What happens when a pharmaceutical drug works, but the side effects are also devastating? That’s the question the Food and Drug Administration is weighing as it considers what to do about Avastin, the widely popular anti-cancer drug, which has produced widely varied results—shrinking tumors in some patients and causing severe damage to vital organs in others. The FDA last month announced it was withdrawing approval of the drug for treatment of late stage breast cancer. Doctors can still choose to prescribe it off-label, since it remains approved for treatment of colon, lung, brain and kidney cancers, but Medicare and private insurance carriers who use FDA approval to guide their coverage policies may decide against paying for it. At about $8,000 a month, it’s unlikely many patients could afford it on their own. Meanwhile, Avastin’s fate has already divided the breast cancer advocacy community—pitting Susan G. Komen for the Cure against other leading groups like the National Breast Cancer Coalition, which applauds the decision. How does the FDA weigh the benefits and risks of a drug before approval and, once it’s on the market, should it deny approval for risky, expensive treatments?
Dr. Susan Love, President and founder of the Dr. Susan Love Research Foundation and Clinical Professor of Surgery at UCLA’s David Geffen School of Medicine