| 2004N-0559 - Joint Meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee|
|FDA Comment Number :||EC79|
|Submitter :||Mrs. Gayla Little||Date & Time:||02/07/2005 07:02:38|
|Organization :||IBC Research Foundation|
| To the members of the Drug Safety and Risk Management Advisory Committee:
Please do not end the trials studying the cancer suppression ability of COX-2 inhibitors.
In the year 2000, I was diagnosed with stage 4 Inflammatory Breast Cancer. At that time, almost two thirds of the women diagnosed with this disease died within a year of their diagnosis. The first day I saw my oncologist, I told him about joint pain I had and he put me on Celebrex, in addition to chemotherapy and the other treatments for my cancer. I gratefully remain on Celebrex to this day. PLEASE do not end the clinical studies examining the cancer suppressing quality of COX-2 inhibitors, especially Celebrex. The reality, for me, is that if my cancer comes back, I will have to fight for my life again. The chances of having a heart attack and dying are much less for someone in my situation. I understand that this drug should not be used casually; however, there is no way to know, at this time, if it is what tipped the balance for me and let me survive. Please allow these vital studies to continue so that we will KNOW what role COX-2 inhibitors play in the treatment of cancer.