2005P-0411

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

FDA Comment Number :

EC430

Submitter :

Mrs. Susan Damanti

Date & Time:

01/26/2006 06:01:58

Organization :

Mrs. Susan Damanti

Category :

Individual Consumer

Issue Areas/Comments

GENERAL

It is my understanding that the Wyeth Co. (maker of synthetic hormone replacement therapy are trying to get a bill passed through Congress to make it harder to get bioidentical hormone replacement therapy. I would like to share my story about the lack of success I had with synthetic HRTs and the miracle that came into my life in the form of BHRT. 1 1/2 years ago I had a hysterectomy. My Dr. informed me that afterward I would simply take a little pill (synthetic HRT) and I would feel just wonderful afterward. I tried the "one size fits all" synthetic HRT. It was a complete disaster. For one month I did not sleep, I could not concentrate on anything, I could not remember a thought long enough to finish a sentence. I had become a completely different person. I was very depressed at the thought of having to accept this "new" person I had become. I was nothing of my former self, vibrant, excited about life, etc. Not sleeping for an entire month day or night made me crazy. A friend shared her story of the dramatic change BHRT made in her otherwise menopausal life. I asked my DR. He foolishly said, "Let's double your (synthetic) HRT." I foolishly followed his advice. When that made me feel worse, he suggested going with 1/2 the original dosage. I suggested that we were guessing. He agreed, the "one size fits all" was a little inaccurate. To make a long story short, I went the BHRT route. My Dr. took blood to find MY exact Hormone levels. Within 3 days they had compounded a hormone therapy just for me, that being in cream form meant I use less hormones because I do not loose or use too much as it goes through my whole body (it doesn't go through my stomach as synthetic HRT's do). I had gone 30 days without sleep before this and depression was becoming my new friend. With in 24 hours, I was sleeping like a rock. Within 1 week, the cloud I had been under had lifted. I was remembering how I wanted to finish my sentences without writing it down first. I had found "myself" again. I have been using it for approx. 20 months now and I feel great!. I would never go back to the synthetic. I hate to sound violent about this but if someone took this away from me I would have to hurt someone, if you know what I mean. My story is not an unusual one. I shared my story with friends who were having similar problems on synthetic HRTs. Those friends raved about the success on BHRTs, just as I had. The word is spreading fast. These work great because they are not made for the masses, they are not made in a "one size fits all" method. How ridiculous to think we are all made exactly the same. My pharmecist calls regularly and asks

"how are you feeling, what can we change. My old Dr. simply had to guess with the synthetics. I feel Wyeth is threatened by what they see as something that is sweeping the nation among women as a huge success story, and that threatens their pocketbooks. I do not know one single woman who has tried it who was not absolutely thrilled by the success of their BHRT. Please, please, please, do not take the best thing that has ever happened to me, that gave me back myself, that helps me be a strong, productive, contritubuting woman in society away from me. I am begging you. Please look carefully at Wyeth's motives, and the true, statistical facts of synthetic drug success vs. bioidentical hormone replacement therapy success. Consider this... you may have to live with your wife on synthetic menopausal HRT someday....she may do alright.... or she may drive you to drink....

Thank you for your consideration.

Susan Damanti

Springfield, Ohio