Avastin faces FDA approval hearing again
People who believe that Avastin saved their lives are appearing before the FDA at a rare appeal hearing, hoping the drug will be approved.
Thu, Jun 30, 2011 at 08:22 AM
AVASTIN: Headquarters of Swiss pharmaceutical giant Roche in Basel, Switzerland in 2005. Their breast cancer drug Avastin is under scruinity by the FDA. (Photo: ZUMA Press)
SILVER SPRING, Maryland - She made her doctor repeat it several times: There's nothing there. There's nothing there. There's no evidence of cancer.
Last May, after four years of battling breast cancer — cancer that infested the lining of her lungs with tumors and had her siphoning off built-up fluids through a tube and feeling like she "got hit by a bus" from chemotherapy — Patricia Howard sat in her doctor's office in New York, stared at her CT scan and cried.
"It's nothing short of miraculous to have your doctor tell you you don't have cancer," said the feisty 66-year-old retired art teacher, a New Yorker now living in Summerfield, Florida.
"He was jumping up and down, we were hugging ... it almost takes your breath away."
Howard has been one of the women taking the Roche Holding drug Avastin for several years, one of its most outspoken proponents and one of the women left at a loss on Wednesday when U.S. health advisers rejected the medicine's use for breast cancer.
"I'm mulling it over, I'm kind of like ... numb," she said with a pause. "My only alternative is hardcore chemo."
After several years of studies, U.S. Food and Drug Administration advisers found the drug's benefits too murky to outweigh its risks.
Howard was there standing in front of the panel last July when it first rejected the use of Avastin in breast cancer, the lone representative of some 17,000 women using the drug.
She was also standing there this week at a rare appeal hearing, flanked by a handful other women who presented tearful testimonies of how they believe Avastin saved their lives.
"We could die if we get off this drug. I believe that strongly in Avastin," she said.
"I can't walk away super angry, I'm mostly just confused. I don't know who to blame."
Doctors may choose to keep prescribing Avastin without FDA approval, but insurers and government health programs likely will stop covering the drug, which comes with a hefty pricetag of $8,000 a month, or $96,000 a year.
Worried about losing access to the drug, Howard has already written to her oncologist. She writes a lot of letters. She said she wrote to Dr. Karen Midthun, the FDA officer presiding over the Avastin hearing, requesting the hearing be open for public testimony.
She also wrote to golf champion Phil Mickelson, whose wife was diagnosed with breast cancer, and to Oprah Winfrey, hoping to raise awareness about Avastin's troubled fate.
"There are women sitting at the doctor's office as I go into (Avastin) infusions, who don't know anything about it and one day, their doctor is just going to say, 'whoops, you can't have it anymore.'"
Howard was first diagnosed with metastatic, or spreading, cancer after breaking a rib while playing golf in 2006. Since then, first combining Avastin with chemotherapy injection and now with chemotherapy pill Xeloda, also by Roche, she saw the birth of three grandchildren — and still golfs.
"I have an infusion on Tuesday and I have to go into this infusion with an open heart," she said.
"Sweetheart, it's my life we're talking about here."
(Reporting by Alina Selyukh; Editing by Gary Hill)
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