Ann Fonfa's Testimony, 2001 I am Ann Fonfa, founder of The Annie Appleseed Project, which acts to educate and inform cancer patients, healthcare 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 of approval of a particular drug, and not so much toward the benefits to 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 has to be set up the way it often is. 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. And so would those most needing a new therapy-women who have tried just about everything first. In order to benefit those women, a drug may actually have to work in that patient population. So perhaps testing it on them is a GOOD idea. I recently read an article that stated "drug companies can increase the likelihood of a drug's success by using exclusion criteria to, as one investigator told the Inspector General's office, "enrich trials with patients who are most likely to benefit." Yet, having attended two meetings devoted to discussing how to promote clinical trials, I understand that we need completed studies to better aid us in discovering good treatments. Should performance status be a standard for entry? On the other hand, when I look at the actual survival value of most "approved" therapies, I often fail to understand their benefit to patients. At another ODAC meeting I referred to this continued approval of drugs with so little better benefits to patients, than the existing drugs, by comparing the process to crawling on our hands and knees through a field of broken glass. Patients want a leap forward, yet we are continually presented with tiny steps. Yes, they add up to moderate gains, as has been stated at the 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 result will be two more months of survival laden with the negative effects of the therapy. I will end by urging every one in this room to consider the benefits of complementary, natural therapies. Studies in animals and cell culture indicate benefits may include better tolerance to cytotoxic regimens, support for the host (that's 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 sponsored The Annie Appleseed Project. 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.