stop the FDA's claim that compounded drugs were somehow "new drugs."  The law passed clearly stated that items with a USP monograph could be compounded. 

At the same time, the FDA continues to support synthetic hormone replacement drugs offered by the big drug companies, even though studies have raised questions about possible heart and cancer risks from these hormones - a fact the FDA knows full well, since they have placed their own Black Box Warnings on each of them.

These drugs come from horses or are imprecise versions of natural human hormones. Why would any woman prefer horse hormones or imprecise-yet-patentable copies of human hormone molecules to ones chemically identical to those found naturally in her body?

The FDA is ignoring the 70,000 responses from the public urging them to not restrict access to bio-identical hormones and appears to be in acting in the best interest of synthetic hormone manufacturers who have made it well known that they wish bio-identical hormones would be banned as it would open the market for their dwindling products' sales. 

I urge you to take action immediately to preserve congressional intent in the FDA reauthorization bill in 1997, and stop the FDA from denying women the right to choose their own hormone replacement therapy, and denying the right of physicians to practice medicine within their scope, training and expertise.  There is no valid scientific or medical reason for this new action by the FDA. 

I urge you to stop the FDA's usurpation of power.  I hope you will help to preserve our access to bio-identical hormones.

David Collins

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