They already fight for their lives every day – all women diagnosed with stage-4 breast cancer – but their struggle seemed to grow more desperate this month 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 – but if the federal agency withdraws approval for stage-4 breast cancer, Avastin would become an “off label” drug for Morgan and Fleming. They fear health insurance companies, Medicare and Medicaid will no longer pay for them to get Avastin, which is a very expensive drug – 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.”
Morgan lashed out with repeated e-mails this month – some with all the words in capital letters – 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 Saudi Arabian husband-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.
The trials done so far, federal officials say, do not show Avastin made a significant difference for most women patients and had serious side effects. In July, a medical advisory committee to the Food and Drug Administration voted 12 to 1 to withdraw federal approval for Avastin for the treatment of stage-4 breast cancer. In the fall, federal officials delayed a decision on Avastin, giving hope to Charlotte women who have reacted well to the drug. At the time, Dr. John Powderly, a Charlotte-area oncologist/researcher, said he hoped federal officials would give researchers more time to figure out why Avastin works so well for women like Shannon Morgan and Carol Fleming and not for others.
But this month, 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 (or ‘holes’) 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 doctors should watch their patients closely and take them off Avastin if they see those problems. That’s still not a reason to deny evidence that Avastin has prolonged the lives of thousands of other women, including his wife, Shannon, 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.
“Should oncologists be limited in providing life-saving procedures? Is this even America? I understand a petition will be forwarded to your office tonight with thousands of comments from women whose lives are being saved by Avastin. And think of all the others that were never exposed to this petition.”
Politics is trumping medicine, Pat Morgan said. Pressure from “Obama care” to reduce health-care costs, including expensive drugs, prompted federal administrators’ action, he believes. Ironically, Morgan points out, 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.”