| 2005P-0411 | Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs | ||||||||||||||||||||||
| FDA Comment Number : | EC387 | ||||||||||||||||||||||
| Submitter : | Ms. Denise St. Clair | Date & Time: | 01/26/2006 06:01:23 | ||||||||||||||||||||
| Organization : | Concerned Citizen | ||||||||||||||||||||||
| Category : | Individual Consumer | ||||||||||||||||||||||
| Issue Areas/Comments | |||||||||||||||||||||||
| GENERAL | |||||||||||||||||||||||
| GENERAL | |||||||||||||||||||||||
| I am outraged that this petition is even being considered. The petition is the obvious effort of a pharmaceutical company to stamp out a proven and effective natural treatment for hormone deficiencies in order to more successfully promote its own synthetic patented drugs. Since bio-identical hormones such as those found in my own hormone replacement therapy (estradiol, estriol, progesterone) are not patentable, Wythe will gain no profit from their purchase or use. Hence, Wythe?s petition to eliminate this formidable competition. You can rest assured that if natural hormones were patentable, Wythe would be the first on the band wagon to manufacture, sell, and promote them under some catchy name like Natur-est, or Pro-nature like they did with their current product, Premarin. Pre (pregnant) mar (mare) in (urine)? how catchy is that?
More and more doctors and women are becoming aware of the significant health risks and side effects that synthetic hormones pose and are choosing natural hormone replacement therapy (NHRT) instead. I had a total hysterectomy in 1995 and had used their products for approximately 2 years after that. I used Premarin, and PremPro. I never felt so horrible in my entire life. I quickly developed painful fibrocystic breast disease, migraine headaches, severe depression, and weight gain while on their synthetic hormones. Through my own research and with the help of compassionate doctors and pharmacists who are knowledgeable in the, for some reason, mysterious, field of NATURAL hormone replacement therapy, I have regained my health and well being. I have not suffered from any of the fore mentioned symptoms since I began a balanced NHRT regimen. I implore you to become thoroughly informed in regards to natural hormone replacement therapy and the benefit of bio-identical hormones. Please research the information available about the thousands of women like myself that have been helped by our doctors and pharmacists to recover our lives through NHRT. It should be clear to you that Wythe?s only interest is of the economic impact of informed women and health professionals on their bottom line. I speak for myself and the many other women helped by NHRT when I ask you to do the right thing. Do not take away our only means to lead normal, healthy lives. Thank you, Denise R. St. Clair | |||||||||||||||||||||||