2005P-0411
  

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

  


  

  

  


  

  


  

  


  

  
FDA Comment Number : 
  

  
EC1734
  



  

  
Submitter : 
  

  
Dr. Kathleen MacIsaac
  

  
Date & Time: 
  

  
02/13/2006 01:02:54
  



  

  
Organization : 
  

  
Dr. Kathleen MacIsaac
  



  

  
Category : 
  

  
Health Professional
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 I wish to voice my opposition to the complaint filed by Wyeth Pharmaceuticals with the FDA, regarding the issue of bioidentical compounded hormones. 



I am a physician, and have studied the pharmacology of these hormones, and have used them in my medical practice for nearly eight years. I have found them to provide an invaluable, safe therapy for my patients. 



The tragedy of it all is that the general population is unfamiliar with the distinction between bioidentical and synthetic mimicry of hormones, and drug companies such as Wyeth are playing on this mis-information. The overwhelming evidence that hormone replacement with chemicals such as Premarin and Prempro proved to be a disaster must be acknowledged. Massive profits for the drug companies were generated in the heyday of Premarin, and now that the same population of patients once using Premarin is switching to bioidentical hormones(largely by their own request!), the dollars are going elsewhere,hence the fervor on the part of Wyeth to stomp out the action of compounding pharmacies. 



As a physician, and woman using bioidentical hormone therapy, I strongly support the use of these compounds. I see multiple health benefits when used under the guidance of a physician.



I would point out that nearly all of my patients choose to pay out of their pockets for this approach, for it is rare for them to receive reimbursement from their insurance companies. This is outrageous, for it limits the number of individuals with access to the treatment merely do to expense. Of course , the expense is minimal compared to the cost of ANY prescription drug nowadays . . .none of which are as safe and globally effective as bioidentical hormones !!