FDA Avastin Decision Potential Death Sentence to Breast Cancer Sufferers (ContributorNetwork)

COMMENTARY | After an exhaustive hearing, the Food and Drug Administration has delivered what may well be a death sentence to a number of women with advanced stage breast cancer. Avastin will no longer be approved for the treatment of breast cancer.

The position of the FDA is Avastin has a number of serious side effects. At the same time in the view of the FDA, it does not prolong life or the quality of life for most women. Those few women for whom Avastin has had some life extending benefit are out of luck. The fact Avastin in tandem with some chemotherapies has had positive results is also not well understood. Since it is not known why some women respond positively to Avastin, the FDA has told them, in essence, that they can drop dead.

The Avastin drama began in 2008 when Avastin was approved for treatment of women with end stage breast cancer on a fast track basis. Avastin works by choking off blood flow to tumors, thus stopping their growth. It had already been approved for colorectal cancer and lung cancer.

Then, as further studies suggested that Avastin did not have benefit for most women, an advisory panel of the FDA abruptly voted to rescind its approval. This meant that it was likely that the $100,000 a year drug would not been covered by private insurance or Medicare. Thus the decision was a death sentence for those women who were responding positively to the drug. The decision taken Friday was final, pending the results of further studies.

The Wall Street Journal is pretty sure the FDA decision has more to do with an assertion of regulatory power over the private sector than it does from sound, medical evidence. The suggestion is made that Avastin should remain an option, to be prescribed by oncologists using their informed judgment and not restricted by government bureaucrats.

Fortunately Genetech, the drug's manufacturer, will conduct clinical trials to determine which biomarkers determine who will respond to Avastin and who will not. Avastin will also still be covered, for now, by Medicare. But the FDA's decision is still a chilling example of the effects of state power and regulatory zeal over the lives-and deaths-of real people.

Source: http://us.rd.yahoo.com/dailynews/rss/health/*http%3A//news.yahoo.com/s/ac/20111119/us_ac/10479629_fda_avastin_decision_potential_death_sentence_to_breast_cancer_sufferers

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