2005P-0411
  

  

  


  

  

  


  

  
FDA Comment Number : 
  

  
EC740
  



  

  
Submitter : 
  

  
Mrs. Becky Gage
  

  
Date & Time: 
  

  
02/03/2006 04:02:06
  



  

  
Organization : 
  

  
Mrs. Becky Gage
  



  

  
Category : 
  

  
Individual Consumer
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 I have used bio-identical hormones for 9 months.  They have been  compounded to the strength that my body needs by different compounding pharmacies.  They have changed my life. 





I have spent most of my adult years (from age 21 through age 54) on various types of synthetic estrogen and progesterone.  I have had weight gain, bloating, and continual spotting with synthetic estrogens, to the extent that I underwent a D&C procedure to end the bleeding.  Nothing helped. So, I took myself off of these drugs 3 years ago. 







I then spent about 2 1/2 years in misery with night sweats & hot flashes.  Life wasn't at all good.  My temper was quick, and my husband took the brunt of it.  Last April, I became acquainted with bio-identical hormones.  My problems with hot flashes and sweating have ended.  Along with bio-identical estrogen & progesterone, I am also on bio-identical testosterone and cortisol.  My whole life has improved, as my husband will attest.







It surprises me to hear that one pharmaceutical company wants to corner the market on bio-identical hormones.  In the past, this market was not lucrative enough to entice a pharmaceutical to enter, no matter how great the need.  Now Wyeth apparently sees that it could be very lucrative, but only if it eliminates all of the competition from the compounding pharmacies.  







Wyeth spent years and millions of dollars telling me that horse estrogen was the same as mine.   I don't trust Wyeth to decide that it alone knows what is bio-identical, and it alone should supply my medications at whatever cost it wants to charge.  I want the option to buy from the pharmacies who have been willing to meet my needs until now.





I am asking the FDA to keep competition open in this area, and deny Wyeth's request to block out the little pharmacies.  I welcome Wyeth as a competitor of the compounding pharmacies, but not as the sole supplier and decider of what my body does need.