Avastin and Breast Cancer

Time to get back up on my soap box.

Next month, the FDA is supposed to consider taking the unique, first-time-ever step of revoking a drug’s indication not because it’s dangerous, but because it doesn’t work well enough to offset its risks. Never mind that it costs about $8,000 a month.

The drug is Avastin (bevacizumab), a targeted monoclonal antibody that  prevents tumors from creating and maintaining their own blood supply, a process called angiogenesis. Without oxygen and nutrients from blood, tumors can’t keep growing.

Avastin is the world’s best-selling cancer drug, approved for use with chemotherapy to treat lung cancer and metastatic colorectal and breast cancer. It is also being investigated (and, likely, being prescribed off label) for numerous other cancers.

The problem comes with breast cancer. Avastin was approved for breast cancer under an FDA program called “accelerated approval” in which the agency provides “conditional” approval for a life-saving drug that appears effective so as to get it to patients quickly while requiring that the manufacturer conduct more studies demonstrating its long-term effectiveness. About 90 drugs have been approved under the accelerated approval program in the past 20 years and none has ever had its approval revoked (one … Continue Reading

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cancer clinical trials cost healthcare costs healthcare reform

Back Away from the Quacks!

breast cancerSo my cousin emailed me the other night. She had a breast cancer recurrence about 6 years ago. Before you feel too sorry for her, however, know this: She’s doing great, moving from one targeted treatment/chemotherapy/laser knife procedure to another. Her doctors are fabulous. Her attitude is amazing. And, as she constantly tells us, she feels great and is loving life. No, this isn’t about her. It’s about her friend, the one she emailed me about.

Her friend was diagnosed with an early stage of an aggressive form of non-small cell lung cancer a year ago. After chemotherapy, a CT scan this summer showed her lungs clear of cancer; but a followup CT scan last week showed some spots. This woman had participated in a clinical trial during her first round of treatment and her doctor wanted her to join another clinical trial. But my cousin’s friend is freaked out; she doesn’t want to feel like a “guinea pig.” So when her daughter suggested she see a doctor who specializes in an unproven and experimental therapy called insulin potentiation therapy, she was ready … Continue Reading

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alternative therapy cancer clinical trials quackery