Breast-Cancer Survivors Plead With the FDA for Avastin

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Dozens of women with late-stage breast cancer begged a federal panel Tuesday not to pull approval for their use of Avastin, a cancer therapy that has disappointed researchers but is keeping many women alive.

Some who testified before the Food and Drug Administration (FDA) advisory committee, in a hearing that is set to continue on Wednesday, argued that the group is effectively acting like a death panel: “I never thought that in the U.S., I would have to beg for a drug that’s keeping me alive,” said Patricia Howard of New York.

“What if I was your wife? What is I was your grammy?” Howard asked the six members of the advisory panel, five of whom were male, and all of whom looked elsewhere as she spoke.

A man pleaded, “Please just leave my dear wife alone.” His mic was switched off as he said, “This hearing is a death trial.” His allotted three minutes were up, but as a metaphor, the locked-in time limit did not work in the agency’s favor.

On Wednesday, the panel will vote on whether to revoke approval of the top-selling cancer drug for women with metastatic breast cancer. Although Avastin is commonly used to treat patients with colon, lung and brain cancers, the latest data show that on average it does not increase survival in women with late-stage breast cancer; the data also show that about 1% of patients taking Avastin with other cancer drugs die; that’s why a previous advisory panel voted in July 2010 to withdraw the drug’s approval for these terminally ill women.

But many patients and some cancer experts say that there is also data to suggest that the drug extends life for a minority of late-stage breast cancer patients, known as “super-responders.” And if you happen to be one of the roughly 17,500 patients in the United States for whom the drug is working, you don’t really want to hear that your experience is statistically insignificant.

In December, the FDA’s Center for Drug Evaluation and Research proposed rescinding Avastin’s breast-cancer approval. But in an unusual move, the agency relented and scheduled this two-day hearing ahead of a final decision, following an appeal from Genentech-owned Roche, which manufactures the drug, and pushback from survivors, who showed up on Tuesday in every shade of pink.

In the aggregate, “there is no evidence that Avastin saves or extends lives,” said Patricia Keegan, of the agency’s Office of Oncology Drug Products. The FDA’s director of the Office of New Drugs, John Jenkins, said approval should be revoked, for now anyway, because the drug is so risky.

Beth DuPree, a Pennsylvania breast cancer doctor who as a surgeon does not prescribe Avastin but does have patients who are on it, mocked the supposed scariness of the 1% chance of death from the drug — for use by women with a 100% chance of dying of Stage 4 breast cancer. “It sounds bad to say,” she told me outside the hearing, “but if you take the drug and it doesn’t work for you, you die right away,” not because of the drug, but because of the cancer.

DuPree said she has had patients get a couple of extra years of life as a result of Avastin since it was provisionally approved — pending further clinical-trial data — for patients with late-stage breast cancer in 2008. Since then, Roche has failed to prove that it sufficiently extends or improves the quality of life for women with terminal breast cancer. Yet, for some reason, it does seem to help a minority of patients.”I had one woman who got to watch her child go from 12 to 14″ because of Avastin, DuPree said. Is that a big deal? If you’re that woman or her child, of course, that’s not even a serious question.

Nancy Haunty, a 41-year-old who showed the panel a photo of herself climbing Mount Adams in Washington State last year, said she has been symptom-free for the entire 21 months she’s been on the drug. Crystal Hanna, a 35-year-old mom from Parkersburg, W. Va., said all she’d gotten out of being on it so far is the chance to see her child baptized, to travel with her family to Disney World, and to attend her brother’s wedding. “Every moment is important to us,” she told the panel, adding that if the FDA does withdraw its approval for use by women with late-stage cancer,” my insurance won’t pay and I can’t afford it.” Avastin is one of the most expensive drugs in the world, at $2,000-$3,000 a monthly dose.

Shannon Morgan, of Charlotte, N.C., brought her husband and oncologist with her to the hearing, where she testified that Avastin has “even given me times I don’t think about cancer.”

A young nurse named Elizabeth Cleary admonished the panel, “We’re talking about cancer — not growing our eyelashes or having more satisfying sex lives.” Her doctor, Stanley Waintraub, followed her to the microphone and yelled, “These women would actually die if you withdraw Avastin from the market! Look at Elizabeth! Does she look sick? I humbly beg you,” not to go through with the planned withdrawal of approval, he said.

Since the drug would remain on the market for other uses, doctors would still be able to prescribe it for advanced breast-cancer patients regardless of what the FDA decides. The problem, though, as Hanna pointed out, is that many insurance companies would not likely continue paying for a treatment that is not government-approved.

The handful of those who told the panel that the drug is too risky to stay on the market for breast-cancer patients got rough treatment from others in the crowd of cancer survivors and their families. Helen Schiff, an advocate for breast and ovarian cancer patients, told the panel, “We wanted it to succeed, but we have to admit it didn’t.”

Christine Brunswick of the National Breast Cancer Coalition said the drug raises false expectations and is simply too dangerous: “We now know that women died because of this drug.”

But that’s not what the majority wanted to hear; the speaker after Brunswick began by saying, “I’m completely disgusted to have to follow someone like that,” and a man in the crowd shouted, “She wants to tell all the fine women in here they have to die.”

This is the first time the FDA has considered an appeal from a drug company. Roche’s Avastin sales total almost $6 billion a year, $1 billion of that in the U.S., and the company has petitioned the FDA to keep the drug available to late-stage breast cancer patients while it does further study.

In the end, it will be up to FDA Commissioner Margaret Hamburg to decide whether or not to follow the panel’s recommendation, as FDA commissioners generally do. Cost-containment is not supposed to be taken into consideration, but if the FDA does withdraw its approval, the Obama appointee will be accused of putting potential savings to Medicare ahead of the lives of the women who appealed to the panel on Tuesday.

I covered Hamburg when she was New York City’s Health Commissioner in the mid-1990s, and put the likelihood that she would decide on that basis at zero, give or take. She won’t be swayed by emotional appeals from survivors, either, myself included; her job is to evaluate the science. But can 17,500 women really be anecdotal?

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