2005P-0411

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

FDA Comment Number :

EC7123

Submitter :

Mrs. Sue Mayes

Date & Time:

03/06/2006 10:03:13

Organization :

Mrs. Sue Mayes

Category :

Individual Consumer

Issue Areas/Comments

GENERAL

Dear Madam or Sir:

My name is Sue Mayes and I have been using bio-identical progesterone cream for several years. I recently added an estriol cream. After being diagnosed with hormone receptor positive breast cancer almost five years ago, and experiencing chemotherapy induced menopause, I have been extrememly pleased with the results I have acheived with these natural horomone therapies. I used the pharmeceutical, generic hormone therapy for over 20 years prior to my diagnosis. I was in excellent health, exercised for a living, was at a healthy BMI, did not smoke or drink, had no family history, had virtually no risk factors for breast cancer. In my mind, the only risk factor I had was excessive use of the artificial hormones.

I would not even consider using these artificial hormones again, no matter how miserable I was. On the other hand, I have come to depend on the natural, bio-identical therapies to manage my hot flashes, mood swings, and various other menopausal symptoms.

I have been extremely pleased with the results I have acheived with these hormone therapies. The benefit of BHRT is that it is designed for me and I am concerned that Wyeth's petition (Docket #2005P-0411) would limit the ability of my physicians and pharmacist to keep prescribing and preparing these individualized doses for me. The FDA should reject Wyeth's petition in my opinion. I absolutely want to have the option of which hormones I choose to use.

Sincerely,

Sue Mayes

Fayetteville, AR