2005P-0411
  
   Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs 

  		


  
  
  


  
  


  
  


  
  FDA Comment Number : 
  
  EC7182
  




  
  Submitter : 
  
  Ms. Deborah Feil
  
  Date & Time: 
  
  03/06/2006 11:03:22
  




  
  Organization : 
  
  Ms. Deborah Feil
  




  
  Category : 
  
  Individual Consumer
  




  
  Issue Areas/Comments 
  


  
  


  
  GENERAL
  


  
  




  
  GENERAL
  


  
  




  
   Please prevent Wyeth's Petition from restricting our freedom of medical treatment choice. I have seen reports of the synthetic horse urine dirvative hormone replacement therapy to be cancer producing. It is MY CHOICE to use the customized to by body chemistry, bio-identical hormone treatment.



I have been using bio-identical hormones for 6 months. It has been a tremendous comfort to me as it:

1. alleviates hotflashes that I had every 45 minutes day and night, to the point of turning beet red from head to toe and sweating so profusely my toes made my socks soggy in my shoes, and my skin on my arms and body were as wet as if getting out of the shower. At night I'd wake up every 45 minutes extremely hot and then get 'freezing cold' throwing the covers off and putting them back on, just shivering. I would get up to put on new dry night shirts as this happened throughout the night. I got NO REST! 



2. Now I can sleep comfortably through the entire night and consequently can function in a rational and sane and high energy level at work. (also I am not NOT embarassing the men managers, or my subordinates, or myself by turning beet red and sweating like a pig.)

3. I literally felt like something inside of me was dying, like I was dying from the inside out. I literally felt like life was not worth living if it were to remain at that low quality. IT WAS HORRIBLE!



****I had put up with the intensity of those symptoms for a year before I looked into bio-identical hormones. I am so glad to have access to them over the products made of horse urine that have proven to be cancer producing. I do not appreciate the large drug companies giving me the option of their synthetic hormmone replacement product (either take it and get cancer or not take it and die from heart attacks) just so they can protect their income. Women do not need to be treated that way. I WANT MY CHOICE! 



4.There are more symptoms that these bioidentical hormones have taken care of. These aforementioned ones threatened my very ability to continue to support myself via a job/career. I am SO GREATFUL FOR BIO-IDENTICAL HORMONES and the fact THEY ARE CUSTOMIZED TO MY BODY CHEMSITRY.



{I CONSULT WITH MY PHYSICAN, WHO PRESCRIBES BIO-IDENTICAL HORMONES SPECIFICALLY FOR ME, AND MY PHARMACIST PREPARES THEM. WITHOUT THIS MEDICATION, I WOULD NOT BE ABLE TO SLEEP AND WOULD PROBABALY HAVE BEEN FORCED OUT OF THE JOB MARKET WITH NO INCOME IN SIGHT AND/OR HAVE SUFFERED A NERVOUS BREAKDOWN DUE TO SLEEP DEPRIVATION.(AND STILL NO JOB IN SIGHT)

   ***These are just the survival issues***  What about intimate issues?



5.I had NO vaginal moisture or lubrication left (which sets up all kinds of health problems) not to mention NO SEXUAL DESIRE and NO pleasurable sensation to stimulation. In fact it was less than the feeling you get from touching your arm  to the point of no sensation at all.

  		


  
  


  
  


  
  


  
  


  
  


  
  


  
  


  
  


  
  


  
  


  
  


  
  


  
  


  
  


  
  


  
  


  
  


  
  


  
  


  
  


  
  


  
  


  
  


  
  


  
  


  
  


  
  


  
  


  
  


  
  


  
  


  
  


  
  


  
  


  
  


  
  


  
  


  
  


  
  


  
  


  
  


  
  












  
   Intercourse or masterbation was not an option due to pain. The entire area has lost much physical definition (atrophy). It is now more moist and not irritated and itchy. It seems there is a tiny bit of definintion increase.



6. Skin: My nipple and surrounding area is getting its color back again. It had turned almost the same color shade as my arm skin. My facial skin has a better quality to it. And there are other subtle differences.



***the biggest deal is being able to continue to stay employed and functioning in a positive manner and maintain health.    



********The benefit of BHRT is that it is designed for me and I am concerned that Wyeth's petition (Docket# 2005P-0411)would limit the ability of my physican and pharmacist to keep prescribing and preparing these individualized doses for me. The FDA should reject Wyeth's petition.



Sincerely,



Deborah D. Feil

Stillwater, Minnesota 55082