2005P-0411
  

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

  


  

  

  


  

  


  

  


  

  
FDA Comment Number : 
  

  
EC2667
  



  

  
Submitter : 
  

  
Mr. Bernard Wally
  

  
Date & Time: 
  

  
02/16/2006 12:02:28
  



  

  
Organization : 
  

  
American Hormones
  



  

  
Category : 
  

  
Health Professional
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 Gentlemen,

   I have been a pharmacist for 40 years and for the first time patients are saying "Thank you" for improving the quality of their life.

   Compounding topical testosterone in a dose correct for body weight and menopausal symptoms of decreased libido have improved my women patients enjoyment of their middle years and made their marriages more rewarding. I know this because these patients tell me so, and so do their spouses. This is not off the shelf dosing, but patient appropriate custom dosing not available to them without my ability and their doctors ability to tailor a dose correctly.

   Bio-identical hormones, compounded in patient appropriate doses allow peri- and post-menopausal women to alleviate many of their symptoms. It is not just the chemical entities (all of which meet USP standards) but the infinite variations in doses and dosage forms that make this medication so important to so many women. The ability to design and compound a lactose free preparation for a lactose-intolerant patient, or a sub-lingual drop or topical for a patient that cannot swallow allows those special patients access to medication they so sorely require. If we are to treat each patient as an individual, then it becomes obvious that the limited doses and dosage forms cannot meet every womans needs...only the average woman.

   I compounded a testosterone product for a 75 year old male (with special needs), lovingly married to a 55 year female and suffering the angst of old age libido. Only through a specially compounded product could this couple accomplish the physicality they both needed in their marriage. Manufactured, one size fits all, medication just didn't fit.

   My patient wasn't converting her T4 thyroid to T3 thyroid correctly and she needed a special balance (not 4.2:1 armour thyroid, nor levothyroxine alone) of 9:1 thyroid mixture, and not porcine sourced (for religious reasons). What could she do...especially if there were no componding pharmacists?

   In the 40 years I have been practising, and the 10 years before that I apprenticed in my neighborhood urban pharmacy, was there ever a time when a special needs patient or a special needs physician could not design a specially compounded preparation to fill that niche left vacant by big business pharmaceutical houses that would not, or could not, produce medication that was not profitable, in general demand and patentable.

   My patients do not wish to take Premarin. They think it is not in their best interest to take a combination of 217 estrogenic hormones derived from pregnant mares and available in only 4 strengths. They do not wish to take Provera, a product that only exists because its simpler, pure form is not patentable. Some women, given the side effect profile of both synthetic and bio-identical hormones chose to take the bio-identical. It is their right to make this choice, especially since it cannot be demonstrated that either preparation is more dangerous than the other.

   Perhaps the FDA might consider why it is that the majority of women who have begun the Premarin/Provera or Prempro/Premphase protocols have always, even before WHI discontinued taking their medication. For the majority, the patentable medication provided little if any relief and enhanced the side effects of what they were already suffering. It would seem the same is not true for women taking bio-identical hormones; ie, their relief is greater and their side effect profile is much milder. This however, if anecdotal, and would require more study to prove. 

   Finally, if the patentable product was so good (so successful, so symptom relieving) why haven't more women returned to the fold and re- introduced Premarin and Provera into their hormone therapy? Why haven't doctors? Why have so many looked at, tried, and continue to use Bio- identical Hormone Replacement Therapy.


  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  








  

  
   Thank you for allowing me to express my thoughts on this issue.