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Dying by the FDA's Rules

For patients dying from a terminal illnesses, sometimes the only comfort they have is being able to choose the manner in which they ‘check out'. A variety of treatments mean that patients can decide the best course of action, medically and psychologically for themselves and their families. They get to decide, that is, unless regulation gets in the way. As reported today, the FDA is hinting that it will not approve the drug Avastin for use in breast cancer patients (currently approved for colon and lung cancer). Avastin is used for people with metastatic cancer—cancer that is spreading. While it did not appear to significantly lengthen the lives of those in the trial, it did double the time they had before the cancer spread or got worse. But there are side-effects including heart problems, bowel perforation, and death (5 of the 722 patients died). The FDA hinted that the benefits of Avastin were not great enough to outweigh the risk. But who is the FDA to make that judgment? Each person values different things for different reasons. While someone on the FDA might find little value in improving the time before you die, for the women and families of women with metastatic breast cancer (who live an average of 24 months) the potential benefit is immeasurable. We should not let the FDA tell us what to value in life.