2005P-0411 Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
FDA Comment Number : EC7154
Submitter : Dr. Lisa Olsen Date & Time: 03/06/2006 11:03:32
Organization : Dr. Lisa Olsen
Category : Health Professional
Issue Areas/Comments
GENERAL
GENERAL
I am a physician as well as a patient who uses bioidentical hormone preparations from compounding pharmacies. These are valuable pharmaceutical products that help women get through menopause. They are chemically identical to what is produced in the body. I feel great using these, and I would otherwise be subject to horrible symptoms of menopause such as hot flashes, memory loss, weight gain, depression, and fatigue. I do not want to use the synthetic hormones made from pregnant horse urine because these have side effects such as weight gain and do not work as well as the bioidentical ones. I have been a physician for 7 years, and it is only after suffering through menopause myself that I became aware of this alternative program for hormone replacement, which is thought by many to be superior to the premarin-prempro system provided by Wyeth. THis is all about money and not about patient health. Patients prefer the bioidentical hormones because they feel well when they take them. THe big drug companies cannot patent natural hormones - only synthetic ones. So they push synthetic hormones on us and try to take away the bioidentical ones. If they could patent natural estrogen and make money off of it, they would be pushing that. No one wants to take a pill made from horse urine when they could take a substance that is identical to what the body made in youth. If these are really banned from the market, I will go to Canada or Europe to get mine. I am a veteran of OPeration Iraqi Freedom - I have fought for freedom overseas. Please don't let a greedy drug company take away my freedom to have access to inexpensive, custom made medecine that works.