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, July 5, 2011

Return from Washington

Photo taken from NPR piece.
Dear Family and Friends,

Jake and I returned from Washington DC on Thursday after giving public testimony at the Avastin hearing. It was interesting and emotionally draining all at the same time. If you want a challenge, try condensing my complex medical history into 3 minutes while convincing a panel of experts who have already made up their minds. I can't really box up the arguments into a short post, so grab a cup of coffee, this is a long read.

For starters, the FDA is convinced there is no benefit from Avastin and that it's a dangerous treatment. This did not sit well with patients in the audience, especially the ones who have been living on Avastin alone for years. If patients' anecdotal evidence is not enough, consider that the National Comprehensive Cancer Network (NCCN), an alliance of the world's leading cancer centers, has unanimously affirmed the use of Avastin for metastatic breast cancer looking at the same clinical data. The NCCN is comprised of breast cancer experts, quite a contrast to the FDA panel, who had no breast cancer expertise. Thankfully for us, the NCCN, not the FDA, sets the reimbursement guidelines, so Avastin will continue to be covered by insurance at least for now. Still not convinced? Consider that the European equivalent to the FDA not only affirms the use Avastin, they just expanded their clinical guidelines to use it with additional chemotherapy partners, again using the same clinical research data.

The FDA argued that Avastin does not improve overall survival (we agree) but, importantly, does not improve progression-free-survival to a statistically significant degree (we disagree). Genentech argued that the progression-free-survival benefit is demonstrated by the data, statistically significant, and, more importantly, clinically meaningful. Jake and I could not agree more.

So what is progression-free-survival (PFS)? It is the time it takes for the disease to get worse. Stated another way, it is the amount of time it takes for the cancer to outsmart treatment and start growing again. I have yet to experience my first progression since being diagnosed 21 months ago, which is far longer than the median statistics, particularly given my situation (heavily tumor burdened, aggressive disease including multiple large tumors in my liver, considered the most deadly). I am nearly symptom-free from my cancer, which is amazing considering the round-the-clock pain I was in when I was diagnosed and the broad extent of my recurrence. Progression-free-disease translates into quality of life. To drive home this point during my 3 minute testimony, I put up a photo of me standing on top of Mt. Adams. Experts might argue over the extent of progression free survival benefit, but all of the studies have concluded their IS a PFS benefit with Avastin.

Regarding safety, the FDA was relentless in talking about the dangers of Avastin, which was so frustrating for the patients and breast oncologists in the audience. Avastin does cause a rise in blood pressure (easily managed) and causes bleeding (i.e. nosebleeds). Avastin has fewer, less toxic side effects than most of the chemos I've received over the years. A very small number of patients may have serious side effects such as pulmonary embolism, but that goes with the territory of cancer treatment. All cancer drugs are poison. You just have to hope the poison is more effective at killing the cancer than it is at killing you. As many of us joked during the trial, we prefer the side effects of Avastin to the side effect of death.

My cancer is incurable and very few if any treatments have proven, statistically significant survival benefit. The best we can hope for is to increase time between progressions.

Here's a quote from MD Anderson that sums it up..

The woman whose breast cancer has metastasized or who has been diagnosed initially at Stage IV must live with the reality that her breast cancer can no longer be cured, and that the disease is very likely to take her life. Consequently, the length of the remaining time she has to live, and the quality of that time, become issues of paramount concern. For her, access to the best care can make a significant difference, both in length of survival and in quality of life. With luck, excellent care, family support, personal motivation, and a skillful oncologist, her disease is likely to respond to a number of lines of treatment that can serve to extend her life-many of which may be quite costly. She may join a clinical trial, or try to get compassionate access to experimental drugs prior to their approval through single-patient INDs or expanded access programs.
Whatever path she chooses, she will be in treatment for the rest of her life, and she will require close follow-up, which will include costly scans and other tests. As her disease progresses, she will need pain-management and control of her other symptoms, and she is likely to undergo several hospitalizations to deal with particular crises in the course of the illness. Eventually, she will need hospice care.

The hearing was really frustrating in that the FDA was indifferent to our pleas. Several of the folks on the panel were so rude during the hearing they were literally reading their blackberries during the public testimony. As Jake commented, "I would have appreciated being patronized because at least we would have been acknowledged." So true! We were completely ignored on the first day and treated like we were wasting their time.
Much has been made about the cost of Avastin. Like other treatments, it is expensive, but certainly not outside the norm for oncologic therapies. When I was receiving Avastin, it was about the same price as paclitaxel (Abraxane) on a monthly basis. Cancer treatment is expensive, but we are thankful that it is available since the benefits in terms of quality of life are easily justified.


Larry Asher said...

I watched some of the proceedings online (unfortunately, didn't catch your testimony) and the whole scene of disinterested bureaucrats was so frustrating. Is there a next step in terms of influencing the FDA to come to a different decision? Meantime, that was great of you to go to the expense and trouble of speaking before this committee. I realize the stakes are high, but it would also be easy to give up in the face of such bullheaded opposition.

Medeah said...

I am amazed by your strength. You will be in my prayers. Keep fighting, Nancy. You are doing such important work.

Leilani's Mom said...

Today, in my garden I was trimming my Susan Koman geranium we planted almost 2 years ago in your honor. I often think of you, we shared an LID for China and I pray you are doing well.