Clinical Trial Issues

October 1998

1. Clinical trials are designed to prove (sometimes minimal)efficacy to facilitate drug approval. That means they do not often provide answers to questions that patients may have. A perfect example of this is the confusion over hormone replacement therapy, Tamoxifen and Raloxifene among other issues. There is still no definitive answers as to how safe hormone replacement therapy is. The data is confusing and subject to interpretation. Studies have not yielded answers for women on this issue. The Breast Cancer Research Foundation in NYC held its annual symposium (10/20/98)with Larry Norton, MD moderating a panel with Laura Esserman, MD, Benita Katzenellenbogen, PhD and Marc Lippman, MD. No studies have compared estrogen to soy to Tamoxifen or Raloxifene(discussed at this event as a good idea). During their discussions and the extensive Q&A, it became clear that patients ‘ need to know would not be dealt with. Studies abound and still the answers are unclear.

2. What are the endpoints used for cancer drugs? Do they have a real value for patients? Standards were set a long time ago that allows measurement of tumor reduction. It has been stated many times by many people including Dr. Robert Templeton of FDA, that tumor response does not necessarily correlate with increased survival. In fact true survival statistics are not released. We have been told by FDA that such data may exist in their filings but are not required to be released. Patients can access this information by individuals bringing lawsuits against FDA! So when drugs do gain approval, they may not actually do what cancer patients want them to do-improve our survival time.

3. Animal studies are conducted after the test tube (in vitro)proofs. However, quite often physicians and others will tell us that we should disregard the (negative) animal results because animals are not like people. We often hear that mice do not have menopause so that studies are confounded. Animals rarely develop metastatic cancer. Tumors in experimental animals are usually artificially induced. These circumstances may indeed cause major differences in results. Several questions arise from this: Are animal studies valid, or is this model simply left-over from another era? If animal studies are valid, how should we interpret them? If they are not particularly valid, why are they being used? Why do doctors and other scientists feel okay about ignoring results from such tests/studies?

4. Often the studies take so long to organize that the drugs being tested are obsolete by the time the study has finished. Second or even third generation drugs may be available at time of completion. New drugs are compared to old drugs, sometimes making one or the other look better than it really is in clinicaluse.

6. I have heard many oncologists and researchers say that they "knew" the results before they were achieved. In other words the studies may have been very basic or unnecessary or who knows what? The LI BC study will look at issues we almost already ‘know’ about. Why have researchers resisted adding new areas to this study? Endocrine disrupters and in-utero exposure are now implicated in our cancer struggle. Let’s include these issues in studies.

7. Clinical trials are often repeated with minute variations that have been said to "waste" patient participation. I have heard this said at many conferences. Is this just professional jealousy?

8. Pharmaceutical companies concerns are first in these arenas, patients’ concerns are third, fourth or tenth in line.

We can address that issue by our very presence at an IRB (Institutional Review Board-they make the decisions on a local level to allow trials to go forward). We need to make our presence felt at every level possible.

Our value is not just to recruit patients for trials. We offer a patient perspective, and as outlined above, that can be very different from any other point of view. We need to humanize this process. We need to say what we think about the value to patients of the planned outcome of a trial. We must offer our perspective as the ongoing value of any information obtained. Our input as to what is needed , where and why could be critical. We can focus attention to areas of concern and importance to the patient community. (Think about how long it took for lumpectomy to be the standard, or for sentinel node to be explore, although both ideas were proposed decades before any studies were undertaken). We do not need to question any scientific perspective, although we can, our purpose should be to humanize, re-orient and quantify all the other aspects.

We HAVE to participate. It is our lives and we need to know most of all. This should not be about making money but about human lives and health.

Remember we are NOT Doctors and have NO medical training.

This site is like an Encyclopedia - 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.