2005P-0411
  

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

  


  

  

  


  

  


  

  


  

  
FDA Comment Number : 
  

  
EC2830
  



  

  
Submitter : 
  

  
Mrs. Dana Black
  

  
Date & Time: 
  

  
02/16/2006 04:02:37
  



  

  
Organization : 
  

  
Mrs. Dana Black
  



  

  
Category : 
  

  
Individual Consumer
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 Dear Sirs-

I have been relying on bio-identical hormone replacement therapy for ten years with only great benefit to my health, and especially, to my well being. I have obtained these medicines, prescribed by my medical doctor, from a variety of compounding pharmacies over the years, and I have had absolutely no problems with the prescriptions or the pharmacies. Without these hormones, my symptoms are so severe that I find it very difficult to function. 



Patented hormone preparations have been shown to cause a variety of health problems such as cancer and heart disease, whereas no such problems have been associated with bio-identical hormones, when used and monitored properly. After all, these substances are composed of exactly identical molecules to those produced naturally by the human body, so the body is designed and equipped to handle them. The human body was not designed nor was it equipped to handle the patented medicines, which cause serious side effects for many persons.



It seems clear that Wyeth Pharmaceuticals is attempting to restrict the sale of safe, effective bio-identical hormones in order to protect the profits from their (proven by scientific studies to be) dangerous patented drugs and not in any way for the protection of public health. To say that safe, doctor-prescribed medicines prepared by licensed compounding pharmacies are dangerous is patently absurd, and the possible restriction or ban on these medicines is where the true danger lies. I beg you to please deny this ridiculous and dangerous petition by Wyeth Pharmaceuticals.

Thank you.