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Stop Wyeth and the FDA from Denying Your Right to Choose Bio-identical Hormones

Wyeth Pharmaceutical wants the FDA to take away your right to choose safe, effective and natural, bio-identical hormones and regulate your choice of health treatments. We have until April 4, 2006 to stop them.

Wyeth, the maker of Premarin and Prempro, filed a "Citizens Complaint" with the FDA on October 16, 2005, requesting that the FDA effectively prohibit compounding pharmacies from providing bio-identical hormones to their patients. This would mean that you would no longer be able to get your bio-identical hormones from us or from any one else.

Since the 2002 Women’s Health Initiative (WHI) which demonstrated that Wyeth’s products, Premarin and Prempro, caused a significant increase in breast cancer, blood clots to the lungs, heart attacks and strokes, Wyeth has seen a dramatic decline in the sales of these counterfeit hormones. Wyeth’s financial reports, which are available online at www.wyeth.com , indicate the following significant decline in sales of Premarin Family products;  2002 – $2,072,000,000; 2003 – $1,275,000,000; 2004 – $880,000,000.

This represents a 68% decline in sales of Premarin Family products between 2002 – 2004. Wyeth’s profits have likewise declined precipitously; 2002 – $4,447,000,000; 2003 – $2,051,192,000; 2004 – $1,234,000,000, a 72% decline in profits.

Tens of thousands of women have forsaken Premarin family drugs for bio-identical hormones.Wyeth is simply trying to stop its losses and regain its market share. Wyeth wants to force women to take their counterfeit hormones by eliminating the competition from bio-identical hormones prepared by compounding pharmacies. 

The FDA receives drug user fees, totaling at least $300,000,000 in 2004, from the pharmaceutical companies for the drugs they sell. The less drugs that Wyeth sells, the less money the FDA makes.

The FDA collects no drug user fees from compounding pharmacies because they are regulated by the states, not the federal government. So the FDA wants to eliminate compounding pharmacies as well.  Pharmaceutical companies recruit key FDA employees to work for them at huge salaries.

This is the dream of many bureaucrats, to get a high paying job with a big drug company. So you can understand why FDA regulators have an incentive to please Wyeth.  

Wyeth, like all the major pharmaceutical companies, contributes billions of dollars to various medical societies and patient advocacy organizations. So it is not surprising that many of these organizations have written responses to the FDA in support of Wyeth’s complaint.

Because of their money ties to Wyeth, these organizations endorse Wyeth’s products and do Wyeth’s bidding. When an organization supports something which is obviously detrimental to women and men, it is important to follow the money trail.  Wyeth can and must be defeated in its attempt to restrict patients’ rights to choose to safe, effective and natural treatments using bio-identical hormones.  

You can voice your opposition to the Wyeth Complaint by going directly to the FDA comment link below and telling the FDA your story about the benefits that bio-identical hormones have made in your life. The comment filing period ends on April 4, 2006 at which time the FDA will make its decision.

To stop Wyeth and the FDA we need at least 20,000 comments opposing the Wyeth complaint. So write your comment on line today! Please forward this information to any one who will support this effort. FDA Comment Link for the Wyeth Complaint The comment period on the Wyeth Petition is open until April 4, 2006. 

Here is a link where comments can be filed with the FDA on-line: http://www.accessdata.fda.gov/scripts/oc/dockets/comments/commentsmain.cfm?EC_DOCUMENT_ID=794&SUBTYP=NEXT&CID=&AGENCY=FDA

If you are receiving this information by e-mail then just click on the above link.

After entering the requested information (zip code, name, etc.), hit the continue button to get the comment screen.  Comments can be up to 4,000 characters.

Hit the continue button to get to the next screen, where attachments can be filed.  Hit the button Save Comments to submit (doesn’t make sense, but I tried it with a test comment).

Hard copy comments (which can also be scanned and submitted as an attachment using the above link) can be mailed to: 

Food and Drug Administration Dockets Management Branch (HFA-305) 5630 Fishers Lane Room 1061 Rockville , MD 20852

Allow me to recommend for your consideration that you go to the above link and draft your response on the job today. Also please forward this e-mail to everyone on your distribution lists.

Your ability to continue to choose your treatment depends upon our success in blocking Wyeth and the FDA in their plan to eliminate bio-identical hormones.  Thanking you for supporting patients’ rights to choose bio-identical hormones.

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