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

cancer clinical trials cost healthcare costs healthcare reform

Why You Should Ration Your Healthcare

Questions and Answers signpost A few months ago my 72-year-old mother told me she was having a CT scan because she had a lot of back pain. Her doctor thought it was a bulging disc. Given her age, it was most likely related to degenerative disc disease, i.e., old age. He had already prescribed physical therapy and some anti-inflammatories.

So why, I asked her, are you having a CT scan? How would your doctor’s treatment plan change based on what the CT shows? Are you going to have surgery? Take stronger drugs?

She couldn’t answer. She couldn’t answer because she never asked the questions. Just as she never asks her doctors why they prescribe one medication over another, or why they recommend knee arthroscopy for her aching joint (which studies find no more effective than conservative medical treatment) instead of knee replacement (which studies find extremely effective both from a medical and a cost perspective because it keeps keep older people active, reducing the risk of additional medical problems and improving their quality of life).

Now, this is not to pick on my mother … Continue Reading

cost managed care rationing