SURVIVAL, make that long term survival. Hold that thought! Time-to-progression sounds like it may be an advantage over tumor response, which has never been correlated with increased survival and often, not even with delayed disease progression. FDA has a long history of approving drugs that are only minimally better than the ones they are compared to. I often speak of this as crawling on our hands and knees through a field of broken glass. There are those of us who long to leap over the field. How can we do this? By holding oncologic drugs to the highest standards possible. After all millions of dollars are spent on clinical trials but from the patient perspective, it is about our lives. We are wasting our precious time taking drugs that are little better than awfully expensive and very toxic placebos. How much time in the time-to-progression are we talking about? If it is months, then I insist that we also look at quality of life. For cancer patients, there are only two important imperatives, increased survival and decent quality of life. It is why I have spent many years asking for studies on and the use of complementary and alternative treatments. These are almost always less toxic than the current chemotherapy drugs. Can we correlate time-to-disease progression to improved survival? Since most trials are done using metastatic patients who by definition, are close to death, I cannot understand why true survival data is not reported after every trial. Indeed a new standard for drug approval is long overdue and would be very welcome BUT only if patients could then expect that our survival will be positively impacted. I suggest, as I have for years, that we begin examining natural, non-toxic regimes. Patients are choosing to use these methods right now. They have not waited for studies. Almost all of us are now into vitamins, supplements and probably nutritional interventions. We don’t use a single isolated element either. It is time for FDA and drug companies to recognize this situation. We must begin studies immediately that offer an arm for patients who are utilizing these substances. Perhaps an arm for patients using natural substances will show greater efficacy. Some small studies have already indicated that many nutrients can potentiate treatment, possibly slow cancer cell growth and possibly encourage apoptosis. Treatment failure is one of the most open secrets in oncology. It seems only the patients find out the hard way. Discussions at ODAC as reported in The Cancer Letter among others clearly shows that oncologists know that many drugs they offer are little better than placebo. But they want to give the patients something under the theory that something, even a useless something is better than nothing. Where I come from this may be the same as false hope. I always said there was no such thing, but if the doctor already knows there is almost no chance of the administered drug being effective at all, then that indeed is false. Of course I would suggest turning to the alternative world and exploring the many possibilities that exist there. One obvious advantage is that it would be a much less toxic way to go. And indeed, it would offer real hope as many of the possibilities have worked for others. And my totally empirically viewpoint is if it worked for someone, it could work again. I can personally testify that I have achieved disease stabilization using several non-toxic methods. This may be anecdotal, but it is my own story. Oncologists have formed the practice of giving patients chemotherapy almost until the day of their death, completely disregarding quality of life as an issue. This is no longer acceptable to patients. As we have become more educated, our standards have changed. We want treatments that are effective, minimally toxic and we want to discuss our options fully with our health care providers. I worry that the design of trials are set up so that we get information about the group but not much that is really useful for an individual. Take the example of Tamoxifen in the adjuvant setting. I know that there is a 50% benefit in reducing further cancer by taking this drug. Yet upon further analysis, I find that about 10 women in 100 were likely to recur or get a new cancer. This has indeed been reduced to about 5 per 100. The end result is that 90 women take Tamoxifen, a highly toxic drug, for whom it is completely unnecessary. Additionally another 5 women don’t get the benefit since they recur anyway. A better method should be found to yield much more specific information so that we can clearly identify the 5 women out of 100 whose cancers will be stopped by the drug. Of course, I wonder who will pay for such a trial? As a cancer patient I have had to face the fact that this is a big business and profit is above patients. No company seems willing, no researchers seem to feel comfortable discovering how many fewer patients need to take a drug (especially after it has been approved). FDA needs to address the questions that may reduce market share, no one else will. A magazine article, recently published in a bimonthly news magazine for oncology professionals encourages their reader to tell patients dosages of drugs to be administered. This way the patient can help ensure appropriate doses and correct drugs are given. Patients need and want to be involved in their treatment. We want to hold our health care providers to a much higher standard than previously. When we are diagnosed most of us don’t know a damn thing about cancer. We usually welcome chemotherapy if all we know is what we have read in the popular press. If, as is increasingly common, we have seen a family member or loved one go through the treatment, we are less welcoming. Patients demands are changing the face of oncology treatment. This is right and very good. In line with this change is FDA’s need for a new standard for drug approval. My challenge to you is: Will time-to-disease progression matter to patients? Will we see this new standard translate to longer life, to better quality while we undergo treatment? This is a really important question. When I decided to testify today, I thought about what is important. I could not come up with anything more meaningful than improved survival. Can you demonstrate that for us? Will we see true progress with new drugs. Not just approval faster and of more drugs, but will these drugs truly help us live longer? Will they make it easier to go through treatment because they take into account our need for a decent quality of life? I worry about our current view that we can give a pill to reduce the unwanted effects of a treatment. Soon we have to offer the patient another drug to offset the unwanted effects of the pill for the first set of unwanted effects. You will notice that I do not call these unwanted effects, side effects. I have determined that they are not aside from anything. They are "in our face" and they are very real and potent. A patient may end up with 8 or 9 medications to treat all the unwanted effects in order to tolerate a truly toxic treatment that may be relatively ineffective. This is a bad situation. That patient’s liver still has to process the drugs, her or his body still has to undergo the violent, painful, difficult-to-tolerate regimens. And survive. So think carefully as you enter this new era. Think of us as people with a disease, not as only patients with cancer or disease targets. We need standards from FDA that will offer our best hope for continued long-term survival and useful quality of life. We will all thank you if this is kept in mind as you debate new standards. Thank you Ann E. Fonfa President 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.