2006N-0062
  

  
Expanded Access to Investigational Drugs for Treatment Use
  


  

  

  


  

  
FDA Comment Number : 
  

  
EC16
  



  

  
Submitter : 
  

  
Ms. Ann Fonfa
  

  
Date & Time: 
  

  
03/13/2007 06:03:05
  



  

  
Organization : 
  

  
The Annie Appleseed Project
  



  

  
Category : 
  

  
Consumer Group
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 We do not have attorneys to read over your regulations so please forgive any errors incurred by this layperson.





One of the many criticisms we have of the current system is that clinical trials rarely include people with co morbidities or with truly advanced disease.  Thus the healthiest populations are the human research subjects for an investigational drug or therapy.  Those who will be seeking very early stage investigational drugs will be much more ill.



The world of so-called Alternative Medicine  the term alternative immediately conjuring system outsiders, includes many, many therapies. These are often sought by people who are in immediate life threatening situations, those who have exhausted all current, satisfactory, conventional treatments.



A second criticism is the limitation on types of protocols studied, tested and explored.  For many years, the Annie Appleseed Project has been suggesting an exploration of combinations of natural substances used by patients in the so-called world of Alternative Medicine.  Studies have consistently shown that people with cancer are using many supplements, many lifestyle modalities, treatments in combination  in ways that have NOT been formally studied.  Why not?  The answer we most often hear is that they are not patentable.



There is something seriously flawed with a health system that cannot study such therapy protocols.



The third criticism is connected to the second  it is extremely expensive to introduce products, drugs and combination protocols into clinical trials.  The companies that can afford to do this are themselves limiting what they work on.

Natural products may never be part of our system of study.



However, the Annie Appleseed Project sees this new and expanded access as a way to introduce alternative therapies into the mix.  People with cancer will continue to seek them, why not allow them to be used under the same regulations as the drugs or protocols in Phase I.  In many cases, there is MUCH more evidence around alternative medicines than most Phase I introductions.  



Remember they have been used by people in truly life threatening circumstances for many years (in most cases).  And in fact various levels of evidence already exist.  It is level one that is missing and perhaps this is a true opportunity to change that.



Thus we urge acceptance of so-called alternative medicine therapies as part of the newly expanded access program.  It will offer opportunities for those with immediate life-threatening illness and those who have exhausted all available conventional methods.



Thank you for the opportunity to express our position.