Fall 2009: Jake and Nancy learned that Nancy's breast cancer was stage four. Winter 2013: They are still fighting. This is a gathering place to follow their story, offer support, love and prayers... to be by their side.

Tuesday, March 22, 2011

Update and a Face on the Avastin Debate

Dear friends and family,

Sorry it has been so long since I've posted an update, we've been busy! Lots of good things to report. For starters, my health is great. I had another PET/CT scan last week and the results were positive, no changes in the tumors and everything is stable and "quiet" according to Dr. Rinn. I will meet with her on Wed and have my monthly Zometa infusion, so she'll go over the results in detail then. I went back to work in October and things couldn't be better, I even managed to get myself promoted. My energy level is great and I'm having a lot of fun being back in the swing of things work-wise. I went snow-shoeing a couple weeks ago with my friends from Team Survivor, which was great fun (photo attached - I'm in front wearing the bright red jacket).
In other news, I attended a symposium at the UW Law School a couple weeks ago called, "Regulating the Treatment of Cancer: Who Decides and How." It was an amazing opportunity to hear from experts in the field, including one of the four decision makers from the FDA on the use of Avastin. The format for the day was a series of lectures and panel discussions with time for questions from the audience. About midway through the conference I overcame my fears and decided to ask a question to the panel. My question was along the lines of "I have advanced breast cancer and I'm alive/healthy as a result of taking Avastin for 7+ months, help me understand why the FDA is taking it away as a weapon in my oncologist's arsenal?" I wanted to put a face on the Avastin debate and hopefully was successful. It was a fascinating day from a public policy perspective - I wish it wasn't so personal - but am excited to get involved in the fight. I was so fired up after the conference I decided I want to do more and am headed to Washington DC in early May for a conference and session on Capitol Hill. Stay tuned for more!

One of the speakers at the symposium (probably my favorite panelists from the day) was Robert Erwin, who is president of Canceractionnow.org, an advocacy group who keeps a careful eye on the FDA and was founded in honor of his late wife, Marti Nelson, MD. Mr. Erwin shared a letter with me, sent to the FDA, regarding Avastin (text from the letter is below). I urge all of you to read up on the issue and let me know if you have any questions or want to get involved. The Avastin issue is complex and certainly controversial, but I truly believe it is worth fighting for. Mr. Erwin's letter articulates this well. The Avastin appeal is scheduled for June and I'm hoping to get more involved.-Nancy

Marti Nelson Cancer Foundation
1520 East Covell Blvd. B5#103
Davis, California 95616

February 14, 2011

Re: Comments on FDA Docket No. 2010-N-0621

Dear Dr. Hamburg,

We encourage the FDA to hold a public hearing on its proposal to withdraw approval of the metastatic breast cancer indication for bevacizumab. We believe there are at least two issues of relevance that are best considered or debated at greater length in a public forum.

First, we would like further consideration of an apparent lack of data directly contradicting the results of the E2100 clinical trial, the primary basis for the accelerated approval of bevacizumab for metastatic breast cancer. The results of subsequently published clinical trials testing bevacizumab in combination with other chemotherapeutic agents have certainly been disappointing, and they suggest that bevacizumab is not as valuable a clinical tool for the treatment of breast cancer as many of us had hoped it would be. However, the specific combination of bevacizumab with paclitaxel has clearly been of benefit to some patients with metastatic breast cancer and may offer benefit to many more in the future. We are concerned that fully withdrawing the breast cancer indication at this time will deprive some future patients of meaningful clinical benefit and believe this is an issue worth further public consideration.

We are disappointed that despite substantial resources committed to various bevacizumab clinical studies, Genentech and Roche have not obtained sufficient data to definitively replicate or invalidate the results of the E2100 study of bevacizumab specifically in combination with paclitaxel. However, we do not think this failure alone, at this time, is adequate reason to deny the possibility of clinical benefit from this drug combination to breast cancer patients who cannot afford to obtain it off-label and unreimbursed while we wait for the results of planned clinical trials.

It is clear that many patients treated with bevacizumab may suffer its side effects without receiving benefit, while a minority may receive significant benefit. Unfortunately, no one can predict which patient is which prior to initiating treatment. Ultimately, we believe these difficult regulatory decisions need to be made with the individual patient in mind, both the person who is harmed and the person who is helped. Legal arguments and procedural arguments should take a distant back seat to issues of science, medicine and patient well-being. In the face of substantial uncertainty, each patient, as a valued individual, must make an treatment irreversible decision in consultation with one or more individual physicians. Under these circumstances, more information is always better; thus, our exhortations to the FDA to conduct thorough and even redundant public analysis prior to taking final action and to Genentech and Roche to deploy the necessary resources to answer open and critical clinical questions about bevacizumab as rapidly and unambiguously as possible.

A second issue of broad public health and public policy importance we believe justifies a public hearing is the need to further consider, and more objectively define, clinical significance versus statistical significance in the context of the use of progression free survival versus overall survival as clinical trial endpoints to support drug approval applications. Although such a broad issue would not be the primary purpose of a public hearing, and the issue has been, and will continue to be, debated in other venues, we believe a public hearing on the immediate bevacizumab issue may contribute important understanding to this important technical policy issue.

We believe that a clinically meaningful and statistically significant improvement in progression free survival provides an important clinical benefit to patients, even in the absence of a demonstrated statistically significant improvement in overall survival. Many intelligent and well-informed people disagree with our view on this issue. The bases for agreement and disagreement on this topic are complex and beyond the scope of this letter, but we believe those who disagree with our view would agree that more extensive public discourse on this topic could be valuable.

We understand that the decisions the FDA makes are not easy and are made carefully. We do not have access to all the expertise or data available to the FDA, nor does the public at large, nor does the individual patient or physician in the exam room or hospital room. We believe a public hearing will enhance public understanding of the difficult work performed by the FDA and also provide this specific issue with the careful, complete and public analysis its importance warrants.

Very truly yours,
Robert Erwin
Marti Nelson Cancer Foundation

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