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- Posted: Fri, 13 Sep 2013 17:24:00 +0000
Imagine being terminally ill and told that the one thing that might save your life is just out of reach.
For Andrea Sloan, that's a reality. The 45-year-old is suffering from stage 3 ovarian cancer, and she’s launched a social media campaign in the hopes of convincing a pharmaceutical company to give her a drug that’s in the early stages of development.
Sloan is an attorney and executive director of the Texas Advocacy Project, an Austin-based group that offers free services to victims of domestic violence. At the age of 37, after visiting her doctor for intermittent abdominal pain, she received devastating news. “My doctor told me that I had stage 3 ovarian cancer,” Sloan told Yahoo Shine. “Three years later, I learned I had inherited the BRCA1 gene.” The gene leads to a heightened risk of breast and ovarian cancer (65 percent and 39 percent, respectively).
One week after her diagnosis, Sloan began treatment—chemo, surgery to remove the cancer, a hysterectomy — and her cancer went into remission for a full 22 months. However, over the next five years, the cancer went in and out of remission. And in July, when it returned for the fourth time, her doctor informed Sloan that she was running out of options. “We had the conversation where he told me to get my affairs in order. However we both weren’t ready to give up,” said Sloan.
Andrea Sloan/Facebook Her physician, Charles Levenback, M.D., at the University of Texas's MD Anderson Cancer Center in Houston, TX, said Sloan had one possible shot: A drug called BMN-673 was being developed by a company called BioMarin and although it wasn’t yet FDA-approved or tested for ovarian cancer, it might save Sloan’s life — if the company allowed her to use it by way of a policy called “compassionate use.” In certain situations, the Food and Drug Administration (FDA) allows companies to give experimental drugs to people in life-or-death situations, although companies aren’t required to comply.
The only problem: BioMarin won't let Sloan use the drug.
“The drug is BioMarin’s intellectual property so the company is within its rights to not permit usage and there is rationale behind it — if, for example, Andrea suffers from side effects, that could deny or prevent the drug from being approved,” Levenback told Yahoo Shine. “However, we already know the drug works on other types of cancer so it’s not a shot in the dark. It’s definitely worth trying and would likely work — BioMarin just has to let her use it.”
And the FDA agrees. Says Sloan: “They’ve said that I’m qualified for ‘compassionate use’ and have no concerns about me taking BMN-673. The hold up is with Biomarin. I’ve begged through letters and emails; I’ve even sent them photos of myself to show that I’m a real person in desperate need and offered to be their spokesperson if the drug is effective.”
Clearly, Sloan isn't giving up — and neither are her friends. The Facebook page “Andi’s Army,” originally intended to be a community for Sloan’s close friends, has exploded with almost 3,000 likes and a Change.org petition is circulating, garnering over 50,000 signatures over the last few weeks. Sloan has even attracted the attention of high-profile politicians. Former U.S. representative Newt Gingrich wrote an essay called A Sick Bureaucracy on Sloan’s battle to obtain the drug from BioMarin and posted it on his Gingrich Productions website. And the politician made a phone call to BioMarin to urge them to reconsider. So far, nothing has worked, however Sloan is working with various politicians on legislature that benefits both companies and patients.
A rep for BioMarin emailed the following statement to Yahoo Shine: "We empathize with anyone facing a terminal illness. As a company, we strongly support pre-approval expanded access programs. We implement these programs when we have sufficient preliminary scientific evidence to support both the safety and the efficacy of a product for an indication, which is generally after the successful completion of a well-controlled trial… BMN 673 is not sufficiently far along in the development process to implement expanded access in ovarian cancer….Although we have publicly reported that the initial data is promising, we do not yet have sufficient evidence that the compound is safe and effective."
However, Sloan is ready to take a risk: "I just want a chance to live a long and healthy life and I'll continue fighting until I get it."
Drugs
For Andrea Sloan, that's a reality. The 45-year-old is suffering from stage 3 ovarian cancer, and she’s launched a social media campaign in the hopes of convincing a pharmaceutical company to give her a drug that’s in the early stages of development.
Sloan is an attorney and executive director of the Texas Advocacy Project, an Austin-based group that offers free services to victims of domestic violence. At the age of 37, after visiting her doctor for intermittent abdominal pain, she received devastating news. “My doctor told me that I had stage 3 ovarian cancer,” Sloan told Yahoo Shine. “Three years later, I learned I had inherited the BRCA1 gene.” The gene leads to a heightened risk of breast and ovarian cancer (65 percent and 39 percent, respectively).
One week after her diagnosis, Sloan began treatment—chemo, surgery to remove the cancer, a hysterectomy — and her cancer went into remission for a full 22 months. However, over the next five years, the cancer went in and out of remission. And in July, when it returned for the fourth time, her doctor informed Sloan that she was running out of options. “We had the conversation where he told me to get my affairs in order. However we both weren’t ready to give up,” said Sloan.
Andrea Sloan/Facebook Her physician, Charles Levenback, M.D., at the University of Texas's MD Anderson Cancer Center in Houston, TX, said Sloan had one possible shot: A drug called BMN-673 was being developed by a company called BioMarin and although it wasn’t yet FDA-approved or tested for ovarian cancer, it might save Sloan’s life — if the company allowed her to use it by way of a policy called “compassionate use.” In certain situations, the Food and Drug Administration (FDA) allows companies to give experimental drugs to people in life-or-death situations, although companies aren’t required to comply.
The only problem: BioMarin won't let Sloan use the drug.
“The drug is BioMarin’s intellectual property so the company is within its rights to not permit usage and there is rationale behind it — if, for example, Andrea suffers from side effects, that could deny or prevent the drug from being approved,” Levenback told Yahoo Shine. “However, we already know the drug works on other types of cancer so it’s not a shot in the dark. It’s definitely worth trying and would likely work — BioMarin just has to let her use it.”
And the FDA agrees. Says Sloan: “They’ve said that I’m qualified for ‘compassionate use’ and have no concerns about me taking BMN-673. The hold up is with Biomarin. I’ve begged through letters and emails; I’ve even sent them photos of myself to show that I’m a real person in desperate need and offered to be their spokesperson if the drug is effective.”
Clearly, Sloan isn't giving up — and neither are her friends. The Facebook page “Andi’s Army,” originally intended to be a community for Sloan’s close friends, has exploded with almost 3,000 likes and a Change.org petition is circulating, garnering over 50,000 signatures over the last few weeks. Sloan has even attracted the attention of high-profile politicians. Former U.S. representative Newt Gingrich wrote an essay called A Sick Bureaucracy on Sloan’s battle to obtain the drug from BioMarin and posted it on his Gingrich Productions website. And the politician made a phone call to BioMarin to urge them to reconsider. So far, nothing has worked, however Sloan is working with various politicians on legislature that benefits both companies and patients.
A rep for BioMarin emailed the following statement to Yahoo Shine: "We empathize with anyone facing a terminal illness. As a company, we strongly support pre-approval expanded access programs. We implement these programs when we have sufficient preliminary scientific evidence to support both the safety and the efficacy of a product for an indication, which is generally after the successful completion of a well-controlled trial… BMN 673 is not sufficiently far along in the development process to implement expanded access in ovarian cancer….Although we have publicly reported that the initial data is promising, we do not yet have sufficient evidence that the compound is safe and effective."
However, Sloan is ready to take a risk: "I just want a chance to live a long and healthy life and I'll continue fighting until I get it."
Drugs
