Andrea Sloan is an Austin attorney and executive director for the Texas Advocacy Project, an organization that provides free legal services statewide to victims of domestic violence. She was diagnosed with ovarian cancer seven years ago at age 37. Since that time she has beat the odds fighting through extensive treatment including 5 surgeries, 3 rounds of chemo and 2 rounds of radiation.
Now her cancer is back and she and her doctors believe BioMarin's BMN 673, an experimental drug, could be the answer. The FDA has not approved the drug for use, but has approved Andrea's use of experimental treatment through its “compassionate use” policy. The manufacturer BioMarin must also approve its use and has thus far refused to do so.
The impact she has had on others' lives is evident by the outpouring of support she has received through all of these channels. Whoever is doing BioMarin's social media will be quite busy over Labor Day because the petition is nearing its goal of 7,500 and Andrea is hoping to get an answer before her next doctor's appointment this Thursday.
Over the weekend Andrea released an open letter to BioMarin which you can read below the jump…Originially published at KXAN:
I'd like to ask you to imagine you're me, Andrea Sloan, for just a moment. You're a young woman of 45 with many of the most productive years of your life ahead of you. You've been fighting advanced ovarian cancer for seven years and defying the odds. You've endured five surgeries, three rounds of chemotherapy – the last so powerful it killed your bone marrow and caused you to need a stem cell transplant – two rounds of radiation and too many scans to count. You hear for a fifth time, “Your cancer is back.” The good news is your cancer is responsive. The bad news is your bone marrow can no longer tolerate traditional therapies greatly limiting your treatment options. But your doctor tells you about a breakthrough therapy – BMN 673 – that is showing great promise for women like you with the inherited BRCA1 mutation. This news fills you with HOPE. And then you're told you can't have it. What would you do?
I believe that most people would do what I'm doing and fight like hell to save their lives. I am a daughter, a sister, an aunt and a friend to many. I am an advocate for survivors of domestic violence and abuse. And I love animals, especially my horse, Heathen. My life matters to me and to the people I love. I owe it to myself to fight for my life, and I owe it to them.
I'm not asking for special treatment. I've exhausted all my other options. My world-renowned doctors at MD Anderson Cancer Center and executives at the FDA agree that I am an excellent candidate for compassionate use and that I qualify for single patient access. I was heartened to learn yesterday that you do embrace compassionate use policies, but disappointed that you don't have one for the drug I need. I find it perplexing that a company as innovative as BioMarin does not practice compassionate use across the board.
You said in your statement yesterday that you implement compassionate use programs only when you can ensure that they will not inhibit your plans for a disease. People get cancer. People with cancer need the compassion – not the disease. I respectfully implore you to consider the moral and ethical decisions as well as the business ones.
Earlier this year, CEO Jean-Jacques Bienaime told your shareholders, “We are pleased with the momentum of the BMN 673 program because of maturing and improving responses, completed positive regulatory discussions and earlier phase 3 timelines than originally anticipated.” BioMarin Chief Medical Officer Hank Fuchs, M.D., has said BMN 673 has potential to be “the best-in-class PARP inhibitor” and “appears to have superior potency, selectivity, and bioavailability as compared to other products in development.”
I agree. I believe.
A drug study with advanced timelines and presentations at the premier oncology conferences in the world is a serious indication of safety, efficacy and success. I offer my sincere congratulations on your progress with the BMN 673 study. It's not my intention to cause you grief or be a burden. I'm enormously grateful to you for creating this drug. I want to sing your praises and serve as a living beacon of hope to other women facing an ovarian cancer diagnosis.
I appreciate your consideration of my request for a single patient access compassionate use exemption of BMN 673. I respectfully ask you to make the right decision – the ethical decision – and help me in my effort to save my life.