We need more FORCE

During chemo

 

Back on June 11, 2013 I introduced you to FORCE: Facing Our Risk of Cancer Empowered.  It is an advocacy group, helping women with inherited mutations of the genes BRCA1 & BRCA 2.  These genes code for proteins that are important in fixing errors introduced during cell replication.  As you know, whenever a cell divides it must duplicate its entire collection of DNA   Given that the number of nucleic acids that must be duplicated extends into the billions, the process is remarkably efficient.  Nevertheless, some mistakes are made.  The BRCA genes provide tools to help fix those mistakes. Absent functional BRCA genes, ovarian and breast cancer are much more likely to result.  The mission of FORCE is to further the detection and treatment of women with defective BRCA genes. 

FORCE recently testified at a hearing of something called the ODAC, which is the Oncological Drug Advisory Committee of the FDA.  The subject of the hearing was a drug called olaparib.  Specifically, FORCE (and others) wanted this drug approved for use in the case of BRCA 1,2 -positive women.  Research long in progress has shown that this drug – a PARP inhibitor, also involved in DNA damage repair – extends "Progression Free Survival" in women with advanced ovarian and breast cancer; that is, it enhances quality of life, and postpones death.  However, the available evidence did not demonstrate with sufficient statistical rigor that olaparib affects” Overall Survival.”  It seemed to prolong life, but not enough to be “significant”.  So ODAC turned them down;.  “More research is needed.”

Okay, this leaves me with a dilemma.  I am on record as wanting to throw dead cats at people who claim a “major breakthrough” for drugs or therapies that merely shrink tumors or extend life for a few miserable weeks.  On the other hand, I lived with a woman who died of ovarian cancer.  After chemo she had a prolonged period of remission; long enough to re-grow her hair, feel good, and go on several wonderful trips.  Those nine or ten months were amongst the best of our lives together.  So, if olaparib will extend remission by another six months or so, why in hell not use it while the “more research” is going on?  "First, do no harm."  Bullshit!  I don’t understand.

There is an obvious problem here, but I don’t know what to suggest.  Maybe you should consider joining FORCE, or at least getting on their mailing list.  I wish I knew a way to help clean the sludge out of the arteries of the FDA, but I don’t.

Here is the FORCE blog.  http://facingourrisk.wordpress.com/2014/06/29/fda-approval-of-promising-targeted-therapy-likely-stalled-until-more-research-studies-are-completed/