2005P-0411
  

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

  


  

  

  


  

  


  

  


  

  
FDA Comment Number : 
  

  
EC1636
  



  

  
Submitter : 
  

  
Mrs. Sandy  Blake
  

  
Date & Time: 
  

  
02/13/2006 12:02:46
  



  

  
Organization : 
  

  
Mrs. Sandy  Blake
  



  

  
Category : 
  

  
Individual Consumer
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
     It has come to my attention that Wyeth Pharmaceutical filed a citizen?s complaint with the FDA to take away our rights to choose safe, effective and natural, bio-identical hormones and regulate our choice of health treatments. 



   I trust that the FDA will not ignore the 1996 Johns Hopkins study that concluded women low in natural progesterone have an 80% higher risk of developing breast cancer and that the risk of developing other malignant cancers increases ten-fold. 

 

    The FDA has a responsibility to the public, not to be the hand maiden of the Drug companies.  Wyeth's petition is driven by a profit motive, In other words GREED! Since the 2002 Women's Health Initiative (WHI) which demonstrated that Wyeth's products, Premarin and Prempro, caused a significant increase in breast cancer, blood clots to the lungs, heart attacks and strokes, Wyeth has seen a dramatic decline in the sales of these counterfeit hormones; a 72% decline to be exact. And there is indeed a good reason for the decline. People have found better and safer products.



   I was using some of these drug company substitutes, instead of the real bioidentical hormones.  The fact is that her treatment results have been far superior, and more economical with the use of the compounded natural hormones.

We don't want an inferior, and even dangerous, altered hormone,foisted upon us. When the bio-identical one works far better.  You and I both know, the reason that the drug companies alter the hormones is strictly because they can then be patented, which translates into huge profits for the drug companies. But the consumers suffer with an inferior product.   



I am hoping that the health and safety of millions of women will be the determining factor in making this decision.  I understand that the FDA received drug user fees, totaling at least $300,000,000 in 2004, from the pharmaceutical companies for the drugs they sell. If this is true, it seems the FDA could be in a compromised position, if it were to side with Wyeth in this complaint. It seems that such a decision may even open the door to charges of collusion. Particularly since,the fewer drugs Wyeth sells, the less money the FDA makes.  



I hope that we still live in a society where men and women within our government can make decisions that are motivated my hard core research and not greed.   Do not underestimate the magnitude of this decision.  Withholding these basic human rights from women will unleash a backlash, from an informed public, that could re-structure the FDA permanently.



 

Sincerely,



Sandy Blake ,  an extremely concerned citizen.