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liveonearthThe drug is also known as Bevacizumab. It's not approved but Medicare is still paying for it. It's the #1 selling cancer drug on the planet, made by Genetech, Inc that is owned by Roche. Why was it removed from FDA approval? Because there's no proof that it extends life at all, and has potentially life-threatening side effects. The side effects possible include severe hypertension, hemorrhage, heart attack and failure, and gastrointestinal perforations. Avastin is considered a last ditch option for metastatic breast cancer patients.
Why was it approved in the first place? Your guess is as good as mine. Money, probably. The cost for a year's treatment is $100,000, and it is covered by medicare. How's that for a bailout? That bailout of course is for the pharmaceutical companies. Genetech, and a bunch of patients, are lobbying hard to keep the drug as an option. Genetech says it does work, when combined with traditional chemo, and so is appealing the FDA decision. I wonder how much cashola the FDA will get back during the appeals process. The FDA approval happened while studies were in progress to prove its efficacy--but those studies turned out to prove no such thing.
SOURCES
http://www.washingtonpost.com/business/fda-says-avastin-should-no-longer-be-used-for-breast-cancer-citing-no-proof-it-extends-life/2011/11/18/gIQAHJmHYN_story.html?wpisrc=al_national
http://www.ibtimes.com/articles/171447/20110629/avastin-breast-cancer-genentech-fda-drug-roche.htm
Why was it approved in the first place? Your guess is as good as mine. Money, probably. The cost for a year's treatment is $100,000, and it is covered by medicare. How's that for a bailout? That bailout of course is for the pharmaceutical companies. Genetech, and a bunch of patients, are lobbying hard to keep the drug as an option. Genetech says it does work, when combined with traditional chemo, and so is appealing the FDA decision. I wonder how much cashola the FDA will get back during the appeals process. The FDA approval happened while studies were in progress to prove its efficacy--but those studies turned out to prove no such thing.
SOURCES
http://www.washingtonpost.com/business/fda-says-avastin-should-no-longer-be-used-for-breast-cancer-citing-no-proof-it-extends-life/2011/11/18/gIQAHJmHYN_story.html?wpisrc=al_national
http://www.ibtimes.com/articles/171447/20110629/avastin-breast-cancer-genentech-fda-drug-roche.htm
