AUSTIN (KXAN) - Andrea Sloan has dedicated her life to helping others. And now she's fighting to save her own life.
It's a fight against time and a fight against a company's rules that are keeping her from obtaining an experimental drug that has shown great promise for people like her who have ovarian cancer.
But it's not a fight Sloan is waging alone, and not one she's waging with bitterness.
“I do have that peace that surpasses understanding,” Sloan told KXAN at her modest downtown Austin office. “I have been fighting hard for seven years, but I've also been living this unbelievably incredible and blessed life.”
Sloan is a respected attorney and the executive director of Texas Advocacy Project, where she and her staff fight for victims of domestic violence.
"We help women who are experiencing violence in their homes,” Sloan said in front of the mural painted on her wall displaying the words Peace, Hope, Faith, Courage, Freedom, Empowerment and Love.
Sloan has amassed an army of support and many of her supporters who have joined her quest to persuade the pharmaceutical company, BioMarin, to allow her access to an investigational drug called BMN 673.
In clinical trials, the drug has shown success in patients with Sloan's type of BRCA 1 ovarian cancer. In fact, the chief medical officer, Dr. Hank Fuchs, Chief Medical Officer of BioMarin said in a July BioMarin news release:
"The data emerging from the ongoing study is progressively more encouraging."
In early stages of clinical trials Fuchs said in 2011 BioMarin news release:
"BMN 673 appears to have superior potency, selectivity, and bioavailability as compared to other products in development."
Living with cancer
Seven years ago at age 37, Sloan was diagnosed with Stage 3C ovarian cancer. Since then she's been through two full rounds of chemotherapy, five surgeries, a stem-cell transplant, and in February she completed her last round of radiation treatment.
But last month she learned the cancer had returned and it was time for her and her doctors to figure out how to fight it again. All other traditional cancer treatments had been exhausted. Then, one of her doctors at MD Anderson in Houston told Sloan they had found hope.
“She said, ‘This drug is amazing and this is the drug I wish I could give you.’ And once she said that, I'm getting that drug,” Sloan said.
BMN 673 is still in the investigational phase and not yet approved by the U.S. Food and Drug Administration. But BioMarin is conducting clinical trials of the drug with cancer patients at MD Anderson, not far from where Sloan is undergoing treatments.
In an email, the FDA told Sloan she qualifies for an expanded access, or "compassionate-use" exemption.
FDA regulations allow compassionate-use access to investigational drugs if the patient does not qualify for a clinical trial or has no comparable or satisfactory alternatives. Dr. Charles Levenback, Sloan's doctor at MD Anderson, said Sloan is a great candidate for compassionate use of the experimental drug.
But to get the compassionate-use exemption, the drug manufacturer has to approve it. The FDA can’t force a drug manufacturer to approve the exemption. And so far, BioMarin has denied Andrea access to the drug. In a letter last week, Fuchs told Sloan:
“We are not currently recruiting patients with ovarian cancer to clinical trials. We are evaluating whether to conduct additional clinical trials in ovarian cancer but have not come to a conclusion yet. And I can’t give you a time frame in which a conclusion might be reached. Similarly, we have not initiated expanded use trials of the drug. We are evaluating whether and when to conduct such trials, but have not come to a conclusion yet, and no time frame has been set for reaching a conclusion.”
Cancer patient information and resources:
In her interview with KXAN, we asked her what it's like knowing that there is a medication that could help her, but remains unavailable to her.
“That is hard to answer because that puts my heart in a place that I don't like my heart to be -- because I don't understand it and I know that people are basically good,” Sloan said. “I have to fight for this drug because I need it to save my life.”
She is not giving up, she told KXAN, “Because I have the best life of anyone I know and I have things to do."
BioMarin told KXAN that it does not comment on individual patients, but said in a written statement:
"It is too early to know if the experimental therapy is safe or effective, or will even prolong life, until we conduct the appropriate Phase 3 trials," the company said in its statement.
The statement also says BioMarin does "support preapproval compassionate use programs."
"We implement these programs when we have sufficient scientific evidence to support both the safety and the efficacy of a product for an indication" the statement reads. "Additionally, we implement these programs only when we can ensure that access will be provided equitably, ensuring that the process is appropriately blinded, and when we are confident that the expanded access will not inhibit our clinical trial plans or clinical trials for a disease generally," the statement continued.
Reaching out for help
For so many years, Sloan’s fight has been a quiet one. But now she, like so many she serves, needs help from others. She's reached out through social media to help spread the word about her situation and how she and her doctors feel the drug could help.
“I'm being public because my life matters to me and a lot of other people,” she said. “I don't want anyone that touches my life to think for a minute that I am out of hope or that I think this is the last of me. Or that anything has changed in the last three weeks since we started talking about it because it absolutely has not. I am going to win. I need the drug to help me do it.”
Sloan is getting a lot of help from supporters in the online campaign to convince BioMarin to allow her to be treated with their experimental drug. An online petition which has garnered thousands of signatures in only a few days will soon be delivered to BioMarin.
Yet despite being denied the drug her doctors believe could help save her life, Sloan is appreciative of BioMarin’s efforts and has not lost hope.
“I do want to thank the people at BioMarin for developing this drug," she said. "It’s amazing. I just want to be their poster child. I'm getting it or we are all going to die trying. I'm getting it.”
BioMarin is planning its next clinical trial for BMN 673 in late September but it's only for BRCA 1 breast cancer patients, not for ovarian cancer patients.
The BMN 673 inhibitor has shown to be promising not only for breast cancer and ovarian cancer patients, but has also shown good results in Leukemia and Lymphoma patients.
KXAN will continue to follow Andrea Sloan's fight for her life and BioMarin’s response to her plea for help.
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