2005P-0411
  

  

  


  

  

  


  

  
FDA Comment Number : 
  

  
EC582
  



  

  
Submitter : 
  

  
Ms. Grace Overcash
  

  
Date & Time: 
  

  
02/03/2006 11:02:51
  



  

  
Organization : 
  

  
Ms. Grace Overcash
  



  

  
Category : 
  

  
Individual Consumer
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 As a menopausal woman and health care professional, I object to the FDA taking any action to prevent bio-identical hormones from being available to those that do not want the risks of synthetic Hormone Replacement Therapy.  I was on Premarin (Wyeth laboratories) for 8 years and started using transdermal bio-identical natural progesterone with excellent results.  Wyeth labs has lost a lot of money because women have been able to take charge of there own health.  The dangers of Premarin and PremPro versus the safety of bio-identical hormones should be a no brainer. However, it is very apparent to me that it is all about the money...not about what is in the best interest of the consumer (who happen to be women) I do NOT want the Federal government to tell me that I cannot go to a compounding pharmacy or that I cannot use a product or supplement!!  This is the USA and the last time I checked that means that I have rights and freedoms.  STOP doing what is best for your "bottom-line" and for the pharmeceutical companies "bottom-line".  We are aware of what is going on and we object.  The following information shows what the FDA and the pharmaceutical companies are interested in...not in our safety and health, but in money!!



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. Wyeth's financial reports, which are available online at www.wyeth.com, indicate the following significant decline in sales of Premarin Family products;  2002 - $2,072,000,000; 

2003 - $1,275,000,000; 2004 - $880,000,000. This represents a 68% decline in sales of Premarin Family products between 2002 - 

2004. Wyeth's profits have likewise declined precipitously; 2002 - $4,447,000,000; 

2003 - $2,051,192,000; 2004 - $1,234,000,000, a 72% decline in profits. Tens of thousands of women have forsaken Premarin family drugs for bio-identical hormones. Wyeth is simply trying to stop its losses and regain its market share. Wyeth wants to force women to take their counterfeit hormones by eliminating the competition from bio-identical hormones prepared by compounding pharmacies. 

 

The FDA receives drug user fees, totaling at least $300,000,000 in 

2004, from the pharmaceutical companies for the drugs they sell. The less drugs that Wyeth sells, the less money the FDA makes. The FDA collects no drug user fees from compounding pharmacies because they are regulated by the states, not the federal government. So the FDA wants to eliminate compounding pharmacies as well. 

 

Pharmaceutical companies recruit key FDA employees to work for them at huge salaries. This is the dream of many bureaucrats, to get a high paying job with a big drug company. So you can understand why FDA regulators have an incentive to please Wyeth. 

 

Wyeth, like all the major pharmaceutical companies, contributes billions of dollars to various medical societies and patient advocacy organizations. So it is not surprising that many of these organizations have written responses to the FDA in support of Wyeth's complaint. Because of their money ties to Wyeth, these organizations endorse Wyeth's products and do Wyeth's bidding. When an organization supports something which is obviously detrimental to women and men, it is important to follow the money trail. 

 

Wyeth can and must be defeated in its attempt to restrict patients' rights to choose to safe, effective and natural treatments using bio-identical

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  








  

  
 hormones. 

 

So I am asking as a tax payer, concerned consumer, female healthcare practioner and a United States Citizen to say no to Wyeth's complaint and to allow us to make our own informed decision about our health care.