Friday, March 27, 2009

A Letter to the FDA for Avastin Approval

Dear Cheryl,

I am sure you are smiling down from heaven as you watch our progress effect all of world so other families will not suffer from this tragedy. We are making great strides in honor of your memory and our daughter's future.

Dear FDA representative,

I am a member of the Grey Ribbon Crusade (C.E.O. and Founder of C.E.V.A.N. Louie Foundation, a privately funded society towards brain cancer in early developmental phases) and just got the notification over the weekend about speaking at the FDA approval for Avastin event that I will be personally attending. I beg for your consideration on behalf of my late wife, Cheryl Fernandez Louie, and our 20 month old daughter to speak on behalf of the efficacy of Avastin. My late wife passed away of GBM IV on November 2, 2008 and was a very influential woman in the state of Hawaii (Head of several organizations, responsible for the West Coast tourism that fed the local microeconomy, runner up for Miss Hawaii and won several pageants, and was well known by many). After my wife had 2 cranial resects and an emergency C section within a 4 day span, we went through the standard protocols of treatment. To our dismay, Temador (the only FDA approved chemo with exception to maybe the Gliadel Wafer) proven entirely ineffective with her tumor mass increased dramatically due to immunity. Our oncology shifted to Cedars Sinai Brain Tumor Center under the guidance of Dr. Phuphanich, Dr. Jeremy Rudnick, and of course under Dr. Keith Black and Dr. John Yu in neurosciences. We consulted with the staff at UCLA (Dr. Linda Liau), Duke (Dr. Henry Friedman), and Cedars Sinai (Dr. Keith Black) regarding experimental regimens and they all pointed us towards Avastin. My wife’s tumor tissue was not cryogenically frozen under a controlled environment at Loma Linda University and was wax paraphin blocked at their pathology department. Henceforth, we were not eligible for clinical trials due to the fact that they required biomarkers to track efficacy since there are several tumor types in existence. Fortunately, our insurance approved Avastin (which is 50/50) and we immediately initiated treatment which proved highly effective. My wife asked me to promise that I dedicate my life to giving her just more days to see her daughter and spend time with me and her family. Avastin gave us that chance and the first MRI demonstrated a 80% reduction in tumor size and 95% in the subsequent MRI. I will be willing to authorize release of these medical records to validate these claims from Cedars Sinai (I know because of HIPPA regulatory requirements). We were asked to be a testimonial from the researchers at Genentech (known as a subsidiary of Roche now) since the efficacy was astronomical. On behalf of our brain cancer community, please give me this opportunity to present this information to the FDA to further accelerate the approval of Avastin since it has been a long anticipated wait within our community. Our board consists of a UCLA professor for non profits, CRO – biotech consultant, oncologist from Cedars Sinai network, financial backing from private donors effected by the disease, and extensive networks of volunteers to further our cause. We are an entity that will not take external charitable donations and are considered a well capitalized private foundation. It would be my personal dream to discuss these matters in memory of my late wife, Cheryl Fernandez.

God Bless and thank you for your considerations,

Evan Louie
Founder and C.E.O.
C.E.V.A.N. Louie Foundation for Brain Cancer

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