2005P-0411 Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
FDA Comment Number : EC5454
Submitter : Mrs. Debra Johnson Date & Time: 02/27/2006 09:02:42
Organization : Mrs. Debra Johnson
Category : Individual Consumer
Issue Areas/Comments
GENERAL
GENERAL
My name is Debra Johnson. I live in Orlando, FL and drive to Jacksonville Beach to see my doctor and his wonderful staff.I am 49 years old and have been suffering with menopause symptoms since 1999. I am a post-graduate educated mother of 2 grown sons. I am a former dance studio owner/instructor who was in top physical condition for many, many years before the onset on menopause started. After menopause, I developed severe joint problems, severe irritability, gained over 75 pounds, had severe nightsweats/hot flashes, insomnia, and short term memory loss? to name just a few.I have read every book on the subject that I could get my hands on; Suzanne Somers? book, The Sexy Years, then others by well respected doctors on the subject.I called dozens of doctors asking for help in natural ways to control these symptoms including Bioidentical hormones. Their reaction was all the same.Either they had no idea what I was talking about or they dismissed me as an ignorant person who had no idea about my own body and what was normal health for me. I was told I should just accept their diagnosis. They knew best?CAUSE THEY WERE THE DOCTOR?.Then, while watching the Early show on CBS one morning, I happen to catch an interview Rene Siler was having with soft spoken, warm, and quite funny, doctor who was mentored by Dr. John Lee, a greatly respected pioneer in the field of female hormones. I was glued to the TV. Rene was being a typical journalist(no disrespect)?persistent, and slightly antagonistic with her questions. He handled the interview brilliantly. I went to CBS website to find out where this doctor was located in the country. I was willing to fly anywhere to see him. You see, I have been trying, at this point, to find relief from someone who had his exact philosophy about Women?s health. I was thrilled to find him. Come to find out, he was in Jacksonville Beach and I was in Orlando. Before Dr. Randolph, during my search, I tried many other methods of treatments, i.e. Premarin, c-c-t oral hormone therapy(capsules). I?ve tried over the counter remedies. Nothing helped?it almost cost me my marriage and family. It wasn?t until I was tested and treated by my doctor that my symptoms began to disappear. Relief was not overnight, but it did happen and no side effects. It was just what I was needed. Placebo effect?? Just ask my husband. The pharmacutical people don?t know what they are talking about. Recently, I was unable to get to my compounding pharmacist because of my work schedule and their store hours. I ran out of my hormone creams that they make especially for me prescribed by Dr Randolph. I was fine for about 2 or 3 days and then the symptoms came back with a vengeance. They wake me out of a sound sleep. Within a day of starting back on my compounded creams, the symptoms subside. Since being on the BHRT, I have no more hot flashes or night sweats. I have dropped two pants sizes & 13 lbs. My joints are better, not perfect, but better. I have a sex life again. My husband is thrilled. I am no longer a forgetful, irritating *itch. My memory has been gradually getting better. My experience is that most who dismiss this treatment are highly under-educated in the area of woman?s health and the body?s ability to heal itself. They dismiss results this treatment brings and refuse to encourage this safer course of action. I believe they follow the pack of Pharmaceutical companies who, driven by Boards of Directors with their profits and losses and who fund medical learning institutions essentially, are limiting what new doctors learn. I believe I am a smart person who takes great pride in being an educated consumer and owner of my own health and well-being. I believe in my doctor and his philosophy. I will drive, fly, swim, hike, run, to him and his staff. I only hope he is able to mentor other doctors, so we can begin to see others in other areas of the country get this knowledge. PLEASE PLEASE don't take away my compounding resources.