2005P-0411
  

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

  


  

  

  


  

  


  

  


  

  
FDA Comment Number : 
  

  
EC1542
  



  

  
Submitter : 
  

  
Dr. Mark Silverman
  

  
Date & Time: 
  

  
02/13/2006 11:02:45
  



  

  
Organization : 
  

  
Dr. Mark Silverman
  



  

  
Category : 
  

  
Health Professional
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 Approximately eight months ago I was suffering from multiple symptoms which after medical evaluation and blood testing it was determined that I was testosterone defficient. I chose bio-identical testosterone administered through a cream rather than synthetic testosterone.  My feeling was that bio-identical would be less of a shock to my system, could be more easily absorbed, and would potentially have less side effects than synthetic testosterone.  Most of the medical physicians I spoke to did not feel that the bio-identical would be as effective.  I'm extremely happy to report that my testosterone level, by taking 50mg of the testosterone cream twice a day, is now well within normal limits and all of the symptoms that I was exhibiting have disapperead. I feel it would be an incredible disservice to the public if bio-identical hormones were not able to be easily utilized by the American public.  If anything, there needs to be more education about how effective bio-identical hormones really are. I also understand it is not in the best interest, economically, for the pharmaceutical industry, as well as the FDA, to promote bio-identical hormones due to the fact that these products have to be compounded for each individual's needs.  The drug industry can only continue to make their billions of dollars in profits by mass producing medications ignoring individuals' personal needs.  In my opinion, it would be a crime to, in any way, eliminate or inhibit the utilization of bio-identical hormones. I'm sure it's no coincidence that Wyeth's decreasing profits, due to the side effects of their medications, have led to the tactic of "If you can't beat them, destroy them." People should be able to make their own decisions of which types of medical treatments are best for them.



                                          Thanks, 

                                          Mark Silverman