FDA Considers Withdrawing Cancer Drug Avastin for Safety Concerns, Lack of Efficacy

By December 23, 2010Dangerous Drugs

A recent FDA decision got my attention as a dangerous drug attorney, even before it became a political issue. As the Los Angeles Times reported Dec. 17, the U.S. Food and Drug Administration has started the process to revoke its approval of the drug Avastin (bevacizumab) as a treatment for breast cancer. In a safety alert issued Dec. 16, the agency said four clinical studies showed Avastin had serious side effects but didn’t seem to prolong patients’ lives or slow their diseases. The side effects cited included heart attack and heart failure; development of holes in the intestines, stomach and nose; strokes; and hemorrhage. The drug is not yet withdrawn from the market, but may be after further FDA action and an expected appeal from Genentech, its manufacturer. Avastin is still approved for colon, kidney, brain and lung cancers.
Avastin was approved in 2008 for metastatic breast cancer using the FDA’s “fast-track” approval process, which allows drug manufacturers to skip the testing and approval process if their drugs meet a need not currently being met, or have major advantages over existing treatments. Avastin’s placement in this category was controversial, because the advisory council voted against approval on the grounds that it didn’t improve patients’ survival. In July, another panel came to the same conclusion and recommended on a 12-1 vote that the drug be withdrawn. The FDA’s most recent action came after four clinical trials showed no benefit and significant risks to the drug when used in breast cancer patients. Avastin has also failed to pass muster with the British National Health Service, which found no evidence in its own trials that Avastin extended patients’ lives.
The FDA’s most recent action has become politicized, with conservatives calling it an example of “rationing” health care and breast cancer advocates calling for insurance companies to continue covering the drug off-label for patients it seems to help. As a defective drug lawyer, I sympathize with concerns that a life-prolonging drug could be taken away from patients who desperately need it. However, the scientific evidence doesn’t seem to support the idea that Avastin is a life-prolonging drug. In fact, from the very start, all of the studies on this drug have suggested the opposite — that Avastin seems to actually hurt other parts of breast cancer patients’ health. The FDA doesn’t save money by taking drugs off the market, and it’s unclear what effect this might have on Medicare, so there’s reason to think the FDA’s action is an attempt to save money. However, Avastin costs about $100,000 per patient in the U.S. and generated $2.7 million in sales for Genentech in 2008, so it’s clear that the manufacturer and its allies have a financial incentive to keep it on the market.


Carey, Danis & Lowe represents people who have suffered serious illnesses or injuries as a result of taking medicines that were supposed to help them. Unfortunately, this is not uncommon. As the stories of Avastin, Vioxx and other drugs suggest, the FDA is willing to approve drugs with serious side effects, even when its own scientific and medical advisors object. Under the law, drug companies are just like any other manufacturer — they can be held legally liable for serious injuries their products cause through safety flaws or failure to warn patients about serious risks. Our pharmaceutical liability attorneys help patients in this situation assert their legal rights, through individual lawsuits or class actions. In a drug liability claim, patients can win compensation for all of their medical costs; lost income from missing work due to illness or injury; and compensation for the loss of a loved one or a permanent disability.
If you were hurt after taking a medicine you thought you could trust, don’t hesitate to contact Carey, Danis & Lowe for help. To learn more or set up a free consultation, call us today at 1-877-678-3400 or send us an email.