My name is Ann Fonfa. I am a five and a half year breast cancer survivor. I consider myself an activist. I am very glad to be here today because I have a very strong point of view on what we have heard, and much stronger on what we haven't heard. [On tape, a "voice from the grave": "Thank you for saving me from breast cancer. Too bad I died from a pulmonary embolism.] Survival is what counts for cancer patients. What I heard here today only aggravated the feelings that I felt when I first read the newspaper information and everything that has been published so far about the trial. Women died of breast cancer who took placebo; women died of breast cancer who took tamoxifen; women died of pulmonary embolism who took tamoxifen. This pains me because as far as I can see when you are dead, you are dead. It doesn't matter what you died from. I have a great concern about women who come in healthy and die because of something that they take, thinking that it is going to prevent them from dying from something else. There is a real problem here. Some of my concerns include the fact that for tamoxifen, while we hear that there are hundreds of thousands of hours of follow-up, it is actually not very lengthy in time. And time is what will indicate what may be further problems when healthy women are given this drug. So, all we really have is about 5-years of information, and from what I heard today, the follow-up is really very shaky. It is only good if the women consent, if the company consents, and if we are able to continue to look at what happens. We don't know whether women who are healthy taking tamoxifen at this point will benefit for any length of time afterwards. Yes, we can say that there haven't been any cases but how far out are we from the end of the study? We are not even 6 months. So, we are not looking at any long-term follow-up right now to say, yes, there has been a tremendous benefit conveyed; that these women now are safe from breast cancer for the future. We don't know at all that they are. So, my point is really that there are endless questions about what is going on, and I think it is way too soon to allow this drug to be in the general population because you know darned well that once doctors are able to prescribe it -- let's face it, we have had very good success in making people aware that there is an epidemic of breast cancer and, therefore, lots of women are going to want it from doctors and lots of doctors are going to give it to the women regardless of their risk-benefit. Women with cancer and women without cancer are not foolish. They need information. We have presented the trial as being prevention when it has clearly been indicated today that it is not; it is really a risk reduction and that should be made very, very clear to the population and to the physicians. I think that is very important. And, once it is out in the trenches, which is what I call the world of women who have cancer and the women who fear cancer, they are not going to be able to hold to the standards that are established, and you have to be aware of that in a very serious way. Women will be asking for it; doctors will be granting it. We know they are doing that now with lots of other drugs. I envision a situation in which you go to see your doctor and the doctor says, "do you want hormone replacement or do you want tamoxifen?" and, you are on a pill taking care of something that may or may not be useful. We don't know yet. My main point has been questions. I came here waiting to hear what was presented, figuring I would start my talk based on everything I heard, but I didn't hear anything that actually changed my point of view. There has been no new information. There are still tons of questions. We are saying women under 49. Women under 49 is a huge category. A young woman in my organization, in New York, has been talking to me about the idea that women under 35 may have different circumstances. We haven't heard a word about that subset and that is really scary to me. Yet, women under 35 who have high risk, who have family connections, who are fearful of breast cancer -- how are they going to know what to do? We don't have any information. Women of color -- we have no information. We are leaving out all these subsets of populations, saying, well, women over 60, we will just give them tamoxifen if they are not taking hormone replacement, or maybe they will be taking both. There is something wrong with this picture. I have a very, very strong concern about where this is going to go. Remember that when doctors are prescribing it, when you are out in your doctor's office asking what you should do and talking about your risks and benefits, there are a lot of blurred lines. It is not going to be clear. How ever many scientists here are truly clear about what they have heard and what they have found out, it is not going to be clear in the doctor's office. It is going to make a difference. Women will not know what to do. I think we need a lot more information. I have a concern about the fact that we are saying we only need one trial here, in the United States. That is a concern for me. I don't feel that is a benefit for patients or for healthy women or high risk women. I think we are rushing things in a way which we should not be doing. There is no reason to. It is not even like that many women got breast cancer within the trial. If they are really high risk -- I just don't see this. It is not strong enough for me. Also, we saw a slide that said the tamoxifen study began in 1978. So, overall we don't even have long-term follow-up to know what is going on. Leslie Ford was quoted in the Journal of NCI, Volume 88, August 28, 1996: Tamoxifen has been available for 30 years. It wasn't until the late 1980s that we found about tamoxifen in the uterus. Again, I say that over time they find things out that we don't find in the hours of use because that is not the same thing. You can have 300 women take it for an hour each and that is 300 hours but it is not the same as having long-term years out and we need to see those effects. So, my main point really is that we don't know enough to go forward on this at this time, and I really feel we need more studies; we need more information. That is really about all I have to say. Does anyone have any questions for me? I would also like to point out that no drug company has ever paid me for my opinions. [Laughter] NOTE: Tamoxifen was approved as risk reduction for healthy women. A "risk disk" has been created for doctors to help answer the question of who should be given this drug. It is still being debated in many circles. Activists continue to be concerned about how this drug will act in healthy women. 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.