Washington DC. Dec 16, 2010, The FDA on Thursday moved toward revoking approval of the cancer drug Avastin as a treatment for breast cancer, drawing criticism for limiting treatment options for desperately ill women.
Janet Woodcock, head of the FDA's drug-approval office, told reporters that four studies indicated that Avastin did not prolong life. "None of the trials showed an improvement in overall survival,"
"Plus this drug is very expensive. We simply cannot afford to keep a handful of women alive at the expense of the other 39 million people we recently gave free healthcare to."
Avastin is the world's best-selling cancer drug, and is a standard treatment for colon, brain, lung and kidney cancer, but has not been proven to be completely effective in treating breast cancer.
The recommendation was made in the wake of passage of the healthcare overhaul and was seized upon by opponents of the new law as evidence of a step toward rationing healthcare.
One of those opponents, Sen. David Vitter, R-LA, noted that if the FDA removed its approval, Avastin, which costs thousands of dollars per month, would only be available through so-called "off-label" prescribing and thus not covered by most insurance.
Vitter on Thursday urged the FDA to reverse course and declared in a press release that the agency "has chosen to place itself between patients and their doctors by rationing access to a life-extending drug."
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