DR. TEMPLETON-SOMERS: Next we have a letter from Ann Fonfa, founder of the Annie Appleseed Project which educates and informs cancer patients, health care providers and others on issues of interest, especially complementary alternative therapies. This is an extremely difficult question to address but I want to share with you some of my thoughts on the issue of compassionate use of unapproved therapies. As a woman who has had neither chemotherapy nor radiation, I am not eligible for most trials. While I understand why there are study entry criteria, I wonder if they are directed to ease the approval of a particular drug and not so much toward the benefits of the trial participants or the patient population in general. For patients who have been heavily pretreated, and there are so many of these with metastatic breast cancer, I wonder if the entry criteria have to be set up they way they often are. If someone like myself, and I am not alone in this category, wanted to enter a trial we could not. We would have to have compassionate use approval. So, with those most needing a new therapy-women who have tried just about everything else first-in order to benefit these women a drug may actually have to work in that patient population. Therefore testing it on them may be a good idea. I recently read an article that stated drug companies can increase the likelihood of a drug success by using exclusion criteria, as one investigator told the Inspector General's office, "to enrich trials with patients who are most likely to benefit". Yet, having attended two meetings devoting to discussing how to promote clinical trials, I understand that we need completed studies to better aid us in discovering good treatment. Should performance status be a standard for entry? On the other hand, when I look at the actual survival of most approved therapies I often fail to understand their benefit to patients. At another ODAC meeting I referred to continued approval of drugs with so little better benefits to patients than existing drugs by comparing the process to crawling on our hands and knees through a field of broken glass. Patients want to leap forward, yet we are continually presented with tiny steps. Yes, they add up to moderate gains, as has been stated at various medical conferences I attend, but must we continue to crawl inch by inch or is that simply an artifact of the current system? So, part of my problem is continuing to doubt whether we are using the best possible methods of finding,testing and approving drugs at all. As a cancer patient myself, I cannot imagine denying women with advanced disease the opportunity to try one more conventional therapy even when the end results will be two more months of survival laden with the negative effects of the therapy. I will end by urging everyone in this room to consider the benefits of complementary natural therapies. Studies in animals and cell cultures indicate benefits may include better tolerance to cytotoxic regimens, support to the host -- that is us, human beings -- and possibly enhancement of therapy. Please consider starting trials immediately that will look at chemotherapy with the use of antioxidants. Thank you for your attention. As you may imagine, no pharmaceutical company has ever sponsored the Annie Appleseed project. [Laughter] Remember we are NOT Doctors and have NO medical training. This site is like an Encylopedia - there are many pages, many links on many topics. Support our work with any size DONATION - see left side of any page - for how to donate. You can help raise awareness of CAM.