Aug. 22It's no surprise Patricia Howard is a champion of the cancer drug Avastin. The Long Beach resident, who has been battling advanced breast cancer since 2006, has responded well to the medication that has transformed her life.
But Avastin is embroiled in a national debate so fierce it touches every hot-button issue in today's supercharged medical policy arena patients' rights, exorbitant medication costs, and questions about curbs on medical spending.
A retired art teacher, Howard, 65, wants the U.S. Food and Drug Administration to ignore the recommendation of its cancer-drug advisory panel, which last month voted 12-1 to withdraw Avastin's approval for advanced breast cancer, a disease that's incurable but can be kept under control with treatment.
Avastin was approved conditionally for the disease two years ago on an FDA fast track but with a caveat: New rounds of research needed to show Avastin extends lives. But when results were reported in July, statistics revealed no boost in overall life expectancy. Worse, Avastin caused hemorrhaging, high blood pressure and kidney problems in some patients.
FDA's top officials have until Sept. 17 to accept or reject the panel's recommendation. While the agency rarely goes against its experts' advice, Howard is hoping that, in this case, it does. She's involved in a letter-writing campaign and e-mailing anyone who'll hear her plea.
"I get infused with this drug every three weeks and I can tell you this: My quality of life is beyond fabulous," said Howard, whose cancer returned in 2006. Cancer-free since the early 1990s, she has been on Avastin since 2008 and also takes the anti-cancer drug Xeloda.
"I have enjoyed the birth of two grandchildren, with another one on the way. I go shopping with my girlfriends; I play golf. I have been married 43 years and I hope to have many, many more anniversaries."
She has responded robustly dramatically to Avastin. Fluid that made breathing difficult disappeared. Tumors in the protective lining of a lung shrank. Scientists have no way of identifying patients like Howard, who are considered "super-responders," subjects who benefit the most from certain medications.
However, similar responders were noted with the now-embattled lung cancer drug Iressa. Some patients experienced notable tumor shrinkage, while others received no benefit. The FDA, nevertheless, placed strict limitations on Iressa in 2005 because it didn't help most patients live longer.
Benefit vs. cost, side effects
Avastin isn't cheap. It can run as high as $88,000 a year. Howard's treatment is paid by Medicare and supplemental health insurance. The drug's maker caps costs at $57,000 annually for people earning less than $100,000.
Manufactured by Genentech, Avastin is the best-selling cancer drug worldwide. Approved for colon cancer in 2004, it's also approved for lung, kidney and brain cancers. Avastin is a so-called targeted therapy, designed to block tumor blood vessels, cutting off their nutrient supply. Regardless of the cancer, Avastin is always used in combination with chemotherapy to produce potent anti-tumor activity. Scientists can't yet determine whether Avastin alone or its combination with other drugs causes tumors to shrink.
If the FDA rescinds Avastin's approval for advanced breast cancer disease that has spread it's likely insurers will halt coverage. Doctors, however, would be able to prescribe it off-label, which means recommending it as they see fit, but patients would have to pick up the costs. "If it's off-label, none of us will have coverage from our insurance companies," Howard said.
Much of Avastin's opposition comes from major breast cancer advocacy groups: The National Breast Cancer Coalition and Breast Cancer Action, among others. They cite Avastin's side effects, high cost and limited cancer-fighting benefits for most women.
Musa Mayer, an advocate in Manhattan who runs AdvancedBC.org, an online community of 1,500 women with metastatic breast cancer, has written to the FDA calling on officials to revoke approval.
She likens the clamor for Avastin to women in the 1990s who rallied behind bone marrow transplants for breast cancer, which proved expensive and deadly. Mayer says some members of her online community have experienced Avastin-related side effects but patients, she said, place hopes in the latest treatments. "The public perception is that any new drug is a good drug," said Mayer, a breast cancer survivor.
In testimony to the FDA, a Genentech researcher Sandra Horning said the drug had been given to more than 90,000 breast cancer patients, which gave "confidence in the safety of Avastin."
Varying results on patients
Studies presented to the FDA showed only modest boosts in so-called "progression free survival," the amount of time patients gain while under treatment without progression of the disease, or death. Some women died while on Avastin, but its maker attributed the deaths to breast cancer, not the drug.
"Yes, women do die while on the medication that does happen," said Howard, who participated in one of the clinical trials. "Yes, some women do not get past the first year. But some of us are thriving."
Some scientists are calling for screening tests to determine which patients will thrive, like Howard, on Avastin.
Great Neck oncologist Dr. Francis Arena, who specializes in breast cancer, has prescribed Avastin to many patients. "I think this is a travesty, a real crime that women might lose this drug," he said. "Every medical oncologist has a patient on an Avastin protocol who has done extremely well. Money has become the biggest issue here, which is why there has been an incredible problem. They're shoving the doctor-patient relationship aside."
Howard served as a patient representative at the FDA meeting last month. "I was the lone soldier speaking for patients who need this drug," she said.
"One doctor got up during the meeting and said, 'This drug gets women only to first base and we want a home run,' " she said. "I felt like jumping up and saying I don't mind just being in the ballgame. I am alive."
A LOOK AT AVASTIN
Avastin is the best-selling cancer drug in the world, with global sales of $5.4 billion. About $5.8 million is for advanced metastatic breast cancer.
Avastin is also among the most expensive cancer drugs worldwide, costing about $88,000 for a year's treatment. About 17,500 women receive the medication for advanced breast cancer.
It was first approved by the U.S. Food and Drug Administration in 2004 for metastatic colon cancer. It has since garnered federal approvals for lung, kidney and brain cancers.
Avastin is a genetically engineered protein that blocks the signals tumors generate to grow blood vessels, which tap into the patient's blood supply and draw nutrients to fuel tumor growth.
Cancer drugs that act on a single mechanism that drives cancer growth are popularly known as "targeted therapies."
Avastin has side effects: It can be toxic to the kidneys, cause blood clots that lead to heart attacks and strokes, increase blood pressure, and cause bleeding in the stomach and bleeding and perforations in the intestines.
The FDA approved Avastin as a treatment for advanced breast cancer in 2008 under its "accelerated approval" program, designed to speed drugs to desperate patients. The approval came with the stipulation that more research was needed.
An FDA advisory panel of outside experts last month voted 12-1 to withdraw the drug's approval for advanced breast cancer because new research showed it did not extend patients' lives. The FDA will decide around Sept. 17 whether to accept the panel's decision.
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