John H. Boyles, M.D. James J. Howard, M.D. William E. Rogers, M.D.
Steven Hotze, M.D., best selling author of “Hormones, Health, and Happiness,” is leading a wellness revolution around the country educating women on bio-identical hormones, now a big drug company is trying to squash a woman’s right to choose natural hormones over synthetic ones.
Dr. Hotze says “Wyeth Pharmaceuticals wants the FDA to take away your right to choose safe, effective and natural, bio-identical hormones by regulating your choice of health treatments.”
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 you could no longer get bio-identical hormones,” said Hotze.
Since the 2002 Women’s Health Initiative (WHI), which demonstrated 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 sale of their products.
“Tens of thousands of women have forsaken synthetic hormones for bio-identical hormones, Hotze said, Wyeth is simply trying to stop its losses and regain its market share.”
The FDA collects no drug user fees from compounding pharmacies because they are regulated by the states, not the federal government. However, the FDA does receive drug user fees, totaling over $300,000,000 in 2004, from the pharmaceutical companies for the drugs they sell. The fewer drugs that Wyeth sells, the less money the FDA makes. Dr. Hotze syas that the FDA wants to eliminate compounding pharmacies as well.
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.
“Wyeth can and must be defeated in its attempt to restrict patients’ rights to choose safe, effective and natural treatments using bio-identical hormones,” says Hotze.
You can voice your opposition to the Wyeth Complaint by going directly to the FDA comment link below and telling the FDA your story. The comment filing period ends on April 4, 2006 at which time the FDA will make its decision. The FDA Link is;
Dr. Hotze urges, “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.”
Drs. Richard and Karilee Shames website on this topic;
Dr. Erika Schwarz's website on this topic;
http://drerikav2.metacanvas.com/EN/resource/wyeth_bioidentical_controversy.html