HOUSTON (KXAN) - Andrea Sloan has been granted compassionate use of a drug doctors believe could help prolong her life, but it's not the one she fought publicly to get.
Sloan was diagnosed with ovarian cancer seven years ago, at age 37. When her cancer returned in August, Sloan asked California-based drug manufacturer, BioMarin, to grant her compassionate use of their experimental drug, BMN 673, developed specifically to fight her type of genetic ovarian cancer, as well as genetic, or BRCA 1, breast cancer.
But BioMarin repeatedly denied Sloan the drug, citing concerns about safety and effectiveness.
BMN 673 is one of nearly a dozen in a class of drugs called PARP inhibitors currently in clinical trials. Sloan's doctors at MD Anderson believe this class of drugs is her best hope, since all other traditional treatments have been exhausted. But BioMarin would not grant Sloan compassionate use, even though their drug is headed in to Phase 3 trials and has been highly touted by company executives for its results in the first two phases of clinical trials.
Sloan and her doctors fought publicly for access to the drug through compassionate use, since she met all of the criteria required by the Food and Drug Administration. The compassionate use system allows patients who meet the requirements access to promising medicine even before all of the clinical trials are complete.
Behind the scenes, Sloan and her physicians were exploring other avenues, as it became clear BioMarin would not grant her access to their drug. This week, they learned another drug manufacturer agreed to grant compassionate use of their experimental PARP inhibitor to Sloan.
"I am so incredibly grateful to MD Anderson and especially to Dr. Levenback and Dr. Coleman," Sloan told KXAN during an interview in Houston this week. "I have known from the first time I talked to you that I was going to get my miracle and its funny that it didn't come in exactly the packaging but it came in such better packaging."
The drug manufacturer who ultimately granted Sloan compassionate use wants to remain anonymous.
"I think some people like to do what they do in exchange for a lot of limelight and I think that we also have unsung heroes who just like to do what they do because its the right thing to do," Sloan said.
Sloan and her physician at MD Anderson, Dr. Charles Levenback, are determined to reform the compassionate use system for other patients.
"Everybody wants the same thing which is safe, effective, novel treatments for patients who, the standard treatments have been exhausted or arent working or becoming futile," said Levenback. "I've got to believe that there's an easier way and most importantly, that for really deserving patients, one party can't say no the way we experienced it."
As director of the Texas Advocacy Project, Sloan provides free legal advice for victims of domestic violence and knows about advocating for others. Her mission now is to advocate for others like her.
"My focus now is I'm just going to hold on to the gratitude that I'm feeling today so that I can use it to move forward and make some meaningful change in this area," Sloan said. "We need to hold companies like BioMarin, who have an absolutely abysmal record when it comes to compassionate use, we need to figure out a way to help them see that it's just the right thing to do if you're going to be a patient-centric company."
Sloan will begin her treatment immediately and her doctors hope to see some improvement in her condition in two to three months.
"Nobody has made any promises or guarantees, that would be inappropriate," said Levenback. "We strongly believe she could benefit from it and has a good chance of responding."
Sloan amassed a large social media following in her campaign to gain compassionate use. An online petition has garnered more than 180,000 signatures supporting her cause.
"We are pleased to hear this update from Ms. Sloan," a BioMarin spokesperson said. "We wish her the best in her journey."
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