Drawing a line on medical costs
7. FDA revokes approval of Avastin for breast cancer
Avastin remains on the market to treat other cancers, but the Federal Drug Administration reported it appeared to be a false hope for breast cancer. Studies found the drug did not help breast cancer patients live longer or provide enough other benefits to outweigh the potential side effects. Doctors are allowed to prescribe the drug as they see fit, but many insurers will not cover a medication revoked by the FDA.
breast cancer.
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Credit: AP/2011
The difficulty of getting the health care industrial complex to cut back on unwise spending now has a compelling example: Avastin.
In 2008, the Food and Drug Administration approved the drug for patients with advanced breast cancer, even while testing continued. On Friday, however, despite tremendous pressure, the FDA revoked this approval of Avastin.
The federal regulator found that the drug offered false hope. Later studies determined it had minimal benefits for a small group of patients and that those benefits were outweighed by serious side effects such as heart attacks, severe high blood pressure and hemorrhaging. The drug, which costs $100,000 a year per patient and had $6.2 billion in sales last year, is still approved for other cancers.
Just a few days later, however, private insurers and Medicare announced they will still pay for Avastin for breast cancer. A decision made on scientific and medical evidence by one federal agency is being disregarded by another to avoid the political and consumer blowback.
Medicare's drug coverage is not determined by the FDA, but instead by advisory panels of experts in those diseases -- some of whom may have ties to the pharmaceutical firms making the drugs.
The Avastin case is wrenching. Most who received it were not helped; some were even harmed. For a few patients, it has extended their lives, a priceless gift. For the rest of society, it is one we can no longer afford.
