| 2005P-0411 | Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs | |||||||||||||||||||||||
| FDA Comment Number : | EC1718 | |||||||||||||||||||||||
| Submitter : | Mrs. Tammy Alger | Date & Time: | 02/13/2006 01:02:06 | |||||||||||||||||||||
| Organization : | Mrs. Tammy Alger | |||||||||||||||||||||||
| Category : | Individual Consumer | |||||||||||||||||||||||
| Issue Areas/Comments | ||||||||||||||||||||||||
| GENERAL | ||||||||||||||||||||||||
| GENERAL | ||||||||||||||||||||||||
| Dear Sir or Madame:
I am writing to express my strong disagreement with the actons that Wyeth Pharmaceuttcals is taking to try and ban the production of bio-identical hormones for use in hormone replacement therapy for women. I am a current user of bio-identical hormone therapy products, and have been for the pasr 2 1/4 years. I am a 35 year old woman in overall good health, with one exception; I have suffered from homrmone deficiency problems since I was 17 years old. I had seen numerous medical professionals, had undergone countless tests, and still had no answer to what was causing my medical problems, which included ammenorhea. Due to the lack of monthly cycles, I was forced to take sythetic drugs to induce what my body could not do on its own. I have never been one to like to rely on "unnatural" and potentially unhealthy medications. However, at the age of 33, I saw a doctor who had done extensive research on the use of bio-identical hormone replacement, and the safety of the hormones themselves. After another round of very extensive blood work, it was recommended that I start taking bio-identical progesterone and estrogen, which I have done now for over 2 years. Since beginning treatment, I have had regular monthly cycles, my bone density has increased, and my anxiety about my "female" health has disappeared. I have regular blood work done to check the different levels of hormones, along with consulting on a regular basis with the prescribing physician. I have had no ill side effects from the hormones, and I feel so much more at ease taking something I know is completely natural and closest to what my own body would make if it could do so. The documented risk factors of sythnetic hormone factors are not ones I am willing to take. To be quite candid, I would venture to guess that if the general population was aware of what exactly is in the synthetic hormones that are produced by the big pharmaceutical companies there would be a much louder outcry of protest against these companies and the products they are trying to peddle. I wonder how many women taking premarin actually know that it is derived form mare's urine, a substance that is surely not identical to what the human body produces. The safety of bio-identical hormnones is not the issue. The bottom line is the pharmaceutical companies "bottom line." It's all about the loss of revenue, which for them is huge. It's not about the safety of the people taking the medications. It's all about the money. People's lives are far more important than the all mighty dollar. For my sake, and so many others like me, please, do not allow this banning of bio-identical hormones to take place. It would be a great injustice to those of us who choose to treat our hormonal imbalances with the most natural and safe alternative available. Thank-you for your time and willingness to listen to my concerns. Sincerley, Tammy ALger Ooltewah, TN | ||||||||||||||||||||||||