Fed decision on Avastin dismays stage-4 breast-cancer patients

by Frank DeLoache

They already fight for their lives every day – all women diagnosed with stage-4 breast cancer – but their struggle seemed to grow more desperate last week when the U.S. Food and Drug Administration said it will no longer approve the cancer drug Avastin for use against breast cancer.
The decision deals physical and financial blows to women like south Charlotte’s Shannon Morgan and Huntersville’s Carol Fleming.
Though their cancer is incurable and inoperable, it is not untreatable, and Avastin has all but eliminated the presence of new cancer cells in both women’s blood tests. Now, they face the prospect of losing access to their own miracle.
Federal officials continue to approve Avastin for treatment of other forms of cancer – colorectal, lung, kidney and brain cancers. With the change, Avastin becomes an “off label” drug for breast cancer treatment. Morgan and Fleming fear health insurance companies, Medicare and Medicaid would no longer pay for Avastin if it’s not an approved treatment. The drug costs about $100,000 a year.
“I’m disappointed, angry and disillusioned,” Pat Morgan, Shannon’s husband, said last week. “It makes me ashamed of my country, to be an American.”
Pat Morgan has lashed out with repeated e-mails last week to any federal, state or local official who will listen.
“You FDA (Food and Drug Administration) autocrats are the worst kind of homegrown terrorists, and may God have mercy on your spineless souls,” he said. “You just imposed genocide on my wife and tens of thousands like her. We will now possibly be forced to sell everything to continue her life-giving treatments. And to prove what cowards you are, I know you will not respond to me as you never have even once since July.”
Fleming is a former American diplomat who lost all her financial resources when her husband, a Saudi Arabian diplomat, died of cancer in 2009. She has been slowly rebuilding her life here but depends on Medicaid to pay for her medicine.
“I’m sure I am typical of many of the women who rely on Avastin,” Fleming said in an e-mail in recent days. “I have not slept since hearing the FDA’s decision. I don’t want to go back to chemotherapy, which debilitated me, if there is a drug like Avastin which is not only working for me but allowing me to have some quality in my life, too.”
Since Avastin works so effectively against other cancers, federal officials gave it accelerated approval as a treatment for breast cancer in 2008, while still requiring trials to measure its effectiveness.
But last week, following a year of back and forth decisions on the drug, the agency announced it would withdraw approval for Avastin “after reviewing the results of four clinical studies of Avastin in women with breast cancer.”
“The data indicate that the drug does not prolong overall survival in breast cancer patients,” the announcement said, “or provide a sufficient benefit in slowing disease progression to outweigh the significant risk to patients.
“These risks include severe high blood pressure; bleeding and hemorrhage; the development of perforations in the body, including in the nose, stomach and intestines; and heart attack or heart failure,” agency officials said.
Pat Morgan acknowledges that some women may experience side effects from Avastin, but thinks doctors should watch their patients closely and take them off Avastin if they see side effects. That’s still not a reason to deny evidence that Avastin has prolonged the lives of thousands of other women, including his wife, he said.
“My wife’s CTC (cancer) markers remain at zero after more than two years (approx) on Avastin,” Pat Morgan wrote, “and she has the energy of a young girl, even going to work after treatments. Side effects are minimal, and in addition, along with the outstanding care of her oncologist and staff, she knows she is blessed to have such treatments and drugs available.”
Politics is trumping medicine, Pat Morgan said. Pressure from recently passed healthcare legislation to reduce health-care costs, including expensive drugs, prompted federal administrators’ action, he believes. Ironically, Morgan points out, that European medical authorities announced last week that they will maintain approval of Avastin for stage-4 breast cancer. The New York Times reported the European Medicines Agency, operating under different rules but with the same data, left Avastin available to breast cancer patients but in a narrower way.
Genentech, Avastin’s manufacturer, says it will appeal the Food and Drug Administration ruling on Avastin, but that may delay the official action only a matter of months.
In the meantime, Carol Fleming and others are trying to make their voices heard.
“I am willing to speak out to any media source about this FDA decision travesty,” she said. “I have already written about this decision on my daily blog as well as posting to Facebook. I think those of us who are being ambushed by this decision should use every venue available to speak out and spread awareness on the impact of this decision.”

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