2005P-0411

Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs

FDA Comment Number :

EC1747

Submitter :

Ms. Karen Hull

Date & Time:

02/13/2006 02:02:29

Organization :

Ms. Karen Hull

Category :

Individual Consumer

Issue Areas/Comments

GENERAL

I would like to express my total disagreement of Wyeth's attempt to ban women's options of obtaining bioidentical hormones through compounding pharmacies. I had a hysterectomy and my right ovary removed. As a reuslt I instantly went into surgically induced menopause. In fact it was so severe that my health and life was short of being ruined. What was prescribed by the conventional doctor did not work. I tried for months and months to do what the conventional doctor said to no avail.

My life and health were not restored until I found a memopause clinic that specializes in balancing women's hormones using bioidentical hormones of progesterone cream and estrodial from a compounding pharmacy. Within a week of being on bioidentical hormones from the compounding pharmacy I was feeling back to normal.

If you want research then you can take a look at my life.

I wholeheartedly agree with Dr. Erika. Why didn't Wyeth call for such sanctions against itself when the 2002 NIH study - Women's Health Initiative linked Premarin and Prempro?, synthetic hormone drugs manufactured by Wyeth to increased risk of stroke, breast cancer, heart attacks and circulatory disease.

Your attempts to bury bioidentical hormones and remove this option for women has nothing to do with concerns for women's health and issues of safety and effectiveness of bioidentical hormones. It has everything to do with wanting to have sole control like a dictator, revenue and profit.

Please stop your attempts to ban compounding pharmacies and allow women the option to make healthy choices -- choices that work and restore women's health.